title-216•216-RICR — Department of Health
# 216-RICR — Department of Health
## **Chapter 10** Public Health Administration
### **Subchapter 05** Practices and Procedures
#### **216-RICR-10-05-1** Access to Public Records
##### **216-RICR-10-05-1 § 1.1** Authority {#sec-216-ricr-10-05-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-1#1.1}
These regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws Chapter 38-2, for the purpose of establishing the procedures and methods for obtaining access to public records of the Rhode Island Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-1 § 1.2** Definitions {#sec-216-ricr-10-05-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-1#1.2}
A.When used in these regulations, the following words and terms, except as otherwise required by the context, shall have the following meaning:
1.“Act” means R.I. Gen Laws Chapter 38-2 entitled “Access to Public Records.”
2."Department" means the Rhode Island Department of Health.
3."Director" means the Director of the Department of Health or her/his designee.
4.“Public record” or “public records” means all documents, papers, letters, maps, books, tapes, photographs, films, sound recordings, magnetic or other tapes, electronic data processing records, computer stored data (including electronic mail messages, except specifically for any electronic mail messages of or to elected officials with or relating to those they represent and correspondence of or to elected officials in their official capacities) or other material regardless of physical form or characteristics made or received pursuant to law or ordinance or in connection with the transaction of official business by any agency.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-1 § 1.3** General Provisions {#sec-216-ricr-10-05-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-1#1.3}
1.3.1 Public Records Policy
The Department recognizes both the public’s right to access public records and the individual’s right to dignity and privacy. It is the Department’s policy to facilitate public access to all public records as defined in accordance with the Act. It is also the policy of the Department to make all public records in the Department’s possession available for public inspection and copying consistent with applicable state or federal law, unless otherwise prohibited by a court of competent jurisdiction.
1.3.2 Exclusions
A. Categories of records specifically excluded pursuant to R.I. Gen. Laws § 38-2-2(4) shall not be deemed public records for the purpose of these Regulations.
B. Treatment of segregable portions of public records is pursuant to R.I. Gen. Laws § 38-2-3(b).
1.3.3Non-applicability
Records requested by subpoena or a government oversight committee are not considered requests “for access to public records.” Therefore, this Part is not applicable to those requests.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-1 § 1.4** Access to Public Records {#sec-216-ricr-10-05-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-1#1.4}
1.4.1 Public Records
All public records of the Department shall be open for public inspection, in accordance with provisions of R.I. Gen. Laws § 38-2-3, and in accordance with the policy established in § 1.4.6 of this Part.
1.4.2 Procedures for Requesting Public Records
A.The Department has instituted the following procedures for members of the public to obtain public records:
1. A written request is not required for records available pursuant to the Act or other documents prepared for or readily available to the public. Members of the public can request public records from the Department by accessing the Department's website: http://www.health.ri.gov/records/about/requests, or by contacting the Department’s Office of Legal Services, which is the Department’s designated public records unit. The mailing address is: Department of Health, Office of Legal Services, 3 Capitol Hill, Providence, RI 02908.
2.You are not required to provide identification or the reason you seek the information. Your right to access public records will not depend upon providing identification or reasons.
3. In order to assure that the Department is able to respond to the request as efficiently and as completely as possible, the request should identify and describe the records being requested with as much specificity as possible. If the description of records being requested is not sufficient to allow the Department to identify and locate the requested records, the Department will notify the person requesting such records that additional information is needed in order to properly respond to the request.
4.Copies of public records will be provided electronically, by facsimile or by mail in accordance with the requestor’s choice, unless complying would be unduly burdensome due to the volume of records requested or the costs that would be incurred. The requestor is responsible for the actual cost of delivery, if any.
5.The timeframes for the Department's response are pursuant to R.I. Gen. Laws § 38-2-3(e).
6. Any denial of access to records, in whole or in part, will be provided through a written response to the requestor indicating the reasons for the denial of access to records or for the denial of certain information contained in a record that is otherwise public pursuant to R.I. Gen. Laws § 38-2-2. The written response will also include the process for appeals outlined in R.I. Gen. Laws § 38-2-8.
7.Any individual who receives a denial for copies of requested records or the ability to inspect records may petition the Director for a review of the determinations. The Director shall make a final determination whether or not to allow public inspection within ten (10) business days. If the denial is confirmed, the individual may file a complaint with the Office of the Attorney General, who will then investigate and make a determination pursuant to R.I. Gen. Laws § 38-2-8. The individual may also file a lawsuit in Superior Court pursuant to R.I. Gen. Laws § 38-2-9.
1.4.3 Copy of Official Publications and Rules and Regulations
Official publications which the Department prepares in the discharge of its duties to inform the public on matters of public interest shall be furnished free of charge when available. The Department shall supply one (1) copy of its rules and regulations, on a particular subject, to an individual requesting the same, free of charge. Electronic copies of the rules and regulations promulgated by the Department are also available on the Office of the Secretary of State website [http://www.sos.ri.gov/rules/]. Certified copies of Department regulations may also be obtained from the Office of the Secretary of State.
1.4.4 Fee for Records
A.The Department charges a fee for copying and/or search and retrieval of requested documents consistent with applicable state law.
1. The costs for copying and/or search and retrieval of documents is pursuant to R.I. Gen. Laws § 38-2-4.
2. Upon request, the Department will provide the requester with an estimate of the copying costs and search and retrieval costs prior to responding to the request. The Department however, will charge the actual fees for the number of copies and the actual cost for search and retrieval time if those are more or less than estimated.
3. The Department reserves the right to require a deposit of the estimated costs if the estimated costs are fifty dollars ($50.00) or more.
4. Department personnel or, where applicable an outside copy service, will make copies of requested records. The Department does not have a copy machine available for use by the public to make copies.
1.4.5 Payment in Advance
The cost of copying and search and retrieval as provided in § 1.4.4 of this Part must be paid in advance of or at the time of delivery or inspection of the requested documents.
1.4.6 Hours of Inspections
A. When a request is made to inspect public records, the requester will be advised when the records are available and he/she can then make an appointment to inspect those documents at the Department between the hours of 8:30 a.m. and 3:30 p.m. Monday through Friday.
B. The time frame for the Department to respond to requests to inspect public records is the same as the time frame applicable to responding to requests for copies of public records as set forth in § 1.4.2 of this Part.
1.4.7 Supervision of Inspections
No records shall be removed from the location of inspection by the requestor. The inspection of public records must be accomplished in a manner which will provide for general supervision by authorized Departmental staff. This is necessary to prevent the misplacement or unauthorized removal of records or any other action which may impair the integrity of the public record.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 04/30/2018 Click here to view previous versions of this Part.*
#### **216-RICR-10-05-2** Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health
##### **216-RICR-10-05-2 § 2.1** Authority {#sec-216-ricr-10-05-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.1}
A.These Regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws §§ 23-1-3(b), 23-1-17, and 23-1-54, and are for the purpose of establishing the specific licensing, laboratory or administrative fees contained in the individual statute(s) cited in this Part.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.2** Definitions {#sec-216-ricr-10-05-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1."Department" means the Rhode Island Department of Health.
2."Director" means the Director of the Rhode Island Department of Health or their designee.
3."License" means an authorization granted by the Department to engage in a business or occupation that is subject to regulations by the Department. For the purpose of this Part, a registration, certification, permit or similar authorization issued by the Department is also considered to be a license.
4.“Private well water supply” means a source of well water used for human consumption and which is not a Public Water System.
5.“Public water system” means a system for the provision to the public of piped water for human consumption, provided such system has at least fifteen (15) service connections or regularly serves an average of at least twenty-five (25) individuals daily at least sixty (60) days out of the year, pursuant to Part 50-05-1 of this Title.
6.“State health laboratories” means the State Health Laboratories maintained by the Rhode Island Department of Health.
7.“Well water” means water that is taken from below the ground through piping or similar installed devices utilizing external force or vacuum.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.3** Applicability and Scope {#sec-216-ricr-10-05-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.3}
A.This Part is promulgated to establish a consolidated fee schedule for licensing, laboratory and administrative services provided by the Department.
B.The provisions of this Part are in addition to, and not in substitution for, other licensing Rules and Regulations promulgated by the Director pursuant to authority conferred by applicable R.I. Gen. Laws statutes.
1.Nothing in this Part shall be construed as requiring the use of the State Health Laboratories where other clinical laboratories, licensed by the Department pursuant to R.I. Gen Laws § 23-16.2-4(a), are available to perform the requested laboratory services.
2.Nothing in this Part shall be construed as requiring the use of the State Health Laboratories where other analytical laboratories, licensed by the Department pursuant to R.I. Gen Laws § 23-16.2-4.1, are available to perform the requested laboratory services.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.4** Designation of Certain Clinical Tests as a Covered Benefit {#sec-216-ricr-10-05-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.4}
A.Pursuant to the authority conferred by R.I. Gen. Laws § 23-1-3(c), the clinical tests listed in § 2.15 of this Part have been designated by the Director as a covered benefit and shall be reimbursable by all health insurers, as defined in R.I. Gen. Laws § 27-38.2-2(4), providing health insurance coverage for specific diseases, hospital indemnity Medicare supplements, or other supplemental policies. The charges for those testing programs shall be borne by the hospitals or other licensed healthcare providers and facilities in the absence of a third (3rd) party payor.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.5** Fees for Lead Poisoning Screening {#sec-216-ricr-10-05-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.5}
A.The fee for any lead poisoning screening or lead screening-related services provided by the State Health Laboratories shall be determined on the basis of rates paid by the healthcare insurers to private laboratories for blood lead analysis.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.6** Licensing, Laboratory and Administrative Services Fees {#sec-216-ricr-10-05-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.6}
A.The fees for licensing, laboratory and administrative services performed by the Department are contained in §§ 2.9 through 2.18 of this Part as follows:
1.§ 2.9 – Health Professions
2.§ 2.10 – Health Facilities
3.§ 2.11 – Food Protection
4.§ 2.12 – Drinking Water Quality
5.§ 2.13 – Asbestos, Lead and Radon
6.§ 2.14 – Radioactive Materials, X-Ray and Tanning
7.§ 2.15 – Clinical Laboratory Services Provided by the State Health Laboratories
8.§ 2.16 – Analytical Laboratory Services Provided by the State Health Laboratories for Private Well Water Supplies and Other Substances of Public Health Concern
9.§ 2.17 – Vital Records, Newborn Screening Program, Certificate of Need and Medical Examiner
10.§ 2.18 – Miscellaneous
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.7** Payment of Fees {#sec-216-ricr-10-05-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.7}
A.Unless otherwise specified in this Part, payment for all licensing, laboratory and administrative services performed by the Department shall be non-returnable and non-refundable and shall be in the form of a check or money order made payable to the General Treasurer, State of Rhode Island.
B.Payment for all clinical laboratory services, including all screening for lead poisoning and lead screening-related services, performed by the State Health Laboratories shall be submitted to the Department within thirty (30) days of receipt of the invoice or other period of time agreed to by the Department.
C.Payment for all testing of private well water supplies performed by the State Health Laboratories shall be prepaid. The testing fee(s) shall be submitted at the time the sample is forwarded to the State Health Laboratories.
D.The application/initial licensure fee established in this Part shall be submitted in accordance with the requirements specified in the Regulations governing the profession and/or activity for which the license application is being submitted.
E.All license and renewal fees in this Part are specified on a license cycle basis. Consequently, license categories common to more than one (1) profession [e.g., Controlled Substances Registration (CSR)] will be assessed on an annualized fee basis x the number of years in the license cycle.
F.The applicable renewal fee established in this Part shall be submitted prior to the expiration date of the current license. Failure to submit the applicable renewal fee prior to the expiration date of the current license may subject the licensee to assessment of a late fee, as established by this Part, as well as additional administrative sanctions specified in the Regulations governing the profession and/or activity for which the license was issued.
G.When online renewal is available for a license, payment shall be made in any of the forms designated on the renewal website.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.8** Compliance and Severability {#sec-216-ricr-10-05-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.8}
A.All hearings and reviews required under this Part shall be held in accordance with the provisions of Part 4 of this Subchapter.
B.If any provision of this Part or the application thereof to any person or circumstances shall be held invalid, such invalidity shall not affect the provisions or applications of this Part which can be given effect, and to this end of the provisions of this Part is declared to be severable.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.9** Health Professions Fees {#sec-216-ricr-10-05-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.9}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.10** Health Facilities Fees {#sec-216-ricr-10-05-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.10}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.11** Food Protection Fees {#sec-216-ricr-10-05-2-2.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.11}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.12** Drinking Water Quality Fees {#sec-216-ricr-10-05-2-2.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.12}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.13** Asbestos, Lead, and Radon Fees {#sec-216-ricr-10-05-2-2.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.13}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.14** Radioactive Material, X-Ray, and Tanning Fees {#sec-216-ricr-10-05-2-2.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.14}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.15** Fees for Clinical Laboratory Services Provided by the State Health Laboratories {#sec-216-ricr-10-05-2-2.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.15}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.16** Fees for Analytical Laboratory Services Provided by the State Health Laboratories for Private Well Water Supplies and Other Substances of Public Health Concern {#sec-216-ricr-10-05-2-2.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.16}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.17** Vital Records, Newborn Screening Program, Certificate of Need and Medical Examiner Fees {#sec-216-ricr-10-05-2-2.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.17}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
##### **216-RICR-10-05-2 § 2.18** Miscellaneous Fees {#sec-216-ricr-10-05-2-2.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-2#2.18}
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Amendment — effective from 2025-05-14 to 03/25/2026*
- *Amendment — effective from 2024-12-02 to 05/14/2025*
- *Amendment — effective from 2024-01-31 to 12/02/2024*
- *Amendment — effective from 2023-06-08 to 01/31/2024*
- *Amendment — effective from 2022-07-31 to 06/08/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/31/2022*
- *Amendment — effective from 2021-02-03 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-08-19 to 02/03/2021*
- *Amendment — effective from 2019-01-01 to 08/19/2021*
- *Amendment — effective from 2018-05-15 to 01/01/2019*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-05-15 to 05/15/2018*
- *Amendment — effective from 2018-01-01 to 05/15/2018*
- *Amendment — effective from 2017-01-03 to 01/01/2018*
- *Amendment — effective from 2015-11-23 to 01/03/2017*
- *Amendment — effective from 2015-06-01 to 11/23/2015*
- *Technical Revision — effective from 2015-03-05 to 06/01/2015*
- *Amendment — effective from 2015-03-05 to 03/05/2015*
- *Amendment — effective from 2015-01-27 to 03/05/2015*
- *Amendment — effective from 2014-10-23 to 01/27/2015*
- *Amendment — effective from 2014-08-12 to 10/23/2014*
- *Amendment — effective from 2014-04-23 to 08/12/2014*
- *Technical Revision — effective from 2013-12-16 to 04/23/2014*
- *Amendment — effective from 2013-12-16 to 12/16/2013*
- *Adoption — effective from 2012-12-10 to 12/16/2013*
#### **216-RICR-10-05-3** Equal Access to Justice
##### **216-RICR-10-05-3 § 3.1** Authority {#sec-216-ricr-10-05-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-3#3.1}
These regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws Chapter 42-92, for the purposes of providing equal access to justice for small businesses and individuals and governing the application and award of reasonable litigation expenses to qualified parties in adjudicatory proceedings conducted by the Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-14 to 01/04/2022*
- *Amendment — effective from 2018-05-15 to 04/14/2020*
- *Periodic Refile — effective from 2002-01-02 to 05/15/2018*
##### **216-RICR-10-05-3 § 3.2** Definitions {#sec-216-ricr-10-05-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-3#3.2}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 42-92 entitled “Equal Access to Justice for Small Businesses and Individuals.”
2.“Adjudicative officer" means the deciding official without regard to whether the official is designated as an administrative law judge, hearing officer, examiner, or otherwise, who presided at the adjudicatory proceeding.
3."Adjudicatory proceeding" means any proceeding conducted by, or on behalf of, the Department, whether administratively or quasi-judicially, that may result in: the loss of benefits; the imposition of a fine; or the denial, probation, suspension, or revocation of a license, registration, certification, or permit; or that may result in a party being compelled to perform an act or restricted from performing an act.
4."Department" means the Rhode Island Department of Health, any agent thereof, and any board or commission lodged therein.
5."Party" means any individual whose net worth is less than five hundred thousand dollars ($500,000) at the time the adjudicatory proceeding was first initiated; and any individual, partnership, corporation, association, or private organization doing business and located in the state, which is independently owned and operated, not dominant in its field, and which employs one hundred (100) or fewer persons at the time the adjudicatory proceeding was initiated.
6."Reasonable litigation expenses" means those expenses which were reasonably incurred by a party in an adjudicatory proceeding, including but not limited to, attorney's fees, witness fees of all necessary witnesses, and other costs and expenses as were reasonably incurred, except that:
a.The award of attorney's fees must conform to the requirements set forth in the Act; and
b.No expert witness may be compensated at a rate in excess of the highest rate or compensation for experts paid by the Department.
7."Substantial justification" means that the initial position of the Department, as well as the Department's position in the adjudicatory proceeding, have reasonable bases in law and fact.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-14 to 01/04/2022*
- *Amendment — effective from 2018-05-15 to 04/14/2020*
- *Periodic Refile — effective from 2002-01-02 to 05/15/2018*
##### **216-RICR-10-05-3 § 3.3** Procedures Governing Applications for Awards of Reasonable Litigation Expenses {#sec-216-ricr-10-05-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-3#3.3}
A.All claims for an award of reasonable litigation expenses shall be made on forms provided by the Department and shall be filed with the adjudicative officer within thirty (30) days of the date of the conclusion of the adjudicatory proceeding which gives rise to the right to recover such an award. The adjudicatory proceeding shall be deemed to be concluded as of the date:
1.The adjudicative officer renders a written ruling or decision in connection therewith;
2.The Department terminates or disposes of it; or
3.Any other act occurs that brings finality to it.
B.The adjudicative officer may, in his or her discretion, permit a party to file a claim after the filing deadline provided in § 3.3(A) of this Part upon a showing of proof and finding by such adjudicative officer that good and sufficient cause exists for allowing a claim to be so filed.
C.All claims filed hereunder shall be submitted on the approved application form pursuant to § 3.3(A) of this Part. All claims must be delivered to the adjudicative officer no later than thirty (30) days from the date of the conclusion of the adjudicatory proceeding. Such claims must contain the following information:
1. A summary of the legal and factual bases for filing the claim;
2. A list of witnesses, if any, that the claimant expects to call to substantiate the claim if a separate hearing on said claim is conducted by the Department;
3. A detailed breakdown of the reasonable litigation expenses incurred by the party in the adjudicatory proceeding, including copies of invoices, bills, affidavits, or other documents, all of which may be supplemented or modified at any time prior to the issuance of a final decision on the claim by the adjudicative officer; and
4. A sworn affidavit attesting to the accuracy and truthfulness of the statements and information contained in the claim, and/or filed in support thereof. In this affidavit, the claimant must also attest that the legal fee time amounts were contemporaneously kept and that attempts were made to minimize the time spent.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-14 to 01/04/2022*
- *Amendment — effective from 2018-05-15 to 04/14/2020*
- *Periodic Refile — effective from 2002-01-02 to 05/15/2018*
##### **216-RICR-10-05-3 § 3.4** Allowance of Awards {#sec-216-ricr-10-05-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-3#3.4}
A.Whenever a party prevails in an adjudicatory proceeding, an award shall be made to such party of reasonable litigation expenses actually incurred in connection with that proceeding; provided that:
1.Such party has satisfied the requirements of § 3.3 of this Part; and
2.The adjudicative officer has determined that the Department did not have substantial justification.
B.The decision of the adjudicatory officer to make an award shall be made a part of the record, shall include written findings and conclusions with respect to the award, and shall be sent to the claimant, unless same is represented by an attorney, in which case, the decision will be sent to the attorney of record.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-14 to 01/04/2022*
- *Amendment — effective from 2018-05-15 to 04/14/2020*
- *Periodic Refile — effective from 2002-01-02 to 05/15/2018*
##### **216-RICR-10-05-3 § 3.5** Disallowance of Awards {#sec-216-ricr-10-05-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-3#3.5}
A.No award of fees or expenses may be made if the adjudicative officer finds that the Department had substantial justification. Any action initiated as the result of a statutorily-mandated complaint shall be deemed to have substantial justification for the investigation of that complaint and the adjudicatory proceeding subsequent to the investigation of that complaint.
B.A claim for fees or expenses shall be denied if the party is not actually the prevailing party.
C.The adjudicative officer may, at his or her discretion, deny fees or expenses if special circumstances make an award unjust. An explanation of the special circumstances precluding fees and expenses shall be included in the adjudicative officer’s decision.
D.Whenever the adjudicative officer finds reasonable grounds to do so, he or she may recalculate the amount to be awarded to the prevailing party, without regard to the amount claimed to be due on the application for an award.
E.Notice of the decision disallowing an application for an award of fees and expenses shall be sent to the party by the Department via mail; provided, however, that if the party is represented by an attorney, said notice shall be sent to the attorney of record.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-14 to 01/04/2022*
- *Amendment — effective from 2018-05-15 to 04/14/2020*
- *Periodic Refile — effective from 2002-01-02 to 05/15/2018*
##### **216-RICR-10-05-3 § 3.6** Appeals {#sec-216-ricr-10-05-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-3#3.6}
Any appeal of a fee determination under this Part shall be pursued as set forth in R.I. Gen. Laws § 42-92-5.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-14 to 01/04/2022*
- *Amendment — effective from 2018-05-15 to 04/14/2020*
- *Periodic Refile — effective from 2002-01-02 to 05/15/2018*
#### **216-RICR-10-05-4** Practices and Procedures Before the Rhode Island Department of Health
##### **216-RICR-10-05-4 § 4.1** Authority {#sec-216-ricr-10-05-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapter 42-35 for the purpose of establishing uniform procedures and practices governing administrative proceedings before the Department of Health and all boards, councils, and commissions therein.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.2** Definitions {#sec-216-ricr-10-05-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.2}
A.When used in these Rules, the following words and or terms, except as otherwise required by the context, shall have the following meaning:
1."Act" means R.I. Gen. Laws Chapter 42-35.
2."AHO" means the Administrative Hearing Officer authorized by law or duly designated by the Director and/or Board, to hear and decide, or to make a recommended order and/or decision to the Director or Board.
3."Authorized representative" means an attorney, legal guardian or, in the case of fair hearings for the WIC and Children with Special Needs Programs, another person authorized by a party for the WIC and Children with Special Needs Programs, another person authorized by a party to represent her/him in an Administrative Proceeding.
4."Board" means any of the various boards, committees, councils, and commissions within the Department which offer parties hearings regarding legal rights, duties and/or privileges of those parties.
5."Contested case(s)" means a proceeding, including but not restricted to ratemaking, price fixing, licensing and benefits, in which the legal rights, duties, or privileges of a specific party are required by law to be determined by the Department after an opportunity for hearing. If the parties agree, proceedings not required by law may also be conducted under this Part.
6."Department" means the Rhode Island Department of Health and any Board, Commission, Council or other entity within the Department.
7."Director" means the Director of the Department of Health or her/his designee.
8."Division" means a subsection of the Department with authority to carry out statutorily designated departmental functions.
9."Ex Parte" communications means a discussion, correspondence or contact regarding a contested case between the AHO and a party to a contested case, or a non-party who has an interest in the outcome of the case, without all parties being present to such communication. Communications for the purpose of scheduling and other administrative functions shall not be considered ex parte.
10."License" means the whole or part of any Department license, permit, certificate, approval, registration, charter or similar form of permission required by law.
11."Licensing" means the agency process respecting the grant, denial, renewal, revocation, suspension, annulment, withdrawal, or amendment of a license.
12."Party" or "Parties" means the specifically named person(s) whose legal rights, duties or privileges are being determined in an adjudicatory proceeding, or who are admitted as a party, or properly seeking and entitled as of right to be admitted as a party in a contested case, or intervenors which may be otherwise admitted.
13."Person" means any individual, partnership, corporation, limited liability company, association, governmental subdivision, public or private organization of any character, or their designee(s), but does not include the Department.
14."Petitioner" means an individual or legal entity(ies) who initiates a petition which results in an administrative proceeding
15."Regular business hours" means between the hours of 8:30 A.M. to 4:30 P.M., Monday through Friday, excluding State holidays. Filing by telecopier or facsimile is prohibited unless specifically allowed prior to such filing.
16."Respondent" means a party who is the subject of a complaint and/or department investigation or any others not bearing the burden of proof.
17."Rule(s)" and/or "Regulation(s)" means each Department statement of general applicability that implements, interprets, or prescribes law or policy or describes the organization, procedure, or practice requirements of the Department. The term includes the amendment or repeal of a prior Rule, but does not include:
a.Statements concerning only the internal management of an agency and not affecting private rights or procedures available to the public; or
b.Declaratory rulings issued pursuant to R.I. Gen. Laws § 42-35-8;
c.Intra-Department memoranda; or
d.An order.
18."Rule making proceeding" means a proceeding before the Department for purposes of adopting, amending or repealing any Rule or Regulation of the Department.
19."Sua sponte" means of their own will or motion, without prompting or suggestion.
20."Subpoena" means a process whereby a witness is commanded to appear and give testimony.
21."Subpoena duces tecum" means a process whereby a witness is commanded to produce documents and/or papers.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.3** Scope {#sec-216-ricr-10-05-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.3}
This Part delineates the procedures and practices which will be utilized by the Department and all Boards and commissions established therein. All hearings and reviews required by law or Regulations shall be conducted in accordance with this Part and with applicable provisions of R.I. Gen. Laws Chapter 42-35.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.4** Representation {#sec-216-ricr-10-05-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.4}
4.4.1Appearance
A.The Department shall inform a party of her/his right to be represented by legal counsel in a contested proceeding.
B.Except as may be otherwise provided by law, or in the sole discretion of the AHO, no person may appear in a representative capacity other than:
1.Members in good standing of the Bar of Rhode Island;
2.A bona fide officer, partner, director, member or full-time employee of an individual firm, association, partnership, limited liability company or corporation on behalf of that entity;
3.A person who is a party to an administrative proceeding or his/her professional engineer, architect, or land surveyor or other designee, as specifically authorized in writing and notarized if the party is not present. In Fair Hearings, involving the WIC or Children with Special Needs programs, a person other than an attorney may represent a party.
4.All persons shall conform to the standards of ethical conduct required of practitioners before the courts of Rhode Island. If any such person does not conform to such standards, the AHO may decline to permit such person to appear in a representative capacity in any proceeding before the AHO.
4.4.2Representative/Attorney Unavailability
A.Absent agreement by the parties, the AHO at his/her sole discretion, for good cause shown, may grant a continuance of an administrative proceeding. For good cause shown, the parties may agree to up to two (2) continuances. Thereafter, any continuance requested may be granted only by the AHO in his/her sole discretion for good cause shown. All requests for continuances pursuant to this section shall be made in writing.
B.Organizations which are parties to an administrative proceeding, and which are not represented by legal counsel, shall designate a spokesperson to participate on their behalf at the proceeding. Should the designated spokesperson be unavailable on a scheduled hearing date, they shall notify the AHO of the specific reason for their unavailability.
C.Spokesperson for parties not represented by counsel, who have a conflict with hearing dates, shall be required to inform the AHO of the specific nature of the conflict and the reason for his/her unavailability.
D.Should the AHO grant a continuance, it shall be the responsibility of the party requesting the continuance to notify immediately all other parties of record and their representatives. The Department shall insure that at the site of the hearing a cancellation notice is posted at the entrance to the facility, said notice to include the date and time of the next scheduled hearing, if known, or the name and telephone number of the person who will be able to provide that information.
E.It shall be the further responsibility of the party requesting the continuance to notify the AHO of any anticipated scheduling conflict as soon as possible.
F.Ex Parte Communications. No person who is a party to or a participant in any proceeding before the Department, or the party's counsel, employee, agent, or any other individual, acting on the party's or their own or another's behalf, shall communicate ex parte with the AHO or the Director about or in any way related to the proceeding, and the AHO and/or Director shall not request or entertain any such ex parte communications. The prohibitions contained above do not apply to those communications which relate solely to general matters of procedure and scheduling.
4.4.3By Present or Former Employees of Department
A.In accordance with R.I. Gen. Laws Chapter 36-14, no person who is currently an employee of the Department may appear personally, or on behalf of, or represent any other person, or act as an expert witness before the Department except in the performance of her/his official duties.
B.Also in accordance with R.I. Gen. Laws Chapter 36-14, no person having been employed at the Department may, within one (1) year after employment has ceased, appear personally, or on behalf of any other person, or act as an expert witness before the Department, unless he/she appears on behalf of the Department.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.5** Time {#sec-216-ricr-10-05-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.5}
A.Timely Filing. Papers required or permitted to be filed under this Part, or any provision of the applicable law, must be filed with the Department or AHO within the time limits for such filings as are set by Department Regulation or by the AHO or established by law. Papers filed in the following manner shall be deemed filed as set forth in this Part:
1.Hand-delivery. Papers hand delivered during regular business hours shall be deemed filed on the date of hand-delivery. Papers delivered by hand at times other than during regular business hours shall be deemed filed on the next regular business day when recorded as received by the Department.
2. Mailing. Papers deposited in the U.S. Mail shall be deemed filed on the date received by the Department. In the event that no date received appears, papers shall be deemed filed on the date so postmarked. All papers shall show the date received by the Department.
3.Electronic Transmission. Papers transmitted by facsimile or email shall not be accepted for filing unless specifically exempted from this provision by the AHO and arrangements made for an authorized person to receive the transmitted papers as they are transmitted.
B.Computation of Time. Unless otherwise specifically provided by law or this Part, computation of any time period referred to in this Part shall begin with the first (1st) day following the act which initiates the running of the time period. The last day of the time period so computed is to be included unless it is a Saturday, Sunday or legal holiday, or any other day on which the Department is closed, in which event the period shall run until the end of the regular business hours of the next following business day. When the time period is less than eleven (11) days, intervening days when the Department is closed shall be excluded in the computation.
C.Extension of Time. It shall be within the discretion of the AHO, for good cause shown, to extend any time limit contained in this Part, unless precluded by statute. All requests for extensions of time shall be made by written motion before the expiration of the original or previously extended time period provided, however, that the AHO may, during hearings, grant such extensions upon oral motion.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.6** Filings Generally {#sec-216-ricr-10-05-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.6}
A.Title. All pleadings and other documents filed with the Department shall, whenever possible, state the file number, if any, the title of the proceeding, and the name of the person on whose behalf the filing is made. Additionally, the name, phone number, and bar numbers, if any, of the persons filing the pleading(s) or document(s) are required on the documents being filed.
B.Signatures. Papers filed with the Department shall be signed and dated by the party on whose behalf the filing is made or by the party's authorized representative. This signature constitutes a certification that the individual has read the document, knows the content thereof, and to the best of her/his knowledge, that such statements are true, that it is not interposed for delay, and that if the document has been signed by an authorized representative she/he has full power and authority to do so. Failure to comply may be cause for sanctions.
C.Designation of Division. Any Department Division which is a party to a contested case shall be designated by its name and not by the name(s) of particular individual(s) holding office, and if while the contested hearing is pending, a change occurs in an individual(s) holding office, the proceeding shall not abate solely for this reason, and no substitution of parties shall be necessary.
D.Form and Size. All papers, except those submittals and documents which are kept in a smaller or larger format during the ordinary course of a party's business, shall be submitted on 8½ x 11 inch paper. All papers shall be hand printed or typewritten.
E.Copies. The original and one (1) copy of all pleadings, motions, briefs and memorandums shall be filed with the Department however, the AHO may deem additional copies to be provided.
4.6.1Service
A.Service Upon Parties. Simultaneously with the filing of any and all papers with the Department, the party filing such papers shall send a copy thereof to all other parties, if any, or their authorized representative to the proceedings, by hand delivery, or first-class US mail to her/his place of business, home address or other address as may be required by applicable law or Regulations. Service by mail is complete upon mailing, even if unclaimed or returned, when sent to the last known address of the party.
B.Certificate of Service. There shall accompany and be included in the original of each pleading filed with the Department a Certificate of Service showing service on all parties.
C.Date of Certificate to Govern. In addition to the provisions in this section, the provisions of § 4.5 of this Part also apply and the time for response to all pleadings shall commence as of the date of mailing the certificate of service.
D.Construction. All pleadings shall be liberally construed and errors or defects therein which do not mislead or affect the substantial rights of the parties involved may be disregarded.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.7** Commencement of Formal Proceedings {#sec-216-ricr-10-05-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.7}
A.Notice. Whenever a proceeding may be initiated as a result of an action taken or proposed to be taken by the Department, Board, or other entity of the Department, a notice shall be sent which shall comply with the requirements set forth under § 4.13(B) of this Part.
B.Request for Hearing. Any person having a right to request a hearing shall follow the procedures set forth in R.I. Gen. Laws Chapter 42-35 and other applicable statutory and regulatory requirements. All requests for a hearing/s shall be on a sheet of 8½ x 11-inch paper; shall be processed in a timely fashion and shall be forwarded to the Department legal counsel no more than ten (10) days after receipt by the Department or any of its divisions.
C.Content of Hearing Request. The request for a hearing shall state clearly and concisely the specific issues which are in dispute, and the facts in support thereof, the relief sought, if any, the license or permit sought or involved, and any additional information required by applicable statutes and Regulations.
D.Amendments and Withdrawal of Pleading. The AHO, upon her/his own initiative or upon the motion of any party, may order any party to file an answer or other pleading, or to reply to any pleading and further permit either party to amend its pleading upon conditions just to all parties.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.8** Motions/General Requirements {#sec-216-ricr-10-05-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.8}
A.Motion Practice. By motion, any party may request of the AHO any order or action not inconsistent with law or this Part. Such a request shall be called a motion. A copy of all written motions shall be served upon all parties to the case.
B.Presentation/Objection to Motions. Motions may be made in writing at any time before or during the hearing, or they may be made orally during the hearing. A written motion submitted before the commencement of a hearing shall set forth the grounds for the desired order or action and state whether oral argument is requested. Within ten (10) business days after a written motion is filed with the AHO, a party opposing said motion must file a written objection to the allowance of the motion and shall, if desired, request oral argument. All motions and objections shall be accompanied by a written memorandum, specifying the legal basis and support of the party's position. Failure to file a written objection within the prescribed time period will be deemed a waiver of the objection.
C.Action on Motion. The AHO may, if she/he determines oral argument on the motion is warranted, give at least five (5) business days' notice of the time and place for such argument. The AHO may grant requests for continuances for good cause shown. The AHO may rule on a motion without a hearing if delay would seriously injure a party, or if the motion involves a matter as to which presentation of testimony or oral argument would not advance the AHO's understanding of the issues involved, or if disposition without a hearing would best serve the public interest. The AHO may act on a motion when all parties have responded thereto, or the deadline for response has passed, whichever comes first.
D.Factual Basis. The parties may offer at a hearing on the motions only such evidence as is relevant to the particular motion in accordance with R.I. Gen. Laws § 42-35-10.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.9** Special Requests {#sec-216-ricr-10-05-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.9}
A.Withdrawals. A petitioner at any time may withdraw his request for hearing, but the withdrawal must be submitted in writing to the AHO and be signed by the petitioner or his authorized representative.
B.Emergency Scheduling. Upon request of a party, the AHO may, for good cause, order an accelerated hearing. Any request for an order accelerating the scheduling of a hearing shall be addressed to the AHO in writing and shall state the grounds therefor.
C.Disqualification of Administrative Hearing Officer. Any party may make a motion to disqualify or remove the AHO from a proceeding. The motion shall be accompanied by an affidavit setting forth the reasons for the proposed disqualification.
D.Other Requests. A request may be made by a party, or his/her authorized representative, in writing at any time, or orally during a hearing, for rulings or relief, and may, after notice to the other parties, be ruled upon by the AHO without a hearing.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.10** Exchange of Information {#sec-216-ricr-10-05-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.10}
A.General. The Department encourages prompt and complete disclosure and exchange of information between the parties to an Administrative Proceeding. Any party may request the names and addresses of all proposed witnesses in accordance with § 4.12 of this Part.
B.Production of Documents and Other Tangible Items. Any party, by written request served upon all other parties, may request the other party to produce for inspection, copying or photocopying a document, object or tangible thing which is relevant to the subject matter of the hearing. Any party wishing to object to such a request shall do so in as timely a manner as is possible prior to the date of the hearing and only after discussing the matter with the opposing party in an attempt to reach an agreement. The AHO in her/his discretion may establish limits on such requests.
C.From Parties. Any party to the proceeding may request an order of the AHO requiring any other party to produce and to make available for inspection, copying or photocopying, at a prehearing conference or other specific time and place, any designated documents and tangible items, not privileged, which constitute or contain relevant evidence. The party seeking production should serve copies of the application on the other party(ies) to the proceeding, who should be given an opportunity to notify the AHO of any objections. The AHO shall order the production of such designated documents and tangible things unless he/she finds there is not good cause for doing so.
D.From Non-parties. Any party to the proceeding may obtain a subpoena requiring a non-party to produce relevant designated documents and tangible items, not privileged, at a pre-hearing conference, at the taking of the non-parties deposition, or at any other specific time and place designated by the AHO.
E.Hearing Delay. No hearing shall be continued to permit the completion of discovery unless prior due diligence is shown.
4.10.1Protective Orders
A.The AHO may, upon motion and for good cause shown, issue an order to protect a party or person from annoyance, embarrassment, oppression, disclosure of proprietary or confidential information, or undue burden or expense.
B.The AHO may, upon motion of a party or another person, and for good cause shown, by order:
1.Restrict or defer disclosure by a party of the name of a witness, a narrative summary of expected testimony of a witness, or in the case of a Department witness, any prior statement of the witness, and
2.Prescribe other appropriate measures to protect a witness.
C.Any party affected by such action will have an adequate opportunity, once she\he learns the name of the witness(s) and obtains the narrative summary of her/his expected testimony, or, in the case of a Department employee witness, her/his prior statement or statements, to prepare for cross-examination and for the presentation of their case.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.11** Intervention and Participation {#sec-216-ricr-10-05-4-4.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.11}
A.Intervention. Any person not initially a party who wishes to intervene or participate in a contested hearing shall file a written petition to intervene or participate with the AHO.
B.Form and Content. The motion shall set forth clearly and concisely the facts from which the nature of the movant's alleged right or interest can be determined, the grounds for the proposed intervention and the position of the movant in the proceeding.
C.Rights of Intervenors. Intervenors shall be persons who have demonstrated an injury in fact which will result from a challenged action or application and whose interests are not adequately represented by other parties to the hearing. Any person permitted to intervene shall be a full party. Every petition to intervene shall be treated in the alternative as a petition to participate.
D.Rights to Participate. Only those persons admitted as parties or intervenors to a proceeding shall be permitted to participate in an administrative proceeding. If the particular statute under which the hearing is held permits persons other than parties to participate, they shall be allowed to participate. Permission to participate, unless otherwise stated, shall not be deemed to constitute an expression that the person allowed to participate is a party in interest who may be aggrieved by any final decision. Participation may be limited to the filing of a brief. If the person allowed to participate is permitted to make a statement on the record, said person shall be under oath and subject to cross examination from any party. The AHO shall set such limits on public participation as she/he deems necessary to ensure that the hearing is held in an orderly and expeditious fashion without undue prejudice to a party. A person who petitioned to intervene and who was denied party status but allowed to participate, may participate without waiving his/her rights to judicial review of the denial of said petition to intervene.
E.Rules of Evidence. The Rhode Island Rules of Evidence shall apply to evidence introduced during public participation to the same extent as the rules apply to evidence admitted by other parties. Testimony and papers submitted by members of the public which do not comport with the evidentiary requirements of R.I. Gen. Laws § 42-35-10 may be accepted, made a part of the record for identification purposes and marked as a public comment; however, if any of the testimony or evidence is utilized to arrive at a decision, there shall be a statement identifying said testimony and or evidence in the decision and or order.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.12** Pre-Hearing Conferences {#sec-216-ricr-10-05-4-4.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.12}
4.12.1Pre-Hearing Conference
A.In any proceeding, the AHO may require the parties to appear for a pre-hearing conference prior to the scheduled commencement of the hearing to consider:
1.The simplification or clarification of the issues;
2.The possibility of obtaining stipulations, admissions, agreements on documents, understanding on matters already of record, or similar agreement which will avoid unnecessary proof;
3.The identification and limitation of; the number of witnesses, expert witnesses and avoidance of similar cumulative evidence, if the case is to be heard;
4.The possibility of agreement disposing of all or any of the issues in dispute; and
5.Consideration of outstanding motions and status of settlement negotiations, if any;
6.Any matters pertaining to exchange of information;
7.Scheduling of hearings and such other matters as may aid in the disposition of the contested hearing or the other matters under consideration.
B.All parties attending the pre-hearing conference shall be fully prepared to discuss all matters involved in the proceedings.
C.The AHO may require the parties to submit the following at the commencement of the prehearing conference:
1.Any stipulations of fact which have been agreed upon in advance;
2.A concise summary of each party's position;
3.A list of exhibits and expert witnesses. Anticipated objections to various exhibits shall be submitted to the AHO no later than five (5) business days prior to the scheduled hearing. Every proposed exhibit to which objection shall be made at hearing shall be marked for identification, and a schedule of those exhibits shall be prepared, along with summary notations of anticipated objections by a party, e.g. "privilege", "authenticity", "hearsay", etc. A party shall not be permitted, except in the discretion of the AHO, to introduce into evidence in said party's direct case exhibits which are not filed in accordance with the order;
4.A list of pending motions which require action prior to the hearing;
5.The names and address of witnesses each party intends to produce in its direct case.
D.Submission Without a Hearing. Any party may elect to waive a hearing and to submit its case upon the record. Submission of a case without a hearing does not relieve the parties from the necessity of providing the facts supporting their burdens, allegations or defenses.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.13** Contested Hearings {#sec-216-ricr-10-05-4-4.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.13}
A.Hearings, When and Where Held. Hearings will be held at a designated location. Any party may, by motion, request that a hearing be held at some place other than that designated, due to disability or infirmity of the party or witness, or where justice and equity would be best served. Upon motion of any party and upon good cause shown, the AHO may in her/his discretion advance or delay a case for hearing.
B.Notice of Hearing. In any contested case, the Department shall give notice of hearing which will apprise interested persons of the opportunity for hearing on the matter in controversy which shall include, at a minimum:
1.The date, time and place of the hearing and/or pre-hearing conference;
2.A statement of the petitioner's right to appear personally, to be represented by counsel or an authorized representative, as permitted by § 4.4 of this Part present at the prehearing conference and/or hearing, and that she/he may respond and present evidence and witnesses and cross examine other witnesses;
3.Sufficient notice of the specific issues involved, the specific sections of statutes and/or rules and regulations involved, the specific violations alleged, and/or the specific reason(s) for denial so that the parties may have a reasonable opportunity to prepare and present evidence and argument regarding the allegations and/or denial. If the information stated in this paragraph cannot be fully stated in advance of the hearing, the information shall be fully stated as soon as practicable. In all cases of a delayed issues statement, or where subsequent amendment of the issues is necessary, sufficient time shall be allowed, at the discretion of the AHO, after full statement or amendment to afford all parties reasonable opportunity to prepare and present evidence and argument respecting the issues;
4.A statement that notwithstanding failure to appear at a scheduled hearing, absent good cause, the AHO will proceed with the hearing and enter an order based upon the evidence presented;
5.The notice of hearing must set forth the requirements for intervention as outlined in § 4.11 of this Part.
C.General. Hearings may be as informal as may be reasonable and appropriate under the circumstances, and except as otherwise provided by law, all hearings shall be open to the public.
D.Decorum. All parties, authorized representatives, witnesses, and other persons present at a hearing shall conduct themselves in a manner consistent with the standards of decorum commonly observed in any statewide Rhode Island court. Where such decorum is not observed, the AHO may take appropriate action which includes ejectment or adjournment, if necessary.
E.Duties of Administrative Hearing Officer. The AHO shall:
1.Conduct the hearing;
2.Make all decisions regarding admission or exclusion of evidence or any other procedural matters;
3.Administer an oath or affirmation to all witnesses or ask the stenographer to do so;
4.Submit a decision and/or order after due consideration of the hearing record, and only the hearing record, and matters noted on the record;
5.Not communicate with any employee involved with the administration of a matter, or with any Board member empowered by law to adjudicate a matter, regarding any decision or order, or any proposed decision or order, excepting on the record with all parties present;
6.Participate in the proceedings to ensure that the hearing proceeds in an orderly and expeditious fashion and to ensure evidence sufficient to determine the facts are on the record;
7.Question any party or witness for the purpose of clarifying her/his statement and or the AHO's understanding or to clarify the record. This subsection is not intended to change the provisions of this Part regarding parties not appearing, without good cause, at a scheduled hearing where evidence may be admitted with some party(ies) not present.
4.13.1Order of Proceedings
A.Opening. Except as otherwise required by law, it shall be the usual practice that in proceedings initiated by an application for a license or permit, the party bearing the burden of proof shall open. The opposing party or parties may make an opening statement immediately after the opening statement by the party bearing the burden of proof.
B.Discretion of AHO. Where evidence is peculiarly within the knowledge of one (1) party, or in cases in which contested hearings have been consolidated, or where there are multiple parties, the AHO may direct who shall open and shall designate the order of presentation.
4.13.2Presentation
A.Rights of Parties. All parties shall have the right to present evidence, cross examine witnesses, make objections, bring motions and make oral arguments. Whenever appropriate, the AHO shall permit further examination as she/he deems necessary.
B.Default. If any party to a proceeding fails to answer a complaint and appear at a hearing, or otherwise fails to defend an action as provided by these Rules, the AHO may hear and receive evidence and enter a judgment, or take other such action, based upon the pleadings and or evidence submitted by the non-defaulting party(ies), as the AHO deems appropriate.
4.13.3Witnesses and Evidence
A.Witnesses
1.All witness testimony shall be under oath or affirmation.
2.A party may conduct cross examination required for a full and true disclosure of the facts.
3.Witnesses may be excluded from the hearing room upon motion of any party.
4.Protective orders may be issued for witnesses for good cause shown.
5.If an interpreter is used to assist a witness giving testimony, the interpreter's understanding is the final word of the witness. The interpreter shall be considered an expert for purposes of translation.
6.If a witness refuses to answer questions under cross-examination, the AHO may strike her/his direct testimony from the record.
B.Rules of Evidence
1.In contested cases, the Rhode Island Rules of Evidence as applied in civil cases in the Superior Courts of this State shall govern. Irrelevant, immaterial or unduly repetitious evidence shall be excluded in all proceedings wherein evidence is taken.
2.While the Rhode Island Rules of Evidence as applied to civil cases in the Superior Courts of this State shall be followed to the extent practicable, the AHO shall not be bound by technical evidentiary Rules. Evidence not otherwise admissible may be admitted, unless precluded by statute, when necessary to ascertain facts not reasonably susceptible of proof under the Rules, if it is of a type commonly relied upon by reasonably prudent persons in the conduct of their affairs. The rules of privilege recognized by law shall apply.
3.Objections to evidentiary offers may be made and shall be noted on the record. Parties objecting to the introduction of evidence shall state the precise grounds of such objection at the time such evidence is offered. When objection is made to the admissibility of evidence, such evidence may be received subject to a later ruling. The AHO may, in her/his discretion, either with or without objection, exclude inadmissible or cumulative evidence.
4.In all cases where evidence is taken, documentary evidence may be received in the form of copies or excerpts, if the original is not readily available. Upon request, parties shall be given an opportunity to compare the copy with the original.
5.When portions only of a document are to be relied upon, the offering party shall prepare the pertinent excerpts, together with a statement indicating the purpose for which such materials will be offered, to the AHO and to the other parties. Only the excerpts, so prepared and submitted, shall be received in the record. However, the whole of the original document shall be made available for examination and for use by all parties to the proceeding, and where appropriate, admitted into evidence.
C.Offer of Proof. An offer of proof made in connection with an objection taken to a ruling of the AHO rejecting or excluding proffered testimony shall consist of a statement and substance of the evidence which the party contends would be adduced by such testimony, if the excluded evidence consists of evidence in documentary or written form, or of reference to documents or records, a copy of such evidence shall be marked for identification and shall constitute the offer of proof.
D.Written Testimony. The AHO may order the parties to file, where practicable, prior to the commencement of any hearing, the testimony of any or all of their respective witnesses and to submit such testimony to the AHO and the opposing party or the opposing counsel by such date as the AHO shall determine. The witness shall testify under oath, and all of such testimony shall be in a question and answer format. Save for good cause shown, said testimony shall be the direct examination of said witness; provided, however, that said witness shall be available at the hearing for cross examination by the opposing party or opposing counsel.
E.Documentary Evidence in Advance. Where practicable, the AHO may require:
1.That all documentary evidence which is to be offered during the taking of evidence be submitted to the AHO and the other Parties to the proceeding sufficiently in advance of such taking of evidence to permit study and preparation or cross examination and rebuttal evidence;
2.That documentary evidence not submitted in advance, as may be required by subdivision above, may not be received in evidence in the absence of a clear showing that the offering party had good cause for their failure to produce the evidence sooner;
3.That the authenticity of all documents submitted in advance in a proceeding in which such submission is required, be deemed admitted unless written objection thereto is filed prior to the hearing, except that a party will be permitted to challenge such authenticity at a later time upon a clear showing of good cause for failure to have filed such written objection.
F.Evidence Included. All evidence, including any records, investigative reports, documents, and stipulations must be offered and made a part of the record. Documentary evidence may be received in evidence in the form of copies or excerpts.
G.Administrative Notice. The AHO may take notice of any fact which may be judicially noticed by the courts of this State, or of general, technical or scientific facts within the AHO's specialized knowledge, only if the parties are notified of the material so noticed and are given an opportunity to contest the facts so noticed. Notice may also be taken of properly adopted Rules and Regulations adopted by the Department and other agencies of this State or Federal Government. The AHO's experience, technical competence and specialized knowledge may be utilized in the evaluation of the evidence. The burden is on the party requesting the AHO's administrative notice to produce the documents or other matter for the AHO's review.
H.Subpoenas. Pursuant to the provisions of R.I. Gen. Laws §§ 21-28-3.25 and 2-1-11, and/or under any other applicable statute, in all cases of any nature before the Department, the AHO or other official authorized by law, may issue subpoenas requiring the attendance and testimony of witnesses and to compel the production and examination of papers, books, accounts, documents, records, certificates and other legal evidence that may be necessary or proper for the determination and decision of any question before or the discharge of any duty required by law of the said AHO.
1.Signature Required. All subpoenas and subpoena duces tecum shall be signed by the AHO, or other person authorized by law to sign subpoenas, and shall be served as required by law.
2.Motion to Vacate or Modify. Any person to whom a subpoena is directed may, within a five (5) business day period, file in writing a motion that the subpoena be vacated or modified. The AHO may grant such motion in whole or in part, upon a finding that the testimony, or the evidence, whose production is requested, does not relate with reasonable directness to any matter in question, or upon a finding that a subpoena for attendance of a witness or the production of documents or evidence is unreasonable or oppressive, or has not been issued a reasonable period in advance of the time when the evidence is requested or for other good and sufficient cause. The AHO may, sua sponte, or on motion of any of the parties or witnesses, issue such protective orders, grant such motions to quash, and grant such other motions as justice or fairness may require.
3.Contumacy. In cases of contumacy or refusal to obey the command of the subpoena so issued, the AHO or the Department may make application to the Superior Court for an order to show cause why the disobeying Person shall not be held in contempt and for such further relief as may be appropriate.
I.Transcript of Proceedings.
1.Recording and Transcripts. A complete record of the testimony and argument at the hearing shall be either stenographically or electronically recorded. Transcripts of the proceedings shall be supplied to any party at her/his own expense upon request to the stenographer.
2.Correction of Transcript. Corrections in the official transcript may be made only to make it conform to the evidence presented at the hearing. Transcript corrections, agreed to by opposing parties, may be incorporated into the record, if and when approved by the AHO, at any time during the hearing, or after the close of evidence. The AHO may call for the submission of proposed corrections and may make disposition thereof at appropriate times during the course of the proceeding.
J.Close of Proceedings. At the conclusion of the evidence, the AHO may, in her/his discretion, permit the parties to argue orally or to submit written briefs. The AHO may, within her/his discretion, direct that proposed findings of fact and conclusions of law be submitted by the parties. The record of the proceeding shall close after oral argument, or after the deadline for filing of the briefs, or upon such date as may be set by the AHO.
K.Contents of Records. The record shall, at all reasonable times, be available for inspection by the parties. Confidential, proprietary, or trade secret information including information qualifying as a non-public record under R.I. Gen. Laws § 38-2-2(4) shall, upon motion of a party and for good cause shown, be received at a closed hearing and not be released for public scrutiny. Any such evidence received on a confidential basis shall not be subject to disclosure for purposes of R.I. Gen. Laws Chapter 38-2. The AHO may take all steps reasonably necessary to preserve any confidential, proprietary or trade secret information and to keep the same secret and confidential from the general public. The record of every contested case shall include the hearing notice, all pleadings, motions, all rulings, exhibits, evidence considered, statements of matters officially noted, proposed findings of fact and law and exceptions claimed thereto, decision and/or order, proposed decision and /or order, or report of the AHO.
L.Evidence after Completion. No evidence shall be admitted after completion of a hearing or after a case submitted on the record, unless the AHO reopens the hearing or the parties agree to the submission, and all the parties have been notified of said reopening. No Board shall take evidence, comments, recommendations, summaries, opinions, or any information regarding the case, or participate in any ex parte conversations after the close of a hearing, except that proposed decisions/orders from an AHO who conducted the hearing, which the Board may discuss among themselves only.
M.Weight of Evidence. The weight to be attached to any evidence in the record will rest within the sound discretion of the AHO. The matter is closed after the final decision and order is issued.
N.Exceptions. Formal exceptions to rulings on evidence and procedure are unnecessary. It is sufficient that a party, at the time that a ruling is made or sought, makes known his/her objection to such action and his/her grounds therefore, provided that, if a party has no opportunity to object to a ruling at the time it is made, or to request a particular ruling at an appropriate time, such party within three (3) business days of notification of action taken or refused, shall state his/her objection and the grounds therefor.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.14** Decisions {#sec-216-ricr-10-05-4-4.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.14}
A.Decisions and Orders. All decisions and orders rendered by the AHO shall be in writing, or stated on the record, and shall comply with the requirements of R.I. Gen. Laws § 42-35-12 and shall be made public unless otherwise restricted by law. Every final decision and order shall contain findings of fact and conclusions of law as necessary to comply with the requirements of R.I. Gen. Laws § 42-35-12, and shall contain a notice indicating the right to enter an appeal of the decision and order to the Superior Court pursuant to R.I. Gen. Laws § 42-35-15.
B.Withdrawal of Exhibits. After a decision has become final and all appeal periods have lapsed, the AHO may in her/his discretion, upon motion, permit the withdrawal of original exhibits or any part thereof by the party or person entitled thereto.
C.Presiding Officer Unavailable. When an AHO becomes incapacitated or unavailable, for an unreasonable period of time, to complete a hearing and/or decision and order, the Director may appoint another AHO who shall complete the hearing.
D.Advisory Opinions. The Department shall make a witness available to sponsor and be examined on any Advisory Opinion issued by the Department. Issuance of Advisory Opinions by the Department shall not be subject to requirements for public notice or public comment.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.15** Consent Order {#sec-216-ricr-10-05-4-4.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.15}
A.Negotiations. At any time prior to the AHO rendering a final decision, parties to a hearing may attempt to dispose of a matter by entering into a consent order. A joint request for a stay of a hearing for this purpose shall be forwarded to the AHO and shall indicate the present status of negotiations. If an agreement is not reached within the time period for which any stay is approved, the hearing process shall continue at the point from which the stay was issued.
B.Contents of Agreement. Every agreement shall contain, in addition to an appropriate order, an admission of all jurisdictional facts and express waivers of further procedural steps before the AHO and of the right to appeal and shall also state that such agreement is enforceable as an order of the Department in accordance with procedures prescribed by law. In addition, the agreement may contain a statement that the signing thereof is for settlement purposes only and does not constitute an admission by any party that the law or Regulations have been violated as alleged in the hearing notice.
C.Disposition of Proposed Agreement. Upon receiving such agreement, the AHO may:
1.Accept it and issue the order agreed upon;
2.Reject it and reschedule a hearing; or
3.Take such other action as the AHO deems appropriate.
4.The provisions of this Rule shall not preclude settlement of the proceedings in any other manner.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.16** Appeals to Decisions/Orders {#sec-216-ricr-10-05-4-4.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.16}
Any party aggrieved by a final written order of the AHO may file a complaint with the Superior Court pursuant to R.I. Gen. Laws § 42-35-15. The filing of a complaint does not automatically stay the decision or order unless so ordered by the Superior Court. In the absence of a timely appeal, the order or decision of the AHO shall become final and no further administrative appeal may be taken.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.17** Petitions for Rule Making, Amendment or Repeal {#sec-216-ricr-10-05-4-4.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.17}
A.Any interested person may petition the Director requesting the promulgation, amendment or repeal of any Rule in the form prescribed by § 4.6 of this Part and R.I. Gen. Laws § 42-35-6.
1.Where a petition requests the promulgation of a Rule, the requested or Proposed Rule must be set out in full. The petition must also include all the reasons for the requested Rule together with memoranda of any applicable law. Where the petition requests the amendment or repeal of a Rule presently in effect, the rule or portion of the Rule in question must be set out as well as a suggested form, if any. The petition must include all reasons for the requested amendment or repeal of the Rule.
2.All petitions shall be considered by the Director who may, in her/his discretion, order a hearing for further consideration and discussion of the requested promulgation, amendment, repeal or modification of any Rule.
3.The Director shall notify the petitioning party, within thirty (30) days of receipt of the petition, of the disposition of the petition.
4.A hearing shall be granted if requested by twenty-five (25) persons, or by a governmental subdivision or agency, or by an association having not less than twenty-five (25) members. The Department shall consider fully all written and oral submissions respecting the proposed Rule.
5.The Department shall issue a concise explanatory statement regarding rulemaking pursuant to R.I. Gen. Laws § 42-35-2.6.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.18** Declaratory Rulings {#sec-216-ricr-10-05-4-4.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.18}
A.As prescribed by R.I. Gen. Laws § 42-35-8, any interested person may petition the Director, in the form prescribed by § 4.7 of this Part for a declaratory ruling. The Director shall consider the petition and within a reasonable time shall:
1.Issue a declaratory ruling; or
2.Notify the petitioner that no declaratory ruling is to be issued.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.19** Exculpatory Material {#sec-216-ricr-10-05-4-4.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.19}
Any Department attorney or employee, appearing in an adjudicatory proceeding on behalf of them Department, has a duty to disclose to the other parties to the proceeding relevant material or information which supports the position of any other party, where the value of the material or information to that party is or should have been apparent, or where disclosure of the material or information is specifically requested by a party. The duty of the attorney or employee extends to material or information within her/his personal knowledge or possession, or in the possession or control of or known by any person who assisted the Department in the investigation or preparation of the proceeding, and who either regularly reports to or with reference to the particular proceeding has reported to the attorney or employee.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.20** Hearings Conducted as Part of License Renewal for Hospitals {#sec-216-ricr-10-05-4-4.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.20}
A.In accordance with its inspection and investigatory responsibility and authority under R.I. Gen. Laws Chapter 23-17 (Licensing of Health Care Facilities), the Department may conduct, or cause to be conducted, a public hearing as part of the hospital licensure renewal process. Such public hearing shall occur prior to the licensure renewal date and shall be conducted pursuant to R.I. Gen. Laws Chapter 42-46 (Open Meetings), except that a minimum of thirty (30) days advance notice shall be provided.
B.In addition to information required pursuant to R.I. Gen. Laws Chapter 42-46, the public notice for such hearings shall specify that the Department is soliciting input from the public regarding the compliance of licensed hospitals with the following:
1.License conditions;
2.Hospital Conversion Act;
3.Certificate of Need conditions;
4.Financial disclosure;
5.Community benefit derived from operation of the hospital;
6.Community health assessment;
7.Federal CLAS standards; and
8.Other specific information the Director deems relevant to the renewal of a hospital’s license.
C.The public notice for such hearings shall also identify the contact person in the Department to whom comments may be submitted, in electronic format, prior to the hearing.
D.If a hearing involves more than one (1) hospital, testimony will be heard in alphabetical order of the hospitals involved in the hearing.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
##### **216-RICR-10-05-4 § 4.21** Licensure Review for Individuals Convicted of a Crime {#sec-216-ricr-10-05-4-4.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-05-4#4.21}
Applications by a person who has been convicted of a crime or crime(s) for an occupational license, permit, certificate, or registration issued by the Department shall be reviewed in accordance with R.I. Gen. Laws § 28-5.1-14. To the extent that any Department regulation conflicts with § 4.21 of this Part, the provisions of § 4.21 of this Part control.
**History**
- *Amendment — effective from 2022-01-09 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/09/2022*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018 Click here to view previous versions of this Part.*
### **Subchapter 10** Registries
#### **216-RICR-10-10-1** Rules and Regulations Governing Vital Records
##### **216-RICR-10-10-1 § 1.1** Authority and Purpose {#sec-216-ricr-10-10-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.1}
These amended Rules and Regulations Governing Vital Records are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-3-3, as amended, and are established for the purpose of adopting an efficient statewide vital records system for the protection of the health, welfare and safety of the public.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.2** Incorporated Materials {#sec-216-ricr-10-10-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.2}
These Regulations hereby adopt and incorporate the World Professional Association for Transgender Health's "Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People" (2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.3** Definitions {#sec-216-ricr-10-10-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.3}
A.Wherever used in these Regulations, the terms listed below shall be construed in the following manner; and, furthermore, every word importing the masculine gender only, may be construed to extend to and to include females as well as males.
1."Act" refers to R.I. Gen. Laws Chapter 23-3, entitled "Vital Records."
2.“Adoptee” refers to a person who was born in Rhode Island and whose original birth certificate was sealed and a new birth record created due to an adoption.
3.“Adoptee vital records file” means a file operated by the Office of Vital Records that maintains pre-adoption birth certificates, and includes contact preference form(s). The Office of Vital Records will provide qualified adult adoptees with non-certified copies of their birth certificates from this file.
4.“Adult adoptee” refers to an adoptee, born in Rhode Island, as defined by R.I. Gen. Laws § 23-3-1.
5."Amendment" means any change, correction or addition made to a vital record after filing of same; except that any minor correction or addition made to a birth record less than one (1) year after the date of the birth shall not be considered an amendment.
6.“Birth parent” refers to the person, father or mother of genetic origin of the child, who is legally presumed under the laws of Rhode Island or has been adjudged by a court of competent jurisdiction to be the father or mother of genetic origin of the child.
7."Certifying physician" refers to a physician who has attended a person during his last illness prior to death; or the physician declaring a person dead; or, if death occurred in a hospital, a registered hospital medical officer duly appointed by the hospital director or administrator.
8."Community of resident" means the city or town within the State of Rhode Island of a person's home address at the time of his/her marriage or death or of his/her mother's home address at the time of his/her birth.
9.“Contact preference form” means a form prepared and maintained by the Office of Vital Records that birth parent(s) of adoptees may file to express his or her preference regarding contact with the adoptee. The birth parent(s) shall be given the contact options found in R.I. Gen. Laws § 23-3-15(g)(2). The contact preference form shall also include language informing the birth parent(s) of their ability to provide genetic, social, and health history to the Passive Voluntary Adoption Mutual Consent Registry as defined in R.I. Gen. Laws § 15-7.2-1.
10."Dead body" means a lifeless human body or parts of such body or bones thereof from the state of which it reasonably may be concluded that death occurred.
11."Director" means the Director of the Rhode Island Department of Health.
12."Fetal death" means death prior to the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy; the death is indicated by the fact that after such expulsion or extraction the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of the voluntary muscles.
13."Filing" means the presentation of a certificate, report, or other record provided for in law and in these Regulations, for registration by the local registrar and/or the State Registrar, as specified in these Regulations. (See "Registration").
14."Final disposition" means the burial, interment, cremation, or other disposition of a dead body or fetus.
15.“Foundling” refers to an infant of unknown parentage.
16."Funeral director" means a person licensed to practice pursuant to R.I. Gen. Laws Chapter 5-33.2.
17."Institution" means any establishment, public or private, which provides in-patient medical, surgical, or diagnostic care or treatment; or nursing, custodial, or domiciliary care to two (2) or more unrelated individuals; or to which persons are committed by law.
18.“Issue” refers to lineal descendants of the person on the birth certificate and/or record (children, grandchildren and their children to the remotest degree).
19."Live birth" means the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy, which, after such expulsion or extraction, breathes or shows any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of the voluntary muscles, whether or not the umbilical cord has been cut, or the placenta is attached.
20."Local registrar" means a city or town clerk in Rhode Island or any other person designated for that purpose by the governing body of a city or town in Rhode Island pursuant to R.I. Gen. Laws § 23-3-6.
21."Office" means the Office of Vital Records of the Rhode Island Department of Health.
22."Physician" refers to a person authorized or licensed to practice medicine pursuant to R.I. Gen. Laws Chapter 5-37, and, as used in these Rules and Regulations Governing Vital Records only, a person licensed as a certified nurse practitioner pursuant to R.I. Gen. Laws Chapter 5-34 or licensed as a physician’s assistant pursuant to R.I. Gen. Laws Chapter 5-54.
23."Registrant(s)" means the subject(s) of the vital record.
24."Registration" means the acceptance by the local registrar and/or the State Registrar and the incorporation in their official records of certificates, reports, or other records provided for in law, or in these Regulations.
25."Delayed registration" means the registration of any vital record one (1) year or more after the date of occurrence of the vital event.
26."Late registration" means the registration of any vital record twenty (20) or more days after the last day of the month of occurrence, but less than one (1) year following the vital event.
27.“Signing” or “Signature” means the application of either a hand signature to a paper record or an electronic process approved by the State Registrar of Vital Records.
28."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
29."State registrar" means the State Registrar of Vital Records, who is also the Chief of the Office of Vital Records, appointed by the Director pursuant to R.I. Gen. Laws § 23-3-4.
30."System of vital records" means the registration, collection, preservation, amendment, and certification of vital records, and activities related thereto, including the tabulation, analysis, and publication of statistical data derived from such records.
31."These regulations" mean all parts of Rhode Island Rules and Regulations Governing Vital Records.
32."Vital records" means a birth, death, fetal death, or marriage, or divorce and the legal registration and data collection of the demographic and medical data related to those events.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.4** Duties of the State Registrar of Vital Records {#sec-216-ricr-10-10-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.4}
A.Pursuant to the provisions of R.I. Gen. Laws § 23-3-5, the State Registrar shall:
1.Administer and enforce the Act and these Regulations and issue instructions for the efficient administration of the statewide system of vital records.
2.Direct and supervise the statewide system of vital records and the Office of Vital Records and be custodian of its records.
3.Direct, supervise and control the activities of local registrars and the activities of town and city clerks related to the operation of the system of vital records.
4.Prescribe, with approval of the Director, and distribute such forms as are required by the Act and these Regulations.
5.Prepare and publish annual reports of vital records of Rhode Island and such other reports as may be required by the Director.
6.Provide a copy of each certificate of birth, death, and marriage to the city or town clerk of the community of residence of the registrant(s) on or before the tenth (10th) day of the month after the certificate is received by the Office, except for those certificates filed directly with the State Registrar or where the city or town has electronic access to the vital record pursuant to R.I. Gen. Laws § 23-3-10(d)(3).
B.Pursuant to R.I. Gen. Laws § 23-3-5(b), the State Registrar, with the approval of the Director, may delegate such functions and duties vested in the State Registrar to employees of the Office and to local registrars as deemed necessary or expedient.
C.Upon request, the State Registrar shall provide to all funeral directors, attorneys, and other interested persons in Rhode Island, information regarding current fees for certified copies of death records and addresses of vital records offices in other States. In addition, the State Registrar shall provide information on services available in each state to expedite requests for certified copies of death records.
1.The State Registrar, in bona fide emergency situations, will attempt to further expedite issuance of the certified copy of the death certificate by personally contacting the State registrar or other person in charge of the vital records office in the other State.
2.Costs for electronic funds transfers and/or overnight delivery services shall be borne by the original applicant in need of the expedited return of the certified copy of death.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.5** Duties of Local Registrars {#sec-216-ricr-10-10-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.5}
A.Pursuant to the provisions of R.I. Gen. Laws § 23-3-7, the local registrar with respect to his/her city or town shall:
1.Administer and enforce the provisions of the Act, these Regulations, and instructions issued hereunder.
2.Require that certificates be completed and filed in accordance with provisions of the Act and these Regulations.
3.Transmit in accordance with §§ 1.10 and 1.21(D) of this Part, or such other sections of these Regulations, the certificates, reports, or other returns filed with him/her for the preceding month to the State Registrar or more frequently when directed to do so by the State Registrar.
4.Maintain such records, make such reports, and perform such other duties as may be required by the State Registrar.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.6** Authorized Forms {#sec-216-ricr-10-10-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.6}
A.In order to promote and maintain uniformity in the system of vital records, the forms of certificates, records, and other reports required by the Act or these Regulations shall include, as a minimum, the items recommended by the Federal agency responsible for national vital statistics, subject to the approval of and modification by the Director.
B.No forms other than those supplied by the State Registrar shall be used for vital records, and all such forms, records, and reports are the property of the State of Rhode Island and shall be surrendered to the State Registrar or his/her representative upon demand.
C.The State Registrar shall prepare and issue such instructions concerning the use of forms and supplies as may be required to secure the uniform observance of the Act and the maintenance of an adequate system for the collection, registration and preservation of vital records throughout Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.7** Duties to Report Information Required for Vital Records {#sec-216-ricr-10-10-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.7}
Pursuant to R.I. Gen. Laws § 23-3-27, any person having knowledge of the facts regarding any birth, death, fetal death, marriage or divorce, shall report such information as he/she may possess upon demand of the State Registrar and in accordance with these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.8** Acceptance of Certificates {#sec-216-ricr-10-10-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.8}
A.The State Registrar and each local registrar to whom certificates are presented for registration shall examine the certificates to determine that they have been completed on authorized forms and in accordance with the Act, these Regulations, and instructions of the State Registrar.
B.The State and local registrar shall only accept a certificate or such other forms for registration if:
1.It is completed preferably electronically or by machine with black non-water soluble ink;
2.It contains the hand, machine or electronically printed name and the original signature, or electronic signature as approved by the State Registrar, of the certifier on a birth, death, or fetal death record, or of the officiant and witnesses on a marriage record.
3.The cause of death is hand, machine or electronically printed on the death record;
4.It is the original certificate on the authorized form;
5.It contains proper and consistent data;
6.It contains no corrections made with correction fluid or correction tape;
7.It includes all the information requested on the form or satisfactorily accounts for any omission; and
8.It is satisfactorily completed in accordance with the Act and these Regulations.
C.When any certificate, presented to the State or local registrar for registration, is deemed to be unacceptable for any of the reasons stated in § 1.8(B) of this Part, it shall be the duty of the registrar to notify the person responsible for filing or completing the certificate. The registrar may require the responsible person either to supply complete and correct information to be entered on the certificate or to complete and file a new certificate which shall not be marked "copy" or "duplicate."
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.9** Registration Procedure {#sec-216-ricr-10-10-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.9}
A.When the State or local registrar with whom a certificate or other form is filed for registration determines that the certificate or other form is acceptable for registration, the registrar shall register the certificate or such other form by entering on its face the date of registration and his/her signature.
1.The State Registrar and each local registrar shall number vital records consecutively. Such numbering is to be carried out separately for each category of vital event, beginning with the number 1 on the first certificate of each vital event, registered for each calendar year.
2.Each local registrar shall retain copies of all certificates registered as required above or as otherwise directed by the State Registrar.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.10** Transmittal Procedure {#sec-216-ricr-10-10-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.10}
A.Each local registrar shall, on or before the twenty-fourth (24th) day of each month, transmit to the State Registrar all original certificates filed within his/her jurisdiction for vital events which have occurred during or prior to the first fifteen (15) days of that month.
B.On or before the ninth (9th) day of each month, each local registrar shall transmit to the State Registrar all original certificates filed within his/her jurisdiction for vital events which have occurred during or prior to the sixteenth (16th) through the last day of the prior month.
C.Transmittal forms provided by the State Registrar shall be completed and signed by the local registrar and shall accompany each transmittal.
D.If no certificate of birth, death, fetal death, or marriage was filed in any month, the local registrar shall, on or before the ninth (9th) day of the following month, transmit such report to the State Registrar on forms provided for that purpose by the State Registrar.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.11** Void Certificates {#sec-216-ricr-10-10-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.11}
When the State Registrar shall determine that any vital record was registered improperly, such as through fraud, misrepresentation or duplication, the registrar shall give written notice to the registrant or informant of his/her intention to void said certificate. This notice shall give such person an opportunity to appear and show cause why the certificate should not be voided. The notice shall be served on such person by certified mail, return receipt requested, to his/her last known address on file in the Office. Unless such person shall demonstrate to the State Registrar within thirty (30) days after the date of mailing that there is satisfactory cause that the certificate should not be voided, the State Registrar shall void the certificate and it shall not be available for certification. Neither the State nor local registrar shall issue copies until the matter is resolved.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.12** Birth Registration {#sec-216-ricr-10-10-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.12}
A.A certificate of birth for each live birth which occurs in Rhode Island on or after January 1, 2005 shall be filed electronically and directly with the Office of Vital Records.
B.When a birth occurs in an institution, the person in charge of the institution or his/her designee shall obtain the personal data, prepare the certificate, secure the signatures required on the certificate, and file it with the State Registrar. The physician and/or midwife in attendance shall certify the facts of birth and provide medical information required on the certificate within three (3) days after the birth.
C.When a birth occurs outside an institution, the certificate shall be prepared and filed by one (1) of the following in the indicated order of priority:
1.The physician in attendance at or immediately after the birth; or
2.In the absence of the person identified in § 1.12(C)(1) of this Part, any other health care person in attendance at or immediately after the birth; or
3.In the absence of a person identified in § 1.12(C)(2) of this Part, the father, the mother, or, in the absence of the father and the inability of the mother, the person in charge of the premises where the birth occurred.
4.When a birth occurs in a moving conveyance, the place of birth shall be that address in the city or town where the child is first removed from that conveyance.
D.The name of the father and the surname of the child to be recorded on the birth certificate shall be determined as follows:
1.If the mother was married either at the time of conception or birth, the name of the husband shall be entered on the certificate as the father of the child unless paternity has been determined otherwise by a court of competent jurisdiction, in which case the name of the father as determined by the court shall be entered.
2.If the mother was not married, either at the time of conception or birth, the name of the father shall be entered on the certificate only if paternity has been established by affidavit of both parents or by determination of a court of competent jurisdiction.
3.If the mother was not married either at the time of conception or birth and paternity has not been established by affidavit of both parents or by determination of a court of competent jurisdiction, the name of the father shall not be entered on the certificate and the child shall bear the mother's current legal surname.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.13** Foundling Registration (Infants of Unknown Parentage) {#sec-216-ricr-10-10-1-1.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.13}
A.Whoever assumes the custody of a living infant of unknown parentage shall file a report as prescribed by the State Registrar within four (4) days, with the following information:
1.The report shall be made on a certificate of live birth that shall be plainly marked "Foundling Registration" in the top margin and shall include the following information:
a.The name given to the child by the custodian;
b.The place where the child was found, which shall be entered as the place of birth;
c.The date of birth, which shall be determined by approximation;
d.The sex of the child; and
e.Other data as required by the State Registrar.
2.Parentage data shall be left blank.
3.The custodian, as determined by a court of competent jurisdiction or the State agency responsible for well-being of the child, shall certify to the facts of birth.
4.The name and address of the person(s) or institution with whom said child has been placed for care, the date of the finding of said child, and the approximate age of the child, if determined by the custodian, shall be considered part of the birth certificate and maintained as directed by the State Registrar.
5.If the child is identified and a certificate of birth is found or obtained, any report registered under § 1.12 of this Part shall be sealed and filed and may be opened only by order of a court of competent jurisdiction.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.14** New Certificates of Birth Following Adoption, Legitimation, and Paternity Determinations or Acknowledgements {#sec-216-ricr-10-10-1-1.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.14}
A.Pursuant to R.I. Gen. Laws § 23-3-15, the State Registrar shall establish a new certificate of birth for a person born in Rhode Island when the State Registrar receives one (1) of the following:
1.An adoption report as provided in R.I. Gen. Laws § 23-3-14 or a certified copy of a decree of adoption from a court of competent jurisdiction in another State or Country, together with the information necessary to identify the original certificate of birth and to establish a new certificate of birth; except that a new certificate of birth shall not be established if the court decreeing the adoption, the adoptive parents, or the adopted person requests that such new certificate shall not be established; or
2.A request that a new certificate be established and evidence of legitimation as required in § 1.14(B) of this Part; or
3.A request that a new certificate be established and a certified copy of an order from a court of competent jurisdiction determining the paternity of such a person; or
4.A request that a new certificate be established and a sworn acknowledgment of paternity made by both parents of a registrant born out of wedlock, as required in § 1.14(B) of this Part.
B.Absent a court determination of paternity, the following evidence shall be required for legitimation or paternity acknowledgment of a person born in Rhode Island:
1.A sworn acknowledgment by the mother that she was free to marry both at the time of conception and at the time of the birth of the registrant; and
2.A sworn acknowledgment of paternity made by the mother listed on the registrant's original certificate of birth and by the man to be named as father, certifying that they are the natural parents of the registrant; and
3.In addition, for a legitimation, a certified copy of a certificate of marriage showing that the aforementioned natural parents of the registrant have been married in accordance with the statutes of Rhode Island or of another State or Country, or a court order recognizing such marriage.
C.Absent a court determination of paternity, the State Registrar shall not establish a new certificate of birth when application to do so is made by the mother and a putative father if the name of a man other than the putative father is listed as the father on the original certificate of birth or if the mother was not free to marry both at the time of conception and at the time of birth of the registrant.
D.New certificates of birth subsequent to adoption, legitimation, or paternity shall be established in conformance with the following procedures:
1.Information required to locate the existing certificate and to complete the new certificate shall be provided on such forms as the State Registrar may require.
2.The new certificate of birth shall be the certificate in use at the time the birth occurred. If such certificate is not available, the certificate in current use shall be used.
3.The parents of a child who has been legitimated may choose a new given name and/or surname for the child; such name(s) shall be entered as the name(s) of the registrant on the new certificate of birth.
4.Pursuant to R.I. Gen. Laws § 23-3-21(d), following a sworn acknowledgement of paternity where the parents have not married each other after the birth of the registrant, neither the given name nor the surname of the registrant shall be changed unless an order by a court of competent jurisdiction or a legal change of name is presented to the State Registrar.
5.The new certificate of birth shall include the following items and such other information as required to complete the certificate:
a.The actual place and date of birth as transcribed from the original certificate;
b.The names and personal information of the adoptive parents or of the natural parents, as appropriate;
c.The printed name of the person in attendance at birth;
d.The State file number and local file number, if any, assigned to the original birth certificate; and
e.The original filing date.
6.If no certificate of birth is on file for the person for whom a new certificate is to be established, a delayed certificate of birth shall be filed with the State Registrar, as provided in R.I. Gen. Laws §§ 23-3-12 or 23-3-13 and in these Regulations, before a new certificate of birth is established, except that when the date and place of birth and parentage have been established in the adoption proceedings in accordance with R.I. Gen. Laws § 23-3-15, a delayed certificate shall not be required.
E.A new certificate of birth established following adoption, legitimation, or paternity shall be substituted for the original certificate, as follows:
1.The original certificate and the evidence of adoption, legitimation, or paternity shall be placed in a sealed file and shall not be subject to inspection except upon order of a court of competent jurisdiction, or as allowed by R.I. Gen. Laws § 23-3-15 in the case of an adult adoptee.
2.All copies of the original certificate in the custody of local registrars in Rhode Island shall be forwarded to the State Registrar provided that, where such copies are in the form of entries in permanent ledgers wherein removal of a single record is impossible or not feasible, the entries on such records shall be eradicated with indelible ink.
F.Upon receipt of a court order nullifying an adoption, legitimation, or paternity, the State Registrar shall:
1.Remove the certificate created by the adoption, legitimation, or paternity from the Office's files and place it and the court order in a sealed file. Such records shall not be subject to inspection except upon order of a court of competent jurisdiction;
2.Restore the original certificate of birth to the Office's files;
G.Upon receipt from a passive voluntary adoption mutual consent registry of a certificate provided for in R.I. Gen. Laws § 15-7.2-12(b), or as in accordance with R.I. Gen. Laws § 23-3-15, the adult adoptee named in the certificate, and only that person, shall be entitled to receive non-certified copies of his/her original birth certificate.
H.Pursuant to R.I. Gen. Laws § 23-3-15, the general public shall have access to the following records in regards to adult adoptee access to original birth certificates on a quarterly basis:
1.Number of original birth certificates released since the effective date of the relevant chapter of the Act;
2.Number of contact preference forms filed; and
3.Number of birth parent(s) who indicated on the contact preference form that they would like to be contacted, would like to be contacted only through an intermediary, or do not want to be contacted.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.15** Certificates of Foreign Birth {#sec-216-ricr-10-10-1-1.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.15}
A.The State Registrar shall, upon request, prepare and register a certificate in Rhode Island for a person born in a foreign country who is not a citizen of the United States and who was adopted through a court of competent jurisdiction in Rhode Island.
1.The certificate shall be established upon receipt of a report of adoption from the court decreeing the adoption, proof of the date and place of the child's birth, and a request from the court, the adopting parents, or the adopted person if eighteen (18) years of age or over that a certificate be prepared.
2.The certificate shall be labeled "certificate of foreign birth" and shall show the actual country of birth.
3.After registration of the birth certificate in the new name of the adopted person, the State Registrar shall seal and file the report of adoption which shall not be subject to inspection except upon order of a court of competent jurisdiction or as provided by regulation.
B.If the child was born in a foreign country but was a citizen of the United States at the time of birth, the adoptive parent(s) must use the procedures for obtaining a revised birth certificate for their child through the U.S. Department of State. A "certificate of foreign birth" application will not be appropriate for this situation.
C.A new certificate of birth following foreign adoption shall be exempt from judicial proceeding when the child automatically acquired United States citizenship following a foreign adoption and received the subsequent certificate of citizenship under the Child Citizenship Act, 8 U.S.C. § 1431-33.
1.A Rhode Island resident who is a United States citizen and adopts a foreign born child who automatically acquires citizenship in accordance with the “Child Citizenship Act” must submit a written request to the State Registrar for a “Certificate of Foreign Birth.” The following documents must be shown to be in order to obtain the certificate:
a.A certified English translation of certificate of citizenship or IR-3 designation or proof of IR-3 designation;
b.A certified English translation of foreign birth certificate;
c.Original documents certified by United States Embassy abroad (certification of foreign adoption and certified English translation);
d.Permanent United States Identification card or passport; and
e.Social Security card.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.16** Death Registration {#sec-216-ricr-10-10-1-1.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.16}
A.A death certificate for each death which occurs in Rhode Island shall be filed within seven (7) calendar days after such death and prior to removal of a dead body from Rhode Island.
B.Death certificates shall be filed with the local registrar of the city or town:
1.In which death occurred; or
2.In which a dead body is found, if the place of death is unknown; or
3.In which a dead body was first removed from a moving conveyance, if death occurs in such conveyance.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.17** Responsibility of Funeral Director {#sec-216-ricr-10-10-1-1.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.17}
A.The funeral director, his/her duly authorized agent or person acting as such, who first assumes custody of a dead body shall file the certificate of death after that person has completed the certificate:
1.By entering the personal data obtained from the next of kin or best qualified person or source available;
2.By obtaining medical certification of cause of death from the person responsible therefor (the physician who attended the deceased person during his/her last illness; or the physician declaring such person dead; or, if the death occurred in a hospital, a registered hospital medical officer duly appointed by the hospital director or administrator; or the medical examiner, pursuant to R.I. Gen. Laws § 23-3-16(d); and
3.By obtaining medical certification on the burial-transit permit in accordance with § 1.25 of this Part.
B.A funeral director or other person who removes a dead body or fetus from the place of death or transports or finally disposes of a dead body or fetus shall keep a record containing information which shall identify the body, the date and place of death, and the name of the individual who released the dead body or fetus, pursuant to R.I. Gen. Laws § 23-3-26(c).
C.When a dead body or fetus is to be disinterred, the funeral director, his/her duly authorized agent or person acting as such, shall obtain a disinterment permit from the local registrar at the place of disinterment, in accordance with § 1.26 of this Part.
D.Each funeral director shall, on or before the tenth (10th) day of each month, file a report with the State Registrar listing funerals performed and/or decedents serviced following deaths or fetal deaths during the previous month. Such reports shall be made on forms approved by the State Registrar. Failure to file these reports within the prescribed time shall be grounds for disciplinary action, including revocation of license by the state board of examiners in embalming and funeral directors.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.18** Responsibility of Physician {#sec-216-ricr-10-10-1-1.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.18}
A.Immediately following a person's death, the attending physician or the physician declaring a person dead, or if the death occurs in a hospital, a registered hospital medical officer duly appointed by the hospital director or administrator shall complete the physician's portion of the burial-transit permit, provided that the death does not fall under the jurisdiction of the medical examiner in accordance with § 1.18(C) of this Part, so that the burial-transit permit can be released with the dead body. Within forty-eight (48) hours of a person's death, the physician shall also give the funeral director a certificate of death on which only the following information has been completed:
1.The name of the deceased which shall be entered in the margin;
2.The date of death;
3.A properly completed medical certification of death, with cause of death printed or typed in black ink;
4.The certifier's signature and hand or machine printed name; and
5.Such other information as may be required in the medical certification section of the death certificate.
B.A staff member of an institution assisting the physician in completing the medical certification section of a death certificate shall complete only the medical certification section as designated by the physician.
C.The certifying physician shall not complete or sign the medical certification or burial-transit permit but shall refer the case to the medical examiner, where the decedent may appear to have met death in any manner as specified in Part of this Title, Medical Examiner System, and R.I. Gen. Laws Chapter 23-4.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.19** Responsibility of Medical Examiner {#sec-216-ricr-10-10-1-1.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.19}
A.In all cases where the medical examiner has assumed medico-legal jurisdiction in accordance with Part of this Title, Medical Examiner System, and R.I. Gen. Laws Chapter 23-4, the medical examiner shall execute and sign the medical certification and burial-transit permit in accordance with §§ 1.21, 1.24, and 1.25 of this Part and within forty-eight (48) hours after taking charge of the case.
B.Furthermore, when death occurred without medical attendance as set forth in R.I. Gen. Laws § 23-3-16(c), the medical examiner shall investigate the cause of death and shall complete and sign the medical certification and burial-transit permit within forty-eight (48) hours after taking charge of the case pursuant to R.I. Gen. Laws § 23-3-16(d).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.20** Responsibility of Institution {#sec-216-ricr-10-10-1-1.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.20}
A.Each director or administrator of an institution shall on or before the tenth (10th) day of each month file a report with the State Registrar, listing deaths and fetal deaths occurring in the institution during the previous month.
B.When a dead human body is released or disposed of by an institution, the person in charge of the institution shall keep a record showing the name of the deceased, date of death, name and address of the person to whom the body is released, date of removal from the institution, or, if finally disposed of by the institution, the date, place and manner of disposition shall be recorded, pursuant to R.I. Gen. Laws § 23-3-26(b).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.21** Medical Certification of Cause of Death {#sec-216-ricr-10-10-1-1.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.21}
A.Completed and properly executed medical certification of cause of death shall mean the printed or typed entry of a definite medical diagnosis of cause of death by a physician or medical examiner. This may be:
1.Entry of the clinical findings of the physician who attended the deceased for the illness or condition that resulted in death; or
2.Entry of tentative clinical findings that may or may not be supported by the gross findings of an autopsy; or
3.Entry of autopsy findings where necessary to establish a definite medical diagnosis of cause of death.
B.In any case where an autopsy is to be performed, it shall not be necessary to defer the entry of the cause of death until a full report is available or until microscopic or toxicological studies are completed.
C.In any case where the autopsy findings significantly change the cause of death already entered on the death certificate, a supplemental report of the cause of death shall be forwarded to the State Registrar by the certifying physician, attending physician, or medical examiner as soon as the findings are available. The report shall be made on a form supplied by the State Registrar and shall be signed by the certifying physician, attending physician or medical examiner. Upon receipt of this form, the State Registrar shall enter the new information on the death certificate in accordance with §§ 1.37 and 1.38 of this Part.
D.Whenever a local registrar receives a death certificate which has been certified by a certifying physician or medical examiner and which states that the cause of death is "pending", such certificate shall be registered upon receipt and immediately sent to the State Registrar. Immediately upon determining the cause of death, the medical examiner or certifying physician shall forward the cause of death to the State Registrar on forms furnished for that purpose.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.22** Fetal Death Registration {#sec-216-ricr-10-10-1-1.22 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.22}
A.Fetal deaths of less than twenty (20) weeks gestation shall be reported directly to the State Registrar within seven (7) calendar days after delivery.
B.A fetal death certificate for each fetal death which occurs in Rhode Island after a gestation period of twenty (20) or more weeks shall be filed with the State Registrar or as otherwise directed by the State Registrar. The certificate shall be filed within seven (7) calendar days after delivery and prior to removal of the fetus from Rhode Island. The State Registrar shall accept the certificate for registration if it has been completed and filed in accordance with the requirements of the Act and these Regulations, provided that:
1.When the place where the fetal death occurred is unknown, a fetal death certificate shall be filed within seven (7) days with the State Registrar or as otherwise directed by the State Registrar; or
2.If the fetal death occurred in a moving conveyance, a fetal death certificate shall be filed within seven (7) days with the State Registrar or as otherwise directed by the State Registrar.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.23** Responsibility for Filing {#sec-216-ricr-10-10-1-1.23 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.23}
A.Responsibility for filing of the fetal death certificate shall reside with one (1) of the following:
1.The funeral director, his/her duly authorized agent or person acting as such, who first assumes custody of a fetus for the purpose of final disposition or removal from the State; or
2.The person in charge of the institution where the fetal death occurred, when the institution disposes of the fetus; or
3.The physician or other person in attendance at or after the delivery, when the fetal death does not occur in a hospital or other institution and no funeral director assumes custody of the fetus.
B.Prior to filing the fetal death certificate, the person responsible for its filing shall obtain the personal information required on the certificate from the best source available and the medical certification, including cause of death, from the person responsible therefor.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.24** Responsibility for Medical Certification {#sec-216-ricr-10-10-1-1.24 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.24}
A.The medical certification shall be completed and signed within forty-eight (48) hours after delivery by the physician in attendance at or after the delivery, in accordance with § 1.21 of this Part, unless inquiry by the medical examiner is required by law.
B.When a fetal death occurs without medical attendance upon the mother at or after the delivery or when inquiry is required pursuant to Part of this Title, Medical Examiner System, and R.I. Gen. Laws Chapter 23-4, the medical examiner shall investigate the cause of fetal death and shall complete and sign the medical certification within forty-eight (48) hours after taking charge of the case in accordance with R.I. Gen Laws § 23-3-17(e) and § 1.21 of this Part.
1.A certificate containing the facts found in the corresponding fetal death certificate may be marked “delayed” if not registered within one (1) year of the delivery date.
C.Filing of Certificates of Birth Resulting in Stillbirth. The State Registrar shall produce a certificate of birth resulting in stillbirth for fetal deaths only if a fetal death certificate was already completed and filed. The certificate shall:
1.Only be issued at the request of either individual listed as mother or father on the report of the fetal death;
2.Meet all formatting requirements for a certificate of live birth as provided in the Act; and,
3.If the parents of the stillborn child refrain from naming the stillborn child, the person preparing the certificate shall leave any references to the stillborn child’s name blank.
D.If parent(s) listed on the fetal death certificate would like to change anything on the certificate of birth resulting in stillbirth the fetal death certificate shall be amended first.
E.The State Registrar shall file the certificate of birth resulting in stillbirth with the original fetal death certificate and mark the creation date as the date filed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.25** Permits for Burial-Transit {#sec-216-ricr-10-10-1-1.25 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.25}
A.A burial-transit permit shall be completed before a dead body can be cremated, buried, or removed from Rhode Island. The permit shall be made available for removal with the dead body except when:
1.The funeral director, his/her duly authorized agent or person acting as such, has been told by the certifying physician that the death is not under the jurisdiction of the medical examiner, and that such certifying physician will complete the burial-transit permit and medical certification as required by these Regulations, prior to final disposition or removal of the dead body from Rhode Island; or
2.The death is under the jurisdiction of the medical examiner who has authorized the funeral director to remove the dead body.
B.The funeral director, his/her duly authorized agent or person acting as such, who first assumes the custody of a dead body shall prepare the burial-transit permit; such burial-transit permit shall be signed by the funeral director and by the certifying physician or medical examiner in accordance with §§ 1.18 and 1.19 of this Part.
C.A burial-transit permit issued under the law of another State which accompanies a dead body brought into Rhode Island shall be authority for final disposition of the dead body in Rhode Island.
D.The burial-transit permit shall accompany the dead body during transportation except for first removals within Rhode Island, as specified in § 1.25(A) of this Part.
E.Burial-transit permits shall be presented to and shall be signed by the sexton or person in charge of the cemetery, crematory, or other place of final disposition of a dead body prior to disposal of the dead body.
F.On or before the fifth (5th) day of each month, the sexton or other person in charge of the place of final disposition of a dead body shall transmit all burial-transit permits received during the prior month to the local registrar of the city or town in which the place of final disposition is located.
G.Local registrars shall retain burial-transit permits for not less than five (5) years.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.26** Permits for Disinterment and Reinterment {#sec-216-ricr-10-10-1-1.26 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.26}
A.A permit for disinterment and reinterment shall be required prior to disinterment of a dead body or fetus unless otherwise ordered by a court of competent jurisdiction. However, if the dead body or fetus is to be disinterred and reinterred in the same cemetery, no permit shall be required provided that the sexton or other person in charge of the cemetery shall establish a record relative to the facts of disinterment and reinterment within the cemetery.
B.The permit shall be issued in quadruplicate to the funeral director by the local registrar of the city or town in which the place of disinterment is located, upon proper application on a form provided by the State Registrar.
C.The funeral director shall retain one (1) copy, shall file the second (2nd) copy with the sexton or person in charge of the cemetery from which disinterment is to be made, shall use the third (3rd) copy during transportation and give it to the sexton or person in charge of the cemetery of reinterment, and shall forward the fourth (4th) copy to the State Registrar.
D.The sexton or other person in charge of the cemetery of disinterment shall establish a record of the facts of disinterment and reinterment and shall, prior to the fifth (5th) day of the following month, send the second copy to the local registrar of the city or town in which the cemetery of disinterment is located.
E.The sexton or other person in charge of the cemetery of reinterment shall establish a record of the facts of disinterment and reinterment and shall, prior to the fifth (5th) day of the following month, send the third (3rd) copy to the local registrar of the city or town in which the cemetery of reinterment is located.
F.The Office shall enter on the face of the death certificate the date of reinterment and the location of the cemetery of reinterment.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.27** Final Disposition by Medical School {#sec-216-ricr-10-10-1-1.27 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.27}
A.Following the final disposition of the remains of a dead body which has been conveyed to a medical school to be used for anatomical study or other medical purposes, said school shall notify the State Registrar in writing, prior to the fifth (5th) day of the following month, of the date, manner, and place of final disposition.
B.The State Registrar shall enter on the face of the death certificate the date, manner, and place of final disposition.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.28** Cremation Certificates {#sec-216-ricr-10-10-1-1.28 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.28}
A.The body of a deceased person shall not be cremated in or removed from Rhode Island for the purpose of cremation without a cremation certificate having been obtained from the Office of State Medical Examiners in accordance with Part of this Title, Medical Examiner System, and R.I. Gen. Laws § 23-3-18(e).
B.A deceased person shall not be cremated within twenty-four (24) hours after death unless death resulted from a contagious or infectious disease.
C.If the death occurred within Rhode Island, the dead body shall not be received or cremated by any corporation authorized to cremate a dead body until its officers have received the burial-transit permit required by law before burial and a cremation certificate from the medical examiner certifying that the medical examiner has made a personal inquiry into the cause and manner of death and is of the opinion that no further examination or judicial inquiry concerning the same is necessary.
D.If the death occurred without Rhode Island, the reception and cremation of the body of the deceased person shall be governed by the receipt of the burial-transit permit or other appropriate certificate as the cremation certificate from the Medical Examiner of the State of Rhode Island.
E.The funeral director shall mail the cremation certificate to the State Registrar for filing.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.29** Issuance of Marriage License {#sec-216-ricr-10-10-1-1.29 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.29}
A.Persons intending to be married in Rhode Island must first obtain a marriage license from:
1.If both persons live in Rhode Island, they may apply for a marriage license from the local registrar or his/her assistant, at the city or town hall where either person resides; or
2.If only one (1) person lives in Rhode Island, they must apply for a marriage license from the local registrar or his/her assistant, at the city or town hall where the Rhode Island resident lives, or
3.If neither person lives in Rhode Island, they must apply for a marriage license from the local registrar or his/her assistant from the city or town hall of the city or town where the marriage ceremony will be performed. Applicants for a marriage license must know the city or town in which the marriage will be solemnized should the property of the marriage site be situated across two (2) or more municipalities.
B.In a situation described in §§ 1.29(A)(1) or (2) of this Part, the marriage may be performed in any city or town in Rhode Island. In a situation described in § 1.29(A)(3) of this Part, the marriage shall be performed only in the city or town where the marriage license was issued.
C.Applicants for a marriage license shall provide all the information requested to complete the marriage license, and shall attest to the truth of the information by signing the license in the presence of the local registrar or his/her assistant. Furthermore, applicants must submit the following supporting documentation:
1.A valid government issued form of identification and a government issued certificate providing birth facts for each applicant, preferably a certified copy of a birth certificate;
2.Pursuant to R.I. Gen. Laws § 15-2-11, a minor's permit signed in the presence of the local registrar, or his/her assistant, by the parent(s) or guardian(s), if the person entering into the marriage is a minor of at least sixteen (16) years of age but less than eighteen (18) years of age;
3.Pursuant to R.I. Gen. Laws § 15-2-11, a written order from the Family Court to issue the license if either person is less than sixteen (16) years of age; and
4.A certified copy of a final divorce decree/dissolution, or of a death certificate, if the applicant has been previously married or party to a registered civil union or domestic partnership/relationship.
D.The license shall be valid for three (3) months after the date of issuance. If the marriage is not performed within the three (3) months, the license becomes invalid and the party or parties in possession of the license shall return it immediately to the local registrar from whom it was obtained.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.30** Marriage Solemnization {#sec-216-ricr-10-10-1-1.30 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.30}
A.The persons to be married shall present the valid marriage license, signed by both of them and by the local registrar of the place of issuance, to the officiant, who shall be a person empowered to join persons in marriage pursuant to the provisions of R.I. Gen. Laws §§ 15-3-5 and 15-3-6.
B.The presence of at least two (2) witnesses of legal age other than the officiant is required for the solemnization of a marriage.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.31** Completion and Filing of Marriage License {#sec-216-ricr-10-10-1-1.31 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.31}
A.After a marriage has been performed, the officiant shall provide for the completion of the following items on the marriage license:
1.The signatures of the two (2) witnesses, with names hand, machine or electronically printed;
2.The date of the marriage;
3.The city or town where the marriage was performed;
4.The type of ceremony;
5.The title, the name of the court, or the denomination of the officiant, as appropriate;
6.The address of the officiant; and
7.The signature of the officiant, with his/her name hand, machine or electronically printed, attesting to the facts of the marriage.
B.All items must be completed legibly in non-water soluble black ink; all signatures must also be in non-water soluble black ink.
C.The completed and signed marriage license shall be filed by the officiant, within seventy-two (72) hours of the ceremony, with the local registrar of the city or town in which the marriage license was issued and shall be considered the marriage certificate for vital records purposes.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.32** Delayed Registration of Certificates {#sec-216-ricr-10-10-1-1.32 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.32}
A.All delayed certificates shall be filed directly with the State Registrar on forms authorized for each vital event and shall be clearly marked "delayed."
B.Certificates shall be accepted for delayed registration only if:
1.A search by the Office reveals that no certificate for the event has been previously registered;
2.The evidence as required in § 1.32(C) of this Part, has been submitted and found satisfactory to the State Registrar;
3.Payment of the required statutory fee is made;
4.The certificate has been completed as required; and
5.The appropriate provisions of § 1.32(D) of this Part have been met.
C.Documentary evidence submitted in order to establish the date and place of the vital event and the name(s) of the registrant(s) shall be original records or certified copies thereof and shall include as a minimum:
1.Two (2) evidentiary documents, if the certificate is filed within seven (7) years of the occurrence of the vital event, one (1) of which must have been established within three (3) years of the date of the vital event.
2.Three (3) evidentiary documents if the record is filed seven (7) years or more after the occurrence of the vital event. Such documents shall be at least five (5) years old and at least two (2) documents must have been established within seven (7) years of the date of the vital event.
D.A delayed certificate of a vital event may be filed with the State Registrar by the person who was responsible for filing the certificate within the prescribed statutory and regulatory time requirements, with a statement indicating that the information was taken from his/her records; or
1.For delayed birth certificates:
a.The registrant, if of legal age; or
b.The parent or guardian.
2.For delayed death certificates:
a.The certifying physician; or
b.The medical examiner when the case was under his/her jurisdiction; or
c.The next of kin of the decedent; or
d.The legal representative of the next of kin or of the estate of the decedent.
3.For delayed marriage certificates:
a.Either married party; or
b.A legal representative of either married party in the event one (1) of the parties is deceased or physically incapacitated.
E.The State Registrar may require an explanation for the delayed filing from the person who requests the filing. Such explanation shall be made a part of the delayed certificate.
F.If the State Registrar determines after a review of evidentiary documentation that such evidence is unsatisfactory, the applicant shall be so notified.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.33** Delayed Registration of Birth Certificates {#sec-216-ricr-10-10-1-1.33 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.33}
A.The following facts, as a minimum, must be established to register a delayed birth certificate:
1.The full name of the person at the time of birth, except that a name established by adoption, legitimation, court determination of paternity, other court order, or sworn acknowledgment of paternity may be reflected on the delayed registration;
2.The date and place of birth; and
3.The name(s) of the parent(s), except that inclusion of the father's name shall be subject to § 1.12(D) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.34** Medical Certification on Delayed Death Certificates {#sec-216-ricr-10-10-1-1.34 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.34}
A.If the medical certification of the cause of death is indicated on the delayed death certificate, it must be established by one (1) of the following:
1.The certifying physician; or
2.The medical examiner; or
3.A physician who has reviewed the medical records of the decedent.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.35** Delayed Registration of Marriage Certificates {#sec-216-ricr-10-10-1-1.35 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.35}
As a minimum, evidence must be submitted that the registrants complied with the statutory requirements of R.I. Gen. Laws Chapter 15-2, for obtaining a marriage license.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.36** Late Registration of Certificates {#sec-216-ricr-10-10-1-1.36 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.36}
A.A late registration of a certificate shall be completed on the authorized form in use at the time of vital event.
B.Satisfactory documentation, substantiating the name of the person and the date and place of the occurrence of the vital event may be submitted to the State or local registrar in order to register a late certificate of a vital event.
C.The State or local registrar may require an explanation for the failure to file the certificate within the time prescribed by the Act and these Regulations. Either registrar may also require that documentary evidence prescribed for delayed registration, in accordance with § 1.32(C) of this Part, be submitted for the late registration. Such explanation or evidence shall be made a part of the registration of the late certificate.
D.No certificate shall be accepted for late registration unless the evidentiary documentation is found satisfactory to the State or local registrar or unless so ordered by a court of competent jurisdiction. When a certificate is not accepted, the applicant shall be so notified.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.37** Requirements to Amend Vital Records {#sec-216-ricr-10-10-1-1.37 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.37}
A.A vital record may be amended only by the State Registrar, in accordance with R.I. Gen. Laws § 23-3-21 and these Regulations.
B.In order to preserve the integrity and accuracy of vital records, the State Registrar may initiate amendments to vital records. In such cases, the State Registrar may waive the requirements of § 1.37(E) of this Part.
C.The following person(s) may apply to the State Registrar for an amendment to a vital record:
1.The person(s) originally responsible for filing the certificate; or
2.The person(s) required to provide or complete the information thereon; or
3.The registrant, his/her parent(s), guardian, next of kin, or legal representative.
D.The person who applies for an amendment to a vital record must submit satisfactory evidentiary documentation to support the change(s), as required by § 1.37(E) of this Part. If the State Registrar deems the evidence is unsatisfactory, he/she shall notify the applicant that the registrar shall not amend the record unless so ordered by a court of competent jurisdiction.
E.Evidentiary documentation to support an amendment to a vital record shall consist of the following:
1.An affidavit executed by the registrant(s) or his/her relative, or a person with knowledge of the correct information; and
2.At least one (1) original document supporting the amendment, or a certified copy thereof, signed by the custodian of the original document, provided that such document must have been established within seven (7) years of the fact or event that it substantiates.
3.For corrections of errors relating to race on a vital record, certified copies of the birth records of either the registrant(s), or his/her parent(s), identifying race or color; or documents of similar validity;
4.For corrections of errors in the given name of a registrant on a birth record, an affidavit executed only by the registrant, if of legal age, his/her parent(s) or his/her legal guardian(s), or his/her legal representative; and one (1) evidentiary document, except as provided in §§ 1.37(G) and 1.39 of this Part.
5.For corrections to sex on the birth certificate that differ from the sex on the original birth certificate, the State Registrar shall change the certificate of birth to reflect the new sex designation, without indicating such change, upon receipt of:
a.An affidavit executed by:
(1)The registrant if of legal age; or
(2)The registrant’s parent(s), legal guardian(s) or legal representative if not of legal age; and
b.Correction requests regarding sex on a birth certificate that include a request for a legal name change will be marked as amended only with respect to the name change, pursuant to § 1.38 of this Part.
F.Except for the medical certification section on a death record, once an item has been amended on a vital record in accordance with the evidentiary requirements of § 1.37(E) of this Part, such item shall not be amended again unless the State Registrar is ordered to do so by a court of competent jurisdiction.
G.After thirty (30) days from registration in the Office, changes to the given name of the registrant on a birth certificate which reflect a new given name, rather than a minor correction in spelling, a variant form of the name, or a clerical error, shall be made only upon submission of an order to do so from a court of competent jurisdiction.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.38** Procedure to Amend Vital Records {#sec-216-ricr-10-10-1-1.38 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.38}
A.An amendment to a vital record shall be completed by one (1) of the following methods:
1.Completing a blank item with the correct information and denoting the amended information with an asterisk; or
2.Drawing a single line through the incorrect information, noting the correct information directly above or next to it, and denoting the corrected information with an asterisk; or
3.Preparing a new certificate with the corrected information, when corrected in accordance with § 1.14 of this Part; or
4.If the vital event was registered electronically, then all the information must be amended as directed within the current electronic registration system noting the date of the amendment, the information being amended and any applicable comments on the bottom of the certified copy or as otherwise directed by the State Registrar.
B.A vital record which has been amended shall be marked "Amended" and the date of the amendment shall be entered on the vital record, except as provided in §§ 1.14, 1.37(E) and 1.39 of this Part.
1.In the case of a legal name changed granted by a court of competent jurisdiction, the name of the court granting the legal name change and the date granted must appear on the certificate unless the name is changed through a paternity, legitimation or adoption or as authorized in § 1.39 of this Part.
C.Except as provided in § 1.14 of this Part, when the name of the registrant on a birth certificate is changed by court order, pursuant to R.I. Gen. Laws §§ 23-3-21(a) and (c), the birth certificate shall be marked "Amended" and the effective date of the order and the name of the court shall be entered on the birth certificate.
D.When the State Registrar amends a vital record, a record of all evidentiary documentation supporting the amendment shall be preserved in a permanent cross-reference file in the Office. The State Registrar shall report all amendments to the local registrar(s) who have the records on file by transmitting a photocopy or other notification of the amendment, in order that the local registrar shall amend his/her copy of the vital record to agree with the original vital record on file at the Office.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.39** Additions or Minor Corrections to Birth Certificates Within One Year of the Date of Birth {#sec-216-ricr-10-10-1-1.39 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.39}
A.Pursuant to R.I. Gen. Laws § 23-3-21(b), additions or minor corrections of the types indicated below made to birth certificates within one (1) year of the date of birth shall not be marked "Amended":
1.The addition of the given name of the registrant, when the given name is blank;
2.Corrections to the given name of the registrant on a birth certificate which reflect a minor correction in spelling, a variant form of the name, or clerical error;
3.Corrections of typographical or transcription errors, or clearly inconsistent information; and
4.Corrections or additions to items in the "Information for Medical and Health Use Only" section, except that race and marital status shall be corrected only in accordance with §§ 1.37 and 1.38 of this Part.
B.The State Registrar may require evidentiary documentation and/or an affidavit executed by the parent(s) listed on the birth certificate or the legal guardian of the registrant prior to additions or minor corrections to birth certificates within one (1) year of the date of birth.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.40** Disclosure of Vital Records {#sec-216-ricr-10-10-1-1.40 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.40}
A.Pursuant to R.I. Gen. Laws § 23-3-23, except as provided in § 1.40(E) of this Part, in order to protect the integrity of vital records, to ensure their proper use, and to ensure the efficient and proper administration of the vital records system, no person shall permit inspection of or disclose information contained in a vital record, or copy or issue a copy of all or part of any such record prior to the time a record is determined to be a public record, except to those person(s) or entities listed below:
1.For birth records, the registrant, if over eighteen (18) years of age, the registrant’s parent or guardian, grandparent(s), sibling(s), if over eighteen (18) years of age, spouse, civil union or registered domestic partner, issue(s), if over eighteen (18) years of age; or
a.Attorneys-at-law, title examiners, or members of legally incorporated genealogical societies, in the conduct of their official duties; or
b.Persons requiring information for the determination or protection of a personal or property right; or
c.A person who presents to the State or local registrar a court order instructing the registrar to provide disclosure.
2.For all other vital records, the registrant’s spouse/partner or registered domestic partner, sibling(s) if over eighteen (18) years of age, parent(s) or guardian(s), grandparent(s), or his/her issue(s) if over eighteen (18) years of age; or
a.Attorneys-at-law, title examiners, or members of legally incorporated genealogical societies, in the conduct of their official duties; or
b.Persons requiring information for the determination or protection of a personal or property right;
c.A person who has been granted a court order instructing the registrar to provide disclosure; or
d.A person who can demonstrate to the State or local registrar a legitimate direct and tangible interest in such records.
(1)If a request by such person is denied by the local registrar, the person may submit the request to the State Registrar.
e.Firms, agencies or individuals that are given approval pursuant to §§ 1.40(B)(4) and/or (5) of this Part.
B.Research and Administrative Purposes. Except as prohibited in § 1.40(B)(5) of this Part, the Director or his/her designee may authorize, under appropriate privacy safeguards, the disclosure of data contained in vital records for research and administrative purposes to one (1) or more of the following:
1.The National Center for Health Statistics, provided both that the State shall be reimbursed for the cost of furnishing data and that such data shall be used only for statistical purposes by the national office, unless authorized to do otherwise by the State Registrar; or
2.Federal, State, local and other public or private agencies in the conduct of their official duties; or
3.Persons or institutions engaged in research; or
4.With regards to death certificates only, public or private agencies required to determine if an account/policy holder is deceased and such account/policy funds may be subject to being escheated to the State as unclaimed/abandoned property as long as such agencies demonstrate a legitimate direct and tangible interest in the State’s death records; or
5.With regards to death certificates only, an agency or firm that seeks to verify Fact of Death and that is approved by the State Registrar through the national Electronic Verification of Vital Events system as long as such agency or firm demonstrates a legitimate direct and tangible interest in the State’s death records.
C.Disclosure to the parties listed in § 1.40(B) of this Part shall be subject to the following limitations, where applicable:
1.The information disclosed to them shall be used only for the stated purposes;
2.No information from vital records shall be published or disseminated in a form that might permit identification of individuals, corporations, or institutions named or listed in vital records, unless permission of these respondents shall have been independently obtained;
3.No communications shall be made with individuals, corporations, or institutions named or listed on vital records, or with family members, or with informants or certifying officials, unless approval has been obtained by the Director or his designee;
4.No statement shall be made indicating or suggesting that interpretations drawn from vital records data are those of the Department or of state government.
D.Pursuant to R.I. Gen. Laws § 23-3-23(d), the State or local registrar shall not require evidence of a direct and tangible interest in order to disclose information from vital records for vital events which have occurred one hundred (100) years or more prior to disclosure.
E.Disclosure of Out-of-Wedlock Births. Pursuant to R.I. Gen. Laws § 23-3-23(c), information in vital records indicating that a birth occurred out of wedlock may be disclosed only to one (1) of the following:
1.The mother listed on the certificate; or
2.Persons or agencies who have the written approval of the mother listed on the certificate; or
3.The registrant, if over the age of eighteen (18); or
4.The natural father, if his name appears on the certificate; or
5.A person who presents proof of legal guardianship of a child born out of wedlock; or
6.A person who has been granted a court order instructing the Office to issue a certified copy; or
7.Attorneys or adoption agencies who request certified copies for adoption proceedings; or
8.Attorneys who represent either the registrant, the mother listed on the certificate, or the father, if his name appears on the certificate.
F.Information indicating that a birth occurred out of wedlock may be disclosed to the following only, according to the indicated restrictions:
1.At the discretion of the State Registrar, Federal, State, county, or municipal agencies charged by law with the duty of detecting or prosecuting crime, preserving the internal security of the United States, or determining citizenship; or
2.With the approval of the Director, public health agencies which demonstrate that failure to disclose such information to them would be detrimental to the registrant or to the administration of a public health program.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.41** Reproduction for Preservation of Vital Records {#sec-216-ricr-10-10-1-1.41 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.41}
To preserve original documents, the State Registrar is authorized to prepare electronic, photographic, or other reproductions of original records and files in his/her office. Such reproductions when certified by him/her shall be accepted as the original records, pursuant to R.I. Gen. Laws § 23-3-22.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.42** Certified Copies of Vital Records {#sec-216-ricr-10-10-1-1.42 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.42}
A.Certified copies of vital records may be prepared and issued only by the State Registrar and, where applicable, by the local registrar, in accordance with these Regulations. Only authorized forms provided by the State Registrar may be used for preparing certified copies.
B.Each certified copy issued shall show the following:
1.The date of registration at the place where the record was first registered;
2.The date of issuance of the copy;
3.The signature of the issuing registrar, or an authorized facsimile signature thereof;
4.The seal of the issuing office or as otherwise directed by the State Registrar; and
5.A statement that the facts are true facts as recorded.
C.Pursuant to R.I. Gen. Laws § 23-3-24, certified copies issued from records marked "delayed" or "amended," or "court order" shall indicate that the record is delayed, amended, or the result of a court order and the effective date.
1.Certified copies of delayed certificates shall include an abstract of the evidence submitted to substantiate the registration of the record, when such evidence has been made part of the record.
2.All certified copies of birth certificates which have been amended following a legal change of name shall show the effective date of the order and the name of the court shall be entered on the certified copy.
D.Pursuant to R.I. Gen. Laws § 23-3-24(c), a certified copy of a certificate or any part thereof, issued in accordance with the Act and these Regulations shall be considered for all purposes the same as the original, and shall be prima facie evidence of the facts therein stated, provided that the evidentiary value of a certificate or record filed more than one (1) year after the event, or a record which has been amended, shall be determined by the judicial or administrative body or official before whom the certificate is offered as evidence.
E.The State or local registrar may issue certified copies only of vital events recorded as having occurred in Rhode Island, except that certified copies of vital events recorded in Rhode Island, but having occurred elsewhere, may be made when evidence is presented that the event is not recorded at the place of occurrence.
F.Non-certified copies may be provided by the State or local registrar to governmental agencies or to individuals or institutions doing research in accordance with §§ 1.40(B) and (C) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.43** Fees {#sec-216-ricr-10-10-1-1.43 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.43}
A.Certified copies and searches:
1.The State Registrar shall charge fees for certified copies and searches as follows:
a.For a search of two (2) consecutive calendar years under one (1) name and for issuance of a certified copy of a certificate of birth, fetal death, death, or marriage, or a certification of birth, or a certification that the record cannot be found, the fee is as set forth in Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter. For each duplicate copy of a certificate or certification issued at the same time, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter;
b.For each additional calendar year search, if applied for at the same time or within three (3) months of the original request and if proof of payment for the basic search is submitted, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter;
c.For providing expedited service, the additional handling fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter;
d.For processing of adoptions, legitimations, or paternity determinations as specified in R.I. Gen. Laws §§ 23-3-14 and 23-3-15, there shall be a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter.
e.For making authorized corrections, alterations, and additions, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter; provided, no fee shall be collected for making authorized corrections or alterations and additions on records filed before one (1) year of the date on which the event recorded has occurred.
f.For examination of documentary proof and the filing of a delayed record, a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter, and in addition to that fee, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter, for the issuance of a certified copy of a delayed record.
2.The local registrar shall charge fees for certified copies and searches as follows:
a.For a search of two (2) consecutive calendar years under one (1) name and for issuance of a certified copy of a certificate of birth, fetal death, death, delayed birth, or marriage, or a certification of birth or a certification that the record cannot be found, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter. For each duplicate copy of a certificate or certification issued at the same time, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter.
b.For each additional calendar year search, if applied for at the same time or within three (3) months of the original request and if proof of payment for the basic search is submitted, the fee is as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter.
3.Fees collected under § 1.43(A)(2) of this Part by the local registrar shall be deposited in the city or town treasury according to the procedures established by the city or town treasurer except that an amount set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter, of the certified copy fees shall be submitted to the State Registrar for deposit in the General Fund of the State of Rhode Island.
B.Marriage licenses: Upon issuing a marriage license, the local registrar shall charge, collect, and deposit fees for the marriage license in accordance with the provisions of R.I. Gen. Laws §§ 15-2-9 and 15-2-9.1 and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Subchapter 05 Part 2 of this Chapter.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.44** Violations and Penalties {#sec-216-ricr-10-10-1-1.44 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.44}
Any person who willfully and knowingly violates any provisions of the Act, or the requirements of these Regulations, shall be subject to the penalties as set forth in the Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-10-10-1 § 1.45** Severability {#sec-216-ricr-10-10-1-1.45 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-1#1.45}
If any provision of these Regulations or the application to any person or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the Regulations which can be given effect, and to this end the provisions of these Regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-03-31 to 01/04/2022*
- *Technical Revision — effective from 2014-11-11 to 03/31/2021*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Technical Revision — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2014-11-11 to 11/11/2014*
- *Amendment — effective from 2012-12-10 to 11/11/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-10-10-2** Rhode Island Cancer Registry
##### **216-RICR-10-10-2 § 2.1** Authority {#sec-216-ricr-10-10-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.1}
These Rules and Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-1-18(2), 23-8-1, and 23-12-4 for the purpose of establishing a unified procedure for the reporting of cancer to the Rhode Island Cancer Registry.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.2** Definitions {#sec-216-ricr-10-10-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.2}
A.Whenever used in these Regulations, the following terms shall be construed as follows:
1."Acts" refers to R.I. Gen. Laws Chapters 23-1, 23-8, and 23-12.
2."Administrator of the Rhode Island Cancer Registry" means the individual within the Department of Health designated by the Director to be responsible for the operation of the Rhode Island Cancer Registry. For the purpose of this Part, this individual may also be referred to as the Registrar.
3."Director" means the Director of the Rhode Island Department of Health.
4."Health care facility and/or health care provider" means hospitals, freestanding ambulatory surgical centers and radiotherapy facilities, health maintenance organizations, independent clinical laboratories providing histopathology and/or cytology, licensed pursuant to R.I. Gen. Laws Chapters 23-17, 23-16.2 or 27-41 and furthermore includes such other health care facilities not listed above and health care providers (such as physicians, dentists) licensed in accordance with statutory provisions of this State, who may produce a positive test result for, make a diagnosis of, or provide treatment for cancer as defined in § 2.2(A)(5) of this Part, independent of the health care facilities listed above.
5."Reportable case" means all incident cancer, benign neoplasm (tumor), or premalignant (precancerous) case specified by the Rhode Island Cancer Registry as follows:
a.“Benign neoplasm of the brain or central nervous system,” a diagnosis of benign or borderline neoplasm, established by a licensed physician, occurring in the brain, meninges, spinal cord, cauda equina, a cranial nerve or nerves, other part of the central nervous system, pituitary gland, pineal gland, craniopharyngeal duct, or other related anatomical sites, by the current amended “International Classification of Diseases for Oncology” (ICD-O) published by the World Health Organization.
b."Cancer," a diagnosis of in situ or invasive malignant disease (made microscopically and/or non-microscopically) established by a licensed physician which includes cancers at all sites and all stages of the disease and which are listed in the current amended "International Classification of Diseases for Oncology" (ICD-O), published by the World Health Organization. Excluded are squamous cell and basal cell carcinomas of the skin, but included are all carcinomas (including in situ) of the breast (including lobular carcinoma in situ: LCIS), cervix (also known as squamous intraepithelial neoplasia 3: CIN-3 or high-grade squamous epithelial lesion: HSIL), vagina (including intraepithelial neoplasia 3: VAIN-3), prepuce, clitoris, vulva (including intraepithelial neoplasia 3: VIN-3), labia, penis and scrotum.
6."Rhode Island Cancer Registry" means the Central Registry established within the Department of Health by the Director pursuant to R.I. Gen. Laws §§ 23-1-1, 23-1-18(2), 23-8-1 and 23-12-4 as the statewide Registry for the collection and recording of information on reportable cases as defined in § 2.2(A)(5) of this Part for the purpose of understanding the extent and nature of the diseases among the citizens of the State and to apply preventive and control measures.
7.“This Part” mean all parts of the Rules and Regulations pertaining to the Rhode Island Cancer Registry (216-RICR-10-10-2).
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.3** Administration of the Rhode Island Cancer Registry {#sec-216-ricr-10-10-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.3}
A.All cases as defined in § 2.2(A)(5) of this Part shall be reportable in accordance with the statutory and regulatory provision herein.
B.Pursuant to R.I. Gen. Laws § 23-12-4, the Director may enter into a contract with a non-profit organization to be responsible to the Rhode Island Cancer Registry for the collection and recording of all reportable cases as defined in § 2.2(A)(5) of this Part.
1.A contract entered into with a non-profit organization shall clearly delineate the mutual responsibilities of the parties involved and shall include other terms of agreement such as reimbursement, designation of services to be rendered, confidentiality, disclosure of data, assurance of compliance with the requirements herein, and such other terms of agreement as may be mutually acceptable.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.4** Reporting Requirements {#sec-216-ricr-10-10-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.4}
A.Health care facilities and/or health care providers as defined in § 2.2(A)(4) of this Part, shall be responsible to report to the Rhode Island Cancer Registry and the organization and/or agency approved by the Director, each reportable malignant disease indicated by test results, diagnosed and/or confirmed within the health care facility and/or by the health care provider on and after October 1, 1986, each reportable benign neoplasm of the brain or central nervous system indicated by test results, diagnosed and/or confirmed within the health care facility and/or by the health care provider on and after January 1, 1998, and each reportable in situ carcinomas of the cervix (also known as squamous intraepithelial neoplasia 3: CIN-3 or high-grade squamous epithelial lesion: HSIL) indicated by test results, diagnosed and/or confirmed within the health care facility and/or by the health care provider on and after January 1, 2018, including all histopathology and cytology specimens removed elsewhere but found to be positive for each reportable case upon initial reading or upon consultative reading at the health care facility and/or by the health care provider. Health care facilities and/or health care providers shall report each reportable case treated within the health care facility and/or by the health care provider if that case was diagnosed therein or thereby, or if the treatment therein or thereby is part of the first course of definitive treatment for the case.
B.Each health care facility and/or health care provider shall electronically submit such data and information on reportable cases and shall meet data element requirements, format, completeness, quality, and timelines prescribed by:
1.Chapter VII “Record Layout Table” of the “Standards Volume II” of the “Central Cancer Registry Standards” (Version 22, Revised October 28, 2021) published by the North American Association of Central Cancer Registries, incorporated herein by reference, not including any later editions or amendments thereof; and
2.“Standards for Oncology Registry Entry” (January 1, 2022) published by the Commission on Cancer, incorporated herein by reference, not including any later editions or amendments thereof.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.5** Procedure for Reporting {#sec-216-ricr-10-10-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.5}
A.Each health care facility and/or health care provider shall submit a set of available information on reportable cases within thirty (30) to forty-five (45) days from the date of a case first seen by provider (including but not limited to: patient demographic information, date of diagnosis, primary site, histology, behavior, tumor identifier, tumor sequence number, and facility/provider information), as defined in § 2.2 of this Part, and specified by the Rhode Island Cancer Registry.
B.Within one hundred eighty (180) days from the date of a reportable case first seen by provider as defined in § 2.2 of this Part, a health care facility and/or health care provider shall report complete all required information, as specified by the Rhode Island Cancer Registry. The originating health care facility and/or provider shall retain a duplicate copy of submitted information for a two (2) year period from the date of submission. Said information and data shall be submitted in a manner consistent with § 2.4 of this Part.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.6** Validation of Data {#sec-216-ricr-10-10-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.6}
A.To ensure the accuracy of the data and the completeness of reporting, the Administrator is authorized to review periodically patients' medical records and all other sources of patient information, including but not limited to, pathology reports or logs, cytology reports or logs, disease indexes, operating room logs, or radiation therapy logs, as may be necessary to substantiate the accuracy of the data and the completeness of reporting.
1.Nothing under the provisions of the Acts and this Part shall be construed to compel any individual to submit to physical examination or medical supervision.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.7** Confidentiality {#sec-216-ricr-10-10-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.7}
A.The Rhode Island Cancer Registry shall maintain comprehensive records of all reports of reportable cases submitted pursuant to the provisions of the Acts and the Rules and Regulations herein. Such reports shall be confidential in accordance with R.I. Gen. Laws Chapter 5-37.3 and subject to the restrictions on release incorporated therein.
1.The mutual exchange of cancer related data with neighboring States pursuant to reciprocal contracts for said purpose shall also be subject to the aforementioned statutory provisions on confidentiality.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.8** Ownership and Publication of Data {#sec-216-ricr-10-10-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.8}
All individual records and aggregate data relating to the Rhode Island Cancer Registry are the property of the Rhode Island Department of Health. The use of confidential records by any person shall be subject to the approval of the Director in accordance with applicable Federal and State law, Rules and Regulations regarding confidentiality and public access to data.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.9** Violations/Sanctions {#sec-216-ricr-10-10-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.9}
Failure of any health care facility and/or health care provider to comply with the provisions of the Acts and this Part, shall be subject to sanctions and referred to the appropriate licensing and/or disciplinary body.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
##### **216-RICR-10-10-2 § 2.10** Exception {#sec-216-ricr-10-10-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-2#2.10}
A.Modification of any individual requirement of this Part may be granted by the Director upon motion of the Rhode Island Cancer Registry or upon request of a contracting agency and/or organization in a specific case, if the Director finds that the modification to the requirement is not contrary to the purpose of the Rhode Island Cancer Registry nor contrary to the public interest.
1.A request for modification of a requirement shall require advance written request to the Director and written approval by the Director.
**History**
- *Amendment — effective from 2022-01-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/12/2022*
- *Amendment — effective from 2021-01-18 to 01/04/2022*
- *Amendment — effective from 2018-12-14 to 01/18/2021*
- *Amendment — effective from 2018-01-28 to 12/14/2018*
- *Amendment — effective from 2011-10-17 to 01/28/2018*
- *Periodic Refile — effective from 2002-01-02 to 10/17/2011*
#### **216-RICR-10-10-3** Rhode Island Birth Defects Registry
##### **216-RICR-10-10-3 § 3.1** Authority {#sec-216-ricr-10-10-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.1}
A.These regulations are promulgated pursuant to the authority conferred in R.I. Gen. Laws § 23-13.3-3(f), and are hereby adopted for the purpose of establishing a unified procedure for the reporting of birth defects of newborns and spontaneous fetal deaths to the Rhode Island Birth Defects Registry.
B.The Rhode Island General Assembly has found that birth defects are a major cause of infant deaths and childhood disabilities; and that early recognition and response to birth defects often prevents more serious effects; and that the epidemiological patterns of specific birth defects may provide keys to improved birth outcomes. An active birth defects surveillance and information system is essential to developing programs and disseminating information that can reduce birth defects and infant mortality. An active birth defects surveillance and information system serves to describe occurrence of birth defects in the newborn and children up to five; detect trends of morbidity and mortality, stimulate epidemiological research to diminish the impact of birth defects and infant mortality; and identify newborns and children with birth defects to intervene on a timely basis for treatment.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.2** Incorporated Materials {#sec-216-ricr-10-10-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.2}
These regulations hereby adopt and incorporate the National Center for Health Statistics' "International Classification of Diseases, 10th Revision Clinical Modification" (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.3** Definitions {#sec-216-ricr-10-10-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.3}
A.Where used in this Part, the following terms shall be construed as followed:
1."Act" means R.I. Gen. Laws Chapter 23-13.3.
2.“Birth defects” means structural and chromosomal abnormalities that affect the development of organs and tissues of an infant or child and may be identified during pregnancy, at birth or following birth before a child's fifth (5th) birthday. Possible causes or contributing factors to birth defects include genetics, environmental pollutants, occupational hazards, dietary factors, medications and personal behaviors.
3."Clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, radiobioassay, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings, and licensed pursuant to R.I. Gen. Laws Chapter 23-16.2.
4.“Council” means the Birth Defects Surveillance and Information Advisory Council.
5.“Department” means the Rhode Island Department of Health.
6.“Director” means the Director of the Department of Health.
7."Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services); rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free- standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, and physician ambulatory surgery centers and podiatry ambulatory surgery centers providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, outpatient clinics, infirmaries and health centers, school based health centers and neighborhood health centers. The term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-5.1, or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association).
8."Health care practitioner" means a physician, physician assistant, certified registered nurse practitioner, or midwife who provides primary care to children five (5) years of age and younger.
9.“Primary care” means the basic or general health care furnished by a practitioner who is responsible for the overall and ongoing coordination of a patient’s health care. In most instances, primary care is focused on the point at which a patient first seeks assistance from the health care system for non-emergency services.
10."Registrar of the Rhode Island Birth Defects Registry” hereinafter referred to as Registrar, means the person within the Department designated by the Director to be responsible for the operation of the Rhode Island Birth Defects Registry.
11."Rhode Island Birth Defects Registry" means the central registry established within the Department by the Director pursuant to the Act as the statewide registry for the collection and recording of information on certain cases of birth defects for the purpose of describing the occurrence of birth defects in the newborn and children up to five; detecting trends of morbidity and mortality, stimulating epidemiological research, diminishing the impact of birth defects and infant mortality; and identifying newborns and children with birth defects to intervene on a timely basis for treatment.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.4** General Reporting Requirements {#sec-216-ricr-10-10-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.4}
A.Due to increasingly timely and accurate detecting methods in the prenatal stages, all new cases of reportable birth defects as listed in § 3.5 of this Part diagnosed on and after July 1, 2016 in all unborn fetuses and children up to sixty (60) months (five years) of age shall be reportable by health care facilities, health care practitioners, and clinical laboratories in accordance with the Act and this Part. Reporting is required for all children residing in Rhode Island.
B.The administrative officer, or his/her designee, of each health care facility, health care practitioner practice setting, or clinical laboratory shall be responsible for establishing the reporting procedures at that facility or practice setting. These procedures shall ensure that every case up to sixty (60) months [five (5 years)] of age that is diagnosed in the facility-operated inpatient or outpatient setting, by a health care practitioner, or by a clinical laboratory shall be reported to the Registry. If a child is transported to another facility, the health care facility, health care practitioner practice setting, or clinical laboratory at which the reportable diagnosis is first made shall be responsible for reporting. This reporting requirement also applies in cases where the child dies before the age of five (5) or in cases where the birth defect is corrected.
C.Within sixty (60) days from the date of diagnosis or confirmation of a new case of a reportable birth defect as listed in § 3.5 of this Part, a health care facility, health care practitioner, or clinical laboratory shall report in the manner specified by the Department all the information and data requested. The originating health care facility, health care practitioner, or clinical laboratory shall retain a duplicate copy of submitted information for a two (2) year period from the date of submission.
D.Nothing under the provisions of the Act and this Part shall be construed to compel any individual to submit to medical or Department examination or supervision.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.5** Reportable Defects {#sec-216-ricr-10-10-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.5}
A.Health care facilities and clinical laboratories shall report those defects identified by the “Q” codes listed in the publication entitled, “International Classifications of Diseases, 10th Revision, Clinical Modification” incorporated above at 3.2 of this Part, as well as the following selected codes: C09-11, C22, C56-58, C62, C64- 66, C68-69, C74-75, F84, H54, H90-919, P96.1, P04.41, and P04.4. The Q codes for birth defects are separated by the following body systems:
1.Q00-Q07 – Nervous System
2.Q10-Q18 – Eye, Ear, Face, and Neck Anomalies
3.Q20-Q28 – Cardiovascular System
4.Q30-Q34 – Respiratory System
5.Q35-Q37 – Orofacial Anomalies
6.Q38-Q45 – Digestive System
7.Q50-Q56 – Reproductive System
8.Q60-Q64 – Urinary System
9.Q65-Q79 – Musculoskeletal System
10.Q80-Q89 – Other Anomalies
11.Q90-Q99 – Chromosomal Abnormalities
B.The Birth Defects Registrar shall report those defects identified by the following selected codes listed in the publication entitled, “International Classifications of Diseases, 10th Revision, Clinical Modification” incorporated above in § 3.2 of this Part.
C.Each health care facility, health care practitioner, or clinical laboratory shall submit data in such a manner as to make uniform a system of periodic reporting and shall include no less than the following detailed statistical data and information:
1.Patient's full name; parent/guardian’s full name;
2.Street address, city or town, state and zip code at the time of diagnosis;
3.Date of birth;
4.Sex;
5.Ethnicity: Hispanic/Latino; Non-Hispanic/Latino;
6.Race: White; Black/African American; Asian/Pacific Islander; American Indian/Native Alaskan; Other;
7.Primary diagnosis (text and ICD-10 codes);
8.All applicable laboratory tests by which the primary diagnosis was determined;
9.Date, place and method of diagnosis;
10.Extent/nature of disease at diagnosis;
11.Medical record number;
12.Reporting facility;
13.Date of admission;
14.Source of information [type of medical record];
15.Primary physician;
16.Such other data as may be required by the Director.
D.Data and information on cases of birth defects shall be reported electronically or by US postal mail unless reporting by another means has been approved in writing by the Director.
E.Such data and information shall be abstracted from medical charts and other sources of patient information by personnel possessing, at a minimum, a basic working knowledge of medical terminology, human anatomy, and physiology.
F.Such data and information shall be coded in a manner specified by the Director.
G.Such data and information shall be submitted with sufficient narrative substantiation to allow a visual assessment of the accuracy of coded data and information.
H.The Department shall not require the reporting of information or entering of information into the birth defects surveillance and information system regarding birth defects of a child whose parents or legal guardian objects.
I.Parents and/or guardians shall have the right to prohibit the release of individually identifiable information on their children from the birth defects surveillance and information system, and shall have the right to prohibit being contacted by the birth defects surveillance program.
J.The Department shall provide timely notification to parents and/or guardians of their rights as stated above.
K.There shall be written documentation of a parent/guardian’s prohibition of the release of their child’s individually identifiable information from the birth defects surveillance and information system, or of their objection to the reporting or entering of their child's information into the birth defects surveillance and information system. Written documentation shall include, but not be limited to: a parent/guardian’s signature maintained on file by the Department, health care facility, clinical laboratory, or health care practitioner prohibiting release of the information by the Birth Surveillance Defects Program or contact by the Birth Defects Surveillance Program; or a note regarding the prohibition of reporting of information into the birth defects surveillance and information system entered into the child’s medical record by the attending health care practitioner.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.6** Validation of Data {#sec-216-ricr-10-10-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.6}
To ensure the accuracy of the data and the completeness of reporting, the Registrar is authorized to review periodically patients' medical records and all other sources of patient information, including but not limited to, disease/diagnosis indices, labor and delivery logs, nursery log, newborn intensive care unit log, pediatric log, pediatric intensive care log, stillborn log, pathology/autopsy log, ultrasound reports, or cytogenetic reports as may be necessary to substantiate the accuracy of the data and the completeness of reporting.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.7** Confidentiality {#sec-216-ricr-10-10-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.7}
A.The birth defects surveillance and information system shall maintain comprehensive records of all reports submitted pursuant to the Act and this Part. These reports shall be confidential in accordance with R.I. Gen. Laws Chapter 5-37.3 and subject to the restrictions on release incorporated in that Chapter. Provided, however, any such information shall be available only for the purposes of the Act, and any data requested for demographic or epidemiological studies shall be provided in a format without individually identifiable information.
B.All individual records and aggregate data including abstract report forms relating to the Rhode Island Birth Defects Registry are the property of the Department. The use of records and aggregate data by any person shall be subject to the approval of the Director. Furthermore, requests for access to data compiled pursuant to the provisions of this Part may be granted only by the Director in accordance with applicable federal and state law, rules and regulations regarding confidentiality and public access to data.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.8** Violations/Sanctions {#sec-216-ricr-10-10-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.8}
Failure of any health care facility or clinical laboratory to comply with the provisions of the Act and this Part shall be subject to sanctions and referred to the appropriate licensing and/or disciplinary body.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
##### **216-RICR-10-10-3 § 3.9** Exception and Severability {#sec-216-ricr-10-10-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-3#3.9}
A.Modification of any individual rule and regulation of this Part may be granted by the Director upon motion of the Registrar or upon request of a contracting agency and/or organization in a specific case, if the Director finds that the modification to the rule is not contrary to the purpose of the Rhode Island Birth Defects Registry nor contrary to the public interest. A request for modification of a rule shall require advance written request to the Director and written approval by the Director.
B.If any provision of this Part or the application thereof to any facility or provider or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of this Part which can be given effect, and to this end the provisions of this Part are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-10-14 to 01/04/2022*
- *Technical Revision — effective from 2017-03-08 to 10/14/2019*
- *Technical Revision — effective from 2017-03-08 to 03/08/2017*
- *Amendment — effective from 2017-03-08 to 03/08/2017*
- *Adoption — effective from 2005-11-29 to 03/08/2017*
#### **216-RICR-10-10-4** Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry
##### **216-RICR-10-10-4 § 4.1** Authority {#sec-216-ricr-10-10-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.1}
This Part pertaining to the Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry is promulgated pursuant to the authority conferred in R.I. Gen. Laws § 23-1-49 for the purpose of establishing a unified procedure for the reporting of traumatic brain injuries and spinal cord injuries to the Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry maintained by the Rhode Island Department of Health.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.2** Incorporated Materials {#sec-216-ricr-10-10-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.2}
This Part hereby adopts and incorporates the International Classification of Diseases, 10th Revision, Clinical Modification (ICD–10–CM) (2015), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.3** Definitions {#sec-216-ricr-10-10-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.3}
A.Wherever used in this Part, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws § 23-1-49.
2.“Traumatic brain injury” means all injuries codes: F07.81,S02.0, S02.1,S02.5XXA, S02.8,S02.91,S04.02, S06, S07.1, S09.90XA, and T74.4 as defined by the International Classification of Diseases, 10th Revision, Clinical Modification (ICD–10–CM) (2015), incorporated above at § 4.2 of this Part.
3.“Spinal cord injury” means all injuries codes: S14.0, S24.0, and S34.0 as defined by the International Classification of Diseases, 10th Revision, Clinical Modification (ICD–10–CM) (2015), incorporated above at § 4.2 of this Part.
4.“Department” means the Rhode Island Department of Health.
5.“Director” means the Director of the Department of Health or their designee.
6."Hospital" means a facility licensed in Rhode Island with a governing body, an organized medical staff and a nursing service providing equipment and services primarily for inpatient care to persons who require definitive diagnosis and treatment for injury, illness or other disabilities or pregnancy. A hospital shall provide psychiatric and/or medical and/or surgical care and at least the following services: dietetic, infection control, medical records, laboratory, pharmaceutical and radiology, except that a psychiatric facility need not provide radiology services.
7."Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry" or "Registry" means the central registry established within the Department by the Director pursuant to the Act as the statewide registry for the collection and recording of information on all cases of traumatic brain injuries and spinal cord injuries for the purpose of describing the occurrence of traumatic brain injury and spinal cord injury among Rhode Islanders; detecting trends of morbidity and mortality, stimulating epidemiological research, diminishing the impact of these injuries; and identifying survivors of these injuries in order to intervene on a timely basis for treatment.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.4** General Reporting Requirements {#sec-216-ricr-10-10-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.4}
A.All newly diagnosed traumatic brain and/or spinal cord injuries and the submission of any specified additional information on reported injuries that the Director deems necessary and appropriate for the recognition, prevention, or control of those injuries shall be reported to the Department in the manner described herein.
1.All cases of traumatic brain injury and spinal cord injury as listed in § 4.5 of this Part diagnosed on and after July 1, 2007 shall be reportable by hospitals in accordance with the statutory and regulatory provisions herein. Reporting is required for all such injuries occurring in Rhode Island.
2.The administrative officer, or his/her designee, of each hospital shall be responsible for establishing the reporting procedures at that facility. These procedures shall ensure that every case that is diagnosed either in the facility-operated inpatient or emergency department shall be reported to the Registry. Cases wherein death occurs prior to discharge from the facility shall also be reported to the Registry.
3.Within fourteen (14) days from the date of diagnosis or confirmation of a new case of a reportable traumatic brain injury or spinal cord injury as listed in § 4.5 of this Part, a hospital shall report in the manner specified by the Department all the information and data requested. The originating hospital shall retain a duplicate copy of submitted information for a two (2) year period from the date of submission.
4.Nothing under the provisions of the Act and this Part herein shall be construed to compel any individual to submit to medical or Departmental examination or supervision.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.5** Reportable Injuries {#sec-216-ricr-10-10-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.5}
A.Hospitals shall report those injuries identified by the following selected codes listed in the publication entitled, “International Classifications of Diseases, 10th Revision, Clinical Modification” as incorporated above at § 4.2 of this Part:
1.Traumatic Brain Injury
a.F07.81 Post-concussional syndrome
b.S02.0 Fracture of vault of Skull
c.S02.1 Fracture of base of Skull
d.S02.8 Fracture of other specified skull and facial bones
e.S02.9 Fracture unspecified fracture of skull and facial bones
f.S04 Injury of Cranial Nerve
g.S06 Intracranial Injury
h.S07.1 Crushing injury of skull
i.T74.4 Shaken Infant Syndrome
j.S09.90XA unspecified injury of head, initial encounter
2.Spinal Cord Injury
a.S14.0 Concussion and edema of cervical spinal cord
b.S24.0 Concussion and edema of thoracic spinal cord
c.S34.0 Injury of lumbar and sacral spinal cord and nerves at abdomen, lower back and pelvis level
B.Each hospital shall submit data in such a manner as to make uniform a system of periodic reporting and shall include no less than the following detailed statistical data and information:
1.Patient’s full name;
2.Social Security number;
3.Street address, city or town, state and zip code at the time of diagnosis;
4.Date of birth;
5.Sex;
6.Ethnicity: Hispanic or Latino; Non-Hispanic or Latino;
7.Race: White; Black or African American; Asian; American Indian or Alaska Native; Native Hawaiian or Pacific Islander; Other;
8.Date of injury;
9.Date of admission;
10.Date of discharge;
11.Place of incident (ICD-10 Place of Occurrence codes Y92);
12.Traumatic Brain/Spinal Cord Injury related diagnosis (ICD-10 CM codes and description as stated above);
13.Other diagnosis codes (ICD-10 CM codes and descriptions);
14.Cause of injury (ICD-10 CM external cause codes V00-Y99);
15.Initials of person completing the form;
16.Type of discharge (code specified on form);
17.Hospital code;
18.Patient medical record number; and,
19.Date form completed.
C.Data and information on cases of traumatic brain injury/spinal cord injury shall be reported electronically or by United States postal mail unless reporting by another means has been approved in writing by the Director.
D.Such data and information shall be abstracted from medical charts and other sources of patient information by personnel possessing, at a minimum, a basic working knowledge of medical terminology, human anatomy, and physiology.
E.Such data and information shall be coded in a manner specified by the Director.
F.Such data and information shall be submitted with sufficient narrative substantiation to allow a visual assessment of the accuracy of coded data and information.
4.5.1Rights of Survivors/Parents/Legal Guardians
A.The Department shall remove personal identifying information from the Registry upon request of the traumatic brain injury/spinal cord injury survivor or legal guardians. The survivor or legal guardian shall also have the right to prohibit being contacted by the Department.
B.The Department shall provide timely notification to survivors or legal guardians of their rights as stated above.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.6** Confidentiality {#sec-216-ricr-10-10-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.6}
The Traumatic Brain Injury and Spinal Cord Injury Registry shall maintain comprehensive records of all reports submitted pursuant to the Act and this Part herein. These reports shall be confidential in accordance with R.I. Gen. Laws Chapter 5-37.3 and subject to the restrictions on release incorporated in that Chapter.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.7** Ownership and Publication of Data {#sec-216-ricr-10-10-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.7}
All individual records and aggregate data including abstract report forms relating to the Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry are the property of the Department. The use of records and aggregate data by any person shall be subject to the approval of the Director. Furthermore, requests for access to data compiled pursuant to the provisions of this Part may be granted only by the Director in accordance with applicable federal and state law, and rules and regulations regarding confidentiality and public access to data.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.8** Violations/Sanction {#sec-216-ricr-10-10-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.8}
Failure of any hospital to comply with the provisions of the Act and this Part herein shall be subject to sanctions and referred to the appropriate licensing and/or disciplinary body. If the hospital is aggrieved by the action of the licensing agency, the hospital may appeal the decision and request a hearing in accordance Part 05-4 of this Chapter, Practices and Procedures Before the Rhode Island Department of Health.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.9** Exception and Severability {#sec-216-ricr-10-10-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.9}
Modification of any individual rule and regulation herein may be granted by the Director upon motion of the Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry or upon request of a contracting agency and/or organization in a specific case, if the Director finds that the modification to the rule is not contrary to the purpose of the Rhode Island Traumatic Brain Injury and Spinal Cord Injury Registry nor contrary to the public interest. Provided, however, modifications shall not be made to the confidentiality protections contained in §§ 4.5.1, 4.6 and 4.7 of this Part.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
##### **216-RICR-10-10-4 § 4.10** Severability {#sec-216-ricr-10-10-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-4#4.10}
If any provision of this Part herein or the application thereof to any facility or provider or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of this Part which can be given effect, and to this end the provisions of the Part are declared to be severable.
**History**
- *Amendment — effective from 2026-09-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 09/02/2026*
- *Technical Revision — effective from 2007-05-17 to 01/04/2022*
- *Adoption — effective from 2007-05-17 to 05/17/2007*
#### **216-RICR-10-10-5** Rhode Island All-Payer Claims Database
##### **216-RICR-10-10-5 § 5.1** Authority {#sec-216-ricr-10-10-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17.17-4(b) and are established for the purpose of defining the reporting requirements for health plans and Insurers to submit data and information to the Rhode Island All-Payer Claims Database (APCD), and to define the parameters for release of data, including the administrative process for release in a manner that maximizes public access while adhering to the highest standards of data privacy and security as permitted by applicable State and Federal law.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.2** Definitions {#sec-216-ricr-10-10-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Alternative payment model (APM) file” means a data file composed of payments made to providers outside of the traditional fee-for-service (FFS) model. For example, alternative payment models may include, but are not limited to, pay for performance/penalty, shared savings/shared risk, global budget, limited budget, and capitation. Alternative payment models may also include FFS payments which are settled or reconciled under a certain alternative payment model category. The APM file also includes all payments made to providers under the traditional FFS model. In accordance with R.I. Gen. Laws § 23-17.17-9(e), the APM file shall not include trade secrets as defined in R.I. Gen. Laws § 6-41-1(4).
2.“Applicant” means an individual or organization that requests health care claims data set and information in accordance with the procedures and requirements instituted by the Department pursuant to this Part.
3.“Data aggregator” means a vendor selected by the Director that has a contract to act on behalf of the Department to collect and process health care claims data on behalf of the Director.
4.“Department” means the Rhode Island Department of Health.
5.“Dental claims file” means a data file composed of service-level remittance information for all submitted and non-denied adjudicated claims for each billed dental service, including but not limited to Member Encrypted Unique Identifier, provider information, charge/payment information, and dental procedure codes.
6.“Director” means the Director of the Department of Health or his or her duly authorized designee.
7.“Direct personal identifier” means any information, as to a Member, other than case or code numbers used to create anonymous or encrypted data, that plainly discloses the identity of an individual, including:
a.Names;
b.Street addresses (other than town or city, State and five (5) digit ZIP code);
c.Telephone numbers;
d.Fax numbers;
e.Electronic mail addresses;
f.Social Security numbers;
g.Medical record numbers;
h.Health plan beneficiary numbers;
i.Patient account numbers;
j.Certificate license numbers;
k.Vehicle identifiers and serial numbers, including license plate numbers;
l.Device identifiers and serial numbers;
m.Uniform resource locators (URL);
n.Personal Internet protocol (IP) addresses;
o.Biometric identifiers, including finger and voice prints; and
p.Full face photographs (or comparable images).
8.“Disclosure” means the release, transfer, provision of access to, or divulging in any other manner of information outside the entity holding the information.
9.“Encrypted unique identifier” means a code or other means of record identification to allow each Patient, Member or enrollee to be tracked across the data set, including across payers and over time, without revealing Direct Personal Identifiers. Encrypted Unique Identifiers are assigned to each Patient, Member or enrollee in order that all Direct Personal Identifiers can be removed from the data when data is submitted. Using the Encrypted Unique Identifier, all records relating to a Patient, Member or enrollee can be linked for analytical, public reporting and research purposes without identifying the Patient, Member or enrollee.
10.“Encrypted unique identifier vendor” means a vendor selected and approved by the Director to collect demographic data only from Insurers, assign an Encrypted Unique Identifier to each Patient, Member, or enrollee, and transmit that identifier to the Insurer.
11.“Hashing” means a one (1) way method by which the true value of data has been transformed (through the conversion of the information into an unrecognizable string of characters) in order to prevent the identification of persons or groups. True value of hashed elements is deliberately non-recoverable by any recipient, including the Data Aggregator.
12.“Health benefit plan” means a policy, contract, certificate or agreement entered into, or offered by an Insurer to provide, deliver, arrange for, pay for or reimburse any of the costs of health care services.
13.“Health care claims data set” means a collection of individual claims-based data files, including Dental Claims File, Medical Claims Files, Pharmacy Claims Files, Member Eligibility Files and Provider Files, whether in electronic or manual form.
14.“Health care facility” means the same meaning as contained in R.I. Gen. Laws Chapter 23-17 and the Regulations promulgated pursuant to that Chapter.
15.“Health care provider” means any person or entity licensed to provide or lawfully providing health care services, including, but not limited to, a physician, hospital, intermediate care facility or other Health Care Facility, dentist, nurse, optometrist, podiatrist, physical therapist, psychiatric social worker, pharmacist or psychologist, and any officer, employee, or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health care services.
16.“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing Regulations (45 C.F.R. Parts 160 through 164).
17.“Insurer” means any entity subject to the insurance laws and Regulations of Rhode Island, that contracts or offers to contract to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services and/or dental services, including, without limitation, an insurance company offering accident and sickness insurance, a health maintenance organization, as defined by R.I. Gen. Laws § 27-41-1, a nonprofit hospital or medical service corporation, as defined by R.I. Gen. Laws Chapters 27-19 and 27-20, or any other entity providing a plan of health insurance or health benefits. For the purpose of this Part, a third (3rd) party Payer, third (3rd) party Administrator, Pharmacy Benefits Manager or Medicare or Medicaid health plan sponsor is also deemed to be an Insurer.
18.“Medical claims file” means all submitted and non-denied adjudicated claims for each billed service paid by an Insurer as defined in § 5.2(A)(16) of this Part on behalf of a Member as defined in § 5.2(A)(18) of this Part regardless of where the service was provided. This data file includes but is not limited to service level remittance information including, but not limited to, Member Encrypted Unique Identifier, provider information, charge/payment information, and clinical diagnosis/procedure codes as described further in the RIAPCD Technical Specification Manual.
19.“Member” means a Rhode Island resident who is a Subscriber and any spouse or dependent who is covered by the Subscriber’s policy under contract with an Insurer. The term also includes Members of a small employer health insurance plan as defined by R.I. Gen Laws § 27-50-3 regardless of the State of residency of the Member.
20.“Member eligibility file” means a data file composed of demographic information for each individual Member eligible for medical or pharmacy benefits as specified in the RIAPCD Technical Specification Manual, for one (1) or more days of coverage at any time during the reporting month.
21.“Patient” means any person in the data set that is the subject of the activities of the claim submitted to and/or paid by the Insurer or covered by the health benefits plan.
22.“Personal health information” means information, as to a Member, about health status or provision of healthcare, including demographic information, medical history, test and laboratory results, insurance information and other data that a healthcare professional collects to identify an individual and determine appropriate care.
23.“Pharmacy benefits manager” or “PBM” means any person or entity that develops or manages pharmacy benefits, pharmacy network contracts, or the pharmacy benefit bid process pursuant to a contract held with an Insurer for the provision of such services.
24.“Pharmacy claims file” means a data file composed of service-level remittance information including, but not limited to, Member demographics, provider information, charge/payment information, and national drug codes from all submitted and non-denied adjudicated claims for each prescription filled.
25.“Provider file” means a data file composed of provider information for each provider included on a medical, pharmacy or dental claim submitted during the reporting period, regardless of the type of provider or location where the services were provided, as specified in the RIAPCD Technical Specification Manual.
26.“Rhode Island all-payer claims database” or “RIAPCD” means a health care quality and value database for the collection, management and reporting of eligibility, claims and provider data submitted pursuant to R.I. Gen. Laws Chapter 23-17.17.
27.“RIAPCD technical specification manual” means the document entitled RIAPCD Technical Specification Manual Version 1.6 issued by the Department, or its contracted agent, that sets forth the required data file format, record specifications, data elements, definitions, code tables and edit specifications.
28.“Subscriber” means the individual responsible for payment of premiums to an Insurer or whose employment is the basis for eligibility for Membership in a Health Benefit Plan.
29.“Third-party administrator” or “TPA” means any person with a certificate of authority, issued pursuant to R.I. Gen Laws § 27-20.7-12, who directly or indirectly solicits or effects coverage of, underwrites, collects charges or premiums from, or adjusts or settles claims on Members, pursuant to R.I. Gen. Laws § 27-20.7-2(1).
30.“Third-party payer” means a State agency that pays for health care services, or an insurer, carrier, including a carrier that provides only administrative services for plan sponsors, nonprofit hospital, medical services organization, or managed care organization licensed in Rhode Island.
31.“User” means any person who the Department has authorized to access and use data from the Rhode Island All-Payer Claims Database.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.3** General Provisions {#sec-216-ricr-10-10-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.3}
5.3.1Applicability
Unless specifically exempted pursuant to § 5.3.2 of this Part, this Part applies to all Insurers, as defined in § 5.2(A)(16) of this Part.
5.3.2Exemptions
A.The requirements of this Part shall not apply to:
1.An Insurer that on January 1 of a reporting year has less than three thousand (3,000) enrolled or covered Members; or
2.Insurance coverage providing benefits for:
a.Hospital confinement indemnity;
b.Disability income;
c.Accident only;
d.Long-term care;
e.Medicare supplement;
f.Limited benefit health insurance as defined by R.I. Gen. Laws § 27-50-3(x);
g.Specified disease indemnity;
h.Sickness or bodily injury or death by accident or both; or
i.Other limited benefit policies, including but not limited to those exempt from the application of R.I. Gen. Laws § 27-50-3 pursuant to subsection (t)(2) through (4) of that statute.
5.3.3Optional Consent
A.A covered Insurer must permit enrolled or covered Members to “opt out” of having any information or health care claims relating to them submitted to the RIAPCD.
1.The State will contract with a commercial vendor to operate a secure online portal to administer members’ opt-out requests. The online portal will be available twenty-four (24) hours a day, except for scheduled maintenance time, and will allow members to opt-out, opt back in, and check the status of their opt-out request.
2.The State will also offer a toll-free telephone number that members can call to opt-out over the phone.
3.Each covered Insurer shall notify all existing or new members of the option to opt-out via the secure portal or the toll-free telephone number, prior to submitting any of the members’ data to the RIAPCD. Each member must be notified of the opt-out provision at least once during their membership duration.
4.The method of notifying members of the opt-out provision will be at the discretion of each covered Insurer. Insurers may follow existing business practices to provide this notification.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.4** Confidentiality {#sec-216-ricr-10-10-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.4}
5.4.1Access to RIAPCD Information
A.Health Care Claims Data Sets and any other information submitted pursuant to this Part, by and between Insurers, the RIAPCD, the Data Aggregator, and the Encrypted Unique Identifier Vendor:
1.Shall not be a public record as defined pursuant to R.I. Gen. Laws § 38-2-2. No Disclosure of any RIAPCD data set(s) or health information shall be made unless specifically authorized by the Director pursuant to this Part and as otherwise may be prescribed by law or Regulation.
2.Shall be transmitted in accordance with the Rules adopted in HIPAA (45 C.F.R. Parts 160 through 164), Confidentiality of Health Care Communications and Information Act (R.I. Gen. Laws Chapter 5-37.3) and other applicable law(s).
5.4.2Removal of Direct Personal Identifiers
All Health Care Claims Data Sets submitted to the Department or Data Aggregator pursuant to § 5.5 of this Part shall be protected by the removal or Hashing of all Direct Personal Identifiers. The Department or Data Aggregator shall not collect any data containing Direct Personal Identifiers.
5.4.3Encrypted Unique Identifier
A.As part of the Health Care Claims Data Set, Insurers shall submit a Member Eligibility File, as specified in the RIAPCD Technical Specification Manual, for each of its Members to the Encrypted Unique Identifier Vendor to effectuate this requirement in accordance with the timeline outlined in § 5.6.2 of this Part. Under no circumstances shall the Insurer submit any Personal Health Information to the Encrypted Unique Identifier Vendor at any time or for any reason. Only Member demographic information, devoid of all Personal Health Information of any kind, shall be submitted to the Encrypted Unique Identifier Vendor.
1.Demographic data elements include but are not limited to: Member name, date of birth, Social Security number if available and date of enrollment.
2.The Encrypted Unique Identifier Vendor shall assign each Member an Encrypted Unique Identifier and transmit that information to the Insurer.
3.The Encrypted Unique Identifier Vendor shall maintain records wholly separately from the Director, the Department, the Data Aggregator and the RIAPCD as defined by R.I. Gen. Laws Chapter 23-17.17 and referenced by R.I. Gen. Laws § 23-17.17-10(b).
4.Notwithstanding any contractual arrangements, any Member’s Direct Personal Identifiers sent by an Insurer to the Encrypted Unique Identifier Vendor shall not be shared with any other party including the Department, the Director, the Data Aggregator or with the RIAPCD.
5.Data which is required to be sent to the Encrypted Unique Identifier Vendor by the Insurers shall not be considered data collected by the Department, the Director, the Data Aggregator or the RIAPCD.
5.4.4Transmission of Encrypted Unique Identifier to Insurers
A.The Encrypted Unique Identifier vendor shall provide the Encrypted Unique Identifier assigned to a Member to the Insurer of record for that Member. Prior to sending data sets to the Data Aggregator, the Insurer shall attach the assigned Encrypted Unique Identifier to each record. Prior to transmitting the data sets and Encrypted Unique Identifier to the Data Aggregator, all Direct Personal Identifiers shall be removed and/or hashed.
1.The Insurer and/or payer shall maintain a record of the assignment of the Encrypted Unique Identifier assigned to each Member in such a way that would permit an audit or ongoing maintenance by the Director if necessary. Under no circumstance shall such audit or ongoing maintenance allow the Department, the Director, the Data Aggregator, or the RIAPCD to re-identify a Member.
2.The Insurer and/or payer being audited may request that such audit include a third (3rd) party review of the Unique Encrypted Identifier Vendor’s process for assignment and transmission of the Encrypted Unique Identifier assigned to each Member of that submitter. However, approval of a third (3rd) party review shall be at the sole discretion of the Director.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.5** Submission Requirements {#sec-216-ricr-10-10-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.5}
5.5.1Specific Submission Requirements
A.Except as specifically exempted pursuant to § 5.3.2 of this Part, each Insurer shall submit to the Director a Health Care Claims Data Set pursuant to § 5.5.3 of this Part and an APM File, pursuant to § 5.5.4 of this Part. The Health Care Claims Data Set shall include claims-line detail for all health care services provided to a Member, whether or not the health care was provided within Rhode Island. Such data shall include, but shall not be limited to, fully-insured and self-funded accounts, all commercial medical products for all individuals and all group sizes and Medicare or Medicaid health plans. Such data shall not include Direct Personal Identifiers. The APM File shall include all payments for Members under contracts sitused in Rhode Island. For contracts issued at the group level, the contract is considered sitused in the State where the contract is sold. For contracts that are issued at the individual level, the contract is considered sitused in the State where the individual resides.
1.Should the Insurer have insufficient information to populate a Provider File in compliance with § 5.5.3(E) of this Part for services provided to a Member by an out-of-State, out-of-network provider, the Insurer may omit the Provider File from an otherwise complete health care claims data set file submission.
2.Each Insurer shall also be responsible for the submission of all health care claims data and APM File data processed by any sub-contractor on its behalf unless such sub-contractor is already submitting the identical data as an Insurer in its own right.
3.The Health Care Claims Data Set submitted shall include, where applicable, a Member Eligibility File, not including any Direct Personal Identifiers, but utilizing the Unique Encrypted Identifier assigned to the Member, covering every Member enrolled during the reporting month whether or not the Member utilized services during the reporting period, and a Provider File, to be defined in the RIAPCD Technical Specification Manual.
4.The data submitted shall also include supporting definition files for payer specific provider specialty taxonomy codes and procedure and/or diagnosis codes.
B.The Health Care Claims Data Sets and APM File shall be submitted to the Data Aggregator in the format required in the RIAPCD Technical Specification Manual.
1.All Health Care Claims Data Sets submitted to the Data Aggregator will have a Unique Identifier attached and shall be protected by the removal or Hashing of all Direct Personal Identifiers.
C.Insurers shall transmit the required Health Care Claims Data Sets and APM File by means of a secure file transfer system to the Data Aggregator in a manner that is fully compliant with HIPAA and applicable Rhode Island statutes and Regulations.
5.5.2RIAPCD Contact and Enrollment Update Form
A.Each Insurer shall submit to the Director or his or her designee by December 31st of each year, in a format outlined in the RIAPCD Technical Specification Manual, a contact and enrollment update form indicating if health care claims are being paid for Members and, if applicable, the types of coverage and estimated enrollment for the following calendar year.
B.It shall be the responsibility of the Insurer to resubmit or amend the form whenever modifications occur relative to the health care claims data set files, type(s) of business conducted, or contact information.
5.5.3Health Care Claims Data Set Files to be Submitted
A.Medical Claims File: Insurers shall submit data files consistent with the definition contained in § 5.2(A)(17) of this Part. As detailed in the RIAPCD Technical Specification Manual, payers shall report information about services provided to Members under all reimbursement arrangements, including but not limited to fee for service, capitated arrangements, and any other claims-based payment methods.
B.Pharmacy Claims File: Insurers shall submit data files consistent with the definition contained in § 5.2(A)(23) of this Part for all pharmacy paid claims for covered pharmacy benefits that were actually dispensed to Members.
C.Dental Claims File: Insurers shall submit data files consistent with the definition contained in § 5.2(A)(4) of this Part for all dental paid claims for covered dental benefits that were actually dispensed to Members.
D.Member Eligibility File: Insurers shall submit data files consistent with the definition contained in § 5.2(A)(19) of this Part. As detailed in the RIAPCD Technical Specification Manual, payers shall report information on every Member enrolled during the reporting month whether or not the Member utilized services during the reporting period. This data submission shall not include the Member’s Direct Personal Identifiers. The submission will have a Unique Identifier attached and shall be protected by the removal or Hashing of all Direct Personal Identifiers.
E.Provider File: Insurers shall submit files consistent with the definition contained in § 5.2(A)(24) of this Part. As detailed in the RIAPCD Technical Specification Manual, payers shall report information that will uniquely identify Health Care Providers and allow retrieval of related information from Eligibility, Medical, and Pharmacy Claims Files.
1.Tax ID numbers shall be submitted as part of the dataset except in the case that a provider uses their personal Social Security number as their tax ID number in which case the tax ID number need not be submitted.
5.5.4Information Collected in Addition to the Health Care Claims Data Set
A.The Director may require Insurers to submit and periodically update information about the insurance product covering each Member, including covered services, market sector, plan characteristics, total premiums, deductibles, co-insurance and copayments as set forth in the RIAPCD Technical Specification Manual.
B.Alternative Payment Model File: Insurers shall submit annual APM files. As detailed in the RIAPCD Technical Specification Manual, payers shall report information on all payments made to providers, inclusive of those under the traditional FFS model, and contracts under payment arrangements outside of the traditional FFS model. In accordance with R.I. Gen. Laws § 23-17.17-9(e), the APM File shall not include trade secrets, as defined in R.I. Gen. Laws § 6-41-1(4).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.6** Technical Requirements {#sec-216-ricr-10-10-5-5.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.6}
5.6.1Code Sources and File Specifications
Only code sources and file specifications specified in this Part and/or the RIAPCD Technical Specification Manual shall be utilized in submission of the Health Care Claims Data Sets required pursuant to § 5.5 of this Part.
5.6.2Schedule for Submissions
A.Insurers shall submit information to the RIAPCD and the Encrypted Unique Identifier Vendor in the specified format in accordance with the following schedule:
1.Test Data Submissions
a.Within one hundred twenty (120) days of notification by the Department, or other date mutually agreed upon by the Department and Insurer, Insurers shall submit test files containing a month of representative Member Eligibility Files or as specified in the RIAPCD Technical Specification Manual to the Encrypted Unique Identifier Vendor.
b.The Encrypted Unique Identifier Vendor shall return the Member Eligibility File to the Insurer with an assigned Encrypted Unique Identifier within fifteen (15) days of a test file submission by an Insurer.
c.Within one hundred and fifty (150) days of notification by the Department, or other date mutually agreed upon by the Department and Insurer, Insurers shall submit part one of their test files containing a month of representative Member Eligibility Files, Medical Claims Files, Pharmacy Files, Dental Files, and Provider Files as specified in the RIAPCD Technical Specification Manual to the Data Aggregator.
2.Health Care Claims Data Set Historical Data Submissions
a.Within two hundred seventy (270) days of notification by the Department, or other date mutually agreed upon by the Department and Insurer, Insurers shall submit Member Eligibility Files as specified in the RIAPCD Technical Specification Manual to the Encrypted Unique Identifier Vendor.
b.The Encrypted Unique Identifier Vendor shall return the historical Member Eligibility File to the Insurer with an assigned Encrypted Unique Identifier within thirty (30) days of a submission of historical files by an Insurer. Within three hundred thirty (330) days of notification by the Department, or other date mutually agreed upon by the Department and Insurer, Insurers shall submit Member Eligibility Files, Medical Claims Files, Pharmacy Files, Dental Files, and Provider Files as specified in the RIAPCD Technical Specification Manual, to the Data Aggregator.
(1)This submission period may be extended within the discretion of the Director to up to three hundred sixty (360) days from notification by the Department, or other date mutually agreed upon by the Department and Insurer.
c.Submissions of additional Health Care Claims Data Sets for remaining dates of service for months up to thirty (30) days prior to three hundred thirty (330) days of notification by the Department shall be submitted according to a schedule provided within the RIAPCD Technical Specification Manual.
3.Health Care Claims Data Set Regular Data Submissions
a.Upon completion of Historical Data Submissions as required by § 5.6.2(A)(2) of this Part, Insurers shall commence Regular Data Submissions.
(1)The timeline for Regular Data Submissions shall commence with the next month following the completion of Historical Data Submissions.
b.Insurers shall submit a Member Eligibility File for each of its Members, as specified in the RIAPCD Technical Specification Manual, to the Encrypted Unique Identifier Vendor.
(1)Monthly data files are due twenty-one (21) business days after the month’s end.
(2)For example, files containing data relating to eligibility during September 2018 shall be submitted by October 30, 2018 (accounts for weekends and holidays).
c.The Encrypted Unique Identifier Vendor shall return the Member Eligibility File to the Insurer with an assigned Encrypted Unique Identifier within ten (10) business days of a regular data submission by an Insurer.
d.Effective upon ten (10) business days after the receipt of the Member Eligibility File from the Encrypted Unique Identifier Vendor, Insurers shall submit Member Eligibility Files, Medical Claims Files, Pharmacy Claims Files, Dental Claims Files, and Provider Files, as specified in the RIAPCD Technical Specification Manual, to the Data Aggregator.
(1)Monthly data files are due within ten (10) business days of receipt of the assigned Encrypted Unique Identifier by the Insurer.
(2)For example, files containing data relating to services paid during September 2018 shall be submitted to the Data Aggregator by November 29, 2018 (accounts for weekends and holidays).
e.Within five (5) business days of the Insurer’s submission to the Data Aggregator, the Insurer will submit data resubmissions as required by the Data Aggregator, which will communicate discrepancies, failures, and resubmissions.
4.Alternative Payment Model Test Data Submissions
Within one hundred fifty (150) days of notification by the Department, or other date mutually agreed upon by the Department and Insurer, Insurers shall submit their test files containing one (1) calendar year of representative APM Files, as specified in the RIAPCD Technical Specification Manual, to the Data Aggregator.
5.Alternative Payment Model Historical Data Submissions
a.Within three hundred thirty (330) days of notification by the Department, or other date mutually agreed upon by the Department and Insurer, Insurers shall submit three (3) calendar years of representative APM Files as specified in the RIAPCD Technical Specification Manual to the Data Aggregator.
(1)This submission period may be extended within the discretion of the Director to up to three hundred sixty (360) days from notification by the Department, or other date mutually agreed upon by the Department and Insurer.
6.Alternative Payment Model Regular Data Submission
a.Upon completion of Historical Data Submissions, Insurers shall commence Regular Annual Data Submissions.
(1)The Regular Annual Data Submissions shall commence the January following the Historical Data Submissions and shall be due by the last day of January each year thereafter.
(2)Each Regular Annual Data Submission shall include information on all payments made to providers, or contracts under payment arrangements outside of the traditional FFS model, made two (2) calendar years prior.
(3)For example, if Historical Data is submitted to the Data Aggregator on March 20th 2022, the first Regular Data Submission shall be due by the end of January 2023 and shall include all payments made to providers, or contracts under payment arrangements outside of the traditional FFS model made during calendar year 2021.
7.All Health Care Claims Data Sets submitted to the Data Aggregator will have a Unique Identifier attached and shall be protected by the removal of all Direct Personal Identifiers and/or hashed. The Department or Data Aggregator shall not collect any data containing Direct Personal Identifiers.
8.The Director has the authority within his or her discretion to modify the RIAPCD Technical Specification Manual to effect changes to the submissions schedule.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.7** Compliance with Data Standards {#sec-216-ricr-10-10-5-5.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.7}
5.7.1Standards
A.The Data Aggregator shall evaluate each Member Eligibility File, Provider File, Medical Claims File, Pharmacy Claims File, and Dental File in accordance with the following standards:
1.The applicable code for each data element shall be as identified in the RIAPCD Technical Specification Manual and shall be included within eligible values for the element;
2.Coding values indicating “data not available,” “data unknown,” or the equivalent shall not be used for individual data elements unless specified as an eligible value for the element;
3.The Encrypted Unique Identifier assigned to each Member shall be consistent across files; and
4.Files submitted to the Data Aggregator shall not contain Direct Personal Identifiers.
5.7.2Notification
Upon completion of this evaluation, the Director or his or her designee will notify each Insurer whose data submissions do not satisfy the standards for any reporting period. This notification will identify the specific file and the data elements that are determined to be unsatisfactory.
5.7.3Response
A.Each Insurer notified under § 5.7.2 of this Part shall resubmit within ten (10) business days of the date of notification with the required changes.
1.The Director shall have the discretion to require a response as required by this subsection in a reasonable time commensurate with the level of difficulty for the level of correction required to a data submission.
5.7.4Compliance
Failure to file, report, or correct Health Care Claims Data Sets in accordance with the provisions of this Part may be considered a violation of R.I. Gen. Laws Chapter 23-17.17 except that an Insurer may seek a variance as specified in § 5.10 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.8** Procedures for the Approval and Release of Data {#sec-216-ricr-10-10-5-5.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.8}
5.8.1Release Policies and Procedures
A.General Provisions
1.The Department may release RIAPCD data to a person or organization engaged in improving, evaluating, or otherwise measuring health care provided to Members.
2.The Department may provide pre-determined files at varying levels of detail to meet requests for RIAPCD data, per the procedures established by the Department, pursuant to this Part.
3.All Users of RIAPCD data, including Rhode Island State Agencies, shall adhere to the following privacy guidelines:
a.No User shall attempt to identify an individual Member using RIAPCD data, or data outputs derived from RIAPCD data.
b.RIAPCD data shall not be linked with any other data source that could potentially re-identify a member or patient.
c.All Users shall adhere to RIAPCD data display and reporting requirements when disclosing RIAPCD data or data outputs to the public or any person who has not been authorized as a User by the Department, as follows, and as specified in the Data Use Agreement entered into by the User and the Department:
(1)“Outputs” refers to any reports, analyses, displays, products, tables, manuscripts, presentations, and other data uses derived from APCD Data.
(2)All RIAPCD Data Outputs must adhere to CMS cell size suppression requirements for CMS Research Identifiable Files.
(3)Outputs must use complementary cell suppression techniques to ensure that observations in suppressed cells cannot be identified by manipulating data in the Output.
(4)Member-level records may not be disseminated or published in any form.
B.RIAPCD Public Reports
The Department may issue reports with aggregated RIAPCD data that adhere to RIAPCD data display and reporting requirements on the Department or another State Agency’s website.
C.Requests for RIAPCD Data
1.The Director or his or her designee may approve requests for reports with aggregated RIAPCD data.
2.The Director or his or her designee may approve requests for access to the RIAPCD by Rhode Island State Agencies under the Executive Office of Health and Human Services, the Office of the Health Insurance Commissioner (OHIC), and the Health Benefits Exchange (also known as HealthSource RI or HSRI), or from persons or organizations performing work on behalf of these agencies, subject to the terms of a Data Use Agreement.
a.All other requests for RIAPCD data shall require a written application that:
(1)Describes the intended purpose and justifies why de-identified data is necessary for the project and, if applicable, why more sensitive member-specific data elements such as service dates and member five (5) digit zip codes are necessary.
(2)Specifies the security and privacy measures that will be used to safeguard Member privacy and prevent unauthorized access to or use of the data.
(3)Describes how the results of the applicant’s analysis will be published and follow RIAPCD data display and reporting requirements, as specified in § 5.8.1(A)(3)(b) of this Part.
(4)Describes the steps the applicant will take to prevent re-identification of members if linking to other data sets.
b.The Department shall post all applications to the Department’s website for a minimum of ten (10) business days to invite written public comments on the applications. The Department shall not post those portions of applications that specify security measures or applications from law enforcement entities to the extent that posting the application on the website may impede the investigatory process. The Department shall have a mechanism for alerting interested parties when a new application is posted.
3.A Data Release Review Board or “Board” shall review requests for RIAPCD data and advise the Director on whether the final products of the proposed project present minimal risk of identification of Members.
a.The Board shall have a Chairperson and Members appointed by the Director. Board Members shall have demonstrated expertise in a diverse range of health care areas including, but not limited to, State and Federal privacy law and data security. The Board shall be comprised of eleven (11) to fifteen (15) Members and shall include but not be limited to:
(1)At least two (2) members representing Health Insurers;
(2)At least one (1) member representing Health Care Facilities;
(3)At least one (1) member representing Health Care Providers;
(4)At least one (1) member representing health care consumers;
(5)At least one (1) member representing a privacy protection advocacy organization;
(6)At least one (1) member representing researchers;
(7)At least one (1) member representing the Department;
(8)At least one (1) member representing OHIC;
(9)At least one (1) member representing EOHHS;
(10)At least one (1) member representing HSRI.
b.The Board shall provide a non-binding recommendation to the Director regarding requests for RIAPCD data.
c.The Board and Director, as part of their review, shall consider:
(1)Whether access to the requested data is necessary to achieve the proposed project’s intended goals;
(2)Whether the Applicant will adhere to the RIAPCD data display and reporting requirements in any data outputs;
(3)Whether the RIAPCD data will or could be linked to other data sets that could be used to re-identify an individual Member;
(4)Whether the appropriate privacy and security controls are in place to protect Member privacy; and
(5)Whether the Applicant is qualified to protect and responsibly handle the requested data.
d.The Director shall make a final decision to approve or deny requests for RIAPCD data. The Director’s decisions shall be final except as provided for in Rhode Island statute.
e.Upon approval of the request, the Applicant shall sign a Data Use Agreement specifying that the Applicant shall adhere to RIAPCD privacy guidelines and shall fully execute the approved data management plan, and that the Applicant shall not combine RIAPCD data with other data sets unless explicitly approved by the Director or his or her designee.
4.The fees for RIAPCD data sets that have been approved for release by the Department include the costs for programming and report generation, duplicating charges and other costs associated with the production and transmission of data sets.
a.Fees shall be deposited into a restricted receipt account to support costs of producing reports, program planning, management operations and infrastructure;
b.The Department and other State Agencies may issue reports that are available to the public at no charge;
c.The fees may be reduced or waived for the following entities at the discretion of the Department:
(1)CMS;
(2)Rhode Island State Agencies;
(3)Submitting Insurers; and
(4)Other entities that have extenuating circumstances that prevent them from paying the full fee.
d.The Department shall have a record of payment in full prior to providing data to approved Applicants.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.9** Compliance and Enforcement {#sec-216-ricr-10-10-5-5.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.9}
5.9.1Enforcement Options
A.The Director may pursue any combination of the following administrative and judicial enforcement actions, depending upon the circumstances and gravity of each case:
1.Compliance orders pursuant to R.I. Gen. Laws § 23-1-20;
2.Immediate compliance orders pursuant to R.I. Gen. Laws § 23-1-21;
3.Enforcement of compliance orders pursuant to R.I. Gen. Laws § 23-1-23; and
4.Criminal penalties pursuant to R.I. Gen. Laws § 23-1-25.
B.The imposition of one (1) or more remedies and/or penalties provided in § 5.9.1(A) of this Part shall not prevent the Director from jointly exercising any other remedy or penalty available to him or her by statute or Regulation.
C.Consent Agreement/Order
Nothing in this Part shall preclude the Director from resolving outstanding violations or penalties through a Consent Agreement or Consent Order at any time he or she deems appropriate.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.10** Variance Procedure {#sec-216-ricr-10-10-5-5.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.10}
The Department may grant a variance from the provisions of a Rule or Regulation in a specific case if it finds that enforcement of such provision will result in unnecessary hardship to the Applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of residents.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.11** Rules Governing Practices and Procedures {#sec-216-ricr-10-10-5-5.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.11}
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17.17 shall be held in accordance with the provisions of Subchapter 05 Part 4 of this Chapter, Practices and Procedures Before the Rhode Island Department of Health, and Subchapter 05 Part 1 of this Chapter, Access to Public Records.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
##### **216-RICR-10-10-5 § 5.12** Severability {#sec-216-ricr-10-10-5-5.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-5#5.12}
A.If any provision of this Part or their applicability to any person or circumstance shall be held invalid, such holding shall not affect the provisions or application of this Part that can be given effect, and to this end the provisions of this Part are declared to be severable.
B.If the effect of such a holding that a provision or application of this Part is invalid is to compromise any of the Member privacy or data security measures contained herein, such that Direct Personal Identifiers may be in any way put at risk of Disclosure, the Director shall have the authority, upon his or her discretion, to suspend the release of all Health Care Claims Data Set(s) and/or analytic files for a period of time sufficient to address such concerns.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Periodic Refile — effective from 2022-01-04 to 01/04/2022*
- *Amendment — effective from 2021-12-06 to 01/04/2022*
- *Technical Revision — effective from 2018-08-21 to 12/06/2021*
- *Amendment — effective from 2018-08-21 to 08/21/2018*
- *Adoption — effective from 2013-07-09 to 08/21/2018*
#### **216-RICR-10-10-6** Regional Health Information Organization and Health Information Exchange
##### **216-RICR-10-10-6 § 6.1** Authority {#sec-216-ricr-10-10-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.1}
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-37.7-5 for the purpose of establishing safeguards and confidentiality protections for the Health Information Exchange (HIE) in order to improve the quality, safety and value of health care, keep confidential health information secure and confidential and use the HIE to prevent disease and protect and promote the health and safety of the people of Rhode Island.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.2** Definitions {#sec-216-ricr-10-10-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 5-37.7 entitled, “The Rhode Island Health Information Exchange Act of 2008.”
2.“Administrative review” means the administrative processes contained in Practices and Procedures Before the Rhode Island Department of Health (Subchapter 05 Part 4 of this Chapter), and as otherwise permitted by the Administrative Procedures Act.
3."Authorized representative" means:
a.A person empowered by the patient participant to assert or to waive confidentiality, or to disclose or authorize the disclosure of confidential information, as established by this Part. That person is not, except by explicit authorization, empowered to waive confidentiality or to disclose or consent to the disclosure of confidential information; or
b.A person appointed by the patient participant to make health care decisions on his or her behalf through a valid durable power of attorney for health care as set forth in R.I. Gen. Laws § 23-4.10-2; or
c.A guardian or conservator, with authority to make health care decisions, if the patient participant is decisionally impaired; or
d.Another legally appropriate medical decision maker, temporarily, if the patient participant is decisionally impaired and no health care agent, guardian or conservator is available; or
e.If the patient participant is deceased, his or her personal representative or, in the absence of that representative, his or her heirs-at-law; or
f.A parent with the authority to make health care decisions for the parent's child; or
g.A person authorized by the patient participant or their authorized representative to access their confidential health information from the HIE, including family members or other proxies as designated by the patient, to assist patient participant with the coordination of their care.
4."Business associate" means a business associate as defined by HIPAA, and its implementing Regulations (45 C.F.R. Parts 160 through 164).
5."Confidential health information" means all identifiable information relating to a patient participant's health care history, diagnosis, condition, treatment, or evaluation.
6."Data submitting partner" means an individual, organization or entity that has entered into a business associate agreement with the RHIO and submits patient participants' confidential health information through the HIE.
7."Department" means the Rhode Island Department of Health.
8.“Director” means the Director of the Rhode Island Department of Health or his or her designee(s).
9."Disclosure report" means a report generated by the HIE relating to the record of access to, review of and/or disclosure of a patient's confidential health information received, accessed or held by the HIE.
10."Electronic mobilization" means the capability to move clinical information electronically between disparate health information systems while maintaining the accuracy of the information being exchanged.
11."Emergency" means the sudden onset of a medical, mental, or substance use, or other condition manifesting itself by acute symptoms of severity (e.g., severe pain) where the absence of medical attention could reasonably be expected, by a prudent layperson, to result in placing the patient's health in serious jeopardy, serious impairment to bodily or mental functions, or serious dysfunction of any bodily organ or part.
12."Gender markers" means the sex or gender designation recorded in a patient's medical records.
13."Health care provider" means any person or entity licensed by this State to provide or lawfully providing health care services, including, but not limited to, a physician, hospital, intermediate care facility or other health care facility, dentist, nurse, optometrist, podiatrist, physical therapist, psychiatric social worker, pharmacist or psychologist, and any officer, employee, or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health care services.
14."Health care services" means acts of diagnosis, treatment, medical evaluation, referral or counseling or any other acts that may be permissible under the health care licensing statutes of this State.
15."Health Information Exchange" or "HIE" means the technical system operated by the RHIO under State authority allowing for the statewide electronic mobilization of confidential health information, pursuant to the Act and this Part.
16."Health plan" means an individual plan or a group plan that provides, or pays the cost of, health care services for patient participants.
17."HIE Advisory Commission" means the advisory body established by the Department in order to provide community input and policy recommendations regarding the use of the confidential health information of the HIE.
18."HIPAA" means the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (45 C.F.R. Parts 160 through 164).
19.“HIPAA Final Omnibus Rule” means the HIPAA Regulations promulgated and effective March 25, 2013.
20.“HITECH” means the Health Information Technology for Economic and Clinical Health Act of 2009, Pub. Law 111-5 and its implementing Regulations.
21."Opt-out form" means the form described in § 6.5.4 of this Part and by which a patient participant revokes permission for the RHIO to allow provider participants access to, review of, and/or disclosure of the patient participant's confidential health information by electronic, written or other means.
22."Participant" means a patient participant, a patient participant's authorized representative, a provider participant, a data submitting partner, the regional health information organization, and the Department that has stored, submitted, accessed, and/or disclosed confidential health information via the HIE in accordance with the Act and this Part.
23."Participation" means a participant's authorization, submission, access and/or disclosure of confidential health information in accordance with the Act and this Part.
24."Patient matching" means the process of identification and linking of one (1) patient's data within and across the health systems at the RHIO in order to obtain a comprehensive view of that patient's health care record.
25."Patient participant" means a person who receives health care services from a provider participant and whose protected health information is included in the HIE through the mechanisms established in the Act and this Part.
26.“Protected health information” means individually identifiable health information including demographic information that is collected from an individual and is created or received by a health care provider, health plan, employer or health care clearinghouse that relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual that identifies the individual or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.
27."Provider participant" means a pharmacy, laboratory, health care provider, or health plan that is providing health care services or pays for the cost of health care services for a patient participant and/or is submitting or accessing health information through the HIE and has executed an electronic and/or written agreement regarding disclosure, access, receipt, retention or release of confidential health information to the HIE.
28."Public Health Authorities" means an agency or authority of the United States Government, a State, a Territory, a Political Subdivision of a State or Territory, or an Indian Tribe, that is responsible for public health matters as a part of its official mandate. With regards to this Regulation, this includes: the Rhode Island Department of Health (RIDOH), Executive Office of Health and Human Services (EOHHS), the Department of Children, Youth and Families (DCYF), and the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals (BHDDH).
29."Regional health information organization" or "RHIO" means the organization designated as the RHIO by the State of Rhode Island to provide administrative and operational support to the HIE.
30."Security incident" means a security event that results in a compromise to the confidentiality, integrity, or availability of RHIO network resources, including information system damage, network disruptions, or significant loss of vital business assets. A security event that results in the unauthorized disclosure of confidential data is also known as a security breach.
31.“Unanticipated events” means instances in which the provider participant is unavailable and another health care provider is providing coverage to treat the patient participant.
32.“Unsecured protected health information” means protected health information that is not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the United States Secretary of Health and Human Services in guidance issued under § 13402(h)(2) of Pub. Law 111-5.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.3** General Provisions {#sec-216-ricr-10-10-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.3}
6.3.1Participation in the Health Information Exchange (HIE)
A.A statewide Health Information Exchange (HIE) has been established pursuant to R.I. Gen. Laws Chapter 5-37.7. Confidential health information shall only be accessed, released or transferred from the HIE pursuant to R.I. Gen. Laws Chapter 5-37.7. In addition to the requirements set forth in R.I. Gen. Laws 5-37.7:
1.Patients and health care providers shall have the choice to participate in records-sharing via the HIE, as defined by the Act and this Part. Patient participants shall be able to rescind permission for disclosure to health care providers via the HIE ("opt out") by signing an opt-out form provided by the HIE. Patient participants may indicate his or her desire to opt out pursuant to § 6.5.1(A) of this Part and may subsequently reverse an opt-out decision pursuant to § 6.5.1(A)(5) of this Part.
2.Individuals shall be informed about the opportunity to opt out through provider participants and other publicly available means, and provider participants shall offer the opportunity to discuss HIE participation and consent options at the request of an individual patient. Individuals will be informed about the HIE through materials that explain the context and process of disclosure of health information through the HIE, including any and all choices available to the individual. The RHIO shall provide examples or templates of educational materials and any needed technical assistance to provider participants on patient education about the HIE.
3.When entering into a treating relationship with a provider participant or no later than six (6) months after a provider begins submitting records to the HIE, individuals will be clearly informed of their opportunity to opt-out in a distinct written document, whether paper, electronic, or web-based. The notification may be contained within a document detailing other privacy practices, but the HIE shall be specifically discussed. The notification shall include an explanation that due to his or her provider's participation in the HIE, at a minimum, their protected health information may be disclosed to:
a.Health care providers that care for them in emergencies, on a temporary basis;
b.Public health authorities in the process of carrying out their functions, pursuant to R.I. Gen. Laws § 5-37.7-7(b)(2); and
c.Health plans where information is necessary for care management, quality, and performance measure reporting.
4.Individuals shall be notified by provider participants of their opportunity to opt-out of participation in the HIE a minimum of sixty (60) days prior to opt-out policies going into effect ("go live"). This notification shall include all components specified in § 6.3.1(A)(3) of this Part, as well as clearly outline the methods available to complete an opt-out form as specified in § 6.5.1(A)(4) of this Part.
5.Mental health treatment information received from data submitting partners shall be included in the RHIO's repository of protected health information, and shall be subject to any opt-out form completed by a patient participant. Mental health treatment information shall not be stored or disclosed separately except as otherwise required by law or Regulation.
6.The RHIO shall maintain a dedicated telephone number staffed with qualified personnel who can respond to individuals’ questions related to any and all choices and processes available to the individual. If there are remaining concerns or complaints after contacting the RHIO, individuals can contact the Department of Health “Health Information Line.”
7.The RHIO shall maintain a process for reviewing and resolving complaints related to it, and to assist patient participants in resolving complaints.
a.The RHIO and all provider participants will accept complaints pertaining to the RI HIE. Provider participants will forward complaints to the RHIO.
b.The RHIO will appoint a Privacy Officer who will review all complaints. Complaints will not be public and will be kept confidential as required by law. Any confidential health information contained in the complaint will be protected in accordance with applicable State and Federal law.
c.Neither the RHIO nor provider participants will retaliate, discriminate against, intimidate, coerce or otherwise reprise patient participants or patient advocates relating to the filing of a complaint or for filing a complaint.
d.The RHIO will contractually require provider participants to comply with HIPAA, including establishing and implementing HIPAA compliant policies and procedures.
e.Patient participants may lodge a complaint with the provider participant directly, with the RHIO or with the Department of Health. If a complaint is lodged directly with the RHIO and the RHIO refers the patient participant to the provider participant and the provider participant cannot directly resolve the complaint or believes the complaint is in error, the patient participant may then submit it to the RHIO Privacy Officer for review and assistance as requested by the patient participant.
f.All patient participants lodging complaints directly with the RHIO will be directed to fill out a patient complaint form and will be given assistance if requested. If the complaint involves a provider participant, the RHIO will notify the provider participant if it addresses actions by the provider participant.
g.Any complaint regarding breach of security, if appropriate, may invoke the response to breach procedures by the RHIO.
h.The RHIO shall maintain copies of all written patient complaint forms.
i.The disposition of the complaint shall be documented by the RHIO Privacy Officer as part of the complaint process.
j.For complaints lodged directly to the Department, the Department will follow its usual process for investigating complaints and the complaint shall remain confidential to the public until it has been resolved. If applicable, once it is resolved, the Department will notify the RHIO Privacy Officer and/or provider participant. Any patient participant wishing to lodge a verbal complaint may do so by calling the Department of Health “Health Information Line.”
k.Any complaint lodged by a patient participant with the provider participant, the RHIO or the Department shall be resolved within thirty (30) days of submission.
l.The Department reserves the right to access the records of complaints received by the RHIO and the resolution of such complaints.
6.3.2Rhode Island Regional Health Information Organization (RHIO)
A.The RHIO shall function pursuant to R.I. Gen. Laws Chapter 5-37.7. Additionally, the RHIO shall develop, implement, and maintain current policies and procedures including, but not limited to, the following topics:
1.Participant process to opt out (health care provider, health plan, and individual) that is consistent with § 6.3.1(A)(1) of this Part;
2.Termination of a patient participant's opt out status that is consistent with § 6.5.1(A)(5) of this Part;
3.Handling patient participant complaints and inquiries that is consistent with § 6.3.1(A)(2) of this Part;
4.The process through which a patient participant can obtain a copy of his or her confidential health information from the HIE that is consistent with § 6.5.1(A)(1) of this Part;
5.The process through which a patient participant can obtain a copy of the disclosure report pertaining to his or her confidential health information consistent with § 6.5.1(A)(4) of this Part;
6.Patient participant requests to amend his or her own information through the provider participant consistent with § 6.3.3(A)(2) of this Part;
7.Tiered access to confidential health information (i.e., criteria and controls to obtain varying degrees of access to data maintained by the HIE) consistent with § 6.3.3 of this Part;
8.Privacy, confidentiality and security pertaining to access and maintenance of patient participant confidential health information consistent with §§ 6.5 and 6.6 of this Part;
9.Temporary access to HIE data by provider participants that need to treat a person in emergencies consistent with § 6.3.1(A)(3) of this Part. Temporary access procedures should be easily accessible to a variety of health care team members and not present an undue burden during a medical emergency;
10.Patient participant notification, if required by either R.I. Gen. Laws Chapter 11-49.3 [Rhode Island Identity Theft Protection Act of 2015] or the HIPAA Final Omnibus Rule, regarding a detected breach of the security of the system of the HIE that may have resulted in the unauthorized access, use or disclosure of protected health information, personal information or Unsecured Protected Health Information consistent with § 6.5.1(A)(5) of this Part; and
11.Patient matching, including patient participants who have opted out of disclosure to health care providers.
a.The RHIO shall ensure that each submitted opt-out form is reviewed for completeness, accuracy, and effective matching to previously submitted medical records by provider participants.
b.Additional attention shall be paid to gender markers in patient matching and, wherever practical, effort shall be expended to ensure identity resolution takes into account gender diverse experiences.
12.Ongoing identity management, including a simplified process by which patient or provider participants may notify the RHIO that specific patient records should undergo review.
13.Data integrity, quality, and standardization.
14.Handling of sensitive types of protected health information, including but not limited to behavioral health, Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), treatment for domestic violence or sexual assault, and genetic information.
B.The RHIO shall utilize a committee structure that encourages community involvement and transparency in the process of the development and implementation of its policies.
C.Patient participants have the right to access the RHIO’s notice of privacy practices which will be posted on the RHIO’s websites. The Notice of Privacy Practices will be written in plain language and will contain applicable information such as: the uses and disclosures of PHI through the HIE, patient participants’ individual rights, the RHIO’s responsibilities regarding the privacy of patient participants’ information and the complaint process.
D.In the event that the RHIO fails to comply with this Part or has policies that do not comply with Federal and State laws, Rules and Regulations, the Director may notify the RHIO by certified or registered mail or by personal service setting forth the failure(s) and the RHIO shall be given the opportunity to cure such failure within the time designated by the Director. If the RHIO does not cure the failure, the Department may invoke contractual remedies, require specific monitoring or supervision to occur, or limit or suspend actions of the RHIO until such time as the corrective action has cured the failure. The Department may also notify the Secretary of the United State Department of Health and Human Services and the Rhode Island Department of Attorney General if the Department of Health believes the failure to comply with this Part amounts to a HIPAA violation. The RHIO, or the Department may request a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9. Nothing in this Part shall limit the authority of the jurisdiction conferred upon the Department of Attorney General to bring an action against the RHIO pursuant to § 6.8 of this Part for a violation of this Part and/or HITECH.
E.In the event of the insolvency or involuntary dissolution of the RHIO, the assets and operations comprising the HIE, including the protection of the protected health information of the enrollees of the HIE, shall be transitioned or transferred in accordance with an Order of a court of proper jurisdiction.
F.In the event of a voluntary dissolution of the RHIO, the RHIO will give the Department thirty (30) days’ notice. The Department has a contractual right of first refusal to purchase only the assets comprising the HIE at the appraised value.
G.In the event of either of the above, the RHIO shall be responsible to safeguard the protected health information in its care, custody and control until the PHI has been transferred to another entity.
6.3.3Special Requirements Pertaining to the Health Information Exchange (HIE) and the Rhode Island Regional Health Information Organization (RHIO)
A.Pursuant to R.I. Gen. Laws § 5-37.7-4(e), the HIE and the RHIO have an obligation to maintain, and abide by the terms of, HIPAA-compliant business associate agreements, as well as:
1.The RHIO will maintain user access permission profiles to determine which PHI may be accessed by authorized users according to specific role classification and shall implement policies and procedures regarding user authentication;
2.In response to a request by a patient participant to make an amendment to his or her PHI contained in the HIE, the RHIO will provide the patient participant with a “Request to Amend Health Information” form to submit to the originating provider participant and if so, directed by the provider participant, will amend the record in accordance with HIPAA, the Act and this Part. The “Request to Amend Health Information” form shall be available from the RHIO website, by calling the RHIO, or by requesting the form in writing.
a.As soon as possible, but no later than sixty (60) days after receipt of a request from a patient participant to amend health information, the provider participant shall either forward the corrected information to the RHIO for processing or notify the patient participant, in writing, why the request to amend health information has been denied.
b.As soon as possible, but no later than thirty (30) days after receipt of a request from a provider participant to amend a confidential health care record, the RHIO/HIE shall process the request and notify the provider participant, in writing, that the requested amendment to health information has been completed.
3.If the patient participant requests a change to his or her CurrentCare record, and the RHIO determines that the change is due to an operational issue, the RHIO will address the error pursuant to its internal error resolution procedures by making the correction and notifying the patient participant within thirty (30) days of the correction that the correction has been made.
4.The RHIO shall have written data sharing agreements in place with provider participants who submit data to the HIE. Such agreements shall, at a minimum, contain all required business associate agreement components.
5.The RHIO shall have written end user agreements in place with provider participants who access data in the HIE. Such agreements shall, at a minimum, describe roles and responsibilities of both the end user and the RHIO regarding appropriate use of the HIE and assuring patient rights in accordance with applicable Federal and State law.
6.3.4Reconciliation with Other Authorities
A.Reconciliation with other authorities shall be pursuant to R.I. Gen. Laws § 5-37.7-12.
6.3.5Professional Responsibilities
A.In accordance with applicable State laws and Regulations promulgated thereunder, a provider participant that abandons a patient or denies treatment to a new or existing patient solely on the basis of the patient’s decision to opt out of disclosures from the HIE, when the patient’s health information can be obtained from other sources, may be subject to administrative review by the Department, including, but not limited to the Department’s Professional Boards, and the Director. The processes contained in Practices and Procedures Before the Rhode Island Department of Health (Subchapter 05 Part 4 of this Chapter), and as otherwise permitted by the Administrative Procedures Act, shall apply.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.4** HIE Advisory Commission {#sec-216-ricr-10-10-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.4}
A.The HIE Advisory Commission shall consist of nine (9) members. The membership of the HIE Advisory Commission shall include individuals with expertise in topics such as: HIPAA and privacy and security of healthcare information requirements; operations, maintenance and security of complex electronic databases; consumer advocacy; minority or underserved populations; epidemiology and the use of data for public health purposes; and active employment in direct patient care. The Director shall recommend prospective HIE Advisory Commission members to the Governor.
B.Pursuant to R.I. Gen. Laws § 5-37.7-5(c), the Director shall recommend prospective HIE Advisory Commission members to the Governor, subject to the advice and consent of the Senate. The membership of the HIE Advisory Commission shall include one (1) person with experience in HIPAA and privacy and security of health care information requirements, one (1) person with experience in operations, maintenance and security of complex electronic databases, one (1) person who is a health care consumer or consumer advocate, one (1) person who represents a minority or underserved population, one (1) person who has experience in epidemiology and the use of data for public health purposes, and no more than three (3) persons employed by a health care delivery organization, at least two (2) of whom shall be a physician licensed pursuant to R.I. Gen. Laws Chapter 5-37. The remaining member(s) shall be selected from business professionals and health care consumers whose experience and expertise will facilitate the work of the Commission.
C.The Director shall appoint a chairperson for the HIE Advisory Commission.
D.HIE Advisory Commission members shall be appointed for a term of two (2) years. A Commission member may be reappointed for an additional term, but shall not be eligible to serve more than three (3) consecutive terms. RHIO staff and board members shall not be eligible for appointment to the Commission.
E.The HIE Advisory Commission shall meet at least annually and shall not vote on any recommendations regarding the use of confidential health information unless a quorum is present.
F.The RHIO shall report at least annually to the HIE Advisory Commission and the Department on topics such as, but not limited to:
1.Usage of the HIE;
2.Security assessment results;
3.Opt-out frequency and characteristics;
4.Patient matching;
5.Education and outreach campaigns regarding public awareness of the HIE;
6.Data requests; and
7.Disclosure report requests.
8.Additionally, the HIE Advisory Commission may request at any time to review the policies and procedures required of the RHIO in §§ 6.3.2 and 6.6 of this Part.
G.The HIE Advisory Commission shall be informed of any newly introduced exchanges of confidential health information from the RHIO to the Department for public health purposes, in order to ensure transparency to the public on uses of data contained within the HIE.
H.The HIE Advisory Commission shall actively obtain and consider public input on all recommendations prior to submitting them to the Director. All meetings of the HIE Advisory Commission shall be subject to R.I. Gen. Laws Chapter 42-46 (Open Meetings).
I.The Director may recommend to the Governor that any HIE Advisory Commission member be removed for cause, including but not limited to, failure to attend Commission meetings on a regular basis.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.5** Confidentiality Protections {#sec-216-ricr-10-10-6-6.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.5}
6.5.1Patients’ Rights
A.In addition to the requirements of R.I. Gen. Laws Chapter 5-37.7 and this Part, a patient participant who has his or her confidential health information in the HIE shall have the following rights:
1.To obtain a copy of his or her confidential health information from the HIE by:
a.Submitting a valid and authenticated request to access the HIE record via the methods made available by the RHIO.
b.The form and methods shall be publicly available through posting on the HIE website including enrolling in any available patient portal.
c.Requestors may also call the CurrentCare information line to complete and submit the information on the form over the phone. To do so, the requestor must successfully complete the requirements of the identity verification process by supplying identifying information through a series of questions initiated by a RHIO representative over the phone and for the sole purpose of a single occurrence of a telephone request to submit the form.
d.If the requestor prefers, he or she may fill out a form in person at the RHIO offices after identity verification has occurred. The requestor may either obtain an enrollee request to access record form via the website or request a form be mailed to them.
e.If neither is possible, then the requestor may send a letter containing the same information as is required by the form and have it authenticated in the same manner as the written form.
2.To obtain a copy of the disclosure report pertaining to his or her confidential health information by submitting a request for a disclosure report. The forms along with information about where to submit the form shall be publicly available through posting on the HIE website; The RHIO will make every effort to provide disclosure reports in a prompt manner while recognizing that State and Federal law allow up to sixty (60) days to respond. If extenuating circumstances arise, the RHIO may have an additional thirty (30) days to provide the disclosure report to the enrollee. Each request for disclosure history will be addressed in accordance with 45 C.F.R. § 164.528. A charge for a copy of the disclosure report may be imposed if consistent with State law and 45 C.F.R. § 164.528. In accordance with 45 C.F.R. § 164.528(c)(2), the first (1st) disclosure report shall be provided to a patient participant in any twelve (12) month period at no cost to the patient participant.
3.To be notified, if required by either R.I. Gen. Laws Chapter 11-49.2 [Rhode Island Identity Theft Protection Act], or the HIPAA Final Omnibus Rule, of a breach of the security system of the HIE that resulted in the unauthorized access, use or disclosure of personal information or unsecured protected health information.
4.To opt out of having health information disclosed to health care providers through the HIE at any time in accordance with the Act and this Part by submitting an Opt-Out form to the RHIO.
a.Opt-out forms provided by the HIE shall be broadly available and accessible through a variety of methods. At minimum, such methods must include paper forms submitted by fax or mail, and electronic submission by website.
b.Opt-out forms shall be provided with appropriate accommodations to individuals experiencing disabilities, to the extent possible.
c.Opt-out forms provided by the HIE shall be available in a multitude of languages reflecting those most commonly used by Rhode Island patients, including, but not limited to, English, Spanish, and Portuguese.
d.Consent decisions of any type shall be recorded or indicated directly by the patient participant or his or her authorized representative, and not by a provider participant or other intermediary.
5.A completed opt-out form may be revoked at any time ("opting in" again) in accordance with the Act and this Part. The form and methods for reversing an opt-out decision shall be publicly available through posting on the HIE website or the patient participant or authorized representative may call the RHIO to request a form be sent to them.
6.Upon a patient participant’s completed opt-out form the patient’s confidential health information in the HIE will no longer be accessible to a provider participant. Nothing in this Part shall preclude a provider participant from accessing the provider participant’s own record of the patient. A patient's decision to opt-out will not affect the previous disclosures or access to the patient’s health information.
a.A patient participant's opt-out form shall apply to any disclosure of protected health information to health care providers by the RHIO where that protected health information was obtained due to designation as the RHIO, except as otherwise described for temporary access in an emergency.
7.Since the HIE does not create patient confidential health information, but receives confidential health information from provider participants, the patient participant may request to amend his or her own information through provider participants by submitting a request to amend confidential health information form consistent with this Part. The form and methods shall be publicly available through posting on the HIE website or the patient participant or authorized representative may call the RHIO to request a form be sent to them. The RHIO will respond directly to a patient participant request and follow its policies and procedures if there is an administrative error that does not require an amendment to the record received from the provider participant.
8.Following any health care provider's temporary access of a patient participant's protected health information via emergency procedures in the HIE, the health care provider shall notify the patient participant or his or her authorized representative of the temporary access as soon as is feasible. The temporary access shall not extend beyond the duration of the emergency. The health care provider or facility treating the emergency shall determine the existence of a medical emergency, its duration, and which personnel are needed to address the medical emergency.
6.5.2Confidentiality Protections
A.Confidentiality protections for patient participants in the HIE are pursuant to R.I. Gen. Laws Chapter 5-37.7 and this Part. The RHIO shall submit the policies and procedures described in § 6.3.2(A) to the Department upon request and at least annually.
1.Confidentiality protections for patient participants in the HIE are also pursuant to R.I. Gen. Laws § 40.1-5-26, 45 C.F.R. § 164.528 and 42 C.F.R. Part 2.
6.5.3Secondary Disclosure
A.Secondary disclosure Rules shall be pursuant to those stated in R.I. Gen. Laws § 5-37.7-9.
6.5.4Opt-Out Form
A.The opt-out form for opting out of access to, or the disclosure, release or transfer of, confidential health information from the HIE shall conform with the requirements of R.I. Gen. Laws Chapter 5-37.7; and additionally contain other information required by the RHIO, in consultation with the HIE Advisory Commission and the Director.
B.Except as specifically set forth in R.I. Gen. Laws § 5-37.7-7(b), the RHIO shall not allow access to or disclosure of a patient participant’s confidential health information unless it is in accordance with the patient participant’s authorization.
C.Except as set forth in R.I. Gen. Laws § 5-37.7-7(b), the RHIO will not allow access to or disclosure of a patient participant’s confidential health information to a provider participant unless the recipient has entered into a Data Use Agreement with the RHIO.
D.The RHIO shall not accept or respond to any authorization for requesting disclosure of the patient participant’s health information for any purpose other than as set forth by the Act and this Part.
E.Any request to opt-out from the HIE pursuant to § 6.5.1 of this Part shall be on forms which are provided by the RHIO in accordance with § 6.5.1 of this Part. Requests to opt out from the HIE shall be made in accordance with § 6.5.1(A)(6) of this Part.
6.5.5Release of Confidential Health Information in Conjunction with Legal Proceedings
A.Release of confidential health information in conjunction with legal proceedings shall occur pursuant to R.I. Gen. Laws Chapter 5-37.7.
6.5.6Requests for Confidential Healthcare Information for Analytic or Research Purposes
A.Confidential healthcare information shall not be accessed or released from the HIE system for analytic or research purposes without explicit written direction from either data-submitting partners or the State.
1.Analytic or research purposes means data requests that are for purposes other than clinical treatment, healthcare operations, or those exceptions outlined specifically in R.I. Gen. Laws § 5-37.7-7(b), including requests for aggregate reports, de-identified line-level data sets or identified line-level data sets.
B.The Department has authority to approve or deny any analytic or research request submitted under State authority for use of HIE data, records, or confidential healthcare information, whether identified, deidentified, or aggregate.
1.Notwithstanding the required approval by the Department of any analytic or research request under State authority for HIE data, records, or confidential healthcare information, whether identified, deidentified or aggregate, that pertains to any provider licensed by the Department of Behavioral Healthcare, Developmental Disabilities and Hospital (BHDDH), shall be subject to the approval of BHDDH and no such analytic or research request shall be approved without the explicit prior approval of BHDDH.
C.Nothing in this Part shall preclude data-submitting partners from utilizing the technical infrastructure of the HIE to share the data-submitting partner’s own confidential healthcare information as permitted by other state and federal laws under appropriate legal agreements, including for analytic or research purposes.
D.Analytic or research requests submitted for access or disclosure under State authority shall be considered only when the requestor can demonstrate a near-term benefit to the State or to Rhode Island residents, such as in policymaking, budget determinations, service coverage decisions, or for the immediate health and safety of Rhode Islanders. In all other cases, access or disclosure specifically permitted by legal agreement with the data-submitting partner(s) should be utilized.
1.Whether a request effectively demonstrates a near-term benefit to the State or to Rhode Island residents shall be determined by the Director or their designee as part of the request approval process, with advisory input and recommendations from the HIE Advisory Commission as requested by the Director or their designee.
E.Analytic or research requests submitted for access or disclosure under State authority, as opposed to access or disclosure specifically permitted by legal agreement with the data-submitting partner(s) per § 6.5.4(C) of this Part, shall undergo review by the Department for a period of time not more than three (3) months, including:
1.Consideration by the Department Institutional Review Board;
2.Execution of a Data Use Agreement (DUA) with the RHIO prior to receipt of data, where said DUA contains an expiration date, instructions on retention and destruction of released data, and strictly prohibits any dissemination without a new fully executed DUA for second or other usage. The DUA must contain a Certification of Destruction which must be produced to the State at the expiration date;
3.Department review for a period of time not more than two (2) months of any resulting outputs before release, where outputs include any reports, analyses, displays, products, tables, manuscripts, presentations or other data uses derived from HIE data;
4.Department cell size suppression policy, including prohibition on dissemination or publication of individual-level records in any form; and
5.A written description of study purpose and intent shall accompany each request. Once approved, secondary analysis or re-use of records outside of the stated study purpose shall not be permitted unless the request is amended and separately approved by the Director or their designee.
F.Patients with an active opt out consent form on record shall not have their confidential healthcare information included in any report, data set or disclosure other than for those purposes specifically outlined in R.I. Gen. Laws § 5-37.7-7(b).
G.The RHIO shall provide reports of requests for confidential healthcare information for analytic or research purposes to the HIE Advisory Commission annually and upon request. These reports must contain:
1.Institutional Review Board of record for each study, if applicable;
2.Principal Investigator and names of all who have access to the data;
3.Associated DUA or agreements;
4.Any resulting outputs; and,
5.Description of study, including purpose and intent.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.6** Security Requirements {#sec-216-ricr-10-10-6-6.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.6}
6.6.1Minimum Security Requirements
A.The RHIO and HIE shall implement security procedures pursuant to R.I. Gen. Laws § 5-37.7-8.
6.6.2Safeguards and Security Measures
A.The RHIO shall have in place appropriate physical, technical and procedural safeguards and security measures to ensure the technical integrity, physical safety, and confidentiality of any confidential health information in the HIE. These safeguards and security measures shall be in place at all times and at any location at which the RHIO, its workforce members, or its contractors hold or access confidential health information. Such safeguards and security measures shall comply with State and Federal confidentiality laws and Regulations including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and its implementing Regulations (45 C.F.R. Parts 160 through 164), HITECH and the HIPAA Final Omnibus Rule.
6.6.3Security Framework
A.The RHIO shall develop appropriate and scalable security standards, policies, and procedures in compliance with the Rhode Island Division of Information Technology Enterprise Strategy and Services policies which are developed and align with the National Institute of Standards and Technology (NIST) security policies and controls.
6.6.4Security Management
A.The RHIO shall:
1.Maintain and effectively implement written policies and procedures that conform to the requirements of this Section to protect the confidentiality, integrity, and availability of the confidential health information that is processed, stored, and transmitted; to protect against any reasonably anticipated threats or hazards to the security or integrity of the confidential health information and to monitor, modify and improve the effectiveness of such policies and procedures, and
2.Train the RHIO workforce who access or hold confidential health information regarding the requirements of the Act, this Part and the RHIO's policies and procedures regarding the confidentiality and security of confidential health information. The RHIO will secure written acknowledgement of training of its employees.
6.6.5Separation of Systems
A.The RHIO shall:
1.Maintain confidential health information, whether in electronic or other media, physically and functionally separate from any other system of records;
2.Protect the media, whether in electronic, paper, or other format, that contain confidential health information, limiting access to authorized users and sanitizing and destroying such media before disposal or release for reuse; and
3.Establish physical and environmental protections, to control and limit physical and virtual access to places and equipment where confidential health information is stored or used.
6.6.6Security Control and Monitoring
A.The RHIO shall:
1.Identify those authorized to have access to confidential health information and an audit capacity to detect unlawful, unauthorized or inappropriate access to confidential health information, and
2.Establish measures to prevent unauthorized removal, transmission or disclosure of confidential health information in the HIE.
6.6.7Security Assessment
A.The RHIO shall:
1.Perform periodic assessments of security risks and controls, as determined appropriate by the RHIO, to establish if its controls are effective, to correct any deficiency identified, and to reduce or eliminate any vulnerabilities.
2.Address system and communications protection, to monitor, control, and protect RHIO uses, communications, and transmissions involving confidential health information to and from entities authorized to access the HIE.
3.Inform the Department of any security incidents or potential security incidents including credible complaints of potential security incidents, as soon possible but no later than twenty-four (24) hours after the occurrence.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.7** Immunity and Waivers {#sec-216-ricr-10-10-6-6.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.7}
A.Immunity and waiver Rules shall be pursuant to those stated in R.I. Gen. Laws §§ 5-37.7-11 and 5-37.7-14.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
##### **216-RICR-10-10-6 § 6.8** Penalties — Attorneys’ Fees for Violations {#sec-216-ricr-10-10-6-6.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-6#6.8}
A.Penalties shall be pursuant to those stated in R.I. Gen. Laws § 5-37.7-13.
**History**
- *Amendment — effective from 2026-04-29 to current*
- *Amendment — effective from 2022-12-08 to 04/29/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-07-17 to 08/27/2018*
- *Adoption — effective from 2009-08-11 to 07/17/2014*
#### **216-RICR-10-10-7** Health Care Quality Program
##### **216-RICR-10-10-7 § 7.1** Authority {#sec-216-ricr-10-10-7-7.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-7#7.1}
A.These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17.17-4, as amended, and are established for the purpose of the development and reporting of quality performance measures to guide quality improvement initiatives and promote quality in the state's healthcare system.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Technical Revision — effective from 2006-01-29 to 01/04/2022*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2003-12-29 to 01/29/2006*
- *Adoption — effective from 2002-05-02 to 12/29/2003*
##### **216-RICR-10-10-7 § 7.2** Definitions {#sec-216-ricr-10-10-7-7.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-7#7.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Core-staffing plan,” as used herein, means as defined in R.I. Gen. Laws § 23-17.17-8(b)(1).
2."Customer satisfaction" means the degree to which the facility or provider meets or exceeds the patient’s/resident’s/client’s/family’s or member’s expectations as perceived by the patient/resident/client/family or member by focusing on those aspects of care that the patient/resident/client/family or member can judge.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Department of Health or their designee.
5."Healthcare facility" shall have the same meaning as contained in R.I. Gen. Laws Chapter 23-17, as amended, and the regulations promulgated thereunder.
6."Home care provider" means any person that provides, arranges to provide, offers to provide, or in any other way provides for the delivery of any direct health care services in the home requiring supervision by a registered nurse (RN), but excludes the delivery of direct nursing care by a registered (RN) or licensed practical (LPN) nurse on an on-going basis; and includes services rendered by a licensed health care professional, including but not limited to: a speech pathologist/audiologist, physical, occupational, or respiratory therapist. Also as used herein, "home care provider" includes homemaker services as defined in Licensing of Home Nursing Care Providers and Home Care Providers, Part 40-10-17 of this Title.
7."Home nursing care provider" means any person that provides, arranges to provide, offers to provide, or in any other way provides for the delivery of direct nursing services in the home by a registered (RN) or licensed practical (LPN) nurse, and provided such services are rendered in accordance with Licensing of Home Nursing Care Providers and Home Care Providers, Part 40-10-17 of this Title.
8."Hospital" means a healthcare facility with a governing body, an organized medical staff and a nursing service, providing equipment and services primarily for inpatient care to persons who require definitive diagnosis and treatment for injury, illness or other disabilities or pregnancy. A hospital shall provide psychiatric and/or medical and/or surgical care and at least the following services: dietetic, infection control, medical records, laboratory, pharmaceutical and radiology, except that a psychiatric facility need not provide radiology services.
9."Nursing facility" means a place, however named, or an identifiable unit or distinct part thereof that provides twenty-four (24) hour in-resident nursing, therapeutic, restorative or preventive and supportive nursing care services for two (2) or more residents unrelated by blood or marriage whose condition requires continuous nursing care and supervision.
10.“Patient care unit” means as defined in R.I. Gen. Laws § 23-17.17-8(b)(3).
11."Performance measure" means as defined in R.I. Gen. Laws § 23-17.17-2(h).
12."Person" means as defined in R.I. Gen. Laws § 23-17-2(16).
13."Reporting program" means as defined in R.I. Gen. Laws § 23-17.17-2(j).
14."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Technical Revision — effective from 2006-01-29 to 01/04/2022*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2003-12-29 to 01/29/2006*
- *Adoption — effective from 2002-05-02 to 12/29/2003*
##### **216-RICR-10-10-7 § 7.3** General Program Requirements {#sec-216-ricr-10-10-7-7.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-7#7.3}
7.3.1Healthcare Quality Reporting Program
A.The Healthcare Quality Reporting Program shall include quality performance measures and reporting for healthcare facilities licensed in Rhode Island.
B.The Healthcare Quality Reporting Program established under R.I. Gen. Laws Chapter 23-17.17 shall incorporate the requirements provided in R.I. Gen. Laws § 23-17.17-4(a).
C.The Department may deny, suspend, or revoke the license or curtail the activities of any healthcare facility that has failed to comply with this Part.
7.3.2Program Reporting Requirements for Healthcare Facilities
A.Pursuant to R.I. Gen. Laws § 23-17.17-10, each licensed healthcare facility shall establish and maintain records and data in such a manner as to make uniform a system of periodic reporting to the Healthcare Quality Reporting Program. The manner in which the requirements of this Part may be met shall be prescribed from time to time in directives promulgated by the Director.
7.3.3Reporting Requirements for Hospitals, Nursing Facilities, and Home Care Providers/Home Nursing Care Providers
A.Hospitals, nursing facilities, and home care providers/home nursing care providers licensed under the provisions of R.I. Gen. Laws Chapter 23-17, shall be required to implement a customer satisfaction survey at periodic intervals as prescribed by the Director.
B.Prior to implementation, such customer satisfaction survey instrument shall be approved by the Director after consultation with the Health Care Quality Steering Committee, pursuant to R.I. Gen. Laws § 23-17.17-6(a)(3). Said survey shall consist of a standardized format and data set that shall be reported to the Director in such a manner so as to facilitate public reporting.
C.Hospitals, nursing facilities, and home care providers/home nursing care providers shall provide the Director with patient specific information necessary for the Director to conduct the survey.
7.3.4Annual Hospital Staffing Report
A.In accordance with R.I. Gen. Laws § 23-17.17-8, annually in the month of January, every licensed hospital shall submit its core-staffing plan to the Department in a form and manner as prescribed by the Department.
B.Such plan shall specify for each patient care unit and each shift, the information required pursuant to R.I. Gen. Laws § 23-17.17-8(a).
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Technical Revision — effective from 2006-01-29 to 01/04/2022*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2003-12-29 to 01/29/2006*
- *Adoption — effective from 2002-05-02 to 12/29/2003*
##### **216-RICR-10-10-7 § 7.4** Administrative Requirements {#sec-216-ricr-10-10-7-7.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-7#7.4}
7.4.1Healthcare Quality Steering Committee
A.The Director shall establish and serve as chairperson of a Healthcare Quality Steering Committee of no more than nineteen (19) members to advise in the matters required by R.I. Gen. Laws § 23-17.17-6.
B.The members of the Healthcare Quality Steering Committee shall include the individuals required by R.I. Gen. Laws § 23-17.17-6(b).
1.In addition to the provisions of R.I. Gen. Laws § 23-17.17-6(b), the Director shall appoint five (5) members of the Health Care Quality Performance Steering Committee for a one (1) year term, four (4) members of the Health Care Quality Performance Steering Committee for a two (2) year term, and four (4) members of the Health Care Quality Performance Steering Committee for a three (3) year term. Thereafter, all terms of appointments shall be for three (3) years.
C.In addition to the provisions of R.I. Gen. Laws § 23-17.17-6,the Director may remove any member of the Healthcare Quality Steering Committee appointed by them for cause, including but not limited to, failure to attend Committee meetings on a regular basis.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Technical Revision — effective from 2006-01-29 to 01/04/2022*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2003-12-29 to 01/29/2006*
- *Adoption — effective from 2002-05-02 to 12/29/2003*
##### **216-RICR-10-10-7 § 7.5** Practices and Procedures and Severability {#sec-216-ricr-10-10-7-7.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-10-10-7#7.5}
7.5.1Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17.17, shall be held in accordance with the provisions of Practices and Procedures Before the Rhode Island Department of Health, Subchapter 05 Part 4 of this Chapter, and Access to Public Records, Subchapter 05 Part 1 of this Chapter.
7.5.2Severability
A.If any provision of these rules and regulations or the circumstance shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end the provisions of the regulations are declared to be severable.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Technical Revision — effective from 2006-01-29 to 01/04/2022*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Technical Revision — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2006-01-29 to 01/29/2006*
- *Amendment — effective from 2003-12-29 to 01/29/2006*
- *Adoption — effective from 2002-05-02 to 12/29/2003*
## **Chapter 20** Community Health
### **Subchapter 05** Maternal and Child Health
#### **216-RICR-20-05-2** Comprehensive Family Planning Program
##### **216-RICR-20-05-2 § 2.1** Authority {#sec-216-ricr-20-05-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-2#2.1}
These rules are promulgated pursuant to R.I. Gen. Laws §23-13-21, Pub. L. 91-572, and 42 U.S.C. § 300 and are established for the purpose of adopting requirements for the implementation of the Family Planning Program, which is designed to provide comprehensive services, including patient education, medical services, and access to safe and effective methods of contraception to Rhode Island citizens who have no health insurance and whose family income is between 100 and 185 percent of the federal poverty level.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-11-03 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 11/03/2017*
##### **216-RICR-20-05-2 § 2.2** Incorporated Materials {#sec-216-ricr-20-05-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-2#2.2}
These regulations hereby adopt and incorporate the HHS Office of Population Affairs, Title X: Family Planning, 42 C.F.R. part 59, subpart A (2014) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. https://www.hhs.gov/opa/sites/default/files/ogc-cleared-final-april.pdf
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-11-03 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 11/03/2017*
##### **216-RICR-20-05-2 § 2.3** Definitions {#sec-216-ricr-20-05-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-2#2.3}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1."Act" means the R.I. Gen. Laws Chapter 23-13, entitled "Maternal and Child Health/Services for Children with Special Health Care Needs.
2."Covered Services" means the services provided through the Family Planning Program pursuant to statutory provisions of the Act.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Rhode Island Department of Health.
5."Family Planning Program" means the educational, counseling, and comprehensive medical and contraceptive services provided pursuant to R.I. Gen. Laws § 23-13-21.
6."Income" means the gross annual income of the applicant, and of the applicant's spouse provided they are married and living in the same household.
7."Person" means an individual, trust or estate, partnership, corporation (including associations, joint stock companies) state or political subdivision or instrumentation of a state.
8."Provider" means those persons participating in the Family Planning Program for the provision of covered services.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-11-03 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 11/03/2017*
##### **216-RICR-20-05-2 § 2.4 General Requirements and Administrative Procedures** 2.4 General Requirements and Administrative Procedures {#sec-216-ricr-20-05-2-2.4-general-requirements-and-administrative-procedures omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-2#2.4 General Requirements and Administrative Procedures}
2.4.1 General Requirements
A.Recipients of Services:
1.In order for a person to be eligible for Family Planning Program services, he/she must meet the eligibility requirements set forth in R.I. Gen. Laws § 23-13-21.
B.Provider of Services:
1.In order to participate in the Family Planning Program, a provider must meet the following eligibility criteria:
a.Be located in the state of Rhode Island;
b.Provide comprehensive family planning and sex education services as described in § 2.4.2(A) of this Part;
c.Agree to on-site assessments as described in § 2.4.3(B) of this Part; and
d.Enter into provider agreements, as described in § 2.4.3 of this Part.
2.4.2 Provider Requirements
A.Basic Services:
1.Family Planning Program providers are required to adopt policies and procedures which assure the delivery of coordinated, interdisciplinary and comprehensive reproductive health services,
a.The provider must directly provide medical, social, educational and counseling services; and
b.The provider must assure referral and follow-up for services not provided by the project.
c.The provider must provide the services listed in R.I. Gen. Laws § 23-13-21(b)(1-3).
d.The provider will exclude services in accordance with R.I. Gen. Laws § 23-13-21(c).
B.Accessibility of Services
1.Family planning providers must plan and conduct community outreach activities to encourage all individuals to seek family planning services and to increase community awareness of the availability of such services. The provider is responsible for assuring that appropriate community organizations, social service agencies, and other health care providers are aware of and actively refer appropriate patients for family planning services.
C.Comprehensive Initial Family Planning Visit
1.If a determination is made that a client is eligible for Family Planning Services, the initial visit should be completed as soon as possible.
2.The comprehensive initial family planning visit must include at a minimum the following services:
a.Complete history;
b.Patient education/counseling;
c.Physical examination;
d.Laboratory studies;
e.Provision of an appropriate family planning method; and
f.Appropriate referral and follow-up.
2.4.3Provider Agreements
A.Upon approval of the application of a Provider for Family Planning Program Services, said provider must enter into a written agreement with the Director in order to be reimbursed for covered services under the Family Planning Program. The terms of such agreement shall include, but not be limited to:
1.The designation of service(s) to be provided to clients in accordance with Title X Family Planning Guidelines incorporated above at § 2.2 of this Part;
2.The responsibility of the Family Planning provider to deliver services in accordance with prevailing standards of practice;
3.Assurance of compliance with the policies of the Department;
4.Provisions for monitoring of services rendered to clients;
5.Provisions for the review of clinical progress notes of services and care rendered to clients;
6.Assurance that personnel and services meet the standards and qualifications as set forth by the Department;
7.Assurance of referral and follow-up services and coordination of information;
8.Provisions pertaining to assurance of no balance billing for covered services in accordance with § 2.4.4 of this Part, and assurance that the payment of the Department Family Planning Program represents full and total payment for covered services; and
9.Such other provisions as may be mutually agreed upon by parties involved.
10.For each client served, the service provider must complete a Clinic Visit Record (CVR), and submit this information for data processing.
B.Approval of Providers
1.Family Planning Providers - The Department will conduct on-site administrative, fiscal and clinical evaluations of all providers participating in the Family Planning Program. All service providers will be approved for one year of funding, unless approval is sooner revoked or suspended, and will be eligible to receive reimbursement for services in accordance with this Part.
2.Every provider shall be given notice by the Director or his/her designee of all the results of an on-site assessment.
2.4.4Reimbursement of Services
A.The Family Planning Program shall reimburse covered services rendered by providers to eligible recipients. Authorized services shall be reimbursed in accordance with the written agreement and these Regulations.
1.Payment by the Family Planning Program shall represent full and total payment for covered services for persons eligible for the program.
2.Uninsured clients of the Family Planning Program whose documented income is between 100% and 185% of the federal poverty level are not to be billed for mandated and clinically indicated services. However, services not mandated or clinically indicated may be billed to the client on a sliding fee schedule based on actual cost.
3.Services must be offset by the approved patient sliding fee schedule.
4.Patient sliding fee schedules require approval of the Director and shall be drafted in accordance with Title X Family Planning Guidelines incorporated above at § 2.2 of this Part.
B.HIV/AIDS Counseling and Testing Formal risk assessment, HIV/AIDS testing and counseling shall be offered in accordance with R.I. Gen. Laws § 23-6.3-3.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-11-03 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 11/03/2017*
##### **216-RICR-20-05-2 § 2.5** Denial or Termination of Services {#sec-216-ricr-20-05-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-2#2.5}
A.The Director is authorized to deny participation of a recipient and/or provider, to terminate client and/or provider of services or deny payment for a service for the following reasons:
1.Failure of the applicant to meet the eligibility requirements of the Family Planning Program;
2.Failure of the provider to comply with the terms of the agreement;
3.Failure to comply with the statutory and regulatory provisions of this Part; and
B.A proposal to deny, terminate services, or an agreement shall be as follows:
1.Whenever an action shall be proposed to deny eligibility, services, terminate services or an agreement with an applicant or provider, the Director or designee shall notify the applicant or provider in writing, setting forth the reasons for the proposed action, and the provider or applicant shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9.
2.If the Director, however, finds that public health, safety or welfare of clients requires emergency action and incorporates a finding to that effect in its order, the Director may order summary termination pending proceedings for termination of agreement or services in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-11-03 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 11/03/2017*
##### **216-RICR-20-05-2 § 2.6** Rules Governing Hearings and Reviews {#sec-216-ricr-20-05-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-2#2.6}
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-13, shall be held in accordance with the provisions of the rules and regulations regarding the Practices and Procedures Before the Rhode Island Department of Health (216-RICR-10-05-4).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-11-03 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 11/03/2017*
#### **216-RICR-20-05-3** WIC Program
##### **216-RICR-20-05-3 § 3.1** Authority {#sec-216-ricr-20-05-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.1}
These Regulations pertaining to the WIC Program are promulgated pursuant to R.I. Gen. Laws § 23-13-17. Pursuant to R.I. Gen. Laws § 23-13-17, these regulations shall be administered in a manner consistent with 42 U.S.C. § 1786.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.2** Incorporated Materials {#sec-216-ricr-20-05-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.2}
A.These regulations hereby adopt and incorporate 7 C.F.R. § 246 (2016) by reference (https://www.fns.usda.gov/sites/default/files/wic/WICRegulations-7CFR246.pdf), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate Department of Agriculture; Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): 2016/2017 Income Eligibility Guidelines, 81 Fed. Reg. 14826 (March 18, 2016) (https://www.gpo.gov/fdsys/pkg/FR-2016-03-18/pdf/2016-06222.pdf) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.3** Definitions {#sec-216-ricr-20-05-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.3}
A.As used in these regulations, the following terms shall have the meaning indicated:
1.“Agreement” means the written document between the Rhode Island Department of Health WIC Program and a local agency which states the responsibilities and obligations of both parties in order to provide the WIC Program. The period covered by the WIC agreement is the Federal fiscal year.
2.“Applicant” means an individual who makes application for WIC Program benefits.
3.“Breastfeeding Women” means women up to one year postpartum who are breastfeeding their infants on average of at least once a day.
4.“Certification” means the use of criteria and procedures to assess and document each applicant's eligibility for the Program.
5.“Children” means persons who have had their first birthday but have not yet attained their fifth birthday.
6.“Clients” means pregnant women, breastfeeding women, postpartum women, infants, and children who are receiving supplemental foods or food instruments under the WIC Program and the breastfed infants of breastfeeding women who are receiving supplemental foods or food instruments under the WIC Program.
7.“Clinic” means a facility where applicants are certified.
8.“Competent Professional Authority (CPA)” means an individual on the staff of the local agency who is authorized to determine nutritional risk and prescribe supplemental foods. The professional qualifications required of competent professional authorities are set forth in Federal Regulations. A competent professional authority is herein considered to be a physician, a nutritionist, a dietician, a registered nurse, a physician's assistant or a state or local medically trained health professional approved by the state agency. Also applies to qualified persons not on the staff of the local agency who are qualified to provide medical/nutritional assessment data.
9.“Confidential health care information” means all information relating to a patient's health care history, diagnosis, condition, treatment or evaluation.
10.“Days” means calendar days except for those time standards which specify working days.
11.“Disqualification” means the act of ending Program participation of a participant, food Vendor, or authorized state or local agency, whether as a punitive sanction or for administrative reasons.
12.“Dual Participation” means simultaneous participation in the Program in one or more than one WIC clinic.
13.“Family” means a group of related or non-related individuals who are living together as one economic unit, except that residents of a homeless facility or an institution shall not all be considered as members of a single family.
14.“FNS” means the Food and Nutrition Service of the United States Department of Agriculture.
15.“Fiscal Year” means the period of 12 calendar months beginning 1 October of any calendar year and ending 30 September of the following calendar year.
16.“Homeless Facility” means the following types of facilities which provide meal service: A supervised publicly or privately operated shelter (including a welfare hotel, congregate shelter or shelter for victims of domestic violence) designed to provide temporary living accommodations; a facility that provides a temporary residence for individuals intended to be institutionalized; or a public or private place not designed for or normally used as a regular sleeping accommodation for human beings.
17.“Homeless Individual” means one who lacks a fixed and regular nighttime residence or whose primary nighttime residence is one of the following:
a.A supervised publicly or privately operated shelter (including a welfare hotel, congregate shelter or shelter for victims of domestic violence) designed to provide temporary living accommodations;
b.an institution that provides a temporary residence for individuals intended to be institutionalized;
c.a temporary accommodation in the residence of another individual; or
d.a public or private place not designed for, or ordinarily used as a regular sleeping accommodation for human beings.
18.“Income Poverty Guidelines” means 185% of the United States Department of Agriculture (USDA) poverty guidelines.
19.“Infants” means persons under one year of age.
20.“Institution” means any residential accommodation which provides meal service, except private residences and homeless facilities.
21.“Local Agency” means an agency under contract with the Rhode Island Department of Health to provide WIC Program services.
22.“NSA Funds” means Nutrition and Administration funds used to provide WIC services.
23.“Nutrition Education” means individual or group educational sessions and the provision of information and educational materials designed to improve health status, achieve positive change in dietary habits, and emphasize relationships between nutrition and health, all in keeping with the individual's personal, cultural, and socioeconomic preferences.
24.“Nutritional Risk” means:
a.Detrimental or abnormal nutritional conditions detectable by biochemical or anthropometric measurements;
b.Other documented nutritionally related medical conditions;
c.Dietary deficiencies that impair or endanger health or
d.Conditions that predispose persons to inadequate nutritional patterns or nutritionally related medical conditions.
25.“Participation” means the number of persons who have received supplemental foods or food instruments in the reporting period plus the number of breastfed infants of breastfeeding women who have received supplemental foods or food instruments in the reporting period.
26.“Payee” means the custodial parent or guardian or, if unavailable, the delegated caretaker for an infant or child. Authorized to pick up checks and redeem them for food at authorized Program Vendors.
27.“Postpartum Women” means women up to six months after termination of pregnancy.
28.“Pregnant Women” means women determined to have one or more embryos or fetuses in utero.
29.“Resident” means a person making one's home in a place, who can provide evidence of such residence or who is homeless and living in an authorized WIC homeless facility or institution or is homeless and can show evidence of living and sleeping in a place not designed for or normally used as a regular sleeping accommodation for human beings.
30.“RIDOH” means Rhode Island Department of Health.
31.“State agency” means Rhode Island Department of Health.
32.“Vendor” means a grocer, pharmacy, small corner store that has contracted with RIDOH WIC Program to provide WIC authorized foods to WIC clients and accepting WIC checks as payment.
33.“WIC Program” means the Special Supplemental Nutrition Program for Women, Infants and Children.
34.“WIC Check” means a check issued by the Rhode Island Department of Health WIC Program specifying certain WIC allowed foods which is used by a participant to obtain the specified foods.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.4** Application of Eligibility and Determination {#sec-216-ricr-20-05-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.4}
A.WIC applicant income screening will be determined by USDA WIC Income Poverty Guidelines, incorporated above at § 3.2(A) of this Part. WIC participants must be either eligible under the USDA WIC Income Poverty Guidelines or be adjunctively eligible.
B.All WIC applicants must sign an applicant agreement form that gives the WIC Program permission for coordination of services, describes rights and responsibilities of both the client and the program and indicates agreement that the information provided is accurate.
C.To be eligible to receive available benefits of the WIC Program, a person must be:
1.A resident of the State of Rhode Island; and
2.A pregnant, breastfeeding or postpartum woman; an infant; or a child up to his/her fifth birthday; and
3.A member of a household with an income at or less than 185 percent of the poverty level guideline or be adjunctively eligible (based on enrollment in SNAP, Medicaid, TANF, Katie Beckett); and
4.Be at nutritional risk.
D.A Competent Professional Authority (CPA) determines nutritional risk by performing a complete nutritional assessment on an individual basis. Each individual seeking certification or recertification for participation in the program shall be physically present at the clinic site for determination of program eligibility. This applies to all new applicants for their initial certification as well as those applying for a subsequent certification.
1.The following assessment tools must be considered in determining the individual's nutritional status:
a.WIC Medical Information Form (if applicable);
b.Prenatal Weight Gain Grid (if applicable);
c.Infant/ Child WHO growth standards for children birth to 2 years (if applicable);
d.Child Growth Charts, for children over two years, measuring stature (if applicable);
d.Client Centered Survey tool for Infants, Children and Women
2.An individual history must include a Client Centered Assessment.
a.A Client Centered Assessment must include:
(1)An understanding of and response to the clients major concerns to build rapport and provide referrals and support that is most important to the client.
(2)A nutrition assessment: Understanding and description of food preferences, family mealtime dynamics, nutritional supplements, fads, or any factors that impact nutritional status.
(3)Medical history related to nutrition: The history may be obtained through a review of the applicant's medical record or referral information from a competent professional not on staff of the local agency.
(4)Socioeconomic factors that affect nutrition including: resources available for food purchase, availability of food storage and cooking facilities and educational level of the participant.
(5)Anthropometric Measurements: The consistent and accurate use of pregnancy weight gain grids, or growth grids as a recording and evaluation tool for the heights, weights, and BMI following measurements is necessary.
(6)Laboratory Analyses: A blood test for anemia such as a hemoglobin, hematocrit, shall be performed and/or documented at certification or within 90 days of certification. Review of Lead results that was performed within the past 12 months, provided by the client's doctor.
E. Nutrition Education and Follow up
1.At the first nutrition education meeting, contact staff must create obtainable nutrition goals with the client and the client's child.
2. At the first nutrition education appointment contact staff must explain to clients/guardian:
a. Why the client qualified for WIC Program benefits and what is provided by the program and that the nutrition and food benefit is for the individual that has applied whether it be a child, pregnant woman, or breastfeeding woman;
b. WIC Program procedures pertaining to the appointment, anthropometrics, hematological, counselling, check pick up and cashing WIC checks and follow-up appointments;
c. The fact that the WIC Program is a supplemental nutrition program, that does not provide the complete nutritional needs for the client;
d. The current nutritional standing of the client; and
e. What the client's nutritional risks are; and
f. The importance of regular physician checkups; and
g. Counseling on breastfeeding (if applicable);
e. The importance of STD testing and the risk of transmission to their child (if applicable);
f. The detrimental effects of drugs, alcohol, and tobacco; and
g.The nutrition goals set with the client or the client's guardian.
2. The Second Nutrition Education Contact (SNEC)
a.SNECs are to be provided by CPA’s only.
b.Routine nutrition education contact:
(1)The Local WIC site must provide group information sessions which can count as a SNEC or schedule a SNEC on an individual basis. The client can refuse the SNEC education and still receive the remaining benefits.
(2)This secondary contact is the time in which individual goals must be discussed and adjusted as necessary.
b.High risk nutrition education contact: All clients designated as high risk, according to state and local agency criteria, will receive a high risk care plan outlined in the client notes. It will include a plan designed by the local agency nutritionist and client/guardian. Each high risk client will receive a minimum of one follow-up visit. An individualized care plan can also be provided to any non-high risk participant at his/her request.
3.Breastfeeding Education and Support: Ongoing support and rapport building for Pregnant and Breastfeeding Women
a. Prenatal Clients: At least 1 contact at each trimester (1-3 months, 3-6 months, 6-9 months) and again at 2-4 weeks before anticipated due date.
b.Postpartum: Follow-up contacts within 2-3 days or as requested by participant. Follow-up on problems within 24 hours (see Problem Referrals). After first 2 weeks postpartum: contact at 2-3 weeks, 4-8 weeks, and 3-4 months postpartum. Maintain contact as needed or as requested for entire breastfeeding duration.
c.Breastfeeding Problems: Follow-up is required referrals by WIC staff within 24 hours of receiving referral of breastfeeding problems. Follow-up contact with client must be within 24 hours of problem discussion.
4. Referrals and Coordination: Local Agencies shall refer WIC participants to additional services provided by other health and human resources to avoid duplication of effort.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.5** Management Evaluations and Monitoring Reviews {#sec-216-ricr-20-05-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.5}
A.Upon being contacted by the state agency, the local agency administrator and local WIC staff will mutually establish the time with the state staff for the team to conduct an on-site review.
B.Local agency staff members must be available to participate in discussions with the review team, to provide observation of local agency procedures and review of local agency records, and to arrange participant interviews. Local agency staff members must be available to assist the review as required. All local WIC records must be made available as requested by the review team.
C.Local agency staff must respond to the process in a constructive, objective, and professional manner that will result in conclusions that are useful to the local agency. State and local staff must identify local agency needs and deficiencies, and feasible corrections and improvements.
D.Any deficiencies corrected prior to the completion of the review must be brought to the attention of state review staff.
E.At the completion of the local agency review, a local agency administrator, above the level of the WIC Program Coordinator, and other staff at the administrator's discretion must meet with the review team in an exit conference, to discuss a verbal summary of findings and recommendations.
F.Upon receipt of the written formal statement of review findings and recommendations by the WIC state agency, the local agency staff must review the findings and formulate the plan of correction.
G.Within thirty days of the receipt of the letter of the review findings, the local agency must submit to the state agency a written response to the findings, including plans of corrections and projected dates of implementation (and dates of corrections that have already been made).
H.The plan of correction must be signed by the Executive Director, or other management level administrator acceptable to the RIDOH, to assure administrative review of WIC Program operations and agency commitment to the plan.
I.The state agency will accept the plan of correction or notify the local agency of needed revisions.
J.The local agency shall implement the plan of corrections according to the stated timetable. If it is unable to do so, the local agency must notify the state agency and submit a revised plan of corrections acceptable to the state agency.
K.If the state agency determines that an acceptable plan of correction is not submitted within thirty days, or if corrective action is not completed according to the schedule established in the corrective action plan, the state agency may withhold administrative and program services funds through a reduction in the local agency funds allocation.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.6** Program Abuse and Participant Sanctions {#sec-216-ricr-20-05-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.6}
A.Abuse
1.Dual/Multiple Participation
a.Whether discovered through participation reports or other sources, once dual participation is verified, the State Agency shall not issue checks.
b.The local agency with which the participant has the next scheduled appointment or check pickup shall:
(1)Discuss dual participation with client; and
(2)Inform client that dual participation is not allowed; and
(3)Have client determine which agency he/she prefers; and
(4)Retrieve the WIC ID folder of other agency and send it to the Rhode Island Department of Health WIC Office; and
(5)Determine with the state agency whether checks should be issued. The dual benefits received should, in most cases, be applied towards the current or next month; and
(6)Notify in writing the state agency as to local agency preference, and steps that have been taken; and
(7)Terminate the client from one agency.
c.The circumstances of the dual participation will be reviewed by a state supervisor and local agency liaison and the local agency. This review must include a determination as to whether the child participants have been receiving the supplemental foods.
d.The state and local agency shall then determine the severity of the violation, procedures to be followed, and sanctions, if any, to be imposed.
e.If the client refuses reduction of service to one local agency only or persistently denies dual participation, in the face of conclusive evidence or there is evidence of deliberate dual participation, a supervisor at the state agency and the WIC coordinator at the local agencies involved must review the case for disqualification from the WIC Program.
2.Other Violations of Program Abuse
a.Violations of Program rules, shall include but not be limited to:
(1)The violations described where evidence indicates absence of intent or deliberateness or where other extenuating circumstances would not support a conclusion of WIC Program abuse.
(2)Failure of a payee to make all supplemental food available to a participant.
(3)Failure to inform the local agency of a change in address, residence, or other circumstances which might have an effect on eligibility.
(4)Failing to report any unused WIC foods to the local agency WIC staff.
(5)Any other violation of Program regulations, rules, or procedures.
(6)Attempting any violation of Program rules.
b.Investigation: When there is reasonable evidence of violations, the local agency must notify the client (via telephone or mail) and offer an interview to consult with and counsel the client covering relevant topics, including but not limited to:
(1)What occurred and where, in a manner indicating that the participant is given the benefit of the doubt (if applicable);
(2)Advising the client that the practice is in violation of program regulations or procedures and warn that person that any information given may be used against him/her in determining sanctions or penalties or in any subsequent appeal procedure, and inform them of the penalties that may be instituted for such practices (if applicable);
(3)Counsel and educate the client on the proper procedures to be used, in picking up and cashing WIC checks, indicating the correct procedures and why they are necessary. Offer the client the opportunity to ask any questions and answer them (if applicable);
(4)A determination will then be made of the client's intention, the severity of any violation, and of the client's cooperation in attempting to change the practices (if applicable). The local agency will then take appropriate additional measures as warranted.
c.Prosecution of Fraud and Abuse
(1)All instances of fraud, abuse or misrepresentation must be reported to the State WIC Office.
(2)The state agency may, at its discretion, refer cases which appear to violate the provisions of R.I. Gen. Laws § 23-13-17 to federal, state or local authorities for prosecution pursuant to the provisions of 7 C.F.R. § 246.23, incorporated in § 3.2(A) of this Part.
B.Sanctions Against Clients
1.The local agency will follow procedures to handle abuse or violations of the program. The local agency will confer with the state agency, before imposing any sanction. The state agency reserves the authority to direct that sanctions be imposed by the local agency or that sanctions be modified or not imposed.
a.When sanctions are to be imposed, the local agency shall notify the participant by registered mail, return receipt requested, that there is evidence that he/she has engaged in violation(s) or abuse of the WIC Program. Notice of imposition of the sanction may be included or deferred until further steps are completed.
b.The participant shall be advised of the sanction to be imposed for the abuse or violation, and/or the effective date of the sanction (giving at least fifteen days' notice). He/she shall be offered an opportunity prior to the imposition or effective date of the sanction to meet in conference to present any information or evidence that the information is in error, that the violation did not take place, that extenuating circumstances exist, or that severe hardship or serious health risk may result from WIC Program disqualification.
c.The Competent Professional Authority shall determine whether a serious health risk may result from WIC Program disqualification.
d.The local agency must consider a serious health risk to the participant and other relevant factors in determining whether or not the sanction should be waived in a particular case.
e.If restitution by the participant is required under 7 C.F.R. § 246.23(c), incorporated above at § 3.2(A) of this Part such restitution will be in cash and will equal the value of Program benefits improperly issued unless it is determined that the recovery would not be cost effective.
f.If not waived or modified, the following sanctions shall apply:
(1)Category I: Disqualification for three months and, if appropriate, restitution of the value of benefits improperly issued.
(2)Category II: Disqualification for one month and, if appropriate, restitution of the value of any benefits improperly received.
g.In the event of physical abuse or threat of physical abuse of staff the sanction will be imposed without offering a conference, or despite a determination of health risk, this is appropriate to protect the safety of staff. The local agency staff must notify the client that, such abuse during a certification appointment may prevent the completion of the certification/recertification and lead to denial of eligibility or failure to recertify.
h.Before disqualifying a child participant, the local agency must determine whether the abusive person can be excluded from the agency and an acceptable alternative payee utilized.
i.If not already accomplished, the participant shall be given fifteen day notification by certified mail, return receipt requested, of the implementation of the disqualification from the WIC Program. Any notice of violation or disqualification shall include the Fair Hearing statement, request, and information forms. The notification must specify the date that the person may reapply for the WIC Program. This date should allow for enough time in advance of the end of the disqualification period for the person to be reinstated in the following month.
j.After this period, the local agency shall review the eligibility of the participant as a new applicant.
C. In addition to the sanctions above, additional measures may include:
1A warning letter, indicating further violations would be grounds for more severe penalties or for establishing a case of abuse.
2.Cancellation of checks or reduction or deletion of items in the food package as determined by the competent professional authority as being unusable, unneeded, excess benefits, or not being made available to the participant.
3.Disqualification for one month if the investigation or review reveals that the participant is ineligible or violates WIC Program rules, regulations, or requirements twice within a 24 month period, or disqualification for three months for three violations within a 24 month period.
4.If restitution by the participant is required, such restitution will be in cash and will equal the value of WIC Program Benefits improperly issued unless it is determined that the recovery would not be cost effective.
5.Document in the record the efforts for counseling, content, and the response of the participant.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.7** Confidentiality {#sec-216-ricr-20-05-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.7}
A.Limitations on Disclosure
1.Each agency shall restrict the disclosure of information obtained from WIC Program applicants or participants to:
a.Persons directly connected with the administration or enforcement of the Program; or
b.Those public health or helping organizations listed on the Client Agreement which the state agency has designated for purposes of establishing eligibility; or
c.Other programs or services which may be of help to the participants.
(1)Any person seeking permission to inspect WIC records shall provide his/her identity and shall state his/her reasons for making such a request.
(2)A client's confidential health care information shall not be released or transferred without the written consent of such client or his authorized representative, on a consent form meeting designated requirements.
(3)Consent forms for the release or transfer of confidential health care information shall contain the following information:
(AA)A statement of the need for and proposed uses of such information.
(BB)A statement that all information is to be released or clearly indicating the extent of the information to be released.
(CC)A statement that such information will not be given, sold, transferred or in any way relayed to any other person not specified in the consent form or notice without first obtaining the individual's additional written consent on a form stating the need for the proposed new use of such information or the need for its transfer.
(DD)A statement that the consent for release or transfer of information may be withdrawn at any future time.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.8** WIC Vendor Systems {#sec-216-ricr-20-05-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.8}
A. Threshold requirements:
1.An application will only be issued to a grocery or pharmacy owner, partner or corporate officer which satisfies the requirements of these regulations.
2.Mobile stores and home Vendor companies are not eligible to be WIC Vendors.
B. The applicant-Vendor must return the following documents prior to approval:
1.Vendor Application signature Page from Online Application;
2.Email Price Survey List;
3.Proof of ownership;
4.Annual or quarterly tax forms;
5.Copy of a recent driver's license or other positive photo identification; and
6.List names of stores, owner, partnership, manager, spouse, and clerk, to be reviewed by the WIC program, after completed by the Vendor.
C.Vendor Agreements
1.All approved Vendors must review and execute a Vendor Agreement prior to participation.
2.Each Vendor Agreement shall include a sanction schedule for Vendor Violations in accordance with 7 C.F.R. § 246.12(I)(3).
D.Application Denials
1.If the Vendor has withheld, misrepresented or falsified any information required by the application process, the application will be denied and/or any subsequent Vendor Agreements relating to the application will be immediately rendered null and void, upon discovery.
2.If the Vendor has participated in any actions which are violations of Program rules or accepted WIC checks prior to authorization, (in accordance with Vendor Compliance, V-4) the application will be denied and/or any subsequent Vendor Agreement relating thereto will be immediately rendered null and void, upon discovery.
3.The Vendor may not be accepted if it has been debarred or suspended from participating in any transactions involving federal funds or other assistance with grantees and sub grantees of federal funds.
E.FNS and WIC: Unless needed to serve an area, a grocery Vendor will not be approved to accept WIC, unless the Vendor is authorized by the Supplemental Nutrition Assistance Program (SNAP) under the current ownership. If the Vendor is disqualified from SNAP as a result of disqualification from the WIC Program, the Vendor may not reapply until SNAP authorization is reinstated.
1.A Vendor will not be approved if an individual as a Vendor owner, officer, partner, or manager
a.Has not paid in full any fiscal claim, penalty, or fine owed to any USDA or other Federal or State Program or if the Vendor has not corrected any previous violation.
b.Has committed or been convicted of any violation of, or been found in violation of, any of the laws and/or regulations, or rules of any USDA or other Federal or State Program, or the terms of any previous Vendor Agreement.
c.The Vendor will not be accepted for one to six years from the time of the last violation committed, or from the time it was determined the violation had been committed, or prior to the end of any disqualification, sentence, or sanction imposed with respect to that violation; whichever of these occurred last.
2.A Vendor will not be approved if they were sanctioned with a civil money penalty, or fine or other monetary settlement imposed in lieu of a disqualification, or agreed to as part of resolution of a charge of violation of USDA rules, until the monetary penalty is paid in full.
3.If a Vendor was removed from the WIC Program, re-applicant(s) must serve the length of time of the sanction the WIC Program before they can be re-approved as a WIC Vendor or such term as consistent with the nature of the act and penalties for a similar act. The WIC Program may accept such a Vendor if it deems Vendor would be a special benefit to the WIC Program and acceptance of the Vendor would be in the best interests of the WIC Program, and impose an alternative penalty and/or special conditions of participation in lieu of denial of participation.
4.A Vendor will not be approved if the store is owned, in whole or in part, or is managed by any person who has committed or been convicted of any violation of or found in violation of the laws, regulations, or rules, of any USDA Program in accordance with the above.
5.A Vendor will not be approved if the Vendor employs any person who has committed or been convicted of any violation of, or found in violation of, any of the laws, regulations, or rules of any USDA Program in accordance with the above, whether such violations occurred in relation to that applicant store while the store was under previous ownership, or any other store where such person committed such violations unless such person is under on-site supervision of a superior during all hours of WIC Program related activity and is not allowed to take part in any WIC check transactions.
6.A Vendor will not be approved if the Vendor has committed any violation of the laws, rules, or regulations of any USDA Program, while under disqualification or other sanction by any USDA Program, or when not participating in SNAP.
7.A Vendor will not be approved where there is evidence of an attempt to circumvent, or assist in a circumvention of, a period of disqualification from any USDA Program or a civil money penalty imposed for violations of the rules or regulations of any USDA Program.
8.A Vendor will not be approved where there is likelihood that a former owner, who would not him/herself qualify, still retains direct or indirect ownership in, control over or interest in the business or its operations.
F.Re-application/Re- approval of Vendor Agreement: When reliable evidence or likelihood exists of violations of the regulations, rules, or procedures of any USDA Program in accordance with RIDOH Vendor Policies, such evidence shall be grounds for denial of the WIC Vendor Agreement. The WIC Program may deny Vendor participation in the WIC Program for a period in accordance with the WIC Vendor Policies contained in the Vendor Agreement, or until such time as the Vendor is no longer subject to, or under judicial, administrative penalties, sanctions and/or sanction reviews, or other punishment, whichever last occurs. Any of the conditions of the above, shall constitute a violation for purposes of re-approval of a Vendor even when it has been served under any USDA Program but not under the WIC Program (i.e. SNAP Applicant(s) or re-applicant(s) must serve this time under the WIC Program before he/she can be re-approved as a WIC Vendor.
1.The WIC Program may, at its option, enter into a conditional Vendor Participation Agreement when a Vendor is pending judicial or administrative finding, decision, or applicant sanction for an alleged violation, or being readmitted following an allegation of violation, or for special authorization needs.
2.Each applicant Vendor, including re-applications, will be reviewed for compliance with any current or previous WIC Agreement for the past three years from the date of application or from the termination of the most recent WIC Agreement.
G.A Vendor who is currently operating as a WIC Vendor will not be accepted or renewed if the Vendor:
1.Is currently suspended or disqualified from any USDA Program for noncompliance, or is under threat of disqualification related to pending charges. This shall not be subject to administrative or judicial review under the WIC Program.
2.Has committed three violations of the Vendor Agreement such as would be grounds for a 90 day or less disqualification.
3.Has committed two violations, and/or was issued two notices of violation: per the Violations and Sanction Types described in the Vendor Policies within the Vendor Agreement.
4.Has received two suspensions or disqualifications during the preceding three years. Such Vendors shall not be renewed or approved for participation for from one to three years from the date of termination of their current or most recent WIC Vendor Agreement.
5.Has been determined to be charging excessive prices, either by charging for foods not received on the WIC check or charging for foods at higher prices than submitted on the quarterly price survey.
6.If federal regulations for the WIC Program change the maximum disqualification or suspension term or standards for Vendor authorization, during the period of disqualification the WIC Program may modify the terms of disqualification or non-approval for participation in accordance with the standards set forth in the new federal regulations. The WIC Program cannot modify any federal sanctions.
7.If the WIC Program has reason to believe a change of ownership or control may have occurred and the Vendor fails to furnish sufficient proof that a change has not occurred.
8.If a new WIC Vendor is determined to be an “Above 50% Vendor” (A50%V), they will be authorized on a six month probationary period. During this time, monthly redemption data will be reviewed to identify if, in fact, the probationary WIC Vendor is an A50%V. If this is confirmed, they will be terminated from the WIC Program.
a.The “potentially Above-50% Vendor” (PA50%V) peer group will be assigned to applicants who have the potential for total WIC Program sales to comprise more than 50% of their total food sales.
b.The “Above 50% Vendor” (A50%V) Peer group will be applied to those Vendors whose total WIC sales comprise 50% or more of their total food sales.
c.The redemption histories of all new WIC authorized grocery (i.e. non-pharmacy, non-farmers market) Vendors will be reviewed during the application process. To identify a potential Above 50% Vendor (PA50%V) the following information will be considered:
(1)If the applicant is a new business with no redemption history;
(2)Recent Supplemental Nutrition Assistance Program (SNAP) redemption data for the applicant;
(3)Self-reported total gross food sales for the prior year;
(4)Recent State of RI Monthly Sales & Use Tax Return;
(5)Recent State of RI Quarterly Reconciling;
(6)Recent State of RI Annual Reconciling;
(7)Projected WIC food sales, based on the WIC Program’s analysis of peer group food redemption profiles;
(8)A new Vendor with no food sales history or SNAP sales history will be considered a potential A50%V for the first 6 months of WIC authorization;
(9) A new branch of a national chain grocery store will not be considered as a potential A50%V;
d.During the 6-month period of time, the potential A50%V’s redemptions will be monitored to ensure their reimbursements are no greater than the statewide average price of their peer group, or the maximum allowed price for their peer group (whichever is the lower amount).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.9** Program Expenditures {#sec-216-ricr-20-05-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.9}
A.The following are acceptable program expenditures for local agencies:
1.In addition to the cost of nutrition education requirements, breastfeeding education and support must be calculated:
a.During each fiscal year, the local agency shall use a minimum amount of 20% of the local agency's NSA expenditures for nutrition education and Breastfeeding Promotion. The local agency shall document the full amount of total NSA expenditures attributable to nutrition education and breastfeeding, including grant funds and other funds or values in its final closeout report for each fiscal year. If the local agency's reported nutrition education expenditures are less than the amount required to be spent, RIDOH may issue a claim for the difference. The local agency may request prior written permission from RIDOH to spend less than the required amounts for nutrition education and breastfeeding promotion and support if the local agency can document that a total of funds from other sources and WIC Program funds will be expended at amounts equal to the required amount. Nutrition education costs are limited to activities which are distinct and separate efforts to help clients understand the importance of nutrition and breastfeeding promotion and support to health.
2.The cost of dietary assessments for the purpose of certification and the cost of prescribing and issuing supplemental foods shall not be applied to the one-sixth minimum amount required to be spent on nutrition education. Costs to be applied to the one-sixth minimum amount required to be spent on nutrition education may include, but need not be limited to:
a.Salary and other costs for time spent on nutrition education consultations whether with an individual or group;
b.The cost of procuring and producing nutrition education materials including handouts, flip charts, food models or other teaching aids and mailing nutrition education materials to participants;
c.The cost of training nutrition educators, including costs related to conducting training sessions and purchasing and producing training materials;
d.The cost of breastfeeding promotion and support, education and encouragement is an allowable nutrition education cost. Breastfeeding costs include the above categories and specific breastfeeding aids such as breast pumps, nursing bras, and nursing pads, which directly support the initiation and continuation of breastfeeding, and salary and benefits expenses of peer counselors to assist women to continue with an initial decision to breastfeed.
3.The cost of Program certification procedures, including the following:
a.Laboratory fees incurred for tests conducted to determine whether persons are at nutritional risk;
b.Expendable medical supplies necessary to determine whether persons are at nutritional risk;
c.In connection with nutritional risk determinations, medical equipment used for taking anthropometric measurements, such as scales, measuring boards, and skin fold calipers; and for blood analysis to detect anemia;
d.Salary and other costs for time spent on certification.
4.The cost of outreach services.
5.The cost of administering the food delivery system.
6.The cost of translators for materials and interpreters.
7.The cost of fair hearings including the cost of an independent medical assessment of the appellant, if necessary.
8.The cost of transporting rural participants to clinics when prior approval for using WIC Program funds to provide transportation has been granted by the state agency and documentation that such service is considered essential to assure WIC Program access has been filed at the state agency. Additional part time sites will be considered whenever there is a request for such funds. Direct reimbursement to participants for transportation cost is not an allowable cost.
9.The cost of monitoring and reviewing Program operations.
10.Costs for auditing both the WIC Program Services and Administration costs and expenditures for food benefit redemptions. Food benefits values are determined by the state agency based on actual redemptions (disregarding rebate credits) for months in which all issued checks have been paid or expired, and state agency estimated redemption values for any month for which checks have been issued but not yet paid or expired. Figures are available upon request from the state agency.
11.Training nutrition educators is an allowable nutrition education cost when it directly relates to the program. Periodic training such as in-service meetings, professional meetings and seminars for the nutrition professional including breastfeeding promotion and support, are a necessary and a justifiable expense.
12.The following costs are allowable only with the prior approval of RIDOH:
a.Capital expenditures over $500(per unit) must be approved by the RIDOH Office. Capital expenditures exceeding $5,000 must also be approved by USDA/FNS.
b.Requests for approval of purchases of $500 or more up to $999, must be accompanied by three quotes, which can be obtained verbally but must be recorded at the time. If the local agency's preference is not the lowest price, the preference must be sufficiently justified in writing.
c.Purchases over $1,000 must go out to bid.
(1)If an agency has formal policies which differ from this, it may request permission to follow its normal policies, instead, but is this is not automatically approved by RIDOH.
(2)Any requests for purchasing medical equipment shall be submitted to the state WIC agency with complete information regarding the items to be purchased, including manufacturer's and model numbers for approval.
(3)Management Information System Expenditures. Any expenditures for automated information systems, except for those used in general management and payroll, including acquisition of automatic data processing hardware or software, whether by outright purchase, rental-purchase agreement or other method of acquisition, must receive prior approval of the state WIC agency and USDA/FNS, if funded in whole or in part with WIC administrative funds.
(4)Local agencies may not use WIC administrative funds for college or graduate school tuition or expenses nor for college courses or training in the pursuit of a college or graduate school degree.
(5) All local agency travel requests over $100 requires prior approval from the state WIC agency in accordance with State Travel procedures. In requesting travel local agencies must follow the following procedures:
(AA)Planning: Travel requests must be in writing and mailed, emailed or faxed to the Chief, Office of WIC Program as far in advance as possible to the date of travel, for approval or rejection from the State WIC Agency.
(BB)Travel Advance: If necessary, a local agency employee may obtain a travel advance for conference fees and/or registration. If travel is approved; proper supporting documentation must be provided to the state agency.
(CC)Meal Allowance: in accordance with State Provisions Meal allowances for local agency WIC personnel.
(DD)Lodging: Overnight accommodations will not be allowed within a 55 mile radius from workstation. Distance from home cannot be used in calculating the 55 mile radius.
(EE)Supporting Documentation: A copy of all supporting documentation must be submitted to the local agency's finance staff who will then include it with the local agency's monthly NSA expenditure report to the State WIC Agency.
(FF)If there are any questions prior to travel, contact the State WIC Office Chief or Fiscal Manager, to avoid delay or denial in initial approval or reimbursement in accordance with 7 C.F.R. § 246.14, incorporated above at § 3.2(A) of this Part.
d.State and local agencies must have established internal procedures to meet the financial management objectives of federally assisted programs.
e.State and local agencies must providing accurate and reliable information to the Federal government.
13.The local agency shall have an independent annual audit conducted.
14.Each local agency shall send a copy of all local agency sponsored audit reports covering any aspect of local WIC Program related activities including, but not limited to, the complete A-110 and/or A-133 audit report and any related findings, separate reports and local agency response and corrective plans.
a.Such copies are due at the State WIC Agency no later than six months from the end of the fiscal year covered by the report.
b.The cost of these audits shall be considered a part of administrative and program services costs and may be funded from the local agency administrative and program services funds, as appropriate. For purposes of determining the WIC Program's pro rata share of indirect costs associated with organization-wide audits, the value of food instrument redemptions shall be considered in the total dollar amount of the Program. Program service funds and food instrument values shall be listed separately in 7 C.F.R. § 246.20, incorporated above at § 3.2(A) of this part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.10** Claims and Penalties {#sec-216-ricr-20-05-3-3.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.10}
A.If the state agency determines through a review of the local agency's reports, program or financial analysis, monitoring, audit, or otherwise that any WIC Program funds provided to a local agency for supplemental foods or administrative and program services purposes were, through local agency negligence or fraud, misused or otherwise diverted from the WIC Program purposes, a formal claim will be assessed by state agency against the Local agency. The local agency shall promptly pay the State agency a sum equal to the amount of the administrative and program services funds or the value of supplemental foods or food instruments so misused or diverted.
B.If the state agency determines that any part of the WIC Program funds received by a local agency; or supplemental foods, either purchased or donated commodities; or food instruments were lost as a result of thefts, embezzlements or unexplained causes, the local agency shall, on demand, pay a sum equal to the amount of the money or the value of the supplemental foods or food instruments so lost.
C.The local agency shall have full opportunity to submit evidence, explanation or information concerning alleged instances of noncompliance or diversion before a final determination is made in such cases.
D.Penalties. In accordance with section 12(g) of the National School Lunch Act, whoever embezzles willfully misapplies, steals or obtains by fraud any funds, assets or property provided under Section 17 of the Child Nutrition Act of 1966, as amended, whether received directly or indirectly from USDA, or whoever receives, conceals or retains such funds, assets or property for his or her own interest, knowing such funds, assets or property have been embezzled, willfully misapplies, stolen, or obtained by fraud shall, if such funds, assets or property are of the value of $100 or more, be fined not more than $10,000 or imprisoned not more than five years, or both, or if such funds, assets or property are of a value of less than $100, shall be fined not more than $1,000 or imprisoned for not more than one year, or both, incorporated above at § 246.23 of this part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
##### **216-RICR-20-05-3 § 3.11** Fair Hearing Procedures {#sec-216-ricr-20-05-3-3.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-05-3#3.11}
A.Grounds for a Fair Hearing: An individual may request a Fair Hearing to appeal a state or local agency action which results in the individual's denial of participation, disqualification or termination from the Program, or the attempted recovery of the cash value of benefits issued to such individual.
B.Local Agency Responsibilities:
1.Inform each WIC applicant of his/her right to a Fair Hearing during the initial contact with the local agency.
2.Assure an applicant (or client), against whom sanctions have been imposed, of unrestricted freedom to request a Fair Hearing.
3.Offer assistance to help the applicant prepare and submit the Fair Hearing Request.
4.Inform the applicant that he/she may request copies of any documents in his/her WIC record, in advance of the Fair Hearing.
5.Inform each applicant (or client), against whom sanctions have been imposed, in writing, at the time the sanction is imposed, of the reason for the sanction, the right to a Fair Hearing, and how to request a Fair Hearing. This written information is contained in a separate form, "Fair Hearing Information," given to participants at the time of initial certification and at the time of denial, termination from the Program or other sanction.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-11-15 to 01/04/2022*
- *Adoption — effective from 2017-11-15 to 11/15/2017*
- *Amendment — effective from 2011-06-02 to 11/15/2017*
- *Amendment — effective from 2010-07-05 to 06/02/2011*
- *Amendment — effective from 2009-08-11 to 07/05/2010*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2008-02-20 to 08/11/2009*
- *Amendment — effective from 2007-02-18 to 02/20/2008*
- *Amendment — effective from 2004-05-02 to 02/18/2007*
- *Amendment — effective from 2003-02-26 to 05/02/2004*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-02-17 to 02/26/2003*
- *Amendment — effective from 2002-01-28 to 02/26/2003*
### **Subchapter 10** Screening, Medical Services, and Reporting
#### **216-RICR-20-10-1** Permits for Screening Programs
##### **216-RICR-20-10-1 § 1.1** Authority {#sec-216-ricr-20-10-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-1#1.1}
These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-16.2-5, as amended, and are established for the purpose of adopting minimum standards for the issuance of permits for screening programs held in the state of Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-10-1 § 1.2** Incorporated Material {#sec-216-ricr-20-10-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-1#1.2}
A.These regulations hereby adopt and incorporate 42 C.F.R. §?493.15 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate 29 C.F.R. § 1910.1030 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-10-1 § 1.3** Definitions {#sec-216-ricr-20-10-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-1#1.3}
A.Wherever used in these rules and regulations the following terms shall be construed as follows:
1."Act" refers to R.I. Gen. Laws Chapter 23-16.2, entitled, "Laboratories."
2."Clinical Laboratory" means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, radiobioassey, cytological, pathological, or other examination of materials derived from the human body for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Rhode Island Department of Health.
5."General public" means a person as defined herein.
6."Limited function test" means those tests listed 42 C.F.R. §?493.15 (2017) as waived tests.
7."Medical health professional" means either a medical technician with a 2-year Associate's degree from an accredited educational institution, a medical technologist, with a Bachelor's degree from an accredited educational institution, or a nurse or physician who is licensed in the state.
8."Person" means any individual, firm, partnership, corporation, company, association, or joint stock association.
9."Physician" means a person with a license to practice allopathic or osteopathic medicine in this state under the provisions of R.I. Gen. Laws Chapter 5-37.
10."R.I. Gen. Laws" means Rhode Island General Law, as amended.
11."Screening program or health promotion program," hereinafter referred to as "screening program," means a temporary or ad hoc health promotion program that offers to the general public, on a non-continual, non-permanent basis, screening procedures of biological materials (specimens) derived from the human body, for the purpose of providing information for the assessment of the health of human beings pursuant to R.I. Gen. Laws § 23-16.2-3 and in accordance with the requirements herein.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-10-1 § 1.4** Procedure for Permits {#sec-216-ricr-20-10-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-1#1.4}
1.4.1General Requirements
A.It shall be unlawful for any persons, corporation, or other form of entity to own, maintain, conduct or operate a temporary or ad hoc screening program in this state without meeting the requirements of the rules and regulations herein. Furthermore:
1.Any screening program in this state shall be conducted or operated under the overall supervision of either a physician licensed in this state, a clinical laboratory of a hospital licensed in this state, or an independent clinical laboratory licensed in this state and include appropriate personnel in accordance with the provisions of §§ 1.5.1 through 1.5.2 of this Part.
a.A permit shall be required for those persons seeking to operate an ad hoc screening program under the overall supervision of a physician licensed in this state.
(1)Said permit shall be required to be obtained annually.
b.A permit shall not be required for those clinical laboratories of hospitals licensed in this state or independent clinical laboratories licensed in this state to operate an ad hoc screening program. In these cases, the screening program shall be conducted under the licensee’s hospital or independent clinical laboratory license.
2.All persons conducting screening programs shall be required to submit a schedule of each screening site, clearly identifying the specific screening tests to be conducted, and the dates, times and locations of the screening program.
3.The permit fee shall be as set forth in the “Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.”
a.It is within the Director’s discretion to waive the fee. Nothing herein shall require any licensed persons, corporations, or other entity to pay the permit fee, if the screening program is provided free of charge to the public by the licensed persons, corporation, or entity.
4.Any person conducting or operating a screening program shall be required to acquire liability insurance to cover any injury which may be incurred as a result of negligence.
B.A screening program shall represent itself in its advertisements, publications, or other forms of communication, as providing only those categorical screening procedures for which a screening is being conducted and shall not advertise in a manner which tends to mislead or deceive the public.
1.4.2Application for Permit and Fee
A.Persons seeking to operate an ad hoc screening program under the overall supervision of a physician licensed in this state shall submit an application for a permit to conduct or operate said screening program to the Rhode Island Department of Health, Division of Facilities Regulation, on forms provided by the Department and available through the Division. The application shall contain such information as the Department reasonably requires, including but not limited to:
1.The name of the person and/or agency operating or conducting the screening program and the name of the person responsible for the overall medical direction of the program, the name(s) and qualifications of the on-site supervisor and other staff personnel in accordance with § 1.5.2(A) of this Part and the location of the site, the date, time and schedule of the screening program;
2.Evidence of ability to comply with the requirements herein including evidence of the qualifications of staff personnel and of holding liability insurance in accordance with §§ 1.4.1(A)(4), 1.5.1, and 1.5.2 of this Part;
3.A written description pertaining to all aspects of the administration and operation of the screening program including but not limited to:
a.Assurance that the specific screening test(s) to be offered will be conducted in accordance with the guidelines established by the Rhode Island Department of Health, Division of Facilities Regulation;
b.The procedure(s) for monitoring, obtaining informed consents, interpretation and reporting of test results, and follow-up on positive findings, participant education, and referral of identified cases, including an explanation of results, and recommendations for appropriate treatment, prevention and control;
c.Analytical method(s) to be used, type of equipment and/or instrument(s) to be used, and documented evidence to determine accuracy and precision of the instrument(s);
d.A description of the supervisory methods and quality controls, in accordance with § 1.5.3 of this Part;
e.Staff training program and qualifications of staff;
f.Copies of educational materials pertaining to specific test(s) and condition(s) to be distributed to the general public at the screening site;
g.Quality control and instrument maintenance records;
h.Provisions to handle emergencies; and
i.Procedures for the disposal of waste consistent with the provisions for the management of medical waste from the Department of Environmental Management’s “Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island.”
B.The completed application for a screening program permit shall be accompanied by the documentary requirements of § 1.4.2(A) of this Part, including the fee as set forth in the “Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.”
1.The fee shall be made payable by check or money order to the General Treasurer, state of Rhode Island, and submitted along with the application form at least thirty (30) days prior to the first scheduled screening program. Said materials shall be mailed to the:
a.Division of Facilities Regulation Rhode Island Department of Health 3 Capitol Hill, Room 306Providence, RI 02908
1.4.3Issuance of Permit
A.Upon receipt of an application for a permit and accompanying fee, the Department shall issue a permit, if the applicant is found to be in compliance with the statutory and regulatory requirements herein.
B.The permit issued shall be valid only for a period of one (1) year, and only for the specific category(ies) of screening procedures specified on the permit.
C.A permit issued hereunder shall be the property of the state and loaned to the applicant. The permit shall be kept posted in a conspicuous place at the location of the screening program and is not transferable.
1.4.4Denial and/or Revocation of Permit
A.The Department is authorized to deny an application for the issuance of a permit and to revoke any permit issued, if the statutory and regulatory provisions herein are not met.
B.Whenever an action shall be proposed to deny or revoke a permit, the Department shall notify the applicant by certified mail, setting forth reasons for the proposed action, and the applicant shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of § 1.6.3 of this Part.
1.However, if the Department finds that public health, safety or welfare of clients requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of the permit pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-10-1 § 1.5** Delivery of Services {#sec-216-ricr-20-10-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-1#1.5}
1.5.1Medical Direction & Responsibility
A.Every person conducting or operating a screening program shall enter into a provider arrangement with either a physician or an independent clinical laboratory or a clinical laboratory of a hospital, all of whom must be licensed in Rhode Island, and who will be responsible for the overall medical direction and supervision of the operation of the screening program and services and ensure the delivery of quality services, unless the person conducting or operating the screening program is either a physician, an independent clinical laboratory, or a hospital clinical laboratory licensed in this state.
1.Furthermore the person responsible for the medical direction of the screening program shall:
a.Develop and/or approve the professional components of the screening program(s) including policies and procedures governing the technical practices pertaining to no less than the provisions of § 1.4.2(A) of this Part; and
b.Ensure that the specific screening tests being offered shall be conducted in a manner consistent with the guidelines established by the Rhode Island Department of Health, Division of Facilities Regulation.
1.5.2Personnel
A.Staff Personnel
1.On-site Supervisor
a.Every screening program shall have a person designated to supervise the program and personnel;
b.The supervisor shall be a medical health professional, licensed and/or registered in this state, who must have the appropriate training in the specific instrumentation(s) to be used in conducting the screening program. The training shall consist of no less than one (1) day (i.e., 7 hours) training conducted by an experienced laboratory instructor (at the minimum level of a medical technologist). Said training shall consist of instruction in no less than:
(1)Calibration and operation of the specific instrument(s) to be used in the screening program;
(2)Detecting problems and performing usual instrument maintenance;
(3)Handling emergencies and medical waste;
(4)Participant education and referral protocols; and
(5)Such other areas as may be deemed relevant.
c.Furthermore, the on-site supervisor shall be required to be on the premises at all times during the screening program and shall be responsible to oversee the work performance of the individuals conducting the screening tests in order to ensure the accuracy of the methods and the maintenance of quality controls and the provision of appropriate education and/or referral.
2.Screening Personnel
a.Individuals performing procedures defined herein as "limited function tests" shall be required to complete a training program that shall consist of no less than a minimum of one (1) day's training (i.e., 7 hours) conducted by experienced laboratory trainer(s) and shall include no less than:
(1)Calibration and operation of the specific instrument (s) to be used;
(2)Detecting problems and performing usual instrument maintenance;
(3)Educational and referral protocols; and
(4)Such other areas as may be deemed relevant.
b.In addition to this training, a minimum of one (1) week (i.e., 35 hours) supervised field experience in operating the instrument(s) shall be required. Screening personnel shall be subject to ongoing supervision for all aspects of their performance at the screening program.
3.First Aid or Cardiopulmonary Resuscitation (CPR)
a.At least one (1) staff person shall hold a current certificate in first aid or CPR and must be on the premises and available at all times during the testing.
B.Worker Safety
1.In order to protect screening personnel from occupational exposure to blood borne pathogens, procedures for workers' safety should be carried out in accordance with the Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogen Standards, 29 C.F.R. §1910.1030 (2017). Work practices should be designed to minimize or eliminate exposure to blood and other body fluids.
1.5.3Methodologies for Quality Control
A.Each screening program shall establish an acceptable internal program of quality control covering each type of screening procedure performed for the verification and assessment of accuracy, measurement of precision, and detection of error. The factors which constitute the quality control provisions shall be based on current acceptable national standards of practice.
B.Each screening program shall establish an acceptable external program of quality control covering each type of screening procedure performed for the verification and assessment of accuracy, measurement of precision, and detection of error. The factors which constitute the quality control provisions shall be based on current acceptable national standards of practice.
1.5.4Prohibitions Against Referral
No licensed physician or clinical laboratory shall make any referral which would violate the provisions of R.I. Gen. Laws §§ 23-16.2-5.1 or 5-37-21, or any other relevant provisions of the law.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-10-1 § 1.6** Practices and Procedures, Violation and Severability {#sec-216-ricr-20-10-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-1#1.6}
1.6.1Variance Procedure
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case, if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such variance will not be contrary to the public interest, public health and/or health and safety of the public.
B.A request for a variance shall be filed by an applicant in writing setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the Department and within thirty (30) days thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the applicant appeals the denial.
1.6.2Violations
Any person who violates the statutory provisions and the regulations herein shall be subject to the sanctions of R.I. Gen. Laws Chapter 23-16.2.
1.6.3Rules Governing Practices & Procedures
All hearings and reviews required under the provisions of the rules and regulations herein shall be held in accordance with the Rules and Regulations of the Rhode Island Department of Health Regarding Practices and Procedures Before the Department of Health and Access to Public Records of the Department of Health.
1.6.4Severability
If any provision of these rules and regulations or the application thereof to any individual or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect and to this end the provisions of the regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-20-10-3** Medical Marijuana Program
##### **216-RICR-20-10-3 § 3.1** Authority and Purpose {#sec-216-ricr-20-10-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.1}
These amended Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Health are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 21-28.6-5, as amended, and are established for the purpose of updating standards for the implementation of a medical marijuana program, and other changes mandated pursuant to R.I. Gen. Laws Chapter 21-28.6, as amended.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.2** Incorporated Materials {#sec-216-ricr-20-10-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.2}
These regulations hereby adopt and incorporate the Colorado Department of Revenue's "Marijuana Equivalency and Dosage" (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.3** Definitions {#sec-216-ricr-20-10-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.3}
A.Wherever used in these Regulations the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 21-28.6-1 entitled “The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act.”
2.“Authorized purchaser” means a natural person, who is at least twenty-one (21) years old, and who is registered with the Department of Health for the purpose of assisting a qualifying patient in purchasing marijuana from a compassion center. An authorized purchaser may assist no more than one patient, and is prohibited from consuming marijuana obtained for the use of the qualifying patient.
3.“Cardholder" means a person who has registered with the Department of Health pursuant to R.I. Gen. Laws Chapter 21-28.6 and has been issued and possesses a valid registry identification card or license.
4.“Commercial unit” means a building, office, suite or room within a commercial or industrial building for use by one business and is rented or owned by that business or person.
5.“Compassion center” means a not-for-profit corporation subject to the provisions of R.I. Gen. Laws Chapter 7-6, and registered under R.I. Gen. Laws § 21-28.6-12 of the Act that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, supplies or dispenses marijuana, and/or related supplies and educational materials, to patient cardholders and/or their registered caregiver cardholder and authorized purchaser.
6.“Debilitating medical condition” means:
a.Cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, Hepatitis C, post-traumatic stress disorder; or the treatment of these conditions;
b.A chronic or debilitating disease or medical condition or its treatment that produces one or more of the following: cachexia or wasting syndrome; severe, debilitating, chronic pain; severe nausea; seizures, including but not limited to, those characteristic of epilepsy; or severe and persistent muscle spasms, including but not limited to, those characteristic of multiple sclerosis or Crohn’s disease; or agitation of Alzheimer's Disease; or
c.Any other medical condition or its treatment approved by the Department of Health pursuant to § 3.4.4 of this Part.
7."Department of Business Regulation” means the Rhode Island Department of Business Regulation or its successor agency.
8.“Department of Health” means the Rhode Island Department of Health or its successor agency.
9.“Department of Public Safety” means the Rhode Island Department of Public Safety or its successor agency.
10.“Dried usable marijuana” means the dried leaves and flowers of the marijuana plant after the wet harvested leaves and flowers of the marijuana plant have undergone the drying process.
11.“Dwelling unit” means a room or group of rooms within a dwelling used or intended for use by one family or household, or by no more than three (3) unrelated individuals, for living, sleeping, cooking and eating.
12.“Equivalent amount” means the portion of usable marijuana, be it extracted, edible, concentrated or any other form, found to be equal to a portion of dried usable marijuana, as defined in § 3.13 of this Part.
13.“Full assessment” means evaluation by practitioner which at a minimum documents in the medical record: history of present illness, social history, past medical and surgical history, alcohol and substance use history, physical exam and documentation of therapies with inadequate response.
14.“Marijuana” has the meaning given that term in R.I. Gen. Laws § 21-28-1.02(26) and is as follows: all parts of the plant (Cannabis sativa, L.), whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the plant which is incapable of germination.
15.“Marijuana infused products” means a product infused with medical marijuana or an extract of medical marijuana that is intended for use or consumption other than by smoking, including, but not limited to edible products, ointments, oils and tinctures. These products when manufactured or sold by a licensed medical marijuana compassion center shall not be considered a food or drug.
16."Mature marijuana plant" means a marijuana plant that has flowers or buds that are readily observable by an unaided visual examination.
17.“Medical marijuana program tracking system” shall refer to any system designated by the Department of Business Regulation and the Department of Health designed and used to record all medical marijuana program regulated activities with unique identifiers to track all activities and transactions from point of origin to point of sale (“seed to sale”), “Seed to sale” activities and transactions include but are not limited to: all cultivation, harvest, processing, manufacturing, and packaging and labeling; all purchases, acquisitions or third party supply of marijuana; all sales and dispensing transactions, and any other transfers of marijuana as permitted by the Department of Business Regulation; any instances of destruction of marijuana; and testing compliance tracking. The Medical Marijuana Program Tracking System may also be used to record and/or report any other additional information directed by the Department of Business Regulation or the Department of Health consistent with the Department of Business Regulation regulations and/or Department of Health regulations.
18.“Medical use” means the acquisition, possession, cultivation, manufacture, use, delivery, transfer, or transportation of marijuana or paraphernalia relating to the consumption of marijuana to alleviate a patient cardholder's debilitating medical condition or symptoms associated with the medical condition.
19.“Paraphernalia”, as used in these Regulations, means any equipment, product, or material of any kind that is primarily intended or designed for use in planting, propagating, growing, cultivating, harvesting, manufacturing, compounding, converting, producing, processing, preparing, inhaling, or otherwise introducing into the human body marijuana, including but not limited to: metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, or punctured metal bowls; water pipes, roach clips: meaning objects used to hold burning material, such as a marijuana cigarette, that has become too small or too short to be held in the hand; bongs; ice pipes or chillers.
20.“Parent or legal guardian” means the custodial parent for a person under eighteen (18) years of age or the legal guardian with responsibility for health care decisions for a person of any age.
21.“Practitioner” means a person who is licensed to practice medicine with authority to prescribe drugs pursuant to R.I. Gen. Laws Chapter 5-37 or a physician licensed with authority to prescribe drugs in Massachusetts or Connecticut.
22.“Primary caregiver” means a natural person who is at least twenty-one (21) years old and is a resident of Rhode Island. A primary caregiver may assist no more than five (5) qualifying patients with their medical use of marijuana.
23.“Qualifying patient” means a person who has been diagnosed by a practitioner as having a debilitating medical condition and is a resident of Rhode Island.
24.“Registry identification card” means a document issued by the Department of Health that identifies a person as a registered qualifying patient, a registered primary caregiver, or an authorized purchaser.
25.“R.I. Gen. Laws” means the General Laws of Rhode Island, as amended.
26."Seedling" means a marijuana plant with no observable flowers or buds.
27.“These regulations” mean all parts of Rhode Island rules and regulations related to the Medical Marijuana Program administered by the Department of Health.
28."Unusable marijuana" means marijuana seeds, stalks, seedlings, and unusable roots.
29.“Usable marijuana” means the dried leaves and flowers of the marijuana plant, and any mixture or preparation thereof, but does not include the seeds, stalks, and roots of the plant.
30.“Wet marijuana” means the harvested leaves and flowers of the marijuana plant before they have reached a dry usable state. Marijuana that has been dried to a usable state shall be assumed to have yielded twenty percent (20%) of the weight of the wet marijuana as defined in § 3.13 of this Part.
31.“Written certification” means the qualifying patient’s medical records, and a statement signed by a practitioner, stating that in the practitioner’s professional opinion the potential benefits of the medical use of marijuana would likely outweigh the health risks for the qualifying patient. A written certification shall be made only in the course of a bona fide practitioner-patient relationship after the practitioner has completed a full assessment of the qualifying patient's medical history. The written certification shall specify the qualifying patient's debilitating medical condition or conditions.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.4** General Requirements {#sec-216-ricr-20-10-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.4}
3.4.1Administration of the Program
The Division of Customer Services within the Department of Health shall be responsible for the administrative functions required to implement the provisions of the Act and these Regulations related to qualified patients, primary caregivers and authorized purchasers, as they apply to the implementation of the medical marijuana program in Rhode Island.
3.4.2Written Certifications
A.Practitioners shall provide written certifications for their patients on such forms as shall be provided by the Department of Health.
B.The written certification shall specify the qualifying patient's debilitating medical condition or conditions and include a copy of the relevant patient medical records as specified in § 3.3(A)(31) of this Part, documenting the debilitating medical condition or conditions.
C.A written certification shall be made only in the course of a bona fide practitioner-patient relationship after the practitioner has completed a full assessment of the qualifying patient's medical history.
3.4.3Practitioner(s) Responsibility
A.The certifying practitioner shall obtain three (3) hours or equivalent of Category 1 CME regarding medical marijuana every two (2) years as part of usual CME/CE requirement.
B.The certifying practitioner shall document in the medical record the basis for issuance of a written certification regarding use of medical marijuana, specifically identifying the debilitating condition(s) being met.
C.Patient Education: The certifying practitioner shall document in the medical record and provide in written or verbal format, that patient was educated regarding maximum daily dose of active ingredient, minimum interval between doses, possible drug interactions – including risk of co-ingesting alcohol.
D.The certifying practitioner must document after examination, the patient’s response to conventional medical therapies and explain the risks and benefits of the use of marijuana to the qualifying patient.
E.The certifying practitioner must be committed to the continual assessment of the patient and the patient’s response to the use of marijuana. This must be demonstrated through follow-up appointments, semi-annually at minimum, before the card is renewed. The practitioner will send updates to the primary care provider (if not the PCP), at intervals not to exceed twelve (12) months, documenting patients progress or experience using medical marijuana.
F.The certifying practitioner must have a current license to practice medicine, as specified in § § 3.3(A)(21) of this Part, and current DEA registration and appropriate state controlled substance registration.
G.Before issuing a written certification, a certifying physician must review the Rhode Island Prescription Drug Monitoring Program, review the patients’ prescription history and make a judgement about the potential for drug interaction, adverse events or untoward clinical outcome from adding medical marijuana.
H.Document in the medical record a full assessment as defined in § 3.3(A)(13) of this Part
3.4.4Addition of Debilitating Medical Conditions
A.The Department of Health shall accept a written petition from any person requesting that a particular disease or condition be included among the diseases and conditions that qualify as “debilitating medical conditions” contained in § 3.3(A)(6) of this Part.
B.The petitioner shall provide to the Department of Health, as available:
1.An explanation stating the reason(s) why the condition should be included;
2.Any scientific peer reviewed literature supporting the addition of the condition to the list;
3.Letter(s) of support from physicians or other licensed health care professional knowledgeable about the condition and its treatment;
C.In considering such petitions, the Department shall include public notice of, and an opportunity to comment in a public hearing, upon such petitions.
1.The Department shall, after hearing, approve or deny such petitions within one hundred eighty (180) days of submission.
2.The approval or denial of such a petition shall be considered a final Department of Health action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.
3.The denial of a petition shall not disqualify qualifying patients with that condition, if they have a debilitating medical condition as defined in R.I. Gen. Laws § 21-28.6-3 and § 3.3(A)(6) of this Part.
3.4.5Primary Caregiver Cardholder, Authorized Purchaser cardholder and Patient Cardholder Possession Limits
A.The following possession limits are established for each primary caregiver cardholder, authorized purchaser card holder and patient cardholder:
1.Pursuant to R.I. Gen. Laws § 21-28.6-4(e), a primary caregiver cardholder may possess an amount of marijuana which does not exceed twelve (12) mature marijuana plants, that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation, and two and one-half (2.5) ounces of dried usable marijuana or its equivalent amount and twelve and one-half (12.5) ounces of wet marijuana for each patient cardholder to whom he or she is connected through the Department of Health’s registration process established pursuant to these Regulations.
2. Notwithstanding the provisions of § 3.4.5(A)(1) of this Part, and pursuant to R.I. Gen. Laws § 21-28.6-4(o), no primary caregiver cardholder shall possess an amount of marijuana in excess of:
a.Twenty-four (24) mature marijuana plants, that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation,
b.Five (5) ounces of dried usable marijuana or its equivalent amount and twenty-five (25) ounces of wet marijuana for patient cardholders to whom the primary caregiver is connected through the Department of Health’s registration process established pursuant to these Regulations.
3.Pursuant to R.I. Gen. Laws § 21-28.6-4(b), an authorized purchaser cardholder may possess an amount of marijuana that does not exceed two and one-half (2.5) ounces of dried usable marijuana or its equivalent amount purchased legally from a compassion center for their designated patient.
4.Pursuant to R.I. Gen. Laws § 21-28.6-4(a), a patient cardholder may possess an amount of marijuana that does not exceed twelve (12) mature marijuana plants, that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation and two and one-half (2.5) ounces of dried usable marijuana or its equivalent amount, and twelve and one half (12.5) ounces of wet marijuana. Said plants shall be stored in an indoor facility.
5.Pursuant to R.I. Gen. Laws § 21-28.6-4(f), a patient cardholder shall be allowed to possess a reasonable amount of unusable marijuana, including up to twelve (12) seedlings that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation.
6.Pursuant to R.I. Gen. Laws § 21-28.6-4(f), a primary caregiver cardholder shall be allowed to possess a reasonable amount of unusable marijuana, including up to twenty-four (24) seedlings that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation.
7.Pursuant to R.I. Gen. Laws § 21-28.6-4(q), no more than twenty-four (24) mature marijuana plants that are accompanied by valid medical marijuana tags shall be grown or otherwise located at any one dwelling unit or commercial unit. The number of qualifying patients or primary caregivers residing, owning, renting, growing or otherwise operating at a dwelling or commercial unit does not affect this limit.
3.4.6Primary Caregiver and Authorized Purchaser Eligibility
A.The primary caregiver and authorized purchaser applicant must apply to the Bureau of Criminal Identification of the Department of Attorney General, State Police, or local police department for a national criminal records check that shall include fingerprints submitted to the Federal Bureau of Investigation. Upon the discovery of any disqualifying information as defined in R.I. Gen. Laws § 21-28.6-6(e)(1), and in accordance with the rules promulgated by the Director, the Bureau of Criminal Identification of the Department of Attorney General, State Police, or the local police department shall inform the applicant, in writing, of the nature of the disqualifying information; and, without disclosing the nature of the disqualifying information, shall notify the Department of Health, in writing, that disqualifying information has been discovered.
B.In those situations in which no disqualifying information has been found, the Bureau of Criminal Identification of the Department of Attorney General, State Police, or the local police shall inform the applicant and the Department of Health, in writing, of this fact.
1.The Department of Health shall maintain on file evidence that a criminal records check has been initiated on all applicants seeking a primary caregiver registry identification card and the results of the checks.
2.The primary caregiver cardholder shall not be required to apply for a national criminal records check for each patient he or she is connected to through the Department of Health’s registration process, provided that he or she has applied for a national criminal records check within the previous two (2) years in accordance with the Act and these Regulations.
3.The Department of Health shall not require a primary caregiver cardholder or an authorized purchaser to apply for a national criminal records check more than once every two (2) years.
4.The primary caregiver cardholder must notify the Department of Health of any disqualifying information that occurs during the two year time period between the national criminal records check required in § 3.4.6(A) of this Part. The disqualifying information must be reported to the Department of Health within ten (10) days of any conviction defined in § 3.4.6(C) and § 3.4.6(E) of this Part.
C.Information produced by a national criminal records check pertaining to a conviction for any felony offense under R.I. Gen. Laws Chapter 21-28 ("Rhode Island Controlled Substances Act"), murder, manslaughter, rape, first degree sexual assault, second degree sexual assault, first degree child molestation, second degree child molestation, kidnapping, first degree arson, second degree arson, mayhem, robbery, burglary, breaking and entering, assault with a dangerous weapon, assault or battery involving grave bodily injury, and/or assault with intent to commit any offense punishable as a felony or a similar offense from any other jurisdiction shall result in a letter to the applicant and the Department of Health disqualifying the applicant.
D.The primary caregiver or authorized purchaser applicant shall be responsible for any expense associated with the national criminal records check.
E.For purposes of Section § 3.3.6 of this Part "conviction" means, in addition to judgments of conviction entered by a court subsequent to a finding of guilty or a plea of guilty, those instances where the defendant has entered a plea of nolo contendere and has received a sentence of probation and those instances where a defendant has entered into a deferred sentence agreement with the Attorney General.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.5** Application for Department of Health Registry Identification Cards and Fees {#sec-216-ricr-20-10-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.5}
3.5.1Registry Identification Cards for Qualifying Patients, Primary Caregivers and Authorized Purchasers
A.The Department of Health shall issue registry photo identification cards to qualifying patients, primary caregivers and authorized purchasers who submit the following:
1.Written certification as defined in § 3.3(A)(31) of this Part;
2.Non-returnable, non-refundable application or renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title, for each qualifying patient, primary caregiver, or authorized purchaser of the qualifying patient identified on the application;
a.Provided, however, for a qualifying patient or primary caregiver who submits satisfactory evidence to the Department of Health of being a recipient of Medicaid, Supplemental Security Income (SSI), Social Security Disability Insurance (SSDI), Veteran Disability, or Railroad Disability, a non-returnable, non-refundable application or renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title, shall be submitted.
3.Name, address, and date of birth of the qualifying patient. If the qualifying patient is homeless, no address is required.
4.Name, address, and telephone number of the qualifying patient’s practitioner; and
5.Name, address, and date of birth of one primary caregiver and one authorized purchaser, for the qualifying patient, if any.
6.Whether the qualifying patient elects to grow medical marijuana plants for himself or herself.
7.Each applicant for qualifying patient registry identification card shall also indicate if he or she would like the Department of Health to notify him or her of any clinical studies about marijuana's risk or efficacy.
8.Individuals licensed by the Department of Business Regulation shall obtain registry photo identification cards from the Department of Health.
3.5.2Registry Identification Cards for Minors
A.The Department of Health shall not issue a registry identification card to a qualifying patient under the age of eighteen (18) unless:
1.The qualifying patient's practitioner has explained the potential risks and benefits of the medical use of marijuana to the qualifying patient and to a parent, guardian or person having legal custody of the qualifying patient; and
2.A parent, guardian or person having legal custody consents in writing to:
a.Allow the qualifying patient's medical use of marijuana;
b.Serve as the qualifying patient's primary caregiver or authorized purchaser; and
c.Control the acquisition of the marijuana, the dosage, and the frequency of the medical use of marijuana by the qualifying patient.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.6** Issuance and Renewal of Department of Health Registry Identification Cards {#sec-216-ricr-20-10-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.6}
A.The Department of Health shall verify the information contained in an application or renewal as a qualified patient, a primary caregiver or an authorized purchaser submitted pursuant to the Act, and shall approve or deny an application or renewal within thirty-five (35) days of receiving it.
B.The Department of Health shall issue registry identification cards within five (5) days of approving an application or renewal that shall expire one (1) year after the date of issuance.
1.If the Department of Health fails to issue a valid registry identification card in response to a valid application submitted pursuant to the Act or these Regulations within thirty-five (35) days of its submission, the registry identification card shall be deemed granted and a copy of the registry identification application shall be deemed a valid registry identification card. Patients who are currently receiving chemotherapy or have been admitted to hospice will be expedited and their applications will be approved within seventy-two (72) hours.
2.The Department of Health shall issue a registry identification card to one primary caregiver and one authorized purchaser, if any, who is named in a qualifying patient's approved application.
C.The Department of Health may deny an application or renewal only if the applicant did not provide the information required pursuant to the Act, or if the Department of Health determines that the information provided was falsified.
D.Rejection of an application or renewal is considered a final Department of Health action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.
E.A registry identification card shall not be transferable.
F.Registry identification cards shall contain:
1.The date of issuance and expiration date of the registry identification card;
2.The name of the qualifying patient, primary caregiver or authorized purchaser;
3.A random registry identification number;
4.A photograph; and
5.Any additional information as required by these Regulations or the Department of Health.
3.6.1Requirements Related to Department of Health Registry Identification Cards
A.Persons issued registry identification cards shall be subject to the following:
1.A patient cardholder must notify the Department of Health of any change in the patient cardholder's name, address, primary caregiver, or authorized purchaser; or if he or she ceases to have his or her debilitating medical condition, within ten (10) days of such change.
2.If a patient cardholder has ceased to suffer from a debilitating medical condition, the card shall be deemed null and void and the person shall be liable for any other penalties that may apply to the person's non-medical use of marijuana.
3.A registered primary caregiver cardholder or authorized purchaser cardholder shall notify the Department of Health of any change in his or her name or address within ten (10) days of such change.
4.When a patient cardholder, primary caregiver cardholder or authorized purchaser cardholder notifies the Department of Health of any changes listed in § 3.4.6 of this Part, the Department of Health shall issue the patient cardholder, primary caregiver cardholder or authorized purchaser cardholder a new registry identification card within ten (10) days of receiving the updated information and a non-returnable, non-refundable fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title for each new registration card to be issued.
5.When a patient cardholder changes his or her primary caregiver or authorized purchaser, the Department of Health shall notify the primary caregiver cardholder or authorized purchaser cardholder within ten (10) days. The primary caregiver cardholder’s protections as provided in the Act as to that patient shall expire ten (10) days after notification by the Department of Health. If the primary caregiver cardholder is connected to no other patient cardholders in the program, he or she must return his or her registry identification card to the Department of Health.
6.If a patient cardholder, caregiver cardholder or authorized purchaser card holder loses his or her registry identification card, he or she shall notify the Department of Health and submit a non-returnable, non-refundable fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title, within ten (10) days of losing the card. Within five (5) days of receiving this notification, the Department of Health shall issue a new registry identification card with new random identification number.
3.6.2Patient Cardholder and Primary Caregiver Cardholder Marijuana Grow Location
A.The premise where the patient cardholder or primary caregiver cardholder elects to grow marijuana must register with the Department of Health. The patient cardholder or primary caregiver cardholder must notify the Department of Health of any changes to this registered grow location information.
B.Registered patient cardholders and primary caregiver cardholders who elect to grow marijuana are subject to regulations promulgated by the Department of Business Regulation.
1.The Department of Business Regulation and the Department of Health have jointly determined that DBR will primarily administer all aspects of the medical marijuana plant tag program to fulfill the state obligation to monitor and verify compliance with the statutory requirements that patients and cardholders electing to grow and primary caregiver cardholders do not exceed plant limits, properly tag all permitted plants, and do not grow at more than one location.
C.Effective January 1, 2019, if a patient cardholder chooses to alter his or her registration with regard to the growing of medical marijuana for himself or herself, he or she must notify the Department of Health prior to the purchase of medical marijuana tags from the Department of Business Regulation or the growing of medical marijuana plants.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.7** Compassion Center Inspection {#sec-216-ricr-20-10-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.7}
A.Compassion centers are subject to reasonable inspection by the Department of Health. During an inspection, the Department of Health may review the compassion center's confidential records, including its dispensing records, which shall track transactions according to qualifying patients' registry identification numbers to protect their confidentiality.
1.Pursuant to R.I. Gen. Laws § 21-28.6-12(e), a compassion center may also be subject to inspection by the Department of Business Regulation.
B.Compassion centers are subject to testing requirements for usable marijuana promulgated in regulation by the Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.8** Protections for the Medical Use of Marijuana {#sec-216-ricr-20-10-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.8}
A.A practitioner shall not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by the Rhode Island Board of Medical Licensure and Discipline or by any other business or occupational or professional licensing board or bureau solely for providing written certifications or for otherwise stating that, in the practitioner's professional opinion, the potential benefits of the medical marijuana would likely outweigh the health risks for a patient.
B.A practitioner, nurse, nurse practitioner, physician’s assistant, or pharmacist shall not be subject to arrest, prosecution or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau solely for discussing the benefits or health risks of medical marijuana or its interaction with other substances with a patient.
C.A registry identification card, or its equivalent, issued under the laws of another state, U.S. territory, or the District of Columbia to permit the medical use of marijuana by a patient with a debilitating medical condition, or to permit a person to assist with the medical use of marijuana by a patient with a debilitating medical condition, shall have the same force and effect as a registry identification card issued by the Department of Health pursuant to the Act and these Regulations.
D.For the purposes of medical care, including organ transplants, a patient cardholder’s authorized use of marijuana shall be considered the equivalent of the authorized use of any other medication used at the direction of a physician, and shall not constitute the use of an illicit substance.
E.No state employee shall be subject to arrest, prosecution or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty, disciplinary action, termination, or loss of employee or pension benefits, for any and all conduct that occurs within the scope of his or her employment regarding the administration, execution and/or enforcement of the Act, and the provisions of R.I. Gen. Laws §§ 9-31-8 and 9-31-9 shall be applicable to § 3.8 of this Part.
F.A patient cardholder or primary caregiver cardholder may give marijuana to another patient cardholder or primary caregiver cardholder to whom they are not connected by the Department of Health’s registration process, provided that no consideration is paid for the marijuana, and that the recipient does not exceed the limits specified in § 3.4.5 of this Part.
G.The manufacture of marijuana by a patient cardholder or primary caregiver cardholder using a solvent extraction process that includes the use of a compressed, flammable gas as a solvent shall not be subject to the protections specified by the Act and these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.9** Confidentiality Provisions {#sec-216-ricr-20-10-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.9}
A.Applications and supporting information submitted by qualifying patients, including information regarding their primary caregivers, authorized purchasers, and practitioners, are confidential and protected under the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996, as amended.
B.The Department of Health shall maintain a confidential list of the persons to whom the Department of Health has issued registry identification cards.
1.Individual names and other identifying information on the list:
a.Shall be confidential and not be considered a public record pursuant to R.I. Gen. Laws § 38-2-2(4); and
b.Shall not subject to disclosure, except to authorized employees of the Department of Health as necessary to perform official duties of the Department of Health, and pursuant to § 3.9(A)(2) of this Part.
2.The Department of Health shall verify to law enforcement personnel whether a registry identification card is valid solely by confirming the random registry identification number or name. This verification may occur through the use of shared database, provided that any confidential information in this database is protected in accordance with § 3.9 of this Part.
3.All records maintained by a compassion center which pertain to one or more registered qualifying patients, registered primary caregivers or authorized purchasers shall be considered:
a.Confidential health care information under applicable Rhode Island law; and
b.Protected health care information for purposes of the Federal Health Insurance Portability and Accountability Act of 1996, as amended.
4.Pursuant to R.I. Gen. Laws § 21-28.6-6(k), the Department of Health may notify law enforcement personnel about falsified or fraudulent information submitted to the Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.10** Purchase and Issuance of Medical Marijuana Plant Tags {#sec-216-ricr-20-10-3-3.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.10}
A.Pursuant to R.I. Gen. Laws § 21-28.6-15(a), effective April 1, 2017, every marijuana plant, possessed by a qualified patient or primary caregiver cardholder must be accompanied by a physical medical marijuana plant tag purchased through the Department of Business Regulation and issued by the Department of Health. Plant tags being issued by the Department of Health shall mean the following:
1.The Department of Health has approved the application of the qualified patient or primary caregiver and issued a registry photo identification card to the applicant; or for qualified patients and primary caregivers who are renewing their medical marijuana registration, the Department of Health has approved the renewal application of the qualified patient or primary caregiver and issued a registry photo identification card to the applicant.
2.The Department of Business Regulation verifies with the Department of Health the status of the card and any information submitted on the Department of Business Regulation plant tag purchasing form in accordance with R.I. Gen. Laws § 21-28.6-15(a)(2). For plant tags issued to qualified patient cardholders after January 1, 2019 the Department of Business Regulation will verify both the status of the card and the election to grow with the Department of Health in accordance with R.I. Gen. Laws § 21-28.6-15(a)(3).
3.The plant tag set fee is paid to the Department of Business Regulation and the plant tag is distributed by the Department of Business Regulation to the qualified patient or primary caregiver cardholder.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.11** Scope of the Act {#sec-216-ricr-20-10-3-3.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.11}
A.The Act and these Regulations shall not permit:
1.Any person to undertake any task under the influence of marijuana, when doing so would constitute negligence or professional malpractice;
2.The smoking of marijuana:
a.In a school bus or other form of public transportation;
b.On any school grounds;
c.In any correctional facility;
d.In any public place;
e.In any licensed drug treatment facility in this state; or
f.Where exposure to the marijuana smoke significantly adversely affects the health, safety, or welfare of children
3.Any person to operate, navigate, or be in actual physical control of any motor vehicle, aircraft, or motorboat while under the influence of marijuana. However, a registered qualifying patient shall not be considered to be under the influence solely for having marijuana metabolites in his or her system.
B.Nothing in the Act or these Regulations shall be construed to require:
1.A government medical assistance program or private health insurer to reimburse a person for costs associated with the medical use of marijuana; or
2.An employer to accommodate the medical use of marijuana in any workplace.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.12** Penalties for Violations {#sec-216-ricr-20-10-3-3.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.12}
A.Fraudulent representation to a law enforcement official of any fact or circumstance relating to the medical use of marijuana to avoid arrest or prosecution shall be punishable by a fine of five hundred dollars ($500) which shall be in addition to any other penalties that may apply for making a false statement for the non-medical use of marijuana.
B.If a patient cardholder, primary caregiver cardholder or authorized purchaser cardholder willfully violates any provision of the Act or these Regulations, as determined by the Department of Health, his or her registry identification card may be revoked.
C.A patient cardholder who fails to notify the Department of Health of any changes required pursuant to § 3.6.1(A) of this Part shall be responsible for a civil infraction, punishable by a fine of no more than one hundred fifty dollars ($150).
D.A primary caregiver cardholder or authorized purchaser cardholder, who fails to notify the Department of Health of any changes required pursuant to § 3.6.1(A) of this Part shall be responsible for a civil infraction, punishable by a fine of no more than one hundred fifty dollars ($150).
E.The registry identification card shall be revoked and shall not be reissued for any cardholder who is convicted of; placed on probation; whose case is filed pursuant to R.I. Gen. Laws § 12-10-12 where the defendant pleads nolo contendere; or whose case is deferred pursuant to R.I. Gen. Laws § 12-19-19 where the defendant pleads nolo contendere for any felony offense under R.I. Gen. Laws Chapter 21-28 ("Rhode Island Controlled Substances Act") or a similar offense from any other jurisdiction.
F.A cardholder shall be subject to arrest and prosecution under R.I. Gen. Laws Chapter 21-28 if he or she exceeds the possession limits set forth in § 3.4.5 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.13** Equivalency and Conversion Amounts {#sec-216-ricr-20-10-3-3.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.13}
A.The processing of finished plant material used to derive cannabis resin or concentrates alters the physical form and quantity (i.e., weight and volume) of the usable marijuana. To enable the comparison of usable marijuana in the various product types the Department of Health developed assumptions in accordance with "Marijuana Equivalency and Dosage", incorporated above at § 3.2(A) of this Part.
1.The Department of Health will use this document to express the quantity of usable marijuana in cannabis resins or concentrates in terms of the equivalent ounces of plant material.
a.Conversion Factors between Marijuana Flower Weight and Non-Flower Product Units
(1)
Marijuana Flower Weight
Equivalent Number of 10mg Edible Units
1 Oz of Flower
83
0.25 Oz of Flower
21
1 Gram of Flower
3
(2)
Marijuana Flower Weight
Equivalent grams of Concentrate
1 Oz of Flower
7.7
0.25 Oz of Flower
1.9
1 Gram of Flower
0.3
b.Conversion of Wet Flower Amounts to Dry Flower Amounts
Wet Flower Weight
Dry Flower Weight (20% of Wet Flower Weight)
12.5 Oz of Wet Flower
2.5 Oz of Dry Flower
25 Oz of Wet Flower
5.0 Oz of Dry Flower
37.5 Oz of Wet Flower
7.5 Oz of Dry Flower
50 Oz of Wet Flower
10.0 Oz of Dry Flower
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.14** Practices and Procedures {#sec-216-ricr-20-10-3-3.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.14}
All hearings and reviews required under the provisions of the Act or these Regulations shall be held in accordance with the provisions of the “Rules and Regulations Pertaining to Practices and Procedures before the Rhode Island Department of Health”.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
##### **216-RICR-20-10-3 § 3.15** Severability {#sec-216-ricr-20-10-3-3.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-3#3.15}
If any provision of the Act or these Regulations or its application thereof to any person or circumstance is held invalid, such invalidity shall not affect other provisions or applications of the Act or these Regulations, which can be given effect without the invalid provision or application, and to this end the provisions of the Act and these Regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-07-24 to 08/16/2020*
- *EMERGENCY RULE Amendment — effective from 2020-06-22 to 07/24/2020*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 06/22/2020*
- *Technical Revision — effective from 2017-01-03 to 01/04/2022*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2017-01-03 to 01/03/2017*
- *Amendment — effective from 2017-01-03 to 01/03/2017*
- *Technical Revision — effective from 2012-12-23 to 01/03/2017*
- *Amendment — effective from 2012-12-23 to 12/23/2012*
- *Amendment — effective from 2010-03-18 to 12/23/2012*
- *Amendment — effective from 2008-02-14 to 03/18/2010*
- *Adoption — effective from 2006-09-04 to 02/14/2008*
- *EMERGENCY RULE Adoption — effective from 2006-03-31 to 09/04/2006*
#### **216-RICR-20-10-4** School Health Programs
##### **216-RICR-20-10-4 § 4.1** Authority {#sec-216-ricr-20-10-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 16-21-7(a) and 23-1-18(4), and are established for the purpose of adopting prevailing standards pertaining to school health programs.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.2** Incorporated Materials {#sec-216-ricr-20-10-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.2}
A.These Regulations hereby adopt and incorporate the Rhode Island Health Education Framework: Health Literacy for All Students (2010) standards by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the RIDE Comprehensive Health Instructional Outcomes (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the Rhode Island Physical Education Framework standards (2003) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate the Substance Abuse and Mental Health Services Administration (SAMHSA) National Registry of Evidence Based Programs and Practices (2014), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
E.These Regulations hereby adopt and incorporate the Occupational Safety and Health Administration (OSHA) Toxic and Hazardous Substances Standard - 29 C.F.R. Parts 1910-1450 (2012) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
F.These Regulations hereby adopt and incorporate the American Speech-Language-Hearing Association Guidelines for Audiology Service Provision in and for Schools (2002) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
G.These Regulations hereby adopt and incorporate the American National Standards Institute Specifications for Audiometers Standards (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
H.These Regulations hereby adopt and incorporate the Occupational Safety and Health Administration Occupational Noise Exposure Standard, 29 C.F.R. § 1910.95(c) (2008) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
I.These Regulations hereby adopt and incorporate the Scoliosis Research Society Screening for Early Detection for Idiopathic Scoliosis in Adolescents standards (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
J.These Regulations hereby adopt and incorporate the U.S. Consumer Product Safety Commission Standards for public playground safety (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
K.These Regulations hereby adopt and incorporate the Uniform Federal Accessibility Standards (2004) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
L.These Regulations hereby adopt and incorporate the National Center for Children's Vision and Eye Health's Vision Screening Recommendations (2019) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.3** Definitions {#sec-216-ricr-20-10-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.3}
A.Wherever used in these Rules and Regulations the terms listed below shall be construed as follows:
1.“Administrative head of school” means the person with the greatest responsibility for the care and supervision of a public-school district or community as defined in § 4.3(A)(10) of this Part, or a non-public school (e.g. headmaster, principal, superintendent).
2."Anaphylaxis" means a potentially fatal, acute allergic reaction to a substance (such as stinging insects, foods and medications) that is induced by an exposure to the substance. Manifestations of anaphylaxis may be cutaneous (such as hives, itchiness, swelling), cardiorespiratory (swelling of tongue, throat, wheezing, difficulty breathing, low blood pressure), central nervous system (lethargy, coma) and others.
3."Audiologist" means an individual licensed in this State in accordance with Part 40-05-33 of this Title, Speech Pathologists and Audiologists.
4."Audiometric aide" means an individual registered in this State in accordance with Part 40-05-33 of this Title, Speech Pathologists and Audiologists.
5."Bullying and cyber-bullying", as used in this Part, are defined by R.I. Gen. Laws § 16-21-33.
6."Certified health educator" means an individual who is certified by the Rhode Island Department of Education (RIDE) in accordance with 200-RICR-20-20-, Regulations Governing the Certification of Educators in Rhode Island.
7."Certified school nurse" means an individual who is licensed as a professional (registered) nurse in this State pursuant to R.I. Gen. Laws Chapter 5-34 and is certified by RIDE as an All Grades Registered School Nurse and is not eligible to serve as a teacher of record in accordance with 200-RICR-20-20-1, Regulations Governing the Certification of Educators in Rhode Island.
8."Certified school nurse-teacher" means an individual who is licensed as a professional (registered) nurse in this State pursuant to R.I. Gen. Laws Chapter 5-34 and is certified by RIDE as an All Grades School Nurse-Teacher and as a Health Teacher in accordance with 200-RICR-20-20-, Regulations Governing the Certification of Educators in Rhode Island.
9."Community" means any city, town or regional school district established pursuant to State law and/or DCYF and any school operated by RIDE; provided, however, that the Department for Children, Youth and Families shall not have those administrative responsibilities and obligations as set forth in R.I. Gen. Laws Chapter 16-2 ("Education").
10.“Comprehensive school health program” means a school health program consisting of health education, health services and a healthful school environment, approved by the State Commissioner of Elementary and Secondary Education and the Director of Health in accordance with R.I. Gen. Laws § 16-21-7.
11.“Competitive foods” means all foods and beverages other than meals reimbursed under the National School Lunch Act (42 U.S.C. § 1751 et seq.), 200-RICR-20-25-4, Regulations Governing Nutritional Requirements for Reimbursable Meals and Competitive Foods and Beverages; Limitations on Competitive Foods and Beverages at Meal Time and the Child Nutrition Act of 1966 (42 U.S.C.§ 1771 et seq.) available for sale to students on the school campus during the school day.
12."Confidential health care information" means all information relating to a patient's health care history, diagnosis, condition, treatment or evaluation obtained from a health care provider who has treated the patient.
13."Controlled substance" means a drug, substance, or immediate precursor in schedules I-V of R.I. Gen. Laws § 21-28-1.02.
14.“Dating partner” means any person involved in an intimate association with another, primarily characterized by the expectation of affectionate involvement, whether casual, serious, or long-term.
15.“Dating violence” means a pattern of behavior wherein a person uses threats of, or uses, physical, sexual, verbal or emotional abuse to control his/her dating partner.
16."Dental hygienist", means a person with a license to practice dental hygiene in this State under the provisions R.I. Gen. Laws § 5-31.1-1.
a.Public health dental hygienist, as used in this Part means any practicing registered dental hygienist who may perform dental hygiene procedures in a public health setting under the provisions of R.I. Gen. Laws § 5-31.1-39.
17."Dentist", as used in this Part, means a person with a license to practice dentistry in this State under the provisions of R.I. Gen. Laws § 5-31.1-1.
18.“DCYF” means the Rhode Island Department of Children, Youth and Families.
19."Education record" means those records that are:
a.Directly related to a student; and
b.Maintained by an educational agency or institution or by a party acting for the agency or institution.
20."Emergency" means a medical or psychological condition where the absence of immediate intervention could reasonably be expected to result in placing the student's health (or another student's health) in serious jeopardy; serious impairment to bodily or psychological functions; or serious dysfunction of any bodily organ or part.
21.“Emergency care plan” or “ECP” means a set of procedural guidelines that provides specific directions about what to do in an emergency. A student with special health care needs may have both an ECP and an individualized health care plan (IHCP). The ECP may be formulated as part of the IHCP. As used in this Part, “emergency care plan (ECP)” shall have the same meaning as “emergency health care plan (EHCP).”
22."Epinephrine auto-injectors" means any device that is used for the automatic injection of epinephrine into the human body to prevent or treat anaphylaxis.
23."Eye care provider" means an individual licensed in the Rhode Island to practice optometry or medicine (i.e., ophthalmology) pursuant to the provisions of R.I. Gen. Laws Chapter 5-35.1.
24."Follow-up" means the contact with a student’s parent as defined in this Part, and/or service provider to verify receipt of services, provide clarification and determine the need for additional assistance.
25.“Governing body” means the body or board or committee or individual, or the designated agent(s) or designee(s) of the aforementioned responsible for, or who has control over, the administration of any elementary or secondary school, public or non-public, in the State of Rhode Island.
26."Hazardous chemical" means a chemical for which there is statistically significant evidence based on at least one (1) study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed persons. The term "health hazard" includes chemicals that are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents that act on the hematopoietic systems, and agents that damage the lungs, skin, eyes, or mucous membranes.
27."Health" means the quality of a person's physical, psychological, and sociological functioning that enables him/her to deal effectively with self and others in a variety of situations.
28."Health care provider/agency" means any person/agency licensed by this State to provide or otherwise lawfully able to provide health care services, including, but not limited to, a physician, chiropractor, hospital, intermediate care facility or other health care facility, dentist, dental hygienist, nurse, physician assistant, nurse practitioner, optometrist, podiatrist, pharmacist, physical therapist, psychiatric/clinical social worker, mental health counselor, or psychologist and any officer, employee or agent of that provider acting in the course and scope of his/her employment or agency related to or supportive of health services.
29."Health education" means comprehensive sequential kindergarten through grade twelve (K through 12) instruction that builds a foundation of health knowledge, develops the motivation and skills required of students to cope with challenges to health and provides learning opportunities designed to favorably influence health attitudes, practices and behavior that will impact lifestyles, educational performance and achievements and long range health outcomes and is in accordance with the requirements of § 4.5(D) of this Part.
30."Hearing impairment" means an impairment in hearing, whether permanent or fluctuating, that affects a student's educational performance.
31.“Individualized health care plan” or “IHCP” means a comprehensive plan for care of children with special health care needs developed by the school nurse in collaboration with the student, parents/guardians, school staff, community, and health care provider(s), as appropriate.
32.“Individualized health services” means services provided to individual students who attend school within the community which are specific to the health needs of the individual student, such as medication administration, and are not included in the health examination/screenings, record keeping and reporting requirements described in § 4.9.1(B) of this Part.
33."Laboratory" means a facility where the laboratory use of hazardous chemicals occurs. It is a place where relatively small quantities of hazardous chemicals are used on a non-production basis.
34."Mandated instructional health outcomes" means statements which indicate what health knowledge and skills students should have at the completion of a specific health unit.
35.“Medically accurate” means verified or supported by research conducted in compliance with accepted scientific methods and published in peer-reviewed journals, where appropriate, and recognized as accurate and objective by professional organizations and agencies with expertise in the relevant field, such as the federal Centers for Disease Control and Prevention.
36.“Medical marijuana” means as defined in § 230-RICR-80-05-1.1(A)(27) and can only be purchased from a licensed compassion center.
37."Medication" means any FDA-approved substance regarded as effective for the use for which it is designed in bringing about the recovery, maintenance or restoration of health, or the normal functioning of the body.
38.“OSHA” means the Occupational Safety and Health Administration.
39."Parent" means a natural parent, a legal guardian, or an individual acting as a parent in the absence of a parent or a legal guardian.
40."Physician" means an individual licensed in the United States to practice allopathic or osteopathic medicine pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
a.Chiropractic physicians licensed under the provisions of R.I. Gen. Laws Chapter 5-30 are entitled to the same services of the laboratories of RIDOH and other institutions, and shall be subject to the same duties and liabilities, and are entitled to the same rights and privileges in their professional calling pertaining to public health which may be imposed or given by law or Regulations upon or to physicians qualified to practice medicine by R.I. Gen. Laws § 5-37-2; provided, however, that chiropractic physicians shall not write prescriptions for drugs for internal medication nor practice major surgery.
41.“Population-based health services” means services provided to all students attending school within the community which are not focused on the individual health needs of the particular student but are provided to all students as part of the health examination/screenings, record keeping, and reporting requirements described in § 4.9.1(B) of this Part.
42."Prescription" means an order for medication signed by a licensed practitioner with prescriptive authority or transmitted by the practitioner to a pharmacist by telephone, facsimile, or other means of communication and recorded in writing by the pharmacist.
43."Record" means any information recorded in any way, including, but not limited to, handwriting, print, tape, electronic storage, computer diskette, film, microfilm, and microfiche.
44.“RIDE” means the Rhode Island Department of Elementary and Secondary Education.
45.“RIDOH” means the Rhode Island Department of Health.
46."School campus" means all areas of the property under the jurisdiction of the school that are accessible to students during the school day.
47."School" means all public or privately supported schools for students in grades Kindergarten (K) through 12 in Rhode Island. In addition, a preschool program operated by or within an approved school (per the requirements of § 4.4(A) of this Part) shall be considered a "school" for the purposes of this Part.
48."School nurse" means a certified school nurse teacher as defined in § 4.3 of this Part, or a certified school nurse as defined in § 4.3 of this Part.
49."School personnel" means all persons employed directly by the school or under contract to the school.
50."Scoliosis screening" means screening for detection of an abnormal curvature of the spine, as defined by current American Academy of Orthopaedic Surgeons and Scoliosis Research Society standards.
51."Self-administration of medication” means that the student uses the medication with parental authorization in the manner directed by the health care provider, and by following the age appropriate instructions on the medication label, without additional assistance or direction.
52."Self-carry" means that the student carries medication on his/her person, if self-administration of the medication is necessary.
53."Speech or language impairment" means a disorder in articulation, language, voice and/or fluency that adversely affects the student's educational performance. A speech and language impairment may range in severity from mild to severe; it may be developmental or acquired. A speech and language impairment may be the result of a primary disabling condition or it may be secondary to other disabling conditions. A dialect is a variation of a symbol system used by a group of individuals that reflects and is determined by shared regional, social or cultural/ethnic factors and is not considered to be a disorder of speech.
54."Speech/language pathology" includes identification of students with speech or language impairments; diagnosis and appraisal of specific speech or language impairments; referral for medical or other professional attention necessary for the habilitation of speech or language impairments; provision of speech and language services for the habilitation or prevention of communicative impairments; and counseling and guidance of parents, children and teachers regarding speech and language impairments.
55."Speech/language pathologist" means a professional who identifies, assesses, diagnoses, prevents, and treats speech, voice, language, communication, and swallowing disorders.
a."Certified speech/language pathologist" means a speech/language pathologist certified by RIDE in accordance with 200-RICR-20-20-1, Regulations Governing the Certification of Educators in Rhode Island to perform speech-language pathology services for the public-school system.
b."Licensed speech/language pathologist" means a speech/language pathologist licensed by the Rhode Island Board of Examiners in Speech Pathology and Audiology to perform speech-language pathology services in all settings outside the public-school system.
56."Speech/language pathology aide" means an individual registered in this State in accordance with Part 40-05-33 of this Title, Speech Pathologists and Audiologists.
57."Student" means any individual who is or has been enrolled at an educational agency or institution and regarding whom the agency or institution maintains educational records.
58."Vision screening," as used in this Part, means a limited series of tests to identify individuals who may have a vision or eye health problem.
59."Visual impairments" include:
a."Partial sight" means a visual acuity ranging from 20/70 to 20/200 in the better eye after refraction, or a significant loss of fields of vision in both eyes as a result of, but not limited to, hemeralopia, glaucoma, retinitis pigmentosa, retinoschisis, or diabetes retinopathy that, with correction, affects a student's educational performance.
b."Blindness" means a visual acuity ranging from a central visual acuity of 20/200 or less in the better eye after refraction, or a peripheral field of vision that subtends an angle no greater than twenty (20) degrees that, even with correction, affects a student's educational performance.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.4** General Requirements {#sec-216-ricr-20-10-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.4}
A.All schools, as defined in § 4.3(A)(48) of this Part, that are approved pursuant to R.I. Gen. Laws §§ 16-19-1 and 16-19-2 are required to have a comprehensive school health program approved by RIDE and RIDOH in accordance with R.I. Gen. Laws § 16-21-7.
B.A comprehensive school health program as defined in § 4.3(A)(11) of this Part, consists of three (3) components:
1.Health education;
2.Health services; and
3.A healthful school environment.
a.All schools that sell or distribute competitive foods and beverages as defined in § 4.3 must do so in accordance with the provisions of R.I. Gen. Laws §§ 16-21-7(c) and (d); and pursuant to 200-RICR-20-25-4, Regulations Governing Nutritional Requirements for Reimbursable Meals and Competitive Foods and Beverages; Limitations on Competitive Foods and Beverages at Meal Time.
b.The prohibition on advertising unhealthy food and beverages is pursuant to R.I. Gen. Laws § 16-21-7.1.
4.The health education program (curriculum and personnel) for non-public schools must be consistent with the provisions of § 4.5(A) of this Part.
C.The administrative head of school(s) is responsible for the comprehensive school health program and is required to:
1.Develop a manual of procedures (protocols) governing health education, health services and a healthful school environment. This manual must be available at the Superintendent's office and at each school. Procedures must address the statutory and regulatory requirements of this Part and include provisions pertaining to, but not limited to, the following:
a.Students and/or employees infected with HIV/AIDS or hepatitis;
b.Substance abuse;
c.The use of alcohol and tobacco products on school premises and at authorized school activities;
d.Suicidal behavior;
e.The prevention and management of injuries and violent behaviors for the protection and safety of students on school premises and at authorized school activities; and
f.Provisions regarding the three (3) statutory waivers for exemption of a student from health education curricula pursuant to R.I. Gen. Laws §§ 16-22-18(c) sexuality and family life; 16-22-17(c) HIV/AIDS; and 16-21-7(a) the characteristics, symptoms or treatment of disease.
2.Provide an adequate number of personnel for a comprehensive school health program in accordance with the statutory requirements and the requirements of this Part. Required personnel include no less than a school physician, dentist, certified health educator and a school nurse.
a.Non-public schools may employ registered nurses licensed in Rhode Island pursuant to R.I. Gen. Laws Chapter 5-34, to provide individualized health services, but not to provide population-based health services and other requirements of the school health program as described in this Part.
3.Designate an individual(s) or committee to be accountable for the comprehensive school health program. The name of the individual(s) must be included in the annual school health report as required in § 4.4(C)(4) of this Part.
4.Submit an annual school health report to RIDE pertaining to the comprehensive school health program no later than sixty (60) days from a date established by RIDE. The report should be prepared with input from district school improvement teams when appropriate.
D.No requirement of this Part shall be construed as requiring a school nurse or other licensed health care provider to act in a manner contrary to the provisions of the laws and Regulations governing the practice of their profession.
E.Nothing in this Part is meant to preclude any student or the parents of any student from pursuing their rights to appropriate educational services and accommodations guaranteed by Federal and State laws.
4.4.1Child Abuse/Neglect Reporting; Reporting of Sexual Abuse of a Child in an Educational Program
A.Any person who has reasonable cause to know or suspect that any child has been abused or neglected, as defined in R.I. Gen. Laws § 40-11-2, or has been the victim of sexual abuse by another child is required to transfer that information to DCYF in accordance with the requirements of R.I. Gen. Laws § 40-11-3.
B.Any person who has reasonable cause to know or suspect that any child has been the victim of sexual abuse by an employee, agent, contractor or volunteer of an educational program as defined in R.I. Gen. Laws § 40-11-2, is required to transfer that information to DCYF in accordance with the requirements of R.I. Gen. Laws § 40-11-3.3.
C.The school's protocol for reporting child abuse or neglect and sexual abuse shall specify the responsibilities of all school personnel related to child abuse or neglect and sexual abuse, such as identification, reporting, multidisciplinary cooperation, in-service training, and public awareness.
D.Pursuant to R.I. Gen. Laws § 16-21-36, all schools are required to post the DCYF child abuse hotline telephone number available on DCYF's Child Protective Services website.
4.4.2Health and Wellness Subcommittee
The school committee for each school district is required to establish a district-wide coordinated school health and wellness subcommittee in accordance with the requirements of R.I. Gen. Laws § 16-21-28.
4.4.3Free-Play Recess
All schools are required to provide daily, at least twenty (20) consecutive minutes of unstructured free-play recess for students in elementary grades Kindergarten through six (6) in accordance with R.I. Gen. Laws § 16-22-4.2.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.5** Administration of the Health Education Program {#sec-216-ricr-20-10-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.5}
A.Health education is required for grades K through twelve (12) in all schools. The health education program (curriculum and personnel) of non-public schools will be approved by RIDE if deemed substantially equivalent.
B.Pursuant to the provisions of R.I. Gen. Laws § 16-1-5(14), RIDE in conjunction with RIDOH will provide guidance and technical assistance in the development and adoption of school health education curricula.
C.The administrative head of school(s) is required to designate a certified health educator to administer the health education program.
D.Pursuant to the RIDE certification requirements in 200-RICR-20-20-, Regulations Governing the Certification of Educators in Rhode Island and the provisions of this Part, teachers providing health education shall consist of:
1.At the secondary level: certified school nurse-teachers, health and physical education teachers or health educators, all of whom must hold appropriate certification as health educators in accordance with the 200-RICR-20-20-1, Regulations Governing the Certification of Educators in Rhode Island.
2.At the elementary level: certified school nurse-teachers, health and physical education teachers or health educators, all of whom must hold appropriate certification as health educators in accordance with the 200-RICR-20-20-1, Regulations Governing the Certification of Educators in Rhode Island, or any certified elementary teacher.
E.Health education instruction must comply with the Comprehensive Health Instructional Outcomes incorporated at § 4.2(B) of this Part, which conforms to the statutory provisions of R.I. Gen. Laws § 35-4-18, the curriculum requirements of RIDE, and other statutory and regulatory requirements of this Part.
F.Health education instruction and materials must be age-appropriate for use with students of all races, genders, sexual orientations, ethnic and cultural backgrounds, and students with disabilities.
G.All students in K through twelve (12) attending schools, are required to receive instruction in health and physical education as prescribed and approved by RIDE, for periods which shall average at least twenty (20) minutes in each school day in accordance with the provisions of R.I. Gen. Laws §§ 16-22-4 and 16-1-5(14).
1.Recess, free play, and after-school activities shall not be construed as physical education.
2.Exemption from the requirements of § 4.5(G) of this Part is pursuant to R.I. Gen. Laws § 16-100-3(d).
H.No non-public instruction will be approved by any school committee for the purposes of R.I. Gen. Laws Chapter 16-19 as substantially equivalent to that required by law for a student attending a public school in the same city and/or town unless instruction in health and physical education similar to that required in public schools is given.
I.Planned and ongoing in-service programs are required to update health educators and other relevant personnel in their knowledge of health and teaching skills, and to obtain their input regarding health curriculum, assessment and improvement. These must be consistent with the provisions of R.I. Gen. Laws §§ 35-4-18, 16-1-5(14), 16-22-12, 16-22-14, and 16-22-24 pertaining to substance abuse, alcohol, suicide prevention and mental health services, teen dating violence, and such other relevant laws.
J.Provisions must be made for participation by representatives from parent groups, community agencies, professional organizations, health agencies, business, educational institutions and other groups, to actively involve them in the planning and the implementation of the health education program.
K.Teaching methods and learning materials must be consistent with the mandated health instructional outcomes of § 4.7 of this Part, and available to health educators and students in the classroom.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.6** Health Education Curriculum {#sec-216-ricr-20-10-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.6}
A.The health education curriculum must:
1.Be sequential and comprehensive for K through twelve (12);
2.Be medically accurate;
3.Be aligned with the standards in the Rhode Island Health Education Framework;
4.Include standards-based goals, objectives, examples of teaching and learning strategies and materials, and assessment;
5.Address the mandated health instructional outcomes in § 4.7 of this Part; and
6.Be developmentally appropriate so that all students can achieve high standards.
B.A curriculum team consisting of representatives from the school district teaching and administrative staff, parents, and community members including health professionals must periodically review and revise, as necessary, the health education curriculum. The health education curriculum of each school district must be available for review by RIDE upon request.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.7** Mandated Health Instructional Outcomes {#sec-216-ricr-20-10-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.7}
A.Pursuant to R.I. Gen. Laws § 16-22-4, the health education curriculum must be based on the Rhode Island Health Education Framework: Health Literacy for All Students standards and consistent with the mandated health instructional outcomes incorporated at §§ 4.2(A) and (B) of this Part, and must be evidence-based. These outcomes must pertain to no less than the following required content area topics appropriate to grade or developmental level:
1.Alcohol, Tobacco and Other Substance Abuse: the causes, effects, treatment and prevention of the use of tobacco and abuse of alcohol and other drugs, including but not limited to information that mixing opioids and alcohol can cause accidental death, pursuant to R.I. Gen. Laws §§ 16-22-3, 16-22-4, 16-22-12, 16-1-5(14), and 35-4-18;
2.Cardiopulmonary Resuscitation (CPR): the procedures and proper techniques for CPR, automated external defibrillator (AED), and the Heimlich Maneuver, pursuant to R.I. Gen. Laws §§ 16-22-15 and 16-22-16;
3.Child Abuse: the signs, symptoms and resources available for assistance;
4.Community Health: the significance of the relationship between the individual and the community, and the impact that individual health has on the community’s health within a framework of geographical, social, cultural, and political factors;
5.Consumer Health: the factors involved in decision-making, selecting, evaluating, accessing and utilizing health information, products and services;
6.Environmental Health: environmental factors that affect the health of individuals and society, strategies to minimize the negative effects of the environment on the community and its members, and the importance of protecting and improving all aspects of the environment;
7.Family Life and Sexuality: responsibilities of family membership and adulthood, issues related to reproduction, abstinence, dating and dating violence, marriage, parenthood, information about sexually transmitted diseases, the law and meaning of consent, sexuality and sexual orientation, as part of comprehensive sexuality education pursuant to R.I. Gen. Laws § 16-22-18.
8.HIV (Human Immunodeficiency Virus)/AIDS (Acquired Immune Deficiency Syndrome): the causes, effects, treatment, and prevention, pursuant to R.I. Gen. Laws § 16-22-17.
9.Human Growth and Development: growth and development as a process of natural progression influenced by heredity, environment, culture, and other factors and which encompasses the continuum from conception to death;
10.Mental Health: the emotional, behavioral, and social factors that influence both mental and physical health;
11.Nutrition: the role of nutrition in the promotion and maintenance of good health;
12.Physiology and Hygiene: the basic structure and functions of the human body systems, health habits, and sanitary practices for the preservation of health, pursuant to R.I. Gen. Laws § 16-22-3;
13.Physical Activity: the relationship of physical activity to health and physical fitness;
14.Prevention and Control of Disease: the causes, effects, treatment, and prevention of chronic and communicable diseases, with exclusion of instruction thereof pursuant to R.I. Gen. Laws § 16-21-7(a).
15.Safety and Injury Prevention: the causes, effects, treatment, and prevention of behaviors that can result in unintentional or intentional injury; and:
a.Suicide Prevention: the causes, effects, and treatment of behaviors related to suicide, and information that mixing opioids and alcohol can cause accidental death, pursuant to R.I. Gen. Laws §§ 16-22-4 and 16-22-14.
b.Teen Dating Violence (grades seven (7) through twelve (12)): defining dating violence, recognizing dating violence warning signs and characteristics of healthy relationships, as stipulated in R.I. Gen. Laws § 16-22-24, and as defined in this Part.
(1)Students must be provided with the school district’s dating violence policy in accordance with R.I. Gen. Laws § 16-21-30(c).
(2)Upon written request to the school principal, and within a reasonable period after the request is made, a parent or legal guardian of a student less than eighteen (18) years of age must be permitted to examine the dating violence education program instruction materials at the school in which the student is enrolled.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.8** Physical Education Curriculum {#sec-216-ricr-20-10-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.8}
A.The physical education curriculum must:
1.Be sequential and comprehensive for grades K through twelve (12);
2.Be aligned with the Rhode Island Physical Education Framework standards incorporated at § 4.2(C) of this Part;
3.Include standards-based goals, objectives, examples of teaching and learning strategies and materials, and assessment; and
4.Be developmentally appropriate so that all students can achieve high standards.
B.A curriculum team consisting of representatives from the school district teaching and administrative staff, parents, and community members must periodically review and revise, as necessary, the physical education curriculum.
C.The physical education curriculum of each school district must be available for review by RIDE upon request.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.9** Health Services {#sec-216-ricr-20-10-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.9}
4.9.1Population-Based Health Services
A.In accordance with R.I. Gen. Laws § 16-21-9, each community is required to provide adequate and appropriate personnel to conduct mandated population-based health services, as described in this Part, for all students attending schools within its geographical boundaries.
B.Population-based services must include no less than the following components:
1.Health examinations and screenings in accordance with §§ 4.12 through 4.16 of this Part;
2.Record keeping requirements in accordance with §§ 4.17 through 4.21 of this Part;
3.Reporting and managing any school-based communicable, environmental, or occupational disease, as directed by a physician and in accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental and Occupational Diseases.
4.9.2Individualized Health Services
A.Each school must provide adequate and appropriate personnel and/or equipment to provide individualized health services to all students enrolled in the school. At a minimum, the services must include those ordered by a physician, such as medication administration.
1.All personnel providing individualized health services to students must be licensed and/or certified in Rhode Island in accordance with all applicable State laws and Regulations.
4.9.3Students Assisted by Medical Technology and Special Health Care Needs
A.Pursuant to the provisions of R.I. Gen. Laws § 23-13-26, school nurses who provide direct care for technology-dependent students must develop individualized health care plans (IHCPs) for such students and provide care accordingly.
B.All students assisted by medical technology and/or with other specialized health care needs, who are currently enrolled in grades K through twelve(12); entering Kindergarten; or currently attending or entering a public school-sponsored preschool, must have as part of their permanent school health record, an individualized health care plan (IHCP) and/or an emergency care plan (ECP/EHCP), as necessary and/or appropriate to ensure health, safety, and learning for the student while at school or at school-sponsored activities. The plan must include, but not be limited to the following:
1.A description of all services that will be provided to the student, including those services related to school-sponsored transportation and off-site school-sponsored activities;
2.Persons responsible for providing each service and a description of service(s) provided in school or at school-sponsored activities;
3.Qualifications of the person(s) providing services;
4.Training requirements for person(s) providing services and focus of responsibility for providing training;
5.Supervision of person(s) providing services.
C.All school personnel who may be involved in the care of a student assisted by medical technology must be informed of the IHCP and ECP/EHCP, on a need-to-know basis.
D.The IHCP and ECP/EHCP must be developed by the school nurse in collaboration with the medical provider, parent or guardian, student (when appropriate), principal, and other school staff, as appropriate. It must be signed by the school nurse, parent/guardian, and student (when appropriate).
E.The IHCP and ECP/EHCP must be developed in addition to an Individualized Education Plan (IEP) or a 504 Plan, when appropriate. The IEP or 504 Plan may serve as the IHCP or ECP/EHCP if it meets all the requirements stated in this Part.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.10** School Health Personnel {#sec-216-ricr-20-10-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.10}
The administrative head of school(s) with the advice and consent of the school committee of each community, school district or appropriate non-public school authority (e.g., superintendent, headmaster or principal) is required to arrange for the appointment of all school health personnel necessary to implement the health services requirements described in this Part, pursuant to the requirements of R.I. Gen. Laws Chapter 16-21.
4.10.1School Physician
A.Qualifications and general duties of the school physician include the following:
1.Must be licensed to practice allopathic or osteopathic medicine in Rhode Island in accordance with R.I. Gen. Laws Chapter 5-37.
2.Must be qualified by training and experience to assume the role of a school health physician consultant (e.g., develops school health protocols, provides in-service training for school nurses) and/or primary care provider (e.g., performs physicals, examines outbreak cases) for a wide range of comprehensive school health services.
3.Must have knowledge of all State and local laws, Regulations and protocols pertaining to schools.
4.Must ensure implementation of all such laws, Regulations and protocols in collaboration with the school’s administrative authorities and school health personnel.
5.Must have a contract with the school system defining mutually agreed upon expectations and objectives.
6.Must provide a regular report, a minimum of one (1) per year, on consultation and/or direct service activities provided.
7.At least annually, must review and approve school health service plans, protocols, and programs (except those developed and provided by the school dentist[s]) including but not limited to:
a.Delivery of school health services and screenings;
b.Consultations;
c.Furnishing information on health-related matters;
d.Review of standing orders, protocols and procedures; and
e.Reporting and management of infectious diseases and outbreaks, in accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental and Occupational Diseases and RIDOH recommendations related to infection control in the school environment.
4.10.2Certified School Nurse-Teachers and Certified School Nurses
A.Qualifications and general duties of the school nurse include the following:
1.Must be licensed as a professional (registered) nurse pursuant to R.I. Gen. Laws Chapter 5-34 and certified by RIDE as a certified school nurse or as a certified school nurse-teacher pursuant to 200-RICR-20-20-1, Regulations Governing the Certification of Educators in Rhode Island..
2.Must provide population-based health services to students in public and non-public schools in the community.
3.Must provide individualized health services to all public-school students in the community.
a.This requirement shall not be construed as prohibiting certified school nurse-teachers or certified school nurses from providing individualized health services to students in non-public schools.
B.Exemption from Certified School Nurse Requirement
1.Non-public schools are authorized to employ registered nurses licensed in Rhode Island pursuant to R.I. Gen. Laws Chapter 5-34 who are not certified by RIDE for the purpose of providing individualized health services, including dispensing medications, to students in the non-public school setting.
2.Registered nurses may not provide the population-based health services and other requirements of the school health program as described in this Part.
4.10.3Dentist/Public Health Dental Hygienist/Dental Hygienist
A.Qualifications
1.The school dentist(s)/public health dental hygienist/dental hygienist for a community must be licensed to practice dentistry/dental hygiene, respectively, in Rhode Island in accordance with R.I. Gen. Laws Chapter 5-31.1, and have at least three (3) years of clinical experience as specified in R.I. Gen. Laws § 16-21-9.
a.Public health hygienists performing the dental screenings pursuant to the provisions of R.I. Gen. Laws § 16-21-9 must do so in accordance with R.I. Gen. Laws § 5-31.1-39.
b.Dental hygienists performing the dental screenings pursuant to the provisions of R.I. Gen. Laws § 16-21-9 must do so under the general supervision as defined in Part 40-05-2 of this Title, Dentists, Dental Hygienists, and Dental Assistants, of the dentist liable and responsible under the contract with the community.
B.General Duties
1.The school dentist, public health hygienist, or dental hygienist as specified in § 4.10.3(A)(1)(b) of this Part may perform any of the required dental screenings of students.
2.Each dentist must also examine students referred by the administrator, school nurse, or physician for suspected dental disease.
3.The school dentist, public health hygienist and dental hygienist, when applicable, must be qualified by virtue of training and experience to assume the role of a school health dental consultant (e.g., develops school health protocols, provides in-service training for school nurses or dental hygienists) and/or service provider in accordance with Part 40-05-2 of this Title, Dentists, Dental Hygienists and Dental Assistants.
4.The school dentist, public health hygienist and dental hygienist, when applicable, must have knowledge of all relevant State and local laws, Regulations and protocols affecting schools, and must participate actively to ensure implementation of all such laws, Regulations and protocols in collaboration with the school’s administrative authorities and school health personnel.
5.The school dentist or public health hygienist must establish a contract with the school system defining mutually agreed upon expectations and objectives and the dentist, public health hygienist and/or dental hygienist, when applicable, must provide a regular report, (a minimum of one (1) per year),on consultation and/or direct service activities rendered to the school system.
6.Referrals of students screened by the school dentist, public health hygienist and dental hygienist, must be made in accordance with the provisions of R.I. Gen. Laws § 16-21-9(c).
a.Referrals by a dentist, public health hygienist or a dental hygienist to non-profit dental programs that provide oral health services on a reduced or sliding fee scale basis are exempt from the provisions of § 4.10.3(B)(6) of this Part.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.11** Health Examinations {#sec-216-ricr-20-10-4-4.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.11}
4.11.1Health Examination Requirements
A.General health examinations must be a complete, age-appropriate medical history and physical examination, assessing the health and well-being of the student and evaluating any challenges to the student's success in school and school-related activities.
B.These general health examinations must be conducted by the student's primary care physician, a physician's assistant under the physician's supervision, or a certified registered nurse practitioner.
C.Every student who has not been previously enrolled in a school in this State is required to have a health examination completed. This health examination may be performed in the twelve (12) months preceding the date of school entry, but if not, it must be completed within six (6) months of school entry.
D.A second (2nd) general health examination and health clearance is required upon entry to the seventh (7th) grade. This health examination may be performed during the sixth (6th) grade, but no later than six (6) months after entry into the seventh (7th) grade.
E.A third (3rd) health examination is required upon entry to the twelfth (12th) grade. This health examination must be performed after the student turns sixteen (16) years of age, and no later than six (6) months after the student enters the twelfth (12th) grade.
F.If there is no evidence that the required health examination has been performed, the school must make provisions for the health examination by the end of the school year in which it is required.
1.No student shall be excluded from school for failure to provide documentation of completion of a health examination.
G.For students suspected or identified as having special health needs, referrals by a school nurse must be made as specified in this Part or in 200-RICR-20-30-6, Regulations Governing the Education of Children with Disabilities.
H.Each school system may require additional health examinations, to ensure the mental and physical health of each student to participate in classroom, athletic, or special activities sponsored or conducted by the school.
4.11.2Health Examination Documentation & Follow-up
A.Written or electronic documentation of the health examination results is acceptable and must be in a standardized format with one (1) copy available from RIDOH or any format that captures the same required fields of information.
1.Documentation of the health examination results must be included in the student's cumulative school health record.
B.A care plan for health problems must be developed by the school nurse in conjunction with the parent, student, and other appropriate health care providers as defined in § 4.3 of this Part.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.12** Lead Screening {#sec-216-ricr-20-10-4-4.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.12}
A.Pursuant to R.I. Gen. Laws § 23-24.6-8, evidence that students under six (6) years of age have been screened for lead poisoning is required in accordance with guidelines established under R.I. Gen. Laws § 23-24.6-7.
1.A statement on a school health form signed by a healthcare provider is sufficient to comply with this requirement.
B.The lead screening entry requirement does not apply if a parent signs a statement indicating that lead screening is contrary to their religious beliefs.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.13** Vision Screening {#sec-216-ricr-20-10-4-4.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.13}
4.13.1General Vision Screening Requirements
A.Pursuant to R.I. Gen Laws §§ 16-21-14 and 16-21-14.1, vision screening is required for all students upon entry to school, and in preschool programs operated by public school districts, and first (1st), second (2nd), third (3rd), fourth (4th), fifth (5th), seventh (7th) and ninth (9th) grades.
B.If evidence is presented to the school physician or school nurse that an eye examination was completed within the preceding twelve (12) months of the initial screening by the student's ophthalmologist, optometrist, pediatric ophthalmologist, pediatric optometrist or primary care provider, the student may be exempt from this screening requirement for that school year.
C.A school must screen vision using evidence-based, optotype-based screening, or evidence-based, instrument-based screening, depending on the age of the student in accordance with the National Center for Children’s Vision and Eye Health's Vision Screening Recommendations (https://nationalcenter.preventblindness.org/vision-screening-recommendations) incorporated by reference at § 4.2(L) of this Part.
1.Certain students who have a higher rate of vision problems should bypass vision screening in accordance with the National Center for Children’s Vision and Eye Health's Vision Screening Recommendations and be referred directly to an eye specialist for a comprehensive examination. The school nurse may determine which children should be referred directly.
D.It is recommended that vision screening occur early in the school year. Preschool and kindergarten screening must be completed within thirty (30) administrative days of the start of school.
E.Vision screening outside of the grade level required for screening must occur upon referral from teachers, parents/caregivers, or with presentation of signs or symptoms of a vision problem.
F.Students transferring to a school without record of previous vision screening must be screened.
G.When a trained, unlicensed individual, or individuals from an outside entity, conducts the initial screening, the school nurse must rescreen the student before making a referral.
1.Rescreening for all vision tools, except instrument-based screening, will occur as soon as possible, but no later than six (6) months following the initial screen.
H.Students who do not pass vision screening must be referred to their parents/caregivers and provided with a referral form to bring to their health care provider or eye specialist.
I.Periodic reporting of vision screening results to RIDE and/or RIDOH may be required.
4.13.2 Distance Visual Acuity
A.Students in preschool, kindergarten, and grades one (1) through five (5), seven (7), and nine (9) must be screened for distance visual acuity.
B.For those students required to wear prescription glasses, screening must occur with student wearing glasses.
C.Screening tools recommended for preschool and kindergarten (and grade one (1) if students cannot identify letters in random sequence) are:
1.LEA SYMBOLS® chart (illuminated preferred, critical line screening permissible; five (5) foot and ten (10) foot charts or booklets are permissible); and
2.HOTV chart (illuminated preferred, critical line screening is permissible;
3.Computer-based screening programs using either HOTV or LEA SYMBOLS® optotypes.
D.Screening tools recommended for students in grades one (1) (if students can identify letters in random sequence) and grades two (2) through five (5), seven (7), and nine (9) are:
1.Sloan Letters chart (illuminated preferred if using nine inch by fourteen inch (9"x14") charts, charts exceeding nine inches by fourteen inches (9"x14") are permissible);
2.Computer-based screening programs using Sloan Letters.
E.Instrument-Based Screening may be used as an alternative to distance visual acuity screening for:
1.Children ages three (3), four (4), and five (5) years
2.Children ages six (6) years and older when children cannot participate in optotype-based vision screening.
3.If conducting instrument-based screening, record pass or refer.
4.13.3Near Visual Acuity
A.Students in preschool, kindergarten, and grades one (1) through five (5), seven (7), and nine (9) must be screened for near visual acuity.
B.For those students required to wear prescription glasses, screening should occur with student wearing glasses.
4.13.4Referral Requirements
A.Referral of students to qualified vision professionals, such as an ophthalmologist, optometrist, pediatric ophthalmologist, or pediatric optometrist, must occur in the following circumstances:
1.Age three (3) years, unable to correctly identify at least three (3) of five (5) optotypes on 20/50 line with each eye individually if using threshold method.
2.Ages four (4) and five (5) years, unable to correctly identify three (3) of five (5) optotypes on the 20/40 line with each eye individually if using threshold method.
3.Ages six (6) years and older, unable to correctly identify at least three (3) of five (5) optotypes on the 20/32 line with each eye individually if using threshold method.
4.Refer students who have a two (2) line difference between the eyes, even in the passing lines (e.g., 20/20 and 20/32), if using threshold method.
5.If using threshold screening, record the visual acuity value for each eye.
6.If using critical line screening, use the age line per the chart manufacturer’s instructions and record pass or refer.
B.The school nurse will follow up with the parents/caregivers of students referred to determine the outcome of the referral.
C.The school nurse will follow up with students referred for further evaluation by an eye care provider (pediatric ophthalmologist, pediatric optometrist, ophthalmologist, or optometrist) to ensure treatment plans are implemented at school, if necessary.
4.13.5Stereoacuity Screening
A.Stereoacuity screening – to determine how well eyes work together – is optional and if used for students in preschool, kindergarten, and grades one (1) through five (5), seven (7), and nine (9), will be used in conjunction with optotype-type based screening, but not instrument-based screening.
B.Preschool Assessment of Stereopsis with a Smile (PASS) II is the recommended tool for stereoacuity screening with all students. Manufacturer's instructions must be followed for use of any tools used for stereoacuity screening.
4.13.6Color Vision Deficiency Screening
A.Color Vision Deficiency Screening is optional. If such screenings are conducted, recommended age for use is in preschool, kindergarten, and upon entry to the school.
B.Books with pseudoisochromatic plates should be used. Options include:
1.HRR Standard Pseudoisochromatic Test, 4th Edition;
2.Good-Lite ColorCheck Complete Vision Screener; and
3.Waggoner Color Vision Testing Made Easy.
C.Manufacturer's instructions must be followed for use of any tools used for color vision deficiency screening.
4.13.7Personnel & Training Requirements
A.The school vision screening must be conducted by a formally trained school nurse, trained in the administration of these tools to ensure uniformity across procedures.
B.Trained volunteers or other school personnel who are directly supervised on-site by a school nurse may be utilized in the vision screening program.
4.13.8Follow-up & Documentation Requirements
A.A student who does not pass vision screening must be rescreened on a different day and as soon as possible but no longer than six (6) months before the parents/caregivers are notified of the results of the screening.
1.Students who fail the screening criteria set must be re-screened by the school nurse.
2.Parents of students who fail to meet the minimal visual requirements on the second screening must be notified in accordance with the requirements of § 4.19 of this Part in order to arrange for a comprehensive vision examination by an eye care provider.
B.If the corrected visual acuity of the student is found to be in the range of 20/70 – 20/200 in the better eye after an eye examination, the school nurse in charge of the screening must, within thirty (30) days, report the result of the eye examination to the administrator of the Division of Services for the Blind and to the Special Education Supervisor, indicating that specialized services may be indicated.
1.Students identified with a visual impairment must be referred for specialized services and follow-up in accordance with the provisions of the 200-RICR-20-30-6, Regulations Governing the Education of Children with Disabilities.
C.A student's vision screening results must be recorded in the "Vision Screening" section of the school health record.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.14** Hearing Screening {#sec-216-ricr-20-10-4-4.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.14}
4.14.1General Hearing Screening Requirements
A.Students in preschool programs operated by public school districts, and all students in kindergarten, first (1st), second (2nd), and third (3rd) grades and any student(s) new to a school without a prior record of a hearing screening must be given a hearing screening test by a properly trained and qualified person in accordance with the guidelines of the American Speech-Language-Hearing Association (ASHA) incorporated at § 4.2(G) of this Part.
B.Students who failed the hearing screening tests in previous years, repeat a grade, have a history of hearing difficulty or pathology, are enrolled in curricular or extracurricular activities where there is exposure to noise levels that meet or exceed current Occupational Safety and Health Administration (OSHA) standards incorporated at § 4.2(I) of this Part, or are suspected by school personnel of a hearing loss must be screened as often as is necessary.
C.The "passing" criteria for the hearing screening test shall be in accordance with the guidelines of the American Speech-Language-Hearing Association (ASHA) incorporated at § 4.2(G) of this Part.
D.The screening must consist of an initial Otoacoustics Emission hearing test. Students who fail the initial screen must be re-screened within four (4) weeks with tympanometry and pure tone in accordance with the American Speech/Language and Hearing guidelines incorporated at § 4.2(G) of this Part.
E.Any student who provides documentation from a parent that a hearing screening test has been performed in accordance with § 4.14.1(A) of this Part is exempt from this screening requirement.
1.In the absence of this documentation from the parent, the school is required to make provisions for the screening.
4.14.2Equipment
All equipment utilized in the hearing screenings must be calibrated according to the American National Standards Institute Specifications for Audiometers incorporated at § 4.2(H) of this Part.
4.14.3Personnel Requirements
A.A school nurse is responsible for coordinating the requirements of this section.
B.Personnel who may perform the screening requirements of this section include: an audiologist, speech language pathologist, school nurse, audiometric aide under the supervision of a licensed audiologist, or a speech/language pathology assistant under the supervision of a certified speech language pathologist.
C.Any supporting personnel utilized by an audiologist/speech language pathologist in the hearing screening program must meet the requirements in Part 40-05-33 of this Title, Speech Pathologists and Audiologists.
4.14.4Follow-up & Documentation Requirements
A.The parent of a student who does not meet the "passing" criteria of the hearing screening must be notified, in accordance with the requirements of § 4.14.3(B) of this Part, and recommended to obtain a comprehensive audiological evaluation and/or medical follow-up with the student’s primary care provider.
B.Students identified with a potentially educationally-significant hearing impairment must be referred by the school nurse for in-school supportive accommodations, Teacher Support Team, or other educational services, as appropriate or as specified in 200-RICR-20-30-6, Regulations Governing the Education of Children with Disabilities.
C.The hearing status of students referred for further evaluation must be confirmed and noted by the school nurse within three (3) months of the initial referral.
D.A student's hearing screening results must be entered into the school health record by the school nurse, or the person performing the screening. At a minimum, the following components must be noted in the record:
1.Date screening completed;
2.Screening results;
3.Follow-up plan, as indicated.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.15** Speech/Language Screening {#sec-216-ricr-20-10-4-4.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.15}
4.15.1General Speech/Language Requirements
A.Every elementary school student who has not been previously screened for speech/language impairments must be screened for speech and language impairments by a trained and qualified person as described in § 4.15.2 of this Part. Any student may be screened on an “as needed” basis.
1.For those students who have been previously screened, results of said screening must be transferred to each new school in accordance with the requirements of § 4.18.2 of this Part.
B.Any student who has never been previously enrolled in a Rhode Island school who provides documentation from a parent that a speech screening has been performed by a certified and/or licensed speech language pathologist must be exempt from this screening requirement.
1.In the absence of this documentation from the parent, the school must make provisions for the screening.
C.A speech/language screening must consist of an assessment of the following:
1.Articulation;
2.Voice characteristics;
3.Fluency (e.g., stuttering) and;
4.Receptive/expressive language skills.
4.15.2Personnel Requirements
A.A certified speech language pathologist certified by RIDE in accordance with 200-RICR-20-20-, Regulations Governing the Certification of Educators in Rhode Island is responsible for implementing the requirements of § 4.15.1 of this Part.
B.Any support personnel (e.g., a speech/language pathology assistant) utilized by a speech/language pathologist must meet the training and supervision requirements outlined in Part 40-05-33 of this Title, Speech Pathologists and Audiologists.
4.15.3Instruments
A.A school's speech screening program may be conducted utilizing commercially available kindergarten/elementary school level screening instruments.
B.In developing techniques for screening students ages eight (8) and above, informal items may be adapted from available tests. This informal screening would not provide standardized procedures but would yield an acceptable method of screening to determine the need for further testing.
4.15.4Follow-up and Documentation Requirements
A.A student who does not pass the speech/language screening must be referred immediately for a comprehensive speech/language evaluation. The parent of any student who does not pass the speech screening must be notified of the findings, in accordance with the requirements of § 4.19 of this Part.
B.The speech language pathologist or the school nurse must enter the results into the student's school health record.
1.The following components must be noted in the record:
a.Date screening completed;
b.Screening results (i.e., pass/fail); and
c.Follow-up plan for a student who does not pass.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.16** Scoliosis Screening {#sec-216-ricr-20-10-4-4.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.16}
4.16.1General Scoliosis Screening Requirements
A.Annual scoliosis screening, conducted by a school nurse, is required for students in grades six (6) through eight (8) pursuant to R.I. Gen. Laws § 16-21-10.
B.No school-based scoliosis screening shall be conducted before students are introduced to the nature of the condition, its effects, and the nature of the scoliosis screening procedure.
C.The screening of male and female students must be conducted separately and individually. A private, well-lit screening area should be available.
D.The parent of any student may have the scoliosis screening conducted by a private physician.
E.If these results are made available to the local school department, the student will be exempt from the scoliosis screening requirement.
F.The screening is not required of any student whose parents object on the grounds that the test conflicts with their religious beliefs.
4.16.2Follow-up and Documentation Requirements
A.The school nurse is responsible for notifying the parent of any student who is found to have positive signs or symptoms of scoliosis, based on standards published by the American Academy of Orthopedic Surgeons or the Scoliosis Research Society incorporated at § 4.2(E) of this Part, in order to arrange for further evaluation or treatment, as indicated.
B.A student's scoliosis screening results must be documented in the student health record.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.17** Dental Health Screening {#sec-216-ricr-20-10-4-4.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.17}
4.17.1General Dental Health Screening Requirements
A.Every student who has not been previously enrolled in a public or non-public school in this State must be given a dental screening by a licensed dentist, licensed dental hygienist, or a licensed public health dental hygienist with at least three (3) years of clinical experience.
1.Thereafter, every student must be given an annual dental screening by a licensed dentist, dental hygienist, or a licensed public health dental hygienist through the fifth (5th) grade and must be screened at least once between the sixth (6th) and tenth (10th) grades.
a.Provided, however, that dental screenings for students in kindergarten, third (3rd) and ninth (9th) grades must be performed by a licensed dentist or licensed public health dental hygienist.
b.Dental hygienists performing the dental screenings pursuant to the provisions of this section must do so under the general supervision of the dentist liable and responsible under the contract with the community as required under R.I. Gen. Laws § 16-21-9(b).
c.Public health dental hygienists performing the dental screenings pursuant to the provisions of R.I. Gen. Laws § 16-21-9 must do so in accordance within the collaborative agreement guidelines between the public health dental hygienist and a licensed dentist, or an authorized facility. (For a definition of “general” supervision or “collaborative agreement”, see Part 40-05-2 of this Title, Dentists, Dental Hygienists and Dental Assistants.
2.Schools are required to report to RIDOH annually, aggregate screening results on grades K, three (3), and six (6) (if 6th grade is screened).
B.Students who are screened by private dentists/dental hygienists and who provide written documentation containing information outlined by RIDOH of the screening being performed at the intervals prescribed by § 4.17.1(A)(1) of this Part are exempt from the requirements of this section and may elect not to be screened.
C.To screen for hard tissue disease (tooth decay), soft tissue disease (gum disease) and urgent treatment need, the school dental screening must consist of a non-invasive inspection of the student's mouth using the RIDOH standardized screening form.
D.Equipment to perform the screening requirements must include: a mirror, tongue depressor, a light source, and non-latex disposable gloves.
E.The initial dental screening preferably should be conducted by the student’s family dentist/dental hygienist within the six (6) months preceding the date of school entry, and the succeeding screenings should be conducted by him/her at any time during the school year (including vacations) for which the screening is required.
1.Screening results must be documented in writing using the RIDOH standardized form and submitted to the school for all grades and to the RIDOH Oral Health Program upon screening completion for grades K and three (3), or as indicated by the RIDOH.
2.The RIDOH standardized form is available to all schools via the RIDOH website.
4.17.2Follow-up and Documentation Requirements
A.When a school dental screening has revealed that a dental problem may exist, the parent must be notified in writing, using the RIDOH standardized form, so that a dental visit may be arranged.
B.A student's dental screening results must be documented on the school health record.
C.Each community must provide to parents or custodians of students who require professional or skilled treatment, a current list of both dental practices in the community which accept patients insured by Medical Assistance and/or RIte Care and dental practices which provide services on a sliding scale basis to uninsured individuals.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.18** Health Records {#sec-216-ricr-20-10-4-4.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.18}
A.The school nurse is responsible for the complete, cumulative school health record for each student at the school in which the student is enrolled. The health record must include:
1.Immunization status;
2.Health history, including chronic conditions and treatment plan;
3.Screening results and necessary follow-up;
4.Health examination reports;
5.Documentation of traumatic injuries and episodes of sudden illness referred for emergency health care (see also requirements in “First Aid and Emergencies" § 4.21 of this Part);
6.For a student with documented anaphylaxis, the parental authorization of a student's treatment for allergies and the physician's order to administer an epinephrine auto-injector must be entered into the student's health record.
7.Documentation of any nursing assessments completed;
8.Documentation of any consultations with school personnel, students, parents, or health care providers related to a student's health problem(s), recommendations made, and any known results;
9.Documentation of the health care provider's orders, if any, and parental permission to administer medication or medical treatment in school by the school nurse.
B.The student's cumulative health record is confidential and subject to the provisions of R.I. Gen. Laws Chapter 5-37.3, ("Confidentiality of Health Care Information Act"), and other applicable State and Federal laws and Rules and Regulations.
C.The record must be stored in an appropriately secured location with convenient access by the school nurse and must be used only in connection with the provision of treatment to the student.
D.Appropriate steps must be taken for the protection of all student health records, including the provisions for the following:
1.Securing records at all times, including confidentiality safeguards for electronic records;
2.Establishing, documenting and enforcing protocols and procedures consistent with the confidentiality requirements of R.I. Gen. Laws Chapter 5-37.3 and this Part;
3.Training school personnel who handle student school health records in security objectives and techniques.
E.The record must be maintained by the school for a minimum of five (5) years after the student turns eighteen (18) years of age or five (5) years after the student leaves the school district.
4.18.1Confidentiality
A.Any school personnel, including health care providers, who maintain cumulative school health records containing confidential health care information are responsible for ensuring full confidentiality of this information as provided in R.I. Gen. Laws § 5-37.3-4 ("Confidentiality of Health Care Information Act") and other applicable State and Federal laws and Rules and Regulations.
B.Any school personnel, including health care providers, who release confidential health care information from cumulative school health records in accordance with R.I. Gen. Laws § 5-37.3-4 ("Confidentiality of Health Care Information Act") and other applicable State and Federal laws and Rules and Regulations, must document each release in the cumulative school health records by indicating the following:
1.The date of release;
2.A description of the information released;
3.The name(s) of the person(s) to whom the information was released;
4.The reason for the release of information.
C.Violations Pertaining to Confidentiality: Any person suspected of violating the Health Care Information Act must be reported to the Attorney General's Office for prosecution and any subsequent penalties, in accordance with statutory provisions.
4.18.2Transfer of Health Records
A.Whenever a student transfers to another school building or school system in or out of Rhode Island, the original, a copy, or electronic version of the complete, cumulative school health record must be transferred at the same time to the health personnel of the school building or school system to which the student is transferring.
B.This record must be sent in a manner consistent with the provisions of the Health Insurance Portability and Accountability Act (Pub. Law 104-191) to a health care professional authorized to receive confidential health care information at the new school or handed to the parent, as appropriate.
C.A copy of the record (or the original) must be maintained by the community for a minimum of five (5) years after the student turns eighteen (18) years of age or five (5) years after the student leaves the school district.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.19** Notification of Parents {#sec-216-ricr-20-10-4-4.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.19}
A.Parents and/or guardians must be notified, according to established local school district procedures, of any suspected deviation from normal or usual health found as a result of a screening test (e.g., vision screening), health examination, and/or school personnel observation, in accordance with all applicable State and/or Federal laws and Regulations.
B.Each school district must develop procedures or protocols for documenting and implementing a follow-up and referral plan for students identified as needing additional services.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.20** School Disease Reporting Requirements {#sec-216-ricr-20-10-4-4.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.20}
A.In accordance with the Rules and Regulations pertaining to Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental and Occupational Diseases, the basic responsibility for reporting infectious, environmental and occupational diseases lies with:
1.Physicians licensed in accordance with R.I. Gen. Laws Chapter 5-37 who are attending the case or suspected case;
2.Laboratories;
3.Other authorized health professionals working under the auspices of a physician; and
4.Other health care professionals authorized by law or Regulation to practice independently (e.g., registered nurse practitioners).
5.In the school setting, this requirement encompasses school nurses directed by a physician to report in accordance with the regulatory requirements cited above.
6.Licensed health care facilities that operate school-based health clinics must report communicable, environmental and occupational diseases in accordance with the Rules and Regulations for the Licensing of Organized Ambulatory Care Facilities and Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental and Occupational Diseases.
B.In accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental and Occupational Diseases, any health care provider (e.g., school physicians, school nurses, school dentists/dental hygienist) having knowledge of any outbreak or undue prevalence of infectious or parasitic disease or infestation (based upon his/her professional judgment), whether listed in this Part or not, must promptly report the facts to RIDOH. Exotic diseases and unusual group expressions of illness that may be of public health concern should also be reported immediately.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.21** First Aid and Emergencies {#sec-216-ricr-20-10-4-4.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.21}
A.Each school must have written protocols and standing orders available in the event of injuries and acute illnesses, including anaphylaxis and cardiac arrest.
B.Protocols and standing orders must be prepared, dated, signed, reviewed and updated, as appropriate, but at least on an annual basis by the school physician(s).
C.Protocols must also be reviewed annually by all school personnel designated by the school principal (or other designated school authority), who might be involved in managing an emergency in a school, including anaphylaxis, prior to the arrival of more fully trained persons.
D.No requirement in this Part shall be construed as prohibiting the issuance of a standing order by a school physician for the administration of an epinephrine auto-injector by a school nurse to a student who has not been previously medically identified for the prevention or treatment of anaphylaxis. This standing order must be reviewed in accordance with § 4.21(B) of this Part.
4.21.1Basic First Aid Training
A.In-service basic first aid training must be provided for school personnel who might be involved in managing an injury or other medical emergency.
B.Personnel must be identified by the school principal, or other designated school authority, and listed in the emergency protocol described in §§ 4.21(B) through (D) of this Part.
C.First aid subjects to be covered must include, but not be limited to: control of major bleeding, use of universal/standard precautions, management of ocular trauma and emergencies, management of burns, diabetes-related signs and symptoms, accessing the "911" emergency medical system, proper application and removal of disposable gloves and equipment, and movement and transportation of an injured person.
D.No less than one (1) hour of basic first aid training or current certification for the allotted term of said certification in basic first aid by a nationally recognized organization shall be required of school personnel designated by the school administrator during every school year.
E.The school principal, or other authorized school personnel, must maintain a record-keeping system documenting that the basic first aid training (as required under § 4.21.1(D) of this Part) has been provided to all designated school personnel.
F.The training must be delivered by a school nurse, or other designated instructor, utilizing a training curriculum that adheres to standards established by a nationally-recognized body.
G.Students engaged in potentially hazardous tasks (including, but not limited to, activities during normal school hours in science laboratories, industrial arts, physical education, and family/consumer science classes) should be directly supervised by teachers or instructors who are trained in the administration of basic first aid, and who have posted and discussed safety rules with the students.
4.21.2Cardiopulmonary Resuscitation Training
A.At all times, during normal school hours and at on-site school-sponsored activities, each school must have available at least one (1) person other than the school nurse who is trained, competent and responsible for the administration of basic first aid, child/adult cardiopulmonary resuscitation (CPR), including emergency procedures for obstructed airways (choking) and drowning, and administration of the epinephrine auto-injector.
B.Requirements for automated external defibrillators (AEDs) in high schools and middle schools are pursuant to R.I. Gen Laws § 16.21-33.1(b).
4.21.3Anaphylaxis Training
Training must be provided for school personnel who might administer an epinephrine auto-injector in a case of anaphylaxis. Subjects to be covered must include, but not be limited to,: signs and symptoms of anaphylactic shock, proper epinephrine auto-injector administration, adverse reactions, accessing the "911" emergency medical system, and preparation for movement and transport of the student.
4.21.4Response to and Treatment for Anaphylaxis
A.To prevent or treat a case of anaphylaxis (as defined in § 4.3(A)(2) of this Part), the school nurse or trained school personnel must administer the epinephrine auto-injector to an identified student. School nurses must administer the epinephrine auto-injector in accordance with standard nursing practice.
B.In the event of a suspected case of anaphylaxis, school personnel may administer the emergency protocol, including an epinephrine auto-injector to a medically identified student when authorized by a parent/guardian and when ordered by a physician or other licensed prescriber.
C.School health programs must develop and adopt a procedure for addressing incidents of anaphylaxis and the use of the epinephrine auto-injector on previously medically identified students. Such procedures must pertain to no less than the requirements described in this Part and must include the following:
1.Parents must provide a physician's or other licensed prescriber's order, parent authorization, and filled prescription(s) such as, the epinephrine auto-injector(s)) notifying the school of the student's allergy and the need to administer the epinephrine auto-injector in a case of anaphylaxis.
2.School administrators must communicate the required medical information from the parent to the appropriate school personnel, including the school nurse, teachers, food service workers, and school bus drivers and bus monitors.
3.The school physician must review these procedures on an annual basis.
4.Such procedures must stipulate that the epinephrine auto-injector be used only on the student for whom it was prescribed, in accordance with the provisions of R.I. Gen. Laws Chapter 21-28.2.
5.Such procedures must provide for the development of an individualized emergency care plan for a student at risk for anaphylaxis.
6.Procedures for accessing the community's emergency medical system, also known as, "911".
D.Students who are treated for anaphylaxis at the school must be transported by a licensed ambulance/rescue service promptly to an acute care hospital for medical evaluation and follow-up.
E.If appropriate, a student identified as being at risk for anaphylaxis should carry the epinephrine auto-injector at all times. If this is not appropriate, the epinephrine auto-injector must, if necessary for the student’s safety, as determined by the physician, or other licensed prescriber, be available in the classroom, cafeteria, physical education facility, health room and/or other areas where the epinephrine auto-injector is most likely to be used. Reasonable provisions must be made for the availability, safekeeping and security of the epinephrine auto-injector. The school must develop protocols and procedures related to the availability, safekeeping and security of the epinephrine auto-injector.
F.School personnel who have been trained in accordance with §§ 4.21.1, 4.21.2, and/or 4.21.3 of this Part are authorized to administer the epinephrine auto-injector to an identified student. If trained school personnel are not available, any willing person may administer the epinephrine auto-injector to a medically identified student. None of the requirements of this Part shall preclude the self-administration of an epinephrine auto-injector by a medically identified student.
G.In accordance with R. I. Gen Laws § 16-21-22(e), school districts may permit schools to maintain epinephrine auto-injectors for emergency first aid to students who experience allergic reactions.
4.21.5Good Samaritan Provisions
School personnel who voluntarily assist persons suffering from anaphylaxis are immune from liability for ordinary negligence in accordance with R. I. Gen Laws §§ 9-1-27.1 and 16-21-22(d).
4.21.6Food Allergy Management
A.Schools that have students with peanut/tree nut allergies are required to post a notice in accordance with R.I. Gen Laws § 16-21-31.
B.In all public and non-public elementary, middle or junior high schools, the school authority shall develop a policy designed to provide a safe environment for students with peanut/tree nut allergies pursuant to R.I. Gen Laws § 16-21-32.
C.Students with peanut/tree nut allergies, must have an IHCP and EHCP developed in accordance with R.I. Gen Laws § 16-21-32 prior to entry into school or immediately thereafter for students diagnosed with an allergy.
D.In addition to the requirements of R.I. Gen Laws § 16-21-32, the IHCP and EHCP must be part of the student’s permanent record, include both preventative measures to help avoid accidental exposure to allergens, and emergency measures in case of exposure. Additional measures shall include:
1.Educating school personnel, students, and families about food allergies; and,
2.Implementing protocols around cleaning surfaces touched by food products, washing of hands after eating, etc.
E.The EHCP must be consistent with applicable provisions contained in this Part, including, but not limited to, training, communication, plan review, Good Samaritan protections in accordance with R.I. Gen Laws § 9-1-27.1, and follow-up and documentation.
F.All school personnel who may be involved in the care of a student who has been diagnosed with a peanut/tree nut allergy must be informed of the IHCP and the EHCP, as appropriate.
4.21.7Follow-up & Documentation Requirements
A.Following a traumatic injury, an episode of anaphylaxis, or other emergency, a written report must be completed and filed in the student health record and verbal notification made to the student's parents as soon as possible by the school principal or designee.
B.Following a minor injury, the school nurse, or other appropriate school authority, must make a notation of the minor injury in a log book maintained by the school specifically for this purpose. At a minimum, the following items must be noted:
1.Date and time of injury;
2.Location where injury occurred;
3.Chief complaint;
4.Treatment administered;
5.Disposition (e.g., back to class);
6.Signature of responder.
C.For each student, emergency information must be documented and updated on an annual basis. Such emergency information must include no less than the following:
1.Name and telephone number of the student's parent and additional contact person(s) in the event of an emergency;
2.Name and telephone number of the student’s primary care provider;
3.Health insurance (optional);
4.Known allergies (including drug, food, insect bite and chemical allergies);
5.Medical conditions that may need attention, such as, past surgeries, heart problems, seizure disorders, nosebleeds, or diabetes;
6.Current, routine prescription medications and authorized OTC medications.
D.Protocols or procedures shall be developed to require an individualized emergency care plan for a student at risk for anaphylaxis, asthmatic conditions and/or any other medical emergencies, as defined in § 4.3 of this Part.
4.21.8Concussions/Head Injuries in Recreational and/or Athletic Competition
A.A youth athlete who is suspected of sustaining a concussion or head injury in a practice or game related to recreational and/or athletic competition must be removed from that practice or competition at that time.
B.A youth athlete who has been removed from play may not return to play until the athlete is evaluated by a licensed physician and until the athlete receives written clearance to return to play from that licensed physician.
C.A report of a concussion or head injury and written clearance to return to play should be logged in the student’s health record.
D.All coaches, trainers and volunteers involved in youth recreational and/or athletic competition must complete a training course, and a refresher course annually thereafter, in concussions and traumatic brain injuries.
E.All school nurses must complete a training course and an annual refresher course in concussions and traumatic brain injuries.
F.School districts and schools are required to use training materials of the US Center for Disease Control and Prevention entitled "Heads Up: Concussion in High School Sports/Concussion in Youth Sports" or materials substantially equivalent.
4.21.9Opioid-related Drug Overdose in School Settings
A.All public and private elementary, middle, junior, and high schools must develop policies and procedures for the provision and maintenance of a supply of opioid antagonists (Naloxone) in the school setting to treat suspected opioid overdose in accordance with R.I. Gen. Laws. § 16-21-35.
1.School nurses and other school personnel are immune from liability for ordinary negligence for acts or omissions relating to the use of the opioid antagonist in accordance with R.I. Gen. Laws § 16-21-35.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.22** Diabetes Care Management {#sec-216-ricr-20-10-4-4.22 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.22}
A.Each school district must develop a policy or protocol that allows students who are diagnosed with diabetes to self-manage their disease whenever possible. The policy or protocol must be developed in collaboration with licensed health care providers, parents, students, school nurses and administrators, as appropriate.
B.Such policy or protocol must require no less than the following:
1.Developing an individualized health care plan (IHCP) and an emergency care plan (ECP/EHCP);
2.Permitting self-testing in the classroom or other appropriate place(s) on the school campus or at school-sponsored activities, as designated in the IHCP;
3.Permitting healthy snacks in the classroom or other appropriate place(s) on the school campus or at school-sponsored activities, as designated in the IHCP;
4.Permitting bathroom and water fountain privileges in the classroom or other appropriate place(s) on the school campus or at school-sponsored activities as designated in the IHCP,
5.Ensuring the accompaniment of a symptomatic student to a health area by a designated adult, per the IHCP and the ECP/EHCP, unless such action puts the student at increased health risk.
C.The student’s IHCP and EHCP must be part of their permanent school health record and be developed by the school nurse in collaboration with the student’s health care provider, the parents/guardians of the student, and the student (if appropriate).
4.22.1Glucagon Administration
A.As part of the ECP/EHCP, a parent or legal guardian may authorize school employees (or those employed on behalf of the school), for when there is no school nurse immediately available, to administer glucagon on such student in case of an emergency, while at school or school-sponsored activities.
1.A parent or legal guardian must provide a diabetes management plan or physician's order, signed by the student's health care provider, that prescribes the care and assistance needed by the student including glucagon administration.
2.The glucagon must be kept in a conspicuous place, readily available, but with reasonable provisions made for the safekeeping and security of the glucagon, so that the security of the medication will not be compromised.
3.Glucagon administration training may be provided by a licensed physician, physician assistant, advanced practiced registered nurse, or registered nurse, however in no case shall school nurses be required to provide the training.
a.The school administration shall allow properly trained staff to voluntarily assist with the emergency administration of glucagon when authorized by a parent or legal guardian.
b.A school employee, including administrative staff, shall not be subject to penalty or disciplinary action for refusing to be trained in glucagon administration.
c.The training and supervision of personnel, other than the school nurse, who provide emergency medical assistance to students under this section, shall be governed by performance standards and guidelines developed by the Rhode Island Department of Health, in conjunction with the American Diabetes Association, and the Rhode Island Chapter of the American Academy of Pediatrics. Such personnel shall be authorized to provide such assistance only upon successful completion of glucagon administration training.
4.No school teacher, school administrator, school health care personnel, person employed on behalf of the school, any other school personnel, nor any local educational authority shall be liable for civil damages which may result from acts or omissions in use of glucagon which may constitute ordinary negligence. This immunity does not apply to acts or omissions constituting gross negligence or willful or wanton conduct.
B.All school personnel who may be involved in the care of a student who has been diagnosed with diabetes must be informed of the IHCP and the ECP/EHCP, as appropriate.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.23** Medical Marijuana Administration {#sec-216-ricr-20-10-4-4.23 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.23}
4.23.1Requirements for All Medical Marijuana Administration to Students
A.Every school authority must develop protocols or procedures authorizing parents, parents’ designees, legal guardians, and school nurses in accordance with § 4.23.2 of this Part, to administer medical marijuana to a student while the student is on school campus. The protocols or procedures must include, at a minimum, the following:
1.A requirement that the student be authorized to engage in use of medical marijuana pursuant to R.I. Gen. Laws § 21-28.6.
2.An established written process for verifying the student's medical marijuana cardholder registration and ongoing medical marijuana cardholder authorization status.
3.Written instructions for medical marijuana administration that includes:
a.The signature of the certifying physician, advanced practice nurse practitioner, or physician assistant;
b.The student’s debilitating medical condition;
c.The dose of medical marijuana, including the amount of CBD and/or THC (where applicable) per dose;
d.Minimum interval between dosage; and
e.Possible side effects to be included in the student’s IHCP.
4.A requirement that all medical marijuana products utilized under § 4.23 of this Part shall only be obtained from a Rhode Island licensed compassion center. All medical marijuana products utilized must be labeled with the following information:
a.The student’s name;
b.The student’s date of birth;
c.Dosage;
d.Ingredients of product.
5.Documentation of each dose of medical marijuana administered to a student. Documentation must include:
a.Date and time;
b.Dosage;
c.Route of administration; and
d.The signature of the parent, parents’ designees, legal guardian, or school nurse who is administering the medical marijuana.
e.In the event the dosage is not administered as dictated by the instructions required under § 4.23.1(A)(2) of this Part, the reason(s) therefore must be noted.
6.Prohibition on administering medical marijuana to a student by smoking or other form of inhalation.
7.Identification of locations on the school campus where medical marijuana may be administered.
8.A written and signed statement from the student's parent or legal guardian releasing the school, and employees and volunteers of the school, from liability, except in cases of willful or wanton conduct or disregard of the criteria of the IHCP.
9.Prohibition of students handling or self-administering medical marijuana on the school campus.
10.Prohibition of student possession, use, distribution, or sale of marijuana that is inconsistent with the provisions of § 4.23 of this Part and R.I. Gen. Laws §§ 16-21-16 and 16-21-21.1.
11.A requirement that a student who is authorized to use medical marijuana shall not be considered under the influence of marijuana and not penalized pursuant to R.I. Gen. Laws §§ 16-21-16 and 16-21-21.1.
B.The provisions of § 4.23 of this Part do not apply during the time a student is engaged in a school-sponsored trip or activity outside the state of Rhode Island.
C.The school may not discipline or otherwise discriminate against a student who is administered medical marijuana and may not deny the student's eligibility to attend school solely because the student requires the administration of medical marijuana.
D.§ 4.23 of this Part does not apply to FDA-approved cannabinoid medications.
E.A school is exempt from implementing the provisions of § 4.23 of this Part if the school can reasonably demonstrate that it would lose Federal funding as a result of the implementation of the provisions of § 4.23 of this Part.
4.23.2Administration of Medical Marijuana by a School Nurse
A.Pursuant to R.I. Gen. Laws § 21-28.6-4(n), a school nurse may administer medical marijuana to a student. Administration of medical marijuana to students by school nurses must follow all requirements of § 4.23.1 of this Part. Additionally:
1.All medical marijuana to be administered by the school nurse must be kept in a secured cabinet designated by the school.
2.No school nurse shall be subject to disciplinary action by the applicable Rhode Island professional licensing board solely for following an appropriate written certification to administer medical marijuana.
3.Nothing in this Part requires a school nurse to administer medical marijuana to a student, provided that the school nurse’s decision not to administer medical marijuana applies to all students authorized to use medical marijuana.
a.School’s whose school nurse refuses to administer medical marijuana shall make arrangements for the student to receive his or her medical marijuana during the school day.
4.23.3Administration of Medical Marijuana by Parents, Parents’ Designees, and Legal Guardians
A.Administration of medical marijuana to students by parents, parents’ designees, and legal guardians must follow all requirements of § 4.23.1 of this Part. Additionally:
1.Any medical marijuana taken onto the school campus by the parent, parents’ designee, or legal guardian must be either:
a.Consumed/utilized in its entirety by the student; or
b.The excess medical marijuana which is not consumed/utilized by the student must be removed in its entirety from the school campus, with the exception of any disposable packaging which no longer contains medical marijuana.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.24** Medication Administration {#sec-216-ricr-20-10-4-4.24 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.24}
A.Each school district or authority must develop protocols or procedures related to medication administration in schools that include, at a minimum, the following provisions:
1.A school nurse must administer medication(s) to student(s) within the public school setting except as provided in §§ 4.21.4(F), 4.22.1, 4.24.3, 4.24.4, or 4.24.5 of this Part. The school nurse must be licensed in Rhode Island in accordance with the requirements of R.I. Gen. Laws Chapter 5-34. He or she must also be certified in accordance with the provisions of R.I. Gen. Laws § 16-21-8.
a.All medications, including prescription and over-the-counter (OTC), must be administered only in accordance with a written order from a licensed health care prescriber, except as provided in §§ 4.21.4(F), 4.22.1, 4.24.3, 4.24.4, or 4.24.5 of this Part. All medications must be administered in keeping with safe standards of health care practice and in accordance with all applicable State and Federal laws and Regulations.
2.A school nurse or other registered nurse must administer medication to student(s) in a non-public school except as provided in §§ 4.21.4(F), 4.22.1, 4.24.3, 4.24.4, or 4.24.5 of this Part. Such a registered nurse must be licensed in Rhode Island in accordance with the requirements of R.I. Gen. Laws Chapter 5-34.
3.No lay person, other than a parent, may administer medication to a student in the school setting. Exceptions: §§ 4.21.4(F) and 4.22.1 of this Part (related to the administration of epinephrine and glucagon).
4.24.1Provisions Related to Nurse Administration
A.Each dose of medication administered by a school nurse or other registered nurse must be documented. Documentation must include: date, time, dosage, route of administration and the signature of the school nurse or other registered nurse administering the medication or supervising the student in self-administration. In the event a dosage is not administered as ordered, the reason(s) therefore must be noted.
B.All medications to be administered by the school nurse or other registered nurse, as provided in this Part, must be kept in a secured cabinet.
C.A licensed provider's (with prescriptive privileges) order must be obtained and verified by the school nurse or other registered nurse for all medications to be administered by the school nurse or registered nurse, including school physician standing orders. Verbal orders to the nurse and facsimile transmissions may be accepted. Verbal orders must be followed up by a written order from the licensed prescriber within three (3) working days. Upon receipt, the orders must be confirmed with the parent by the nurse.
D.For prescription medications, all parent authorizations and licensed provider’s orders must be renewed no less than annually by the school nurse or other registered nurse.
4.24.2Controlled Substances
Except as provided in § 4.2.5 of this Part, no controlled substance is permitted to be in the possession of or administered by anyone other than a school nurse, other registered nurse, licensed prescriber, or parent of the child for whom the medications have been prescribed. A student may deliver his/her own medication to school in accordance with protocols or procedures developed by the school but may not self-administer the controlled substance while on school property.
4.24.3Self-Carry and Self-Administration of Medication
A.All school districts or school authorities must develop protocols or procedures to permit students to self-carry and/or self-administer prescription medication if the student, parent, school nurse or registered nurse, and licensed prescribing health care provider enter into a written agreement that specifies the conditions under which the prescription medication must be self-carried and/or self-administered. The school principal must be informed of the existence of said agreement.
1.School districts or school authorities may develop protocols or procedures to permit students to self-carry and/or self-administer medication that does not require a licensed prescriber’s note. In developing such protocols or procedures, school districts or school authorities must give consideration to such factors as the age of the child, the duration of the need for the medication, and the ability of the child to self-administer.
B.The protocols or procedures related to student self-administration of medication must include provisions for the following:
1.All medication must be stored in its original prescription or manufacturer-labeled container.
2.For prescription medication, a licensed health care prescriber’s written order is required.
C.A student is prohibited from sharing, transferring, or in any way diverting his/her own medication(s) to any other person.
4.24.4Inhalers
A.Each school district must develop a procedure to allow students to carry and use prescription inhalers while in school or at a school sanctioned function or event, when prescribed by a licensed healthcare provider with prescriptive privileges. Students who carry inhalers must provide the school with medical documentation that the inhaler has been legitimately prescribed and that the child needs to self-carry due to a medical condition. No child shall be disciplined for failure to provide such documentation in advance.
1.No school teacher, school administrator, or school health personnel, or any other school personnel will be liable for civil damages which may result from acts or omissions in the use of prescription inhalers by children which may constitute ordinary negligence. This immunity does not apply to acts or omissions constituting gross negligence or willful or wanton conduct.
4.24.5Medication Administration at Off-site School-sponsored Activities
A.Each school district or non-public school authority must develop a procedure or protocol to allow students to self-carry and self-administer a day’s supply of medication for each day off-site, including a controlled substance, during an off-site school-sponsored activity.
1.The medication must be supplied by the parent with a parent’s written authorization for use of the medication during the off-site school-sponsored activity and must be stored and transported in its original prescription-labeled container (in the case of a prescription medication) or its manufacturer-labeled container (in the case of a non-prescription medication).
2.In the case of a prescription medication, a licensed health care prescriber’s written order must be provided, if it is not already on file in the school.
3.A student is prohibited from sharing, transferring, or in any way diverting his/her own medication(s) to any other person.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.25** Immunization and Testing for Communicable Diseases {#sec-216-ricr-20-10-4-4.25 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.25}
Pursuant to Part 30-05-3 of this Title, Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities, all schools in Rhode Island must adopt, at a minimum, the standards for immunization and communicable disease testing described therein.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.26** Standards for School Building(s) and Approval {#sec-216-ricr-20-10-4-4.26 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.26}
A.Pursuant to R.I. Gen. Laws § 16-21-3, the State Building Codes Standards Committee, the State Fire Marshall, the State Health Department, and the Department of Labor and Training, Division of Occupational Safety shall determine whether the school buildings in the several cities and towns or on State property conform to appropriate State and Federal laws and Regulations within their respective jurisdiction.
1.Furthermore, it shall be the responsibility of each local Fire Chief, local Building Inspector, the Director of the State Department of Health, and the Director of the State Labor and Training Department to determine and notify each local school superintendent or non-public school official by August 1 of each year as to whether the public and non-public nursery, elementary and secondary school buildings conform to appropriate State and Federal laws and Regulations within their respective jurisdiction.
2.In the case of those schools on State property, it shall be the responsibility of the State Building Commissioner, the State Fire Marshall, the Director of the State Department of Health, and the Department of Labor and Training to notify the department director responsible for the operation of the school as to whether these schools conform to appropriate State and Federal laws and Regulations.
B.Pursuant to R.I. Gen. Laws § 16-21-3.1, it shall be the responsibility of the school administrator, the non-public school official, in the case of State operated schools, the responsibility of the director of the State operated school, to ensure that schools are not opened until notification is received from the aforementioned agencies that the schools are in compliance with their respective codes.
1.Neglect by any superintendent, non-public school official, or director of any State operated school to comply with the statutory provisions of § 4.26(B) of this Part shall be subject to the sanction as set forth in R.I. Gen. Laws § 16-21-3.1.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.27** New Construction, Renovation or Conversion of Existing Buildings to Schools {#sec-216-ricr-20-10-4-4.27 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.27}
4.27.1General Requirements
A.All new construction or the alteration, extension, or modification of an existing building(s) is subject to all applicable Federal, State and local laws, codes, Regulations, and ordinances, including but not limited to the following regulatory provisions enforced by the specific agency:
1.IBC-1 State Building Code, et al, R.I. Gen. Laws Chapter 23-27.3, R.I. State Building Code Standards Committee;
2.The Uniform Federal Accessibility Standards (UFAS) incorporated at § 4.2(L) of this Part and State accessibility for persons with disability standards:
a.R.I. Gen. Laws § 37-8-15, “Access for People with Disabilities”;
b.The Federal Rehabilitation Act of 1973, as amended, (29 U.S.C. § 791 et seq.) § 504, 34 C.F.R. Part 104, Program Accessibility for Persons with Disabilities and the Americans with Disabilities Act of 1990 (42 U.S.C. § 12101 et seq.), 28 C.F.R. Parts 35 and 36, Accessibility for Persons with Disabilities in Public Entities and Public Accommodations;
c.R.I. Gen. Laws § 42-26-13 Open Meetings-Accessibility for Persons with Disabilities; 510-RICR-00-00-17, RISBC-17 Public Meetings Accessibility Standard;
3.Construction, Division of Occupational Safety, Rhode Island Department of Labor and Training, incorporated at § 4.2(I) of this Part;
4.R.I. Gen. Laws § 16-21-5.1, "Carbon monoxide detectors required in school buildings;
5.§ 450-RICR-00-00-7.1.10 of the Fire Safety Code Board of Appeal and Review's Fire Safety Code; and,
6.200-RICR-20-05-4, Rhode Island School Construction Regulations
7.Such other applicable statutory and regulatory provisions.
B.All architectural plans for school construction, renovations, or conversions must be submitted to the appropriate staff at RIDE, the Governor’s Commission on Disabilities, the State Building Commissioner and all other State or local agencies as appropriate prior to construction for review for compliance with all applicable Federal, State and local laws, codes, Regulations and ordinances.
1.All architectural plans for new school construction, submitted for approval must include provisions for a health room that includes, at a minimum, a private toilet, hand washing facilities, a private area for consultation, and a waiting area.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.28** Existing School Buildings/General Requirements {#sec-216-ricr-20-10-4-4.28 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.28}
A.All existing structures must comply with all applicable Federal, State and local laws, codes, Regulations, and ordinances including but not limited to the following regulatory requirements enforced by the specified agency:
1.510-RICR-00-00-13, Standards for Existing Schools, through the local building officials or the State Building Commissioner;
2.Where applicable, the Federal and State accessibility for persons with disability standards:
a.R.I. Gen. Laws § 37-8-15, “Access for People with Disabilities”;
b.The Federal Rehabilitation Act of 1973, as amended, (29 U.S.C. § 791 et seq.) § 504, 34 C.F.R. Part 104, Program Accessibility for Persons with Disabilities and the Americans with Disabilities Act of 1990 (42 U.S.C. § 12101 et seq.), C.F.R. Parts 35 and 36, Accessibility for Persons with Disabilities in Public Entities and Public Accommodations;
c.R.I. Gen. Laws § 42-26-13 Open Meetings--Accessibility for Persons with Disabilities; 510-RICR-00-00-17, RISBC-17 Public Meetings Accessibility Standard
3.R.I. Gen. Laws Chapter 23-24.9, "Mercury Reduction and Education Act;"
4.29 C.F.R. Parts 1910 and 1926, Construction, Division of Occupational Safety, R.I. Department of Labor and Training;
5.R.I. Gen. Laws § 16-21-5.1, "Carbon monoxide detectors required in school buildings;
6.R.I. Gen. Laws Chapter 23-28.12 and § 7, Chapters 1 through 8 and Chapters 24 through 43 of 450-RICR-00-00-7, RI Fire Code ; and,
7.Such other applicable statutory or regulatory requirements.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.29** Pesticide Applications and Notification of Pesticide Applications at Schools {#sec-216-ricr-20-10-4-4.29 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.29}
All school buildings are subject to the provisions of R.I. Gen. Laws § 23-25-37 for the notification and application of pesticides.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.30** Asbestos {#sec-216-ricr-20-10-4-4.30 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.30}
All school buildings are subject to the provisions of R.I. Gen. Laws Chapter 23-24.5 and Part 50-15-1 of this Title, Asbestos Control.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.31** Lead {#sec-216-ricr-20-10-4-4.31 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.31}
All schools serving children under the age of six (6) years (e.g., kindergartens, day care sites) are subject to the provisions of R.I. Gen. Laws Chapter 23-24.6 and Part 50-15-3 of this Title, Lead Poisoning Prevention.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.32** Radon {#sec-216-ricr-20-10-4-4.32 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.32}
All school buildings are subject to the provisions of R.I. Gen. Laws Chapter 23-61 and Part 50-15-2 of this Title, Radon Control.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.33** Latex Gloves {#sec-216-ricr-20-10-4-4.33 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.33}
Any school that utilizes latex gloves must do so in accordance with the provisions of Subchapter 15 Part 3 of this Chapter, Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.34** Food Service {#sec-216-ricr-20-10-4-4.34 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.34}
A.Food service in all schools, including food service facilities, must comply with the following statutory and regulatory provisions relating to food protection including, but not limited to:
1.R.I. Gen. Laws Chapter 21-27 and § 23-1-31;
2.Part 50-10-1 of this Title, Rhode Island Food Code;
3.Part 50-10-2 of this Title, Certification of Managers in Food Safety.
B.No less than one (1) person certified as a manager in food safety within each school must be designated as the person in charge to supervise all food preparation personnel to ensure food safety in accordance with Part 50-10-1 of this Title, Rhode Island Food Code.
C.In accordance with Part 50-10-1 of this Title, Rhode Island Food Code, each school serving hot potentially hazardous foods must have a written plan for assessing, monitoring, and controlling foodborne disease hazards within the facility. The plan must include, but not be limited to, monitoring of food temperatures at the shipping and receiving end for satellite feeding operations and a plan for the restriction and exclusion of ill personnel.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.35** Health Room {#sec-216-ricr-20-10-4-4.35 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.35}
A.Schools must have a designated health room(s) to be utilized for health services. The room(s) must be equipped with no less than the following accommodations:
1.Within the health room:
a.Hand washing facilities, including warm (not to exceed one hundred twenty degrees Fahrenheit (120° F) [forty-nine degrees Celsius (49° C)]) and cold running water, soap dispensers and soap (liquid or powdered), and either disposable towels or a heated-air hand drying device;
b.A cot or other suitable area for reclining, with accommodations for privacy;
c.All supplies necessary for the disposal of biohazardous waste, including but not limited to, a sharps container that must be managed in accordance with the requirements of 250-RICR-140-15-1, Rhode Island Department of Environmental Management Medical Waste Regulations;
d.A secure medication storage area, including a locked storage site for controlled substances;
e.A telephone;
2.Either within or adjacent to the health room:
a.A toilet;
b.A secure refrigerator for exclusive use of medications and health supplies (e.g., ice packs);
c.A secure cabinet for medical record storage;
d.An area for students to comfortably await services;
3.Either within or accessible to the health room on the same floor of the building:
a.A private area for consultations that ensures that confidentiality is maintained.
4.The minimum lighting level for the health room must be fifty foot (50’) candles.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.36** Sanitation Facilities {#sec-216-ricr-20-10-4-4.36 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.36}
A.The premises of each school must include an appropriate number of hand washing facilities, toilets, and drinking fountains for all students and school personnel and must be maintained in a working and sanitary condition as determined by RIDOH and in accordance with the most recent version of the Code of Federal Regulations of the Division of Occupational Safety, R.I. Department of Labor and Training.
1.Hand washing facilities: In addition, hand washing facilities must have cold and warm (not to exceed one hundred twenty degrees Fahrenheit (120° F) [forty-nine degrees Celsius (49° C)]) running water and be stocked at all times with soap dispensers and soap (liquid or powdered) and either disposable towels or a heated-air hand drying device. An adequate number of alcohol-based personal hand washing stations for students and teachers must also be available within school premises in accordance with Executive Order 07-01.
2.Toilets: At a minimum, the following ratios of toilets must be accessible to students:
Type of School
Minimum Ratio of Toilets per Student
Boys
Girls
Elementary School
1:40
1:35
Secondary School
1:75
Urinals 1:30
1:45
3.Showers: In those schools where shower facilities are in use, they must be properly cleaned and maintained and supplied with cold and warm (not to exceed one hundred twenty degrees Fahrenheit (120° F) [forty-nine degrees Celsius (49° C)]) running water.
4.All sanitation facilities must be accessible to persons with disabilities in accordance with all applicable local, State and Federal laws and Regulations.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.37** Housekeeping {#sec-216-ricr-20-10-4-4.37 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.37}
Each school must maintain a comprehensive list of all solutions, compounds and other products used in and around the school for cleaning and maintenance. This list must include, but not be limited to, cleaning products used in all parts of the school, lawn care products used on school campus, and products used to maintain facilities such as swimming pools. The list must be kept in a readily accessible location, such as the school administrative office, be updated regularly and provided to any individual upon request.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.38** Swimming Pools {#sec-216-ricr-20-10-4-4.38 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.38}
Swimming pools are subject to the statutory provisions of R.I. Gen. Laws Chapter 23-22 and any other applicable law relating to Part 50-05-4 of this Title, Licensing Aquatic Venues.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.39** Water Supply {#sec-216-ricr-20-10-4-4.39 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.39}
A.Each school building must be furnished with an adequate supply of potable water in accordance with Part 50-05-1 of this Title, Public Drinking Water.
1.Potable water must be supplied to all food service areas, lavatories, janitorial and shower areas.
2.An adequate supply of potable drinking water must be available for consumption through a sufficient number of well-maintained and accessible sources and in accordance with 510-RICR-00-00-3, RISBC-3 Rhode Island Plumbing Code.
B.A community water system must be used as the source of supply where available.
1.Where a community water system is unavailable the water supply system utilized by the school must meet the requirements of R.I. Gen. Laws Chapters 46-13, 23-65, and Part 50-05-6 of this Title, Drinking Water State Revolving Fund.
C.All proposed schools that meet the definition of a public water system pursuant to Part 50-05-1 of this Title, Public Drinking Water, or proposed alterations to existing public water systems in schools must be approved by RIDOH.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.40** Tobacco {#sec-216-ricr-20-10-4-4.40 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.40}
School buildings, school campus, and all facilities used by a school, are subject to the provisions of R.I. Gen. Laws Chapters 23-20.9 entitled “Smoking in Schools” and Chapter 23-20.10 the “Public Health and Workplace Safety Act”.
4.40.1Violations and Penalties
In accordance with R.I. Gen. Laws Chapter 23-20.10 if an employer violates the provisions of the statute, civil penalties will be levied in accordance with R.I. Gen. Laws §§ 23-20.10-10 and 23-20.10-14.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.41** School Safety {#sec-216-ricr-20-10-4-4.41 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.41}
4.41.1School Safety Assessments
The school district of each city, town, and regional school department is required to conduct an assessment every three (3) years to examine the safety of each school building in accordance with R.I. Gen Laws § 16-21-23(a).
4.41.2School Safety Teams
The school committee or superintendent of each city, town, and regional school department is required to appoint a school safety team and a school crisis response team in accordance with R.I. Gen. Laws §§ 16-21-23(b) through (c).
4.41.3School Safety Plans
A.In accordance with R.I. Gen. Laws § 16-21-23(b), the school committee of each city, town, and regional school department is required to adopt a comprehensive school safety plan that addresses preparedness, response and recovery and meets the policy and procedure requirements in R.I. Gen. Laws § 16-21-24.
1.The school safety plan must include best practices and relevant provisions of the current State model plan as published by RIDE including:
a.Guidance for communicating threats of violence or harm to the specifically identifiable student(s) and/or school personnel who are the subject of said threats by individuals or groups.
b.Standards for determining those threats of violence or harm that meet the threshold of seriousness and reasonableness so that communication of said threats to specifically identifiable students and/or school personnel is justified;
2.The school safety plan must include written policies for the establishment of threat assessment teams, completion of an emergency action plan and submission of the all hazards site safety survey report in accordance with the requirements of R.I. Gen. Laws § 16-21-23.
3.The school committee is required to review and update the school safety plans by November 1 of each year in accordance with R.I. Gen. Laws § 16-21-25.
4.41.4Statewide Bullying Policy
In accordance with R.I. Gen. Laws §§ 16-21-33 and 16-21-34, any form or degree of bullying at school is prohibited. All school districts, charter schools, career and technical schools, approved private day or residential schools and collaborative schools must adopt a policy pursuant to 200-RICR-30-10-2, Safe School Act – Statewide Bullying Policy and 200-RICR-30-10-1, Regulations Governing Protections for Students Rights to be Free from Discrimination on the Basis of Sex, Gender, Sexual Orientation, Gender Identity or Gender Expression.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.42** Weapons and Firearms {#sec-216-ricr-20-10-4-4.42 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.42}
A.All schools are required to have policies prohibiting possession of firearms and other weapons and imposing penalties for such possession in conformity with R.I. Gen. Laws § 16-21-18 and the “Gun Free Schools Act,” 20 U.S.C. § 8921 et seq.
1.All school districts must ensure the discipline policies regarding incidents of students in possession of weapons are imposed on a case-by-case basis.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.43** Alcohol and Other Drugs {#sec-216-ricr-20-10-4-4.43 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.43}
A.All schools are required to have policies regarding possession of alcohol and other drugs and must have on-going prevention activities and programs as supported by the “Safe and Drug-Free Schools and Communities Act,” 20 U.S.C. § 7101 et seq.
1.All school districts must ensure that the discipline policies regarding incidents of students in possession of alcohol or drugs are imposed on a case-by-case basis.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.44** Recreational Facilities {#sec-216-ricr-20-10-4-4.44 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.44}
A.All recreation facilities and areas, including gymnasiums, playgrounds, and athletic fields must be maintained and operated in a safe manner, including, at a minimum, the following provisions:
1.Playground surfaces and equipment must demonstrate compliance with all applicable guidelines of the most recent version of the Handbook for Public Playground Safety issued by the U.S. Consumer Products Safety Commission incorporated at § 4.2(B) of this Part.
B.In accordance with 36 C.F.R. Part 1191, recreational facilities, athletic fields and playgrounds must be accessible to persons with disabilities.
C.Adequate, convenient, and well-maintained changing areas and facilities must be provided for secondary school students, as needed.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.45** Vehicular and Pedestrian Traffic Safety {#sec-216-ricr-20-10-4-4.45 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.45}
A.Each school is required to develop written procedures or protocols to reduce the risk of motor vehicle injuries and exposure to motor vehicle exhaust fumes among students. These procedures must be reviewed annually by school representatives and local police authorities and must address no less than the following issues:
1.Arrival and departure areas for busses, private automobiles, bicyclists, and pedestrians;
2.Parking and idling locations for motor vehicles, including busses;
3.Signage and crosswalks;
4.Traffic flow on and adjacent to school campus; and,
5.Emergency procedures.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.46** Asset Protection {#sec-216-ricr-20-10-4-4.46 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.46}
Each public school and district is subject to the provisions of R.I. Gen. Laws Chapter 16-7.1, requiring all public schools and districts to provide an annual asset protection plan to the Commissioner of RIDE.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.47** Enforcement {#sec-216-ricr-20-10-4-4.47 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.47}
A.Pursuant to the provisions of R.I. Gen. Laws § 16-5-30, the Commissioner of RIDE may for violation or neglect of law or for violation or neglect of Rules and Regulations in pursuance of law by any city or town or city or town officer or school committee, order the General Treasurer to withhold the payment of any portion of the public money that has been or may be apportioned to the city or town.
B.The General Treasurer upon the receipt in writing of the order shall hold the public money due the city or town until such time as the Commissioner by writing requests the withheld funds for the purposes of eliminating the violation or neglect of law or Regulation that caused the order to be issued, or the Commissioner of RIDE shall notify the Treasurer that the city or town has complied with the order as the Department shall make in the premises, in which case payment shall be made to the town forthwith.
C.The Council on Elementary and Secondary Education shall report to the General Assembly annually all infractions of school law which shall be brought to its attention, with a record of such action as the Department shall have taken in each instance.
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
##### **216-RICR-20-10-4 § 4.48** Laboratories, Shops and Other Special Purpose Areas {#sec-216-ricr-20-10-4-4.48 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-4#4.48}
A.Special purpose areas of school facilities that must include, but not be limited to, the cafeteria, home economics laboratory, industrial arts and vocational laboratories, art rooms, and science laboratories must be in compliance with the following provisions:
1.Rhode Island Department of Labor and Training "OSHA Regulations 1910" Occupational Safety and Health Standards, as filed with the Secretary of State pursuant to R.I. Gen. Laws Chapter 28-20;
2.29 C.F.R. Part 1200, General Industry Standards 1910. Hazardous Communication that requires employers to maintain in the workplace copies of the required material safety data sheets for each hazardous chemical, and must ensure that they are readily accessible during each work shift to employees when they are in their work area(s), and to provide training in accordance with State and Federal Regulations.
3.Rhode Island Department of Labor and Training "OSHA Regulations 1926": Safety and Health Regulations for Construction, as filed with the Secretary of State pursuant to R.I. Gen. Laws Chapter 28-20;
4.R.I. Gen. Laws § 16-7-24, entitled “Minimum Appropriation by a Community for Approved School Expenses”;
5.Rhode Island Council on Elementary and Secondary Education’s Basic Education Program (BEP) 200-RICR-20-10-1.
4.48.1Chemical Hygiene Plan
A.For the purposes of this Part, the protective measures required for employees pursuant to 29 C.F.R. Part 1450, as incorporated by reference in § 4.2(A) of this Part, must extend to students.
B.Any school engaged in the laboratory use of hazardous chemicals as defined in this Part must develop and implement a written chemical hygiene plan that sets forth procedures, equipment, personal protective equipment, and work practices that are capable of protecting employees and students from the health hazards presented by hazardous chemicals used in that particular school setting in accordance with the requirements of 29 C.F.R. Part 1450, as incorporated by reference in § 4.2(A) of this Part. Said plan must also include a section regarding the purchase, storage, and disposal of potentially hazardous chemicals and the training of staff and students on their use.
C.School personnel (e.g., art teachers, shop teachers, classroom teachers, maintenance staff) must ensure compliance with 29 C.F.R. Part 1200, as incorporated by reference in § 4.2(A) of this Part, for those areas under their control or supervision. Safety data sheets for all chemicals stored, handled or used in those areas must be reviewed with the school’s chemical hygiene officer to ensure that the chemicals are appropriately managed in accordance with school’s chemical hygiene plan.
D.The written chemical hygiene plan required by this Part must include a prohibition on the use of the chemicals listed below.
1.State-approved career and technical education programs, as governed by 200-RICR-20-10-3, Regulations Governing Career and Technical Education in Rhode Island, shall be exempt from the chemical prohibition of § 4.2(A) of this Part, but must maintain a safe and healthy environment where risks are minimized through education, training, administrative and engineering controls, personal protective equipment, proper work practices, and the use of the safest available materials and products, in accordance with current occupational and environmental standards and Regulations.
Full Chemical Name
CAS #
Reference
1-(2-tert-Butylperoxy isopropyl)-3-isopropenylbenzene
96319-55-0
49 C.F.R. § 173.225
1-(o-Chlorophenyl)thiourea
5344-82-1
EPA Acutely Toxic (P Listed)
1,1-Di-(tert-amylperoxy)cyclohexane
15667-10-4
49 C.F.R. § 173.225
1,1-Di-(tert-butylperoxy)-3,3,5-trimethylcyclohexane
6731-36-8
49 C.F.R. § 173.225
1,1-Di-(tert-butylperoxy)cyclohexane
3006-86-8
49 C.F.R. § 173.225
1,1'-Diazoaminonaphthalene
DOT Forbidden
1,1-Dimethyl-3-hydroxybutylperoxyneoheptanoate
49 C.F.R. § 173.225
1,2,3-Propanetriol, trinitrate (R)
55-63-0
EPA Acutely Toxic (P Listed)
1,2,4-butanetriol trinitrate
DOT Forbidden
1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-
51-43-4
EPA Acutely Toxic (P Listed)
1,2-Diazidoethane
DOT Forbidden
1,2-Dibromo-3-Chloropropane
96-12-8
Reproductive Toxin, Select Carcinogen
1,2-Propylenimine
75-55-8
EPA Acutely Toxic (P Listed)
1,3,4 oxadiazole
IARC List of Known and Suspected Human Carcinogens
1,3-butadiene
106-99-0
OSHA Listed Chemicals
1,3-Diazopropane
DOT Forbidden
1,3-dinitro-5,5-dimethyl hydantoin
DOT Forbidden
1,3-Dithiolane-2-carboxaldehyde, 2,4-dimethyl-, O- [(methylamino)-carbonyl]oxime
26419-73-8
EPA Acutely Toxic (P Listed)
1,4-Butanediol Dimethylsulfonate
55-98-1
Select Carcinogen
1,7-octadine-3, 5-diyne-1, 8-dimethoxy-9-octadecynoic acid
DOT Forbidden
1,8-dihydroxy-2,4,5,7-tetranitroanthraquinone
DOT Forbidden
1,9-dinitroxy pentamethylene-2,4, 6,8-tetramine
DOT Forbidden
1-Acetyl-2-thiourea
591-08-2
EPA Acutely Toxic (P Listed)
1-bromo-3-nitrobenzene
DOT Forbidden
2-(2-Hydroxyethoxy)-1-(pyrrolidin-1-yl)benzene-4-diazonium zinc chloride
15005-97-7
49 C.F.R. § 173.224
2-(N,N-Ethoxycarbonylphenylamino)-3-methoxy-4-(N-methyl-N-cyclohexylamino)benzenediazonium zinc chloride
49 C.F.R. § 173.224
2-(N,N-Methylaminoethylcarbonyl)-4-(3,4-dimethyl-phenylsulphonyl)benzene diazonium zinc chloride
49 C.F.R. § 173.224
2,2'-Azodi(2,4-dimethyl-4-methoxyvaleronitrile)
49 C.F.R. § 173.224
2,2'-Azodi(2,4-dimethylvaleronitrile)
4419-11-8
49 C.F.R. § 173.224
2,2-Azodi(2-methylbutyronitrile)
49 C.F.R. § 173.224
2,2'-Azodi(ethyl 2- methylpropionate)
49 C.F.R. § 173.224
2,2'-Azodi(isobutyronitrile)
78-67-1
49 C.F.R. § 173.224
2,2-Di-(4,4-di(tert-butylperoxy)cyclohexyl)propane
1705-60-8
49 C.F.R. § 173.225
2,2-di-(4,4-di-tert-butylperoxycyclohexyl) propane
DOT Forbidden
2,2-Di-(tert-butylperoxy) butane
DOT Forbidden
2,2-di-(tert-Butylperoxy)butane
2167-23-9
49 C.F.R. § 173.225
2,2-Di-(tert-butylperoxy)propane
1705-60-8
49 C.F.R. § 173.225
2,2-Dihydroperoxypropane
2614-76-8
49 C.F.R. § 173.225
2,2-dinitrostilbene
DOT Forbidden
2,4-Dinitrophenol
51-28-5
EPA Acutely Toxic (P Listed)
2,5 Dimethyl 2,5 di-2-ethylhexanoylperoxyhexane
49 C.F.R. § 173.225
2,5-Diethoxy-4-(phenylsulphonyl)benzenediazonium zinc chloride
49 C.F.R. § 173.224
2,5-Diethoxy-4-2,5-Diethoxy-4-morpholinobenzenediazonium zinc chloride
26123-91-1
49 C.F.R. § 173.224
2,5-Diethoxy-4-morpholinobenzenediazonium tetrafluoroborate
4979-72-0
49 C.F.R. § 173.224
2,5-Diethoxy-4-morpholinobenzenediazonium zinc chloride
26123-91-1
49 C.F.R. § 173.224
2,5-Dimethoxy-4-(4-methylphenylsulphony)benzene diazonium zinc chloride
49 C.F.R. § 173.224
2,5-Dimethyl-2,5-di-(3,5,5-trimethylhexanoylperoxy)hexane
49 C.F.R. § 173.225
2,5-Dimethyl-2,5-di-(benzoylperoxy)hexane
2618-77-1
49 C.F.R. § 173.225
2,5-Dimethyl-2,5-di-(tert-butylperoxy)hexane
78-63-7
49 C.F.R. § 173.225
2,5-Dimethyl-2,5-di-(tert-butylperoxy)hexyne-3
1068-27-5
49 C.F.R. § 173.225
2,5-dimethyl-2,5-dihydroperoxy hexane
DOT Forbidden
2,5-Dimethyl-2,5-dihydroperoxyhexane
3025-88-5
49 C.F.R. § 173.225
2-acetylaminofluorene
53-96-3
OSHA Listed Chemicals
2-Acetylaminofluorine
Select Carcinogen
2-Cyclohexyl-4,6-dinitrophenol
131-89-5
EPA Acutely Toxic (P Listed)
2-Diazo-1-Naphthol-4-sulphochloride
49 C.F.R. § 173.224
2-Diazo-1-Naphthol-5-sulphochloride
49 C.F.R. § 173.224
2-Methyllactonitrile
75-86-5
EPA Acutely Toxic (P Listed)
2-Propanone, 1-bromo-
598-31-2
EPA Acutely Toxic (P Listed)
2-Propen-1-ol
107-18-6
EPA Acutely Toxic (P Listed)
2-Propenal
107-02-8
EPA Acutely Toxic (P Listed)
3(2H)-Isoxazolone, 5-(aminomethyl)-
2763-96-4
EPA Acutely Toxic (P Listed)
3-(2-Hydroxyethoxy)-4-(pyrrolidin-1-yl)benzenediazonium zinc chloride
15005-97-7
49 C.F.R. § 173.224
3,3,6,6,9,9-Hexamethyl-1,2,4,5-tetraoxacyclononane
22397-33-7
49 C.F.R. § 173.225
3,3-dichlorobenzidine
91-94-1
OSHA Listed Chemicals
3-3'-Dichlorobenzidine
91-94-1
Select Carcinogen
3-Azido-1, 2-Propylene glycol dinitrate
DOT Forbidden
3-Chloro-4-diethylaminobenzenediazonium zinc chloride
49 C.F.R. § 173.224
3-Chloroperoxybenzoic acid
937-14-4
49 C.F.R. § 173.225
3-Chloropropionitrile
542-76-7
EPA Acutely Toxic (P Listed)
3-Isopropylphenyl N-methylcarbamate
64-00-6
EPA Acutely Toxic (P Listed)
3-Methyl-4-(pyrrolidin-1-yl)benzenediazonium tetrafluoroborate
36422-95-4
49 C.F.R. § 173.224
3-tert-Butylperoxy-3-phenylphthalide
25251-51-8
49 C.F.R. § 173.225
4-(Benzyl(ethyl)amino)-3-ethoxybenzenediazonium zinc chloride
49 C.F.R. § 173.224
4-(Benzyl(methyl)amino)-3-ethoxybenzenediazonium zinc chloride
49 C.F.R. § 173.224
4,4'-Methylenebis (2-Chloroaniline)
95-51-2
Select Carcinogen
4,6-Dinitro-o-cresol, & salts
534-52-1
EPA Acutely Toxic (P Listed)
4-Aminobiphenyl
92-67-1
Select Carcinogen
4-Aminopyridine
504-24-5
EPA Acutely Toxic (P Listed)
4-bromo-1, 2-dinitrobenzene
DOT Forbidden
4-Dimethylamino-6-(2-dimethylaminoethoxy)toluene-2-diazonium zinc chloride
49 C.F.R. § 173.224
4-Dimethylaminoazobenzene
60-11-7
Select Carcinogen
4-Dipropylaminobenzenediazonium zinc chloride
49 C.F.R. § 173.224
4-Methylbenzenesulphonylhydrazide
49 C.F.R. § 173.224
4-Nitrobiphenyl
92-93-3
Select Carcinogen
4-Nitrosophenol
104-91-6
49 C.F.R. § 173.224
4-Pyridinamine
EPA Acutely Toxic (P Listed)
5-(Aminomethyl)-3-isoxazolol
2763-96-4
EPA Acutely Toxic (P Listed)
5-Azido-1-hydroxy tetrazole
DOT Forbidden
5-Mercaptotetrazol-1-acetic acid
57658-36-3
DOT Explosive
5-nitrobenzotriazol
169796-98-9
DOT Explosive
7-Benzofuranol, 2,3-dihydro-2,2-dimethyl-, methylcarbamate
1563-66-2
EPA Acutely Toxic (P Listed)
7-Oxabicyclo[2.2.1]heptane-2,3-dicarboxylic acid
145-73-3
EPA Acutely Toxic (P Listed)
A-alpha-C [2-amino-9H-pyrido[2,3-b]indole]
IARC List of Known and Suspected Human Carcinogens
Acetal
105-57-7
Peroxidizable
Acetaldehyde
75-07-0
Reproductive Toxin
Acetaldehyde, chloro-
107-20-0
EPA Acutely Toxic (P Listed)
Acetamide, 2-fluoro-
640-19-7
EPA Acutely Toxic (P Listed)
Acetamide, N-(aminothioxomethyl)-
591-08-2
EPA Acutely Toxic (P Listed)
Acetic acid, fluoro-, sodium salt
62-74-8
EPA Acutely Toxic (P Listed)
Acetyl acetone peroxide
37187-22-7
49 C.F.R. § 173.225
Acetyl benzoyl peroxide
644-31-5
49 C.F.R. § 173.225
Acetyl cyclohexanesulfonyl peroxide
3179-56-4
49 C.F.R. § 173.225
acetyl peroxide
110-22-5
DOT Forbidden
acetylaminofluorene, 2-
IARC List of Known and Suspected Human Carcinogens
acetylene silver nitrate
7761-88-8
DOT Forbidden
Acrolein
107-02-8
EPA Acutely Toxic (P Listed)
Acrylamide
79-06-1
Select Carcinogen
Acrylonitrile
107-13-1
Select Carcinogen
actinomycin D
IARC List of Known and Suspected Human Carcinogens
adriamycin [doxorubicin]
IARC List of Known and Suspected Human Carcinogens
AF-2 [2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide]
IARC List of Known and Suspected Human Carcinogens
Aflatoxin
1402-68-2
Select Carcinogen
Aflatoxin B1
1162-65-8
Select Carcinogen
Aflatoxin B2
7220-81-7
Select Carcinogen
Aflatoxin G1
1165-39-5
Select Carcinogen
Aflatoxin G2
7241-98-7
Select Carcinogen
Aflatoxin M1
6795-23-9
Select Carcinogen
agaritine
IARC List of Known and Suspected Human Carcinogens
Aldicarb
116-06-3
EPA Acutely Toxic (P Listed)
Aldicarb sulfone.
1646-88-4
EPA Acutely Toxic (P Listed)
Aldrin
309-00-2
EPA Acutely Toxic (P Listed)
Allyl alcohol
107-18-6
EPA Acutely Toxic (P Listed)
Allyl isothiocyanate
IARC List of Known and Suspected Human Carcinogens
Allyl isovalerate
IARC List of Known and Suspected Human Carcinogens
alpha,alpha-Dimethylphenethylamine
122-09-8
EPA Acutely Toxic (P Listed)
Alpha-Naphthylamine
134-32-7
Select Carcinogen
Alpha-Naphthylthiourea
86-88-4
EPA Acutely Toxic (P Listed)
Aluminum phosphide (R,T)
20859-73-8
EPA Acutely Toxic (P Listed)
amino-2-methylanthraquinone, 1-
IARC List of Known and Suspected Human Carcinogens
amino-5-(5-nitro-2-furyl)-1,3,4-thiadiazole
IARC List of Known and Suspected Human Carcinogens
amino-5-nitrothiazole, 2-
IARC List of Known and Suspected Human Carcinogens
aminoanthraquinone, 2-
IARC List of Known and Suspected Human Carcinogens
aminoazobenzene, p-
IARC List of Known and Suspected Human Carcinogens
aminoazotoluene, o- [solvent yellow 3]
IARC List of Known and Suspected Human Carcinogens
aminobipheny, 4-
IARC List of Known and Suspected Human Carcinogens
amitrole
IARC List of Known and Suspected Human Carcinogens
Ammonium azide
DOT Forbidden
Ammonium bromate
DOT Forbidden
Ammonium chlorate
10192-29-7
DOT Forbidden
Ammonium fulminate
DOT Forbidden
Ammonium nitrate
6484-52-2
DOT Explosive
Ammonium nitrite
DOT Forbidden
Ammonium perchlorate
7790-98-9
DOT Explosive
Ammonium permanganate
DOT Forbidden
Ammonium picrate (R)
131-74-8
EPA Acutely Toxic (P Listed)
Ammonium vanadate
7803-55-6
EPA Acutely Toxic (P Listed)
androgenic (anabolic) steroids
IARC List of Known and Suspected Human Carcinogens
aniline
IARC List of Known and Suspected Human Carcinogens
anisidine hydrochloride, o-
IARC List of Known and Suspected Human Carcinogens
anisidine, o-
IARC List of Known and Suspected Human Carcinogens
anlagesic mixtures containing phenacetin
IARC List of Known and Suspected Human Carcinogens
anthanthrene
IARC List of Known and Suspected Human Carcinogens
antimony sulfide
1345-04-6
DOT Forbidden
aramite
IARC List of Known and Suspected Human Carcinogens
Argentate(1-), bis(cyano-C)-, potassium
506-61-6
EPA Acutely Toxic (P Listed)
Arsenic
7440-38-2
Reproductive Toxin, Select Carcinogen
Arsenic acid H3 AsO4
7778-39-4
EPA Acutely Toxic (P Listed)
Arsenic oxide As2 O3
1327-53-3
EPA Acutely Toxic (P Listed)
Arsenic oxide As2 O5
1303-28-2
EPA Acutely Toxic (P Listed)
Arsenic pentoxide
1303-28-2
EPA Acutely Toxic (P Listed)
Arsenic sulfide
56320-22-0
DOT Forbidden
Arsenic trioxide
1327-53-3
EPA Acutely Toxic (P Listed)
Arsine
7784-42-1
Acutely Toxic
Arsine, diethyl-
692-42-2
EPA Acutely Toxic (P Listed)
Arsonous dichloride, phenyl-
696-28-6
EPA Acutely Toxic (P Listed)
Asbestos
1332-21-4
Select Carcinogen
ascaridole
DOT Forbidden
auramine
IARC List of Known and Suspected Human Carcinogens
azacitidine
IARC List of Known and Suspected Human Carcinogens
azaserine
IARC List of Known and Suspected Human Carcinogens
Azathioprine
Select Carcinogen
azaurolic acid
DOT Forbidden
azido guanidine picrate
DOT Forbidden
azidodithiocarbonic acid
DOT Forbidden
azidoethyl nitrate
DOT Forbidden
Aziridine
151-56-4
EPA Acutely Toxic (P Listed)
Aziridine, 2-methyl-
75-55-8
EPA Acutely Toxic (P Listed)
Azodi(hexahydrobenzonitrile)
2094-98-6
49 C.F.R. § 173.224
Azodicarbonamide formulation
123-77-3
49 C.F.R. § 173.224
Barium azide
18810-58-7
DOT Explosive
Barium Chromate
10294-40-3
Select Carcinogen
Barium cyanide
542-62-1
EPA Acutely Toxic (P Listed)
barium styphnate
20236-55-9
DOT Explosive
benz[a]anthracene
IARC List of Known and Suspected Human Carcinogens
benz[c]acridine
IARC List of Known and Suspected Human Carcinogens
Benzenamine, 4-chloro-
106-47-8
EPA Acutely Toxic (P Listed)
Benzenamine, 4-nitro-
100-01-6
EPA Acutely Toxic (P Listed)
Benzene
71-43-2
Reproductive Toxin, Select Carcinogen
Benzene diazonim chloride
DOT Forbidden
Benzene sulphohydrazide
80-17-1
49 C.F.R. § 173.224
Benzene triozonide
DOT Forbidden
Benzene, (chloromethyl)-
100-44-7
EPA Acutely Toxic (P Listed)
Benzene-1,3-disulphohydrazide
49 C.F.R. § 173.224
Benzeneethanamine, alpha,alpha-dimethyl-
122-09-8
EPA Acutely Toxic (P Listed)
Benzenethiol
108-98-5
EPA Acutely Toxic (P Listed)
Benzidine
92-87-5
Select Carcinogen
benzo[a]pyrene
IARC List of Known and Suspected Human Carcinogens
benzo[b]fluoranthene
IARC List of Known and Suspected Human Carcinogens
benzo[j]fluoranthene
IARC List of Known and Suspected Human Carcinogens
benzo[k]fluoroanthene
IARC List of Known and Suspected Human Carcinogens
benzotrichloride
IARC List of Known and Suspected Human Carcinogens
Benzoyl (3-methylbenzoyl) peroxide
214425-85-1
49 C.F.R. § 173.225
Benzoyl azide
DOT Forbidden
Benzyl chloride
100-44-7
EPA Acutely Toxic (P Listed)
Benzyl violet 4B
IARC List of Known and Suspected Human Carcinogens
beryllium & beryllium compounds (e.g. oxide or sulfate)
IARC List of Known and Suspected Human Carcinogens
Beryllium powder
7440-41-7
EPA Acutely Toxic (P Listed)
Beta-naphthylamine
91-59-8
OSHA Listed Chemicals
Beta-Propiolactone
57-57-8
Select Carcinogen
bieomycins
IARC List of Known and Suspected Human Carcinogens
biphenyl triozonide
DOT Forbidden
bis(chloroethyl) nitrosourea [BCNU]
IARC List of Known and Suspected Human Carcinogens
bis(chloromethyl)ether [BCME]
IARC List of Known and Suspected Human Carcinogens
bitumens, extracts of steam and air refined
IARC List of Known and Suspected Human Carcinogens
bromine azide
13973-87-0
DOT Forbidden
Bromoacetone
598-31-2
EPA Acutely Toxic (P Listed)
bromosilane
DOT Forbidden
Brucine
357-57-3
EPA Acutely Toxic (P Listed)
Butadiene
106-99-0
Peroxidizable
butadiene, 1,3-
IARC List of Known and Suspected Human Carcinogens
butylated hydroxyanisole [BHA]
IARC List of Known and Suspected Human Carcinogens
butyrolactone, beta-
IARC List of Known and Suspected Human Carcinogens
C.I. basic red 9 monohydrochloride
IARC List of Known and Suspected Human Carcinogens
Cadmium and cadmium compounds
Reproductive Toxin
Calcium cyanide
592-01-8
EPA Acutely Toxic (P Listed)
captan
133-06-2
IARC List of Known and Suspected Human Carcinogens
Carbamic acid, [(dibutylamino)- thio]methyl-, 2,3-dihydro-2,2-dimethyl- 7-benzofuranyl ester
55285-14-8
EPA Acutely Toxic (P Listed)
Carbamic acid, dimethyl-, 1-[(dimethyl-amino)carbonyl]- 5-methyl-1H- pyrazol-3-yl ester
644-64-4
EPA Acutely Toxic (P Listed)
Carbamic acid, dimethyl-, 3-methyl-1- (1-methylethyl)-1H- pyrazol-5-yl ester
119-38-0
EPA Acutely Toxic (P Listed)
Carbamic acid, methyl-, 3-methylphenyl ester
1129-41-5
EPA Acutely Toxic (P Listed)
carbazole
86-74-8
IARC List of Known and Suspected Human Carcinogens
Carbofuran
1563-66-2
EPA Acutely Toxic (P Listed)
Carbon Disulfide
75-15-0
Reproductive Toxin
Carbon tetrachloride
56-23-5
IARC List of Known and Suspected Human Carcinogens
Carbonic dichloride
75-15-0
EPA Acutely Toxic (P Listed)
Carbosulfan
55285-14-8
EPA Acutely Toxic (P Listed)
carrageenan
9000-07-1
IARC List of Known and Suspected Human Carcinogens
Chloramabucil
Select Carcinogen
chloramphenicol
56-75-7
IARC List of Known and Suspected Human Carcinogens
chlorbenzilat
510-15-6
IARC List of Known and Suspected Human Carcinogens
chlordane
57-74-9
IARC List of Known and Suspected Human Carcinogens
chlordecone [kepone]
143-50-0
IARC List of Known and Suspected Human Carcinogens
chlorendic acid
115-28-6
IARC List of Known and Suspected Human Carcinogens
chlorinated, alpha- toluenes
(benzal chloride [98-87-3], benzotrichloride [98-07-7], benzyl chloride [100-44-7]) and benzoyl chloride [98-88-4]
IARC List of Known and Suspected Human Carcinogens
Chlorine azide
DOT Forbidden
Chlorine dioxide
10049-04-4
DOT Forbidden
Chlorine Gas
7782-50-5
Acutely Toxic
chlormadinone acetate
302-22-7
IARC List of Known and Suspected Human Carcinogens
Chlornaphazine
Select Carcinogen
chlornaphazine [n,n-bis(2-chloroethyl)-2-naphthylamine]
494-03-1
IARC List of Known and Suspected Human Carcinogens
Chloroacetaldehyde
107-20-0
EPA Acutely Toxic (P Listed)
chloroacetone
78-95-5
DOT Forbidden
chloroethyl)-3-cyclohexyl-1-nitrosourea, 1-(2- [CCNU]
IARC List of Known and Suspected Human Carcinogens
chloroform
67-66-3
IARC List of Known and Suspected Human Carcinogens
Chloromethyl ethyl ether
3188-13-4
IARC List of Known and Suspected Human Carcinogens
Chloromethyl Methyl Ether
Select Carcinogen
chloro-o-phenylenediamine, 4-
95-83-0
IARC List of Known and Suspected Human Carcinogens
chloro-o-toluidine, p-
95-69-2
IARC List of Known and Suspected Human Carcinogens
chloro-o-toluidine, p- and its HCl salt
IARC List of Known and Suspected Human Carcinogens
chlorophenols
IARC List of Known and Suspected Human Carcinogens
chlorophenoxy herbicides
IARC List of Known and Suspected Human Carcinogens
Chloroprene
126-99-8
Peroxidizable
chloroprene
126-99-8
DOT Forbidden
chlorothalonil
1897-45-6
IARC List of Known and Suspected Human Carcinogens
chlorozotocin
54749-90-5
IARC List of Known and Suspected Human Carcinogens
cholesterol
57-88-5
IARC List of Known and Suspected Human Carcinogens
Chromium and chromium compounds
7440-47-3
Select Carcinogen
chrysene
218-01-9
IARC List of Known and Suspected Human Carcinogens
cinnamyl anthranilate
87-29-6
IARC List of Known and Suspected Human Carcinogens
cisplatin [trade name=platinol]
15663-27-1
IARC List of Known and Suspected Human Carcinogens
citrus red no. 2
6358-53-8
IARC List of Known and Suspected Human Carcinogens
clofibrate
637-07-0
IARC List of Known and Suspected Human Carcinogens
coal tar pitch volatiles
IARC List of Known and Suspected Human Carcinogens
Copper acetylide
DOT Forbidden
Copper amine azide
DOT Forbidden
Copper cyanide
544-92-3
EPA Acutely Toxic (P Listed)
Copper tetramine nitrate
DOT Forbidden
creosotes
IARC List of Known and Suspected Human Carcinogens
cresidine, p-
120-71-8
IARC List of Known and Suspected Human Carcinogens
Cumene
98-82-8
Peroxidizable
Cumyl hydroperoxide
80-15-9
49 C.F.R. § 173.225
Cumyl peroxyneodecanoate
26748-47-0
49 C.F.R. § 173.225
Cumyl peroxypivalate
23383-59-7
49 C.F.R. § 173.225
cupferron
135-20-6
IARC List of Known and Suspected Human Carcinogens
Cyanides (soluble cyanide salts), not otherwise specified
EPA Acutely Toxic (P Listed)
Cyanogen
460-19-5
EPA Acutely Toxic (P Listed)
Cyanogen chloride
506-77-4
EPA Acutely Toxic (P Listed)
cyanuric triazide
DOT Forbidden
cycasin [methylazoxmethanol]
14901-08-7
IARC List of Known and Suspected Human Carcinogens
cyclamates
139-05-9
IARC List of Known and Suspected Human Carcinogens
Cyclohexanone peroxide(s) [as a paste]
78-18-2
49 C.F.R. § 173.225
Cyclohexanone peroxide(s) [as a solution]
12262-58-7
49 C.F.R. § 173.225
Cyclohexene
110-83-8
Peroxidizable
cyclopenta[cd]pyrene
27208-37-3
IARC List of Known and Suspected Human Carcinogens
Cyclopentene
142-29-0
Peroxidizable
Cyclophosphamide
50-18-0
Select Carcinogen
cyclosporin
79217-60-0
IARC List of Known and Suspected Human Carcinogens
cyclotetramethylene tetranitramine
DOT Forbidden
cyclotetramethylenetetranitramine
2691-41-0
DOT Explosive
D, 2,4- (salts and esters) e.g. phenolyacetic acid
94-75-7
IARC List of Known and Suspected Human Carcinogens
dacarbazine [trade name=DIC or DTIC]
4342-03-4
IARC List of Known and Suspected Human Carcinogens
danthron
117-10-2
IARC List of Known and Suspected Human Carcinogens
dapsone
80-08-0
IARC List of Known and Suspected Human Carcinogens
daunomycin [daunorubicin]
20830-81-3
IARC List of Known and Suspected Human Carcinogens
DDT
50-29-3
IARC List of Known and Suspected Human Carcinogens
decabromodiphenyl oxide
1163-19-5
IARC List of Known and Suspected Human Carcinogens
Decalin
91-17-8
Peroxidizable
Di-(1-hydroxycyclohexyl)peroxide
2407-94-5
49 C.F.R. § 173.225
Di-(1-hydroxytetrazole)
DOT Forbidden
Di-(2-ethoxyethyl)peroxydicarbonate
52373-74-7
49 C.F.R. § 173.225
Di-(2-ethylhexyl)peroxydicarbonate
16111-62-9
49 C.F.R. § 173.225
Di-(2-ethylhexyl)peroydicarbonate
49 C.F.R. § 173.225
Di(2-ethylhexyl)phthalate
117-81-7
IARC List of Known and Suspected Human Carcinogens
Di-(2-methylbenzoyl)peroxide
3034-79-5
49 C.F.R. § 173.225
Di-(2-neodecanoylperoxyisopropyl)benzene
49 C.F.R. § 173.225
Di-(2-phenoxyethyl)peroxydicarbonate
41935-39-1
49 C.F.R. § 173.225
Di-(2-tert-butylperoxyisopropyl)benzene
279671-18-0
49 C.F.R. § 173.225
Di-(3,5,5-trimethyl-1,2-dioxolanyl- 3)peroxide
49 C.F.R. § 173.225
Di-(3,5,5-trimethylhexanoyl)peroxide
49 C.F.R. § 173.225
Di-(3-methoxybutyl)peroxydicarbonate
52238-68-3
49 C.F.R. § 173.225
Di-(3-methylbenzoyl)peroxide
96436-26-9
49 C.F.R. § 173.225
Di-(4-methylbenzoyl)peroxide
895-85-2
49 C.F.R. § 173.225
Di-(4-tert-butylcyclohexyl)peroxydicarbonate
15520-11-3
49 C.F.R. § 173.225
Di-(beta-nitroxyethyl) ammonium nitrate
DOT Forbidden
Di-(tert-butylperoxy) phthalate
DOT Forbidden
Di-(tert-butylperoxy)phthalate
2155-71-7
49 C.F.R. § 173.225
Di-2,4-dichlorobenzoyl peroxide
133-14-2
49 C.F.R. § 173.225
Di-2,4-dichlorobenzoyl peroxide
DOT Forbidden
Di-4-chlorobenzoyl peroxide
94-17-7
49 C.F.R. § 173.225
Diacetone alcohol peroxides
54693-46-8
49 C.F.R. § 173.225
Diacetyl peroxide
110-22-5
49 C.F.R. § 173.225
diacetylbenzidine, n,n'-
613-35-4
IARC List of Known and Suspected Human Carcinogens
Diacetylene
446-86-6
Peroxidizable
diallate
2303-16-4
IARC List of Known and Suspected Human Carcinogens
diaminoanisole sulfate, 2,4-
IARC List of Known and Suspected Human Carcinogens
diaminoanisole, 2,4-
615-05-4
IARC List of Known and Suspected Human Carcinogens
diaminodiphenyl ether, 4,4'-
101-80-4
IARC List of Known and Suspected Human Carcinogens
diaminotoluene, 2,4-
95-80-7
IARC List of Known and Suspected Human Carcinogens
diazoaminotetrazole
DOT Forbidden
Diazomethane
334-88-3
Acutely Toxic
diazonium nitrates
DOT Forbidden
diazonium perchlorates
DOT Forbidden
dibenz[a,c]anthracene
215-58-7
IARC List of Known and Suspected Human Carcinogens
dibenz[a,h]acridine
226-36-8
IARC List of Known and Suspected Human Carcinogens
dibenz[a,h]anthracene
53-70-3
IARC List of Known and Suspected Human Carcinogens
dibenz[a,j]acridine
224-42-0
IARC List of Known and Suspected Human Carcinogens
dibenz[a,j]anthracene
224-41-9
IARC List of Known and Suspected Human Carcinogens
dibenzo[a,e]fluoranthene
5385-75-1
IARC List of Known and Suspected Human Carcinogens
dibenzo[a,e]pyrene
192-65-4
IARC List of Known and Suspected Human Carcinogens
dibenzo[a,h]pyrene
189-64-0
IARC List of Known and Suspected Human Carcinogens
dibenzo[a,i]pyrene
189-55-9
IARC List of Known and Suspected Human Carcinogens
dibenzo[a,l]pyrene
191-30-0
IARC List of Known and Suspected Human Carcinogens
dibenzo[c,g]carbazole, 7H-
194-59-2
IARC List of Known and Suspected Human Carcinogens
Dibenzoyl peroxide
94-36-0
49 C.F.R. § 173.225
Dibenzyl peroxydicarbonate
2144-45-8
49 C.F.R. § 173.225
dibenzyl peroxydicarbonate
DOT Forbidden
Diborane
19287-45-7
Acutely Toxic
dibromo-3-chloropropane, 1,2- [DBCP]
96-12-8
IARC List of Known and Suspected Human Carcinogens
dibromoacetylene
624-61-3
DOT Forbidden
dibromomethane, 1,2- [DBM]
IARC List of Known and Suspected Human Carcinogens
Dicetyl peroxydicarbonate
26322-14-5
49 C.F.R. § 173.225
dichloro-4,4'-diaminodiphenyl ether, 3,3'-
28434-86-8
IARC List of Known and Suspected Human Carcinogens
dichloroacetylene
7572-29-4
DOT Forbidden
dichlorobenzene, 1,4-
106-46-7
IARC List of Known and Suspected Human Carcinogens
dichlorobenzidine, 3,3'-
91-94-1
IARC List of Known and Suspected Human Carcinogens
dichloroethane, 1,2- [EDC] [ethylene dichloride]
107-06-2
IARC List of Known and Suspected Human Carcinogens
dichloroethyl sulfide
DOT Forbidden
dichloromethane
75-09-2
IARC List of Known and Suspected Human Carcinogens
Dichloromethyl ether
542-88-1
EPA Acutely Toxic (P Listed)
Dichlorophenylarsine
696-28-6
EPA Acutely Toxic (P Listed)
dichloropropane, 1,2- [propylene dichloride]
78-87-5
IARC List of Known and Suspected Human Carcinogens
dichloropropene, 1,3-
542-75-6
IARC List of Known and Suspected Human Carcinogens
dichlorovinylchloroarsine
DOT Forbidden
dicofol
115-32-2
IARC List of Known and Suspected Human Carcinogens
Dicumyl peroxide
80-43-3
49 C.F.R. § 173.225
Dicyclohexyl peroxydicarbonate
1561-49-5
49 C.F.R. § 173.225
Dicyclopentadiene
77-73-6
Peroxidizable
Didecanoyl peroxide
762-12-9
49 C.F.R. § 173.225
Dieldrin
60-57-1
IARC List of Known and Suspected Human Carcinogens
Dieldrin
60-57-1
EPA Acutely Toxic (P Listed)
dienoestrol
84-17-3
IARC List of Known and Suspected Human Carcinogens
diepoxybutane
1464-53-5
IARC List of Known and Suspected Human Carcinogens
diethanol nitrosamine dinitrate
DOT Forbidden
Diethyl Ether
60-29-7
Peroxidizable
Diethyl peroxydicarbonate
14666-78-5
49 C.F.R. § 173.225
Diethyl sulfate
64-67-5
IARC List of Known and Suspected Human Carcinogens
Diethylarsine
692-42-2
EPA Acutely Toxic (P Listed)
Diethylene glycol bis(allyl carbonate) + Diisopropylperoxydicarbonate
49 C.F.R. § 173.224
Diethylene Glycol Dimethyl Ether
11-96-6
Peroxidizable
diethylene glycol dinitrate
693-21-0
DOT Forbidden
diethyleneglycol dinitrate
628-96-6
DOT Explosive
diethylgold bromide
DOT Forbidden
diethylhydrazine, 1,2- OR n,n'-diethylhydrazine
1615-80-1
IARC List of Known and Suspected Human Carcinogens
Diethylnitrosamine
Select Carcinogen
Diethyl-p-nitrophenyl phosphate
311-45-5
EPA Acutely Toxic (P Listed)
Diethylstilbestrol
56-53-1
Select Carcinogen
diglycidyl resorcinol ether
101-90-6
IARC List of Known and Suspected Human Carcinogens
dihydrosafrole
94-58-6
IARC List of Known and Suspected Human Carcinogens
diiodoacetylene
DOT Forbidden
Diisobutyryl peroxide
3437-84-1
49 C.F.R. § 173.225
Diisopropyl peroxydicarbonate
105-64-6
49 C.F.R. § 173.225
Diisopropylbenzene dihydroperoxide
29014-32-2
49 C.F.R. § 173.225
diisopropylbenzene hydroperoxide
DOT Forbidden
Diisopropylfluorophosphate (DFP)
55-91-4
EPA Acutely Toxic (P Listed)
Diisotridecyl peroxydicarbonate
49 C.F.R. § 173.225
Dilauroyl peroxide
105-74-8
49 C.F.R. § 173.225
Dimethoate
60-51-5
EPA Acutely Toxic (P Listed)
dimethoxybenzidine, 3,3'- [o-dianisidine]
119-90-4
IARC List of Known and Suspected Human Carcinogens
Dimethyl Sulfate
77-78-1
Select Carcinogen
dimethylamino)methylimino]-5-[2-nitro-2-furyl)vinyl]-
IARC List of Known and Suspected Human Carcinogens
dimethylaminoazobenzene (also 4 or para-)
60-11-7
IARC List of Known and Suspected Human Carcinogens
dimethylbenzidine, 3,3'- [o-toludine]
119-93-7
IARC List of Known and Suspected Human Carcinogens
dimethylcarbamoyl chloride
79-44-7
IARC List of Known and Suspected Human Carcinogens
dimethylhexane dihydroperoxide
DOT Forbidden
dimethylhydrazine, 1,1-
57-14-7
IARC List of Known and Suspected Human Carcinogens
dimethylhydrazine, 1,2-
540-73-8
IARC List of Known and Suspected Human Carcinogens
Dimethylmercury *
593-74-8
Acutely Toxic
dimethylvinyl chloride
513-37-1
IARC List of Known and Suspected Human Carcinogens
Dimetilan
644-64-4
EPA Acutely Toxic (P Listed)
Dimyristyl peroxydicarbonate
53220-22-7
49 C.F.R. § 173.225
Di-n-butyl peroxydicarbonate
16215-49-9
49 C.F.R. § 173.225
Di-n-butyl peroxydicarbonate
DOT Forbidden
dinitroglycoluril
55510-04-8
DOT Explosive
dinitrophenol
51-28-5
DOT Explosive
dinitropropylene glycol
DOT Forbidden
dinitropyrene, 1,6-
42397-64-8
IARC List of Known and Suspected Human Carcinogens
dinitropyrene, 1,8-
42397-65-9
IARC List of Known and Suspected Human Carcinogens
dinitroresorcinol
519-44-8
DOT Explosive
dinitrosobenzene
25550-55-4
DOT Explosive
Di-n-nonanoyl peroxide
762-13-0
49 C.F.R. § 173.225
Di-n-octanoyl peroxide
762-16-3
49 C.F.R. § 173.225
Dinoseb
88-85-7
EPA Acutely Toxic (P Listed)
Di-n-propyl peroxydicarbonate
16066-38-9
49 C.F.R. § 173.225
Dioxane
123-91-1
Peroxidizable
dioxane, 1,4-
123-91-1
IARC List of Known and Suspected Human Carcinogens
Diperoxy azelaic acid
1941-79-3
49 C.F.R. § 173.225
Diperoxy dodecane diacid
66280-55-5
49 C.F.R. § 173.225
Diphenyloxide-4,4'-disulphohydrazide
80-51-3
49 C.F.R. § 173.224
Diphosphoramide, octamethyl-
152-16-9
EPA Acutely Toxic (P Listed)
Diphosphoric acid, tetraethyl ester
107-49-3
EPA Acutely Toxic (P Listed)
dipicryl sulfide
2217-06-3
DOT Explosive
Dipropionyl peroxide
3248-28-0
49 C.F.R. § 173.225
dipropionyl peroxide
DOT Forbidden
direct black 38
1937-37-7
IARC List of Known and Suspected Human Carcinogens
direct blue 6
2602-46-2
IARC List of Known and Suspected Human Carcinogens
direct brown 95
16071-86-6
IARC List of Known and Suspected Human Carcinogens
Di-sec-butyl peroxydicarbonate
19910-65-7
49 C.F.R. § 173.225
disperse blue 1
2475-45-8
IARC List of Known and Suspected Human Carcinogens
Distearyl peroxydicarbonate
52326-66-6
49 C.F.R. § 173.225
Disuccinic acid peroxide
123-23-9
49 C.F.R. § 173.225
Disulfoton
298-04-4
EPA Acutely Toxic (P Listed)
Di-tert-amyl peroxide
10508-09-5
49 C.F.R. § 173.225
Di-tert-butyl peroxide
110-05-4
49 C.F.R. § 173.225
Di-tert-butyl peroxyazelate
16580-06-6
49 C.F.R. § 173.225
Dithiobiuret
541-53-7
EPA Acutely Toxic (P Listed)
Divinyl Ether
109-86-4
Peroxidizable
Endosulfan
115-29-7
EPA Acutely Toxic (P Listed)
Endothall
145-73-3
EPA Acutely Toxic (P Listed)
Endrin
72-20-8
EPA Acutely Toxic (P Listed)
Endrin, & metabolites
72-20-8
EPA Acutely Toxic (P Listed)
epichlorohydrin
106-89-8
IARC List of Known and Suspected Human Carcinogens
erionite
66733-21-9
IARC List of Known and Suspected Human Carcinogens
estradiol 17b
50-28-2
IARC List of Known and Suspected Human Carcinogens
estrone
53-16-7
IARC List of Known and Suspected Human Carcinogens
Ethanedinitrile
460-19-5
EPA Acutely Toxic (P Listed)
Ethanimidothioc acid, 2-(dimethylamino)-N-[[(methylamino) carbonyl]oxy]-2-oxo-, methyl ester
23135-22-0
EPA Acutely Toxic (P Listed)
Ethanimidothioic acid
16752-77-5
EPA Acutely Toxic (P Listed)
ethanol amine dinitrate
DOT Forbidden
ethidium bromide
1239-45-8
Potent mutagen
ethinyloestradiol
57-63-6
IARC List of Known and Suspected Human Carcinogens
ethion
563-12-2
IARC List of Known and Suspected Human Carcinogens
Ethyl 3,3-di-(tert-amylperoxy)butyrate
67567-23-1
49 C.F.R. § 173.225
Ethyl 3,3-di-(tert-butylperoxy)butyrate
55794-20-2
49 C.F.R. § 173.225
Ethyl acrylate
140-88-5
IARC List of Known and Suspected Human Carcinogens
Ethyl cyanide
107-12-0
EPA Acutely Toxic (P Listed)
Ethyl hydroperoxide
DOT Forbidden
Ethyl methanesulfonate
62-50-0
IARC List of Known and Suspected Human Carcinogens
Ethyl perchlorate
DOT Forbidden
Ethylencimine
OSHA Listed Chemicals
Ethylene diamine diperchlorate
DOT Forbidden
Ethylene Dibromide
106-93-4
Select Carcinogen
Ethylene dichloride [1,2-dichloroethane]
107-06-2
IARC List of Known and Suspected Human Carcinogens
Ethylene Glycol Dimethyl Ether
110-71-4
Peroxidizable
Ethylene Glycol Monoethyl Ether
110-80-5
Peroxidizable, Reproductive Toxin
Ethylene Glycol Monomethyl Ether
109-86-4
Peroxidizable, Reproductive Toxin
Ethylene Oxide
75-21-8
Reproductive Toxin, Select Carcinogen
Ethylene thiourea
96-45-7
IARC List of Known and Suspected Human Carcinogens
Ethylenimine
151-56-4
Select Carcinogen
ethyl-n-nitrosourea, n-
759-73-9
IARC List of Known and Suspected Human Carcinogens
ethynodiol diacetate
297-76-7
IARC List of Known and Suspected Human Carcinogens
eugenol [oil of cloves]
97-53-0
IARC List of Known and Suspected Human Carcinogens
Famphur
52-85-7
EPA Acutely Toxic (P Listed)
Fluorine
7782-41-4
EPA Acutely Toxic (P Listed)
Fluoroacetamide
640-19-7
EPA Acutely Toxic (P Listed)
Fluoroacetic acid, sodium salt
62-74-8
EPA Acutely Toxic (P Listed)
fluorouracil
51-21-8
IARC List of Known and Suspected Human Carcinogens
Formaldehyde (Any solution or product with greater than .1%)
50-00-0
Select Carcinogen
Formetanate hydrochloride
23422-53-9
EPA Acutely Toxic (P Listed)
Formparanate
17702-57-7
EPA Acutely Toxic (P Listed)
formylhydrazino)-4-(nitro-2-furyl)thiazole, 2-(2-
3570-75-0
IARC List of Known and Suspected Human Carcinogens
Fulminic acid, mercury(2+) salt (R,T)
628-86-4
EPA Acutely Toxic (P Listed)
Furan
110-00-9
Peroxidizable
furfaltadone
IARC List of Known and Suspected Human Carcinogens
glu-p-1(2-amino-6methyldipyrido[1,2-a:3',2'-d]imidazole
67730-11-4
IARC List of Known and Suspected Human Carcinogens
glu-p-2(2-aminodipyrido[1,2-a:3',2'-d]imidazole
67730-10-3
IARC List of Known and Suspected Human Carcinogens
glycerol gluconate trinitrate
DOT Forbidden
glycerol-1, 3-dinitrate
DOT Forbidden
glycidaldehyde
765-34-4
IARC List of Known and Suspected Human Carcinogens
griseofulvin
126-07-8
IARC List of Known and Suspected Human Carcinogens
guanyl nitrosaminoguanylidene hydrazine
DOT Explosive
guanyl nitrosaminoguanylidene hydrazine
DOT Forbidden
gyromitrin [acetaldeyde formylmethylhydrazone]
16568-02-8
IARC List of Known and Suspected Human Carcinogens
Heptachlor
76-44-8
EPA Acutely Toxic (P Listed)
hexachlorobutadiene
87-68-3
IARC List of Known and Suspected Human Carcinogens
hexachlorocyclohexane isomers [e.g. lindane]
IARC List of Known and Suspected Human Carcinogens
Hexaethyl tetraphosphate
757-58-4
EPA Acutely Toxic (P Listed)
hexamethylene triperoxide diamine
DOT Forbidden
Hexamethylphosphoramide
680-31-9
Select Carcinogen
hexanitroazoxy benzene
DOT Forbidden
hexanitrodiphenyl urea
DOT Forbidden
hexanitrodiphenylamine
131-73-7
DOT Explosive
hexanitrostilbene
49850-40-0
DOT Explosive
hydralazine
86-54-4
IARC List of Known and Suspected Human Carcinogens
Hydrazine
302-01-2
Select Carcinogen
hydrazine sulfate
10034-93-2
IARC List of Known and Suspected Human Carcinogens
Hydrazine, methyl-
60-34-4
EPA Acutely Toxic (P Listed)
Hydrazinecarbothioamide
79-19-6
EPA Acutely Toxic (P Listed)
hydrazobenzene
122-66-7
IARC List of Known and Suspected Human Carcinogens
Hydrocyanic Acid
74-90-8
EPA Acutely Toxic (P Listed)
Hydrocyanic Acid
74-90-8
DOT Forbidden
Hydrofluoric Acid
7664-39-3
Acutely Toxic
Hydrogen cyanide
74-90-8
EPA Acutely Toxic (P Listed)
Hydrogen Fluoride
7664-39-3
Acutely Toxic
Hydrogen phosphide
7803-51-2
EPA Acutely Toxic (P Listed)
Hyponitrous Acid
DOT Forbidden
indeno[1,2,3-cd]pyrene
193-39-5
IARC List of Known and Suspected Human Carcinogens
Inorganic arsenic
OSHA Listed Chemicals
iron dextran complex
9004-66-4
IARC List of Known and Suspected Human Carcinogens
Isodrin
465-73-6
EPA Acutely Toxic (P Listed)
Isolan
119-38-0
EPA Acutely Toxic (P Listed)
isonizid [isonicotinic acid hydrazide]
54-85-3
IARC List of Known and Suspected Human Carcinogens
Isopropyl Ether
108-20-3
Peroxidizable
Isopropylcumyl hydroperoxide
57242-90-7
49 C.F.R. § 173.225
isosafrole
120-58-1
IARC List of Known and Suspected Human Carcinogens
kepone [chlordecone]
143-50-0
IARC List of Known and Suspected Human Carcinogens
lasiocarpine
303-34-4
IARC List of Known and Suspected Human Carcinogens
Lead and lead compounds
7439-92-1
Reproductive Toxin
Lead mononitroresorcinate
51317-24-9
DOT Explosive
Lead styphnate
15245-44-0
DOT Explosive
lindane
58-89-9
IARC List of Known and Suspected Human Carcinogens
Manganese dimethyldithiocarbamate.
15339-36-3
EPA Acutely Toxic (P Listed)
Manganese, bis(dimethylcarbamodithioato-S,SŒ)-
15339-36-3
EPA Acutely Toxic (P Listed)
mannitol hexanitrate
15825-70-4
DOT Explosive
m-Cumenyl methylcarbamate
64-00-6
EPA Acutely Toxic (P Listed)
mea-alpha-c [2-amino-3-methyl-9H-pyrido[2,3-b]indole]
IARC List of Known and Suspected Human Carcinogens
medroxyprogesterone acetate
71-58-9
IARC List of Known and Suspected Human Carcinogens
megestrol acetate
595-33-5
IARC List of Known and Suspected Human Carcinogens
Melphalan
148-82-3
Select Carcinogen
melphalan [alkeran]
148-82-3
IARC List of Known and Suspected Human Carcinogens
mercaptopurine, 6-
50-44-2
IARC List of Known and Suspected Human Carcinogens
Mercury
7439-97-6
Reproductive Toxin
Mercury fulminate
628-86-4
DOT Explosive
Mercury fulminate (R,T)
628-86-4
EPA Acutely Toxic (P Listed)
Mercury, (acetato-O)phenyl-
62-38-4
EPA Acutely Toxic (P Listed)
merphalan
531-76-0
IARC List of Known and Suspected Human Carcinogens
mestranol
72-33-3
IARC List of Known and Suspected Human Carcinogens
Methanamine, N-methyl-N-nitroso-
62-75-9
EPA Acutely Toxic (P Listed)
Methane, isocyanato-
624-83-9
EPA Acutely Toxic (P Listed)
Methane, oxybis[chloro-
542-88-1
EPA Acutely Toxic (P Listed)
Methane, tetranitro- (R)
509-14-8
EPA Acutely Toxic (P Listed)
Methanethiol, trichloro-
75-70-7
EPA Acutely Toxic (P Listed)
Methanimidamide, N,N-dimethyl-NŒ-[2-methyl-4-[[(methylamino)carbonyl]oxy]phenyl]-
23422-53-9
EPA Acutely Toxic (P Listed)
Methanimidamide, N,N-dimethyl-NŒ-[3-[[(methylamino)-carbonyl]oxy]phenyl]-, monohydrochloride
17702-57-7
EPA Acutely Toxic (P Listed)
Methiocarb
2032-65-7
EPA Acutely Toxic (P Listed)
Methomyl
16752-77-5
EPA Acutely Toxic (P Listed)
methotrexate [trade name=mexate or folex]
59-05-2
IARC List of Known and Suspected Human Carcinogens
methoxsalen therapy [PUVA]
IARC List of Known and Suspected Human Carcinogens
methoxypsoralen, 5-
484-20-8
IARC List of Known and Suspected Human Carcinogens
Methyl Acetylene
74-99-7
Peroxidizable
Methyl bromide
74-83-9
IARC List of Known and Suspected Human Carcinogens
Methyl chloride
74-87-3
IARC List of Known and Suspected Human Carcinogens
Methyl chloromethyl ether
107-30-2
OSHA Listed Chemicals
Methyl ethyl ketone peroxide
1338-23-4
49 C.F.R. § 173.225
Methyl Fluorosulfate
421-20-5
Acutely Toxic
Methyl hydrazine
60-34-4
EPA Acutely Toxic (P Listed)
Methyl hydrazine [monomethyl hydrazine]
60-34-4
IARC List of Known and Suspected Human Carcinogens
Methyl iodide
74-88-4
IARC List of Known and Suspected Human Carcinogens
Methyl Isobutyl Ketone
108-10-1
Peroxidizable
Methyl isobutyl ketone peroxide
28056-59-9
49 C.F.R. § 173.225
Methyl isocyanate
624-83-9
EPA Acutely Toxic (P Listed)
Methyl methanesulfonate
66-27-3
IARC List of Known and Suspected Human Carcinogens
Methyl parathion
298-00-0
EPA Acutely Toxic (P Listed)
methyl-1-nitroanthraquinone, 2-
129-15-7
IARC List of Known and Suspected Human Carcinogens
methylaziridine, 2- [propyleneimine]
75-55-8
IARC List of Known and Suspected Human Carcinogens
methylazoxymethanol and its acetate
590-96-5 and 592-62-1
IARC List of Known and Suspected Human Carcinogens
methylchrysene, 2-
3351-32-4
IARC List of Known and Suspected Human Carcinogens
methylchrysene, 3-
3351-31-3
IARC List of Known and Suspected Human Carcinogens
methylchrysene, 4-
3351-30-2
IARC List of Known and Suspected Human Carcinogens
methylchrysene, 5-
3697-24-3
IARC List of Known and Suspected Human Carcinogens
methylchrysene, 6-
1705-85-7
IARC List of Known and Suspected Human Carcinogens
Methylcyclohexanone peroxide
11118-65-3
49C49 C.F.R. § 173.225
Methylcyclopentane
96-37-7
Peroxidizable
methylenbis(n,n-dimethylaniline), 4,4'-
101-61-1
IARC List of Known and Suspected Human Carcinogens
Methylene bis(2-chloroaniline), 4,4'- [MOCA]
101-14-4
IARC List of Known and Suspected Human Carcinogens
Methylene bis(n,n-dimethyl)benzeneamine, 4,4'-
101-61-1
IARC List of Known and Suspected Human Carcinogens
Methylene chloride
75-09-2
OSHA Listed Chemicals
Methylenedianiline
101-77-9
OSHA Listed Chemicals
methylenedianiline, 4,4'-
101-77-9
IARC List of Known and Suspected Human Carcinogens
methyl-n'-nitro-n-nitrosoguanidine, n- [MNNG]
70-25-7
IARC List of Known and Suspected Human Carcinogens
methyl-n-nitrosourethane, n-
615-53-2
IARC List of Known and Suspected Human Carcinogens
methylthiouracil
56-04-2
IARC List of Known and Suspected Human Carcinogens
Metolcarb
1129-41-6
EPA Acutely Toxic (P Listed)
metronidazole
443-48-1
IARC List of Known and Suspected Human Carcinogens
Mexacarbamate
315-18-4
EPA Acutely Toxic (P Listed)
michler's ketone
90-94-8
IARC List of Known and Suspected Human Carcinogens
mirex
2385-85-5
IARC List of Known and Suspected Human Carcinogens
mitomycin C
50-07-7
IARC List of Known and Suspected Human Carcinogens
monocrotaline
315-22-0
IARC List of Known and Suspected Human Carcinogens
morpholinomethyl-3-[(5-nitrofurfurylidene)amino]-2- oxazolidinone, 5-(
3795-88-8
IARC List of Known and Suspected Human Carcinogens
Mustard Gas
Select Carcinogen
myleran [1,4-butanediol dimethanesulfonate]
55-98-1
IARC List of Known and Suspected Human Carcinogens
N,N'- Dinitrosopentamethylenetetramine
101-25-7
49 C.F.R. § 173.224
N,N'-Dinitroso-N, N'-dimethyl-terephthalamide
133-55-1
49 C.F.R. § 173.224
N-[[(methylamino)carbonyl]oxy]-, methyl ester
EPA Acutely Toxic (P Listed)
nafenopin
3771-19-5
IARC List of Known and Suspected Human Carcinogens
naphthylamine, 1-
134-32-7
IARC List of Known and Suspected Human Carcinogens
naphthylamine, 2-
91-59-8
IARC List of Known and Suspected Human Carcinogens
n-Butyl peroxydicarbonate
DOT Forbidden
n-Butyl-4,4-di-(tert-butylperoxy)valerate
995-33-5
49 C.F.R. § 173.225
N-Formyl-2-(nitromethylene)-1,3-perhydrothiazine
49 C.F.R. § 173.224
Nickel and some nickel compounds
7440-02-0
IARC List of Known and Suspected Human Carcinogens
Nickel Carbonyl
13463-39-3
Acutely Toxic, Select Carcinogen
Nickel carbonyl Ni(CO)4, (T-4)-
13463-39-3
EPA Acutely Toxic (P Listed)
Nickel cyanide
557-19-7
EPA Acutely Toxic (P Listed)
Nickel cynaide Ni(CN)2
557-19-8
EPA Acutely Toxic (P Listed)
Nicotine, & salts
54-11-5
EPA Acutely Toxic (P Listed)
nifuradene(1-[(5-nitrofurfurylidene)amino]-2-imidazolinone)
IARC List of Known and Suspected Human Carcinogens
niridazole
61-57-4
IARC List of Known and Suspected Human Carcinogens
nithiazide
139-94-6
IARC List of Known and Suspected Human Carcinogens
Nitric oxide
10102-43-9
EPA Acutely Toxic (P Listed)
nitrilotriacetic acid
139-13-9
IARC List of Known and Suspected Human Carcinogens
nitro urea
556-89-8
DOT Explosive
nitro-2-furyl)-2-thiazolyl]acetamide, n-[4-(5-
531-82-8
IARC List of Known and Suspected Human Carcinogens
nitroacenaphthene, 5-
602-87-9
IARC List of Known and Suspected Human Carcinogens
nitroanisole, o-
91-23-6
IARC List of Known and Suspected Human Carcinogens
nitrobiphenyl, 4-
92-93-3
IARC List of Known and Suspected Human Carcinogens
nitrocellulose
9004-70-0
DOT Explosive
nitrochrysene, 6-
7496-02-8
IARC List of Known and Suspected Human Carcinogens
nitrofen
1836-75-5
IARC List of Known and Suspected Human Carcinogens
Nitrogen dioxide
10102-44-0
EPA Acutely Toxic (P Listed)
Nitrogen mustard [trade name=mustargen]
51-75-2
IARC List of Known and Suspected Human Carcinogens
Nitrogen mustard n-oxide
126-85-2
IARC List of Known and Suspected Human Carcinogens
Nitrogen oxide NO
10102-43-9
EPA Acutely Toxic (P Listed)
Nitrogen oxide NO2
10102-44-0
EPA Acutely Toxic (P Listed)
nitrogen trichloride
10025-85-1
DOT Forbidden
nitroglycerin
55-63-0
DOT Explosive
Nitroglycerine (R)
55-63-0
EPA Acutely Toxic (P Listed)
nitroguanidine
556-88-7
DOT Explosive
nitro-ortho-anisidine, 5-
99-59-2
IARC List of Known and Suspected Human Carcinogens
nitropropane, 2-
25322-01-4
IARC List of Known and Suspected Human Carcinogens
nitropyrene, 1-
5522-43-0
IARC List of Known and Suspected Human Carcinogens
nitropyrene, 4-
IARC List of Known and Suspected Human Carcinogens
nitrosoamines (chemical name includes nitroso)
IARC List of Known and Suspected Human Carcinogens
nitrosodiethanolamine, n-
IARC List of Known and Suspected Human Carcinogens
nitrosodiethylamine, n-
55-18-5
IARC List of Known and Suspected Human Carcinogens
nitrosodimethylamine, p-
62-75-9
IARC List of Known and Suspected Human Carcinogens
nitrosodi-n-butylamine, n-
IARC List of Known and Suspected Human Carcinogens
nitrosodi-n-propylamine, n-
IARC List of Known and Suspected Human Carcinogens
nitrosomethylamino)-1-(3-pyrdyl)-1-butanone, 4-(n-
64091-91-4
IARC List of Known and Suspected Human Carcinogens
nitrosomethylamino)propionitrile, 3-(n-
60153-49-3
IARC List of Known and Suspected Human Carcinogens
nitrosomethylethylamine, n-
10595-95-6
IARC List of Known and Suspected Human Carcinogens
nitrosomethylvinylamine, n-
4549-40-0
IARC List of Known and Suspected Human Carcinogens
nitrosomorpholine, n-
59-89-2
IARC List of Known and Suspected Human Carcinogens
nitroso-n-ethylurea, n-
759-73-9
IARC List of Known and Suspected Human Carcinogens
nitroso-n-methylurea, n-
684-93-5
IARC List of Known and Suspected Human Carcinogens
nitrosonornicotine, n-
80508-23-2
IARC List of Known and Suspected Human Carcinogens
nitrosopiperidine, n-
100-75-4
IARC List of Known and Suspected Human Carcinogens
nitrosopyrrolidine, n-
930-55-2
IARC List of Known and Suspected Human Carcinogens
nitrososarcosine, n-
13256-22-9
IARC List of Known and Suspected Human Carcinogens
nitrostarch
9056-38-6
DOT Explosive
nitrotriazolone
DOT Explosive
n-n'-Dichlorazodicarbonamidine
DOT Forbidden
N-Nitrosodimethylamine
62-75-9
EPA Acutely Toxic (P Listed)
N-Nitrosomethylvinylamine
4549-40-0
EPA Acutely Toxic (P Listed)
norethisterone
68-22-4
IARC List of Known and Suspected Human Carcinogens
norethynodrel
68-23-5
IARC List of Known and Suspected Human Carcinogens
O,O-Diethyl O-pyrazinyl phosphorothioate
297-97-2
EPA Acutely Toxic (P Listed)
O-[(methylamino)carbonyl]oxime
EPA Acutely Toxic (P Listed)
O-[4-[(dimethylamino)sulfonyl]phenyl] O,O-dimethyl ester
EPA Acutely Toxic (P Listed)
ochratoxin A
303-47-9
IARC List of Known and Suspected Human Carcinogens
Octamethylpyrophosphoramide
152-16-9
EPA Acutely Toxic (P Listed)
octolite
DOT Explosive
octonal
DOT Explosive
oestradiol-17 beta
IARC List of Known and Suspected Human Carcinogens
oestrone
53-16-7
IARC List of Known and Suspected Human Carcinogens
oil or orange SS
2646-17-5
IARC List of Known and Suspected Human Carcinogens
Osmium oxide OsO4, (T-4)-
20816-12-0
EPA Acutely Toxic (P Listed)
Osmium tetroxide
20816-12-0
EPA Acutely Toxic (P Listed)
Oxamyl
23135-22-0
EPA Acutely Toxic (P Listed)
oxydianiline, 4,4'-
101-80-4
IARC List of Known and Suspected Human Carcinogens
oxymentholone
IARC List of Known and Suspected Human Carcinogens
Ozone
10028-15-6
Acutely Toxic
panfuran S [dihydroxymethylfuratizine]
794-93-4
IARC List of Known and Suspected Human Carcinogens
Parathion
56-38-2
EPA Acutely Toxic (P Listed)
p-Chloroaniline
106-47-8
EPA Acutely Toxic (P Listed)
p-Diazidobenzene
DOT Forbidden
Peracetic acid
79-21-0
49 C.F.R. § 173.225
Peroxyacetic acid
79-21-0
49 C.F.R. § 173.225
petasitenine
60102-37-6
IARC List of Known and Suspected Human Carcinogens
phenacetin
62-44-2
IARC List of Known and Suspected Human Carcinogens
phenazopyridine
94-78-0
IARC List of Known and Suspected Human Carcinogens
phenazopyridine hydrochloride
136-40-3
IARC List of Known and Suspected Human Carcinogens
phenelzine
51-71-8
IARC List of Known and Suspected Human Carcinogens
phenobarbital
50-06-6
IARC List of Known and Suspected Human Carcinogens
Phenol, (3,5-dimethyl-4-(methylthio)-, methylcarbamate
2032-65-7
EPA Acutely Toxic (P Listed)
Phenol, 2-(1-methylpropyl)-4,6-dinitro-
88-85-7
EPA Acutely Toxic (P Listed)
Phenol, 2,4,6-trinitro-, ammonium salt (R)
131-74-8
EPA Acutely Toxic (P Listed)
Phenol, 2,4-dinitro-
51-28-5
EPA Acutely Toxic (P Listed)
Phenol, 2-cyclohexyl-4,6-dinitro-
131-89-5
EPA Acutely Toxic (P Listed)
Phenol, 2-methyl-4,6-dinitro-, & salts
534-52-1
EPA Acutely Toxic (P Listed)
Phenol, 3-(1-methylethyl)-, methyl carbamate
64-00-6
EPA Acutely Toxic (P Listed)
Phenol, 3-methyl-5-(1-methylethyl)-, methyl carbamate
2631-37-0
EPA Acutely Toxic (P Listed)
Phenol, 4-(dimethylamino)-3,5-dimethyl-, methylcarbamate (ester)
315-18-4
EPA Acutely Toxic (P Listed)
phenoxybenzamine and its hydrochloride
59-96-1
IARC List of Known and Suspected Human Carcinogens
phenyl-beta-naphthylamine, n-
135-88-6
IARC List of Known and Suspected Human Carcinogens
Phenylmercury acetate
62-38-4
EPA Acutely Toxic (P Listed)
phenylphenol, o-
90-43-7
IARC List of Known and Suspected Human Carcinogens
Phenylthiourea
103-85-5
EPA Acutely Toxic (P Listed)
phenytoin (and its sodium salts)
57-41-0
IARC List of Known and Suspected Human Carcinogens
Phorate
298-02-2
EPA Acutely Toxic (P Listed)
Phosgene
75-44-5
EPA Acutely Toxic (P Listed)
Phosphine
7803-51-2
EPA Acutely Toxic (P Listed)
Phosphoric acid, diethyl 4-nitrophenyl ester
311-45-5
EPA Acutely Toxic (P Listed)
Phosphorodithioic acid, O,O-diethyl
298-04-4
EPA Acutely Toxic (P Listed)
Phosphorodithioic acid, O,O-dimethyl S-[2-(methylamino)-2-oxoethyl] ester
60-51-5
EPA Acutely Toxic (P Listed)
Phosphorofluoridic acid, bis(1-methylethyl) ester
55-91-4
EPA Acutely Toxic (P Listed)
Physostigmine salicylate
57-64-7
EPA Acutely Toxic (P Listed)
Physostigmine
57-47-6
EPA Acutely Toxic (P Listed)
Pinanyl hydroperoxide
28324-52-9
49 C.F.R. § 173.225
Plumbane, tetraethyl-
78-00-2
EPA Acutely Toxic (P Listed)
p-Menthyl hydroperoxide
26762-92-5
49 C.F.R. § 173.225
p-Nitroaniline
100-01-6
EPA Acutely Toxic (P Listed)
polybrominated biphenyls [PBBs]
67774-32-7
IARC List of Known and Suspected Human Carcinogens
polychlorinated biphenyls [PCBs]
53469-21-9
IARC List of Known and Suspected Human Carcinogens
ponceau 3R
3564-09-8
IARC List of Known and Suspected Human Carcinogens
ponceau MX
3761-53-3
IARC List of Known and Suspected Human Carcinogens
Potassium
7440-09-7
Peroxidizable
Potassium cyanide
151-50-8
EPA Acutely Toxic (P Listed)
Potassium silver cyanide
506-61-6
EPA Acutely Toxic (P Listed)
procarbazine
671-16-9
IARC List of Known and Suspected Human Carcinogens
procarbazine hydrochloride trade name=matulan
366-70-1
IARC List of Known and Suspected Human Carcinogens
Promecarb
2631-37-0
EPA Acutely Toxic (P Listed)
Propanal, 2-methyl-2-(methyl-sulfonyl)-, O-[(methylamino)carbonyl] oxime
1646-88-4
EPA Acutely Toxic (P Listed)
Propanal, 2-methyl-2-(methylthio)-
116-06-3
EPA Acutely Toxic (P Listed)
propane sultone, 1,3-
1120-71-4
IARC List of Known and Suspected Human Carcinogens
Propanenitrile
107-12-0
EPA Acutely Toxic (P Listed)
Propanenitrile, 2-hydroxy-2-methyl-
75-86-5
EPA Acutely Toxic (P Listed)
Propanenitrile, 3-chloro-
542-76-7
EPA Acutely Toxic (P Listed)
Propargyl alcohol
107-19-7
EPA Acutely Toxic (P Listed)
propiolactone, beta-
57-57-8
IARC List of Known and Suspected Human Carcinogens
propylene dichloride [1,2-dichloropropane]
78-87-5
IARC List of Known and Suspected Human Carcinogens
propylene oxide
75-56-9
IARC List of Known and Suspected Human Carcinogens
propyleneimine [1,2-propylenimine or 2-methylaziridine]
75-55-8
IARC List of Known and Suspected Human Carcinogens
propylthiouracil
51-52-5
IARC List of Known and Suspected Human Carcinogens
Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-, & salts
54-11-5
EPA Acutely Toxic (P Listed)
quercetin
117-39-5
IARC List of Known and Suspected Human Carcinogens
Radioactive Materials (Non-Excempt)
OSHA Listed Chemicals
reserpine
50-55-5
IARC List of Known and Suspected Human Carcinogens
S-[(ethylthio)methyl] ester
EPA Acutely Toxic (P Listed)
S-[2-(ethylthio)ethyl] ester
EPA Acutely Toxic (P Listed)
safrole
94-59-7
IARC List of Known and Suspected Human Carcinogens
Selenious acid, dithallium(1+) salt
12039-52-0
EPA Acutely Toxic (P Listed)
selenium sulfide
7488-56-4
IARC List of Known and Suspected Human Carcinogens
Selenourea
630-10-4
EPA Acutely Toxic (P Listed)
senkirkine
2318-18-5
IARC List of Known and Suspected Human Carcinogens
Silver cyanide
506-64-9
EPA Acutely Toxic (P Listed)
Sodium 2-diazo-1-naphthol-4-sulphonate
49 C.F.R. § 173.224
Sodium 2-diazo-1-naphthol-5-sulphonate
2657-00-3
49 C.F.R. § 173.224
Sodium Amide
7782-92-5
Peroxidizable
Sodium azide
26628-22-8
EPA Acutely Toxic (P Listed)
Sodium cyanide
143-33-9
EPA Acutely Toxic (P Listed)
Sodium metal
7440-23-5
Water Reactive
sodium o-phenylphenate
132-27-4
IARC List of Known and Suspected Human Carcinogens
spironolactone
52-01-7
IARC List of Known and Suspected Human Carcinogens
sterigmatocystin
10048-13-2
IARC List of Known and Suspected Human Carcinogens
streptozotocin
18883-66-4
IARC List of Known and Suspected Human Carcinogens
Strychnidin-10-one, & salts
57-24-9
EPA Acutely Toxic (P Listed)
Strychnidin-10-one, 2,3-dimethoxy-
35757-3
EPA Acutely Toxic (P Listed)
Strychnine, & salts
57-24-9
EPA Acutely Toxic (P Listed)
Styrene
100-42-5
Peroxidizable
styrene oxide
96-09-3
IARC List of Known and Suspected Human Carcinogens
sulfallate
95-06-7
IARC List of Known and Suspected Human Carcinogens
sulfamethoxazole
723-46-6
IARC List of Known and Suspected Human Carcinogens
Sulfuric acid, dithallium(1+) salt
7446-18-6
EPA Acutely Toxic (P Listed)
symphytine
22571-95-5
IARC List of Known and Suspected Human Carcinogens
telone II (mostly 1,3-dichloropropene)
542-75-6
IARC List of Known and Suspected Human Carcinogens
tert-Amyl hydroperoxide
3425-61-4
49 C.F.R. § 173.225
tert-Amyl peroxy-2-ethylhexanoate
686-31-7
49 C.F.R. § 173.225
tert-Amyl peroxy-2-ethylhexyl carbonate
70833-40-8
49 C.F.R. § 173.225
tert-Amyl peroxybenzoate
4511-39-1
49 C.F.R. § 173.225
tert-Amyl peroxyneodecanoate
68299-16-1
49 C.F.R. § 173.225
tert-Amyl peroxypivalate
29240-17-3
49 C.F.R. § 173.225
tert-Amylperoxy-3,5,5-trimethylhexanoate
49 C.F.R. § 173.225
tert-Butoxycarbonyl azide
DOT Forbidden
tert-Butyl cumyl peroxide
30580-75-7
49 C.F.R. § 173.225
tert-Butyl hydroperoxide
75-91-2
49 C.F.R. § 173.225
tert-Butyl monoperoxymaleate
1931-62-0
49 C.F.R. § 173.225
tert-Butyl monoperoxyphthalate
15042-77-0
49 C.F.R. § 173.225
tert-Butyl peroxy-2-ethylhexanoate
3006-82-4
49 C.F.R. § 173.225
tert-Butyl peroxy-2-ethylhexylcarbonate
49 C.F.R. § 173.225
tert-Butyl peroxy-2-methylbenzoate
22313-62-8
49 C.F.R. § 173.225
tert-Butyl peroxy-3,5,5-trimethylhexanoate
13122-18-4
49 C.F.R. § 173.225
tert-Butyl peroxyacetate
107-71-1
49 C.F.R. § 173.225
tert-Butyl peroxyacetate
DOT Forbidden
tert-Butyl peroxybenzoate
614-45-9
49 C.F.R. § 173.225
tert-Butyl peroxybutyl fumarate
49 C.F.R. § 173.225
tert-Butyl peroxycrotonate
23474-91-1
49 C.F.R. § 173.225
tert-Butyl peroxydiethylacetate
2550-33-6
49 C.F.R. § 173.225
tert-Butyl peroxyisobutyrate
109-13-7
49 C.F.R. § 173.225
tert-Butyl peroxyneodecanoate
26748-41-4
49 C.F.R. § 173.225
tert-Butyl peroxyneoheptanoate
26748-38-9
49 C.F.R. § 173.225
tert-Butyl peroxypivalate
927-07-2
49 C.F.R. § 173.225
tert-Butylperoxy isopropylcarbonate
2372-21-6
49 C.F.R. § 173.225
tert-Butylperoxystearylcarbonate
49 C.F.R. § 173.225
tert-Hexyl peroxypivalate
51938-28-4
49 C.F.R. § 173.225
tert-Hexylperoxyneodecanoate
49 C.F.R. § 173.225
testosterone and its esters
58-22-0
IARC List of Known and Suspected Human Carcinogens
tetrachlorodibenzo-dioxin [TCDD]
IARC List of Known and Suspected Human Carcinogens
tetrachlorodibenzo-p-dioxin, 2,3,7,8- [TCDD]
1746-01-6
IARC List of Known and Suspected Human Carcinogens
tetrachloroethylene [perchloroethylene]
127-18-4
IARC List of Known and Suspected Human Carcinogens
tetrachlorvinphos
22248-79-9
IARC List of Known and Suspected Human Carcinogens
Tetraethyl lead
78-00-2
EPA Acutely Toxic (P Listed)
Tetraethyl pyrophosphate
107-49-3
EPA Acutely Toxic (P Listed)
Tetraethyldithiopyrophosphate
3689-24-5
EPA Acutely Toxic (P Listed)
Tetrafluoroethylene
116-14-3
Peroxidizable
Tetrahydrofuran
109-99-9
Peroxidizable
Tetralin
119-64-2
Peroxidizable
Tetramine palladium (II) nitrate
49 C.F.R. § 173.224
Tetranitromethane (R)
509-14-8
EPA Acutely Toxic (P Listed)
Tetraphosphoric acid, hexaethyl ester
757-58-4
EPA Acutely Toxic (P Listed)
Thallic oxide
1314-32-5
EPA Acutely Toxic (P Listed)
Thallium oxide Tl2 O3
1314-32-5
EPA Acutely Toxic (P Listed)
Thallium(I) selenite
12039-52-0
EPA Acutely Toxic (P Listed)
Thallium(I) sulfate
7446-18-6
EPA Acutely Toxic (P Listed)
thioacetamide
62-55-5
IARC List of Known and Suspected Human Carcinogens
thiodianiline, 4,4'-
139-65-1
IARC List of Known and Suspected Human Carcinogens
thiotepa
52-24-4
IARC List of Known and Suspected Human Carcinogens
thiourea
62-56-6
IARC List of Known and Suspected Human Carcinogens
Thorium Dioxide
Select Carcinogen
tolidine, o-
119-93-7
IARC List of Known and Suspected Human Carcinogens
Toluene
108-88-3
Reproductive Toxin
toluene diisocyanate [TDI]
584-84-9
IARC List of Known and Suspected Human Carcinogens
toluidine hydrochloride, o-
540-23-8
IARC List of Known and Suspected Human Carcinogens
toluidine, o-
95-53-4
IARC List of Known and Suspected Human Carcinogens
toluidine, p-
106-49-0
IARC List of Known and Suspected Human Carcinogens
toxaphene
8001-35-2
IARC List of Known and Suspected Human Carcinogens
Treosulfan
299-75-2
Select Carcinogen
triafur [2-amino-5-(nitro-2-furyl)-1,3,4-thiadiazole]
IARC List of Known and Suspected Human Carcinogens
trichloroethane, 1,1,2-
79-00-5
IARC List of Known and Suspected Human Carcinogens
trichloroethylene
79-01-6
IARC List of Known and Suspected Human Carcinogens
trichlorophenol, 2,4,6-
88-06-2
IARC List of Known and Suspected Human Carcinogens
trichloropropane, 1,2,3-
96-18-4
IARC List of Known and Suspected Human Carcinogens
tris(1-aziridinyl)phosphine sulfide trade name=thiotepa
52-24-4
IARC List of Known and Suspected Human Carcinogens
tris(2,3-dibromopropyl)phosphate
126-72-7
IARC List of Known and Suspected Human Carcinogens
tris(aziridinyl)-p-benzoquione [triaziquone]
68-76-8
IARC List of Known and Suspected Human Carcinogens
trp-P-1 [3-amino,1,4-dimethyl-5H-pyrido[4,3-b]indole]
62450-06-0
IARC List of Known and Suspected Human Carcinogens
trp-P-2 [3-amino-1-methyl-5H-pyrido[4,3-b]indole]
IARC List of Known and Suspected Human Carcinogens
trypan blue
72-57-1
IARC List of Known and Suspected Human Carcinogens
uracil mustard trade name=uramustine
66-75-1
IARC List of Known and Suspected Human Carcinogens
urethane [ethyl carbamate]
51-79-6
IARC List of Known and Suspected Human Carcinogens
Vinyl Actetate
108-05-4
Peroxidizable
Vinyl bromide
593-60-2
IARC List of Known and Suspected Human Carcinogens
Vinyl Chloride
75-01-4
Peroxidizable, Reproductive Toxin, Select Carcinogen
vinyl fluoride
75-02-5
IARC List of Known and Suspected Human Carcinogens
Vinylacetylene
689-97-4
Peroxidizable
vinylcyclohexene, 4-
100-40-3
IARC List of Known and Suspected Human Carcinogens
vinylidene chloride [1,1-dichloroethylene]
75-35-4
IARC List of Known and Suspected Human Carcinogens
vinylidene fluoride monomer
75-38-7
IARC List of Known and Suspected Human Carcinogens
Vinylidine Chloride
75-35-4
Peroxidizable
Vinylpyridine
1337-81-1
Peroxidizable
Xylene
1330-20-7
Reproductive Toxin
zearalenone
17924-92-4
IARC List of Known and Suspected Human Carcinogens
zinc chromate
13530-65-9
IARC List of Known and Suspected Human Carcinogens
**History**
- *Amendment — effective from 2022-04-11 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/11/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 07/02/2018*
- *Amendment — effective from 2009-02-19 to 08/12/2014*
- *Amendment — effective from 2007-01-30 to 02/19/2009*
- *Amendment — effective from 2005-07-17 to 01/30/2007*
- *Amendment — effective from 2003-11-16 to 07/17/2005*
- *Periodic Refile — effective from 2002-01-02 to 11/16/2003*
#### **216-RICR-20-10-5** Epinephrine Auto-Injectors for Emergency Administration
##### **216-RICR-20-10-5 § 5.1** Authority {#sec-216-ricr-20-10-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-5#5.1}
These regulations are established pursuant to the authority conferred under R.I. Gen. Laws Chapter 23-6.4, for the purpose of establishing the procedures for an authorized entity to acquire and maintain a supply of epinephrine auto-injectors for administration to an individual experiencing anaphylaxis.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-19 to 01/04/2022*
- *Amendment — effective from 2018-07-01 to 04/19/2020*
- *Adoption — effective from 2015-03-05 to 07/01/2018*
##### **216-RICR-20-10-5 § 5.2** Definitions {#sec-216-ricr-20-10-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-5#5.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1."Act" means R.I. Gen Laws Chapter 23-6.4, entitled "Life-saving Allergy Medication - Stock Supply of Epinephrine Auto-Injectors - Emergency Administration."
2.“Administer” means the direct application of an epinephrine auto-injector to the body of an individual.
3.“Authorized entity” means any entity or organization at, or in connection with, where allergens capable of causing anaphylaxis may be present, as specified in § 5.3.1 of this Part.
4.“Authorized health care provider” means a physician, nurse, or other person duly authorized by law, in the state in which they practice, to prescribe drugs.
5.“Department” means the Rhode Island Department of Health.
6."Director" means the Director of the Rhode Island Department of Health.
7.“Epinephrine auto-injector” means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
8.“Provide” means the supplying of one or more epinephrine auto-injectors to an individual.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-19 to 01/04/2022*
- *Amendment — effective from 2018-07-01 to 04/19/2020*
- *Adoption — effective from 2015-03-05 to 07/01/2018*
##### **216-RICR-20-10-5 § 5.3** Applicability {#sec-216-ricr-20-10-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-5#5.3}
This Part applies to authorized health care providers, pharmacists and authorized entities, as defined by the Act and this Part.
5.3.1Authorized Entity
A.Pursuant to R.I. Gen. Laws § 23-6.4-1(2), the Director has determined that the following entities and organizations are considered authorized entities:
1.A food business required to register with the Department on an annual basis pursuant to R.I. Gen. Laws § 21-27-10;
2.A pre-school, school, college or university as defined in the Department’s rules and regulations pertaining to Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities (Part 30-05-3 of this Title);
3.A family day care home as defined in R.I. Gen. Laws § 23-28.1-5(5);
4.A place of assembly as specified in R.I. Gen. Laws Chapter 23-28.6;
5.A state or local governmental agency or facility;
6.An organized athletic team, league or association; and
7.A place of employment which provides in-house employee health services.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-19 to 01/04/2022*
- *Amendment — effective from 2018-07-01 to 04/19/2020*
- *Adoption — effective from 2015-03-05 to 07/01/2018*
##### **216-RICR-20-10-5 § 5.4** Training for Use of Epinephrine Auto-injectors {#sec-216-ricr-20-10-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-5#5.4}
A.Anaphylaxis training must be completed in accordance with R.I. Gen. Laws § 23-6.4-6.
1.A healthcare provider (e.g., physician, physician assistant, nurse, EMT, etc.) who is currently licensed by the Department, and who has received anaphylaxis training as part of their professional development, is not required to complete this additional training.
5.4.1Operations Plan Required
A.An authorized entity described in § 5.3.1 of this Part which chooses to acquire and stock a supply of epinephrine auto-injectors must maintain an Operations plan on the premises. The plan shall include at a minimum:
1.How the training described in R.I. Gen. Laws § 23-6.4-6 will be provided.
2.How the epinephrine auto-injectors will be acquired.
3.Name and contact information for the prescribing authorized health care provider.
4.Where and how the epinephrine auto-injectors will be stored.
5.Names of the designated employees and/or agents who have completed the training program and are authorized to administer the epinephrine auto-injectors.
6.Description of the process to allow individuals, other than those trained per R.I. Gen. Laws § 23-6.4-6, to be provided the epinephrine auto-injectors via remote authorization by an authorized health care provider, after consultation with the authorized health care provider by audio, tele-video, or other similar means of electronic communication, pursuant to R.I. Gen. Laws § 23-6.4-5.
7.How and when the epinephrine auto-injectors will be inspected for an expiration date that has not passed, and how that will be recorded.
8.Description of the process to replace an epinephrine auto-injector that is nearing its expiration date or if one has been administered.
9.Description of the process to report each incident to the Department pursuant to R.I. Gen. Laws § 23-6.4-8.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-19 to 01/04/2022*
- *Amendment — effective from 2018-07-01 to 04/19/2020*
- *Adoption — effective from 2015-03-05 to 07/01/2018*
##### **216-RICR-20-10-5 § 5.5** Reporting Requirements {#sec-216-ricr-20-10-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-10-5#5.5}
Authorized entities must comply with the reporting requirements contained in R.I. Gen. Laws § 23-6.4-8. Such reporting must occur according to procedures and format required by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-04-19 to 01/04/2022*
- *Amendment — effective from 2018-07-01 to 04/19/2020*
- *Adoption — effective from 2015-03-05 to 07/01/2018*
### **Subchapter 15** Information for Health Care Professionals
#### **216-RICR-20-15-1** Health Professional Loan Repayment Program
##### **216-RICR-20-15-1 § 1.1** Authority {#sec-216-ricr-20-15-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-1#1.1}
These regulations are established pursuant to the authority conferred by R.I. Gen. Laws § 23-14.1-5(6) for the purpose of adopting standards for the implementation of the State Loan Repayment Program in order to improve statewide access to primary medical care, mental health care, and dental care by providing educational loan repayment to health professionals committed to work in federally designated primary care health professional shortage areas, dental health professional shortage areas, or mental health care professional shortage areas.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-20-15-1 § 1.2** Definitions {#sec-216-ricr-20-15-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-1#1.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1.“Board” means the Health Professional Loan Repayment Board.
2.“Community health center” means the health care facility as defined and licensed under R.I. Gen. Laws Chapter 23-17.
3.“Director” means the Director of the Rhode Island Department of Health.
4.“Eligible health professional” means a physician, dentist, dental hygienist, nurse practitioner, certified nurse midwife, physician assistant, or any other eligible health care professional under the Public Health Service Act licensed in the State, who has entered into a contract with the board to serve medically underserved populations.
5.“Health care facility” includes, but is not limited to, hospital ambulatory care facilities, organized ambulatory care facilities or other entities delivering medical, mental health, or dental services. Said facility must be a non-profit organization or agency.
6.“HPSA” means a designated Health Professional Shortage Area as defined by the Shortage Designation Branch of the Bureau of Health Workforce, within the Health Resources and Services Administration, U.S. Department of Health and Human Services.
7.“HPLRP” means the Health Professional Loan Repayment Program whose purpose shall be to provide loan repayment to eligible health professionals for qualifying loans relating to the graduate or undergraduate education as a recruitment or retention incentive for health professionals to practice in high-need areas.
8.“Loan repayment” means an amount of money to be repaid to satisfy loan obligations incurred to obtain a degree or certification in an eligible health professional.
9.“Qualifying loans” are government and commercial loans for actual costs paid for tuition, reasonable educational expenses, and reasonable living expenses relating to the graduate or undergraduate education of a health professional.
10.“RIOPC” means the Rhode Island Office of the Postsecondary Commissioner.
11.“Site” means a community health center located in a federally designated HPSA or other entity delivering medical, mental health, or dental services. Said entity shall be a non-profit organization or agency.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-20-15-1 § 1.3** General Requirements and Administrative Procedures {#sec-216-ricr-20-15-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-1#1.3}
1.3.1The Health Professional Loan Repayment Board
A.In order to participate in the HPLR Program, health professionals and sites must apply for and obtain approval from the Board based upon the criteria set forth in this Part and the availability of funds.
B.The Board shall receive, review and evaluate all applications from sites and health care professionals to determine eligibility for participation in the program based on criteria set forth in this Part and the availability of funding. Once approval is granted, the health professional must enter into a contract with the RIOPC and adhere to requirements of the contract to maintain participation.
C.Composition of the Board and appointment of the Board’s chairperson are pursuant to R.I. Gen. Laws §§ 23-14.1-4(a) and (b).
D.Terms of appointment and compensation are pursuant to R.I. Gen. Laws § 23-14.1-4(a).
E.In addition to the duties stated in R.I. Gen. Laws § 23-14.1-5, the Board shall:
1.Score and rank site applications and approve sites for funding;
2.Maintain oversight of the health professional’s adherence of contracts;
3.Recommend to the Director termination of contracts for imposition of penalties where health professional fails to comply with the terms of the contract or this Part;
4.Review and approve, when appropriate, all requests for contract extensions up to 6 months; no contract can be extended for more than 6 months unless compelling evidence of need is presented to the Board; and
5.Review and approve, when appropriate, all requests for termination of contracts.
1.3.2Requirements for Eligibility for Sites
A.In order for a site to obtain approval for a funded position of a health professional qualified under the HPLR Program, the site must:
1.Be located in a federally designated HPSA;
2.Agree that it will accept assignment under § 1842 (b)(3)(B)(ii) of the Social Security Act for all services for which payment may be made under Part B of Title XVIII;
3.Not discriminate on the basis of the ability of the individual to pay for such care or on the basis that payment for such care will be made pursuant to the program established in Title XVIII (Medicare) of the Social Security Act, or pursuant to the program established in Title XIX (Medicaid) of such Act;
4.Submit an application to the Board and documentation satisfactory to the Board that the site meets the requirements;
5.Agree to report to the Board those health professionals unable to fulfill the contract; and
6.Be a non-profit organization or agency.
1.3.3Requirements for Eligibility for Health Care Professional
A.In order to obtain approval to participate in the HPLR Program, the health care professional must:
1.Have a valid contract for a two year commitment to provide full-time services at a site that has been approved for funding, or have a valid contract for a four year commitment to provide part-time services at a site that has been approved for funding;
2.Present evidence of outstanding loan obligations;
3.Be licensed or in the process for applying for a license or certification in the appropriate profession;
4.Be a citizen of the United States;
5.Agree to comply with all contract provisions and the rules and regulations as promulgated by the Board; and
6.Submit to the Board an application form and documentation satisfactory to the Board that he/she meets all requirements for eligibility.
B.Health care professionals are not eligible to participate:
1.If they have previously incurred an obligation for health professional service to the Federal, State, or local government, or other entity unless the obligation is completely satisfied prior to the beginning of service under this program;
2.If a breach of obligation has occurred for health professional service to the Federal Government, State Government or other entity;
3.And shall not be allowed credit for any practice done while in a professional school or graduate training programs; and
4.Shall not be allowed loan repayment for any professional practice performed prior to the effective date of the health professional’s HPLR contract.
C.Requirements of the health professional to maintain eligibility:
1.After a health care professional has been awarded a loan repayment contract, he/she must comply with the following practice:
a.Charge for professional services at the usual and customary rates prevailing in the areas in which such services are provided. If a person is unable to pay such charge, such person shall be charged at a reduced rate or not charged any fee;
b.Must serve in the clinical practice of their profession full time (40 hours per week), with no more than 20% of the time devoted to administrative work;
c.Agree that, in providing primary health services, he/she will not, in the case of any individual seeking care, discriminate on the basis of the ability of the individual to pay for such care or on the basis that payment for such care will be made pursuant to the program established in Title XVII (Medicare) of the Social Security Act or pursuant to the program established in Title XIX (Medicaid) of such Act;
d.Agree that he/she will accept assignment under § 1842 (b)(3)(B)(ii) of the Social Security Act for all services for which payment may be made under Part B of Title XVII and will enter into an appropriate agreement with the State agency that administers the State plan for medical assistance under Title XIX of such Act to provide service to individuals entitled to medical assistance under the plan; and
D.The health professional may not engage in any activity which is in violation of the contract or this Part.
1.3.4Board Approval
The Board shall approve for participation all eligible applicants who meet the criteria stated in §§ 1.3.2 and 1.3.3 of this Part. The loan repayment amount will be based upon fund availability and priorities established by the Board.
1.3.5Duties of the Director
A.The Director shall:
1.Grant loan repayment to successful applicants as determined by the Board.
1.3.6Duties of RIOPC
A.The RIOPC shall have the responsibility to process all approved applications including:
1.Confirmation of existing loan and amount, and determination if the health care provider has defaulted on any other loans;
2.Issue payment to the lender, upon receiving Board notification that the medical care provider qualifies for loan repayment; and
3.Implement legal proceedings against those health professionals determined to be in breach of contract.
1.3.7Breach of Contract
Penalties for failure to complete contracts pursuant to this Part are pursuant to R.I. Gen. Laws § 23-14.1-9 and 42 U.S.C. 6(A), Subchapter II, Part D, Subpart iii, § 254o.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
#### **216-RICR-20-15-2** Pain Assessment
##### **216-RICR-20-15-2 § 2.1** Authority {#sec-216-ricr-20-15-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-2#2.1}
These regulations are promulgated under the authority contained in R.I. Gen. Laws § 5-37.6-5(a) and are established for the purpose of adopting requirements relating to the assessment of pain by health care facilities and health care providers in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Adoption — effective from 2003-05-29 to 08/21/2018*
##### **216-RICR-20-15-2 § 2.2** Definitions {#sec-216-ricr-20-15-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-2#2.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“The Act” means R.I. Gen. Laws Chapter 5-37.6.
2."Assessment of pain" means the act of assessing an unpleasant sensation occurring in varying degrees of severity as a consequence of injury, disease, or emotional disorder.
3.“Department” means the Rhode Island Department of Health.
4.“Director” means the Director of the Rhode Island Department of Health.
5.“Faces rating scale” means a pain intensity tool that contains graphical representations of faces in various stages of pain intensity, with a happy face representing no pain and a tearful face representing the worst possible pain.
6."Health care facility", pursuant to R.I. Gen. Laws Chapter 23-17, means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider, or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services or as a nursing service agency); nursing service agency; rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, and physician ambulatory surgery centers/podiatry ambulatory surgery centers. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school-based health centers and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-5.1 (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association). Individual categories of health care facilities shall be defined in rules and regulations promulgated by the licensing agency with the advice of the Health Services Council. Rules and regulations concerning hospice care shall be promulgated with regard to the "Standards of Practice for Hospice Programs", promulgated by the National Hospice and Palliative Care Organization. Any provider of hospice care who provides such hospice care without charge shall be exempt from the licensing provisions of R.I. Gen. Laws Chapter 23-17, but shall meet the "Standards of Practice for Hospice Programs." Facilities licensed by the Department of Behavioral Health, Developmental Disabilities and Hospitals, and the Department of Human Services, and clinical laboratories licensed in accordance with R.I. Gen. Laws Chapter 23-16.2, as well as Christian Science institutions (also known as Christian Science Nursing Facilities) listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of R.I. Gen. Laws Chapter 23-17.
7.“Health care provider” means any person licensed by this state to provide or lawfully providing health care services, including, but not limited to, a physician, dentist, optometrist, nurse, podiatrist, physical therapist, nurse practitioner or physician assistant.
8.“Numeric rating scale” means a pain intensity tool that quantifies a patient’s subjective pain for the health care provider. It may be visually or verbally administered and usually contains numbers 0--5 or 0--10 along a horizontal or vertical line, with 0 meaning “no pain” and 5 or 10 representing the worst pain imaginable.
9.“Pain” means an unpleasant sensation that can range from mild, localized discomfort to agony. Pain has both physical and emotional components. The physical part of pain results from nerve stimulation. Pain may be contained to a discrete area, as in an injury, or it can be more diffuse, as in disorders like fibromyalgia. Pain is mediated by specific nerve fibers that carry the pain impulses to the brain where their conscious appreciation may be modified by many factors.
10.“Pain” means a usually localized physical suffering associated with bodily disorder (as a disease or an injury); also a basic bodily sensation induced by a noxious stimulus, characterized by physical discomfort (as pricking, throbbing, or aching) and typically leading to evasive action; pain also may include mental or emotional distress or suffering.
11.“Pain intensity tool” means a tool for the evaluation of a patient’s subjective pain which is a component of pain assessment. Common pain intensity tools include: faces rating scales, visual analog scales, descriptive verbal response to pain, behavior observation scale, and numeric rating scales.
12."Person" means any individual, trust or estate, partnership, limited liability corporation, corporation (including associations, joint stock companies, and insurance companies), state, or political subdivision or instrumentality of a state.
13."Regular basis" means a procedure done on a customary, usual, normal, orderly, even, or symmetrical schedule.
14.“Visual analog scale” means a horizontal or vertical representation of pain, with “no pain” anchored at one end of the scale and “worst possible pain” anchored at the other end. The patient is asked to mark where the pain intensity falls along the continuum.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Adoption — effective from 2003-05-29 to 08/21/2018*
##### **216-RICR-20-15-2 § 2.3** General Requirements: Pain Assessment {#sec-216-ricr-20-15-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-2#2.3}
A.Health care facilities and health care providers, as defined in this Part, shall conduct an assessment of pain experienced by a patient on a regular basis, according to a written protocol established by the health care facility or health care provider, respectively.
B.Pain shall be assessed in all inpatients upon admission, using a combination of patient’s self-report, a health care provider’s assessment, and/or a pain intensity tool. Pain assessment shall provide for an evaluation of, and/or further testing to collect additional information to determine any underlying causes or reasons for, the identified presence and severity of pain. As appropriate, assessments shall utilize a pain intensity tool and address the location, duration, onset, and characteristics of pain, the patient’s goals, and alleviation of causative factors. Physical examination shall be conducted as indicated.
C.Pain shall be assessed in all outpatients upon intake or initial evaluation using a combination of patient’s self-report, a health care provider’s assessment, and/or a pain intensity tool. Pain assessment shall provide for an evaluation of, and/or further testing to collect additional information to determine any underlying causes or reasons for, the identified presence and severity of pain. As appropriate, assessments shall utilize a pain intensity tool and address the location, duration, onset, and characteristics of pain, the patient’s goals, and alleviation of causative factors. Physical examination shall be conducted as indicated.
D.Outpatients presenting for diagnostic tests only (e.g., laboratory studies, radiological examinations) shall be exempted from the pain assessment requirements of this Part.
E.On a regular basis, all patients shall be re-assessed for pain according to a written protocol established by the health care facility or health care provider.
F.All pain assessments and re-assessments shall be documented in the patient's clinical record.
G.More than one pain intensity tool may be used by the health care facility or health care provider. Provided, however, the same pain intensity tool shall be utilized consistently in assessing the same patient and provided the tool is, and continues to be, appropriate for the patient.
H.At least annually, health care facilities shall ensure competency in pain assessment among appropriate clinicians as designated by the health care facility.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Adoption — effective from 2003-05-29 to 08/21/2018*
##### **216-RICR-20-15-2 § 2.4** Penalties {#sec-216-ricr-20-15-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-2#2.4}
Penalties are pursuant to R.I. Gen. Laws § 5-37.6-7.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Adoption — effective from 2003-05-29 to 08/21/2018*
#### **216-RICR-20-15-3** Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department
##### **216-RICR-20-15-3 § 3.1** Authority {#sec-216-ricr-20-15-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#3.1}
These rules and regulations are promulgated under the authority of R.I. Gen. Laws Chapters 23-73 and 23-17 and are established for the purpose of adopting requirements for the use of latex gloves by health care workers, by other persons, firms, or corporations licensed or registered by the Department of Health, and the use of latex gloves in licensed health care facilities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
##### **216-RICR-20-15-3 § 3.2** Incorporated Materials {#sec-216-ricr-20-15-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#3.2}
These regulations hereby adopt and incorporate 29 C.F.R. § 1910.1030 (2014), "Bloodborne Pathogens", Occupational Safety and Health Administration (OSHA) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
##### **216-RICR-20-15-3 § 3.3** Definitions {#sec-216-ricr-20-15-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#3.3}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1.“Department” means the Rhode Island Department of Health.
2.“Director” means the Director of the Rhode Island Department of Health.
3."Health care facility", pursuant to R.I. Gen. Laws Chapter 23-17, means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider, or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services or as a nursing service agency); nursing service agency; rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, and physician office settings providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school-based health centers and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-5.1 (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association). Individual categories of health care facilities shall be defined in rules and regulations promulgated by the licensing agency with the advice of the Health Services Council. Rules and regulations concerning hospice care shall be promulgated with regard to the "Standards of a Hospice Program of Care", promulgated by national hospice organization. Any provider of hospice care who provides such hospice care without charge shall be exempt from the licensing provisions of R.I. Gen. Laws Chapter 23-17, but shall meet the "Standards of a Hospice Program of Care." Facilities licensed by the Department of Behavioral Health, Developmental Disabilities, and Hospitals, and the Department of Human Services, and clinical laboratories licensed in accordance with R.I. Gen. Laws Chapter 23-16.2, as well as Christian Science institutions (also known as Christian Science Nursing Facilities) listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of R.I. Gen. Laws Chapter 23-17.
4.“Health care provider” means any person holding a license, certificate, or registration issued by the Director and/or the Department that authorizes the person to provide health care services. For the purposes herein, “health care provider” does not include those persons who are employed by a “health care provider” or those persons employed by a licensed health care facility.
5.“Health care worker” means any person who has or may have direct patient contact in a health care facility, including, but not limited to, a physician, dentist, nurse, optometrist, podiatrist, physical therapist, social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency who has or may have exposure to latex gloves or other latex products. For the purposes of these Regulations, "health care worker" shall also mean those non-employee staff, such as volunteers, who are involved in direct patient contact. Transient employees not involved in direct patient contact or outside contractors not involved in direct patient contact are exempt from the requirements stated herein.
6.“Latex gloves” or “natural latex gloves”, as used herein, mean gloves that are made, in whole or in part, of natural rubber latex, including gloves that are packed in powder which includes natural rubber latex particles.
7."Other person, firm, or corporation licensed or registered by the Department", as used herein, means any individual or facility that is licensed or registered by the Department and does not fall into the category of either health care provider or health care facility, as defined herein, and uses latex gloves in the course of rendering services for which the license or registration is issued (e.g., tattoo artist, hair dresser).
8."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivisions or instrumentality of a state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
##### **216-RICR-20-15-3 § 3.4** General Requirements {#sec-216-ricr-20-15-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#3.4}
In those instances where a health care provider is employed by a health care facility or by another health care provider, the employer (i.e., health care facility or health care provider) shall be responsible for implementing the regulatory requirements contained herein.
3.4.1Food Services
The use of disposable, nonsterile and sterile natural rubber latex gloves shall be prohibited by any person, firm, or corporation, registered pursuant to R.I. Gen. Laws §21-27-10 and R.I. Gen. Laws §21-27-11 (e.g., retail food service establishments, restaurants, cafeterias).
3.4.2Notices
A.Health care providers, licensed health care facilities, and other persons, firms, or corporations licensed or registered by the Department that utilize latex gloves shall post a notice informing and warning employees and the public:
1. That natural rubber latex gloves are used;
2.That exposure to latex may result in the development of an allergy;
3.That allergic reactions to natural rubber latex can manifest by skin rash, hives, nasal and eye irritation, asthma, and shock; and
4.That should you or your family experience allergic reaction symptoms, then you should contact your health care provider.
B.The notice required in §3.4.2(A) of this Part shall include letters which are at least three-eighths (3/8) of an inch high and shall be posted in conspicuous areas (e.g., lobby, patient care areas, employee bulletin boards) throughout the premises.
C.The notice required in §3.4.2(A) of this Part shall be posted in English, Spanish and other languages, as appropriate, to the language needs of the individuals served by the health care provider, health care facility, or other person, firm, or corporation licensed or registered by the Department. An example of an English language notice that contains the minimum required language appears in § 3.6 of this Part. (For sample notices in languages other than English, please reference the Department's website: www.health.ri.gov).
3.4.3Health Care Workers
A.Health care providers and licensed health care facilities shall provide health care workers with initial education and annual in-service education pertaining to latex safety. Such education may include:
1.Obligations and requirements under the Act and the rules and regulations herein;
2.Nature of latex allergy;
3.Products and procedures that have been adopted by the facility or provider to minimize occupational allergy.
B.Licensed health care facilities shall ensure that health care workers are represented on latex allergy or safety committees.
C.Health care providers, licensed health care facilities, and other persons, firms, or corporations licensed or registered by the Department shall minimize health care workers’ exposure to latex consistent with maintaining safety in regulated industries whose workers are exposed to blood borne pathogens pursuant to the provisions of the OSHA Bloodborne Pathogens Standard, incorporated in § 3.2 of this Part. Non-latex gloves which provide a blood borne pathogen barrier are available which can minimize health care workers exposure to latex and protect the health care worker from blood borne pathogens.
3.4.4Latex Minimization
A.Health care providers, licensed health care facilities, and other persons, firms, or corporations licensed or registered by the Department shall be engaged in latex minimization activities that may include the following components:
1.Establishing protocols that evaluate symptoms suggestive of latex allergy during pre- employment and periodic evaluations;
2.Systematically evaluating and replacing latex gloves with non-latex gloves;
3.Utilizing only latex products that are nonpowdered; and
4.Assessing the impact of preventive measures.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
##### **216-RICR-20-15-3 § 3.5** Severability {#sec-216-ricr-20-15-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#3.5}
If any provision of these rules and regulations or the application thereof to any person or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end the provisions of the rules and regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
##### **216-RICR-20-15-3 § 3.6** Appendix A {#sec-216-ricr-20-15-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#3.6}
WARNING: Latex gloves are used in this facility. Repeated contact with latex may cause a latex allergy or may worsen a present latex allergy. Reactions to latex may include: skin rashes hives asthma nasal, eye, or sinus symptoms and allergic shock (anaphylactic shock). If you or your family are having these symptoms, call your health care provider (your physician, nurse, or dentist) immediately. PURSUANT TO R.I. GEN. LAWS § 23-73-2 (b)
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
##### **216-RICR-20-15-3** Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department {#sec-216-ricr-20-15-3- omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-3#}
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-06-10 to 01/04/2022*
- *Adoption — effective from 2002-06-10 to 06/10/2002*
#### **216-RICR-20-15-4** Medical Orders for Life Sustaining Treatment
##### **216-RICR-20-15-4 § 4.1** Authority {#sec-216-ricr-20-15-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-4#4.1}
These rules and regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws Chapter 23-4.11, and establish the procedures for Medical Orders for Life Sustaining Treatment (MOLST) and the structure and content of Medical Orders for Life Sustaining Treatment forms.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2013-09-29 to 01/04/2022*
- *Technical Revision — effective from 2013-09-29 to 09/29/2013*
- *Adoption — effective from 2013-09-29 to 09/29/2013*
##### **216-RICR-20-15-4 § 4.2** Definitions {#sec-216-ricr-20-15-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-4#4.2}
A.Whenever used in these Regulations, the following terms shall be construed as follows:
1. “Act” means R.I. Gen. Laws Chapter 23-4.11 entitled “Rights of the Terminally Ill Act”.
2. "Advance directive protocol" means a standardized, state-wide method developed for emergency medical services personnel by the department of health and approved by the ambulance service advisory board, of providing palliative care to, and withholding life-sustaining procedures from, a qualified patient.
3.“Advance health care directive” means a written document that states an individual’s choices for health care or names someone to express those choices the individual if the individual become unable to make health care decisions for themselves. An advance directive may be known as a Living Will, Durable Power of Attorney for Health Care, or health care proxy.
4."Artificial feeding" means the provision of nutrition or hydration by parenteral, nasogastric, gastric or any means other than through per oral voluntary sustenance.
5."Attending physician" means the physician who has primary responsibility for the treatment and care of the patient.
6."Declaration" means a witnessed document executed in accordance with the requirements of R.I. Gen. Laws §§ 23-4.11-3 or 23-4.11-3.1.
7.“Department” means the Rhode Island Department of Health.
8."Director" means the Director of the Rhode Island Department of Health.
9."Emergency medical services personnel" means paid or volunteer firefighters, law enforcement officers, first responders, emergency medical technicians, or other emergency services personnel acting within the ordinary course of their professions.
10.“Health care decision maker” means a person authorized by law or by the qualified patient to make health care decisions for the qualified patient. The qualified patient may revoke at any time and in any manner the appointment of a health care decision maker.
11."Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, as defined in R.I. Gen. Laws § 23-17-2(6).
12."Health care provider" means a person who is licensed, certified, or otherwise authorized by the law of Rhode Island to administer health care in the ordinary course of business or practice of a profession.
13."Life sustaining procedure" means any medical procedure or intervention that, when administered to a qualified patient, will serve only to prolong the dying process. "Life sustaining procedure" shall not include any medical procedure or intervention considered necessary by the attending physician to provide comfort and care or alleviate pain.
14.“Medical orders for life sustaining treatment” or “MOLST” means a voluntary request that directs a health care provider regarding resuscitative and life-sustaining measures.
15.“Medical orders for life sustaining treatment form” or “MOLST Form” means a document which directs health care providers regarding resuscitative and life-sustaining measures.
16.“MOLST qualified health care provider” means the physician, registered nurse practitioner, or physician assistant who is authorized by the patient to sign a MOLST form.
17.“Physician assistant” means a person licensed as a physician assistant under R.I. Gen. Laws Chapter 5-54.
18."Person" means an individual, corporation, business trust, estate, trust, partnership, association, government, governmental subdivision or agency, or any other legal entity.
19."Physician" means an individual licensed to practice medicine under R.I. Gen. Laws Chapter 5-37.
20."Qualified patient" means a patient who has executed a declaration in accordance with the Act and these Regulations, and who has been determined by the attending physician to be in a terminal condition.
21.“Registered nurse practitioner” means a person licensed as such under R.I. Gen. Laws Chapter 5-34.
22."Reliable documentation" means a standardized, state-wide form of identification such as a nontransferable necklace or bracelet of uniform design, adopted by the director of health, with consultation from the local community emergency medical services agencies and licensed hospice and home health agencies, that signifies and certifies that a valid and current declaration is on file and that the individual is a qualified patient.
23.“Request regarding resuscitative and life sustaining measures” means a written document, signed by:
a.A qualified patient with capacity, or a recognized health care decision maker; and
b.The MOLST qualified health care provider, which directs a health care provider regarding resuscitative and life sustaining measures. Such a request regarding resuscitative and life sustaining measures is a medical order.
24."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
25."Terminal condition" means an incurable or irreversible condition that, without the administration of life sustaining procedures, will, in the opinion of the attending physician, result in death.
26.“These Regulations” means all parts of Rhode Island rules and regulations pertaining to Medical Orders for Life Sustaining Treatment.
27.“Updating a MOLST form” means to revise an existing MOLST form by voiding the existing form and completing a new MOLST form in accordance with these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2013-09-29 to 01/04/2022*
- *Technical Revision — effective from 2013-09-29 to 09/29/2013*
- *Adoption — effective from 2013-09-29 to 09/29/2013*
##### **216-RICR-20-15-4 § 4.3** Scope and Application {#sec-216-ricr-20-15-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-4#4.3}
A.These Regulations set out the Medical Orders for Life-Sustaining Treatment (MOLST) form, instructions and certain related procedures and requirements developed by the Department pursuant to the Act.
B.If a qualified patient with a MOLST order is transferred from a hospital, another health care facility, or the community, the MOLST order or plan shall remain effective until a MOLST qualified health care provider first examines the transferred qualified patient, whereupon a MOLST qualified health care provider shall issue appropriate orders to continue the prior order or plan. Such orders may be issued without obtaining another consent to withhold or withdraw life-sustaining treatment pursuant to the Act and these Regulations.
C.Beginning 1 January 2014, the following health care facilities are required to accept, update if appropriate, and offer each qualified patient the opportunity to complete a MOLST form during the admission process:
1.A nursing facility;
2.An assisted living residence;
3.A hospice;
4.A kidney dialysis center; and
5.A home health agency.
D.Beginning 1 January 2014, a hospital shall:
1.Accept and update if appropriate, a completed MOLST form; or
2.Offer each patient the opportunity to complete a MOLST form during the qualified patient’s inpatient stay if the patient is to be discharged or transferred to another health care facility.
E.A nursing home or an assisted living residence shall also offer each patient admitted before 1 January 2014, and who continues to reside in the nursing facility or assisted living residence after 1 January 2014, an opportunity to complete a MOLST form.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2013-09-29 to 01/04/2022*
- *Technical Revision — effective from 2013-09-29 to 09/29/2013*
- *Adoption — effective from 2013-09-29 to 09/29/2013*
##### **216-RICR-20-15-4 § 4.4** Medical Orders for Life Sustaining Treatment {#sec-216-ricr-20-15-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-4#4.4}
4.4.1Treatment of Qualified Patients.
A qualified patient has the right to make decisions regarding use of life sustaining procedures as long as the patient is able to do so. If a qualified patient is not able to make those decisions, the declaration governs decisions regarding use of life sustaining procedures.
4.4.2Medical Orders for Life Sustaining Treatment.
A.The MOLST is a voluntary option for qualified patients. No patient is required to elect a MOLST.
B.A declaration by a qualified patient may be recorded as a medical order for life-sustaining treatment provided that:
1.The medical orders for life-sustaining treatment and medical intervention and procedures are explained by a MOLST qualified health care provider to the qualified patient or recognized health care decision maker. The MOLST qualified health care provider shall further inform the qualified patient of the difference between an advance health care directive and MOLST medical order;
2.A MOLST qualified health care provider has conducted an evaluation of the qualified patient; and
3.A MOLST form documenting the declaration has been completed by a MOLST qualified health care provider based on qualified patient preferences and medical appropriateness, and has been signed by a MOLST qualified health care provider and the qualified patient or his or her recognized health care decision maker.
C.A MOLST qualified health care provider may conduct an evaluation of the qualified patient and, if necessary, in consultation with the qualified patient or recognized health care decision maker, issue a MOLST consistent with the most current information available about the qualified patient's health status and care preferences.
D.A MOLST form shall be completed or updated by a MOLST qualified health care provider in accordance with instructions provided by the Department. Except as otherwise provided by the Act or these Regulations, a MOLST qualified health care provider shall complete or update a MOLST form in a manner that is consistent with:
1.The known decisions of:
a.A competent qualified patient; or
b.A recognized health care decision maker.
2.Any known advance directive if the qualified patient is incapable of making an informed decision.
E.A health care provider shall treat a qualified patient in accordance with the qualified patient's MOLST, subject to the provisions of the Act and these Regulations.
F.A request regarding resuscitative measures may also be evidenced by the words "do not resuscitate" or the letters "DNR," in a qualified patient's medical record and/or through a mechanism established by the Department consistent with the provisions of the Act and these Regulations.
G.A recognized health care decision maker may execute the MOLST form if the qualified patient lacks capacity, or if the qualified patient has designated that the health care decision maker's authority is valid.
4.4.3MOLST Form
A.A MOLST shall be documented on an easily identifiable form approved by the Director.
B.The MOLST form approved by the Director is the only MOLST form that may be completed and signed within the State of Rhode Island.
C.The MOLST form shall contain all other information as required by these Regulations.
D.The MOLST form shall be signed by the qualified patient, or the qualified patient's recognized health care decision maker, and a MOLST qualified health care provider.
4.4.4Validity of MOLST Form.
A.A MOLST form shall apply regardless of whether the qualified patient executes the MOLST form within or outside a hospital or other health care setting.
B.The MOLST form is valid within or outside a hospital or other health care setting.
4.4.5Revocation of a MOLST Form.
A.A qualified patient or his/her recognized health care decision maker may, at any time, revoke in any manner that communicates an intent to revoke his/her declaration by informing the MOLST qualified health care providers, other health care providers, or any member of the medical or nursing staff of the revocation of the declaration concerning life-sustaining or resuscitative measures.
B.Any member of the medical or nursing staff informed of a revocation shall immediately notify a MOLST qualified health care provider of the revocation.
C.The MOLST qualified health care provider informed of a revocation of MOLST made pursuant to these Regulations shall immediately:
1.Record the revocation in the qualified patient's medical record;
2.Cancel any orders implementing the decision to withhold or withdraw treatment; and
3.Notify the health care providers and staff directly responsible for the qualified patient's care of the revocation and any cancellations.
D.If a decision to withhold or withdraw life-sustaining treatment has been made by a recognized health care decision maker pursuant to the Act or these Regulations, and the MOLST qualified health care provider determines at any time that the decision is no longer appropriate or authorized because the qualified patient has regained decision-making capacity or because the qualified patient’s condition has otherwise improved, the MOLST qualified health care provider shall immediately:
1.Include such determination in the qualified patient's medical record;
2.Cancel any orders or plans of care implementing the decision to withhold or withdraw life-sustaining treatment;
3.Notify the recognized health care decision maker who made the decision to withhold or withdraw treatment; and
4.Notify the other health care providers, including the medical and nursing staff directly responsible for the qualified patient’s care, of any cancelled MOLST orders or plans of care.
E.A MOLST form shall only be voided by a MOLST qualified health care provider.
F.To void a MOLST form, draw a diagonal line through the sheet, write “VOID” in large letters across the page, and sign and date below the line.
4.4.6Resolving Conflicts Between MOLST Forms.
If the medical records of a qualified patient contain more than one MOLST form, the orders contained in the most recent MOLST form shall be followed unless and until the form is updated.
4.4.7Reproduction and Alteration of the MOLST Form.
A.A health care provider may freely copy, store electronically, and subsequently print or otherwise reproduce a MOLST form provided by the Department.
B.A MOLST qualified health care provider may not alter the contents or format of a MOLST form provided by the Department.
4.4.8Voiding a MOLST Form.
A.A MOLST qualified health care provider can give a verbal order to void the MOLST form if there is documentation that there was discussion with the qualified patient or the patient’s recognized health care decision maker about discontinuing the MOLST order. A nurse can then take the verbal order to VOID the MOLST form. Documentation of the MOLST discussion will be placed in the patient's record when the verbal order is verified.
B.The voided MOLST form shall be kept in the patient’s active or archived medical record.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2013-09-29 to 01/04/2022*
- *Technical Revision — effective from 2013-09-29 to 09/29/2013*
- *Adoption — effective from 2013-09-29 to 09/29/2013*
##### **216-RICR-20-15-4 § 4.5** Severability {#sec-216-ricr-20-15-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-4#4.5}
If any provisions of these Regulations or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of these Regulations which can be given effect, and to this end the provisions of these Regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2013-09-29 to 01/04/2022*
- *Technical Revision — effective from 2013-09-29 to 09/29/2013*
- *Adoption — effective from 2013-09-29 to 09/29/2013*
#### **216-RICR-20-15-5** Continuing Care Provider Registration and Disclosure
##### **216-RICR-20-15-5** Continuing Care Provider Registration and Disclosure {#sec-216-ricr-20-15-5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-5}
**History**
- *Technical Revision — effective from 2002-01-02 to current*
- *Periodic Refile — effective from 2002-01-02 to 01/02/2002*
#### **216-RICR-20-15-6** Hypodermic Needles, Syringes, and Other Such Instruments
##### **216-RICR-20-15-6 § 6.1** Authority {#sec-216-ricr-20-15-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-6#6.1}
These amended Rules and Regulations Governing Hypodermic Needles, Syringes, and Other Such Instruments are promulgated pursuant to the authority set forth in R.I. Gen. Laws 21-28-3.01, and are established for the purpose of promoting public health by permitting the sale of hypodermic needles and syringes in licensed pharmacies and adopting provisions governing hypodermic needles, syringes, and other such instruments without the need for a prescription.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-01-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 01/02/2002*
##### **216-RICR-20-15-6 § 6.2** Definitions {#sec-216-ricr-20-15-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-6#6.2}
A.“Authorized pharmacy personnel” means a person who is licensed, registered, or enrolled by the Department pursuant to R.I. Gen. Laws Chapter 5-19 and the Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
B."Department" means the Rhode Island Department of Health.
C.“Director” means the Director of the Rhode Island Department of Health.
D.“Pharmacy” means that portion or part of a premises where prescriptions are compounded and dispensed, including that portion utilized for the storage of prescription drugs or legend drugs, and which is licensed pursuant to R.I. Gen. Laws Chapter 5-19 and the Department of Health’s Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-01-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 01/02/2002*
##### **216-RICR-20-15-6 § 6.3** Sale of Hypodermic Needles and Syringes in Licensed Pharmacies {#sec-216-ricr-20-15-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-6#6.3}
6.3.1General Requirements
A.As of September 1, 2000, a prescription shall no longer be required for each sale of a hypodermic syringe(s), needle(s), or any instrument adapted for the administration of drugs by injection.
B.Hypodermic needles and syringes shall be sold only in licensed pharmacies.
1.Hypodermic needles and syringes shall be stored in the pharmacy. Access to hypodermic needles and syringes shall be by authorized pharmacy personnel only.
C.Upon each sale of a hypodermic needle(s) and syringe(s), the pharmacist shall make available to the purchaser, information on the safe disposal of hypodermic syringes or needles that shall include:
1.Information on the safe disposal of home-generated medical waste; and
2.A list of local disposal locations; and/or
3.A telephone number to call for information on local disposal sites and methods of disposal.
D.Pharmacists may also provide purchasers with information on drug addiction treatment, including a local telephone number to get assistance.
6.3.2Pharmacy Certification
A.The registrant of each licensed pharmacy in the state shall certify to the Director, on a form provided by the Department, his/her participation in an appropriate activity for the safe disposal of hypodermic needles and syringes. Activities shall include:
1.Pharmacy is registered as a regulated medical waste generator with the Department; or
2.Pharmacy is an established site for the collection for home-generated medical waste in a medical waste program certified by the Director, or provides information to purchasers that lists the locations of the local collection sites for home-generated medical waste; or
3.Pharmacy provides written information relating to the safe disposal of hypodermic needles and syringes.
B.When there is a change in registrant, the incoming registrant shall certify participation in activities as outlined in § 5.3.2(A) of this Part.
6.3.3Destruction of Excess, Undesired, and Contaminated Hypodermic Needles, Syringes, or Other Such Instruments
A.The legal destruction of hypodermic needles, syringes or other such instruments is the responsibility of the last entitled or authorized possessor.
B.Methods of Disposal: In accordance with the requirements of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island, the following methods of disposal are intended to accomplish the purpose of adequate final destruction without danger of contamination of or injury to waste disposal personnel and to prevent diversion of the instruments or transmission of communicable diseases to the general population.
1.The requirements cited below shall apply to all health care facilities and individuals licensed by the Department of Health and authorized to handle needles, syringes, and other such instruments.
a.Pursuant to R.I. Gen. Laws § 21-29.1-1, all facilities or persons legally entitled to use disposable syringes and needles including but not limited to hospitals, physicians, skilled nursing and intermediate care facilities, shall destroy them after one (1) use. Any violation of this provision shall constitute a misdemeanor.
b.Excess and undesired needles, syringes and other such instruments shall be stored in impervious, rigid, puncture-resistant containers for disposal. Intact needles must be placed directly into the collection containers (i.e., without recapping, clipping, breaking or compacting) unless the person can demonstrate that an alternative is feasible and the alternatives are approved by the Department of Health, or that such action is required by a specific medical procedure.
c.Personnel handling disposal waste materials such as needles, syringes, and other such instruments may treat and destroy such waste on-site in a Department of Environmental Management (DEM)-permitted incinerator or by a DEM-approved alternative treatment/destruction technology or prepare the regulated medical waste for off-site transport by a DEM-permitted medical waste transporter.
d.Containers with used or unused needles, syringes, and other sharps may be treated and destroyed on-site in a DEM-permitted incinerator or by a DEM-approved alternative medical waste treatment/destruction technology, or at an off-site treatment and destruction facility.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-01-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 01/02/2002*
##### **216-RICR-20-15-6 § 6.4** Severability {#sec-216-ricr-20-15-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-6#6.4}
A.If any provision of these regulations or the application thereof to any facility or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provision of the regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2002-01-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 01/02/2002*
#### **216-RICR-20-15-7** Immunization, Testing, and Health Screening for Health Care Workers
##### **216-RICR-20-15-7 § 7.1** Purpose {#sec-216-ricr-20-15-7-7.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.1}
These Regulations establish requirements for adopting standards for immunization and communicable disease screening and testing for health care workers prior to employment in Rhode Island-licensed health care facilities.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.2** Authority {#sec-216-ricr-20-15-7-7.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.2}
These Regulations are promulgated pursuant to the authority conferred under Chapters 23-17 and 23-17.7.1 of the General Laws of Rhode Island.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.3** Incorporated Materials {#sec-216-ricr-20-15-7-7.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.3}
A.These Regulations hereby adopt and incorporate the Centers for Disease Control and Prevention (CDC) General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR, Recommendations and Reports (January 2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations. https://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf.
B.These Regulations hereby adopt and incorporate the CDC Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (November 2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations. https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf.
C.These Regulations hereby adopt and incorporate the CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings MMWR, Recommendations and Reports (December 2005) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate the Occupational Safety and Health Administration (OSHA) Blood Borne Pathogens Standard (29 C.F.R Parts 1910 - 1030), (April 2012) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.4** Definitions {#sec-216-ricr-20-15-7-7.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.4}
A.Wherever used in these Regulations, the following terms shall be construed as follows:
1."Advance practice registered nurse" or "APRN" means an individual licensed in accordance with R.I. Gen. Laws § 5-34-45.
2.“Advisory Committee on Immunization Practices (ACIP) recommendations", as used in these Regulations, means official Federal recommendations for the use of vaccines in the United States and as published by the Centers for Disease Control and Prevention. ACIP recommendations represent the standard of care for immunization practice in the United States.
3.“Assisted living residence” means as defined in R.I. Gen. Laws § 23-17.4-2(4).
4.“Assisted living residence worker” means any person who is temporarily or permanently employed by the assisted living residence, or who serves as a volunteer in an assisted living residence, or any person who is compensated by a third (3rd) party that has an agreement with the assisted living residence to provide staffing services and has or may have direct contact with a patient in that assisted living residence. This may include, but not be limited to students and trainees, contractual staff not employed by the assisted living residence; other health care providers, including those who have privileges at, but are not employed by, the assisted living residence; and persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, administrative, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted from person to person. This term shall not apply to a residence’s family member or friend who visits or otherwise assists in the care of that patient in an assisted living residence.
5.“Department” means the Rhode Island Department of Health.
6."Direct patient contact" means any routinely anticipated face-to-face interaction with patients in a health care facility.
7.“Director” means the Director of the Rhode Island Department of Health or his or her designee.
8.“Healthcare facility”, as used herein, means a facility as defined in R.I. Gen. Laws § 23-17-2(9), as well as adult daycare programs, as defined in R.I. Gen. Laws § 23-1-52 and stations, as defined in R.I. Gen. Laws § 23-16.2-2.
9.“Healthcare worker” means any person who is temporarily or permanently employed by a health care facility, or who serves as a volunteer in a health care facility, or any person who is compensated by a third (3rd) party that has an agreement with the health care facility to provide staffing services, and has or may have direct contact with a patient in that health care facility. This may include, but not be limited to, a physician, physician assistant, nurse, nursing assistant, therapist, technician, clinician, behavioral analyst, social worker, occupational, physical or speech therapist, phlebotomist, emergency medical service personnel, dental personnel, pharmacist, laboratory personnel, autopsy personnel, students and trainees, contractual staff not employed by the health-care facility; other health care providers, including those who have privileges at, but are not employed by, the health care facility; and persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, administrative, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted from person to person. This term shall not apply to a patient’s family member or friend who visits or otherwise assists in the care of that patient in a health care facility.
10."Nurse" means an individual licensed in this State to practice nursing pursuant to the provisions of R.I. Gen. Laws Chapter 5-34.
11."Period in which flu is widespread" means a period that commences when the Director declares that there is an outbreak of influenza that is widespread within a facility, or within a defined geographic area in which the facility is located, or throughout Rhode Island; and that ends when the Director declares to such a health care facility or facilities that the outbreak is no longer widespread.
12.“Physician” means an individual licensed under the provisions of R.I. Gen. Laws Chapter 5-37.
13."Physician assistant" means an individual licensed in this State to practice as a physician assistant pursuant to the provisions of R.I. Gen. Laws Chapter 5-54.
14."Practitioner" means a physician, advance practice registered nurse, registered nurse, licensed practical nurse, or a physician assistant.
15."Pre-employment health screening" means the review of health records, pertinent laboratory results, and other documentation of a health care worker performed by a licensed practitioner in order to determine that the health care worker is free of the communicable diseases cited in these Regulations, and is also appropriately immunized, tested, and counseled prior to employment.
16."Up to date" means a person has received all recommended doses of a COVID-19 vaccine, including any booster dose(s), when eligible.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.5** General Requirements {#sec-216-ricr-20-15-7-7.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.5}
A.Healthcare facilities shall adopt, at a minimum, the standards of immunization and communicable disease testing and standards for health screening contained herein.
B.It shall be the responsibility of the administrative head, or his or her designee, of any healthcare facility to secure compliance with these Regulations.
C.Each healthcare facility shall develop policies, procedures, and/or protocols for compliance with the requirements described in these Regulations.
D.Transient employees or outside contractors who are not involved in direct patient contact and are not potentially exposed in the course of employment to infectious agents that can be transmitted from person to person, are exempt from the requirements stated in these Regulations.
E.Healthcare facilities and healthcare workers shall comply with additional immunization and screening requirements that the Director may prescribe from time to time to control communicable diseases.
F.Persons discovering communicable diseases (e.g., physicians, physician assistants, registered nurse practitioners), in the process of screening health care workers shall comply with the reporting requirements contained in Part 30-05-1 of this Title.
G.In accordance with ACIP recommendations, for all vaccines discussed in these Regulations, vaccine doses administered less than or equal to four (4) days before the minimum interval or age shall be counted as valid. Doses administered five (5) or more days earlier than the minimum interval or age shall not be counted as valid doses and shall be repeated as age-appropriate. The repeat dose should be spaced after the invalid dose by the recommended minimum interval as provided in § 7.3(A) of this Part.
H.Healthcare workers who receive the first (1st) dose of a multi-dose vaccine series may begin to work after this first (1st) dose is received.
I.Each healthcare facility shall provide, at no financial charge, an adequate supply of medical masks or higher-grade masks (e.g., N95) to any health care worker.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.6** Minimum Standards for Immunization and Communicable Disease Testing for Health Care Workers {#sec-216-ricr-20-15-7-7.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.6}
A.A pre-employment health screening shall be required for each healthcare worker involved in direct patient contact. Acceptable evidence shall be provided by the healthcare worker that testing and/or immunization for the communicable diseases listed in these Regulations for pre-employment health screening have been completed.
B.The healthcare facility shall document, in written or electronic form, that said acceptable evidence has been provided by the healthcare worker and validated by the practitioner as being acceptable in accordance with § 7.7 of this Part. Copies of said acceptable evidence shall be maintained in the healthcare worker’s file.
C.A practitioner shall have responsibility for performance of the pre-employment health screening. Such a practitioner may be an employee of the facility where employment is sought or may be an independent non-employee, contracted practitioner.
D.A healthcare worker who is not in compliance with these requirements shall be excluded from attending patients in a healthcare facility until the requirements are met.
7.6.1Immunization and Testing Requirements
A.In accordance with the guidelines set forth in § 7.3(B) of this Part, evidence of immunity is required for all healthcare workers (except for healthcare workers who receive a medical exemption) against:
1.Measles, Mumps and Rubella
a.Pre Employment: Two (2) doses of MMR (measles-mumps-rubella) vaccine. Alternatively, two (2) doses of a live measles-containing vaccine, two (2) doses of a live mumps-containing vaccine and one (1) dose of a rubella vaccine. The first (1st) dose of vaccine must have been administered on or after the first (1st) birthday. The second (2nd) dose of a measles or mumps containing vaccine must be administered at least four (4) weeks after the first (1st) dose. or
b.Laboratory evidence of immunity or laboratory confirmation of disease (i.e., laboratory report of positive IgG titers for measles, and mumps and rubella). An equivocal laboratory result for measles, mumps and/or rubella are considered negative and vaccination is required.
c.Current Healthcare Workers. For unvaccinated health care workers born before 1957 who lack laboratory evidence of measles immunity or laboratory confirmation of disease, two (2) doses of MMR vaccine is recommended.
d.Outbreak Control. For unvaccinated healthcare workers born before 1957 who lack laboratory evidence of measles immunity or laboratory confirmation of disease, health-care facilities shall require two (2) doses of MMR vaccine during an outbreak of measles.
2.Varicella (Chickenpox)
a.Two (2) doses of varicella vaccine. The second (2nd) dose of varicella vaccine must be administered at least four (4) weeks after the first (1st) dose; or
b.Laboratory evidence of immunity or laboratory confirmation of disease; or
c.A healthcare provider diagnosis of varicella or healthcare provider verification of history of varicella disease; or
d.History of herpes zoster based on healthcare provider diagnosis.
3.Tetanus, Diphtheria and Pertussis (Whooping Cough)
a.Pre-employment: One (1) single dose of Tdap (tetanus-diphtheria-pertussis) vaccine is required for all healthcare workers who have not previously received a dose of Tdap vaccine.
b.Effective 1 January 2014: This requirement shall apply to current employees, as well as new employees.
4.Annual Seasonal Influenza
a.Annual influenza vaccination is required for all healthcare workers, subject to § 7.8(F) of this Part.
b.Each healthcare facility shall develop a specific plan to require annual influenza vaccination of all health care workers in a timely manner in keeping with ACIP guidelines, and at no cost to the health care worker.
c.Each healthcare facility shall maintain an active surveillance program to track and record influenza vaccination levels among healthcare workers, including vaccinations obtained outside of the formal healthcare facility program.
d.Each healthcare facility shall be responsible for reporting to the Department:
(1)The number of healthcare workers who are eligible for vaccination;
(2)The number of healthcare workers who received vaccination; and
(3)The number of healthcare workers who decline annual influenza vaccination for medical or personal reasons, reported by each of the two (2) categories.
(4)Such reporting shall occur according to procedures and format required by the Department.
5.Tuberculosis (TB)
a.Pre-employment: Evidence that the healthcare worker is free of active tuberculosis based upon the results of a negative two (2) step tuberculin skin test shall be required.
(1)If documented evidence is provided by the healthcare worker that a two (2) step tuberculin skin test, performed within the most recent twelve (12) months prior to hire, was negative, the requirements of this section shall be met. For healthcare workers who can present documentation of serial tuberculin testing with negative results in the prior two (2) years (or more), a single baseline negative tuberculin test result is sufficient evidence of absence of TB infection.
(2)A negative U.S. Food and Drug Administration (FDA)-approved blood assay for Mycobacterium tuberculosis (BAMT) may be used instead of a two (2) step tuberculin skin test. If the baseline BAMT is positive, screening should proceed as indicated below for positive PPD.
(3)Documentation shall include date and result of the tuberculin skin test (PPD), and reaction size in millimeters or an actual copy of the laboratory test result from a BAMT.
(4)If the PPD test or BAMT is positive, consistent with the most current CDC guidance, or a previous one is known to have been positive, a physician's or other licensed practitioner's (acting within his or her scope of practice) certification that the health care worker is free of active disease shall be required. Such certification shall be based on documentation of adequate chemotherapy for TB disease or chemo-prophylaxis for latent TB infection in the past, and a current history of freedom from signs and symptoms of TB. In the absence of documentation of chemotherapy or chemo-prophylaxis, a negative chest x-ray shall be required for certification. The chest x-ray shall have been performed at any time after the most recent positive PPD test result.
(5)A physician, certified registered nurse practitioner, or a physician assistant may certify that the healthcare worker is currently free of TB based on his or her clinical judgment for complex cases or unusual circumstances that do not fit the above criteria.
b.Current Healthcare Workers
(1)Periodic follow up testing of all healthcare workers must be based on the CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings incorporated above at § 7.3(C) of this Part.
(2)Effective 1 January 2013, healthcare workers with newly detected latent TB infection (LTBI) at initial or periodic testing are required to be referred for care with intent to obtain treatment for latent TB infection. Referral of previously (prior to 1 January 2013) known LTBI for care is recommended.
(3)Effective 1 January 2013, LTBI cases detected in healthcare workers must also be reported to the RI TB Program on standard reporting forms.
6.Hepatitis B Vaccination and Testing
a.Healthcare facilities shall abide by the OSHA Blood Borne Pathogens Standard, incorporated above at § 7.3(D) of this Part including the offering of hepatitis B vaccination along with all recommendations for infection control training and provision of protective equipment to those healthcare workers at risk.
b.An exposure control plan shall be in place in all healthcare facilities licensed by the Department, pursuant to the provisions of R.I. Gen. Laws Chapter 23-17.
c.Employees at risk of exposure to blood-borne pathogens shall be offered hepatitis B vaccine within ten (10) days of employment.
(1)The hepatitis B vaccination series consists of three (3) doses of vaccine given as two (2) doses four (4) weeks apart followed by a third (3rd) dose five (5) months after the second (2nd) dose.
(2)It is recommended that testing for anti-HBs be performed one (1) to two (2) months after the last dose.
(3)Persons failing to develop a titer shall be offered a repeat three (3) dose series with follow up titers.
(4)Employees have the option of signing a standard OSHA declination form if they choose not to be vaccinated and should be counseled regarding risk.
d.If the healthcare worker, upon hire, has written documentation of a full hepatitis B vaccine series administered in accordance with ACIP guidelines, testing for anti-HBs shall not be necessary. If the healthcare worker has a subsequent exposure to HBV, hepatitis B immunoprophylaxis should be administered following ACIP guidelines for a person who has been vaccinated, but the immune response is not known.
B.In accordance with the guidelines set forth in § 7.3(B) of this Part, with respect to SARS-CoV-2 (COVID-19) vaccination, a healthcare worker or assisted living residence worker shall:
1.Be up to date with all CDC recommended doses of FDA approved or authorized COVID-19 vaccine (e.g., Moderna, Pfizer, or Johnson & Johnson) or have received all recommended dose(s) of another COVID-19 vaccine approved by the Department (e.g., Novavax); or
2.Wear an N95 mask at each healthcare facility or assisted living residence during where he or she is employed or volunteering, or with which he or she is compensated by a third (3rd) party which has an agreement with the healthcare facility to provide staffing services during each direct patient contact or while in a patient care area in the performance of his or her duties when a period in which the COVID-19 prevalence rate in the State is greater than or equal to fifty (50) cases per one hundred thousand (100,000) people per week, as reported by the Department.
3.In accordance with the Center for Medicaid and Medicare Services (CMS) 86 FR 61555, all Medicare and Medicaid certified providers, suppliers, and healthcare workers are required to receive the primary series (e.g., two (2) doses of Pfizer or Moderna, or one (1) dose of Johnson & Johnson) of a COVID-19 vaccine.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.7** Documentation of Immunity and Testing (Immunization Records) {#sec-216-ricr-20-15-7-7.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.7}
A.Acceptable documentation of completion of immunizations shall include the day, month, year and type/name of each dose of vaccine administered. The record of such evidence shall be signed by a practitioner (the signature of the healthcare worker is not acceptable).
1.Acceptable documentation of completion of immunization consists of:
a.An official immunization record card, school immunization record, medical passport, World Health Organization immunization record, a copy of a medical record indicating administration of vaccine; or other official immunization records acceptable to the Director; or
b.An electronically stored and/or transmitted documentary record (facsimile transmission, computerized record, including, but not limited to, a record on magnetic media or similar record) as may be utilized by a school; or
c.Presentation of laboratory evidence of immunity is made in the case of measles, mumps, rubella, varicella, or hepatitis B.
B.Each healthcare facility shall ensure the documentation in its internal records of the COVID-19 immunization status of its healthcare workers. With such documentation, each healthcare facility shall additionally maintain documentary proof of COVID-19 vaccination. Documentation of status and proof of vaccination, including month, day and year of vaccine administration shall be made available to the Department upon request.
C.A healthcare facility and/or healthcare worker must provide documentation of immunization to the Department upon request.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.8** Influenza Vaccination Refusal {#sec-216-ricr-20-15-7-7.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.8}
A.Any healthcare worker may refuse the annual seasonal influenza vaccination requirements described in these Regulations; provided, however, that he or she provides proper annual written notice of such refusal prior to December 15 of each year to each healthcare facility in or at which he or she is employed or volunteering, or with which he or she has an employment contract; and provided, however, that he or she who so refuses shall be required during any declared period in which flu is widespread to wear a procedure mask or higher-grade mask (e.g., KN95 or N95) during each direct patient contact or while in a patient care area in the performance of his or her duties at any healthcare facility. For healthcare workers licensed by RIDOH, compliance with this provision is part of his or her professional licensing obligations.
1.No healthcare worker shall be required to explain his or her refusal to obtain an annual seasonal influenza vaccination, nor shall any healthcare facility inquire into the basis of such refusal.
B.Whenever the Director declares a period in which flu is widespread in a healthcare facility, within a defined geographic area, or throughout Rhode Island, the requirements in § 7.8 of this Part for wearing surgical face masks shall apply only to those nonimmunized healthcare workers at facilities or in geographic areas for which the period is declared.
C.If the Director declares that a shortage exists for annual seasonal influenza vaccine, the Director shall be permitted to modify and/or suspend any requirement for some or all healthcare workers to obtain an annual seasonal influenza vaccination and/or any requirement for healthcare workers to wear surgical face masks in any healthcare facility; and shall be permitted to extend the deadlines in § 7.8(A) of this Part.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.9** Violations {#sec-216-ricr-20-15-7-7.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.9}
A.Healthcare facilities, assisted living residences and healthcare workers and assisted living residence workers that violate any provisions of this Part are subject to administrative action by the Department, and any other action provided for under applicable law and Regulations, including R.I. Gen. Laws § 23-1-25, in addition to any action against the professional and/or facility license, as applicable.
1.Healthcare facilities and assisted living residences shall have seven (7) days from the promulgation of this Part to implement measures necessary to ensure compliance with this Part.
2.Healthcare facilities now covered by this Part (i.e., Adult Day Cares and Stations) shall have three (3) months from the promulgation of this Part to implement measures necessary to ensure compliance with vaccination documentation.
3.Healthcare workers who are employed at newly covered healthcare facilities (i.e., Adult Day Cares and Stations) shall have three (3) months from the promulgation of this Part to receive all required vaccinations.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
##### **216-RICR-20-15-7 § 7.10** Severability {#sec-216-ricr-20-15-7-7.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-15-7#7.10}
If any provision of these Regulations or the application thereof to any person or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of these Regulations which can be given effect, and to this end the provisions of these Regulations are declared to be severable.
**History**
- *Amendment — effective from 2022-06-15 to current*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 05/26/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-09 to 01/02/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/09/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/06/2021*
- *Technical Revision — effective from 2012-10-25 to 06/15/2022*
- *Amendment — effective from 2012-10-25 to 10/25/2012*
- *Amendment — effective from 2007-02-14 to 10/25/2012*
- *Adoption — effective from 2002-08-04 to 02/14/2007*
### **Subchapter 20** Drugs
#### **216-RICR-20-20-1** Disposal of Drugs
##### **216-RICR-20-20-1 § 1.1** Authority {#sec-216-ricr-20-20-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-1#1.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 21-28-5.07 and 21-31-20, and are established for the purpose of adopting methods for the disposal of drugs in this state, and for the protection of the health, safety and welfare of the public.
**History**
- *Amendment — effective from 2023-06-08 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/08/2023*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 06/21/2018*
##### **216-RICR-20-20-1 § 1.2** Incorporated Materials {#sec-216-ricr-20-20-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-1#1.2}
These regulations hereby adopt and incorporate 21 C.F.R. § 1317 (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Amendment — effective from 2023-06-08 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/08/2023*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 06/21/2018*
##### **216-RICR-20-20-1 § 1.3** Definitions {#sec-216-ricr-20-20-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-1#1.3}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1.“Abandoned drugs” means non-controlled or controlled substances that have been brought into the health care facility by a patient admitted to a health care facility and have been left behind by the patient or their family, or if the patient is deceased.
2."Controlled substance" means a drug, substance or immediate precursor in R.I. Gen. Laws § 21-28-2.08 Schedules I - V.
3."Health care facility" means any health care institution as defined in R.I. Gen. Laws § , and licensed according to the provisions of R.I. Gen. Laws Chapter .
4."Drug" means any drug so designated pursuant to the provisions of R.I. Gen. Laws § 21-31-2(8).
5."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies) state or political subdivision or instrumentality of the state.
**History**
- *Amendment — effective from 2023-06-08 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/08/2023*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 06/21/2018*
##### **216-RICR-20-20-1 § 1.4** Disposal of Controlled Substances or Hazardous Waste Pharmaceuticals {#sec-216-ricr-20-20-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-1#1.4}
Any health care facility or person licensed by the Rhode Island Department of Health that is lawfully in possession of excess or undesired controlled substances, including abandoned drugs brought into a health care facility, shall inventory and dispose of all such controlled substances in accordance with 21 C.F.R. § 1317 incorporated above at § 1.2 of this Part and all other applicable federal, state, and local regulations. Hazardous waste pharmaceuticals collected as abandoned drugs can be disposed of as either controlled substances or as hazardous waste as per the Department of Environmental Management’s Rules and Regulations for Hazardous Waste Management (§ 250-RICR-140-10-1.7.1(E)(2)).”
**History**
- *Amendment — effective from 2023-06-08 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/08/2023*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 06/21/2018*
##### **216-RICR-20-20-1 § 1.5** Disposal of All Other Drugs (i.e., Non - controlled Substances) {#sec-216-ricr-20-20-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-1#1.5}
A.All other drugs (i.e., those not classified as controlled substances), including abandoned drugs brought into a health care facility, shall be the responsibility of the health care facility or person to dispose of as provided in one of the following ways:
1.Drugs may be disposed of as solid waste provided that all of the following conditions are met:
a.The drugs are rendered unrecognizable;
b.The drugs would not pose a threat to the public or to the environment; and
c.The drugs cannot be recycled. OR
2.The drugs may be disposed of as regulated medical waste (defined in Medical Waste Regulations (250-RICR-140-15-1)), through the use of an entity holding a regulated medical waste transporter permit issued pursuant to the requirements of the Medical Waste Regulations, 250-RICR-140-15-1, and in compliance with the Medical Waste Regulations, 250-RICR-140-15-1.
3.The Director of Health or her/his designee is authorized to:
a.Enter any premises where drugs, including controlled substances, are maintained and/or held for disposal pursuant to the requirements of this Part;
b.Inspect any and all aspects of the disposal process and related records; and
c.Obtain and test samples of any and all controlled substances being processed for disposal for the purpose of determining compliance with state and federal laws.
**History**
- *Amendment — effective from 2023-06-08 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/08/2023*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 06/21/2018*
#### **216-RICR-20-20-3** Prescription Drug Monitoring Program
##### **216-RICR-20-20-3 § 3.1** Authority {#sec-216-ricr-20-20-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.1}
A.These regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws §§ 21-28-3.18(d)(2) and 21-28-3.32(n)(3), and are established for the purpose of defining minimum standards for the transfer of electronic data between the Department of Health and pharmacies for schedule II, III, IV, and V controlled substances, and opioid antagonists.
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.2** Exemption {#sec-216-ricr-20-20-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.2}
A.Pharmacies that do not have a Rhode Island Controlled Substance Registration (CSR) pursuant to R.I. Gen. Laws § 21-28-3.02(a) are not required to report the dispensing of schedule II, III, IV, and V controlled substances and opioid antagonists to the prescription drug monitoring program (PDMP).
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.3** Definitions {#sec-216-ricr-20-20-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.3}
A.Wherever used in this Part, the following terms shall be construed as follows:
1."Controlled substance" means as defined in R.I. Gen. Laws § 21-28-1.02(8).
2.“Department" means the Rhode Island Department of Health.
3.“Nonresident pharmacy" means a pharmacy located outside Rhode Island in any state in the United States or any province or territory of Canada that ships, mails, or delivers prescription drugs and/or devices to a patient or person in Rhode Island.
4.“Parent or legal guardian” means the custodial parent for a person under eighteen (18) years of age or the legal guardian with responsibility for healthcare decisions for a person of any age.
5.“Pharmacy” means that portion or part of a premise where prescriptions are compounded and dispensed, including that portion utilized for the storage of prescription or legend drugs.
6.“Practitioner” means a physician, physician assistant, dentist, veterinarian, nurse or other person duly authorized by law in the state in which they practice to prescribe drugs.
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.4** General Requirements {#sec-216-ricr-20-20-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.4}
A.A pharmacy licensed as a retail pharmacy that dispenses schedule II, III, IV, or V controlled substances or opioid antagonists shall transmit prescription dispensing data for these substances to the Department in accordance with §§ 3.5(A) and (B) of this Part.
1.A pharmacy licensed as an institutional pharmacy that dispenses schedule II, III, IV, or V controlled substances or opioid antagonists shall transmit prescription dispensing data for these substances to the Department when dispensed to outpatients only and shall not be required to submit zero fill reports.
a.A pharmacy that possesses a Rhode Island Controlled Substance Registration (CSR) pursuant to R.I. Gen. Laws § 21-28-3.02(a) which does not dispense any controlled substances shall report “zero fills,” every twenty-four (24) hours.
b.Any pharmacy that does not possess a Rhode Island Controlled Substance Registration (CSR) is not required to submit “zero fills” reports.
2.A pharmacy licensed as a non-resident pharmacy shall be considered a pharmacy for the purpose of compliance with the reporting requirements of this Part.
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.5** Reporting and Management of Information {#sec-216-ricr-20-20-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.5}
A.A pharmacy that dispenses schedule II, III, IV, or V controlled substances or opioid antagonists to a person, who is not an inpatient of a hospital, shall transmit electronically to the Department the information stated in R.I. Gen. Laws § 21-28-3.32(b).
B.A pharmacy licensed as a retail pharmacy or a nonresident pharmacy shall transmit the required prescription information by means of a secure web-based data system, or other approved electronic methods, designated by the Department.
1.Pursuant to R.I. Gen. Laws § 21-28-3.18(n), A pharmacy shall transmit the information required pursuant to this Part one (1) business day following the date of dispensing.
2.A pharmacy shall transmit the information required pursuant to this Part to the Department in such a manner as to ensure the confidentiality of the information in compliance with all applicable federal and state statutes and regulations, including the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
3.Notification to the prescribing physician by the pharmacist for refusal to fill a prescription is pursuant to R.I. Gen. Laws § 21-28-3.32(k).
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.6** Management of Information {#sec-216-ricr-20-20-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.6}
A.The Department shall only disclose information obtained pursuant to this Part in accordance with R.I. Gen. Laws § 21-28-3.32(a).
B.A patient may request from the dispensing pharmacy correction of any inaccurate information contained within the PDMP in accordance with the procedure specified by R.I. Gen. Laws § 5-37.3-5(c).
C.Maintenance of records of information disclosed is pursuant to R.I. Gen. Laws § 21-28-3.32(e).
D.Removal of prescription information contained within the PDMP is pursuant to R.I. Gen. Laws § 21-28-3.32(f).
E.Notification of improper disclosure is pursuant to R.I. Gen. Laws § 21-28-3.32(g).
F.Notification to patients of the PDMP is pursuant to R.I. Gen. Laws § 21-28-3.32(h).
G.Department disclosure of information to patients is pursuant to R.I. Gen. Laws § 21-28-3.32(c).
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.7** Storage of Information {#sec-216-ricr-20-20-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.7}
A.The Department shall ensure the privacy of patients and confidentiality of patient information transmitted or obtained is maintained in accordance with applicable state and federal laws, rules, and regulations.
1.No person shall access information in the PDMP except to the extent and for the purposes authorized by § 3.6(A) of this Part.
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.8** Evaluation {#sec-216-ricr-20-20-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.8}
A.The Department may evaluate the prescription information received from pharmacies for the purposes of preventing controlled substance diversion, public health initiatives, and statistical reporting.
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
##### **216-RICR-20-20-3 § 3.9** Delegation of Access to the Electronic Prescription Database {#sec-216-ricr-20-20-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-3#3.9}
A.Notwithstanding the provisions of § 3.6(A) of this Part, a pharmacist or prescriber is allowed to share access to the PDMP with an authorized designee of the practitioner and/or pharmacist, to consult the PDMP on the practitioner's and/or pharmacist's behalf, or with a medical director of the practitioner's practice for quality improvement activities within the practice, provided that the requirements of R.I. Gen. Laws § 21-28-3.32(a)(3) are satisfied.
**History**
- *Amendment — effective from 2025-02-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/20/2025*
- *Amendment — effective from 2018-05-15 to 01/04/2022*
- *Amendment — effective from 2014-10-13 to 05/15/2018*
- *Amendment — effective from 2014-07-17 to 10/13/2014*
- *Periodic Refile — effective from 2002-01-02 to 07/17/2014*
#### **216-RICR-20-20-4** Pain Management, Opioid Use and the Registration of Distributors of Controlled Substances in Rhode Island
##### **216-RICR-20-20-4 § 4.1** Authority {#sec-216-ricr-20-20-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 21-28-3.01, for the purpose of establishing minimum requirements for pain management and opioid prescribing by a practitioner, and requiring registration of every person who manufactures, distributes, prescribes, administers or dispenses any controlled substance within Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.2** Incorporated Materials {#sec-216-ricr-20-20-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.2}
These regulations hereby adopt and incorporate 21 C.F.R. § 1311 (Requirements for Electronic Orders and Prescriptions) (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.3** Definitions {#sec-216-ricr-20-20-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.3}
A.Wherever used in these regulations, the following terms shall be construed as follows:
1."Act" means the R.I. Gen. Laws Chapter 21-28 entitled, "Uniform Controlled Substances Act."
2."Acute pain" means the normal, predicted physiological response to a noxious chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, trauma, and disease. Acute pain generally results from nociceptor activation due to damage to tissues. Acute pain typically resolves once the tissue damage is repaired. The duration of acute pain varies. For the purpose of this Part, acute pain shall not include chronic pain management, pain associated with a current cancer diagnosis, palliative care or nursing home care.
3. “Addiction medicine physician” means a physician who is specifically trained in a wide range of prevention, evaluation and treatment modalities addressing substance use disorder in ambulatory care settings, acute care and long-term care facilities, psychiatric settings, and residential facilities.
4.“Recovery from a substance use disorder” means a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential in areas of health, home, purpose and community, making informed, healthy choices that support physical and emotional wellbeing.
5."Chronic pain" means pain of greater than ninety (90) days duration, excluding pain requiring palliative care.
6."Common carrier" means any person who or which undertakes, whether directly or by any other arrangement, to transport property, or any class or classes of property, by motor vehicle between points within this state; for the general public for compensation, over the publicly used highways of this state, whether over regular or irregular routes, pursuant to R.I. Gen. Laws § 39-12-2.
7."Contract carrier" means any person who or which engages in transportation of property by motor vehicle, in intrastate commerce for compensation, under continuing contract with one (1) person, or an unlimited number of persons, for the furnishing of transportation services of a special and individual nature required by the shipper, and not generally provided by common carriers, pursuant to R.I. Gen. Laws § 39-12-2.
8.“Controlled substance" means a drug, substance, or immediate precursor in Schedules I-V of R.I. Gen. Laws Chapter 21-28. The term shall not include distilled spirits, wine, or malt beverages, as those terms are defined or used in R.I. Gen. Laws Chapter 3-1, nor tobacco.
9."Department" means the Rhode Island Department of Health.
10."Director" means the Director of the Rhode Island Department of Health.
11."Distribute" means to deliver (other than by administering or dispensing) a controlled substance or an imitation controlled substance, and includes actual, constructive, or attempted transfer.
12."Distributor" means a person who so delivers a controlled substance, or an imitation controlled substance, pursuant to R.I. Gen. Laws § 21-28-1.02(18).
13."Electronic prescription" means a secure (encrypted and encoded) technology system that allows practitioners to create, sign, transmit, and file prescriptions from a computer or smart device to a pharmacy computer directly and electronically. Electronic prescriptions do not include handwritten, emailed, or faxed prescriptions or calling in prescriptions.
14."Hospice" means a model of care that focuses on relieving symptoms and supporting patients with a life expectancy of six (6) months or less. Hospice involves an interdisciplinary approach to provide health care, pain management, and emotional and spiritual support. The emphasis is on comfort, quality of life, and patient and family support. Hospice can be provided in the patient's home as well as freestanding hospice facilities, hospitals, nursing homes, or other long-term care facilities.
15.“Initial prescription” means first prescription given to someone who is new to the prescription of opioids from your institution or office, and has not used opioids in the most recent thirty (30) calendar days.
16."Interstate carrier" means any person who or which operates motor vehicles for the transportation of property of others for compensation, over the publicly used highways of this state in interstate commerce, authorized or certified by the Interstate Commerce Commission, pursuant to R.I. Gen. Laws § 39-12-2.
17.“Long acting and extended release opioids” – opioids intended for long acting or extended use have a half-life long enough that they are generally prescribed less than three (3) times a day. Examples of long acting and extended release opioids include, but are not limited to: Avinza (morphine sulfate) Extended-Release Capsules, Dolophine (methadone hydrochloride) Tablets, Duragesic (fentanyl transdermal system), Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release Capsules, Exalgo (hydromorphone HCl) Extended-Release Tablets, Kadian (morphine sulfate) Extended-Release Capsules, MS Contin (morphine sulfate) Extended-Release Tablets, Nucynta ER (tapentadol) extended-release tablets, Opana ER (oxymorphone hydrochloride) Extended-Release Tablets, Oxycontin (oxycodone hydrochloride) Extended-Release Tablets, Palladone (hydromorphone hydrochloride) Extended-Release Capsules) as well as other similar and future U.S. FDA-approved medications in this classification as defined by the U.S. FDA.
18."Medical record" means a record of a patient's medical information and treatment history maintained by physicians and other medical personnel, which includes, but is not limited to, information related to medical diagnosis, immunizations, allergies, x-rays, copies of laboratory reports, records of prescriptions, and other technical information used in assessing the patient's health condition, whether such information is maintained in a paper or electronic format.
19."Morphine milligram equivalents" or "MMEs" means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables. [A copy of this tool may be downloaded from: http://www.health.ri.gov/healthcare/medicine/about/safeopioidprescribing/]
20."Multidisciplinary pain clinic" means a clinic or office that provides comprehensive pain management provided by different health care disciplines including at least two (2) medical specialties and non-physician professionals. It shall include care provided by multiple available disciplines and treatment modalities in an integrated fashion.
21."Opioid induced hyperalgesia" means increased perception of pain out of proportion to what is expected, that results from the effects of opioids on the central nervous system (CNS).
22.“Pain” means an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.
23."Pain medicine physician" means a physician whose usual course of practice is to treat patients who have acute and/or chronic pain as a condition.
24."Palliative care" means patient and family centered medical care that optimizes quality of life by anticipating, preventing, and treating suffering caused by advanced serious illness. Palliative care throughout the continuum of illness involves addressing physical, emotional, social and spiritual needs and facilitating patient autonomy, access to information, and choice. Palliative care includes, but is not limited to, discussions of the patient’s goals for treatment; discussion of treatment options appropriate to the patient, including, where appropriate, hospice care; and comprehensive pain and symptom management.
25."Person" means any corporation, association, partnership, or one or more individuals.
26."Physical dependence" means a state of adaptation that is manifested by a drug-class-specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing the level of the drug in the blood.
27."Practitioner" means, for the purpose of this Part, a physician licensed pursuant to R.I. Gen. Laws Chapter 5-37, a physician assistant licensed pursuant to R.I. Gen. Laws Chapter 5-54; an Advanced Practice Registered Nurse (APRN) licensed pursuant to R.I. Gen. Laws Chapter 5-34; dentist; podiatrist; veterinarian; scientific investigator; or other person licensed, registered or permitted to prescribe, distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in Rhode Island.
28."Private carrier" means any person, other than a common carrier, or a contract carrier, or an interstate carrier, who or which transports in intrastate or interstate commerce by motor vehicle, property of which such person is the owner, lessee, or bailee, when such transportation is for the purpose of sales, lease, rent, or bailment, or in the furtherance of any commercial enterprise, pursuant to R.I. Gen. Laws § 39-12-2.
29."Substance use disorder" means a diagnosis provided by a licensed practitioner meeting the diagnostic criteria of the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-5), or the coding of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
30."Tolerance" means a state of adaptation in which exposure to a substance induces changes that result in a diminution of one or more of the substance’s effects over time.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.4** Pain Management and Prescribing {#sec-216-ricr-20-20-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.4}
A.Patient Evaluation. The practitioner shall obtain, evaluate and document the patient's health history and physical examination in the health record prior to treating for chronic pain.
B.Documentation of Treatment Plan. Documentation in the medical record for chronic pain shall state the objectives that will be used to determine treatment success and shall include, at a minimum:
1.Any change in pain relief;
2.Any change in physical and psychosocial function; and
3.Additional diagnostic evaluations or other planned treatments.
C.Opioid Use in Acute Pain Management: For the purpose of this Part, acute pain shall not include chronic pain management, any chronic illness with recurrent acute pain that is a known expression of the chronic disease, pain associated with sickle cell disease, pain associated with a current cancer diagnosis, palliative care or nursing home care.
1.If a patient is given opioids in an inpatient setting and then discharged from an inpatient setting, and prescribed an opioid on discharge, this is considered an initial prescription if they have not otherwise used opioids in the past thirty (30) days.
2.The initial prescription for an opioid for acute pain for an individual who has not received opioids in the last 30 days shall not exceed thirty (30) MMEs total dose per day for a maximum of twenty (20) doses.
3.Long-acting and extended-release opioids, including methadone, shall not be prescribed for acute pain.
4.Pursuant to § 4.4(E) of this Part, a practitioner must review the Prescription Data Monitoring Program (PDMP) prior to initiating an opioid, including prescriptions prescribed in an inpatient setting.
5.Initial prescription of opioids for a patient under the age of eighteen (18) will not exceed twenty (20) doses. There is no limit on daily MME, however prescribers must document in the medical record their rationale for prescribing greater than thirty (30) MME per day for a minor. For the purpose of this Part, acute pain for patients under the age of eighteen (18) does not include chronic pain management, any chronic illness with recurrent acute pain that is a known expression of the chronic disease, pain associated with sickle cell disease, pain associated with a current cancer diagnosis, palliative care, or nursing home care.
D.Patient Education/ Informed Consent. If prescribing opioids, the practitioner will advise patients specifically about adverse risks of taking alcohol or other psychoactive medications (e.g., sedatives and benzodiazepines), tolerance, dependence, overdose or death if acute or long-term use. For those patients in recovery from substance use disorder, education shall be focused on relapse risk factors. This education, which must be documented in the medical record, will be communicated orally or in writing depending on patient preference and shall include as a minimum:
1.Acknowledgment that it is the patient's responsibility to safeguard all medications and keep them in a secure location; and
2.Educate patient regarding safe disposal options for unused portion of a controlled substance.
3.Requirement for Conversation: Prior to initiating a prescription for an opioid drug and, upon the second refill and/or upon the third prescription, specifically discuss with the patient who is eighteen (18) years of age or older, or the patient's parent or guardian if the patient is under eighteen (18) years of age:
a.The risks of developing a dependence or substance use disorder to the prescription opioid drug and potential of overdose or death;
b.The adverse risks of concurrent use of alcohol or other psychoactive medications;
c.The risk the medication(s) or underlying medical condition may impair an individual’s ability to safely operate any motor vehicle;
d.The responsibility to safeguard all medications;
e.If the prescriber deems it appropriate, discuss such alternative treatments (including non-opioid medications, as well as non-pharmacologic treatments) as may be available; and
f.For patients in recovery from substance use disorder, education shall be focused on relapse risk factors. This discussion shall be noted in the patient's medical record at each applicable visit.
4.Prescribers may find resources for patient education on the Department website at www.health.ri.gov/saferx.
E.Mandatory PDMP Review. Prior to initially prescribing any opioid, including prescriptions prescribed in an inpatient setting, and regardless how the prescription is issued, prescribers must review the PDMP, and must recheck the PDMP at least every three (3) months for patients under active treatment or who are receiving an ongoing opioid prescription.
F.Written Patient Treatment Agreement.
1.Chronic pain patients who receive opioid medication(s) shall have a written patient treatment agreement which shall become part of their medical record. This written agreement may be started at any point, at the practitioner’s discretion, based on individual patient history and risk; however, no later than after ninety (90) days of treatment with an opioid medication. The written agreement shall be signed between, at a minimum, the practitioner and the patient (or their proxy). This written patient agreement for treatment may include, at the practitioner’s discretion:
a.The patient's agreement to take medications at the dose and frequency prescribed with a specific protocol for lost prescriptions and early refills;
b.Reasons for which medication therapy may be discontinued, including but not limited to, violation of the written treatment agreement or lack of effectiveness;
c.The requirement that all chronic pain management prescriptions are provided by a single practitioner or a limited agreed upon group of practitioners;
d.The patient's agreement to not abuse alcohol or use other medically unauthorized substances or medications;
e.Acknowledgment that a violation of the agreement may result in action as deemed appropriate by the prescribing practitioner such as a change in the treatment plan or referral to a substance use disorder treatment program; and
f.A request that toxicology screens be performed at random intervals at the practitioner’s discretion.
2.At their discretion, practitioners may have a written patient treatment agreement with any patient who receives opioid medication for any duration, based on individual patient history and risk.
G.Periodic Review. Periodic reviews, including an in-person visit, shall take place at intervals not to exceed six (6) months.
1.During the periodic review, the practitioner shall determine:
a.Patient's adherence with any medication treatment plan;
b.If pain, function, or quality of life have improved or diminished using objective evidence; and
c.If continuation or modification of medications for pain management treatment is necessary based on the practitioner's evaluation of progress towards treatment objectives.
2.The practitioner shall consider tapering, changing, or discontinuing treatment when:
a.Function or pain does not improve after a trial period; or
b.There is reason to believe there has been misuse, development of substance use disorder, or diversion.
3.For patients the practitioner is maintaining on continuous opioid therapy for pain for six (6) months or longer, the practitioner shall review information from the PDMP at least every twelve (12) months. Documentation of that review shall be noted in the patient’s medical record.
H.Pain Medicine/Addiction Medicine Physician. To qualify as a pain medicine or addiction medicine physician, a physician shall meet one (1) or more of the following qualifications:
1.Board certified or board eligible by an American Board of Medical Specialties (ABMS) approved board in physical medicine and rehabilitation, neurology, neurosurgery, rheumatology, addiction medicine, addiction psychiatry or anesthesiology; or by the American Board of Pain Medicine (ABPM); or Board-certified or board-eligible by an American Osteopathic Association (AOA)-approved board in physical medicine and rehabilitation, neurology and psychiatry, anesthesiology, or neuromusculoskeletal medicine; or
2.Possess a subspecialty certificate in pain medicine by an ABMS-approved board; or
3.Possess a certification of added qualification in pain management or pain medicine or a certification of special qualification in rheumatology by the AOA; or
4.Completion of a minimum of three (3) years of clinical experience in a chronic pain management care setting, including:
a.Successful completion of at least eighteen (18) continuing education hours in pain management during the past two (2) years; and
b.At least thirty percent (30%) of the physician's current practice being the direct provision of pain management care or in a multidisciplinary pain clinic.
I.Multidisciplinary Approach to Treatment of Chronic Pain.
1.Medication is only one aspect of treating chronic pain. Chronic pain often requires a multidisciplinary approach and the patient will often benefit from appropriate consultation not just with pain management specialists, but other professionals who offer treatment for pain. Other professionals such as chiropractors, acupuncturists, behavioral health providers, occupational therapists, and physical therapists are examples of providers who can use their skills to help alleviate patient’s chronic pain.
2.Practitioners shall consider referral to other professionals as clinically indicated, some indications would include, patients self-escalating their doses, early refills, inadequate pain relief, co-existing morbidities such as requirement for dialysis, chronic liver disease, prior history of a substance disorder or prior over-dose.
3.The consideration, and documentation of consideration, for consultation threshold for adults is ninety (90) MMEs per day (orally). In the event a practitioner prescribes a dosage amount that meets or exceeds the consultation threshold of ninety (90) MME per day (orally), a consideration of consultation with a pain medicine physician is required, and must be documented in the medical record.
a.If consultation is not obtained, the practitioner shall document in the patient’s medical record that a consultation was considered and the rationale for not obtaining such consultation;
b.Consultation may include:
(1)An office visit with the patient and the pain medicine physician;
(2)A telephone consultation between the pain medicine physician and the practitioner;
(3)An electronic consultation between the pain medicine physician and the practitioner; or
(4)An audio-visual evaluation conducted by the pain medicine physician remotely, where the patient is present with either the practitioner or a licensed health care practitioner designated by the practitioner or the pain medicine physician.
4.Nothing in this Part shall limit any practitioner’s ability to contractually require a consultation with a pain medicine physician at any time.
J.Transition of Care for Patients on Long-term Opioid Therapy. Periodically, a practitioner will require a patient to seek care from another practitioner for ongoing treatment. Referring practitioner shall facilitate a safe transition of care for any patient being referred to another practitioner. Safe transition shall include documented practitioner to practitioner contact regarding the patient and appropriate steps to prevent a disruption in the patient’s continuity of care for pain management.
K.Transmission of Controlled Substance Prescriptions.
1. Effective January 2, 2020, a practitioner must review, sign, transmit, and file (confirmation of successful transmittal) prescriptions electronically for controlled substances in Schedules II, III, IV, and V.
a.The software utilized by a practitioner to sign, transmit, and file electronic prescriptions must meet all federal security requirements for electronic prescribing of controlled substances (EPCS) including, but not limited to, 21 C.F.R. § 1311, incorporated by reference at § 4.2 of this Part.
b.A practitioner is prohibited from using any software application to process electronic prescriptions if the software does not meet federal and state confidentiality and security requirements.
2.The practitioner must:
a.Print out the electronic prescription in hardcopy; or
b.Store the electronic record so that it is readily retrievable in the patient’s medical record.
3.A practitioner is not required to process prescriptions electronically when:
a.Electronic prescribing is not available due to temporary technological or electronic failure. For the purposes of this Part, temporary technological or electrical failure means:
(1)The failure of a computer system, application, or device; or
(2)The loss of electrical power to such system, application, or device; or
(3)Any other service interruption to such system, application, or device that prevents the practitioner from utilizing his or her system to electronically transmit a prescription.
(4)The practitioner must document in the patient’s medical record that a written prescription was issued or given by verbal order to a pharmacist over the telephone along with the reason for failure of the electronic prescription.
b.The practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner and that the delay would have a negative impact on the patient’s health. The prescription duration shall not exceed a five (5) day supply. The practitioner must document in the patient’s medical record the reason(s) electronic prescription would be impractical for the patient.
c.The practitioner determines that electronic prescription would have a negative impact on or delay patient care, such as:
(1)A prescription containing two (2) or more substances to be compounded by a pharmacist;
(2)A prescription for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion;
(3)A prescription with long and complicated directions; or
(4)An oral prescription communicated to the pharmacist by a practitioner in a licensed chronic and convalescent nursing home, hospice facility, or emergency department.
(5)The practitioner must document in the patient’s medical record the reason electronic prescription would have a negative impact on or delay patient care.
d.A prescription is issued for a drug for which the U.S. FDA requires the prescription to include certain elements that are not able to be accomplished with electronic prescription including, but not limited to, a drug with risk evaluation and mitigation strategies that include elements to assure safe use. The practitioner must document the reason in the patient’s medical record.
e.The prescription cannot be transmitted electronically due to the constraints of the National Council for Prescription Drug Programs (SCRIPT) Standard.
f.The prescription will be dispensed at a pharmacy outside of the state without access to electronic transmission of controlled substances.
g.The prescription is being transmitted to a Veteran’s Administration pharmacy to be dispensed, or the prescription is being dispensed through an Indian Health Services facility.
h.A practitioner prescribes a drug under a research protocol.
4.Any prescription issued in a form other than an electronically transmitted prescription, as allowed by § 4.4(K)(3) of this Part, must be issued as a written order or, to the extent permitted by federal and state laws and regulations, as an oral order, or transmitted by facsimile machine. Such oral order or order transmitted by facsimile machine must be promptly reduced to writing on a prescription blank or a hard copy printout or created as an electronic record and filed by the pharmacist filling it.
a.No duplicate, carbon, or photographic copies, and no printed or repeatedly used, or rubber stamped, orders shall be considered valid prescriptions.
5.Nothing in this Part shall be construed as requiring a prescription drug plan to verify that a practitioner is exempt from the requirements of § 4.4(K)(3)(a) through (h) of this Part. Nothing in this Part shall be construed as affecting the ability of the plan to cover or the pharmacist’s ability to continue to dispense covered drugs from otherwise valid written, oral, or fax prescriptions that are consistent with statute and regulations.
6.Nothing in this Part shall be construed as preventing a patient from transferring their electronic prescription from one pharmacy to another pharmacy, or as preventing a pharmacy from transferring a patient's electronic prescription to another pharmacy, so long as such transfer of electronic prescription is conducted in accordance with 21 C.F.R. § 1311, incorporated by reference at § 4.2 of this Part.
a.The choice of the pharmacy to which a patient wishes their electronic prescription to be transferred will be retained by the patient, and the pharmacy transferring the electronic prescription may not limit the pharmacy to which it transfers an electronic prescription, in order to preserve patient choice in the disposition of their prescription.
7.A practitioner shall not authorize or allow an unlicensed staff member (e.g., medical assistant) to telephone or otherwise transmit a prescription for a controlled substance to a pharmacy.
8.A practitioner may apply for a waiver from the electronic prescription requirements of § 4.4(K) of this Part by providing acceptable evidence to the Department that the practitioner will experience undue economic hardship from the implementation of the requirements of § 4.4(K).
L.Documentation of ICD-10 Code on Controlled Substance Prescriptions. Prescribers are required to enter an ICD-10 code, or equivalent thereto as determined by the Department (such as the diagnosis of the condition requiring the prescription), on all controlled substance prescriptions.
M.Co-prescribing of Naloxone. A prescriber must co-prescribe naloxone when:
1.Prescribing an opioid which individually or in aggregate with other medications is more than or equal to fifty (50) MMEs per day, or document in the medical record why this is not appropriate for the patient.
2.Prescribing any dose of an opioid when a benzodiazepine has been prescribed in the past thirty (30) days, or will be prescribed at the visit. Prescribers shall note medical necessity of the co-prescription of the opioid and the benzodiazepine and explain why the benefit outweighs the risk given the U.S. FDA black box warning.
3.Prescribing any dose of an opioid to a patient with a prior history of opioid use disorder or overdose. Prescribers must note medical necessity of prescribing of the opioid and explain why the benefit outweighs the risk given the patient’s previous history.
N.Long-Acting and Extended-Release Opioids.
1.All practitioners prescribing long-acting and extended-release opioids shall have completed an educational program compliant with the Extended Release/Long Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy Educational requirements issued by the U.S. FDA. This may be from a continuing education program or from an accredited professional preparation education program including approved residency training programs.
2.For patients on long-acting and extended-release opioids, including methadone, practitioners shall monitor use closely, especially upon initiation and following any dose increases. Practitioners shall also document in the medical record that the following education has been given to the patient and the patient has had the opportunity to ask questions and understands the following risks:
a.Serious life-threatening or even fatal respiratory depression may occur;
b.Methadone treatment may initially not provide immediate pain relief, and patient needs to be aware of overdose potential if taken in excess of dose, as prescribed;
c.Accidental consumption of long-acting and extended-release opioids especially in children, can result in fatal overdose;
d.Long-term opioid use can result in physical dependence on opiates and abrupt stopping of medication may cause withdrawal symptoms including, but not limited to: runny eyes, runny nose, insomnia, diarrhea, vomiting, restlessness, nausea, weakness, muscle aches, leg cramps and hot flushes; and
e.Substance use disorder.
3.Patients who receive long-acting and extended-release opioid medication(s) on a long-term basis (ninety (90) days or greater) shall have a written patient treatment agreement, which shall become part of their medical record. This written agreement may be started at any point at the practitioner’s discretion, based on individual patient history and risk; however; no later than after ninety (90) days of treatment with an opioid medication. The written agreement shall be signed between, at a minimum, the practitioner and the patient (or their proxy). This written patient agreement for treatment may include, at the practitioner’s discretion:
a.The patient's agreement to take medications at the dose and frequency prescribed with a specific protocol for lost prescriptions and early refills;
b.Reasons for which medication therapy may be discontinued, including but not limited to, violation of the written treatment agreement or lack of effectiveness;
c.The requirement that all chronic pain management prescriptions are provided by a single practitioner, or a limited agreed upon group of practitioners;
d.The patient's agreement to not abuse alcohol, misuse other prescribed medications or use other medically unauthorized substances or medications;
e.Acknowledgment that a violation of the agreement may result in action as deemed appropriate by the prescribing practitioner such as a change in the treatment plan or referral to a substance use disorder treatment program; and
f.A request that toxicology screens be performed at random intervals at the practitioner’s discretion.
O.Intrathecal Pump and the Use of Chronic Opioids.
1.A practitioner shall review the PDMP prior to refilling or initiating opioid therapy with an intrathecal pump.
2.A practitioner is responsible to educate the patient and document in the medical record about risks and benefits of an intrathecal pump as well as risk of withdrawal if the pump goes dry, or the pump malfunctions causing interruption of delivery of medication.
3.An intrathecal pump can only be refilled by licensed professional, who has documented competency in performing this task.
4.An intrathecal pump shall only be used if there is a pain agreement, highlighting risks of using alcohol and/or taking other controlled substances.
P.Prescriber Training Requirement for Best Practices Regarding Opioid Prescribing. This specific training requirement is required only once and must be completed before renewal of controlled substance registration or two (2) years, whichever is longer.
1.Any practitioner who prescribes a Schedule II opioid is required to successfully complete eight (8) hours of Category 1 Continuing Medical Education (or equivalent in Continuing Education Units/Continuing Education) in any or all of the following topics:
a.Appropriate prescribing of opioids for pain;
b.Pharmacology;
c.Adverse events;
d.Potential for dependence;
e.Tolerance;
f.Substance use disorder; and
g.Alternatives to opioids for pain management.
2.Although no one specific course is required, the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver training course qualifies for the above requirement. (Practitioners who have completed the DATA 2000 waiver training course and have an active Drug Enforcement Certificate with an “X” designation are exempt from this additional training.)
Q.Voluntary Non-Opiate Directive. Pursuant to R.I. Gen. Laws § 21-28-3.33, patients may file a voluntary non-opiate directive form, which indicates to all practitioners that the individual must not be administered or offered a prescription or medication order for an opiate.
1.The patient may revoke the voluntary non-opiate directive for any reason and may do so in writing or orally.
2.The voluntary non-opiate directive form, or the revocation of such form, must be filed in both the patient's electronic health record (or in the paper health record if the practitioner does not use electronic health records), and in the PDMP.
3.Patients may appoint a duly authorized guardian or health care proxy to override a previously recorded voluntary non-opiate directive form.
4.Protections for pharmacists, health care providers acting in good faith, and agents/health care proxies are stated in R.I. Gen. Laws § 21-28-3.33(c) through (e).
5.For those patients who are able to consent, pre-hospital emergency medical services practitioners must obtain verbal consent before administering an opioid. For patients who are unable to consent, pre-hospital emergency medical services practitioners who administer opioids in good faith and pursuant to the Rhode Island Statewide Emergency Medical Services Protocols and Standing Orders shall not be subject to penalties pursuant to non-compliance with § 4.4(Q) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.5** Registration Requirements {#sec-216-ricr-20-20-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.5}
A.Pursuant to R.I. Gen. Laws § 21-28-3.02(a), every person who manufactures, distributes, prescribes, administers, or dispenses any controlled substance within Rhode Island, or who proposes to engage in the manufacture, distribution, prescribing, administering, or dispensing of any controlled substance within Rhode Island, must obtain a registration, issued by the Director, at intervals not to exceed two (2) years, unless exempt in accordance with R.I. Gen. Laws § 21-28-3.30.
1.Application for registration may be obtained at:
Rhode Island Department of Health - Board of Pharmacy
Three Capitol Hill, Room 205
Providence, RI 02908
2.An applicant for registration shall comply with the federal registration requirements set forth by the federal Drug Enforcement Administration, Department of Justice (or successor agency).
3.In addition to all other applicable requirements of this Part, an applicant for a distributor registration must hold a current Rhode Island state license for distribution of drugs, medicines and poisons, issued by the Rhode Island Board of Pharmacy, pursuant to the provisions of R.I. Gen. Laws Chapter 5-19.1 and the rules and regulations pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers, and Distributors (Part 40-15-1 of this Title).
4.The ability of an applicant or registrant to maintain effective controls against diversion, as required pursuant to § 4.6 of this Part, will be considered by the Director in determining whether issuance of a registration is consistent with the public interest.
5.A filing fee, as set forth in the Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), is required for all classes of registration.
6.All practitioners shall, as a condition of the initial registration or renewal of the practitioner's authority to prescribe controlled substances, register with the PDMP.
B.Pursuant to R.I. Gen. Laws § 21-28-3.03, the Director may refuse registration, where the issuance of said registration would be inconsistent with the public interest.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.6** Limitation on Registration {#sec-216-ricr-20-20-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.6}
A.The registration issued by the Department shall limit distribution to controlled substances permitted by the applicant’s federal registration.
B.Distributors may not distribute controlled substances labeled "Physician's Sample", "Complimentary", "Physician's Sample - Not to be Sold", "Complimentary Package", "Patient Starter Package", "Professional Sample", or any other designation indicating other than a trade package available for resale by, or to, a registrant in the public interest.
C.Nothing in this Part shall prohibit a distributor from distributing controlled substances to a practitioner, upon required order forms, by means of common, contract, or interstate carrier, at the usual and customary cost, or as a gift.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.7** General Security Requirements {#sec-216-ricr-20-20-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.7}
A.All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.
B.In determining whether an applicant or registrant has demonstrated maintenance of effective security controls pursuant to R.I. Gen. Laws § 21-28-3.28, the Director may consider, but not be limited to, the following factors:
1.The type of activity conducted;
2.The type and form of controlled substances handled;
3.The quantity of controlled substances handled;
4.The location of the premises and the relationship such location bears on security needs;
5.The type of building construction comprising the facility and the general characteristics of the building or buildings;
6.The type of vault, safe, and secure enclosures or other storage system used;
7.The type of closures on vaults, safes, and secure enclosures;
8.The adequacy of key control systems and/or combination lock control systems;
9.The adequacy of electric detection and alarm systems, if any including use of supervised transmittal lines and standby power sources;
10.Method sought to be used for transportation of said controlled substance being distributed (e.g., common carrier, contract carrier, interstate carrier, private carrier, or other);
11.The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;
12.The adequacy of supervision over employees having access to manufacturing and storage areas;
13.The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;
14.The availability of local police protection or of the registrant's or applicant's security personnel;
15.Recordkeeping requirements of the Act;
16.Drug destruction requirements of the Act;
17.The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations;
18.The applicability of the security requirements contained in all Federal and Rhode Island laws and regulations governing the management of waste;
19.Past experience of the Department;
20.Past patterns of abuse, arrest, and noncompliance by distributors in Rhode Island, drug destruction data, citizen and police complaints, detection of samples, outside of legitimate channels, seizure of misbranded drugs; and
21.Any other factor which would assist the Director to conclude that the registration for each distributor is not inconsistent with the public interest.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-20-20-4 § 4.8** Violations and Hearings {#sec-216-ricr-20-20-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-4#4.8}
A.Any person who violates any provision of the Act, or this Part, shall be subject to the penalty provisions as specified in the Act.
B.All hearings and reviews required by this Part shall be held in accordance with the provisions of R.I. Gen. Laws Chapter 42-35 and the rules and regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-01-02 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 01/02/2020*
- *Technical Revision — effective from 2017-03-22 to 07/02/2018*
- *Technical Revision — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2017-03-22 to 03/22/2017*
- *Amendment — effective from 2015-03-16 to 03/22/2017*
- *Amendment — effective from 2012-12-10 to 03/16/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-20-20-5** Opioid Overdose Prevention and Reporting
##### **216-RICR-20-20-5 § 5.1** Authority {#sec-216-ricr-20-20-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-5#5.1}
These rules and regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws Chapter 23-1, and establish the procedures for administration of an opioid antagonist to an individual experiencing an opioid overdose or suspected overdose, and mandatory procedures for hospitals to report all actual and suspected opioid-related overdoses.
**History**
- *Amendment — effective from 2022-07-26 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/26/2022*
- *Technical Revision — effective from 2014-10-23 to 01/04/2022*
- *Technical Revision — effective from 2014-10-23 to 10/23/2014*
- *Adoption — effective from 2014-10-23 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-04-03 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-03-03 to 09/29/2014*
##### **216-RICR-20-20-5 § 5.2** Definitions {#sec-216-ricr-20-20-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-5#5.2}
A.Wherever used in these Regulations, the following terms shall be construed as follows:
1.“BHDDH” means the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities and Hospitals.
2.“Department” means the Rhode Island Department of Health.
3."Director" means the Director of the Rhode Island Department of Health.
4.“Healthcare professional” means a physician, physician assistant, or an advanced practice registered nurse licensed in Rhode Island, who is authorized to prescribe drugs or any pharmacists licensed in Rhode Island authorized to dispense drugs.
5.“Opioid” means any synthetic or natural opiate listed in R.I. Gen. Laws § 21-28-2.08.
6."Opioid antagonist" means a drug used to reverse the effects of opioids, such a naloxone hydrochloride, commonly referred to as naloxone or by the brand name Narcan, which is a competitive antagonist that binds to opioid receptors with higher affinity than agonists but does not activate the receptors. For the purposes of this Part, opioid antagonist does not include any drugs, such as naltrexone hydrochloride, used for addiction treatment.
7.“Opioid-related drug overdose” means, as defined in R.I. Gen. Laws § 16-21-35, a condition including, but not limited to, extreme physical illness, decreased level of consciousness, respiratory depression, coma, or death resulting from the consumption or use of an opioid, or another substance with which an opioid was combined, or that a layperson would reasonably believe to be an opioid-related drug overdose that requires medical assistance. This would include any condition for which there is a clinical suspicion for an opioid-related drug overdose (respiratory depression, unconsciousness, altered mental status) and/or for which there is either a urine toxicology screen positive for opioids or negative urine toxicology screen without other conditions to explain the clinical condition.
8."Patient" means a person who has experienced or is experiencing or is at risk of experiencing an opioid-related drug overdose.
9."Patient information" includes but is not limited to information provided to the patient on:
a.Drug overdose prevention and recognition;
b.How to perform rescue breathing and resuscitation;
c.Opioid antidote dosage and administration;
d.The importance of calling 911;
e.Care for the overdose victim after administration of the overdose antidote; and
f.Other issues as necessary.
10.“Person at risk of experiencing an opioid-related drug overdose” includes but is not limited to a person for whom one (1) or more of the following applies:
a.Has ever received emergency medical care involving opioid intoxication or opioid-related drug overdose;
b.Has a suspected history of substance use or use disorder or non-medical opioid use, including a history of treatment or a referral for treatment;
c.Is prescribed methadone or buprenorphine;
d.Is receiving an opioid prescription for pain and one (1) or more of the following applies:
(1)Is given a higher dose of opioids (greater than fifty (50) mg morphine equivalent per day);
(2)Has rotated from one opioid to another because of possible incomplete cross tolerance;
(3)Has concurrent smoking, COPD, emphysema, asthma, sleep apnea, respiratory infection, or other respiratory illness or potential obstruction;
(4)Has pre-existing renal dysfunction, hepatic disease, cardiac illness, HIV/AIDS;
(5)Has known or suspected concurrent alcohol or cocaine use;
(6)Has concurrent use of a benzodiazepine or other sedative prescription or who has a history of illicit benzodiazepine use;
(7)Is concurrently taking a prescription antidepressant.
e.May have difficulty accessing emergency medical services.
**History**
- *Amendment — effective from 2022-07-26 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/26/2022*
- *Technical Revision — effective from 2014-10-23 to 01/04/2022*
- *Technical Revision — effective from 2014-10-23 to 10/23/2014*
- *Adoption — effective from 2014-10-23 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-04-03 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-03-03 to 09/29/2014*
##### **216-RICR-20-20-5 § 5.3** Prescribing, Dispensing and Administering Opioid Antagonists {#sec-216-ricr-20-20-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-5#5.3}
A.Use of an opioid antagonist in accordance with this Part shall be considered first aid or emergency treatment for the purpose of any statute relating to liability.
B.Notwithstanding any other law or Regulation, any person may lawfully possess opioid antagonists.
C.Notwithstanding any other law or Regulation, any healthcare professional may dispense opioid antagonists, consistent with the provisions of this Part.
D.Any prescription for an opioid antagonist shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice.
5.3.1Prescribing, Dispensing, and Administering Opioid Antagonists by Healthcare Professionals
A.Opioid antagonists may lawfully be prescribed and dispensed to:
1.Any person at risk of experiencing an opioid-related overdose; and
2.Any person or persons, such as a family member or friend of a person at risk of experiencing an opioid-related overdose, who is reasonably expected by the prescriber to be in a position to respond to such person at risk of experiencing an opioid-related overdose.
B.Prescribing and dispensing healthcare professionals shall ensure that all persons prescribed and/or dispensed opioid antagonists receive the patient information specified in § 5.2(A)(9) of this Part. Provision of the patient information shall be appropriately documented. Patient information may be provided by:
1.Prescribing and dispensing healthcare professionals;
2.Community-based organizations;
3.BHDDH licensed or certified community programs offering support to individuals with a substance use diagnosis; or
4.Any other organization that has a written agreement with a healthcare professional, which agreement must include descriptions of:
a.How the organization will provide patient information about overdose response and use of an opioid antagonist;
b.How employees or volunteers providing patient information are trained; and
c.How patient information is documented.
C.The administering, dispensing, prescribing, purchasing, acquisition, possession, or use of an opioid antagonist by a healthcare professional shall not constitute unprofessional conduct or a violation of any statute or Regulation otherwise enforceable by the Department, provided that the healthcare professional’s actions upon which the alleged unprofessional conduct or violation are based were made with reasonable care and based on a good faith effort to assist:
1.A person experiencing, or suspected to be experiencing, an opioid-related drug overdose; or
2.Any person or persons, such as a family member or friend of a person at risk of experiencing an opioid-related overdose, who is in a position to respond to such person experiencing, or suspected to be experiencing, an opioid-related drug overdose.
D.A healthcare professional who prescribes or dispenses an opioid antagonist shall not be subject to any professional disciplinary action for:
1.Prescribing or dispensing in accordance with this Part, or
2.Any outcomes resulting from the administration of an opioid antagonist in accordance with this Part.
E.All emergency medical responders (EMRs), emergency medical technicians (EMTs), Advanced EMT-Cardiac practitioners, and paramedics, licensed in Rhode Island, are authorized and permitted to administer opioid antagonists as clinically indicated.
5.3.2Administration of an Opioid Antagonist (General)
A.Any person may in an emergency, exercising reasonable care, administer an opioid antagonist to him or herself or another person that the administering person believes in good faith is experiencing an opioid-related drug overdose. The person administering the opioid antagonist shall not, as a result of his or her acts or omissions, be liable for any violation of any statute or Regulations enforceable by the Department and shall not be considered to be engaged in the unauthorized practice of medicine or the unlawful possession of an opioid antagonist.
1.Unless a healthcare professional or EMR, the person administering the opioid antagonist shall not bill for administering the opioid antagonist. The person administering the opioid antagonist can never bill for administering the opioid antagonist to him or herself.
B.The administering, purchasing, acquisition, possession, or use of an opioid antagonist in accordance with this Part by any person, including asset forth in § 5.3.1(C) of this Part, any healthcare professional shall not constitute unprofessional conduct or a violation of any statute or Regulation otherwise enforceable by the Department, provided that the person's actions upon which the alleged unprofessional conduct or violation are based were made with reasonable care and on a good faith effort to assist:
1.A person experiencing, or suspected to be experiencing, an opioid-related drug overdose; or
2.Any person or persons, such as a family member or friend of a person at risk of experiencing, an opioid-related drug overdose who is in a position to respond to such person experiencing or suspected to be experiencing an opioid-related drug overdose.
C.A person who, acting in good faith and with reasonable care, administers an opioid antagonist to a person experiencing or suspected to be experiencing an opioid-related drug overdose shall be immune from sanction under any professional licensing statute, in addition to immunity already granted in R.I. Gen. Laws Chapter 21-28.9.
5.4Reporting Requirements
A.Hospitals in which medical care for an opioid-related drug overdose is provided or sought to be provided, shall report the opioid-related drug overdose using the reporting format approved by the Department, within forty-eight (48) hours of initial contact with the patient. Such report shall include any results of drug screening/testing performed on a patient who experienced an opioid-related drug overdose. Any additional pertinent information, including patient's name, date of birth, address, and any retrospective data not previously provided, which is requested by the Department after the initial reported case, shall be reported to the Department promptly upon request.
1.Reports regarding an opioid-related drug overdose shall be submitted utilizing a secure means of data transfer determined by the Department
2.Data collected under § 5.4(A) of this Part may be used by the Department for the purposes of conducting program and policy evaluation, and research as approved by the Department's Institutional Review Board. Data collected pursuant to § 5.4(A) of this Part may be linked to other data accessible to the Department for those purposes.
3.Data under § 5.4(A) of this Part shall not be shared with law enforcement.
4.Data collected under § 5.4(A) of this Part shall not be shared with third party payers, or other entities outside of the Department for activities outside of Department approved evaluation, surveillance and research.
a.Exception. Data shall be shared with the Director of BHDDH or his or her designee in accordance with the inter-agency memorandum of understanding.
5.Data collected under § 5.4(A) of this Part are not public information. The collection, storage, use, or sharing of any data obtained pursuant to this Part shall be in accordance with all applicable State and Federal law, including the Confidentiality of Health Care Information Act (R. I. Gen. Laws §§ 5-37.3-1 et seq.), the Health Insurance Portability and Accountability Act (including all effective Regulations promulgated thereunder), the Identify Theft Protection Act of 2015 (R. I. Gen. Laws §§ 11-49.3-1 et seq.), and all other applicable laws. Any transfer of these data must meet State data encryption policy.
B.In addition to complying with the provisions of § 60-10-1.10(H)(6) of this Title, hospitals shall submit residual biological samples (e.g., blood, urine) obtained in the course of hospitalization of patients who experienced an opioid related drug overdose which resulted in whole or in part, in current hospitalization. Such biological specimen shall be submitted to the Department's laboratory in accordance with Department guidance.
C.Any hospital or agent thereof, that makes a report under § 5.4(A) of this Part or provides a blood specimen as described in § 5.4(B) of this Part, is not subject to civil or criminal liability for damages arising out of the report or provision of the biological specimen. An individual who makes a good-faith report or provision under these Regulations is not subject to civil or criminal liability for damages arising out of such act.
D.All opioid-related drug overdose reports submitted pursuant to these Regulations shall be handled in accordance with all applicable State and Federal statutes and Regulations pertaining to confidentiality of healthcare information.
**History**
- *Amendment — effective from 2022-07-26 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/26/2022*
- *Technical Revision — effective from 2014-10-23 to 01/04/2022*
- *Technical Revision — effective from 2014-10-23 to 10/23/2014*
- *Adoption — effective from 2014-10-23 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-04-03 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-03-03 to 09/29/2014*
##### **216-RICR-20-20-5 § 5.5** Severability {#sec-216-ricr-20-20-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-20-20-5#5.5}
If any provisions herein or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application herein which can be given effect, and to this end the provisions herein are declared to be severable.
**History**
- *Amendment — effective from 2022-07-26 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/26/2022*
- *Technical Revision — effective from 2014-10-23 to 01/04/2022*
- *Technical Revision — effective from 2014-10-23 to 10/23/2014*
- *Adoption — effective from 2014-10-23 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-04-03 to 10/23/2014*
- *EMERGENCY RULE Adoption — effective from 2014-03-03 to 09/29/2014*
## **Chapter 30** Infectious Diseases
### **Subchapter 05** Infectious Diseases
#### **216-RICR-30-05-1** Reporting and Testing of Infectious, Environmental, and Occupational Diseases
##### **216-RICR-30-05-1 § 1.1** Authority {#sec-216-ricr-30-05-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-1-1 and 23-8-1 for the purpose of adopting prevailing standards for confidentiality and reporting of infectious, occupational, and environmentally related diseases in Rhode Island.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.2** Incorporated Materials {#sec-216-ricr-30-05-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.2}
A.These Regulations hereby adopt and incorporate HIPAA Privacy Rule and Public Health: Guidance from CDC and the U.S. Department of Health and Human Services May 2, 2003/52 (S-1); 1-12. by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate The American Society of Microbiology Sentinel Level Clinical Laboratory Protocols for Suspected Biological Threat Agents and Emerging Infectious Diseases 2013 for Botulinum Toxin, Novel Influenza Viruses, Smallpox, and Staph Enterotoxin B by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate The American Society of Microbiology Sentinel Level Clinical Laboratory Protocols for Suspected Biological Threat Agents and Emerging Infectious Diseases 2016 for Bacillus anthracis, Brucella, Burkholderia (mallei and pseudomallei), Coxiella burnetii, Yersinia pestis, and Francisella tularensis by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate The American National Standards Institute CLSI M48-A “Laboratory Detection and Identification of Mycobacteria Approved Guideline” 2008 by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.3** Definitions {#sec-216-ricr-30-05-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.3}
A."Asbestos" means that unique group of naturally occurring minerals that separate into fibers of high tensile strength, resistant to heat, wear, and chemicals, described as the following types: chrysotile, amosite, crocidolite, tremolite, anthopyllite, and actinolite, and every product containing any of these materials that have been chemically treated and/or altered which after manufacture are used for such products and end uses including but not limited to insulation, textiles, paper, cement, sheets, floor tile, wall covering, decorations, coating, sealants, cement pipe and reinforced plastics and other compounds.
B."Asbestos-related disease" means any illness or disease, other than for benign conditions of the pleura, suspected of being related to asbestos exposure, including, but not limited to, mesothelioma, asbestosis, and lung cancer believed to be caused by asbestos exposure.
C."Carrier" means a person or animal that harbors a specific infectious agent without discernible clinical disease and serves as a potential source of infection.
D."Case" or "Patient" means a person who is suspected or confirmed to be ill, infected, exposed to, or diagnosed with a reportable disease.
E."Clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, radiobioassay, cytological, pathological, genomic, or any other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.
F."Controlled substance" means a drug, substance, or immediate precursor in schedules I-V listed by R.I. Gen Laws Chapter 21-28.
G.“Culture Independent Diagnostic Test” or “CIDT” means any laboratory assay that detects the molecular or antigenic signature of pathogens independent of generating an isolate, including but not limited to microscopy, immunoassays, and Nucleic Acid Amplification Test (NAAT)s.
H."Diagnosis of AIDS" means the most current surveillance case definition for AIDS published by the Centers for Disease Control & Prevention (CDC).
I."Diagnosis of HIV" means the most current surveillance case definition for HIV infection published by the CDC.
J."Director" means the Director of Health or his/her designee.
K."Disease report" means an official notice to the appropriate authority of the occurrence of a specified disease in humans or animals, in accordance with the requirements stated in these Regulations.
L."Emergency service worker" means a worker responding on behalf of a licensed ambulance/rescue service, fire department, or law enforcement agency.
M."Health care facility" means those facilities licensed by the Department in accordance with the provisions of R.I. Gen Laws Chapter 23-17.
N."Health care provider" means a physician, physician assistant, or certified nurse practitioner licensed to practice in Rhode Island.
O."Infectious disease" means an illness due to a specific infectious agent or its toxic products that arises through transmission of that agent or its products from an infected person, animal, or inanimate reservoir to a susceptible host.
P."Occupational disease" means a disease or condition which is believed to be caused or aggravated by conditions in the individual's workplace.
Q."Occupational health representative" means an individual, within a health care facility, trained to respond to occupational, particularly blood borne, exposures.
R.“RIDOH” means the Rhode Island Department of Health.
S."Surveillance" means the practice of monitoring the occurrence and spread of disease. Included are the systematic collection and evaluation of: morbidity and mortality reports; special reports of field investigations, epidemics and individual cases; isolations and identifications of infectious agents in laboratories; data concerning the availability and use of vaccines; immune globulin, pesticides and other substances used in disease control; information regarding immunity levels in segments of the population, and of other relevant epidemiologic data. The procedure applies to all jurisdictional levels of public health, from local to international.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.4** Confidentiality Provisions {#sec-216-ricr-30-05-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.4}
A.All information concerning cases or suspected cases shall be held in confidence in accordance with the provisions of R.I. Gen Laws § 5-37-3 and all other applicable State and Federal statutes and Regulations.
B.Pursuant to the HIPAA Privacy Rule, disclosures to RIDOH without individual authorization are permitted for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention.
1.4.1Persons and Entities Responsible for Reporting Diseases
A.The following individuals and entities attending the case or suspected case are required to report the diseases listed in § 1.5.3 of this Part:
1.Physicians
2.Physician assistants
3.Certified registered nurse practitioners
4.Clinical laboratories
5.Hospitals (from both inpatient and outpatient settings)
a.When a diagnosis or suspected diagnosis of a case is made within a hospital, the facility administrator, or his/her designee (e.g., infection control practitioner), must ensure the reporting of the case in accordance with the procedures outlined in these Regulations.
6.All other health care facilities, including but not limited to: organized ambulatory care facility, school-based health center, college/university-health center, freestanding emergency care facility, home care/home nursing care provider, hospice, birth center, nursing facility, rehabilitation hospital center, freestanding ambulatory surgical center, kidney disease treatment center, blood centers, and prison health services.
a.When a diagnosis or suspected diagnosis of a case is made within a licensed health care facility, the facility administrator or medical director, or his/her designee (e.g., infection control practitioner), must ensure the reporting of the case in accordance with the procedures outlined in these Regulations.
7.Veterinarians who have knowledge of: a single case of rare and/or unusual veterinary diagnosis that has the potential to cause illness in humans, or knowledge of outbreaks of unusual zoonotic vectorborne diseases that can cause illness in humans;
B.It is recommended that the following individuals and entities report the diseases listed in § 1.5.3 of this Part:
1.Certified school nurse-teachers who have knowledge of a single case of rare and/or unusual diagnoses, or knowledge of outbreaks of diseases;
2.Dentists who have knowledge of a single case of rare and/or unusual diagnoses, or knowledge of outbreaks of disease;
3.Other entities or persons (such as day care centers, drug treatment facilities, travel clinics, social service agencies that serve the homeless, camp counselors, funeral directors, transportation authority, assisted living facilities, community-based organizations that screen for infectious diseases, etc.) who have knowledge of a single case of rare and/or unusual diagnoses or knowledge of outbreaks of diseases.
C.Exemptions
1.Reporting of the diseases listed in § 1.5.3 of this Part shall not be required in the following cases:
a.In research protocols and all other situations where the person conducting the research or ordering the test is unaware of the identity of the person being tested.
b.Anonymous HIV testing.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.5** Timeframe, Methods, and Reportable Conditions {#sec-216-ricr-30-05-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.5}
1.5.1Timeframes
A.The lists cited in § 1.5.3 of this Part pertain to individuals and facilities required to report pursuant to § 1.4.1 of this Part. Cases due to the diseases listed below shall be reported to the RIDOH within the timelines indicated. Reportable diseases are grouped as follows:
1.Immediately reportable diseases shall be reported within twenty-four (24) hours of recognition or strong suspicion of disease.
2.All other reportable conditions shall be reported within four (4) days of recognition or suspicion.
1.5.2Methods
A.Case reports must be submitted on a RIDOH case report form as specified by the RIDOH website. The minimal information required when submitting a case report form includes: disease being reported, patient’s full name, address, city, State, zip code, phone number, date of birth, gender, race and ethnicity, date of onset, and physicians’ name and phone number.
B.Clinical laboratories, including those outside of Rhode Island, performing examinations on any specimens derived from Rhode Island residents that yield evidence of infection due to the diseases listed in § 1.5.3 of this Part shall report such evidence of infection directly to RIDOH.
1.Clinical laboratories shall submit specimens, isolate, or samples to RIDOH immediately upon request.
C.The minimal information required when submitting a laboratory report includes: a laboratory contact, test results, date of specimen collection, patient’s full name, date of birth, sex, address, patient’s phone number, and name of ordering health care provider.
D.Reporting methods include, but are not limited to the following:
1.Mail to: Rhode Island Department of Health, Division of Preparedness, Response, Infectious Diseases, and Emergency Medical Services, 3 Capitol Hill, Providence RI 02908-5097.
2.Fax to RIDOH using fax numbers on the reporting forms.
3.Telephone: Between 8:30 am – 4:30 pm (Monday – Friday): (401) 222-2577. For telephone reporting for immediately reportable diseases after hours call (401) 272-5952.
4.Electronic reporting of clinical and laboratory results to RIDOH.
5.Organizations that house reportable disease data must allow RIDOH to access the database for data mining from various data sources, including, but not limited to: electronic laboratory reports, medical records, health information exchange feeds, syndromic surveillance feeds, immunization and other disease registries, and billing data.
1.5.3Reportable Disease and Conditions
A.For the conditions listed below, invasive disease must be confirmed by isolation from blood, cerebral spinal fluid, pericardial fluid, pleural fluid, peritoneal fluid, joint fluid, urine, or other normally sterile site.
B.Pregnant women with a reportable infectious disease listed in § 1.5.3 of this Part that can be transmitted to the unborn child or infant must be reported within four (4) days of recognition. For example, HIV, Zika, syphilis, Hepatitis B, Hepatitis C, rubella, etc.
C.If testing is positive for any of the reportable conditions listed below and is performed with a Culture Independent Diagnostic Test (CIDT), the laboratory must perform reflexive culture or transport the original specimen to another laboratory to perform culture. If the culture is positive, the isolate must be recovered and sent to the Rhode Island State Health Laboratories for those organisms as indicated in §§ 1.4.3(D) and (E) of this Part. Both positive and negative culture results must be reported to RIDOH.
D.Immediately Reportable Diseases and Conditions must be reported within twenty-four (24) hours.
1.Animal bites
2.Anthrax (Bacillus anthracis and Bacillus cereus biovar anthracis)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
3.Arboviral infections (e.g., West Nile, Eastern Equine Encephalitis, Powassan, Zika, Chikungunya, Yellow Fever)
4.Botulism (Clostridium botulinum)
a.Laboratories must submit the specimen to the Rhode Island State Health Laboratories.
5.Brucellosis (Brucella species)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
6.Cholera (Vibrio cholerae)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
7.Ciguatera
8.Clostridium perfringens epsilon toxin
9.Diphtheria (Corynebacterium diptheriae)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
10.Encephalitis (any infectious cause)
11.Glanders (Burkholderia mallei)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
12.Hantavirus (All species)
13.Hepatitis A
a.Laboratories must report aspartate aminotransferase (AST), alanine aminotransferase (ALT), and Bilirubin Total and Bilirubin Direct.
14.Measles (Rubeola)
a.Laboratories must submit the specimen to the Rhode Island State Health Laboratories.
15.Melioidosis (Burkholderia pseudomallei)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
16.Meningococcal Disease- invasive (Neisseria meningitidis)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
17.Novel or emerging respiratory viruses
18.Outbreaks and clusters as defined in §1.5.4 of this Part
19.Paralytic shellfish poisoning
20.Plague (Yersinia pestis)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
21.Poliomyelitis (polio virus)
22.Q-Fever (Coxiella burnetii)
a.Laboratories must submit specimen to the Rhode Island State Health Laboratories.
23.Rabies (animal)
a.Laboratories must submit the animal to the Rhode Island State Health Laboratories.
24.Rabies (human)
a.Laboratories must submit specimen to the Rhode Island State Health Laboratories.
25.Ricin poisoning
26.SARS-CoV-2 (COVID-19)
a.Laboratories must submit specimen to the Rhode Island State Health Laboratories.
b.Any public or private entity administering an FDA-approved COVID-19 test shall submit all results, including positive and negative results, promptly with RIDOH.
27.SARS-CoV-2 associated deaths
28.SARS-CoV-2 associated hospitalizations
29.Scombroid poisoning
30.Smallpox (Variola)
a.Laboratories must submit specimen to the Rhode Island State Health Laboratories.
31.Staphylococcal enterotoxin B poisoning
32.Staphylococcus aureus invasive infections: Vancomycin Resistant Staphylococcus aureus (VRSA) or Vancomycin Intermediate Staphylococcus aureus (VISA)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
33.Tularemia (Francisella tularensis)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
34.Typhoid fever (Salmonella typhi)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
35.Unexplained deaths (possibly due to unidentified infectious causes)
36.Vibriosis (all Vibrio species)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
37.Viral hemorrhagic fevers (Ebola, Lassa, Marburg, etc.)
a.Laboratories must submit specimen to the Rhode Island State Health Laboratories.
E.Other Reportable Conditions must be reported within four (4) days
1.Acute Flaccid Myelitis
2.Anaplasmosis (Anaplasma phagocytophilium)
3.Babesiosis (all species)
4.Campylobacteriosis (Campylobacter all species)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
5.Carbapenem-resistant Gram-negative bacteria
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
6.Chancroid (Haemophilus ducreyi)
7.Chlamydia trachomatis (genital and ophthalmic)
8.Coccidioidomycosis (Coccidioides immitis)
9.Cryptosporidiosis (Cryptosporidium all species)
10.Cyclosporiasis (Cyclospora cayetanensis)
11.Dengue virus
12.Ehrlichiosis (Ehrlichia chaffeensis)
13.Escherichia coli, Shiga toxin-producing (STEC)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
14.Giardiasis (Giardia lamblia)
15.Gonorrhea (Neisseria gonorrhoeae)
16.Granuloma Inguinale (Klebsiella granulomatis)
17.Haemophilus influenzae disease, all serotypes-invasive
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
18.Hansen's disease or Leprosy (Mycobacterium leprae)
19.Hemolytic uremic syndrome (HUS)
20.Hepatitis B, C, D, E, and unspecified viral hepatitis
a.Laboratories must report all positive results.
b.Laboratories must report aspartate aminotransferase (AST), alanine aminotransferase (ALT), and Bilirubin Total and Bilirubin Direct.
c.Physicians must report all acute Hepatitis cases.
d.Physicians must report pregnancy in a chronic Hepatitis B or Hepatitis C-positive woman using forms required by RIDOH.
21.Human Immunodeficiency Virus (HIV) 1 and 2 /Acquired Immunodeficiency Syndrome (AIDS)
a.Laboratories must report every CD4 cell count and HIV viral load test result performed on an HIV-positive individual.
b.Physicians must report pregnancy in an HIV-positive woman using forms required by RIDOH.
22.Influenza associated deaths
23.Influenza associated hospitalizations
24.Influenza novel virus infections
a.Laboratories much submit all unsubtypable Influenza A specimens to the Rhode Island State Health Laboratories.
25.Latent Tuberculosis Infection (LTBI) (Mycobacterium tuberculosis)
26.Legionellosis (Legionella pneumophila)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
27.Leptospirosis (Leptospira interrogans)
28.Listeriosis- invasive (Listeria monocytogenes)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
29.Lyme disease (Borrelia burgdorferi)
30.Lymphogranuloma Venereum (Chlamydia trachomatis)
31.Malaria (Plasmodium species)
32.Meningitis (aseptic, bacterial, viral, or fungal)
33.Multisystem Inflammatory Syndrome in Children (MIS-C)
34.Mumps (Paramyxovirus)
a.Laboratories must submit the specimen to the Rhode Island State Health Laboratories.
35.Ornithosis/Psittacosis (Chlamydophila psittaci)
36.Pelvic inflammatory disease (PID): all cases, based upon clinical diagnosis
37.Pertussis (Bordetella pertussis)
38.Pneumococcal Disease-invasive (Streptococcus pneumoniae)
a.Laboratories must submit an isolate to the RI State Health Laboratories for any individual less than five (5) years of age.
39.Rickettsiosis, including Rocky Mountain Spotted Fever (Rickettsia – all species)
40.Rubella (including congenital rubella)
a.Laboratories must submit the specimen to the Rhode Island State Health Laboratories.
41.Salmonellosis (Salmonella – all species)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
42.Shigellosis (Shigella – all species)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
43.Streptococcal Disease-Group A – invasive
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
44.Streptococcal Disease – Group B- invasive
45.Streptococcal Toxic Shock Syndrome (Streptococcus pyogenes)
46.Syphilis – all stages including neurosyphilis and congenital syphilis (Treponema pallidum)
47.Tetanus (Clostridium tetani)
48.Toxic Shock Syndrome (non-Streptococcal)
49.Transmissible spongiform encephalopathies (including Creutzfeldt Jakob Disease)
50.Trichinosis (Trichinella species)
51.Tuberculosis Disease (Mycobacterium tuberculosis)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
52.Varicella (Varicella-Zoster virus)
53.Yersiniosis (Yersinia enterocolitica)
a.Laboratories must submit isolate to the Rhode Island State Health Laboratories.
1.5.4Reporting of Outbreaks
A.Any person or entity who is required to report and has knowledge of an outbreak of infectious disease or a cluster of unexplained illness, infectious or non-infectious, whether or not listed in these Regulations, shall immediately report the facts to RIDOH.
B.Outbreaks required to be reported include, but are not limited to:
1.Exotic diseases and unusual group expressions of illness which may be of public health concern.
2.A single case of a disease long absent from a population or the first invasion by a disease not previously recognized in that area.
3.Outbreaks or clusters identified by significant increases in the usual occurrence of the disease in the same area, among the specified population, at the same season of the year.
4.The occurrence of two (2) or more cases of a similar illness resulting from the ingestion of a common food or water source.
5.A cluster of similar illness in institutional settings, including but not limited to nursing homes, hospitals, schools, and day care centers.
6.A single case of rare and/or unusual diagnoses, including but not limited to avian influenza, smallpox, Ebola, SARS, Zika, Borrelia miyamotoi, Candida auris, or human rabies.
7.Outbreaks of unusual diseases or illness that may indicate acts of terrorism using biological agents, including but not limited to anthrax and botulism. See complete list of biological agents in § 1.7.2(A)(1) of this Part.
8.Any condition compatible with exposure to nuclear, radiological, or chemical substances, which could be indicative of radiological or chemical terrorism events.
9.Clusters of overdoses or adverse reactions to a drug, whether prescription or illicit.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.6** Special Disease Surveillance Projects {#sec-216-ricr-30-05-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.6}
A.Reporting will be required for surveillance related to special and/or complex surveillance systems (e.g., Zika, latent TB infection, influenza, new and emerging disease threats, and evaluation and validation projects related to surveillance) at the discretion of RIDOH.
B.Reporting will be required for any additional surveillance systems that are developed and implemented to prepare for or respond to public health threats at the discretion of RIDOH at any time.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.7** Instructions for Laboratories {#sec-216-ricr-30-05-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.7}
1.7.1General Instructions
A.Whenever a Rhode Island licensed clinical laboratory performs tests or has the sample(s) tested out of State for those diseases cited in § 1.5.3 of this Part, the laboratory shall submit to RIDOH all positive findings.
B.Negative laboratory results for those diseases cited in § 1.5.3 of this Part, must be reported for public health surveillance and investigation purposes at the discretion of RIDOH.
C.The report shall consist of a copy of the laboratory findings submitted to the physician or other licensed health care provider who ordered the test. This report shall indicate the name of the case, address of the case, gender, date of birth, telephone number, race, ethnicity, and name of attending physician.
D.All genotyping, molecular detection, and phylogenetic testing results on reportable conditions must be reported to RIDOH.
1.7.2Reporting of Agents of Bioterrorism
A.An immediate report must be made to RIDOH by telephone when an ordering provider requests a test for a potential agent of bioterrorism. After normal business hours, the RIDOH’s after-hours on-call physician must be informed.
1.Potential agents of bioterrorism are:
a.Anthrax (Bacillus anthracis)
b.Botulism (Clostridium botulinum)
c.Brucellosis (Brucella species)
d.Clostridium perfringens epsilon toxin
e.Glanders (Burkholderia mallei)
f.Melioidosis (Burkholderia pseudomallei)
g.Plague (Yersinia pestis)
h.Q-fever (Coxiella burnetii)
i.Ricin Poisoning
j.Smallpox (Variola)
k.Staphylococcal enterotoxin B poisoning
l.Tularemia (Francisella tularensis)
m.Viral hemorrhagic fevers (Ebola, Lassa, Marburg, etc.)
2.Clinical laboratories that isolate a potential agent of bioterrorism from a clinical specimen shall perform testing in accordance with the most current American Society of Microbiology (ASM) Sentinel Laboratory protocol as incorporated in §§ 1.2(B) and (C) of this Part, and, if unable to definitively rule out the agent, must submit the isolate to the Rhode Island State Health Laboratories for confirmation or further testing.
1.7.3Reporting of Acid Fast Bacilli (AFB) and Mycobacterium tuberculosis (MTB)
A.Clinical laboratories receiving clinical specimens for the purposes of performing testing for the presence of Acid Fast Bacilli (AFB) or Mycobacterium tuberculosis (MTB) testing must submit a specimen to the Rhode Island State Health Laboratories for analysis.
1.This requirement is waived for a Rhode Island licensed hospital laboratory, provided a written memorandum of agreement is in place between the State Health Laboratories and the hospital laboratory.
2.In order to obtain a memorandum of agreement, a hospital laboratory’s mycobacteriology testing methodology and practice must be consistent with national consensus standards as incorporated in § 1.2(D) of this Part.
a.Licensed hospital laboratories that have a written memorandum of agreement with the State Health Laboratories and are performing MTB testing by any methodology shall report all positive results to RIDOH.
b.Positive culture results on an individual must be accompanied by all prior AFB smear results performed by the respective laboratory, and associated with the current episode of illness, whether positive or negative.
B.As part of LTBI surveillance, Interferon Gamma Release Assay (IGRA) positive results must be reported.
1.7.4Reporting Perinatal Exposure to HIV
Persons and entities described in § 1.4.1 of this Part must report all positive and negative HIV virologic laboratory tests on infants, zero (0) through twelve (12) months of age.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
##### **216-RICR-30-05-1 § 1.8** Reporting of Environmental Exposures and Occupational Diseases {#sec-216-ricr-30-05-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-1#1.8}
1.8.1Persons and Entities Attending the Case or Suspected Case Responsible for Reporting Environmental Exposures and Occupational Diseases
A.Physicians
B.Physician assistants
C.Certified registered nurse practitioners
D.Clinical laboratories
E.Hospitals (from both inpatient and outpatient settings)
1.When a diagnosis or suspected diagnosis of a case is made within a hospital, the facility administrator, or his/her designee (e.g., infection control practitioner), must report occupational diseases and exposures.
1.8.2Environmental Exposures and Occupational Diseases that Must be Reported
A.Diseases diagnosed related to exposure to:
1.Arsenic
2.Asbestos
3.Beryllium
4.Cadmium
5.Carbon monoxide
6.Lead
7.Mercury
B.Any of the following occupational diseases:
1.Chemical Pneumonitis
2.Metal fume fever
3.Simple asphyxiation
4.Silicosis
C.Any cluster of occupational disease.
1.8.3Methods and Timeframes for Reporting
A.Reporting of Asbestos-related Diseases
1.Mail report of diagnosis to RIDOH’s Center for Healthy Homes and Environment, 3 Capitol Hill, Providence, RI 02908-5097, within six (6) months of diagnosis.
2.Send the patient or next of kin a dated notification of the suspected role of asbestos as it relates to the patient's condition within six (6) months of diagnosis by certified mail with a return receipt requested.
B.Reporting of Non-occupational Acute Carbon Monoxide Poisoning
1.Submit the CO Poisoning Reporting form to RIDOH’s Center for Healthy Homes and Environment according to the instructions on the form within four (4) working days following diagnosis.
C.Reporting of Childhood Lead Poisoning and Exposure Results
1.Childhood blood lead sample results shall be reported to RIDOH’s Center for Healthy Homes and Environment in accordance with the specifications in RIDOH’s Lead Poisoning Prevention Regulation (Part 50-15-3 of this Title).
D.Reporting of Blood Lead Sample Results and all other Environmental Exposures and Occupational Diseases
1.Submit all blood lead sample results to RIDOH’s Center for Healthy Homes and Environment.
2.For all other environmental exposures and occupational diseases, submit the Environmental Exposure and Occupational Disease reporting form to RIDOH’s Center for Healthy Homes and Environment within thirty (30) days following diagnosis according to the instructions on the form.
E.Clinical laboratories shall submit the results of biomonitoring tests for evaluating environmental or occupational exposures to RIDOH electronically or in hard copy.
**History**
- *Amendment — effective from 2022-01-15 to current*
- *Amendment — effective from 2022-01-03 to 01/15/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-26 to 01/03/2022*
- *EMERGENCY RULE Amendment — effective from 2021-07-07 to 07/26/2021*
- *Adoption — effective from 2018-03-22 to 07/07/2021*
#### **216-RICR-30-05-3** Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities
##### **216-RICR-30-05-3 § 3.1** Authority {#sec-216-ricr-30-05-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.1}
A.These regulations are promulgated pursuant to R.I. Gen. Laws §§16-38-2 and 23-1-18 and are established for the purpose of adopting standards pertaining to requirements for immunizations and testing of communicable diseases for child care workers in preschools and students at any preschool or school in grades Kindergarten-12 and students entering colleges and universities in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.2** Incorporated Materials {#sec-216-ricr-30-05-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.2}
A.These regulations hereby adopt and incorporate the Centers for Disease Control and Prevention (CDC) General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR, Recommendations and Reports (January 2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. https://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf
B.These regulations hereby adopt and incorporate the "Rhode Island Department of Health Rules and Regulations Pertaining to the Reporting of Communicable, Environmental and Occupational Diseases" (November 2013) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. http://sos.ri.gov/documents/archives/regdocs/released/pdf/DOH/7434.pdf
C.These regulations hereby adopt and incorporate the "CDC Guidelines for Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection MMWR, Recommendations and Reports" (June 2000) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. https://www.cdc.gov/mmwr/PDF/rr/rr4906.pdf
D.These regulations hereby adopt and incorporate the "National Resource Center for Health and Safety in Childcare and Early Education's Guidelines for Early Care and Education Programs" (October 2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. http://cfoc.nrckids.org/WebFiles/CFOC3_updated_final.pdf
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.3** Definitions {#sec-216-ricr-30-05-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.3}
A.Whenever used in these regulations, the following terms shall be construed as follows:
1."Advisory Committee on Immunization Practices (ACIP) recommendations", as used in these Regulations, means official federal recommendations for the use of vaccines in the United States and as published by the Centers for Disease Control and Prevention. ACIP recommendations represent the standard of care for vaccination practice in the United States.
2."Child care worker" means any person who is temporarily or permanently employed by a preschool (as defined in § 3.3(A)(7) of this Part) who has direct or indirect contact with children in the preschool.
3."College" or "university" means any public or private institution of higher learning in the State of Rhode Island.
4.“Director” means the Director of the Rhode Island Department of Health or his or her duly authorized designee.
5.“Department” means the Rhode Island Department of Health.
6."Entering" means formal registration by a student for attendance at a pre-school, school, college or university in Rhode Island.
7.“Preschool” means all public and non-public child day-care centers, family day-care homes, nursery schools, or any program licensed or certified by the Department of Children, Youth and Families which provides regular educational services to preschool-aged children in Rhode Island.
8.“Physician” means an individual licensed under the provisions of R.I. Gen. Laws Chapter 5-37, or an individual licensed to practice allopathic or osteopathic medicine under the laws of another state or territory of the United States, provided those laws are deemed to be substantially equivalent to R.I. Gen. Laws Chapter 5-37.
9.“R.I. Gen. Laws” means the General Laws of Rhode Island, as amended.
10.“School” means all public or non-public schools for students in grades Kindergarten through 12 in Rhode Island.
11."Student" means any individual who is or has been enrolled, full time or part time, at a preschool or school, and any person entering any public or private college or university in Rhode Island as a: full-time undergraduate or graduate student; part-time undergraduate or graduate student in a health science program who may be in contact with patients. The term “student” shall also include any person from another country attending or visiting classes or educational programs as part of a formal academic visitation or exchange program.
12.“These Regulations” means all parts of the Rules and Regulations Pertaining to Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities.
13.“Waiting period” means the time interval between scheduled doses of vaccine. The length of waiting periods is defined by the ACIP.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.4** General Requirements {#sec-216-ricr-30-05-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.4}
A.Preschools and schools shall adopt, at a minimum, the standards of immunization and communicable disease testing in § 3.5 of this Part.
1.It shall be the responsibility of the administrative head or his/her designee of any preschool or school to secure compliance with these Regulations.
B.Colleges and universities shall adopt, at a minimum, the standards of immunization and communicable disease testing contained in § 3.6 of this Part.
1.It shall be the responsibility of the administrative head, or his/her designee, of any college or university to secure compliance with these Regulations.
C.In accordance with ACIP recommendations, for all vaccines discussed in these Regulations, vaccine doses administered less than or equal to four (4) days before the minimum interval or age shall be counted as valid. Doses administered five (5) or more days earlier than the minimum interval or age shall not be counted as valid doses and shall be repeated as age-appropriate. The repeat dose should be spaced after the invalid dose by the recommended minimum interval as provided in ACIP recommendations incorporated above at § 3.2(A) of this Part.
D.Persons charged with reporting communicable diseases (e.g., physicians, physician assistants, registered nurse practitioners, midwives, laboratories, certified school nurse teachers and other entities or persons) shall comply with the reporting requirements issued by the Department incorporated above at § 3.2(B) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.5** Minimum Standards for Immunization and Communicable Disease Testing for Students Entering Preschools and Schools (K-12) {#sec-216-ricr-30-05-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.5}
A.Each student, upon initial entry to any preschool or school in Rhode Island, shall furnish evidence to the administrative head of the preschool or school (pursuant to the requirements of § 3.5.3 of this Part) that the student has been immunized, as required in §§ 3.5.1(A)(1)(a) and 3.5.2(A)(1-7) of this Part, unless the student is in an exempt category.
1.For the immunization requirements stipulated in §§ 3.5.1-(A)(1)(a) and 3.5.2(A) of this Part, a student who is not in compliance with these requirements shall be excluded from attending preschool or school until the requirements are met, unless the student belongs in an exemption category or is in a waiting period between doses as described in § 3.5.4 of this Part.
3.5.1 Preschool Entry Requirements
A.No student shall enter a preschool without an immunization record as defined in § 3.5.3 of this Part documenting that the student has been or is age appropriately immunized in accordance with the current Recommended Childhood Immunization Schedule approved by the Advisory Committee on Immunization Practices (ACIP)/American Academy of Pediatrics(AAP)/American Academy of Family Physicians (AAFP) against diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella, Haemophilus influenzae type b, hepatitis B, varicella (chickenpox), and pneumococcal disease.
1.Beginning August 1, 2015, immunization against hepatitis A and rotavirus will be added to the immunizations required pursuant to § 3.5.1 of these Regulations.
a.Beginning August 1, 2015, annual influenza vaccination, given between July 1 and December 31 of each year, is required for all preschool children six to fifty-nine (6-59) months of age.
3.5.2 School Entry Requirements
A.Each student, upon initial entry to any school, shall furnish evidence as required in § 3.5.3 of this Part of having received the vaccines described below:
1.Diphtheria, Tetanus, and Pertussis Vaccine
a.Five (5) doses of diphtheria, tetanus and acellular pertussis (DTaP) vaccine. If the fourth (4th) dose was given after the fourth (4th) birthday, a fifth (5th) dose is not necessary (total of four (4) doses). Where pertussis vaccine is medically contraindicated, diphtheria-tetanus (DT) vaccine is to be substituted.
(1)Where the student is seven (7) or more years of age and requires additional doses of vaccine to satisfy § 3.5.3(1)(a), Tdap (tetanus-diphtheria-pertussis) or Td (tetanus-diphtheria) shall be given in place of DTaP/DT according to ACIP age appropriate recommendations.
b.One (1) dose of Tdap vaccine is required for students entering seventh (7th) grade (or in the case of an ungraded classroom, for students twelve (12) years of age or older).
2.Poliomyelitis Vaccine
a.Four (4) doses of any combination of either oral poliovirus vaccine (OPV) or inactivated poliovirus vaccine (IPV). The final dose should be given on or after the fourth (4th) birthday. If the third (3rd) dose was given after the fourth (4th) birthday, a fourth (4th) dose is not necessary (total of three (3) doses), if all three (3) doses were either all OPV or all IPV; or a series administered in accordance with ACIP recommendations.
b.For students eighteen (18) years of age and older, poliovirus vaccine is not required.
3.Measles, Mumps, and Rubella Vaccines
a.Two (2) doses of live measles, mumps and rubella vaccine given at least four (4) weeks apart beginning on or after twelve (12) months of age shall be required for students entering kindergarten (K) and grade seven (7) in accordance with ACIP recommendations.
b.Beginning on August 1, 2015, this requirement shall apply to all students entering grades K through 12 and all students in ungraded classrooms. The following dates are in effect for the grades, as specified below:
(1)August 1, 2014 K,1,2,3,4,5,7,8,9,10,11,12
(2)August 1, 2015 K,1,2,3,4,5,6,7,8,9,10,11,12
4.Hepatitis B Vaccine
a.Three (3) doses of hepatitis B vaccine administered in accordance with ACIP recommendations are required for students entering grades kindergarten (K) through grade twelve (12) and all students in ungraded classrooms.
5.Varicella (Chickenpox) Vaccine
a.Two (2) doses of varicella vaccine given at least four (4) weeks apart beginning at or after twelve (12) months shall be required for students entering kindergarten (K) and grade seven (7) (or in the case of an ungraded classrooms, students twelve (12) years of age or older).
b.Beginning on August 1, 2015, this requirement shall apply to all students entering grades K through 12 and all students in ungraded classrooms. The following dates are in effect for the grades, as specified below:
(1)August 1, 2014 K,1,2,3,4,5,7,8,9,10,11,12
(2)August 1, 2015 K,1,2,3,4,5,6,7,8,9,10,11,12
6.Meningococcal Vaccine
a.All students entering seventh (7th) grade, shall be required to receive one (1) dose of meningococcal vaccine in accordance with ACIP recommendations.
b.Beginning August 1, 2014, this requirement shall apply to all students entering grades seven (7) through twelve (12) and all students in ungraded classrooms. The following dates are in effect for the grades, as specified below:
(1)August 1, 2014 7,8,9,10,11,12
cBeginning August 1, 2015, all students entering grade twelve (12), who had their first dose at age fifteen (15) years or younger, are required to have a booster dose given on or after sixteen (16) years of age.
7.Human Papillomavirus (HPV) Vaccine
aBeginning August 1, 2015, all students entering seventh (7th) grade shall be required to have at least one (1) dose of the HPV vaccine series.
bBeginning August 1, 2016, all students entering eighth (8th) grade shall be required to have at least two (2) doses of the HPV vaccine series.
cBeginning August 1, 2017, all students entering ninth (9th) grade shall be required to have completed the HPV vaccine series (3 doses).
3.5.3Immunization Records
A.Acceptable evidence of completion of immunizations shall include the day, month, year and type/name of each dose of vaccine administered. Such evidence shall consist of a record signed by a physician, registered nurse practitioner, physician’s assistant, or his/her designee (the signature of the student's parents is not acceptable). This record may be submitted to the preschool or school by a health care provider, another preschool or school, a parent or a guardian.
1.An official immunization record card, preschool or school immunization record, Medical Passport, World Health Organization immunization record, or other official immunization records acceptable to the Department; or
2.An electronically stored and/or transmitted documentary record (facsimile transmission, computerized record, including, but not limited to, a record obtained from the KIDSNET statewide registry or other statewide registry, record on magnetic media or similar record) as may be utilized by a preschool or school; or
3.Presentation of laboratory evidence of immunity is made in the case of measles, mumps, rubella, hepatitis B and varicella (chickenpox); or,
4.For chickenpox (varicella), a physician, a physician assistant, a certified registered nurse practitioner, or other licensed practitioner acting within his/her scope of practice signs a statement that the student has a history of chickenpox disease (varicella).
5.Telephone confirmation by the preschool or school or college of the existence of immunization records as defined above, provided all of the following conditions are met:
a.An acceptable documentary record is on file with the preschool or school officials at a preschool or school which the student previously attended, or is on file with a health provider, public health agency, other health professional or preschool or school official responsible for maintenance of immunization records; and
b.Telephone confirmation is obtained by a preschool or school official at the preschool or school in which the student enrolls; and
c.Telephone confirmation is sought and obtained within one (1) working day of the student's initial entry; and
d.Written documentation is made in the student's preschool or school health record of the telephone confirmation call, including the date and time of the call, the name, address, and telephone number of the person who confirmed the immunization status; and
e.A written documentary record of immunization is received by the preschool or school in which the student has enrolled within ten (10) working days of initial entry; and
f.The preschool or school shall implement the telephone confirmation as described above, if a student is seeking entry and does not present a copy of immunization records.
3.5.4Provisions for Exclusions, Waiting Periods and Exemptions
A.Exclusions
1.Students who have not received the minimum number of required immunizations, who are not in a prescribed waiting period between doses, as specified in § 3.5.4(B) of this Part and who are not exempt pursuant to § 3.5.4(C) of this Part, shall be excluded from the preschool or school by the administrative head of the preschool or school, pending the completion of the required dose(s) of vaccine(s).
2.Students upon initial entry to any preschool or school shall be excluded unless evidence is submitted that the student has received initial dose(s) of required vaccine(s) for preschool or school entry as set forth in these Regulations.
a.The presence of a vaccine-preventable disease outbreak is determined in consultation with the Department. If an outbreak of vaccine-preventable disease should occur, an exempt student shall be excluded from school by the administrative head of school for a period of time as determined by the Department based on a case-by-case analysis of public health risk.
b.The preschool or school shall have a written protocol in place for the exclusion of unvaccinated students in the event of an outbreak. An accurate and current listing of unvaccinated students shall be maintained by the preschool or school for this purpose.
B.Waiting Periods
1.If at initial preschool or school entry a student is within a waiting period for the minimum number of doses for a given vaccine, the student shall be registered and/or admitted to preschool or school. It shall be the responsibility of the administrative head of the preschool or school or his/her designee to ensure the completion of at least the minimum number of immunizations, following the prescribed waiting period(s) and consistent with the provisions of these Regulations.
a.The administrative head of the preschool or school or his/her designee shall sign a Temporary Immunization Exemption Certificate, provided by the school, indicating that an appointment with a health care provider for the required immunization(s) has been made. This temporary exemption shall expire on the date of the immunization appointment.
2.At initial preschool or school entry a student who is under the care of the Department of Children, Youth and Families (DCYF) shall be enrolled in school upon presentation of a completed intra-state education identification card in accordance with the requirements of R.I. Gen. Laws § 42-72.4-1 or as stipulated in § 3.5.3 of this Part.
C.Exemptions
1.A student may only be exempt from the immunization requirements described in these Regulations for either of the two (2) reasons stated below:
a.A physician, a physician assistant, a certified registered nurse practitioner, or other licensed practitioner acting within his/her scope of practice signs the Rhode Island Department of Health’s “Medical Immunization Exemption Certificate” provided by the school attesting that the student is exempt from a specific vaccine because of medical reasons, in accordance with ACIP recommendations; or
b.A parent or guardian completes and signs the Department’s “Religious Immunization Exemption Certificate” provided by the school, attesting that immunization conflicts with the tenets of their religious beliefs.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.6** Minimum Standards for Immunization and Communicable Disease Testing for Students Entering Colleges or Universities {#sec-216-ricr-30-05-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.6}
A.Each student, upon entering any college or university in Rhode Island, shall furnish evidence to the administrative head of the college or university (pursuant to the requirements of § 3.6.2 of this Part) that the student has been immunized, as required in § 3.6.1 of this Part, unless the student is in an exempt category (e.g., documented evidence of immunity).
B.For the immunization requirements stipulated in § 3.6.1 of this Part, a student who is not in compliance with these requirements shall be excluded from attending college or university classes until the requirements are met, unless the student belongs in an exemption category or is in a waiting period between doses as described in § 3.6.3(B) or § 3.6.3(C) of this Part.
3.6.1College or University Entry: Immunization Requirements
A.Each student, upon entering any college or university, shall furnish evidence as required in § 3.6.2 of this Part of having received the vaccines described below:
1.Tetanus, Diphtheria, Pertussis Vaccine. Evidence of having received a single dose of Tdap vaccine.
2.Measles, Mumps, and Rubella Vaccines. Two (2) doses of live measles, mumps and rubella vaccine given at least four (4) weeks apart beginning on or after twelve (12) months of age.
3.Hepatitis B Vaccine. Three (3) doses of hepatitis B vaccine administered in accordance with ACIP recommendations.
4.Varicella (Chickenpox) Vaccine. Two (2) doses of varicella vaccine given at least four (4) weeks apart beginning on or after twelve (12) months of age.
5.Meningococcal Vaccine. Beginning August 1, 2015, one (1) dose of meningococcal conjugate (MCV4) vaccine in the last 5 years is required for previously unvaccinated newly enrolled full-time undergraduate and graduate students (under twenty-two (22) years of age) in a degree program at a college or university who will live in a dormitory or comparable congregate living arrangement approved by the institution.
3.6.2Immunization Records
A.Acceptable evidence of completion of immunizations shall include the day, month, year and type/name of each dose of vaccine administered. The record of such evidence shall be signed by a physician, physician assistant, certified registered nurse practitioner, or other licensed practitioner acting within his/her scope of practice (the signature of the student's parents is not acceptable). This record may be submitted to the college or university by a health care provider, another college or university, the student, or a parent/guardian.
B.For students who initially entered primary school on or before 31 December 1989, existing immunization records shall be deemed acceptable, provided the record contains a valid exemption form or contains documentation that the student has completed the required immunizations.
C.Acceptable evidence of completion of immunization consists of:
1.An official immunization record card, school immunization record, Medical Passport, World Health Organization immunization record, or other official immunization records acceptable to the Department; or
2.An electronically stored and/or transmitted documentary record (facsimile transmission, computerized record, including, but not limited to, a record on magnetic media or similar record) as may be utilized by a school; or
3.Presentation of laboratory evidence of immunity is made in the case of measles, mumps, rubella, hepatitis B, and varicella (chickenpox); or
4.A physician, physician assistant, certified registered nurse practitioner, or other licensed practitioner acting within his/her scope of practice signs a statement that the student has a history of chickenpox disease (varicella).
3.6.3Provisions for Exclusions, Waiting Periods, and Exemptions
A.Exclusions
1.Students who have not received the minimum number of required immunizations, who are not in a prescribed waiting period between doses, as specified in § 3.6.1 of this Part and who are not exempt pursuant to § 3.6.3(C) of this Part, shall be excluded from the college or university by the administrative head of the college or university, pending the completion of the required dose(s) of vaccine(s).
2.Students upon entering any college or university shall be excluded unless evidence is submitted that the student has received initial dose(s) of required vaccine(s) for college or university entry as set forth in these Regulations.
3.The presence of a vaccine-preventable disease outbreak is determined in consultation with the Department. If an outbreak of vaccine-preventable disease should occur, an exempt student shall be excluded from school by the administrative head of school for a period of time as determined by the Department based on a case-by-case analysis of public health risk.
4.The college or university shall have a written protocol in place for the exclusion of unvaccinated students in the event of an outbreak. An accurate and current listing of all unvaccinated students shall be maintained by the college or university for this purpose.
B.Waiting Periods
1.If, at college or university entry, a student is within a waiting period for the minimum number of doses for a given vaccine, the student shall be enrolled and/or admitted to the college or university. It shall be the responsibility of the administrative head of the college or university or his/her designee to ensure the completion of at least the minimum number of immunizations, following the prescribed waiting period(s) and consistent with the provisions of these Regulations.
C.Exemptions
1.A student may be exempt from the immunization requirements described in these Regulations provided that:
a.A physician, physician assistant, certified registered nurse practitioner, or other licensed practitioner acting within his/her scope of practice signs the Department’s “Medical Immunization Exemption Certificate” provided by the college/university attesting that the student is exempt from a specific vaccine because of medical reasons, in accordance with ACIP guidelines; or
b.A parent or guardian or student (if eighteen) 18 years of age or older completes and signs the Department’s “Religious Immunization Exemption Certificate” provided by the college/university, attesting that immunization conflicts with the tenets of their religious beliefs; or
c.The administrative head of the college or university or his/her designee signs a Temporary Immunization Exemption Certificate, provided by the college/university, indicating that an appointment with a health care provider for the required immunization(s) has been made. This temporary exemption shall expire on the date of the immunization appointment.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.7** Tuberculosis Testing for Colleges/Universities {#sec-216-ricr-30-05-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.7}
A.Targeted tuberculosis (TB) testing is required for entering students who are from highly endemic countries of the world and have been a resident in the United States for less than five (5) years. All other testing should be conducted according to the CDC Guidelines incorporated above at § 3.2(C) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.8** Minimum Standards for Immunization and Communicable Disease Testing for Child Care Workers in Preschools {#sec-216-ricr-30-05-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.8}
A.Beginning August 1, 2015, in accordance with the National Health and Safety Performance Standards for Early Care and Education Programs incorporated above at § 3.2(D) of this Part, evidence of immunity is required for all child care workers (with the exception of child care workers who receive a medical exemption) against:
1.Tetanus, Diphtheria and Pertussis: one (1) dose of Tdap vaccine
2.Measles, Mumps and Rubella: two (2) doses of MMR vaccine
3.Chickenpox: two (2) doses of Varicella vaccine
4.Influenza: annual influenza vaccination, administered between July 1 and December 31 of each year, is required for all child care workers
5.Acceptable evidence of completion of immunization consists of:
a.An official immunization record card, school immunization record, Medical Passport, World Health Organization immunization record, or other official immunization records acceptable to the Department; or
b.An electronically stored and/or transmitted documentary record (facsimile transmission, computerized record, including, but not limited to, a record on magnetic media or similar record) as may be utilized by a school; or
c.Presentation of laboratory evidence of immunity is made in the case of measles, mumps, rubella, hepatitis B, and varicella (chickenpox); or
d.A physician, physician assistant, certified registered nurse practitioner, or other licensed practitioner acting within his/her scope of practice signs a statement that the student has a history of chickenpox disease (varicella).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.9** Reporting {#sec-216-ricr-30-05-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.9}
A.The administrative head (or designee) of each preschool, school, college and university shall be responsible for reporting the immunization status of students and the number of students with a medical and/or religious exemption to the Department.
B.Such reporting shall occur according to procedures and format required by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
##### **216-RICR-30-05-3 § 3.10** Severability {#sec-216-ricr-30-05-3-3.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-30-05-3#3.10}
A.If any provisions of these Regulations or the application thereof to any facility or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of these Regulations which can be given effect, and to this end the provisions of these Regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2014-08-12 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/12/2014*
- *Amendment — effective from 2009-05-14 to 08/12/2014*
- *Amendment — effective from 2005-07-04 to 05/14/2009*
- *Amendment — effective from 2002-10-21 to 07/04/2005*
- *Periodic Refile — effective from 2002-01-02 to 10/21/2002*
## **Chapter 40** Professional Licensing and Facility Regulation
### **Subchapter 05** Professional Licensing
#### **216-RICR-40-05-1** Licensure and Discipline of Physicians
##### **216-RICR-40-05-1 § 1.1** Authority and Incorporated Materials {#sec-216-ricr-40-05-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-1#1.1}
1.1.1Authority
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 5-37-1.4(5) and 5-19.2-3, and are established for the purpose of updating prevailing standards governing the licensure and discipline of physicians in Rhode Island.
1.1.2Incorporated Materials
A.This Part hereby adopts and incorporates by reference the Centers for Disease Control ("CDC") "Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care" (September 2016), not including any further editions or amendments thereof, and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2026-08-26 to current*
- *Amendment — effective from 2022-04-24 to 08/26/2026*
- *Periodic Refile — effective from 2022-01-04 to 04/24/2022*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 10/31/2018*
- *Amendment — effective from 2015-11-23 to 09/26/2017*
- *Amendment — effective from 2014-10-13 to 11/23/2015*
- *Amendment — effective from 2014-04-24 to 10/13/2014*
- *Amendment — effective from 2012-12-10 to 04/24/2014*
- *Amendment — effective from 2012-06-21 to 12/10/2012*
- *Amendment — effective from 2012-04-01 to 06/21/2012*
- *Amendment — effective from 2009-09-17 to 04/01/2012*
- *Amendment — effective from 2008-09-17 to 09/17/2009*
- *Amendment — effective from 2007-11-11 to 09/17/2008*
- *Amendment — effective from 2004-11-03 to 11/11/2007*
- *Amendment — effective from 2004-05-12 to 11/03/2004*
- *Amendment — effective from 2003-01-27 to 05/12/2004*
- *Periodic Refile — effective from 2002-01-02 to 01/27/2003*
##### **216-RICR-40-05-1 § 1.2** Definitions {#sec-216-ricr-40-05-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-1#1.2}
A.Wherever used in this Part, the terms listed below shall be construed in the following manner:
1.“Acupuncture” means the insertion of needles into the human body by piercing the skin of the body, for the purpose of controlling and regulating the flow and balance of energy in the body. For the purposes of this Part; “medical acupuncture” means acupuncture as practiced by physicians licensed under the provisions of R.I. Gen. Laws Chapter 5-37.
2."Act" means R.I. Gen. Laws Chapter 5-37 entitled "Board of Medical Licensure and Discipline."
3."Board" means the Rhode Island Board of Medical Licensure and Discipline or any committee or subcommittee thereof established under the provisions of R.I. Gen. Laws § 5-37-1.1.
4."Chief administrative officer" means the administrator of the Rhode Island Board of Medical Licensure and Discipline.
5."Collaborative pharmacy practice" means that practice of pharmacy whereby a pharmacist with advanced training and experience relevant to the scope of collaborative practice agrees to work in collaboration with one (1) or more physicians for the purpose of drug therapy management of patients, such management to be pursuant to a protocol or protocols authorized by the physician(s) and subject to approval by the Department and any conditions and/or limitations thereto. A health care professional who has prescribing privileges and is employed by a collaborating physician may be in such an agreement.
6.“Compounding” means the act of combining two (2) or more ingredients as a result of a practitioners prescription or medication order occurring in the course of professional practice based upon the individual needs of a patient and a relationship between the practitioner, patient and pharmacists. Compounding does not mean the routine preparation, mixing, reconstitution or assembling od drug products that are essentially copies of a commercially available product. Pharmacy compounding includes the preparation of drugs or devices pursuant to a prescription or medication order or in anticipation or prescription or medication orders based upon routine, regularly observed prescribing patterns.
7.“Compounding sterile preparations” or “CSPs” means a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.
8.“Department” means the Rhode Island Department of Health.
9."Director" means the Director, Rhode Island Department of Health.
10.“Doctor of acupuncture” means a person who has been licensed under the provisions of R.I. Gen. Laws Chapter 5-37.2 to practice the art of healing known as acupuncture.
11."Drug therapy management" means the review, in accordance with a collaborative practice agreement, of drug therapy regimen(s) of patients by a pharmacist for the purpose of rendering advice to one (1) or more physicians that are party to the agreement, or their physician designees, regarding adjustment of the regimen. Decisions involving drug therapy management shall be made in the best interests of the patient. In accordance with a collaborative practice agreement, drug therapy management may include:
a.Modifying and managing drug therapy;
b.Collecting and reviewing patient histories;
c.Obtaining and checking vital signs, including pulse, temperature, blood pressure, and respiration; and
d.Under the supervision of, or in direct consultation with a physician, ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and providing such evaluation does not include any diagnostic component.
12."Foreign medical graduate" means a physician (individual) whose basic medical degree or qualification was conferred by an allopathic medical school located outside the United States, Canada and Puerto Rico.
13.“Good standing” means a licensee has an unrestricted license to practice medicine.
14.“Intern, resident, or fellow” means a physician in training in an accredited postgraduate training program.
15."License" is synonymous with registration certificate.
16."Medical malpractice" or "malpractice" means any tort, or breach of contract based on health care or professional services rendered, or which should have been rendered, by a physician, dentist, hospital, clinic, health maintenance organization or professional service corporation providing health care services and organized under R.I. Gen. Laws Chapter 7-5.1, to a patient or the rendering of medically unnecessary services except at the informed request of the patient.
17.“Medical record” means a record of a patient’s medical information and treatment history maintained by physicians and other medical personnel, which includes, but is not limited to, information related to medical diagnosis, immunizations, allergies, x-rays, copies of laboratory reports, records of prescriptions, and other technical information used in assessing the patient’s health condition, whether such information is maintained in a paper or electronic format.
18.“Non-ablative treatment” means any laser/intense pulsed light treatment or other energy source, chemical, or modality that is not expected or intended to remove, burn, or vaporize tissue. This shall include treatments related to laser hair removal.
19."Person" means any individual, partnership, firm corporation, (including, but not limited to, associations, joint stock companies, limited liability companies, and insurance companies), trust or estate, state or political subdivision or instrumentality of a State.
20."Physician" means any person licensed to practice allopathic or osteopathic medicine pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
21.“Postgraduate training” means satisfactory training after earning the medical degree at an accredited program, or its equivalent as determined by the Board, including internship, residency and fellowship. Such training shall include one (1) year of internship and one (1) or two (2) years of progressive residency or comparable fellowship.
22."Practice of medicine" means the practice of allopathic and osteopathic medicine. Any person shall be regarded as practicing medicine within the meaning of the Act who holds himself or herself out as being able to diagnose, treat, perform surgery, use a laser/intense pulsed light, or prescribe for any person for disease, pain, injury, deformity or physical or mental condition or prescribe for any person ill or alleged to be ill with disease, pain, injury, deformity or abnormal physical or mental condition, or who shall either profess to heal, offer or undertake, by any means or method, to diagnose, treat, perform surgery, or prescribe for any person for disease, pain, injury, deformity or physical or mental condition. In addition, one who attaches the title M.D., physician, surgeon, D.O., osteopathic physician and surgeon, or any other similar word or words or abbreviation to his or her name indicating that he or she is engaged in the treatment or diagnosis of the diseases, injuries or conditions of persons shall be held to be engaged in the practice of medicine. Non-ablative treatment is part of the practice of medicine.
23.“Prescriber” means a health care provider who is licensed in the State of Rhode Island who has prescribing privileges.
24.“Surgery” is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of human tissue which include lasers, ultra-sound, ionizing radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel. Notwithstanding the above, the following injection procedures are not considered surgery: FDA-approved Botulinum toxin type A (BoNT-A) products for cosmetic purposes, FDA-approved dermal filler for cosmetic purposes, Platelet-Rich Fibrin for cosmetic purposes, and Platelet-Rich Plasma for cosmetic purposes.
25.“Telemedicine” means, as defined in R.I. Gen. Laws § 27-81-3, the delivery of clinical healthcare services by use of real time, two (2) way synchronous audio, video, telephone-audio-only communications or electronic media or other telecommunications technology including but not limited to: online adaptive interviews, remote patient monitoring devises, audiovisual communications, including the application of secure video conferencing or store-and-forward technology to provide or support healthcare deliver, which facilitate the assessment, diagnosis, counseling an prescribing treatment and care management of a patient’s healthcare while such patient is at an originating site and the healthcare provider is at a distant site, consistent with applicable Federal laws and Regulation. Telemedicine does not include an email message or facsimile transmission between the provider and patient, or an automated computer program used to diagnose and/or treat ocular or refractive conditions.
**History**
- *Amendment — effective from 2026-08-26 to current*
- *Amendment — effective from 2022-04-24 to 08/26/2026*
- *Periodic Refile — effective from 2022-01-04 to 04/24/2022*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 10/31/2018*
- *Amendment — effective from 2015-11-23 to 09/26/2017*
- *Amendment — effective from 2014-10-13 to 11/23/2015*
- *Amendment — effective from 2014-04-24 to 10/13/2014*
- *Amendment — effective from 2012-12-10 to 04/24/2014*
- *Amendment — effective from 2012-06-21 to 12/10/2012*
- *Amendment — effective from 2012-04-01 to 06/21/2012*
- *Amendment — effective from 2009-09-17 to 04/01/2012*
- *Amendment — effective from 2008-09-17 to 09/17/2009*
- *Amendment — effective from 2007-11-11 to 09/17/2008*
- *Amendment — effective from 2004-11-03 to 11/11/2007*
- *Amendment — effective from 2004-05-12 to 11/03/2004*
- *Amendment — effective from 2003-01-27 to 05/12/2004*
- *Periodic Refile — effective from 2002-01-02 to 01/27/2003*
##### **216-RICR-40-05-1 § 1.3** License Requirements {#sec-216-ricr-40-05-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-1#1.3}
1.3.1Generally
A.No person, unless licensed to practice medicine in Rhode Island, shall practice allopathic or osteopathic medicine or surgery or attempt to practice allopathic or osteopathic medicine or surgery, or any of the branches of allopathic or osteopathic medicine or surgery after having received therefore or with the intent of receiving therefore, either directly or indirectly, any bonus, gift or compensation or who shall open an office with intent to practice allopathic or osteopathic medicine or shall hold himself or herself out to the public as a practitioner of allopathic or osteopathic medicine, whether by appending to his or her name the title of doctor or any abbreviation thereof, or M.D., or D.O. or any other title or designation implying a practitioner of allopathic or osteopathic medicine.
1.All physicians who are licensed to practice medicine in Rhode Island must obtain and sustain medical malpractice coverage prior to seeing patients. Proof of malpractice insurance shall be provided to the Board upon request. It is incumbent upon the licensee to ensure that malpractice coverage does not lapse while engaged in the practice of medicine.
1.3.2Practice of Medical Acupuncture
A.Any physician licensed in Rhode Island under the provisions of the Act who seeks to practice medical acupuncture as a therapy shall comply with the following:
1.Meet the requirements for licensure as a doctor of acupuncture set forth in Part 8 of this Subchapter, Licensing Doctors of Acupuncture and Oriental Medicine promulgated by the Rhode Island Department of Health; or
2.Successfully complete a course offered to physicians that has been approved by the American Board of Medical Acupuncture (ABMA).
B.Any physician licensed in Rhode Island under the provisions of the Act who seeks to practice acupuncture limited to the ear shall complete an approved course of at least four (4) hours duration.
1.3.3Visiting Physicians
A.Notwithstanding the provisions of § 1.3.1 of this Part, the exceptions to licensure requirements are pursuant to R.I. Gen. Laws § 5-37-16.2.
1.3.4Limited Medical Registration Requirements for Interns, Residents or Fellows
A.Except for physicians licensed pursuant to R.I. Gen. Laws Chapter 5-37, no person shall perform the duties of an intern, resident or fellow in Rhode Island without holding a limited medical registration certificate pursuant to R.I. Gen. Laws § 5-37-16.
1.Limited medical registration shall only be granted to individuals appointed as intern, resident or, fellow in a hospital licensed in Rhode Island, or other institution or clinic pursuant to R.I. Gen. Laws § 5-37-16 for the purpose of obtaining training in a medical program accredited by the Accreditation Council for Graduate Medical Education, (ACGME), the American Osteopathic Association, (AOA), or other accrediting body approved by the Board, or to a fellow for the purpose of teaching, research and/or training in conjunction with a medical education program in a medical school accredited by the Liaison Committee for Medical Education (LCME) or by the Commission on Osteopathic College Accreditation (COCA).
B.A limited medical registration certificate (for postgraduate training) shall entitle the holder thereof to practice medicine in the hospital or other institution designated on the certificate of limited registration, or outside such hospital or other institution for the treatment under the supervision of one of its medical staff who is a duly licensed physician [i.e. full licensure], of persons accepted by it as patients, or in any hospital, institution, clinic or program affiliated for training purposes with the hospital, institution or clinic designated on such certificate, which affiliation is approved by the Department. In all cases the practice of medicine under a limited medical registration shall be in accordance with policies and procedures established by the hospital, institution or other clinic designated on the certificate.
1.It shall be the responsibility of each hospital, clinic or other institution to submit, on or before April 1 of each year to the Department for its approval, a list of affiliated hospitals, institutions, clinics or programs providing training programs for interns, residents or, fellows.
2.Any hospital, clinic or institution providing training programs for interns, residents, or fellows, that are subject to statutory licensure in Rhode Island, shall hold a current license.
C.Once a full license to practice medicine in the State of Rhode Island has been granted, all concurrent limited medical registration privileges shall cease.
D.Physicians who have a full license in this or another jurisdiction who come to a Rhode Island graduate medical education program.
1.Physicians who are fully licensed in Rhode Island or in an alternate jurisdiction, and who are entering or re-entering an accredited graduate medical education program (training program) are eligible for limited medical registration (training license). The limited medical registration shall be granted annually for the duration of training.
2.If the physician chooses to practice outside of the accredited graduate medical education program at any time during the period of training, a full medical license is required.
E.A physician in training greater than five (5) years shall obtain a full, unrestricted license to practice medicine in Rhode Island, unless the physician remains in an accredited training program and has successfully passed all three (3) parts of the United States Medical Licensing Examination (USMLE) or all three (3) levels of the Comprehensive Osteopathic Medical Licensing Examination of the United States (COMLEX-USA).
**History**
- *Amendment — effective from 2026-08-26 to current*
- *Amendment — effective from 2022-04-24 to 08/26/2026*
- *Periodic Refile — effective from 2022-01-04 to 04/24/2022*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 10/31/2018*
- *Amendment — effective from 2015-11-23 to 09/26/2017*
- *Amendment — effective from 2014-10-13 to 11/23/2015*
- *Amendment — effective from 2014-04-24 to 10/13/2014*
- *Amendment — effective from 2012-12-10 to 04/24/2014*
- *Amendment — effective from 2012-06-21 to 12/10/2012*
- *Amendment — effective from 2012-04-01 to 06/21/2012*
- *Amendment — effective from 2009-09-17 to 04/01/2012*
- *Amendment — effective from 2008-09-17 to 09/17/2009*
- *Amendment — effective from 2007-11-11 to 09/17/2008*
- *Amendment — effective from 2004-11-03 to 11/11/2007*
- *Amendment — effective from 2004-05-12 to 11/03/2004*
- *Amendment — effective from 2003-01-27 to 05/12/2004*
- *Periodic Refile — effective from 2002-01-02 to 01/27/2003*
##### **216-RICR-40-05-1 § 1.4** Qualifications {#sec-216-ricr-40-05-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-1#1.4}
1.4.1Allopathic Physicians
A.Graduates of Schools Located in the United States and Puerto Rico. An applicant seeking licensure to practice medicine in Rhode Island must:
1.Be of good moral character;
2.Have graduated from a medical school accredited by the Liaison Committee for Medical Education (LCME);
3.Have satisfactorily completed two (2) years of progressive post graduate training, internship and residency, in a program accredited by the Accreditation Council for Graduate Medical Education;
4.Have satisfactorily passed an examination approved by the Board; and
5.Meet such other requirements as set forth by Regulation or as may be established by the Board.
B.Graduates of Schools Located in Canada. An applicant seeking licensure to practice medicine in Rhode Island must:
1.Be of good moral character;
2.Have graduated from a medical school accredited by the Liaison Committee for Medical Education (LCME);
3.Have satisfactorily completed two (2) years of progressive post graduate training in a program accredited by the Accreditation Committee of the Federation of the Medical Licensing Authority of Canada or the Royal College of Physicians and Surgeons of Canada;
4.Have satisfactorily passed an examination approved by the Board; and
5.Meet such other requirements as set forth by Regulation or as may be established by the Board.
C.Foreign Medical Graduates. An applicant seeking licensure to practice medicine in Rhode Island who is a Foreign Medical Graduate must:
1.Be of good moral character;
2.Have graduated from a medical school located outside the United States which is recognized by the World Health Organization and the Board;
3.Have received certification by the Education Commission for Foreign Medical Graduates (ECFMG);
4.Applicants must have satisfactorily completed two (2) years of progressive postgraduate training, internship and residency or a comparable fellowship in a training program accredited by the Accreditation Council for Graduate Medical Education (ACGME). The Board may grant up to twelve (12) months of credit at the internship level to an applicant with a minimum of three (3) years of progressive international postgraduate training when advanced standing is also granted by the American Board of Medical Specialties.
5.Have satisfactorily passed an examination approved by the Board; and
6.Meet such other requirements as set forth by Regulation or as may be established by the Board.
D.Foreign Medical Graduates/United States Citizens (Fifth [5th] Pathway). An applicant seeking licensure to practice medicine in Rhode Island and who is a Foreign Medical Graduate and a United States citizen at the time of attendance at said foreign school and who has completed all of the formal requirements of said medical school except internship and/or social services must:
1.Be of good moral character;
2.Have successfully completed a course of study from a medical school located outside the United States which is recognized by the World Health Organization and the Board;
3.Have satisfactorily passed the Educational Commission for Foreign Medical Graduates Examinations;
4.Have attained a score satisfactory to a medical school approved by the Liaison Committee on Medical Education on a qualifying examination acceptable to the State Board for Medicine;
5.Applicants shall have satisfactorily completed two (2) years of progressive postgraduate training, internship and residency or fellowship in a training program accredited by the Accreditation Council for Graduate Medical Education.
6.Have satisfactorily passed an examination approved by the Board; and
7.Meet such other requirements as set forth by Regulation or as may be established by the Board.
E.Waiver of Training Requirements – Allopathic Physicians
1.Notwithstanding the requirements of § 1.4.1(A)(3) of this Part, all or some of the postgraduate training requirement for graduates of schools located in the United States and Puerto Rico may be waived, at the discretion of the Board, for graduates who hold a full and unrestricted medical license in another State/jurisdiction for at least five (5) years and are certified by an American Board of Medical Specialty (ABMS) Board.
2.Notwithstanding the requirements of § 1.4.1(B)(3) of this Part, all or some of the postgraduate training requirement for graduates of schools located in Canada may be waived, at the discretion of the Board, for graduates who hold a full and unrestricted medical license in another State/jurisdiction for at least five (5) years and are certified by an ABMS Board.
3.Notwithstanding the requirements of § 1.4.1(D)(4) of this Part, all or some of the postgraduate training requirement for foreign medical graduates may be waived, at the discretion of the Board, for international graduates with advanced international postgraduate training, who hold full and unrestricted medical licensure in another State/jurisdiction, and five (5) years of clinical practice experience in good standing in the alternate jurisdiction.
1.4.2Osteopathic Physicians
A.Graduates of Schools of Osteopathic Medicine. An applicant seeking licensure to practice Osteopathic Medicine in Rhode Island must:
1.Be of good moral character;
2.Have graduated from an osteopathic medical school located in the United States that is accredited by the American Osteopathic Association;
3.Have satisfactorily completed two (2) years of progressive post graduate training, internship and residency in a program approved by the American Osteopathic Association or the Accreditation Council for Graduate Medical Education:
4.Have satisfactorily passed an examination approved by the Board; and
5.Meet such other requirements as set forth by Regulations or as may be established by the Board.
B.Waiver of Training Requirements – Osteopathic Physicians. Notwithstanding the requirements of § 1.4.2(A) of this Part, all or some of the postgraduate training requirement for graduates of schools of osteopathic medicine may be waived, at the discretion of the Board, for graduates who hold a full and unrestricted license to practice osteopathic medicine in another State/jurisdiction for at least five (5) years and are certified by the AOA or an ABMS Board.
1.4.3Licensure by Endorsement
A.The Board may grant expedited full and unrestricted licensure to applicants with a verified full and unrestricted licensure in another State with administrative approval from the Chief Administrative Officer provided that the candidate shall:
1.Have no formal disciplinary actions or active or pending investigations; past, pending, public or confidential restrictions or sanctions, by the board of medicine, licensing authority, medical society, professional society, hospital, medical school or institution staff sanctions in any State, country or jurisdiction. A disciplinary action includes, but is not limited to, the refusal to issue or renew a license to practice medicine by any aforementioned entity.
2.Hold unrestricted licenses in every jurisdiction that the candidate holds a license.
3.Meet minimum requirements for a license in the State of Rhode Island.
4.Have submitted a completed application, in the English language or accompanied by a certified translation thereof into English for reciprocal licensure. Such licenses shall be considered provisional until ratified at a meeting of the full Board. Willful violation of the provisions of this Section by a licensing candidate shall be grounds for immediate license suspension.
1.4.4Temporary Post-Graduate License
A.Licensure. A temporary post-graduate license is a full unrestricted license that can be granted after one (1) year of post-graduate training and may not be renewed more than once. The Board may grant a temporary post-graduate license to practice medicine in Rhode Island as a physician to an individual who meets all of the following requirements:
1.Have successfully completed one (1) year of post graduate training in an accredited Rhode Island training program.
B.Issuance and Renewal
1.Fees. The fee for a temporary post-graduate physician license is the same as a full license (since valid for one (1) year is pro-rated fifty percent (50%)). The Fee for a temporary post-graduate physician license may be waived (for initial license and renewal) if within nine (9) months of issuance of this license the physician supplies to the Department proof of obtaining a DEA waiver (“X” number) to treat patients with medication assisted treatment. Physicians who receive a fee waiver who do not supply evidence of aforementioned DEA waiver (“X” number) within nine (9) months will be billed for the full license fee. Physicians who do not pay the balance within three (3) months will be referred to the Board for unprofessional conduct.
2.A temporary post-graduate physician license is valid for one (1) year from issue date may be renewed only once, the fee upon renewal is the same as a physician license and may be waived, if physician has submitted evidence to the department of DEA waiver (“X” number).
C.Continuing medical education (CME) shall be required in accordance with § 1.5.5(A) of this Part, participation in an accredited post-graduate medical education program shall satisfy the requirements of CME.
1.4.5Volunteer Physicians
A.Licensure. The Board may grant a license to practice medicine in Rhode Island as a volunteer physician to an individual who meets all of the following requirements:
1.Be otherwise qualified for licensure as a physician pursuant to this Part.
2.Be retired from the active practice of medicine and whose only clinical activities will be volunteering in clinics and other facilities that provide medical care to underinsured or uninsured patients.
3.Receive no monetary or in-kind compensation for any clinical services provided as a physician.
4.Submit documentation to the Board from an IRS-approved 501(c)(3) organization, or other similar entity, providing care for underinsured or uninsured patients, attesting to the physician's status as a volunteer physician and the absence of compensation (monetary or in-kind).
5.Separate documentation shall be provided for each organization where the applicant intends to provide services as a volunteer physician.
6.Submit documentation to the Board that malpractice insurance will be provided, either by the organization or by the applicant.
B.Issuance and Renewal
1.Fees. There shall be no licensure fee for a volunteer physician license.
2.Upon completion of the requirements contained in § 1.4.5(A) of this Part, the Director may issue a volunteer physician license in accordance with § 1.5.6(A) of this Part.
3.A volunteer physician license may be renewed in accordance with § 1.5.6(B) of this Part.
C.Continuing Education. A volunteer physician shall be required to complete continuing medical education in accordance with § 1.5.5(A) of this Part.
D.Conversion to Full/Unrestricted License. A physician with a volunteer license who wishes to resume active practice may convert the license to full/unrestricted license by paying the licensure fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
1.4.6Academic Faculty
A.The requirements for limited registration of academic faculty are pursuant to R.I. Gen. Laws § 5-37-16.1.
**History**
- *Amendment — effective from 2026-08-26 to current*
- *Amendment — effective from 2022-04-24 to 08/26/2026*
- *Periodic Refile — effective from 2022-01-04 to 04/24/2022*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 10/31/2018*
- *Amendment — effective from 2015-11-23 to 09/26/2017*
- *Amendment — effective from 2014-10-13 to 11/23/2015*
- *Amendment — effective from 2014-04-24 to 10/13/2014*
- *Amendment — effective from 2012-12-10 to 04/24/2014*
- *Amendment — effective from 2012-06-21 to 12/10/2012*
- *Amendment — effective from 2012-04-01 to 06/21/2012*
- *Amendment — effective from 2009-09-17 to 04/01/2012*
- *Amendment — effective from 2008-09-17 to 09/17/2009*
- *Amendment — effective from 2007-11-11 to 09/17/2008*
- *Amendment — effective from 2004-11-03 to 11/11/2007*
- *Amendment — effective from 2004-05-12 to 11/03/2004*
- *Amendment — effective from 2003-01-27 to 05/12/2004*
- *Periodic Refile — effective from 2002-01-02 to 01/27/2003*
##### **216-RICR-40-05-1 § 1.5** Application for License & Fees {#sec-216-ricr-40-05-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-1#1.5}
1.5.1Application
A.Application for licensure shall be made on forms provided by the Board which shall be completed, including the physician's signature and a recent identification photograph of the applicant, head and shoulder front view, approximately two inches by three inches (2” x 3”) in size submitted to the Board.
B.Such application shall be accompanied by the following documents and fee (non-refundable and non-returnable):
1.The applicant must submit a self-query of the National Practitioner Data Bank.
2.Each license application, except from an applicant who qualifies for a license by endorsement pursuant to § 1.4.3(A) of this Part, must also include a completed Federation Credentials Verification Form (FCVS) from the Federation of State Medical Boards of the United States, Inc.
3.A statement from the Board of Examiners in Allopathic or Osteopathic Medicine in each State in which the applicant has held or holds licensure to be submitted to the Board of this state attesting the licensure status of the applicant during the time period applicant held licensure in said State;
4.The application examination fee, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health;
5.Such other information as may be deemed necessary and appropriate by the Board.
C.The Board, at its discretion, reserves the right to require any or all applicants to appear before the Board for an interview.
D.An applicant shall not be eligible for licensure by endorsement if the Board finds that the applicant has engaged in any conduct prohibited by this Part.
E.Granting of licensure after a lapse for non-disciplinary reasons. If a physician has not engaged in the active practice of medicine for two (2) years or more the Board shall establish clinical competency of the applicant prior to reactivation or reinstatement. The Board may establish clinical competency based on any or all of the following:
1.Documentation of appropriate continuing medical education;
2.Evidence of maintenance of certification from an American Board of Medical Specialty or American Osteopathic Association Board;
3.An evaluation of clinical competency by a Board approved organization, such as the Center for Personalized Education for Physicians (CPEP). The applicant is responsible to report the results of an evaluation from a Board approved organization and follow the recommendations for ongoing competence; and
4.Successfully passing a Board approved exam.
F.Granting of licensure after a lapse for disciplinary reasons. If a physician has not engaged in the active practice of medicine for two (2) years or more based on a disciplinary action from the Board or any other jurisdiction, the Board shall establish clinical competency based on any or all of the following:
1.An evaluation of clinical competency by a Board approved organization, such as the Center for Personalized Education for Physicians (CPEP). The applicant is responsible to report the results of an evaluation from a Board approved organization and follow the recommendations for ongoing competence; and
2.Successfully passing a Board approved exam.
G.Applicants whose physician licenses either are or have been suspended or revoked in another jurisdiction must submit a letter of good standing to the Board from the originating jurisdiction prior to their application being considered in Rhode Island.
1.5.2Interns, Residents, or Fellows
A.An application for limited medical registration as an intern, resident or fellow be made on forms provided by the Board, shall be submitted through the hospital, institution, clinical facility, or medical practice, and shall be accompanied by the following documents and fee (non-refundable and non-returnable):
1.Being eighteen (18) years of age or older;
2.Good moral character;
3.Successful graduation and completion of no less than two (2) years of study in a medical school accredited by the LCME or COCA and having power to grant degrees in medicine or osteopathic medicine;
4.Appointment as an intern, resident or fellow in an accredited training program pursuant to § 1.3.4(A) of this Part; and
5.The application fee, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health;
6.Such other information as may be deemed necessary by the Board.
B.Furthermore, each applicant from an accredited training program or its equivalent shall have the application for limited medical registration signed by:
1.The Administrator/Chief Executive Officer of the hospital, clinic, or other institution that has granted the appointment as an intern, resident or fellow; and
2.The program director attesting to the provisions of § 1.5.2(A)(3) of this Part.
C.Applicants from foreign medical schools shall present evidence of valid certification by the Educational Commission for Foreign Medical Graduates (ECFMG) including the provisions of § 1.5.2(B)(1) of this Part.
1.This requirement may be waived at the discretion of the Board for candidates approved by the Board who are participating in a short-term [less than six (6) month duration] postgraduate experience as part of a formal program administered by the director of an ACGME or AOA accredited residency or fellowship.
1.5.3Academic Faculty
A.Application for limited registration for "academic faculty" shall be made on forms provided by the Department which shall be completed and submitted to the Board at least thirty (30) days prior to the scheduled date of Board meeting.
B.Such application shall be accompanied by the following documents and fee (non-refundable and non-returnable):
1.For U.S. citizens: a certified copy of birth certificate; or
2.For foreign medical physicians: if a certified copy of birth certificate cannot be obtained, immigration papers or resident alien card or such other birth verifying papers acceptable to the Board;
3.One (1) recent photograph of the applicant, head and shoulder front view approximately two inches by three inches (2” x 3”) in size;
4.A statement from the board of examiners in medicine in each State in which the applicant holds or has held a license confirming the applicant to be or have been in good standing. Such statement shall be submitted to the Board;
5.A certified copy of medical diploma;
6.A complete curriculum vitae;
7.A written statement from the dean of the medical school attesting that an offer has been made to the individual for a full-time senior level academic appointment, including the recommendation that the applicant is a person of professional rank (i.e., associate or full professor) whose knowledge and special training will benefit the medical school; and
8.The application fee, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
C.All documents not written in the English language shall be accompanied by certified translations.
1.5.4Examination
A.By Examination for Allopathic & Osteopathic Physicians: Applicants shall be required to pass such examination as the Board deems necessary to test the applicant's knowledge and skills to practice medicine in Rhode Island pursuant to the Act and this Part.
B.For written examinations, the Board requires applicants to successfully pass the following:
1.The National Board of Allopathic or Osteopathic Medical Examination (NBME) or (NBOME); or
2.The United States Medical Licensing Examination (USMLE);
3.The Comprehensive Osteopathic Medical Licensing Examination of the United States (COMLEX-USA)
4.The Licentiate Medical Council of Canada (LMCC);
5.Or any combination of examinations acceptable to the Board and as recommended by the United States Medical Licensing Examination;
6.The passing score for each section of the above examinations must be seventy-five (75) or more (The Board does not accept averaging of the separate components.)
7.Applicants for licensure in Rhode Island must pass each section of the required examination by the third (3rd) attempt. In the event of a third (3rd) failure, opportunity for re-examination(s) shall be subject to the applicant’s completion of additional requirements as recommended by the Board on a case by case basis.
1.5.5Continuing Education
A.Every physician licensed to practice allopathic or osteopathic medicine in Rhode Island under the provisions of the Act and this Part, shall on or before the first (1st) day of June of every even-numbered year, on a biennial basis, earn a minimum of forty (40) hours of AMA PRA Category 1 Credit™/AOA Category 1a continuing medical education credits and shall document this to the Board.
1.A physician’s participation in an American Board of Medical Specialty’s (ABMS) Maintenance of Certification program will be considered equivalent to meeting CME requirement.
2.A physician’s participation in the AOA’s Osteopathic Continuous Certification (OCC) program will be considered equivalent to meeting CME requirement.
B.The application shall include evidence satisfactory to the Board of completion of a prescribed program of continuing medical education established by the appropriate medical or osteopathic society. Participation by duly appointed members of the Board in regular Board meetings and investigating committee meetings shall be considered acceptable on an hours served basis in lieu of AMA PRA Category 1 Credit™/AOA Category 1a continuing medical education hours.
C.The Board may extend for only one (1) six (6) month period such educational requirements pursuant to the provisions of R.I. Gen. Laws § 5-37-2.1.
D.It shall be the sole responsibility of the individual physician to obtain documentation from the approved sponsoring or co-sponsoring organizations, agencies or other, of his or her participation in a learning experience and the number of dated credits earned.
1.Those documents must be safeguarded, for a period of three (3) years, by the physician for review by the Board if required. Only a summary list of those documents, not the documents themselves, shall be submitted with the application for renewal of the certification.
E.Licensure renewal shall be denied to any applicant who fails to provide satisfactory evidence of continuing medical education as required by this Part.
1.5.6Issuance and Renewal of License and Fee
A.Upon completion of the aforementioned requirements and upon submission of the initial licensure fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, the Director may issue a license to those applicants found to have satisfactorily met all the requirements of this Part. Said license unless sooner suspended or revoked shall expire biennially on the first (1st) day of July of the next even-numbered year.
B.Every physician licensed during the current year who intends to practice allopathic or osteopathic medicine during the ensuing two (2) years shall file with the Board, before the first (1st) day of July of each even-numbered year, a renewal application, on such forms as the Chief Administrative Officer deems appropriate, and duly executed together with the renewal fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health on or before the first (1st) day of July in each even-numbered year. Payment shall be postmarked on or before July 1.
C.Upon receipt of a renewal application and payment of fee, a license renewal, subject to the terms of the Act and this Part, shall be issued, effective for two (2) years, unless sooner suspended or revoked.
D.The licenses (registration certificates) of all allopathic or osteopathic physicians whose renewals, accompanied by the prescribed fee, are not filed on or before the first (1st) day of July shall be automatically lapsed. The Board may in its discretion and upon the payment by the physician of the current licensure (registration) fee, plus an additional fee, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health reinstate any license (certificate) lapsed under the provisions of R.I. Gen. Laws § 5-37-10 and § 1.5.6(E) of this Part.
E.Every person to whom a license to practice medicine in Rhode Island has been granted by the duly constituted licensing authority in Rhode Island and who intends to engage in the practice of medicine during the ensuing two (2) years, shall register his or her license by filing with the Board such application duly executed together with such registration form and fee as established by the Director.
F.In order to update for the profile the information initially supplied to the Board by the physician at initial application for licensure, each physician shall provide the following information through the questionnaire:
1.Specialty board certification;
2.Number of years in practice in any State;
3.Name(s) of the hospital(s) where the physician has privileges in any State, and
4.The location of the physician’s primary practice setting.
G.A limited medical registration certificate as an intern, resident or fellow shall be valid for a period of not more than one (1) year from the date of issuance and may be renewed annually for not more than four (4) consecutive years by the Department, except as provided in § 1.3.4(E) of this Part.
H.A limited registration certificate for academic faculty shall be valid for a period of not more than one (1) year, expiring on the thirtieth (30th) day of June following its initial effective date and may be renewed for not more than five (5) consecutive years by the Board, provided however, such registration shall automatically expire when the holder's relationship with the medical school is terminated or substantially changes. The holder shall reapply for limited registration in accordance with the requirements of §§ 1.5.3(A) through (C) of this Part if the relationship with the medical school substantially changes. After the fifth (5th) consecutive renewal, a physician may reapply for limited registration in accordance with the provisions of §§ 1.5.3(A) through (C) of this Part.
1.5.7Refusal of License
A.The Director at the direction of the Board, after due notice and hearing, in accordance with the procedures set forth in R.I. Gen. Laws §§ 5-37-5.2 to 5-37-6.2, may refuse to grant the original license to any physician and/or applicant who fulfills the grounds for such refusal pursuant to R.I. Gen. Laws § 5-37-4.
1.5.8Inactive List
A.The requirements regarding the physician inactive list are pursuant to R.I. Gen. Laws § 5-37-11. During the period of inactive status referenced in the Act, the physician may not practice medicine, as defined in § 1.2(A)(20) of this Part.
B.Any physician whose name has been included in the inactive list pursuant to § 1.5.8(A) of this Part shall be restored to active status by the Director upon the filing of a written request accompanied by the registration form and fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. Furthermore, at the discretion of the Board, the applicant may be required to appear before the Board for an interview.
C.Reactivation or Reinstatement of an inactive or expired license after a lapse for non-disciplinary reasons is processed pursuant to § 1.5.1(E) of this Part.
D.Reinstatement of a license after a lapse for disciplinary reasons is processed pursuant to § 1.5.1(F) of this Part.
1.5.9Unprofessional Conduct
A.The Director is authorized to deny or revoke any license to practice allopathic or osteopathic medicine or otherwise discipline a licensee upon finding by the Board that the person is guilty of unprofessional conduct which shall include, but not be limited to those items, or combination thereof, listed in R.I. Gen. Laws § 5-37-5.1.
B.Licenses that have been revoked by the Director shall not be eligible for consideration for re-instatement for a period of five (5) years. Re-instatement of revoked licenses shall be at the discretion of the Board.
C.Physician Self-treatment or Treatment of Immediate Family Members. A physician is not authorized to prescribe a controlled substance to him or herself or an immediate family member under any circumstances. However, a physician may prescribe a non-controlled substance for him or herself or an immediate family member for less than thirty (30) days, with appropriate documentation.
D.Discharging a Patient from a Practice. Periodically, a physician/practice may need to terminate the physician-patient relationship. This shall be done via written notice, which shall be documented in the medical record. The physician/practice must be available to the patient for thirty (30) days for medication refills, urgent or emergent conditions. A physician does not have to refill controlled substances if there is a suspicion of diversion.
E.Boundary Violations
1.Physicians shall not engage in a romantic or sexual relationship with a current patient.
2.Psychiatrists shall not engage in a romantic or sexual relationship with a current or former patient ever.
F.Gifts. Physicians may not receive as a gift from any patient greater than one hundred dollars ($100.00) in cash, or the market value equivalent thereof in goods or services, per calendar year.
G.Compounding of Sterile Products. Non-sterile and sterile compounding performed by practitioners must conform to current standards of practice for the compounding of pharmaceuticals set forth in § 15-1.7 of this Chapter and the United States Pharmacopeia (“USP”).
H.Standard of Care
1.Infection Prevention. The Board accepts the CDC’s “Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care” (September 2016) incorporated by reference at § 1.1.2 of this Part, and any successor documents, as the prevailing standard of care regarding infection prevention.
2.Telemedicine. Treatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of appropriate practice as those in face-to-face settings. Therefore, consistent with the definition of telemedicine, provided in § 1.2(A)(25) of this Part, treatment, including issuing a prescription, based solely on an online questionnaire without an appropriate evaluation does not constitute an acceptable standard of care and is considered unprofessional conduct. Asynchronous evaluation of a patient, without contemporaneous real-time, interactive exchange between the physician and patient, is not appropriate.
I.Issuing of fines for disciplinary actions
1.The Board is authorized to issue monetary fines, in addition to other sanctions.
2.The Board will not issue a fine based on the first count or charge, and will not issue a fine that exceeds one thousand dollars ($1,000.00) for the second (2nd) count or charge, and will not issue a fine for subsequent counts or charges that exceeds five thousand dollars ($5,000.00) per count or charge.
3.The Board will consider various factors, yet is not limited to these factors, when assessing fines, such as;
a.Prior complaints of similar nature
b.Prior disciplinary actions
c.Impact of violation on patient safety
d.Impact of violation on public safety
e.Willingness of physician to ensure further violations do not occur
1.5.10Closing a Medical Practice
A.In the event of a planned voluntary closure of a medical practice, the physician shall, at least ninety (90) days before closing his or her practice, give public notice as to the disposition of patients' medical records in a media venue with, at a minimum, statewide influence, and shall notify the Rhode Island Medical Society and the Board of the location of the records. The public notice shall include the date of the office closure, and where and how patients may obtain their records both prior to and after closure of the physician's practice.
1.At least ninety (90) days before voluntary closure of his or her practice, the physician shall send notice to the last known address (mail and/or email) of each patient seen within two (2) years of the actual or expected date of closure, which notice must include, at minimum, the actual or expected date of closure and instructions for obtaining patient medical records before and after closure.
B.The heirs or estate of a deceased physician who had been practicing at the time of his or her death shall, within ninety (90) days of the physician's death, give public notice as to the disposition of patients' medical records in a media venue with a statewide circulation, and shall notify the Rhode Island Medical Society and the Board of the location of the records.
C.Any physician closing his or her practice, or the heirs or estate of a deceased physician who had been practicing at the time of his or her death, shall store the physician's patient records in a location and manner so that the records are maintained and accessible to patients.
D.Any person or corporation or other legal entity receiving medical records of any retired physician or deceased physician who had been practicing at the time of his or her death, shall comply with and be subject to the provisions of R.I. Gen. Laws Chapter 5-37.3, the Confidentiality of Health Care Information Act, and shall be subject to the Rules and Regulations promulgated in accordance with R.I. Gen. Laws § 23-1-48 and with the provisions of R.I. Gen. Laws §§ 5-37-22(c) and (d), even though this person, corporation, or other legal entity is not a physician.
1.5.11Mammography and Medical Records Mammography
A.All aspects of mammography services shall be performed in accordance with the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.
B.The requirements for retention of mammography x-rays by health care providers are pursuant to R.I. Gen. Laws § 23-4.9-1.
1.5.12Medical Records
A.Medical records and medical bills may be requested by the patient or the patient’s personal representative. All medical record requests to physicians shall be made in writing through a properly executed Authorization for Release of Health Care Information.
B.Reimbursement
1.Reimbursement to the physician for responding to a patient a copy of their medical record, regardless of format, shall be consistent with Federal law specifically 45 C.F.R. § 164.524.
2.Physicians are prohibited from charging patients who requests their own records a retrieval or certifying fee for duplicating medical records.
3.The physician may not require prior payment of charges for medical services as a condition for obtaining a copy of the medical record. The physician may not require prepayment of charges for duplicating or retrieving records as a condition prior to fulfilling the patient's request for the medical record if the request is for the purpose of continuity of care. Copying of X-rays or other documents not reproducible by photocopy shall be at the physician's actual cost plus reasonable fees for clerical service not to exceed twenty-five dollars ($25.00). Charges shall not be made if the record is requested for immunization records required for school admission or by the applicant or beneficiary or individual representing an applicant or beneficiary for the purposes of supporting a claim or appeal under the provision of the Social Security Act or any Federal or State needs-based program such as Medical Assistance, RIte Care, Temporary Disability Insurance and Unemployment compensation.
4.No fees shall be charged to an applicant for benefits in connection with a Civil Court Certification Proceeding or a claim under the Worker’s Compensation Act, R.I. Gen. Laws § 28-29-38 as reflected in R.I. Gen. Laws § 23-17-19.1(16).
5.Requested records must be provided within thirty (30) days of the receipt of the written request or signed authorization for records. Requests for medical records made by authorized third (3rd) parties (e.g., attorneys representing the patient, attorneys not representing the patient, a patient's estate on behalf of the patient, or insurance companies) submitting a properly executed Authorization for Release of Information shall be billed at not more than two dollars and fifty cents ($2.50) per page for the first ten (10) pages, then seventy-five cents ($0.75) per page for the next fifty (50) pages, then fifty cents ($0.50) per page. An additional charge to reflect actual cost of postage is permissible.
6.Should instances arise relating to the retrieval and copying of medical records which are not specifically covered by this Part, a fee structure consistent with that described above shall apply.
7.No fees shall be charged when a medical record is being sent from one (1) provider to the next in the context of a consultation.
8.When a patient requests in writing that his or her medical records be transferred to another physician, the original physician shall promptly honor such request. The physician shall be reimbursed for reasonable expenses (as defined in § 1.5.12(B) of this Part) incurred in connection with copying such medical records.
C.Medical Records shall be stored by physicians or their authorized agents for a period of at least seven (7) years unless otherwise required by law or Regulation.
D.Medical Records shall be legible and contain the identity of the physician or physician extender and supervising physician by name and professional title who is responsible for rendering, ordering, supervising or billing each diagnostic or treatment procedure. The records must contain sufficient information to justify the course of treatment, including, but not limited to: active problem and medication lists; patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
E.A medical record in paper or electronic format must be available in a completed format available for review by another healthcare provider for purposes of continuity of care in a timely manner. Failure to have the medical record in a completed format will be deemed to be grounds for unprofessional conduct.
1.5.13Patient Disclosure
A.The requirements regarding patient disclosures are pursuant to R.I. Gen. Laws § 5-37-22.
1.A physician who practices medical acupuncture as a therapy shall provide full written disclosure to his/her patient receiving medical acupuncture that the physician’s qualifications to practice medical acupuncture are not equivalent to those of doctors of acupuncture licensed in accordance with R.I. Gen. Laws Chapter 5-37.2. Further, a physician integrating medical acupuncture into his/her medical practice shall disclose to the patient the type of pathway (i.e., pain management, primary care) in which the physician was trained.
1.5.14Collaborative Pharmacy Practice
A.A physician/pharmacist may engage in a collaborative practice agreement with a Rhode Island licensed pharmacist/physician, or group of pharmacists/physicians, pursuant to a collaborative practice agreement.
1.All collaborative practice agreements must be approved by the Board of Pharmacy (“BOP”), the Board of Medical Licensure and Discipline (“BMLD”), and the Director, each of which may request revisions to any proposed collaborative practice agreement as a condition of approval. Each proposed collaborative practice agreement must first be submitted to the BOP. Upon BOP approval, the collaborative practice agreement will be forwarded to the BMLD. Upon BMLD approval, the collaborative practice agreement will be forwarded to the Director for approval.
B.No collaborative practice may commence unless and until the corresponding collaborative practice agreement is approved by the Director. The Director may also terminate a collaborative practice agreement at any time.
C.All collaborative practice agreements must include the following:
1.Purpose of the agreement;
2.Citation of the authority to establish the agreement;
3.Identification and signatures of all parties to the agreement, as well as date of signature;
4.Site and settings where the collaborative practice is to take place;
a.The agreement shall specify the site(s) and setting(s) where the collaborative practice occurs. All services provided pursuant to a collaborative practice agreement shall be performed in a setting that ensures patient privacy and confidentiality.
b.Any site locations must have secure access to an Electronic Health Record (EHR) that ensures patient privacy and confidentiality.
c.Signatories to the collaborative practice agreement shall keep a copy of the agreement on file at their primary place(s) of practice.
5.Authorization of specific patient care functions;
a.The physician shall approve all protocols and activities for pharmacist driven drug therapy management, provide written protocols that describe the activities in which a pharmacist is authorized to engage, including but not limited to the procedures, decision criteria, and plan a pharmacist shall follow when providing medication therapy management.
b.The pharmacist shall have prescriptive privileges including but not limited to initiating, adjusting, monitoring or discontinuing medication therapy.
(1)The pharmacist(s) shall document each initiation, modification, or discontinuation of medication therapy in the patient’s electronic medical record. Documentation shall also include other pertinent information including but not limited to changes in conditions, telephone encounters, test results, and patient assessment.
c.A physician or other prescriber shall be allowed to override a collaborative practice decision made by the pharmacist when appropriate.
6.Scope of conditions or diseases to be managed;
a.A description of the types of diseases and/or conditions, medication categories involved, and medication therapies management;
7.Training and education requirements of all parties, as agreed upon by the signing parties and not inconsistent with any applicable training and education requirements for professional licensure;
8.An attestation form that all parties have professional liability insurance;
a.All parties shall have professional liability insurance during the term of the agreement. Proof of liability insurance must be available to the Department upon request.
9.Communication requirements between parties;
a.Care provided to the patient by the pharmacist will be in coordination with the provider.
10.Cross coverage and continuity of care plan;
a.In the event either party is unable to continue the agreement, an appropriate qualified provider must be available for consultation during business hours.
11.Provisions for review and revisions to the collaborative practice agreement;
a.Collaborative practices may review or revise their collaborative practice agreements at any time at the request of the signatories. However, the agreement must be reviewed by the signatories at least once every two (2) years. Any changes to the agreement must be signed and dated by all signatories.
b.In the event substantive or material changes are made to the agreement, such as addition of new disease states or conditions to be managed, the collaborative practice agreement shall be resubmitted to for BOP, BMLD, and Director approval.
(1)No substantive changes to any collaborative practice agreements may be implemented without prior approval from BOP, BMLD, and the Director.
(2)Addition or removal of physicians, pharmacists and other qualified provider does not require BOP, BMLD, or Director approval.
c.New participants in the collaborative practice agreement shall be kept up to date with names and signatures at the practice site.
12.Provisions relative to signatory withdrawal from the agreement;
a.A signatory may withdraw from the agreement at any time; provided, however, that in the event that withdrawal of such signatory would result in failure of the agreement for want of a party, a new party must contemporaneously be substituted consistent with the provisions of § 1.5.14 of this Part.
b.A patient may withdraw from treatment under the agreement at any time.
D.The Department may request additional information as required to determine compliance with this Part.
**History**
- *Amendment — effective from 2026-08-26 to current*
- *Amendment — effective from 2022-04-24 to 08/26/2026*
- *Periodic Refile — effective from 2022-01-04 to 04/24/2022*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 10/31/2018*
- *Amendment — effective from 2015-11-23 to 09/26/2017*
- *Amendment — effective from 2014-10-13 to 11/23/2015*
- *Amendment — effective from 2014-04-24 to 10/13/2014*
- *Amendment — effective from 2012-12-10 to 04/24/2014*
- *Amendment — effective from 2012-06-21 to 12/10/2012*
- *Amendment — effective from 2012-04-01 to 06/21/2012*
- *Amendment — effective from 2009-09-17 to 04/01/2012*
- *Amendment — effective from 2008-09-17 to 09/17/2009*
- *Amendment — effective from 2007-11-11 to 09/17/2008*
- *Amendment — effective from 2004-11-03 to 11/11/2007*
- *Amendment — effective from 2004-05-12 to 11/03/2004*
- *Amendment — effective from 2003-01-27 to 05/12/2004*
- *Periodic Refile — effective from 2002-01-02 to 01/27/2003*
##### **216-RICR-40-05-1 § 1.6** Practices and Procedures {#sec-216-ricr-40-05-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-1#1.6}
1.6.1Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of the Act and this Part shall be held pursuant to R.I. Gen. Laws §§ 5-37-5.3 and 5-37-5.4.
**History**
- *Amendment — effective from 2026-08-26 to current*
- *Amendment — effective from 2022-04-24 to 08/26/2026*
- *Periodic Refile — effective from 2022-01-04 to 04/24/2022*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 10/31/2018*
- *Amendment — effective from 2015-11-23 to 09/26/2017*
- *Amendment — effective from 2014-10-13 to 11/23/2015*
- *Amendment — effective from 2014-04-24 to 10/13/2014*
- *Amendment — effective from 2012-12-10 to 04/24/2014*
- *Amendment — effective from 2012-06-21 to 12/10/2012*
- *Amendment — effective from 2012-04-01 to 06/21/2012*
- *Amendment — effective from 2009-09-17 to 04/01/2012*
- *Amendment — effective from 2008-09-17 to 09/17/2009*
- *Amendment — effective from 2007-11-11 to 09/17/2008*
- *Amendment — effective from 2004-11-03 to 11/11/2007*
- *Amendment — effective from 2004-05-12 to 11/03/2004*
- *Amendment — effective from 2003-01-27 to 05/12/2004*
- *Periodic Refile — effective from 2002-01-02 to 01/27/2003*
#### **216-RICR-40-05-2** Dentists, Dental Hygienists, and Dental Assistants
##### **216-RICR-40-05-2 § 2.1** Authority {#sec-216-ricr-40-05-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapter 5-31.1, and are established for the purpose of adopting prevailing standards governing the licensure of dentists, dental hygienists, Public Health Dental Hygienists and Dental Anesthesia Assistant National Certification Examination (DAANCE)-certified maxillofacial surgery assistants; the practice of dentistry as it pertains to dentists, dental hygienists and dental assistants; continuing education for dentists, dental hygienists, and DAANCE-certified maxillofacial surgery assistants; the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation and/or nitrous oxide sedation; and to establish administrative procedures for the implementation of the statutory and regulatory provisions.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.2** Incorporated Materials {#sec-216-ricr-40-05-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.2}
A.These regulations hereby adopt and incorporate by reference the Center for Disease Control and Prevention’s “Summary of Infection Prevention Practices in Dental Health Care Settings” (2016), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate 29 C.F.R. § 1910 (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate by reference the American Dental Association’s “Guidelines for the Use of Sedation and General Anesthesia by Dentists” (2016), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
D.These regulations hereby adopt and incorporate by reference the American Dental Association’s “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (2016), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
E.These regulations hereby adopt and incorporate 21 C.F.R. §§ 1300-1316 (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
F.These regulations hereby adopt and incorporate by reference the National Institute for Occupational Safety and Health’s “Controlling Exposures to Nitrous Oxide during Anesthetic Administration” (1994), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
G.These regulations hereby adopt and incorporate by reference the National Institute for Occupational Safety and Health’s “Control of Nitrous Oxide in Dental Operatories” (1996), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
H.These regulations hereby adopt and incorporate ASA Physical Status Classification System for Dental Patient Care (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
I.These regulations hereby adopt and incorporate the American Academy of Pediatrics, American Academy of Pediatric Dentistry, Guidelines for Monitoring and Management of Pediatric Patients Before, During and After Sedation for Diagnostics and Therapeutic Procedures (2016), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.3** Definitions {#sec-216-ricr-40-05-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.3}
A.Wherever used in this Part the following terms shall be construed to mean:
1."Act" refers to R.I. Gen. Laws Chapter 5-31.1, entitled “Dentists and Dental Hygienists". Also known as the Dental Practice Act.
2."Adult" means a person thirteen (13) years of age or older.
3."Advisory consultants" means those individuals appointed by the Board to serve as advisory consultants to the Board in determining compliance with the statutory and regulatory provisions of this Part, of applicants seeking a permit to administer or to permit the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation. Such consultants may be Diplomates of the American Board of Oral and Maxillofacial Surgery, Members or Fellows of the American Association of Oral and Maxillofacial Surgeons, or Diplomates of the National Dental Board of Anesthesiology or the American Dental Society of Anesthesiology, and may include a Board Certified Anesthesiologist and a licensed dentist with experience in the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation.
4."Analgesia" means the diminution or elimination of pain.
5."Biennial" means occurring every second (2nd) year.
6."Board" refers to the Board of Examiners in Dentistry, or any committee or subcommittee thereof, established in the Rhode Island Department of Health pursuant to the provisions of the Act.
7."Competency" means displaying special skill or knowledge derived from training and experience.
8.“Continuous” means prolonged without any interruption at any time.
9.“DAANCE-certified maxillofacial surgery assistant” means a person currently certified by the American Association of Oral and Maxillofacial Surgeons to provide supportive anesthesia care.
10."DANB-certified assistant" means a person currently certified by the Dental Assisting National Board, Inc. (DANB), or its successor agency, holding the certified Dental Assistant (CDA) certification in general dental assisting duties or another DANB certification in a specific area of advanced or specialty practice, and employed for the purpose of assisting a dentist in the performance of procedures/duties related to dental care in accordance with the provisions of this Part.
11.“Dental administrator” means the Administrator of the Rhode Island Board of Examiners in Dentistry.
12.“Deep sedation” means a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
13.“Dental assistant" means a person not currently certified by the Dental Assisting National Board, Inc. (DANB) holding the certified Dental Assistant (CDA) certification in general dental assisting duties or another DANB certification in a specific area of advanced or specialty practice, and employed for the purpose of assisting a dentist in the performance of procedures/duties related to dental care in accordance with the provisions of this Part.
14."Dental auxiliary personnel" refers to a dental hygienist, a public-health dental hygienist, a DANB-certified assistant, a DAANCE-certified maxillofacial surgery assistant or a dental assistant.
15."Dental hygienist" means an individual licensed under the provisions of the Act to practice dental hygiene.
16."Dental office or facility" means a place, however named, where a dentist actively, regularly, and personally practices dentistry, pursuant to the provisions of R.I. Gen. Laws § 5-31.1-1(16).
17."Dentist" means an individual licensed under the provisions of the Act to practice dentistry in Rhode Island.
18.“Dentistry" means the evaluation, diagnosis, prevention and/or treatment (non-surgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, cranio-maxillofacial area and/or the adjacent and associated structures and their impact on the human body, including any service or product that may change the anatomy, appearance or arrangement of teeth provided by a dentist, within the scope of his or her education, training and experience, in accordance with the ethics of the profession and applicable law.
19.“Department” means the Rhode Island Department of Health.
20.“Digital scan” means a virtual computer generated replica of the hard and soft tissue of the mouth using lasers or other optical scanning devices.
21.“Director” means the Director of the Rhode Island Department of Health.
22.“Enteral” means any technique of administration in which the agent is absorbed through the gastrointestinal tract.
23."General anesthesia" means a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.
24.“Homebound” means an individual confined to his or her home if the individual has a condition, due to illness or injury, that restricts the ability of the individual to leave his or her home except with the assistance of another individual or the aid of a supportive device or if an individual has a condition such that leaving his or her home is medically contraindicated. While an individual does not have to be bedridden to be considered “confined to his home”, the condition of the individual should be such that there exists a normal inability to leave home and that leaving home requires a considerable and taxing effort by the individual and/or others.
25.“Immediately available” means on site in the facility and available for immediate use.
26.“Impression” means an imprint or negative likeness of teeth and/or other tissues of the oral cavity from which a positive reproduction may be made.
27.“Infection control” refers to policies and procedures used to minimize the risk of spreading infections, within the dental healthcare setting. Compliance is based on conformance with current recommendations developed by the Centers for Disease Control and Prevention (CDC) and published in the document entitled “Guidelines for Infection Control in Dental Health-Care Settings” and incorporated in this Part.
28.“Inhalation” means a technique of administration in which a gaseous or volatile agent is introduced into the lungs and whose primary effect is due to the absorption through the gas/blood interface.
29."License", as used in this Part, is not synonymous with “registration.”
30."Local anesthesia" means the elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug.
31."Minimal sedation" means a state of sedation in which the patient is at a minimally depressed level of consciousness. This state is produced through a pharmacological dosage less than or equal to the U.S. FDA maximum recommended dose along with nitrous oxide. Characteristics of minimal sedation include:
a.Patient retains the ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command;
b.Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected;
c.Patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of minimal sedation;
d.If more than one enteral drug is administered to achieve the desired effect, with or without the concomitant use of nitrous oxide, the guidelines for moderate sedation must apply.
32.“Mobile dental facility” or “MDF” means any self-contained facility where dentistry will be practiced which may be driven, moved, towed, or transported from one location to another. See definition of Portable Dental Operation in § 2.3(A)(39) of this Part.
33.“Mobile dental facility (MDF) director” or “Portable dental operation (PDO) director” means a dentist who is currently licensed to practice dentistry in the State of Rhode Island or a public health dental hygienist practicing pursuant to R.I. Gen. Laws § 5-31.1-39 for the purposes of providing dental hygiene services in public health settings who is responsible for dental services provided by the MDF or PDO.
34.“Mobile dental facility (MDF) permit holder” or “portable dental operation (PDO) permit holder” means a dentist who is currently licensed to practice dentistry in the State of Rhode Island or a public health dental hygienist in whose name the MDF and/or PDO Facility Permit is issued. Where the MDF or PDO is not wholly owned by a dentist(s) or public health dental hygienist licensed to practice in the State of Rhode Island, the owner(s) shall apply for a license to operate as a healthcare facility unless the entity is exempt from such licensure.
35."Moderate sedation" means a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
36."Nitrous oxide sedation" means the administration of nitrous oxide to diminish or eliminate the sensibility to pain in the conscious patient, designating in particular the relief of pain without loss of consciousness. However, consciousness may be moderately impaired.
37.“Operating dentist” means the dentist with primary responsibility for providing dental care.
38.“Parenteral” means a technique of administration in which the drug bypasses the gastrointestinal (GI) tract [i.e., intramuscular (IM), intravenous (IV), intranasal (IN), submucosal (SC), intraosseous (IO)].
39.“Portable dental operation” or “PDO” means any non-facility where dental equipment utilized in the practice of dentistry is transported to and utilized on a temporary basis at an out-of-office location. See related definitions under Mobile Dental Facility (MDF).
40.“Public health dental hygienist” or “PHDH” means a registered dental hygienist who holds a valid license to practice in the State of Rhode Island and who has a minimum of three (3) years of full-time or an equivalent four thousand five hundred (4500) hours of clinical experience and who has the fulfilled the necessary training requirements and who works in a public health setting pursuant to a written collaborative agreement with a local or state government agency or institution or a dentist who holds a valid license issued in the State of Rhode Island pursuant to this Part.
41.“Public health setting” includes, but is not limited to, residences of the homebound, schools, Head Start programs, nursing homes and long-term care facilities, licensed clinics, community health centers, hospitals, medical facilities, prisons, residential treatment facilities, federal, state or local public health programs, mobile dental facilities and portable dental programs.
42.“Qualified dentist” means a dentist providing sedation and anesthesia in compliance with this Part.
43.“Qualified provider” means a licensed healthcare provider providing sedation and anesthesia services at a specific dental facility site holding the necessary Facility Host Permit pursuant to § 2.11.4(E) of this Part, in compliance with applicable rules and regulations for their profession.
44."Supervision" includes four (4) types of supervision for all dental auxiliary personnel as follows:
a."Direct supervision" means the dentist is in the dental office, personally diagnoses the condition to be treated, personally authorizes the procedure(s)/duty(ies), remains in the dental office while the procedure(s)/duty(ies) are being performed and examines the patient before his/her dismissal.
b."General supervision" means the dentist has authorized the procedure/duty and such is being carried out in accordance with his/her diagnosis and treatment plan. The dentist does not have to be physically present in the dental office when such treatment is being performed under general supervision.
c."Indirect supervision" means the dentist is in the dental office, personally diagnoses the condition to be treated, personally authorizes the procedure(s)/duty(ies), and remains in the dental office while the procedure(s)/duty(ies) is being performed by the dental auxiliary.
d.“Direct visual supervision” means supervision by an oral and maxillofacial surgeon (with a permit to administer deep sedation and general anesthesia) by verbal command and under direct line of sight.
45.“Time-oriented anesthesia record” means documentation at appropriate time intervals of drugs, doses and physiologic data obtained during patient monitoring.
46.“Titration” means administration of incremental doses of an intravenous or inhalation drug until a desired effect is reached.
47.“Transdermal” means a route of administration whereby the active pharmacological ingredients are transmitted across the skin.
48."Unprofessional conduct" shall include, but not be limited to, the provisions of R.I. Gen. Laws § 5-31.1-10, and is further defined as failure to conform to the Category IC recommendations of the Centers of Disease Control Guidelines for Infection Control in Dental Health-Care Settings incorporated by reference at § 2.2(A) of this Part, or its amendments.
49.“Written collaborative agreement” or “WCA” means a written agreement that complies with R.I. Gen. Laws § 5-31.1-39(c). Written Collaborative Agreement (WCA) with a Public Health Dental Hygienist is between a public health dental hygienist and a local or state government agency or institution or with a licensed dentist who holds a valid Rhode Island license and who agrees to provide the appropriate level of communication and consultation with the public health dental hygienist to ensure patient health and safety.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.4** Dentists/Licensing Requirements {#sec-216-ricr-40-05-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.4}
2.4.1License Requirements
No person shall perform any act which constitutes the practice of dentistry in Rhode Island unless such person is duly licensed in accordance with the regulatory and statutory provisions of the Act as a dentist, dental hygienist, a public health dental hygienist, or a DAANCE-certified maxillofacial surgery assistant. Furthermore, dental hygienists, public health dental hygienists, or a DAANCE-certified maxillofacial surgery assistant, dental assistants and DANB-certified assistants shall perform only those auxiliary dental services, procedures and duties, and under the specified type of supervision, as set forth in § 2.10.2 of this Part. Exempt from these requirements are those persons listed in R.I. Gen. Laws § 5-31.1-37
2.4.2Pain Assessment
All health care providers licensed in Rhode Island to provide health care services and all health care facilities licensed under R.I. Gen. Laws Chapter 23-17 shall assess patient pain in accordance with the requirements of the rules and regulations for Pain Management, Opioid Use and the Registration of Distributors of Controlled Substances in Rhode Island (Part 20-20-4 of this Title) promulgated by the Department.
2.4.3Latex
Any dentist, dental hygienist, a public health dental hygienist, dental assistant, or a DAANCE-certified maxillofacial surgery assistant who utilizes latex gloves shall do so in accordance with the provisions of the rules and regulations pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title) promulgated by the Department.
2.4.4Scheduled Controlled Substances
All actions related to the ordering, prescribing, dispensing, administration, inventory and storage or administration of controlled substances shall be in conformity with the provisions of R.I. Gen. Laws Chapter 21-28, “Controlled Substances Act” and 21 C.F.R. §§ 1300-1316 incorporated in § 2.2(E) of this Part.
2.4.5Volunteer Dental/Dental Hygiene Permit
A.Notwithstanding any other provision of the Act or this Part, the Board may issue a volunteer dental/dental hygiene permit that allows an out-of-state dentist/dental hygienist to provide dental or dental hygiene services in Rhode Island without obtaining a Rhode Island license.
1.Services provided pursuant to a volunteer dental/dental hygiene permit shall be limited to:
a.A free clinic or similar charitable medical/dental event providing free health care services; or
b.The Special Olympics or similar athletic event attracting a large number of out-of- state participants; or
c.Participation in A Mission of Mercy program.
2.Application: An applicant for a volunteer dental/ dental hygiene permit shall submit the following information to the Board at least sixty (60) days prior to the event:
a.A copy of the application form to the Board and a letter of good standing from the state where the applicant is currently licensed: and
b.A letter, signed by an authorized representative of the sponsoring agency, which specifies the date(s) and location(s) of the event, and the type(s) of volunteer dental or dental hygiene services that will be provided; and
c.A statement, signed by both the applicant and an authorized representative of the sponsoring agency, which specifies that it has been agreed between the parties that no compensation shall be paid for any dentistry or dental hygiene services rendered in Rhode Island while in possession of a volunteer dental permit.
2.4.6Qualifications for Licensure for Dentists
A.An applicant seeking licensure to practice dentistry in the state of Rhode Island shall:
1.Be of good moral character;
2.Be eighteen (18) years of age or over;
3.Be a graduate of a school of dentistry accredited by the American Dental Association Commission on Dental Accreditation or its designated agency and approved by the Board;
4.Have passed to the satisfaction of the Board the required examinations in accordance with § 2.5 of this Part or met the requirements for endorsement stipulated in § 2.5(A)(1)(c)((3)) of this Part; and
5.Be in good standing in each state in which he/she holds a license, which shall include a Board query to the National Practitioners Databank.
2.4.7Application for License and Fee
A.Application for license shall be made on forms provided by the Board, which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents (non-returnable):
1.A copy of the applicant’s state driver’s license, a state-issued identification card or such other identification papers acceptable to the Director that include birthdate and a picture;
2.Supporting official transcript of grades and/or verification of graduation signed by the dean or registrar of the dental school;
3.National board results in accordance with § 2.5(A)(1)(b) of this Part submitted either with application or submitted by the National Dental Examination Commission to the Board;
4.The results of the American Board of Dental Examiners (ADEX) examination or other dental examination organizations (as required in § 2.5(A) of this Part) submitted directly to the Board by the Commission on Dental Competency Assessment, or by the board of the other dental examination organizations;
5.Verification that the licensee is in good standing in state(s) where licensed [if licensed in another state(s)];
6.The application fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (part 10-05-2 of this Title) in accordance with R.I. Gen. Laws § 5-31.1-6.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.5** Examination for Licensure as a Dentist {#sec-216-ricr-40-05-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.5}
A.By Examination: Applicants shall be required to pass such examination(s) as the Board deems most practical and expeditious to test the applicant's knowledge and skills to practice dentistry in this Rhode Island pursuant R.I. Gen. Laws § 5-31.1-6; and:
1.The Board requires each applicant to:
a.Have graduated from a school of dentistry in accordance with § 2.4.6(A)(3) of this Part; and
b.Have successfully passed the national examination of the Joint Commission on National Dental Examination (Parts I and II); and
c.Have successfully passed the ADEX exam, including the periodontal examination portion within five (5) years from the date of application for licensure in Rhode Island; or
(1)Have successfully passed an examination, approved by the Board, other than a regional board that is similar to the examination for which the applicant is seeking waiver, with an earned score of seventy-five percent (75%) in each discipline, clinical skill, procedure or knowledge area that is tested on the ADEX Examination, including the periodontal examination portion using the internal weighting and scoring methods the CDCA uses to score the ADEX Examination in Dentistry; and
(2)Have successfully passed a comprehensive examination in applied clinical diagnosis and treatment planning (CDCA Dental Simulated Clinical Exercise {DSCE} written) with an earned score of seventy-five percent (75%); or
(3)Hold a current license in good standing to practice dentistry in another state for five (5) years immediately prior to submitting an application for licensure in RI. Said state shall have required successful completion of a clinical exam, not part of the applicant’s training program, to be considered for RI licensure.
2.Applicants shall submit to the Board, the application accompanied with the appropriate documentation as set forth in § 2.4.7 this Part.
3.Sites and schedules of examinations may be obtained directly from the examination service(s) referred to above or from the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.6** Continuing Education—Dentists {#sec-216-ricr-40-05-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.6}
A.Continuing education for dentists requires those professionals to maintain a systematic course of continual learning as a condition to maintain their professional license. In addition, continuing education is an effective way for dental professionals to sustain knowledge of current and evolving tools, techniques, technology, innovative medications and in-depth information on emerging topics that will enhance their professional skills and abilities.
B.Pursuant to the provisions of R.I. Gen. Laws § 5-31.1-7, all dentists licensed to practice in Rhode Island under the provisions of the Act and this Part, on or before the first (1st) day of May of each even-numbered year shall maintain evidence that in the preceding two (2) years he or she has satisfactorily completed at least forty (40) hours of continuing dental education courses, according to the criteria established by the Rhode Island Dental Association and approved by the Board. Continuing education requirements cited in this Part shall be prorated for a licensee whose license is in effect for a period of less than two (2) years (i.e., an average of twenty (20) hours of continuing education shall be required each year the license is in effect).
C.It shall be the sole responsibility of the individual dentist to obtain documentation from the approved sponsoring or co-sponsoring organization, agency or other, of his or her participation in a learning experience, including the date, and number of hours earned.
D.At the time of license renewal, each licensee shall be required to attest to the fact that he or she has complied with the continuing education requirements established by this Part. Course descriptions, proof of attendance, or other documentation of completion shall be retained by the licensee for a minimum of five (5) years and is subject to random audit by the Board. Failure to produce satisfactory documentation of completion of requirements upon request of the Board may constitute grounds for disciplinary action.
E.All dentists practicing in a dental setting shall receive a minimum of one (1) hour per year of training on the CDC Infection Control Guidelines.
F.All dentists practicing in a dental setting shall hold a current certificate of completion from an approved course in Basic Life Support (BLS) for Healthcare Providers that includes a hands-on skill component and conforms to the current American Heart Association Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC), and is offered by any accredited agency approved by the Board.
G.If the applicant attests to completion of the prescribed course(s) of continuing dental education as set forth in § 2.16 of this Part, as approved by the Board, and is in compliance with the provisions of R.I. Gen. Laws § 5-31.1-7, the Board shall issue the applicant a license registration for a two (2) year period in accordance with the requirements of § 2.6.1 of this Part.
H.Licensure renewal shall be denied to any applicant who fails to attest to the completion of continuing dental education as required by § 2.6(D) of this Part.
I.Notwithstanding the provisions of § 2.4.6(A) of this Part, no license to practice dentistry in Rhode Island shall be refused, nor shall any license be suspended or revoked except as:
1.Provided in the Act; and
2.For failure to attest to completion of continuing dental education as required by this Part.
J.The Board may, however, extend for only one (1) six (6) month period such educational requirements, if the Board is satisfied that the applicant has suffered hardship which prevented him/her from meeting the requirements of this Part.
2.6.1Issuance and Renewal of License
A.A license shall be issued by the Board to an applicant found to have satisfactorily met all requirements of this Part. Said license, unless sooner suspended or revoked, shall expire biennially on the 30th of June of the even numbered years.
B.Every person so licensed who desires to renew his or her license must file with the Board before the first (1st) of May in each even-numbered year, a renewal application duly executed together with attestation to completion of continuing education requirement and the renewal fee as determined biennially by the Director of Health in consultation with the Board, and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Upon receipt of such application and payment of such fee, a license renewal shall be granted effective for the biennial licensure period unless sooner suspended or revoked.
1.For those licensees who have attained the age of not less than seventy (70) years ("emeritus active") as of June 30th of the year of licensure, the renewal fee (non- refundable) shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Pursuant to the provisions of R.I. Gen. Laws § 5-31.1-21, the registration certificate of all dentists whose renewals accompanied by the prescribed fee are not filed on or before the first day of July of the even numbered years shall be automatically revoked. The Board may in its discretion and upon the payment by the dentist of the current licensure (registration) fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), reinstate any license (certificate) revoked under the provisions of the Act and this Part.
D.Inactive Status
1.Dentists not intending to practice in Rhode Island may request on a biennial basis to be placed on inactive status. Such requests shall be made in writing to the dental administrator and shall be accompanied by a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.Persons on inactive status may be reinstated by paying the current annual registration fee and shall meet such requirements established by the Act and as prescribed in this Part, including attesting to completion of the required continuing dental education courses as specified in § 2.6(A) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.7** Dental Hygienists Licensing Requirements {#sec-216-ricr-40-05-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.7}
2.7.1License Requirements
A.No person shall perform any act which constitutes the practice of dental hygiene or public health dental hygiene in Rhode Island unless such person is duly licensed in accordance with the Act and this Part as a dentist, dental hygienist, or a public health dental hygienist.
1.Furthermore, dental hygienists, dental assistants and DANB-certified assistants, DAANCE-certified maxillofacial surgery assistants or dental assistants, shall perform only those auxiliary dental services, procedures/duties, and under the specified type of supervision, as set forth in § 2.10.2 of this Part. Exempt from these requirements, are those persons listed in R.I. Gen. Laws § 5-31.1-37.
2.7.2Qualifications for Licensure for Dental Hygienists
A.An applicant seeking licensure to practice dental hygiene in Rhode Island shall:
1.Be of good moral character;
2.Be eighteen (18) years of age or over;
3.Have graduated from a program for dental hygienists accredited by the Commission on Dental Accreditation or its designated agency and approved by the Board;
4.Have passed to the satisfaction of the Board the required examinations in accordance with § 2.5 of this Part or met the requirements for endorsement stipulated in § 2.5(A)(1)(c)((3)) of this Part; and
5.Be in good standing in each state in which he/she holds a license.
2.7.3Application for Licensure and Fee
A.Application for licensure must be made on forms provided by the Board which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents (non-returnable):
1.A copy of the applicant’s state driver’s license, a state-issued identification card or other such identification papers acceptable to the Director that include birthdate and a picture.
2.Supporting official transcript of education credentials signed by the dean or registrar of the program of dental hygiene;
3.National board results in accordance with § 2.5(A)(1)(a) of this Part, (submitted either with the application or submitted by the National Board Dental Hygiene Examination to the Board);
4.The results of the American Board of Dental Examiners (ADEX) examination (formerly Northeast Regional Board of Dental Examiners, Inc., examination (NERB)) or other dental examination organizations (as required in § 2.5(A) of this Part) submitted directly by the Commission on Dental Competency Assessment (CDCA) (formerly the Board of Northeast Regional Board of Dental Examiners, Inc.) or by the board of the other dental examination organizations;
5.Verification that the licensee is in good standing in state(s) where licensed [if licensed in another state(s)]; and
6.The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) in accordance with R.I. Gen. Laws § 5-31.1-6.
2.7.4Examination for Licensure as a Dental Hygienist
A.By Examination: Applicants shall be required to pass such examination(s) as the Board deems most practical and expeditious to test the applicant's knowledge and skills to practice dental hygiene in Rhode Island pursuant to R.I. Gen. Laws § 5-31.1-6, and:
B.The Board requires each applicant to:
1.Have graduated from an accredited program for dental hygienists in accordance with § 2.4.6(A)(3) of this Part; and
2.Have passed the National Board Dental Hygiene Examination; and
3.Have passed ADEX examination given by the Commission on Dental Competency Assessment (CDCA) on Dental Hygiene (formerly the Northeast Regional Board Examination in Dental Hygiene (NERB)) including the computer simulation Northeast Regional Board Examination in Dental Hygiene within five (5) years prior to from the date of application for licensure in Rhode Island; or
4.Have passed an examination, approved by the Board, other than a regional board that is similar to the examination for which the applicant is seeking waiver, with an earned score of seventy-five percent (75%) using the internal weighting and scoring methods that the Commission on Dental Competency Assessment (CDCA, formerly NERB) uses to score the ADEX Examination in Dental Hygiene, and
5.Have passed a simulated patient clinical exercise (CDCA Computer Simulated Clinical Examination {CSCE} written) with an earned score of seventy-five percent (75%); or
6.Hold a current license in good standing to practice dental hygiene in another state for five (5) years that required the successful completion of a clinical board examination in order to be eligible for licensure;
C.Applicants shall submit to the Board, the application accompanied with the appropriate documentation as set forth in § 2.7.3 of this Part.
D.Sites and schedules of examinations may be obtained directly from the examination service(s) referred to above.
2.7.5Continuing Education--Dental Hygienists
A.Continuing education for dental hygienists requires those professionals to maintain a systematic course of continual learning as a condition to maintain their professional license. In addition, continuing education is an effective way for dental professionals to obtain knowledge of current and evolving tools, techniques, technology, innovative medications and in-depth information on emerging topics that will enhance their professional skills and abilities. Pursuant to the provisions of R.I. Gen. Laws § 5-31.1-7, all dental hygienists licensed to practice in Rhode Island under the provisions of the Act and this Part, shall, on or before the first (1st) day of May of each even- numbered year maintain evidence that in the preceding two (2) years he or she has satisfactorily completed at least twenty (20) hours of continuing education courses relevant to the practice of dental hygiene, according to the criteria in § 2.16 of this Part and approved by the Board. Continuing education requirements cited in this Part shall be prorated for a licensee whose license is in effect for a period of less than two (2) years (i.e., an average of ten (10) hours of continuing education shall be required each year the license is in effect).
B.All dental hygienists practicing in a dental setting shall receive a minimum of one (1) hour per year of training on the CDC Infection Control Guidelines.
C.All dental hygienists practicing in a dental setting shall hold a current certificate of completion in Basic Life Support (BLS) for the Healthcare Provider that includes a hands-on skill component and conforms to the current American Heart Association Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) offered by any accredited agency approved by the Board.
D.If the applicant attests to completion of prescribed course(s) of continuing education and is in compliance with the provisions of R.I. Gen. Laws § 5-31.1-6, the Board shall issue the applicant a license registration for a two (2) year period in accordance with the requirements of this Part.
E.It shall be the sole responsibility of the individual dental hygienist to obtain documentation from the approved sponsoring or co-sponsoring organization, agency or other, of his or her participation in the learning experience, including the date and number of hours earned.
1.These documents shall be safeguarded by the dental hygienist for a minimum of five (5) years for random audit by the Board, if requested. At the time of license renewal, each licensee shall be required to attest that he/she has complied with the continuing education requirements stated in this Part. Failure to produce satisfactory documentation of completion of continuing education requirements upon request by the Board may constitute grounds for disciplinary action.
F.Licensure renewal shall be denied to any applicant who fails to attest to completion of continuing education courses relevant to the practice of dental hygiene as required by this Part.
1.Notwithstanding the provisions of § 2.6(G) of this Part, no license to practice dentistry or dental hygiene in Rhode Island shall be refused, nor shall any license be suspended or revoked, except as:
a.provided for in the Act; and
b.failure to attest to completion of continuing education as provided by this Part.
G.The Board may, however, extend for only one (1) six (6) month period such educational requirements, if the Board is satisfied that the applicant has suffered hardship which prevented the applicant from meeting the requirements of this Part.
2.7.6Issuance and Renewal of License – Dental Hygienists
A.A license shall be issued by the Board to an applicant found to have satisfactorily met all the requirements of this Part. Said license unless sooner suspended or revoked shall expire biennially on the 30th of June of each even-numbered year.
B.Every person so licensed who desires to renew his or her license shall file with the Board by the 1st of May in each even-numbered year, a renewal application duly executed together with attestation to completion of continuing education requirements and the renewal fee as determined biennially by the Director of Health in consultation with the Board, and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Upon receipt of such application and payment of said fee, a license renewal shall be granted effective for the biennial licensure period unless sooner suspended or revoked.
1.For those licensees who shall have attained the age of not less than seventy (70) years ("emeritus active") as of June 30th of the year of licensure, the renewal fee (non- refundable) shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Pursuant to the provisions of section R.I. Gen. Laws § 5-31.1-21 of the Act, the registration certificate of all dental hygienists whose renewals accompanied by the prescribed fee are not filed on or before the first day of July of each even numbered year, shall be automatically revoked. The Board may in its discretion and upon the payment by the dental hygienist of the current licensure (registration) fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), reinstate any license (certificate) revoked under the provisions of the Act and this Part.
2.7.7Inactive Status
A.Dental hygienists not intending to practice in this state may request on a biennial basis to be placed on inactive status. Such requests shall be made in writing to the dental administrator and shall be accompanied by a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Persons on inactive status may be reinstated by paying the current annual registration fee and shall meet such requirements established by the Act and as prescribed in this Part, including attesting to completion of the required continuing dental education courses relevant to the practice of dental hygiene as specified in § 2.8.2 of this Part.
2.7.8Continuing Education and Training of Dental Assistants
All dental assistants practicing in a dental setting shall hold a current certificate of completion. Basic Life Support (BLS) for the Healthcare Provider that includes a hands-on skill component and conforms to the current American Heart Association Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) offered by any accredited agency approved by the Board. Additionally, all dental assistants practicing in a dental setting shall receive a minimum of one (1) hour per year of training on the CDC Infection Control Guidelines.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.8** DAANCE-Certified Maxillofacial Surgery Assistant Licensing Requirements {#sec-216-ricr-40-05-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.8}
2.8.1License Requirements
A.No person shall perform any act which constitutes the practice of certified maxillofacial surgery assisting in Rhode Island unless such person is duly licensed in accordance with the Act and this Part as a DAANCE-certified maxillofacial surgery assistant.
1.Furthermore, dental hygienists, public health dental hygienists, DAANCE-certified maxillofacial surgery assistants, DANB-certified assistants and dental assistants, shall perform only those auxiliary dental services, procedures/duties, and under the specified type of supervision, as set forth in § 2.8 of this Part. Those persons listed in R.I. Gen. Laws § 5-31.1-37 are exempt from these requirements.
2.8.2Qualifications for Licensure- DAANCE-certified Maxillofacial Surgery Assistant
A.An applicant seeking licensure to practice maxillofacial surgery assisting in Rhode Island shall:
1.Be of good moral character;
2.Be eighteen (18) years of age or over;
3.Have successfully completed an approved program for Dental Anesthesia Assistants National Certification Examination (DAANCE) accredited by the American Association of Oral and Maxillofacial Surgeons or its designated agency;
4.Be certified as a dental anesthesia assistant by the American Association of Oral and Maxillofacial Surgeons or its designated agency;
5.Hold a current certificate of completion of an approved course in Advanced Cardiac Life Support (ACLS); and be in good standing in each state in which he/she holds a license.
2.8.3Application for Licensure and Fee
A.Application for licensure shall be made on forms provided by the Board which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents (non-returnable):
1.A copy of the applicant’s state driver’s license, a state-issued identification card or such other identification papers acceptable to the Director that include birthdate and a picture;
2.Supporting official documentation of certification by Dental Anesthesia Assistants National Certification Examination;
3.Supporting documentation of certificate of completion of an approved course in Advanced Cardiac Life Support (ACLS).
4.Verification that the licensee is in good standing in state(s) where licensed [if licensed in another state(s)]; and
5.The application fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department (Part 10-05-2 of this Title) in accordance with R.I. Gen. Laws § 5-31.1-6.
2.8.4Continuing Education--DAANCE-Certified maxillofacial surgery assistants
A.Continuing education for DAANCE-certified maxillofacial surgery assistants requires those professionals to maintain a systematic course of continual learning as a condition to maintain their professional license. In addition, continuing education is an effective way for dental professionals to sustain knowledge of current and evolving tools, techniques, technology, innovative medications and in-depth information on emerging topics that will enhance their professional skills and abilities.
B.Pursuant to the provisions of R.I. Gen. Laws § 5-31.1-7, all DAANCE-certified maxillofacial surgery assistants licensed to practice in Rhode Island under the provisions of the Act and this Part, shall, on or before the first (1st day of May of each even-numbered year, maintain evidence that in the preceding two (2) years he or she has satisfactorily completed at least twenty (20) hours of continuing education courses relevant to the practice of certified maxillofacial surgery assistants, according to the criteria in § 2.16 of this Part. Continuing education requirements cited in this Part shall be pro-rated for a licensee whose license is in effect for a period of less than two (2) years (i.e., an average of ten (10) hours of continuing education shall be required each year the license is in effect).
C.All DAANCE-certified maxillofacial surgery assistants practicing in a dental setting shall receive a minimum of one (1) hour per year of training on the CDC Infection Control Guidelines.
D.All DAANCE-certified maxillofacial surgery assistants practicing in a dental setting shall hold a current certificate of completion of an approved course in Advanced Cardiac Life Support (ACLS) for the Healthcare Provider that includes a hands-on skill component and conforms to the current American Heart Association Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) offered by any accredited agency approved by the Board.
E.If the applicant attests to completion of prescribed course(s) of continuing education and is in compliance with the provisions of R.I. Gen. Laws § 5-31.1-6, the Board shall issue the applicant a license registration for a two (2) year period in accordance with the requirements of § 2.6.1 of this Part.
F.It shall be the sole responsibility of the individual DAANCE-certified maxillofacial surgery assistant to obtain documentation from the approved sponsoring or co- sponsoring organization, agency or other, of his or her participation in the learning experience, including the date and number of hours earned.
G.These documents shall be safeguarded by the DAANCE-certified maxillofacial surgery assistant for a minimum of five (5) years for random audit by the Board, if requested. At the time of license renewal, each licensee shall be required to attest that he/she has complied with the continuing education requirements stated in this Part. Failure to produce satisfactory documentation of completion of continuing education requirements upon request by the Board may constitute grounds for disciplinary action.
H.Licensure renewal shall be denied to any applicant who fails to attest to completion of continuing education courses relevant to the practice of maxillofacial surgery assisting as required by this Part.
I.Notwithstanding the provisions of § 2.8.4(F) and 2.8.4(G) of this Part, no license to practice dentistry or dental hygiene or maxillofacial surgery assisting in Rhode Island shall be refused, nor shall any license be suspended or revoked, except as:
1.Provided for in the Act; and
2.Failure to attest to completion of continuing education as provided by this Part.
J.The Board may, however, extend for only one (1) six (6) month period such educational requirements, if the Board is satisfied that the applicant has suffered hardship which prevented the applicant from meeting the requirements of this Part.
2.8.5Issuance and Renewal of License – DAANCE- Certified Maxillofacial Surgery Assistant
A.A license shall be issued by the Board to an applicant found to have satisfactorily met all the requirements of this Part. Said license unless sooner suspended or revoked shall expire biennially on the 30th of June of each even-numbered year.
B.Every person so licensed who desires to renew his or her license shall file with the Board by the 1st of May in each even-numbered year, a renewal application duly executed together with attestation to completion of continuing education requirements and the renewal fee as determined biennially by the Director in consultation with the Board, and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Upon receipt of such application and payment of said fee, a license renewal shall be granted effective for the biennial licensure period unless sooner suspended or revoked.
1.For those licensees who shall have attained the age of not less than seventy (70) years ("emeritus active") as of June 30th of the year of licensure, the renewal fee (non-refundable) shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Pursuant to the provisions of R.I. Gen. Laws § 5-31.1-21, the registration certificate of all DAANCE-certified maxillofacial surgery assistants whose renewals accompanied by the prescribed fee are not filed on or before the 1st day of July of each even numbered year, shall be automatically revoked. The Board may in its discretion and upon the payment by the DAANCE-certified maxillofacial surgery assistant of the current licensure (registration) fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), reinstate any license (certificate) revoked under the provisions of the Act and this Part.
D.Inactive Status
1.DAANCE-Certified maxillofacial surgery assistants not intending to practice in Rhode Island may request on a biennial basis to be placed on inactive status. Such requests shall be made in writing to the dental administrator and shall be accompanied by a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.Persons on inactive status may be reinstated by paying the current annual registration fee and shall meet such requirements established by the Act and as prescribed in this Part, including attesting to completion of the required continuing dental education courses relevant to the practice of maxillofacial surgery assisting as specified in § 2.8.4 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.9** Public Health Dental Hygiene Practice {#sec-216-ricr-40-05-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.9}
2.9.1Qualifications
A.A public health dental hygienist may provide dental services which are educational, preventive, therapeutic, prophylactic and intra-oral in nature as may be authorized by the Board and may perform all tasks as set forth under the Act and this Part.
B.Educational requirements for the Public Health Dental Hygiene Practitioner
1.Prior to practicing as a public health dental hygienist a dental hygienist shall complete a minimum of twelve (12) hours of continuing education as follows:
a.A minimum of six (6) hours of hands-on experience in a public health setting.
b.Successful completion of the following courses within twenty-four (24) months prior to license issuance:
(1)Public Health Fundamentals:
(AA)CDC Guidelines (Infection Control);
(BB)Risk management for practice in a public health setting; and
(CC)Management of medical emergencies.
(DD)The courses specified by §§ 2.9.1(B)(1)(b)((1))(AA) through (CC) of this Part must be by an educational institution with a program accredited by the Commission on Dental Accreditation, or by a program approved by the Board.
2.The public health dental hygienist shall permanently retain documentation demonstrating compliance of continuing educational requirement including a signed affidavit that confirms successful completion.
C.A public health dental hygienist practicing in a public health setting may perform those services which are authorized by the Board to be provided in a public health setting, pursuant to a written collaborative agreement (WCA).
D.A registered dental hygienist practicing in a public health setting may provide dental hygiene services including placement of sealants, without first having a dentist examine the patient, pursuant to a written collaborative agreement (WCA).
E.Public health dental hygienists shall maintain current malpractice insurance.
2.9.2Application Process
A.Application for licensure shall be made on forms provided by the Board
B.Rhode Island Registered Dental Hygienists shall provide the following documents with their application:
1.Verification that their license is in good standing in state(s) where licensed [if licensed in another state(s)];
2.Verification that they have worked full time as a Registered Dental Hygienist for at least three (3) years full time or have completed at least 4500 hours of clinical experience;
3.Verification of additional training as set forth in § 2.9 of this Part;
4.The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) in accordance with R.I. Gen. Laws § 5-31.1-6.
C.Applicants holding a Dental Hygienist License from another state shall provide the following documents with their application:
1.A state driver’s license, a state-issued identification card or such other identification papers acceptable to the Director that include birthdate and a picture;
2.Verification that the licensee is in good standing in state(s) where licensed [if licensed in another state(s)];
3.Verification that they have:
a.Worked full time as a Registered Dental Hygienist for at least three (3) years full time; or
b.Have completed at least four thousand five hundred (4500) hours of clinical experience; or
c.Hold a current license in good standing to practice Public Health Dental Hygiene or equivalent, as determined by the Board, in another state for five (5) years that required the successful completion of a clinical board examination in order to be eligible for licensure.
4.Verification of additional training as set forth in § 2.9.9 of this Part; and the application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) in accordance with R.I. Gen. Laws § 5-31.1-6.
2.9.3Written Collaborative Agreement (WCA) with a Public Health Dental Hygienist
A.A public health dental hygienist shall:
1.Enter into a written collaborative agreement (WCA) which complies with the requirements of R.I. Gen. Laws § 5-31.1-39(c) and § 2.9.3(C) of this Part before rendering treatment to provide any dental hygiene services in a public health setting pursuant to the collaborative agreement;
2.Maintain contact and document communication with the dentist with whom the public health dental hygienist has entered into a written collaborative agreement (WCA) as set forth within that agreement.
3.Practice in accordance with R.I. Gen. Laws § 5-31.1-39 and this Part;
4.Practice in accordance with systems, policies and procedures established pursuant to the Board, the Act and this Part.
5.Obtain written and signed informed consent from the patient or legal representative which complies with R.I. Gen. Laws § 23-4.6-1 and the Board regulations which informs the patient or legal representative that the services provided by the public health dental hygienist are not a substitute for a dental examination by a dentist and informs the patient that the patient or legal representative should obtain, or should have had a dental examination by a dentist within ninety (90) days.
6.Provide each patient with a written Information Sheet at the conclusion of the patient’s visit. Said Information Sheet shall, at a minimum, include the following:
a.Results of the dental hygiene evaluation;
b.The name(s) of the public health dental hygienists and any licensed dentist and other dental auxiliaries who provided services;
c.A description of the treatment rendered including, but not limited to, billable service codes and fees associated with treatment, and tooth numbers, when appropriate;
d.Information on how to contact the public health dental hygienist, public health setting’s program director, mobile dental facility or portable dental operation permit holder;
e.If necessary, provide a referral for emergency assessment by a dentist;
f.When a referral is made, the patient or legal representative shall be referred to the patient’s regular dentist if one is identified. If none is identified, then the patient or legal representative shall be provided with the names of dentist(s), community health center(s) or dental school clinic(s) located within a reasonable geographic distance from the patient’s home and with whom the public health dental hygienist or dental health services program has communicated with regarding the acceptance of referrals;
g.The name and signature of the public health dental hygienist; and
h.If the patient or legal representative has given consent for an institutional facility (e.g. school, nursing home) to access the patient’s dental health records, then the dental hygienist shall also provide the institution with a copy of the Information Sheet for each patient.
B.A dentist entering into a written collaborative agreement (WCA) with a public health dental hygienist may, but is not required to, provide subsequent dental treatment to patients served under said agreement.
C.Written Collaborative Agreement (WCA). The collaborative agreement between a public health dental hygienist and a municipality or state agency or institution, or with a licensed dentist who holds a valid Rhode Island dental license shall, at a minimum address all of the following:
1.Identify by name(s) the dentist(s) who shall be available to provide the appropriate level of communications and consultation with the public health dental hygienist to ensure patient health and safety;
2.Describe, with specificity how communication and consultation between the dentist and public health dental hygienist will be accomplished including the frequency and arrangements for back-up coverage when the dentist is not accessible to provide communication and consultation (e.g. during vacation, illness);
3.Provide the names, license numbers, address(es), telephone and facsimile number(s) and emergency contact information for the dentist(s) and public health dental hygienist;
4.Identify entity(ies) and geographic area(s) where public health dental hygienist services will be provided pursuant to the collaborative agreement;
5.Specify the dental hygiene procedures to be provided and the populations to be served pursuant to the collaborative agreement;
6.Specify and describe responsibilities for creating, maintaining, storing, retrieving and providing for the confidentiality of patient records;
7.Specify and describe responsibilities for establishing systems, policies and procedures to ensure compliance with Board regulations, including but not limited to requirements of Mobile and Portable Dentistry as may be applicable;
8.Specify and describe responsibilities for developing, implementing, and maintaining emergency medical protocols and for the provision of periodic review and training on same;
9.Include any considerations for age-related procedure-specific protocols as may be deemed necessary by the dentist or public health dental hygienist;
10.Include any considerations for medically-compromised patients as may be deemed necessary by the dentist or public health dental hygienist;
11.Outline responsibilities for billing and reimbursement for services rendered by the dental hygienist in the public health setting, if indicated;
12.Identify a process for the public health dental hygienist to legally obtain prescription products (e.g. chemotherapeutics, fluoride varnish) pertinent to the provision of dental hygiene services and which are to be utilized when rendering services in a public health setting; and
13.Term of the collaborative agreement, if applicable.
D.The dentist and public health dental hygienist shall review and update the written collaborative agreement on an annual basis, as a minimum frequency.
E.The dentist and public health dental hygienist shall immediately notify each other and, if applicable, the municipality, state agency or institution involved in the collaborative agreement of any disciplinary action imposed by the Board or any other governmental agency against his/her license to practice dentistry or dental hygiene in the State of Rhode Island.
F.A copy of the written collaborative agreement shall be maintained by the municipality, state agency or institution, licensed dentist and the public health dental hygienist. Upon written request, said agreement shall be made available to the Board, or to a patient who received treatment pursuant to the agreement or his/her legal representative.
G.Each public health dental hygienist shall maintain the following data to be reported to the Rhode Island Department of Health Oral Health Program on forms and in accordance with procedures and timelines established by that program:
1.The dates of each session with name and address of the site where public health dental hygiene services were provided; and
2.The number of patients served.
2.9.4Availability of Dental Records
A.Request for Copy of Dental Record. The public health dental hygienist shall provide upon request by a patient or a specifically authorized person, a complete copy of the patient’s dental record in accordance with R.I. Gen. Laws § 5-31.1-10 (10) A copy of the patient record including radiographs and other images, shall be provided within a reasonable amount of time not to exceed thirty (30) calendar days from the date of the request. The public health dental hygienist may charge a reasonable fee for the expense of providing a patient’s dental record, not to exceed the cost of either labor and/or material incurred in the copying of the patient record, radiographs and models. The Public Health Dental Hygienist shall not require payment for dental services rendered as a condition of providing a copy of the dental record.
B.Treatment in a School Setting. Where consent has been granted by the patient or legal representative, a copy of the patient’s summary of care or other written summary of the screening, examination, or treatment shall be provided to the official designated by the school.
C.Treatment in a Nursing Home or Residential Treatment Facility. A copy of the patient’s summary of care or other written summary of the screening, examination, or treatment shall be provided to the official designated by the facility or institution and shall be made part of the patient record maintained by the nursing home or residential facility
D.Electronic patient records shall comply with the requirements of HIPAA and the Confidentiality of Health Care Communications and Information Act, R.I. Gen. Laws Chapter 5-37.3 and shall be unalterable and producible in paper form upon request.
2.9.5Content of Patient Records
A.The patient record shall be a complete record of all patient contact, including, but not limited to, a general description of the patient’s medical and dental history and status at time of examination, assessments and /or diagnosis provided by a dentist, patient education, treatment plan, referral for specialty treatment, medications administered and prescribed, pre- and post-treatment instructions and information conveyed to the patient. Patient records shall be legible and clear in meaning to a subsequent examining or treating dentist, the patient, dental auxiliary or other authorized persons.
B.Public health dental hygienist proprietary forms shall include language as approved by the Board.
2.9.6Required Referrals
Public health dental hygienists will refer patients without a dental provider to a public or private dentist with the goal of establishing a dental home for the patient. When the public health dental hygienist determines at a subsequent appointment that there are conditions present which require evaluation for treatment, and the patient has not seen a dentist as referred, the dental hygienist will make every practical or reasonable effort to schedule the patient with a Rhode Island dentist or local private dentist volunteer for an examination, treatment plan and follow up care, or a community health center if available.
2.9.7Radiograph
Digital radiographs shall be conducted pursuant to the regulations for Radiation (Subchapter 20 of this Chapter). The collaborating and currently licensed Rhode Island dentist shall evaluate the radiographs within thirty (30) days of exposure.
2.9.8Temporary Restorative Procedures
A public health dental hygienist, as defined by this Part may perform reversible procedures including but not limited to temporary restorative procedures without a dentist present under protocols developed by the Board of Dentistry as outlined in § 2.17 of this Part.
2.9.9Continuing Education Requirements
A.Public health dental hygienists; prior to renewal of licensure shall obtain a minimum of six (6) hours of continuing education in courses related to public health. These six (6) hours are included in the required twenty (20) hours of continuing education required every two (2) years following the criteria listed in § 2.16 of this Part. The following public health topics are recommended:
1.Home & Community – Based Care
a.Youth Services
(1)School-based care
(2)Head Start & Early Head Start
(3)Day Care
2.Eldercare Services
3.Community- based settings (e.g. nursing homes, assisted living)
4.Homebound – All Populations (including individuals with disabilities)
B.Third Party Payment Models & Business 101
C.Grant Writing 101
D.Diversity Training & Case Management Concepts
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.10** Delegable Procedures/Duties to Dental Hygienists, Public Health Dental Hygienists, DANB-Certified Assistants, DAANCE-Certified Maxillofacial Surgery Assistants and Dental Assistants with Specific Type of Supervision {#sec-216-ricr-40-05-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.10}
2.10.1General Requirements
A.Dental Hygienists. Pursuant to R.I. Gen. Laws § 5-31.1-33, any licensed dentist, public institution or school authority may employ any licensed dental hygienist whose activities shall be confined to those dental services, procedures/duties that licensed dental hygienist he/she has been educated to perform and which are authorized by the Board, and under the specific type of supervision as set forth in § 2.10.2 of this Part. Such dental procedures/duties may be delegated by the dentist and performed under the direction of the dentist, in accordance with the provisions of the Act and this Part.
1.Nothing in this section shall be construed to authorize a licensed dental hygienist or public health dental hygienist to perform any of the non-delegable (exclusionary) procedures/ duties as set forth in § 2.10.3 of this Part.
B.DANB-Certified Assistants, DAANCE-Certified Maxillofacial Surgery Assistants and Dental Assistants. A dentist may delegate to a DANB-certified assistant, DAANCE-certified maxillofacial surgery assistant or a dental assistant, based on the individual's competency and/or training, reversible intraoral dental services, procedures or duties which are to be performed under the supervision of the dentist as approved by the Board and set forth in § 2.10.2 of this Part. Provided, however, oral prophylaxis shall be performed only by a licensed dentist or a licensed dental hygienist.
1.Nothing in this section shall authorize a DANB- certified assistant or a dental assistant to perform any of the non-delegable (exclusionary) procedures/duties as set forth in § 2.10.3 of this Part.
C.All procedures/duties performed by dental auxiliaries shall be performed under the direct supervision of a dentist, unless otherwise specified in § 2.10.2 of this Part.
D.Any reversible intraoral procedure not specifically enumerated as delegable or non- delegable (exclusionary) pursuant to §§ 2.10.2 and 2.10.3 of this Part, may be delegated to any category of dental auxiliary, (dental hygienist, public health dental hygienist, DANB-certified assistant, DAANCE-certified maxillofacial surgery assistant and dental assistant) based on the discretion of the delegating dentist, the education and training and competency of the dental auxiliary.
E.The supervising dentist shall be accountable and fully responsible for all dental services, procedures and duties performed by any dental auxiliary under his or her supervision. However, a dental auxiliary is responsible for his/her own professional behavior and shall be guided by existing professional standards.
2.10.2Delegable Procedures/Duties
A.A dentist may delegate to auxiliary personnel those procedures which the dentist may deem advisable, except for those procedures excluded in § 2.10.3 of this Part. Any delegated procedures shall be both the responsibility of and under the specified supervision of the dentist.
1.Dental Hygienist and Public Health Dental Hygienist. A dental hygienist or a public health dental hygienist, may remove calculus, accretions and stains from both supragingival and subgingival tooth surfaces by scaling and root planing, as well as any duties performed by a DANB-certified assistant or a dental assistant. These procedures may be accomplished under general supervision, in a dental office, and under general supervision of the dentist.
2.DANB-Certified Assistant
a.A DANB-certified assistant may perform reversible intraoral procedures under the direct supervision of the dentist.
b.Such procedures may include the application of pit and fissure sealants, coronal polishing, placing and/or removing retraction cord; fluoride treatments; and placement or removal of bonded orthodontic attachments and/or cementation or removal of orthodontic bands provided:
(1)Such procedures were incorporated into the academic training from which the DANB-certified assistant graduated; OR
(2)Provided he/she has completed academic clinical training to clinical competence.
3.The DANB- certified assistant may not perform any of the procedures specifically listed for a dental hygienist, nor any irreversible intraoral procedures.
4.Dental Assistant. A dental assistant may perform reversible intraoral procedures under the direct supervision of the dentist. He or she may not perform any of the procedures listed specifically for a licensed dental hygienist or DANB-certified assistant nor any irreversible intraoral procedures.
a.A dental assistant may perform a final digital scan with final inspection and approval of the dentist.
B.Dentists licensed pursuant to R.I. Gen. Laws § 5-31.1-6 may delegate to any dental hygienists licensed pursuant to R.I. Gen. Laws § 5-31.1-6 who are employed on a regular basis by such dentists any procedures which he or she may deem advisable; including those procedures specified under § 2.10.2 of this Part pertaining to dentists and dental hygienists and any such dental hygienists may engage in the practice of dental hygiene outside of such dentists' office in order to render to residents of nursing facilities licensed pursuant to R.I. Gen. Laws Chapter 23-17 without the on-site direct supervision of a dentist licensed pursuant to R.I. Gen. Laws § 5-31.1-6, those dental services, procedures and duties that he or she has been educated to perform and which are authorized by the Board or through R.I. Gen. Laws § 5-31.1-39.
C.Delegable procedures and duties for DAANCE-certified maxillofacial surgery assistants are set forth in R.I. Gen. Laws § 5-31.1-31.
2.10.3Non-Delegable (Exclusionary) Procedures/Duties
A.Notwithstanding the provisions of § 2.14 of this Part, nothing in this Part authorizes a dental hygienist, public health dental hygienist, DANB-certified assistant or dental assistant, to perform any of the following procedures or duties:
1.Diagnosis and treatment planning;
2.Surgical procedures on hard or soft tissue;
3.Prescribing medications;
4.Administering general anesthesia/deep sedation, moderate sedation and/or minimal sedation, or nitrous oxide plus medication;
5.Administering sedative inhalants;
6.Taking conventional/ physical impressions for models upon which full or partial dentures, or permanent crowns, bridges, inlays, onlays, posts and cores will be fabricated;
7.Adjusting occlusion of fixed and removable prosthodontic appliances;
8.Final cementation of permanent crowns, bridges, inlays, onlays and posts and cores; and insertion of final prosthesis.
9.Condensing and carving restorative materials in teeth, except temporary restoratives;
10.Placement of sutures;
11.Exposure of radiographs without successful completion of a course in dental radiography which is offered by an education institution with a program accredited by the Commission on Dental Accreditation and which fulfills institutional requirements as set forth in R.I. Gen. Laws § 40-20-1;
12.Perform direct pulp capping procedures;
13.Orthodontic arch wire detailing with the exception of minor adjustments to eliminate pain or discomfort;
14.Flush root canal;
15.Temporary wire ligation; and
16.Use of a rotary instrument in the oral cavity unless licensed or certified under the provisions of the Act and this Part. (See also § 2.10.2(A)(2)(b) of this Part).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.11** Administration of Anesthesia in Dental Offices {#sec-216-ricr-40-05-2-2.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.11}
2.11.1General Requirements
A.Any dentist licensed to practice dentistry in Rhode Island pursuant to R.I. Gen. Laws § 5-31.1-6, who holds an individual anesthesia permit, may administer anesthesia or sedation as authorized by his or her category of individual permit at any facility which has been issued a corresponding facility permit by the Board.
B.Notwithstanding the foregoing, any licensed dentist who intends to administer anesthesia services within a dental office in Rhode Island who has been issued an individual permit and has not been issued a facility permit shall only be permitted to do so by prior approval of the Board.
C.As a condition for approval for an Individual Anesthesia Permit or a Facility Anesthesia Permit, the Board, or its designee, shall conduct an onsite inspection with the applicant of all equipment, medications, and staff utilized for the purpose of administering deep sedation/general anesthesia and moderate sedation. Emergency scenario must be performed, with staff, as well as observation of actual surgical cases where appropriate. Said equipment shall meet all applicable requirements of this Part.
D.Because sedation and general anesthesia are a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to diagnose and manage the physiologic consequences (rescue) for patients whose level of sedation becomes deeper than initially intended.
E.For all levels of sedation, the qualified dentist must have the training, skill, drugs, and equipment to identify and manage such an occurrence until either assistance arrives (emergency medical service) or the patient returns to the intended level of sedation without airway or cardiovascular complications.
2.11.2Professional Permitting Requirements
A.The Board shall issue the following permits to qualified Dentists and Facilities:
1.Individual Anesthesia Permit:
a.Authorizes a Qualified Dentist, licensed by the State, to administer one or all of the following levels of sedation, which shall be delineated on the permit: minimal and nitrous oxide-oxygen alone, or in conjunction with a local anesthetic, moderate, deep sedation and/or general anesthesia, in a dental facility that has the required Facility Permit for the type of anesthesia or sedation being administered in compliance with this Part.
2.Portable Individual Anesthesia Permit:
a.Authorizes a trained Dentist Anesthesiologist to perform sedation services at any dental facility with the appropriate Facility Host Permit.
3.Pediatric Individual Anesthesia Permit: Authorizes a Qualified Dentist with additional training in pediatric sedation as set forth in this Part, licensed by the State of Rhode Island, to Administer moderate sedation to patients under the age of thirteen (13) in a dental facility that has the required Pediatric Facility Permit in compliance with this Part.
4.Facility Permit: Authorizes the administration of one or all of the following levels of sedation, which shall be delineated on the Permit: minimal and nitrous oxide-oxygen alone, or in conjunction with a local anesthetic, moderate, deep sedation and/or general anesthesia, by the onsite Qualified Dentist.
5.Facility Host Permit (H Permit): Authorizes the administration of moderate and deep sedation and/or general anesthesia at the specific site named on the Permit by the Qualified Providers.
6.Pediatric Facility Permit: Authorizes the administration of anesthesia to patients under the age of thirteen (13) by an onsite Qualified Dentist or Qualified Provider at the specific site named on the Permit.
2.11.3Qualifications for Individual Anesthesia Permit
A.All applicants for anesthesia individual permits must have been issued a Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6; and meet the individual qualifications for the permit they are seeking.
B. Applicants for a Nitrous Oxide Individual Anesthesia Permit must meet the following qualifications:
1.Have satisfactorily completed a minimum of fourteen (14) hours of nitrous oxide sedation training program from a CODA, PACE, or CERP approved advanced education program and whose training program is consistent with the provisions of the Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students (2016) incorporated by reference at § 2.2(J) of this Part, and which included experience in the administration of nitrous oxide sedation.
2..Have fulfilled one of the following requirements set forth in §§ 2.11.3(C), (D), or (E) of this Part; and
C.Applicants for an Individual Anesthesia Permit in Minimal Sedation must demonstrate competency by having successfully completed:
1. Training in minimal sedation consistent with that prescribed in the ADA Guidelines for Teaching Pain Control and Sedation to Dentist and Dental Students (2016) incorporated by reference in § 2.2(D) of this Part; or
2.Comprehensive training in minimal sedation that satisfies the requirements described in the Minimal Sedation section of the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students at the time training was commenced; or
3.An advanced education program accredited by the Commission on Dental Accreditations that affords comprehensive and appropriate training necessary to administer and manage minimal sedation commensurate with these guidelines; and
4.A current certification in Basic Life Support (BLS) for Healthcare Providers; and
5.Successful completion of a respiratory rescue course employing high fidelity human manikins intended for dental professionals.
D.Applicants for an Individual Anesthesia Permit in Moderate Sedation must meet the following criteria:
1.Have successfully completed a minimum of sixty (60) hours of Moderate Sedation training to include a combination of enteral and parenteral sedation course in addition to management of at least twenty (20) adult case experiences as provided by the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students (2016) incorporated by reference in § 2.2(J) of this Part; and
2.Have completed a board approved simulation course that uses high fidelity human simulation.
3.Have a current certification in ACLS.
E.Applicants for Pediatric Individual Anesthesia Permit for Moderate Sedation must meet the following criteria:
1.To administer moderate sedation to all patients up to the age of twenty-one (21) as well as Special Health Care Needs (SHCN) patients of any age (as defined by the American Academy of Pediatric Dentistry Guidelines incorporated by reference in § 2.2(I) of this Part, applicants must have fulfilled one of the following education and training requirements:
a.Have completed a CODA-approved Pediatric Residency Program or are candidates or Diplomates of the American Board of Pediatric Dentistry (ABPD); or
b.Have completed a post-doctoral training program in Oral and Maxillofacial Surgery; or
c.Have completed a post-doctoral training program in Dental Anesthesiology.
2.Dentists who are Diplomates of the American Board of Pediatric Dentistry (ABPD), may administer moderate sedation to all patients up to age twenty-one (21) as well as Special Health Care Needs (SHCN) patients (as defined by the American Academy of Pediatric Dentistry Guidelines incorporated by reference in § 2.2(I) of this Part), of any age.
3.Dentists who hold a pediatric Moderate Sedation Permit and wish to treat children thirteen (13) years of age or over must also obtain an Adult Moderate Sedation Permit.
4.A separate Pediatric Individual Anesthesia Permit for Moderate Sedation Permit is not required for a dentist who holds a Deep Sedation/General Anesthesia Permit.
F.Applicants for Individual Anesthesia Permit in General Anesthesia/Deep Sedation must meet the following criteria:
1.Have completed a Board approved simulation course that uses high fidelity human simulation, and fulfilled one of the following education and training requirements:
a.Completion of an advanced training program in anesthesia and related subjects beyond the undergraduate dental curriculum; or
b. Completion of a post-doctoral training program (e.g. Oral and Maxillofacial Surgery (OMFS) or Dental Anesthesiology (DA)) which affords comprehensive appropriate training necessary to administer and manage general anesthesia/deep sedation.
2.Hold a current certification in ACLS.
G.Applicants for a Pediatric Individual Anesthesia Permit to administer or to authorize the administration of deep sedation/general anesthesia to pediatric patients must meet all the foregoing requirements and:
1.Maintain current American Heart Association (AHA) Advanced Cardiovascular Life Support (ACLS)/Pediatric Advanced Life Support (PALS) certification;
2.Be a candidate for or hold current board certification by the American Board of Oral and Maxillofacial Surgery (ABOMS), or
3.Be a candidate or diplomate of the American Dental Board of Anesthesiology (ADBA), or
4.Proof of education or training commensurate with the type of individual permit sought, as follows:
a.Completed an education program accredited by the ADA’s Commission on Dental Accreditation (CODA) that provides comprehensive training necessary to administer and manage general anesthesia and deep sedation.
H.Applicants for a Portable Individual Anesthesia Permit:
1.A Qualified Provider who is transporting and utilizing equipment necessary to provide sedation and anesthesia services at a specific dental facility site holding the necessary Facility Host Permit must obtain both a Portable Individual Anesthesia Permit as well as hold an Individual Anesthesia Permit for the designated level of anesthesia that will be provided.
2.An applicant for a Portable Individual Anesthesia Permit must meet the following criteria:
a.Must hold a valid Rhode Island Dental License;
b.Must have current certification in ACLS and PALS; and
c.Must hold a valid Individual Anesthesia Permit for the level of sedation to be administered.
3.Successful completion of an on-site evaluation performed by a Board appointed office evaluation team, of all mobile equipment, including medications, and staff to be utilized in the administration of anesthesia services in a host facility. Evaluations and inspections shall be at the time of application, at renewal, or as requested by the Board.
2.11.4Qualifications for a Facility Permit
A.Qualifications for Nitrous Oxide Facility Permit:
1.An applicant for licensure shall submit to the Board written evidence on forms furnished by the Board that said applicant:
a.Has a Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6;
b.Has a nitrous oxide sedation individual permit in accordance with the requirements set forth in § 2.11.3(B) of this Part; and
c.Has submitted a duly executed nitrous oxide sedation self-assessment form that complies with the standards established by the Board.
B.Qualifications for a Minimal Sedation Facility Permit:
1.Approval for a Minimal Sedation facility permit shall require the following prerequisites:
a.A Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6; and
b.A nitrous oxide sedation individual permit in accordance with the requirements set forth in § 2.11.3(B) of this Part; and
c.Submission of a duly executed minimal sedation self-assessment form that complies with the standards established by the Board.
C.Qualifications for a Moderate Sedation Facility Permit:
1.Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6;
2.A moderate sedation individual permit in accordance with the requirements set forth in § 2.11.3(D) of this Part; and
3.Successful completion of an on-site office evaluation performed by an office evaluation team approved by the Board and the Director.
a. An office evaluation team shall consist of two or more persons chosen and approved by the Board and the Director. At least one of the evaluators must hold an Individual General Anesthesia Permit. At least one member of the team must have substantial experience in the administration of the method of delivery of anesthesia or sedation used by the dentist being evaluated.
b.The board may appoint a licensee member of the board to serve as a consultant at any evaluation.
4.An applicant for a Facility Permit to administer moderate sedation shall obtain a written agreement from a hospital to accept emergency patients, or show evidence of membership on a hospital staff.
D.Qualifications for a General Anesthesia/Deep Sedation Facility Permit:
1.Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6;
2.A general anesthesia/deep sedation individual permit in accordance with the requirements set forth in § 2.11.3(E) of this Part; and
3.Successful completion of an on-site office evaluation performed by an office evaluation team appointed by the Board and the Director.
4.An applicant for a Facility Permit to administer deep sedation or general anesthesia shall obtain written agreement from a hospital to accept emergency patients, or show evidence of membership on a hospital staff.
E.Qualifications for a Facility Host Permit (H Permit):
1.An applicant pursuing a Facility Host Permit (H Permit) authorizing the administration of moderate or deep anesthesia and/or general anesthesia at the specific site named on the permit by a Qualified provider who is not the Operating Dentist must submit an attestation to the safety of all equipment used in connection with the administration of anesthesia.
2.An applicant for a Facility Host Permit to administer moderate sedation, deep sedation, or general anesthesia shall obtain written agreement from a hospital to accept emergency patients, or show evidence of membership on a hospital staff.
3.Successful completion of an on-site office evaluation performed by an office evaluation team appointed by the Board and the Director.
2.11.5Application
A.Application for a permit shall be made on forms provided by the Board which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents (non-returnable and non-refundable):
1.Supporting official transcripts of verification of the qualification requirements as set forth in §§ 2.11.2, 2.11.3, and 2.11.4 of this Part;
2.A statement attesting that he or she has not been involved in any morbidity or mortality secondary to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation; and
3.The permit fee, where applicable, as determined annually by the Director of Health in consultation with the Board and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
4.Such other information as may be deemed necessary and as may be requested by the Board.
2.11.6Issuance and Renewal of Permit
A.Upon receipt of an application for a permit to administer or to permit the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, the Board with the advice of the advisory consultant(s), may issue a permit to an applicant found to meet all the prescribed requirements of this Part. Said permit unless sooner suspended or revoked shall expire on June 30 of each even numbered year.
B.Every person issued a permit who desires to renew his or her permit shall file with the Board one (1) month before the date of expiration of permit, a renewal application duly executed together with the renewal fee, where applicable, as determined biennially by the Director in consultation with the Board and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Upon receipt of such renewal application and payment of any fee, a renewal shall be issued effective for two (2) years from the date of renewal, unless sooner suspended or revoked.
C.Any person who allows his or her permit to lapse through accident, mistake or unforeseen cause by failing to renew the permit on or before the expiration date, may be reinstated upon filing an application with payment of the current renewal fee, where applicable, in accordance with § 2.11.6(B) of this Part.
2.11.7Inspections
A.The Board may, through appointed advisory consultants, conduct such inspections and investigations as deemed necessary by the Board to ensure compliance with the requirements of this Part.
B.Refusal to permit an inspection shall constitute a valid ground for permit denial, suspension or revocation.
C.Every applicant shall be given notice by the Board of all deficiencies reported as a result of an inspection or investigation.
2.11.8Inactive Status
A.A dentist who holds a permit for the administration of or to permit the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation in his or her dental office and who desires to withdraw from the practice of dental anesthesia in his or her office, may request from the Board that his or her permit be withdrawn and placed on an inactive status.
B.A dentist whose permit has been inactive for more than one (1) year may be reactivated upon application to the Board and submission of any current application fee, as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The Board shall determine, at its discretion, whether or not to reactivate the permit or require renewed proof of competency or need for additional educational requirements.
2.11.9Personnel Requirements for Nitrous Oxide Sedation, Minimal Sedation, Moderate Sedation, and General Anesthesia/Deep Sedation
A.Personnel
1.A dentist administering or permitting the administration of nitrous oxide sedation, minimal sedation, moderate sedation, and general anesthesia/deep sedation must ensure that there is a sufficient number of members on the team of auxiliary personnel to assist in handling procedures and emergencies.
B.Minimal Sedation:
1.At least one additional person trained in Basic Life Support (BLS) for providers must be present in addition to the dentist.
C.Moderate Sedation:
1.During the administration of moderate sedation, the dentist must ensure that there are a minimum of three (3) trained individuals present and on the team of auxiliary personnel:
a.At least one staff member shall be designated as the patient monitor. The patient monitor may assist in the delivery of anesthesia under the personal supervision of the operating dentist. The provider must be trained in Advanced Cardiac Life Support (ACLS) and if they are treating a patient less than thirteen (13) years old they must be trained in Pediatric Advanced Life Support (PALS).
b.The second staff member must have ACLS and PALS training.
c.The third member of the team must be trained in BLS for providers and must be present in the facility. This staff member must be immediately available in case of emergency or if the staff member in charge of monitoring is involved in interruptible patient related tasks of short duration.
2.A dentist administering or permitting the administration of moderate sedation to pediatric patients must meet the requirements set forth in § 2.11.3(F) of this Part.
3.A Qualified Provider administering anesthesia in a host facility must attest to the adequacy and competency of the host facility and staff.
D.General Anesthesia/Deep Sedation:
1.The dentist administering General Anesthesia/Deep Sedation shall hold a current certificate in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS), as described in the ADA Guidelines for the Use of Sedation and General Anesthesia by Dentist incorporated by reference in § 2.2(C) of this Part.
2.An Oral and Maxillofacial Surgeon holding a Permit issued by the Board for the administration of general anesthesia/deep sedation may employ and utilize the services of a DAANCE-certified maxillofacial surgery assistant in accordance with the following criteria:
a.Satisfactory evidence of completion of a Dental Anesthesia Assistants National Certification Examination (DAANCE)-certified surgical assistant training course prepared and administrated by the American Association of Oral and Maxillofacial Surgeons and recertification in the DAANCE training program every five (5) years; and
b.Completion of a board of examiners in dentistry-approved Advanced Cardiac Life Support (ACLS) course and/or Pediatric Advanced Life Support (PALS) and recertification in advanced cardiac Life Support (ACLS) and/or Pediatric Advanced Life Support (PALS) every two (2) years; and
c.The valid Deep Sedation/ General Anesthesia Individual Permit by the Oral and Maxillofacial Surgeon where the DAANCE assistant will be performing his or her services; and
d.Direct supervision by an Oral and Maxillofacial Surgeon holding a valid General Anesthesia/Deep Sedation Permit; and
e.Direct visual supervision by an Oral and Maxillofacial Surgeon holding a valid General Anesthesia/Deep Sedation Permit where the DAANCE- certified maxillofacial assistant is performing the following tasks:
(1)Following instructions to prepare and assist in the administration of medications:
(2)Adjusting the rate of intravenous fluid infusion beyond a keep-open rate;
(3)Adjusting an electronic device to provide medications, such as an infusion pump; or
(4)Assisting with preparation/delivery/infusion/administration of emergency medications in order to assist the Oral and Maxillofacial Surgeon in an emergency.
f.The Oral and Maxillofacial Surgeon shall remain immediately available in the facility for the patient, and the DAANCE-certified maxillofacial surgery assistant for evaluation and treatment until the patient meets discharge criteria; and
g.The DAANCE-certified maxillofacial surgery assistant who is assigned to monitoring the patient may not have any other responsibilities while monitoring the patient under general anesthesia/Deep Sedation; and
h.The licensed provider will be responsible for the patient’s recovery; and
i.Peri-operative monitoring consisting of at least continuous electrocardiogram, monitoring of blood pressure, pulse oximetry, and end-tidal carbon dioxide consistent with published national standards adopted by the American Association of Oral and Maxillofacial Surgeons in conjunction with the American Society of Anesthesiologists; and
j.The conclusion of the peri-operative monitoring period shall be at the discretion of the licensed provider, using the modified Aldrete scale/scoring system. The patient may then be transferred to a discharge area and shall no longer require continuous monitoring.
3.Supervision. A DAANCE-certified maxillofacial surgery assistant shall perform the functions authorized by the Act and this Part only by delegation or authority from the Oral and Maxillofacial Surgeon and under the appropriate level of direct or direct visual supervision, and provided the Oral and Maxillofacial Surgeon is acting within the scope of his or her license. The responsibility for monitoring a patient and determining the selection of the drug, dosage, and timing of all anesthetic mediations rests solely with the Oral and Maxillofacial surgeon.
4.A dentist administering or permitting the administration of deep sedation/general anesthesia to pediatric patients must ensure that at least three (3) trained individuals are present, one of whom may be the dentist operator:
a.An individual, trained in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS), other than the dentist operator, to continually observe vital signs, airway patency, and adequacy of ventilation;
b.An individual who is trained in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS) and is skilled in airway management; and
c.An individual, trained in Basic Life Support (BLS), who must remain in attendance in the discharge area until the patient is approved for discharge by a Qualified Provider.
5.A Qualified Provider administering anesthesia in a host facility must attest to the adequacy and competency of the host facility and staff.
6.The dentist administering or permitting the administration of general anesthesia/ deep sedation shall hold a current certificate in Advanced Cardiac Life Support, as described in the Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) incorporated by reference in § 2.2(C) of this Part.
7.The dentist administering or permitting the administration of moderate sedation shall hold a current certificate in Advanced Cardiac Life Support, as described in the most current version of the American Dental Association, Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) incorporated by reference in § 2.2(C) of this Part.
8.The dentist administering or permitting the administration of minimal sedation shall hold a current certificate in Basic Cardiac Life Support, as described in the American Dental Association, Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) incorporated by reference in § 2.2(C) of this Part.
9.The dentist administering or permitting the administration of nitrous oxide sedation shall hold a current certificate in Basic Life Support (BLS).
10.Each member of the team of auxiliary personnel shall hold a current certificate in Basic Life Support (BLS).
E.Management of Services:
1.Written policies and procedures shall be established regarding:
a.the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation;
b.maintenance of safety controls;
c.qualifications and supervision of the team of auxiliary personnel involved in the general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation service.
2.In addition, the policies shall include provisions for no less than the following:
a.Pre-anesthesia evaluation;
b.Safety of the patient during the anesthesia period;
c.Review of patient's condition prior to induction of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, and post-anesthetic evaluation;
d.Signed informed consent obtained prior to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation. In the case of a minor, consent from a parent or legal guardian shall be obtained; in case of emergency, an oral permit will be acceptable;
e.Recording of all events related to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation;
f.Written report(s) of any morbidity requiring hospitalization or mortality occurring in the dental office as a result of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, and/or Board certified or Board eligible anesthesiologists, employed by or practicing in conjunction with a dentist shall remain on the premises of the dental office until the patient has been discharged from the dentist’s (or anesthesiologist’s) care.
F.Monitoring and Documentation
1.A dentist administering or permitting the administration of general anesthesia/deep sedation, moderate sedation or minimal sedation shall ensure that the following monitoring and documentation requirements are met:
a.Monitoring: direct clinical observation of the patient during administration shall occur.
b.Oxygenation: the color of mucosa, skin or blood should be continually evaluated. Oxygen saturation shall be evaluated continuously by pulse oximetry.
c.Ventilation: chest excursion shall be observed. For minimal sedation the dentist shall continuously auscultate breath sounds or monitor end-tidal CO2. For deeper levels of sedation, continuous monitoring of end-tidal CO2 is required.
d.Circulation: The dentist shall continually evaluate blood pressure and heart rate (unless the patient is unable to tolerate such monitoring).
e.Documentation: An appropriate time-oriented anesthetic record shall be maintained. The dentist shall document individuals present during the administration of anesthesia.
f.Recovery and Discharge: Oxygen and suction equipment shall be immediately available in the recovery area and operatory. There shall be continual monitoring of oxygenation, ventilation, and circulation when the anesthetic is no longer being administered. The patient shall have continuous supervision until oxygenation, ventilation, and circulation are stable and the patient is appropriately responsive for discharge from the facility. The dentist shall determine and document that oxygenation, ventilation, and circulation are stable prior to discharge. The dentist shall provide explanation and documentation of postoperative instructions to the patient and/or a responsible adult at the time of discharge. The dentist shall determine that the patient has met discharge criteria prior to leaving the office.
2.The anesthesia permit holder shall be responsible for the anesthetic management, adequacy of the facility/office, and treatment of emergencies associated with the administration of anesthesia, including immediate access to pharmacologic antagonists, if any, and age and size appropriate equipment for establishing a patent airway and providing positive pressure ventilation with oxygen.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.12** Administration of Local Anesthesia by Dental Hygienists {#sec-216-ricr-40-05-2-2.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.12}
A.A dental hygienist shall be qualified to administer local anesthesia only after successfully completing a course in local anesthesia that:
1.Is offered by an institution accredited by the Commission on Dental Accreditation of the American Dental Association;
2.Is a minimum of twenty (20) didactic hours and twelve (12) clinical hours;
3.Includes no less than the following topics:
a.Neurophysiology of pain and pain control;
b.Pharmacology of local anesthetic solutions and drug interactions;
c.Potential local and systemic complications;
d.Medical and dental indications and contraindications and emergency management;
e.Medical and dental history and assessment;
f.Safe assembly and handling of a syringe;
g.Location of anatomical landmarks associated with local anesthesia;
h.Injection techniques;
i.Clinical experience with maxillary and mandibular injections by administering infiltration and block injections;
j.Legal issues associated with local anesthesia administration by a dental hygienist;
k.Record keeping.
4.Provides written evidence of successful course completion provided by the sponsoring organization; and
5.Current certification in basic life and cardiopulmonary resuscitation at the “health care provider” level by a nationally recognized organization.
B.A dental hygienist qualified to administer local anesthesia shall have successfully completed a local anesthesia examination administered by the CDCA.
C.A dental hygienist qualified to administer local anesthesia shall do so only under the indirect supervision of a licensed dentist. Dental hygiene faculty members who are licensed to administer local anesthesia may do so within the scope of the academic setting of which they are employed under the general supervision of the program’s consulting dentist in the event that a supervising dentist is not available.
D.If a dental hygienist graduated from an American Dental Association accredited school of dental hygiene that did not include a course in local anesthesia that meets the requirements of § 2.12(A) of this Part, a course that meets such requirements shall be successfully completed before local anesthesia may be administered by the dental hygienist.
E.A dental hygienist who has qualified to administer local anesthesia in another jurisdiction may qualify for endorsement by the Board to perform that function by presenting written documentation of training equivalent to § 2.12(A) of this Part, including successful completion of the local anesthesia portion of the CDCA examination or successful completion of a substantially similar examination in the alternate jurisdiction.
2.12.2Application for Permit
A.Application for a two-year permit shall be made on forms provided by the Board which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents (non-returnable and non-refundable):
1.Local anesthesia. Supporting official transcripts of verification of the qualification requirements as set forth in § 2.12 of this Part;
2.Nitrous Oxide. Supporting official transcripts of verification of the qualification requirements as set forth in § 2.13.3 of this Part;
3.Local anesthesia. A statement attesting that he or she has or has not been involved in any morbidity or mortality secondary to the administration of local anesthesia;
4.Nitrous Oxide. A statement attesting that he or she has or has not been involved in any morbidity or mortality secondary to the administration of nitrous oxide;
5.Local anesthesia. A payment as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for a two (2) year permit;
6.Nitrous Oxide. A payment as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for a two (2) year permit; and
7.Such other information as may be deemed necessary and as may be requested by the Board.
2.12.3Administration of Nitrous Oxide by Dental Hygienists
A.A dental hygienist shall be qualified to administer nitrous oxide only after successfully completing a course in nitrous oxide administration that:
1.Is offered by an institution accredited by the Commission on Dental Accreditation of the American Dental Association;
2.Is a minimum of fifteen (15) didactic hours and five (5) clinical hours;
3.Includes no less than the following topics:
a.Nitrous oxide techniques;
b.Pharmacology of nitrous oxide;
c.Nitrous oxide sedation medical emergency techniques; and
d.Selection of pain control modalities, if available.
4.Provides written evidence of successful course completion provided by the sponsoring organization; and
5.Current certification in basic life and cardiopulmonary resuscitation at the “health care provider” level by a nationally recognized organization.
B.A dental hygienist qualified to administer nitrous oxide shall have successfully completed a nitrous oxide examination administered by the CDCA
C.A dental hygienist qualified to administer nitrous oxide shall do so only under the direct supervision of a dentist.
D.If a dental hygienist graduated from an American Dental Association accredited school of dental hygiene that did not include a course in nitrous oxide that meets the requirements of § 2.12(A) of this Part, a course that meets such requirements shall be successfully completed before nitrous oxide may be administered by the dental hygienist.
E.A dental hygienist who has qualified to administer nitrous oxide in another jurisdiction may qualify for endorsement by the Board to perform that function by presenting written documentation of training equivalent to § 2.12(A) of this Part, including successful completion of the nitrous oxide portion of the CDCA examination or successful completion of a substantially similar examination in the alternate jurisdiction.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.13** Physical Facility, Equipment and Safety {#sec-216-ricr-40-05-2-2.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.13}
2.13.1Equipment Requirements for Nitrous Oxide Sedation, Minimal Sedation, Moderate Sedation, or General Anesthesia/Deep Sedation Services
A.In order to ensure the protection and safety of patients receiving general anesthesia/deep sedation, moderate sedation, minimal sedation, or nitrous oxide sedation in a dental office, the following standards shall be applied in determining the adequacy and safety of the physical facility and equipment.
1.The current standards of the American Dental Association, Guidelines for the Use of Sedation and General Anesthesia by Dentists (2016) incorporated by reference in § 2.2(C) of this Part including but not limited to the following equipment requirements:
a.Equipment shall have a fail-safe system that is appropriately checked and calibrated;
b.Equipment shall have an appropriate scavenging system; and
c.If nitrous oxide and oxygen delivery equipment capable of delivering less than 25% oxygen is used, an in-line oxygen analyzer shall be used;
2.The standards for “Occupational Exposure to Waste Anesthetic Gases and Vapors" of the National Institute for Occupational Safety and Health (NIOSH) incorporated by reference in § 2.2(F) of this Part; and
3.The Rhode Island Fire Safety Code where flammable anesthetics are present.
B.The licensed dentist administering or permitting the administration of nitrous oxide sedation shall meet the following equipment requirements:
1.Automated external defibrillator (AED);
2.Gas delivery machines checked and calibrated periodically as required by manufacturer;
3.Equipment capable of delivering positive pressure ventilation;
4.Gas delivery system must have the following:
a.An oxygen fail-safe system;
b.Safety keyed hose attachment;
c.Capability to administer one hundred percent (100%) oxygen in all rooms in which nitrous oxide is administered;
d.Storage signage for nitrous oxide/oxygen tanks in compliance with applicable safety codes;
e.Adequate waste gas scavenging system;
f.Autoclavable or disposable hoods.
C.Minimal Sedation:
1.The dentist administering or permitting the administration of minimal sedation shall have the following age and size appropriate equipment:
a.Sphygmomanometer;
b.Automatic External Defibrillator (AED); and
c.Appropriate emergency drugs as determined by the Board.
D.Moderate Sedation:
1.A dentist administering or permitting the administration of moderate sedation shall have the following age and size appropriate equipment:
a.Sphygmomanometer and stethoscope;
b.Pulse Oximeter;
c.Capnograph;
d.AED; and
e.Appropriate emergency drugs as determined by the Board.
2.The equipment necessary for monitoring end-tidal CO2 and auscultation of breath sounds must be immediately available.
3.The equipment necessary to administer positive pressure ventilation.
4.An appropriate scavenging system must be available if gases other than oxygen or air are used.
5.The equipment necessary to establish intravascular or intraosseous access must be available until the patient meets discharge criteria.
6.When inhalation equipment is used, it must be a fail-safe system that is appropriately checked and calibrated. The equipment must also have a functioning device that prohibits the delivery of less than thirty percent (30%) oxygen.
E.General Anesthesia/Deep Sedation:
1.The dentist administrating or permitting the administration of general anesthesia/general anesthesia shall have the following equipment:
a.A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
b.When inhalation equipment is used, it must be a fail-safe system that is appropriately checked and calibrated in accordance with manufacturer’s recommendations. The equipment must also have a functioning device that prohibits the delivery of less than thirty percent (30%) oxygen.
c.An appropriate scavenging system must be available if gases other than oxygen or air are used.
d.The equipment necessary to establish intravenous access must be available.
e.Equipment and drugs necessary to provide advanced airway management.
f.Resuscitation medications and a defibrillator must be immediately available.
g.The dentist administering or permitting the administration of general anesthesia/deep sedation shall have equipment as referenced in the Office Inspection Form approved by the Board.
2.13.2Clinical Guidelines
A.General Anesthesia/Deep Sedation
1.Patient History and Evaluation: Patients considered for deep sedation or general anesthesia must undergo an evaluation prior to the administration of any sedative. This must consist of their medical history and medication use and NPO (nothing by mouth) status. In addition, patients with considerable medical considerations (e.g., ASA Ill, IV of the ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference above in § 2.2(H) of this Part), may also require consultation with their primary care physician or consulting medical specialist Assessment of Body Mass Index (BMI) should be considered part of a pre-procedural workup.
2.Preoperative Evaluation and Preparation
a.The patient, parent (if a minor), legal guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative or anesthetic agent and informed consent for the proposed sedative/anesthesia must be obtained.
b.A focused physical evaluation must be performed as deemed appropriate.
c.Baseline vital signs including body weight, height, blood pressure, pulse rate, respiration rate, and blood oxygen saturation by pulse oximetry must be obtained unless invalidated by the patient, procedure or equipment. In addition, body temperature should be measured when clinically appropriate.
d.Pre-operative verbal and written instructions must be given to the patient, escort, legal guardian or care-giver, including pre-operative fasting instructions based on the ASA Summary of Fasting and Pharmacological Recommendations.
e.An intravenous line, which is secured throughout the procedure, must be established except as provided in part IVC.6 “Special Needs Patients" of the American Dental Association Guidelines for the Use of Sedation and General Anesthesia by Dentists (2016) incorporated by reference in § 2.2(C) of this Part.
3.Monitoring and Documentation
a.Monitoring. A Qualified Dentist or Qualified Provider administering deep sedation/general anesthesia/deep sedation must remain in the operatory room until the patient meets the criteria for recovery. The Qualified Dentist or Qualified Provider must not leave the facility until he or she has personally observed that the patient meets the criteria for discharge and has signed off on the patient's release. Monitoring must include:
(1)Oxygenation: the color of mucosa, skin, or blood should be continuously evaluated, Oxygen saturation must be evaluated continuously by pulse oximetry.
(2)Ventilation: Intubated patient: End-tidal CO2 must be continuously monitored and evaluated. Non-intubated patients: End-tidal CO2 must be continuously monitored and evaluated unless precluded or invalidated by the nature of the patient, procedure, or equipment. In addition, ventilation should be monitored and evaluated by continuous observation of qualitative signs, including auscultation of breath sounds with a precordial or pretracheal stethoscope.
(3)Respiratory rate must be continuously monitored and evaluated.
(4)Circulation: The dentist shall continually evaluate heart rate and rhythm via ECG throughout the procedure, as well as pulse rate via pulse oximetry.
(5)The Qualified Dentist or Qualified Provider must continually evaluate blood pressure.
(6)Temperature: A device capable of measuring body temperature must be readily available during the administration of deep sedation or general anesthesia. The equipment to continuously monitor body temperature should be available and must be performed whenever triggering agents associated with malignant hypothermia are administered.
b.Documentation
(1)Documentation of compliance with manufacturers' recommended maintenance of monitors, anesthesia delivery systems, and other anesthesia-related equipment should be maintained. A pre-procedural check of equipment for each administration must be performed.
(2)Appropriate time-oriented anesthetic record must be maintained, including the names of all the drugs, dosages and their administration times, including local anesthetics and monitored physiological parameters.
(3)Pulse oximetry and end-tidal CO2 measurements, heart rate, and respiratory rate must be continuously monitored. Blood pressure must be continually monitored. If continuous monitoring is not possible in pediatric or special needs patients, the reason why must be documented.
4.Recovery and Discharge
a.Oxygen and suction equipment must be immediately available in the discharge area and operatory.
b.The patient shall have continuous supervision until oxygenation, ventilation, and circulation are stable and the patient is appropriately responsive for discharge from the facility.
c.The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation and level of consciousness.
d.The Qualified Dentist or Qualified Provider shall determine and document that oxygenation, ventilation, and circulation are stable prior to discharge.
e.The Qualified Dentist or Qualified Provider or his or her designee shall provide explanation and documentation of postoperative instructions to the patient and/or responsible adult at the time of discharge.
f.If a pharmacological reversal agent is administered before discharge criteria have been met, the patient must be monitored for a longer period than usual before discharge, since re-sedation may occur once the effect of the reversal agent has waned.
5.Emergency Management
a.The Qualified Dentist or Qualified Provider is responsible for sedative/anesthetic management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of deep sedation or general anesthesia and providing the equipment, drugs and protocols for patient rescue except as required for the Facility Host Permit.
b.The Board certified or Board eligible anesthesiologist, employed by or practicing in conjunction with a dentist must remain on the premise of the dental office until the patient has been discharged from the dentist's (or anesthesiologist's) care.
c.Proper documentation must include the following:
(1)Maintenance of an appropriate time-oriented anesthetic record including monitoring of blood pressure every five (5) minutes.
(2)Record of the individuals present during the administration of the anesthetic prepared by the dentist.
(3)Recording of all events relative to the administration of nitrous oxide, minimal sedation, moderate sedation, or deep sedation/general anesthesia.
(4)Written report(s) of any morbidity requiring hospitalization or mortality occurring in the dental office as a result of minimal sedation or nitrous oxide sedation, moderate sedation, or deep sedation/general anesthesia.
B.Moderate Sedation
1.Patient History and Evaluation:
a.Patients considered for moderate sedation must be suitably evaluated prior to the start of any sedation procedure. In healthy or medically stable individuals (ASA I, II of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) this may consist of a review of their current medical history and medication use.
b.In addition, patients with multiple medical comorbidities (ASA III, IV of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) may require consultation with his or her primary care provider or consulting medical specialist.
2.Pre-operative Evaluation and Preparation is pursuant to the requirements of § 2.13.2(A)(2) of this Part.
3.Monitoring and Documentation
a.Monitoring
(1)A Qualified Dentist or Qualified Provider administering moderate sedation must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. When active treatment concluded and the patient recovers to a minimally sedated level a qualified auxiliary may be directed by the dentist to remain with the patient and continue to monitor them as explained in the guidelines until they are discharged from the facility. The dentist must not leave the facility until he or she has personally observed that the patient meets the criteria for discharge and has signed off on the patient's release. Monitoring must include:
(AA)Consciousness: Level of sedation (e.g., responsiveness to verbal command) must be continually assessed.
(BB)Oxygenation: Oxygen saturation must be evaluated by pulse oximetry continuously.
(CC)Ventilation: The dentist must observe chest excursions continually. The dentist must monitor ventilation and/or breathing by monitoring end-tidal CO2 unless precluded or invalidated by the nature of the patient, procedure or equipment Ventilation should be monitored by continuous observation of qualitative signs, including auscultation of breath sounds with precordial or pretracheal stethoscope or as needed if CO2 capnograph is used.
(DD)Vital signs including blood pressure must be obtained and recorded continually.
(EE)Circulation: The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must continually monitor the patient's blood pressure and level of consciousness. Oxygenation and heart rate must be continuously monitored.
b.Documentation
(1)Appropriate time-oriented anesthesia record must be maintained, including the names of all drugs, dosages and their administration times, including local anesthetics, dosages and monitored physiological parameters.
(2)Pulse oximetry, heart rate, respiratory rate, blood pressure and level of consciousness must be recorded continually.
4.Recovery and Discharge
a.Oxygen and suction equipment must be immediately available if a separate discharge area is utilized.
b.The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must continuously oxygenation and continually monitor the patient's blood pressure, heart rate, and level of consciousness.
c.Post-operative written instructions must be signed by the Qualified Dentist or Qualified Provider. The written and verbal instructions must be given to the patient, parent, escort, legal guardian or care-giver.
d.If a pharmacological reversal agent is administered before discharge criteria have been met, the patient must be monitored for a longer period than usual before discharge, since re-sedation may occur once the effect of the reversal agent has waned.
5.Emergency Management
a.If a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient is returned to the intended level of sedation.
b.The Qualified Dentist or Qualified Provider is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of moderate sedation and providing the equipment, drugs, and protocol for patient rescue.
C.Minimal Sedation
1.Patient History and Evaluation
a.Patients considered for minimal sedation must be suitably evaluated prior to the start of any sedation procedure. In healthy or medically stable individuals (ASA I, II of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) this may consist of a review of their current medical history and medication use.
b.In addition, patients with multiple medical comorbidities (ASA III, IV of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) may require consultation with his or her primary care provider or consulting medical specialist.
2.Pre-Operative Preparation
a.Informed consent must be obtained from the patient, person designated as the patient’s power of attorney for healthcare, or parent if the patient is a minor.
b.Patient evaluation must be obtained unless invalidated by the nature of the patient, procedure, or equipment. Body temperature must be measured when clinically indicated.
c.An appropriate focused physical evaluation must be performed.
e.Pre-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.
3.Monitoring and Documentation
a.Monitoring. A dentist, or at the dentist's direction, an appropriately trained individual, must remain in the operatory during active sedation to monitor the patient on a continual basis until the patient meets the criteria for discharge. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:
(1)Consciousness: Level of sedation (e.g., responsiveness to verbal command) must be continually assessed.
(2)Oxygenation: Oxygen saturation by pulse oximetry may be clinically useful and should be considered.
(3)Ventilation: The dentist and/or appropriately trained individual must observe chest excursions. The dentist and/or appropriately trained individual must verify respirations.
(4)Circulation: Blood pressure and heart rate must be evaluated pre-operatively, post-operatively and intraoperatively as necessary (unless patient is unable to tolerate such monitoring).
b.When administering nitrous oxide, the gas must be turned off when the dentist or dental hygienist administering the drug leaves the room. A dental assistant must stay in the room to monitor the patient if the dentist or dental hygienist is not physically present.
c.Documentation: An appropriate sedation record must be maintained, including names of all drugs administered, time administered and route of administration including local anesthetics, dosages, and monitored physiological parameters.
4.Recovery and Discharge
a.Oxygen and suction equipment must be immediately available if a separate discharge area is utilized.
b.The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must monitor the patient during recovery until the patient is ready for discharge by the dentist.
c.The Qualified Dentist or Qualified Provider must determine and document that level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge, using an Aldrete score, or a similar set of standards approved by the board.
d.Post-operative verbal and written instructions must be given to the patient, parent, escort, legal guardian, or caregiver.
D.Nitrous Oxide Sedation. When administering nitrous oxide, the gas must be turned off when the dentist or dental hygienist administering the drug leaves the room. A dental assistant must stay in the room to monitor the patient if the dentist or dental hygienist is not physically present.
E.Dental Pediatric Anesthesia.
1.A Pediatric Individual Anesthesia Permit for Moderate Sedation is required for:
a.The administration of Nitrous Oxide-Oxygen sedation in a concentration higher than fifty percent (50%) or the administration of a lower concentration of Nitrous Oxide-Oxygen Analgesia via face mask, which may produce general anesthesia.
b.The administration of Nitrous Oxide-Oxygen while the child is under the influence of any other sedative agent.
c.Treatment of children younger than eighteen (18) months old, with moderate sedation, may only be administered by a Deep Sedation/General Anesthesia permit holder.
2.Patient History and Evaluation as well as Pre-Operative Evaluation and Preparation are pursuant to the requirements of §§ 2.13.2(B)(1) and (2) of this Part.
3.Monitoring Equipment
a.Ventilation, oxygenation circulation and level of consciousness must be monitored continuously.
b.Continuous monitoring of oxygen saturation, heart rate, respiratory rate and end tidal carbon dioxide must be provided via the following monitors:
(1)Pulse oximeter
(2)Capnograph
(3)Continual monitoring (every 5-10 minutes) of blood pressure with size appropriate cuff is mandatory.
(4)Continuous monitoring with pulse oximetry, and capnography and continual intermediate monitoring of blood pressure with size appropriate cuff must be employed, unless precluded or invalidated by the nature of the patient, procedure or equipment, which should be specifically noted in the patient record.
c.Heart rate, respiratory rate, blood pressure, oxygen saturation, and expired carbon dioxide values should be recorded, at minimum every ten (10) minutes in a time-based record.
d.Continuous monitoring of heart rate and oxygen saturation must be maintained in the recovery area with presence of at least one trained individual. Vital signs should be recorded at specific intervals (every 10-15) minutes, until discharge criteria are met. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility.
e.In addition the equipment requirements noted in AAP and American Academy of Pediatric Dentistry guidelines, oxygen and suction equipment must be immediately available in the discharge area and operatory.
(1)Stethoscope or precordial stethoscope/amplified, audible pretracheal stethoscope.
(2)Electrocardiographic monitor (ECG) with a minimum of 3- leads.
(3)Defibrillator with size-appropriate patches/paddles for use in pediatric patients.
(4)A device capable of measuring body temperature.
4.Personnel
a.In addition to the dentist, at least one other person trained in PALS, and capable of providing advanced airway skills must be present in the operatory at all times. It is required that at least one of the practitioners present in the room be skilled at obtaining vascular access in children. The individual assigned for monitoring may be responsible for assisting with interruptible patient-related tasks of short duration, such as holding an instrument or troubleshooting equipment for the monitoring of appropriate physiologic parameters.
b.A third individual trained in BLS Basic Life Support for Providers must be present in the facility. This staff member should be immediately available in case of emergency or if the staff member-in-charge of monitoring is involved in the dental treatment rendered, beyond interruptible patient-related tasks of short duration.
5.Discharge
a.Oxygen and suction equipment must be immediately available immediately available in the discharge area and operatory.
b.The patient shall have continuous supervision until oxygenation, ventilation, and circulation are stable and the patient is appropriately responsive for discharge from the facility.
c.The dentist or clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation and. level of consciousness.
d.The Qualified Dentist or Qualified Provider shall determine and document that oxygenation, ventilation, and circulation are stable prior to discharge.
e.The dentist or his or her designee shall provide explanation and documentation of postoperative instructions to the patient and/or responsible adult at the time of discharge.
6.Emergency Management
a.The Qualified Dentist or Qualified Provider shall be responsible for the anesthetic management, and treatment of emergencies associated with the administration of anesthesia, including immediate access to pharmacological antagonists, if any, and appropriately sized equipment for establishing a patent airway and providing positive pressure ventilation with oxygen.
b.The Facility Host Permit holder is responsible for the adequacy of the facility.
2.13.3Facility Permit
A.Prior to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation in a dental office by a qualified dentist as described in § 2.11.2 of this Part and/or a Board certified or Board eligible anesthesiologist employed by or practicing in conjunction with a dentist, each office site shall obtain a facility permit to allow the administration of these anesthesia services on the premises.
1.A facility permit is issued for one office site, and is non-transferable.
a.Those dental office sites in which all anesthesia services are administered by a licensed dentist approved by the Board to administer anesthesia services as described in § 2.11.1(B) of this Part are exempt from the requirements of § 2.13.3 of this Part.
2.Application for a permit shall be made on forms provided by the Board. These forms shall be completed, notarized and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by:
a.The permit fee (non-refundable and non-returnable) as determined annually by the Director of Health in consultation with the Board, and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
b.Such other information as may be deemed necessary and as may be requested by the Board.
3.Upon receipt of an application for a facility permit as described above, the Board, with the advice of the advisory consultant(s), may issue a permit to an applicant found to meet all the prescribed requirements of this Part. Said permit unless sooner suspended or revoked will expire five (5) years from the date of issuance.
a.To renew such permit, the applicant will file with the Board a renewal application at least one (1) month before the date of expiration of the permit, duly executed together with the renewal fee as determined annually by the Director of Health in consultation with the Board, and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Upon receipt of such renewal application and payment of any fee, a renewal shall be issued effective for five (5) years from the date of renewal, unless sooner suspended or revoked.
b.Any applicant allowing this permit to lapse through accident, mistake or unforeseen cause by failing to renew the permit on or before the expiration date, may be reinstated upon filing an application with payment of the current renewal fee in accordance with § 2.13.3(A)(3) of this Part.
4.Those dental offices holding facility permits as described above may be subject to inspections as described in § 2.11.5 of this Part.
2.13.4Violations & Sanctions
A.Failure to comply with any of the provisions of § 2.11 of this Part shall be cause for denial, revocation or suspension of permit for the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, and of disciplinary action in accordance with § 2.15.1 of this Part.
B.Furthermore, all hearings and reviews pertaining to the requirements as set forth in this Part, will be subject to the provisions of § 2.15.2 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.14** Record Keeping and Disclosure {#sec-216-ricr-40-05-2-2.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.14}
2.14.1Availability of Dental Records
A.A licensed dentist and/or other licensee shall maintain a dental record for each patient which is adequate to enable the licensee and/or another licensee to provide proper diagnosis and treatment. The dentist shall maintain a patient's written dental record and radiographs (x-rays) for a minimum of five (5) years from the date of the last dental visit, in accordance with R.I. Gen. Laws § 23-3-26, entitled ”Vital Records." Records of minors shall be kept for at least five (5) years after such minor will have reached the age of eighteen (18) years. Records shall be maintained in a manner which permits the patient and/or successor dentist access to these records.
B.At a minimum, said records shall be legible and include:
1.The name, address and date of birth of the patient and, if a minor, the name of the parent or guardian and any disclosure statements, authorizations and/ or consent forms;
2.The patient’s medical history;
3.A record of results of a clinical examination, where appropriate, or an indication of the patient’s chief complaint;
4.A treatment plan, where appropriate;
5.The dates of each patient visit and a description of the treatment or services rendered at each visit;
6.A description of all radiographs taken and of diagnostic models made;
7.The date, dosage and amount of any medication or drug prescribed, dispensed or administered to the patient and Prescription Drug Monitoring Program query results, if appropriate; and,
8.A record of any recommendations or referrals for treatment or consultation by a specialist, including those which were refused by the patient.
C.Upon a patient's written request, a dentist shall provide a patient or another specifically authorized person with a complete copy of and a detailed summary of the patient's dental record, which includes all relevant data.
D.A dentist may charge a reasonable fee for the expense of providing a patient's dental record, not to exceed cost. The dentist shall not require prior payment of charges for dental services as a condition for providing a copy of the dental record.
E.Dentists shall maintain patient confidentiality in the storage and transfer of records pursuant to the provisions of R.I. Gen Laws § 5-37.3, ”Confidentiality of Health Care Information Act."
F.A dentist or other licensee treating the patient shall sign or initial the patient’s dental record after each procedure or visit.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.15** Violations and Sanctions {#sec-216-ricr-40-05-2-2.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.15}
2.15.1Denial, Revocation or Suspension of License/Violations and Sanctions
A.Any dentist, dental hygienist, public health dental hygienist, or DAANCE-certified maxillofacial surgery assistant may have his or her license revoked or suspended by the Board: if said person has been found guilty of unprofessional conduct, which will include, but not be limited to those items listed in R.I. Gen. Laws § 5-31.1-10 and as stated below:
1.Fraudulent or deceptive procuring or use of a license or limited registration;
2.All advertising of dental or dental hygiene business which is intended or has a tendency to deceive the public or a dentist advertising as a specialty in an area of dentistry unless the dentist:
a.Is a diplomate of or a fellow in a specialty board accredited or recognized by the American Dental Association; or
b.Has completed a post graduate program approved by the Commission on Dental Accreditation of the American Dental Association;
3.Conviction of a crime involving moral turpitude; conviction of a felony; conviction of a crime arising out of the practice of dentistry or of dental hygiene;
4.Abandonment of patient;
5.Dependence upon controlled substances, habitual drunkenness or rendering professional services to a patient while the dentist or dental hygienist, or limited registrant is intoxicated or incapacitated by the use of drugs;
6.Promotion by a dentist, dental hygienist, limited registrant or DAANCE-certified maxillofacial surgery assistant of the sale of drugs, devices, appliances, or goods or services provided for a patient in a manner as to exploit the patient for the financial gain of the dentist, dental hygienist, public health dental hygienist, or limited registrant DAANCE-certified maxillofacial surgery assistant;
7.Immoral conduct of a dentist, dental hygienist, limited registrant, DAANCE-certified maxillofacial surgery assistant in the practice of dentistry dental hygiene, public health dental hygiene, or DAANCE-certified maxillofacial surgery assisting;
8.Willfully making and filing false reports or records in the practice of dentistry or dental hygiene;
9.Willful omission to file or record, or willfully impeding or obstructing a filing or recording, or inducing another person to omit to file or record dental or other reports as required by law;
10.Failure to furnish details of a patient's dental record to succeeding dentists, or dental care facility upon proper request pursuant to the Act;
11.Solicitation of professional patronage by agents or persons or profiting from acts of those representing themselves to be agents of the licensed dentist, dental hygienist, public health dental hygienist, limited registrant, or DAANCE-certified maxillofacial surgery assistant;
12.Division of fees or agreeing to split or divide the fees received for professional services for any person for bringing to or referring a patient;
13.Agreeing with clinical or bioanalytical laboratories to accept payments from those laboratories for individual tests or test series for patients, or agreeing with dental laboratories to accept payment from those laboratories for work referred;
14.Willful misrepresentation in treatments;
15.Practicing dentistry with an unlicensed dentist or practicing dental hygiene with an unlicensed dental hygienist except in an accredited training program, or with a dental assistant in accordance with the rules and regulations of the Board or aiding or abetting those unlicensed persons in the practice of dentistry or dental hygiene;
16.Gross and willful overcharging for professional services; including filing of false statements for collection of fees for which services are not rendered or willfully making or assisting in making a false claim or deceptive claim or misrepresenting a material fact for use in determining rights to dental care or other benefits;
17.Offering, undertaking, or agreeing to cure or treat disease by a secret method, procedure, treatment, or medicine;
18.Professional or mental incompetence;
19.Incompetent, negligent, or willful misconduct in the practice of dentistry or dental hygiene, which includes the rendering of unnecessary dental services and any departure from or the failure to conform to the minimal standards of acceptable and prevailing dental or dental hygiene practice in his or her area of expertise as is determined by the Board. The Board need not establish actual injury to the patient in order to adjudge a dentist, dental hygienist, public health dental hygienist, limited registrant, or DAANCE-certified maxillofacial surgery assistant guilty of the previously named misconduct;
20.Failure to comply with the provisions of R.I. Gen. Laws Chapter 23-4.7;
21.Revocation, suspension, surrender, or limitation of privilege based on quality of care provided or any other disciplinary action against a license to practice dentistry or dental hygiene or DAANCE-certified maxillofacial surgery assisting in another state or jurisdiction, or revocation, suspension, surrender, or other disciplinary action as to membership on any dental staff or in any dental or professional association or society for conduct similar to acts or conduct which would constitute grounds for action as prescribed in the Act;
22.Any adverse judgment, settlement, or award arising from a dental liability claim related to acts or conduct similar to acts or conduct which would constitute grounds for action as defined in the Act or this Part;
23.Failure to furnish the Board, its dental administrator, investigator, or representatives, information legally requested by the Board;
24.Violation of any provision(s) of the Act or the rules and regulations of the Board or any rules and regulations promulgated by the Director or of an action, stipulation or agreement of the Board;
25.Cheating on or attempting to subvert the licensing examination;
26.Violating any state or federal law or regulation relating to controlled substances;
27.Failure to maintain standards established by peer review boards, including, but not limited to, standards related to proper utilization of services, and use of non-accepted procedure and/or quality of care;
28.Malpractice as defined in R.I. Gen. Laws § 5-37-1(8).
29.No person licensed to practice dentistry in the state of Rhode Island may permit a non-dentist who operates a dental facility in the form of a licensed out-patient health care center or management service organization to interfere with the professional judgment of the dentist in the practice.
30.Failure to follow current minimum infection control recommendations developed by the Centers for Disease Control and Prevention (CDC) published in the document entitled Guidelines for Infection Control in Dental Health-Care Settings and weekly spore testing.
B.Any disciplinary and/or criminal action shall be reported to the Board within twenty (20) days of adjudication
C.Furthermore, any violation pursuant to any provisions of the Act and this Part, may be cause for denial, revocation or suspension of license or for imposing such other penalties as prescribed in the Act.
2.15.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.16** Continuing Education Criteria {#sec-216-ricr-40-05-2-2.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.16}
2.16.1Criteria for continuing education credits developed by the Rhode Island Dental Association and approved by the Board
A.Introduction
1.Continuing education is reported biennially. The biennial accrual period for continuing education is July 1st.
2.Dentist licensees shall obtain a total of forty (40) continuing education credits every two years.
3.Dental hygienist and public health dental hygienist licensees shall obtain a total of twenty (20) continuing education credits every two years.
4.Certified maxillofacial surgery assistant licensees shall obtain a total of twenty (20) continuing education credits every two years.
B.Continuing Education Credit will be given only for the time the course was attended.
C.One (1) continuing education credit for each hour of attendance at lectures, seminars, institutes, meetings approved for credit by:
1.Accredited educational institutions.
2.Board recognized professional associations and societies. Accredited post-doctoral programs.
3.Federal, state, local governmental health agencies and health institutions.
4.Accredited community and teaching hospitals. Credit will be given only for the time the course was attended.
D.Two (2) continuing education credits for each hour of attendance at clinical or laboratory participating courses approved for credit by:
1.Accredited educational institutions.
2.Board recognized professional associations and societies (Accredited post-doctoral programs.
3.Federal, state, local governmental health agencies and health institutions.
4.Accredited community and teaching hospitals.
5.Responsibility of the Licensee. It is the responsibility of each licensee to maintain an authenticated record of all continuing education activities completed, and to submit documentation as evidence of completion of the above requirement, when requested.
2.16.2Categories of Credit
A.The following guidelines will assist the licensee in identifying acceptable courses of continuing education activity. The licensee is free to select areas of study from within the stated categories, keeping in mind the restriction of minimum/maximum number of hours allowed in each category.
1.Educational and Scientific Courses.
a.The following amounts of continuing education credits per biennial accrual period may be obtained in this category by licensee as follows:
(1)Dentists: forty (40) hours.
(2)Dental hygienists: twenty (20) hours.
(3)Certified maxillofacial surgery assistants: twenty (20) hours.
b.This category includes educational and scientific courses sponsored by or approved by any of the following:
(1)Accredited educational institutions.
(2)Board recognized professional associations and societies. Accredited post-doctoral programs.
(3)Federal, state, local governmental health agencies and health institutions.
(4)Accredited community and teaching hospitals.
2.Self-instructed Courses
a.Successful completion of a post-test is necessary to obtain credit for self-instructional courses.
b.The number of continuing education credits will be determined by sponsor.
c.The following amounts of continuing education credits per biennial accrual period may be obtained in this category by licensee as follows:
(1)Dentists: forty (40) hours.
(2)Dental hygienists: twenty (20) hours.
(3)Certified maxillofacial surgery assistants: twenty (20) hours.
d.This category includes home study courses, correspondence courses, educational television courses, audio, and video cassettes, and Internet (web-based) courses sponsored by or approved by any of the following:
(1)Accredited educational institutions.
(2)Board recognized professional associations and societies.
(3)Accredited post-doctoral programs.
(4)Federal, state, local government health agencies and health institutions.
(5)Accredited community and teaching hospitals.
3.Papers, Publications and Scientific Presentations. A maximum of twenty-eight (28) continuing education credits per biennial accrual period may be obtained in this category.
a.Eight (8) continuing education credits for authoring an original scientific paper published in a scientific professional journal.
b.Two (2) continuing education credits for each hour of a presentation (paper, essay or formal lecture) to a recognized group of health professionals.
4.Teaching and Research Appointments. A maximum of twelve (12) continuing education credits per biennial accrual period may be obtained in this category. Any dental professional involved in teaching or research activities may receive two (2) continuing education credits for each one (1) hour of documented teaching or research time per semester in an accredited dental or dental auxiliary educational program.
5.Table Clinics, Scientific and Product Exhibits. A maximum of six (6) continuing education credits per biennial accrual period may be obtained in this category.
a.Two (2) continuing education credit hours for each presenter in a table clinic.
b.One (1) continuing education credit hour for attendance at product exhibits. Examples of product exhibits include Yankee Dental Conference Exhibits.
6.Community Service. A maximum of six (6) continuing education credits per biennial accrual period may be obtained in this category. The number of continuing education credits will be approved in advance by:
a.Accredited educational institutions.
b.Board recognized professional associations and societies. Accredited post-doctoral programs.
c.Federal, state, local governmental health agencies and health institutions.
d.Accredited community and teaching hospitals.
7.Cardio-Pulmonary Resuscitation (CPR). A maximum of three (3) continuing education credits per biennial accrual period – one (1) continuing education credit for each hour of participation – may be obtained by completion of the CPR for Healthcare Providers course.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
##### **216-RICR-40-05-2 § 2.17** Protocols for the Placement of Temporary Restorations by a Public Health Dental Hygienist {#sec-216-ricr-40-05-2-2.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-2#2.17}
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-04 to 01/04/2022*
- *Technical Revision — effective from 2017-06-04 to 04/04/2019*
- *Technical Revision — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2017-06-04 to 06/04/2017*
- *Amendment — effective from 2012-12-10 to 06/04/2017*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 10/17/2011*
- *Amendment — effective from 2006-03-13 to 10/18/2007*
- *Amendment — effective from 2004-11-21 to 03/13/2006*
- *Periodic Refile — effective from 2002-01-02 to 11/21/2004*
#### **216-RICR-40-05-3** Licensing of Nurses and Standards for the Approval of Basic Nursing Education Programs
##### **216-RICR-40-05-3 § 3.1** Authority {#sec-216-ricr-40-05-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.1}
These regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws § 5-34-7(1), and are established for the purpose of defining prevailing standards for the licensure of advanced practice registered nurses, professional registered nurses, and practical nurses, and for the approval of basic nursing education programs in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.2** Definitions {#sec-216-ricr-40-05-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-34 entitled, "Nurses".
2.“Adjunct clinical faculty” means individuals employed solely to supervise clinical nursing experiences of students and meet all the qualifications in § 3.12(B)(4) of this Part.
3.“Advanced practice registered nurse” or “APRN” is the title given to an individual licensed to practice advanced practice registered nursing within one of the following roles: certified nurse practitioner (CNP), certified registered nurse anesthetist (CRNA) as defined in R.I. Gen. Laws Chapter 5-34.2, or certified clinical nurse specialist (CNS), and who functions in a population focus. An APRN may serve as a primary or acute care provider of record.
4."Advanced practice registered nursing" means an independent and expanded scope of nursing in a role and population focus approved by the Board that includes the registered nurse scope of practice and may include, but is not limited to, performing acts of advanced assessment, diagnosing, prescribing and ordering. Each APRN is accountable to patients, the nursing profession and the Board for complying with the requirements of the Act and the quality of advanced nursing care rendered; recognizing limits of knowledge and experience; planning for the management of situations beyond the APRN’s expertise; and for consulting with or referring patients to other health care providers as appropriate.
5."Approval" means the process whereby the Board evaluates and grants official recognition to basic nursing education programs in this state which meet the established criteria and standards of this Part.
6.“Approved basic professional nursing education program" means a course of study for professional nurses that has been approved the Board, by the licensing authority of another state or territory, or by a national accrediting body.
7."Approved nurse practitioner program" means a Board approved course of study for nurse practitioners conducted within an academic institution which is regionally accredited or accredited by such other agency as may be recognized by the Board. Said course shall include both a didactic component and a supervised clinical experience.
8."Basic nursing education program", hereafter referred to as nursing program, means an educational unit within a hospital, junior college, senior college or university, which has as its major goal the preparation of individuals to be responsible practitioners of nursing and to grant appropriate diploma or degree in nursing.
9."Board" means the Board of Nurse Registration and Nursing Education established pursuant to the provisions of R.I. Gen. Laws § 5-34-4.
10.“Certified clinical nurse specialist" is an Advanced Practice Registered Nurse who independently provides care to clients, facilitates attainment of health goals, and provides innovation in nursing practice, based on clinical expertise, evidence-based decision-making, and leadership skills. The clinical nurse specialist practices with individual clients and populations; nurses and other multidisciplinary team members; and organizations to effect system-wide changes to improve programs of care. The practice may include prescriptive privileges.
11."Certified registered nurse anesthetist” or “CRNA" means an Advanced Practice Registered Nurse as defined in R.I. Gen. Laws Chapter 5-34.2.
12."Certified nurse practitioner" means an Advanced Practice Registered Nurse utilizing independent knowledge of physical assessment, diagnosis and management of health care and illnesses. The practice includes prescriptive privileges. Certified nurse practitioners are members of the health care delivery system practicing in areas including, but not limited to, family practice, pediatrics, adult health care, geriatrics and women’s health care in primary, acute, long-term and critical care settings in health care facilities and the community. Certified nurse practitioners may be recognized as the primary care provider or acute care provider of record.
13.“Chief academic officer” means the individual who holds the earned degree in nursing that is required to lead the specific nursing education program, as stipulated in this Part, and is directly responsible for the activities and outcomes of that program. This individual may be titled within their specific institution as Chair, Dean, Director, etc., as determined by the policies and culture of their institution.
14.“Client” means the same as “patient” or “resident.”
15.“Collaboration” means an independent working relationship between an Advanced Practice Registered Nurse and other licensed health care professionals, including but not limited to, physicians, pharmacists, podiatrists, dentists and nurses, but does not require such relationship to be evidenced by a written collaboration agreement, to be with a specific designated physician, or for services to be performed at the same physical location as any collaborating licensed health care practitioner.
16.“Continuing education hour” means a unit of measurement that describes sixty (60) minutes of an organized learning activity that is either a didactic or clinical experience. This is also known as a “contact hour.”
17.“Continuing education unit” or “CEU” means a specific, standard measure [e.g., ten (10) clock hours] of educational achievement used by many universities and professional organizations under the criteria of the International Association for Continuing Education and Training (IACET) to attest to clock hour completion of continuing education activities.
18."Controlling institution" means the agency or institution that has authority and responsibility for financing the nursing education program employing the chief academic officer and faculty, graduating students and granting the diploma, certificate or degree.
19."Coordinated licensure information system" means an integrated process for collecting, storing, and sharing information on nurse licensure and enforcement activities related to nurse licensure laws, which is administered by a non-profit organization composed of and controlled by state nurse licensing boards.
20.“Delegatee” means the certified nursing assistant or other unlicensed assistive personnel receiving the authority to perform a nursing activity.
21."Delegation" means the transferring to a competent individual the authority to perform a selected nursing activity in a selected situation. The nurse retains the accountability for the delegation.
22."Dentist" means an individual licensed in the State of Rhode Island to practice dentistry pursuant to the provisions of R.I. Gen. Laws Chapter 5-31.1.
23."Department" means the Rhode Island Department of Health.
24."Director" means the Director of the Rhode Island Department of Health.
25."Health" means optimum well-being.
26."Healthcare" means those services provided to promote the optimum well-being of individuals.
27.“Independent practice” means an Advanced Practice Registered Nurse working without a formal collaborative agreement with a physician licensed in accordance with R.I. Gen. Laws Chapter 5-37.
28."Licensed" means status of qualified individuals who have completed a designated process by which the Board grants permission to individuals accountable and/or responsible for the practice of nursing to engage in that practice, prohibiting all others from legally doing so.
29.“Non-clinical nursing faculty” means faculty employed for their expertise in a specific subject matter that is included in the curriculum of an approved nursing program and meet all the qualification in § 3.12(B)(3) of this Part.
30."Non-disciplinary alternative program" means the voluntary, confidential non-disciplinary program for nurses who abuse or are chemically dependent upon drugs or alcohol or who have been diagnosed with any mental illness as listed in the most recent revised publication or the most updated volume of either the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association or the International Classification of Disease Manual (ICO) published by the World Health Organization and that substantially limits the life activities of the person with the illness.
31."Nursing" means the provision of services that are essential to the promotion, maintenance, and restoration of health throughout the continuum of life. It provides care and support of individuals and families during periods of wellness, illness, and injury and incorporates the appropriate medical healthcare plan of care as prescribed by a licensed Advanced Practice Registered Nurse, certified nurse midwife, licensed physician, dentist or podiatrist. It is a distinct component of health services. Nursing practice is based on specialized knowledge, judgment, and nursing skills acquired through educational preparation in nursing and in the biological, physical, social, and behavioral sciences.
32."Physician" means an individual licensed to practice medicine in the State of Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
33."Podiatrist" means an individual licensed in the State of Rhode Island to practice podiatry pursuant to the provisions of R.I. Gen. Laws Chapter 5-29.
34.“Population foci” means focus of the patient population. Population foci shall include: Family/Individual across the lifespan; Adult-gerontology; Neonatal; Pediatrics; Women’s health/gender-related; and Psychiatric/mental health.
35."Practical nursing", pursuant to R.I. Gen. Laws § 5-34-3(g), is practiced by licensed practical nurses (L.P.N.s). It is an integral part of nursing based on a knowledge and skill level commensurate with education. It includes promotion, maintenance, and restoration of health and utilizes standardized procedures leading to predictable outcomes which are in accord with the professional nurse regimen under the direction of a registered nurse. In situations where registered nurses are not employed, the licensed practical nurse functions under the direction of a duly licensed physician, dentist, podiatrist, or other licensed health care providers authorized by law to prescribe. Each L.P.N. is responsible for the nursing care rendered.
36."The practice of certified registered nurse anesthesia" means providing certain health care services in collaboration with anesthesiologists, licensed physicians or licensed dentists, in accordance with R.I. Gen. Laws § 5-31.1-1(16) and Chapter 5-34.2, which requires substantial specialized knowledge, judgment and skill related to the administration of anesthesia, including pre-operative and post-operative assessment of patients; administering anesthetics; monitoring patients during anesthesia; management of fluid in intravenous therapy and management of respiratory care.
37.“Preceptor” means an individual at or above the level of licensure that an assigned student is seeking who may serve as a teacher, mentor, role model and/or supervisor in a clinical setting under the supervision of an assigned faculty member.
38."Professional nurse" is synonymous with "registered nurse".
39."Professional nursing" is practiced by registered nurses (R.N.s). The practice of professional nursing is a dynamic process of assessment of an individual's health status, identification of health care needs, determination of health care goals with the individual and/or family participation and the development of a plan of nursing care to achieve these goals. Nursing actions, including teaching and counseling, are directed toward the promotion, maintenance, and restoration of health and evaluation of the individual's response to nursing actions and the medical regimen of care. The professional nurse provides care and support of individuals and families during periods of wellness and injury and incorporates where appropriate, the medical plan of care as prescribed by a duly licensed physician, dentist or podiatrist or other licensed health care provider licensed to prescribe. Each R.N. is directly accountable and responsible to the consumer for the nursing care rendered.
40."Psychiatric and mental health nurse clinical specialist" is a certified clinical nurse specialist working in the population foci of psychiatric/mental health as an Advanced Practice Registered Nurse utilizing independent knowledge in psychiatric mental health assessment, diagnosis, health promotion, psychotherapeutic modalities and management of mental health and illnesses. The practice may include prescriptive privileges within their scope of practice. The practice may also include consultation and education.
41."Regionally accredited" means the official guarantee that a college or university or other educational institution is in conformity with the standards of education prescribed by a regional accrediting commission recognized by the U.S. Commissioner of Education.
42."State" means a state, territory, or possession of the United States, the District of Columbia.
43.“Stable and predictable” means a condition in which a client’s clinical and behavioral status, as assessed by the registered nurse, is determined to be non-fluctuating and consistent, is not recuperative in nature, and does not require the regularly scheduled care of a registered or licensed practical nurse.
44."State approved program" means the official recognition of a basic nursing education program granted by a state body statutorily authorized to approve basic nursing education programs in the respective state in which the nursing program is conducted.
45."State approved program of practical nursing" means a course of study for practical nurses that has been approved the Board, by the licensing authority of another state or territory, or by a national accrediting body.
46.“Substantive change” means a significant modification or expansion in the nature and scope of education.
47."Supervision" means the provision of guidance by a professional or practical nurse for the accomplishment of a nursing activity with initial direction of the activity and periodic inspection of the actual act of accomplishing the activity. Total nursing care of an individual remains the responsibility and accountability of a licensed nurse.
48.“Unlicensed assistive personnel” means persons who are not registered, certified, or otherwise licensed by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.3** Licensing Requirements for Advanced Practice Registered Nurses, Professional (Registered), and Practical Nurses {#sec-216-ricr-40-05-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.3}
3.3.1Titles and Abbreviations and Criminal Records Review
A.Titles and Abbreviations. Pursuant to R.I. Gen. Laws § 5-34-2, it shall be unlawful for any person to practice or offer to practice nursing in the State of Rhode Island or to use any title, sign, abbreviation, card or device indicating authority to practice nursing unless such person has been duly licensed and registered in accordance with the statutory provisions of the Act and this Part, except persons exempt in accordance with R.I. Gen. Laws § 5-34-31.
1.Professional (Registered) Nurse Title. Any person who holds a license to practice as a professional nurse in this state shall have the right to use the title "registered nurse" and the abbreviation "R.N."
2.Advanced Practice Registered Nurse Title. Any person who holds a license or privilege to practice as an Advanced Practice Registered Nurse in the State of Rhode Island shall have the right to use the title “Advanced Practice Registered Nurse” and the roles of "certified registered nurse anesthetist," "certified clinical nurse specialist" and "certified nurse practitioner", and the abbreviations "APRN," "CRNA," "CNS" and "CNP" respectively. The abbreviation for the APRN designation of a certified registered nurse anesthetist, a certified clinical nurse specialist and for a certified nurse practitioner will be APRN, plus the role title (i.e., CRNA, CNS, and CNP).
3.Practical Nurse Title. Any person who holds a license to practice nursing as a practical nurse in the State of Rhode Island shall have the right to use the title "licensed practical nurse" and the abbreviation "L.P.N."
B.No other person shall assume such titles or use such abbreviations or any other words, letters, signs, figures or devices to indicate that the person using the same is an Advanced Practice Registered Nurse, licensed professional nurse or licensed practical nurse in accordance with this Part.
1.Misrepresentation of Credentials. A nurse licensed by the Board shall not misrepresent his or her credentials related to the practice of nursing including, but not limited to, those indicating education, type of nurse licensure, APRN authorization, or certification related to the practice of nursing.
C.Criminal Records Review. Pursuant to R.I. Gen. Laws § 5-34-43, each person seeking a license to practice under the Act, or who is previously licensed and authorized to practice under the Act and is seeking employment, shall apply to the Bureau of Criminal Identification (BCI) for a national criminal records check that shall include fingerprints submitted to the Federal Bureau of Investigation. This background check shall be processed prior to receiving a license to practice or to enter into employment. All applicable fees associated with the national criminal records check shall be paid by the applicant/licensee.
3.3.2Qualifications for Licensure
A.Professional (Registered) Nurse. An applicant seeking initial licensure to practice professional nursing in the State of Rhode Island must:
1.Be of good moral character;
2.Have completed at least an approved high school course of study or the equivalent supported by diploma or certificate thereof as determined by the rules and regulations of the State Board of Education; and
3.Have successfully completed the prescribed curriculum in a Board-approved basic professional nursing education program and holds a diploma from the program,
4.Foreign trained applicants must meet the requirements set forth in § 3.3.4(C) of this Part.
B.Advanced Practice Registered Nurse. An applicant seeking initial licensure to practice as an Advanced Practice Registered Nurse (APRN) in the State of Rhode Island shall:
1.Be of good moral character;
2.Hold a current Rhode Island license as a registered nurse or privilege to practice and shall not hold an encumbered license or privilege to practice as an RN in any state or territory;
3.Graduation from an APRN graduate or post-graduate program, as evidenced by official documentation received directly from an APRN program accredited by a nursing accrediting body that is recognized by the U.S. Secretary of Education and/or the Council for Higher Education Accreditation (CHEA), or its successor organization, as acceptable by the Board.
4.Be currently certified by a national certifying body recognized by the Board in the APRN role and population focus appropriate to educational preparation.
5.Report any criminal conviction, nolo contendere plea, Alford plea or other plea arrangement in lieu of conviction;
6.Have committed no acts or omissions that are grounds for disciplinary action as set forth in the Act and this Part; and
7.Provide other evidence as required by this Part.
8.All clinical nurse specialists seeking initial licensure as an APRN in the State of Rhode Island must meet all the criteria as stated in the Act and this Part including national certification in a role and population focus recognized by the Board.
9.Status of Current Licensees. Any person holding a license to practice nursing in the State of Rhode Island as a certified nurse practitioner, psychiatric clinical nurse specialist or certified registered nurse anesthetist, as defined in the Act, R.I. Gen. Laws Chapters 5-34 and 5-34.2, that was valid as of June 17, 2013 shall be deemed to be licensed as an APRN, with his or her current privileges and shall be eligible for renewal of such license as defined under the provisions of the Act and this Part.
C.Licensed Practical Nurse. An applicant seeking initial licensure to practice practical nursing in the State of Rhode Island must:
1.Be of good moral character;
2.Have completed at least an approved high school course of study or the equivalent supported by diploma or certificate thereof as determined by the rules and regulations of the State Board of Education;
3.Have furnished satisfactory proof that he or she successfully completed the prescribed curriculum in an approved program of practical nursing and holds a diploma or certificate from the program or is a graduate of an approved school of professional nursing or was a student in good standing at an approved school of professional nursing before completing the program of studies and, at the time of withdrawal, had completed a program of study, theory and clinical practice equivalent to that required for graduation from an approved school of practical nursing;
4.Foreign trained applicants must meet the requirements set forth in § 3.3.4(C)(2) of this Part.
3.3.3 Application for Licensure and Fee
A.Application for licensure to practice in the State of Rhode Island as a professional nurse, or practical nurse, shall be made on forms provided by the Department, which shall be completed, notarized and submitted to the Department. An applicant shall schedule his/her own examination date. Such application shall be accompanied by the following documents:
1.Official transcripts of education credentials sent directly to the Department and the Board from the school of nursing.
2.One (1) photograph of the applicant (head and shoulder view) approximately 2 X 3 inches in size, which is mounted on the application, and
3.The application fee (non-refundable) as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
4.Documentation of compliance with § 3.3.1(C) of this Part by:
a.Submitting a copy of the written notification from the BCI indicating that no disqualification information has been found; or
b.Requesting the BCI to provide the Department with a copy of the criminal background report.
B.Nurses registered in the State of Rhode Island who are seeking initial licensure to practice as an Advanced Practice Registered Nurse must submit appropriate certification credentials, as described in § 3.2 of this Part, plus an application fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.The fee for application for prescriptive privileges shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.Nurses not registered in Rhode Island who are seeking initial licensure to practice as an Advanced Practice Registered Nurse (APRN) in the State of Rhode Island shall:
a.Hold a current license or privilege to practice as an RN and APRN in a state or territory;
b.Not have an encumbered license or privilege to practice in any state or territory;
c.Graduation from an APRN graduate or post-graduate program, as evidenced by official documentation received directly from an APRN program accredited by a nursing accrediting body that is recognized by the U.S. Secretary of Education and/or the Council for Higher Education Accreditation (CHEA), or its successor organization, as acceptable by the Board.;
d.Be currently certified by a national certifying body recognized by the Board in the APRN role and at least one population focus appropriate to educational preparation. Primary source of verification of certification is required.
e.Report any conviction, nolo contendere plea, Alford plea or other plea arrangement in lieu of conviction;
f.Have committed no acts or omissions, which are grounds for disciplinary action in another jurisdiction;
g.Provide other evidence as required by the Department and Board in this Part; and
h.An application fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
(1)The fee for application for prescriptive privileges shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
3.3.4Licensing of Advanced Practice Registered Nurses, Professional and Practical Nurses
A.By Examination. Applicants, except those exempt pursuant to § 3.3.4(B) of this Part, shall be required to pass an examination as determined by the Board to test the qualifications of the applicants to practice nursing as a professional or practical nurse pursuant to the requirements of the Act and this Part.
1.The National Council Licensure Examination (NCLEX) or other recognized professional examination service may be used to test the applicant's competency, skill and knowledge to practice nursing.
2.All applications and supporting credentials as required in § 3.3.3 of this Part shall be filed with the Board and the Department.
3.Re-examination. In case of failure of any applicant to satisfactorily pass an examination such applicant shall be entitled to re-examination. Applicants may take the licensing examination as often as prescribed by the National Council Licensure Examination service. The fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) shall be resubmitted.
B.Without Examination by Endorsement. A license to practice nursing as a professional or practical nurse may be issued without examination to an applicant who provides evidence of being currently licensed by examination or endorsement as a professional nurse or practical nurse under the laws of another state or territory or District of Columbia, if in the opinion of the Board, the applicant meets the qualifications required of professional or practical nurses in the State of Rhode Island as set forth in this Part.
1.A completed licensure application form and fee shall be filed with the Department in accordance with § 3.3.3 of this Part, and such additional supporting documentation as may be requested, and furthermore:
a.The licensing agency in each state in which the applicant holds or has held a registration or license must submit to the Board a statement confirming the applicant to be or have been in good standing; and
C.Foreign Trained Applicants
1.Professional (Registered) Nurses. Applicants from foreign nursing schools seeking initial U.S. licensure in the State of Rhode Island shall present evidence of credentials evaluation by a Board approved agency that provides evaluation of foreign credentials, including the requirements of §§ 3.3.2(A) and 3.3.3 of this Part and, furthermore, shall meet all of the appropriate requirements for licensure to the satisfaction of the Board and in accordance with the statutory and regulatory provisions of this Part. Applicants who have graduated from foreign nursing schools who are actively licensed in good standing in another state or jurisdiction shall be required to:
a.Have their credentials evaluated by a Board approved agency that provides evaluation of foreign credentials;
b.Have successfully completed the NCLEX;
c.Have successfully completed a Board approved English language proficiency examination; and
d.Submit the required application and fees in accordance with § 3.3.3 of this Part.
2.Practical Nurses. Applicants from foreign schools of practical nursing must present to the Board the following documented evidence:
a.High school education credentials equivalent to those of the State of Rhode Island;
b.Official transcript from a government approved school of practical nursing that offered a general basic curriculum inclusive of the physical and biological sciences, social sciences and nursing, including concepts in medical, surgical, obstetrical, pediatric and psychiatric nursing;
c.Credentials evaluation of the educational program by a Board approved agency that provides evaluation of foreign credentials;
d.Successful completion of a Board approved English language proficiency examination;
e.Successful completion of the NCLEX; and
f.The applicant must furthermore submit the requirements of § 3.3.3 of this Part and must meet to the satisfaction of the Board, appropriate statutory and regulatory licensure requirements of this Part.
3.Advanced Practice Registered Nurse (APRN). An internationally educated applicant for initial licensure as an APRN in the State of Rhode Island shall:
a.Graduate from a graduate or post-graduate level APRN program equivalent to an APRN educational program in the U.S. accepted by the Board;
b.Submit documentation through an official transcript directly from the nursing education program and verified through a Board-approved qualified credentials evaluation process for the license being sought; and
c.Meet all other licensure criteria required of applicants educated in the U.S.
D.Advanced Practice Registered Nurses. A license to practice as an Advanced Practice Registered Nurse shall be issued if the applicant meets the qualifications for the Advanced Practice Registered Nurse (APRN).
E.The Board shall act on each application within ninety (90) days of its submission.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.4** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.4}
A.Upon the recommendation of the Board, the Director shall issue to applicants who have satisfactorily met the licensure requirements of this Part, a license to practice either as an Advanced Practice Registered Nurse, a professional nurse, or practical nurse, in the State of Rhode Island. Said license, unless sooner suspended or revoked, shall expire on the first (1st) day of March of every other year following the date of issuance of the original license.
B.On or before the first (1st) day of January of every year, the Department shall mail a notice for renewal of license to every person scheduled to be licensed that year on an odd/even basis with respect to the license number. Every Advanced Practice Registered Nurse, professional or practical nurse so licensed who wishes to renew his or her license shall file with the Department a renewal application duly executed together with a renewal fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) before the fifteenth (15th) day of February of that year.
1.Every Advanced Practice Registered Nurse so licensed who wishes to renew his or her license shall file with the Department such renewal application duly executed together with a renewal fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Evidence of current national certification, or recertification as applicable, as an Advanced Practice Registered Nurse shall be verified at renewal.
a.Notwithstanding the requirements of § 3.4(B)(1) of this Part, an individual holding a license to practice nursing in the State of Rhode Island as a nurse practitioner (no prescriptive privileges) that was valid as of June 17, 2013 may file with the Department such renewal application duly executed together with a renewal fee (non-refundable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) without providing evidence of current national certification, or recertification as applicable, as an Advanced Practice Registered Nurse.
C.Upon receipt of such renewal application and payment of said fee, the accuracy of the application shall be verified and the Department shall grant a renewal license effective the second (2nd) day of March, and expiring on the first (1st) day of March two (2) years later unless the license is sooner suspended or revoked.
D.Any person who allows his or her license to lapse by failing to renew it on or before the first (1st) day of March of the next two (2) years as provided above may be reinstated by the Department upon submission of an application and on payment of the current renewal fee, unless license has been suspended or revoked.
1.Any person using the title Advanced Practice Registered Nurse, professional nurse, or practical nurse, or who practices nursing during the time that his or her license has lapsed shall be subject to the penalties for violations of the provisions of the Act and this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.5** Continuing Education Requirements {#sec-216-ricr-40-05-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.5}
A.Every person seeking renewal of a license under the provisions of the Act and this Part, shall provide satisfactory evidence to the Department that in the preceding two years the practitioner (i.e., licensee) has completed the ten (10) required continuing education hours as established in this section.
1.One (1) continuing education hour shall be equivalent to one (1) contact hour. One continuing education unit shall be equivalent to ten (10) continuing education hours.
B.Continuing education hours related to nursing practice will be accepted by the Board for course work that has been presented, accepted or approved by the American Nurses Credentialing Center (ANCC) or its local chapter, other recognized professional nursing organizations, any department or school of nursing approved by a board of nursing, or such other professional, labor organization, or accrediting agency as may be approved by the Board.
C.At the time of license renewal, each licensee will be required to sign a statement attesting to the completion of the above continuing education requirements.
D.It shall be the sole responsibility of the individual practitioner to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
E.Failure to produce satisfactory documentation of completion of the requirements of this section, upon request by the Board, constitutes grounds for disciplinary action under the provisions of the Act.
F.The Department may extend for only one (1) six (6) month period the continuing education requirements if the Department is satisfied that the applicant has suffered hardship which prevented meeting the educational requirements of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.6** Transfer to Inactive List - Reinstatement {#sec-216-ricr-40-05-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.6}
A.Pursuant to R.I. Gen. Laws § 5-34-20, a nurse who does not intend to practice nursing during a two (2) year period, upon written request to the Department, may have his or her name transferred to an inactive list and shall not be required to pay the renewal fee for as long as the inactive status is maintained.
1.Should a nurse resume practice at some future time, he or she will so notify the Department, remit the renewal fee, sign a statement attesting to the completion of the above continuing education requirements for the period during which the license was inactive [i.e., five (5) hours per year] or a re-entry program approved by the Board, and upon approval of the Board, the license shall be reinstated in accordance with the provisions of § 3.4 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.7** Other Requirements for Advanced Practice Registered Nurses {#sec-216-ricr-40-05-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.7}
A.Prescriptive Authority – Advance Practice Registered Nurses
1.An Advanced Practice registered Nurse (APRN) licensed by the Board may prescribe, order, procure, administer, dispense and furnish over the counter, legend and controlled substances pursuant to applicable state and federal laws, when the APRN has completed an educational program as described in § 3.3.2(B) of this Part, that includes courses in pathophysiology, pharmacology and physical assessment and is within the APRN's role and population focus.
2.Prescribing, ordering, dispensing and furnishing shall include the authority to:
a.Diagnose, prescribe and institute therapy or referrals of patients to health care agencies, health care providers and community resources;
b.Prescribe, procure, administer, dispense and furnish pharmacological agents, including over the counter, legend and controlled substances; and
c.Plan and initiate a therapeutic regimen that includes ordering and prescribing non- pharmacological interventions, including, but not limited to, durable medical equipment, medical devices, nutrition, blood and blood products, and diagnostic and supportive services including, but not limited to, home health care, hospice, and physical and occupational therapy.
3.Prior to prescribing those drugs classified under R.I. Gen. Laws Chapter 21-28 as controlled substances, an Advanced Practice Registered Nurse shall be required to register for such privileges with the Board of Pharmacy, Rhode Island Department of Health, and the Registration Unit of the federal Drug Enforcement Administration.
B.Prescriptive Authority – APRN - Certified Nurse Practitioner. Prescriptive privileges for a certified nurse practitioner shall include all the authority under the APRN license including prescription of legend medications and prescription of controlled substances from schedules II, Ill, IV and V that are established in regulation.
C.Prescriptive Authority – APRN - Certified Registered Nurse Anesthetist
1.Prescriptive privileges for a certified registered nurse anesthetist may be granted in accordance with the provisions of R.I. Gen. Laws Chapter 5-34.2.
2.Certified registered nurse anesthetists shall practice in accordance with the current American Association of Nurse Anesthetists Guidelines for Nurse Anesthesia Practice, if the nurse anesthetists guidelines for nurse anesthesia practice neither violate nor contradict this Part or the provisions of R.I. Gen. Laws Chapter 5-34.2.
D.Prescriptive Authority – APRN - Certified Clinical Nurse Specialist
1.Prescriptive privileges for a certified clinical nurse specialist shall include:
a.Diagnosing, prescribing and instituting therapy or referrals of patients to health care agencies, health care providers and community resources; and
b.Planning and initiating a therapeutic regimen that includes ordering and prescribing non-pharmacological interventions, including, but not limited to, durable medical equipment, medical devices, nutrition, blood and blood products, and diagnostic and supportive services including, but not limited to, home health care, hospice, and physical and occupational therapy; and
c.Prescription of over the counter medications within their population focus.
2.Prescriptive privileges for APRNs with the population focus of psychiatric/mental health:
a.Shall include prescription of certain psychotropic and certain legend medications, controlled substances from Schedule II classified as stimulants, and controlled substances from Schedule III and IV that are allowed pursuant to applicable Rhode Island and federal laws and regulations, and are within their population focus;
b.Shall not include controlled substances from Schedules I, II, and V and those certain legend medications not included in § 3.7(D)(2)(a) of this Part.
3.Each setting where such prescriptive privileges are allowed may further restrict prescriptive practices according to their own protocols.
E.Advanced Practice Nurse Advisory Committee shall be consistent with the provisions of R.I. Gen. Laws § 5-34-40.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.8** Standards of Nursing Practice Delegation {#sec-216-ricr-40-05-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.8}
A.Nurses may delegate to nursing assistants who are registered or licensed with the Department.
1.In addition, nurses may delegate nursing activities that are consistent with the level of knowledge, skills, training, experience, and cultural awareness of the unlicensed assistive personnel when the client’s health status is stable and predictable, as defined in this Part.
B.Delegation of nursing activities shall comply with the following requirements:
1.The licensed professional nurse shall make an assessment of the patient's nursing care needs prior to delegating the nursing activity. A licensed LPN, acting within the scope of his/her practice, as defined in § 3.2(A)(35) of this Part, may delegate to licensed nursing assistants and to unlicensed assistive personnel when the registered nurse’s assessment allows such delegation to occur.
2.The nursing activity shall be one that a reasonable and prudent nurse, utilizing sound nursing judgment, would determine to be appropriate for delegation.
3.The licensed nurse delegating the nursing activity shall be accountable for the quality of nursing care given to the patient through the process of delegation.
C.Criteria for determining nursing activities that may be delegated shall include the following:
1.Knowledge and skills of the delegatee;
2.Verification of the clinical competence of the delegatee as determined by the organization providing the health care services;
3.Stability of the client’s condition such that it involves predictability, absence of risk complication, and rate of change;
4.The variables in each service setting that include, but are not limited to, the following:
a.Accessible resources and established policies, procedures, practices, and channels of communication that lend support to the type of nursing activities being delegated;
b.Complexity and frequency of care needed by a given client population;
c.Number and qualifications of other staff present;
d.Accessibility of the licensed nurse.
5.Nursing activities that inherently involve ongoing assessment, interpretation or decision- making that cannot be logically separated from the procedure(s) shall not be delegated.
6.Nursing activities for which the delegatee has not demonstrated competence shall not be delegated.
D.Supervision
1.A licensed nurse shall provide the necessary supervision, as defined in § 3.2(A)(5) of this Part, of delegated nursing activities.
E.Pain Assessment
1.All health care providers licensed by the State of Rhode Island to provide health care services and all health care facilities licensed under R.I. Gen. Laws Chapter 23-17 shall assess patient pain in accordance with the requirements of the Pain Assessment rules and regulations (Part 20-15-2 of this Title).
F.Signature
1.On all documentation requiring a nurse's signature, the nurse shall sign his or her name as it appears on his or her license, followed by licensure status (LPN, RN, APRN). If APRN, followed by licensed role (CNP, CRNA, or CNS).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.9** Grounds for Denial, Revocation or Suspension of License {#sec-216-ricr-40-05-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.9}
A.The Board shall have the power to deny, revoke, or suspend any license or otherwise to discipline any person licensed upon proof that the person committed any of the actions stated in R.I. Gen. Laws §§ 5-34-24, 5-34-40(c)(2)(i)(A) through (H), and 5-34.2-4(c).
B.All hearings and reviews as may be required by this Part shall be conducted in accordance with the provisions of § 3.14.1 of this Part.
C.Required Notification to the Board:
1.An individual licensed as an Advanced Practice Registered Nurse pursuant to this Part shall notify the Board, in writing, within five (5) business days of receiving notification from a national certification board that any national certification required pursuant to § 3.2 of this Part has been revoked and/or subject to any restriction, limitation or other sanction.
2.An individual licensed as an Advanced Practice Registered Nurse pursuant to this Part shall notify the Board, in writing, within five (5) business days of failure to renew or other lapse of any national certification required pursuant to § 3.3.2(B) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.10** Non-disciplinary Alternative Program {#sec-216-ricr-40-05-3-3.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.10}
A.The Board may provide for a non-disciplinary alternative in situations involving alcohol and drug abuse; or any mental illness as listed in the most recent revised publication or the most updated volume of either the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association or the International Classification of Disease Manual (ICO) published by the World Health Organization and that substantially limits the life activities of the person with the illness; provided, that the nurse agrees to voluntarily participate in a program of treatment and rehabilitation.
B.Requirements for Participation in the Non-disciplinary Alternative Program
1.Participation in the non-disciplinary program is voluntary. A nurse participating in the program shall:
a.Agree in writing to comply with terms of the contract;
b.Be responsible for all costs for assessment, treatment, and monitoring;
c.Agree to evaluations, including random body fluid testing, necessary to determine treatment and monitoring needs;
d.Agree to a role in the treatment program as determined by the health care provider(s) approved by the Board.
2.Information related to the non-disciplinary program shall be provided to the nurse's employer to ensure adequate worksite monitoring and compliance.
C.Disqualification Criteria from the Non-disciplinary Program
1.Criteria which shall disqualify a nurse from participating in a non-disciplinary program include the following:
a.Has been previously enrolled and terminated for non-compliance in a non-disciplinary program in the State of Rhode Island or other jurisdiction;
b.Has a chemical dependency problem or diagnosis of mental illness of such severity that it could represent a clear and present danger to patient health and safety or has had nursing practice problems resulting in the death of a patient or involving significant harm or potentially significant harm to a patient;
c.Has had previous formal disciplinary action (related to his/her chemical dependency or mental illness) taken by a nursing board against her/him;
d.Has been convicted of any crime related to a controlled substance or legend prescription drug.
D.Causes for Termination from the Non-disciplinary Program
1.A nurse participating in the program may be terminated for any of the following reasons:
a.Noncompliance with any aspect of the contract;
b.Receipt of information by the Board, which after investigation, results in disciplinary action by the Board.
c.Engaged in any act that would have been cause to have initially disqualified the nurse applicant from participation in the program.
2.If the nurse does not agree to voluntarily participate in a treatment program protocol, or fails to satisfactorily complete a treatment program, the Board may initiate disciplinary proceedings.
E.Confidentiality
1.All records pertaining to a nurse's participation in the non-disciplinary program are confidential and not subject to discovery, subpoena or public disclosure.
2.A nurse’s record shall be maintained in confidence as required by federal and state laws and regulations, and in particular, in accord with section 408 of Public Law 92-55 (the Drug Abuse Prevention, Treatment and Rehabilitation Act, 21 U.S.C. § 1175), as amended, and the regulations contained in 42 C.F.R. Part 2.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.11** Standards Pertaining to Basic Nursing Education Programs {#sec-216-ricr-40-05-3-3.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.11}
3.11.1Approval Criteria
A.Any school, college, university or institution or such other facility, including proprietary institutions and/or entities, in the State of Rhode Island conducting or operating a basic nursing education program for the purpose of preparing individuals to be responsible practitioners of nursing and of granting appropriate diplomas or degrees in nursing (professional or practical nursing) is required to have been duly authorized to grant such degree or diploma by the appropriate state education body and/or authority pursuant to R.I. Gen. Laws §§ 16-40-1 and 16-40-2, and is required furthermore to receive approval from the Board. Such approval may be granted if the nursing program meets the statutory and regulatory requirements and standards of this Part. Approval shall consist of:
1."Initial approval" which is the official recognition granted by the Board to a new program upon application by the controlling institution after survey and evaluation by the Board to determine that the institution is reasonably ready to admit students based on the provisions of § 3.11.1(A) of this Part; or
2."Approved program" which is the official recognition of approval as defined in § 3.2(A)(5) of this Part, granted by the Board to the basic nursing education program in Rhode Island which is in compliance with the statutory and regulatory provisions of § 3.12 of this Part.
3.11.2Application for and Issuance of Approval
A.Initial Approval. An institution desiring to conduct an educational program for the preparation of individuals for examination and licensure to practice nursing (professional or practical nursing), shall apply to the Board and submit at least eighteen (18) months prior to the date it expects to admit the first student, a completed application. The proposed program shall provide, at a minimum, the following information to the Board:
1.General information about the controlling institution as specified in the application, including organizational and administrative relationships of the controlling institution and the program;
2.Governing institution approval and support;
3.Results of a needs assessment, including identification of potential students and employment opportunities for program graduates;
4.Type of educational program proposed;
5.Identification of sufficient financial and other resources;
6.Evidence of community readiness to accept and support the program in appropriate ways;
7.Clinical opportunities and availability of resources, including sources and locations of classrooms, clinical laboratory, conference rooms and other resources;
8.The philosophy, purposes and accreditation status of the controlling institution and the major facilities to be used for clinical laboratory experience;
9.Availability of qualified faculty;
10.A proposed time line for initiating and expanding the program, covering a period of at least eighteen (18) months; and
11.Any other evidence as deemed necessary and as may be requested by the Board.
B.When an institution has submitted evidence to the Board that it is prepared to meet the prescribed requirements and the preliminary procedures have been completed to the satisfaction of the Board, authorization shall be granted by the Board to the institution to initiate the basic nursing education program.
C.At least six (6) months prior to the date of admission of students, a report on the proposed education program shall be submitted to the Board by the nurse director which verifies that the following program components and processes have been completed:
1.Employment of a chief academic officer and faculty to develop program.
2.Overview of total curriculum:
a.Content;
b.Schedule (course sequence);
c.Course descriptions and objectives;
d.Contracts for clinical sites;
e.Program evaluation plan;
f.Consultation with the Board; and
g.Course syllabi for first year with identified timeline for submission of syllabi for next years.
3.Establishment of student policies for admission, progression, retention and graduation.
4.RN programs preparing students at the diploma and/or associate degree levels shall also submit evidence of an articulation agreement with a State of Rhode Island-approved Baccalaureate nursing degree-conferring program.
D.A site visit and an evaluation to validate compliance with §§ 3.11.1(A) and 3.12 of this Part of the new nursing program shall be made by the state director of nursing education and/or other authorized representative of the Board, who shall submit written reports of findings to the Board for their evaluation of the nursing program. This site visit may also include an authorized representative of the Rhode Island Board of Governors for Higher Education.
E.If, in the opinion of the Board, the nursing program is found to meet the criteria of this Part, the Board shall grant an initial approval. Such approval shall extend from the date of Board action which precedes admission of the first students, and shall terminate on graduation of the first students. The Board may request periodic reports from the new program regarding initial program operations before granting official state approval.
F.Approved Program. Upon expiration of the initial approval, the Board may grant official state approval, if the program is found to meet the prescribed standards of § 3.12 of this Part. Such approval shall be based on data obtained from site visits conducted by the state director of nursing education and/or other authorized representative(s) of the Board and submission of program’s ongoing evaluation plan and data.
G.Evaluation of Approved Programs
1.No later than January 31st of each year, an approved nursing program shall submit an annual report for the prior academic year to the Board which addresses, as a minimum, the criteria established by § 3.11.2(G)(2) of this Part. The Board may require an approved nursing program to submit additional information to determine compliance with the standards of this Part.
2.It shall be the duty of the Board through the state director of nursing education and/or other authorized representative(s) of the Board to conduct periodically, as may be deemed necessary, an evaluation of all basic nursing education programs in this state to validate continued compliance with the standards of this Part. Written reports shall be submitted to the Board for its determination of compliance with the standards of this Part. The Board shall also monitor and analyze various sources of information regarding program performance, including, but not limited to:
a.Annual reports from accrediting bodies
b.Accreditation site visit recommendations
c.Substantive change reports submitted to accreditation bodies
d.Credentials of faculty including adjunct clinical faculty who are a matriculating graduate student in a graduate nursing education program.
e.For programs preparing students at the diploma and/or associate degree levels, a current articulation agreement with a State of Rhode Island approved nursing education program authorized to confer a baccalaureate degree with a major in nursing.
3.If the National Council Licensure Examination (NCLEX) score of program graduates who are submitting to said examination for the first time, falls below the eighty percent (80%) pass rate for this population, for a period from January 1st through December 31st of the following year, the Board will notify the program, requesting a proposal for analyzing the problem. Such proposal shall be submitted within ninety (90) days of the request. A plan of correction is to be submitted within nine months of the submission of the proposal.
a.If the program fails to respond to the request from the Board, or if the plan of correction is found to be deficient, a hearing would be held in accordance with this Part.
b.If the NCLEX results continue to fall below the eighty percent (80%) passing standard, the program representatives may be invited to meet with members of the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.12** Standards for Approved Programs {#sec-216-ricr-40-05-3-3.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.12}
A.Organization and Administration. The basic nursing education program shall be an organized sequence of study within or with an affiliated regionally accredited college or university or other similar controlling institution, authorized to confer credentials in nursing. A practical nursing educational program shall only be conducted as a post-secondary educational program. The nursing program shall:
1.Have written statements of purpose, philosophy and objectives, which are consistent with those of the sponsoring institution;
2.Be organized with clearly defined authorities and responsibilities and shall have a chart showing the relationships and channels of communication of the program to the Board, the other departments in the controlling institution, to other cooperating agencies and institutions, and within the program;
3.Include clinical experiences in the episodic and distributive areas of nursing practice in health care facilities providing the specialized clinical nursing service(s). Mutual agreements with cooperating agencies and/or institutions or facilities shall be developed which demonstrate active participation in the central clinical placement registry; and
4.Establish written policies and procedures pertaining to the nursing program which shall include provisions for the involvement of faculty members in the development of policies and procedures regarding planning, implementing and evaluating the curriculum.
5.An approved program shall be required to obtain and maintain accreditation of the nursing program by a national nursing accrediting body acceptable to the Board.
B.Faculty. The nursing program shall be staffed with a sufficient number of qualified faculty to meet the purposes and objectives of the nursing education program. The qualifications of the staff shall be commensurate with their respective functions and responsibilities.
1.Registered nurse educational programs
a.Registered nurse educational programs shall have a chief academic officer who meets the following qualifications:
(1)A current, active, unencumbered RN license or privilege to practice issued pursuant to the Act and this Part;
(2)A doctoral degree in nursing; or a master’s degree in nursing and a doctoral degree in a related field. Notwithstanding this requirement, a chief academic officer hired prior to January 1, 2010 shall only be required to hold at least a master's degree in nursing;
(3)Educational preparation or experience in teaching and learning principles for adult education, including curriculum development and administration; and
(4)A current knowledge of registered nursing practice.
b.All other nurse faculty members shall have:
(1)A current, active, unencumbered RN license or privilege to practice issued pursuant to the Act and this Part;
(2)A minimum of a master’s degree with a major in nursing or a nursing doctorate degree. Notwithstanding this requirement, a faculty member hired prior to April 1, 1985 shall only be required to hold at least a master's degree in a field related to nursing;
(3)Relevant clinical experience; and
(4)Current knowledge of RN nursing practice.
2.Practical nursing education programs
a.Practical nursing education programs shall have a chief academic officer who meets the following qualifications:
(1)A current, active, unencumbered RN license or privilege to practice issued pursuant to the Act and this Part;
(2)A minimum of a baccalaureate degree in nursing and masters in nursing; or a nursing doctorate degree;
(3)Educational preparation or experience in teaching and learning principles for adult education, including curriculum development and administration; and
(4)A current knowledge of nursing practice at the practical/vocational level.
b.All other nursing faculty members shall have:
(1)A current, active, unencumbered RN license or privilege to practice issued pursuant to the Act and this Part;
(2)A minimum of a master’s degree with a major in nursing. Notwithstanding this requirement, a faculty member hired prior to April 1, 1985 shall only be required to hold at least a master's degree in a field related to nursing;
(3)Relevant clinical experience; and
(4)Current knowledge of LPN nursing practice.
3.Faculty who teach non-clinical nursing course shall have graduate academic and professional preparation and experience in their respective field in accordance with the policies of the controlling institution.
4.Adjunct clinical faculty employed solely to supervise clinical nursing experiences of students shall:
a.Meet all the faculty qualifications for the program level, as defined by this Part, they are teaching.
b.Possess a current, active, unencumbered RN license or privilege to practice issued pursuant to the Act and this Part.
c.In an emergent situation, the Chief Academic Officer of a nursing program may request a waiver from the Board to hire a specific person to fill a specific position for a specified period of time.
5.Preceptors. Clinical preceptors shall possess a current, active, unencumbered RN license or privilege to practice issued pursuant to the Act and this Part, have demonstrated competencies related to the area of assigned clinical teaching responsibilities and will serve as a role model and educator to the student.
a.Clinical preceptors may be used to enhance faculty-directed clinical learning experiences.
b.Clinical preceptors shall be licensed as a nurse at or above the level for which the student is preparing.
6.Faculty members shall be recruited, appointed and promoted on the basis of academic and professional qualifications and demonstrated professional competence in accordance with established policies consistent with those of the controlling institution and hold such licensure or certification as may be required by law.
7.Faculty shall be responsible for:
a.Developing, implementing and evaluating curriculum;
b.Developing standards for admission, promotion and graduation of students;
c.Participating in academic guidance and counseling;
d.Participating in professional and community activities; and
e.Such other as may be deemed appropriate.
8.Written policies pertaining to faculty rights and responsibilities which are consistent with the policies of the controlling institution shall be established and shall include provisions pertaining to:
a.Freedom of inquiry and opinion;
b.Criteria for evaluation of faculty performance;
c.Grievance procedure; and
d.Rank and status comparable to that afforded other faculty members of the controlling institution.
C.Students. Each nursing program shall provide directly to students, on an annual basis, written policies pertaining to no less than the following:
1.Admission, readmission, progression, retention, dismissal and graduation requirements which are consistent with policies of the controlling institution and the requirements of this Part;
2.Health and welfare, counseling and guidance, financial aid and housing (if any);
3.Participation in the development and evaluation of some aspects of the nursing program;
4.Availability of clinical facilities and services to the nursing program;
5.Student rights; and
6.Conditions of access to student records.
D.Resources, Facilities and Services. Each nursing program shall have adequate resources, facilities and services, consonant with the philosophy, purposes, objectives and policies of the nursing program and its controlling institution. Such resources, facilities and services shall include no less than:
1.Classroom, offices, conference rooms, laboratory and library facilities, accessible to and adequate for the number of students, faculty and other personnel;
2.Sufficient instructional materials to meet the needs of students, faculty and staff;
3.Furnishings of appropriate size and numbers as may be required for the varied instructional programs and for the number of students and staff;
4.An adequate number of agency and service resources to provide the kinds of student learning experiences as required to meet curriculum objectives; and
5.Adequate financial support to implement and operate the nursing program.
E.Curriculum. The curriculum of the nursing program shall be developed, organized, implemented and evaluated by the faculty. The framework of the curriculum shall be within the philosophy, purposes, and objectives of the program, as well as the policies of the controlling institution, and shall be consistent with the laws and regulations governing the practice of nursing. Furthermore, such curriculum shall be revised as may be necessary to maintain a program which reflects the developments in health care and its delivery, and to ensure that students are adequately prepared to meet the professional and legal expectations of a licensed professional (registered) or practical nurse.
1.Organization of the Curriculum
a.The selection and organization of the learning experience shall consist of an organized sequence of theory and clinical practice;
b.Theory and clinical experience shall be provided concurrently where appropriate;
c.Course outlines shall be kept current and available;
d.The organization of courses as model program design shall be in accordance with acceptable and recognized standards for baccalaureate degree, diploma and associate degree programs in nursing, and practical nursing programs shall be no less than forty (40) week academic programs.
2.Curriculum Content. Nursing education programs shall enable the student to develop the nursing knowledge, skills and competencies necessary for the level, scope and standards of nursing practice consistent with the level of licensure. Professional courses should build on a foundation of general education so that graduates are prepared to provide safe and effective nursing care to a diverse population.
a.The general education shall include content in English communication and interpersonal relations; humanities; cross-cultural competence; mathematics and quantitative reasoning; natural sciences and their relationship to each other; and social sciences that emphasize the study of human behavior.
b.The nursing specific content should be consistent with the current standards for national accreditation. This would include:
(1)Didactic content and supervised clinical experience in the prevention and treatment of illness and the promotion, restoration and maintenance of health in patients across the life span and in a variety of clinical settings;
(2)Experiences that promote the development of sound clinical judgment for optimal care, including the integration of research and evidence-based practice, the honoring of patient values, and the meeting ethical /legal standards;
(3)Opportunities to develop leadership and management skills, and professional socialization consistent with the level of licensure. This includes working in interdisciplinary teams, and delegation to/supervision of other health care providers;
(4)Using informatics to communicate, manage knowledge, mitigate error, and support decision making; and
(5)Participating in quality improvement processes to measure client outcomes, identify hazards and errors, and develop changes in processes of client care.
3.Evaluation of Curriculum. A systematic plan for on-going evaluation of the curriculum shall be established which includes evaluation provisions pertaining to no less than:
a.The implementation of the curriculum design;
b.The congruency of the curriculum with needs of society and developments in health care and its delivery; and
c.Revisions and/or modifications of curriculum as may be necessary based on evaluation data.
F.Innovative Approaches in Nursing Clinical Skills Education. Nursing programs are encouraged to explore and integrate effective ways to provide quality nursing education that develops the clinical skills of students so that graduates are adequately prepared to practice safely, competently, and ethically within the scope of practice as defined in the Act and this Part.
1.Purposes
a.To foster innovative models of nursing clinical education in approved nursing education programs so that preparation of nurses is reflective of the changing expectations of nurses in health care.
b.To assure that innovative approaches are conducted in a manner consistent with the Board’s role of protecting the public.
c.To keep the Board informed of innovative approaches in nursing education and explicate how the selected approaches conform to the quality outcome standards of core education criteria outline in § 3.12(E) of this Part.
2.Eligibility
a.The nursing education program shall hold official state approval without conditions.
b.There are no substantiated complaints in the last two (2) years.
c.There are no rule violations in the past (2) years.
3.Notification.
a.Substantive changes in clinical education will be described to the Board within the annual report. The information will include:
(1)A brief description of the innovation, including educational objectives;
(2)Rationale with available evidence supporting this approach;
(3)An explanation as to why it is desirable to implement this change;
(4)Identification of any possible risk to the public;
(5)Identification of where in the curriculum this innovation will be implemented.
(6)Expected impact on the preparation of the students;
(7)Plan for implementation, including timetable; and
(8)Evaluation plan to determine effectiveness.
b.At any time if an eligible school wishes to inform or work with the Board in developing an innovative approach time will be provided during the meeting of the Board or with the Education Sub-Committee of the Board.
4.Board Intervention
a.The Board may require the program to make modifications if the Board receives substantiated evidence indicating adverse impact on either the public or the students.
b.The nursing program shall provide documentation of corrective measures and their effectiveness.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.13** Denial or Revocation of Approval {#sec-216-ricr-40-05-3-3.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.13}
A.If the Board determines that a state-approved nursing program is not maintaining the standards prescribed by this Part, written notice of such deficiency shall be communicated by the Board to the nursing education program chief academic officer. When failure to correct the noted deficiency(ies) to the satisfaction of the Board within a reasonable period of time as recommended by the Board occurs, the Board shall notify the controlling institution of a proposed pending action to deny or revoke approval of the program and the controlling institution shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of § 3.14.1 of this Part.
B.Conditional Approval of Nursing Education Programs
1.If the Board determines that an approved nursing education program is not meeting the criteria set forth in this Part, the governing academic institution shall be given a reasonable period of time to submit an action plan and to correct the identified program deficiencies.
2.The Board may grant conditional approval when it determines that a program is not fully meeting approval standards.
C.Reinstatement of Approval. The Board may reinstate approval if the program submits evidence of compliance with nursing education standards within the specified time frame.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
##### **216-RICR-40-05-3 § 3.14** Violations and Sanctions/Practices and Procedures {#sec-216-ricr-40-05-3-3.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-3#3.14}
3.14.1Violations and Sanctions
Any violations of the provisions of the Act and this Part, shall be cause for the Board to impose such sanctions as denial, revocation or suspension of an individual's license or imposing such other disciplinary action, and the Board may deny, revoke or suspend state approval of a basic nursing education program which fails to comply with the standards of this Part. Furthermore, pursuant to R.I. Gen. Laws § 5-34-29, any violations of the provisions of the Act shall be subject to the penalties of that section.
3.14.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act shall be held in accordance with established Board policies and the rules and regulations pertaining to Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2014-10-23 to 08/21/2018*
- *Amendment — effective from 2012-12-10 to 10/23/2014*
- *Amendment — effective from 2012-02-19 to 12/10/2012*
- *Amendment — effective from 2008-04-16 to 02/19/2012*
- *Amendment — effective from 2007-10-18 to 04/16/2008*
- *Amendment — effective from 2007-07-08 to 10/18/2007*
- *Amendment — effective from 2005-01-06 to 07/08/2007*
- *Amendment — effective from 2004-07-05 to 01/06/2005*
- *Periodic Refile — effective from 2002-01-02 to 07/05/2004*
#### **216-RICR-40-05-4** Barbers, Hairdressers/Cosmeticians, Manicurists, Estheticians, and Instructors
##### **216-RICR-40-05-4 § 4.1** Authority {#sec-216-ricr-40-05-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.1}
This Part is promulgated pursuant to the authority conferred by R.I. Gen. Laws § 5-10-2(a)(4), for the purpose of establishing prevailing standards for the licensing of barbers, hairdressers/cosmeticians, manicurists, estheticians, and instructors for these professions.
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.2** Incorporated Materials {#sec-216-ricr-40-05-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.2}
This Part hereby adopt and incorporate 29 C.F.R. § 1910.1000 “Air Contaminants” (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.3** Definitions {#sec-216-ricr-40-05-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.3}
A.The following words, when used in these Rules and Regulations, shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 5-10, entitled “Barbers, Hairdressers, Cosmeticians, Manicurists and Estheticians.”
2."Apprentice barber" means an employee whose principal occupation is service with a barber who has held a current license as a barber for at least three (3) years with a view to learning the “practice of barbering,” as defined in § 4.3(A)(15) of this Part.
3."Barber" means any person who shaves or trims the beard, waves, dresses, singes, shampoos or dyes the hair or applies hair tonics, cosmetic preparations, antiseptics, powders, oil clays, or lotions to scalp, face or neck of any person; or cuts the hair of any person, gives facial and scalp massages or treatments with oils, creams, lotions, or other preparations.
4."Board" means the state Board of Barbering and Hairdressing as provided for in the Act.
5."Department" means the Rhode Island Department of Health.
6."Esthetician" means a person who engages in the practice of esthetics, and is licensed as an esthetician.
7."Esthetician shop" means a shop licensed under the Act and this Part to do esthetics on any person.
8."Esthetics" means the practice of cleaning, stimulating, manipulating and beautifying skin, including but not limited to the treatment of such skin problems as dehydration, temporary capillary dilation, excessive oiliness and clogged pores.
9."Hair design shop" means a shop licensed under the Act and this Part to do barbering or hairdressing/cosmetic therapy, or both, to any person.
10."Hairdresser and cosmetician" means any person who arranges, dresses, curls, cuts, waves, singes, bleaches or colors the hair or treats the scalp, or manicures the nails of any person either with or without compensation or who, by the use of the hands or appliances, or of cosmetic preparations, antiseptics, tonics, lotions, creams, powders, oils or clays, engages, with or without compensation, in massaging, cleansing, stimulating, manipulating, exercising or beautifying or in doing similar work upon the neck, face or arms or who removes superfluous hair from the body of any person.
11."Instructor" means any person licensed as an instructor under the provisions of the Act and this Part.
12."Manager" means a person licensed as a barber, hairdresser/cosmetician, manicurist or esthetician for at least one (1) year who is registered with the Department by the owner of the shop to be responsible for supervising the operation of the shop and its employees as it relates to the Act and this Part.
13."Manicuring shop" means a shop licensed under the Act and this Part to do manicuring only on the nails of any person.
14."Manicurist" means any person who engages in manicuring for compensation, and is licensed as a manicurist.
15."The practice of barbering" means the engaging by any licensed barber in all or any combination of the following practices: shaving or trimming the beard or cutting the hair; giving facial and scalp massages or treatments with oils, creams, lotions, or other preparations either by hand or mechanical appliances; singeing, shampooing, arranging, dressing, curling, waving, chemical waving, hair relaxing, or dyeing the hair or applying hair tonics; applying cosmetic preparations, antiseptics, powders, oils, clays or lotions to scalp, face or neck.
16."The practice of hairdressing and cosmetic therapy" means the engaging by any licensed hairdresser/cosmetician in any one (1) or more of the following practices: the application of the hands or of mechanical or electrical apparatus, with or without cosmetic preparations, tonics, lotions, creams, antiseptics, or clays, to massage, cleanse, stimulate, manipulate, exercise, or otherwise to improve or to beautify the scalp, face, neck, shoulders, arms, bust or upper part of the body or the manicuring of the nails and toenails of any person; or the removing of superfluous hair from the body of any person; or the arranging, dressing, curling, waving, weaving, cleansing, cutting, singeing, bleaching, coloring or similarly treating the hair of any person. Provided, however, that the practice of hairdressing and cosmetic therapy shall not include natural hair braiding.
17."The practice of manicuring" means the cutting, trimming, polishing, tinting, coloring or cleansing the nails of any person.
18."School" means a school approved under R.I. Gen. Laws Chapter 16-40 devoted to the instruction in and study of the theory and practice of barbering, hairdressing/cosmetic therapy, esthetics and/or manicuring.
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.4** License Requirements {#sec-216-ricr-40-05-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.4}
A.No person shall practice barbering, hairdressing/cosmetic therapy, esthetics, or manicuring in this State, unless the person shall have first obtained a license from the Department or has been registered as an apprentice barber as provided by the Act and this Part.
B.No person shall engage in barbering instruction, hairdressing/cosmetic therapy instruction, manicuring instruction or esthetics instruction in any school as defined in § 4.3(A)(18) of this Part unless the person shall have first obtained an instructor license as provided by the Act and this Part.
C.Students enrolled in programs of hairdressing/cosmetic therapy or barbering may enter into a work-study arrangement after they have completed at least one thousand (1,000) hours of classroom instruction.
1.Students participating in a work study arrangement shall be under the direct supervision of a licensed hairdresser/cosmetician, or barber.
2.The level of hairdressing/cosmetic therapy or barbering procedures performed by the student shall be as determined by the registered manager or owner/manager, of the hair design shop, who shall be responsible for all procedures performed by the student.
3.Students shall wear a name tag that clearly identifies the person as a student.
4.No classroom hours of instruction credit shall be granted for a student’s participation in a work-study arrangement.
5.No student shall work at any time while the school they are enrolled in is in session.
6.The work study arrangement shall not continue beyond the student's graduation from school or completion of course work.
4.4.1Exemptions
Exemption from this Part is pursuant to R.I. Gen. Laws § 5-10-29.
4.4.2General Qualifications for All Applicants
A.In addition to the qualifications for licensure specified by R.I. Gen. Laws § 5-10-8, all applicants for licensure under this Part must meet the following requirements:
1.Have satisfactorily completed a course of instruction in an approved school of barbering, hairdressing/cosmetic therapy, manicuring, or esthetics as outlined in § 4.4.3 of this Part; and
2.Have satisfactorily passed a written and practical examination as outlined in § 4.5.2 of this Part to determine the fitness of the applicant to receive a license; and
3.Have complied with § 4.4.3 of this Part and other requirements stated in this Part.
4.4.3Classes of Licenses
A.Hairdresser/Cosmetician
1.The Department shall issue a hairdresser/cosmetician license to an individual who meets the requirements of § 4.4.2 of this Part and who meets the following requirements:
a.Has completed a course of instruction in hairdressing/cosmetic therapy consisting of not less than one thousand (1,000) hours of continuous study and practice in an approved school.
(1)Students participating in a hairdressing/cosmetic therapy course of instruction in an approved school prior to June 22, 2017 must complete one thousand five hundred (1,500) hours of continuous study and practice.
B.Manicurist. The license requirements for manicurists are pursuant to R.I. Gen. Laws § 5-10-9(3).
C.Esthetician
1.The Department shall issue an esthetician license to an individual who meets the requirements of § 4.4.2 of this Part and meets the following requirements:
a.Has completed a course of instruction in esthetics consisting of not less than six hundred (600) hours of continuous study and practice over a period of not less than four (4) months in an approved school of hairdressing/cosmetic therapy; or
b.Holds a diploma or certificate from a skin care school that is recognized as a skin care school by the State or nation in which it is located, provided that the skin care school required at least six hundred (600) hours of continuous study and practice in order to graduate.
D.Barber
1.The Department shall issue a barber license to an individual who meets the requirements of R.I. Gen. Laws §§ 5-10-9(5)(i) through (ii) and § 4.4.2 of this Part. Alternatively, the Department shall issue a barber license to an individual who meets the following requirement:
a.Has successfully completed one thousand (1,000) hours of barber instruction in an approved school and has completed a minimum of eight hundred forty (840) hours of barber on-the-job training, as a registered barber apprentice, obtained within a minimum of six (6) months as a registered apprentice.
E.Apprentice Barber
1.The Department shall issue an apprentice barber registration to an individual who meets the following requirements:
a.Submits acceptable evidence that any training the apprentice receives shall be conducted by and under the direct supervision of a licensed barber in a licensed hair design shop.
b.Apprentice barbers shall be under the direct supervision of a licensed barber who must be on the premises with the apprentice barber.
c.The number of apprentice barbers which a licensed barber may supervise in a licensed hair design shop serving the general public shall be no more than one (1) apprentice barber to one (1) licensed barber.
d.The number of inmates, registered as apprentice barbers, which a licensed barber may supervise in a licensed hair design shop serving the inmate population of the Department of Correction's inmate facilities or a detention center shall be no more than fifty (50).
F.Hairdresser/Cosmetician, Barber, Manicurist, or Esthetician Instructor
1.The Department shall issue a hairdresser/cosmetician, barber, manicurist or esthetician instructor license to an individual who meets the requirements of § 4.4.2 of this Part, and who meets the following requirements:
a.Has held a licensed hairdresser's/cosmetician's license, a barber’s license, a manicurist’s license or an esthetician’s license, issued under the laws of this State, or another State, for at least three (3) years preceding the date of application for an instructor's license; and
b.Has satisfactorily completed three hundred (300) hours of instruction in hairdressing/cosmetic therapy, barber, manicurist, or esthetician teacher training approved by the Department.
c.Passed an examination approved by the Department.
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.5** Application for License and Fees {#sec-216-ricr-40-05-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.5}
4.5.1Application
A.Application for licensure shall be completed and submitted on forms provided by the Department. The application shall be accompanied by the following documents and fee:
1.U.S. born applicants: a certified copy of birth certificate
2.Foreign born applicants: proof of lawful entry into the country
3.Professional education transcripts: Supporting certified transcript of educational credentials as required in § 4.4.2 of this Part, signed by an official, verifying the dates of attendance and completion of the appropriate program. Such documentation must be sent directly from the school to the Department and must consist of original statements and/or photocopies bearing the signature of the school official and the imprint of the school seal.
4.High school graduation: Verification of high school graduation or equivalent may be an original signed statement from an official of the high school or equivalent program or a notarized photocopy of the original document, or, in lieu of high school graduation or the equivalent; verification of twenty-five (25) or more years of prior experience in the practice for which the license is sought.
5.Applicants who obtained their high school education in a foreign country must have their high school credentials evaluated by a recognized educational documentation evaluation center for equivalency.
6.Fees: The license fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
4.5.2Licensing by Examination
A.Applicants shall be required to satisfactorily pass an examination(s) for the specific class of license the applicant is seeking (barber, hairdresser/cosmetician, manicurist, esthetician or hairdressing/cosmetician, manicurist, esthetician instructor), as determined by the Department to test the qualifications of the applicant to practice in a specific classification(s) in accordance with the statutory and regulatory requirements of this Part.
B.For written examination(s), the Department may utilize a nationally recognized examination, such as the National Interstate Council (NIC) of State Boards of Hairdressing Examination or such other examination from a recognized examination service or agency as may be determined by the Department.
1.The minimal passing score of the written examination(s) approved by the Department for hairdresser/cosmetician, manicurist, esthetician, barbers, and instructors shall be seventy percent (70%).
C.Practical examinations shall be given in a manner prescribed by the Department and the minimal passing score shall be seventy percent (70%).
D.Re-Examination
In case of failure of any applicant to satisfactorily pass an examination, the applicant shall be entitled to re-examination upon payment of the required re-exam fee to the examination service or agency that administers the nationally recognized examination for the Department.
4.5.3Requirements for Applicants Licensed in Another State
A.Any person licensed to practice barbering, hairdressing/cosmetic therapy, manicuring or esthetics in another State where the requirements are the equivalent of those of this State, the applicant shall be entitled to a license for barbering, hairdresser/cosmetician, manicurist or esthetician, upon the acceptance of his or her credentials by the Department including but not limited to:
1.Verification of licensure in good standing from each State in which the applicant holds or has held a license as a barber, hairdresser/cosmetic therapist, manicurist or esthetician.
2.The applicant must have satisfactorily passed a written and practical examination acceptable to the Department of the theory and practice of barbering, hairdressing/cosmetic therapy, manicuring or esthetics, depending on the licensure classification which the applicant is seeking.
3.If the requirements of another State are not equivalent to the requirements of this State, the Department may grant the following:
a.Barber/hairdresser/cosmetician applicant one hundred (100) hours of instructional credit for each three (3) month period that said applicant was licensed and actively practicing, up to a limit of five hundred (500) hours.
b.Esthetician applicant forty (40) hours of instructional credit for each three (3) month period that said applicant was licensed and actively practicing, up to a limit of two hundred (200) hours.
c.Manicurist applicant twenty (20) hours of instructional credit for each three (3) month period that said applicant was licensed and actively practicing, up to a limit of one hundred (100) hours.
B.Persons who have been duly licensed by examination under the laws of other States of the United States or Territories, and the District of Columbia shall not be prevented from practicing the profession for which they have been trained in either barbering, hairdressing/cosmetic therapy, manicuring or esthetics in this State for a period of three (3) months, provided:
1.The applicant files an application and obtains a license from the Department within three (3) months from the start of their employment.
2.The privilege to work for three (3) months as provided for in § 4.5.3(B) of this Part shall not be extended or renewed beyond the three (3) months from the date of issuance of the temporary permit.
4.5.4Requirements for Applicants from Another Country
A.Any person licensed to practice barbering, hairdressing/cosmetic therapy, manicuring or esthetics in another country where the educational requirements are essentially equivalent of those of this State may be entitled to apply to sit for the licensing examination for barbering, hairdresser/cosmetician, manicurist or esthetician, upon the acceptance of his or her credentials by the Department.
1.If the education and training requirements of another country are not equivalent to the requirements of this State, the Department may grant the applicant up to one thousand (1,000) hours of instructional credit for a combination of foreign training and experience for a minimum of two and one half (2 ½) years (thirty (30) months) of actively practicing their profession in a foreign country.
B.The applicant must satisfactorily meet all of the requirements of § 4.4.2 of this Part.
C.The applicant shall not be prevented from practicing the profession for which they have been trained either in barbering, hairdressing/cosmetic therapy and/or manicuring or esthetics in this State for a period of three (3) months, provided:
1.The applicant files an application and obtains a license from the Department within three (3) months from the start of their employment.
2.The privilege to work for three (3) months as provided for in § 4.5.4(C) of this Part shall not be extended or renewed beyond the three (3) months from the date of issuance of the temporary permit.
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.6** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.6}
A.The Department shall issue to applicants who have satisfactorily met the licensure requirements of this Part, a license to practice barbering, hairdressing/cosmetic therapy, or manicuring, or esthetics or to be an instructor in this State. The license unless sooner suspended or revoked, shall expire on the thirtieth (30th) day of September of every other year following the date of issuance of original license, which will be determined on an odd-even year basis.
B.Every licensed person who wishes to renew his or her license shall file a renewal application with the Department together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) submitted to the Department on or before the thirtieth (30th) day of September in each renewal year.
C.Upon receipt of such renewal application and fee, the Department shall grant a renewal license effective the first (1st) day of October and expiring two (2) years later on the thirtieth (30th) day of September.
D.Any person who has failed to renew his or her license on or before the thirtieth (30th) day of September following the date of issuance may be renewed by the Department upon payment of the current renewal fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
E.Each licensee shall have his or her license on their person while performing the duties for which they are licensed and shall be readily available upon the request of an agent of the Department.
4.6.1Demonstrator's Permit
A.Any person recognized by the Department as an authority or expert in the theory or practice of barbering, hairdressing/cosmetic therapy, manicuring or esthetics and is the holder of a current esthetician's, manicurist's, or a barber's, hairdresser's/cosmetician's license in this State, another State or the District of Columbia may be issued a demonstrator’s permit by the Department for not more than six (6) days duration for educational and instructive demonstration.
1.For the purposes of this Part, an authority or expert in the theory or practice of barbering, hairdressing/cosmetic therapy, manicuring or esthetics shall be any person sponsored by a recognized manufacturer or distributor of hair and/or skin products, or sponsored by a State hairdressing or barber association.
B.Furthermore, a demonstrator shall be a person qualified to demonstrate in the area of specialty(ies) such as barbering, hairdressing/cosmetic therapy, manicuring or esthetics, to licensed hairdressers/cosmeticians, manicurists, or estheticians, and/or to students in approved schools which shall exclude public participation.
C.A demonstrator's permit shall not be used in the sense of a license to practice barbering, manicuring, esthetics or hairdressing/cosmetic therapy.
D.Applicants seeking a demonstrator's permit must apply to the Department, complete forms provided by the Department and return said forms to the Department accompanied by the fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.7** Licensure Requirements for Shops {#sec-216-ricr-40-05-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.7}
4.7.1General Requirements
A.No shop, place of business or establishment shall be opened or conducted within the State by any person, association, co-partnership, corporation, or otherwise for the practice of barbering, manicuring and/or hairdressing/cosmetic therapy or esthetics without being licensed in accordance with the statutory and regulatory provisions of this Part.
B.No license shall be granted to any shop, place of business or establishment for the practice of barbering, hairdressing/cosmetic therapy, manicuring or esthetics unless the designated supervising manager in the practice of barbering, hairdressing/cosmetic therapy, manicuring or esthetics thereof is duly licensed and shall have been licensed in the appropriate class of license as set forth in § 4.4.3 of this Part for a period of at least one (1) year immediately prior to the filing of the application for the licensure of the shop.
C.Persons working in a shop who are independent contractors, not considered to be employees of the shop owner for tax purposes, are considered to be an independent business requiring a separate hair design shop license.
D.Latex
1.Any shop, place of business or establishment licensed for the practice of barbering or hairdressing/cosmetic therapy that utilizes latex gloves shall do so in accordance with the provisions of the rules and regulations pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
4.7.2Exemptions
Exemptions to the practice of barbering, hairdressing, cosmetic therapy, manicuring and esthetics in a fixed place of business is in accordance with the provisions set forth in R.I. Gen. Laws § 5-10-23.
4.7.3Application for License and Fee
A.Application for a license to conduct, maintain or operate a shop for the practice of barbering, hairdressing/cosmetic therapy, or manicuring, or esthetics shall be made on forms provided by the Department and shall contain such information as the Department requires, and in accordance with the provisions of this Part.
B.Forms shall be completed and submitted to the Department with the following documentation:
1.Evidence of compliance with the local zoning laws, in which the shop, place of business or establishment is located;
2.Application for registration of the supervising manager; and
3.License fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
4.7.4Issuance and Renewal of License and Fee
A.The Department may issue a license or renewal thereof for a period of no more than one (1) year, if the applicant meets the requirements of this Part. The license, unless sooner suspended or revoked, shall expire on the first (1st) day of July following the date of issuance and may be renewed from year to year subject to inspection and approval by the Department.
B.For each license renewal thereof, the licensure renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) must accompany the application renewal form provided by the Department.
C.A license shall be issued to a specific licensee for a specific address and shall not be transferable to a new address. The license shall be issued only for the premises and the individual owner, operator or lessee or to the corporate entity responsible for the operation.
D.A license issued under this Part shall be the property of the State and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
4.7.5Organization and Management (Manager)
A.Each shop, establishment or business engaged in barbering, hairdressing/cosmetic therapy, manicuring or esthetics shall have an individual to serve as manager, who could be the owner, provided the individual meets the qualifications of § 4.7.1(B) of this Part. Said manager shall furthermore be required to be available at all times during the hours of the shop's operation.
B.In addition, the manager of each shop shall be registered with the Department. Written documentation of name, address and qualifications of the manager must be submitted by the owner to the Department.
C.No manager shall manage more than one (1) shop at any given time.
D.The owner of a licensed shop and the manager shall notify the Department in writing within ten (10) days from the date of termination of employment of the manager of any licensed shop, establishment, or place of business. The license of said shop shall expire forty-five (45) days from the date the Department was notified by the owner, if no manager meeting the qualifications of § 4.7.5(A) of this Part is registered with the Department.
4.7.6Environmental Maintenance and Sanitation
A.Each shop, establishment or place of business shall be maintained to provide a safe, sanitary, clean and comfortable environment. All furnishings shall be kept in good repair. The premises shall be kept free of hazards at all times.
B.The following sanitary practices shall be exercised at all times:
1.Hand washing between patrons with soap and warm water;
2.A clean towel shall be used for each patron;
3.All linens and towels shall be deposited in a closed receptacle after use;
4.Used linens and towels shall be laundered either by commercial laundering or by a noncommercial laundering process which includes immersion in water at a temperature of at least one hundred forty degrees Fahrenheit (140° F) for not less than fifteen (15) minutes during the washing or rinsing treatment;
5.Whenever a haircloth, protective drape or cape is used on a patron, a clean towel or other clean protection shall be placed around the patron's neck in such a manner as to prevent the patron's skin from contacting the haircloth, protective drape or cape;
6.The headrest of chairs shall be covered with a clean towel or paper sheet for each patron.
7.All combs, brushes, non-electrical instruments with a sharp point or edge (scissors, tweezers cuticle nippers, manicure/pedicure scissors etc.) and other such articles, after use on a patron, must be:
a.Thoroughly cleaned with a detergent and hot water and then rinsed;
b.Treated with an effective disinfectant registered by the Environmental Protection Agency (EPA) with demonstrated bactericidal, fungicidal and virucidal activity and used according to manufacturer's instructions.
c.Stored until their next use in a manner that will prevent recontamination.
8.All electrical instruments (clippers, vibrators, etc.), after use on a patron, must be:
a.Thoroughly cleaned to remove foreign matter;
b.Treated with an effective disinfectant registered by the Environmental Protection Agency (EPA) with demonstrated bactericidal, fungicidal and virucidal activity and used according to manufacturer's instructions.
c.Stored until their next use in a manner that will prevent recontamination.
9.When household bleach is used for disinfecting environmental surfaces it shall be used in a 1:10 dilution (or one quarter (1/4) cup bleach to two and one half (2 1/2) cups of tap water).
10.The use of a lancet or any other type of device to break the skin is prohibited.
11.The use of a straight edge multi-use razor is prohibited. Only single use (disposal) razors are acceptable and shall be properly discarded after each use.
12.The use of a razor blade callus shaver is prohibited.
13.The reuse of any depilatories and any paraffin wax which has been adhered to any part of a client's body is prohibited.
14.No persons shall bring allow to be brought into, or permit to remain in a shop any animal, fowl, or reptile, irrespective of any designation as comfort animal, emotional support animal, or therapy animal. Service animals, as defined in R.I. Gen. Laws § 40-9.1-1.1(6), accompanying a qualified individual with a disability in accordance with R.I. Gen. Laws §§ 40-9.1-1, et seq. and 42-87-1, et seq. and/or the Americans with Disabilities Act, 42 U.S.C. 12101, et seq. are exempted from this section. Aquariums containing fish are allowed.
15.The multi-use of cosmetics is prohibited. This includes the use of:
a.Applicators, septic pencils which are not disposable;
b.Multi-use of lipsticks, powder puffs and brushes;
c.Curlers and such supplies in which hair strands cannot be easily removed or cleaned or sanitized; and
d.Any other equipment and supplies that the Department may determine inappropriate because of sanitary and safety reasons.
16.When only a portion of a cream, liquid, powder or other cosmetic preparation is to be removed from the container, it shall be removed in such a way as not to contaminate the remaining portion.
17.The possession and/or use of any cosmetic nail preparation containing methyl methacrylate (MMA) shall be prohibited.
4.7.7Structural, Air and Environmental Requirements, Equipment and Supplies
A.A shop, place of business or establishment licensed to practice hairdressing/cosmetic therapy, manicuring or esthetics must meet the following structural requirements:
1.The Fire Safety requirements of the State Fire Code;
2.The State Building Code Commission requirements;
3.The local zoning laws; and
4.Federal Occupational Safety and Health Administration (OSHA) standards for air contaminants as published in the Federal Register 29 C.F.R. § 1910.1000 "Air Contaminants," incorporated by reference at § 4.2 of this Part.
B.Furthermore, the following provisions must be maintained:
1.Every salon must have an adequate supply of potable hot and cold water;
2.The floors must have washable floor coverings;
3.Storage space must be provided to keep clean supplies and linens separate from soiled linens and supplies; and
4.Each shop shall provide, on the premises or in the same building, adequate (in compliance with the State Plumbing Code) toilet and lavatory facilities. Toilet facilities and hand washing sinks shall be kept clean and sanitary without offensive odors and in working condition at all times. Each hand washing sink shall have a soap dispenser and disposable towels or an air dryer for hands.
C.An adequate amount of appropriate equipment, instruments and supplies in accordance with the type of services provided, shall be maintained on the premises. In addition:
1.Covered receptacles must be provided for debris;
2.Containers and/or cabinets for clean supplies and soiled towels and/or articles;
3.Clean and soiled supplies must be kept separately (e.g., towels, combs, brushes)
4.All mechanical and electrical equipment shall be maintained in a safe and operating condition.
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.8** Inspection, Advertising and Permanent Makeup {#sec-216-ricr-40-05-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.8}
4.8.1Inspections
The provisions for inspection are in accordance with the R.I. Gen. Laws § 5-10-25.
4.8.2Advertising
No person or establishment licensed under the statutory and regulatory provisions of this Part shall advertise by written or spoken words of a character tending to deceive or mislead the public.
4.8.3Permanent Makeup
The implanting of pigment into the skin or "permanent makeup" is prohibited by any person licensed under the Act and this Part unless such person is also licensed as a physician under the provisions of R.I. Gen. Laws Chapter 5-37, or a tattoo artist in accordance with Tattoo Artists and Tattoo Parlors (Subchapter 10 Part 15 of this Chapter).
4.8.4Electrolysis
In accordance with R.I. Gen. Laws § 5-10-20, no license issued under the provisions of the Act and this Part shall be construed to authorize, as a part of the practice of hairdressing/cosmetic therapy, the practice of “electrolysis,” which, for the purpose of the Act, is defined as the insertion of an electrically heated instrument at the root of a hair to prevent the growth thereof. Persons practicing electrolysis shall be licensed to do so in accordance with Practice of Electrolysis (Part 29 of this Subchapter).
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
##### **216-RICR-40-05-4 § 4.9** Revocation or Suspension, Violations, Sanctions, Practices and Procedures {#sec-216-ricr-40-05-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-4#4.9}
4.9.1Revocation or Suspension of License, Permit or Certificate
Any license, permit, certificate of approval or registration issued by the Department may be revoked or suspended by the Department for violation of any provisions of the Act and this Part. Furthermore failure to comply with this Part, failure to comply with the prevailing standards of practice, or such other cause as the Department deems sufficient, may be cause for the license, permit or certification of approval or registration to be denied, suspended or revoked, provided however that no license, permit, certificate of approval or registration shall be suspended or revoked without the holder having been given ten (10) days notice in writing specifying the complaint made and the charges preferred against the accused and a reasonable opportunity given the accused to present evidence and testimony and to be represented by counsel at a hearing or hearings, to be held by the Department upon the complaint and charges preferred against the accused.
4.9.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act shall be held in accordance with requirements of Practices and Procedures before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Amendment — effective from 2025-05-30 to current*
- *Amendment — effective from 2023-11-03 to 05/30/2025*
- *Amendment — effective from 2022-07-27 to 11/03/2023*
- *Periodic Refile — effective from 2022-01-04 to 07/27/2022*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-02-22 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/22/2007*
#### **216-RICR-40-05-5** Athletic Trainers
##### **216-RICR-40-05-5 § 5.1** Authority {#sec-216-ricr-40-05-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-60-5(1) and are established for the purpose of adopting administrative procedures and minimum standards for the licensing of athletic trainers.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.2** Definitions {#sec-216-ricr-40-05-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-60 entitled, "Licensing of Athletic Trainers."
2."Accredited college or university" means the official guarantee that a college or university is in conformity with the standards of education prescribed by a regional accrediting body recognized by the U.S. Commission on Education.
3."Athletic trainer" is defined pursuant to R.I. Gen. Laws § 5-60-2(1).
4."Board" means the Rhode Island Board of Athletic Trainers established pursuant to the provisions of R.I. Gen. Laws § 5-60-4.
5.“BOC” means the Board of Certification for the Athletic Trainer.
6."Board sanctioned amateur athletic organization" means those athletic organizations which sponsor within the state of Rhode Island athletic teams or programs and are recognized and affiliated with national and/or state and/or regional athletic associations.
7.“CAATE” means the Commission on Accreditation of Athletic Training Education.
8.“Department” means the Rhode Island Department of Health.
9.“Director” means the director or state official in charge of the Department of Health.
10."NATA" refers to the National Athletic Trainers Association, Inc.
11."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability companies, state or political subdivisions or instrumentality of the state.
12."Physician" means an individual licensed to practice medicine in this state pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.3** License Requirement {#sec-216-ricr-40-05-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.3}
A.No person shall use the title of "Athletic Trainer" or use any abbreviation sign, card, or device to indicate that such a person is an athletic trainer, or perform the duties thereof unless such a person has been duly licensed in this state to perform such duties pursuant to the provisions of the Act and rules and regulations herein, except those exempt pursuant to § 5.3(A)(1) of this Part.
1.The provisions of the Act need not apply to athletic trainers from another state who are employed by an athletic team or organization which is competing in this state only on a visiting basis, provided the practice of the athletic trainers is limited only to the members of their respective athletic team or organization.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.4** Qualifications for Licensure {#sec-216-ricr-40-05-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.4}
A.An applicant seeking licensure in this state as an athletic trainer must:
1.Be a graduate from an accredited college or university and have completed the following minimum curriculum requirements:
a.The specific course requirements pursuant to R.I. Gen. Laws §§ 5-60-10(a)(1)(i) through (xi); and
b.Clinical Experience in accordance with national standards as recognized by the BOC certifying body and as approved by the Director; or have successfully completed a CAATE-approved athletic training program from a college or university sponsoring a CAATE approved graduate or undergraduate program; and
2.Have passed to the satisfaction of the Board the required examination in accordance with § 5.6 of this Part and been certified by the BOC; and
3.Not have committed an act which constitutes grounds for denial of a license pursuant to § 5.10 of this Part.
B.The clinical experience (internship) referred to under § 5.4(A)(1) of this Part must be provided under the direct supervision of an BOC-certified athletic trainer.
C.An applicant for initial licensure shall be required to demonstrate:
1.Proof of graduation from an accredited college or university and have met minimum athletic training requirements as established by the Department;
2.Proof of having passed the required examination, approved by the Department, and been certified by the national certifying body recognized by the BOC.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.5** Application for License {#sec-216-ricr-40-05-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.5}
A.Application for licensure shall be made on forms provided by the Department which shall be completed and submitted to the Department. Such application shall be accompanied by the following documents:
1.Supporting official transcripts of education credentials and clinical experience as required in § 5.4(A)(1) of this Part;
2.National board results in accordance with § 5.6 of this Part (submitted either with application or submitted to the Department by the certifying body of the Board of Certification (BOC); and
3.A copy of the applicant’s resume.
B.Out-of-state applicants must submit, in addition to the above documents, documentation of licensure or certification in another state or jurisdiction.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.6** Examination for Licensure {#sec-216-ricr-40-05-5-5.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.6}
A.By Examination: Applicants for licensure shall be required to successfully pass such examination as the Board deems most practical and expeditious to test the applicant's knowledge and skills pursuant to R.I. Gen. Laws § 5-60-12.
1.Applicants certified by the National Athletic Trainers Association prior to July 31, 1970, must successfully complete a written examination approved by the Board. All other applicants must successfully pass the examination administered by the BOC.
2.Sites and schedules of examinations may be obtained directly from the examination services referred to in § 5.6(A)(1) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.7** Issuance and Renewal of License/Fee {#sec-216-ricr-40-05-5-5.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.7}
A.Upon completion of the aforementioned requirements, a license shall be issued by the Board to an applicant found to have satisfactorily met all the requirements of this Part and upon payment of a licensing fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Said license unless sooner suspended or revoked shall expire on the thirtieth (30th) day of June of the next odd numbered year following the date of issuance of the license.
B.On or before the 30th day of April of each odd numbered year, the Department shall mail an application for renewal of license to every person to whom a license has been issued or renewed during the current licensure period. Every person so licensed who desires to renew his or her license shall file with the Department such renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) on or before the thirtieth day of May of each odd year.
C.Upon receipt of such renewal application and payments of said fee, the accuracy of the application shall be verified, and the Board shall grant a renewal license effective the first day of July and expiring on the 30th day of June of the next odd year unless sooner suspended or revoked.
D.Any person who allows his or her license to lapse by failing to renew it on or before the 30th day of May of the next odd year, as provided above, may be reinstated on payment of the current renewal fee plus an additional late fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
E.Each licensed athletic trainer who wishes to continue licensure as an athletic trainer shall present satisfactory evidence to the Board that he or she has completed the continuing education requirements established by the Board and contained in § 5.9 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.8** Practice Guidelines for Athletic Trainers {#sec-216-ricr-40-05-5-5.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.8}
A.Athletic trainers licensed in this state or any other state may discharge such responsibilities and functions as specified in § 5.8(C) of this Part provided these functions are carried out upon the direction of the physician designated as the team or consulting physician to the team by an educational institution, professional and/or Board sanctioned amateur athletic association.
B.Furthermore, athletic trainers shall limit the scope of practice of prevention and/or physical reconditioning to injuries or conditions incurred by only those athletes participating in or preparing for an athletic event conducted under the aegis of an institution, agency or organization.
C.The functions which an athletic trainer may perform may consist of any of the following:
1.Prevention of athletic injury which may include such procedures as strength training, pre-event warm-ups, prophylactic taping, fitting of protective equipment;
2.Provide physical reconditioning for the restoration of motion and re-establishment of strength, endurance and cardiovascular fitness of an injured athlete;
3.Perform tests and measurements as an aid in the evaluation of an athletic injury; and
4.Apply physical modalities such as heat, light, sound, cold, electricity, exercise, or mechanical devices related to care and reconditioning.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.9** Continuing Education {#sec-216-ricr-40-05-5-5.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.9}
Athletic trainer seeking biennial licensure renewal shall meet continuing education requirements as prescribed by the BOC.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.10** Grounds for Refusal or Revocation of License {#sec-216-ricr-40-05-5-5.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.10}
A.In addition to the provisions of R.I. Gen. Laws § 5-60-14, the Board may refuse to issue a license to an applicant or may suspend, revoke or refuse to renew a license if he or she has:
1.Secured a license under the Act and this Part by fraud or deceit; or
2.Unfit or incompetent by reason of negligence or habits; or
3.Guilty of unprofessional conduct; or
4.Mentally incompetent; or
5.Violated the provisions of the BOC Code of Ethics or the NATA Code of Ethics as adopted by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.11** Violations and Penalties {#sec-216-ricr-40-05-5-5.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.11}
Any violation of the provisions of the Act and the rules and regulations herein, may be cause for denial, revocation or suspension of license or for imposing such other penalties in accordance with the provisions of R.I. Gen. Laws § 5-60-17.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
##### **216-RICR-40-05-5 § 5.12** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-5-5.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-5#5.12}
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 5-60, shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2003-05-22 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 05/22/2003*
#### **216-RICR-40-05-6** Chemical Dependency Professionals
##### **216-RICR-40-05-6 § 6.1** Authority {#sec-216-ricr-40-05-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-6#6.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-69-5 and are adopted for the purpose of establishing prevailing standards for the licensure of chemical dependency professionals and chemical dependency clinical supervisors in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Adoption — effective from 2009-02-15 to 12/10/2012 Click here to view previous versions of this Part.*
##### **216-RICR-40-05-6 § 6.2** Incorporated Materials {#sec-216-ricr-40-05-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-6#6.2}
These regulations hereby adopt and incorporate the Confidentiality of Substance Use Disorder Patient Records. Final Rule. U.S. Department of Health and Human Services, Public Health Service. 42 C.F.R. Part 2 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Adoption — effective from 2009-02-15 to 12/10/2012 Click here to view previous versions of this Part.*
##### **216-RICR-40-05-6 § 6.3** Definitions {#sec-216-ricr-40-05-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-6#6.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1."ACDP" means an advanced chemical dependency professional certification as per the Rhode Island Board for Certification of Chemical Dependency Professionals requirements.
2.“ACDP II” means an advanced chemical dependency professional II certification as per the International Certification and Reciprocity Consortium/Alcohol and Other Drug Abuse, “ICRC/AODA.”
3."Act" means R.I. Gen. Laws Chapter 5-69, entitled, "Rhode Island Chemical Dependency Professionals Act.”
4.“Acudetox specialist” or “ADS” means an individual licensed as a chemical dependency professional or clinical supervisor who holds a certificate of training that meets or exceeds the National Acupuncture Detoxification Association (NADA) training from a recognized agency.
5."Advertise" includes, but is not limited to, the issuing or causing to be distributed any card, sign, or device to any person; or the causing, permitting, or allowing any sign or marking on or in any building or structure, or in any newspaper or magazine or in any directory, or on radio or television, or by the use of any other means designed to secure public attention.
6."Approved continuing education" means research and training programs, college and university courses, in-service training programs, seminars and conferences designed to maintain and enhance the skills of substance abuse counselors or clinical supervisors and which are recognized by the ICRC/AODA member board.
7.“Auricular acudetox” means the subcutaneous insertion of sterile, disposable, acupuncture needles in consistent, predetermined, bilateral locations on the ear in accordance with the National Acupuncture Detoxification Association (NADA) protocol.
8."CDCS" means chemical dependency clinical supervisor.
9."Clergy" includes any minister, priest, rabbi, Christian Science practitioner, or any other similar religious counselor.
10."Continuum of care network" means public and private substance abuse care agencies such as detoxification centers, emergency rooms, hospitals, treatment centers, outpatient and day treatment clinics, and community residences for substance abusers. This service employs or refers to medical, psychological, health, and counseling professions that treat substance abuse and related concerns.
11."Department" means the Rhode Island Department of Health.
12."Director" means the Director of the Rhode Island Department of Health.
13."Documented professional work experience" means the ICRC/AODA member board approved form completed by employer or approved supervisor verifying dates of employment and responsibilities.
14."Experience" means six thousand (6,000) hours of supervised practice of chemical dependency counseling in a Department of Behavioral Healthcare, Developmental Disabilities and Hospitals licensed or ICRC/AODA member board approved facility during a sixty (60) month period of time immediately preceding the date of application for licensure.
15.“ICRC/AODA” means International Certification and Reciprocity Consortium/Alcohol and Other Drug Abuse.
16."Licensed chemical dependency clinical supervisor" means an individual licensed by the Department to practice and supervise substance abuse counseling and who meets the qualifications set forth in the Act and the rules and regulations herein.
17."Licensing board" or "Board" means the Board of Licensing for Chemical Dependency Professionals.
18.“Member board” means the Rhode Island Board for Certification of Chemical Dependency Professionals.
19.“National Acupuncture Detoxification Association” or “NADA” means the not-for-profit organization that provides a certificate of acudetox training.
20.“Practice of substance abuse counseling” means rendering or offering to render professional service for any fee, monetary or otherwise, documented to individuals, families or groups. Those professional services include the application of the ICRC/AODA specific knowledge, skills, counseling theory and application of techniques to define goals and develop a treatment plan of action aimed toward the prevention, education or treatment in the recovery process of substance abuse within the continuum of care service network. The practice further includes, but is not limited to, networking and making referrals to medical, social services, psychological, psychiatric, and/or legal resources when so indicated.
21."Recognized education institution" means any educational institution which grants an associate, bachelor, masters or doctoral degree and which is recognized by the Board, or by a nationally or regionally recognized educational or professional accrediting organization.
22."Substance abuse" means addictive (chronic or habitual) consumption, injection, inhalation or behavior of/with substance (such as alcohol and drugs), progressively injuring and afflicting the user's psychological, physical, social, economical and/or spiritual functioning.
23."Supervision" means no less than one (1) hour per week and shall consist of individual or group supervision with a clinician licensed or certified in substance abuse counseling with education, supervisory experience, and ethics approved by the ICRC/AODA member.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Adoption — effective from 2009-02-15 to 12/10/2012 Click here to view previous versions of this Part.*
##### **216-RICR-40-05-6 § 6.4** Chemical Dependency Professional Licensing Requirements {#sec-216-ricr-40-05-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-6#6.4}
6.4.1Licensure Requirements
A.Any individual licensed under the provisions of the Act and this Part may use the title "licensed chemical dependency professional" and the abbreviation "LCDP" or the title "licensed chemical dependency clinical supervisor" and the abbreviation "LCDCS" provided that the title and abbreviation correspond to the license held pursuant to the Act.
B.No individual shall represent herself/himself as a "licensed chemical dependency professional", "LCDP" or a "licensed chemical dependency clinical supervisor", "LCDCS", unless she/he holds the corresponding appropriate license as set forth in R.I. Gen. Laws § 5-69-3(b).
C.No individual shall represent herself/himself as an “acudetox specialist” or perform auricular acudetox as defined in § 6.3(A)(7) of this Part unless he/she holds a certificate of training that meets or exceeds the NADA training from a recognized agency; and is licensed under the provisions of the Act and this Part as a “licensed chemical dependency professional” or a “licensed chemical dependency clinical supervisor”.
6.4.2Qualifications for Licensure
The Department shall issue the appropriate license to applicants who meet the qualifications for the license as specified in R.I. Gen. Laws § 5-69-8.
6.4.3Application for Licensure and Fees
A.Application for license to practice as a licensed chemical dependency professional or licensed chemical dependency clinical supervisor shall be made on forms provided by the Department, which shall be completed and submitted to the Board.
B.The application shall be accompanied by the following:
1.For U.S. born applicants: a certified copy of birth certificate;
2.For Non-U.S. born applicants: documented evidence of lawful entry into the country;
3.Verification of current certification at the appropriate level from the ICRC/AODA member board;
4.A non-refundable, non-returnable license fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
5.Sworn statement that the applicant is free of sanctions, felony convictions, mentally incompetent decrees and/or the use of any controlled substance or any alcoholic beverage to the extent that the use impairs the ability of the person to conduct with safety to the public the practice authorized by this license, in accordance with R.I. Gen. Laws §§ 5-69-8(b)(3), 5-69-8(b)(4), 5-69-8(b)(5), and 5-69-8(b)(6).
6.4.4Endorsement for Licensure as a Licensed Chemical Dependency Professional and Licensed Chemical Dependency Clinical Supervisor
A.Licensure By Endorsement:
1.License application with accompanying documents and fee as required in § 6.4.3(B) of this Part;
2.If applicable, a statement from the certification board in each state in which the applicant has held or holds licensure to be submitted to the Rhode Island ICRC/AODA member board, attesting to the licensure status of the applicant during the time period the applicant held licensure in said state;
3.A statement from the licensing/certification board in the jurisdiction upon which endorsement is to be based setting forth the requirements for licensure/certification in that jurisdiction. Said requirements shall be substantially similar to those in place in Rhode Island at the time of application. This determination shall be made by the licensing board.
6.4.5Issuance and Renewal of License
A.The Department, on recommendation of the Board of Chemical Dependency Professionals, shall issue licenses to those qualified under the Act. The license, unless sooner suspended or revoked, shall expire on the first day of October of each even-numbered year following the date of issuance of the original license.
B.Every licensed person who desires to renew his/her license shall file a renewal application with the Department, together with a non-refundable renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) on or before the thirtieth (30th) day of September of each even-numbered year.
C.Applicants for license renewal shall submit evidence of current certification by the Rhode Island Board of Certification of Chemical Dependency Professionals and the continuing education requirements necessary to maintain said certification.
6.4.6Privilege Exemptions
A.Privilege exemptions are in accordance with the provisions set forth in R.I. Gen. Laws § 5-69-4(b).
B.No person licensed under the Act and this Part or an employee of a licensee may disclose any information acquired from clients or persons consulting with the licensee to render professional services except under the provisions of the federal regulation 42 C.F.R. Part 2, incorporated by reference above at § 6.2 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Adoption — effective from 2009-02-15 to 12/10/2012 Click here to view previous versions of this Part.*
##### **216-RICR-40-05-6 § 6.5** Denial, Suspension, and Revocation of Licenses and Procedures for Discipline {#sec-216-ricr-40-05-6-6.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-6#6.5}
6.5.1Grounds for Denial, Suspension or Revocation of License/Violations
Licensees subject to the Act shall conduct their activities, services and practice in accordance with the Act and this Part. The licensing board may recommend to the Director refusal to grant a license to, or to suspend, revoke, condition, limit, qualify, or restrict the license of any individual for grounds as set forth in R.I. Gen. Laws § 5-69-10, or for grounds that the individual has departed from or failed to conform to the current standards of acceptable and prevailing practice of substance abuse counseling.
6.5.2Disciplinary Process
A.Disciplinary procedures under the Act shall be conducted in accordance with R.I. Gen. Laws Chapter 42-35.
B.The licensing board, or its designee, shall hear evidence produced in support of the formal charges and contrary evidence produced by the licensee. At the conclusion of the hearing, the licensing board shall make recommendations to the Director who shall issue an order.
6.5.3Disciplinary Sanctions
The licensing board may recommend that the Director impose any sanctions set forth in R.I. Gen. Laws § 5-69-13, singly or in combination when it finds that a licensee is guilty of any offenses in § 6.5.1 of this Part.
6.5.4Rules Governing Practices and Procedures
All hearing and reviews required under the provisions of R.I. Gen. Laws Chapter 5-69, shall be held in accordance with the provisions of the Act and of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Adoption — effective from 2009-02-15 to 12/10/2012 Click here to view previous versions of this Part.*
#### **216-RICR-40-05-7** Clinical Social Workers and Independent Clinical Social Workers
##### **216-RICR-40-05-7 § 7.1** Authority {#sec-216-ricr-40-05-7-7.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-7#7.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-39.1-5 and are established for the purpose of adopting prevailing standards pertaining to the licensure of clinical social workers and independent clinical social workers in this state.
**History**
- *Amendment — effective from 2023-03-23 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/23/2023*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-7 § 7.2** Incorporated Materials {#sec-216-ricr-40-05-7-7.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-7#7.2}
These regulations hereby adopt and incorporate the “The NASW Code of Ethics (1999)” of the National Association of Social Workers by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Amendment — effective from 2023-03-23 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/23/2023*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-7 § 7.3** Definitions {#sec-216-ricr-40-05-7-7.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-7#7.3}
A.Wherever used in these rules and regulations the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-39.1, entitled, "License Procedure for Social Workers.”
2.“ASWB” means the Association of Social Work Boards.
3."Board" means the Board of Social Work Examiners within the Department, established pursuant to the provisions of R.I. Gen. Laws § 5-39.1-6.
4."Clinical social work practice" means the professional application of social work theories, methods and values in the diagnosis, assessment and treatment of cognitive, affective and behavioral disorders arising from physical, environmental or emotional conditions. Clinical social work services shall include, but shall not be limited to, diagnosis, assessment, evaluation, psychotherapy and counseling for individuals, couples, families and groups, client-centered advocacy, consultation and supervision.
a.The practice of case work, group work and community organization services under the supervision of a licensed clinical social worker or the practice of basic data gathering and the formulation and implementation of plans to achieve specific goals related to specific life issues for groups or for individuals, or the assessment, evaluation and counseling of individuals or groups other than for a specific mental illness or the conduct of a psychosocial evaluation, excluding the diagnosis and treatment of a mental illness, such as may be performed by bachelor's level social workers in a nursing care facility or similar setting, shall not be considered to be the practice of clinical social work for the purposes of this Part.
b.Clinical social work services shall not include psychological testing and nothing in this Part shall be construed as permitting social workers to practice psychology.
5."Contact hours" means hours acquired through attendance or participation at programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences, or workshops.
6."Continuing education hours" means actual hours earned in continuing education courses, seminars, and workshops.
7."Department" means the Rhode Island Department of Health.
8."Director" means the Director of the Rhode Island Department of Health.
9."Experience" means three thousand (3,000) hours of post-master's practice of clinical social work during a twenty-four (24) month to seventy-two (72) month period of time immediately preceding the date of application for licensure. One thousand five hundred (1,500) hours must consist of providing clinical social work services directly to clients.
a.If performed in Rhode Island, said experience shall be completed while the person is licensed in Rhode Island as a clinical social worker or while performing clinical social work services in a statutorily exempt setting (e.g., a state employee).
10."NASW" means the National Association of Social Workers.
11.“Non-contact hours” means Internet courses, correspondence courses, tapes, or other continuing education programs that do not provide for direct interaction between faculty and the participant.
12.“Patient”, as used in this Part, shall have the same meaning as “client.”
13."Supervision" means face-to-face contact with a licensed independent clinical social worker for the purpose of apprising the supervisor of the diagnosis, assessment, and treatment of each client; receiving oversight and guidance from the supervisor in the delivery of clinical social work services to each client; and being evaluated by the supervisor. This contact must consist of:
a.A minimum of two (2) hours of supervision every two (2) weeks; and
b.A minimum of one (1) hour of supervision per twenty (20) hours of direct contact with clients whether or not the number of hours of supervision required for a two (2) week period have been met; and
c.One-to-one contact with the supervisor at least seventy-five percent (75%) of the time with group supervision of no more than ten (10) supervisees during the balance of the time; and
d.Supervision by an individual other than the applicant's parents; spouse; former spouse; siblings; children; employees; or anyone sharing the same household or any romantic, domestic, or familial relationship; and
e.Supervisors shall be responsible for ensuring that supervisees are appropriately licensed in clinical social work or are otherwise exempt from licensure.
**History**
- *Amendment — effective from 2023-03-23 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/23/2023*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-7 § 7.4** Social Worker Licensing Requirements {#sec-216-ricr-40-05-7-7.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-7#7.4}
7.4.1License Requirements
A.In addition to the Title and practice regulation set forth in R.I. Gen. Laws § 5-39.1-3, all persons licensed under the provisions of the Act and this Part shall adhere to the current standards of practice and to the National Association of Social Workers’ NASW Code of Ethics incorporated by reference in § 7.2 of this Part, or other such code(s) of professional ethics as adopted by the Board.
B.Exemptions from licensure are stated in R.I. Gen. Laws § 5-39.1-4(b).
1.If a state employee obtains a license, he/she shall maintain compliance with all of the requirements stated in this Part.
C.Individuals who have attained a Master of Social Work degree from an accredited college or university are exempt from licensure for a period of eighteen (18) months from the date of graduation, provided that the individual meets all of the following conditions:
1.On and after August 15, 2025, the individual is authorized to take the examination required herein and has not previously failed that examination more than once;
2.The individual performs all such social work services under the direct personal supervision of a person who holds a valid Rhode Island license as a licensed independent clinical social worker pursuant to § 5-39.1-8;
3.The individual is designated or identified as “social-work intern”, “social-work trainee” or other clearly indicating training status; and
4.The individual does not hold themselves out to the public as any title or description that states or implies that the individual is licensed to practice social work in Rhode Island.
7.4.2Qualifications for Licensure
A.Any applicant for licensure shall submit to the Board written evidence on forms furnished by the Department, verified by oath that said applicant meets all of the following requirements:
1.Prerequisites – "Licensed clinical social worker" – A license as a "licensed clinical social worker" is issued to an applicant who meets the following qualifications:
a.Has graduated with a doctorate in clinical social work from a duly accredited college or university or has graduated with a master's degree from a school of social work accredited by the Council on Social Work Education, and
b.After August 15, 2025, has satisfactorily completed a national examination at the appropriate level for this license as specified in § 7.4.3(A)(5)(a) of this Part.
2.Prerequisites – "Licensed independent clinical social worker" – A license for a "licensed independent clinical social worker" is issued to an applicant who meets the following qualifications:
a.Is licensed under the Act as a "licensed clinical social worker"; and
b.Has twenty-four (24) months of experience acceptable to the Board, which experience shall only be acceptable if the applicant was licensed as a licensed clinical social worker (if required in the jurisdiction where the experience was attained) and under appropriate supervision; and
c.Has fulfilled the continuing education requirements for this license; and
d.Has satisfactorily completed a national examination at the appropriate level for this license as specified in § 7.4.3(A)(5)(b) of this Part.
B.In addition to the qualifications stated in § 7.4.2(A) of this Part, an applicant for any of these titles must meet the provisions set forth in R.I. Gen. Laws § 5-39.1-8(d).
7.4.3Application for Licensure and Fee
A.Application for licensure to practice social work in this state, shall be made on forms provided by the Department. Such application shall be accompanied by the following documents:
1.For U. S. Citizens:
A certified copy of birth certificate, U.S. passport, or other official U.S. government identification.
2.For Non-U.S. Citizens:
Documented evidence of lawful entry into the country.
3.Supporting official transcripts of education credentials as required in § 7.4.2(A) of this Part sent directly from the school.
4.A statement from the board of social work in each state in which the applicant has held or holds licensure to be submitted to the Board of this state, attesting to the licensure status of the applicant during the time period the applicant held licensure in said state.
5.The official results of the appropriate level written examination:
a.For licensure as a clinical social worker this shall be the intermediate level of the examination administered by the ASWB or such other examination as the Board shall consider to be acceptable.
b.For licensure as an independent clinical social worker this shall be the clinical level of the examination administered by the ASWB or such other examination as the Board shall consider to be acceptable.
6.The non-refundable application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
7.For applicants for licensure at the independent social work level:
a.Statement(s) documenting the required hours of post-master's supervised practice under a licensed independent clinical social worker.
7.4.4Examinations for Licensure of Social Workers
A.By Examination: The requirements of §§ 7.4.4(A) and (B) of this section (below) are suspended until August 15, 2025 for licensed clinical social worker applicants.
1.Applicants, except those exempt pursuant to § 7.4.4(B) of this Part, shall be required to pass an examination approved by the Board.
a.Applicants shall be responsible for the payment of the examination/re-examination fee in accordance with the fee schedule and instructions developed by the examination vendor.
b.Requests for testing accommodations under the Americans with Disabilities Act or inquiries concerning other issues involving the examination process shall be directed to the Board.
B.Re-Examination
1.In the case of the failure of any applicant to satisfactorily pass an examination, such applicant shall be entitled to a re-examination upon submission of an additional fee to the examination service without making further application to the Board. In making application for re-examination the applicant shall be subject to any standards imposed by the ASWB or other examination vendor regarding the minimum time interval between administrations of the examination.
2.In order to qualify for re-examination after three (3) failures, the applicant must request a formal meeting with the Board, at which time requirements (consisting of additional course work and/or training) for re-examination may be determined. If such requirements are determined by the Board, they must be fulfilled prior to admittance to a future examination.
C.By Endorsement
1.A license to practice social work may be issued by endorsement to an applicant who has a comparable license, certification, or registration from the state, or another state or territory of the United States that imposes qualifications substantially similar to those of the Act.
a.Until such time as a license has been issued, the candidate for licensure by endorsement may not practice as a clinical social worker in Rhode Island.
7.4.5Issuance and Renewal of License - Continuing Education
A.Upon the recommendation of the Board, the Director shall issue to applicants who have satisfactorily met the licensure requirements of this part, a license to practice clinical social work in this state. Said license, unless sooner suspended or revoked, shall expire on the first day of May of the next odd year following the date of issuance of the original license.
B.Every licensed person who desires to renew his/her license shall file with the Department a renewal application together with a renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) on or before the first day of May of each odd year.
C.The applicant shall attest to completion of continuing education requirements. Upon receipt of the renewal application and fee, the accuracy of the application shall be verified, and the Department shall grant a renewal license effective the second day of May, and expiring of the first day of May of the next odd numbered year.
D.Any person who allows his or her license to lapse by failing to renew it on or before the first day of May of the next odd year, as provided above may be reinstated by the Department on payment of the current renewal fee plus an additional fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Any person who applies for reinstatement of his/her license shall sign a statement attesting to the Department that the continuing education requirements as stated in this Part for the most recent licensure cycle (i.e., the previous two years) have been met.
1.Any person using the title "clinical social worker" or "independent clinical social worker" or practicing clinical social work during the time that his or her license has lapsed shall be subject to the penalties provided for violations of this Part and the Act.
E.Continuing Education
1.Every person desiring to renew his or her license shall present such evidence as may be required by the Board attesting to the completion of thirty (30) contact hours of continuing social work education during the preceding twenty-four (24) months in accordance with the following requirements:
a.A minimum of three (3) contact hours shall be in the area of cross-cultural practice to include the alleviation of oppression.
b.A minimum of three (3) contact hours shall be in the area of social work professional ethics.
c.Credit may be claimed for serving as a supervisor for students duly enrolled in a program of studies at an accredited social work program at a college or university in accordance with the following:
(1)A maximum of six (6) hours credit may be claimed during a renewal period for either the supervision of a master's level social work student or for the supervision of a bachelor's level social work student for a full academic year.
d.Upon prior agreement with the Board, credit may be claimed for serving as a supervisor to an impaired practitioner or to a practitioner under disciplinary sanction by the Board at the rate of six (6) hours for a one (1) year period of supervision.
F.Continuing education hours will be accepted by the Board for course work, including online courses, that have been presented, accepted, or approved by:
1.The NASW or its local chapter or other state licensing boards of social work;
2.The ASWB;
3.Other recognized social work professional organizations that include but are not limited to the Federation of Clinical Social Work Societies and the National Association of Black Social Workers;
4.Any department or school of social work accredited by the Council on Social Work Education (CSWE) to offer the Master's in Social Work (MSW) degree.
G.Twenty-two (22) hours of the required thirty (30) hours of continuing education in a two- year period shall be contact hours. The remaining eight (8) hours of continuing education may be non-contact hours.
H.At the time of license renewal, each licensee will be required to attest to the fact of having complied with the requirements of §§ 7.4.5(A) through (G) of this Part. Course descriptions, proof of attendance or other documentation of completion will be retained by the licensee for a minimum of four (4) years and is subject to random audit by the Board. Failure to produce satisfactory documentation of completion upon request by the Board constitutes grounds for disciplinary action under the provisions of R.I. Gen. Laws § 5-39.1-10(4).
I.An extension of time to complete continuing education requirements may be granted to a social worker solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
J.Social workers initially licensed after the May 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., April 30th of the next odd numbered year).
7.4.6Social Worker Privilege
Social Work Privilege is set forth in R.I. Gen. Laws § 5-39.1-4.
**History**
- *Amendment — effective from 2023-03-23 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/23/2023*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-7 § 7.5** Grounds for Denial, Suspension, Revocation or Violations and Procedures for Discipline {#sec-216-ricr-40-05-7-7.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-7#7.5}
7.5.1Grounds for Denial, Suspension or Revocation of License/Violations
A.The Director may deny, suspend, revoke, condition, limit or restrict a license in accordance with the provisions set forth in R.I. Gen Laws § 5-39.1-10 and for the following:
1.Violation of any provisions of R.I. Gen. Laws Chapter 5-39.1 or the provisions of the NASW Code of Ethics incorporated in § 7.2 of this Part and as adopted by the Board.
2.Any departure from or failure to conform to the minimal standards of acceptable and prevailing social work practice.
7.5.2Disciplinary Process
Disciplinary procedures are in accordance with the provisions set forth in the R.I. Gen Laws § 5-39.1-12.
7.5.3Disciplinary Sanctions
Disciplinary sanctions are set forth in R.I. Gen Laws § 5-39.1-13.
7.5.4Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 5-39.1 shall be held in accordance with the provisions of and rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1).
**History**
- *Amendment — effective from 2023-03-23 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/23/2023*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-40-05-8** Licensing Doctors of Acupuncture and Oriental Medicine
##### **216-RICR-40-05-8 § 8.1** Authority and Purpose {#sec-216-ricr-40-05-8-8.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.1}
These rules and regulations for licensing Doctors of Acupuncture and Doctors of Acupuncture and Chinese Medicine are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-37.2-7(3), and are established for the purpose of adopting minimum standards for the licensure of Doctors of Acupuncture and Doctors of Acupuncture and Chinese Medicine in this state.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.2** Definitions {#sec-216-ricr-40-05-8-8.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.2}
A."ACAHM" means the Accreditation Commission for Acupuncture and Herbal Medicine.
B."Act" means R.I. Gen. Laws Chapter 5-37.2, entitled, "The Practice of Acupuncture and Chinese Medicine."
C."Acupuncture" means the insertion of needles into the human body for the purpose of regulating physiology.
D."Auricular acudetox," also known as "5 Needle Protocol," "5NP," or "NADA protocol" means as defined in R.I. Gen. Laws § 5-37.2-2(3).
E."Auricular acupuncture technician" or “AAT" means as defined in R.I. Gen. Laws § 5-37.2-2(4).
F."Chinese herbal medicine" means as defined in R.I. Gen. Laws § 5-37.2-2(5).
G."Department" means the Rhode Island Department of Health.
H."Director" means the Director of the Rhode Island Department of Health.
I."Doctor of Acupuncture" means as defined in R.I. Gen. Laws § 5-37.2-2(7).
J."Doctor of Acupuncture and Chinese Medicine" means as defined in R.I. Gen. Laws § 5-37.2-2(8).
K.“General supervision” means as defined in R.I. Gen. Laws § 5-37.2-2(9).
L.“National Acupuncture Detoxification Association” or “NADA” means as defined in R.I. Gen. Laws § 5-37.2-2(10).
M."NCCAOM" means the National Certification Commission for Acupuncture and Oriental Medicine.
N.“Qualified individual” means as defined in R.I. Gen. Laws § 5-37.2-2(11).
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.3** Qualifications for Licensure {#sec-216-ricr-40-05-8-8.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.3}
8.3.1General Requirements
A.Persons licensed and registered as physicians under R.I. Gen. Laws Chapter 5-37 who are authorized to practice acupuncture and Chinese medicine are exempt from the licensure requirements of §§ 8.4 – 8.8 of this Part in accordance with R.I. Gen. Laws § 5-37-20.
B.All Doctors of Acupuncture and Doctors of Acupuncture and Chinese Medicine licensed in accordance with the Act must abide by the NCCAOM Code of Ethics.
8.3.2Doctor of Acupuncture
A.Before any applicant seeking licensure as a Doctor of Acupuncture is eligible for licensure, they must furnish satisfactory proof to the Department that they:
1.Are a United States citizen or legal alien;
2.Have passed the examination administered by the National Commission for the Certification of Acupuncture and Oriental Medicine or any credentialing body meeting the standards for professional certification programs approved by the Department.
3.Have demonstrated proficiency in the English language by successfully completing the test administered by the NCCAOM (or similar credentialing body that meets the standards for professional certification programs approved by the Department) in English or by successfully completing the Test of English as a Foreign Language (TOEFL).
4.Are at least twenty-one (21) years of age.
5.Meet the requirements for completion of an accredited program as specified in R.I. Gen. Laws § 5-37.2-12.1(5).
6.Meet the clinical internship training as designated as appropriate by the National Commission for the Certification of Acupuncture and Oriental Medicine (or any credentialing body meeting the standards for professional certification programs approved by the Department).
7.Have two (2) letters of reference from reputable individuals other than relatives, at least one (1) of which shall be from a licensed or registered acupuncturist.
8.3.3Requirements for a Doctor of Acupuncture and Chinese Medicine License
A.Acupuncture licensees who obtained licensure prior to January 1, 2022, and employ herbal therapy, including herbal formulations, and who submitted evidence of herbal training that the Department has determined was substantially equivalent or exceeded the ACAHM curricular requirements regarding Chinese herbal medicine may continue to employ herbal therapy and may be granted a Doctor of Acupuncture and Chinese Medicine license by the Department.
B.In addition to the licensure requirements of § 8.3.2(A) of this Part, an applicant seeking licensure as a Doctor of Acupuncture and Chinese Medicine may apply by submitting evidence of one (1) of the following:
1.Completion of an ACAHM accredited or candidate status Oriental Medicine program, or traditional Chinese Medicine program, or an herbal medicine program that the Department determines is substantially equivalent or exceeds the ACAHM curriculum requirements regarding herbal medicine; or,
2.A passing score on the NCCAOM exam module for Chinese Herbology.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.4** Application for Licensure and Fees {#sec-216-ricr-40-05-8-8.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.4}
8.4.1Documentation
A.In order to apply for a license as a Doctor of Acupuncture or Doctor of Acupuncture and Chinese Medicine, an applicant must submit the following on forms provided by the Department:
1.Completed application including, but not limited to, name, address, date of birth, social security number, telephone number and email address;
2.Application fee as defined in Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The fee is non-refundable and non-returnable;
3.Two (2) letters of reference from reputable individuals other than relatives, at least one (1) of which shall be from a licensed or registered acupuncturist;
4.A certified copy of birth certificate; or if a certified copy of birth certificate cannot be obtained, immigration papers or resident alien card or such other birth verifying papers acceptable to the Department;
5.The results of the NCCAOM examination submitted to the Department directly by the National Commission for the Certification of Acupuncture and Oriental Medicine which confirms the applicant met the qualifications for the NCCAOM examination.
8.4.2License by Reciprocity
A.The Department may, at its discretion, issue a license without examination to an acupuncturist who has been licensed, certified, or formally legally recognized as an acupuncturist in any state or territory if all of the conditions specified in R.I. Gen. Laws § 5-37.2-12.2 are met to its satisfaction.
B.In order to apply for a license as a Doctor of Acupuncture or Doctor of Acupuncture and Chinese Medicine by reciprocity, an applicant must submit the following on forms provided by the Department:
1.Completed application including, but not limited to, name, address, date of birth, social security number, telephone number and email address;
2.Application fee as defined in Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The fee is non-refundable and non-returnable;
3.Verification that the applicant is licensed and in good standing as an acupuncturist in all states and territories where the applicant has a current license as an acupuncturist or was previously licensed as an acupuncturist.
8.4.3Previously Licensed Doctors of Acupuncture
A.Any Doctor of Acupuncture validly licensed, certified, or registered under a prior law of Rhode Island is considered licensed in accordance with the requirements of R.I. Gen. Laws Chapter 5-37.2. A previously licensed, certified, or registered acupuncturist is only allowed to perform those professional duties and responsibilities which are in accordance with their professional education, training, and/or experience.
B.Any Doctor of Acupuncture or Doctor of Acupuncture and Chinese Medicine licensed in accordance with R.I. Gen. Laws § 5-37.2-12.4 cannot accept or perform professional responsibilities which the licensee knows or has reason to know that they are not qualified by training, experience, or certification to perform. Violation of this section of the Act will subject the licensee to the revocation or suspension of their license.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.5** Issuance of License {#sec-216-ricr-40-05-8-8.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.5}
A license as a Doctor of Acupuncture or Doctor of Acupuncture and Chinese Medicine may be issued to an applicant who meets the relevant requirements for licensure as required by the Act and this Part.
8.5.1Auricular Acudetox and Auricular Acupuncture Technicians
A.An auricular acupuncture technician, qualified and trained to perform auricular acudetox (‘5NP’), may perform the procedure within that individual’s current scope of practice, provided that the individual obtains a certificate of training from a recognized organization or agency that meets or exceeds NADA training.
B.Acudetox may be performed by auricular acupuncture technicians working in, or in collaboration with, behavioral health and healthcare agencies, or other state-approved programs or agencies.
C.Any complaints filed against an auricular acupuncture technician relating to the performance of any 5NP procedure shall be handled by the licensing board or Department in conformance with the requirements of that individual’s healthcare license or certification.
D.Any individual performing auricular acudetox shall not use the title “acupuncturist” or “Doctor of Acupuncture” or “Doctor of Acupuncture and Chinese Medicine,” as defined in R.I. Gen. Laws § 5-37.2-2, or otherwise represent themself as an acupuncture professional and shall not perform acupuncture outside of the scope of the auricular acudetox procedure.
E.Nothing in the Act is intended to limit, interfere with, or prevent a certified auricular acupuncture technician from practicing within the scope of their certification.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.6** Continuing Education {#sec-216-ricr-40-05-8-8.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.6}
A.Mandatory continuing education requirements for a Doctor of Acupuncture or Doctor of Acupuncture and Chinese Medicine licensed in this state, shall include, but not be limited to, the following:
1.Each person licensed under the Act must complete forty (40) hours of continuing education within each biennial (two (2) year) renewal period, except during the initial annual renewal period.
2.Continuing education hours will be accepted by the Department for course work which has been presented, accepted or approved by a nationally recognized acupuncture organization or its local chapter, or any accredited school of Acupuncture and Oriental Medicine.
3.At the time of license renewal, each licensee will be required to attest to having complied with the continuing education requirements of §§ 8.6(A)(1) and (2) of this Part. Course descriptions, proof of attendance or other documentation of completion will be retained by the licensee for a minimum of three (3) years and is subject to random audit by the Department.
a.Failure to produce satisfactory documentation of completion upon request by the Department is grounds for disciplinary action under the provisions of the Act.
4.If a licensee has not completed the required number of continuing education hours, the deficient hours of continuing education must be made up during the following renewal period in addition to the current continuing education requirements for the renewal period. If any Doctor of Acupuncture or Doctor of Acupuncture and Chinese Medicine fails to make up the deficient hours and complete the subsequent renewal period then their license shall not be renewed until all the required hours are completed and documented to the Department.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.7** Renewal of License {#sec-216-ricr-40-05-8-8.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.7}
A.Expiration. The license of every person licensed in accordance with the requirements of the Act and this Part will expire annually on the first (1st) day of February of each year.
B.Renewal. Every licensed person who intends to continue to practice as a Doctor of Acupuncture or a Doctor of Acupuncture and Chinese Medicine must file a renewal application together with the renewal fee as defined in Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The application and renewal fee must be submitted to the Department on or before the thirty-first (31st) day of January in each year. The license renewal will be effective the first (1st) day of February of that year.
C.Failure to Renew
1.If a licensee fails to renew their license on or before the thirty-first (31st) day of January in each year, as required by this Part, the license will expire.
2.An expired license may be renewed by completion of the renewal application and payment of the required fee.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.8** Recording of License and Display of License {#sec-216-ricr-40-05-8-8.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.8}
A.In accordance with R.I. Gen. Laws § 5-37.2-14, every person holding a license to practice Acupuncture or Acupuncture and Chinese Medicine in Rhode Island must record their license with the city or town hall in the city or town where their office or residence are located.
1.Every licensee who changes their residence or office must have his or her license recorded in the municipality to which they have moved their office or residence.
B.Every licensee must display their current license in their office, place of business or place of employment.
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-8 § 8.9** Grounds for Refusal, Revocation or Suspension of License {#sec-216-ricr-40-05-8-8.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-8#8.9}
A.The Department may refuse to issue or may suspend or revoke any license for grounds in accordance with R.I. Gen. Laws § 5-37.2-15.
1.Any license, issued by the Department may be revoked or suspended by the Department for violation of any provisions of the Act, in accordance with R.I. Gen. Laws § 5-37.2-16. No such action may be taken unless twenty (20) days advanced written notice specifying the charge against them is given to the accused licensee. A reasonable opportunity will be given to the accused to present evidence and testimony and to be represented by counsel at a hearing or hearings.
2.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 5-37.2, shall be held in accordance with the provisions of the Act and Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Amendment — effective from 2024-02-12 to current*
- *Periodic Refile — effective from 2022-01-04 to 02/12/2024*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-40-05-9** Licensing of Podiatrists
##### **216-RICR-40-05-9 § 9.1** Authority {#sec-216-ricr-40-05-9-9.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-9#9.1}
These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapters 5-29-4, 5-29-5, and 5-29-13(b), and are established for the purpose of adopting minimum requirements for the licensure of podiatrists in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-9 § 9.2** Definitions {#sec-216-ricr-40-05-9-9.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-9#9.2}
A.Wherever used in these rules and regulations the terms listed below shall be construed in the following manner:
1."Act" means R.I. Gen. Laws Chapter 5-29, entitled "Podiatrists.”
2."Board" means the Board of Examiners in Podiatry established in accordance with the provisions of R.I. Gen. Laws § 5-26-2.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Rhode Island Department of Health.
5."Division" means the Division of Customer Service, Rhode Island Department of Health.
6."Foot" means the pedal extremity of the human body and its articulations, and shall include the soft tissue structures of the lower leg only as they shall be involved in the condition of the foot.
7."Health care facility" means any institutional health service provider licensed pursuant to the provisions of R.I. Gen. Laws Chapter 23-17.
8."Health maintenance organization" means a public or private organization licensed pursuant to the provisions of R.I. Gen. Laws Chapter 27-41.
9."Limited registrant" means a person holding a limited registration certificate pursuant to the provisions of the Act.
10."Nonprofit medical services corporation" or "nonprofit hospital service corporation" or "nonprofit podiatry/medical service corporation" means any corporation organized pursuant to R.I. Gen. Laws Chapters 27-19 or 27-20 for the purpose of establishing, maintaining and operating a nonprofit medical hospital.
11."Peer Review Board" means any committee of a state or local podiatry association or society, or a committee or any licensed health care facility, or the podiatry staff thereof, or any committee of a podiatric care foundation or health maintenance organization, or any staff committee or consultant of a hospital, medical, or podiatric service corporation, the function of which, is to evaluate and improve the quality of podiatric care rendered by providers of podiatric care service or to determine that podiatric care services rendered were professionally indicated or were performed in compliance with the applicable standard of care or that the cost for podiatric care rendered was considered reasonable by the providers of professional podiatric care services in the area and shall include a committee functioning as a utilization review committee under the provisions of the health insurance for the aged act (Medicare) or as a professional standards review organization or statewide professional standards review council under the provisions of Public Law 92-603 and 42 U.S.C. § 1301 et seq. (professional standards review organizations) or a similar committee or a committee of similar purpose, to evaluate or review the diagnosis or treatment of the performance or rendition of podiatric services which are performed under public podiatric programs of either state or federal design.
12."Person" means any individual, partnership, firm, corporation, association, trust or estate, state or political subdivision or instrumentality of a state.
13."Podiatric residency" means post doctoral training sponsored by and primarily conducted in an institution approved by the Council of Podiatric Medical Education of the American Podiatric Medical Association.
14.“Podiatrist” means a person with a license to practice podiatric medicine and surgery in this state under the provisions of the Act. “Podiatrist,” a person licensed as described in the Act, shall be considered a physician and surgeon of the foot and ankle. For the purposes of reimbursement by and for subscriber benefits/participation agreements with health maintenance organizations, nonprofit medical service corporations, for-profit medical service corporations, and third party insurers, it shall be unlawful to discriminate against podiatrists.
15.“Podiatric Medicine” means that profession of the health sciences concerned with the diagnosis and treatment of conditions affecting the human foot and ankle, and their governing and related structures, including the local manifestations of systemic conditions, by all appropriate systems and means.
16."Practice of podiatry" means any person shall be said to be practicing podiatry within the meaning of the Act who uses or permits to be used, directly or indirectly, for profit or otherwise, for himself or for any other person, in connection with his name, the word "podiatrist" or "podiatric physician and surgeon," or the title DPM, or any other words, letters, titles, or descriptive matter, personal or not, which directly or indirectly implies the practice of podiatry, or who owns, leases, maintains, or operates a podiatry business in any office or other room or rooms where podiatry operations are performed, or directly or indirectly is manager, proprietor or conductor of the same; or who directly or indirectly informs the public in any language, orally, in writing, or by drawings, demonstrations, specimens, signs, or pictures that he/she can perform or will attempt to perform foot operations of any kind; or who undertakes, by any means or method, gratuitously or for a salary, fee, money or other reward paid or granted directly or indirectly to himself or to any other person, to diagnose or profess to diagnose, or to treat or profess to treat, or to prescribe for or profess to prescribe for any of the lesions, diseases, disorders, or deficiencies of the pedal extremity. The foot is defined to be the pedal extremity of the human body and its articulations, and shall include the tendons and muscles of the lower leg only as they shall be involved in the condition of the foot.
17."Recognized college or university" means an institution of higher learning approved by the Office of Higher Education of any given state.
18."R.I. Gen. Laws" means Rhode Island General Law, as amended.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-9 § 9.3** Lice n sure Req u irements {#sec-216-ricr-40-05-9-9.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-9#9.3}
9.3.1General Requirements
A.Any person desiring to commence to practice podiatry and to continue to practice podiatry in this state must possess a license to practice podiatry in accordance with the statutory and regulatory requirements of this Part.
1.Furthermore, no person granted a license under the statutory and regulatory provisions herein, shall display or use the title "doctor" or its synonym without the designation of "chiropodist" or "podiatrist" and shall not mislead the public as to the limited professional qualification to treat human ailments pursuant to R.I. Gen. Laws §§ 5-29-23 and 5-29-25.
9.3.2Qualifications for Licensure
A.In addition to the requirements of R.I. Gen. Laws § 5-29-6, an applicant seeking licensure to practice podiatry must:
1.Have satisfactorily completed a residency in Podiatric Medicine and surgery as determined, recognized and accredited by the Council on Podiatric Medical Education of the American Podiatric Medical Association. Said program must also have been accredited by the credentialing body at the time of residency participation.
2.Have satisfactorily passed the National Board of Podiatric Examination and the Podiatric Medical Licensing Examination for States (PM LEXIS Examination).
3.Meet such other requirements as set forth by regulation or as may be established by the Board.
9.3.3Application for Licensure and Fee
A.Application for licensure shall be made on forms provided by the Division which shall be completed and submitted to the Division sixty (60) days prior to the scheduled date of examination.
1.Such application shall be accompanied by the following documents and fee (non-returnable and non-refundable) unless for due cause pursuant to R.I. Gen. Laws § 5-29-7);
2.Three (3) statements of good moral character from reputable individuals in this state other than relatives;
a.For U.S. born: a certified copy of birth certificate;
b.For those born outside the U.S.: proof of citizenship or lawful alien status;
3.Two (2) recent identification photographs of the applicant, head and shoulder front view, approximately 2 x 3 inches in size; one photograph shall be signed on the reverse side by the dean or registrar of the school attesting to the likeness of the photograph to that of the applicant submitted directly by the school;
4.Supporting certified transcripts of education credentials as required in § 9.3.2 of this Part, signed by the dean or registrar of the school or college verifying the dates of attendance and completion of podiatric program. Such documentation must consist of original statements and/or photocopies bearing the signature of the dean or registrar and the imprint of the school and must be sent directly by the school;
5.A statement from a responsible authority for the residency program verifying successful completion of the residency program and submitted directly to the Board, including a certificate of successful completion of the requirements of § 9.3.2 of this Part;
6.The results of the National Board of Podiatric Examination of the National Board of Podiatry Examiners AND the PM LEXIS examination, shall be submitted directly to the Board;
7.A statement from the Board of Podiatry Examiners in each state in which the applicant has held or holds licensure, to be submitted directly to the Board of this state attesting to the licensure status of the applicant during the time period applicant held licensure in said state;
8.The application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
9.Such other information as may be deemed necessary by the Board.
9.3.4Examination
A.By Examination:
1.Applicants shall be required to pass an examination to test the applicant's knowledge and skills to practice podiatry in this state, pursuant to the statutory and regulatory provisions herein.
2.For written examination the Board requires the applicants to successfully pass the National Board of Podiatric Examination, and the PM LEXIS, which can be taken upon satisfactory completion of the didactic requirements herein.
3.The current PMLexis examination fee shall be made payable directly to the National Board of Podiatric Medical Examiners.
B.Re-Examination:
1.The current PMLexis re-examination fee shall be made payable directly to the National Board of Podiatric Medical Examiners.
2.Applicants seeking licensure under this section shall be subject to the same application requirements as listed in § 9.3.3 of this Part.
9.3.5Continuing Education
A.Every podiatrist licensed to practice podiatry in this state under the provisions of the Act and the regulations herein, shall complete at least 30 (thirty) credits of continuing education approved by the Board and completed preceding relicensure and available upon request from the Board. Such approval shall be based on the Standards, Requirements, and Guidelines for Approval of Continuing Education in Podiatric Medicine of the Council on Podiatric Medical Education of the American Podiatry Medical Association.
B.It shall be the sole responsibility of the individual podiatrist to obtain documentation from the approved sponsoring or co-sponsoring organization, agency or other, of his or her participation in a continuing education course including the date, time, sponsoring agency and number of credits obtained.
1.Those documents must be safeguarded by the podiatrist for review by the Board if required. Only a summary list of those documents, not the documents themselves, shall be submitted to the Board with the application for renewal of license.
C.Failure to provide satisfactory evidence of continuing education as required herein shall be cause for denial of license renewal.
9.3.6Limited Registration
A.Except for podiatrists licensed pursuant to the Act, no person shall perform the duties of an intern, resident, fellow or podiatry officer in this state without holding a limited podiatric registration pursuant to R.I. Gen. Laws § 5-29-13, and registered with the Division as a hospital podiatric officer.
1.Hospital podiatric officers may be granted limited podiatric registration for such time as said Division may prescribe, provided the following criteria are met:
a.An application, on behalf of the applicant signed by the administrator/chief executive officer of a hospital licensed in Rhode Island is submitted to the Division accompanied by the following:
(1)A signed statement by the chief of the medical staff attesting to the approval of the applicant's credentials in accordance with the credentialing process of the medical staff by-laws;
(2)A signed statement that the applicant has not previously held a limited podiatric registration;
(3)Information satisfactory to the Board if submitted by the hospital regarding the duties and responsibilities of the applicant and the person to be responsible for the supervision of the applicant; and
b.Limited podiatric registration issued to a hospital podiatric officer under the provisions herein shall be valid for a period of not more than one (1) year from the date of issuance and may be renewed annually at the discretion of the Board.
B.In addition to the requirements of R.I. Gen. Laws § 5-29-13:
1.It shall be the responsibility of each hospital, clinic, or other institution to submit, on or before the first of June of each year to the Division for its approval, a list of affiliated hospitals, institutions, clinics or programs providing training programs for interns, residents, fellow or podiatric officers.
2.Any hospital, clinic or institution providing training programs for interns, residents, fellows, or podiatric officers, which are subject to statutory licensure in this state, must hold a current license as may be required.
C.Application For Limited Registration
1.In addition to the requirements of R.I. Gen. Laws § 5-29-13, an applicant for limited podiatric registration shall submit through the hospital, institution or clinic, to the Division such other information as may be deemed necessary.
2.A registration fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) must accompany each application for limited podiatric registration.
9.3.7Issuance and Renewal of License and Limited Registration
A.Licensure:
1.Upon completion of the aforementioned requirements, the Director may issue a license to those applicants found to have satisfactorily met all the requirements herein. Said license unless sooner suspended or revoked shall expire biennially on the date of expiration.
2.Thirty days prior to expiration date of license, the Administrator of the Division shall mail an application for renewal of license to every person whose license expires. Every person licensed who intends to engage in podiatry during the ensuing year, shall file a renewal application duly executed together with the renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The renewal fee shall be accompanied by evidence of completion of the requirements of § 9.3.5 of this Part.
B.Limited Registration:
1.A limited registration certificate shall be issued by the Division to applicants who have submitted credentials found to be satisfactory pursuant to § 9.3.6 of this Part. Furthermore, the limited podiatric registration shall be issued through the hospital, clinic, institution or other program designated on the application for limited podiatric registration and approved by the Division.
2.Limited podiatric registration for hospital podiatric officer shall be valid for a period of not more than one (1) year from the date of issuance and may be renewed at the discretion of the Division.
C.Limited Registration: Academic Faculty
1.The requirements for limited registration of academic faculty are pursuant to R.I. Gen. Laws § 5-29-14.
9.3.8Practice of Podiatry
A.Podiatrists licensed to practice podiatry in this state shall be governed by the prevailing standards of practice.
B.Furthermore, the requirements for persons licensed to practice podiatry regarding advertising are pursuant to R.I. Gen. Laws § 5-29-25.
9.3.9Denial, Suspension or Revocation of License
A.The license of any podiatrist violating any of the provisions of the Act and the regulations herein, after such person has been afforded an opportunity to be heard by the Board may be suspended for a period of not less than sixty (60) days; provided however, that if the license of such person has previously been suspended for a prior violation, then after such hearing, the Board may either revoke the license of such person or suspend the same for a period of not less than six (6) months.
B.Furthermore, the Board may suspend, revoke or otherwise sanction the license of any podiatrist, after due notice and hearing, if the licensee is found:
1.Not to be of good moral character;
2.To have violated any of the laws of the state involving moral turpitude or affecting the ability of any podiatrist to practice podiatry;
3.To have been guilty of any fraud or deception committed in obtaining such license; and/or
4.To be guilty of gross unprofessional conduct or conduct of a character likely to deceive or defraud the public. Gross unprofessional conduct shall include but not be limited to those provisions as set forth in R.I. Gen. Laws § 5-29-16.
5.Sexual contact between a podiatrist and patient during the existence of the podiatrist/patient relationship is unprofessional conduct
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-9 § 9.4** Violations / Practices and Proce d ures / Severability {#sec-216-ricr-40-05-9-9.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-9#9.4}
9.4.1Violations
Any person who violates the provisions of the Act and the regulations herein shall be subject to the appropriate sanctions of R.I. Gen. Laws §§ 5-29-23, 5-29-33, 5-29-34, and 5-29-36.
9.4.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act and the rules and regulations herein, shall be held in accordance with the provisions of the rules and regulations of the Rhode Island Department of Health, the Rules and Regulations of the Rhode Island Department of Health Regarding the Practices and Procedures Before the Department of Health and Access to Public Records of the Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/30/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-40-05-10** Massage Therapists
##### **216-RICR-40-05-10 § 10.1** Authority {#sec-216-ricr-40-05-10-10.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-20.8-4(1), and are established for the purpose of defining prevailing standards for the licensure of massage therapists consistent with statutory provisions.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.2** Incorporated Materials {#sec-216-ricr-40-05-10-10.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.2}
A.These Regulations hereby adopt and incorporate the National Certification Board for Therapeutic Massage & Bodywork (NCBTMB) Standards of Practice (September 2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the National Certification Board for Therapeutic Massage & Bodywork (NCBTMB) Code of Ethics (September 2017) by reference, not including any further editions or amendments thereof and only to the extent the provisions therein are not inconsistent with these Regulations.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.3** Definitions {#sec-216-ricr-40-05-10-10.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.3}
A.Wherever used in this Part the following terms shall be construed to mean:
1.“Act” means R.I. Gen. Laws Chapter 23-20.8, entitled “Licensing of Massage Therapists.”
2."Approved school" means any school or institution of learning that is accredited by an agency recognized by the United States Department of Education, approved by a State Board of Education, or other State agency responsible for approving schools or institutions of learning, or whose curriculum is endorsed by the Commission on Massage Therapy Accreditation (COMTA).
3."Continuing education units" means an instructional period of at least fifty (50) continuous minutes per hour in a recognized or approved course as outlined in § 10.8 of this Part.
4.“Department” means the Rhode Island Department of Health.
5.“Director” means the Director of the Rhode Island Department of Health.
6.“Disqualifying information” means offenses including but not limited to those offenses defined in R.I. Gen. Laws Chapters 11-34, 11-34.1, 11-37 and R.I. Gen. Laws § 23-17-37.
7."Licensing agency" means the Rhode Island Department of Health.
8."Massage" means activities as set forth in R.I. Gen Laws Chapters 23-20.8-1(5).
9."Massage therapist" means a person engaged in the practice of massage who has completed a program in or is certified by a school or institution of learning that is an approved school meeting the requirements of R.I. Gen. Laws § 23-20.8-5 and § 10.5(B) of this Part as approved by the Department, other than a correspondence course, which school or institution has for its purpose the teaching of the theory, practice, method, profession, or work of massage, including at least anatomy, physiology, hygiene and professional ethics, pursuant to the statutory provisions.
10."Massage therapy" means activities as set forth in R.I. Gen Laws § 23-20.8-1(7).
11."Person" means any individual, group of individuals, firm, corporation, association, partnership or private or public entity, including a district, county, city, town or other governmental unit or agent thereof, and in the case of a corporation, any individual having active or general supervision of properties of such and corporation.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.4** Licensing Requirements {#sec-216-ricr-40-05-10-10.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.4}
A.Any individual practicing or offering to practice massage, except persons exempt under the provisions of R.I. Gen. Laws § 23-20.8-9 and § 10.4(B) of this Part shall hold a valid and active license to practice massage therapy issued by the Rhode Island Department of Health.
B.Persons Exempt
1.In addition to the provisions of R.I. Gen. Laws § 23-20.8-9, nothing contained in this Part shall prohibit:
a.The practice of massage by any person who is authorized to practice medicine, nursing, osteopathy, physiotherapy, chiropractic, or podiatry in this state.
b.The practice of massage that is customarily given in barber shops or beauty parlors for the purpose of beautification by any licensed barber, hairdresser, or esthetician.
c.The practice of massage by any person employed in a medical institution licensed or chartered by the state or enrolled in a program of a school or institute of massage approved by the board of regents.
d.The practice of massage by any person duly employed as a certified athletic trainer by a professional athletic association, club, or team, or as a member of the physical education department of an accredited university, college, or high school.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.5** Qualifications for Licensure {#sec-216-ricr-40-05-10-10.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.5}
A.In addition to the requirements of R.I. Gen. Laws § 23-20.8-5, an applicant for a license to practice massage therapy in Rhode Island shall:
1.Be a graduate of an approved school as defined in § 10.3 of this Part.
2.The curriculum shall have consisted of at least six hundred fifty (650) hours which included study and practical training specifically designed to provide knowledge and skills necessary for the practice of massage. The content of the six hundred fifty (650) hour program shall include no less than the following classroom subjects, including practical training:
a.Anatomy, physiology and kinesiology
b.Supervised theory and practice
c.Clinical Assessment and bodywork competency
d.Pathology
e.Elective subjects, including first aid and cardiopulmonary resuscitation {CPR}, and any of the following: ethics, boundaries, regulations and guidelines for professional practice, business practices/law, or office procedures
3.Successfully completed the Federation of State Massage Therapy Boards (FSMTB) Massage and Bodywork Licensing Examination (MBLEx); or other examination as approved by the Department.
4.Online and/ or correspondence courses shall not be recognized as acceptable equivalents for practical training and curriculum.
B.Endorsement
1.A license to practice massage therapy by endorsement may be issued to an applicant if the state or territory in which the applicant received their education is equal to or exceeds the requirements set forth in R.I. Gen. Laws § 23-20-8-5 and this Part.
C.Foreign Trained
1.An applicant who has completed a program in a school or institute of massage outside of the United States shall submit evidence of having graduated from a school or institute of massage whose curriculum substantially meets the requirements of § 10.5(B) of this Part and of holding a valid license, permit, certificate or registration to practice massage issued by a foreign country, and in addition may be subject to an examination.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.6** Application for Licensure and Fee {#sec-216-ricr-40-05-10-10.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.6}
A.Application for licensure shall be made on such forms as shall be provided by the licensing agency and shall be accompanied by the following documents:
1.The initial licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.Supporting credentials of education, training, and other requirements of § 10.5 of this Part; and
3.Results of a criminal background check. Applicants shall apply to the Bureau of Criminal Identification of the State Police or local police department for a nationwide criminal records check. Fingerprinting shall be required. Upon the discovery of any disqualifying information as defined herein, the bureau of criminal identification of the state police or the local police department shall inform the applicant, in writing, of the nature of the disqualifying information. The applicant shall be responsible for payment of the costs of the criminal records check.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.7** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-10-10.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.7}
A.Upon approval, the licensing agency shall issue a license or renewal thereof, for a period of one (1) year. Said license, unless sooner suspended or revoked, shall expire on the thirtieth (30th) day of June following its issuance and may be renewed from year to year after approval by the Department, provided the applicant meets the requirements of the rules and regulations of this Part and the statutory provisions of R.I. Gen. Laws Chapter 23-20.8.
B.An annual license renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) shall accompany each application for licensure renewal.
C.Any licensee who allows his or her license to expire may have the license renewed by submitting a renewal application and accompanying documents as required under § 10.8 of this Part and renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
D.Any licensee who allows his or her license to lapse for more than one (1) license cycle may have the license reinstated by submitting a reinstatement application and a renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). In addition, the applicant must submit current results of a criminal background check. Applicants shall apply to the bureau of criminal identification of the state police or local police department for a nationwide criminal records check that includes fingerprinting.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.8** Continuing Education {#sec-216-ricr-40-05-10-10.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.8}
A.On application for renewal of license, massage therapists must show proof of participation in six (6) continuing education units (annually) in scope of practice specific offerings that may include, but not limited to: formal presentations, conferences, coursework from a regionally accredited college/university and/or self-study course, such as online courses (awarded one education unit for each hour completed) and ethics.
B.It is the sole responsibility of the massage therapists to obtain documentation (e.g. course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
C.A licensee who fails to complete the continuing education requirements described may be subject to disciplinary action pursuant to R.I. Gen. Laws § 23-20.8-6.
D.A license may be denied to any applicant who fails to provide satisfactory evidence of completion of continuing education relevant to massage therapy as required in this Part.
E.The board may waive the requirement for these educational requirements if the board is satisfied that the applicant has suffered hardship, which may have prevented meeting the educational requirements.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.9** The Practice of Massage {#sec-216-ricr-40-05-10-10.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.9}
A.The license to practice massage authorizes the holder to engage in applying a scientific system of activity as defined herein and in accordance with the provisions of R.I. Gen. Laws Chapter 23-20.8.
B.Only individuals licensed in Rhode Island under the provisions of R.I. Gen. Laws Chapter 23-20.8 and this Part, shall practice massage and use the title “Massage Therapist.” No person, firm, partnership or corporation shall describe its services in any manner under the title "massage" unless such services as defined hereunder are performed by a person licensed to practice massage. Only a person licensed under R.I. Gen. Laws § 23-20.8-3 and this Part as a massage therapist may use the title "massage therapist," “licensed massage therapist,” and the abbreviation “LMT.”
C.Licensed practitioners shall maintain and be governed by acceptable sanitary, safe and scientific standards of practice in accordance with National Certification Board for Therapeutic Massage and Bodywork (NCBTMB), Standards of Practice incorporated above by reference at § 10.2(A) of this Part.
D.Licensed practitioners shall conduct his or her professional activities in accordance with the National Certification Board for Therapeutic Massage and Bodywork (NCBTMB), Code of Ethics incorporated above by reference at § 10.2(B) of this Part.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.10** Denial, Suspension or Revocation of License {#sec-216-ricr-40-05-10-10.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.10}
A.The denial, suspension or revocation of a license is in accordance with the provisions of R.I. Gen. Laws § 23-20.8-6. In addition, the Director may deny issuance of a license or renewal of license to any individual, or pending an investigation and hearing, suspend for a period not exceeding ninety (90) days any license issued under this Part, and/or after due notice and hearing, revoke the license of any massage therapist who:
1.Is convicted of any offense which is a felony under the laws of Rhode Island, the record of conviction being conclusive evidence thereof;
2.Supplies false information to the licensing agency on the application for licensure or application for licensure renewal;
3.Fails to comply with the statutory and regulatory provisions herein.
B.An applicant whose criminal records check reveals a conviction for any sexual offense, including, but not limited to, those offenses defined in R.I. Gen. Laws Chapters 11-34 and 11-37, shall be denied a license under the Act and this Part.
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
##### **216-RICR-40-05-10 § 10.11** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-10-10.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-10#10.11}
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-20.8, shall be held in accordance with the provisions of the Act and Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Technical Revision — effective from 2024-03-20 to current*
- *Amendment — effective from 2024-03-20 to 03/20/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/20/2024*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2009-02-03 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 02/03/2009*
- *Amendment — effective from 2002-04-15 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/15/2002*
#### **216-RICR-40-05-11** Licensing Clinical Mental Health Counselors and Marriage and Family Therapists
##### **216-RICR-40-05-11 § 11.1** Authority {#sec-216-ricr-40-05-11-11.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-11#11.1}
This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapter 5-63.2 for the purpose of adopting prevailing standards pertaining to the licensure of mental health counselors and marriage and family therapists in this state.
**History**
- *Amendment — effective from 2023-05-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/15/2023*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-11 § 11.2** Definitions {#sec-216-ricr-40-05-11-11.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-11#11.2}
A.In addition to the definitions within R.I. Gen. Laws Chapter 5-63.2, the following terms shall be construed as follows:
1."Act" refers to R.I. Gen. Laws Chapter 5-63.2, entitled, "Clinical Mental Health Counselors and Marriage and Family Therapists."
2.“Allied field” means counselor education, psychology, marriage and family therapy, counseling psychology, community mental health, education with a concentration in counseling or psychology, or other field determined by the Board to be an allied field. Said allied field shall include all components of the core curriculum, as it appears in § 11.5.1 of this Part entitled “The Core Curriculum: Clinical Mental Health Counselors” or in 11.5.2 of this Part entitled “The Core Curriculum: Marriage and Family Therapists”.
3."Board" means the Board of Clinical Mental Health Counselors and Marriage and Family Therapists.
4.“CACREP” means Counsel for Accreditation of Counseling & Related Educational programs.
5."Clinical counselor in mental health" means a person who has been licensed pursuant to R.I. Gen. Laws § 5-63.2-9, which license is in force and not suspended or revoked as of the particular time in question.
6.“Clinical instruction” means all supervised course work within which the student has the opportunity to engage in a broad range of clinical activities similar to those performed by a licensed counselor/therapist. This includes all practice and internships completed within a student’s program.
7."The practice of clinical mental health counseling,” in addition to the definition in R.I. Gen. Laws Chapter 5-63.2, includes the following professional services:
a.Promoting mental health and wellness, which includes the achievement of social, career, and emotional development across the lifespan, as well as preventing and treating mental disorders and providing crisis intervention.
b.Psychotherapy, diagnosis, evaluation, administration of assessments, tests, and appraisals, referral, and treatment of behavioral, emotional, addiction and mental disorders, and establishment of counseling treatment plans for individuals, couples, groups, and families with emotional, mental, addiction, and physical disorders.
c.Consultation and program evaluation, program administration within and to schools and organizations, and training and supervision of interns, trainees, and pre-licensed professional counselors through accepted and established principles, methods, procedures, and ethics of counselor supervision.
d.The practice of clinical mental health counseling does not include functions or practices that are not within the professional’s training or education.
8."Department" means the Rhode Island Department of Health.
9."Director" means the Director of the Rhode Island Department of Health.
10.“Individual (face-to-face) supervision” means a tutorial relationship between a member of the mental health counseling profession and a student trainee. The supervisor monitors the clinical work of the trainee in order to evaluate this work, monitor the quality of services being offered to clients, and enhance the professional growth of the trainee.
11."Internship" means a part of an organized graduate or post-graduate program in counseling therapy and shall constitute a supervised experience within a mental health and/or marriage and family setting.
12.“Marriage and family therapist” means a person who has been licensed pursuant to R.I. Gen. Laws § 5-63.2-10 which license is in force and not suspended or revoked as of the particular time in question.
13.“This Part” means Rules and Regulations for Licensing Clinical Mental Health Counselors and Marriage and Family Therapists.
14."Person" means any individual, firm, corporation, partnership, organization or body politic.
15."Practice of marriage and family therapy" means the rendering of professional services to individuals, family groups, couples or organizations for monetary compensation. These professional services would include applying principles, methods, and therapeutic techniques for the purpose of resolving emotional conflicts, modifying perceptions and behavior, enhancing communications and understanding among all family members and the prevention of family and individual crisis. Individual marriage and family therapists also engage in psychotherapy of a nonmedical and nonpsychotic nature with appropriate referrals to psychiatric resources.
16."Practicum" means a part of an organized graduate program or post-graduate program in counseling therapy and shall constitute a supervised experience within the graduate counseling program or post-graduate program.
17."Recognized educational institution" means any educational institution which grants a Bachelor's, Master's, or Doctoral degree, and which is recognized by the Board of Clinical Mental Health Counselors and Marriage and Family Therapy Examiners or a recognized post-graduate clinical training program as specified in R.I. Gen. Laws §§ 5-63.2-9 and 5-63.2-10.
18.“R.I. Gen. Laws” means Rhode Island General Laws, as amended.
19."Use a title or description of" means to hold oneself out to the public as having a particular status by means of stating on signs, mailboxes, address plates, stationery, announcements, calling cards or other instruments of professional identification.
**History**
- *Amendment — effective from 2023-05-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/15/2023*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-11 § 11.3** Professional Licensing Requirements {#sec-216-ricr-40-05-11-11.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-11#11.3}
11.3.1Qualifications of Licensed Clinical Mental Health Counselor Associates and Licensed Clinical Mental Health Counselors
In addition to the requirements of R.I. Gen. Laws § 5-63.2-9, an applicant for licensure shall submit to the Board written evidence on forms furnished by the Department that said applicant has followed an approved pathway for licensure.
11.3.2Clinical Mental Health Counselor Associate
A.A license as a "clinical mental health counselor associate" shall be issued to an applicant who meets the following qualifications:
1.Has completed the following degree requirements:
a.Has received a master’s or higher level degree from a program accredited by CACREP; or an equivalent accrediting agency approved by both the board and by the cognizable national or regional certifying authority OR
b.Has received a master’s degree or certificate in advanced graduate studies or a doctoral degree in mental health counseling from a recognized educational institution, or a graduate degree in an allied field from a recognized educational institution and a graduate level course work that is equivalent to a master’s degree in mental health counseling. Coursework must include the required components of the Core Curriculum as indicated in § 11.5.1 of this Part AND
c.Has completed sixty (60) semester credit hours or ninety (90) quarter hours within their graduate counseling/therapy program or post graduate program. The sixty (60) semester credit hours or ninety (90) quarter hours must be received prior to beginning post graduate experience and supervised case work hours.
2.Has completed the following educational practicum and internship requirements:
a.Completed requisite CACREP expectations for internship and practicum; OR
b.Twelve (12) semester credit hours or eighteen (18) quarter hours of supervised practicum and a minimum of one (1) calendar year of supervised internship consisting of twenty (20) hours per week deemed equivalent by the Board but in no case less than six hundred (600) hours.
11.3.3Clinical Mental Health Counselor
A.A license as a "clinical mental health counselor" shall be issued to an applicant who has met the qualifications of a clinical mental health counselor associate as above and also meets the following qualifications:
1.Is of good character;
2.Has completed a minimum of two (2) years of relevant postgraduate experience, including at least two thousand (2,000) hours of direct client contact offering clinical or counseling or therapy services with emphasis in mental health counseling subsequent to being awarded a master's degree, certificate of advanced graduate study, or doctorate;
3.Has a minimum of one hundred (100) hours of post-degree supervised case work spread over a two-year (2) period; provided, that the supervision was provided by a person who, at the time of rendering the supervision, was recognized by the board as an approved supervisor;
4.Successfully completes the National Clinical Mental Health Counselor Examination of the National Board of Certified Counselors (NBCC) or other examination approved by the Board to determine the applicant's qualification for licensure as a clinical mental health counselor or is applying for licensure under the provisions of R.I. Gen. Laws § 5-63.2-15.
B.An approved supervisor has completed post graduate experience and supervised case work hours as required in R.I. Gen. Laws § 5-63.2-9 by a person who at the time of rendering the supervision is recognized by the Board as an approved supervisor under the following requirements:
1.Must be a licensed clinical mental health counselor, a licensed psychiatrist, a licensed psychologist, a licensed marriage and family therapist, or a licensed independent clinical social worker, who has been licensed in good standing for at least five (5) years and has at least five (5) years of clinical experience as a licensee AND:
2.Has successfully completed one graduate course in supervision in counseling, taken at an institution of higher learning OR
3.Is approved by the National Clinical Mental Health Counselor Examination of the National Board of Certified Counselors (NBCC) as a certified supervisor; OR
4.Has at least two (2) years’ experience supervising clinical staff in a mental health setting
11.3.4Qualifications of Licensed Marriage and Family Therapist Associates and Licensed Marriage and Family Therapists
In addition to the requirements of R.I. Gen. Laws § 5-63.2-10, an applicant for licensure shall submit to the Board written evidence on forms furnished by the Department that said applicant.
11.3.5Marriage and Family Therapist Associate
A.A license as a "marriage and family therapist associate" shall be issued to an applicant who meets the following qualifications:
1.Is of good character;
2.Has completed the following degree requirements:
a.Has completed a master’s degree or certificate in advanced graduate studies or doctoral degree in marriage and family therapy from a recognized educational institution, or a graduate degree in an allied field from a recognized educational institution and graduate level course work that is equivalent to a master’s degree in marriage and family therapy and must include the required components of the Core Curriculum as indicated in § 11.5.2 of this Part AND
b.Has completed sixty (60) semester credit hours or ninety (90) quarter hours within their graduate degree or post-graduate degree program specializing in marital and family therapy.
3.Has completed the following educational practicum and internship requirements:
a.Has completed a minimum of twelve (12) semester credit hours or eighteen (18) quarter hours of supervised practicum AND
b.Has completed a one (1) calendar year of supervised internship consisting of twenty (20) hours per week deemed equivalent by the Board.
11.3.6Marriage and Family Therapist
A.A license as a "marriage and family therapist" shall be issued to an applicant who has met the qualifications of a marriage and family therapist associate as above and also meets the following qualifications:
1.Has had a minimum of two (2) years of relevant postgraduate experience, including at least two thousand (2,000) hours of direct client contact offering clinical or counseling or therapy services with emphasis in marriage and family therapy subsequent to being awarded a master's degree or doctorate; and
2.Has had a minimum of one hundred (100) hours of post-degree supervised case work spread over two years (2); provided, that the supervision was provided by a person who, at the time of rendering the supervision, was recognized by the board as an approved supervisor; and
3.Has passed to the satisfaction of the board an examination conducted by it to determine the applicant's qualifications for licensure as a marriage and family therapist or is applying for licensure under the provisions of R.I. Gen. Laws § 5-63.2-15.
4.Successfully completes the Association of Marital and Family Therapy Regulatory Boards (AMFTRB) or other examination approved by the Board to determine the applicant's qualification for licensure as a marriage and family therapist or is applying for licensure under the provisions of R.I. Gen. Laws § 5-63.2-15.
B.An approved supervisor has completed post graduate experience and supervised case work hours as required in R.I. Gen. Laws § 5-63.2-10 by a person who at the time of rendering the supervision is recognized by the Board as an approved supervisor under the following requirements:
1.Is duly certified as a supervisor by the American Association for Marriage and Family Therapy (AAMFT); OR
2.Is a licensed marriage and family therapist who has been licensed in good standing for at least five (5) years and has at least five (5) years of clinical experience as a licensee; AND
3.Has successfully completed one graduate-level course in MFT supervision; OR
4.Has successfully completed one (1) MFT supervision course taken through the American Association for Marriage and Family Therapy (AAMFT)/Rhode Island Association for Marriage and Family Therapy (RIAMFT).
11.3.7Application for Licensure and Fees
A.Application for license to practice as a clinical mental health counselor or a marriage and family therapist shall be made on forms provided by the Department, which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting at which they are to be reviewed.
B.Such application shall be accompanied by the following:
A non-refundable application fee as set forth in the rules and regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (216-RICR-10-05-2). In no case shall said fee be returned. Applicants requiring reexamination shall submit a fee as set forth in 216-RICR-10-05-2 for each reexamination.
11.3.8Examination of Applicants
Examination requirements are stated in R.I. Gen. Laws § 5-63.2-14.
11.3.9Endorsement for Licensure
In addition to the requirements in R.I. Gen. Laws § 5-63.2-15, an applicant who is a licensed clinical mental health counselor in another state whose qualifying degree is awarded by a CACREP accredited program in clinical mental health counseling totaling sixty (60) or more semester hours shall be considered equivalent to the requirement established pursuant to the Act.
11.3.10Expiration and Renewal of License
A.Licensed clinical mental health counselor or licensed marriage and family therapists shall abide by all expiration and renewal of licensure requirements in R.I. Gen. Laws § 5-63.2-17.
B.Every clinical mental health counselor and marriage and family therapist who desires to continue licensure as a licensed clinical mental health counselor or licensed marriage and family therapist shall attest to the Department that the licensed clinical mental health counselor or licensed marriage and family therapist has completed a prescribed course of continuing education in accordance with the requirements of § 11.3.12 of this Part.
C.Licenses for Clinical Mental Health Counselor Associates and Marriage and Family Therapist Associates shall expire three (3) years from the date of issuance. However, for good cause shown, a one (1) year extension of the Associate license may be granted to complete all postgraduate requirements, as approved by the Board in its discretion.
11.3.11Transfer to Inactive Lists – Reinstatement
A licensed clinical mental health counselor and/or licensed marriage and family therapist whose name has been transferred to the inactive list pursuant to R.I. Gen. Laws § 5-63.2-19 who wishes to be reinstated must, in addition to the provisions of R.I. Gen. Laws § 5-63.2-19, submit an application and fees to the Department, attesting to the completion of the continuing education requirements in accordance with § 11.3.12 of this Part within the immediate two (2) years prior to the applicant’s request for licensure reactivation, unless the license has been suspended or revoked.
11.3.12Continuing Education Requirements
A.The application for license renewal shall include satisfactory evidence of completion of forty (40) credits of continuing education relevant to the practice of clinical mental health counseling or marriage and family therapy practice, completed over the two (2) year period preceding re-licensure. Furthermore, a minimum of twenty (20) of the forty (40) credits of continuing education shall be completed within Category 1 of § 11.3.12(C) of this Part.
B.Continuing education programs sponsored or approved by the following organizations are deemed to be approved by the Board: American Counseling Association (ACA), American Mental Health Counselors Association (AMHCA), National Board for Certified Counselors, Inc. (NBCC), American Association for Marriage and Family Therapy (AAMFT), Rhode Island Mental Health Counselors Association (RIMHCA), Rhode Island Counseling Association (RICA), Rhode Island Association for Marriage and Family Therapist (RIAMFT), National Association of Social Workers (NASW), American Psychological Association (APA), American Medical Association (AMA) or such other nationally-recognized organizations, as approved by the Board.
C.Categories of Continuing Education Programs and Credits:
1.The Board recognizes the following categories of continuing education programs and/or activities and established credit hours.
Category I: Formal continuing education program that may consist of graduate or post-graduate courses, workshops, and/or institutes, including web-based offerings.
Credit: 1 credit per hour; minimum twenty (20) credits per two (2) year cycle.
Category II: Exceptional contributions to professional development that may consist of: a written publication in a peer-reviewed journal, teaching a relevant, semester-long course in an accredited institution, serving as an elected officer on national or international organizations (e.g., ACA, NBCC, AAMFT). Participation by duly appointed members of the Board in regular Board meetings and investigating committee meetings shall be considered acceptable on an hours served basis for Category II credit.
Credit: ten (10) credits for each publication or formal lecture twenty (20) credits for national or international contribution.
D.An extension of time to complete the continuing education requirements may be granted to a clinical mental health counselor or marriage and family therapist solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
E.It shall be the sole responsibility of the individual clinical mental health counselor or marriage and family therapist to obtain documentation from the approved sponsoring or co-sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity that shall include no less than the date, time, subject matter, name of lecturer or teacher, or such other data, and the number of credits earned. Those documents shall be retained by each licensee for no less than four (4) years (i.e., from the date of license renewal) and are subject to random audit by the Department.
F.A license shall be denied to any applicant who fails to provide satisfactory evidence of continuing education relevant to counseling/family studies as required in this Part.
G.Clinical mental health counselors or marriage and family therapists initially licensed by examination after the July 1st renewal date shall be exempt from the continuing education requirements stated herein until the date of the next renewal cycle (i.e., June 30th of the next even-numbered year).
H.A clinical mental health counselor or marriage and family therapist whose license has been revoked for failing to satisfy the continuing education requirements of this Part shall be required to complete such additional continuing education credits as may be required by the Board for the preceding two (2) year cycle.
I.Failure to comply with any provisions of this section shall be subject to the sanctions set forth in the Act.
11.3.13Privileged Communications
The provisions of R.I. Gen. Laws Chapters 9-17 and 5-37.3, shall apply to persons licensed pursuant to the Act and the rules and regulations herein.
**History**
- *Amendment — effective from 2023-05-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/15/2023*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-11 § 11.4** Grounds For Discipline, Penalties for Violations and Prohibited Acts {#sec-216-ricr-40-05-11-11.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-11#11.4}
11.4.1Grounds for Discipline
In addition to the grounds for discipline set forth in R.I. Gen. Laws § 5-63.2-21, the Board shall have the power to deny, revoke or suspend any registration applied for or issued by the Department or otherwise discipline a licensed clinical mental health counselor and/or a licensed marriage and family therapist upon proof that the person has departed from or has failed to conform to the minimal standards of acceptable and prevailing practice of mental health counseling and/or marriage and family therapy and adhere to the National Board of Certified Counselors (NBCC) Code of Ethics adopted by the Board.
11.4.2Criminal Penalties for Violations
Criminal penalties for violation of authorizing act are set forth in R.I. Gen. Laws § 5-63.2-23.
11.4.3Prohibited Acts
Except as specifically provided elsewhere in R.I. Gen. Laws Chapter 5-63.2, no person who is not licensed under this Part shall violate the provisions of R.I. Gen. Laws § 5-63.2-11.
11.4.4Exemptions
Exemptions to this Part and authorizing statute are stated in R.I. Gen. Laws § 5-63.2-12.
11.4.5Rules Governing Practices and Procedures
All hearing and reviews required under the provisions of R.I. Gen. Laws Chapter 5-63.2, shall be held in accordance with the provisions of the Act and the "Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health".
**History**
- *Amendment — effective from 2023-05-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/15/2023*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-11 § 11.5** Core Curriculum {#sec-216-ricr-40-05-11-11.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-11#11.5}
11.5.1The Core Curriculum: Clinical Mental Health Counselors
A.An applicant needs to complete courses in each of the following eight (8) categories, in accordance with the minimum number of credits required in each category, for a total of thirty (30) credits:
1.Helping relationships and counseling theory (nine (9) credits minimum) (i.e., counseling and consultation theories including both individual and systems perspectives as well as coverage of relevant research and factors considered in applications; basic interviewing, assessment, and counseling skills; counselor or consultant characteristics and behaviors that influence helping processes including age, gender, and ethnic differences, verbal and nonverbal behaviors and personal characteristics, orientation, and skills; client or consultee characteristics and behaviors that influence helping processes including age, gender and ethnic differences, verbal and non- verbal behaviors and personal characteristics, traits, capabilities, and life circumstances; and ethical considerations, counseling processes, counseling theories, marriage and family counseling, family counseling, systems concepts).
2.Human growth and development (three (3) credits minimum) (i.e., theories of individual and family development and transitions across the life-span; theories of learning and personality development; human behavior including an understanding of developmental crises, disability, addictive behavior, psychopathology, and environmental factors as they affect both normal and abnormal behavior; strategies for facilitating development over the life-span; ethical considerations).
3.Social and cultural foundations (three (3) credits minimum) (i.e., multicultural and pluralistic trends including characteristics and concerns of diverse groups; attitudes and behavior based on such factors as age, race, religious preference, physical disability, sexual orientation, ethnicity and culture, family patterns, gender, socioeconomic status, and intellectual ability; individual family, and group strategies with diverse populations; and ethical considerations).
4.Groups (three (3) credits minimum) (i.e., principles of group dynamics including group process components, developmental stage theories, group members’ roles and behaviors; group leadership styles and approaches including characteristics of various types of group leaders and leadership styles; theories of group counseling including commonalities, distinguishing characteristics, and pertinent research and literature; group counseling methods including group counselor orientations and behaviors, ethical standards, appropriate selection criteria and methods, and methods of evaluation of effectiveness; approaches used for other types of group work, including task groups, prevention groups, support groups, and therapy groups; and ethical considerations).
5.Lifestyle and career development (three (3) credits minimum) (i.e., career development theories and decision making models; career, avocational, educational and labor market information resources, visual and print media, computer based career information systems; career development program planning, organization, implementation, administration and evaluation; interrelationships among work, family, and other life roles and factors including multicultural and gender issues as related to career development; career and educational placement, follow-up and evaluation; assessment instruments and techniques relevant to career planning and decision making; computer based career development applications and strategies, including computer assisted career guidance systems; career counseling processes, techniques and resources including those applicable to specific populations; and ethical considerations).
6.Appraisal (three (3) credits minimum) (i.e., theoretical and historical bases for assessment techniques; validity including evidence for establishing content, construct and empirical validity; reliability including methods of establishing stability, internal and equivalence reliability; appraisal methods including environmental assessment, performance assessment, individual and group test and inventory methods; behavioral observations, and computer managed and computer assisted methods; psychometric statistics including types of assessment scores, measures of central tendency, indices of variability, standards errors, and correlations; age, gender, ethnicity, language, disability, and cultural factors related to the assessment and evaluation of individuals and groups; strategies for selecting, administering, interpreting, and using assessment and evaluation instruments and techniques in counseling; ethical considerations).
7.Research and program evaluation (three (3) credits minimum) (i.e., basic types of research methods to include qualitative and quantitative research designs; basic parametric and nonparametric statistics; principles, practices, and applications of needs assessment and program evaluation; uses of computer for data management and analysis; ethical and legal considerations in research).
8.Professional orientation (three (3) credits minimum) (i.e., history of the helping professions including significant factors and events; professional roles and functions including similarities and differences with other types of professionals; professional organizations; ethical standards; professional preparation standards, their evolution and current applications; professional credentialing including certification, licensure, and accreditation practices and standards, and the effects of public policy on these issues; and public policy processes including the role of the professional counselor in advocating on behalf of the profession and its clientele).
11.5.2The Core Curriculum: Marriage and Family Therapists
A.Minimum Requirements
Areas of Study
Course(s)
Semester Hours
I. Theoretical Foundations of Marriage and Family Therapy
2
6
II. Clinical Knowledge
6
18
III. Human Development and Family Relations
1
3
Total Required for Areas I, II, and III
9
27
IV. Ethics and Professional Studies
1
3
V. Research
1
3
VI. Graduate credit elective to enhance professional goals
1
3
Supervised Clinical Practice (five hundred (500) hours required for twelve (12) successive months) This may be done on-site or off-site
12
B.The marriage and family therapy core curriculum is based upon a systems/interactional understanding of peoples’ lives. A total of nine courses (twenty-seven (27) semester or equivalent quarter hours) are to be obtained from Areas I, II, and III. A total of three (3) standard courses must be taken in areas IV, V and VI. You must have supervised clinical practice in Area VII. This may be done either on-site or off-site.
C.Area I: Theoretical Foundations of Marriage and Family Therapy
1.A minimum of two (2) courses (six (6) semester or equivalent hours) will be taken in Area I.
2.In Area I, students conceptualize and distinguish the critical epistemological issues in marriage and family therapy.
3.Students learn about the historical development, theoretical foundations, and contemporary conceptual directions of the field of marriage and family therapy.
4.Course content should not be isolated conceptually from clinical concerns; nor is it adequate for students to deal only with practical treatment issues without reference to theoretical literature.
D.Area II: Clinical Knowledge
1.A minimum of six (6) courses (eighteen (18) semester or equivalent quarter hours) will be taken in Area II.
2.Area II courses will provide students with a comprehensive survey and substantive understanding of the major models and clinical issues of marriage and family therapy.
3.Courses taught in Area II will address the applied aspects of marriage and family therapy practice.
4.Courses taught in Area II will focus on two (2) major interdependent components: diagnosis/assessment and treatment processes. Within the context of marital and family systems, students will learn to diagnose and treat both dysfunctional relationship patterns and nervous and mental disorders, whether cognitive, affective, or behavioral. Major marriage and family therapy assessment methods and instruments will be covered. Marriage and family therapy faculty will teach students to use appropriate major mental health assessment instruments within a systemic context.
5.Courses taught in Area II will emphasize the interface between the interpersonal and the intrapersonal. Courses will expose all students to issues of gender as they relate to marriage and family therapy theory and practice. Course content in this area will include sex discrimination and gender role stereotyping. Courses will also expose all students to issues of sexuality as they relate to marriage and family therapy theory and practice. Course content will include sexual orientation and sexual functioning.
6.Courses will expose all students to issues of ethnicity, race, socioeconomic status and culture as they relate to marriage and family therapy and practice. Course content will include social, educational, economic and behavioral factors.
7.Courses taught in Area II will educate students about a wide variety of presenting problems including, but not limited to, sexual abuse, intense stress, problems of life cycle transitions, sexual dysfunctions, substance abuse, suicide, and violence.
E.Area III: Human Development and Family Studies
1.A minimum of one (1) course (three (3) semester or equivalent quarter hours) will be taken in Area III.
2.In Area III, students learn about the developmental processes within the family context. Students will become conversant with the life cycle of the family and the process and modification of family structures over time (e.g., birth of the first child, adolescent sexual development, leaving home, etc.)
3.Courses taught in Area III will emphasize the interface between the interpersonal and the intrapersonal. Courses will expose all students to issues of gender as they relate to marriage and family therapy theory and practice. Course content in this area will include sex discrimination and gender role stereotyping. Courses will also expose all students to issues of sexuality as they relate to marriage and family therapy theory and practice. Course content will include sexual orientation and sexual functioning.
4.Courses will expose all students to issues of ethnicity, race, socioeconomic status and culture as they relate to marriage and family therapy and practice. Course content will include social, educational, economic and behavioral factors.
F.Area IV: Ethics and Professional Studies
1.A minimum of one (1) course (three (3) semester or equivalent quarter hours) will be taken in Area IV.
2.Area IV contributes to the development of a professional attitude and identity. Studies will include professional socialization and the role of professional organizations, licensure and certification, legal responsibilities and liabilities of clinical practice and research, family law, confidentiality issues, the AAMFT Code of Ethics, and interprofessional cooperation.
3.The content of course work will be specific to the practice and profession of marriage and family therapy. A generic course in ethics is inappropriate for Area IV.
G.Area V: Research
1.A minimum of one (1) course (three (3) semester or equivalent quarter hours) will be taken in Area V. In Area V, students gain an understanding of research methodology and data analysis, and learn to evaluate research in marriage and family therapy.
2.Course content will include both quantitative and qualitative research.
H.Area VI: Graduate Elective
A minimum of one (1) course (three (3) semester or equivalent quarter hours) will be taken in Area VI. Additional elective courses will augment students’ specialized interest and background in marriage and family therapy. Additional courses may be chosen from coursework offered in a variety of disciplines.
I.Area VII: Supervised Clinical Practice
1.Students are required to spend a minimum of five hundred (500) face-to-face hours with clients. Programs will document a student’s satisfactory completion of the five hundred (500) hour requirement before awarding a degree. A minimum of one hundred (100) hours of supervision is required in the supervised clinical practicum. A minimum twelve (12) successive months of supervised clinical practice is required.
2.Although students may treat individual clients, at least two hundred fifty (250) hours (fifty percent (50%) of the five hundred (500) direct client contact hours) must be completed with couples or families physically present in the room.
3.Preparation for clinical practice includes any necessary remediation for previous clinical deficiencies.
4.Clinical training will integrate didactic with clinical material. A practicum is a part-time clinical experience completed concurrently with didactic coursework. A practicum typically results in five to ten (5 – 10) direct client hours per week. It also includes such activities as supervision, staff meetings, community relations, and record keeping.
5.Direct client contact is defined as face-to-face (therapist and client) therapeutic meetings. Activities such as brief telephone contact, case planning, observation of therapy, record keeping, travel, administrative activities, consultation with community members or professionals, or supervision, are not considered direct client contact.
6.Assessments may be counted as direct client contact if they are face-to-face processes that are more than clerical in nature and focus.
7.Both individual or dyadic and group supervision of the student’s clinical practice are required. Individual or dyadic supervision will occur at least once (1) per week over a period of one (1) or more years.
**History**
- *Amendment — effective from 2023-05-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/15/2023*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-40-05-12** Occupational Therapists and Occupational Therapy Assistants
##### **216-RICR-40-05-12 § 12.1** Authority {#sec-216-ricr-40-05-12-12.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-40.1-5(a), and are established for the purpose of adopting minimum standards for the licensing of occupational therapists and occupational therapy assistants offering occupational therapy services in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.2** Definitions {#sec-216-ricr-40-05-12-12.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-40.1, entitled "Occupational Therapy".
2."Administrator" means the Administrator of the Division of Professional Regulation.
3."Board" means the Board of Occupational Therapy within the Division of Professional Regulation established pursuant to the provisions of R.I. Gen. Laws § 5-40.1-4.
4."Director" means the Director of the Rhode Island Department of Health.
5."Division" means the Division of Professional Regulation.
6."Occupational therapist" means a person licensed to practice occupational therapy under the provisions of the Act and this Part.
7."Occupational therapy" means the use of purposeful activity or interventions designed to achieve functional outcomes which promote health, prevent injury or disability, and develop, improve, sustain, or restore the highest possible level of independence of any individual who has an injury, illness, cognitive impairment, sensory impairment, psychosocial dysfunction, mental illness, developmental or learning disability, physical disability, or other disorder or condition.
a.Occupational therapy includes evaluation by means of skilled observation of functional performance and/or assessment through the administration and interpretation of standardized or nonstandardized tests and measurements.
b.Occupational therapy services include, but are not limited to:
(1)The evaluation and provision of treatment in consultation with the individual, family or other appropriate persons;
(2)Interventions directed toward developing, improving, sustaining, or restoring daily living skills, including self-care skills and activities that involve interactions with others and the environment, work readiness or work performance, play skills or leisure capacities or educational performance skills;
(3)Developing, improving, sustaining or restoring sensorimotor, oral-motor, perceptual or neuromuscular functioning; or emotional, motivational, cognitive or psychosocial components of performance; and
(4)Education of the individual, family or other appropriate persons in carrying out appropriate interventions.
(5)These services may encompass evaluation of need and the design, development, adaptation, application or training in the use of assistive technology devices; the design, fabrication or
(6)Application of rehabilitative technology, such as selected orthotic devices; training in the functional use of orthotic or prosthetic devices; the application of therapeutic activities, modalities, or exercise as an adjunct to or in preparation for functional performance; the application of ergonomic principles; the adaptation of environments and processes to enhance daily living skills; or the promotion of health and wellness.
8.“Occupational therapy assistant” means a person licensed to practice occupational therapy under the provisions of the Act and this Part.
9.“Occupational therapy aide” means a person not licensed pursuant to the statutes and rules applicable to the practice of occupational therapy, who works under the supervision of a licensed occupational therapist or occupational therapy assistant, who assists in the practice of occupational therapy and whose activities require an understanding of occupational therapy, but do not require professional or advanced training in the basic anatomical, psychological and social sciences involved in the practice of occupational therapy.
10."Supervision" means that a licensed occupational therapist or occupational therapy assistant shall at all times be responsible for supportive personnel and students.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.3** License Requirements {#sec-216-ricr-40-05-12-12.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.3}
A.Pursuant to R.I. Gen. Laws § 5-40.1-6, no person shall practice occupational therapy or hold himself or herself out as an occupational therapist or occupational therapy assistant or as being able to practice as an occupational therapist or occupational therapy assistant or as being able to practice occupational therapy or to render occupational therapy services in this state unless he or she is licensed under the provisions of the Act and this Part.
1.The Act shall not be construed as preventing or restricting the practice, services or activities stated in R.I. Gen. Laws § 5-40.1-7.
2.Limits on the use of words in connection with a licensee’s name or place of business are pursuant to R.I. Gen. Laws §§ 5-40.1-6(c) and (d).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.4** Qualifications for Licensure {#sec-216-ricr-40-05-12-12.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.4}
A.Any applicant seeking licensure as an occupational therapist or occupational therapy assistant in this state must fulfill the requirements of R.I. Gen. Laws § 5-40.1-8, and:
1.Have successfully completed the academic requirements of an education program in occupational therapy accredited by the American Occupational Therapy Association’s Accreditation Council for Occupational Therapy Education or such other accrediting agency as may be approved by the Board;
2.Have successfully completed a period of supervised fieldwork experience arranged by the recognized educational institution where he or she met the academic requirements;
a.For an occupational therapist, a minimum of twenty-four (24) weeks of supervised fieldwork experience is required;
b.For an occupational therapy assistant, a minimum of twelve (12) weeks is required.
3.Have successfully passed the National Certification Examination for Occupational Therapists, Registered or National Certification Examination for Occupational Therapy Assistants of the National Board for Certification in Occupational Therapy (NBCOT) or other occupational therapy certification examination as approved by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.5** Application for Licensure and Fee {#sec-216-ricr-40-05-12-12.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.5}
A.Application for licensure to practice occupational therapy in this state either by endorsement or by examination, shall be made on forms provided by the Division. Such application shall be accompanied by the following:
1.Documented evidence and supporting transcripts of qualifying credentials as set forth in § 12.4 of this Part;
2.A statement from the Board of Occupational Therapy in each state in which the applicant has held or holds licensure or is otherwise subject to state regulation to be submitted to the Board of this state attesting to the licensure status of the applicant during the time period the applicant held licensure in said state;
3.The results of the written national examination; and
4.The non-refundable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.6** Licensure of Occupational Therapists and Occupational Therapy Assistants {#sec-216-ricr-40-05-12-12.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.6}
A.By Examination: Applicants seeking licensure as occupational therapists or occupational therapy assistants shall be required to pass, with a grade determined by the Board, the national written examination of the National Board for Certification in Occupational Therapy (NBCOT) approved by the Board to test the applicant's fitness to engage in the practice of occupational therapy pursuant to the provisions of the Act.
1.The date, time and place of examinations shall be available from the National Board for Certification in Occupational Therapy (NBCOT).
2.In case of failure of any applicant to satisfactorily pass an examination, such applicant shall be entitled to re-examination.
B.Foreign Trained Applicants: Applicants from foreign occupational therapy schools must meet the requirements stated in R.I. Gen. Laws § 5-40.1-8(f).
C.Graduate Practice: Any individual who graduates from an approved occupational therapy school who has filed a completed application for licensure, may upon receiving a receipt (permit to perform as a graduate occupational therapist or graduate occupational therapy assistant) from the Division, perform as an occupational therapist, or occupational therapy assistant, under the supervision of an occupational therapist licensed in this state, only until successful completion of the examination, but in no event shall the receipt (permit) extend beyond ninety (90) days from its issuance.
1.If such an applicant fails to take the examination without due cause or fails to pass the examination within ninety (90) days from the effective date of graduate status and fails to receive a license, the graduate practice permit shall become null and void and all aforementioned privileges shall automatically cease.
2.Furthermore, an individual referred to in § 12.6(C) of this Part, shall, during the interim period (between time of application and examination) identify himself or herself only as a "graduate occupational therapist" or “graduate occupational therapy assistant.”
D.Licensure by Endorsement. Occupational therapists and occupational therapy assistants who are licensed or otherwise regulated to practice under laws of another state or territory or the District of Columbia may perform as an occupational therapist or occupational therapy assistant pursuant to R.I. Gen. Laws § 5-40.1-8(e).
E.Supervision of occupational therapist assistants is pursuant to R.I. Gen. Laws § 5-40.1-21.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.7** Issuance and Renewal of License {#sec-216-ricr-40-05-12-12.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.7}
A.Upon the recommendation of the Board, the Director shall issue to applicants who have satisfactorily met the licensure requirements of this Part, a license to practice occupational therapy in this state. Said license, unless sooner suspended or revoked, shall expire on the thirty-first (31st) day of March, of each even year (biennially).
B.On or before the first (1st) day of March of each even year, the Administrator of the Division shall mail an application for renewal of license to every individual to whom a license has been issued or renewed during the current licensure period. Every individual so licensed who desires to renew his or her license shall file with the Division such renewal application duly executed together with the evidence of continuing education requirements of § 12.7(E) of this Part and the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) on or before the thirty-first day of March of each even year.
C.Upon receipt of such renewal application and payment of fee, the Director, upon the recommendation of the Board, shall grant a renewal license effective the thirty-first (31st) day of March for a period of two (2) years, unless sooner suspended or revoked.
D.Any individual who allows his or her license to lapse by failing to renew it on or before the thirty-first (31st) day of March of the next even year as provided above, may be reinstated by the Director upon receiving a receipt from the Division for payment of the current renewal fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.Any individual using the title "occupational therapist" or “occupational therapy assistant” during the time his or her license has lapsed shall be subject to the penalties provided for violations of this Part and the Act.
E.Continuing Education
1.On application for renewal of license, occupational therapists and occupational therapy assistants must show proof of participation in twenty (20) hours biennially in presentations, clinical instruction, publications, research, inservice programs, continuing education activities offered by the American Occupational Therapy Association or American Occupational Therapy Association approved providers, Rhode Island Occupational Therapy Association, National Board for Certification in Occupational Therapy, university courses, and/or self-study courses. Contact hours of continuing education shall be recognized by the Board as follows:
Category I: Formal continuing education program that may consist of university courses, workshops, inservice programs, and/or institutes.
Credit: One (1) continuing education contact hour for each hour attended
Category II: Professional continuing education activities and scientific meetings and self-directed continuing education activities that may consist of local, regional, national symposia, colloquia, journal clubs, self- study courses, etc.
Credit: One (1) continuing education contact hour for each hour attended or One (1) competency assessment unit (CAU) for each hour completed.
Category III: Formal presentations (including clinical instruction)
Credit: Two (2) hours of continuing education contact hours for each hour of instruction; four (4) hours of continuing education contact hours for two (2) hours of instruction; five (5) hours of continuing education contact hours for three (3) hours of instruction; up to a maximum of five (5) hours of continuing education contact hours.
Category IV: Exceptional contributions to professional development that may consist of written publications
Credit: Continuing education contact hours shall be awarded for each written publication as listed below:
Book: ten (10) continuing education contact hours;
Juried article: eight (8) continuing education contact hours;
Book chapter: five (5) continuing education contact hours;
Non-juried article (must be published in a national publication in order to receive CE credit): four (4) continuing education contact hours.
2.It shall be the sole responsibility of the individual occupational therapist or occupational therapy assistant to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
3.Occupational therapists or occupational therapy assistants initially licensed during the two (2) year period preceding license renewal shall have their credits for continuing education prorated according to the time actually licensed during the two (2) year period.
4.The Board, at its discretion, may grant one of the following to an occupational therapist or occupational therapy assistant for reasons of hardship or other extenuating circumstances:
a.An extension of time to complete the continuing education requirements;
b.A variance from the continuing education requirements;
c.A waiver from the continuing education requirements.
12.7.1 Inactive Status
An individual licensed as an occupational therapist in this state who does not intend to engage in the practice of occupational therapy within this state during any year, may upon request to the Division, may have his or her name transferred to an inactive status in accordance with the provisions of R.I. Gen Laws § 5-40.1-12(b).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.8** Denial, Suspension or Revocation of License and Violations {#sec-216-ricr-40-05-12-12.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.8}
A.Pursuant to R.I. Gen. Laws § 5-40.1-14, the Board may deny a license or refuse to renew a license or may suspend or revoke a license or may impose probationary conditions if the licensee has been found guilty of unprofessional conduct which has endangered or is likely to endanger the health, welfare or safety of the public. Such unprofessional conduct shall include but not be limited to those actions stated in R.I. Gen. Laws § 5-40.1-14(a).
B.A denial, refusal to renew, suspension, revocation or imposition of probationary conditions upon the license may be ordered by the Board or the Director, after a hearing in the manner provided by the Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35, and in accordance with § 12.9 of this Part.
C.The American Occupational Therapy Association’s “Occupational Therapy Code of Ethics” shall be adopted as a public statement of the values and principles used in promoting and maintaining high standards of behavior in occupational therapy. These include, but are not limited to, the following:
1.Occupational therapy personnel shall demonstrate a concern for the well-being of the recipients of their services;
2.Occupational therapy personnel shall respect the rights of the recipients of their services;
3.Occupational therapy personnel shall achieve and continually maintain high standards of competence;
4.Occupational therapy personnel shall comply with laws and association policies guiding the profession of occupational therapy;
5.Occupational therapy personnel shall provide accurate information about occupational therapy services; and
6.Occupational therapy personnel shall treat colleagues and other professionals with fairness, discretion, and integrity.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
##### **216-RICR-40-05-12 § 12.9** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-12-12.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-12#12.9}
All hearings and reviews required under the provisions of the Act, and the rules and regulations thereof, shall be held in accordance with the provisions of the rules and regulations of regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-08 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/08/2003*
#### **216-RICR-40-05-13** Physical Therapists and Physical Therapist Assistants
##### **216-RICR-40-05-13 § 13.1** Authority {#sec-216-ricr-40-05-13-13.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-13#13.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-40-5, and are established for the purpose of adopting prevailing standards pertaining to the licensure of physical therapists and physical therapist assistants in this state.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2023-08-01 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 08/01/2023*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-02-18 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/18/2004*
##### **216-RICR-40-05-13 § 13.2** Incorporated Materials {#sec-216-ricr-40-05-13-13.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-13#13.2}
A.These Regulations hereby adopt and incorporate “American Physical Therapy Association Code of Ethics” (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate “American Physical Therapy Association, Guide for Professional Conduct” (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate “American Physical Therapy Association, Standards of Ethical Conduct for the Physical Therapist Assistant” (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate “American Physical Therapy Association, Guide for Conduct of the Physical Therapist Assistant” (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
E.These Regulations hereby adopt and incorporate “American Physical Therapy Association, Standards of Practice for Physical Therapy” (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2023-08-01 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 08/01/2023*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-02-18 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/18/2004*
##### **216-RICR-40-05-13 § 13.3** Definitions {#sec-216-ricr-40-05-13-13.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-13#13.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-40, entitled, "Physical Therapists."
2.“APTA” means the American Physical Therapy Association.
3."Board" means the Board of Physical Therapy within the Department established pursuant to the provisions of R.I. Gen. Laws § 5-40-3.
4.“CAPTE” means the Commission on Accreditation of Physical Therapy Education.
5.“Department” means the Rhode Island Department of Health.
6."Director" means the Director of the Rhode Island Department of Health.
7."Examination" means an examination approved by the Department, in consultation with the Board.
8.“FSBPT” means the Federation of State Boards of Physical Therapy.
9.“License” means a license issued by the Department to practice physical therapy.
10."On-site supervision" means the immediate and physical presence of patient, person being supervised, and supervisor.
11."Physical therapist" means an individual who is licensed by the Department to practice physical therapy.
12."Physical therapist assistant" means an individual who is licensed by the Department to assist in the practice of physical therapy under the supervision of a physical therapist.
13.“Physical therapy” means the care and services provided by or under the direction and supervision of a physical therapist who is licensed pursuant to R.I Gen. Laws Chapter 5-40.
14."Practice of physical therapy" means those activities and services pursuant to R.I. Gen. Laws § 5-40-1;
15."Supervision" means that a licensed physical therapist is, at all times, responsible for physical therapist assistants, supportive personnel and students.
16."Supportive personnel" means an individual, other than a physical therapist assistant, who does not act independently and works under the direction and supervision of a physical therapist or physical therapist assistant as directed by a physical therapist who is licensed under R.I. Gen. Laws Chapter 5-40.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2023-08-01 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 08/01/2023*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-02-18 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/18/2004*
##### **216-RICR-40-05-13 § 13.4** Physical Therapists/Licensing Requirements {#sec-216-ricr-40-05-13-13.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-13#13.4}
13.4.1License Requirement
A.Pursuant to R.I. Gen. Laws § 5-40-9, it is unlawful for any person to represent him or herself as a physical therapist in this state unless the person has been licensed pursuant to the provisions of the Act and this Part.
B.The right of use of the title of physical therapist shall be in accordance with R.I. Gen. Laws § 5-40-9.
13.4.2Qualifications for Licensure
Any applicant for licensure shall meet all of the requirements as set forth in R.I. Gen. Laws § 5-40-6.
13.4.3Application for Licensure and Fee
A.An applicant for licensure to practice physical therapy in this state must submit the following:
1.Application for licensure on forms provided by the Department that shall be completed and submitted to the Board.
2.The non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
3.Supporting official transcripts of education credentials as required in § 13.4.2 of this Part.
4.The examination scores of the national examination approved by the FSBPT submitted directly to the Board.
5.Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office.
B.Licensure by Endorsement. An applicant for licensure to practice physical therapy by endorsement in this state must submit the following:
1.Application for licensure on forms provided by the Department that shall be completed and submitted to the Board.
2.The non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
3.The examination scores of the national examination approved by the FSBPT submitted directly to the Board.
4.A statement from the Board of Physical Therapy in each state in which the applicant has held or holds licensure submitted to the Board of this state, attesting to the licensure status of the applicant during the time period the applicant held licensure in said state.
5.Out-of-state applicants must obtain their full BCI report from their state of residence.
C.Foreign Trained Applicants. Applicants from foreign physical therapy schools must present evidence that their educational credentials are equivalent of those requirements set forth in § 13.4.2 of this Part by an agency approved by the Board. Furthermore, foreign trained applicants must meet all of the requirements for licensure to the satisfaction of the Board and in accordance with the statutory and regulatory provisions of this Part. An applicant for licensure in this state must provide the following:
1.Application for licensure on forms provided by the Department that shall be completed and submitted to the Board.
2.The non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
3.Provide written proof of authorization to practice as a physical therapist without limitation(s) in the country(ies) where the professional education occurred and/or in country(ies) where the applicant practiced physical therapy.
4.Have successfully passed the national examination as described in § 13.4.4 of this Part.
5.Any applicant for licensure as a physical therapist who has received his or her physical therapy training in a country other than the United States of America, the United Kingdom, the Republic of Ireland, Canada except Quebec Province, Australia or New Zealand, shall submit to the Board evidence of attainment of a passing score, as determined by the Board, on the Test of English as a Foreign Language (TOEFL) examination, which test shall have been taken within the two (2) years immediately preceding the filing of the application for licensure. Such evidence must be submitted with the application for licensure.
6.Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office.
13.4.4Examinations for Licensure of Physical Therapists
A.Applicants, except those exempt pursuant to R.I. Gen. Laws § 5-40-7, shall be required to pass a national examination as set forth in R.I. Gen. Laws § 5-40-6.
1.The Board will adopt the criterion-referenced passing point recommended by FSBPT.
B.Without Examination by Endorsement
1.A license to practice physical therapy may be issued without examination in accordance with R.I. Gen. Laws § 5-40-7(b).
a.Until such time as a license has been issued, the candidate for licensure by endorsement may not practice as a physical therapist in Rhode Island.
C.Re-Examination
In order to qualify for re-examination after three (3) failures, the applicant must request a formal meeting with the Board, at which time requirements consisting of additional coursework and/or training for re-examination will be determined and must be fulfilled prior to admittance to a future examination.
D.Graduate Practice
Graduate practice shall be in accordance with the provisions of R.I. Gen. Laws § 5-40-7(c).
13.4.5Issuance and Renewal of License
A.A license to practice physical therapy in this state, unless sooner suspended or revoked, shall expire on the first day of May of the next even year following the date of issuance of the original license.
B.Every licensed person who desires to renew his or her license shall file a renewal application and documentation in accordance with R.I. Gen. Laws § 5-40-10 together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Any person who allows his or her license to lapse by failing to renew it on or before the thirty-first day of March of the next even year may be renewed by the Department on payment of the current renewal fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.Any person using the title "physical therapist" during the time that his or her license has lapsed shall be subject to the penalties provided for violations of this Part and the Act.
D.Continuing Education Requirements
1.Applicants for biennial licensure renewal shall meet continuing education requirements as prescribed in this Part.
2.On application for renewal of license, physical therapists shall attest to completion of twenty-four (24) hours biennially in scope of practice-specific offerings that may include, but not be limited to: formal presentations, conferences, coursework from a regionally accredited college/university and/or self-study courses, such as on-line courses, one (1) continuing education hour awarded for each hour completed. Teaching and/or clinical supervision of student affiliates by licensed physical therapists in APTA approved programs shall be approved for a maximum of three (3) hours per licensure cycle. Such programs or offerings shall be approved or sponsored by a Board-approved organization as set forth in § 13.4.5(D)(3) of this Part.
3.Continuing education programs or offerings sponsored or approved by the following organizations are deemed to be approved by the Board:
a.Accreditation Council for Continuing Medical Education (ACCME) approved programs;
b.American Academy of Family Physicians (AAFP);
c.American Academy of Neurology;
d.American Academy of Orthopedics;
e.American Academy of Pediatrics;
f.American Cancer Society;
g.American College of Obstetricians and Gynecologists (ACOG);
h.American Heart Association;
i.American Hippotherapy Association (AHA);
j.American Management Association;
k.American Medical Association;
l.American Nursing Association (ANA) or its state affiliate;
m.American Occupational Therapy Association (AOTA);
n.American Physical Therapy Association (APTA);
o.American Red Cross cardiopulmonary resuscitation (CPR)/first aid;
p.American Speech and Hearing Association (ASHA);
q.Any course offered by a department or school of physical therapy, or professional organization, or accrediting agency as may be approved by the Board;
r.Aquatic Exercise Association;
s.Arthritis Foundation;
t.Basic water safety certification;
u.Commission for Accreditation of Rehabilitation Facilities (CARF);
v.Federation of State Boards of Physical Therapy;
w.Educational programs offered by non-profit associations with a primary purpose of providing health education and/or disability support;
x.Educational programs offered by the Alpert Medical School at Brown University;
y.Educational programs offered by the Alpert Medical School at Brown University in public health;
z.Educational programs offered by the Rhode Island Department of Education;
aa.Multiple Sclerosis Society;
bb.National Association of Social Workers (NASW);
cc.National Athletic Trainers Association (NATA);
dd.National Strength and Conditioning Association (NSCA);
ee.Neurodevelopmental Treatment Association;
ff.Paralyzed Veterans of America;
gg.Rhode Island American Physical Therapy Association or any other state physical therapy association;
hh.Rhode Island Medical Society or other state medical society;
ii.Rhode Island State Nurses Association or other state nursing association;
jj.Others as may be approved by the Board; or
kk.Courses that have been presented, accepted, or approved by other state licensing boards of physical therapy.
4.It shall be the sole responsibility of the physical therapist to obtain documentation, e.g., course descriptions, proof of attendance, from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
5.A licensee who fails to complete the continuing education requirements described in this Part may be subject to disciplinary action pursuant to R.I. Gen. Laws § 5-40-13.
6.A license may be denied to any applicant who fails to provide satisfactory evidence of completion of continuing education relevant to physical therapy as required in this Part.
7.Physical therapists initially licensed by examination after the May 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle, i.e., April 30th of the next even-numbered year.
8.The Department may extend for only one six (6) month period these educational requirements if the Department is satisfied that the applicant has suffered hardship, which prevented meeting the educational requirements.
13.4.6The Practice of Physical Therapy
A.Whenever a patient seeks or receives treatment from a physical therapist without referral from a doctor of medicine, osteopathy, dentistry, podiatry, or chiropractic, the physical therapist shall:
1.Disclose to the patient in writing the scope and limitations of the practice of physical therapy and shall obtain their consent in writing in accordance with the “American Physical Therapy Association, Standards of Practice for Physical Therapy” incorporated above by reference at § 13.2(E) of this Part; and
2.Refer the patient to such a practitioner within ninety (90) days after the date treatment commenced; provided, however, a physical therapist shall not be required to make such a referral after treatment is concluded.
B.The physical therapist and the physical therapist assistant is responsible for his/her individual professional development and continued competence in physical therapy in. accordance with the “American Physical Therapy Association, Standards of Practice for Physical Therapy” incorporated above by reference at § 13.2(E) of this Part and the “American Physical Therapy Association, Standards of Ethical Conduct for the Physical Therapist Assistant” incorporated above by reference at § 13.2(C) of this Part.
C.The physical therapist shall adhere to the “American Physical Therapy Association, Standards of Practice for Physical Therapy” incorporated above by reference at § 13.2(E) of this Part and the “American Physical Therapy Association, Code of Ethics” incorporated above by reference at § 13.2(A) of this Part.
D.The physical therapist assistant shall adhere to the “American Physical Therapy Association, Standards of Ethical Conduct for the Physical Therapist Assistant” incorporated above by reference at § 13.2(C) of this Part and the “American Physical Therapy Association, Guide for Conduct of the Physical Therapist Assistant” incorporated above by reference at § 13.2(D) of this Part.
13.4.7Supervision
A.Pursuant to R.I. Gen. Laws § 5-40-1(8) a licensed physical therapist shall at all times be responsible for the supervision of physical therapist assistants, supportive personnel, and students to ensure the safety and welfare of patients. Such supervision shall include but not be limited to the following:
1.A physical therapist shall be present on the premises, and immediately available whenever a physical therapist student is performing treatment procedures or patient-related activities. A physical therapist or physical therapist assistant shall be present on the premises, and immediately available whenever a physical therapist assistant student or supportive personnel is performing treatment procedures or patient-related activities.
2.A qualified physical therapist must be accessible by telecommunications to the physical therapist assistant at all times while the physical therapist assistant is treating patients.
3.The physical therapist shall maintain the following written documentation regarding the supervision of a physical therapist assistant:
a.Necessary instruction;
b.On-site supervision of the physical therapist assistant's performance;
c.Review of the physical therapist assistant’s documentation;
d.A reassessment; and,
e.Appropriate update of the patient's program and goals.
f.All of the above shall occur when re-evaluation of the patient is indicated but no less than once during a one (1) month period.
4.The physical therapist or physical therapist assistant shall maintain the following written documentation regarding the supervision of supportive personnel:
a.Necessary instruction and documented competence;
b.Line-of-sight supervision of the treatment performed by the supportive personnel; and
c.Review of the supportive personnel’s documentation on a daily basis.
5.In licensed facilities providing chronic long term care services, in licensed facilities providing services for the developmentally impaired population, or in school settings certified by the Department of Education, physical therapist assistants and supportive personnel may implement programs designed and supervised by the physical therapist in the above-mentioned settings, if these programs are of the nature and purpose of practicing or maintaining a skill.
a.These programs will be implemented under the direction of the physical therapist with regular interval on-site supervision by the physical therapist, no less than quarterly for physical therapist assistants, and no less than monthly by the physical therapist or physical therapist assistant for supportive personnel.
6.In the settings noted in § 13.4.7(A)(5) of this Part, the physical therapist shall maintain the following written documentation regarding the supervision of a physical therapist assistant or supportive personnel:
a.Necessary instruction;
b.On-site supervision of the physical therapist assistant's/ supportive personnel’s performance;
c.Review of the physical therapist assistant’s/supportive personnel’s documentation;
d.A reassessment; and, appropriate update of the patient's program and goals.
e.All of the above shall occur no less than quarterly for a physical therapist assistant supervised by a physical therapist and no less than monthly for supportive personnel supervised by either a physical therapist or physical therapist assistant.
B.When supervising supportive personnel, the physical therapist shall provide a written plan(s) for the training and supervision of supportive personnel. The plan shall be in accordance with current standards of professional practice and shall be reviewed at least annually and revised as necessary. The plan shall be readily available for review by all physical therapists and physical therapist assistants who work with the supportive personnel and shall include:
1.A list of clinical competencies of each supportive personnel;
2.The method for monitoring and supervising care provided by the supportive personnel; and
3.The date reviewed and signatures of the supervisor and supportive personnel governed by the plan.
C.No physical therapist assistant and/or supportive personnel shall evaluate new patients admitted for physical therapy service and/or establish a physical therapy treatment program based on the physician's referral or prescription; and
D.The physical therapist shall discharge such other supervisory activity(ies) as may be deemed appropriate and in accordance with policies and procedures of the health care facility and/or agency.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2023-08-01 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 08/01/2023*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-02-18 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/18/2004*
##### **216-RICR-40-05-13 § 13.5** Physical Therapist Assistant / License Requirements {#sec-216-ricr-40-05-13-13.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-13#13.5}
13.5.1License Requirement
A.Pursuant to R.I. Gen. Laws § 5-40-9, it is unlawful for any person to represent him or herself as a physical therapist assistant in this state unless the person has been licensed pursuant to the provisions of the Act and this Part.
B.The right of use of the title of physical therapist assistant shall be in accordance with R.I. Gen. Laws § 5-40-9.
13.5.2Qualifications for Licensure
Any applicant for licensure shall meet all of the requirements as set forth in R.I. Gen. Laws § 5-40-6.1.
13.5.3Application for Licensure
A.An applicant for licensure to practice as a physical therapist assistant in this state must submit the following:
1.Application for licensure on forms provided by the Department that shall be completed and submitted to the Board;
2.The non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
3.Supporting official transcripts of educational credentials as set forth in § 13.5.2 of this Part;
4.The examination scores of the national examination approved by the FSBPT submitted directly to the Board.
5.Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office.
B.License by Endorsement. An applicant for licensure to practice as a physical therapy assistant by endorsement in this state must submit the following:
1.Application for licensure on forms provided by the Department that shall be completed and submitted to the Board;
2.The non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
3.The examination scores of the national examination approved by the FSBPT submitted directly to the Board.
4.A statement from the board of physical therapy in each state in which the applicant has held or holds licensure to be submitted to the Board of this state, attesting to the licensure status of the applicant during the time period the applicant held licensure in said state.
5.Out-of-state applicants must obtain their full BCI report from their state of residence.
C.Foreign Trained Applicants. Applicants from foreign physical therapy assistant schools must present evidence that their educational credentials are equivalent of those requirements set forth in § 13.5.2 of this Part by an agency approved by the Board. Furthermore, foreign trained applicants must meet all of the requirements for licensure to the satisfaction of the Board and in accordance with the statutory and regulatory provisions of this Part. An applicant for licensure in this state must provide the following:
1.Application for licensure on forms provided by the Department that shall be completed and submitted to the Board;
2.The non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
3.Provide written proof of authorization to practice as a physical therapist assistant without limitation(s) in the country(ies) where the professional education occurred and/or in country(ies) where the applicant practiced as a physical therapy assistant;
4.Have successfully passed the national examination as required in § 13.5.2 of this Part.
5.Any applicant for licensure as a physical therapist assistant who has received his or her physical therapy assistant training in a country other than the United States of America, the United Kingdom, the Republic of Ireland, Canada except Quebec Province, Australia or New Zealand, shall submit to the Board evidence of attainment of a passing score, as determined by the Board, on the Test of English as a Foreign Language (TOEFL) examination, which test shall have been taken within the two (2) years immediately preceding the filing of the application for licensure. Such evidence must be submitted with the application for licensure.
6.Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office.
13.5.4Examinations for Licensure of Physical Therapist Assistants
A.By Examination:
1.Applicants, except those exempt pursuant to R.I. Gen. Laws § 5-40-7.1, shall be required to pass a national examination as set forth in R.I. Gen. Laws § 5-40-6.1.
a.The Board will adopt the criterion-referenced passing point recommended by FSBPT.
B.Without Examination by Endorsement
1.A license may be issued without examination in accordance with the provisions of R.I. Gen. Laws § 5-40-7.1.
a.Until such time as a license has been issued, the candidate for licensure by endorsement may not practice as a physical therapist assistant in Rhode Island.
C.Re-Examination
In order to qualify for re-examination after three (3) failures, the applicant must request a formal meeting with the Board, at which time requirements consisting of additional coursework and/or training for re-examination will be determined and must be fulfilled prior to admittance to a future examination.
D.Graduate Practice
1.Every student upon graduating from a physical therapist assistant educational program accredited by CAPTE who has filed a physical therapist assistant application for licensure may, upon receiving a permit from the Department, perform as a physical therapist assistant, under the supervision of a physical therapist licensed in this state.
a.During this interim period, the applicant shall identify himself or herself only as a "graduate physical therapist assistant" or use the abbreviation “GPTA.”
b.If an applicant fails to take the examination within ninety (90) days from the effective date of graduate status, without due cause or fails to pass the examination and receive a license, all the aforementioned privileges set forth in §§ 13.5.4(D)(1) and 13.5.4(D)(1)(a) of this Part shall automatically cease.
c.The provisions of § 13.5.4(D) of this Part shall apply only to students upon graduating from a physical therapist assistant educational program accredited by CAPTE and shall not apply to any physical therapist assistant previously licensed under any licensure jurisdiction.
13.5.5Issuance and Renewal of License
A.A license to practice as a physical therapist assistant in this state, unless sooner suspended or revoked, shall expire on the first (1st) day of May of the next even year following the date of issuance of the original license.
B.Every licensed person who desires to renew his or her license shall file a renewal application and documentation in accordance with R.I. Gen. Laws § 5-40-10 together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Any person who allows his or her license to lapse by failing to renew it on or before the thirty first (31st) day of March of the next even year may be renewed by the Department on payment of the current renewal fee plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.Any person using the title "physical therapist assistant" during the time that his or her license has lapsed shall be subject to the penalties provided for violations of this Part and the Act.
D.Continuing Education Requirements
1.Applicants for biennial licensure renewal shall meet continuing education requirements as prescribed in this Part.
2.On application for renewal of license, physical therapist assistants shall attest to completion of twenty-four (24) hours biennially in scope of practice-specific offerings that may include, but not be limited to: formal presentations, conferences, coursework from a regionally accredited college/university and/or self-study courses, such as on-line courses (one (1) continuing education hour awarded for each hour completed). Teaching and/or clinical supervision of student affiliates by licensed physical therapist assistants in APTA approved programs shall be approved for a maximum of three (3) hours per licensure cycle. Such programs or offerings shall be approved or sponsored by a Board-approved organization as set forth in § 13.4.5(E) of this Part.
3.It shall be the sole responsibility of the physical therapist assistant to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
4.A licensee who fails to complete the continuing education requirements described in this Part may be subject to disciplinary action pursuant to R.I. Gen. Laws § 5-40-13.
5.A license may be denied to any applicant who fails to provide satisfactory evidence of completion of continuing education relevant to physical therapy as required in this Part.
6.Physical therapist assistants initially licensed by examination after the May 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., April 30th of the next even-numbered year).
7.The Department may extend for only one six (6) month period these educational requirements if the Department is satisfied that the applicant has suffered hardship, which prevented meeting the educational requirements.
13.5.6Supervision
A.Pursuant to R.I. Gen. Laws § 5-40-1(8), a licensed physical therapist shall be responsible for the supervision, at all times, of the performance of patient care services and treatments provided by physical therapist assistants, supportive personnel and students, consistent with the provisions of § 13.4.7 of this Part.
B.The physical therapist assistant may be the supervisor for physical therapist assistant students, but must be on the premises and immediately available.
C.The physical therapist assistant may be the supervisor for supportive personnel, but must be on the premises, in line-of-sight, and immediately available.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2023-08-01 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 08/01/2023*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-02-18 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/18/2004*
##### **216-RICR-40-05-13 § 13.6** Grounds for Denial, Suspension or Revocation, Violations, Procedure for Discipline {#sec-216-ricr-40-05-13-13.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-13#13.6}
13.6.1Grounds for Denial, Suspension or Revocation of License/Violations
The Board shall have power to deny, revoke or suspend any license applied for or issued by the Department in accordance with the provisions of R.I. Gen. Laws § 5-40-13.
13.6.2Procedure for Discipline
Procedures for discipline shall be in accordance with the provisions of R.I. Gen. Laws § 5-40-14.
13.6.3Penalties for Violations
Penalties for violations shall be in accordance with the provisions of R.I. Gen. Laws § 5-40-17.
13.6.4Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 5-40 shall be held in accordance with the provisions of the Act and the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2023-08-01 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 08/01/2023*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-02-18 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/18/2004*
#### **216-RICR-40-05-14** Veterinarians
##### **216-RICR-40-05-14 § 14.1** Authority {#sec-216-ricr-40-05-14-14.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 5-25-6 and 4-9.1-8 and are established for the purpose of adopting prevailing standards for the licensure of veterinarians in this state.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.2** Incorporation by Reference {#sec-216-ricr-40-05-14-14.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.2}
A.This Part hereby adopts and incorporates the American Veterinary Medical Association’s (AVMA) “Principles of Veterinary Medical Ethics of the AVMA” (2024) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.3** Definitions {#sec-216-ricr-40-05-14-14.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.3}
A.Wherever used in this Part, the terms listed below shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-25, entitled, "Veterinary Practice Act."
2."Animal" means as defined in R.I. Gen. Laws § 5-25-2(1).
3.“Animal rescue” means as defined in R.I. Gen. Laws § 4-9.1-1(1).
4."Board" means the Board of Veterinary Medicine established under the provisions of R.I. Gen. Laws § 5-25-1.
5.“Client” means, for the purposes of this Part, the same as ‘owner,’ and ‘owner’ means the same as ‘client.’
6.“Department” means the Rhode Island Department of Health.
7."Director" means the Director of the Rhode Island Department of Health or their designee.
8.“Donated drug” means a drug that was originally prescribed and dispensed for an animal, then subsequently donated to a licensed veterinarian or a facility in which veterinary medicine is practiced.
9.“Drug” means a regulated substance used for the purpose of treating animals.
10.“Medication” means, for the purposes of this Part, the same as ‘drug,’ and ‘drug’ means the same as ‘medication.’
11.“Must” means, for the purposes of this Part, the same as ‘shall,’ and ‘shall’ means the same as ‘must.’
12.“Non-contact hours” means Internet courses, correspondence courses, tapes, or other continuing education programs that do not provide for direct interaction between faculty and the participant.
13.“Nonprofit corporation” means as defined by R.I. Gen. Laws § 4-9.1-1(3).
14.“Patient” means, for the purposes of this Part, the same as ‘animal,’ and ‘animal’ means the same as ‘patient.’
15."Practice of veterinary medicine" means any person shall be regarded as practicing veterinary medicine, surgery and dentistry within the meaning of the Act who, either directly or indirectly, conducts those activities stated in R.I. Gen. Laws § 5-25-7(a). The term "practicing veterinary medicine" does not include those exceptions stated in R.I. Gen. Laws § 5-25-7(b).
16."Prescription" means an order from a veterinarian to a pharmacist authorizing the dispensing of a prescription veterinary drug to a client for use on or in a patient.
17."Veterinarian" means a person who practices veterinary medicine and is licensed to practice veterinary medicine in this state pursuant to the provisions of R.I. Gen. Laws Chapter 5-25.
18.“Veterinarian/client/patient relationship” or “VCPR” means as defined in R.I. Gen. Laws § 4-9.1-1(5).
19.“Veterinary clinic” means as defined in R.I. Gen. Laws § 4-9.1-1(6).
20.“Veterinary dentistry” means as defined in R.I. Gen. Laws § 5-25-2(7).
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.4** License Requirements {#sec-216-ricr-40-05-14-14.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.4}
A.The unlicensed practice of veterinary medicine is prohibited and is subject to the penalties set forth in R.I. Gen. Laws § 5-25-8.
1.Notwithstanding the provisions of § 14.4(A) of this Part, excluded from the application of the term "practice of veterinary medicine" are those individuals who under given circumstances are excluded from the provisions of the Act as set forth in R.I. Gen. Laws § 5-25-7(b), and consequently excluded from the licensure requirements of this Part.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.5** Qualifications for Licensure {#sec-216-ricr-40-05-14-14.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.5}
14.5.1Graduates of Schools Located in the U.S.A. and Canada
A.An applicant seeking licensure to practice veterinary medicine in this state must meet the requirements of R.I. Gen. Laws § 5-25-10.
B.In addition to the requirements of R.I. Gen. Laws § 5-25-10, the applicant must:
1.Conduct themselves in accordance with the “Principles of Veterinary Medical Ethics of the AVMA” incorporated by reference in § 14.2(A) of this Part.
2.Have satisfactorily completed a national veterinary board licensing examination as approved by the Board and as follows:
a.Prior to May 1, 1979, an applicant shall have successfully completed the National Board Examination (NBE) for Veterinary Medicine;
b.Between May 1, 1979 and April 30, 2000, an applicant shall have successfully completed the NBE and the Clinical Competency Test (CCT);
(1)The passing score for the National Board Examination (NBE) for Veterinary Medicine and the Clinical Competency Test (CCT) shall be minus one (-1.0) Standard Deviation of the median score as determined by the testing service for all applicants who were administered the NBE and the CCT prior to December 1, 1992. For applicants administered the NBE and the CCT on and after December 1, 1992, the passing score shall be the criterion referenced passing score, as recommended by the National Board Examination Committee, Standard Setting Committee.
c.After April 30, 2000, an applicant shall have successfully completed the North American Veterinary Licensing Examination (NAVLE); The passing score shall be the criterion referenced passing score, as recommended by the National Board Examination Committee, Standard Setting Committee.
d.Applicants may complete other national veterinary board examination(s), including a Clinical Competency Test, as may be approved by the Board. The passing score shall be the criterion referenced passing score, as determined by the national veterinary board administering the examination.
14.5.2Licensure by Endorsement
A.A license to practice veterinary medicine may be issued without examination to an applicant who has been duly licensed by examination as a veterinarian under the laws of another state or territory or District of Columbia, provided:
1.The board of veterinary medicine in each state or territory or District of Columbia, in which the applicant has held or holds licensure submits directly to the Board of this state, a statement attesting to the licensure status of the applicant during the time period the applicant held licensure in said state or territory or District of Columbia;
2.The applicant meets the qualifications to practice veterinary medicine in this state in accordance with § 14.5 of this Part; and
3.The applicant submits the licensure application form with supporting certified documentation of credentials in accordance with § 14.6 of this Part.
14.5.3Graduates of Foreign Veterinary Medical Schools
A.An applicant seeking licensure to practice veterinary medicine in this state and who is a graduate of a foreign veterinary medical school must meet the qualifications of R.I. Gen. Laws § 5-25-10. In addition to these qualifications, the applicant must:
1.Conduct themselves in accordance with the “Principles of Veterinary Medical Ethics of the AVMA” incorporated by reference in § 14.2(A) of this Part; and,
2.Have satisfactorily passed the National Board Examination for Veterinary Medicine and the Clinical Competency Test approved by the American Veterinary Medical Association, or other Board-approved examination as indicated in § 14.5.1(B)(2) of this Part.
B.It is within the Department’s discretion to accept a Program for the Assessment of Veterinary Education Equivalence (PAVE) in satisfaction of a certification by the Education Commission for Foreign Veterinary Graduates (ECFVG) as set forth in R.I. Gen. Laws § 5-25-10(1).
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.6** Application for License and Fees {#sec-216-ricr-40-05-14-14.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.6}
A.Application for licensure shall be made on forms provided by the Department and shall be completed and submitted to the Board sixty (60) days prior to the scheduled date of the Board meeting by applicants seeking licensure.
B.Such application shall be accompanied by the following documents and fee (non-refundable and non-returnable):
1.Photographs: a recent identification photograph of the applicant, head and shoulder front view approximately two inches by three inches (2” x 3”) in size;
2.Verification: the Board of Veterinary Medicine in each state or territory or District of Columbia, in which the applicant has held or holds licensure submitted directly to the Board of this state, a statement attesting to the licensure status of the applicant during the time period the applicant held licensure in said state or territory or District of Columbia;
3.Transcripts
a.For graduates of accredited schools in the U.S. and Canada: supporting certified transcript of education credentials as required in the appropriate section of § 14.5 of this Part, signed by the Dean or Registrar of the school of veterinary medicine, verifying the dates of attendance and completion of the veterinary program. Such documentation must consist of original statements and/or photocopies bearing the signature of the Dean or Registrar and the imprint of the school seal;
b.For graduates of foreign "listed or approved" schools: a letter from the ECFVG attesting to the satisfactory completion of evaluation of credentials and veterinary knowledge.
c.The results of the national veterinary board examination as required by § 14.5.1(B)(2) of this Part must be submitted directly to the Board.
4.Fees: the application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) (non-returnable nor non-refundable);
5.Initial Licensure Fee: the initial licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) made payable to the General Treasurer, State of Rhode Island; and,
6.Other: such other information as may be deemed necessary and appropriate by the Board.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.7** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-14-14.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.7}
A.Upon completion of the aforementioned requirements and at the recommendation of the Board, qualified applicants which the Department may accept or reject, the Department may issue an initial license to those applicants found to have satisfactorily met all the requirements of this Part and upon submission of an initial licensure fee as set forth in § 14.6(B)(5) of this Part.
B.The license issuing and renewal procedures shall be pursuant to the provisions of R.I. Gen. Laws § 5-25-12.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.8** Continuing Education {#sec-216-ricr-40-05-14-14.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.8}
A.Continuing education requirements for veterinary medicine practice are pursuant to the provisions of R.I. Gen. Laws § 5-25-12(e).
B.Veterinarians initially licensed after the first (1st) day of May shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., the thirtieth (30th) day of April of the next even numbered year).
C.All veterinarians licensed to practice in this state shall maintain evidence that in the preceding two (2) years, they have satisfactorily completed at least twenty-four (24) hours of continuing veterinary medical education courses offered or sponsored by organizations approved by the Board.
D.Continuing education programs approved by the Board include those offered or approved by:
1.Rhode Island Veterinary Medical Association or other state veterinary medical association;
2.American Veterinary Medical Association (AVMA);
3.Registry of Approved Continuing Education (RACE);
4.American Animal Hospital Association;
5.Boards of licensure of veterinary medicine in other states; and,
6.Academic coursework or continuing education programs offered by an approved school of veterinary medicine.
E.A maximum of eight (8) hours of the required twenty-four (24) hours of continuing education in a two (2) year period may be non-contact hours (e.g., online courses) or articles such as those in the Veterinary Learning Systems Compendium for continuing education. Contact hours may be earned via in-person programs or live online streamed programs which allow for the audience to participate and ask questions to the presenter(s).
F.A maximum of four (4) hours of the required twenty-four (24) hours of continuing education in a two (2) year period may be related to business management. The remaining twenty (20) hours of continuing education in a two (2) year period shall be related to the professional practice of veterinary medicine.
G.It shall be the sole responsibility of the individual veterinarian to obtain documentation from the recognized sponsoring or co-sponsoring organizations, agencies or other, of their participation in the learning experience and the number of dated credits earned. Furthermore, it shall be the sole responsibility of the individual to safeguard the documents for review by the Board, if required. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
H.The Department may extend for any one six (6) month period these educational requirements if the Department is satisfied that the applicant has suffered hardship which prevented them from meeting the educational requirements stipulated in this Part.
I.Failure to produce satisfactory documentation of completion of the continuing education requirements of this Section, upon request by the Board, constitutes grounds for disciplinary action under the provisions of the Act and this Part.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.9** Denial, Suspension, Revocation of License {#sec-216-ricr-40-05-14-14.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.9}
A.The Department is authorized to deny, revoke or suspend any license issued under the statutory and regulatory provisions of this Part or otherwise discipline a licensee upon proof of the actions stipulated by R.I. Gen. Laws § 5-25-14.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.10** Veterinary Practice {#sec-216-ricr-40-05-14-14.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.10}
14.10.1Emergency Services
A.When a practicing veterinarian is not available, they shall provide for referral for emergency veterinary services. Such referral must fulfill the requirements of R.I. Gen. Laws § 5-25-13.
14.10.2Record of Animals Receiving Veterinary Services
A.A veterinarian subject to the provisions of the Act and this Part shall keep a written record in accordance with the requirements of R.I. Gen. Laws § 5-25-7.1
B.In addition to the record keeping requirements set forth in R.I. Gen. Laws § 5-25-7.1, the minimum amount of information which shall be included in written or computerized records and summaries shall include no less than the following:
1.Client’s name;
2.Patient’s name;
3.Patient’s species and breed;
4.Patient’s age or date of birth;
5.Patient’s gender and reproductive status;
6.Patient’s color and/or markings;
7.Dates(s) of treatment;
8.Presenting problem;
9.Pertinent history;
10.Examination findings;
11.Assessment; and,
12.Plan for treatment/care.
C.The minimum duration of time for which a licensed veterinarian or their designee shall retain the written or computerized record, including imaging studies regardless of format, shall be no less than five (5) years from the date of the last patient visit or, for deceased patients, no less than three (3) years from the date of death.
D.An imaging study, regardless of format, is the property of the veterinary practice in which the veterinarian associated with that practice originally ordered it to be prepared, and it shall be released upon the written request of another veterinarian who has the authorization of the owner of the animal to whom it pertains and such imaging study, regardless of format, shall be returned to the original veterinary practice within a reasonable time.
E.When an owner requests in writing that their animal(s)’ records and/or imaging studies, regardless of format, be transferred to another veterinarian, the original veterinarian shall promptly honor such request.
1.The fee charged for the transfer shall not exceed the direct expense incurred to make copies of such veterinary records and/or imaging study(ies), regardless of format.
F.Any veterinarian licensed in the State of Rhode Island who writes a prescription for a patient shall provide a copy of that prescription to the owner of the patient, upon request of the owner, for the purpose of filling the prescription with a licensed pharmacy. Said prescription shall be written in accordance with the requirements of R.I. Gen. Laws Chapter 21-31.1 ("Veterinary Drugs").
G.Veterinary drugs dispensed by a veterinarian shall comply with the requirements of R.I. Gen. Laws § 21-31.1-8, except for the prescription number.
14.10.3Immunity from Liability
A.Immunity from liability is in accordance with R.I. Gen. Laws § 5-25-17.
14.10.4Donation of Veterinary Medications for Use by Nonprofit, State, and Local Facilities
A.Pursuant to statutory provisions of R.I. Gen. Laws Chapter 4-9.1 veterinary medications may be donated to a licensed veterinarian or a facility in which veterinary medicine is practiced if the licensed veterinarian or facility chooses to accept the medication for the purpose of re-dispensing the medication.
B.A Rhode Island licensed veterinarian may re-dispense drugs not otherwise prohibited in R.I. Gen. Laws § 4-9.1-3, upon meeting the conditions stated in R.I. Gen. Laws § 4-9.1-2(b).
C.Drugs that meet the criteria for donation can be re-dispensed under the conditions in R.I. Gen. Laws §§ 4-9.1-4(a) and (b). In addition to these conditions, the following conditions must also be met:
1.A licensed veterinarian shall label the re-dispensed drug in accordance with R.I. Gen. Laws § 5-19.1-18 and Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors § 15-1.5.17 of this Chapter.
2.The medication shall be re-dispensed at no charge and the licensed veterinarian or facility shall not sell or resell donated medication pursuant to R.I. Gen. Laws § 4-9.1-6.
D.Receipt, Storage, and Record Keeping for Donated Medications
1.The licensed veterinarian or facility receiving donated medications shall comply with the requirements of R.I. Gen. Laws § 4-9.1-7. In addition to the requirements of R.I. Gen. Laws § 4-9.1-7, the licensed veterinarian or facility shall:
a.Inspect and deem that the donated medication has not been tampered with and is properly labeled upon arrival at the practice, clinic, or facility and sign a record of this inspection;
b.Ensure adequate measures are in place to prevent diversion of the donated medication;
c.Maintain a record of the name, strength, and quantity of the donated medication received;
d.Store the donated medication(s) according to manufacturer or USP storage requirements;
eConfirm the donated medication does not have any signs of tampering, misbranding, deterioration, compromised integrity, or adulteration;
f.Receive only donated medications delivered personally to a licensed veterinarian and not delivered in a drop-box;
g.Be responsible for medication recalls for donated medications that were re-dispensed and shall have an established mechanism to notify recipients in the event of a medication recall; and,
h.Have a quarantine area for donated medications that are expired, adulterated, recalled, misbranded, or deteriorated such that these medications are separated from medications to be re-dispensed and shall be destroyed pursuant to Part of this Title, Disposal of Drugs.
2.If any one of the conditions contained in this Part are not satisfied, the donated medications shall not be re-dispensed and shall be destroyed pursuant to Part of this Title, Disposal of Drugs.
3.All records in this Section must be maintained for not less than two (2) years and readily retrievable for state and federal inspectors.
E.When re-donating any donated drugs, an inventory of all re-donated drugs must be prepared by the donor and acknowledged by the recipient. A copy of the inventory of all drugs being re-donated must accompany the transfer of said drugs. The recipient of the drugs must verify that the received drugs match the inventory. A copy of the inventory must be maintained by both the donor and recipient.
F.Donations shall be in accordance with the provisions of R.I. Gen. Laws § 4-9.1-2(a).
G.Any entity receiving donated medications pursuant to R.I. Gen. Laws Chapter 4-9.1, that receives an initial donation of medications may only ‘re-donate’ them to entities described in R.I. Gen. Laws § 4-9.1-2(b)(2) in conformity with § 4-9.1-7(b). Any such ‘re-donated’ medications must also comply with requirements set forth in §§ 14.10.4(C) and (D) of this Part.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.11** Violations/Sanctions/Practices and Procedures {#sec-216-ricr-40-05-14-14.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.11}
14.11.1Violations and Sanctions
A.Pursuant to the provisions of the Act, the Department is authorized to deny, revoke or suspend licenses to any person found to have violated any provisions of this Part, and to impose such other sanction pursuant to R.I. Gen. Laws § 5-25-8. The procedure for the discipline of veterinarians shall be in accordance with the provisions set forth in R.I. Gen. Laws § 5-25-15.
14.11.2Rules and Regulations Governing Practices and Procedures
A.All hearings and reviews required under the provisions of the Act and this Part, shall be held in accordance with the provisions of R.I. Gen. Laws § 5-25-15 and Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
##### **216-RICR-40-05-14 § 14.12** Severability {#sec-216-ricr-40-05-14-14.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-14#14.12}
A.If any provision of this Part or the application thereof to any facility or provider or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of this Part which can be given effect, and to this end the provisions of this Part are declared to be severable.
**History**
- *Amendment — effective from 2025-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/27/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-01-11 to 10/18/2007*
- *Amendment — effective from 2006-02-27 to 01/11/2007*
- *Amendment — effective from 2003-07-03 to 02/27/2006*
- *Periodic Refile — effective from 2002-01-02 to 07/03/2003*
#### **216-RICR-40-05-16** Respiratory Care Practitioners
##### **216-RICR-40-05-16 § 16.1** Authority {#sec-216-ricr-40-05-16-16.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-39-6(6), 23-39-7(2), and 23-39-12(7) and (8), and are established for the purpose of adopting prevailing standards for the licensure of respiratory care practitioners in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.2** Incorporated Materials {#sec-216-ricr-40-05-16-16.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.2}
These regulations hereby adopt and incorporate the American Association for Respiratory Care (AARC), Statement of Ethics and Professional Conduct (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.3** Definitions {#sec-216-ricr-40-05-16-16.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.3}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-39, entitled "Respiratory Care Act."
2."Board" means the Board of Respiratory Care established in accordance with the provisions of R.I. Gen. Laws § 23-39-5.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Rhode Island Department of Health.
5."Respiratory care" (including respiratory therapy and inhalation therapy) means a health profession, under qualified medical direction, employed in the therapy, management, rehabilitation, diagnostic evaluation, and care of patients with deficiencies and abnormalities which affect the cardiopulmonary system and associated aspects of other system function.
6."Respiratory care practitioner" means a person who is licensed to practice respiratory care in Rhode Island. The respiratory care practitioner may transcribe and implement a physician's written and verbal orders pertaining to the practice of respiratory care as defined in this Part.
7."Respiratory care training program" means a program accredited or recognized by the Commission on Accreditation of Allied Health Education Programs (CAAHEP) in collaboration with the Committee on Accreditation for Respiratory Care (CoARC) or other such accrediting agency as may be approved by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.4** Licensure Requirements for Respiratory Care Practitioners {#sec-216-ricr-40-05-16-16.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.4}
16.4.1General Requirements
A.No person shall practice respiratory care or represent himself or herself to be a respiratory care practitioner in this state without a valid license, issued by the Department in accordance with the Act and this Part, except as otherwise provided in R.I. Gen. Laws § 23-39-4.
1.No person shall use any title or abbreviation to indicate that he or she is a licensed respiratory care practitioner unless licensed as a respiratory care practitioner under the statutory and regulatory provisions of this Part.
16.4.2Qualifications for Licensure
A.In addition to the qualifications of licensure to practice respiratory care in this state as defined in R.I. Gen Laws § 23-39-7, an applicant shall present evidence that he/she:
1.Has successfully passed the National Board for Respiratory Care (NBRC) entry-level examination;
2.Holds an active certificate as a Certified Respiratory Therapist (CRT) by the National Board for Respiratory Care (NBRC) or hold an active certificate as a Registered Respiratory Therapist (RRT) by the National Board for Respiratory Care (NBRC).
16.4.3Application for Licensure and Fees
A.Any applicant desiring to become licensed as a respiratory care practitioner in this state shall make application to the Board on forms provided by the Department. Said form shall be completed and shall be accompanied by the following:
1.Supporting certified transcripts of education credentials as required in R.I. Gen. Laws § 23-39-7. Such documentation must consist of original statements and/or photocopies bearing the signature of the dean or director of the respiratory care training program and the imprint of the school seal or other supporting documentation as approved by the Board;
2.The results of the entry-level examination submitted to the Department directly by the National Board for Respiratory Care entry-level examination or copy of active certification as a Certified Respiratory Therapist (CRT) by the National Board for Respiratory Care (NBRC) or copy of active certification as a Registered Respiratory Therapist (RRT) by the National Board for Respiratory Care (NBRC);
3.A non-returnable, non-refundable license fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Endorsement: Applicants for licensure by endorsement, in addition to the documents required in § 16.4.3(A) of this Part, shall also provide verification of licensure in good standing from all states where they hold or have held a license as a respiratory care practitioner.
16.4.4Examination
A.By Examination: Applicants shall be required to pass the National Board for Respiratory Care entry-level examination to test the applicant's knowledge and skills to practice respiratory care in this state pursuant to the statutory and regulatory provisions.
B.By Re-Examination: An applicant who fails to successfully pass the National Board for Respiratory Care entry-level examination may be entitled to re-examination in accordance with the policies of the National Board for Respiratory Care Examiners.
16.4.5Temporary Permit
Respiratory care providers who are licensed or otherwise regulated to practice under the laws of another state or territory or the District of Columbia, and who have applied for licensure in this state, may, upon receiving an authorization from the Division, perform as a respiratory care practitioner under the supervision of a qualified and licensed respiratory care practitioner until such time as he/she is licensed. If such applicant fails to receive licensure when the Board reviews the application, all aforementioned privileges shall automatically cease upon notice to the applicant.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.5** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-16-16.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.5}
A.Upon completion of the aforementioned requirements of § 16.4.3 of this Part, the Board may recommend to the Director that a license be issued to those applicants found to have satisfactorily met all the requirements of this Part. Said license unless suspended or revoked shall expire biennially (every two years) on September 1st.
B.Every licensed person who intends to practice as a respiratory care practitioner shall file a renewal application biennially (every two (2) years) on or before September 1st together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), submitted to the Department.
C.Upon receipt of a renewal application and payment of fee, the accuracy of the application shall be verified and a license renewal shall be granted effective September 1st in that year for a two (2) year period, unless sooner suspended or revoked.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.6** Graduate Respiratory Care Practitioners {#sec-216-ricr-40-05-16-16.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.6}
A.Every graduate of a board approved respiratory care school who has filed a respiratory care practitioner application for licensure, may upon receiving a receipt (graduate permit) from the Department for said application and documents, perform as a respiratory care practitioner under the supervision of a respiratory care practitioner licensed in this state.
1.During this interim period, the graduate practitioner shall identify himself or herself only as a "graduate respiratory care practitioner."
2.If a graduate respiratory care practitioner fails to take the entry-level examination within ninety (90) days from the effective date of graduate status, without due cause or fails to pass the entry-level examination, and fails to be granted a license, all aforementioned privileges shall automatically cease upon notice to the applicant.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.7** Inactive Status {#sec-216-ricr-40-05-16-16.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.7}
A.Upon request, the Department shall grant inactive status to a licensee who does not intend to practice his or her profession within this state during the period covered by the inactive status. Said person may be reinstated without payment of a penalty fee upon application and presentation of evidence of completion of such requirements, and payment of current license renewal fee.
B.Upon reinstatement to active status, a licensee must show proof of having an active CRT and/or RRT NBRC certification after July 1, 2002 and show proof of having completed continuing education during the two (2) years immediately preceding reinstatement in such amount as is prescribed in § 16.8 of this Part.
C.Respiratory care provided by respiratory care practitioners shall be consistent with prevailing standards of practice and in accordance with the AARC, Statement of Ethics and Professional Practice incorporated at § 16.2 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.** 8 Continuing Education Requirements {#sec-216-ricr-40-05-16-16. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.}
A.Applicants for biennial licensure renewal shall meet continuing education requirements as prescribed of this Part.
B.On application for renewal of license, respiratory care practitioners shall attest to completion of twelve (12) hours biennially in discipline-specific offerings (see below) that may include, but not be limited to: formal presentations, in-service programs, conferences, and/or self- study courses, such as distance learning and on-line courses. Such programs or offerings shall be approved or sponsored by a Board-approved organization (see § 16.8(E) of this Part).
C.Two (2) hours shall be in the area of ethics. No more than six (6) hours shall be online courses.
D.Hours of continuing education shall be recognized by the Board as follows:
Category I: Formal continuing education programs that may consist of workshops, inservice programs; professional continuing education activities and scientific meetings and self-directed continuing education activities that may consist of local, regional, national symposia, colloquia, journal clubs, self- study courses, on-line courses, distance learning activities and/or institutes; or re-credentialing examinations through the National Board for Respiratory Care (NBRC).
Credit: One (1) hour for each hour attended, except for NBRC re-credentialing examinations that carry the specific number of credit hours approved by the American Association for Respiratory Care (AARC)
Category II: Formal presentations by the licensee at a conference/seminar where continuing education credit has been approved by one of the sponsoring organizations cited in § 16.8(E) of this Part
Credit: Two (2) hours for each hour of instruction; four (4) hours for two (2) hours of instruction; six (6) hours for three (3) hours of instruction; up to a maximum of six (6) hours per two (2) year cycle
Category III: Advanced Level Examination (NBRC) passing score
Credit: Four (4) credit hours maximum
E.Continuing education programs or offerings sponsored or approved by the following organizations are deemed to be approved by the Board:
1.American Academy of Pediatrics;
2.American Association for Respiratory Care;
3.American College of Allergy, Asthma, and Immunology;
4.American College of Chest Physicians;
5.American Heart Association programs excluding Advanced Cardiac Life Support (ACLS) and Basic Life Support (BLS);
6.American Hospital Association;
7.American Lung Association;
8.American Medical Association;
9.American Society of Anesthesiologists;
10.American Society of Electroneurodiagnostic Technologists;
11.American Thoracic Society;
12.National Institute of Health/National Heart Lung Blood Institute;
13.New England Society of Electroneurodiagnostic Technologists
14.Rhode Island Medical Society or other state medical society;
15.Rhode Island State Nurses Association or other state nurses’ association;
16.Or others as may be approved by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.9** Role Components/Professional Development Criteria {#sec-216-ricr-40-05-16-16.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.9}
A.Discipline-specific offerings or programs for respiratory care practitioners are defined to include the following:
1.Patient Care
a.Scientific knowledge, clinical care, and/or critical thinking skills to provide care for patients in the following disease management or health promotion areas:
(1)Cardiopulmonary;
(2)Pediatrics;
(3)Gerontology;
(4)Respiratory;
(5)Neonatology;
(6)Neurology.
b.Advanced knowledge and/or skills to develop clinical expertise within multiple practice arenas (e.g., critical care units, emergency department, rehabilitation, subacute, skilled nursing facilities, ambulatory and home care environments) including, but not limited to, the following therapeutic and diagnostic modalities:
(1)Airway management;
(2)Arterial blood gases;
(3)Cardiopulmonary pharmacology;
(4)Smoking cessation;
(5)Spirometry testing;
(6)Therapeutic modality related to cardiopulmonary care;
(7)Ventilator management.
c.Enhanced skills in patient assessment and care related to:
(1)Patient rights and ethical issues;
(2)Community-based resources to manage the continuum of care;
(3)Sleep disorders;
(4)Functional assessment and discharge planning
2.Education
a.Patient and family educational assessment and teaching skills;
b.Delegation and supervision skills;
c.Health care team resources and consultant role development;
d.Publication, presentation skills.
3.Research
a.Application and evaluation of patient care models:
(1)Managed care/capitated reimbursement;
(2)Coordinated care and case management;
(3)Disease management;
(4)Protocol development;
b.Continuous quality improvement methods and measures;
c.Outcome measures and performance improvements;
d.Data and variance analysis;
e.Research methods and study design;
f.Proposal and grant writing.
4.It shall be the sole responsibility of the individual respiratory care practitioner to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
5.A licensee who fails to complete the continuing education requirements described in this Part may be subject to disciplinary action pursuant to R.I. Gen. Laws § 23-39-14.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-40-05-16 § 16.10** Violations/Sanctions {#sec-216-ricr-40-05-16-16.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-16#16.10}
16.10.1Violations and Sanctions
The Board shall have power to deny, revoke or suspend any license applied for or issued by the Department in accordance with the provisions of R.I. Gen. Laws § 23-39-12. Penalties and action to enforce for violations of the Act are in accordance with R.I. Gen. Laws § 23-39-14.
16.10.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-39 shall be held in accordance with established Board practices, the provisions of the Act and the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-01 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-40-05-17** Licensure and Discipline of Chiropractic Physicians
##### **216-RICR-40-05-17 § 17.1** Authority {#sec-216-ricr-40-05-17-17.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-17#17.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-30-2 for the purpose of adopting minimum standards for the licensure of chiropractic physicians practicing in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-27 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/27/2003*
##### **216-RICR-40-05-17 § 17.2** Definitions {#sec-216-ricr-40-05-17-17.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-17#17.2}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-30, entitled "Chiropractic Physicians."
2."Board" means the state Board of Chiropractic Physicians within the Rhode Island Department of Health, established pursuant to the provisions of R.I. Gen. Laws § 5-30-1.1.
3."Practice of chiropractic medicine" means as defined pursuant to R.I. Gen. Laws § 5-30-1.
4."Chiropractic physician" means an individual licensed to practice chiropractic medicine pursuant to the provisions of the Act and the rules and regulations of this Part.
5.“Department” means the Rhode Island Department of Health.
6."Director" means the Director of the Rhode Island Department of Health.
7."Division" means the Division of Professional Licensing, Boards & Commissions, Rhode Island Department of Health.
8."Hour of instruction" means a documentable unit of participation in a learning experience in a chiropractic medicine-related subject as:
a.Approved by the Council on Chiropractic Education; or
b.Conducted by the Chiropractic Society of Rhode Island (C.S.R.I., Inc.) or by the major chiropractic society or association in another state or jurisdiction and approved by the Division; or
c.Approved courses and programs by the FCLB Providers of Approved Chiropractic Education (PACE); or
d.Completion of post-graduate study at an educational session or institution approved by the Division.
e.For the purposes of approval by the Division, an educational session(s) may be audited by a Board member without charge. Provided, however, said educational session may not be applied toward the Board member's own continuing education requirement as described of this Part.
9."Licensure" is synonymous with the term "certification" for the purposes of the rules and regulations of this Part.
10."Physiotherapist" means an individual licensed to practice physiotherapy/ chiropractic medicine in this state pursuant to the provisions of the Act and the regulations of this Part.
11."Physiotherapy" means the treatment and instruction of human beings within the scope of chiropractic medical practice as defined in R.I. Gen. Laws § 5-30-1, to prevent, correct, alleviate and limit physical disability, physical dysfunction, and pain from injury, disease and any other bodily conditions, including the use of physical measures, activities, and devices, for prevention and therapeutic purposes; and the provision of consultative, educational, and other advisory services for the purpose of reducing the incidence and severity of physical disability, physical dysfunction and pain. No person licensed to practice physiotherapy shall represent him/herself out as practicing physical therapy as defined in R.I. Gen. Laws Chapter 5-40, and the regulations adopted thereunder.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-27 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/27/2003*
##### **216-RICR-40-05-17 § 17.3** Licensure Requirements {#sec-216-ricr-40-05-17-17.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-17#17.3}
17.3.1Chiropractic Medicine
A.No person shall practice chiropractic medicine or any of its branches without a license issued in accordance with the provisions of R.I. Gen. Laws § 5-30-3 and this Part.
B.No person licensed to practice chiropractic medicine issued under the provisions of R.I. Gen. Laws § 5-30-3 and this Part shall practice physiotherapy or any of its branches without a license authorizing him/her to practice physiotherapy in accordance with the provisions of R.I. Gen. Laws §§ 5-30-8 and § 17.5.1 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-27 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/27/2003*
##### **216-RICR-40-05-17 § 17.4** Qualifications for Licensure {#sec-216-ricr-40-05-17-17.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-17#17.4}
17.4.1Chiropractic Medicine
A.In addition to the qualifications for licensure to practice chiropractic medicine in this state as defined in R.I. Gen. Laws § 5-30-6, an applicant shall present evidence that he/she:
1.Has three (3) letters from three (3) licensed chiropractic physicians attesting to the applicant's moral character, including one (1) letter from a faculty member at a college of chiropractic medicine if the applicant has graduated within five (5) years of application;
2.Has successfully graduated from a school or college of chiropractic medicine accredited by the Council on Chiropractic Education and approved by the Division;
3.Has successfully passed:
a.Parts I and II examinations of the National Board of Chiropractic Examiners; and
b.The Written Clinical Competency Examination (WCCE) or Part III of the National Board of Chiropractic Examiners; and
c.Part IV of the National Board of Chiropractic Examiners.
17.4.2Physiotherapy
A.In addition to the qualifications for licensure to practice physiotherapy in this state as defined in R.I. Gen. Laws § 5-30-8 an applicant must:
1.Hold a certificate of completion of a physiotherapy program from a college or school of chiropractic medicine accredited by the Council of Chiropractic Education and;
2.Have successfully passed the examination of the National Board of Chiropractic Examiners section in physiotherapy.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-27 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/27/2003*
##### **216-RICR-40-05-17 § 17.5** Application for Licensure and Fee {#sec-216-ricr-40-05-17-17.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-17#17.5}
17.5.1Application
A.Application for licensure to practice chiropractic medicine and/or physiotherapy in this state shall be made on forms provided by the Division. Such application shall be accompanied by the following:
1.Supporting official transcript of education credentials as set forth in § 17.4.1 of this Part.
2.Official notification of the national examination(s) results submitted directly to the Board by the National Board of Chiropractic Examiners;
3.A non-returnable, non-refundable license fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title)
17.5.2Application by Endorsement
A.In addition to the requirements of R.I. Gen. Laws § 5-30-7, an application for licensure by endorsement in this state to practice chiropractic medicine and/or physiotherapy by endorsement shall be made on forms provided by the Department. Such application shall be accompanied by the following:
1.A non-returnable, non-refundable license fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
2.Official notification of the national examination(s) results submitted directly to the Board by the National Board of Chiropractic Examiners;
3.A statement from the board of chiropractic medicine in each state in which the applicant has held or holds licensure or registration to be submitted to the Department attesting to the licensure status of the applicant during the time period applicant held licensure or registration in said state;
4.Documented evidence that continuing education requirements in the jurisdictions in which continuing education is required have been met by the applicant during the five (5) years prior to application for licensure in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-27 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/27/2003*
##### **216-RICR-40-05-17 § 17.6** Licensing of Chiropractic Physicians with the Practice of Physiotherapy {#sec-216-ricr-40-05-17-17.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-17#17.6}
17.6.1By Examination:
A.Applicants shall be required to successfully pass such examination(s) as established by the Division to determine the applicant's qualifications to practice chiropractic medicine and physiotherapy.
B.For Chiropractic Physicians: Written Examinations:
1.The Division shall utilize for the examination in the basic sciences, subjects of microbiology, anatomy, physiology, chemistry and pathology, vertebral palpation and adjusting, the National Board of Chiropractic Examiners' examinations (Parts I and II) and the Written Clinical Competency Examination (WCCE or Part III) and Part IV of the National Board of Chiropractic Examiners, or such other examination that, in the opinion of the Division, is substantially equivalent thereto.
C.For Physiotherapists:
1.The applicant shall qualify for licensure based upon the requirements of § 17.4.2 of this Part.
D.Passing Score:
1.The Division shall accept the recommended passing score for Parts I, II, III, IV and the Special Purposes Examination for Chiropractic (SPEC) examinations of the National Board of Chiropractic Examiners as acceptable for applicants seeking licensure in Rhode Island.
17.6.2Continuing Education
A.Continuing education requirements are in accordance with R.I. Gen. Laws § 5-30-13. Every chiropractic physician licensed to practice chiropractic medicine in Rhode Island under the provisions of the Act and this Part, on or before the thirtieth (30th) day of October of every third year, shall apply to the Board for certification of triennial registration of continuing education.
1.The application shall include satisfactory evidence to the Board of completion of at least sixty (60) hours of instruction as defined in § 17.2 of this Part, and completed over the three (3) year period preceding recertification. No less than fifty (50) hours of this 60-hour requirement shall be in clinically-related courses.
2.The Board may designate that course work in specific practice areas in specific amounts be included in the time period above. Notification of specific requirements, if any, will be made to each licensee prior to the start of the three (3) year cycle. In addition, within a given three (3) year cycle, the Board may designate that licensees attend programs in specific content areas in response to emerging public health concerns or other immediate concerns identified by the Board. Adequate notice shall be given to allow all licensees the opportunity to attend any specific content area courses so designated.
3.At least thirty (30) hours of instruction in the three (3) year continuing education cycle shall be obtained in live, didactic learning experiences. Such live learning experiences shall include hours of instruction acquired through attendance or participation at programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences, or workshops.
B.It shall be the sole responsibility of the individual practitioner to obtain documentation from the sponsoring organization, agency, institution or other as approved by the Division, of his/her participation in a learning experience or course and the number of dated hours of instruction earned.
1.The documents shall be safeguarded by the individual practitioner for review by the Board as may be requested. These documents shall be retained by each licensee for no less than two (2) years (i.e., from the date of license renewal) and are subject to random audit by the Department.
C.A chiropractic physician failing to comply with the requirements of this Part shall be subject to the sanctions of the Act, except when the educational requirements for a practitioner are waived by the Division for due cause such as an applicant has suffered hardship or for any sufficient reason which prevented the applicant from meeting the continuing educational requirements and said reasons are found acceptable to the Division.
17.6.3Issuance and Renewal of License and Fee
A.Upon recommendation of the Board, the Director shall issue an initial license to applicants who have satisfactorily met the licensure requirements of this Part. Subsequent to the initial license issuance, license renewals shall be issued upon recommendation of the Board to the Director for those applicants who meet the licensure requirements of this Part, including the continuing education requirements. Said license to practice chiropractic medicine and/or chiropractic medicine with physiotherapy, unless sooner suspended or revoked shall expire on the following October 30th following the date of issuance of the original license and annually on November 1st thereafter.
B.Every licensed person who wishes to renew his/her license shall file a renewal application with the Division, during the month of October, together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Any person who allows his/her license to lapse by failing to renew it on or before the first of November annually as provided in this Part, may be reinstated by the Director upon submission of an application and on payment of the current renewal fee, unless the license has been suspended or revoked.
17.6.4Rights and Duties of Chiropractic Physicians
The Rights and Duties of Chiropractic Physicians are set forth in R.I. Gen. Laws § 5-30-11.
17.6.5Advertisement.
A.The name of the licensed chiropractic physician shall be included in any advertisement, sign, stationery or other means which identifies the offering of chiropractic medical treatment.
1.Any person practicing pursuant to the provisions of R.I. Gen. Laws Chapter 5-30, shall be required to post his/her name on the premises where the services are being offered in such a manner as to be clearly visible to the public at the entrance to the premises and on any sign visible outside of the premises which offers the delivery of chiropractic medical services.
2.Any chiropractic physician or group of chiropractic physicians who advertise in print media shall state the name(s) of the chiropractic physician(s) responsible for said advertisement.
B.Chiropractic medical records shall be legible and contain the identity of the chiropractic physician or physician extender and supervising chiropractic physician by name and professional title who is responsible for rendering, ordering, supervising or billing each diagnostic or treatment procedure. The records shall contain sufficient information to justify the course of treatment, including, but not limited to, patient histories, including medications, examination results, and test results leading to a differential diagnosis; and reports of consultations and hospitalizations.
17.6.6Grounds for Denial, Revocation or Suspension of License
A.Pursuant to the provisions of R.I. Gen. Laws § 5-30-13 of the Act, the Division may, after due notice and hearing, deny, revoke or suspend the license of a chiropractic physician. In addition to the definition of “gross unprofessional conduct” as set forth in R.I. Gen. Laws § 5-30-13(b), the following activities are grounds for denial, revocation or suspension of a license:
1.The practice of chiropractic medicine under a false or assumed name that shall include the practice of chiropractic medicine under a fictitious name that does not include the name of a chiropractic physician in its advertising;
2.The advertising for the practice of chiropractic medicine in a deceptive or unethical manner which shall include soliciting professional patronage by agents or persons or profiting from acts of those representing themselves to be agents of the licensed chiropractic physician;
3.Sexual misconduct: any violation of the chiropractic physician-patient relationship in which the licensed chiropractic physician engages in, or attempts to induce a patient who is not the chiropractic physician's spouse to engage in any sexual activity, whether consensual or non-consensual, while such a physician-patient relationship exists;
17.6.7Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of the Act and the rules and regulations regarding Practices and Procedures before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/02/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2003-05-27 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/27/2003*
#### **216-RICR-40-05-18** Assisted Living Residence Administrators
##### **216-RICR-40-05-18 § 18.1** Authority {#sec-216-ricr-40-05-18-18.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-18#18.1}
A.This Part is promulgated pursuant to the authority set forth in R.I. Gen. Laws §§ 23-17.4-21.2 and 23-17.4-29, and is established for the purpose of establishing prevailing standards for the licensure of assisted living residence administrators in Rhode Island.
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Adoption — effective from 2004-01-04 to 01/25/2006*
##### **216-RICR-40-05-18 § 18.2** Definitions {#sec-216-ricr-40-05-18-18.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-18#18.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-17.4, entitled "An Act Relating to Assisted Living."
2."Administrator" means any person who has responsibility for day to day administration or operation of an assisted living residence.
3."Assisted living residence" means a publicly or privately operated residence that provides directly or indirectly by means of contracts or arrangements personal assistance to meet the resident's changing needs and preferences, lodging, and meals to two (2) or more adults who are unrelated to the licensee or administrator, excluding however, any privately operated establishment or facility licensed pursuant to R.I. Gen. Laws Chapter 23-17, and those facilities licensed by or under the jurisdiction of the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, the Department of Children, Youth, and Families, or any other state agency. The Department shall develop levels of licensure for assisted living residences within this definition as provided in R.I. Gen. Laws § 23-17.4-6. Assisted living residences include sheltered care homes, and board and care residences or any other entity by any other name providing the services listed in this subdivision which meet the definition of assisted living residences.
4."Board" means the Assisted Living Residence Administrator Certification Board established pursuant to the provisions of R.I. Gen. Laws § 23-17.4-21.1.
5."Certification" means the same meaning as "licensure."
6."Contact hours" means hours acquired through attendance or participation at programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences or workshops.
7."Department" means the Rhode Island Department of Health.
8."Director" means the Director of the Rhode Island Department of Health.
9.“Disqualifying information” means information produced by a criminal records review pertaining to conviction, for the following crimes will result in a letter to the employee and employer disqualifying the applicant from said employment: murder, voluntary manslaughter, involuntary manslaughter, first degree sexual assault, second degree sexual assault, third degree sexual assault, assault on persons sixty (60) years of age or older, child abuse, assault with intent to commit specified felonies (murder, robbery, rape, burglary, or the abominable and detestable crime against nature), felony assault, patient abuse, neglect or mistreatment of patients, burglary, first degree arson, robbery, felony drug offenses, larceny or felony banking law violations.
10.“Licensing agency" means the Rhode Island Department of Health.
11.“Non-contact hours” means internet courses, correspondence courses, tapes, or other continuing education programs that do not provide for direct interaction between faculty and the participant.
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Adoption — effective from 2004-01-04 to 01/25/2006*
##### **216-RICR-40-05-18 § 18.3** Certification Requirements for Assisted Living Residence Administrators {#sec-216-ricr-40-05-18-18.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-18#18.3}
18.3.1Certification Requirements
A.An assisted living residence shall have an administrator who is certified by the Department in accordance with regulations established in this Part, in charge of the maintenance and operation of the residence and the services to the residents.
B.No person shall act as an assisted living residence administrator unless he or she is the holder of an assisted living residence administrator's certification in accordance with the statutory provisions of the Act and this Part.
C.The licensing agency shall perform a criminal background records check on any person applying or reapplying for certification as an administrator. If disqualifying information is found, the licensing agency shall make a judgment regarding certification for that person.
18.3.2Qualifications for Certification
A.The Department shall issue a certification as an administrator of an assisted living residence for a period of two (2) years if the applicant meets all of the following requirements:
1.Eighteen years (18) of age or older;
2.Good moral character;
3.Initial training that meets one (1) of the following criteria:
a.Successful completion of a training program administered by a Department approved organization and successful completion of a residential care assisted living administrator licensing examination as approved by the Department, with a passing grade as determined by the Department; and have satisfactorily completed a field experience of at least eighty (80) hours, within a twelve (12) month period in a training capacity in a Rhode Island-licensed assisted living residence(s) that shall include training in the following areas: Administration, Nursing, Activities Department, Admissions, Dietary Department, Environment/Maintenance.
(1)At the conclusion of the field experience, the administrator(s) of the licensed assisted living residence(s) where the field experience was performed shall attest that the training included each area as set forth above; or
b.Successful completion of a degree in a health care-related field from an accredited college or university that includes coursework as follows:
(1)Gerontology;
(2)Personnel management; and
(3)Financial management.
(4)And have satisfactorily completed a field experience of at least eighty (80) hours, within a twelve (12) month period in a training capacity in a Rhode Island licensed assisted living residence(s) that shall include training in the following areas: Administration, Nursing, Activities Department, Admissions, Dietary Department, Environment/Maintenance.
(5)At the conclusion of the field experience, the administrator(s) of the licensed assisted living residence(s) where the field experience was performed shall attest that the training included each area.
(6)And successful completion of a residential care assisted living administrator licensing examination as approved by the Department, with a passing grade as determined by the Department; or
c.Possession of a current Rhode Island nursing home administrator’s license in good standing.
18.3.3Application for Certification
A.Application for certification to practice in this state as an assisted living residence administrator shall be made on forms provided by the Department which shall be completed and submitted thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents and any required fees as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title):
1.Proof of lawful entry into the country:
a.For U.S. born applicants, a certified or notarized copy of birth certificate;
b.For foreign born applicants, proof of lawful entry into the country and eligibility for employment in the United States.
2.Good Moral Character: Signed statement on application.
3.Examinations: the results of any required examination under § 18.3.2 of this Part must be submitted directly to the Department.
4.Supporting evidence of education and training credentials in accordance with § 18.3.2 of this Part: such documentation must be sent directly from the school or training program to the Department;
5.One (1) unmounted recent photograph of the applicant (head and shoulder view) approximately two inches by three inches (2" x 3") in size;
6.For applicants licensed in another state, the results of the assisted living residence administrator examination must be sent directly from the state of original licensure or the examination service to the Department;
7.Such other information as the Department may deem necessary.
18.3.4Certification by Examination/Certification by Endorsement
A.By Examination
1.All applicants, except those applicants licensed under the provisions of § 18.3.2(A)(3)(c) of this Part, shall be required to pass a written examination as determined by the Department to test the qualifications of the applicants to practice as an assisted living residence administrator pursuant to the statutory and regulatory requirements of this Part. Prior to sitting for the written examination, an applicant for certification shall be required to complete all requirements for certification, as approved by the Board, except for passing the examination.
a.Applicants who have previously tested unsuccessfully must meet all requirements for licensure prevailing in this state at the time the retest is administered.
b.In order to qualify for re-examination after three (3) failures, the applicant must request the same in writing from the Board, at which time requirements (consisting of additional coursework and/or training) for re-examination will be determined and must be fulfilled prior to admittance to a future examination.
B.By Endorsement
1.A certification may be issued to an assisted living residence administrator without examination to an applicant who has been licensed by examination in an alternate jurisdiction and who holds a current license in good standing as an assisted living residence administrator in said jurisdiction, provided:
a.The Board finds that the standards for licensure in such other jurisdiction are substantially equivalent to those prevailing in this state at the time of application and the applicant meets the qualifications required of assisted living residence administrators in this state as set forth in § 18.3.2 of this Part;
b.The licensing agency in each state in which the applicant holds or has held a registration or license submits to the Board in this state a statement confirming the applicant to be or have been in good standing;
c.The applicant submits thirty (30) days prior to the scheduled meeting of the Board, a completed certification application in accordance with the provisions of § 18.3.4 of this Part.
18.3.5Issuance and Renewal of Certification
A.Upon the recommendation of the Board, the Director shall issue to applicants who have satisfactorily met the certification requirements of this Part, a certification to an assisted living residence administrator to function as such in this state.
B.Assisted living residence administrator certification, unless sooner suspended or revoked, shall be valid for a period of two (2) years and shall expire on June 30th of the next even-numbered year thereafter.
1.Every person so certified who wishes to renew his or her certification shall file with the Department by May 1st of the even-numbered years, a renewal application duly executed together with a two (2) year renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.In May of every even-numbered year, application for renewal of licensure shall be accompanied by an attestation statement of the licensee's having completed a minimum of thirty-two (32) hours biannually of continuing education as provided in § 18.3.6 of this Part.
1.Assisted living residence administrators initially licensed after the May 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., April 30th of the next even-numbered year).
D.Any person who allows his or her certification to lapse by failing to renew it on or before the first day of July every two (2) years as provided above, may be reinstated by the Director upon submission of an application, and upon payment of the current renewal fee, and completion of the continuing education requirements in accordance with § 18.3.6 of this Part within the immediate two (2) years prior to the applicant’s request for licensure renewal, unless the certification has been suspended or revoked.
1.Any person using the title of “assisted living residence administrator” or functioning as an assisted living residence administrator during the time that his or her certification has lapsed shall be subject to the penalties for violation of the statutory and regulatory provisions of this Part.
18.3.6Mandatory Continuing Education Requirements
A.To be eligible for re-licensure every two (2) years following initial licensure, a certified assisted living residence administrator shall have completed thirty-two (32) hours of Department approved continuing education within the previous two (2) years.
B.Sixteen (16) hours of the required thirty-two (32) hours of continuing education in a two-year period shall be contact hours. The remaining sixteen (16) hours of continuing education may be non-contact hours.
C.Approved continuing education programs in assisted-living related areas include those offered or approved by:
1.LeadingAge Connecticut & Rhode Island, formerly Rhode Island Association of Facilities and Services for the Aging (RIAFSA)/LeadingAge RI;
2.Rhode Island Assisted Living Association (RIALA);
3.Rhode Island Health Care Association (RIHCA);
4.Alliance for Better Long Term Care;
5.Rhode Island Chapter, Alzheimer’s Association;
6.Appropriate coursework from any regionally accredited college;
7.A national affiliate of any of the organizations listed above;
8.Any other organizations as may be approved by the Board.
D.It shall be the sole responsibility of the individual assisted living residence administrator to obtain documentation from the recognized sponsoring or co-sponsoring organizations, agencies or other, of his or her participation in the learning experience and the number of dated credits earned. Furthermore, it shall be the sole responsibility of the individual to safeguard the documents for review by the Board, if required. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
E.An extension of time to complete the continuing education requirements may be granted to an assisted living residence administrator solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
18.3.7Grounds for Denial, Revocation or Suspension of Certification
A.The Department may suspend, revoke, or refuse to renew the certification of an assisted living residence administrator for cause, including but not limited to, failure to maintain compliance with the above qualifications, repeated or intentional violations of the Act or this Part, or conviction (including but not limited to a plea of nolo contendere) to charges of resident abuse under the provisions of R.I. Gen. Laws Chapter 23-17.8, or a conviction of a felony, or exploitation.
B.The Department may deny issuance of a certification, suspend, revoke, or refuse to renew any certification issued under the provisions of the Act and this Part, or may reprimand, censure or otherwise discipline, or may require participation in continuing education or professional mentoring or may place an administrator on probation, upon decision and after hearing in accordance with § 18.4.2 of this Part upon proof that the licensee engaged in unprofessional conduct which includes but is not limited to:
1.Has become unfit or incompetent by reason of negligence, habits, or other causes such as physical and mental impairment that would interfere with proper performance of duties;
2.Is in violation of any of the provisions of the Act or this Part, or acted in a manner inconsistent with the health and safety of the residents of the residence in which he or she is the administrator;
3.Has engaged in fraud or deceit in the practice of assisted living residence administration or in his or her admission to such practice;
4.Has been convicted in a court of competent jurisdiction, either within or without this state, of a felony;
5.Neglect or misconduct in professional practice;
6.Any departure from or failure to conform to the minimal standards of acceptable and prevailing practice in assisted living residence administration. Actual injury to a resident need not be established.
C.If an assisted living residence administrator is placed on probation, the Department may require the licensee to:
1.Report regularly to the Department on matters that are the basis of the probation;
2.Limit practice to the areas prescribed by the Department; or
3.Complete a prescribed program of continuing professional education until the licensee attains a degree of skill satisfactory to the Department in those areas that are the basis of the probation.
D.All hearings and reviews as may be required in this Part shall be conducted in accordance with the provisions of § 18.4.2 of this Part.
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Adoption — effective from 2004-01-04 to 01/25/2006*
##### **216-RICR-40-05-18 § 18.4** Violations and Penalties/Practices and Procedures {#sec-216-ricr-40-05-18-18.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-18#18.4}
18.4.1Violations and Penalties
A.Any violations as set forth in § 18.3.7 of this Part shall be cause for the Department to impose such sanctions, or denial, revocation or suspension of certification or imposing a reprimand or censure or such other disciplinary action.
18.4.2Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17.4, shall be held in accordance with the provisions of the Act and the rules and regulations regarding Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Technical Revision — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2018-11-04 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Adoption — effective from 2004-01-04 to 01/25/2006*
#### **216-RICR-40-05-19** Opticians
##### **216-RICR-40-05-19 § 19.1** Authority {#sec-216-ricr-40-05-19-19.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-19#19.1}
These regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws § 5-35.2-14, and are established for the purpose of establishing administrative procedures and prevailing standards for the licensure (registration) of opticians in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-01-26 to 10/18/2007*
- *Amendment — effective from 2002-07-10 to 01/26/2004*
- *Periodic Refile — effective from 2002-01-02 to 07/10/2002*
##### **216-RICR-40-05-19 § 19.2** Definitions {#sec-216-ricr-40-05-19-19.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-19#19.2}
A.Wherever used in this Part, the following terms shall be construed to mean:
1."Act" means R.I. Gen. Laws Chapter 5-35.2 entitled, "Opticians."
2."Advisory Committee" means the Advisory Committee of Opticianry established pursuant to R.I. Gen. Laws § 5-35.2-8.
3."Director" means the Director of the Rhode Island Department of Health.
4."Intern" means a graduate of a school of opticianry who is enrolled in a full-time internship under the supervision of a duly licensed optician or optometrist.
5."License" is synonymous with "registration."
6."Optician" means a person who neither practices nor professes to practice optometry but who may grind ophthalmic lenses, fit spectacles and eyeglasses and may sell spectacles and eyeglasses or lenses on prescription from either a licensed physician or licensed optometrist, nor shall an optician fit, sell, replace or dispense contact lenses pursuant to R.I. Gen. Laws Chapter 5-35.2.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-01-26 to 10/18/2007*
- *Amendment — effective from 2002-07-10 to 01/26/2004*
- *Periodic Refile — effective from 2002-01-02 to 07/10/2002*
##### **216-RICR-40-05-19 § 19.3** Licensure Requirements {#sec-216-ricr-40-05-19-19.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-19#19.3}
19.3.1Licensure Requirements
No person shall conduct the business of optician in this state until he or she has passed an examination approved by the Department, and shall have registered and received a certificate of licensure pursuant to the provisions of the Act and this Part.
19.3.2Qualifications for Licensure
A.In addition to the qualifications for licensure stated in R.I. Gen. Laws § 5-35.2-2(a), An applicant seeking licensure to practice as an "optician" in this state must:
1.Be not less than eighteen (18) years of age;
2.Have successfully graduated from a high school of a standard approved by the department of education in the state in which the applicant graduated, or hold a statement of high school equivalency certified and issued by the department of education in the state in which the applicant obtained the equivalency certificate;
3.Have graduated from a two (2) year school of opticianry approved by the Department and successfully completed one (1) year of postgraduate internship under the supervision of a duly licensed optometrist or optician.
4.Have successfully passed a written examination, such as the National Opticianry Competency Examination or such other written examination as approved by the Department and the Advisory Committee; and
5.Have successfully passed a practical examination approved by the Department with consultation from the Advisory Committee for Opticianry.
B.Notwithstanding any other provisions of R.I. Gen. Laws Chapter 5-35.2, any individual who, at the time of his or her application for licensure, is a citizen or legal resident of the United States; submits satisfactory evidence to the Department and Advisory Committee of successful completion of a two (2) year apprenticeship program; that he or she has previously held a valid license to practice opticianry in another state for at least one year; has practiced opticianry in this or any other state for a period of not less than one (1) year; is in good standing in that state; has previously taken and successfully passed as a prerequisite for licensure in the other state a written examination such as the National Opticianry Competency Examination or such other written examination approved by the Department and the Advisory Committee and otherwise meets the requirements for licensure with the exception of § 19.3.2(A)(4) of this Part; pays to the Department the appropriate fee which shall accompany his or her application; is eligible to apply for licensure on condition that he or she first completes the requirements of § 19.3.2(A)(6) of this Part.
19.3.3Application and Fee
A.Application for licensure shall be made on forms provided by the Department. Said forms shall be completed, notarized and submitted to the Department at least thirty (30) days before the scheduled date of the Advisory Committee meeting. Such application shall be accompanied by the original document, certified copies or notarized photo copies of the following documents:
1.A certified copy of birth certificate;
2.A recent identification photograph of the applicant, head and shoulders, front view, approximately 2x3 inches in size;
3.A statement from the Board of Examiners in Opticianry in each state in which the applicant has held or holds licensure, to be submitted to the Department of this state attesting to the licensure status of the applicant during the time period the applicant held licensure in said state(s);
4.Documented evidence of high school education; supporting certified transcripts of education signed by the dean or registrar of the school of opticianry; and a statement certifying successful completion of an internship, with the exception of those applicants seeking licensure in accordance with § 19.3.2(B) of this Part who must produce evidence of their valid licensure and practice in such other state. Such statements and/or documentation must consist of original transcripts, statements and/or photocopies acceptable to the Advisory Committee.
5.The results of the written national examination as approved by the Department and submitted directly to the Department by the American Board of Opticianry;
6.The initial application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
7.Such other information as may be deemed necessary by the Department and/or the Advisory Committee.
19.3.4Examinations for Licensure
A.Examinations
1.Applicants seeking licensure to practice opticianry in this state shall be required to successfully pass:
a.A written examination as determined by the Department, such as that of the National Opticianry Competency Examination, or such other as determined by the Department and the Advisory Committee. The date, time and place of such examination may be obtained from the American Board of Opticianry or from the Department.
b.A practical examination, approved by the Department with consultation from the Advisory Committee which covers subjects in fields which will test the applicant's knowledge of professional standards of practice.
B.Re-examination
1.In case of failure of any applicant to satisfactorily pass an examination, said applicant shall be entitled to re-examination. In the event of a third failure or any subsequent failure, opportunity for re-examination(s) may be subject to the applicant's completion of additional requirements as recommended by the Advisory Committee on an individual basis.
19.3.5Continuing Education
A.Every person licensed to practice opticianry within this state shall on or before the thirty-first (31st) day of January of each year in which his or her license is due for renewal, present to the Advisory Committee satisfactory evidence of completion of not less than twelve (12) hours of continuing education within the preceding two (2) calendar years.
1.Any course intended to fulfill the requirement of continuing education shall be submitted to the committee for review and approval, provided however, that continuing education derived from attendance at or participation in any of the following shall be deemed approved by the Advisory Committee:
a.Any course and/or courses offered by a provider meeting the guidelines of continuing opticianry education of the American Board of Opticianry;
b.A maximum of one (1) hour per two (2) year period in approved management and marketing course(s); and
c.Any other course approved by the Advisory Committee.
2.The Advisory Committee, in its discretion, may exempt a person from the requirements for continuing opticianry education for hardship or other extenuating circumstances as the Advisory Committee deems appropriate.
19.3.6Issuance and Renewal of License and Fee
A.Upon completion of the aforementioned requirements, the Department may issue a license to those applicants found to have satisfactorily met all the requirements of this Part. Said license shall expire biennially (every two [2] years on the 31st of January), unless sooner suspended or revoked.
B.On or before the 1st of January of every other year, the Department shall mail an application for renewal of license to each person to whom a license has been issued or renewed during the past two (2) years. Every person licensed who intends to practice opticianry during the ensuring two years shall file a renewal application duly executed together with a renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Upon receipt of a renewal application accompanied by evidence of completion of prescribed continuing education requirements as set forth in § 19.3.5 of this Part, and including payment of renewal fee, the accuracy of the application shall be verified and license shall be granted effective for a two (2) year period unless sooner suspended or revoked.
19.3.7Denial, Suspension or Revocation of License
In addition to any other sanctions provided in the statutory and regulatory provisions of this Part, the Director may, pursuant to R.I. Gen. Laws § 5-35.2-10, and after due notice and hearing as provided in § 19.4.3 of this Part, refuse to grant, refuse to renew, suspend or revoke any license to any person who is not of good moral character, or has been guilty of gross unprofessional conduct, or conduct of a character likely to deceive or defraud the public, or for any fraud or deception committed in obtaining such license, and of gross unprofessional conduct as defined in the aforementioned section of the Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-01-26 to 10/18/2007*
- *Amendment — effective from 2002-07-10 to 01/26/2004*
- *Periodic Refile — effective from 2002-01-02 to 07/10/2002*
##### **216-RICR-40-05-19 § 19.4** Advertising, Violations, Practices and Procedures and Severability {#sec-216-ricr-40-05-19-19.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-19#19.4}
19.4.1Advertising
A.No optician licensed and practicing in this state shall advertise by written or spoken word of a character tending to deceive or mislead the public.
B.In addition to § 19.4.1(A) of this Part, any and all advertising conducted by any optician shall conform to the provisions of R.I. Gen. Laws Chapter 6-13.1, entitled, "Deceptive Trade Practices Act."
C.Any person practicing pursuant to the provisions of the Act, shall be required to post his or her name and license number on the premises where the services are being offered.
19.4.2Violations
Any violations of the statutory and regulatory requirements of this Part shall be subject to the statutory sanctions as set forth in § 5-35.2-12 of the Act.
19.4.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-01-26 to 10/18/2007*
- *Amendment — effective from 2002-07-10 to 01/26/2004*
- *Periodic Refile — effective from 2002-01-02 to 07/10/2002*
#### **216-RICR-40-05-20** Optometrists
##### **216-RICR-40-05-20 § 20.1** Authority {#sec-216-ricr-40-05-20-20.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-20#20.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-35.1-22, and are established for the purpose of adopting prevailing standards for the licensure of optometrists in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2009-02-01 to 12/10/2012*
- *Amendment — effective from 2008-01-10 to 02/01/2009*
- *Amendment — effective from 2007-10-18 to 01/10/2008*
- *Amendment — effective from 2003-04-17 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/17/2003*
##### **216-RICR-40-05-20 § 20.2** Incorporated Materials {#sec-216-ricr-40-05-20-20.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-20#20.2}
A.These regulations hereby adopt and incorporate Ophthalmic Practice Rules, 16 C.F.R Part 456 (1992) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate The Contact Lens Rule, 16 C.F.R Part 315 (2004) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2009-02-01 to 12/10/2012*
- *Amendment — effective from 2008-01-10 to 02/01/2009*
- *Amendment — effective from 2007-10-18 to 01/10/2008*
- *Amendment — effective from 2003-04-17 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/17/2003*
##### **216-RICR-40-05-20 § 20.3** Definitions {#sec-216-ricr-40-05-20-20.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-20#20.3}
A.Wherever used in this Part, the following terms shall be construed to mean:
1."Act" means R.I. Gen. Laws Chapter 5-35.1, entitled "Optometrists."
2."Amplified optometrist" means an optometrist licensed in this state to practice optometry and authorized by the Board to administer and prescribe pharmaceutical agents in the treatment of conditions of the human eye and its appendages, including anterior uveitis and glaucoma, without surgery or other invasive techniques, and in accordance with the Act and the requirements herein.
3."Board" means the Board of Optometry established under the provisions of R.I. Gen. Laws § 5-35.1-13.
4."Certified optometrist" means an optometrist licensed in this state to practice optometry and authorized by the Board to administer and prescribe topical ocular pharmaceutical agents in the treatment of ocular conditions of the anterior segment of the human eye and its appendages, (with the exception of uveitis and glaucoma) without surgery or other invasive techniques, and in accordance with the requirements of the Act and this Part.
5.“Department” means the Rhode Island Department of Health.
6."Director" means the Director, Rhode Island Department of Health.
7.“Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.
8.“Electronic transmission prescription” means any prescription, other than an oral or written prescription, that is electronically transmitted from an optometrist authorized to prescribe to a pharmacy without alteration by a third party unless authorized by the optometrist or from one pharmacy to another pharmacy.
9.“Facsimile (FAX) prescription” means a written prescription or order that is transmitted by an electronic device that sends the exact image to the receiver (pharmacy) in a hard copy form.
10."Optometrist" means an individual licensed in this state to practice optometry pursuant to the provisions of R.I. Gen. Laws Chapter 5-35.1 and this Part.
11.“Optometry” means the profession whose practitioners are engaged in the art and science of the evaluation of vision and the examination of vision and the examination and refraction of the human eye which includes: the employment of any objective or subjective means for the examination of the human eye or its appendages; the measurement of the powers or range of human vision or the determination of the accommodative and refractive powers of the human eye or the scope of its functions in general and the adaptation of lenses, prisms, and/or frames for the aid thereof; the prescribing, directing the use of or administering ocular exercises, visual training, vision training, or orthoptics, and the use of any optical device in connection with these; the prescribing of contact lenses for, or the fitting or adaptation of contact lenses to the human eye; the examination or diagnosis of the human eye to ascertain the presence of abnormal conditions or functions; and the application of pharmaceutical agents to the eye. Provided, however, that no optometrist licensed in this state shall perform any surgery for the purpose of detecting any diseased or pathological condition of the eye. With respect to presently licensed optometrists, only presently licensed optometrists who:
a.Have satisfactorily completed a course in pharmacology, as it applies to optometry, at an institution accredited by a regional, professional, or academic accreditation organization which is recognized by a national commission on accreditation, such as the Accreditation Council on Optometric Education (ACOE), with particular emphasis on the application of drugs to the eye for the purposes of detecting any diseased or pathological condition of the eye; or the effects of any disease or pathological condition of the eye, approved by the Board of Optometry and the Department; or
b.Have successfully passed all sections of the National Board of Examiners in Optometry (NBEO) examination; and the treatment and management of ocular disease (TMOD) examination shall be permitted to apply pharmaceutical agents to the eye for the purpose of detecting any diseased or pathological condition of the eye, or the effects of any disease or pathological condition of the eye.
12."Pharmaceutical agents" means any medications as determined by the Department, except those specified in schedules I and II as provided in R.I. Gen. Laws Chapter 21-28.
13.“Vision training”, as referenced in the definition of optometry in § 20.3(A)(11) of this Part, includes:
a.“Vision therapy” means the assessment, diagnosis, treatment, or prescription of treatment for conditions of the visual system or management of a patient with vision therapy, visual training, visual rehabilitation, orthopics or eye exercises. Anyone who holds him/herself out as being able to do so for the rehabilitation and/or treatment of physical, physiological, sensorimotor, neuromuscular or perceptual anomalies of the eyes or vision system or who prescribes or utilizes lenses, prisms, filters, occlusion, or other devices for the enhancement, rehabilitation and/or treatment of the visual system or prevention of visual dysfunctions, except under the supervision and management of a licensed optometrist, is engaged in the practice of optometry.
b.“Low vision rehabilitation” means the evaluation, diagnosis, and management of the low vision patient, including but not limited to, prescription, low vision rehabilitation therapy, education and interdisciplinary consultation when indicated. Any person who prescribes or provides comprehensive low vision care for the rehabilitation and/or treatment of the visually impaired or legally blind patient, prescribes corrective spectacles, contact lenses, prisms, or filters, employs any means for the adaptation of lenses, low vision devices, prisms, filters, evaluates the need for, recommends, or prescribes optical, electronic or other low vision devices; or recommends or provides low vision rehabilitation services independent of a clinical treatment plan prescribed by an optometrist or ophthalmologist shall be considered to be engaged in the practice of optometry.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2009-02-01 to 12/10/2012*
- *Amendment — effective from 2008-01-10 to 02/01/2009*
- *Amendment — effective from 2007-10-18 to 01/10/2008*
- *Amendment — effective from 2003-04-17 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/17/2003*
##### **216-RICR-40-05-20 § 20.4** Licensure and Certification Requirements for Optometrists {#sec-216-ricr-40-05-20-20.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-20#20.4}
20.4.1Licensure and Certification Requirements
A.Any person practicing or offering to practice optometry in this state must be licensed as an optometrist in Rhode Island in accordance with R.I. Gen. Laws Chapter 5-35.1 and regulatory requirements of this Part.
1.Furthermore, optometrists licensed in this state who desire to administer and prescribe pharmaceutical agents in the treatment of ocular conditions of the human eye and its appendages, without the use of surgery or other invasive techniques, must be certified by the Board in accordance with the requirements herein. Provided, however, that as of March 20, 1997, individuals who are licensed and certified to prescribe certain topical therapeutic pharmaceutical agents may continue to prescribe said medications in accordance with that certification; and those individuals who hold diagnostic pharmaceutical privileges as of March 20, 1997, may continue to exercise those privileges.
B.Any optometrist who utilizes latex gloves shall do so in accordance with the provisions of the rules and regulations pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
C.Pain Assessment
1.All health care providers licensed by this state to provide health care services and all health care facilities licensed under R.I. Gen. Laws Chapter 23-17, shall assess patient pain in accordance with the requirements of the “Rules and Regulations Related to Pain Assessment.”
20.4.2Qualifications for Licensure and Certification Basic Licensure Requirements
A.In addition to the requirements of R.I. Gen. Laws § 5-35.1-2, an applicant seeking licensure to practice optometry in this state must:
1.Have successfully passed all sections of the National Board of Examiners in Optometry (NBEO) examination;
2.Candidates seeking initial licensure in Rhode Island must be certified in the use of therapeutic pharmaceuticals in accordance with the requirements of R.I. Gen. Laws § 5-35.1-1(7), and have successfully completed the educational and certification requirements related to the amplification of privileges to treat anterior uveitis and glaucoma of § 20.4.2(B) of this Part.
B.Therapeutic Pharmaceutical Requirements Related to Amplification of Privileges to Treat Anterior Uveitis and Glaucoma
1.All applicants for initial licensure or any licensed applicant who seek certification to use all therapeutic pharmaceuticals used in the treatment of conditions of the human eye and its appendages including, but not limited to, the removal of superficial foreign bodies from the eye and the treatment of the diseases of anterior uveitis and glaucoma, without the use of surgery or other invasive techniques, shall have successfully completed the National Board of Examiners in Optometry (NBEO) examination in "The Treatment and Management of Ocular Disease" administered after January 1, 1999.
C.§ 20.4.2(C)(1) of this Part shall apply to optometrists who have graduated from a college of optometry prior to January 1, 2007:
1.Upon successful completion of the written National Board of Examiners in Optometry (NBEO) examination, in "The Treatment and Management of Ocular Disease" administered after January 1, 1999, a duly licensed optometrist may prescribe all such pharmaceuticals exclusive of those used in the treatment of glaucoma. Prescriptive privileges for those pharmaceuticals used in the treatment of glaucoma will commence upon completion of § 20.4.2(C)(1)(a) of this Part and acceptance of such by the Board.
a.Submit a completed form for each patient providing evidence that the applicant has performed written consultations which satisfy the following requirements:
(1)The applicant has consulted with an ophthalmologist or optometrist with amplified privileges to treat glaucoma, who is licensed in good standing, and who has been treating glaucoma for no less than three (3) years regarding no less than twenty (20) glaucoma-related patients and the ophthalmologist or optometrist with amplified privileges to treat glaucoma, who is licensed in good standing, and who has been treating glaucoma for no less than three (3) years has provided written confirmation of this consultation.
(2)Up to ten (10) of these glaucoma-related patients may have been diagnosed as glaucoma-related up to one (1) year prior to completion of the requirements in § 20.4.2(C)(1) of this Part. All twenty (20) glaucoma- related patients shall be followed for a minimum of one (1) year or until the patient is stabilized (i.e., symptoms controlled, vision loss arrested, medication changes not required) whichever is longer; and
(3)For each glaucoma-related patient, the applicant shall develop, in consultation with the ophthalmologist or optometrist with amplified privileges to treat glaucoma, who is licensed in good standing, and who has been treating glaucoma for no less than three (3) years the following:
(AA)A confirmatory evaluation and diagnosis by the ophthalmologist or optometrist with amplified privileges to treat glaucoma, who is licensed in good standing, and who has been treating glaucoma for no less than three (3) years;
(BB)A written plan for diagnostic workup for each patient. This workup shall be in accordance with the prevailing community standard of care; and
(CC)A treatment plan for each patient which shall take into account the assessment of the optic nerve, the level of the intraocular pressure, and stability of the clinical course.
(4)The methodology of consultation required in §§ 20.4.2(C)(1)(a)((1)) and ((2)) of this Part shall be left to the professional discretion of the ophthalmologist or optometrist with amplified privileges to treat glaucoma, who is licensed in good standing, and who has been treating glaucoma for no less than three (3) years and the applicant; provided, however, the applicant may submit to the Board of Examiners in Optometry the completed form once the patient has reached the agreed upon treatment plan (including target pressure and compliance with medications).
20.4.3Application for License, Certification and Fees Licensure Application
A.Application for licensure shall be made on forms provided by the Department, which shall be completed and submitted to the Department. Such application shall be accompanied by the following documents:
1.If by endorsement, a statement from the board of examiners in optometry in each state in which the applicant has held or holds licensure to be submitted to the board of this state attesting to the licensure status of the applicant during the time period the applicant held licensure in said state;
2.Supporting certified transcripts of education credentials as required in § 20.4.2(A) of this Part.
3.Such documentation must consist of original statements and/or photocopies bearing the signature of the dean or registrar and the imprint of the school seal;
4.The results of the written National Board Examination submitted directly to the Board by the National Board;
5.The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
6.Such other information as the Board and/or Department may deem necessary.
20.4.4Examinations
A.Examinations for Licensure
1.Applicants for licensure to practice optometry shall be required to successfully complete all parts and all sections of the National Board Examination of the National Board of Examiners in Optometry (NBEO) in order to test the applicant's knowledge and skills to practice optometry in this state pursuant to the statutory and regulatory requirements of this Part.
B.Licensure by Endorsement
1.A license to practice optometry may be issued without examination to an applicant who has been duly licensed by examination as an optometrist under the laws of another state or jurisdiction provided:
a.The applicant meets the qualifications to practice optometry in this state in accordance with § 20.4.2 of this Part;
b.That such state accords a like privilege to holders of licenses issued in this state and the applicant has not failed to pass the exam required in this state; and
c.The applicant submits the license application form with supporting certified documentation of credentials and application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
20.4.5Issuance and Renewal of License and Fee
A.Upon completion of the aforementioned requirements, the Director may issue a license to those applicants found to have satisfactorily met all the requirements of this Part. Said license and/or certification shall expire annually on the 31st day of January, unless sooner suspended or revoked.
B.Every person licensed who intends to practice optometry during the ensuing year shall file a renewal application duly executed together with the renewal fee for licensure as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) on or before the 31st day of January in each year.
C.Upon receipt of a renewal application accompanied by evidence of completion of the prescribed continuing education program requirements as set forth in § 20.4.6 of this Part, including payment of fee, the accuracy of the application shall be verified and license shall be granted effective February 1 of that year.
D.In case of neglect or refusal to pay, the Department may revoke or suspend such license provided, however, that no license shall be so suspended or revoked without first giving sixty (60) days notice in each such case of neglect or refusal and within such period any such optometrist shall have the right to receive a renewal of such license on payment of the renewal fee, together with an added penalty as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
E.Retirement from practice for a period not exceeding five (5) years shall not deprive the holder of a license of the right to renew such license upon payment of all annual renewal fees remaining unpaid, and a further fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
20.4.6Continuing Education
A.For Re-Licensure for those Optometrists with Amplified Therapeutic Privileges:
1.Every optometrist licensed to practice optometry with amplified therapeutic privileges in this state under the provisions of the Act and this Part shall on or before the 31st day of January of every year attest to the Board that he/she possesses satisfactory evidence of having completed in the preceding calendar year, no less than twenty (20) hours of continuing education in optometry or other related health field, in course(s) that shall include ten (10) or more hours of approved courses in pharmacology for the treatment and management of ocular conditions of the eye offered, sponsored, or administered by any of the following organizations:
a.American Optometric Association and its affiliated associations;
b.Schools/colleges of optometry;
c.Any course approved by the Council on Optometric Practitioners Education (COPE);
d.American Academy of Ophthalmology – Category I;
e.All courses that meet the requirements of eligibility for Category I of the American Optometric Association Optometric Recognition Award;
f.American Academy of Optometry;
g.Accreditation Council for Pharmacy Education (ACPE);
h.Accreditation Council for Continuing Medical Education (ACCME).
B.For Re-Licensure for those Optometrists without Amplified Therapeutic Privileges:
1.Optometrists licensed to practice optometry without therapeutic privileges must show evidence of sixteen (16) hours of continuing education in optometry or other related health fields in the calendar year preceding the most recent license renewal.
2.The Board may waive the continuing education requirement in specific circumstances for due cause such as hardship or for any sufficient reason, if satisfactory evidence is submitted to the Board to that effect.
3.Optometrists initially licensed after the February 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., January 31st of the next year).
4.It shall be the sole responsibility of the individual optometrist to obtain documentation from the recognized sponsoring or co-sponsoring organizations, agencies or other, of his or her participation in the learning experience and the number of dated credits earned. Furthermore, it shall be the sole responsibility of the individual to safeguard the documents for review by the Board, if required. These documents shall be retained by each licensee for no less than two (2) years and are subject to random audit by the Department.
20.4.7Practice of Optometry
A.Pursuant to § 20.4.2(B)(1) of this Part, optometrists with amplified privileges, as defined in this Part, may:
1.Remove superficial foreign bodies from the conjunctiva, lid and cornea without surgery or other invasive techniques; and
2.Administer and prescribe pharmaceutical agents as provided in this Part for the treatment of ocular conditions of the human eye and its appendages without surgery or other invasive techniques, and in accordance with the prevailing standards of practice as those of duly licensed physicians providing similar services.
3.Treatment of glaucoma shall exclude treatment of infantile and congenital glaucoma. Treatment of acute angle closure glaucoma shall be limited to initiation of immediate emergency care.
B.Scope of Medications
1.Optometrists Without Amplified Therapeutic Privileges
a.Medications which may be used by certified optometrists qualified to administer and prescribe topical therapeutic pharmaceutical agents in the treatment of conditions of the human eye and its appendages but not holding amplified privileges in accordance with § 20.4.2(B)(1) of this Part, include topical medication (mast cell inhibitors or stabilizers), lubricants, decongestants, mucolytics, antibiotics, and steroids with a clinical potency not exceeding 1/4% methyl-prednisolone or equivalent.
2.Optometrists with Amplified Therapeutic Privileges
a.Optometrists authorized by the Board as having amplified privileges, in accordance with § 20.4.2(B)(1) of this Part, may utilize all pharmaceutical agents in the treatment of conditions of the human eye and its appendages, including anterior uveitis and glaucoma, without surgery or other invasive techniques, and in accordance with the requirements of this Part.
C.Scheduled Medications
1.Every optometrist licensed to practice optometry with amplified therapeutic privileges in this state may prescribe oral pharmaceutical agents, including oral steroids and narcotic and non-narcotic analgesics, within the scope of the optometrist's practice, and in accordance with the following:
a.A prescription for oral nonsteroidal anti-inflammatories shall not exceed one seven-day supply;
b.A prescription for oral steroids shall not exceed one seven-day supply;
c.A prescription for any controlled substance listed in schedules III—V of R.I. Gen. Laws Chapter 21-28, shall not exceed one seventy-two (72) hour supply.
d.Licensed optometrists may prescribe schedule II hydrocodone-containing medications provided that the prescription does not exceed one seventy-two (72) hour supply.
e.No optometrist shall deliver any medication by injection.
f.In order to prescribe any controlled substance listed in R.I. Gen. Laws Chapter 21-28, a licensed optometrist must:
(1)Obtain a state registration for prescribing controlled substances by completing the application for registration.
(2)Obtain a federal registration for controlled substances by completing application form DEA-224, or its successor form, and submitting it with its specified filing fee.
(3)The Director will determine whether issuance of a registration is consistent with the public interest, and may refuse registration where the issuance of said registration would be inconsistent with the public interest, according to the provisions of R.I. Gen. Laws Chapter 21-28.
D.Minimum/Initial Examination of New Patients
1.Pursuant to R.I. Gen. Laws § 5-35.1-16, every person practicing optometry shall perform an examination of the patient that is in accordance with the prevailing community standard of care, and record same in the patient’s medical record.
E.Minimum Equipment for Optometric Practice
1.At any location where an optometrist practices his or her profession, an optometrist shall have any equipment that a reasonable and prudent person practicing optometry would have available in order to meet the needs of his/her patients.
F.Spectacle or Eyeglass Prescriptions
1.A spectacle prescription shall contain all of the information necessary for the accurate fabrication, fitting and dispensing of the spectacles (eyeglasses). All spectacle prescriptions shall be in accordance with the requirements of the Federal Trade Commission’s “Ophthalmic Practice Rules” incorporated in § 20.2(A) of this Part.
2.A contact lens prescription shall contain all of the information necessary for the accurate fitting and dispensing of the contact lens. All such prescriptions shall be in accordance with the requirements of the Federal Trade Commission’s “Contact Lens Rule” incorporated in § 20.2(B) of this Part.
G.Electronic Prescribing Standards
1.Optometrists shall be required to adhere to electronic prescribing standards within thirty (30) months of receiving prescriptive authority as defined in R.I. Gen. Laws § 5-35.1-12(a), and § 20.4.7 of this Part.
2.Electronic prescribing standards shall include the following:
a.Technological devices for the transmission or communication of prescriptions between optometrists and pharmacists may be used in accordance with the following requirements:
(1)The transmission of prescriptions for controlled substances shall be in compliance with the provisions of R.I. Gen. Laws Chapters 21-28 ("Uniform Controlled Substances Act") and 5-37.3 ("Confidentiality of Health Care Communications and Information Act"), and all other applicable federal and state laws;
(AA)In compliance with federal requirements, the transmission of prescriptions for controlled substances by technological devices shall consist of a copy of the original prescription that has been signed by the optometrist.
(BB)In compliance with federal requirements, an electronic signature by the optometrist for controlled substance prescriptions is prohibited.
(2)Unless otherwise prohibited by law, prescriptions may be transmitted by electronic means or facsimile from the optometrist to the dispensing pharmacy. The facsimile copy of the prescription may serve as the hard copy of the prescription in accordance with the provisions of R.I. Gen. Laws Chapter 21-28.
(3)In addition to all other information required to be included on a prescription, an electronically transmitted prescription and facsimile prescriptions shall include the date of transmission, and the identity of the receiving pharmacy.
(4)The patient shall have the right to choose the manner in which his/her prescription is transmitted to the pharmacy.
(5)The patient shall have the right to choose the pharmacy to which his/her prescription is transferred.
(6)Technological devices shall not be used to circumvent documentation, verification, or any provisions of R.I. Gen. Laws Chapter 5-19.1. Neither shall they be used to commit any other action that may be deemed unprofessional conduct.
20.4.8Denial, Suspension or Revocation of License and/or Certification
The Director may deny, suspend or revoke a license in accordance with the provisions of R.I. Gen. Laws § 5-35.1-18.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2009-02-01 to 12/10/2012*
- *Amendment — effective from 2008-01-10 to 02/01/2009*
- *Amendment — effective from 2007-10-18 to 01/10/2008*
- *Amendment — effective from 2003-04-17 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/17/2003*
##### **216-RICR-40-05-20 § 20.5** Advertising, Violations, Practices, Procedures and Severability {#sec-216-ricr-40-05-20-20.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-20#20.5}
20.5.1Advertising
A.Pursuant to R.I. Gen. Laws § 5-35.1-9(2)(ii), no optometrist licensed by and practicing in this state shall advertise by written or spoken word of a character tending to deceive or mislead the public.
B.An optometrist who holds him/herself out to be a specialist in a specific field of optometry practice shall include a statement in all advertisements that reads as follows, "The Rhode Island Department of Health licenses all optometrists in the general practice of optometry. The Department does not license or certify any optometrist as an expert or specialist in any field of practice."
C.In addition to § 20.5.1(A) of this Part any and all advertising conducted by any optometrist shall conform to the provisions of R.I. Gen. Laws Chapter 6-13.1, entitled "Deceptive Trade Practices Act."
D.Any person practicing pursuant to the provisions of R.I. Gen. Laws Chapter 5-35.1, shall be required to post his name on the premises where the services are being offered in such a manner as to be clearly visible to the public at the entrance to the premises and on any sign visible outside of the premises which offers the delivery of optometric services.
E.Advertisement of any type (electronic or print media) shall also include the name(s) and address(es) of the responsible optometrist(s).
20.5.2Violations
Penalties for violations are in accordance with R.I. Gen. Laws § 5-35.1-20.
20.5.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2009-02-01 to 12/10/2012*
- *Amendment — effective from 2008-01-10 to 02/01/2009*
- *Amendment — effective from 2007-10-18 to 01/10/2008*
- *Amendment — effective from 2003-04-17 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 04/17/2003*
#### **216-RICR-40-05-21** Interpreters for the Deaf
##### **216-RICR-40-05-21 § 21.1** Authority {#sec-216-ricr-40-05-21-21.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-21#21.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-71-5(d), for the purpose of adopting prevailing standards and qualifications pertaining to the licensure of interpreters for the deaf and to ensure that members of the interpreting profession perform with a high degree of competency in the State of Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-05-30 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/30/2007*
##### **216-RICR-40-05-21 § 21.2** Definitions {#sec-216-ricr-40-05-21-21.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-21#21.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-71, entitled, "Licensure of Interpreters for the Deaf Act.”
2.“American Sign Language” or “ASL” means the visual/gestural language used by deaf/Deaf people in the United States and Canada, with semantic, syntactic, morphological, and phonological rules which are distinct from English.
3."Board" means the state Board of Examiners for Interpreters for the Deaf established pursuant to the provisions of R.I. Gen. Laws § 5-71-4 of the Act.
4."Certified" means any individual who is a certified member of the Registry of Interpreters for the Deaf, Inc., (RID), its successor agency, or other agencies as approved by the Department in consultation with the Board.
5.“Certified deaf interpreter”, “Deaf interpreter” or “Deaf intermediary interpreter” means any individual who is deaf or hard of hearing and who is a certified member of the Registry of Interpreters for the Deaf, Inc. (RID) or its successor agency approved by the Department in consultation with the Board.
6."Consumer" means an individual who is deaf, deaf-blind, hard of hearing or an individual with a disability who does not share a common means of communication. This may include, without limitation, American Sign Language (ASL), visual, gestural, auditory, and tactile modes of communication.
7."Deaf-blind interpreting" means linguistic information through sign language acquired by individuals who are deaf-blind through their preferred methods depending on the causes of their combined vision and hearing loss, their background, and their education, such as close-vision interpreting and tactile interpreting, while spoken language is conveyed into sign language (e.g. ASL), and sign language (ASL) is conveyed into spoken language.
8."Director" means the Director of the Rhode Island Department of Health.
9.“Department” means the Rhode Island Department of Health.
10.“Educational interpreter” means an individual who has specialized certification (elementary and secondary education for grades kindergarten (K) through twelve (12)) and is a certified member of RID or its successor agency approved by the Department in consultation with the Board in the provision of sign language interpreting to students who are deaf, hard-of-hearing or deaf-blind in grades preschool through twelve (12).
11."Emergency" means an urgent circumstance that demands immediate action in order for a consumer to avoid imminent harm or loss.
12."Interpreter" means any person who engages in the practice of interpreting for the deaf as defined in § 21.2 of this Part.
13.“Interpreting" means conveying spoken English into American Sign Language (ASL) or conveying American Sign Language into English, or interpreting English to and/or from a visual gestural system.
14."Intermediary interpreting" means interpreting services rendered by a deaf person to facilitate communication between another deaf person and a licensed interpreter.
15.“Manually coded English” or “MCE” or “Other manually coded sign systems” means any form of visual/gestural communication used by deaf or hard-of-hearing persons in the United States and Canada, with semantic and syntactic rules based either partly or entirely upon English. Such systems, include, but are not limited to, CASE (Conceptually Accurate Signed English), Pidgin Signed English (PSE), Signing Essential English, Signing Exact English, Sign Supported English, Signed English, and the Rochester method.
16."Person" means any individual, firm, corporation, partnership, organization or body politic.
17."Screened deaf interpreter" means any person who is deaf or hard of hearing and who presents proof of an active state screening or its equivalent and presents proof of successful completion of an examination as approved by the Department in consultation with the Board.
18."Screened interpreter" means any person who presents proof of an active state screening or its equivalent and presents proof of successful completion of an examination as approved by the Department in consultation with the Board.
19.“Transliterating” means conveying spoken English into manually coded English, or conveying manually coded English into spoken English (sign-to-voice), or conveying English on the lips so that it is accessible to speech reading (oral transliterating, or any auditory communication as a visual form in English such as cued speech).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-05-30 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/30/2007*
##### **216-RICR-40-05-21 § 21.3** Professional Licensure Requirements {#sec-216-ricr-40-05-21-21.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-21#21.3}
21.3.1Qualifications of Applicants for Licensure Certified
A.License Required.
1.No person shall practice or hold him or herself out as being able to practice interpreting, educational interpreting, or intermediary interpreting as defined in R.I. Gen. Laws § 5-71-3 and this Part unless he or she holds a license.
2.No person shall hold himself or herself out as being able to practice under the Act and this Part unless he or she is licensed pursuant to R.I. Gen. Laws § 5-71-9(b).
B.Licensure. To be eligible for licensure by the Department as a certified interpreter or certified deaf interpreter, the applicant shall meet the qualifications of R.I. Gen. Laws § 5-71-8.
C.To be eligible for licensure by the Department as an educational interpreter for the deaf, the applicant shall meet all of the requirements set forth in R.I. Gen. Laws § 5-71-8.
D.Screened
1.To be eligible for licensure by the Department as a screened interpreter or screened deaf interpreter, the applicant shall:
a.Be of good moral character;
b.Meet the screened requirements as defined in this Part;
c.Successfully complete a recognized state screening or state equivalent within the United States. For the purposes of this Part, a state screening or a state equivalent shall be current and valid; and
d.Submit written verification of successful completion of the National Registry of Interpreters for the Deaf Performance Evaluation (written) or present evidence of completion of coursework in American Sign Language, Deaf Culture, and the Code of Ethics. Such coursework may be completed as part of an interpreter training program, or through individual workshops sponsored by a recognized organization or agency or other training recognized by the National Registry of Interpreters for the Deaf.
21.3.2Persons and Practices Exempted
A.Persons and practices exempted are in accordance with the provisions of R.I. Gen. Laws § 5-71-15.
B.Emergencies
1.In the event of an emergency, the consumer may elect to use the services of a non-licensed interpreter.
21.3.3Licensure
A.Licensure shall be granted in accordance with the provisions in R.I. Gen. Laws § 5-71-9.
B.Categories of Licensure
1.Three types of licensure may be issued to interpreters.
a.A certified license shall be granted to interpreters who meet the requirements of § 21.3.1(B) of this Part. The two (2) types of certified licenses are:
(1)Certified interpreter; and
(2)Certified deaf interpreter.
b.A screened license of limited duration determined by the Board shall be granted to interpreters who:
(1)Have met the educational requirements in § 21.3.1(C) of this Part; and
(2)Who have successfully completed a recognized state screening or state equivalent, as determined by the Department in consultation with the Board.
(3)The two (2) types of screened licenses are:
(AA)Screened interpreter; and
(BB)Screened deaf interpreter.
c.An educational interpreter license may be granted to an interpreter who meets the requirements of R.I. Gen. Laws § 5-71-8.
21.3.4Application and Fees
A.Application for licensure by the Board as an interpreter shall be made on forms provided by the Department. These forms shall be completed and submitted to the Department.
1.Such application shall be accompanied by the following:
a.Documentation of certified membership from the National Registry of Interpreters for the Deaf (RID); or a recognized state screening or state equivalent and documentation of successful completion of the requirements set forth in § 21.3.1 of this Part; and
b.A non-refundable fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). In no case shall said fee be returned.
21.3.5Expiration and Renewal of License
A.Every person licensed under the provisions of the Act and this Part who desires to continue licensure as an interpreter shall present evidence satisfactory to the Board that the interpreter has completed a prescribed course of continuing education in accordance with the requirements of § 21.3.7 of this Part.
B.The license of every person licensed under the provisions of the Act and this Part shall expire on the first day of July of the next year following the date of his/her license.
C.Every licensed interpreter who desires to renew his/her license shall file a renewal application with the Department for each license. Such application shall include payment of the fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) before the first day of July in each year. Upon receipt of such application and payment of said fee, the accuracy of the application shall be verified and the Department shall grant a renewal license effective July 1st and expiring twelve (12) months thereafter.
21.3.6Endorsement
A.Applicants who hold a valid license, certificate, or equivalent issued within another state, provided that the requirements under which that license, certificate, or equivalent was issued meet or exceed the standards required by the Act, and who otherwise meet the requirements of this Part, may be issued a license under the provisions of the Act and this Part.
B.An individual whose license, certification, permit, or equivalent form of permission issued within another state has been revoked, suspended or currently placed on probation shall not be eligible for consideration for licensure unless they have first disclosed to the Department such disciplinary actions.
21.3.7Continuing Education Requirements
A.All certified licensed interpreters, licensed screened interpreters and educational interpreters shall be required to complete five (5) hours of continuing education each year.
1.Courses deemed acceptable for continuing education shall be those approved by the National Registry of Interpreters for the Deaf.
B.It shall be the sole responsibility of the individual licensee to obtain documentation from the approved sponsoring or co-sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity that shall include no less than the date, time, subject matter, name of lecturer or teacher, the number of hours of credit earned, and such other pertinent data.
1.Such documentation shall be safeguarded by the licensee for review by the Board as may be requested.
2.Such documents shall furthermore be retained by each licensee for no less than three (3) years and shall be subject to random audit by the Board.
C.Licensees initially licensed after the July 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., June 30th of the next year).
D.A license renewal may be denied to any applicant who fails to provide satisfactory evidence of continuing education relevant to interpreting as required in this Part.
E.An extension of time to complete the continuing education requirements may be granted to a licensee solely at the discretion of the Department, in consultation with the Board, for reasons of hardship or other extenuating circumstances.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-05-30 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/30/2007*
##### **216-RICR-40-05-21 § 21.4** Grounds for Suspension, Practices & Procedures, and Privileged Communications {#sec-216-ricr-40-05-21-21.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-21#21.4}
21.4.1Grounds for Suspension or Revocation of Licenses
A.All complaints concerning a licensee's professional practice shall be received by the Department in writing or by videotape. Each complaint received shall be logged, recording at a minimum the following information:
1.Licensee's name;
2.Name of the complaining party;
3.Date of incident; and
4.Statement of complaint.
B.The Board may recommend to the Director the issuance, renewal, or revocation of a license, or suspension, placement on probation, censure or reprimand of a licensee, or such other disciplinary action as the Board may deem appropriate, for conduct as set forth in R.I. Gen. Laws § 5-71-13 and in addition, for unprofessional conduct.
1.Unprofessional conduct is defined as including, but not limited to:
a.The use of any false or fraudulent statement in any document connected with the practice of interpreting or transliterating for the deaf ;
b.The willful violation of a privileged communication;
c.The willful violation of confidentiality;
d.Knowingly performing any act which in any way aids or assists an unlicensed person to practice interpreting or transliterating for the deaf in violation of the Act;
e.The practice of interpreting or transliterating for the deaf under a false or assumed name;
f.The advertising for the practice of interpreting or transliterating for the deaf/Deaf in a deceptive or unethical manner;
g.Habitual intoxication or addiction to the use of drugs or performing the duties and functions of an interpreter for the deaf while under the influence of alcohol or other drugs;
h.Presenting an unprofessional or otherwise distracting appearance that interferes with the provision of services to the client;
i.Repeated violations of any of the rules or regulations of the Department or the violation of any section of the Act;
j.Gross incompetence in the practice of his/her profession; or
k.Repeated acts of gross misconduct in the practice of his/her profession.
21.4.2Practices and Procedures
All hearings and reviews required under the provisions of the Act, shall be held in accordance with the provisions of the rules and regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
21.4.3Privileged Communications
Privileged communications of licensed interpreters are pursuant to R.I. Gen. Laws § 5-71-18.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-05 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/05/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-05-30 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 05/30/2007*
#### **216-RICR-40-05-22** Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs
##### **216-RICR-40-05-22 § 22.1** Authority {#sec-216-ricr-40-05-22-22.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17.9-14, and are established for the purpose of defining the minimum standards for the training, competency, evaluation, and licensing of nursing assistants and medication aides; and adopting unified standards for nursing assistants and medication aides to ensure safe and adequate care to individuals receiving health care services from nursing assistants and medication aides within the State.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.2** Incorporated Materials {#sec-216-ricr-40-05-22-22.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.2}
These Regulations hereby adopt and incorporate 42 C.F.R. § 483.152 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Rules and Regulations.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.3** Definitions {#sec-216-ricr-40-05-22-22.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.3}
A.Wherever used in these Rules and Regulations the following terms shall be construed as follows:
1."Abuse" means any assault or battery as defined in R.I. Gen. Laws Chapter 11-5, R.I. Gen. Laws § 11-37-1, or any conduct which harms or is likely to harm a patient, or intentionally engaging in a pattern of harassing conduct which causes or is likely to cause emotional or psychological harm to the patient, including, but not limited to, ridiculing or demeaning a patient, making derogatory remarks to a patient, cursing directed towards a patient, and threatening to inflict physical or emotional harm on a patient, except when the conduct is a part of the care and treatment and in furtherance of the health and safety of the patient.
2."Act" means R.I. Gen. Laws Chapter 23-17.9.
3.“Adult day services program” means a community-based group program, licensed by the Department in accordance with the provisions of R.I. Gen. Laws § 23-1-52, designed to meet the biopsychosocial needs of adults with impairments through individual plans of care.
4."Approval" means the process whereby the Director or designee evaluates and grants official recognition to a nursing assistant or medication aide training program based on the requirements of this Part.
5."Assisted living residence" means a publicly or privately operated residence licensed under the provisions of R.I. Gen. Laws Chapter 23-17.4.
6.“Complicated feeding” means the feeding of patients with complex medical needs and the feeding of patients that require feeding tubes or parenteral/intravenous feedings.
7.“Department” means the Rhode Island Department of Health.
8."Director" means the Director of the Rhode Island Department of Health or designee.
9."Health care facility" means a provider as defined by R.I. Gen. Laws § 23-17-2(9).
10.“Long term care services” means a set of health care, personal care and social services required by persons who lack some degree of functional capacity (e.g., chronically ill, aged, disabled), who are living in an institution on a long-term basis or at home. The term may refer to long-term institutional care such as care provided in nursing homes, adult day care services, and assisted living residences, or to ambulatory services such as home health care.
11.“Medication aide” means a nursing assistant who has had additional training in the administration of medications and is licensed with the Department as a medication aide.
12."Medication aide training program" means an organized course of classroom instruction and clinical training, approved by the Director, designed to prepare individuals to function as assistants to licensed nurses in the administration of medication.
13.“Medication aide exam” means an examination approved by the Director that tests the ability of a person to perform the skills and exercise the judgment necessary to carry out the duties of a medication aide.
14."Neglect" means the intentional failure to provide treatment, care, goods and services necessary to maintain the health and safety of a patient, or the intentional failure to carry out a plan of treatment or care prescribed by a patient’s physician, or the intentional failure to report a patient’s health problems or changes in health conditions to an immediate supervisor or licensed nurse, or the intentional lack of attention to the physical needs of a patient including, but not limited to, toileting, bathing, meals, and safety. Provided, however, no person shall be considered neglected for the sole reason that he or she relies on or is being furnished with treatment in accordance with the tenets and teachings of a well-recognized church or denomination by a duly-accredited practitioner thereof.
15."Nursing assistant" means a paraprofessional who holds a Rhode Island license pursuant to the provisions of the Act and this Part, and who is trained to give personal care and related health care and assistance based on his or her level of preparation to individuals who are sick, disabled, dependent, or infirm, and who are patients at or are receiving services from health care facilities or agencies.
16."Nursing assistant examination" means an examination approved by the Director that includes a written and practical component that tests the ability of a person to perform the skills and exercise the judgment that is necessary to carry out the duties of a nursing assistant as defined in these Regulations.
17."Nursing assistant training program" means an organized course of classroom instruction and practical training, approved by the Director, designed to prepare individuals to function as nursing assistants.
18."Nursing service agency" means any person, firm, partnership or corporation doing business within the State of Rhode Island that supplies, on a temporary basis, licensed nursing assistants to a hospital, nursing home, private home, or other health care facility licensed under R.I. Gen. Laws Chapter 23-17.7.1 and the Rules and Regulations for Licensing Nursing Service Agencies (Subchapter 10 Part 10 of this Chapter).
19."Online nursing assistant training program" means a training program, approved by the Department, that offers courses using web conferencing and other e-learning media to provide access to a classroom experience for students at an off-campus location.
20."Patient" means client and resident.
21.“Registry” means the Department's licensure database that provides a mechanism to verify the status of a nursing assistant’s license.
22."Supervision" means the provision of guidance for the accomplishment of a nursing assistant activity by a supervisor who is a nurse, physician, or other appropriate health professional who is duly licensed and/or certified as required by law.
a."Direct supervision" means supervision provided by a supervisor who is and remains on the premises, in the building, while the nursing assistant is performing his or her duties, and evaluates the performance of the nursing assistant and medication aide.
b."Indirect supervision" means supervision provided by a supervisor who is not on the premises while the nursing assistant is performing his or her duties, but who is responsible for the assignment of duties and evaluation of the performance of the nursing assistant.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.4** Levels of Nursing Assistants {#sec-216-ricr-40-05-22-22.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.4}
A.Pursuant to R.I. Gen. Laws § 23-17.9-2(3), the Director of the Rhode Island Department of Health hereby establishes the following levels of nursing assistants:
1.Nursing Assistant. A nursing assistant is a paraprofessional trained to provide personal care and related health care and assistance to individuals who are sick, disabled, or infirm, and who are residents of or receiving services from health care facilities or agencies licensed by the State, and holds a license as a nursing assistant issued by the Department.
2.Medication Aide. A medication aide is a nursing assistant who has had additional training in the administration of medication, and holds a license as a medication aide issued by the Department.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.5** General Requirements: Nursing Assistants and Medication Aides {#sec-216-ricr-40-05-22-22.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.5}
A.No person shall be employed in this State as a nursing assistant or medication aide unless he or she holds a license as a nursing assistant in accordance with the provisions of the Act and this Part.
B.No person shall assume the title of “nursing assistant” or such similar title or use any abbreviations or any other words, letters, signs, figures, or devices to indicate that the individual using same is a nursing assistant as set forth in these Regulations, unless he or she holds a license as a nursing assistant issued by the Department. The only abbreviation that a nursing assistant may use in this State is "N.A."
C.All nursing assistants and medication aides shall assess patient pain in accordance with the Rules and Regulations Related to Pain Assessment promulgated by the Department of Health, Part 20-15-2 of this Title.
D.All nursing assistants and medication aides must notify the Department of all changes of home address and all changes of employment within ten (10) days of any such change. Failure to provide notice will result in sanctions.
22.5.1Supervision
A.Nursing assistants must be supervised by a licensed nurse, physician, or other appropriate health professional who is duly licensed and/or certified as required by law. The type of supervision, either direct or indirect, shall be determined by the licensed health care facility as defined in R.I. Gen. Laws § 23-17-2(8). Provided, however, those duties listed in § 22.12.1(B) of this Part shall be discharged only under direct supervision of a licensed nurse, physician, or other appropriate health professional who is duly licensed and/or certified as required by law.
B.A medication aide must be supervised by a licensed nurse, physician, or other appropriate health professional who is duly licensed and/or certified as required by law. The type of supervision, either direct or indirect, shall be determined by the licensed health care facility as defined in R.I. Gen. Laws § 23-17-2(8), provided, however, those duties listed in § 22.12.1(B) of this Part shall be discharged only under direct supervision of a licensed nurse, physician, or other appropriate health professional who is duly licensed and/or certified as required by law.
C.For the first three (3) months of employment, a licensed nurse designated by the health care facility, adult day services program, or assisted living residence, as appropriate, shall conduct and document monthly evaluations (in accordance with the evaluation checklist on the Department website) of a medication aide who administers medication. After the first three (3) months, the evaluation shall be conducted no less than quarterly. Copies of said evaluations shall be placed in the medication aides’ personnel records.
D.Persons who are actively enrolled in a bachelor of science program in nursing, associate degree program in nursing, accredited licensed practical nursing program, or registered nurse course of study in a National League for Nursing Accrediting Commission, Inc., or a Commission on Collegiate Nursing Education (CCNE) accredited nursing program, and have completed two (2) clinical courses, including a Fundamentals of Nursing course, and who provide written documentation from the clinical supervisor indicating that the student is prepared to serve as a nursing assistant, are exempt from completing a Nursing Assistant Training Program and from sitting for the National Nurse Assistant Assessment Program Skills portion.
22.5.2General Requirements: Medication Aides
A.Persons licensed by the Department as medication aides may administer medications, as provided in this Part, in nursing facilities, adult day services programs, and assisted living residences.
B.Medication Aides may not administer medications to patients who reside at home.
C.In accordance with R.I. Gen. Laws § 23-17.9-2(3), a medication aide license may be issued to any person who meets the requirements established under the Act and this Part.
D.No person may serve as a medication aide without holding a valid medication aide license issued by the Department.
E.A medication aide applicant shall be required to furnish such information as the Department may prescribe, and simultaneously with the filing of said application, shall pay to the Department the required non-refundable fee as set forth in Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
F.All licenses issued to medication aides shall be valid for a period of two (2) years and shall expire on the same date as the medication aide’s nursing assistant license.
G.A medication aide shall wear a name tag that indicates the aide's name and the appropriate license designation.
22.5.3Qualifications for Applicants
A.An applicant seeking a license as a Nursing Assistant must demonstrate:
1.Successful completion of a department-approved nursing assistant training program; or be actively enrolled in a nursing program in accordance with § 22.5.1(D) of this Part; and
2.Successful completion of the required nursing assistant examination; or
3.Possession of a current license as a nursing assistant in good standing in another State or jurisdiction that includes successful completion of a State-approved training program that meets or exceeds Rhode Island Nursing Assistant training program requirements, and successful completion of a State-approved nursing assistant exam, and provides documentation of the equivalent of three (3) months of full-time work experience as a nursing assistant; or
4.Successful completion of a one hundred (100) hour State-approved training program in another State or jurisdiction that includes a minimum of twenty (20) hours of practical clinical training under supervision, and successful completion of a nursing assistant examination.
B.An applicant seeking License as a Medication Aide shall:
1.Possess an active license as a nursing assistant in Rhode Island;
2.Be a high-school graduate or the equivalent;
3.Not have been convicted of any felony for crimes involving controlled substances (subject to waiver by the Department upon presentation of satisfactory evidence that such conviction does not impair the ability of the person to conduct the duties of a medication aide without endangering public health and safety);
4.Provide proof of successful completion of a Department-approved medication aide training program defined in this Part.
5.Pass the Medication Aide Certification Exam.
C.Duties and Responsibilities of a Medication Aide
A medication aide may perform only those tasks and duties for which he or she has been trained and for which there is documentation of proof of proficiency, as determined by his or her supervisor, but in no case shall those tasks and duties exceed what is permitted by Regulation, law, scope of practice, or as set forth in § 22.12.3 of this Part.
D.License Application
1.Nursing Assistants
a.Application for a Rhode Island license as a nursing assistant shall be made on forms provided by the Department.
b.Such application must be accompanied by the following:
(1)Documented evidence of completion of a Department-approved nursing assistant training program;
(2)Documented evidence of successful completion of the required nursing assistant examination;
(3)The non-refundable processing fee in accordance with R.I. Gen. Laws § 23-17.9-5 and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
(4)If the nursing assistant is employed by a health care facility at the time of application and is continuously employed by the same facility for six (6) months after the license is issued, the fee required pursuant to R.I. Gen. Laws § 23-17.9-5 shall be directly refunded to the applicant by the facility or agency.
(5)Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office;
(6)If seeking registration under the provisions of § 22.5.3(A)(3) of this Part, the applicant shall submit proof of an active license in good standing from the State or jurisdiction, written documentation from an employer attesting to no less than the equivalent of three (3) months of full-time work experience as a nursing assistant, as well as the items required in §§ 22.5.3(D)(1)(b)((1)) through ((3)) of this Part.
(7)If seeking registration under the provisions of § 22.5.3(A)(4) of this Part, the applicant shall submit written documentation of successful completion of a one hundred (100) hour State-approved training program (including the minimum of twenty (20) hours of practical clinical training under supervision) completed in another State or jurisdiction as well as the items required in §§ 22.5.3(D)(1)(b)((2)) and ((3)) of this Part.
2.Medication Aides
a.Application for a Rhode Island license as a medication aide shall be made on forms provided by the Department.
b.Such application must be accompanied by the following:
(1)Documented evidence of completion of a Department-approved medication aide training program including a signed statement from the clinical supervisor or licensed nurse.
(2)The non-refundable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
(3)Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office.
22.5.4Licensure by Examination: Nursing Assistants
A.The nursing assistant written and practical examinations shall be selected and approved by the Director or designee.
B.All applicants shall be required to successfully complete the nursing assistant examinations within a period of one (1) year from the date that the applicant began the nursing assistant training program. If more than one (1) year has passed, the nursing assistant applicant shall be required to complete the nursing assistant training program again.
C.Nursing assistant applicants shall be given three (3) opportunities to successfully complete both the written and practical components of the nursing assistant examinations. After three (3) unsuccessful attempts to complete the nursing assistant examinations, the nursing assistant shall be required to repeat the nursing assistant training program.
D.Applicants for initial licensure as a nursing assistant by examination who have completed a nursing assistant training program in accordance with this Part, may be issued a one hundred twenty (120) day Temporary Permit authorizing the applicant to work under direct supervision of a licensed nurse or physician until the applicant has passed all required portions of the National Nursing Assistant Assessment Program or a nursing assistant written and practical examination selected and approved by the Director or his/her designee.
E.The training program shall provide ongoing assistance to candidates, as necessary and upon the candidate’s request, to assure that testing date(s) are scheduled, and to facilitate the candidate’s attendance and successful performance of the necessary tests. The availability of this assistance shall be communicated to all candidates prior to the conclusion of the training course. These efforts shall be documented and made available to the Department upon demand.
22.5.5Issuance and Renewal of License and Fee
A.The Department shall issue to applicants who have satisfactorily met the license requirements of this Part a license as a nursing assistant and/or medication aide. Unless suspended or revoked, this license shall expire biennially (every two (2) years) on June 30 of every other year following the date of issuance of the original registration.
B.Every nursing assistant and/or medication aide who wishes to renew his or her license shall file a renewal application with the Department together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) before June 15.
C.Upon receipt of such renewal application and payment of the fee, the Department shall renew the license effective July 1, and expiring June 30, two (2) years later unless the license is suspended or revoked.
D.Any nursing assistant and/or medication aide whose license lapses for a period of less than two (2) years may be reinstated by the Department upon submission of an application and payment of the renewal fee(s) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), unless the registration has been suspended or revoked.
E.A nursing assistant seeking renewal shall have been employed as a nursing assistant for at least eight (8) hours within the prior twenty-four (24) months and have completed twelve (12) hours of in-service training per year at the facility where employed; or have successfully completed a nursing assistant training program and passed the exam for licensure within the past twenty-four (24) months.
F.A medication aide seeking renewal shall have been employed as a medication aide for at least eight (8) hours within the prior twenty-four (24) months and submit proof of four (4) Continuing Education Units; or have completed a medication aide training program and have passed the Medication Assistant Certification Exam within the past twenty-four (24) months.
G.A nursing assistant applicant seeking renewal shall have been employed as a nursing assistant in:
1.A Rhode Island-licensed health care facility licensed under the provisions of R.I. Gen. Laws Chapter 23-17;
2.An assisted living residence licensed under the provisions of R.I. Gen. Laws Chapter 23-17.4;
3.An adult day services program licensed under the provisions of R.I. Gen. Laws § 23-1-52; or
4.Employed by a nursing service agency licensed under the provisions of R.I. Gen. Laws § 23-17.7.1-1.
5.Private duty employment does not meet this employment requirement.
H.A medication aide applicant seeking renewal shall have been employed as a medication aide in:
1.A Rhode Island-licensed nursing facility licensed under the provisions of R.I. Gen. Laws § 23-17-1;
2.An assisted living residence licensed under the provisions of R.I. Gen. Laws Chapter 23-17.4; or
3.An adult day services program licensed under the provisions of R.I. Gen. Laws § 23-1-52.
I.Any nursing assistant and/or medication aide whose license lapses for a period of two (2) years or longer, and who cannot provide proof of employment in accordance with §§ 22.5.5(G) and (H) of this Part, shall be required to successfully complete the nursing assistant training and/or medication aide training program, and all required examinations, prior to being reinstated as a nursing assistant and/or medication aide.
J.A nursing assistant applicant seeking renewal shall attest that he or she has been employed within the previous twenty-four (24) months when completing the online renewal form. Renewal applicants are subject to audit and must retain proof of completion of in-service hours and/or Continuing Education Units for a three (3) year period.
K.Continuing Education Requirements: Medication Aides
1.Every medication aide seeking renewal of a license under the provisions of the Act and this Part shall provide satisfactory evidence to the Department that in the preceding two (2) years the licensee has completed four (4) required continuing education hours as established in this section.
2.Continuing education hours related to medication administration will be accepted by the Board for course work that has been presented, accepted, or approved by recognized professional nursing organizations, schools of pharmacy, health care facilities, employing organizations, or other professional organization, labor organization, or accrediting agency as may be approved by the Board.
3.At the time of license renewal, each medication aide will be required to attest to the completion of the above continuing education requirements.
4.It shall be the sole responsibility of the individual medication aide to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his or her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than three (3) years and are subject to random audit by the Department.
5.Failure to produce satisfactory documentation of completion of the requirements of this section, upon request by the Board, constitutes grounds for disciplinary action under the provisions of the Act.
L.Removal of Name from Nurse Aide Registry
1.In the case of a finding of unprofessional conduct, as defined in this Part, a nursing assistant may petition the Department in writing to have his or her record of discipline removed from the registry upon a determination by the Department that the employment and personal history of the nursing assistant does not reflect a pattern of unprofessional conduct; and the conduct involved in the original finding was a singular occurrence.
2.A nursing assistant shall submit a written petition to:
Rhode Island Department of Health
Nursing Assistant Advisory Board
3 Capitol Hill, Room 104
Providence, RI 02908
3.Such petition shall request that the nursing assistant’s offense be removed from the registry in accordance with the criteria stated in § 22.5.5(L)(1) of this Part.
4.The nursing assistant’s name and record of discipline shall remain on the registry for a period of two (2) years from the date on which the name was placed on the registry after which time the name may be removed if the petitioner’s request is granted by the Department.
M.Reinstatement of Nursing Assistant License
1.A nursing assistant who has been licensed in Rhode Island in good standing, has let his or her license lapse, and has been working as a nursing assistant in another State or jurisdiction within the two (2) years immediately preceding the application for reinstatement and has completed twelve (12) hours of in-service per twelve (12) month period, may apply for reinstatement upon submission of the following:
a.Photocopy of active license/registration from the State or jurisdiction where employed as a nursing assistant;
b.Reinstatement processing fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
c.Attestation of employment as a Nursing Assistant for eight (8) hours within the past two (2) years (license must be current at the time of employment) in a nursing home, hospital, home care agency, assisted living residence, adult day services program, or employed by a nursing service agency;
d.Attestation of completion of twelve (12) hours per twelve (12) month period of in-service training;
e.Verification from current State of licensure that the applicant for reinstatement is and has been in good standing in that jurisdiction.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.6** Denial, Revocation or Suspension of Registration: Nursing Assistants and Medication Aides {#sec-216-ricr-40-05-22-22.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.6}
A.Pursuant to R.I. Gen. Laws §§ 23-17.9-8 and 23-17.9-9, and upon a decision after a hearing as provided in accordance with the Rhode Island Administrative Procedures Act and the Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title), the Department may deny, suspend, or revoke a license issued under this Part, or may reprimand, censure, or otherwise discipline an individual who has been found guilty of violations of the Act or this Part in any of the following cases:
1.Upon proof of any of the cases stated in R.I. Gen. Laws §§ 23-17.9-8(1) through 23-17.9-8(5)
2.Upon proof that the nursing assistant or medication aide has engaged in unprofessional conduct including, but not limited to, departure from, or failure to conform to, the standards of acceptable and prevailing practice;
3.Upon proof that the nursing assistant or medication aide has, without the patient’s consent, taken a photograph or made an audio or video recording of a patient, or has uploaded a photograph, audio or video recording of a patient to the internet, or who has disseminated a photograph, audio or video recording of a patient in any manner;
4.Upon proof that the nursing assistant or medication aide abandoned a patient or failed to appear for scheduled employment;
5.Upon proof that the nursing assistant or medication aide has engaged in any form of abuse as defined in this Part;
6.Upon proof that the nursing assistant or medication aide has participated in a physical or financial relationship with a patient. Consent of the patient shall not constitute a defense against the violation of § 22.6(A)(10) of this Part.
7.Upon proof that the nursing assistant or medication aide failed to provide the Department of a change of home address or change of employment within ten (10) days of any such change.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.7** Requirements Pertaining to Nursing Assistant Training Programs {#sec-216-ricr-40-05-22-22.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.7}
22.7.1Application for and Approval of Training Programs
A.Approval of training programs shall be granted for two (2) years, if the program is found to meet the requirements of this Part, and such approval may be renewed biennially unless approval has been sooner revoked or suspended.
B.Any person desiring to conduct a training program for the preparation of individuals to provide nursing assistant services shall apply to the Department for approval by submitting a completed application on forms provided by the Department accompanied by documentation pertaining to no less than the following:
1.Evidence of support and fiscal administration accountability;
2.Sources and locations of potential students, faculty, classrooms, conference rooms, clinical laboratory for practical experience and other resources;
3.Names and qualifications of instructors;
4.Copy of the curriculum including provisions for the practical experience;
5.Written statements of purpose, philosophy and objectives;
6.Organization with clearly defined authorities and responsibilities and a chart showing the relationships and channels of communication of the program to other agencies, programs, etc.;
7.Practical experiences related to areas of instruction of the didactic segment of the program; and
8.Written policies and procedures pertaining to the nursing assistant training program.
C.The application fee for a training program certification shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Any nursing assistant training program within a facility administered and operated by the State of Rhode Island shall be exempt from this fee.
1.Nursing Assistant Training program sites that are not inspected by the Board within four (4) weeks of approval by the Board, will be inspected by the Department.
D.Standards for Nursing Assistant Training Program Approval
1.The nursing assistant training program shall consist of no less than one hundred twenty (120) clock hours including no less than forty (40) hours of practical training integrated with the classroom topics and under supervision in accordance with the definition of “supervision” in § 22.3(A)(22) of this Part.
a.Online nursing assistant training programs may offer the required eighty (80) hours of didactic training via the Internet. The forty (40) hours of practical training shall be provided by the employing facility.
2.A nursing assistant training program conducted in a health care facility shall be completed within ninety (90) days.
3.Paperwork and scheduling required for a candidate to sit for the State Nursing Assistant examination shall be prepared by the nursing assistant training program, and testing scheduled with the testing provider within ten (10) days after the applicant's completion of the program. The nursing assistant training program is required within that time to file an application for nursing assistant license with the Department, and is required to contact the testing provider to schedule a date for testing.
4.The course of instruction shall be designed to prepare students to perform all the nursing assistant duties listed in § 22.12.1 of this Part. At least sixteen (16) hours of classroom instruction shall be required prior to a trainee's direct involvement with patients. Such instruction shall be consistent with the curriculum outline of § 22.12.2 of this Part.
E.Personnel
1.Program Coordinator
Each nursing assistant training program shall have a coordinator who shall be responsible for the management of the instructional and practical portions of the program. The program coordinator must be a registered nurse with a minimum of two (2) years of nursing experience, one (1) of which must be in the provision of long term care services; and must have documented evidence of teaching and/or appropriate supervisory experience. Directors of nursing in nursing facilities are prohibited from performing actual training, but may supervise clinical training.
2.Instructors
Competent resource personnel from various areas of the health field may participate as program instructors at the discretion of the program coordinator. Such personnel may include: licensed registered nurses (RNs)/practical nurses (LPNs) with one (1) year of nursing experience, dietitians; pharmacists; or physical therapists. Instructors shall have completed a course in teaching adults or have experience in teaching adults, or supervising nursing assistants, and shall have at least one (1) year of experience in their respective fields.
F.Policies and Procedures
1.Each nursing assistant training program shall have available for students written policies pertaining to no less than the following:
a.Admission, re-admission, retention, dismissal and course completion requirements;
b.The identification of the resource facilities for the practical experience in a long-term care or appropriate acute care facility;
c.Management of any unique online program issues, such as internet and equipment access;
d.The supervision requirement of nursing assistants in all settings in accordance with the definition of “supervision” in this Part; and
e.Such other provisions as may be deemed appropriate.
f.Licensed Nursing Assistant training programs shall submit all required documentation for students who have successfully completed a nursing assistant training program within one (1) month to the Department or shall be subject to disciplinary action in accordance with § 22.10.1 of this Part.
G.Resources and Facilities
1.Each nursing assistant training program shall have resources/facilities consistent with the philosophy, purposes, objectives and policies of the nursing assistant program. Such resources/facilities shall include no less than:
a.Classroom, offices, and conference rooms accessible to and adequate for the number of students;
b.Sufficient instructional materials to meet the needs of students and instructor, including clinical supplies;
c.Furnishings of appropriate size and numbers as may be required for the instructional program and for the number of students;
d.An adequate number of service resources to provide the kinds of practical learning experiences as required to meet the curriculum objectives;
e.Adequate financial support to implement and operate the nursing assistant program;
f.Compliance with all applicable licensing laws and regulatory requirements.
2.Online nursing assistant training programs must ensure that each student enrolled in the program has internet connection, a computer and/or laptop with a webcam, microphone, and speakers to complete the course(s).
H.Curriculum
The objectives of the nursing assistant training program shall be consistent with 42 C.F.R. § 483.152 incorporated at § 22.2 of this Part and the curriculum outline of § 22.12.2 of this Part and shall promote the provision of quality health care services by nursing assistants who are able to perform competently the duties listed in § 22.12.1 of this Part.
I.Evaluation of Curriculum
1.A systematic plan for on-going evaluation of the curriculum shall be established and include evaluation provisions pertaining to no less than:
a.The implementation of the curriculum design;
b.The relationship of the curriculum to current needs of patients in health care facilities and current standards of practice;
c.Revisions and/or modifications of curriculum as may be necessary based on evaluation data, unique online students' requests, and/or other Federal and State requirements.
J.Examinations
1.An examination shall be administered that tests the knowledge and competency of a person to carry out the duties of a nursing assistant as defined in these Regulations.
2.The nursing assistant program shall determine a person’s skill, knowledge levels, and competency through a manual skills (practical) examination. Such examination shall test no less than the following:
a.Communication and interpersonal skills;
b.Infection control;
c.Safety emergency procedures;
d.Promotion of patients' independence;
e.Respecting patients' rights;
f.Basic nursing skills;
g.Mental health/social service needs;
h.Care of cognitively impaired patients;
i.Basic restorative services.
3.In addition, the nursing assistant program shall test specific manual skills as set forth in § 22.12.1 of this Part. Where appropriate, skills demonstration shall be performed on a real patient, or "pseudo-patient," but shall not be performed on a mannequin.
K.Standards for Medication Aide Training Program Approval
1.Medication aide training programs shall be offered by a college or university that is approved by an appropriate accrediting authority. Correspondence courses and on-line learning programs shall not be approved.
2.Approval of a medication aide training program shall be granted for two (2) years, if the program is found to meet the requirements of this Part, and such approval may be renewed biennially unless approval has been sooner revoked or suspended.
3.Training programs for medication aides that are approved by the Department shall include the following components:
a.Require written documentation for entry into the medication aide training program from a director of nursing or an administrator at an adult day services program, nursing facility, or assisted living residence licensed in Rhode Island;
b.A minimum of forty-five (45) hours of classroom instruction in a medication administration training program that includes theoretical and practical instruction;
c.Skills demonstration, performed within one (1) year of successful completion of the medication aide training program, under the supervision of a registered nurse and approval of a registered nurse in the employing facility;
d.Written guidelines, policies, and procedures that define the specific tasks the medication aide shall be expected to perform;
e.A stipulation of how the medication aide's competency is to be assessed (i.e., examination and practicum).
L.Curriculum for a Department-approved Training Program for Medication Aides
1.Training programs for medication aides that are approved by the Department shall include, but not be limited to, the following course content:
a.Legal constraints;
b.Dose forms;
c.Laxatives, vitamins, cold and cough remedies, and other over-the-counter drugs;
d.Psychiatric medications;
e.Antidiabetic and antiemetic drugs;
f.Asthma and chronic obstructive pulmonary disease (COPD);
g.Hormones (including steroids);
h.Antibiotics;
i.Systems of measurement and medical abbreviations;
j.Anti-Parkinson drugs and muscle relaxers;
k.Cardiac drugs;
l.Seizures and pain;
m.Communication techniques;
n.Security and safety of drugs;
o.Glossary of terms;
p.Drug orders;
q.Over-the-counter and legend medications;
r.Common side effects of drugs;
s.Drug administration preparation;
t.Prescribers;
u.Directions for use;
v.Commonly-used abbreviations and symbols;
w.Number of dosage units;
x.Strengths and systems of measurement;
y.Routes of administration;
z.Frequency of administration;
aa.Interpreting directions for use;
bb.Infection control procedures;
cc.Patient instruction;
dd.Calculations and conversions;
ee.Administration of topical medications;
ff.Patient monitoring of health indicators;
gg.“Five rights” of medication administration: right patient, right drug, right dose, right time, and right route of administration;
hh.Proper documentation in patient medication records;
ii.Accurate administration of the appropriate quantity of drug product.
M.Personnel for a Department-approved Training Program for Medication Aides
1.All instructors in a Department-approved training program for medication aides shall be licensed pharmacists (R.Ph) with no less than a bachelor’s degree in pharmacy. Provided, however, pharmacist instructors may engage competent resource personnel from other health fields, such as nursing, to deliver discrete lectures in their area(s) of expertise.
2.Instructors shall have completed a course in teaching adults or have experience in teaching adults and shall have at least one (1) year of experience in their respective fields.
N.Unless otherwise stated, the provisions of § 22.7 of this Part pertain to both classroom and online nursing assistant training programs.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.8** Denial or Revocation of Approval/Termination of Program {#sec-216-ricr-40-05-22-22.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.8}
A.If the Department determines that an approved nursing assistant training program does not meet the requirements of this Part, the Department shall notify, in writing, the institution and/or agency or such other training program of a proposed pending action to deny or revoke the approval of the program and the institution and/or agency shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of § 22.11 of this Part.
B.Any nursing assistant training program that terminates, for whatever reason, shall make provisions for the appropriate storage of its students' records to ensure future accessibility to the training program data for a minimum of five (5) years after the date of termination.
1.Provisions shall be made for the completion of the nursing assistant training program for any individual who has begun a program, if, for whatever reason, the training program terminates.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.9** Advisory Board {#sec-216-ricr-40-05-22-22.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.9}
A.Within the Department there shall be established an Advisory Board which shall meet at least once a year and shall consist of eleven (11) members:
1.Five (5) of whom shall be registered nurses,
2.One (1) of whom shall be a nursing assistant,
3.Two (2) of whom shall be administrators of health care facilities,
4.One (1) of whom shall be a public member, and
5.Two (2) of whom shall be licensed practical nurses.
B.All Board members shall be currently licensed in Rhode Island, where required, and shall be actively working in his/her profession.
C.Members of the Advisory Board shall be appointed by the Director: three (3) to serve for one (1) year; four (4) to serve for two (2) years; and four (4) to serve for three (3) years. No member shall be appointed for more than two (2) consecutive full terms. A member appointed for less than a full term (originally, or to fill a vacancy) may serve two (2) full terms in addition to that part of a full term, and a former member shall again be eligible for appointment after a period of one (1) or more years passes.
D.Successors to members of the Advisory Board whose terms expire shall be appointed in such year by the Director to hold office for three (3) years or until their respective successors are appointed.
E.The Director may remove any member of the Advisory Board for neglect of duty or incompetency and may fill vacancies that occur for any purpose for the remainder of the unexpired term.
F.Functions of the Advisory Board
The Advisory Board shall serve in an advisory capacity to the Director in matters pertaining to the registration of nursing assistants, medication aides and the practice of nursing assistants and medication aides. The Advisory Board shall advise the Director on such matters as policies affecting examination, qualifications, issuance and renewal, denial or revocation of licenses, and the development of Rules and Regulations.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.10** Violations and Penalties {#sec-216-ricr-40-05-22-22.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.10}
Any person who violates the statutory or regulatory provisions of this Part shall be subject to the disciplinary provisions of this Part and as set forth in R.I. Gen. Laws § 23-17.9-9.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.11** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-22-22.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.11}
All hearings and reviews as may be required under the provisions of R.I. Gen. Laws Chapters 23-17.9 and 42-35 shall be conducted in accordance with the provisions of Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
##### **216-RICR-40-05-22 § 22.12** Duties and Training Program Curriculum {#sec-216-ricr-40-05-22-22.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-22#22.12}
22.12.1Duties of Nursing Assistants
A.A nursing assistant duly registered in this State may discharge the following duties under supervision as described in this Part.
1.Personal Care Skills
a.Assist with complicated feeding, hydration
b.Bed bath, tub bath, shower
c.Care of skin and back
d.Foot care, foot soak, applying foot lotion
e.Nail care
f.Oral hygiene
g.Shampoo hair (sink, tub, bed) comb/brush
h.Shave
2.Basic Nursing Skills
a.Application of dry heat and cold packs to intact skin
b.Sitz bath to intact skin for comfort measures and pain relief only
c.Application of topical over-the-counter (OTC) drugs to intact skin
d.Apply lamb's wool
e.Apply elastic stockings
f.Care of patients on precautions
g.Make an occupied, unoccupied bed
h.Measure intake and output
i.Reinforce simple non-sterile dressings
j.Remind patient to take medication
k.Care for a patient when death is imminent
l.Post-mortem care
m.Specimen collection
n.Apply condom catheter
o.Empty catheter bag, commode, urinal
p.Assist with ostomy appliance
q.Assist with commode, toilet, bedpans and urinals
r.Change urinary drainage bag, excluding any sterile procedures
s.Assist with bowel/bladder retraining
t.Report and record weight and height
u.Take and record vital signs (temperature, pulse, and respiration (TPR) and blood pressure)
3.Rehabilitation Skills
a.Ambulate
b.Encourage self-help
c.Positioning
d.Normal range of motion
e.Restraining and use of appropriate alternatives
f.Transfer from bed, wheel chair, chair, commode
g.Transfer using mechanical lift
h.Use of assistive devices in ambulation, eating and dressing
4.Environment
a.Care of patient environment
b.Handling of blood/body fluid spills
c.Clean patient care area
d.Do basic domestic chores (e.g., laundry, ironing, dishes, food preparation, where appropriate)
5.Recognition of and Reporting Signs and Symptoms
a.Infection
b.Redness
c.Swelling
d.Fever, chills
e.Drainage
6.Respiratory Problems
a.Shortness of breath
b.Rapid respirations
c.Cheyne-Stokes respirations
d.Cough
7.Cardiac Problems
a.Chest pains
b.Cyanosis lips/nails
c.Rapid pulse
8.GI/GU problems
a.Abdominal pain
b.Nausea
c.Vomiting blood
d.Urine/stool: difficulty urinating; diarrhea
9.Endocrine problems
a.Drowsiness
b.Thirst
c.Sweating
B.Duties Which a Nursing Assistant May Perform Under Direct Supervision:
1.Enema
2.Colostomy irrigation
3.Application of hot packs using moist heat device or heat lamp
4.In addition, nursing assistants may be assigned nursing duties beyond those listed in §§ 22.12.1(A) and (B) of this Part (but in no case may they may be assigned any of the duties excluded in § 22.12.1(C), so long as those duties are clearly delineated in facility policies. Documented evidence of training and competency evaluation for each additional duty permitted to be discharged shall be filed in the individual's personnel file.
C.Excluded from the Duties of a Nursing Assistant
1.A nursing assistant shall not perform functions that otherwise require a professional license, certification or registration by State law and shall not perform the following duties that include but are not limited to:
a.Sterile dressing application
b.Gastric lavage or gavage, including any tube feeding
c.Injections
d.Vaginal Irrigations
e.Cutting toenails or fingernails for diabetic
f.Cutting toenails
g.Giving advice on medical/nursing matters
h.Changing a Foley catheter
i.Tracheostomy tube care
j.Any treatment to non-intact skin
k.Oxygen application
D.Medications
1.A nursing assistant may only remind a patient to take medication, unless the nursing assistant is licensed with the Department as a medication aide.
2.Medication aides shall not administer drugs or biologicals under any circumstances in an acute care setting, and shall not administer any Schedule II controlled substances.
22.12.2Curriculum Outline Basic Nursing Assistant Training Program
A.Minimum requirement of:
1.Eighty (80) classroom hours
2.Forty (40) hours of practical experience
B.Being A Nursing Assistant – Introduction
1.Function of the nursing assistant
a.In health care institutions
b.In the home
2.Working with the health care team
3.Ethical responsibilities
a.Accountability
b.Confidentiality
4.Policies and procedures
5.State Rules and Regulations related to the registration of nursing assistants
6.Communication and interpersonal skills
7.Infection control
8.Safety/emergency procedures
9.Promoting patients' independence
10.Respecting patients' rights
C.Basic Human Needs
1.Patients as human beings
a.Physical, emotional, spiritual and mental health needs of patients throughout the life cycle
b.Modifying the nursing assistant's behavior in response to patient's behavior
c.Identifying developmental tasks associated with the life cycle
d.Behavior management (reinforcement, reduction, elimination of behaviors)
e.Allowing maximum independence in relation to patient's ability
f.Working with the patient's family
D.Caring for Patients
1.Admission and discharge procedures
2.Personal care skills
To include instruction relative to all those personal care duties outlined in § 22.12.1 of this Part, which a nursing assistant may discharge under supervision.
3.Basic nursing skills:
a.Taking and recording vital signs
b.Measuring and recording vital signs
c.Caring for patient's environment
d.Observing, reporting and documenting abnormal signs and symptoms of common diseases
e.Caring for patients when death is imminent
f.Specimen collection (urine, stool, sputum)
g.Heimlich maneuver
4.Basic Nutrition:
Food and nutrition
5.Fluid balance:
a.Intake and output
b.Maintaining proper hydration
E.Basic Restorative Services
1.Rehabilitation
a.Basic body mechanics
b.Anatomy/physiology
2.Training the patient in self-care, according to ability
3.Use of assistive devices in transferring, ambulation, eating and dressing
4.Maintenance of range of motion
5.Proper turning and positioning in bed and chair
6.Bowel and bladder training
7.Care and use of prosthetic and orthotic devices
F.Care of Patients with Specific Problems
1.The patient with cognitive impairment or other behavioral health conditions
a.Techniques for addressing the unique needs and behaviors of individuals with dementia (Alzheimer's disease and others)
b.Communicating with patients
c.Understanding behavior
d.Appropriate responses to behavior
e.Methods for reducing the effects of cognitive impairment
2.Care of patients with diseases of other body systems
a.Circulatory problems
b.Respiratory problems
c.Digestive system problems
d.Bowel and bladder problems
e.Musculoskeletal problems
f.Neurological problems
g.Endocrine problems
h.Skin problems
G.Patient’s Rights
1.Privacy/confidentiality
2.The right to personal choices
3.Giving assistance in resolving grievances and disputes
4.Maximizing participation in resident and family groups
5.Maintaining care and security of personal possessions/property
6.Providing care which maintains the patient free from abuse
7.Reporting abuse, mistreatment and neglect
8.The use of restraints; avoiding the use of restraints
H.Practical Training
1.Each student must satisfactorily complete twenty (20) hours of practical training under supervision and such practical experience shall be provided in a clinical setting for the practical application of nursing assistant duties as outlined in § 22.12.1 of this Part.
2.The practical training must be integrated with the didactic portion of the curriculum for a meaningful learning experience.
22.12.3Duties of Medication Aides
A.Medication aides shall consistently apply the community standard of care that includes but is not limited to:
1.Establish competency as a medication aide;
2.Maintain competency as a medication aide;
3.Perform within authorized duties;
4.Follow written instructions of a licensed health care professional authorized to prescribe medications within the scope of his or her practice and as transcribed in the medication administration record (MAR); and
5.Accurately record on the medication administration record (MAR) medications administered, medications withheld or refused, and the reason why a medication was withheld or refused.
B.A medication aide licensed in this State may discharge the following duties under supervision as described in this Part:
1.Under the supervision of a licensed nurse, medication aides may administer:
a.Oral, sublingual and buccal medications;
b.Eye medications;
c.Ear medications;
d.Nasal medications;
e.Rectal medications;
f.Vaginal medications;
g.Skin ointments, topical medications including patches and transdermal medications to intact skin only;
h.Premeasured medication delivered by aerosol/nebulizer; and
i.Medications delivered by metered hand-held inhalers.
2.Under the direct supervision of a licensed nurse, medication aides may apply oxygen.
C.Administration of PRN Medications
1.Medication aides may administer PRN medications to clients according to physician's, nurse practitioner's, or physician assistant’s orders.
2.Medication aides are not allowed to administer medications by the following routes:
a.Central lines;
b.Colostomy;
c.Intramuscular;
d.Intrathecal;
e.Intravenous;
f.Via any tubes (e.g., Nasogastric, gastrostomy)
g.Subcutaneous;
h.Intradermal;
i.Urethral;
j.Epidural; or
k.Endotrachea.
3.Medication aides are not allowed to administer the following kinds of medications:
a.Schedule II controlled substances;
b.Barium and other diagnostic contrast media; or
c.Chemotherapeutic agents, except oral maintenance chemotherapy.
4.Medication aides are not allowed to administer medication by medication pumps, including client-controlled analgesia.
5.Medication aides are not allowed to act as a preceptor to a student in a medication aide training program.
**History**
- *Amendment — effective from 2023-02-01 to current*
- *Amendment — effective from 2022-05-21 to 02/01/2023*
- *EMERGENCY RULE Amendment — effective from 2022-01-26 to 04/05/2022*
- *EMERGENCY RULE Amendment — effective from 2021-10-07 to 01/26/2022*
- *Amendment — effective from 2018-07-12 to 05/21/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2008-03-25 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 03/25/2008*
- *Amendment — effective from 2006-10-10 to 10/18/2007*
- *Amendment — effective from 2005-09-29 to 10/10/2006*
- *Amendment — effective from 2004-08-31 to 09/29/2005*
- *Amendment — effective from 2004-02-19 to 08/31/2004*
- *Periodic Refile — effective from 2002-01-02 to 02/19/2004*
#### **216-RICR-40-05-23** Midwives
##### **216-RICR-40-05-23 § 23.1** Authority {#sec-216-ricr-40-05-23-23.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-13-9 for the purpose of adopting prevailing standards for the practice of midwifery in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.2** Incorporated Materials {#sec-216-ricr-40-05-23-23.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.2}
A.These regulations hereby adopt and incorporate the American College of Nurse-Midwives’ “Standards for the Practice of Midwifery” (2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the American College of Nurse-Midwives’ “The Core Competencies for Basic Midwifery Practice” (2012) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate the American College of Nurse-Midwives’ “Joint Statement of Practice Relations Between Obstetrician-Gynecologists and Certified Nurse- Midwives/Certified Midwives” (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
D.These regulations hereby adopt and incorporate the American College of Nurse-Midwives’ “Position Statement: Collaborative Agreement between Certified Nurse-Midwives/Certified Midwives and Physicians or other Health Care Providers” (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
E. These regulations hereby adopt and incorporate the Midwife Alliance of North America’s "The Midwives Alliance Core Competencies” (2014) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
F.These regulations hereby adopt and incorporate the National Association of Certified Professional Midwives’ "Essential Documents of the National Association of Certified Professional Midwives” (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.3** Definitions {#sec-216-ricr-40-05-23-23.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.3}
A.Wherever used in this Part the following terms shall be construed to mean:
1."Act" means R.I. Gen. Laws § 23-13-9 entitled, "Licensing and Regulation of Midwives – Penalty for Violations".
2."Accredited educational program in midwifery" means an academic and practical program of midwifery accredited by the Accreditation Commission for Midwifery Education (ACME) or the Midwifery Education Accreditation Council (MEAC).
3.“Certified midwife” or “CM” means a person who has successfully completed an accredited educational program in midwifery, holds a current certification as a midwife by the American Midwifery Certification Board (AMCB), and is licensed to practice midwifery in Rhode Island.
4."Certified nurse-midwife” or “CNM" means a person who has successfully completed an accredited educational program in midwifery, holds a current certification as a nurse- midwife by the American Midwifery Certification Board (AMCB), and is licensed to practice midwifery in Rhode Island.
5.“Certified professional midwife” or “CPM” means a person who has successfully completed an accredited educational program in midwifery, holds a current certification as a certified professional midwife by the North American Registry of Midwives (NARM), and is licensed to practice midwifery in Rhode Island.
6."Council" means the Advisory Council on Midwifery as established by this Part.
7.“Department” means the Rhode Island Department of Health.
8."Director" means the Director of the Rhode Island Department of Health.
9."Midwife" means a person who has successfully completed an accredited educational program in midwifery, holds a current certification as a certified nurse-midwife (CNM), certified midwife CM), or certified professional midwife (CPM), and is licensed to practice midwifery in Rhode Island as defined in this Part.
10."Midwifery" means the independent management of cases of childbirth, including prenatal, intrapartum, postpartum, and normal newborn care, and well woman care including the management of common health problems.
11."Physician" means an individual licensed under the provisions of R.I. Gen. Laws Chapter 5-37 to practice medicine with current obstetrical privileges in a licensed hospital.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.4** License Requirements {#sec-216-ricr-40-05-23-23.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.4}
A.Any person practicing or offering to practice midwifery shall be required to submit evidence that such person is qualified to practice and shall be licensed as provided in this Part, in order to safeguard the life and health of the people.
B.It shall be unlawful for any person to practice or to offer to practice midwifery in Rhode Island or to use any title, abbreviation, sign, card or device to indicate that such a person is practicing midwifery unless such person has been duly licensed as a midwife in accordance with the Act and this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.5** Advisory Council on Midwifery {#sec-216-ricr-40-05-23-23.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.5}
A.Within the Department, the Director shall establish an Advisory Council on Midwifery that shall meet at least once a year, and consist of seven (7) members:
1.Two (2) physicians;
2.Three (3) midwives; and
3.Two (2) consumers.
B.No member shall be appointed for more than two (2) consecutive full terms. A member appointed for less than a full term (originally, or to fill a vacancy) may serve two (2) full terms in addition to that part of a full term, and a former member shall again be eligible for appointment after a lapse of one (1) or more years. A full term shall be equal to three (3) years.
C.Successors to members of the Council whose term expires shall be appointed in such year by the Director to hold office for three (3) years or until their respective successors are appointed.
D.The Director may remove any member of the Council for neglect of duty or incompetency and may fill vacancies that occur for any purpose for the remainder of the unexpired term.
23.5.1Functions of Advisory Council
The Council shall serve in an advisory capacity to the Director in matters pertaining to the licensing of midwives and the practice of midwifery. The Council shall advise the Director on such matters as policies affecting qualifications, issuance and renewal, denial or revocation of licenses, and the development of rules and regulations.
23.5.2Administration
The Department shall be responsible for the administrative functions required to implement the provisions of the Act and this Part including such duties as: maintaining a register of all licensed midwives; maintaining all records pertaining to the licensing of midwives; staffing the Council; and discharging such other duties as may be warranted.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.6** Qualifications of Midwives {#sec-216-ricr-40-05-23-23.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.6}
A.An applicant for a license to practice midwifery in Rhode Island shall have successfully completed an accredited educational program in midwifery and has evidence of certification. The Director shall require submission of such information as may be deemed necessary to evaluate the nature and scope of the applicant's academic and clinical preparation in accordance with the requirements of this Part. Such information may include but not be limited to:
1.Transcripts of academic courses or other documented evidence of successful completion of an approved educational program in midwifery;
2.Documentation of successful completion of a written examination in accordance with the requirements of § 23.7.1 of this Part.
3.Certified Nurse-Midwives (CNM) must hold a current Rhode Island license as a registered nurse or privilege to practice and shall not hold an encumbered license or privilege to practice as a registered nurse in any state or territory.
4. Submitting a copy of written notification from the Bureau of Criminal Identification (BCI) indicating that no disqualification information has been found or requesting the BCI provide the Department with a copy of the criminal background report.
5.Payment of required fee as stipulated in §§ 23.7.2(B) and 23.7.3 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.7** Licensing of Midwives {#sec-216-ricr-40-05-23-23.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.7}
23.7.1By Education and Examination:
Applicants for a license to practice midwifery in Rhode Island shall have successfully completed an accredited educational program in midwifery that is accredited by the Accreditation Commission for Midwifery Education (ACME) or the Midwifery Education Accreditation Council (MEAC). Further, applicants shall be required to pass an examination that is administered by the American Midwifery Certification Board (AMCB) or the North American Registry of Midwives (NARM).
23.7.2By Endorsement:
A.If an applicant was licensed as a midwife in another state or territory, she/he may be issued a license to practice midwifery in Rhode Island, if, in the opinion of the Council, she/he meets the licensure qualifications in place in Rhode Island at the time of licensure in the other state or territory.
B.An applicant who submits an application along with the non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), provides acceptable evidence of being currently licensed under the laws of other states of the United States or the District of Columbia and presents evidence of meeting the requirements of § 23.7.1 of this Part shall be provided with a dated receipt to work which shall be valid for ninety (90) days. Provided, however, the applicant shall be duly licensed in Rhode Island within ninety (90) days from the dated receipt to work issued by the Department. This interim work privilege shall not be extended or renewed beyond ninety (90) days.
23.7.3Foreign Trained Midwives:
All midwives prepared in a midwifery program outside the United States of America shall submit evidence of having graduated from a midwifery program meeting the standard set by the International Confederation of Midwifery (ICM), along with the non-refundable, non-returnable application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), and of holding a license in midwifery from the given foreign country. In addition, the applicant shall be required to successfully complete the examination administered by the American Midwifery Certification Board (AMCB) or, if a CPM, attend a Midwifery Education Accreditation Council (MEAC) accredited school and successfully complete the examination administered by the North American Registry of Midwifery (NARM).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.8** Renewal of License {#sec-216-ricr-40-05-23-23.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.8}
A.On or before the first (1st) day of August of every odd-numbered year, the Department shall mail a renewal of license notice to every midwife to whom a license has been issued or renewed for the period ending September 1. Every person so licensed who intends to engage in the practice of midwifery during each ensuing two (2) years shall apply for a license by application to the Department.
B.Upon receipt of the application, the non-refundable, non-returnable renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), and the accompanying attestation of continuing education and continued national certification required by this Part, the accuracy of the application shall be verified and the Director may grant a license renewal effective September 1st and expiring the thirty-first (31st) day of August in the odd- numbered year following the issuance of such license and shall render the holder to be a legal practitioner of midwifery for the period stated on the license renewal unless sooner revoked or suspended.
C.Any licensee who allows his or her license to lapse by failing to renew the license by the appropriate date may be reinstated upon submission of an application and the non-refundable, non-returnable renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), along with the accompanying data as required by this Part and as approved by the Director.
D.Any person practicing midwifery after lapse of licensure shall be considered an illegal practitioner and subject to the penalties of the provisions of the Act.
23.8.1Continuing Education Requirements
A.An application for renewal shall include an attestation statement of completion of twenty (20) hours of continuing education in a two (2) year period, including four (4) hours in pharmacology.
B.It shall be the sole responsibility of the midwife to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than two (2) years and are subject to random audit by the Department.
C.A licensee who fails to complete the continuing education requirements described in this Part may be subject to disciplinary action pursuant to § 23.12 of this Part.
D.A license may be denied to any applicant who fails to provide satisfactory evidence of completion of continuing education relevant to the practice of a midwife as required by this Part.
E.A midwife initially licensed by examination after the August 31st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., September 1st of the next odd-numbered year).
F.An extension of time to complete the continuing education requirements may be granted to a midwife solely at the discretion of the Council for reasons of hardship or other extenuating circumstances.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.9** Practice of Midwifery {#sec-216-ricr-40-05-23-23.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.9}
A.The license to practice midwifery authorizes the holder to practice the independent management of cases of childbirth, including prenatal, intrapartum, postpartum, and normal newborn care, and well woman care including the management of common health problems that provides for consultation, collaborative management, or referral as indicated by the health status of the client in accordance with standards established by the American College of Nurse-Midwives and Midwives Alliance of North America incorporated by reference in § 23.2 of this Part.
B.Licensed midwives shall conform to all state laws pertaining to the conduct of childbirth and management of the newborn, including, but not limited to, the provisions of R.I. Gen. Laws § 23-13-4, "Ophthalmia Neonatorum"; R.I. Gen. Laws § 23-13-19 "HIV"; R.I. Gen. Laws § 23-13-13 "Testing for Hearing Impairments"; R.I. Gen. Laws § 23-13-14 “Newborn Screening”; and R.I. Gen. Laws § 23-3-10, "Birth Registration".
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.10** Prescription Privileges of Licensed Nurse-Midwives and Certified Midwives {#sec-216-ricr-40-05-23-23.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.10}
A.Pursuant to the provisions of the Act, a licensed nurse-midwife or licensed certified midwife is permitted to prescribe all legend medications and those controlled substances cited in § 23.10(B) of this Part.
1.The licensed nurse-midwife or licensed certified midwife shall prescribe any medication(s) referenced in § 23.10(A) of this Part in accordance with the guidelines available at the practice site.
B.Licensed nurse-midwives or licensed certified midwives may apply for authorization to prescribe drugs classified under R.I. Gen. Laws Chapter 21-28 as controlled substances in schedules II, III, IV, and V only. In order to prescribe such drugs, a licensed nurse-midwife or licensed certified midwife must:
1.Obtain a state registration for prescribing controlled substances by completing the application for registration, and submitting it with its specified filing fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) to:
Rhode Island Department of Health, Pharmacy Unit
Three Capitol Hill, Room 205 Providence, RI 02908-5097
2.Obtain a federal registration for controlled substances by completing application form DEA-224, or its successor form, and submitting it with its specified filing fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.The Director will determine whether issuance of a registration is consistent with the public interest, and may refuse registration where the issuance of said registration would be inconsistent with the public interest, according to the provisions of R.I. Gen. Laws Chapter 21-28.
D.A certified professional midwife (CPM) shall not have the ability for prescriptive authority but may carry and administer emergency medications essential to care for a safe out-of-hospital birth. These are to include:
1.Intravenous solution and equipment.
2.Misoprostol.
3.Oxygen.
4.Pitocin.
5.Vitamin K.
6.Erythromycin ophthalmic ointment.
7.Methergine.
8.Lidocaine.
9.Epi-Pen (adult).
10.Rhogam.
11.Prophylaxis for group beta streptococcus.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.11** Records and Reports {#sec-216-ricr-40-05-23-23.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.11}
A.A medical record for each mother and newborn shall be maintained and shall include documentation of all care rendered.
B.All medical records shall be retained for a period of five (5) years in accordance with the provisions of R.I. Gen. Laws § 23-3-26 except in the case of minors [seventeen (17) years of age or under] which medical records shall be kept at least five (5) years after such minor has reached the age of eighteen (18) years.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
##### **216-RICR-40-05-23 § 23.12** Discipline of Licensees {#sec-216-ricr-40-05-23-23.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-23#23.12}
A.The Director is authorized to deny or revoke any license to practice midwifery or otherwise discipline a licensee upon proof that the person is guilty of unprofessional conduct which shall include, but not be limited to:
1.Fraudulent or deceptive procuring or use of a license;
2.All advertising of midwifery business which is intended or has a tendency to deceive the public;
3.Conviction of a crime involving moral turpitude; conviction of a felony; conviction of a crime arising out of the practice of midwifery;
4.Abandonment of patient;
5.Dependence upon controlled substances, habitual drunkenness or rendering professional services to a patient while the midwife is intoxicated or incapacitated by the use of drugs;
6.Promotion by the sale of drugs, devices, appliances, or goods or services provided for a patient in such a manner as to exploit the patient for the financial gain of the midwife;
7.Immoral conduct of a midwife in the practice of midwifery;
8.Willfully making and filing false reports or records in the practice of midwifery;
9.Willful omission to file or record, or willfully impeding or obstructing a filing or recording, or inducing another person to omit to file or record medical or other reports as required by law;
10.Solicitation of professional patronage by agents or persons or profiting from acts of those representing themselves to be agents of the midwife;
11.Division of fees or agreeing to split or divide the fees received for professional services for any person for bringing to or referring a patient;
12.Willful misrepresentation in treatments;
13.Practicing midwifery with an unlicensed midwife or aiding or abetting such unlicensed persons in the practice of midwifery;
14.Gross and willful overcharging for services; including filing of false statements for collection of fees for which services are not rendered or willfully making or assisting in making a false claim or deceptive claim or misrepresenting a material fact for use in determining rights to health care or other benefits;
15.Professional or mental incompetency;
16.Incompetent, negligent or other willful misconduct in the practice of midwifery, which shall include the rendering of medically unnecessary services and/or any departure from or the failure to conform to the minimal standards of acceptable and prevailing midwifery practice. The Director need not establish actual injury to the patient in order to adjudge a midwife guilty of the named conduct;
17.Surrender, revocation, suspension, limitation of privilege based on quality of care provided or any other disciplinary action against a license or authorization to practice midwifery in another state or jurisdiction, or surrender, revocation, suspension or any other disciplinary action relating to a membership on any medical staff or in any medical or professional association or society while under disciplinary investigation by and of those authorities or bodies for acts or conduct similar to acts or conduct which would constitute grounds for action as set forth in R.I. Gen. Laws Chapter 21-28 and this Part;
18.Failure to furnish the Director, his/her investigator or representatives, information legally requested;
19.Violation of any provision(s) of R.I. Gen. Laws Chapter 23-13 or any rules or regulations promulgated by the Director or of an action, stipulation or agreement of the Director;
20.Cheating on or attempting to subvert the licensing examination;
21.Violating any state or federal law or regulation relating to controlled substances;
22.Malpractice.
B.If national certification is withdrawn for reason during licensure, current license would be automatically placed in license hold status after notice to the licensee and not renewed until national certification is reinstated.
1.Complaints charging a person with violation of any rule in this Part or state law, shall be maintained on file by the Department and shall be considered in rendering determination to deny or revoke the license of a midwife.
C.Upon receipt of a complaint charging a person with violations of the provisions of the Act and this Part, an investigation of the charges shall be initiated by the Department or the Director, thence referred to the Council for recommendation to the Director for appropriate action.
D.Whenever an action shall be proposed to deny or revoke the license, the Department shall notify the person by certified mail setting forth the reasons for the proposed action and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35 and the rules and regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
E.Furthermore, when it appears to the Director after due process that a person is violating any provisions of the Act or any of this Part, the Director may initiate an action in accordance with the provisions of such statute.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2014-08-19 to 11/04/2018*
- *Amendment — effective from 2012-12-10 to 08/19/2014*
- *Amendment — effective from 2008-11-05 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 11/05/2008*
- *Amendment — effective from 2007-01-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/29/2007*
#### **216-RICR-40-05-24** Licensure of Physician Assistants
##### **216-RICR-40-05-24 § 24.1** Authority and Purpose {#sec-216-ricr-40-05-24-24.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-54-7(c), and are established for the purpose of updating administrative procedures and prevailing standards for the licensure of physician assistants.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.2** Incorporated Materials {#sec-216-ricr-40-05-24-24.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.2}
These Regulations hereby adopt and incorporate the Centers for Disease Control's ("CDC") "Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care" (September 2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.3** Definitions {#sec-216-ricr-40-05-24-24.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.3}
A.Wherever used in this Part, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-54 entitled, "Physician Assistants.”
2."Approved program" means a program for the education and training of physician assistants that has been accredited by the Accreditation Review Commission on Education for the Physician Assistant, Inc. (ARC-PA) or its successor.
a.For the purpose of these Regulations, ARC-PA shall be defined to include its predecessor certification organizations: American Medical Association's Council on Medical Education (1972-1976); American Medical Association's Committee on Allied Health Education and Accreditation [CAHEA] (1976-1994); and Commission on Accreditation of Allied Health Education Programs [CAAHEP] (1976-2000).
3."Board" means the Board of Licensure of Physician Assistants within the Department established pursuant to R.I. Gen. Laws § 5-54-4.
4.“Department” means the Rhode Island Department of Health.
5."Director" means the Director of the Rhode Island Department of Health.
6."Health care facility" means any facility licensed pursuant to the provisions of R.I. Gen. Laws Chapter 23-17.
7."Physician" means a person licensed under the provisions of R.I. Gen. Laws Chapters 5-29 or 5-37.
8."Physician assistant" or "PA" means a person who is qualified by academic and practical training to provide medical and surgical services in collaboration with physicians.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.4** Licensure of Physician Assistants {#sec-216-ricr-40-05-24-24.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.4}
24.4.1Licensure Requirements
No person who is not licensed as a physician assistant shall use the title of "Physician Assistant" or hold himself out as a physician assistant pursuant to R.I. Gen. Laws§ 5-54-16.
24.4.2Exemptions
A.The provisions of the Act and this Part do not apply to services performed in any of the following areas:
1.The practice of dentistry or dental hygiene as defined in R.I. Gen. Laws Chapter 5-31.1;
2.The practice of chiropractic medicine as defined in R.I. Gen Laws Chapter 5-30;
3.The practice of optometry as defined in R.I. Gen. Laws Chapter 5-35;
4.A physician assistant student enrolled in an approved program, as defined in § 24.3 of this Part, while performing duties in conjunction with an approved program clinical rotation.
5.Technicians, or other assistants or employees of physicians who perform delegated tasks in the office of a physician but who are not rendering services as a physician assistant or identifying themselves as a physician assistant.
24.4.3Qualifications for Licensure
A.An applicant seeking licensure to practice in the State of Rhode Island as a physician assistant must:
1.Have graduated from a physician assistant training program certified by the Accreditation Review Commission on Education for the Physician Assistant, Inc. (ARC-PA) or its successor;
2.Have passed the National Commission on Certification of Physician Assistants, or any other national certifying exam approved by the Board; and,
3.Have submitted a completed application together with the required fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.5** Application for Licensure and Fee {#sec-216-ricr-40-05-24-24.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.5}
A.Application for licensure shall be made on forms provided by the Department which shall be completed and submitted to the Board. Such application shall be accompanied by the following documents:
1.Supporting official transcripts of education credentials;
2.A copy of the valid certificate of having successfully passed a national certifying examination approved by the Board;
3.A statement from the board of physician assistant examiners in each State or territory or District of Columbia, or in which the applicant has held or holds licensure, to be submitted directly to the Board of this State, attesting to the licensure status of the applicant during the time period applicant held licensure in said State; and
4.The non-refundable licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Applicants whose physician assistant licenses are presently or ever have been suspended, surrendered, or revoked in another jurisdiction must submit a letter of good standing to the Board from the originating jurisdiction prior to their application being considered in Rhode Island.
C.If the applicant provides documentation to the Department of credentials verification by the Federation Credentials Verification Service (FCVS) of the Federation of State Medical Boards (FSMB), the requirements set forth in §§ 24.5(A)(1), 24.5(A)(2), and 24.5(A)(3) of this Part shall be met.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.6** Issuance and Renewal of Certificate of Licensure {#sec-216-ricr-40-05-24-24.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.6}
A.The Director shall issue a certificate of licensure as a physician assistant to those individuals recommended by the Board as having met the criteria for licensure in §24.4.3 of this Part. Said certificate of licensure unless sooner suspended or revoked shall expire on the thirtieth (30th) day of June of every odd-numbered year.
B.Every person who desires his or her certificate of licensure to be renewed shall on or before the first (1st) day of June of every odd-numbered year file with the Department:
1.A signed, completed renewal application (on forms provided by the Department); and
2.The renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Upon receipt of such application and fee, the accuracy of such application shall be verified and the Department shall grant a renewal certificate effective July 1st and expiring June 30th two (2) years later, unless said certificate shall sooner be suspended for cause as provided in R.I. Gen. Laws § 5-54-12.
D.Inactive List. A physician assistant licensed to practice who does not intend to engage in the practice of his/her profession during any year, upon written request to the Board may have his/her name transferred to an inactive list, and shall not be required to register annually or pay any renewal as long as he/she remains inactive. Any physician assistant included in the inactive list as provided for in this section shall be restored to active status by the Department upon filing of a written request accompanied by the renewal fee.
E.Granting of licensure after a lapse for non-disciplinary reasons. If a physician assistant has not engaged in active practice for two (2) years or more, such physician assistant must establish his or her clinical competency to the Board’s satisfaction as a condition precedent to reactivation or reinstatement. The Board may require any or all of the following from such physician assistant to establish clinical competency:
1.Documentation of appropriate continuing medical education;
2.Evidence of maintenance of certification from the National Commission on Certification of Physician Assistants; and
3.An evaluation of clinical competency by a Board approved organization, such as the Center for Personalized Education for Physicians (CPEP). The applicant is responsible to report the results of an evaluation from a Board approved organization and follow the recommendations for ongoing competence.
F.Granting of licensure after a lapse for disciplinary reasons. If a physician assistant has not engaged in active practice for two (2) years or more based on a disciplinary action from the Board or any other jurisdiction, such physician assistant must establish his or her clinical competency to the Board’s satisfaction as a condition percent to reactivation or reinstatement. The Board may require any or all of the following from such physician assistant to establish clinical competency:
1.An evaluation of clinical competency by a Board approved organization, such as the Center for Personalized Education for Physicians (CPEP). The applicant is responsible to report the results of an evaluation from a Board approved organization and follow the recommendations for ongoing competence; and
2.Successfully passing a National Commission of Certified Physician Assistants (NCCPA) certifying exam or successor.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.7** Scope of Practice {#sec-216-ricr-40-05-24-24.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.7}
A.Physician assistants' scope of practice is defined in R.I. Gen. Laws § 5-54-8.
24.7.1Prescriptive Privileges and Medical Orders
A.When employed by, or extended medical staff privileges by a licensed hospital or other licensed health care facility, a physician assistant may write medical orders for inpatients as delineated by the medical staff by-laws of the facility, as well as its credentialing process and applicable governing authority.
B.Hospitals and other licensed health care facilities shall have discretion to grant privileges to a physician assistant and to define the scope of privileges or services which a physician assistant may deliver in a facility.
C.Physician assistants employed directly by physicians, health maintenance organizations or other health care delivery organizations may prescribe legend medications, including schedules II, III, IV, and V medications under R.I. Gen. Laws Chapter 21-28 (the Rhode Island Uniform Controlled Substance Act), medical therapies, medical devices and medical diagnostics according to guidelines established by the employing physician, health maintenance organization, or other health care delivery organization.
D.Prescriptive privileges for physician assistants shall be granted for all legend medications, including controlled substances from schedules II, III, IV, and V.
E.If a physician assistant does prescribe controlled substances from schedules II, III, IV, and V, under R.I. Gen. Laws Chapter 21-28, he or she must obtain a Rhode Island registration for prescribing controlled substances from the Board of Pharmacy, as well as a Federal registration.
24.7.2Podiatry Collaboration
When collaborating with a physician licensed under R.I. Gen. Laws Chapter 5-29, the services rendered by the physician assistant shall be limited to the foot. The “foot” is defined as the pedal extremity of the human body and its articulations and shall include the tendons and muscles of the lower leg only as they be involved in the conditions of the foot.
24.7.3Participation in Charitable and Voluntary Care
Physician assistant participation in charitable and voluntary care is permitted consistent with and to the extent authorized pursuant to R.I. Gen. Laws § 5-54-28.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.8** Continuing Medical Education {#sec-216-ricr-40-05-24-24.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.8}
A.Pursuant to R.I. Gen. Laws § 5-54-22 every physician assistant licensed to practice in the State of Rhode Island shall be required to have satisfactorily completed twenty-five (25) hours of approved continuing medical education every years.
B.The period for accumulation of continuing medical education hours shall commence on the first (1st) day of July and run through the thirtieth (30th) day of June. The Department shall not renew the certificate of licensure until the applicant has attested to satisfactory evidence of completion of the required continuing medical education.
C.Course descriptions, proof of attendance, or other documentation of completion shall be retained by the licensee for a minimum of four (4) years and is subject to random audit by the Board.
D.An extension of time to complete the continuing education requirements may be granted to a physician assistant solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
E.Physician assistants initially licensed after the July 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., June 30th of the next odd numbered year).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.9** Denial, Suspension or Revocation of Licensure - Violations {#sec-216-ricr-40-05-24-24.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.9}
Any violation pursuant to the provisions of the Act and this Part may be cause for denial, revocation or suspension of registration, grounds for discipline and imposing other penalties in accordance with the provisions of the Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.10** Non-disciplinary Alternative Program {#sec-216-ricr-40-05-24-24.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.10}
A.The Board may permit a licensee to enter into a non-disciplinary alternative program.
B.All records pertaining to the physician assistant's participation in the non-disciplinary program are confidential and not subject to discovery, subpoena, or public disclosure.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.11** Reports Relating to Professional Conduct and Capacity {#sec-216-ricr-40-05-24-24.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.11}
A.In addition to the requirements of R.I. Gen. Laws § 42-14-2.1, any person, including, but not limited to, corporations, health care facilities, health maintenance organizations, organizations and Federal, State, or local governmental agencies, or peer review boards shall report to the Board any: conviction, determination, or finding that a licensed physician assistant has committed unprofessional conduct as defined in R.I. Gen. Laws §§ 5-54-2 or 24.15.1 of this Part, or to report information which indicates that a licensed physician assistant may not be able to practice with reasonable skill and safety to patients as the result of any mental or physical condition.
B.The following reports, in writing, shall be filed with the Board:
1.Every insurer providing professional liability insurance to a physician assistant licensed under the provisions of the Act shall send a complete report to the Board reporting any formal notice of any claim, settlement of any claim or cause of action, or final judgment rendered in any cause of action for damages for death or personal injury caused by a physician assistant's negligence, error or omission in practice or his or her rendering of unauthorized professional services. The report shall be sent within thirty (30) days after service of the complaint or notice, settlement, judgment, or arbitration award on the parties. All the reports shall present an in-depth factual summary of the claim in question.
2.All hospital and licensed health care facilities including, but not limited to, nursing homes and health maintenance organizations and the Board of Pharmacy must report within thirty (30) days of this action, any action, disciplinary or otherwise, taken for any reason, which limits, suspends, or revokes a physician assistant's privilege to practice, either through formal action by the institution or facility or through any voluntary agreement with the physician assistant.
3.Within ten (10) days after a judgment by a court in the State of Rhode Island that a physician assistant licensed under the provisions of the Act has been convicted of a crime or is civilly liable for any death or personal injury caused by his or her negligence, error or omission in his or her practice or his or her rendering unauthorized professional services, the clerk of the court which rendered the judgment shall report the judgment to the Board.
C.The Board shall publicly report any change of privileges, of which it is aware, to the board of trustees or other appropriate body of all licensed hospitals, licensed health care facilities, health maintenance organizations and any other parties that the Board deems appropriate, within thirty (30) days; provided, that notwithstanding the provisions of this section, the Board may, in instances where the change of privilege is not related to quality of patient care, elect not to disseminate the report of changed privileges. This election may be made in executive session and no decision not to disseminate is made except by the majority vote of the members present at the meeting and only upon a finding of fact by the Board after inquiry that the change was not related to quality of patient care.
D.The contents of any report filed are confidential and exempt from public disclosure, except that it may be reviewed:
1.By the licensee involved or his or her counsel or authorized representative who submits any additional exculpatory or explanatory statements or other information, which statements or information are included in the file, or
2.By the chief administrative officer, a representative of the Board or investigator of the Board, who is assigned to review the activities of a licensed physician assistant.
E.Upon determination that a report is without merit, the Board's records shall be purged of information relating to the report.
F.If any person refuses to furnish a required report, the Board may petition the superior court of any county in which the person resides or is found, and the court issues to the person an order to furnish the required report. Any failure to obey the order is punished by the court as a civil contempt is punished.
G.Every individual medical association, medical society, physician assistant professional organization, health care facility, health maintenance organization, peer review board, medical service bureau, health insurance carrier or agent, professional standards review organization, and agency of the Federal, State, or local government is immune from civil liability, whether direct or derivative, for providing information in good faith to the Board pursuant to the Act or this Part.
H.Nondisclosure agreements are prohibited insofar as they forbid parties from making reports regarding competency and/or unprofessional conduct to the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.12** Communication of Information Among Health Care Facilities {#sec-216-ricr-40-05-24-24.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.12}
A.Any licensed health care facility, acting by and through its chief executive officer or his or her designee, may upon the request of any other licensed health care facility, communicate to the chief executive officer of the requesting facility or his or her designee any and all information available regarding circumstances under which the privileges of any physician assistant were changed as described in § 24.11(C) of this Part.
B.No health care facility, chief executive officer, or his or her designee, communicating information under this section, has liability arising out of the communication, unless the person making the communication is not acting in good faith.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.13** Hospital Responsibility to Take Action Based Upon Adverse Information Received {#sec-216-ricr-40-05-24-24.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.13}
A.Whenever a hospital receives information from the board pursuant to § 24.11(C) of this Part, that indicates that the privileges of a physician assistant or other health care professional have been suspended, revoked, or limited at another hospital, the receiving hospital shall within thirty (30) days initiate a preliminary inquiry into whether the privileges of the affected physician assistant or other health care professional at the receiving hospital should be suspended, revoked, or limited, based upon review of the exercise of privileges at the receiving hospital, unless the information indicates that any adverse action with respect to privileges was administrative in character.
B.Any hospital receiving information described in § 24.13(A) of this Part may take any one (1) or more of the following courses of action in addition to the action required in § 24.13(A) of this Part, any one (1) of which discharges its responsibility under the Act to monitor the qualification and fitness of physician assistants and other health care professionals on its medical staff:
1.In any case that has been referred to the Board, to await final disposition of the Board, and to take further action that is consistent with sanctions, if any, imposed by the Board;
2.In any case in which the matter has resulted in the suspension, revocation, or restriction of privileges at any other hospital, to adopt the factual findings of the other hospital, and to impose the suspension, revocation, or restriction in privileges that the receiving hospital deems appropriate, if any, in light of these factors; or
3.In any case, to conduct a formal inquiry, in accordance with applicable procedural requirements, to determine what action, if any, should be taken with respect to the privileges of the physician assistant or other health care professional.
C.No hospital, or officer, employee, physician assistant or other health care professional associated with these is liable to any physician assistant or other health care professional for any action taken in accordance with §§ 24.12(A) and 24.13(B) of this Part when the action was made in good faith.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.14** Immunity from Liability for Gratuitous Emergency Assistance {#sec-216-ricr-40-05-24-24.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.14}
Participation in Disaster and Emergency Care. No person licensed under the provisions of the Act and this Part or members of the same profession licensed to practice in other States of the United States or members of the same profession credentialed by a Federal employer who voluntarily and gratuitously, and other than in the ordinary course of his or her employment or practice, renders emergency medical assistance during an emergency or a State or local disaster may render such care without collaboration. The immunity granted by this section does not apply to acts or omissions constituting gross, willful, wanton negligence or when the medical assistance is rendered at any hospital, physician's office, or other health care delivery entity where those services are normally rendered.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.15** Unprofessional Conduct {#sec-216-ricr-40-05-24-24.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.15}
A.Unprofessional conduct shall include but not be limited to the following items or any combination thereof:
1.Fraudulent or deceptive procuring or use of a license;
2.Representation of himself or herself as a physician;
3. Conviction of a felony;
4.Conviction of a crime arising out of the practice of medicine;
5.All advertising of medical business which is intended or has a tendency to deceive the public;
6.Abandonment of a patient;
7.The use of habit-forming drugs and/or alcohol, when such use has the effect of impairing the ability to perform licensed duties.
8.Promotion of the sale of drugs, devices appliances, or goods or services provided for a patient in such a manner as to exploit the patient for the financial gain of the physician assistant;
9.Immoral conduct of a physician assistant in the practice of medicine;
10.Willfully making and filing false reports or records;
11.Willful omission to file or record or willfully impeding or obstructing a filing or recording, or inducing another person to omit to file or record medical or other reports as required by law;
12.Agreeing with clinical or bioanalytical laboratories to accept payments from such laboratories for individual tests or test series for patients;
13.Practicing with an unlicensed physician or physician assistant or aiding or abetting such unlicensed persons in the practice of medicine;
14.Offering, undertaking or agreeing to cure or treat a disease by a secret method, procedure, treatment or medicine;
15.Professional or mental incompetence;
16.Surrender, revocation, suspension, limitation of privilege based on quality of care provided, or any other disciplinary action against a license or authorization to practice in another State or jurisdiction; or surrender, revocation, suspension, or any other disciplinary action relating to membership on any medical staff or in any medical professional association, or society while under disciplinary investigation by any of those authorities or bodies for acts or conduct similar to acts or conduct which would constitute grounds for action as set forth in the Act;
17.Surrender, revocation, suspension, limitation of privilege based on quality of care provided, or any other disciplinary action against a license or authorization to practice in another State or jurisdiction; or surrender, revocation, suspension, or any other disciplinary action relating to membership on any medical staff or in any medical professional association, or society while under disciplinary investigation by any of those authorities or bodies for acts or conduct similar to acts or conduct which would constitute grounds for action as set forth in the Act;
18.Failure to furnish the Board, the Department, investigator or representatives, information legally requested by the Board;
19.Violation of any provision(s) of the Act or this Part, or an action, stipulation, or agreement of the Board;
20.Cheating or attempting to subvert the certifying examination;
21.Violating any State or Federal law or Regulation relating to controlled substances;
22.Medical malpractice;
23.Sexual contact between a physician assistant and patient during the existence of the physician assistant/patient relationship;
24.Providing services to a person who is making a claim as a result of a personal injury, who charges or collects from the person any amount in excess of the reimbursement to the physician assistant by the insurer as a condition of providing or continuing to provide services or treatment.
25.Incompetent, negligent, or willful misconduct in the practice of medicine which includes the rendering of medically unnecessary services, and any departure from, or the failure to conform to, the minimal standards of acceptable and prevailing medical practice in his or her area of expertise as is determined by the Board including the CDC's "Guide to Infection Prevention for Outpatient Settings: minimum Expectations for Safe Care" (September 2016) incorporated by reference at § 24.2 of this Part. The Board need not establish actual injury to the patient in order to adjudge a physician assistant guilty of an unacceptable practice pursuant to § 24.15 of this Part.
26.Prescribing a controlled substance to oneself or an immediate family member under any circumstances.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.16** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-24-24.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.16}
All hearings and reviews required under the provisions of the Act and this Part shall be held in accordance with the provisions of the Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
##### **216-RICR-40-05-24 § 24.17** Severability {#sec-216-ricr-40-05-24-24.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-24#24.17}
If any provision of these Regulations or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of these Regulations which can be given effect, and to this end the provisions of these Regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-12 to 01/04/2022*
- *Technical Revision — effective from 2014-09-23 to 12/12/2021*
- *Amendment — effective from 2014-09-23 to 09/23/2014*
- *Amendment — effective from 2012-12-10 to 09/23/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-25 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/25/2006*
#### **216-RICR-40-05-25** Embalmers, Funeral Directors, and Funeral Service Establishments
##### **216-RICR-40-05-25 § 25.1** Authority {#sec-216-ricr-40-05-25-25.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-33.2-3, for the purpose of adopting prevailing standards for the licensing of embalmers, funeral directors, and funeral service establishments.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
##### **216-RICR-40-05-25 § 25.2** Incorporated Materials {#sec-216-ricr-40-05-25-25.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.2}
A.These regulations hereby adopt and incorporate the World Health Organization’s “Guidelines for Transmissible Spongiform Encephalopathies: Report of a WHO Consultation” (1999), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate 16 C.F.R. § 453 titled “Funeral Industry Practices” (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate 29 C.F.R. § 1910.1030 titled “Bloodborne Pathogens” (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
##### **216-RICR-40-05-25 § 25.3** Definitions {#sec-216-ricr-40-05-25-25.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.3}
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-33.2 entitled, "Funeral Director/Embalmer Funeral Service Establishments".
2."Alternative container" means a receptacle, other than a casket, in which human remains are transported to the crematory and placed in the cremation chamber for cremation. An alternative container shall be:
a.Composed of readily combustible materials suitable for cremation;
b.Able to be closed in order to provide a complete covering for the human remains that is resistant to leakage or spillage;
c.Rigid enough for handling with ease; and
d.Able to provide protection for the health, safety, and personal integrity of crematory personnel.
3.“Authorizing agent” means a person legally entitled to authorize the cremation of human remains.
4."Board" means the State Board of Funeral Directors/Embalmers.
5."Body parts" means limbs or other portions of the anatomy that are removed from a person or human remains for medical purposes during treatment, surgery, biopsy, autopsy, or medical research; or human bodies or any portion of bodies that have been donated to science for medical research purposes.
6.“Burial transit permit” means a permit for disposition of a dead human body as required by state legal requirements.
7."Casket" means a rigid container which is designed for the encasement of human remains and which is usually constructed of wood, metal, fiberglass, plastic, or like material, and ornamented and lined with fabric and which may or may not be combustible.
8."Cremated remains" means all remains of the cremated human body recovered after the completion of the cremation process, including pulverization which leaves only bone fragments reduced to unidentifiable dimensions, and which may possibly include the residue of any foreign matter including casket material, bridgework, or eyeglasses, that were cremated with the human remains.
9."Cremation" means a two (2) part procedure whereby a dead human body or body parts are reduced by direct flame to residue which includes bone fragments and the pulverization of said bone fragments to coarse powdery consistency.
10.“Cremation authority” means the legal entity or the authorized representative of the legal entity which is licensed by the state to operate a crematory and perform cremation.
11.“Cremation chamber” means the enclosed space within which the cremation takes place. Cremation chambers subject to this Part shall be used exclusively for the cremation of human remains.
12.“Cremation container” means a container in which human remains are transported to the crematory and placed in the cremation chamber for a cremation. A cremation container should meet substantially all of the following standards:
a.Be composed of readily combustible material suitable for cremation;
b.Be able to be closed in order to provide a complete covering for the human remains;
c.Be resistant to leakage or spillage;
d.Be rigid enough for handling with ease; and
e.Be able to provide protection for the health, safety and personal integrity of crematory personnel.
13."Department" means the Rhode Island Department of Health.
14."Director" means the Director of the Rhode Island Department of Health.
15."Domestic partner" means a person who, prior to the decedent's death, was in an exclusive, intimate and committed relationship with the decedent, and who certifies by affidavit that their relationship met the following qualifications:
a.Both partners were at least eighteen (18) years of age and were mentally competent to contract;
b.Neither partner is married to anyone else;
c.Partners were not related by blood to a degree which would prohibit marriage in the state of Rhode Island;
d.Partners resided together and had resided together for at least one (1) year at the time of death; and
e.Partners were financially interdependent as evidenced by at least two (2) of the following:
(1)Domestic partnership agreement or relationship contract;
(2)Joint mortgage or joint ownership of primary residence;
(3)Two (2) of the following:
(AA)Joint ownership of motor vehicle;
(BB)Joint checking account;
(CC)Joint credit account;
(DD)Joint lease; and/or
(4)The domestic partner had been designated as a beneficiary for the decedent's will, retirement contract or life insurance.
16."Embalmer" means any person who has completed:
a.An internship;
b.Full course of study at an accredited mortuary science school;
c.Has passed the national board examination and the practical examination administered by the Board; and
d.Is engaged in the practice or profession of embalming, as defined by this Part.
17."Embalming" means the practice, science or profession of preserving, disinfecting, and preparing in any manner, dead human bodies for burial, cremation or transportation.
18."Funeral" means a period following death in which there are religious services or other rites or ceremonies with the body of the deceased, including cremated remains, present.
19."Funeral directing" means:
a.Conducting funeral services; or
b.The arrangement for disposition of dead human bodies, except in the case of any religion where the preparation of the body or the provision of funeral services should be done according to religious custom or belief;
c.Only funeral directors/embalmers, working for a licensed funeral establishment, shall be allowed to meet with families for the purpose of arranging funerals.
d.Any person who assumed an ownership interest from one's spouse or any widow or widower of a licensed funeral director who, as of November 1, 1995, has been meeting with families to arrange for the conducting of funeral services shall be allowed to continue this practice.
20."Funeral director/embalmer" means any person engaged, or holding himself or herself out as engaged in the practice, or profession of funeral directing, and the science, practice or profession of embalming as defined by this Part, including a funeral director of record, who may be a funeral director at more than one (1) establishment or any other word or title intending to imply or designate him or her as a funeral director/embalmer, undertaker, or mortician. The holder of this license must be the holder of an embalmer's license.
21."Funeral director/embalmer intern" means any person engaged in learning the practice or profession of funeral directing and the science, practice or profession of embalming under the instruction and supervision of a funeral director/embalmer licensed and registered under the provisions of the Act, and actively engaged in the practice, or profession of funeral directing and embalming in Rhode Island.
22."Funeral establishment" means a fixed place, establishment or premises, licensed by the Department, devoted to the activities which are incident, convenient, or related to the care and preparation, arrangement, financial and otherwise, for the funeral, transportation, burial or other disposition of human dead bodies and including, but not limited to, a suitable room with all instruments and supplies used for the storage and/or preparation of dead human bodies for burial or other disposition.
23."Funeral merchandise" means those items which are normally presented for sale as part of the funeral home operation on a for-profit basis. These items include: caskets, sealed warranted outer burial containers and burial clothing. Items not included are urns, grave markers, and non-sealed outer burial containers. All persons engaged in the sale of funeral merchandise must comply with the provisions of R.I. Gen. Laws Chapter 5-33.1.
24.“Funeral planning agent” means a person who is at least eighteen (18) years of age, who has been duly and lawfully designated, and who has accepted the designation, to act for the principal, and who has authority and responsibility to make all arrangements, regarding funeral preparation, planning, the nature of the funeral goods and services to be provided, the manner in which funeral services are to be conducted, burial, and/or the disposition of the principal's remains, including cremation, upon the death of the principal. Duly and lawful designations shall include, but not be limited to, a legally binding will and, for those serving in the armed forces of the United States, a Department of Defense Record of Emergency Data (DD Form 93), or its successor. The funeral planning agent may be a relative or a non- relative of the principal, except as otherwise provided for in R.I. Gen. Laws § 5-33.3-3(d).
25.“Holding facility” means an area within or adjacent to the crematory facility designated for the retention of human remains prior to cremation that shall:
a.Comply with any applicable health law;
b.Preserve the dignity of the human remains;
c.Recognize the integrity, health and safety of the crematory authority personnel operating the crematory; and
d.Be secure from access by anyone other than authorized personnel.
26."Person" means individuals, partnerships, corporations, limited liability companies, associations and organizations of all kinds.
27."Practice of funeral service" means a person engaging in:
a.Providing shelter, care and custody of human dead remains;
b.The practice of preparing of the human dead remains by embalming or other methods for burial or other disposition;
c.Entering into a funeral service contract; and
d.Engaging in the functions of funeral directing and/or embalming, as presently known, including those stipulated in the Act, and as defined in the Federal Trade Commission's "funeral rule" incorporated by reference above at § 25.2(A) of this Part.
28.“Niche” means a compartment or cubicle for the memorialization or permanent placement of a temporary container or urn containing cremated remains.
29.“OSHA” means the federal Occupational Safety and Health Administration.
30.“Processing” means the reduction of identifiable bone fragments after the completion of the cremation process to unidentifiable bone fragments by manual means.
31.“Pulverization” means the reduction of identifiable bone fragments after the completion of the cremation and processing to granulated particles by manual or mechanical means.
32.“Rental casket” means a casket that may be re-used in accordance with this Part.
33.“Temporary container” means a temporary container that is a receptacle for cremated remains usually made of cardboard, plastic, or similar material designed to hold the cremated remains until an urn or other permanent container is acquired.
34.“Urn” means a receptacle designed to permanently encase the cremated remains.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
##### **216-RICR-40-05-25 § 25.4** Licensing Procedures {#sec-216-ricr-40-05-25-25.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.4}
25.4.1Qualifications of Funeral Directors/Embalmers
A.Requirements for Licensure
1.A funeral director/embalmer’s license shall be issued only to an individual. No corporation, partnership, association, limited liability company or organization shall be entitled to obtain such a license.
B.Qualifications for Licensure
1.In order to qualify for a funeral director/embalmer's license, the applicant must meet the requirements set forth in R.I. Gen. Laws § 5-33.2-6.
C.Licensure By Endorsement
1.Any funeral director/embalmer who is currently licensed in good standing in another state may be licensed by endorsement in Rhode Island.
2.Every funeral director/embalmer seeking such licensure by endorsement shall meet all of the requirements in § 25.4.1(B) of this Part with the exception of completion of a registered funeral director/embalmer internship.
3.Anyone licensed in another state prior to 1985 is hereby exempt from the National Board Examination requirements set forth in § 25.4.1(B) of this Part.
D.Armed Forces Embalming Experience
1.Any person who has served in the armed forces of the United States may provide proof of embalming experience to the Department in accordance with the provisions set forth in R.I. Gen. Laws § 5-33.2-7.
E.Unlicensed Practice: Unlicensed practice is prohibited in accordance with the provisions set forth in R.I. Gen. Laws § 5-33.2-4.
25.4.2Burial Certificate Plan
Participation in burial certificate plans is in accordance with the provisions set forth in R.I. Gen. Laws § 5-33.2-8.
25.4.3Cemetery Operations
Ineligibility of cemetery operators to conduct the business of funeral directing is pursuant to R.I. Gen. Laws § 5-33.2-9.
25.4.4Application and Renewal of License
A.Any person who desires to engage in embalming or funeral directing, or both, shall submit in writing to the Department, an application for a license together with the license fee set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Expiration & Renewal of Licenses
1.All licenses issued under the provisions of the Act and this Part shall be renewed annually. All licenses shall expire on the thirty-first (31st) day of December each year, unless previously suspended or revoked.
C.Each licensee shall pay to the Department a yearly renewal fee as set forth in in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for the renewal of the funeral director/ embalmer's license.
1.Applications, accompanied by the renewal fee, shall be filed with the Department on or before the thirty-first (31st) day of December in each year.
a.Renewal applications filed after the thirty-first (31st) day of December, must be accompanied by a late fee as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) in addition to the renewal fee.
2.Any funeral director/embalmer who acts or holds himself/herself out as such after his/her license has lapsed shall be subject to penalties as provided in this Part.
D.Continuing Education Requirements
1.Every funeral director/embalmer shall be required to participate in a total of five (5) hours annually of continuing education training of which three (3) hours are mandated by annual OSHA training.
a.Funeral directors/embalmers who were sixty-five (65) years of age or older and had forty (40) years of experience as of January 1, 2008 are exempt from these continuing education requirements.
2.On application for renewal of license, a funeral director/embalmer shall attest to completion of five (5) hours annually in scope of practice-specific offerings that may include, but not be limited to: formal presentations, conferences, and/or self-study courses, such on-line courses. Such programs or offerings shall be approved or sponsored by a Board-approved organization.
3.Two (2) of the five (5) hours of continuing education may be selected from programs or offerings sponsored or approved by the following organizations that are deemed to be approved by the Board:
a.Rhode Island Funeral Directors Association (RIFDA);
b.National Conference for Funeral Board Examiners;
c.Academy of Professional Funeral Service Practice (APFSP); or
d.Others as may be approved by the Board.
4.It shall be the sole responsibility of the funeral director/embalmer to obtain documentation (e.g., course descriptions, proof of attendance) from the sponsoring organization, agency, or institution of his/her participation in a continuing education program and/or activity. These documents shall be retained by each licensee for no less than two (2) years and are subject to random audit by the Department.
5.A licensee who fails to complete the continuing education requirements described in this Part may be subject to disciplinary action pursuant to R.I. Gen. Laws § 5-33.2-17.
6.A license may be denied to any applicant who fails to provide satisfactory evidence of completion of continuing education relevant to the practice of a funeral director/embalmer as required by this Part.
7.A funeral director/embalmer initially licensed by examination after the December 31st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., January 1st of the next year).
8.An extension of time to complete the continuing education requirements may be granted to a funeral director/embalmer solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
E.Display of Licenses
1.Every license issued as a funeral director/embalmer shall specify the name of the person to whom it was issued. It shall be displayed conspicuously in his/her place of business or employment and it shall not be transferable.
25.4.5Funeral Director/Embalmer Internship
A.Interns must register with the Department before an internship shall begin. The provisions of internship are in accordance with R.I. Gen. Laws § 5-33.2-16.
B.In addition to the internship provisions of R.I. Gen. Laws § 5-33.2-16, the following is required:
1.Prior to a practical state licensing embalming examination being administered by members of the Board in consultation with the funeral director/embalmer preceptor, a written consent to perform the state licensing embalming examination shall be obtained by the funeral director/embalmer preceptor from the decedent's next-of-kin or other person legally charged with the disposition of the human remains.
2.A quarterly report shall be submitted to the Department summarizing the number of human remains embalmed by the intern during the most recent three (3) month period.
C.The term of internship may be served before, after, or during attendance at mortuary school, at the option of the intern and the preceptor.
D.The number of interns that a licensed funeral establishment is allowed to register and stipulations for embalming during the internship is set forth in R.I. Gen. Laws § 5-33.2-16(b).
E.If more than one (1) intern is completing an internship with a funeral director/embalmer preceptor in accordance with R.I. Gen. Laws § 5-33.2-16(b), each intern shall be responsible for embalming no less than fifty (50) human remains; further, each set of human remains shall only be counted once towards the required total for each intern.
F.Supervision of Interns
1.While an embalmer intern is working in the preparation room at a funeral service establishment, the funeral director/embalmer preceptor shall remain on-site in the preparation room at all times.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
##### **216-RICR-40-05-25 § 25.5** Licensing Procedures for Funeral Establishments {#sec-216-ricr-40-05-25-25.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.5}
25.5.1License Requirements
License requirements for funeral establishments and branch office(s) license requirements are in accordance with the provisions set forth in R.I. Gen. Laws § 5-33.2-12.
25.5.2License Application and Fees
Applications for the funeral establishment license and branch office shall be made on forms furnished by the Department and shall be accompanied by the license fee as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
25.5.3License Renewals
A.All licenses issued under the provisions of the Act and this Part must be renewed annually. The license holder shall pay a yearly renewal fee to the Department for the funeral establishment license and for each funeral establishment branch office license as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.All funeral establishment and branch office licenses shall expire on the thirty-first (31st) of December of each year, unless sooner suspended or revoked.
C.Applications, accompanied by the renewal fee, shall be filed with the Department on or before the thirty-first (31st) day of December in each year.
1.Applications filed after the thirty-first (31st) day of December must be accompanied by a late fee as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) in addition to the renewal fee.
D.Any funeral establishment or funeral establishment branch office that acts or holds itself out as such after its license has lapsed shall be subject to penalties as provided by the Act and this Part.
25.5.4Display of Licenses
A.Every license issued as a funeral establishment or branch office shall specify the name of the establishment as listed on the application. Licenses issued under the provisions of this Part shall not be assignable.
B.Every funeral service establishment shall display the name of the establishment and of the funeral director of record on a sign readily visible to the public and located prominently on the premises.
25.5.5Change of Ownership, Operation or Location
A.A license shall be issued to a specific licensee for a specific location and shall not be transferable.
B.The funeral establishment licensee shall notify the Department in writing, delivered in person or by certified mail, within ten (10) days from the date of termination of employment, for any cause, of the funeral director/embalmer of record for the funeral establishment.
1.The license of the funeral establishment shall expire forty-five (45) days from the date the Department was notified by the licensee, if no new funeral director/ embalmer is registered with the Department.
2.No funeral services shall be conducted at the funeral establishment without a funeral director/embalmer being registered with the Department as the funeral director of record for that funeral establishment.
C.Two (2) licensed funeral directors may operate jointly at one (1) location if one of their existing funeral establishments closes its place of business and joins an existing licensed funeral establishment. Each firm will hold its own separate establishment license. The funeral service establishment that closes its place of business and joins an existing licensed funeral service establishment cannot open a branch office by invoking this section.
D.Operation of an inherited funeral establishment is pursuant to R.I. Gen. Laws § 5-33.2-12(b).
25.5.6General Operational Requirements
A.The practice of conducting funeral services shall be conducted in the presence of a licensed funeral director/embalmer.
B.Human dead remains shall not be held more than forty-eight (48) hours without embalming or without refrigeration for the purpose of maintaining public health.
C.A funeral establishment must, at a minimum, contain a preparation room equipped with tile, cement, or composition floor, necessary drainage and ventilation, and containing necessary instruments and supplies for the preparation and embalming of dead human remains for burial, transportation, or other disposition.
D.Medical Waste
1.Funeral establishments and branch offices shall be in compliance with applicable sections of R.I. Gen. Laws Chapter 23-19.12 and the Rhode Island Department of Environmental Management’s Medical Waste Regulations (250-RICR-140-15-1).
E.Casket Rentals
1.When caskets are made available for rental on a temporary basis, the casket may later be re-used as long as the following provisions are met:
a.Said caskets shall be manufactured specifically for multi-use purposes and shall be equipped with a removable liner or insert. No casket manufactured for a single use shall be used more than once;
b.The removable liner or insert shall be completely removed and replaced with a new liner or insert after each use;
c.No such casket shall be used or re-used after any non-removable portion of that casket has been soiled, stained, or otherwise contaminated by or from any human remains placed therein, or has been placed within a rental casket insert;
d.The customer who rents or re-uses that casket shall be informed in writing, that the casket may have been used previously and that it will be reclaimed by the funeral establishment from which he or she has rented or obtained it immediately prior to the final disposition of the deceased; and
e.Funeral directors/embalmers shall obtain written authorization from the next-of-kin, or other responsible party, attesting to the fact that the funeral merchandise provided has been previously used in whole or in part. The customer who rents or re-uses that casket shall also sign a written disclosure that he or she has received all of the above information in writing and that he or she authorizes the funeral establishment to use the removable liner or insert selected by him or her for the disposition of the deceased.
F.Infection Control
1.Funeral directors/embalmers shall comply with the Occupational Safety and Health Administration's (OSHA) Blood borne Pathogen Standards incorporated by reference above at § 25.2(C) of this Part in order to protect themselves and their employees against occupational exposure to bloodborne pathogens.
a.Compliance shall include, but not be limited to:
(1)A written exposure control plan;
(2)Staff training;
(3)Engineering and work practice controls;
(4)Adoption of universal precautions;
(5)Personal protective equipment;
(6)Hepatitis B vaccinations; and
(7)A protocol for evaluation in the event that an exposure occurs.
2.Funeral directors/embalmers shall comply with the most recent version of the World Health Organization’s Infection Control Guidelines for Transmissible Spongiform Encephalopathies incorporated by reference above at § 25.2(A) of this Part in order to protect themselves and their employees from occupational exposure to blood borne pathogens.
G.Permits
1.Requirements for permits are pursuant to R.I. Gen. Laws § 23-3-18.
2.Fetal death registration requirements are pursuant to R.I. Gen. Laws § 23-3-17.
H.Transport of Human Remains
1.Human remains to be transported by common carrier shall be embalmed. If embalming is not possible, or if the body is in a state of decomposition, it shall be transported only after enclosure in a strong, sealed outer case, to prevent seepage of body fluids to the outside.
I.Proper Authority for Funeral Arrangements and Disposition of Human Remains
1.Every licensed funeral director/embalmer, licensed funeral establishment, licensed crematory, and cemetery shall comply with the rules with respect to proper authority for funeral arrangements and disposition of human remains in accordance with the provisions set forth in R.I. Gen. Laws § 5-33.2-24. In addition to these provisions:
a.Duly and lawful designations shall include, but not be limited to, a legally binding will and, for those serving in the armed forces of the United States, a Department of Defense Record of Emergency Data (DD Form 93), or its successor.
J.Latex
1.Any licensed funeral directors/embalmers, funeral establishments, or cemeteries that utilize latex gloves shall do so in accordance with the provisions of the rules and regulations pertaining to Use of Latex Gloves by Health Care Workers in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
K.Inspections
1.Any licensed funeral director/embalmer employed by the Department duly authorized and empowered may enter any funeral establishment, funeral establishment or branch office licensed under the provisions of this Part, during the hours the funeral establishment or funeral establishment branch office shall be open for business, for the purpose of inspecting the sanitary conditions, complaint investigations, and ascertaining if the provisions of this Part are being observed in the operation of the funeral establishment or funeral establishment branch office.
2.Funeral establishments and branch offices licensed under the provisions of this Part shall be inspected at least once per year. Pre-need contracts shall be audited at least once per year.
3.Inspections shall include all areas of sanitation and public health, complaint investigations, as well as conformity with applicable sections of the Act, and this Part.
4.The inspector may request permission from the Department to be accompanied by another employee of the Department prior to an inspection. Failure or refusal of the person in charge of that funeral establishment or funeral establishment branch office to permit such inspection at all reasonable times shall be deemed sufficient cause for the revocation of any license issued to the funeral establishment or funeral establishment branch office and any certificate of approval issued by the Department.
25.5.7Prohibition on Payments for Securing Business
Every funeral establishment, funeral director/embalmer, or the agent or representatives thereof, who violates the provisions of R.I. Gen. Laws § 5-33.2-14 shall be subject to the penalties as provided in the Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
##### **216-RICR-40-05-25 § 25.6** Licensing for Crematories {#sec-216-ricr-40-05-25-25.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.6}
25.6.1Licensure Application and Fees
A.No person or business shall erect, maintain, or operate a crematory in Rhode Island without first providing the necessary appliances and facilities for the cremation of human remains and without obtaining all the necessary licenses as required by this Part.
B.A crematory authority shall be subject to all local, state and federal health and environmental protection requirements and shall obtain all necessary licenses and permits from the Department, the federal Department of Health and Human Services, the U.S. Environmental Protection Agency, the Rhode Island Department of Environmental Management, or such other appropriate local, state and federal agencies.
C.A crematory may be constructed on or adjacent to any cemetery, in, or adjacent to any funeral home or at any other location consistent with local zoning regulations and state laws.
D.Applications for the crematory license shall be made on forms furnished by the Department accompanied by a non-refundable application fee as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) and copies of all necessary local, state and federal permits and licenses.
E.A license shall be issued to a specific licensee for a specific location and shall not be transferable.
F.The facility and licensee shall meet all requirements as set forth by this Part, consistent with the Act.
25.6.2Renewal of Licenses
A.All licenses issued under the provisions of this Part must be renewed annually by the holders who shall pay to the Department a yearly renewal fee as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for the crematory license.
B.Applications, accompanied by the renewal fee, shall be filed with the Department on or before the 31st day of December in each year.
1.Applications filed after the 31st day of December must be accompanied by a late fee as set forth in the Fee Structure for Licensing, Laboratories and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) in addition to the renewal fee cited in § 25.5.3(A) of this Part.
C.Any crematory that acts or holds itself out as such after its license has lapsed shall be punished as provided by this Part.
25.6.3Inspections
A.Any licensed funeral director/embalmer employed by the Department duly authorized and empowered may enter any crematory licensed under the provisions of this Part, during the hours the crematory shall be open for business, for the purpose of inspecting the sanitary conditions, complaint investigations, and ascertaining if the provisions of this Part are being observed in the operation of the crematory.
B.The inspector may request permission from the Department to be accompanied by another Departmental employee prior to an inspection. Failure or refusal of the person in charge of that crematory to permit such inspection at all reasonable times shall be deemed sufficient cause for the revocation of any license issued to the crematory.
C.Crematories licensed under the provisions of this Part shall be inspected at least once (1) each year.
D.Inspections shall include all areas of sanitation and public health, complaint investigations, as well as conformity with applicable sections of this Part.
25.6.4General Operational Requirements
A.Practice of Cremation
1.The practice of cremation shall include no less than the following provisions:
a.The body of a deceased person shall not be cremated within twenty-four (24) hours after his/her death unless he/she dies of a contagious or infectious disease.
b.The body shall not be received or cremated by any corporation authorized to cremate the bodies of the dead until its officers have received:
(1)A cremation authorization form signed by the authorizing agent, whose right to authorize the cremation was established in accordance with the Act. The cremation authorization form shall contain, at a minimum, the following information:
(AA)The identity of the human remains to be cremated and the time and date of death;
(BB)The name of the funeral establishment that obtained the cremation authorization;
(CC)Notification as to whether the death occurred from a disease declared by the Department to be infectious, contagious, communicable or dangerous to the public health;
(DD)The name and address of the authorizing agent and the relationship between the authorizing agent and the decedent;
(EE)A representation that the authorizing agent does in fact have the right to authorize the cremation, and that the authorizing agent in not aware of any living person who has a superior priority right to that of the authorizing agent. In the event that there is another living person who has an equal priority right to the authorizing agent the form shall contain a representation that the authorizing agent has made reasonable efforts to contact that person, has been unable to do so and has no reason to believe that the person would object to the cremation of the decedent.
(FF)Authorization for the crematory to cremate the human remains;
(GG)A representation that the human remains do not contain a pacemaker or any other material or implant that may be potentially hazardous or cause damage to the cremation chamber or the person performing the cremation;
(HH)The name of the person, or the name of the funeral establishment, authorized to receive the cremated remains from the crematory;
(II)The manner in which final disposition of the cremated remains is to take place, if known;
(JJ)The signature of the authorizing agent attesting to the accuracy of all representations contained on the cremation authorization form;
(KK)If authorization was given as part of a previously executed pre-need funeral contract, then the crematory must receive a copy of that form in accordance with the Act.
(2)A completed and executed burial transit permit required by law before disposition is made indicating that the human remains named on the permit are to be cremated, and
(3)A cremation certificate issued by the Rhode Island Office of the State Medical Examiner. A cremation certificate shall be issued only if the Office of the State Medical Examiner determines that the cause and manner of death is such that no further examination or judicial inquiry concerning the same is necessary.
(4)The cremation certificate issued to the funeral director by the Medical Examiner, in duplicate, shall accompany the body to the crematory. The crematory shall retain the duplicate copy and mail the original copy to the state Division of Vital Records.
c.A crematory shall not take custody of unidentified human remains. The identity of the decedent contained within each cremation container or casket must clearly be indicated on, or labeled attached to, the outside of the container or casket.
2.Every crematory shall establish an internal system of identification of human remains received for cremation. This system shall be designed to track the identity of the remains from the time of receipt until completion of the cremation and delivery of the cremated remains to the authorized person(s) or until otherwise disposed of in accordance with the instructions from the authorized agent(s) or in accordance with this Part once the cremated remains have been abandoned.
3.Human remains designated for cremation shall be cremated without unreasonable delay.
4.When the crematory is unable to cremate the human remains immediately upon taking custody, the crematory shall provide a secured holding facility that shall comply with any applicable public health laws that shall preserve the dignity of the human remains.
5.Holding facilities shall be secure from access by all unauthorized persons.
6.A metal, indestructible identifying disk shall be placed in, or near the control panel of, the cremation chamber with the human remains for the purpose of identifying said remains. The name of the crematory or its license number shall be imprinted on said disk.
7.The crematory shall not simultaneously cremate more than one (1) human remains within the same cremation chamber.
a.Upon completion of each cremation, the human remains shall be removed and the retort shall be cleaned and all recoverable residue of the cremation process shall be removed from the retort before each successive set of human remains are inserted.
8.In cases where the human remains are to be cremated, the funeral director/embalmer shall remove a pacemaker or other medical device(s) from the remains and transmit said device(s) to the next-of-kin or other responsible party.
9.In all cases where the human remains are to be cremated, the next-of-kin or other responsible party shall sign a written consent personally identifying the body prior to cremation. If this is not possible, the funeral director/embalmer shall obtain a written consent from the next-of-kin, or other responsible party, assuming all responsibility for the identification of the human remains.
10.A crematory authority shall not accept a casket or alternative container from which there is any evidence of the leakage of body fluids.
11.Except as provided for in § 25.6.4(A)(13) of this Part, no crematory shall make or enforce any rules requiring that human remains be placed in a casket before cremation or that human remains be cremated in a casket, nor shall the crematory refuse to accept human remains for cremation for the reason that they are not in a casket.
12.Human remains shall be transferred to a crematory in a casket or cremation container.
13.Human remains shall not be removed from the casket or cremation container and the casket or cremation container shall be cremated with the human remains, unless the crematory authority has been provided with written instructions to the contrary by the authorizing agent or unless the crematory does not accept metal caskets for cremation.
14.Upon completion of the cremation, and in so far as possible, all of the recoverable residue of the cremation process shall be removed from the cremation chamber. In so far as possible, all residue from the cremation process shall then be separate from anything other than bone fragments. The bone fragments shall be processed so as to reduce them to unidentifiable particles. Anything other than the particles shall be removed from the cremated residuals as far as possible and shall be disposed of by the crematory.
15.Cremated remains, including the proper identification tag, shall be placed within a temporary container or urn as instructed by the authorizing agent(s). When a temporary container is used the outside of the container shall be clearly identified with the name of the deceased person whose cremated remains are contained therein, the name of the crematory and the crematory’s identification number for those cremated remains. When an urn is used, the urn shall be placed in a suitable box, or cloth bag, and the outside of the box or bag shall be clearly identified with the name of the deceased person whose cremated remains are contained therein, the name of the crematory and the crematory’s identification number for those cremated remains.
16.If the cremated remains are to be shipped, or mailed, the designated receptacle ordered by the authorizing agent shall be packed securely in a suitable, sturdy and pressure resistant container which is not fragile and is sealed properly. Cremated remains shall be shipped, or mailed, only by a method which has an internal tracing system available and which provides a receipt signed by the person accepting delivery.
17.Each crematory shall maintain on its premises, or other business location within the state, an accurate record of all cremation performed. This record, or log, shall include all of the following information:
a.The name of the deceased;
b.The date the body was received by the crematory;
c.The crematory’s identification number assigned to the cremation;
d.The name of the referring funeral home;
e.The time, date and temperature at which the body was inserted into the cremation chamber;
f.The time, date and temperature the body was removed from the cremation chamber; and
g.The name of the individual who supervised the cremation.
18.When the crematory releases the cremated remains, a receipt shall be signed by the individual who is receiving the cremated remains from the crematory.
19.Crematory authorities shall abide by all applicable state and federal laws and regulations.
B.Disposition of Human Remains
1.A crematory or funeral home shall be authorized to arrange for disposition of cremated remains, in a dignified manner, that have been abandoned at the crematory or funeral home for more than six (6) months.
a.All reasonable attempts must be made and due diligence exercised to contact the person in charge who authorized the cremation. Written notice shall be sent by certified mail, return receipt requested, to the last known address of the person who authorized the cremation at least sixty (60) days prior to disposition.
b.Records shall be maintained to indicate the disposition of the human remains after cremation.
2.This section shall not apply to the cremation of various body parts from different human bodies.
C.Medical Waste
1.The facility shall be in compliance with applicable sections of R.I. Gen. Laws Chapter 23-19.12, and the Rhode Island Department of Environmental Management’s Medical Waste Regulations (250-RICR-140-15-1).
D.Latex
1.Any crematory that utilizes latex gloves shall do so in accordance with the provisions of the rules and regulations pertaining to Use of Latex Gloves by Health Care Workers in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
##### **216-RICR-40-05-25 § 25.7** Denial, Suspension, Revocation and Severability {#sec-216-ricr-40-05-25-25.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-25#25.7}
25.7.1Revocations or Suspensions
A.The Department shall have the power to refuse to issue or may revoke or suspend any license issued by it under this Part, after written notification and hearing before the Board for gross incompetency or for unprofessional conduct as defined in R.I. Gen. Laws § 5-33.2-17.
B.Each funeral director/embalmer of record shall, on or before the tenth (10th) day of the following month, file a report with the state registrar of vital records listing funerals and/or decedents serviced following deaths or fetal deaths within the month. (This report is to be filed even if there is no activity within the month to report). Failure to file these reports or any of the certificates required under R.I. Gen. Laws § 23-3-16 within the prescribed time limits shall be grounds for disciplinary action, including revocation of license by the Board.
C.Before any license shall be so revoked or suspended, the holder thereof shall have notice in writing of the charge or charges against him/her and shall have reasonable opportunity to be heard in his/her defense.
D.Any person whose license has been so revoked or suspended may apply to have the certificate reissued, and the certificate shall be reissued to him/her upon a satisfactory showing that disqualification has ceased.
E.Appeals
1.All hearings and reviews required under the provisions of the Act shall be held in accordance with rules and regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
F.Violations and Penalties are pursuant to R.I. Gen. Laws § 5-33.2-21.
25.7.2Variance Procedure
A.The Department may grant a variance upon request of the licensee from the provisions of any rules and regulations of this Part, if it finds in specific cases, that a literal enforcement of such provision will result in unnecessary hardship to the licensee and that such a variance will not be contrary to the public interest.
B.A request for a variance shall be filed by a licensee in writing, setting forth in detail the basis upon which the request is made.
1.Upon filing of each request for variance with the Department and within a reasonable time thereafter, the Department shall notify the licensee by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the licensee appeals the denial. Such hearing must be held in accordance with the provisions of § 25.7.1(E) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2014-12-18 to 08/29/2018*
- *Amendment — effective from 2013-07-09 to 12/18/2014*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-06-23 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 06/23/2008*
- *Amendment — effective from 2004-01-13 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/13/2004*
#### **216-RICR-40-05-26** Registration of Music Therapists
##### **216-RICR-40-05-26 § 26.1** Authority and Purpose {#sec-216-ricr-40-05-26-26.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.1}
These Rules and Regulations for Registration of Music Therapists are promulgated pursuant to the authority set forth in R.I. Gen. Laws Chapter 23-20.8.1-6, for the purpose of defining prevailing standards for the registration of music therapists.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.2** Incorporated Materials {#sec-216-ricr-40-05-26-26.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.2}
A.These regulations hereby adopt and incorporate the Certification Board for Music Therapists (CBMT) "Code of Professional Practice" (2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the American Music Therapy Association (AMTA) and the Certification Board for Music Therapists (CBMT) "Scope of Music Therapy Practice" (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.3** Definitions {#sec-216-ricr-40-05-26-26.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.3}
A.Whenever used in these Regulations, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-20.8.1 entitled “Registration of Music Therapists."
2."Board certified music therapist" means an individual who has completed the education and clinical training requirements established by the American Music Therapy Association; has passed the Certification Board for Music Therapists certification examination; or transitioned into board certification, and remains actively certified by the Certification Board for Music Therapists.
3.“Department” means the Rhode Island Department of Health.
4."Director" means the means the Director of the Rhode Island Department of Health or his or her designee.
5."Music therapist" means a person registered to practice music therapy pursuant to the Act and these Regulations
6."Music therapy" means the clinical and evidence based use of music interventions to accomplish individualized goals within a therapeutic relationship through an individualized music therapy treatment plan for the client that identifies the goals, objectives, and potential strategies of the music therapy services appropriate for the client using music therapy interventions, which may include music improvisation, receptive music listening, song writing, lyric discussion, music and imagery, music performance, learning through music, and movement to music. Music therapy is a distinct and separate profession from other licensed, certified, or regulated professions, including speech-language pathology. The practice of music therapy does not include the diagnosis of any physical, mental, or communication disorder. The term music therapy may include the services defined in R.I. Gen Laws § 23-20.8.1-1(3).
7."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
8.“Supervision” means that a registered music therapist is at all times responsible for supportive personnel and clients. Supervision is further defined in § 26.4(C) of this Part.
9.“These Regulations” mean all parts of Rhode Island Rules and Regulations for Registration of Music Therapists.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.4** General Registration Requirements {#sec-216-ricr-40-05-26-26.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.4}
A.Registration Required. After January 1, 2015, the practice of music therapy is subject to the registration provision in R.I. Gen. Laws § 23-20.8.1-2
B.Exemptions. Exemptions to the requirements of the Act and these Regulations are pursuant to R.I. Gen. Laws § 23-20.8.1-2.
C.Supervision.
1.A registered music therapist is permitted to supervise the following:
a.Registered music therapists;
b.Music therapy interns and students;
c.Care extenders and other team members as appropriate; and
d.Volunteers.
2.A registered music therapist cannot delegate any of the following tasks to individuals under their supervision, who are not registered music therapists:
a.Initiation, planning, adjustment, modification, or performance of music therapy procedures requiring the skills or judgment of a registered music therapist;
b.Acting on behalf of a registered music therapist in any matter related to music therapy which requires decision making or professional judgment.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.5** Qualification for Registration {#sec-216-ricr-40-05-26-26.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.5}
Applicants for registration as a music therapist must meet the requirements of R.I. Gen. Laws § 23-20.8.1-3.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.6** Application for Registration and Fee {#sec-216-ricr-40-05-26-26.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.6}
A.Application for Registration. In order to apply for registration an applicant must submit the following on forms furnished by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address;
2.Application fee as defined in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The fee is non-refundable and non-returnable;
3.Verification of current board certification as a Music Therapist submitted directly to the Department by the Certification Board for Music Therapists;
B.Application for Registration by Endorsement. In order to apply for registration by endorsement an applicant must submit the following on forms furnished by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address;
2.Application fee as defined in rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The fee is non-refundable and non-returnable;
3.Verification of current board certification as a Music Therapist submitted directly to the Department by the Certification Board for Music Therapists;
4.Verification that the applicant is registered and in good standing as a music therapist in all states where the applicant has a current registration as a music therapist and all states where the applicant was previously registered as a music therapist.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.7** Registration {#sec-216-ricr-40-05-26-26.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.7}
Issuance of Registration. A registration as music therapist may be issued to an applicant who meets the relevant requirements for registration as required by the Act and these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.8** Expiration & Renewal of Registrations and Failure to Renew {#sec-216-ricr-40-05-26-26.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.8}
A.Expiration. The registration of every person registered in accordance with the requirements of the Act and these Regulations will expire on the thirty-first (31st) day of January of the next odd-numbered year following the issuance of his or her registration.
B.Renewal. In order to renew a registration the registrant must file a renewal application with the Department together with a renewal fee as defined in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) on or before the thirty-first (31st) day of January in each odd-numbered year. The renewal registration is effective on the first (1st) day of February and expires on the thirty-first (31st) day of January in each odd-numbered year.
C.Failure to Renew.
1.A registration that has not been renewed on or before the thirty-first (31st) day of January in each odd-numbered year, is subject to the provisions of R.I. Gen. Laws § 23-20.8.1-4.
2.In order to restore a forfeited registration the registrant must submit the following to the Department:
a.A renewal application together with the current renewal fee, plus an additional fee as defined in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The fees are non-refundable and non-returnable.
3.In order to reinstate a terminated registration the registrant must submit the following to the Department:
a.A reinstatement application together with the current renewal fee, plus an additional fee as defined in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The fees are non-refundable and non-returnable.
b.Verification of current board certification as a Music Therapist submitted directly to the Department by the Certification Board of Music Therapists.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.9** Maintenance of National Certification {#sec-216-ricr-40-05-26-26.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.9}
A.Renewal Certification. Each renewal application shall contain a statement signed by the registrant attesting to his or her status as a board certified music therapist, as required pursuant to R.I. Gen. Laws § 23-20.8.1-4(a), is active and not subject to any restriction, limitation or other sanction.
B.Required Notification to the Department
1.An individual registered pursuant to these Regulations shall notify the Department, in writing, within five (5) business days of receiving notification from the Certification Board for Music Therapists that his or her status as a board certified music therapist has been revoked and/or subject to any restriction, limitation or other sanction.
2.An individual registered pursuant to these Regulations shall notify the Department, in writing, within five (5) business days of failure to renew or other lapse of his or her status as a board certified music therapist.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.10** Standards for Responsible Professional Conduct {#sec-216-ricr-40-05-26-26.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.10}
A.A registered music therapist must conduct his or her professional activities in accordance with the "CBMT Code of Professional Practice", incorporated above in § 26.2(A) of this Part.
B.A registered music therapist shall practice in accordance with the AMTA and CBMT "Scope of Music Therapy Practice", incorporated above in § 26.2(B) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.11** Denial, Suspension or Revocation of Registration - Violations {#sec-216-ricr-40-05-26-26.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.11}
A.Due Process. Upon due notice and hearing in accordance with R.I. Gen. Laws Chapter 42-35, and the provisions of § 26.12 of this Part, any violation pursuant to the provisions of the Act and these Regulations, may be cause for denial, revocation or suspension of registration or for imposing such other penalties in accordance with the Act.
B.Grounds for Discipline without a Hearing. In accordance with R.I. Gen. Laws § 42-35-14(c), the Director may temporarily suspend the registration of a registered music therapist without a hearing if the Director finds that evidence in his or her possession indicates that a registered music therapist continuing in practice would constitute an immediate danger to the public. In the event that the Director temporarily suspends the registration of a registered music therapist without a hearing, a hearing must be held within ten (10) days after the suspension has occurred.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
##### **216-RICR-40-05-26 § 26.12** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-26-26.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-26#26.12}
All hearings and reviews required pursuant to provisions of the Act and these Regulations shall be held in accordance with the provisions of the Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-03-05 to 04/30/2018*
#### **216-RICR-40-05-27** Licensing of Lactation Consultants
##### **216-RICR-40-05-27 § 27.1** Authority and Purpose {#sec-216-ricr-40-05-27-27.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.1}
A.These Rules and Regulations for Licensing of Lactation Consultants and Counselors are promulgated pursuant to the authority set forth in R.I. Gen. Laws §§ 23-13.6-3 and 23-13.8-12 for the purpose of defining prevailing standards for the licensing of Lactation Consultants and Counselors.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.2** Incorporated Materials {#sec-216-ricr-40-05-27-27.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.2}
A.These Regulations hereby adopt and incorporate the International Board of Lactation Consultant Examiners' "Scope of Practice for International Board Certified Lactation Consultant (IBCLC) Certificants" (2018) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the International Board of Lactation Consultant Examiners' "Code of Professional Conduct for IBCLCs" (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the Academy of Lactation Policy and Practice "Scope of Practice for the Certified Lactation Counselor (CLC)" (2024) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate the Academy of Lactation Policy and Practice "Scope of Practice for the Advanced Lactation Consultant (ALC), Advanced Nurse Lactation Consultant (ANLC)" (2024) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
E.These Regulations hereby adopt and incorporate the Academy of Lactation Policy and Practice “Code of Ethics for Certified Lactation Counselors (CLC)” (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
F.These Regulations hereby adopt and incorporate the Academy of Lactation Policy and Practice “Code of Ethics for Advanced Lactation Consultants (ALC) and Advanced Nurse Lactation Consultants (ANLC)” (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
G.These Regulations hereby adopt and incorporate “Advisory Opinion: Assessment, Diagnosis, and Referral” approved by the IBLCE Board of Directors on 22 March 2017 by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.3** Definitions {#sec-216-ricr-40-05-27-27.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.3}
A.Wherever used in these Regulations, the following terms shall be construed as follows:
1."Care extender" means as defined in R.I. Gen. Laws § 23-13.8-2(1).
2.“Department” means the Rhode Island Department of Health.
3."Director" means the means the Director of the Rhode Island Department of Health or their designee.
4.“Growth Faltering (Failure to thrive)” means a diagnosis of a calculated z score for children with weight, weight for length, or body mass index less than the fifth (5th) percentile or if any of these measurements decrease by more than two (2) percentile lines over time.
5."International Board Certified Lactation Consultant (IBCLC)" means an individual who holds current certification from the International Board of Lactation Consultant Examiners (IBLCE) after demonstrating the appropriate education, knowledge and sitting for and passing the exam.
6."Lactation care and services" means the clinical application of scientific principles and a multidisciplinary body of evidence for the evaluation, problem identification, treatment, education, and consultation to provide lactation care and services to childbearing families.
7."Lactation consultant" means as defined in R.I. Gen. Laws § 23-13.6-2(1). In addition to the language in R.I. Gen. Laws § 23-13.6-2(1), a lactation consultant specializes in the full range of breastfeeding care, particularly high acuity breastfeeding situations. This includes medically complex cases encompassing breastfeeding in preterm birth, birth defects, and parental health complications.
8."Lactation counselor" means as defined in R.I. Gen. Laws § 23-13.8-2(4). In addition to the language in R.I. Gen. Laws § 23-13.8-2(4), a lactation counselor specializes in non-medically complex breastfeeding in healthy term infants and parental health assessment. For the purposes of this Part, reference to a “Lactation Counselor” includes both Lactation Counselors with a CLC certification and Lactation Counselors with an ALC certification.
9.“Medically complex” means children with medical complexity (CMC), who may also be known as “complex chronic” or “medically complex,” have multiple significant chronic health problems that affect multiple organ systems and result in functional limitations, high health care need or utilization, and often the need for or use of medical technology.
10.“Practice" means as defined in R.I. Gen. Laws § 23-13.8-2(5).
11."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
12.“Supervision” means that a licensed Lactation Consultant is at all times responsible for supportive personnel and clients. Supervision is further defined in § 27.4.1(C) of this Part.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.4** Qualifications {#sec-216-ricr-40-05-27-27.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.4}
27.4.1General Licensure Requirements for Lactation Consultants
A.No person can practice as a Lactation Consultant or represent themselves as being able to practice as a Lactation Consultant in Rhode Island unless the person is licensed in accordance with the provisions of R.I. Gen. Laws Chapter 23-13.6 and this Part.
B.Exemptions to the requirements of R.I. Gen. Laws Chapter 23-13.6 and this Part are pursuant to R.I. Gen. Laws § 23-13.6-4.
C.Supervision
1.A licensed Lactation Consultant shall exercise sound judgment and shall provide care within the scope of practice or guidelines in the performance of their duties. A licensed Lactation Consultant is permitted, but not required to supervise the following:
a.Licensed Lactation Consultants;
b.Licensed Lactation Counselors;
c.Students, interns, or persons preparing for practice as a Lactation Consultant;
d.Care extenders and other team members as appropriate; and
e.Volunteers.
2.A licensed Lactation Consultant cannot delegate any of the following tasks to individuals under their supervision, who are not a licensed Lactation Consultant:
a.Initiation, planning, adjustment, modification, or performance of lactation care and services requiring the skills or judgment of a licensed Lactation Consultant; and,
b.Acting on behalf of a licensed Lactation Consultant in any matter related to providing lactation care and services which requires decision making or professional judgment.
27.4.2Qualification for Licensure for Lactation Consultants
A.An applicant for licensure as a Lactation Consultant shall:
1.Be at least eighteen (18) years of age;
2.Successfully complete an academic and practical program in lactation that is accredited by the International Board of Lactation Consultant Examiners (IBLCE);
3.Pass the examination for board certification as an International Board Certified Lactation Consultant (IBCLC) offered by the IBLCE, or any successor organization; and
4.Currently be board certified as an IBCLC.
27.4.3General Licensure Requirements for Lactation Counselors
A.No individual shall practice as a Lactation Counselor unless the individual is licensed in accordance with R.I. Gen. Laws § 23-13.8-3.
B.No Lactation Counselor shall assume the title of “Lactation Consultant” or use the term consultant or use any abbreviations or any other words, letters, signs, figures, or devices to indicate that the individual using same is a Lactation Consultant as set forth in this Part, unless they hold a license as a Lactation Consultant issued by the Department. The only terms Lactation Counselors may use in this state are Lactation Counselor – CLC or Lactation Counselor - ALC.
C.In addition to the requirements outlined in R.I. Gen. Laws § 23-13.8-3, an individual applying to be a Lactation Counselor must designate in the application provided by the Department the category of Lactation Counselor for which they are applying. The options will be as follows:
1.Lactation Counselor – CLC. This is for applicants who hold a current certification from the Academy of Lactation Policy and Practice (ALPP) as a Certified Lactation Counselor.
2.Lactation Counselor – ALC. This is for applicants who hold a current certification from the ALPP as an Advanced Lactation Consultant certification.
D.For the purposes of this Part, reference to a “Lactation Counselor” includes both the “Lactation Counselor – CLC” and “Lactation Counselor – ALC”.
E.Exemptions to the requirements of R.I. Gen. Laws Chapter 23-13.8 and this Part are pursuant to R.I. Gen. Laws § 23-13.8-11.
F.Supervision
1.A licensed Lactation Counselor shall exercise sound judgment and shall provide care within the scope of practice or guidelines in the performance of their duties. A licensed Lactation Counselor is permitted, but not required, to supervise the following:
a.Licensed Lactation Counselor;
b.Students, interns, or persons preparing for practice as a Lactation Counselor;
c.Care extenders and other team members as appropriate; and
d.Volunteers.
27.4.4Qualification for Licensure for Lactation Counselors
A.An applicant for licensure as a Lactation Counselor – CLC or Lactation Counselor – ALC must meet the qualifications for licensure outlined in R.I. Gen. Laws § 23-13.8-4.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.5** Application for Lactation Consultant and Lactation Counselor {#sec-216-ricr-40-05-27-27.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.5}
27.5.1Documentation
A.In order to apply for a license as a Lactation Consultant, an applicant must submit the following on forms provided by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address;
2.Application fee for a Lactation Consultant as defined in Part 10-05-2 of this Title, the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fee is non-refundable and non-returnable; and
3.Verification of current board certification as an IBCLC submitted directly to the Department by the IBLCE.
B.In order to apply for a license as a Lactation Counselor, an applicant must submit the following on forms provided by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address;
2.Application fee for a Lactation Counselor as defined in Part 10-05-2 of this Title, the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fee is non-refundable and non-returnable; and
3.Verification of current certification as a CLC or an ALC submitted directly to the Department by the ALPP.
27.5.2Licensure by Endorsement
A.In order to apply for a license by endorsement an applicant must submit the following on forms provided by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address;
2.Application fee as defined in Part 10-05-2 of this Title, the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fee is non-refundable and non-returnable;
3.Verification that the applicant is licensed and in good standing from all states where the applicant is currently licensed and, if applicable, previously licensed as a Lactation Consultant or Lactation Counselor. Verification must be sent directly to the Department by the certifying and/or licensing authority; and
4.If applying to be a Lactation Consultant, verification of current board certification as an IBCLC submitted directly to the Department by the IBLCE; or
5.If applying to be a Lactation Counselor, verification of current certification as a CLC or an ALC submitted directly to the Department by the ALPP.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.6** Issuance of a License for Lactation Consultants and Lactation Counselors {#sec-216-ricr-40-05-27-27.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.6}
A.A license as a Lactation Consultant may be issued to an applicant who meets the relevant requirements for licensure as required by R.I. Gen. Laws Chapter 23-13.6 and this Part.
B.A license as a Lactation Counselor may be issued to an applicant who meets the relevant requirements for licensure as required by R.I. Gen. Laws Chapter 23-13.8 and this Part.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.7** Expiration & Renewal of a License for Lactation Consultants and Lactation Counselors {#sec-216-ricr-40-05-27-27.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.7}
A.Expiration
1.The licenses of all Lactation Consultants and Lactation Counselors will expire on the thirty-first (31st) day of January of the next odd-numbered year following the issuance of their license.
B.Renewal
1.In order to renew a license, the licensee must file a renewal application with the Department, together with a renewal fee as defined in Part 10-05-2 of this Title, the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, on or before the thirty-first (31st) day of January in each odd-numbered year.
2.The license renewal is effective on the first (1st) day of February.
C.Failure to Renew
1.If a licensee fails to renew their license on or before the thirty-first (31st) day of January in each odd-numbered year, as required by this Part, the license will expire.
2.No one whose license is expired is allowed to practice as a Lactation Consultant or Lactation Counselor or represent themselves as being able to practice in Rhode Island until they have renewed the expired license in accordance with § 27.7(D) of this Part or reinstated the terminated license in accordance with § 27.7(E) of this Part.
D.Expired License
1.A licensee may renew an expired license within one (1) year of the expiration date. In order to renew an expired license, the licensee must submit the following:
a.Renewal application together with the current renewal fee plus an additional fee as defined in Part 10-05-2 of this Title, the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fees are non-refundable and non-returnable.
E.Terminated Licenses
1.If a licensee fails to renew an expired license within one (1) year of the date of its expiration, the license will be terminated. In order to reinstate a terminated license, the licensee must submit the following:
a.A reinstatement application together with the current renewal fee, plus an additional fee as defined in Part 10-05-2 of this Title, the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fees are non-refundable and non-returnable.
b.For a Lactation Consultant, verification of current board certification as an IBCLC must be submitted directly to the Department by the IBLCE.
c.For a Lactation Counselor, verification of current certification as a CLC or an ALC must be submitted directly to the Department by the ALPP.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.8** Scope of Practice for a Lactation Consultant {#sec-216-ricr-40-05-27-27.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.8}
A.A licensed Lactation Consultant may practice independent management of lactation care and services using the clinical application of scientific principles and a multidisciplinary body of evidence for the evaluation, problem identification, treatment, education, and consultation to provide lactation care and services to childbearing families. Furthermore, a licensed Lactation Consultant shall comply with the Scope of Practice for International Board Certified Lactation Consultant Certificants in accordance with "Scope of Practice for International Board Certified Lactation Consultant (IBCLC) Certificants," incorporated above at § 27.2(A) of this Part.
B.Limitation of Practice. A licensed Lactation Consultant shall limit their practice to demonstrated areas of competence as documented by relevant professional education, training, and experience. Unless licensed as a doctor or nurse practitioner, a Lactation Consultant shall not:
1.Give medical advice;
2.Give a medical diagnosis;
3.Prescribe medication;
4.Perform medical procedures; or,
5.Perform medical treatment.
C.A licensed Lactation Consultant shall conduct their professional activities in accordance with the "Code of Professional Conduct for IBCLCs", incorporated above at § 27.2(B) of this Part.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.9** Scope of Practice for a Lactation Counselor {#sec-216-ricr-40-05-27-27.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.9}
A.A Lactation Counselor must provide counseling services within the parameters of R.I. Gen. Laws § 23-13.8-9.
B.In addition to what is outlined in R.I. Gen. Laws § 23-13.8-9, a Lactation Counselor must work with an IBCLC, Physician, or Nurse Practitioner, in accordance with facility policies for such collaboration, when assisting in the lactation care of:
1.Medically complex infants, and
2.Those with current medical diagnoses or current levels of care including:
a.NICU infants;
b.Premature infants born before thirty-seven (37) weeks;
c.Growth Faltering (Failure to Thrive), or
d.Cleft Palate.
3.If the Lactation Counselor assisting in the lactation care of infants referenced in §§ 27.9(B)(1) or (2) is not employed by the facility, they must have a written collaborative agreement in place which lays out the terms of the collaboration with the collaborating healthcare professional.
C.Unless licensed as a Physician or Nurse Practitioner, a Lactation Counselor shall not:
1.Give medical advice;
2.Give a medical diagnosis;
3.Prescribe medication;
4.Perform medical treatment; or,
5.Perform medical procedures.
D.A licensed Lactation Counselor shall conduct their professional activities ethically in accordance with the codes of professional ethics for CLC and ALC from the Academy of Lactation Policy and Practice, incorporated above at §§ 27.2(E) and (F) of this Part.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.10** Maintenance of Certification for Lactation Consultants and Lactation Counselors {#sec-216-ricr-40-05-27-27.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.10}
A.Renewal Certification. A licensee must attest on the renewal application that their status as an IBCLC, CLC, or ALC, as required in §§ 27.4.2(A)(4) and 27.4.3 of this Part is active and not subject to any restrictions, limitations or other sanctions.
B.Required Notification to the Department
1.A licensee must notify the Department, in writing, within five (5) business days of receiving notification from the IBLCE or the ALPP that their status as an IBCLC, as required in § 27.4.2(A)(4) of this Part, or as an ALPP CLC, or ALC has been revoked and/or is subject to any restrictions, limitations of other sanctions.
2.A licensee must notify the Department, in writing, within five (5) business days of failure to renew or other lapse of their status as an IBCLC, or an ALPP CLC, or ALC, as required in §§ 27.4.2(A)(4) and 27.4.3 of this Part.
3.A licensee’s license will be inactive during any period in which the above certifications are not maintained.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.11** Grounds for Refusal, Revocation or Suspension for Lactation Consultants and Lactation Counselors {#sec-216-ricr-40-05-27-27.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.11}
A.Upon due notice and hearing in accordance with R.I. Gen. Laws Chapter 42-35, and the provisions of § 27.11 of this Part, any violation pursuant to the provisions of R.I. Gen. Laws Chapters 23-13.6 and 23-13.8 and this Part, may be cause for denial, revocation or suspension of license or for imposing a fine of not more than one thousand dollars ($1,000.00), in accordance with R.I. Gen. Laws §§ 23-13.6-5 and 23-13.8-13(a).
B.Except as otherwise provided in R.I. Gen. Laws Chapters 23-13.6 and 23-13.8 and this Part, the inspection, enforcement, and penalties for violations of the provisions of R.I. Gen. Laws Chapters 23-13.6 and 23-13.8 or this Part shall be in accordance with the provisions and procedures set forth in R.I. Gen. Laws §§ 23-1-19 through 23-1-25.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
##### **216-RICR-40-05-27 § 27.12** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-27-27.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-27#27.12}
A.All hearings and reviews required pursuant to provisions of R.I. Gen. Laws Chapters 23-13.6 and 23-13.8 and this Part shall be held in accordance with the provisions of Part 10-05-4 of this Title, the Rules and Regulations Pertaining to Practices and Procedures before the Rhode Island Department of Health.
**History**
- *Amendment — effective from 2026-03-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/25/2026*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2015-06-01 to 04/30/2018*
#### **216-RICR-40-05-28** Applied Behavior Analysts and Applied Behavior Assistant Analysts
##### **216-RICR-40-05-28 § 28.1** Authority {#sec-216-ricr-40-05-28-28.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.1}
These regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws § 5-86-7(1), for the purpose of defining the prevailing standards for the licensure of applied behavior analysts and applied behavior assistant analysts.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.2** Incorporated Materials {#sec-216-ricr-40-05-28-28.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.2}
These regulations hereby adopt and incorporate the Behavior Analyst Certification Board (BACB) “Behavior and Ethical Compliance Code” (2017) by reference, not including any further additions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.3** Definitions {#sec-216-ricr-40-05-28-28.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.3}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 5-86 entitled “Licensing of Applied Behavior Analysts”.
2.“Applied behavior analyst” means an individual licensed to practice applied behavior analysis pursuant to provisions of the Act and this Part.
3.“Applied behavior analyst aide” means an individual, not licensed pursuant to the Act and this Part, who works under the supervision of a licensed applied behavior analyst, who assists in the practice of applied behavior analysis and whose activities require an understanding of applied behavior analysis, but do not require professional or advanced training in the basic anatomical, psychological, and social sciences involved in the practice of applied behavior analysis.
4.“Applied behavior assistant analyst” means an individual licensed who practices applied behavior analysis pursuant to the provisions of the Act and this Part.
5.“Board” means the Rhode Island Applied Behavior Analyst Licensing Board established pursuant to the provisions of R.I. Gen. Laws § 5-86-4.
6.“Department” means the Rhode Island Department of Health.
7."Director" means the means the Director of the Rhode Island Department of Health.
8.“Education” means the academic program pursued by the person in obtaining the bachelors, masters or doctorate degree, that the programs to include formal course work, seminars and practica.
9.“Practice of applied behavior analysis” means the design, implementation and evaluation of environmental modifications by a behavior analyst to produce socially significant improvements in human behavior.
a.It includes the empirical identification of functional relations between environment and behavior, known as functional assessment and analysis.
b.Applied behavior analysis interventions are based on scientific research and the direct observation and measurement of behavior and environment. They utilize contextual factors, establishing operations, antecedent stimuli, positive reinforcement and other consequences to help people develop new behaviors, increase or decrease existing behaviors, and emit behaviors under specific environmental conditions.
c.The practice of applied behavior analysis expressly excludes psychological testing, neuropsychology, psychotherapy, cognitive therapy, sex therapy, psychoanalysis, hypnotherapy, and long-term counseling as treatment modalities. Such services are provided by an individual licensed pursuant to Act and this Part only when applied behavior analysis services are prescribed by a child psychiatrist, a behavioral developmental pediatrician, a child neurologist or a licensed psychologist with training in child psychology pursuant to R.I. Gen. Laws 27-20.11-4.
10.“Psychologist with equivalent experience” means an individual deemed to hold equivalent licensure as an applied behavior analyst upon satisfying equivalency requirements through submission and satisfaction of written evidence of education and relevant experience to the Department pursuant to § 28.5.3 of this Part.
11.“Supervised experience” means the practical application of principles, methods and procedures of the science of applied behavioral analysis in accordance with the requirements of §§ 28.5.1(A)(2) of this Part (applied behavior analyst) or 28.5.2(A)(2) of this Part (applied behavior assistant analyst).
12.“Supervision” means that a licensed applied behavior analyst is at all times responsible for supportive personnel and clients. Supervision is further defined in § 28.4.3 of this Part.
13.“Training” means the pre-professional or professional supervised experience received by the person at the pre or post-doctoral level that experience to have been obtained in an internship, clinic, or other similar professional setting.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.4** General Li c ensing Requirements {#sec-216-ricr-40-05-28-28.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.4}
28.4.1License Required
A.It shall be unlawful for any person to practice as a licensed applied behavior analyst or licensed applied behavior assistant analyst, or represent themselves as such, unless they are duly licensed pursuant to the provisions of the Act and this Part.
B.It shall further be unlawful for any person to offer services to the public or to render to individuals or groups of individuals services defined as the “practice of applied behavior analysis,” pursuant to § 28.3(A)(9) of this Part, unless that person is licensed pursuant to the provisions of the Act and this Part.
C.Notwithstanding the provisions of §§ 28.4.1(A) and (B) of this Part, nothing in this Part shall prohibit an individual licensed as a psychologist pursuant to R.I. Gen. Laws Chapter 5-44 from practicing within their field of expertise, including practicing behavior analysis.
28.4.2Title Authorized.
Any individual licensed pursuant to Act and this Part may use the title “licensed applied behavior analyst” and the abbreviation “LBA” or the title “licensed applied behavior assistant analyst” and the abbreviation “LABA”, provided that the title and abbreviation correspond to the license held pursuant to the Act and this Part.
28.4.3Supervision.
Supervision requirements are in accordance with the provisions set forth in R.I. Gen. Laws § 5-86-26.
28.4.4Exemptions.
Persons and practices exempt are in accordance with the provisions set forth in R.I. Gen. Laws § 5-86-21.
28.4.5Temporary Waiver.
An applied behavior analyst licensed or certified in another state, or United States territory may perform applied behavior analysis services in the State of Rhode Island without obtaining a license for up to ten (10) calendar days per calendar year with no more than five (5) days of this activity occurring consecutively. The calendar day limit shall not apply to services as an expert witness in a legal proceeding.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.5** Qualific a ti o n for Licen s i n g {#sec-216-ricr-40-05-28-28.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.5}
28.5.1Applied Behavior Analyst.
A.An applicant for licensure as an applied behavior analyst shall meet the requirements of R.I. Gen. Laws § 5-86-9(a). In addition, the applicant shall meet the following requirements:
1.Has successfully completed the amount of coursework in applied behavior analysis consistent with Behavior Analyst Certification Board (BACB) requirements.
2.Has appropriate supervised experience in accordance with R.I. Gen. Laws § 5-86-9(a)(4) or;
a.Supervised experience as required by the BACB and is acceptable to the Board.
3.Has passed the Board Certified Behavior Analyst examination administered by the Behavior Analyst Certification Board (BACB);
4.Maintain active status and fulfill all relevant requirements for renewal and relicensing with the Behavior Analyst Certification Board (BACB).
28.5.2Applied Behavior Assistant Analyst.
A.An applicant for licensure as an applied behavior assistant analyst shall meet the requirements of R.I. Gen. Laws § 5-86-9(b). In addition, the applicant shall meet the following requirements:
1.Has successfully completed the amount of coursework in applied behavior analysis consistent with BACB requirements.
2.Has appropriate supervised experience in accordance with R.I. Gen. Laws § 5-86-9(b)(4) or,
a.Supervised experience as required by the BACB and is acceptable to the Board.
3.Is supervised by a licensed applied behavior analyst in a manner consistent with the requirements of § 28.4.3 of this Part;
4.Has passed the Board Certified Assistant Behavior Analyst examination administered by the Behavior Analyst Certification Board (BACB);
5.Maintain active status and fulfill all relevant requirements for renewal and relicensing with the Behavior Analyst Certification Board (BACB).
28.5.3Psychologist with Equivalent Experience.
A.An applicant shall also be considered eligible for licensure as an applied behavior analyst if the equivalency requirements in R.I. Gen. Laws § 5-86-9(c) are met to the satisfaction of the Board. In addition, the applicant shall meet the following requirements:
1Has completed one thousand five hundred (1,500) hours of direct client contact offering applied behavior analysis services subsequent to being awarded a doctoral degree in psychology, or as approved by the Board.
2.Be individually licensed by the Department as a psychologist pursuant to R.I. Gen. Laws Chapter 5-44.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.6** Application for Licens u re and Fee {#sec-216-ricr-40-05-28-28.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.6}
28.6.1Application for Licensure
A.Application for licensure shall be made on forms furnished by the Department, which shall be completed and submitted to the Board. Such application shall be accompanied by the following documents:
1.Verification of current BACB certification or current license to practice psychology in the State of Rhode Island;
2.Verification that the applicant is in good standing in state(s) where licensed [if licensed in another state(s)]; and
3.Full Bureau of Criminal Investigation (BCI) check from the Rhode Island Attorney General’s Office.
28.6.2Fee
The application fee (not refundable and non-returnable) as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) shall accompany the application for licensure. Applications received without the required application fee shall be returned to the applicant.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.7** Licensure {#sec-216-ricr-40-05-28-28.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.7}
28.7.1Issuance of License.
A.A license as an applied behavior analyst, applied behavior assistant analyst or psychologist with equivalent experience may be issued to:
1.An applicant who meets the relevant requirements for licensure as required by the Act and this Part; or
2.An applicant who has been certified by an appropriate nationally recognized and accredited organization, as approved by the Department, and licensed as an applied behavior analyst, applied behavior assistant analyst or psychologist with equivalent experience pursuant to laws of another state, United States territory, or foreign country where the Board determines that the requirements are substantially equivalent to those required pursuant to the Act and this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.8** Expiration and Renewal of Licenses, Co n tinuing Education and Lapsed License {#sec-216-ricr-40-05-28-28.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.8}
28.8.1Expiration.
The license of every person licensed pursuant to provisions of the Act and this Part shall expire on the first (1st) day of July of the next even-numbered year following the issuance of his or her license.
28.8.2Renewal.
Every licensed person who desires to renew his or her license shall file with the Department a renewal application, executed, together with a renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), on or before the first (1st) day of June in each even-numbered year. Upon receipt of a renewal application and payment of the renewal fee, the Department may grant a renewal license effective on the first (1st) day of July and expiring on the thirtieth (30th) day of June in each even-numbered year.
28.8.3Continuing Education.
Every person who desires to continue licensure as an applied behavior analyst or applied behavior assistant analyst shall present satisfactory evidence to the Board that they have met BACB continuing education unit requirements to maintain that certification.
28.8.4Lapsed License.
A.Any person who allows his or her license to lapse by failing to renew it on or before the first (1st) day of June in each even-numbered year, as required by this Part, may be reinstated by the Department on payment of the current renewal fee, plus an additional fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Any person who allows his or her license to lapse for greater than one year must submit a reinstatement application for licensure and will be charged a renewal fee plus an additional late fee. In addition, the applicant must submit a new BCI and evidence that they are in compliance with the BACB continuing education unit requirements to maintain that certification.
C.Any person using the title licensed applied behavior analyst, licensed applied behavior assistant analyst or psychologist with equivalent experience who offers services defined as the “practice of applied behavior analysis,” pursuant to § 28.3(A)(9) of this Part, during the time his or her license has lapsed is subject to the penalties provided for violation of the Act and this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.9** Transfers to Inactive List and Reinstateme n t {#sec-216-ricr-40-05-28-28.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.9}
28.9.1Transfers to Inactive List.
A licensed applied behavior analyst, licensed applied behavior assistant analyst or psychologist with equivalent experience who does not intend to continue his or her licensure may, upon written request to the Department, have his or her name transferred to an inactive list, and shall not be required to pay the renewal fee as long as he or she remains inactive.
28.9.2Reinstatement.
If a licensed applied behavior analyst or licensed applied behavior assistant analyst or psychologist with equivalent experience wishes to resume functioning as an applied behavior analyst. applied behavior assistant analyst, or psychologist with equivalent experience (as applicable), he or she must notify the Department and remit his or her renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) along with an application and attestation of completion of the continuing education requirements in accordance with § 28.8.3 of this Part within the immediate two (2) years prior to the applicant’s request for licensure reinstatement.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.10** Standards for Responsible Professional Conduct {#sec-216-ricr-40-05-28-28.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.10}
28.10.1Limitation of Practice.
A.A licensed applied behavior analyst, licensed applied behavior assistant analyst or psychologist with equivalent experience shall limit his or her practice to demonstrated areas of competence as documented by relevant professional education, training, and experience.
B.A licensed applied behavior analyst, licensed applied behavior assistant analyst or psychologist with equivalent experience shall conduct his or her professional activities in accordance with the Behavior Analyst Certification Board (BACB) Behavior and Ethical Compliance Code incorporated by reference above at § 28.2 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.11** D e ni al , S u spensio n o r R e voc a tion of Lic e n s e – Violat i ons {#sec-216-ricr-40-05-28-28.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.11}
28.11.1Due Process.
A.Upon due notice and hearing in accordance with R.I. Gen. Laws Chapter 42-35 (the Administrative Procedures Act), and the provisions of § 28.12 of this Part, any violation pursuant to the provisions of the Act and this Part, may be cause for denial, revocation or suspension of license or for imposing such other penalties in accordance with the Act.
B.The procedure for discipline of applied behavior analysts, applied behavior analyst assistants and psychologists with equivalent experience shall be in accordance with the provisions set forth in R.I. Gen. Laws § 5-86-17.
28.11.2Grounds for Discipline.
The Board has the power to deny, revoke, or suspend any license issued by the Department in accordance with the Act and this Part, or to discipline a licensed applied behavior analyst or licensed applied behavior assistant analyst upon proof that the individual has committed any of the acts stated in R.I. Gen. Laws § 5-86-16.
28.11.3Grounds for Discipline without a Hearing
Discipline without a hearing is pursuant to R.I. Gen. Laws § 5-86-18.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
##### **216-RICR-40-05-28 § 28.12** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-28-28.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-28#28.12}
All hearings and reviews required pursuant to provisions of the Act and this Part shall be held in accordance with the provisions of the rules and regulations pertaining to Practices and Procedures before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Adoption — effective from 2015-11-23 to 11/04/2018*
#### **216-RICR-40-05-29** Practice of Electrolysis
##### **216-RICR-40-05-29 § 29.1** Authority and Purpose {#sec-216-ricr-40-05-29-29.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws , and are adopted for the purpose of establishing minimum standards for the practice of electrolysis and laser hair removal in this state.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.2** Incorporated Materials {#sec-216-ricr-40-05-29-29.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.2}
A.These regulations hereby adopt and incorporate the American Electrology Association "Standards of Practice for Electrologists" (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the American Electrology Association "Infection Prevention Standards for the Practice of Electrolysis" (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate the Occupational Safety and Health Administration (OSHA) "Blood borne Pathogen Standards" 29 C.F.R. 1910.1030 (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.3** Definitions {#sec-216-ricr-40-05-29-29.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.3}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws , as amended, entitled “Electrolysis and Laser Hair Removal.”
2."AEA" means the American Electrology Association.
3.“Department” means the Rhode Island Department of Health.
4.“Electrologist” means a person as defined in R.I. Gen. Laws § 5-32-1(1).
5.“Electrology” means the practice of electrical hair removal to permanently remove human hair from the body.
6.“Electrolysis” means as defined in R.I. Gen. Laws § 5-32-1(2).
7."Laser" means as defined in R.I. Gen. Laws § 5-32-1(3).
8."Laser hair removal" means as defined in R.I. Gen. Laws § 5-32-1(4).
9."Laser light" means as defined in R.I. Gen. Laws § 5-32-1(5).
10.“Licensure” and “certification” shall be synonymous for the purposes of these Regulations as authorized by R.I. Gen. Laws Chapter 5-32.
11."Medical director" means as defined in R.I. Gen. Laws § 5-32-1(6).
12."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
13."These Regulations" means all parts of the Rhode Island Rules and Regulations Related to the Practice of Electrolysis and Laser Hair Removal.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.4** General License Requirements {#sec-216-ricr-40-05-29-29.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.4}
A.License Required. No person can practice as an electrologist or represent himself or herself as being able to practice as an electrologist in Rhode Island unless the person is licensed in accordance with the requirements of the Act and these regulations.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.5** Qualification for Licensure {#sec-216-ricr-40-05-29-29.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.5}
A.In addition to the requirements of R.I. Gen. Laws § 5-32-4, an applicant for licensure must submit to the Department evidence that the applicant has passed the AEA examination in electrology.
B.Endorsement. In addition to the requirements of R.I. Gen. Laws § 5-32-7 an applicant for licensure by endorsement must submit evidence that the applicant has passed the AEA examination in electrology.
29.5.1Apprenticeship
A.The apprenticeship shall include at least six hundred fifty (650) hours of study and practice in the theory and practical application of electrolysis within a term of nine (9) months. The six hundred fifty (650) hour apprenticeship must include instruction and training as stipulated in the "Instruction and Training Requirements for Electrology Apprenticeships" chart below:
Instruction and Training Requirements for Electrology Apprenticeships
Histology
50 hours
Bacteria, sterilization, and hygiene
100 hours
Dermatology
75 hours
Principles of electricity
25 hours
Anatomy, physiology, and endocrinology
75 hours
Magnification, lighting, and equipment
25 hours
Professional ethics, human relations, and office management
25 hours
Practical training
275 hours
TOTAL
650 hours
B.Apprenticeships require the following:
1.The apprentice must register with the Department upon beginning his or her course of instruction;
2.The licensed electrologist who supervises the apprentice must keep a record of the hours of instruction;
3.Upon completion of the apprenticeship, the instructor shall certify the apprenticeship on forms provided by the Department.
29.5.2Qualifications for Teaching Electrolysis
A.In order to qualify for a license as an instructor or teacher of electrolysis to apprentices, an applicant must meet the requirements of R.I Gen. Laws § 5-32-20.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.6** Application for License and Fee {#sec-216-ricr-40-05-29-29.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.6}
A.Application for License. In order to apply for a license as an electrologist an applicant must submit the following on forms furnished by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address.
2.Application fee as defined in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fee is non-refundable and non-returnable.
3.Results of the AEA examination sent directly to the Department by the AEA.
4An affidavit signed by the licensed electrology instructor who supervised the apprentice attesting to the completion of the hours of instruction required in § 29.5.1(A) of this Part.
B.Application for License by Endorsement. In order to apply for a license as an electrologist by endorsement an applicant must submit the following on forms furnished by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address.
2.Application fee as defined in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fee is non-refundable and non-returnable.
3.Verification that applicant has passed the AEA examination sent directly to the Department by the AEA.
C.Application for Instructor License. In order to apply for a license as an electrology instructor an applicant must submit the following on forms furnished by the Department:
1.Completed application including but not limited to name, address, date of birth, social security number, telephone number and email address.
2.Application fee as defined in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. The fee is non-refundable and non-returnable.
3.Verification that applicant has passed the Instructor Examination approved by the Department.
4.Verification that applicant has been actively engaged as a licensed practitioner of electrolysis for at least five (5) years in accordance with R.I. Gen. Laws § 5-32-20(a)(1).
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.7** Issuance of License {#sec-216-ricr-40-05-29-29.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.7}
A.A license to practice electrolysis will be issued to any person that meets the requirements of the Act and these regulations.
1.Every license issued in accordance with these regulations shall specify the name of the person to whom it was issued and must be displayed prominently in the place of business or employment.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.8** Expiration and Renewal of Licenses {#sec-216-ricr-40-05-29-29.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.8}
A.Expiration. All licenses shall expire in accordance with R.I. Gen. Laws § 5-32-6(b).
B.Renewal. In order to renew a license the licensee must file a renewal application with the Department together with a renewal fee as defined in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, on or before the thirtieth (30th) day of April of each year, as required by these regulations. The renewal license is effective on the first (1st) day of May and expires on the thirtieth (30th) day of April of each year.
C.Late Renewal. In order to renew an expired license, an applicant must file a renewal application with the Department together with a renewal fee as defined in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.9** Laser Hair Removal {#sec-216-ricr-40-05-29-29.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.9}
29.9.1Persons licensed before July 1, 2019
A.A person licensed as an electrologist before July 1, 2019, shall be permitted to practice electrology and laser hair removal without medical director oversight pursuant to the conditions in R.I. Gen. Laws § 5-32-21(a).
B.The department may reinstate the requirement to perform laser hair removal under the supervision of a medical director for a period of two (2) years pursuant to the conditions in R.I. Gen. Laws § 5-32-21(a).
29.9.2Persons Licensed After July 1, 2019
A.A person licensed as an electrologist after July 1, 2019, shall practice laser hair removal only under the supervision of a medical director pursuant to R.I. Gen. Laws § 5-32-21(b).
B.A licensed electrologist shall be exempt from § 29.9.2(A) of this Part upon completion of two (2) years of practice under the supervision of a medical director and submission of an application to the department certifying that they meet the criteria in R.I. Gen. Laws §§ 5-32-21(b)(1) through (3).
C.The department may reinstate the requirement to perform laser hair removal under the supervision of a medical director for a period of two (2) years pursuant to the conditions in R.I. Gen. Laws § 5-32-21(b).
29.9.3Equipment
A.All equipment used for laser hair removal shall comply with all applicable rules and regulations of the United States Food and Drug Administration.
B.An electrologist shall maintain a complete record of receipt, transfer, and disposal for each device used for electrolysis and laser hair removal, which shall be in writing or capable of reproduction in written form, and shall contain the data required in R.I. Gen. Laws § 5-32-21(d).
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.10** Practice of Electrolysis {#sec-216-ricr-40-05-29-29.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.10}
A.The practice of electrolysis shall be engaged pursuant to R.I. Gen. Laws § 5-32-9.
B.Licensed electrologists are subject to the AEA "Standards of Practice for Electrologists" incorporated by reference above at § 29.2(A) of this Part.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.11** Infection Control Standards {#sec-216-ricr-40-05-29-29.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.11}
A.Any person licensed to practice electrolysis shall conduct his/her practice in such a manner as to prevent the transmission of communicable diseases and blood borne pathogens in accordance with the standards of the AEA "Infection Prevention Standards for the Practice of Electrolysis" incorporated above at § 29.2(B) of this Part. These standards include follow-up procedures for potential exposures to HBV, HIV and other blood borne pathogens.
B.Persons engaged in the practice of electrolysis shall comply with the Occupational Safety and Health Administration’s (OSHA) Blood borne Pathogen Standards of 29 C.F.R. § 1910.1030 incorporated above at § 29.2(C) of this Part in order to protect themselves (and any employees) against occupational exposure to blood borne pathogens.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.12** Sanctions and Penalties {#sec-216-ricr-40-05-29-29.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.12}
A.Any person, firm, corporation or association violating any of the provisions of the Act or these regulations commits a misdemeanor and, upon conviction, shall be punished by a fine not to exceed two hundred dollars ($200.00), or imprisoned for a period not to exceed three (3) months, or both the fine and imprisonment.
B.Every person who engages in the practice of electrolysis in Rhode Island without being licensed by the Department is subject to the provisions of R.I. Gen. Laws § 5-32-2.
C.The Department shall have power to revoke or suspend any license issued in accordance with these regulations for gross unprofessional misconduct as defined in R.I. Gen. Laws .
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
##### **216-RICR-40-05-29 § 29.13** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-29-29.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-29#29.13}
A.All hearings and reviews required under the provisions of shall be held in accordance with Part 10-05-4 of this Title, Practices and Procedures Before the Rhode Island Department of Health and Part 10-05-1 of this Title, Access to Public Records.
**History**
- *Amendment — effective from 2024-03-17 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/17/2024*
- *Amendment — effective from 2018-02-08 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 02/08/2018*
- *Periodic Refile — effective from 2002-01-02 to 12/10/2012*
#### **216-RICR-40-05-30** Dietitians/Nutritionists
##### **216-RICR-40-05-30 § 30.1** Authority {#sec-216-ricr-40-05-30-30.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 5-64-5(b)(1) and 5-64-16, for the purpose of protecting the health, safety and welfare of the public by establishing prevailing standards for the licensure of dietitians/nutritionists.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.2** Definitions {#sec-216-ricr-40-05-30-30.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.2}
A.Whenever used in this Part, the following terms shall be construed as follows:
1."Act” means R.I. Gen. Laws Chapter 5-64.
2."Board” means the Rhode Island State Board of Dietetics.
3."Commission on Dietetic Registration" or “CDR” means a national commission on dietetic registration that is a member of the National Commission for Health Certifying Agencies.
4."Degree” means a degree received from or validated by a college or university that was regionally accredited through the Council on Postsecondary Accreditation and the U.S. Department of Education at the time the degree was conferred.
5."Dietitian and/or nutritionist” means a person engaged in the practice of dietetics.
6."Registered dietitian” means a dietitian registered by the Commission on Dietetic Registration.
7.“Licensed dietitian/nutritionist” means a person licensed under the Act and this Part.
8.“Director” means the Director of the Rhode Island Department of Health.
9.“Dietetics" means the professional discipline of applying principles derived from the sciences of nutrition, biochemistry, physiology, management, and behavioral and social sciences in the provision of dietetic services.
10.“Examination” means the registration examination for dietitians or other examination as determined by and approved by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.3** Licensing Requirement {#sec-216-ricr-40-05-30-30.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.3}
Only a person licensed or otherwise authorized to practice under the Act and this Part shall practice dietetics or use the title "dietitian/nutritionist" or use the letters L.D.N. or any facsimile thereof.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.4** Qualifications for Licensure {#sec-216-ricr-40-05-30-30.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.4}
A.Licensure by examination. The applicant must present:
1.Evidence of completion of a baccalaureate or post baccalaureate degree from a U.S. regionally accredited university or college and course work approved by the Accreditation Council for Education in Nutrition and Dietetics (ACEND) of the Academy of Nutrition and Dietetics (AND); and
2.Evidence of completion of a Board approved, planned, continuous experience in dietetics practice of not less than nine hundred (900) hours under the supervision of a registered dietitian or dietitian/nutritionist licensed in the state of Rhode Island; or evidence of completion of an Academy of Nutrition and Dietetics (AND)-approved internship of not less than nine hundred (900) hours; and
3.Evidence of having successfully passed the Registration Examination for Dietitians administered by the Commission on Dietetic Registration.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.5** Application for Licensure and Fee {#sec-216-ricr-40-05-30-30.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.5}
A.In addition to the requirements of R.I. Gen. Laws § 5-64-6, an applicant for licensure must submit the following:
1.Evidence of having successfully completed the examination administered by the Commission on Dietetic Registration, mailed directly from the Commission to the Department.
2.Persons who apply for licensure without examination must provide proof of valid registration mailed directly from the Commission on Dietetic Registration.
B.Temporary Permit
1.Any graduate of a program in nutrition/dietetics, that is approved by the Academy of Nutrition and Dietetics’ (AND) Accreditation Council for Education in Nutrition and Dietetics (ACEND), who has filed a completed application (which includes all documents except for examination scores) for licensing, may, upon receiving a permit from the Department, perform as a dietitian/nutritionist under the supervision of a dietitian/ nutritionist licensed in this state.
a.During this period, such an applicant shall identify him or herself only as a "graduate dietitian/nutritionist."
b.If such an applicant shall fail to pass the examination and receive a license within ninety (90) days of receiving a permit from the Department, all aforementioned privileges shall automatically cease.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.6** License Expiration and Renewal {#sec-216-ricr-40-05-30-30.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.6}
A.Licenses shall be valid for up to two (2) years and shall be renewed biennially, the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Every licensed dietitian/nutritionist who wishes to continue practice in the state of Rhode Island must renew their license by November 1 of each odd-numbered year.
C.Any licensee who allows his or her license to lapse by failing to renew the license by November 1st may be reinstated upon submission of a renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) and a late renewal fee as also set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
D.Continuing Education Requirements
1.Licensees renewing their license shall attest to the completion of a minimum of twenty (20) continuing education credits using criteria accepted by the Commission on Dietetic Registration.
2.Dietitians/nutritionists initially licensed by examination after the November 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., October 31st of the next odd-numbered year).
3.It shall be the sole responsibility of the individual dietitian/nutritionist to obtain documentation of his or her participation in the learning experience and the number of dated credits earned. Furthermore, it shall be the sole responsibility of the dietitian/nutritionist to safeguard the documents for review by the Board, if required. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
4.An extension of up to six (6) months to complete the continuing education requirements, or a waiver from these requirements, may be granted to a dietitian/nutritionist solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.7** Denial, Suspension or Revocation of License - Violations {#sec-216-ricr-40-05-30-30.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.7}
A.Any violation pursuant to the provisions R.I. Gen. Laws Chapter 5-64 and this Part, may be cause for denial, revocation or suspension of license or for imposing such other penalties in accordance with R.I. Gen. Laws Chapter 42-35. In addition to the grounds for discipline stated in R.I. Gen. Laws § 5-64-9 such violations, include but are not limited to:
1.Willfully or repeatedly violated any of the provisions of the Act or this Part;
2.Habitually negligent in the performance of his/her duties;
3.Is habitually intemperate or is addicted to the use of habit-forming drugs;
4.Is mentally and/or professionally incompetent;
5.Conviction, including, a plea of nolo contendere, of one (1) or more of the offenses listed in section R.I. Gen. Laws § 23-17-37;
6.Abandonment of a patient;
7.Promotion by a dietitian/nutritionist of the sale of drugs, devices, appliances, or goods or services provided for a patient in a manner as to exploit the patient for the financial gain of the dietitian/nutritionist;
8.Making or filing false reports or records in the practice of dietetics;
9.Repeated failure to file or record, or impede or obstruct a filing or recording, or inducing another person to fail to file or record dietetic reports;
10.Failure to furnish patient records upon proper request;
11.Revocation, suspension, surrender, or limitation of privilege based on quality of care provided or disciplinary action against a license to practice as a dietitian/nutritionist in another state, jurisdiction, or country;
12.Failure to furnish the Board, administrator, investigator, or representatives information legally requested by the Board;
13.Departure from or failure to conform to the current standards of acceptable and prevailing practice;
14.Failure to conform to the code of ethics for the profession of dietetics of the Academy of Nutrition and Dietetics (AND) or its successor organization.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.8** Exemptions {#sec-216-ricr-40-05-30-30.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.8}
Exemptions to this Part and authorizing statute are in accordance with R.I. Gen. Laws § 5-64-12.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
##### **216-RICR-40-05-30 § 30.9** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-30-30.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-30#30.9}
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 5-64 shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-2 of this Title) and Access to Public Records (Part 10-05-2 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-12 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 07/12/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-03-26 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 03/26/2007*
#### **216-RICR-40-05-31** Hearing Aid Dealers and Fitters
##### **216-RICR-40-05-31 § 31.1** Authority {#sec-216-ricr-40-05-31-31.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-49-21, and are adopted for the purpose of establishing prevailing standards for the licensure of hearing aid dealers and fitters in this state.
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
##### **216-RICR-40-05-31 § 31.2** Definitions {#sec-216-ricr-40-05-31-31.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.2}
A.Wherever used in this Part, the terms listed below shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter , entitled “Hearing Aid Dealers and Fitters.”
2.“The Board” means the Board of Hearing Aid Dealers and Fitters.
3.“Department” means the Department of Health.
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
##### **216-RICR-40-05-31 § 31.3** Licensure Requirements {#sec-216-ricr-40-05-31-31.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.3}
31.3.1Qualifications of Applicants
A.Qualifications and licensure requirements are in accordance with the provisions of R.I. Gen. Laws § 5-49-7.
B.Issuance of Licenses
1.License by Examination: Applicants may obtain a license by examination by submitting the following to the Department:
a.A completed application for a license certifying the applicant satisfies the requirements regarding age, character, education, and health set forth in R.I. Gen. Laws § 5-49-7(a);
b.The license fee as set forth in R.I. Gen. Laws § 23-1-54 and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
c.Verification of successful completion of the national written examination approved by the Board; and,
d.Proof the applicant has successfully passed a qualifying examination administered as directed by the Board by means of written and practical tests designed to evaluate the applicant’s technical qualifications set forth in §§ 31.3.4 and 31.3.5 of this Part.
2.License by Endorsement: Applicants may obtain a license by endorsement by submitting the following to the Department:
a.A completed application for a license certifying the applicant satisfies the requirements regarding age, character, education, and health set forth in R.I. Gen. Laws § 5-49-7(a);
b.The license fee as set forth in R.I. Gen. Laws § 23-1-54 and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and,
c.Verification that the applicant is in good standing in all states and territories where the applicant holds or has held a license or certification to engage in the practice of dispensing, selling, fitting, or ordering the use of in hearing aids.
3.Temporary Permits: Applicants may obtain a temporary permit that entitles the applicant to engage in the fitting and sale of hearing aids for a period of one (1) year by submitting the following to the Department:
a.A completed application for a temporary permit certifying the applicant satisfies the requirements regarding age, character, education, and health set forth in R.I. Gen. Laws § 5-49-7(a);
b.The fee as set forth in R.I. Gen. Laws § 23-1-54 and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and,
c.Designation of a supervising licensee responsible for the supervision and training of that applicant in accordance with R.I. Gen. Laws § 5-49-8(c), provided the supervising licensee:
i.Holds a valid hearing aid dealer’s and fitter’s license in Rhode Island; or,
ii.Holds a valid audiologist license in Rhode Island and obtains written approval from the Department after submitting a written attestation establishing at least two (2) years of active clinical experience in dispensing and fitting hearing aids, including the dates and locations of that experience.
4.Supervision of Temporary Permit Holder: In addition to supervision, training, and maintaining adequate personal contact, the supervising licensee described in § 31.3.1(B)(3)(c) of this Part shall ensure the holder of a temporary permit:
a.Receives twenty (20) hours per week of direct supervision for the first thirty (30) days of training;
i.“Direct supervision” means supervision by a licensed hearing aid dealer and fitter or qualified licensed audiologist under § 31.3.1(B)(3)(c)(ii) of this Part who personally authorizes and oversees the activities of the temporary permit holder. The direct supervisor must be physically present in the same location during these activities and ensure proper review and documentation of the results.
b.Has a review of all audiograms, sales and other records for the second thirty (30) days of training; and
c.Has periodic review of audiograms, sales and other records for the remainder of the training period.
31.3.2Renewal of License
A.Licensed hearing aid dealers:
1.All hearing aid dealer and fitter licenses shall expire on the thirty-first (31st) day of January of each even-numbered year, unless sooner suspended or revoked, and shall be renewed for the next ensuing two (2) years by the Department upon:
a.Completion of a renewal application and
b.Payment of a biennial renewal fee as set forth in R.I. Gen. Laws § 23-1-54 and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for each such renewal.
B.Renewal of Temporary Permits
1.If a person who holds a temporary permit under this section has not successfully passed the licensing examination within one (1) year from the date of issuance of the permit, the temporary permit may be renewed or reissued once upon payment of a fee as set forth in § 23-1-54.
31.3.3License for Sale and Fitting of Hearing Aids
A.Requirements to sell or fit hearing aids are as set forth in R.I Gen. Laws § 5-49-2.
B.Notice to Department of Place of Business
1.All licensed persons must notify the Department of the regular address of their place or places of business in accordance with the provisions of R.I Gen. Laws § 5-49-10.
31.3.4Examination Requirements
A.Applicants for license by examination must meet the requirements in R.I. Gen. Laws § 5-49-7 and shall be examined by means of written and practical tests as required in R.I. Gen. Laws § 5-49-9 in order to demonstrate that they are qualified to practice the fitting and sale of hearing aids.
1.For written and practical examinations, the Board, or its designee, shall administer the current International Hearing Society or other national examinations for hearing aid fitters and dealers, as may be approved by the Board.
2.The Department shall issue to each person successfully passing the examinations, where an examination is required, and who otherwise satisfies the Department of their qualifications, a license entitling them to practice said business in this state for the biennial period stated in the license, or until the license shall be revoked or suspended, as hereinafter provided.
3.In case of failure of any applicant to satisfactorily pass the examinations, such applicant shall be entitled to re-examinations. Any examination fees shall be resubmitted upon re-examination.
4.An applicant who fails to pass the written and practical examinations twice shall not be eligible for further examinations until the applicant has satisfactorily completed additional preparation as directed and approved by the Board. This condition for eligibility also applies to each subsequent failure.
31.3.5Scope of Examination
A.In addition to the scope of examination requirements set forth in R.I. Gen. Laws § 5-49-9, the qualifying examination shall include the following topics:
1.R.I. Gen. Laws Chapter 6-45, entitled “Consumer Enforcement of Assistive Technology Device Warranties” (also known as the “Lemon Law”);
2.Rules and regulations as contained in this Part.
31.3.6Persons and Practices Exempted
A.Persons and practices exempted are pursuant to R.I. Gen. Laws § 5-49-4.
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
##### **216-RICR-40-05-31 § 31.4** Repealed {#sec-216-ricr-40-05-31-31.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.4}
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
##### **216-RICR-40-05-31 § 31.5** Repealed {#sec-216-ricr-40-05-31-31.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.5}
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
##### **216-RICR-40-05-31 § 31.6** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-31-31.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.6}
A.Hearings: All hearings and reviews before the Department or the Board shall be held in accordance with Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title).
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
##### **216-RICR-40-05-31 § 31.7** Severability {#sec-216-ricr-40-05-31-31.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-31#31.7}
A.This Part is subject to the severability provisions stated in R.I. Gen. Laws § 5-49-20.
**History**
- *Amendment — effective from 2025-04-15 to current*
- *Periodic Refile — effective from 2022-01-04 to 04/15/2025*
- *Amendment — effective from 2018-11-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/04/2018*
- *Amendment — effective from 2005-06-02 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/02/2005*
#### **216-RICR-40-05-32** Nursing Home Administrators
##### **216-RICR-40-05-32 § 32.1** Authority {#sec-216-ricr-40-05-32-32.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-32#32.1}
A.This Part is promulgated pursuant to the authority set forth in R.I. Gen. Laws § 5-45-13, and is established for the purpose of establishing prevailing requirements for the licensing of nursing home administrators.
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/29/2004*
##### **216-RICR-40-05-32 § 32.2** Definitions {#sec-216-ricr-40-05-32-32.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-32#32.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 5-45, entitled "Nursing Home Administrators."
2."Board" means the Board of Examiners for Nursing Home Administrators established pursuant to the provisions of R.I. Gen. Laws § 5-45-1.
3."Contact hours" means hours acquired through attendance or participation at programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences or workshops.
4."Director" means the Director of the Rhode Island Department of Health.
5."Department" means the Rhode Island Department of Health.
6.“Non-contact hours” means internet courses, correspondence courses, tapes, or other continuing education programs that do not provide for direct interaction between faculty and the participant.
7."Nursing home" means any facility providing nursing care to any in-patient thereof which to operate is required to be licensed under any law or regulation of the state and which is further defined as a skilled nursing home by the licensing authority of the state pursuant to R.I. Gen. Laws § 5-45-4(5).
8."Nursing home administrator" means the individual responsible for planning, organizing, directing and controlling the operation of the nursing home, whether or not such functions are shared by one or more other persons, pursuant to R.I. Gen. Laws § 5-45-4(6).
9."Regionally accredited" means the official guarantee that a college or university or other educational institution is in conformity with the standards of education prescribed by a regional accrediting commission recognized by the U.S. Commissioner of Education.
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/29/2004*
##### **216-RICR-40-05-32 § 32.3** Licensing Requirements for Nursing Home Administrators {#sec-216-ricr-40-05-32-32.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-32#32.3}
32.3.1License Requirement
A.Pursuant to R.I. Gen. Laws § 5-45-5, no nursing home in Rhode Island shall operate except under the supervision of a nursing home administrator, and no person shall be a nursing home administrator unless he or she is the holder of a sufficient nursing home administrator's license in accordance with the statutory provisions of the Act and this Part.
32.3.2Qualifications for Licensure
A.In addition to the qualifications for licensure stated in R.I. Gen. Laws § 5-45-7, an applicant seeking licensure as a nursing home administrator in Rhode Island must:
1.Have satisfactorily completed in a nationally or regionally accredited college or university of higher learning at least a bachelor's degree in the field of health care administration or a bachelor's degree and satisfactory evidence of completion of a minimum of fifteen (15) credit hours in a course of instruction, in a nationally or regionally accredited college or university of higher learning, to include each of the five (5) content areas as set forth below:
a.Resident care management in nursing homes;
b.Personnel management;
c.Financial management;
d.Environmental management of nursing homes; and
e.Governance and management of nursing homes.
2.Have satisfactorily completed a field experience of at least three hundred fifty (350) hours, within a twelve (12) month period in an Administrator-in-Training capacity in a licensed nursing facility, which shall include training in the following areas:
a.Administration;
b.Human Resources;
c.Nursing Department;
d.Rehabilitation Department;
e.Medical/Patient Records;
f.Activities Department;
g.Social Services/Admissions;
h.Business Office;
i.Dietary Department;
j.Housekeeping/Laundry; and
k.Environment/Maintenance.
l.At the conclusion of the field experience, the administrator of the licensed nursing facility where the field experience was performed must attest that the training included each area;
3.Have successfully completed the licensing examination as determined by the Board and the Director in accordance with the provisions of § 32.3.4 of this Part.
32.3.3Application for Licensure
A.Application for licensure to practice in Rhode Island as a nursing home administrator shall be made on forms provided by the Department which shall be completed and submitted thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents:
1.Supporting official transcripts of education and training credentials in accordance with § 32.3.2 of this Part; such documentation must be sent directly from the school to the Department and must bear the signature of the registrar and the imprint of the school seal;
2.For applicants licensed in another state, the results of the nursing home administrator examination must be sent directly from the state of original licensure or the examination service to the Department;
3.Such other information as the Director may deem necessary.
32.3.4Licensing of Nursing Home Administrators
A.By Examination
1.Applicants shall be required to pass a written examination as determined by the Board and the Director to test the qualifications of the applicants to practice as a nursing home administrator pursuant to the provisions of the Act and this Part. Prior to sitting for the written examination, an applicant for licensure shall be required to complete all requirements for licensure, as approved by the Board, except for passing the examination. Applicants who have previously tested unsuccessfully must meet all requirements for licensure prevailing in Rhode Island at the time the retest is administered.
a.For written examination, the Board has designated the National Association of Board of Examiners of Long Term Care Administrators (NAB) as the organization to test the applicant's competency, skill and knowledge of nursing home administration.
b.The national examination recommended passing score will be accepted by the Department as the minimal passing score.
B.By Endorsement
1.A license may be issued to a nursing home administrator without examination to an applicant who holds a current license in good standing as a nursing home administrator in another jurisdiction, provided:
a.The Department finds that the standards for licensure in such other jurisdiction are substantially equivalent to those prevailing in Rhode Island at the time of application;
b.The licensing agency in each state in which the applicant holds or has held a registration or license submits to the Board a statement confirming the applicant to be or have been in good standing; and the applicant provides written documentation from the nursing home licensing authority in each jurisdiction where the applicant has been licensed attesting to the absence of findings of substandard care, fines, or admission restrictions in an administered licensed long-term care facility which he/she administered within the most recent three (3) years prior to application. (If such findings exist, the applicant may be allowed the opportunity to appear before the Board to offer explanation); and
c.The applicant supplies evidence to the Board of completion of forty (40) hours of continuing education in the most recent two (2) years prior to application; and
d.The applicant submits a completed licensure application in accordance with the provisions of § 32.3.3 of this Part; and
(1)The applicant meets the qualifications required of nursing home administrators in Rhode Island as set forth in § 32.3.2 of this Part; or
(2)The applicant is currently certified by and in good standing with the American College of Health Care Administrators (ACHCA), or
(3)The applicant meets all of the following requirements:
(AA)Has earned a bachelor’s degree; and
(BB)Has no less than three (3) years experience (in the most recent five (5) years prior to application) as a licensed nursing home administrator of a licensed long-term care facility or has been in a management position with no less than three (3) years experience (in the most recent five (5) years) having direct responsibility for overseeing and directing three (3) or more licensed nursing home administrators; and
(CC)Successful completion of the national examination in accordance with § 32.3.4(A)(1)(a) of this Part.
32.3.5Issuance and Renewal of License and Fee
A.Upon the recommendation of the Board, the Department shall issue to applicants who have satisfactorily met the licensure requirements of this Part, a license to a nursing home administrator to function as such in Rhode Island. Said license unless sooner suspended or revoked shall expire on June 30th of the next regular expiration date following the date of issuance of the original license and every two (2) years on June 30th of the next even numbered year thereafter.
B.Every licensed person who wishes to renew his or her license shall file with the Department by June 1st, a renewal application together with a renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.In June of every even numbered year, application for renewal of licensure shall be accompanied by or supported by evidence of the licensee's having completed a minimum of forty (40) hours of continuing education as provided in § 32.3.6 of this Part. Said requirement shall be pro-rated as necessary by the Department to reflect periods of less than two (2) years of licensure prior to renewal.
C.Any person who allows his or her license to lapse by failing to renew it on or before the first day of July every two (2) years as provided above, may be reinstated by the Department upon submission of an application and on payment of the current renewal fee, and completion of the continuing education requirements in accordance with § 32.3.5(B)(1) of this Part within the immediate two (2) years prior to the applicant’s request for licensure renewal, unless license has been suspended or revoked.
1.Any person using the title of “nursing home administrator” or functioning as a nursing home administrator during the time that his or her license has lapsed shall be subject to the penalties for violation of the provisions of the Act and this Part.
32.3.6Mandatory Continuing Education
A.Programs for continuing education which are acceptable for continuing education credits set forth in § 32.3.5(B)(1) of this Part and in accordance with § 32.3.2(A)(1) of this Part for nursing facility administrators shall be presented by:
1.The RI Health Care Association
2.LeadingAge Connecticut & Rhode Island, formerly the Rhode Island Association of Facilities for the Aging/LeadingAge RI
3.The American College of Health Care Administrators
4.The Alliance for Better Long Term Care
5.Nationally recognized associations of the aforementioned groups
6.Any duly accredited college or university
7.Programs approved by the National Continuing Education Review Service (NCERS) of the National Association of Boards of Examiners of Long Term Care Administrators.
B.Thirty (30) hours of the required forty (40) hours of continuing education in a two (2) year period shall be contact hours, as defined in this Part. The remaining ten (10) hours of continuing education may be non-contact hours.
C.It shall be the sole responsibility of the individual nursing home administrator to obtain documentation from the recognized sponsoring or co-sponsoring organizations, agencies or other, of his or her participation in the learning experience and the number of dated credits earned. Furthermore, it shall be the sole responsibility of the individual to safeguard the documents for review by the Board, if required. These documents shall be retained by each licensee for no less than four (4) years and are subject to random audit by the Department.
D.An extension of time to complete the continuing education requirements may be granted to a nursing home administrator solely at the discretion of the Board for reasons of hardship or other extenuating circumstances.
32.3.7Grounds for Denial, Revocation or Suspension of License
A.Pursuant to the statutory provisions of R.I. Gen. Laws § 5-45-12, the Department may deny issuance of a license or suspend or revoke any license issued under the provisions of the Act and this Part, or may reprimand, censure or otherwise discipline, upon decision and after hearing in accordance with § 32.4.2 of this Part upon proof that the licensee engaged in unprofessional conduct which includes but is not limited to those grounds stated in R.I. Gen. Laws § 5-45-12(a), and:
1.Has become unfit or incompetent by reason of negligence, habits, or other causes such as physical and mental impairment that would interfere with proper performance of duties;
2.Neglect or misconduct in professional practice; and
3.Any departure from or failure to conform to the minimal standards of acceptable and prevailing practice in nursing home administration. Actual injury to a patient/client/resident need not be established.
B.All hearings and reviews as may be required by this Part shall be conducted in accordance with the provisions of § 32.4.2 of this Part.
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/29/2004*
##### **216-RICR-40-05-32 § 32.4** Violations and Penalties Practices and Procedures Severability {#sec-216-ricr-40-05-32-32.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-32#32.4}
32.4.1Violations and Penalties
A.Any violations as set forth in § 32.3.7 of this Part shall be cause for the Department to impose such sanctions, or denial, revocation or suspension of license or imposing a reprimand or censure on such other disciplinary action. Furthermore, any violations of the provisions of R.I. Gen. Laws § 5-45-11 shall be subject to the penalties of that section.
32.4.2Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of the Act and the rules and regulations regarding Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Amendment — effective from 2026-07-02 to current*
- *Periodic Refile — effective from 2022-01-04 to 07/02/2026*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-29 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 02/29/2004*
#### **216-RICR-40-05-33** Speech Pathologists and Audiologists
##### **216-RICR-40-05-33 § 33.1** Authority {#sec-216-ricr-40-05-33-33.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-48-3(c), for the purpose of establishing prevailing standards and procedures for licensing speech pathologists and audiologists in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.2** Incorporated Materials {#sec-216-ricr-40-05-33-33.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.2}
These regulations hereby adopt and incorporate the American Speech-Language-Hearing Association’s “American Speech-Language-Hearing Association Code of Ethics” (2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.3** Definitions {#sec-216-ricr-40-05-33-33.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.3}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Accredited/approved” means that an institution/program holds regional accreditation from one (1) of six (6) regional accrediting bodies: Middle States Association of Colleges and Schools, New England Association of Schools and Colleges, North Central Association of Colleges and Schools, Northwest Association of Schools and Colleges, Southern Association of Colleges and Schools, and Western Association of Schools and Colleges.
2."Act" means R.I. Gen. Laws Chapter 5-48 entitled, "Speech Pathology and Audiology."
3."Audiologist" means an individual who is licensed by the Board to practice audiology.
4."Audiology" means the application of principles, methods, and procedures related to hearing and the disorders of the hearing and balance systems, to related language and speech disorders, and to aberrant behavior related to hearing loss by an audiologist. A hearing disorder is defined as altered sensitivity, acuity, function, processing, and/or damage to the integrity of the physiological auditory/vestibular systems, in individuals or groups of individuals who have or are suspected of having such disorders.
5."Audiology support personnel" shall operate under the title “audiometric aide” and means an individual who meets minimum qualifications, established by the Board, which are less than those established by the Act as necessary for licensing as an audiologist; does not act independently; is limited to hearing screening with pass/fail criteria, and works under the direction and supervision of an audiologist licensed under the Act who has been actively working in the field for twenty-four (24) months after completion of the postgraduate professional experience and who accepts the responsibility for the acts and performances of the audiometric aide while working under the Act.
6."Board" means the "State Board of Examiners for Speech Pathology and Audiology."
7."Clinical fellowship or traineeship" means the direct clinical work, consultation or other duties relevant to clinical speech language pathology work with individuals presenting disorders in communication, for a cumulative or equivalent total of nine (9) months of full- time employment following completion of professional speech language pathology education under supervision pursuant to R.I. Gen. Laws § 5-48-7.
8."Clinical fellow" means the person who is practicing speech language pathology under the supervision of a licensed speech language pathologist while completing the postgraduate professional experience as required by the Act and who holds a current provisional license in accordance with the requirements described in this Part.
9.“Department” means the Rhode Island Department of Health.
10."Director" means the Director of the Rhode Island Department of Health.
11.“Graduate program” means a post-baccalaureate accredited program leading to a master’s or doctoral degree, including a professional doctoral degree, whether offered through an accredited graduate or professional school.
12.“Newborn Hearing Screener” means an audiometric aide working in a hospital-based newborn hearing screening program under the direction of the RI Department of Health Newborn Hearing Screening Program or its appointee.
13."Person” means an individual, partnership, organization or corporation, except that only individuals can be licensed under the Act.
14."The practice of audiology" means an audiologist rendering or offering to render any service in audiology as defined in R.I. Gen. Laws § 5-48-1(8)(i).
15."The practice of speech language pathology" means rendering or offering to render any service in speech language pathology as defined in R.I. Gen. Laws § 5-48-1(9)(i).
16."Regionally accredited" means the official guarantee that a college or university or other educational institution is in conformity with the standards of education prescribed by a regional accrediting commission recognized by the United States Secretary of Education.
17.“School Hearing Screener” means an audiometric aide working in a school-based hearing screening program under the direction of the RI Department of Education or its appointee.
18."Speech language pathologist” means an individual who is licensed by the Board to practice speech language pathology.
19."Speech language pathology" means the activities defined in R.I. Gen. Laws § 5-48-1(12).
20."Speech language support personnel" means an individual who meets minimum qualifications established by the Board, which are less than those established by the Act as necessary for licensing as a speech language pathologist; does not act independently; and works under the direction and supervision of a speech language pathologist licensed under the Act who has been actively working in the field for twenty-four (24) months after completion of the postgraduate professional experience and who accepts the responsibility for the acts and performances of the speech language pathology assistant while working under the Act..
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.4** License Requirements {#sec-216-ricr-40-05-33-33.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.4}
A.No person shall practice as, advertise as, or use the title of speech pathologist or audiologist unless licensed in accordance with the provisions of the Act and this Part. The provisions of the Act and this Part shall not apply to individuals specifically exempt from the provisions thereof by R.I. Gen. Laws § 5-48-10.
B.A provisional license for the clinical fellow (defined in § 33.3(A)(8) of this Part) shall be required in speech language pathology for that period of postgraduate professional experience as required in R.I. Gen. Laws § 5-48-7 and § 33.5 of this Part. A provisional license shall authorize an individual to practice speech-language pathology solely in connection with the completion of the supervised postgraduate professional experience.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.5** Qualifications for Licensure {#sec-216-ricr-40-05-33-33.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.5}
A.Audiologists
1.In addition to the requirements set forth in R.I. Gen. Laws § 5-48-7.2, persons seeking initial licensure as an audiologist shall meet the following requirements:
a.Submit an official transcript indicating possession of an earned doctorate degree in audiology from a regionally accredited educational institution or other national accrediting organization as may be approved by the Board;
b.Pass a national examination in audiology approved by the Board;
c.Present evidence of practicum experience that is equivalent to a minimum of twelve (12) months of full-time, supervised experience, that may be completed as part of the graduate degree, as delineated in this Part;
d.Applicants with a Master’s Degree holding licensure from another state must present verification of a Certificate of Clinical Competence from the American Speech Language Hearing Association (ASHA) or other national accrediting association as may be approved by the Board.
B.Qualifications for Audiologists Licensed in Alternate Jurisdictions
1.Persons licensed as an audiologist in alternate jurisdictions on or before January 1, 2008 shall meet the requirements of Rhode Island that were in effect at the time of initial licensure in the alternate jurisdiction.
C.Speech Language Pathologists
1.In addition to the requirements set forth in R.I. Gen. Laws § 5-48-7 an applicant seeking licensure to practice as a speech language pathologist in Rhode Island must:
a.Have attained a master's degree or a doctoral degree or equivalent in speech language pathology from an accredited educational institution accredited by the Council on Academic Accreditation (CAA) of the American Speech Language Hearing Association (ASHA) or other national accrediting association as may be approved by the Board. The degree shall consist of course work in accordance with the current minimum requirements for the certificate of clinical competence issued by the American Speech Language Hearing Association (ASHA) or other national accrediting association as may be approved by the Board.
D.Qualifications for a Provisional License for Speech Language Pathologists
1.To be eligible for provisional licensure by the Department, the speech language pathologist must submit an application with the required application fee and be in compliance with the requirements of this Part and § 5-48-7.1 of the Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.6** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-33-33.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.6}
A.The Department shall issue a license as an audiologist or speech language pathologist, or renewal thereof, for a period of two (2) years. The license, unless sooner suspended or revoked, shall expire on the first day of July, two (2) years following its issuance, and may be renewed biennially (in even years), provided the applicant meets the requirements of this Part and the statutory provisions of the Act.
B.A license may be renewed by submission of the renewal application and renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) payable before July 1 of even years (biennially).
C. A provisional license may be renewed annually from the date of issue, if the post- graduate professional experience has exceeded one (1) year, by submission of the renewal application and renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. A provisional license shall not exceed thirty-six (36) months past the initiation of the professional experience and will expire ninety (90) days after the end of the postgraduate professional experience.
D.Any licensee who allows his or her license to lapse by failing to renew it on or before the thirtieth (30th) day of June of even years (biennially), may have the license renewed by submitting to the Department an application and renewal fee plus an additional late fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.Any person who allows his or her license to lapse longer than two (2) consecutive licensing periods may be reinstated by the Department, upon the filing of:
a.A reinstatement application for licensure;
b.Payment of the current licensure renewal fee plus an additional late fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
c.Documentation of completion of CEUs as required in § 33.9(A) of this Part taken during the previous two (2) years.
E.Inactive Status
1.An individual licensed as a speech language pathologist and/or audiologist in Rhode Island, not in the active practice of speech-language pathology or audiology within Rhode Island during any year, may upon request to the Department, have his or her name transferred to an inactive status and shall not be required to register biennially or pay any fee as long as he or she remains inactive.
a.Inactive status may be maintained for no longer than two (2) consecutive licensing periods, after which period licensure will be terminated and a reinstatement application submitted to the Department will be required to resume practice.
b.Any individual whose name has been transferred to an inactive status may be restored to active status within two (2) licensing periods to practice speech language pathology or audiology without a penalty fee, upon the filing of:
(1)An application for licensure renewal with a licensure renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and
(2)Such other information as may be requested by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.7** Denial, Suspension and Revocation of License {#sec-216-ricr-40-05-33-33.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.7}
A.The Board is authorized to suspend or revoke any license to practice speech language pathology and/or audiology upon finding by the Board that the person is guilty of conduct as set forth in R.I. Gen. Laws § 5-48-11, and in addition:
1.Violating any provision of the Act, any lawful order given, or rule or regulation adopted by the Board or departure from or failure to conform to the current standards of acceptable prevailing practice and code of ethics of speech language pathology or audiology as adopted by the Board and as contained in “American Speech-Language-Hearing Association Code of Ethics” as incorporated above at § 33.2 of this Part. The Board need not establish actual injury to clients in order to adjudge a speech language pathologist or audiologist of the above named conduct.
2.The procedure for denial, revocation or suspension shall be as that set forth in R.I. Gen. Laws § 5-48-13.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.8** Support Personnel {#sec-216-ricr-40-05-33-33.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.8}
A.Support personnel for speech language pathologists shall meet the following requirements:
1.Hold a bachelor's degree from an accredited college or university and have successfully completed no less than eighteen (18) hours of graduate credit in the areas of speech language pathology to include the following:
a.Normal processes in speech, language and hearing (3 hours);
b.Disorders of speech, language and hearing (9 hours);
c.Equipment, materials, procedures and data collection used in assessment and/or management of speech, language and hearing disorders (6 hours); and
d.Completion of twenty-five percent (25%) of those practicum hours required for professional personnel by the American Speech-Language Hearing Association (ASHA).
B.Support personnel for audiologists (audiometric aide) must meet the following requirements:
1.Hold a high school diploma;
2.Receive intensive on-the-job training in accordance with American Speech-Language Hearing Association (ASHA) or American Academy of Audiology (AAA) guidelines for support personnel by the supervising licensed audiologist prior to providing services. (Any subsequent supervising licensed audiologist may require retraining of an audiometric aide under his/her supervision).
C.Supervision and Responsibility: A supervising professional must be licensed under the Act who has been actively working in the field for twenty-four (24) months after completion of the postgraduate professional experience, and must be responsible for the acts and performances, patient screening, and specific tasks assigned by the licensee to the speech language pathologist/audiometric aide.
1.A licensee who supervises support personnel must:
a.Utilize the services of only those who meet the minimum requirements enumerated under § 33.8 of this Part;
b.Ensure that the support personnel are assigned only those duties and responsibilities for which the person has been specifically trained and which the assistant is qualified to perform;
c.Ensure that persons who will be receiving services from support personnel, or the person's legal representative, are informed that services are being rendered by support personnel;
d.Provide supervision of the support personnel (other than newborn hearing screeners and school hearing screeners):
(1)A speech/language pathologist supervisor may only supervise one (1) full- time equivalent speech language support personnel and an audiologist supervisor may only supervise three (3) full-time equivalent audiometric aides, unless otherwise approved by the Board;
(2)Observations of support audiometric aides must be completed and documented as to date, amount of time, and accuracy and efficacy of service according to the following:
(AA)Direct on-site observations of the first ten (10) hours of direct client contact; and five percent (5%) of all clinical sessions after the first ten hours for every forty (40) consecutive hours worked; and
(BB)Indirect supervision (e.g. Phone, interactive television, audio/video review or patient record review) of five percent (5%) of each forty (40) consecutive hours worked.
(3)Observations of speech language pathology support personnel must be completed and documented as to date, amount of time, and accuracy and efficacy of service according to the following:
(AA)Direct on-site observations of the first ten (10) hours of direct client contact; and ten percent (10%) of clinical sessions after the first ten (10) hours of each forty (40) consecutive hours worked; and
(BB)(Indirect supervision (e.g. phone, interactive television, audio/video review) of ten percent (10%) of each forty (40) consecutive hours worked.
e.Provide supervision of the support personnel (newborn hearing screeners and school hearing screeners):
(1)Hospital-based newborn hearing screeners and school-based hearing screeners shall be trained by a licensed audiologist working in the newborn hearing or school screening program according to training guidelines established by the programs.
(2)Supervision will include a method of evaluation and documenting the competency of each screener upon completion of the initial training and at least annually thereafter by a licensed audiologist working in the newborn hearing or school screening program.
f.Observe all provisions of the ASHA policy regarding support personnel unless a specific policy is addressed in this Part, including but not limited to, that the licensee must maintain records which document the frequency and type of supervision of support personnel, such records to be available for audit upon request by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.9** Continuing Education Requirements {#sec-216-ricr-40-05-33-33.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.9}
A.On or before the thirtieth (30th) day of June of even years, every person licensed to practice speech language pathology and/or audiology within Rhode Island shall complete not less than twenty (20) clock hours of continuing education within the preceding two (2) years and be able to present satisfactory evidence of completion to the Department.
1.Course descriptions, proof of attendance, or other documentation of completion shall be retained by the licensee for a minimum of four (4) years and is subject to random audit by the Department.
2.Activities approved by the Board for continuing education credit are those sponsored by the American Speech-Language Hearing Association (ASHA), the American Academy of Audiology (AAA), a state department of education, other International Association for Continuing Education and Training (IACET)-authorized providers, and/or continuing medical education units (CMEs) from the Accreditation Council for Continuing Medical Education (ACCME). Approved activities may include conferences, seminars, self- study programs, courses, or workshops sponsored by the organizations noted above, or course work from an accredited institution.
B.Those persons holding licensure in both speech language pathology and audiology must have completed and have evidence of completion of not less than thirty (30) clock hours of continuing education within the preceding two (2) years.
C.Continuing education hours may not be carried over from one (1) renewal period to the next.
D.Speech language pathologist or audiologists initially licensed by examination after the July 1st renewal date shall be exempt from the continuing education requirements stated in this Part until the date of the next renewal cycle (i.e., June 30th of the second year following its issuance).
E.The Board, at its discretion, may extend, reduce, or waive for a person the requirement for continuing education for hardship or other extenuating circumstances as the Board deems appropriate.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.10** Rules Governing the Dispensing and/or Selling of Hearing Aids {#sec-216-ricr-40-05-33-33.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.10}
An audiologist who engages in the dispensing and/or selling of hearing aids shall comply with any and all federal and state laws and regulations governing the sale of hearing aids.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
##### **216-RICR-40-05-33 § 33.11** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-33-33.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-33#33.11}
All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-10-31 to 01/04/2022*
- *Amendment — effective from 2013-07-09 to 10/31/2018*
- *Amendment — effective from 2012-12-10 to 07/09/2013*
- *Amendment — effective from 2008-01-30 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 01/30/2008*
- *Amendment — effective from 2003-07-16 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 07/16/2003*
#### **216-RICR-40-05-34** Licensing of Radiographers, Nuclear Medicine Technologists, and Radiation Therapists
##### **216-RICR-40-05-34 § 34.1** Authority {#sec-216-ricr-40-05-34-34.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.1}
These rules and regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws § 5-68.1-15, and are established for the purpose of establishing standards of education, training, and experience and to require licensure of radiologic technologists (radiographer), nuclear medicine technologists, and radiation therapists.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.2** Definitions {#sec-216-ricr-40-05-34-34.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.2}
A.Wherever used in these Regulations, the terms listed below shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 5-68.1 entitled “Radiologic Technologists”.
2.“Authorized user” means a licensed practitioner who meets the training and experience requirements defined in rules and regulations promulgated pursuant to R.I. Gen. Laws Chapter 23-1.3.
3."Board" means the Board of Radiologic Technology.
4."Department" means the Rhode Island Department of Health.
5."Director" means Director of the Rhode Island Department of Health.
6."Financial interest" means being:
a.A licensed practitioner of radiologic technology; or
b.A person who deals in goods and services that are uniquely related to the practice of radiologic technology; or
c.A person who has invested anything of value in a business that provides radiologic technology services.
7."License" means a license issued by the Department authorizing an individual to practice radiologic technology.
8."Licensed practitioner" means an individual licensed to practice medicine, chiropractic, podiatry or an individual licensed as a registered nurse practitioner or physician assistant in Rhode Island.
9.“Medical physicist” means an individual, other than a licensed practitioner, who practices independently one or more of the subfields of medical physics, and is registered or licensed under rules and regulations promulgated pursuant to R.I. Gen. Laws Chapter 23-1.3
10."National organization" means a professional association or registry, approved by the Director, that examines, registers, certifies or approves individuals and education programs relating to operators of sources of radiation.
11.“Nuclear medicine technologist” means an individual, other than a licensed practitioner, who compounds, calibrates, dispenses and administers radiopharmaceuticals, pharmaceuticals, and radionuclides under the general supervision of an authorized user for benefit of performing a comprehensive scope of nuclear medicine procedures, and who has met and continues to meet the licensure standards of the Act and this Part.
12.“Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state or any other state, or political subdivision of any agency thereof and any legal successor, representative, agent, or agency of the foregoing.
13.“Radiation therapist” means an individual, other than a licensed practitioner, who utilizes ionizing radiation under the general supervision of an authorized user for the planning and delivery of therapeutic procedures, and who has met and continues to meet the licensure standards of the Act and this Part.
14."Radiologic technologist" or "radiographer" means an individual, other than a licensed practitioner, who performs a comprehensive scope of diagnostic radiology procedures under the general supervision of a licensed practitioner using external ionizing radiation, resulting in radiographic or digital images, and who has met and continues to meet the licensure standard of the Act and this Part.
15."Radiologic technology" means a scientific discipline that includes individuals licensed to practice as:
a.a radiologic technologist (radiographer); or
b.nuclear medicine technologist; or
c.radiation therapist.
16."Radiologist" means a licensed practitioner specializing in radiology who is certified by or eligible for certification by the American Board of Radiology or the American Osteopathic Board of Radiology, the British Royal College of Radiology, or the Canadian College of Physicians and Surgeons.
17.“Radiologist assistant” means an unlicensed individual, other than a licensed practitioner, who performs as an advanced-level radiologic technologist and works under the general supervision of a radiologist to enhance patient care by assisting the radiologist in the medical imaging environment, and who has met and continues to meet the licensure standards of the Act and this Part.
18."Source of radiation" means any substance or device emitting or capable of producing ionizing radiation, for the purpose of performing therapeutic or diagnostic radiologic procedures on human beings.
19."Student" means an individual enrolled in a course of study for medicine or radiologic technology.
20."Supervision" means:
a.“Direct supervision" means supervision and control by a licensed practitioner who assumes legal liability for the services rendered by the radiologic technologist, which supervision requires the physical presence of the licensed practitioner for consultation and direction of the actions of the radiologic technologist.
b."General supervision" means supervision whereby a licensed practitioner, who assumes legal liability for the services rendered, authorizes the services to be performed by the radiologic technologist, which supervision, except in cases of emergency, requires the easy availability or physical presence of the licensed practitioner for consultation and direction of the actions of the radiologic technologist.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.3** License Requirement {#sec-216-ricr-40-05-34-34.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.3}
A.No individual shall practice as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist, or represent themselves as such, unless they are licensed under the Act and this Part. The provisions of § 34.3 of this Part do not apply to those individuals stated in R.I. Gen. Laws § 5-68.1-4.
B.This Part does not prohibit an individual enrolled in an approved school of radiologic technology, under the direct supervision of a radiologist or a licensed radiologic technologist, nuclear medicine technologist, or radiation therapist from performing those duties essential for completion of a student's clinical service.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.4** Licensing by Training and Examination {#sec-216-ricr-40-05-34-34.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.4}
A.A license to practice as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist, may be issued to an applicant, provided:
1.The Board receives verification that the applicant has successfully completed a training program approved by the board;
2.The Board receives verification that the applicant is certified by the American Registry of Radiologic Technologists;
3.The applicant makes application to the Board on a written form and in the manner prescribed by the Board; and
4.At the time the application is filed the applicant pays all fees as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Fees are non-returnable and non-refundable.
B.An individual desiring to become licensed in more than one (1) category of radiologic technology shall submit a separate application for each category in which they are to be licensed.
C.Any radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist licensed pursuant to this Part, desiring to obtain a supplemental authorization for computed tomography (CT) procedures shall make application to the Board per § 34.7 of this Part.
D.No individual shall use any title or abbreviation to indicate that the individual is licensed as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist unless they are licensed in that category of radiologic technology pursuant to the Act and this Part.
E.A valid license issued pursuant to the Act and this Part shall be carried on the person of the radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist while performing the duties for which the license is required.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.5** Graduate Practice {#sec-216-ricr-40-05-34-34.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.5}
In addition to the requirements for licensure as a graduate technologist stated in R.I. Gen. Laws § 5-68.1-6(2)(b), such applicants for licensure must provide such other information as may be deemed necessary and appropriate by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.6** Licensing by Endorsement {#sec-216-ricr-40-05-34-34.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.6}
A.A license to practice as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist may be issued without examination to an applicant who has been duly licensed by examination as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist in another state, and the requirements for such certification, license or registration are substantially equivalent to those established under the Act and this Part, provided:
1.The Board receives verification of licensure in good standing from each state in which the applicant has held or holds licensure
2.The Board receives verification that the applicant is certified by the American Registry of Radiologic Technologists
3.The applicant makes application to the Board on a written form and in the manner prescribed by the Board
4.At the time the application is filed the applicant pays all fees as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Fees are non-returnable and non-refundable.
B.An individual desiring to become licensed in more than one (1) category of radiologic technology must submit a separate application for each category in which they are to be licensed.
C.Any radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist, licensed pursuant to this Part, desiring to obtain a supplemental authorization for computed tomography (CT) procedures shall make application to the Board per § 34.7 of this Part.
D.No individual shall use any title or abbreviation to indicate that the individual is licensed as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist unless they are licensed in that category of radiologic technology pursuant to the Act and this Part.
E.A valid license issued pursuant to the Act and this Part shall be carried on the person of the radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist while performing the duties for which the license is required.
F.Applicants must provide such other information as may be deemed necessary and appropriate by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.7** Additional Clinical Competency in Computed T omography (CT ) {#sec-216-ricr-40-05-34-34.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.7}
A.Except as specifically authorized in §§ 34.7(A)(1) through (3) and 34.7(B) of this Part, an individual licensed pursuant to this Part is not authorized to perform CT procedures.
1.Radiologic Technologist (Radiographer).
a.Prior to August 1, 2013, an active license as a radiologic technologist (radiographer), issued pursuant to this Part, shall be deemed sufficient to constitute clinical competency in CT.
b.Effective August 1, 2013, a radiologic technologist (radiographer) shall also require a supplemental authorization for CT procedures pursuant to this Section. The supplemental authorization is not required for a radiologic technologist (radiographer) who does not perform CT procedures.
2.Nuclear Medicine Technologist.
a.A nuclear medicine technologist who performs only PET-CT and/or SPECT-CT (attenuation correction) procedures shall comply with at least one (1) of the following training requirements:
(1)Be certified as a Radiologic Technologist (radiographer) by American Registry of Radiologic Technologists (ARRT); or
(2)Provide documentation for successful completion of both supplemental CT; or
(3)Training approved by the Board and “hands-on” experience with the fusion scanner to be used; or
(4)Obtain supplemental authorization for CT procedures pursuant to § 34.7(A)(1)(b) of this Part.
b.A nuclear medicine technologist who utilizes CT procedures for other than PET-CT and/or SPECT-CT (attenuation correction) shall be required to obtain supplemental authorization for CT procedures pursuant to this section.
3.Radiation Therapist.
a.Prior to August 1, 2013, an active license as a radiation therapist, issued pursuant to this Part, shall be deemed sufficient to constitute clinical competency in CT for positioning and simulation.
b.Effective August 1, 2013, a radiation therapist who utilizes CT procedures only for positioning and simulation shall comply with at least one (1) of the following training requirements:
(1)Obtain certification as a Radiation Therapist by the American Registry of Radiologic Technologists (ARRT) on or after January 1, 2011; or
(2)Provide documentation for completion of manufacturer training for utilization of the CT unit for simulation and positioning, supplemented by "hands-on" training conducted by in-house medical physics staff; or
(3)Be certified as a Radiologic Technologist (radiographer) by American Registry of Radiologic Technologists (ARRT); or
(4)Obtain supplemental authorization for CT procedures pursuant to this section.
c.Effective August 1, 2013, a radiation therapist who utilizes CT procedures for other than positioning and simulation shall also require supplemental authorization for CT procedures pursuant to this section.
B.Documentation of Training.
1.In addition to the requirements of § 34.7(A) of this Part, a licensee shall retain documentation of all supplemental and in-house/hands-on training required to demonstrate compliance with §§ 34.7(A)(2)(a)((2)) and/or 34.7 (A)(3)(b)((2)) of this Part.
2.If any training described in § 34.7(B)(1) of this Part was obtained from a facility other than the licensee’s current employer, copies of all required documentation shall also be provided to the current facility’s radiation safety officer (or equivalent) for inclusion with the facility training records.
C.At the time the application is filed the applicant pays an additional application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Fees are non-returnable and non-refundable.
D.No individual shall use any title or abbreviation to indicate that the individual is licensed as a computed tomographer unless they are licensed in that category of radiologic technology pursuant to the Act and this Part.
E.A valid license issued pursuant to the Act and this Part shall be carried on the person of the computed tomographer while performing the duties for which the license is required.
F.Applicants must provide such other information as may be deemed necessary and appropriate by the Board.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.8** Issuance and Renewal of License and Fee {#sec-216-ricr-40-05-34-34.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.8}
34.8.1Issuance of License
A.Pursuant to the provisions of R.I. Gen. Laws § 5-68.1-8, and at the recommendation of the Board, the Department shall issue a radiologic technology license to an individual who meets the licensure requirements set forth in this Part. A radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist license shall be issued for a period no longer than two (2) years and shall expire on the thirty-first (31st) day of July of each odd numbered year, unless sooner suspended or revoked. The license may be renewed every two (2) years in accordance with the provisions of § 34.8.1(C) of this Part.
B.Pursuant to the provisions of R.I. Gen. Laws § 5-68.1-8, and at the recommendation of the Board, the Department shall issue supplemental authorization for computed tomography (CT) procedures to an individual who holds an active radiologic technology license, and who meets the applicable requirements set forth in this Part. A supplemental authorization for computed tomography (CT) procedures shall be issued for a period no longer than two (2) years and shall expire on the thirty-first (31st) day of July of each odd numbered year, unless sooner suspended or revoked. A supplemental authorization for computed tomography (CT) procedures may be renewed every two (2) years in accordance with the provisions of § 34.8.1(C) of this Part.
C.On or before the first (1st) day of July of each odd-numbered year, the Department shall mail an application for renewal of license to every individual to whom a license has been issued or renewed during the current licensure period.
1.An individual licensed as a radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist who desires to renew his or her license shall file a renewal application, together with the renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) with the Department on or before the thirty-first (31st) day of July of each odd numbered year.
2.An individual licensed in more than one (1) category of radiologic technology shall be required to submit a separate renewal application and fee for each licensed category of radiologic technology.
3.An individual with a supplemental authorization for computed tomography (CT) procedures who desires to renew his or her supplemental authorization shall file a duly executed renewal application, together with the renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) with the Department on or before the thirty-first (31st) day of July of each odd numbered year.
D.Upon satisfactory completion of the renewal requirements in § 34.8.1(C) of this Part, the Department shall grant a renewal license and, if applicable, a supplemental authorization for computed tomography (CT) procedures effective the first (1st) day of August, and expiring on the thirty-first (31st) day of July of the next odd-numbered year.
E.If a license issued pursuant to this Part has expired and a renewal application and appropriate fee are not received by the Department on or before the expiration date of the license, a late renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) shall be submitted with the renewal application.
F.A radiologic technologist (radiographer), nuclear medicine technologist, or radiation therapist who has failed to pay an administrative fine imposed by a final order of the Director shall submit payment of the administrative fine in full as a condition of license renewal.
34.8.2Maintenance of National Certification
Each renewal application shall contain a statement signed by the licensee attesting that all national certifications required pursuant to §§ 34.4, 34.6 and/or 34.7 of this Part are active and not subject to any restriction, limitation or other sanction.
34.8.3Required Notification to the Department:
A.An individual licensed pursuant to this Part shall notify the Department, in writing, within five (5) business days of receiving notification from a national certification board that any national certification required pursuant to §§ 34.4, 34.6 and/or 34.7 of this Part has been revoked and/or subject to any restriction, limitation or other sanction.
B.An individual licensed pursuant to this Part shall notify the Department, in writing, within five (5) business days of failure to renew or other lapse of any national certification required pursuant to §§ 34.4, 34.6 and/or 34.7 of this Part.
C.An individual licensed pursuant to this Part shall notify the Department, in writing, within five (5) business days of all medical malpractice court judgments and all medical malpractice arbitration awards in which payment was awarded to a complaining party in any state in which the individual was licensed, and all settlements of malpractice claims in which payment was made to a complaining party in any state in which the individual was licensed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.9** Denial, Suspension, Revocation, and Reinstatement of Licenses {#sec-216-ricr-40-05-34-34.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.9}
A.The Board may recommend refusal, suspension or revocation of any license in accordance with R.I. Gen. Laws § 5-68.1-11. Additionally, the Board may recommend refusal, suspension or revocation of any license for failure to attest to maintenance of national certification pursuant to § 34.8.2 of this Part.
B.Reinstatement: Application for reinstatement may be made in accordance with the provisions of R.I. Gen. Laws § 5-68.1-11(7)(b). If the Board rejects an application for reinstatement, restoration or modification of probation, the individual shall be required to wait at least six (6) months from the date of the Board’s rejection before submitting a subsequent application for reinstatement, restoration or modification of probation to the Board.
C.The Director may temporarily suspend the license of a radiologic technologist (radiographer), nuclear medicine technologist, radiation therapist without a hearing in accordance with the provisions of R.I. Gen. Laws § 5-68.1-12.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
##### **216-RICR-40-05-34 § 34.10** Rules Governing Practices and Procedures {#sec-216-ricr-40-05-34-34.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-34#34.10}
All hearings and reviews required under the provisions of the Act and this Part shall be held in accordance with the provisions of the Rules and Regulations of the Rhode Island Department of Health Governing the Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records of the Department of Health (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2011-10-17 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/17/2011*
- *Amendment — effective from 2003-12-02 to 06/19/2007*
- *Periodic Refile — effective from 2002-01-02 to 12/02/2003*
#### **216-RICR-40-05-35** Doctors of Naturopathy
##### **216-RICR-40-05-35 § 35.1** Authority {#sec-216-ricr-40-05-35-35.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 5-36.1-10(c), for the purpose of establishing prevailing standards governing the licensure and discipline of doctors of naturopathy in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.2** Definitions {#sec-216-ricr-40-05-35-35.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.2}
A.Wherever used in this Part, the terms listed below shall be construed in the following manner:
1.“Acupuncture” means the insertion of needles into the human body by piercing the skin of the body, for the purpose of controlling and regulating the flow and balance of energy in the body, as defined by R.I. Gen. Laws § 5-37.2-2(1). For the purposes of this Part; “medical acupuncture” means acupuncture as practiced by physicians licensed under the provisions of R.I. Gen. Laws Chapter 5-37.
2."Act" means R.I. Gen. Laws Chapter 5-36.1 entitled, "The Licensure of Naturopathy Act”.
3."Board" means the board of licensure of naturopathy or any committee or subcommittee thereof established under the provisions of R.I. Gen. Laws § 5-36.1-8.
4."Collaborative and consultation agreement" means an agreement between a doctor of naturopathy and a physician licensed under R.I. Gen. Laws Chapter 5-37. The collaboration and consultation agreement shall include all requirements set forth in R.I. Gen. Laws § 5-36.1-12.
5."Director" means the Director of the Rhode Island Department of Health.
6.“Doctor of acupuncture” means a person who has been licensed under the provisions of R.I. Gen. Laws Chapter 5-37.2 to practice the art of healing known as acupuncture.
7. “Doctor of naturopathy” means a person who practices naturopathic health care and is licensed pursuant to the provisions of R.I. Gen. Laws § 5-36.1-13.
8."License" is synonymous with registration certificate.
9.“Medical record” means a record of a patient’s medical information and treatment history maintained by physicians and other medical personnel, which includes, but is not limited to, information related to medical diagnosis, immunizations, allergies, x-rays, copies of laboratory reports, records of prescriptions, and other technical information used in assessing the patient’s health condition, whether such information is maintained in a paper or electronic format.
10. “Natural” means present in, produced by, or derived from nature.
11. “Naturopathic health care” or “practice of naturopathic health care” means a system of health care that utilizes education, natural substances and natural therapies to support and stimulate a patient’s intrinsic self-healing processes and to prevent, and treat human health conditions and injuries.
12."Person" means any individual, partnership, firm corporation, (including, but not limited to, associations, joint stock companies, limited liability companies, and insurance companies), trust or estate, state or political subdivision or instrumentality of a state.
13."Physician" means any person licensed to practice allopathic or osteopathic medicine pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
14.“RIDOH” means the Rhode Island Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.3** License Requirements {#sec-216-ricr-40-05-35-35.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.3}
A.The penalty for misrepresentation is set forth in R.I. Gen. Laws § 5-36.1-4. Misrepresentation shall include the holding of oneself out to the public as a practitioner of naturopathic health care, whether by appending to one’s name the title of doctor of naturopathy or any abbreviation thereof, or NMD, N.D., ND, or any other title or designation implying one is a practitioner of naturopathic health care.
1.All naturopathic doctors who are licensed to practice naturopathic health care in Rhode Island must obtain and sustain malpractice coverage prior to seeing patients. Proof of malpractice insurance shall be provided to the Board upon request. It is incumbent upon the licensee to ensure that malpractice coverage does not lapse while engaged in the practice of naturopathic health care.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.4** Qualifications {#sec-216-ricr-40-05-35-35.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.4}
A.Qualifications for licensure: Applicants for licensure as a doctor of naturopathy must satisfy the conditions set forth in R.I. Gen. Laws § 5-36.1-12.
1.The degree of doctor of naturopathy from a board-approved naturopathic medical college required by R.I. Gen. Laws § 5-36.1-12(1) must include completion of at least twelve hundred (1,200) hours of board-approved clinical before graduation.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.5** Application for License & Fees {#sec-216-ricr-40-05-35-35.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.5}
35.5.1Application
A.Application for licensure shall be made on forms provided by RIDOH which shall be completed, including the doctor of naturopathy’s signature, and submitted to RIDOH.
B.Such application shall be accompanied by the non-refundable, non-returnable license fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Applications for initial licensure by examination must include:
1.A completed application, in the English language or accompanied by a certified translation thereof into English;
2.Provide license verification letters from every jurisdiction that the candidate holds or has held a license;
3.An official transcript, or other official documentation satisfactory to the Board, verifying that the applicant has graduated from a board approved naturopathic medical college, provided that the applicant completed a minimum of twelve hundred (1,200) hours of board-approved clinical before graduation.
4.Evidence of having passed a competency-based state or national naturopathic licensing examination RIDOH deems necessary to test the applicant’s knowledge and skills to practice naturopathic health care in Rhode Island, including but not limited to Part I (biomedical science examination) and Part II (clinical science examination) of the Naturopathic Physicians Licensing Examinations or successor.
5.A written collaboration and consultation agreement with a physician licensed under R.I. Gen. Laws Chapter 5-37, pursuant to R.I. Gen. Laws § 5-36.1-12(4).
6.Such other information as may be deemed necessary and appropriate by RIDOH.
D.An applicant shall not be eligible for licensure by endorsement if the Board finds that the applicant has engaged in any conduct prohibited by this Part.
35.5.2Examination
Applicants shall be required to pass such examination as RIDOH deems necessary to test the applicant's knowledge and skills to practice naturopathic health care in Rhode Island pursuant to the Act and this Part.
35.5.3Continuing Education
A.Every doctor of naturopathy licensed to practice naturopathic health care in Rhode Island under the provisions of the Act and this Part, before the expiration date which occurs every two (2) years starting from the date of issuance, must earn a minimum of thirty (30) hours of continuing education credits and shall document this to the Board upon request.
B.It shall be the sole responsibility of the individual doctor of naturopathy to obtain documentation from the approved sponsoring or co-sponsoring organizations, agencies or other, of his or her participation in a learning experience and the number of dated credits earned.
1.Those documents must be safeguarded, for a period of three (3) years, by the doctor of naturopathy for review by the Board if required. Only a summary list of those documents, not the documents themselves, shall be submitted with the application for renewal of the certification.
C.Licensure renewal shall be denied to any applicant who fails to provide satisfactory evidence of continuing education as required by this Part.
35.5.4Issuance and Renewal of License and Fee
A.Upon completion of the aforementioned requirements and upon submission of the initial application and licensure fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), the Director may issue a license to those applicants found to have satisfactorily met all the requirements of this Part. The license, unless sooner suspended or revoked, shall expire biennially on a day two (2) years from the original date of issuance and every two (2) years thereafter on the same month and day.
B.Every licensed doctor of naturopathy who intends to practice naturopathic health care during the ensuing two (2) years shall file a renewal application with the Board before the expiration date, together with the renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Upon receipt of a renewal application and payment of fee, a license renewal, subject to the terms of the Act and this Part, shall be issued, effective for two (2) years, unless sooner suspended or revoked.
D.The licenses (registration certificates) of all doctors of naturopathy whose renewals, accompanied by the prescribed fee, are not filed before the expiration date shall be automatically lapsed. The license may be renewed upon the payment by the doctor of naturopathy of the current licensure (registration) fee, plus an additional late fee, as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.If the license has been lapsed for greater than one (1) year, the doctor of naturopathy will be subject to the provisions of § 35.5.5(A)(5) of this Part prior to renewal of the license.
35.5.5Refusal of License
A.The Director, after due notice and hearing, in accordance with the procedures set forth in R.I. Gen. Laws § 5-36.1-16, may refuse to grant the original license to any doctor of naturopathy and/or applicant who:
1.Is not of good moral character;
2.Does not meet the requirements for licensure set forth in the Act and/or this Part, who has violated any laws affecting the ability of any doctor of naturopathy and/or applicant to practice naturopathic health care; or
3.Has been found guilty in another state of conduct which if committed in Rhode Island would constitute unprofessional conduct, as defined in R.I. Gen. Laws § 5-36.1-15 and this Part.
4.Has been denied naturopathic health care licensure in another state.
5. A doctor of naturopathy who has been out of clinical practice for a period of time greater than one (1) year may be required to demonstrate competency, as determined by the board prior to issuance or renewal of a license. If the license is allowed to lapse for more than one (1) year, the licensee must re-apply pursuant to § 35.5.1 of this Part.
B.The Director shall serve a copy of his or her decision or ruling upon any person whose original certificate has been refused.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.6 Scope of Practice** 35.6 Scope of Practice {#sec-216-ricr-40-05-35-35.6-scope-of-practice omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.6 Scope of Practice}
Scope of practice of a doctor of naturopathy is set forth in R.I. Gen. Laws § 5-36.1-3.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.7 Prohibited Acts** 35.7 Prohibited Acts {#sec-216-ricr-40-05-35-35.7-prohibited-acts omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.7 Prohibited Acts}
Prohibited acts by a doctor of naturopathy are set forth in R.I. Gen. Laws § 5-36-1-5.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.8 Reporting of Contagious and Infectious Diseases** 35.8 Reporting of Contagious and Infectious Diseases {#sec-216-ricr-40-05-35-35.8-reporting-of-contagious-and-infectious-diseases omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.8 Reporting of Contagious and Infectious Diseases}
Doctors of naturopathy are subject to the provisions of the rules and regulations for Reporting and Testing of Infectious, Environmental, and Occupational Diseases (Part 30-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.9 Informed Consent and Disclosure** 35.9 Informed Consent and Disclosure {#sec-216-ricr-40-05-35-35.9-informed-consent-and-disclosure omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.9 Informed Consent and Disclosure}
Requirements for informed consent and disclosure prior to treating any patient by a doctor of naturopathy are set forth in R.I. Gen. Laws § 5-36.1-18.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.10** Unprofessional Conduct {#sec-216-ricr-40-05-35-35.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.10}
A.The Director is authorized to deny or revoke any license to practice naturopathic health care or otherwise discipline a licensee upon finding by the Board that the person is guilty of unprofessional conduct which shall include, but not be limited to those items, or combinations thereof, listed in R.I. Gen. Laws § 5-36.1-15.
B.Licenses that have been revoked by the Director shall not be eligible for consideration for re-instatement for a period of five (5) years. Re-instatement of revoked licenses shall be at the discretion of RIDOH.
35.10.1 Discharging a Patient from a Practice
Periodically, a doctor of naturopathy may need to terminate the naturopathic doctor-patient relationship. This shall be done via written notice, which shall be documented in the medical record. The doctor of naturopathy/practice must be available to the patient for thirty (30) days for urgent or emergent conditions.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.11** Closing a Medical Practice {#sec-216-ricr-40-05-35-35.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.11}
A.In the event of a planned voluntary closure of a practice, the doctor of naturopathy shall, at least ninety (90) days before closing his or her practice, give public notice as to the disposition of patients' medical records in a media venue with, at a minimum, statewide influence, and shall notify the Board of the location of the records. The public notice shall include the date of the doctor of naturopathy’s retirement, and where and how patients may obtain their records both prior to and after closure of the doctor of naturopathy’s practice.
B.The heirs or estate of a deceased doctor of naturopathy who had been practicing at the time of his or her death shall, within ninety (90) days of the doctor of naturopathy’s death, give public notice as to the disposition of patients' medical records in a media venue with a statewide circulation, and shall notify the Board of the location of the records.
C.Any doctor of naturopathy closing his or her practice, or the heirs or estate of a deceased doctor of naturopathy who had been practicing at the time of his or her death, shall store the doctor of naturopathy’s patient records in a location and manner so that the records are maintained and accessible to patients.
D.Any person or corporation or other legal entity receiving medical records of any retired doctor of naturopathy or deceased doctor of naturopathy who had been practicing at the time of his or her death, shall comply with and be subject to the provisions of R.I. Gen. Laws Chapter 5-37.3, and shall be subject to the rules and regulations promulgated in accordance with R.I. Gen. Laws § 23-1-48 and with the provisions of R.I. Gen. Laws § 5-37-22(c) and (d), even though this person, corporation, or other legal entity is not a doctor of naturopathy.
35.11.1Medical Records
A.Medical records and medical bills may be requested by the patient or the patient’s personal representative. All medical record requests to doctors of naturopathy shall be made in writing through a properly executed Authorization for Release of Health Care Information.
B.Reimbursement.
1.Reimbursement to the doctor of naturopathy for providing a patient a copy of their medical record, regardless of format, shall not actual direct labor cost of reproducing the medical records.
2.The doctor of naturopathy may not require prior payment of charges for naturopathic health care services as a condition for obtaining a copy of the medical record. The doctor of naturopathy may not require prepayment of charges for duplicating or retrieving records as a condition prior to fulfilling the patient's request for the medical record if the request is for the purpose of continuity of care. Copying of X-rays or other documents not reproducible by photocopy shall be at the actual cost plus reasonable fees for clerical service not to exceed twenty-five dollars ($25.00). Charges shall not be made if the record is requested by the applicant or beneficiary or individual representing an applicant or beneficiary for the purposes of supporting a claim or appeal under the provision of the Social Security Act or any federal or state needs-based program such as Medical Assistance, RIte Care, Temporary Disability Insurance and Unemployment compensation.
3.No fees shall be charged to an applicant for benefits in connection with a Civil Court Certification Proceeding or a claim under R.I. Gen. Laws § 28-29-38 as reflected in R.I. Gen. Laws § 23-17-19.1(16).
4.Requested records must be provided within thirty (30) days of the receipt of the written request or signed authorization for records. Requests for medical records made by authorized third parties (e.g., attorneys representing the patient, attorneys not representing the patient, a patient's estate on behalf of the patient, or insurance companies) submitting a properly executed Authorization for Release of Information shall be billed at direct labor cost of reproducing the medical records.
5.No fees shall be charged when a medical record is being sent from one provider to the next in the context of a consultation.
C.Medical Records shall be stored by doctors of naturopathy or their authorized agents for a period of at least seven (7) years unless otherwise required by law or regulation.
D.Medical Records shall be legible and contain the identity of the all health care providers including professional title who is responsible for rendering, ordering, supervising or billing each diagnostic or treatment procedure. The records must contain sufficient information to justify the course of treatment, including, but not limited to: active problem and medication lists; patient histories; examination results; test results; records of medications dispensed, or administered; and reports of consultations and hospitalizations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
##### **216-RICR-40-05-35 § 35.12** Practices and Procedures {#sec-216-ricr-40-05-35-35.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-05-35#35.12}
35.12.1Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of the Act and this Part shall be held in accordance with the provisions of the Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-05-15 to 01/04/2022*
- *Adoption — effective from 2018-05-15 to 05/15/2018*
### **Subchapter 10** Facilities Regulation
#### **216-RICR-40-10-1** Licensing of Nursing Facilities
##### **216-RICR-40-10-1 § 1.1** Authority {#sec-216-ricr-40-10-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.1}
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-17-10, 23-17.5-32, and 23-17.5-33 and are established for the purpose of establishing minimum requirements for the licensure of nursing facilities in Rhode Island, including provisions for resident-directed homes, minimum hours of direct nursing care and reimbursement of any monies that have been prepaid on behalf of a deceased patient to the nursing facility.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.2** Incorporated Materials {#sec-216-ricr-40-10-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.2}
A.These Regulations hereby adopt and incorporate 42 C.F.R. Part 483 (2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate The National Academic Press’s “Dietary Reference Intakes: The Essential Guide to Nutrient Requirements” (2006) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the U.S. Department of Health & Human Services, Office of Minority Health’s “National Standards on Culturally and Linguistically Appropriate Services (CLAS)” (2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate the Facility Guidelines Institute’s “Guidelines for Design and Construction of Residential Health, Care and Support Facilities" (2018 edition) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
E.These Regulations hereby adopt and incorporate the American National Standards Institute’s “Accessible and Useable Buildings and Facilities (ICC A117.1-2009)” by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
F.These Regulations hereby adopt and incorporate 28 C.F.R. Part 36 (1991) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
G.These Regulations hereby adopt and incorporate the National Fire Protection Association’s “Standards on Types of Building Construction [NFPA 220]” (2012) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
H.These Regulations hereby adopt and incorporate by reference 42 C.F.R. § 483.10(c)(6) (2017), not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.3** Definitions {#sec-216-ricr-40-10-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Abuse" means any assault as defined in R.I. Gen. Laws Chapter 11-5, including, but not limited to hitting, kicking, pinching, slapping or the pulling of hair, provided however, unless such is required as an element of offense, it shall not be necessary to prove that the patient or resident was injured thereby, or any assault as defined in R.I. Gen. Laws Chapter 11-37, or any offense under R.I. Gen. Laws Chapter 11-10; or
a.Conduct which harms or is likely to physically harm the resident except where the conduct is a part of the care and treatment, and in furtherance of the health and safety of the resident; or
b.Engaging in a pattern of harassing conduct which causes or is likely to cause emotional or psychological harm to the resident, including but not limited to, ridiculing or demeaning a patient or resident, making derogatory remarks to a patient or resident or cursing directed towards a patient or resident, or threatening to inflict physical or emotional harm on a patient.
2.“Advanced practice registered nurse" or “APRN” means an individual licensed to practice advanced practice registered nursing within one of the following roles: certified nurse practitioner (CNP), certified registered nurse anesthetist (CRNA) as defined in R.I. Gen. Laws Chapter 5-34.2, or certified clinical nurse specialist (CNS), and who functions in a population focus. An APRN may serve as a primary-or acute-care provider of record and is licensed in accordance with R.I. Gen. Laws Chapter 5-34.
3."Alzheimer dementia special care unit or program" means a distinct living environment within a nursing facility that has been physically adapted to accommodate the particular needs and behaviors of those with dementia. Such unit provides increased staffing, therapeutic activities designed specifically for those with dementia and trains its staff on an ongoing basis on the effective management of the physical and behavioral problems of those with dementia. The residents of such a unit/program have had a standard medical diagnostic evaluation and have been determined to have a diagnosis of Alzheimer dementia or another dementia.
4."The licensed bed capacity” means the maximum number of beds a nursing facility is licensed to operate and that may be accommodated within a facility according to the dimensional limitations of § 1.19.7 of this Part.
5.“Census” means a point in time count of all residents physically present in a nursing facility and/or not officially discharged from the nursing facility.
6."Change in operator" means a transfer by the Licensee or the governing body of a licensed nursing facility to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the Licensee/governing body's responsibility to:
a.Hire or fire the chief executive officer of the nursing facility;
b.Maintain and control the books and records of the nursing facility;
c.Dispose of assets and incur liabilities on behalf of the nursing facility; or
d.Adopt and enforce policies regarding operation of the nursing facility.
e.Comply with State and Federal safety regulations including, specifically, those set forth under § 1.2 of this Part.
7."Change in owner" of licensed facility applies to both owners and operators and means:
a.In the case of a nursing facility which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of a nursing facility which is an unincorporated solo proprietorship, the transfer of the title and property to another person;
c.In the case of a nursing facility which is a corporation;
(1)A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two (2) or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a nursing facility which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of a nursing facility which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
8.“Consistent assignment” means the same direct care nursing staff, universal workers, and/or self-directed work teams, consistently caring for the same resident(s) the majority of their shifts whenever they are on duty.
9."Controlling person" means any person in control of a nursing facility directly or indirectly, including all of the following:
a.In the case of a nursing facility which is a limited liability company, or limited liability partnership, a person having a beneficial ownership interest of five percent (5%) or more in the corporation, limited liability company or limited liability partnership to which the nursing facility is licensed;
b.In the case of a nursing facility which is a general partnership or limited partnership, any general partner;
c.In the case of a nursing facility which is a limited liability company, or limited liability partnership any member;
d.A person that operates or contracts with another person for the operation of a nursing facility;
e.Each of the president, vice president, secretary and treasurer of a corporation that is not exempt from taxation under § 501(a) of the United States Internal Revenue Code (26 U.S.C. § 501(a)) as an organization described in § 501(c)(3) of such code; and
f.Such other ownership interest or relationship as may be determined by the Director.
10.“Credentialing” means the administrative process for reviewing, verifying, and evaluating the qualifications and credentials of licensed physicians, physician assistants and advanced practice registered nurses in accordance with criteria established by the nursing facility for the purpose of granting clinical privileges at the nursing facility.
11."Declaration of disaster emergency" means a disaster emergency declared by the Governor pursuant to R.I. Gen. Laws § 30-15-9.
12."Department" means the Rhode Island Department of Health.
13.“Direct care nursing staff” means registered nurses, licensed practical nurses, certified nursing assistants, medication technicians, licensed physical therapists, licensed occupational therapists, licensed speech language pathologists, and physical therapy assistants who are assigned to provide direct nursing care to residents.
14."Direct caregiver" means a person who receives monetary compensation as an employee of the nursing facility or a subcontractor as a registered nurse, a licensed practical nurse, a medication technician, a certified nursing assistant, a licensed physical therapist, a licensed occupational therapist, a licensed speech-language pathologist, or a physical therapist assistant.
15.“Director” means the Director of the Rhode Island Department of Health.
16."Drug administration" means an act in which a single dose of a prescribed drug or biological is given to a resident by an authorized person in accordance with this Part.
17."Employee" means an individual employed, whether directly, by the contract with another entity or as an independent contractor, by a long-term care nursing facility on a part-time or full-time basis.
18.“Equity” means non-debt funds contributed towards the capital costs related to the initial establishment and licensure of a nursing facility or a change in owner or change in operator of a nursing facility which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
19."Essential caregiver" means an individual, whether a family member or friend of a resident of a nursing home or long-term care facility, who is designated by the resident or appointed by an individual with decision-making authority for the resident to provide physical or emotional support to the resident during a declaration of disaster emergency.
20.“Family council” means an organized group of the family members, friends, or representatives of nursing facility residents who may meet in private without the presence of nursing facility staff.
21."Health care facility" means a facility as defined in R.I. Gen. Laws § 23-17-2(9).
22.“Health care provider” means any person licensed in Rhode Island to provide or otherwise lawfully providing health care services, including, but not limited to, a physician, hospital, intermediate care facility or other health care facility, dentist, nurse, optometrist, podiatrist, physical therapist, psychiatric social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of their employment or agency related to or supportive of health services.
23."High managerial agent" means an officer of a nursing facility, the administrator and assistant administrator of the nursing facility, the director and assistant director of nursing services, or any other agent in a position of comparable authority with respect to the formulation of policies of the nursing facility or the supervision in a managerial capacity of subordinate employees.
24."Hours of direct nursing care" means the actual hours of work performed per patient day by a direct caregiver.
25."Immediate jeopardy" means a situation in which the nursing facility's noncompliance or alleged noncompliance with one (1) or more state or federal requirements or conditions has caused, or is likely to cause, serious injury, harm, impairment or death to a resident; or shall be defined in accordance with 42 C.F.R. Part 489 or any subsequent applicable federal regulations.
26.“Lessee” means the person that leases the real property of a nursing facility from its owner. The term “lessee” includes any sublessees of the lessee.
27.“Licensee” means the holder of a nursing facility license issued by the Department.
28."Licensing agency" means the Rhode Island Department of Health.
29."Lift team" means health care nursing facility employees specially trained to perform patient lifts, transfers, and repositioning in accordance with a safe patient handling policy.
30."Long-term care facility or facility" means a health care facility as defined in R.I. Gen. Laws Chapter 23-17, which provides long term health care.
31.“Management company” means a company that provides limited, defined administrative services for a nursing facility owner, operator or lessee. A management company may not discharge functions that are reserved to the operator/licensee/governing body. The nursing facility owner, operator or lessee that engages a management company remains responsible for the services provided by the management company.
32.“Medication technician or aide” means a nursing assistant who has satisfactorily completed a Rhode Island-approved course in drug administration and who may administer oral or topical drugs (with the exception of Schedule II drugs) in accordance with the requirements of § 1.16.10(A) of this Part.
33."Mistreatment" means the inappropriate use of medications, isolation, or use of physical or chemical restraints as punishment, for staff convenience, as a substitute for treatment or care, in conflict with a physician's order, or in quantities that inhibit effective care or treatment, which harms or is likely to harm the patient or resident.
34."Musculoskeletal disorders" means conditions that involve the nerves, tendons, muscles, and supporting structures of the body.
35.“Naloxone” or "Narcan” means a particular drug which is a competitive antagonist that binds to the opioid receptors with higher affinity than agonists but does not activate the receptors, effectively blocking the receptor, preventing the human body from making use of opiates and endorphins.
36."Neglect" means the intentional failure to provide treatment, care, goods and services necessary to maintain the health and safety of the patient or resident, or the intentional failure to carry out a plan of treatment or care prescribed by the physician of the patient or resident, or the intentional failure to report patient or resident health problems or changes in health conditions to an immediate supervisor or nurse, or the intentional lack of attention to the physical needs of a patient or resident including, but not limited to toileting, bathing, meals and safety. Provided, however, no person shall be considered to be neglected for the sole reason that they rely on or is being furnished treatment in accordance with the tenets and teachings of a well-recognized church or denomination by a duly accredited practitioner thereof.
37."Net operating revenue" means net patient revenue plus other operating revenue.
38."Nourishing snack" means a verbal offering of, or unrestricted access to, items, single or in combination, from the basic food groups.
39.“Nursing facility” means a licensed health care facility, building, or portion thereof or an identifiable unit or distinct part thereof, however named, that provides twenty-four (24) hour inpatient and residential nursing, therapeutic, restorative or preventive and supportive nursing care services for two (2) or more residents unrelated by blood or marriage whose assessed health condition requires continuous nursing care and supervision. Resident services shall be based on person-centered principles, however named, that enhance a resident’s quality of life by ensuring the nexus of control in the living environment is resident-directed, puts the emphasis on resident autonomy and individual choices, facilitates communication and mutual respect among the residents and staff, and meets the requirements herein.
40."Nursing assistant" means a nursing, orderly, or home health aide who is a paraprofessional trained to give personal care and related health care and assistance based on their level of preparation to individuals who are sick, disabled, dependent, or infirmed pursuant to the provisions of R.I. Gen. Laws § 23-17.9-2.
41.“Nursing service" means a service organized, staffed and equipped to provide nursing care to residents on a continuous basis.
42."Occupational therapist" means a person licensed to practice occupational therapy in this State, pursuant to the provisions of R.I. Gen. Laws Chapter 5-40.1.
43.“Operator" shall have the same meaning as contained in R.I. Gen. Laws § 23-17-65. Operator responsibilities, such as day-to-day operation of the nursing facility, including employment and supervision of the nursing facility staff, adoption and enforcement of nursing facility policies, disposition of assets and incurring of liabilities on behalf of the nursing facility, controlling the books and records of the nursing facility, conducting repairs, replacements or improvements to the physical plant of the nursing facility, and accounting for the personal needs funds of the residents of the nursing facility, are nondelegable.
44.“Owner” of a nursing facility means the person that owns the real property of the nursing facility. An owner remains responsible for compliance with § 1.19 of this Part.
45."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, State or political subdivision or instrumentality of a state.
46.“Person-centered care” means a holistic model that takes into consideration each resident’s physical, mental, and social needs in the development of a care and treatment plan and the delivery of services that is driven to the greatest extent possible by resident choice.
47."Physical therapist" means a person licensed to practice physical therapy in this state, pursuant to the provisions of R.I. Gen. Laws Chapter 5-40.
48."Physical therapist assistant" means a person licensed in this state to assist in the practice of physical therapy under the supervision of a physical therapist, pursuant to the provisions of R.I. Gen. Laws Chapter 5-40.
49."Physician" means a person licensed to practice allopathic or osteopathic medicine in this State, pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
50."Physician assistant" or "PA" means a person who is qualified by academic and practical training to provide medical and surgical services in collaboration with physicians and pursuant to the provisions of R.I. Gen. Laws Chapter 5-54.
51."Resident" means a person who resides in a long-term care facility as defined in R.I. Gen. Laws Chapter 23-17.
52.“Resident attendant” means an individual who is trained to assist residents in a nursing facility with the activities of eating and drinking. A resident attendant shall not include an individual who:
a.Is a licensed health professional, including but not limited to a nursing assistant, registered dietitian; or
b.Volunteers without monetary compensation as authorized by the resident, or the resident’s appropriate legal representative.
53.“Residential area” means a distinct living environment within a nursing facility that includes no more than sixty (60) beds.
54.“Resident-directed” means a resident, the resident’s family members, and appointed guardians participating in the decision and determination processes that directly impact the personal and collective preferences of the residents and that involve the day to day activities and the operation of the nursing facility or resident-directed home.
55.“Resident-directed home” means the expansion of the bed capacity of a nursing facility pursuant to R.I. Gen. Laws § 23-17-44(d) that includes programs and physical structures that adhere to “Eden Alternative™”, “Green House™”, “Small House”, or any other resident-directed operational model. Primary characteristics of the model as a condition of license require a decentralization of operational systems in support of resident-directed and person-centered care policies and procedures, self-directed work teams, consistent assignment for direct care givers, and an environment that is non-institutional by design and facilitates resident-directed activities.
56.“Safe patient handling" means the use of engineering controls, transfer aids, or assistive devices whenever feasible and appropriate instead of manual lifting to perform the acts of lifting, transferring, and/or repositioning health care patients and residents.
57."Safe patient handling policy" means protocols established to implement safe patient handling.
58.“Self-directed work team” means small, organized groups of nursing facility workers who have day-to-day responsibility for managing themselves and their work.
59."Speech-language pathologist" means a person licensed to practice speech-language pathology in this state, pursuant to the provisions of R.I. Gen. Laws Chapter 5-48.
60."Standing orders" means orders to be automatically implemented for a class of patients without physician direction for an individual patient within the class.
61."Substantial evening meal" means an offering of three (3) or more menu items at one time, one (1) of which includes a high-quality protein such as meat, fish, eggs, or cheese. The meal should represent no less than twenty percent (20%) of the day's total nutritional requirements.
62.“This Part” means all parts of the Rhode Island Rules and Regulations for Licensing of Nursing Facilities (216-RICR-40-10-1).
63.“Turnover rate” means the total number of terminations in a given calendar year divided by the average number of personnel employed for the same calendar year and multiplied by one hundred (100) (for the percentage).
64.“Universal worker” means a direct care nursing staff, who is qualified as outlined in § 1.14.6 of this Part, and through consistent assignment with residents may perform assistance with dietary, laundry, housekeeping activities, and other related services directly related to meeting the needs of that resident.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.4** Certificate of Need Requirements {#sec-216-ricr-40-10-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.4}
A.Any person individually or jointly with any other person(s) who proposes to undertake any substantial construction shall be subject to review by the Department.
B.A certificate of need is required as a precondition to the establishment of a new nursing facility in accordance with R.I. Gen. Laws Chapter 23-15.
C.Any nursing facility which has received a certificate of need as evidence by written approval of the Director of Health after review by the Health Services Council, shall submit plans and specifications for review, prior to signing a construction contract, to the Center for Health Facilities Regulation, Rhode Island Department of Health, to the Office of the State Fire Marshal at the Department of Business Regulation, and to the Center for Food Protection of the Rhode Island Department of Health in accordance with R.I. Gen. Laws Chapter 23-1.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.5** General Requirements for Licensure {#sec-216-ricr-40-10-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.5}
A.No person or governmental unit acting severally or jointly with any other person or governmental unit shall conduct, maintain or operate a or hold itself out as a nursing facility without a license in accordance with the requirements of R.I. Gen. Laws Chapter 23-17.
B.The provisions of this Part, in addition to the provisions of R.I. Gen. Laws Chapter 23-17, shall apply to all nursing facilities and to all residents housed therein, except that persons caring exclusively for relatives shall be exempted from the provisions of R.I. Gen. Laws Chapter 23-17 and the requirements herein.
C.Facilities meeting the definition of nursing facilities by virtue of the residence therein of persons who are mentally, physically and/or emotionally dependent on others for fulfilling the requirements of daily life but which do not include primary medical and nursing components shall not be subject to this Part but shall be subject to the requirements of R.I. Gen. Laws Chapter 23-17.4 and to Part 2 of this Subchapter, Licensing Assisted Living Residences.
D.Any nursing facility that utilizes latex gloves shall do so in accordance with the provisions of Part 20-15-3 of this Title, Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department, promulgated by the Department of Health.
E.The nursing facility shall maintain sufficient financial resources to provide adequate staffing and supplies to care for the residents.
1.5.1Safe Resident Handling
A.Each licensed nursing facility shall comply with the following as a condition of licensure:
1.Each licensed nursing facility shall maintain a safe patient handling committee, which shall be chaired by a professional nurse or other appropriate licensed health care professional. A nursing facility may utilize any appropriately configured committee to perform the responsibilities of this section. At least one half (1/2) of the members of the committee shall be hourly, non-managerial employees who provide direct resident care.
2.The nursing facility shall have a written safe patient handling program, with input from the safe patient handling committee, to prevent musculoskeletal disorders among health care workers and injuries to residents. As part of this program, each licensed nursing facility shall:
a.Implement a safe resident handling policy for all shifts and units of the nursing facility that will achieve the maximum reasonable reduction of manual lifting, transferring, and repositioning of all or most of a resident's weight, except in emergency, life-threatening, or otherwise exceptional circumstances;
b.Conduct a resident handling hazard assessment. This assessment should consider such variables as patient-handling tasks, types of nursing units, resident populations, and the physical environment of resident care areas;
c.Develop a process to identify the appropriate use of the safe resident handling policy based on the resident’s physical and mental condition, the resident's choice, and the availability of lifting equipment or lift teams. The policy shall include a means to address circumstances under which it would be medically contraindicated to use lifting or transfer aids or assistive devices for particular residents;
d.Designate and train a registered nurse or other appropriate licensed health care professional to serve as an expert resource, and train all clinical staff on safe resident handling policies, equipment, and devices before implementation, and at least annually or as changes are made to the safe patient handling policies, equipment and/or devices being used;
e.Conduct an annual performance evaluation of the safe resident handling with the results of the evaluation reported to the safe resident handling committee or other appropriately designated committee. The evaluation shall determine the extent to which implementation of the program has resulted in a reduction in musculoskeletal disorder claims and days of lost work attributable to musculoskeletal disorder caused by resident handling, and include recommendations to increase the program's effectiveness; and
f.Submit an annual report to the safe resident handling committee of the nursing facility, which shall be made available to the public upon request, on activities related to the identification, assessment, development, and evaluation of strategies to control risk of injury to patients, nurses, and other health care workers associated with the lifting, transferring, repositioning, or movement of a resident.
4.Nothing in § 1.5.1 of this Part precludes lift team members from performing other duties as assigned during their shift.
5.An employee may, in accordance with established facility protocols, report to the committee, as soon as possible, after being required to perform a resident handling activity that they believe in good faith exposed the resident and/or employee to an unacceptable risk of injury. Such employee reporting shall not be cause for discipline or be subject to other adverse consequences by their employer. These reportable incidents shall be included in the facility's annual performance evaluation.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.6** Application for License or for Changes in Owner, Operator, or Lessee {#sec-216-ricr-40-10-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.6}
A.Application for License and Renewal
1.Application for an initial license to conduct, maintain or operate a nursing facility shall be made in writing and submitted on forms provided by the licensing agency prior to the opening date for a new nursing facility to begin admitting residents.
2.Licenses will expire at the end of each calendar year unless a renewal application is completed prior to the expiration date. Renewal applications are completed electronically on the licensing agency web site and will be available for on-line renewal seventy (70) days prior to the expiration date.
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership, or corporation, with percentages of ownership designated, shall be provided with the application for licensure and shall be updated annually. If a corporation, the list shall include all officers, directors and other persons or any subsidiary corporation owning stock.
C.Application for changes in the owner, operator, or lessee of a nursing facility shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 1.7(G) of this Part. One (1) paper copy and an electronic copy of such applications are required to be provided.
1.Each application filed pursuant the provisions of § 1.6 of this Part shall be accompanied by a non-returnable, non-refundable application fee, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
D.In accordance with R.I. Gen. Laws § 23-17-4(a), a person that conducts or maintains a nursing facility in a building owned by another person is acting severally or jointly with the building owner to do so. Accordingly, real property that is being operated as a nursing facility may not be acquired or purchased by a person prior to the Department’s review and approval of such transaction. The provisions of this section shall apply to any real property transactions that close on and after October 2, 2023.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.7** Issuance and Renewal of License {#sec-216-ricr-40-10-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.7}
A.The provisions contained in §§ 1.7(G)(1)(c) and 1.7(G)(2)(a)(1) of this Part shall apply to those applicants whose change in effective control applications are submitted for review on and after October 2, 2023; and those applications for a change in effective control review submitted on and before October 2, 2023 that were not deemed to be complete and not accepted for review by the Department.
B.The licensing agency shall issue a license or renewal thereof for a period of no longer than one (1) year. Said license, unless sooner suspended or revoked, shall expire by limitation on the thirty-first (31st) day of December following its issuance and may be renewed from year to year after inspection, and approval by the licensing agency, provided the applicant meets the appropriate requirements of R.I. Gen. Laws Chapter 23-17 and this Part.
C.A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued to the individual owner, operator or lessee, or to the corporate entity responsible for its governance.
1.Any initial licensure or change in owner, operator, or lessee of a licensed nursing facility shall require prior review by the Health Services Council and approval of the licensing agency as provided in §§ 1.7(F) and (G) of this Part as a condition precedent to the transfer, assignment or issuance of a new license.
D.A license issued pursuant to this Part shall be the property of the State of Rhode Island and loaned to such licensee, and it shall be kept posted in a conspicuous place on the licensed premises.
E.A distinct part of a nursing facility which is designed, maintained and primarily devoted to the provision of residential care and assisted living in accordance with R.I. Gen. Laws Chapter 23-17.4 shall obtain a separate license in accordance with the requirements of R.I. Gen. Laws Chapter 23-17.4 and Part 2 of this Subchapter, Licensing Assisted Living Residences.
F.Reviews of applications for changes in the owner, operator, or lessee of licensed nursing facilities shall be conducted according to the following procedures:
1.Applicants for a change in effective control of a nursing facility shall submit all required information as contained in the application provided by the licensing agency.
2.Within ten (10) working days of receipt, in acceptable form, of an application for a license in connection with an initial licensure or a change in the owner, operator or lessee of an existing nursing facility, the licensing agency will notify and afford the public thirty (30) days to comment on such application.
3.The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application for license.
4.The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the licensing agency shall afford written justification for variance therefrom.
5.All applications reviewed by the licensing agency and all written materials pertinent to the licensing agency review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.
G.Except as otherwise provided in R.I. Gen. Laws Chapter 23-17, a review by the Health Services Council of an application for a license in the case of an initial licensure or a proposed change in the owner, operator, or lessee of a licensed nursing facility may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3. In conducting reviews of such applications, the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence, and standing in the community of the proposed owners, operators or directors of the nursing facility as evidenced by:
a.In cases where the proposed owners, operators, or directors of the nursing facility currently own, operate, or direct a nursing facility, or in the past five (5) years owned, operated or directed a nursing facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the nursing facility’s services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of nursing facility services; and
(3)In providing appropriate access to nursing facility services;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the nursing facility.
2.The extent to which the nursing facility will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the nursing facility's services as evidenced by:
a.The immediate and long-term financial feasibility of the proposed financing plan;
(1)The proposed amount and sources of owner's equity to be provided by the applicant,
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the nursing facility;
(3)The relative availability of funds for capital and operating needs;
(4)The applicant's demonstrated financial capability;
(5)Such other financial indicators as may be requested by the state agency;
3.The extent to which the nursing facility will continue to provide safe and adequate treatment for individuals receiving the nursing facility's services and the extent to which the nursing facility will encourage quality improvement in all aspects of the operation of the nursing facility as evidenced by:
a.The applicant’s demonstrated record in providing safe and adequate treatment to individuals receiving services at facilities owned, operated, or directed by the applicant; and
b.The credibility and demonstrated or potential effectiveness of the applicant’s proposed quality assurance programs;
4.The extent to which the nursing facility will continue to provide appropriate access with respect to traditionally underserved populations and in consideration of the proposed continuance or termination of health care services by the nursing facility as evidenced by:
a.In cases where the proposed owners, operators, or directors of the nursing facility currently own, operate, or direct a nursing facility, or in the past five (5) years owned, operated or directed a nursing facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its nursing facilities; and
b.The proposed immediate and long-term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the nursing facility;
5.In consideration of the proposed continuation or termination of health care services by the nursing facility:
a.The effect(s) of such continuation or termination on access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations;
6.And, in cases where the application involves a merger, consolidation or otherwise legal affiliation of two (2) or more health care facilities, the proposed immediate and long-term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
H.Subsequent to reviews conducted under §§ 1.7(F) and (G) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in § 1.7(G) of this Part. This shall not limit the authority of the licensing agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the nursing facility by the licensing agency.
1.7.1Background and Qualifications of the Applicant or Proposed License Holder
A.For purposes of § 1.7 of this Part, applicants must meet a financial threshold that shall include, as a minimum, that the applicant or proposed license holder shall have sufficient resources to operate the nursing facility at licensed capacity for thirty (30) days, evidenced by an unencumbered line of credit, a joint escrow account established with the licensing agency, or a performance bond secured in favor of the State or a similar form of security satisfactory to the licensing agency.
B.The licensing agency may also require background information to be submitted relating to any partner, officer, director, manager or member (if member-managed) of the applicant or proposed license holder, or information relating to each person having a beneficial ownership interest of five percent (5%) or more in the applicant or proposed license holder.
C.In reviewing information required by §§ 1.7.1(A) and (B) of this Part, the licensing agency may require the applicant or proposed license holder to file a sworn affidavit substantiating the validity of any submitted information as required by the licensing agency to substantiate a satisfactory compliance history relating to each State or other jurisdiction in which the applicant, proposed license holder or any other person described by §§ 1.7.1(A) and (B) of this Part operated a nursing facility at any time during the five (5) year period preceding the date on which the application is made. The licensing agency shall determine what constitutes a satisfactory compliance history.
D.The licensing agency may also require the applicant or proposed license holder to file information relating to the current financial condition of the applicant, proposed license holder or any other person described by §§ 1.7.1(A) and (B) of this Part and the history of the financial condition of the applicant, proposed license holder or any other person described by §§ 1.7.1(A) and (B) of this Part with respect to a nursing facility operated in another State or jurisdiction at any time during the five (5) year period preceding the date on which the application is made.
E.In addition to the information required to be provided in §§ 1.7.1(A) through (D) of this Part, the licensing agency shall gather information from State departments and agencies relating to the background and qualifications of the applicant, proposed license holder, or any person having a five percent (5%) or more beneficial ownership interest.
F.Notwithstanding any other provision of the law to the contrary, a nursing facility may take out of service any or all beds of its licensed capacity without impediment to its right to place back into service such beds at a future date under the same terms and conditions as applied at the time of taking them out of service.
1."Take out of service," as used in § 1.7.1(F) of this Part, shall be referred to as “beds on hold” and means an action by a nursing facility to leave a bed(s) unutilized as a nursing facility bed for a specified period of time. Specified periods of time shall be in six (6) month increments, at a minimum.
2.The nursing facility shall inform the licensing agency in writing no less than ten (10) days prior to placing beds on hold and shall describe the alteration of physical space (if any) resulting from taking such bed(s) out of service.
3.Beds on hold and out of service shall reduce a nursing facility's licensed bed capacity by the number of beds on hold.
4.Bed(s) on hold will not automatically be returned to service at the expiration of the specified time-period. Nursing facilities shall request, in writing, that the beds be re-licensed. The request will be reviewed and must be approved for licensure before the nursing facility beds can be occupied.
5.If applicable, the nursing facility shall attest, as part of annual renewal of the nursing facility’s license, to their intent to maintain their current number of bed(s) on hold into the next licensing period.
1.7.2Additional Information Required of all Nursing Facilities
A.Notwithstanding any other provision of the law to the contrary, including any moratorium, any nursing facility applying for initial licensure or renewal of its license that contracts with a management company to assist with the nursing facility's operation shall file a copy of the management contract with the licensing agency including the management fee and, if the management company is a corporation or limited liability company, shall identify every person having an ownership interest of five percent (5%) or more in such corporation or limited liability company and, if the management company is a general partnership or limited partnership, shall identify all general or limited partners of such general partnership or limited partnership.
1.Any nursing facility planning to contract with a management company or change management companies during the license period shall notify the licensing agency in writing thirty (30) days prior to the implementation date of the contract and provide documentation of information as outlined in § 1.7.2 of this Part. The Department has authority to reject management agreements for failure to comply with nursing home regulations.
2.Any nursing facility with any significant changes in its management contract shall submit a copy of the revised management contract to the licensing agency within thirty (30) days of the effective date of the new contract provisions.
3.Any nursing facility, that fails to comply with the provisions of § 1.7.2 of this Part shall be subject to suspension or revocation of its license or curtailment of its activities in accordance with R.I. Gen. Laws §§ 23-17-8 and 23-17-8.1 and the regulations promulgated pursuant thereto.
4.Any nursing facility, licensee, operator or manager that fails to comply with the provisions of this § 1.7.2 of this Part shall be subject to civil penalties in accordance with R.I. Gen. Laws § 23-17-17. Civil penalties may be issued in addition to other disciplinary action provided for under these regulations.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.8** Capacity and Classifications {#sec-216-ricr-40-10-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.8}
A.Each license shall specify the licensed bed capacity of the nursing facility. No nursing facility shall have more residents than the number of beds for which it is licensed.
1.The nursing facility shall identify to the licensing agency the location of licensed beds and shall maintain proper space and furnishings for such locations.
B.Proposed changes in bed capacity within a nursing facility shall be submitted to the licensing agency in writing and shall be subject to the approval of the licensing agency in accordance with the provisions of R.I. Gen. Laws Chapter 23-15.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.9** Change of Ownership, Operation and/or Location {#sec-216-ricr-40-10-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.9}
A.When a change of ownership, as defined in Part 22 of this Subchapter, Determination of Need for New Health Care Equipment and New Institutional Health Care Services, or in operation or location of a nursing facility or when discontinuation of services is contemplated the owner and/or operator shall notify the licensing agency in writing no later than six (6) weeks prior to the proposed action.
B.A license shall immediately become void and shall be returned to the licensing agency when operation of the nursing facility is discontinued, or when any changes in ownership occur in accordance with Part 22 of this Subchapter, Determination of Need for New Health Care Equipment and New Institutional Health Care Services.
C.When there is a change in ownership as defined in Part 22 of this Subchapter, Determination of Need for New Health Care Equipment and New Institutional Health Care Services, or in the operation or control of an existing nursing facility, the licensing agency reserves the right to extend the expiration date of such license, allowing the nursing facility to operate under the same conditions which applied to the prior operator, for such time as shall be required for the processing of a new application or for transfer of residents, not to exceed six (6) weeks.
1.The licensing agency shall be notified immediately when a licensee/owner determines to cease operations and close a nursing facility. A meeting shall be conducted with the licensing agency and prior to notice or notification to residents and the public to ensure there is a formal and comprehensive plan for an orderly closure, sixty (60) days' notice to residents, their guardian, or relative so appointed or elected to be their decision maker, and the safe, orderly discharge and transfer of residents.
2.The nursing facility closure plan shall include, but is not limited to, the following:
a.Letter of intent and/or determining factors/justification for the closure (i.e., voluntary, financial) to include:
(1)Proposed closure date;
(2)Contact information for staff member responsible for implementing the closure plan;
(3)Projected fiscal management plan covering operations during the closure period.
b.Staffing plan(s)
(1)By unit/program/location;
(2)Time line for individual closures of any unit/program/service location;
(3)Staff scale-down process as appropriate given planned transition/reduction of patients/residents.
c.Plans for providing notification and estimated implementation of notices
(1)Notice to third (3rd) party payers (i.e., Medicare/Medicaid);
(2)Notice to Accreditation entities – where appropriate;
(3)Notice to staff/union – meeting date(s);
(4)Public notice;
(5)Community/public meetings – if appropriate and/or planned.
d.Storage/access to medical records
(1)Location for self-storage; or
(2)Company/agency providing contract storage services.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.10** Inspections {#sec-216-ricr-40-10-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.10}
A.The licensing agency shall make such inspections and investigations as deemed necessary and in accordance with R.I. Gen. Laws Chapters 23-17 and 23-15 and this Part. Such inspections shall apply to all nursing facilities licensed under R.I. Gen. Laws Chapter 23-17 and shall apply to all residents housed therein without regard to source of payment.
B.A duly authorized representative of the licensing agency shall have the right to enter at any time without prior notice to inspect the entire premises and services, including all records of any nursing facility for which an application has been received or for which a license has been issued. Any application shall constitute permission for and willingness to comply with such inspections. The duly authorized representative shall provide necessary identification information and shall sign the log or journal of the nursing facility provided in accordance with R.I. Gen. Laws Chapter 23-17.2.
C.Refusal to permit inspections shall constitute a valid ground for license revocation.
D.Every nursing facility shall be given prompt notice within ten (10) business days by the licensing agency of all deficiencies reported as a result of an inspection or investigation and in accordance with the procedures incorporated in R.I. Gen. Laws Chapters 23-17 and 23-1.
E.Written reports and recommendations of inspections and inspection logs or journals shall be maintained on file in each nursing facility for a period of no less than three (3) years.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.11** Denial, Suspension, Revocation of License or Curtailment of Activities & Sanctions {#sec-216-ricr-40-10-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.11}
A.The licensing agency is authorized to deny, suspend, revoke the license, or curtail the activities of any nursing facility which has:
1.Failed to comply with this Part;
2.Aided, abetted or permitted any illegal act or conduct adverse to the health, welfare and safety of residents or of the general public; or
3.Failed to comply with municipal, state or federal law.
B.In those instances wherein the licensing agency determines that a nursing facility licensed in accordance with R.I. Gen. Laws Chapter 23-17 is not being operated in conformity with all of the requirements herein, the licensing agency may (in lieu of suspension or revocation) curtail activities of the nursing facility, order the licensee to be placed on probationary status and set conditions with which the licensee must comply within a set period of time, order the licensee to admit no additional persons to the nursing facility, to provide health services to no additional persons through the nursing facility, to transfer all or some of the persons occupying the nursing facility to other suitable accommodations, or to take any other corrective action necessary to secure compliance with the requirements established under the Act. Notice of the order and any subsequent hearing that may be scheduled shall comply with the requirements of procedural due process stipulated in R.I. Gen. Laws § 23-17-8. Such action may be taken only when the licensing agency determines that operation of the nursing facility shall not result in undue hardship to residents.
1.Notice of an order to curtail any or all activities of a nursing facility in accordance with § 1.12(B) of this Part shall be made in writing by certified mail and shall state the reason thereof, the action to be taken by the licensee and the time within which said action shall be taken.
C.When the licensing agency deems that operation of a nursing facility results in undue hardship to residents as a result of deficiencies enumerated in the notice of deficiencies, the licensing agency is authorized to suspend the license for a stipulated period of time or to revoke the license of a nursing facility.
D.Whenever an action shall be proposed to deny, suspend or revoke the license or curtail activities of a licensee, the licensing agency shall notify the nursing facility, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws Chapter 42-35.
1.However, if the licensing agency finds that public health, safety, or welfare, including the health and safety of residents, imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license pending proceedings for revocation or other action.
E.The appropriate state and federal placement and reimbursement agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension or revocation of license or curtailment of activities of any nursing facility.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.12** Sanctions {#sec-216-ricr-40-10-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.12}
A.The licensing agency may take appropriate action from within the following array for dealing with violations of R.I. Gen. Laws Chapters 23-17, 23-15, or herein.
1.As a result of denial, the rights and privileges attendant upon licensure will not accrue to a nursing facility.
2.As a result of an order to curtail any or all activities of a nursing facility, a licensee may be ordered to admit no additional persons to said nursing facility, and/or transfer to other suitable accommodations all or some of the residents residing in said nursing facility, and/or take any other corrective action necessary to secure compliance with the requirements established by R.I. Gen. Laws Chapter 23-17 and this Part.
3.As a result of suspension, a nursing facility shall be restrained from admitting any residents during the period of suspension and shall be required to transfer all residents to another nursing facility during the period of suspension. The difference between suspension and revocation of license is essentially a temporal one, such that the sanctions imposed as a result of suspension are so imposed until such time as the deficiency is corrected or until such other time as the licensing agency determines, whereas the sanctions imposed as a result of revocation are considered to be permanent and re-application for license would be necessary.
4.As a result of license revocation, a nursing facility loses all rights and privileges related to licensure and will be required to transfer all residents, will be restrained from admitting any residents and will be subject to prosecution for operation without a license if the foregoing actions are not accomplished.
B.In accordance with the requirements of R.I. Gen. Laws § 23-17-12.3, every person including a controlling person, or corporation who shall willfully and continually violate the provisions of R.I. Gen. Laws §§ 23-17-12 through 23-17-12.2, will be subject to a fine up to three hundred dollars ($300.00) for each violation of these sections.
1.12.1Adverse Change in Financial Condition
A.Whenever the licensing agency, or the licensing agency in consultation with the Rhode Island Executive Office of Health and Human Services, determines that a nursing facility's financial status is of concern and determines, through inspection of the nursing facility or investigation of a complaint, that incident(s), event(s) or patterns of care exist that harm or have the potential to result in harm or danger to the residents of a nursing facility, the Departments, acting jointly, shall convene a meeting, as soon as possible but in no event later than ten (10) days after the finding(s) cited above, with the license holder to communicate the State's concerns with respect to the operation of the nursing facility. The license holder shall be given the opportunity to respond to the State's concerns and to offer explanation as to why the concerns are not valid or accurate.
B.In the event that the explanation provided by the license holder is not found by the licensing agency to be adequate or otherwise satisfactory, the licensing agency shall direct the license holder to prepare and submit, within ten (10) days of the meeting cited above, or for good cause shown no later than twenty (20) days after said meeting, a plan of correction and remediation for the licensing agency review and approval, including, but not limited to, the following elements:
1.Specific targeted improvements;
2.Definite deadlines for accomplishing those targeted improvements;
3.Measurable standards that will be used to judge whether the targeted improvements have been accomplished;
4.A spending plan that supports all costs associated with accomplishment of the targeted improvements;
5.Monthly reporting of cash availability, the status of vendor payments and employee payrolls, and staffing levels, as metrics concerning financial status and quality of care; and
6.With regard to concerns regarding resident care, and if directed by the licensing agency, a proposal to engage an independent quality monitor or independent quality consultant, to work, in consultation with the nursing facility administrator and medical director, the implementation of the plan of correction and remediation, and to provide progress updates to the licensing agency.
C.Whenever a nursing facility’s financial status is determined to be marginal, the licensing agency shall cause such a nursing facility to be inspected in order to determine if financial problems are causing the nursing facility to be out of compliance with nursing facility regulatory standards.
D.Whenever a nursing facility is determined to be having severe financial difficulties, the licensing agency shall cause the nursing facility to have more frequent inspections and the Director may, at the nursing facility’s expense:
1.Appoint an independent consultant to review the nursing facility’s management and financial status and make recommendations to improve the nursing facility’s financial status; or
2.Require the hiring of a temporary manager of the nursing facility's operations.
E.With the exception of the plan of correction and remediation, the information obtained by the licensing agency under § 1.11 of this Part is confidential and is not subject to disclosure under R.I. Gen. Laws Chapter 38-2 (“Access to Public Records”). However, upon request, the licensing agency shall release the information to the following who shall treat the information as confidential:
1.The nursing facility;
2.A person other than the nursing facility if the nursing facility consents in writing to the disclosure;
3.The State Medicaid agency responsible for rate setting of nursing facilities;
4.The State long-term care ombudsman; and/or
5.The Department of Attorney General.
F.The provisions in § 1.12.1(D) of this Part relating to the confidentiality of records do not apply:
1.To a nursing facility whose license has been revoked or suspended;
2.To the use of the information in an administrative proceeding initiated by the licensing agency, including implementing enforcement actions, and in judicial proceedings relating thereto.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.13** Organization and Management {#sec-216-ricr-40-10-1-1.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.13}
1.13.1Governing Body or Other Legal Authority
A.Each nursing facility shall have an organized governing body or other legal authority, responsible for:
1.The management and fiduciary control of the operation and maintenance of the nursing facility; and
2.The conformity of the nursing facility with all federal, state and local rules and regulations relating to fire, safety, sanitation, communicable and reportable diseases, resident quality of care and quality of life, and other relevant health and safety requirements and with this Part.
3.The administration of a policy of non-discrimination in the provision of services to residents and the employment of persons without regard to race, color, creed, national origin, gender, gender identity or expression, religion, sexual orientation, marital status, familial status, source of income, age, disability, source of payment or profession in accordance with Title VI of the Civil Rights Act of 1964; U.S. Executive Order #11246 entitled “Equal Employment Opportunity,” U.S. Department of Labor Regulations; Title V of the Rehabilitation Act of 1973, the Rhode Island Fair Employment Practices Act, R.I. Gen. Laws Chapter 28-5 et seq.; the Americans with Disabilities Act; and any other federal or state laws relating to discriminatory practices.
B.The governing body or other legal authority shall provide facilities, personnel and other resources necessary to meet resident and program needs and also:
1.Describe the structure of the nursing facility’s governing body, including functional and staff organizational charts;
2.Provide names and affiliations of members of the nursing facility’s governing body;
3.Provide a copy of the organization’s charter, constitution and/or by-laws.
C.The governing body or other legal authority shall designate a licensed administrator in accordance with R.I. Gen. Laws Chapter 5-45 and shall establish by-laws or policies to govern the organization of the nursing facility, to establish authority and responsibility, to identify program goals, and to provide for an annual evaluation of administrator performance.
D.The governing body or other legal authority shall adopt a written policy statement relating to conflict of interest on the part of members of the governing body receiving financial gain from ownership, medical staff and employees who may influence corporate decisions.
E.The governing body or other legal authority, through the administrator, shall be responsible for the procurement of a sufficient number of trained, experienced and competent personnel to provide appropriate care and supervision for all residents and to ensure that their personal needs are met.
1.13.2Quality Improvement Program
A.Pursuant to R.I. Gen. Laws § 23-17-12.11, each licensed nursing facility shall develop and implement a quality improvement program and establish a quality improvement committee. The governing body shall ensure that this program is effective, ongoing, nursing facility-wide and shall have a written plan of implementation.
B.Each licensed nursing facility shall designate a qualified individual, who shall be determined by the nursing facility’s administrator, to coordinate and manage the nursing facility’s quality improvement program.
1.The nursing facility’s quality improvement committee shall include at least the following members:
2.The nursing facility administrator;
3.The director of nursing;
4.The medical director;
5.A social worker; and
6.A representative of dietary services.
C.The quality improvement committee shall meet at least quarterly; shall maintain records of all quality improvement activities; and shall keep records of committee meetings that shall be available to the licensing agency during any on-site visit.
D.The quality improvement committee for a nursing facility shall annually review and approve the quality improvement plan for the nursing facility. Said plan shall be available to the public upon request.
E.Each nursing facility shall establish a written quality improvement plan that shall be reviewed by the licensing agency during the nursing facility’s annual survey and that includes:
1.Program objectives;
2.Oversight responsibility (e.g., reports to the governing body, QI records);
3.Nursing facility-wide scope;
4.Involvement of all resident care disciplines/services;
5.Includes methods to identify, evaluate, and correct identified problems;
6.Provides criteria to monitor nursing care and services, including, but not limited to:
a.Medication administration;
b.Prevention and treatment of decubitus ulcers;
c.Dehydration, and nutritional status and weight loss or gain;
d.Accidents, injuries and unexpected deaths;
7.Changes in mental or psychological status;
8.Resident and/or Family Council grievances;
9.Plans of correction developed in response to licensing agency’s inspection reports, and
10.Any other data appropriate to monitor resident’s quality of care and quality of life.
F.All resident care services, including services rendered by a contractor, shall be evaluated.
G.The nursing facility shall take and document appropriate remedial action to address problems identified through the quality improvement program. The nursing facility administrator shall take appropriate remedial actions based on the recommendations of the nursing facility’s quality improvement committee. The outcome(s) of the remedial action shall be documented and submitted to the governing body for their consideration.
H.The Director may not require the quality improvement committee to disclose the records and the reports prepared by the committee except as necessary to assure compliance with the requirements of this section.
I.Good faith attempts by the quality improvement committee to identify and correct quality deficiencies will not be used as a basis for sanctions.
J.If the licensing agency determines that a nursing facility is not implementing its quality improvement program effectively and that quality improvement activities are inadequate, the licensing agency may impose sanctions on the nursing facility to improve quality of resident care including mandated hiring of, directly or by contract, an independent quality consultant acceptable to the licensing agency.
1.13.3Health Care Quality Program
A.All nursing facilities licensed under R.I. Gen. Laws Chapter 23-17 shall meet all applicable requirements of Part 10-10-7 of this Title, Health Care Quality Program, promulgated by the licensing agency.
1.13.4Administrator
A.Every nursing facility shall have a full-time administrator licensed in accordance with R.I. Gen. Laws Chapter 5-45, who shall be directly responsible to the governing body or other legal authority for its management and operation, and shall provide liaison between the governing body, medical and nursing staff and other professional staff.
1.When the administrator does not spend full-time in the nursing facility, a substitute shall be designated only with the approval of the licensing agency.
2.In the absence of the administrator, a person shall be designated or authorized in writing, as a substitute on an interim basis.
3.A substitute must be licensed in Rhode Island as a nursing home administrator.
B.The administrator shall be responsible to ensure that services required by residents shall be available on a regular basis, and provided in an appropriate environment in accordance with established policies and the prevailing community standard. Direct resident care shall be provided through a system of consistent assignment and utilizing self-directed work teams whenever possible.
C.The administrator shall be responsible for maintaining accurate time records on all personnel and for posting the work schedule of all direct resident care personnel on a weekly basis. Time records shall be retained by the nursing facility for no less than three (3) years.
D.Nursing facilities shall provide the licensing agency with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. Nursing facilities shall provide a plan, acceptable to the Director, for continued operation of the nursing facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action.
E.The licensing agency shall be promptly notified of any change of the administrator of a nursing facility.
1.13.5Medical Director and Attending Physicians
A.The governing body or other legal authority shall designate a physician to serve as medical director. The medical director shall be a physician licensed to practice in Rhode Island in accordance with the provisions of Subchapter 05 Part 1 of this Chapter, Licensure and Discipline of Physicians. Upon appointment, the name of the medical director shall be submitted to the licensing agency. Each time a new medical director is appointed, the name of said physician shall be reported promptly to the licensing agency. The medical director's Rhode Island medical license number, medical office address, telephone number, emergency telephone number, hospital affiliation and other credentialing information shall be maintained on file at the nursing facility and updated as needed.
1.13.6Duties and Responsibilities of the Medical Director
A.Responsibilities of the medical director shall include, but not be limited to:
1.Coordination of medical care in the nursing facility,
2.Ensuring completion of employee health screening and immunization requirements contained in §§ 1.14.4(A) and 1.14.5 of this Part.
3.The implementation of nursing facility policies and procedures related to the medical care delivered in the nursing facility;
4.Physician and advanced practice practitioner credentialing;
5.Practitioner performance reviews;
6.Employee health including infection control measures;
7.Evaluation of health care delivery, including oversight of medical records and participation in quality improvement;
8.Provision of staff education on medical issues;
9.Participation in State survey process, including the resolution of deficiencies, as needed.
B.The medical director, charged with the aforementioned duties and responsibilities for the delivery of medical care in the nursing facility, shall be immune from civil or criminal prosecution for reporting to the Board of Medical Licensure and Discipline the unprofessional conduct, incompetence or negligence of a nursing facility physician or limited registrant;
C.Provided, that the report, testimony, or other communication was made in good faith and while acting within the scope of authority conferred by § 1.13.5 of this Part.
D.The administrator shall notify the medical director immediately when any enforcement order as described in § 1.11 of this Part is issued by the licensing agency or when the administrator is notified of any Medicare/Medicaid certification enforcement action. The administrator shall provide copies of all statements of deficiencies and related plans of correction to the medical director in a timely fashion.
E.The medical director shall attend the quarterly quality assurance/improvement meetings, as required in § 1.13.2(C) of this Part. The administrator, or their designee, shall provide the medical director with adequate notice of the quarterly quality assurance/improvement meeting.
F.Each nursing facility shall maintain an active file of all physicians attending residents for any reason(s), including their phone numbers and addresses, an emergency phone number, their current medical license numbers, and the physician's preferred admitting hospital. This file of physicians shall be revised and updated, as needed, but no less than annually.
G.The governing body or other legal authority shall make available to each physician attending residents in the nursing facility all of the policies governing resident care management and services.
1.13.7COVID-19 Practices and Procedures
A.Nursing Home Residents
1.The nursing facility must have policies and procedures in place for addressing residents who refuse testing or are unable to be tested. In accordance with the provisions of 42 C.F.R. § 483.10(c)(6), residents (or their representatives) may exercise their right to decline COVID-19 testing.
2.Upon the identification of residents who test positive for COVID-19, the facility shall take proper actions to prevent the transmission of COVID-19.
3.The nursing facility shall document all COVID-19 testing. The documentation shall at a minimum include the individual's name, date of test, and test result.
B.Nursing Home Personnel
1.For the purposes of § 1.13.7 of this Part, "Personnel" includes employees, as well as volunteers, students, trainees, and any individuals whether paid or unpaid, directly employed by or under contract with the nursing facility on a part-time or full-time basis.
2.The nursing facility shall develop and implement policies and procedures for ongoing tracking of personnel who are employed outside of the nursing facility. Tracking shall include the name and location of the establishment, and any other pertinent information.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.14** Personnel {#sec-216-ricr-40-10-1-1.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.14}
1.14.1Criminal Records Check
A.Criminal record review requirements are pursuant to R.I. Gen. Laws §§ 23-17-34 and 28-5.1-14.
B.If an applicant has undergone a statewide criminal records check within eighteen (18) months of an application for employment, then an employer may request from the bureau a letter indicating if any disqualifying information was discovered. The bureau will respond without disclosing the nature of the disqualifying information. This letter must be maintained on file to satisfy the requirements of R.I. Gen. Laws § 23-17-34.
C.Due to the fact that juvenile proceedings before the Rhode Island Family Court are exempt from disclosure, the requirement for a statewide criminal records check shall be waived for nursing facility employees under the age of eighteen (18). Provided, however, the nursing facility must perform a reference check for employees under age eighteen (18). Once the employee turns eighteen (18) years old, the required criminal records check must be completed within seven (7) days of their eighteenth (18th) birthday.
1.14.2Policies and Procedures
A.Each nursing facility shall maintain and implement written personnel policies and procedures supporting long-term care industry standards for personnel practices and sound resident care practices, including but not limited to:
1.Resident-directed care; and
2.Person-centered care practices;
B.Such policies shall be reviewed annually and updated as necessary.
1.14.3Job Descriptions
A.There shall be a job description for each classification of position which delineates qualifications, duties, authority and responsibilities inherent in each position.
1.For those licensed personnel authorized to administer medications in accordance with § 1.16.10(A) of this Part, a job description delineating qualifications, duties and responsibilities shall be provided.
1.14.4Employee Immunization(s) and Health Screening
A.Nursing Facilities are required to adopt, at a minimum, the standards of immunization and communicable disease testing and standards for health screening in accordance with Part 20-15-7 of this Title, Immunization, Testing, and Health Screening for Health Care Workers.
B.Nursing Facilities are required to obtain evidence of immunity for all health care workers in accordance with Part 20-15-7 of this Title, Immunization, Testing, and Health Screening for Health Care Workers.
1.14.5Personnel Records
A.Personnel records shall be maintained for each employee, shall be available at all times for inspection and shall include no less than the following:
1.Current and background information covering qualifications for employment;
2.Records of completion of required orientation training and in-service educational programs, as indicated in § 1.14.6 of this Part;
3.Records of all required health examinations which shall be kept confidential and in accordance with R.I. Gen. Laws Chapter 5-37.3;
4.Evidence of current registration, certification or licensure of personnel subject to statutory Regulation;
5.Annual work performance evaluation records; and
6.Evidence of authorization to administer medications for licensed personnel in accordance with § 1.16.10(A) of this Part.
1.14.6In-Service Education
A.An in-service educational program shall be conducted on an ongoing basis, which shall include an orientation program for new personnel and a program for the development and improvement of skills of all personnel. The in-service program shall be geared to the needs of the elderly, physically disabled, and individuals with dementia, and shall include annual programs on but not limited to:
1.Prevention and control of infection;
2.Food services and sanitation,
3.Emergency preparedness, fire prevention and safety;
4.Confidentiality of resident information;
5.Rights of residents, resident-directed care, and person-centered care; and
6.Any other area related to resident care or services routinely provided at the nursing.
a.Provision shall be made for written documentation of programs, including attendance. Flexible program schedules shall be formulated at least two (2) months in advance.
b.In addition to any State or Federal training requirements pertaining to long term care facilities, or training deemed appropriate by the nursing, each designated universal worker shall maintain a current certification as a Manager Certified in Food Safety pursuant to Part 50-10-2 of this Title, Certification of Managers in Food Safety.
1.14.7Photo Identification
A.A nursing facility shall require all persons, including students, and as directed by the nursing facility, who examine, observe, treat or assist a patient or resident of such nursing facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person. This badge shall be worn in a manner that makes the badge easily seen and read by the resident or visitor.
1.14.8Licensure Verification
A.For every person employed by the nursing facility who is licensed, certified, or registered by the licensing agency, a mechanism shall be in place to electronically verify such licensure via the licensing agency licensure verification database. [https://healthri.mylicense.com/Verification/Search.aspx?facility=N&SubmitComplaint=Y]
1.14.9Handling of Resident Fund
A.Any assignment of residents' property either by contractual agreement or by transfer of real estate, bank accounts or insurance benefits, must be reported together with the terms of the assignment to the residents' guardian, next of kin, sponsoring agency(ies) or representative payor and to the licensing agency.
B.Each operator of a nursing facility acting or intending to act as fiduciary agent for a resident is required to have written revocable authorization from any resident so served. The certification will attest to the resident's understanding of the significance of their action and will be required to be on file for inspection by authorized surveyors of the licensing agency.
C.The operator shall maintain adequate safeguards and accurate records of each resident's monies and valuables and shall provide at least quarterly, and on request, accounting in accordance with § 1.15.4(Q) of this Part. Such records shall be available for inspection.
D.In addition to requirements of §§ 1.14.9(A) through (C) of this Part, each nursing facility shall conform to the standards of Title XIX Section 1919 Protection of Resident Funds in relation to Title XIX Medicaid recipients.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.15** Reporting of Resident Abuse or Neglect, Accidents & Death {#sec-216-ricr-40-10-1-1.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.15}
A.Any physician, physician assistant, nurse or other employee of a nursing facility who has reasonable cause to believe that a resident has been abused, exploited, mistreated, neglected or experiences an injury of unknown origin, as outlined in R.I. Gen. Laws Chapter 23-17.8 shall make, within twenty-four (24) hours of the receipt of said information, a report to the licensing agency and to the office of the State long-term care ombudsman. Any person required to make a report pursuant to this section shall be deemed to have complied with these requirements if a report is made to a high managerial agent. Once notified, the administrator or the director of nursing services shall be required to meet the above reporting requirements.
1.All reports, as required by this Part, shall be provided to the licensing agency in writing via facsimile or electronic transmission to [email protected] on forms supplied by the licensing agency. A copy of each report shall be retained by the nursing facility for review during subsequent inspections by the licensing agency.
2.The nursing facility shall maintain evidence that all allegations of abuse, neglect, and/or mistreatment have been thoroughly investigated and that further potential abuse has been prevented while the investigation is in progress. Appropriate corrective action shall be taken, as necessary. The results of said investigation shall be reported to the licensing agency within five (5) business days.
B.Accidents/incidents resulting in hospital admission or accidents/incidents resulting in death in the nursing facility of any resident shall be reported in writing to the licensing agency within twenty-four (24) hours or before the end of the next working day. A copy of each report shall be retained by the nursing facility for review during subsequent surveys.
C.The death of any resident of a nursing facility occurring within twenty-four (24) hours of admission or prior to the performance of a physical examination in accordance with § 1.16.5(C) of this Part, shall be reported to the Office of the State Medical Examiners.
D.In addition, all resident deaths occurring within a nursing facility which are sudden or unexpected, suspicious or unnatural, the result of trauma, remote or otherwise or when unattended by a physician shall be reported to the nursing facility medical director and to the Office of the State Medical Examiners in accordance with R.I. Gen. Laws Chapter 23-4.
E.Reporting requirements, pursuant to R.I. Gen. Laws Chapter 23-17.8 must be posted.
F.Report all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property; immediately, but not later than two (2) hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than twenty-four (24) hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury (in accordance with 42 C.F.R. § 483.12(c)(1)).
G.Any elopement of a resident that results in police being called must be reported in writing to the licensing agency within twenty-four (24) hours or by the end of the next business day.
H.Unscheduled implementation of fire/evacuation/disaster plan. Report immediately via phone (401) 222-5200, then fax the information to the licensing agency within three (3) business days.
1.15.1Medical Records
A.A medical record shall be established and maintained for every person admitted to a nursing facility in accordance with accepted professional standards and practices. The administrator shall have ultimate responsibility for the maintenance of medical records; such responsibility may be delegated in writing to a staff member.
B.Entries in the medical record relating to treatment, medication, diagnostic tests and other similar services rendered shall be made by the responsible persons at the time of administration. Only physicians shall enter or authenticate medical opinions or judgment.
C.All accidents, including falls, whether resulting in an injury or not, shall be immediately recorded in the resident's record.
D.Detailed descriptions of all pressure ulcers, or other skin lesions, shall be recorded in the resident's record.
E.Each medical record shall contain sufficient information to identify the resident and to justify diagnosis, treatment, care and documented results and shall include as deemed appropriate:
1.Identification data;
2.Pre-admission screening including mental status (or PASARR (Pre-Admission Screening and Annual Resident Review), where appropriate);
3.Medical history;
4.Plan of care and services provided;
5.Physical examination reports;
6.Admitting diagnosis;
7.Diagnostic and therapeutic orders;
8.Consent forms;
9.Physicians', physician assistants’, and advance practice registered nurse practitioners’ progress notes and observations;
10.Nursing notes;
11.Medication and treatment records, including any immunizations;
12.Laboratory reports, X-ray reports, or other clinical findings; consultation reports;
13.Documentation of all care and services rendered (e.g., dental reports, physical and occupational therapy reports, social service summaries, podiatry reports, inhalation therapy reports, etc.);
14.Resident referral forms;
15.Diagnosis at time of discharge; and
16.Disposition and final summary notes.
F.At time of discharge, a discharge summary, summarizing the resident's stay, shall be completed promptly and signed by the attending physician, advanced nurse practitioner or physician assistant.
G.Medical records of discharged residents shall be completed within a reasonable period of time (not to exceed sixty (60) days) with all clinical information pertaining to the resident's stay made part of the resident's medical record.
H.Confidentiality of medical records shall be governed by the provisions of R.I. Gen. Laws Chapter 5-37.3 and the following;
1.Only authorized personnel shall have access to the records.
2.The nursing facility shall release resident's medical information only with the written consent of the resident, parent, guardian or legal representative in accordance with R.I. Gen. Laws Chapter 5-37.3.
I.Provisions shall be made for the safe storage of medical records to safeguard them against loss, destruction or unauthorized use.
J.All medical records, either original or accurately reproduced, shall be preserved for a minimum of five (5) years following discharge or death of the resident in accordance with R.I. Gen. Laws Chapter 23-3.
1.Medical records of minors, however, shall be kept for at least five (5) years after such minor would have reached the age of eighteen (18) years.
K.The medical records of all residents shall be opened for inspection to duly authorized representatives of the licensing agency whose duty it is to enforce the Regulations herein consistent with § 1.15.5(P)(1) of this Part.
1.Information contained in medical records gathered and collected for the purpose of enforcing this Part is confidential in nature and shall not be publicly disclosed by any person obtaining such information by virtue of his office, unless by court order or as otherwise required by law.
1.15.2Transfer Agreements, Contracts, or Agreements
A.The nursing facility shall have in effect transfer agreements with one (1) or more hospitals for the provision of hospital care or other hospital services to be made available promptly to the residents of the nursing facility, as needed. The written transfer agreement shall ensure:
1.Timely transfer or admission of residents between the hospital and the nursing facility, whenever deemed medically appropriate in writing by a physician;
2.Interchange of medical and other information necessary or useful in the care and treatment of residents transferred or to determine the kind of care the resident requires that includes, but is not limited to the following:
a.Clear statement of the reason(s) resident is being transferred to the hospital or for consultation;
b.Name of resident, address, insurance status;
c.Name of attending physician and their telephone number;
d.Resident’s next-of-kin and their telephone number;
e.Name of contact staff person at the nursing facility;
f.List of all diagnoses and complaints;
g.List of all current medications, including adequate indications for use;
h.Recent x-ray reports and laboratory reports, as applicable;
i.Existence, and copies, of any advance directives;
j.Any additional information as cited in the “Continuity of Care” form ("Long Form") available from the licensing agency; and
3.Security and accountability for the resident's personal effects during transfer.
B.Designated nursing facility personnel shall complete, in its entirety:
1.The “Continuity of Care” form approved by the licensing agency, for each resident who is discharged to another health care facility, such as a hospital, or who is discharged home, or any other licensed residential program, with follow-up home care required. Said form shall be provided to the receiving facility, care agency, or appropriate treating provider (e.g., primary care physician) prior to or upon transfer of the resident; or
2.The appropriate “Short Form”, approved by the licensing agency, for each resident who is transferred to an emergency care facility, or to a physician’s office, or other scheduled consultative appointment, prior to or upon transfer of the resident.
3.In the event of an emergency situation that requires a partial or full evacuation of residents, the nursing facility may supplement the Continuity of Care form with forms available through the State's Long-Term Care Mutual Aid Plan, or any form(s) as directed by the Licensing agency.
C.If the nursing facility does not employ full-time qualified professional personnel to render required services, or obtains services from an outside source, arrangements for such services shall be made through written agreements or contracts.
1.The responsibilities, functions, objectives, terms of agreement, financial arrangements, charges and other pertinent requirements shall be clearly delineated in the terms of any contract negotiated by a nursing facility.
2.All contracts or agreements negotiated by a nursing facility shall be consistent with the policies established in accordance with § 1.13.1(D) of this Part concerning conflict of interest.
3.Each consultant or outside source providing services to a nursing facility shall submit monthly reports as services are provided. Said reports and contracts shall be kept on file for inspection for a period of no less than three (3) years.
1.15.3Financial Interest Disclosure
A.Any nursing facility licensed pursuant to R.I. Gen. Laws Chapter 23-17 which refers clients/residents to another such licensed nursing facility or to an assisted living facility licensed pursuant to R.I. Gen. Laws Chapter 23-17.4 or a Supported Care Home, licensed pursuant to R.I. Gen. Laws Chapter 23-17.24, or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client/resident:
1.That the referring entity has a financial interest in the nursing facility or provider to which the referral is being made;
2.That the client/resident has the option of seeking care from a different nursing facility or provider which is also licensed and/or certified by the State of Rhode Island to provide similar services to the client/resident.
B.The referring entity shall also offer the client/resident a written list prepared by the Department of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting:
Rhode Island Department of Health,
Center for Health Facilities Regulation 3 Capitol Hill, Room 306
Providence, RI 02908
401.222.2566
C.Non-compliance with §§ 1.15.4(A) and (B) of this Part shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with R.I. Gen. Laws Chapter 23-17.10.
1.15.4Rights of Residents
A.As part of the procedure for admission of a resident to a nursing facility a written contract shall be entered into between the said resident or his next of kin or legal representative and the nursing facility and the following Rules shall be observed in accordance with R.I. Gen. Laws Chapter 23-17.5 (Rights of Nursing Patients).
B.Each resident shall be offered treatment without discrimination as to gender, gender identity or expression, sexual orientation, age, race, color, marital status, familial status, religion, national origin, disability, or source of payment or profession.
C.Each resident shall be treated and cared for with consideration, respect and dignity and shall be afforded his right to privacy to the extent consistent with providing adequate medical care and with efficient administration.
D.Each resident shall have the right to choose their own physician subject to the physician's concurrence.
E.Each resident or responsible party shall be fully informed, as evidenced by the resident's written acknowledgment, prior to or at the time of admission or during stay, of all Rules and Regulations and policies pertaining to rights of residents and governing resident conduct and responsibilities.
F.Each resident or responsible party shall be informed in writing, prior to, or at the time of admission and during stay, of services available and of related charges including all charges not covered either under Federal and/or State programs by other third (3rd) party payers or by the nursing facility’s basic per diem rate.
G.Each resident admitted to a nursing facility shall be and remain under the care of a physician as specified in policies adopted by the governing body.
H.Each resident shall be informed by a physician of his medical condition unless medically contraindicated, (as documented by a physician in his medical record), and shall participate in the planning and selection of his medical treatment and care.
I.If it is proposed that a resident be used in any human experimentation project, the resident shall first be thoroughly informed in writing of such proposal and shall be offered the right to refuse to participate in such project. A resident who, after being thoroughly informed, wishes to participate must execute a written statement of informed consent. The informed consent documentation shall be maintained on file in the nursing facility.
J.Residents shall be encouraged and assisted to voice their grievances through a documented grievance mechanism established by the nursing facility, involving residents, staff and relatives of residents, which will ensure resident's freedom from restraints, interference, coercion, discrimination or reprisal.
1.There shall be prompt efforts by the nursing facility staff to resolve resident's grievances.
K.Residents shall not be subject to mental and physical abuse and shall be free from chemical and (except in emergencies) physical restraints.
1.Restraining devices are generally prohibited. A controlling device to be used for the protection of the resident may be utilized only as ordered in writing and signed by a physician, physician assistant, or advanced practice registered nurse. The length of time, the purpose and the kind of restraint shall be specified in the physician's, physician assistant’s, or advanced practice registered nurse’s order.
2.If after a trial of less restrictive measures, the nursing facility decides that a physical restraint would enable and promote greater functional independence, then the use of the restraining device must first be explained to the resident, family member, or legal representative, and if the resident, family member or legal representative agrees to this treatment alternative, then the restraining device may be used for the specific periods for which the restraint has been determined to serve the purpose defined above. This does not allow the use of restraints for convenience sake.
3.The restraining device must be authorized by the physician, physician assistant, or advanced practice registered nurse for use for specific periods for which the restraint has been determined to serve the purpose defined in § 1.15.4(K)(2) of this Part. This does not allow the use of restraints for convenience sake.
L.A resident shall not be required to perform services for the nursing facility that are not included for therapeutic purposes in his plan of care.
M.Residents may meet with and participate in activities of social, religious and community groups at their discretion unless medically contraindicated per written medical order.
N.Residents may associate and communicate privately with persons of their choice and shall be allowed freedom and privacy in sending and receiving mail.
1.Posted reasonable visiting hours must be maintained in each nursing facility, with a minimum of four (4) hours daily. The nursing facility must provide immediate access to residents by properly identified appropriate government personnel, family members, physicians, and relatives. However, the resident reserves the right to refuse visitation by any of the aforementioned.
2.All health care providers, as licensed under the provisions of R.I. Gen. Laws Chapters 5-37 and all health care facilities, as defined in R.I. Gen. Laws § 23-17-2(9) shall be required to note in their residents’ permanent medical records, the name of individual(s) not legally related by blood or marriage to the resident, who the resident wishes to be considered as immediate family member(s), for the purpose of granting extended visitation rights to said individual(s), so said individual(s) may visit the resident while they are receiving inpatient health care services in a nursing facility.
a.A resident choosing to designate said individual(s) as immediate family members for the purpose of extending visitation rights may choose up to five (5) individuals and do so either verbally or in writing. This designation shall be made only by the resident and can be initiated and/or rescinded by the resident at any time, either prior to, during, or subsequent to an inpatient stay at the nursing facility.
b.The full names of individual(s) so designated, along with their relationship to the resident, shall be recorded in the resident’s permanent medical records, both at the inpatient nursing facility and with the resident’s primary care physician.
c.In the event the resident has not had the opportunity to have said designation recorded in their medical records, a signed statement in the resident’s own handwriting attesting to the designation of said individual(s) as an immediate family member for the purpose of extending visitation right during the provision of health care services in an inpatient health care facility, along with their relationship to said individual(s) shall meet all the requirements of § 1.15.5 of this Part. The resident’s signature on said signed statement shall be witnessed by two (2) individuals, neither of whom can be the designated individual(s). In the event such signed statement is not available, those designated as agents on a durable power of attorney for health care form shall be allowed visitation privileges.
d.§ 1.15.5 of this Part shall not be construed to prohibit legally recognized members of the resident’s family from visiting the resident if they have not been so designated through the provisions of § 1.15.5 of this Part. No resident shall be required to designate individual(s) under the provisions of § 1.15.5 of this Part.
O.Residents shall have the right to obtain personal services or to purchase needs outside of the nursing facility.
P.The resident's right to privacy and confidentiality shall extend to all records pertaining to the resident. Release of any records shall be subject to the resident's approval except as otherwise provided by law.
1.The right to privacy and confidentiality relates to the public dissemination of specific information contained within resident records and to the identification of specific individuals, but does not abrogate the responsibility of the licensing agency to review all resident records.
Q.A resident shall have the right to manage their own personal financial affairs. The resident may delegate the management of their financial affairs to the nursing facility by means of a formal written request. The written request should specify the period of time for which transfer of financial responsibility is desired. If the nursing facility agrees to accept such responsibility, it shall convey acknowledgment of acceptance to the residents in writing. The nursing facility shall have the obligation to conduct the resident's affairs in conformity with State laws and to provide a written accounting statement at least quarterly or at any time upon demand of the resident.
R.Residents shall be assured privacy for visits by the spouse or other partner. If both are residents in the nursing facility, they may share a room unless medically contraindicated per written order of the physician and subject to the availability of such accommodations within the nursing facility.
S.Before transferring a resident to another nursing facility or level of care within a nursing facility, the resident shall be informed of the need for such a transfer and of any alternatives to such a transfer.
1.A resident shall be transferred or discharged only for medical reasons, or for his welfare or that of other residents or for nonpayment of his stay.
2.Reasonable advance notice for transfers to health care facilities other than hospitals shall be given to ensure orderly transfer or discharge and such actions shall be documented in the medical record.
3.Bed-Hold and Readmission: A nursing facility must provide written information pertaining to bed-hold and readmission for residents transferred for hospitalization or therapeutic leave as follows:
a.Notice before transfer: Before a resident of a nursing facility is transferred for hospitalization or therapeutic leave, a nursing facility must provide written information to the resident and a family member or legal representative concerning:
(1)The provisions of the medical assistance program State plan regarding the period (if any) during which the resident will be permitted under the State plan to return and resume residence in the nursing facility; and
(2)The policies of the nursing facility regarding such a period, which policies must be consistent with § 1.15.4(S)(3)(b) of this Part;
b.Notice upon transfer: At the time of the transfer of a resident to a hospital or for therapeutic leave, a nursing facility must provide written notice to the resident and a family member or legal representative of the duration of any period described in § 1.15.4(S)(3)(c) of this Part; except in an emergency, said notice must be given within twenty-four (24) hours of the transfer.
c.Permitting resident to return: A nursing facility must establish and follow a written policy under which a resident:
(1)Who is transferred from the nursing facility for hospitalization or therapeutic leave; and
(2)Whose hospitalization or therapeutic leave exceeds a period paid for under the State plan for the holding of a bed in the nursing facility for the resident, will be readmitted to the nursing facility immediately upon the first availability of a bed of appropriate level of care in a semi-private room in the nursing facility if at time of readmission, the resident requires the services provided by the nursing facility;
(3)Any nursing facility that accepts private payment for purposes of reserving a bed in the nursing facility for a resident who is transferred from the nursing facility for hospitalization or other institutional therapeutic leave, and that resident’s medical and health care is being paid for by the State Medical Assistance Program, shall not charge an amount per day for reserving a bed in the nursing facility that exceeds the nursing facility’s current Medicaid daily rate; for a minimum of the first five (5) days of said hospitalization or the institutional therapeutic leave.
(4)The Departments of Human Services and of Health shall receive, on a monthly basis, the names from each nursing facility of those persons awaiting readmission under these provisions.
T.A resident shall have the right to live in a tobacco smoke-free environment. It shall be prohibited for any person other than a nursing facility resident to smoke in a nursing facility.
1.Nursing facility residents who smoke may do so only in private or semi-private rooms where both residents smoke, or rooms designated by the administration of the nursing facility.
a.A designated smoking area shall be a room or rooms other than the largest living or assembly room or lounge.
b.A designated smoking area shall be ventilated in such a way that the air therefrom shall not enter other parts of the nursing facility.
2.The resident shall have the right to have their pain assessed on a regular basis.
3.Notwithstanding any other provisions of § 1.15.5 of this Part, upon request, patients receiving care through hospitals, nursing facilities, assisted living residences and home health care providers, shall have the right to receive information concerning hospice care, including the benefits of hospice care, the cost, and how to enroll in hospice care.
U.The nursing facility shall respond in a reasonable manner to the request of a resident's physician, certified nurse practitioner and/or a physician assistant for medical services to the resident. The nursing facility shall also respond in a reasonable manner to the resident's request for other services customarily rendered by the nursing facility to the extent the services do not require the approval of the resident's physician, certified nurse practitioner and/or a physician's assistant or are not inconsistent with the resident's treatment.
V.Heat relief: Pursuant to R.I. Gen. Laws § 23-17.5-27, any nursing facility which does not provide air conditioning in every patient room shall provide an air conditioned room or rooms in a residential section(s) of the facility to provide relief to patients when the outdoor temperature exceeds eighty degrees Fahrenheit (80° F).
W.All rights and responsibilities specified in §§ 1.15.4(D), (I), (Q), and (S) of this Part shall devolve, in order of priority, to a resident's guardian, next of kin, sponsoring agency(ies) or representative payor (except when the nursing facility itself is the representative payor) for residents who are:
1.Adjudicated incompetent in accordance with State law; or
2.Found by the physician, physician assistant, or advanced practice registered nurse to be medically incapable of understanding their rights; or
3.Found to exhibit a communication barrier. If however, the communication barrier is one of speaking a language other than English, then an attempt shall be made to find a qualified and competent medical interpreter in accordance with the National Standards on Culturally and Linguistically Appropriate Services (CLAS) and Title VI of the Civil Rights Act for nursing facilities receiving Medicare/Medicaid reimbursements to allow the resident to knowingly exercise their rights.
X.Posting a Copy of Rights of Residents: Each nursing facility shall provide each resident or their representative upon admission, a copy of the provisions of R.I. Gen. Laws Chapter 23-17.5, entitled "Rights of Nursing Home Patients", and shall display in a conspicuous place, in the nursing facility a copy of the "Rights of Residents" and related information. At a minimum the display must include the following:
1.A summary of the major provisions of the Rights of Residents as set forth in this Part;
2.The address and telephone number of: Health Facilities Regulation, Rhode Island Department of Health, Three Capitol Hill, Providence, R.I. 02908 (Telephone Number: 401-222-2566), the agency which will accept complaints or notice of violations of the provisions of this Part;
3.The results of the most recent State and Federal licensing and certification surveys of nursing facilities must be posted.
4.The telephone number of the State long-term care ombudsman: 401-785-3340.
5.The telephone number of the State Medicaid Fraud Unit: 401-274-4400 x2269.
1.15.5Resident and Family Notification
A.The nursing facility shall:
1.Notify the resident, or their legal representative, the resident’s family representative, the resident’s attending physicians of record and the nursing facility’s medical director, if that resident has been found to be in immediate jeopardy (IJ) to health and safety and/or substandard quality of care.
B.The nursing facility shall provide for notification of changes regarding resident condition as provided in Federal Regulation 42 C.F.R. § 483.10 or successor Regulation.
C.A nursing facility citation for substandard quality of care shall be considered to be a public record ten (10) days following the citation.
1.15.6Essential Caregivers During a Declared Emergency
A.The provisions of this section shall apply for the period commencing fifteen (15) days after a declaration of disaster emergency and last until sixty (60) days after the termination or expiration of the declaration of disaster emergency by executive order, proclamation, or operation of law.
B.Each facility shall allow a resident of a nursing home, or an individual with decision-making authority for the resident, to designate an individual as the resident's essential caregiver during a declaration of a disaster emergency.
C.Qualifications and Caregiver Designation
1.In order to be designated as an essential caregiver to provide in-person physical or emotional support to a resident during a declaration of disaster emergency, the individual must be at least eighteen (18) years old.
2.One (1) essential caregiver may be designated at any given time for each resident.
D.Safety Measures
1.Each facility shall develop and implement safety protocols for essential caregivers within fifteen (15) days of a declaration of disaster emergency. Such protocols must be consistent with the Department, State and Federal guidance. Facilities must update safety protocols in the event of any new guidance from State or Federal partners within seventy-two (72) hours.
2.The safety protocols for an essential caregiver, shall include, but not be limited to, procedures on:
a.Restrictions on travel;
(1)Restrictions on travel must not be more restrictive than travel restrictions for all Rhode Island residents for the declaration of disaster emergency.
b.Enhanced testing for communicable diseases, as applicable; and
(1)Enhanced testing, also known as surveillance testing, for essential caregivers must not be more stringent than surveillance testing required for nursing home staff.
c.Use of personal protective equipment (PPE)
(1)The required PPE for essential caregivers will vary depending on tasks, actions, and nature of emergency.
(2)A nursing home is not required to provide personal protective equipment (PPE) to essential caregivers.
3.An essential caregiver must comply with routine surveillance testing during the course of a declared disaster emergency.
4.The nursing facility shall be responsible for verifying/tracking the testing status, as applicable, of essential caregivers.
5.The essential caregiver must adhere to face-masking, hand hygiene, social distancing, and other safety measures at the direction of nursing facility staff.
6.In accordance with R.I. Gen. Laws § 23-17.5-37(b)(4), a facility that enters a lock down phase to establish safety measures for residents and essential caregivers shall not exceed a period of thirty (30) days. During the lock-down phase, essential caregivers are not permitted to enter.
7.A nursing home may establish additional safety requirements to protect the residents of the nursing home if the requirements meet all of the following criteria:
a.The requirements are directly linked to a declaration of disaster emergency.
b.The requirements are not so burdensome and onerous as to substantially prevent an essential caregiver from being able to physically or emotionally support a resident of the nursing home in person.
E.Administration
1.The nursing facility must establish and implement policies and procedures for designating and utilizing essential caregivers during the period of a declared disaster emergency.
2.The nursing facility must allow an essential caregiver to have regular and sustained in-person visitation and physical access to a nursing home resident.
a.The nursing home must ensure visits with essential caregivers are conducted with a reasonable degree of privacy.
3.The essential caregiver may sign an agreement with the nursing facility that outlines what support and activities will be provided by the essential caregiver.
4.An essential caregiver visit may be suspended in the event of the essential caregiver's failure to comply with the facility requirements or these Regulations during a visit.
5.A nursing home must have a policy or procedure in place for a resident or an individual with decision making authority for the resident, to immediately designate a replacement essential caregiver in the event an essential caregiver is suspended.
6.The nursing facility must have a policy or procedures in place to replace an essential caregiver due to necessary circumstances, including but not limited to, illness or death of the essential caregiver.
7.Nursing facilities shall provide training to essential caregivers that includes, but is not limited, to the following:
a.Infection prevention and control, including proper donning and doffing of PPE, hand hygiene, and mask use;
b.Signs and symptoms of any communicable disease(s) that are associated with the declared disaster emergency;
c.Safety and efficacy of any available vaccination(s) for communicable disease(s) associated with the declared disaster emergency.
1.15.7Family Councils
A.Upon the admission of a resident, the nursing facility shall inform the resident and the resident’s family members, in writing, of their right to form a family council, or if a family council already exists, of the date, time, and location of scheduled meetings.
B.If a family council exists, its role shall be to address issues affecting residents generally at the nursing facility, not to pursue individual grievances. Issues may include, but are not limited to:
1.How the nursing facility facilitates resident choice and resident directed activities; and
2.How the nursing facility staff implements person-centered care practices.
C.The family council shall not be entitled to obtain information about individual residents or staff members, or any other information deemed confidential under State or Federal law.
D.No licensed nursing facility may prohibit the formation of a family council.
E.When requested by a member of a resident’s family or a resident’s representative, a family council shall be allowed to meet in a common meeting room of the nursing facility at least once a month during mutually agreed upon hours.
F.The nursing facility administration shall notify the State long-term care ombudsman of the existence or planned formation of a family council at that nursing facility.
G.The family council may exclude members only for good cause shown, subject to appeal by the excluded party to the State long-term care ombudsman. No member shall be excluded on the basis of race or color, religion, gender, sexual orientation, disability, age, or country of ancestral origin.
H.A nursing facility shall provide its family council with adequate space in a prominent posting area for the display of information pertaining to the family council.
I.Staff or visitors may attend family council meetings at the council’s invitation.
J.The nursing facility shall provide a designated staff person who, at the request of the council, shall be responsible for providing assistance to the family council and for responding to recommendations and requests made by the family council.
K.The nursing facility shall consider the recommendations of the family council concerning issues and policies affecting resident care and life at the nursing facility.
1.15.8Reimbursement of Monies Prepaid to Deceased Patient's Estate
A.The nursing facility shall be required to reimburse any monies that have been prepaid on behalf of a deceased patient to the nursing within ninety (90) days of the patient's date of death. Said reimbursement shall be paid to the person(s), institution or other legal entity who has paid the monies, or if there be none, to the deceased patient's estate, and payment shall be made in the amount remaining after all items and services provided or arranged by the nursing have been paid. However, if payment is required to be made to the deceased patient’s estate, payment shall not become due until sixty (60) days after the nursing is notified that the estate has been filed.
B.A violation of the provisions of § 1.15.5 of this Part shall constitute a violation of the rights of nursing facility residents.
1.15.9Uniform Reporting System
A.Uniform Reporting System: Each nursing facility shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this reporting may be met shall be prescribed from time to time in directives promulgated by the Director with the advice of the Health Services Council.
B.Each nursing facility shall report to the licensing agency detailed financial and statistical data pertaining to its operations, services, and facilities. Such reports shall be made at such intervals and by such dates as determined by the Director and shall include but not be limited to the following:
1.Utilization of nursing services;
2.Unit cost of nursing services;
3.Charges for rooms and services;
4.Financial condition of the nursing facility;
5.Quality of care;
6.Quality of life;
7.Resident census; and
8.Licensed nursing hours and turnover.
C.The licensing agency is authorized to make the reported data available to any State agency concerned with or exercising jurisdiction over the reimbursement or utilization of nursing facilities.
D.Each nursing facility shall report information responsive to R.I. Gen. Laws § 23-17-65, annually, by such date and manner, as determined by the Director.
E.The directives promulgated by the Director pursuant to this Part shall be sent to each nursing facility to which they apply. Such directives shall prescribe the form and manner in which the financial and statistical data required shall be furnished to the licensing agency.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.16** Resident Care Services {#sec-216-ricr-40-10-1-1.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.16}
1.16.1Resident Care Policies
A.Each nursing facility shall have written resident care policies to govern the continuing nursing care and related medical or other services provided.
1.Care practices shall be person-centered in their implementation and resident-directed in their development whenever possible, and
2.The nursing facility shall provide care and services to all residents in accordance with the prevailing community standard of care.
B.Each nursing facility licensed under the provision of R.I. Gen. Laws Chapter 23-17 shall have a written plan for preventing the hazards of resident wandering from the nursing facility. Said plan shall be on file in the nursing facility and available to the licensing agency upon request.
C.As part of the initial resident admission and assessment process, the nursing facility shall review and consider any notice provided to the facility as required in R.I. Gen. Laws § 42-56-10(23) concerning the resident's or prospective resident's status on parole and recommendations, if any, from the Department of Corrections regarding safety and security measures.
D.Resident care policies and procedures shall be developed and reviewed annually, and revised as necessary, in all nursing facilities by a group of professional personnel including one (1) or more physicians, a registered nurse, representatives of self-directed work teams, and other professional personnel as deemed necessary (e.g., social workers, physical therapists, registered nursing assistants, universal workers, etc.). Documentation of this annual review shall be made available to the licensing agency upon request.
E.Resident care policies shall be available for review by all residents, physicians, community agencies, relatives and personnel and shall include provisions for at least the following:
1.Meeting the total medical and psychosocial needs of residents;
2.The establishment of written plans of care for each resident for medical, nursing and other related services provided;
3.The range of services available and provided to residents and constraints imposed by limitations of services, physicians, facilities, staff coverage, payment mechanism or other;
4.The frequency of physician visits shall be at a minimum of ninety (90) days;
5.The protection of residents' personal and property rights;
6.Types of clinical conditions acceptable for admission to specific levels of care and appropriate services;
7.Emergency admissions or discharges and emergency care of residents;
8.Requirements for informed consent by resident, parent, guardian or legal representative for treatment;
9.Notification of next of kin, attending physician or responsible agency of any transfer or discharge;
10.Notification of next of kin, attending physician or responsible agency of any change of condition;
11.Opportunity for resident, resident family, and/or Family Council comment or complaint;
12.Transfer of medical information in accordance with R.I. Gen. Laws Chapter 5-37.3;
13.Discharge and termination of services; and
14.Provision for continuity of resident care as related to discharge planning, which shall include a mechanism for recording, transmitting and receiving information essential to the continuity of resident care. Such information shall contain no less than the following:
a.Resident identification data; such as name, address, age, gender, name of next of kin, health insurance coverage, etc.;
b.Diagnosis and prognosis, medical status of resident, brief description of current illness, medical and nursing plans of care including such information as medications, treatments, dietary needs, baseline laboratory data;
c.Functional status;
d.Special services such as physical therapy, occupational therapy, speech therapy and such other;
e.Psychosocial needs;
f.Bed-hold policy and readmission in accordance with § 1.15.4(S)(3)(c) of this Part; and
g.Such other information pertinent to ensure continuity of resident care.
F.There shall be documented evidence of the designation of responsibility to a physician, or to a nurse or to the medical staff for the execution and implementation of resident care policies.
1.When a nurse is designated as the responsible agent for a day-to-day execution of resident care policies, a physician shall be available to provide necessary medical guidance.
1.16.2Infection Prevention and Control
A.The nursing facility shall be responsible for no less than the following:
1.Establishing and maintaining a nursing facility-wide infection surveillance program;
2.Developing and implementing written policies and procedures for the surveillance, prevention, and control of infections in all nursing facility departments/services;
3.Establishing policies and practices governing the admission and isolation of residents with known or suspected infectious diseases;
4.Developing, evaluating and revising on a continuing basis infection prevention and control policies, procedures and techniques for all appropriate areas of nursing facility operation and services;
5.Developing and implementing a system for evaluating and recording the occurrences of all infections among residents and communicable diseases among personnel; such records shall be made available to the licensing agency upon request;
6.Assuring that all resident care support departments have adequate direction, training, staffing and facilities to perform required infection prevention and control functions;
B.Infection prevention and control policies and procedures shall be established for the mutual protection of residents, employees, and the public.
C.A continuing education program on infection prevention and control shall be established and conducted for all staff.
1.16.3Reporting of Communicable Diseases
A.Each nursing facility shall report promptly to the Rhode Island Department of Health, Division of Emergency Preparedness and Infectious Disease cases of communicable diseases designated as "reportable diseases" when such cases are diagnosed in the facility in accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental, and Occupational Diseases.
B.When infectious diseases present a potential hazard to residents or personnel, these shall be reported to the Rhode Island Department of Health, Division of Emergency Preparedness and Infectious Disease even if not designated as "reportable diseases."
C.When outbreaks of food-borne illness are suspected, such occurrences shall be reported immediately to the Rhode Island Department of Health, Division of Emergency Preparedness and Infectious Disease, or to the Division of Environmental Health, Center for Food Protection.
D.Nursing Facilities must comply with the provisions of R.I. Gen. Laws § 23-28.36-3, which requires notification of fire fighters, police officers and Emergency Medical Technicians after exposure to infectious diseases.
1.16.4Resident Immunization Policies/Practices
A.Every nursing facility in Rhode Island shall request that residents be immunized for influenza virus and pneumococcal disease in accordance with R.I. Gen. Laws Chapter 23-17.19.
B.Influenza, pneumococcal, and other adult vaccination policies and protocols (such as physician’s standing orders) for nursing facility residents shall be developed and implemented by the nursing facility in accordance with the provisions of R.I. Gen. Laws §§ 23-17.19-4(a) through (c).
C.Vaccinations must be provided in accordance with the Centers for Disease Control and Prevention (CDC) Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (November 2011) https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf.
1.Exceptions: No resident shall be required to receive either the influenza or pneumococcal vaccine in accordance with exceptions listed in R.I. Gen. Laws § 23-17.19-6.
1.16.5Physician Service
A.All residents shall remain or be under the care of a physician of their choice, subject to the physician's concurrence.
1.All physician assistant services shall be in accordance with the provisions of R.I. Gen. Laws Chapter 5-54.
2.All nurse practitioner services shall be in accordance with the provisions of R.I. Gen. Laws Chapter 5-34.
B.No less than the following resident care information shall be made available to facilities by the referring source prior to or upon admission and provided only in accordance with the requirements of R.I. Gen. Laws Chapter 5-37.3:
1.Current medical findings;
2.Summary of pre-admission treatment and care; and
3.Diagnosis and medical orders by the physician, physician assistant, or advanced practice registered nurse for immediate resident care.
C.Each nursing facility shall establish and comply with policies governing medical care supervision. Such policies shall include no less than the following:
1.That every resident be under the continued medical supervision of a physician of their choice;
2.That a prescribed medical care plan be established for each resident by the attending physician, or physician assistant or advanced practice registered nurse in collaboration with the attending physician. Accordingly, recommendations or orders from consultants shall be approved by the attending physician, or physician assistant or advanced practice registered nurse in collaboration with the attending physician prior to implementation of the order.
3.That the medical care plan be based on a physical examination done within forty-eight (48) hours of admission unless such was performed within five (5) days prior to admission;
4.That each resident be seen by an attending physician, or physician assistant or advanced practice registered nurse in collaboration with the attending physician and the medical care plan be renewed or revised in accordance with the needs of the resident at least every ninety (90) days;
5.That arrangements be made for physician coverage in the absence of the attending physician; and, and progress notes be written and signed by the physician at the time of each visit.
6.Any physician's, physician assistant’s, or advanced practice registered nurse’s verbal order for drugs, and biologicals shall be given in accordance with the provisions of § 1.16.9(B) of this Part.
D.Written policies and procedures pertaining to emergency medical care including a listing of physician coverage, shall be established and maintained in each residential area. The nursing facility must provide or arrange for physician's services twenty-four (24) hours a day in case of an emergency.
E.Standing orders shall not be permitted. All orders shall be recorded in the resident's medical record and shall be properly signed. However, a physician's, physician assistant’s, or advanced practice registered nurse’s order for an individual resident may refer to treatments described in a written protocol adopted by the nursing facility. An exception to the requirements of § 1.16.5 of this Part shall be made for the administration of influenza and pneumococcal immunizations as provided in § 1.16.4 of this Part and the administration of Naloxone (Narcan) in accordance with Part 20-20-5 of this Title, Opioid Overdose Prevention and Reporting.
1.16.6Nursing Service and Minimum Staffing
A.Each nursing facility shall have a formally organized nursing service with an organization chart reflecting the lines of communication. The authority, responsibilities and duties for each nursing service position and/or category shall be clearly delineated in writing through job descriptions.
B.The nursing service shall be under the direction of a Director of Nurses who shall be a registered nurse and employed full-time. A relief registered nurse shall be employed to ensure full-time coverage in the absence (including vacation, sick time, days off, or other) of the designated registered nurse.
1.The Director of Nurses shall not be the administrator nor the assistant administrator and shall:
a.Have at least two (2) years’ experience in nursing supervision or, by training and experience, shall have demonstrated competency in nursing service management;
b.Be employed by only one (1) facility in said capacity; and
c.Be responsible for the total nursing service which shall include no less than:
(1)Development, maintenance and evaluation of standards of nursing practice;
(2)Development and periodic revision of nursing policies and procedure manuals;
(3)Recommendation to the nursing facility’s administration of the number and categories of nursing personnel required to provide resident care;
(4)Training, assignment, supervision and evaluation of personnel;
(5)Coordination of nursing care services with other services, e.g., medical, nutrition, etc.; and
(6)All other functions and activities related to nursing service management.
C.Each facility shall have a registered nurse on the premises twenty-four (24) hours a day. In addition, the necessary nursing service personnel (licensed and non-licensed) shall be in sufficient numbers on a twenty-four (24) hour basis, to assess the needs of resident, to develop and implement resident care plans, to provide direct resident care services, and to perform other related activities to maintain the health, safety and welfare of residents.
1.There shall be a master plan of the staffing pattern for providing twenty-four (24) hour direct care nursing service; for the distribution of direct care nursing personnel for each floor and/or residential area; for the replacement of direct care nursing personnel; and for forecasting future needs. The staffing pattern shall include provisions for registered nurses, licensed practical nurses, nursing assistants, medication technicians, licensed physical therapists, licensed occupational therapists, licensed speech-language pathologists, physical therapist assistants and other personnel as required.
2.Each nursing facility shall include direct caregivers, including at least one (1) nursing assistant, in the process to create the master plan of the staffing pattern and the federally mandated facility assessment. If the nursing assistants in the nursing facility are represented under a collective bargaining agreement, the bargaining unit shall coordinate voting to allow the nursing assistants to select their representative.
3.The number and type of nursing personnel shall be based on resident care needs and classifications as determined for each residential area. Each nursing facility shall be responsible to have sufficient qualified staff to meet the needs of the residents.
4.At least two (2) individuals who are certified in Basic Life Support must be available twenty-four (24) hours a day within the nursing facility. One (1) of these individuals must be a licensed nurse.
5.Commencing on January 1, 2022, nursing facilities shall provide a quarterly minimum average specified in R.I. Gen. Laws § 23-17.5-32(c)(i).
6.Commencing on January 1, 2023, nursing facilities shall provide a quarterly minimum average specified in R.I. Gen. Laws § 23-17.5-32(c)(ii).
a.In accordance with R.I. Gen. Laws § 23-17.5-32(d), Director of Nursing hours and nursing staff hours spent on administrative duties or non-direct caregiving tasks are excluded and may not be counted toward compliance with the minimum staffing hours requirement in §§ 1.16.6(C)(5) and (6) of this Part.
b.Nursing facilities that are certified by the Federal Centers for Medicare and Medicaid Services (CMS) shall access and report data using CMS' payroll-based journal database in accordance with R.I. Gen. Laws § 23-17.5-33(a)(2).
c.Nursing facilities that are not certified by CMS (State licensure only) shall report data to the licensing agency in a form and manner as prescribed by the Director.
7.In accordance with R.I. Gen. Laws § 23-17.5-32(e), the requirements of §§ 16.6.(C)(5) and (6) of this Part are minimum standards only. Nursing facilities shall employ and schedule additional staff as needed to ensure quality resident care based on the needs of individual residents and to ensure compliance with all relevant State and Federal staffing requirements.
8.Compliance and enforcement for § 1.16.6 of this Part shall be done in accordance with R.I. Gen. Laws § 23-17.5-33.
1.16.7Nursing Staff Posting Requirements
A.Each nursing facility shall post its daily direct care nurse staff levels by shift in a public place within the nursing facility that is readily accessible to and visible by residents, employees, and visitors. The posting shall be accurate to the actual number of direct care nursing staff on duty for each shift per day. The posting shall be in a format prescribed by the Director, to include:
1.The number of registered nurses, licensed practical nurses, nursing assistants, medication technicians, licensed physical therapists, licensed occupational therapists, licensed speech-language pathologists, and physical therapy assistants;
2.The number of temporary, outside agency nursing staff;
3.The resident census as of 12:00 a.m.
4.Documentation of the use of unpaid eating assistants (if utilized by the nursing facility on that date).
5.The minimum number of nursing facility direct caregiver staff per shift that is required to comply with the minimum staffing level requirements contained in § 1.16.6 of this Part; and
6.The telephone number or internet website that a resident, employee or visitor of the nursing facility may use to report a suspected violation by the nursing facility of a regulatory requirement concerning staffing levels and direct patient care.
B.The posting information shall be maintained on file by the nursing facility for no less than three (3) years and shall be made available to the public upon request.
C.The nursing facility shall prepare an annual report showing the average daily direct care nurse staffing level for the nursing facility by shift and by category of nurse to include registered nurses, licensed practical nurses, nursing assistants medication technicians, licensed physical therapists, licensed occupational therapists, licensed speech-language pathologists, and physical therapy assistants; the use of nurse and nursing assistant staff from temporary placement agencies; and the nurse and nursing assistant turnover rates.
1.The annual report shall be submitted with the nursing facility’s renewal application and provide data for the previous twelve (12) months and ending no earlier than September 30th, for the year preceding the license renewal year. Annual reports shall be submitted in a format prescribed by the Director.
D.The information on nurse staffing shall be reviewed as part of the nursing facility’s annual licensing survey and shall be available to the public, both in printed form and on the Department’s website, by nursing facility.
E.The Director of Nurses may act as a charge nurse only when the nursing facility is licensed for thirty (30) beds or less.
F.Whenever the licensing agency determines, in the course of inspecting a nursing facility, that additional staffing is necessary on any residential area to provide adequate nursing care and treatment or to ensure the safety of residents, the licensing agency may require the nursing facility to provide such additional staffing and any or all of the following actions shall be taken to enforce compliance with the determination of the licensing agency.
1.The nursing facility shall be cited for a deficiency and shall be required to augment its staff within ten (10) days in accordance with the determination of the licensing agency.
2.If failure to augment staffing is cited, the nursing facility shall be required to curtail admission to the nursing facility.
3.If a continued failure to augment staffing is cited, the nursing facility shall be subjected to an immediate compliance order to increase the staffing, in accordance with R.I. Gen. Laws § 23-1-21.
4.The sequence and inclusion or non-inclusion of the specific sanctions enumerated in § 1.16.7(F) of this Part may be modified in accordance with the severity of the deficiency in terms of its impact on the quality of resident care.
G.No nursing staff of any nursing facility shall be regularly scheduled for double shifts.
1.16.8Selected Nursing Care Procedures
A.Written resident care plans, including problems, measurable goals, interventions, and time frames, shall be developed and maintained for each resident consonant with the attending physician, physician assistant, or advanced practice registered nurse’s plan of medical care.
1.Resident care plans shall be reviewed, evaluated and revised by professional staff no less than every three (3) months, or when there is a significant change in the resident's health status.
B.The personal hygiene of each resident shall be attended to. All residents shall receive person-centered care including care of skin, shampooing and grooming of hair, oral hygiene, shaving, cleaning and cutting of fingernails and toenails. Residents shall be kept free of offensive odors.
C.Residents shall be encouraged and/or assisted to function at their highest level of self-care and independence. Every effort shall be made to keep residents active and out of bed for reasonable periods of time except when contraindicated by physician, physician assistant, or advanced practice registered nurse orders.
D.Every nursing facility shall have an active program for rehabilitative nursing care.
E.Such supportive and restorative nursing care needed to maintain maximum functioning of the resident shall be provided.
F.Each resident shall be given care to prevent pressure ulcers, contractures and deformities, including:
1.Preventive skin care as appropriate;
2.Changing the position of bedfast and chair-fed residents;
3.Maintaining proper body alignment and joint movement to prevent contractures and deformities; and
4.Encouraging, assisting and training residents in self-care and activities of daily living.
G.Measures shall be taken to prevent and reduce incontinence for each resident which shall include no less than:
1.Written assessment by a registered nurse or physician assistant, within two (2) weeks of admission, of each incontinent resident's ability to participate in a bowel and/or bladder training program;
2.An individualized plan of care for each resident selected for training to be included in the resident's nursing care plan to restore as much normal bladder function as possible.
1.16.9Administration of Drugs
A.Drugs shall be administered in accordance with written orders of the attending physician and procedures established in accordance with §§ 1.17.4(A) and (B) of this Part. Such procedures shall include measures to assure:
1.That drugs are checked against physicians', physician assistants’, or advanced practice registered nurses’ orders;
2.That the resident is identified prior to administration of a drug;
3.That each resident has an individual medication record; and
4.That the dose of drug administered to each resident is properly recorded therein by the person administering the drug.
B.Drugs not specifically limited as to time or number of doses when ordered shall be controlled by automatic stop orders or other methods in accordance with written policies.
C.Physicians', physician assistants’, or advanced practice registered nurses’ verbal orders for drugs and biologicals shall be given only to a licensed nurse, a registered pharmacist or to a physician and shall be immediately recorded and signed by the person receiving the order. Such orders shall be countersigned by the attending physician within fifteen (15) days.
1.16.10Administration of Drugs by Medication Technicians
A.Medication aides or technicians who have satisfactorily completed a State-approved course in drug administration and have demonstrated competency in accordance with the State-approved protocol in drug administration may administer oral or topical drugs, with the exception of all Schedule II drugs, with supervision in accordance with the State-approved protocol in drug administration. If such medication technicians are from temporary employment agencies, the nursing facility shall have onsite evidence of supervision in accordance with the Rhode Island-approved protocol in drug administration.
B.The director of nursing or their registered nurse designee shall conduct and document quarterly evaluations of the medication technicians who are administering drugs. Copies of said evaluations shall be placed in the medication technicians’ personnel records.
1.16.11Assistance with Eating and Hydration
A.Nursing facilities may employ resident attendants to assist residents with activities of eating and drinking. The resident attendant shall not be counted in the direct care staffing levels (see also § 1.16.7(A) of this Part).
B.A nursing facility shall not use any individual on a paid or unpaid basis in the capacity of a resident attendant, as defined in this Part, in the nursing facility unless the individual:
1.Has satisfactorily completed a training program approved by the Director, as described in § 1.16.12 of this Part;
2.Continues to provide competent eating and hydration assistance as determined by the facility’s professional nursing staff.
C.The nursing facility shall ensure:
1.The resident attendant works in congregate dining areas under the supervision of a registered nurse (RN) or licensed practical nurse (LPN);
2.The resident attendant wears a photo identification badge in accordance with § 1.14.7 of this Part;
3.The resident attendant only assists residents selected by the professional nursing staff, based on the charge nurse’s assessment and the resident’s latest assessment and plan of care;
4.The resident attendant assists with eating and drinking for residents who have no complicated eating or eating assistance problems, including but not limited to:
a.Tube or parenteral/enteral nutrition;
b.Recurrent lung aspirations;
c.Difficulty swallowing;
d.Residents at risk of choking while eating or drinking;
e.Residents with significant behavior management challenges while eating or drinking;
f.Residents presenting other risk factors that may require emergency intervention.
5.Maintenance of records regarding individuals acting as resident attendants and the training program attended.
1.16.12Training Program for Resident Attendants
A.Resident attendants shall be required to have successfully completed a basic training program approved by the Director to provide safe and proper eating and hydration assistance to nursing residents with no complicated eating or drinking problems. The program requirements shall include, but are not limited to, the following:
1.The training program shall be conducted by a registered nurse, and may include the assistance of a registered dietitian;
2.The training shall provide a minimum of eight (8) hours of classroom instruction, and participants shall demonstrate an understanding of topics that includes but is not limited to:
a.Eating techniques;
b.Physical mechanics of:
c.Breathing and swallowing;
d.Aspiration;
e.Choking
f.Assistance with eating and hydration (drinking);
g.Infection control;
h.Resident rights;
i.Communication and interpersonal skills;
j.Appropriate responses to resident behavior;
k.Safety and emergency procedures, including the Heimlich maneuver;
3.The training shall provide, either directly or through arrangements with a nursing facility, a minimum of four (4) hours of documented practical experience supervised by a registered nurse.
4.Certificate of classroom completion shall be signed by registered nurse trainer, bear the Department program approval certification number and include an area for documentation of satisfactory completion of practical experience.
5.Organizations or facilities interested in providing a resident attendant eating assistance program should submit a letter of intent to:
HEALTH Center for Health Facilities Regulation
c/o Eating Assistance Program
3 Capitol Hill
Providence, RI 02908
a.The request must include:
(1)An outline of the structure and format for the program;
(2)Resume/curriculum vita for the registered nurse trainer and other trainers;
(3)Curriculum/program outline to be utilized;
(4)Method of ensuring participants’ successful demonstration of competencies;
(5)Program contact information.
6.Following review by HEALTH, numbered program approvals will be provided.
1.16.13Pain Assessment
A.All health care providers licensed by Rhode Island to provide health care services and all health care facilities licensed under R.I. Gen. Laws Chapter 23-17 shall assess patient pain in accordance with the requirements of Part 20-15-2 of this Title, Pain Assessment.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.17** Special Care Units {#sec-216-ricr-40-10-1-1.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.17}
1.17.1Alzheimer and Other Dementia Special Care Units or Programs
A.Any nursing facility that provides or offers to provide care or services for residents in a manner as defined in this Part shall disclose to the licensing agency and any person seeking placement in such Alzheimer and Other Dementia Special Care Unit/Program the form of specialized care and treatment provided that is in addition to the care and treatment required in this Part.
1.The information disclosed shall be on a form prescribed by the Department.
2.The nursing facility shall provide care and services as described in the disclosure form, and consistent with this Part. The information disclosed shall explain the additional care provided in each of the following areas:
a.Philosophy – The special care unit/program’s written statement of its overall philosophy and mission which reflects the needs of residents afflicted with dementia.
b.Pre-Admission, Admission and Discharge – The process and criteria for placement (which shall include a diagnosis of dementia), transfer or discharge from the unit.
c.Assessment, Care Planning and Implementation – The process used for assessment and establishing the plan of care and its implementation, including the method by which the plan of care evolves and is responsive to changes in condition.
d.Staffing Patterns and Training – Staff patterns and training and continuing education programs, which shall emphasize the effective management of the physical and behavioral problems of those with dementia.
e.Physical Environment – The physical environment and design features shall be appropriate to support the functioning and safety of cognitively impaired adult residents.
f.Therapeutic Activities – The frequency and types of resident activities. Therapeutic activities shall be designed specifically for those with dementia.
g.Family Role in Care – The nursing facility shall provide for the involvement of families and family support program.
h.Program Costs – The cost of care and any additional fees.
3.Any significant changes in the information provided by the nursing facility will be reported to the licensing agency at the time the changes are made.
B.In accordance with R.I. Gen. Laws § 23-1.7-6, the nursing facility must complete and implement an operational plan for the recognition and management of residents with Alzheimer's disease or dementia.
1.Such plan shall include a protocol for the following:
a.Identifying the signs and symptoms of cognitive impairments, including Alzheimer's Disease;
b.Management and treatment of residents with Alzheimer's Disease;
c.Training of clinical and non-clinical staff; and
d.Advance care planning; and resources for family members.
2.Such plan shall be maintained by the nursing facility and made available to the licensing agency upon request.
1.17.2Rehabilitation Special Care Unit and Subacute Special Care Unit
A.Any nursing facility that provides or offers to provide care for patients or residents by means of a Rehabilitation Special Care Unit or a Subacute Special Care Unit shall be required to disclose to the licensing agency and to any person seeking placement in a Rehabilitation Special Care Unit or a Special Care Unit of a nursing facility the form of specialized care and treatment provided that is in addition to the care and treatment required in this Part.
1.The information disclosed shall be on a form prescribed by the licensing agency.
2.The nursing facility shall provide care and services as described in the disclosure form, and consistent with this Part.
3.Any significant changes in the information provided by the nursing facility shall be reported to the licensing agency at the time the changes are made.
1.17.3Dietetic Services
A.Each nursing facility shall maintain a dietetic service under the supervision of a full-time person who, as a minimum, is a graduate of a Rhode Island-approved course that provided instruction in food service supervision and nutrition and has experience in the organization and management of food service.
1.When the dietary manager is absent, a responsible person shall be assigned to supervise dietetic service personnel and food service operations.
B.When the dietary manager is not a qualified dietitian who is registered or eligible for registration by the commission of dietetic registration and/or licensed by Rhode Island, the nursing facility shall obtain per written contractual arrangement adequate and regularly scheduled consultation from a qualified dietitian.
C.The responsibilities of the qualified dietitian shall include but not be limited to:
1.Advising the administration and the supervisor of dietetic services on all nutritional aspects of resident care, food service and preparation;
2.Reviewing food service policies, procedures and menus to ensure the nutritional needs of all residents are met in accordance with Dietary Reference Intakes: The Essential Guide to Nutrient Requirements;
3.Serving as liaison with medical and nursing staff on nutritional aspects of resident care;
4.Advising on resident care policies pertaining to dietetic services;
5.Providing dietary counseling to residents when necessary;
6.Planning and conducting regularly scheduled in-service education programs which shall include training in food service sanitation;
7.Preparing reports which shall include date and time of consultation and services rendered, which reports shall be signed and kept on file in the nursing facility; and
8.Recording observations and information pertinent to dietetic treatment in the resident's medical record;
9.Input in care plan development.
D.Adequate space, equipment and supplies shall be provided for the efficient, safe and sanitary receiving, storage, refrigeration, preparation and service of food and other related aspects of the food service operation in accordance with Part 50-10-1 of this Title, Rhode Island Food Code.
E.Policies and procedures shall be established for the dietetic service, pertaining to but not limited to the following:
1.Responsibilities and functions of personnel;
2.Standards for nutritional care in accordance with Dietary Reference Intakes: The Essential Guide to Nutrient Requirements;
3.Alterations or modifications to diet orders or schedules;
4.Food purchasing storage, preparation and service;
5.Safety and sanitation relative to personnel and equipment in accordance with Part 50-10-1 of this Title, Rhode Island Food Code; and
6.Ancillary dietary services, including food storage and preparation in satellite kitchens and vending operations in accordance with Part 50-10-1 of this Title, Rhode Island Food Code; and
7.A plan to include alternate methods and procedures for food preparation and service, including provisions for potable water, to be used in emergencies.
F.All nursing facilities shall provide sufficient and adequately trained supportive personnel, competent to carry out the functions of the dietetic services.
1.The dietetic services shall have employees on duty over a period of twelve (12) or more hours per day, seven (7) days per week.
2.Except as provided in § 1.17.3(F) of this Part, those employees involved in direct preparation of food (as opposed to distribution of food, dishwashing, etc.) shall not be involved in providing resident direct care.
3.Except where employees are designated and qualified as “universal workers,” housekeeping and nursing personnel qualified in accordance with § 1.14.6(A)(6)(b) of this Part may assist in food distribution, and food preparation. Careful hand washing shall be done prior to assisting in food distribution and/or preparation.
G.The nursing facility’s food service operation shall comply with all appropriate standards of Part 50-10-1 of this Title, Rhode Island Food Code.
1.Diet kitchens, nourishment stations, and any other related areas shall be the responsibility of the dietetic service.
H.All menus including alternate choices shall be planned at least one (1) week in advance, to meet the standards for nutritional care in accordance with Dietary Reference Intakes: The Essential Guide to Nutrient Requirements and to provide for a variety of foods, adjusted for seasonal changes, and reflecting the dietary preferences of residents.
1.Menus shall indicate nourishments offered to residents between evening meal and bedtime.
2.Menus shall be posted in a conspicuous place in the dietary department and in resident areas.
3.Records of menus actually served shall be retained for thirty (30) days.
I.All diets shall be ordered in writing by the attending physician.
1.All diets shall be planned, prepared and served to conform to the physician's orders and to meet the standards of Dietary Reference Intakes: The Essential Guide to Nutrient Requirements to the extent medically possible.
2.Diet orders shall be reviewed by the attending physician on same schedule as other physician orders.
J.There shall be a diet manual, approved by the dietitian and available to all dietetic and nursing services personnel. Diets served to residents shall comply with the principles set forth in the diet manual.
K.Each resident shall receive and the nursing facility shall provide at least three (3) meals daily, at regular times comparable to normal mealtimes based upon the individual preference of a resident or group of residents in a residential area and/or at regular times comparable to normal mealtimes in the community.
1.There shall be no more than fourteen (14) hours between a substantial evening meal and breakfast the following day, except as provided in § 1.17.3(K)(3) of this Part.
2.The nursing facility shall offer snacks at bedtime daily.
3.When a nourishing snack is provided at bedtime, up to sixteen (16) hours may elapse between a substantial evening meal and breakfast the following day if a resident, or group of residents in a residential area agrees to this meal span, and there is a nourishing snack.
L.Foods shall be prepared by methods that conserve nutritive value, flavor and appearance, and shall be prepared and served at proper temperatures and in a form to meet individual needs. Food substitutes of similar nutritive value shall be offered when residents refuse foods served for good reason.
1.A file of tested recipes, adjusted to appropriate yield, shall be maintained and utilized corresponding to items on the menu.
2.House diets shall be appropriately seasoned.
3.There shall be a supply of staple foods for a minimum of seven (7) days and of perishable foods for a minimum of two (2) days in the nursing facility.
M.Food shall be attractively served on dinnerware of good quality, such as ceramic, plastic or other materials that are durable and aesthetically pleasing.
N.A dining room shall be available for those residents or residents who wish to participate in group dining in accordance with § 1.19.9(A) of this Part.
O.Self-help feeding devices shall be available to those residents who need them to maintain maximum independence in the activities of daily living.
P.A nursing facility contracting for food service shall require as part of the contract, that the contractor comply with the provisions of this Part.
1.17.4Pharmaceutical Services
A.Each nursing facility shall provide pharmaceutical services either directly within the nursing facility or per contractual arrangement. Such services shall be provided in accordance with the requirements of Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors, and Part 20-20-4 of this Title, Pain Management, Opioid Use, and the Registration of Distributors of Controlled Substances in Rhode Island.
1.In either instance, appropriate methods and procedures for the procurement and the dispensing of drugs and biologicals shall be established in accordance with appropriate Federal and State laws and Regulations.
B.There shall be written policies and procedures relating to the pharmaceutical service which shall require no less than:
1.The authority, responsibility and duties of the registered pharmacist;
2.The selection, procurement, distribution, storage, dispensing or other disposition of drugs and biologicals in accordance with appropriate Federal and State laws and Regulations;
3.Maintenance of records of all transactions, including recording of receipt and dispensing or other disposition of all drugs and biologicals;
4.Inspection of all drug and biological storage and medication areas and documented evidence of findings;
5.Automatic stop orders for drugs or biologicals;
6.The use of only approved drugs and biologicals;
7.Control of medicines from any source;
8.A monitoring program to identify adverse drug reactions, interactions and incompatibilities and antibiotic antagonisms; and
9.Labeling of drugs and biologicals including name of resident, name of physician, drug dosage, cautionary instructions, and expiration date.
C.Adequate space, equipment, supplies and locked storage areas shall be provided for the storage of drugs and biologicals based on the scope of services provided. Refrigerated food storage units shall not be utilized for storage of drugs and/or biologicals except:
1.In facilities of thirty (30) beds or less, a refrigerated food storage unit may be used for drugs and biologicals provided they are locked in an appropriate container.
D.Drugs may be administered to residents from bulk inventories of non-legend and non-controlled substance items such as aspirin, milk of magnesia, etc. as ordered by a licensed physician.
E.An emergency medication kit, approved by the pharmaceutical service committee or its equivalent, shall be available in each residential area.
F.Each residential area shall have adequate drug and biological preparation areas with provisions for locked storage in accordance with Federal and State laws and Regulations.
1.17.5In Nursing Facilities
A.The pharmaceutical service committee or its equivalent, consisting of not less than a registered pharmacist, a registered nurse, a physician and the administrator, shall:
1.Serve as an advisory body on all matters pertaining to pharmaceutical services;
2.Establish a program of accountability for all drugs and biologicals;
3.Develop and review periodically all policies and procedures for safe and effective drug therapy in accordance with § 1.17.4(B) of this Part; and
4.Monitor the service.
B.A registered pharmacist shall assist in developing, coordinating and supervising all pharmaceutical services in conjunction with the pharmaceutical services committee. In addition, a registered pharmacist shall:
1.Review the drug and biological regimen of each resident at least monthly;
2.Report any irregularities to the attending physician and director of nurses. These reports must show evidence of review and response; and
3.Document in writing the performance of such review, which documentation shall be kept on file by the nursing facility and shall be made accessible to inspectors on request.
1.17.6Dental Services
A.Each nursing facility shall provide or obtain from outside resources, dental services for routine and emergency care.
1.Each resident shall have the right to receive dental services from a dentist of their choice.
B.A list of community dentists shall be maintained and available to all residents.
C.When necessary, arrangements shall be made by nursing facilities for the transportation of residents to and from the dental care office.
1.17.7Laboratory and Radiologic Services
A.All nursing facilities shall make provisions for laboratory, x-ray and other services to be provided either directly by the nursing facility or per contractual arrangements with an outside provider.
1.If the nursing facility provides its own laboratory and x-ray services, these shall meet all applicable statutory and regulatory requirements.
B.All services shall be provided only per order of the attending physician who shall be promptly notified of the findings in accordance with a protocol established by the nursing facility. Such a protocol shall describe which laboratory values mandate a call to the resident’s attending physician.
C.Signed and dated reports of all findings shall become part of the resident's medical record.
1.17.8Social Services
A.Every nursing facility shall provide social services to attain or maintain the highest practicable physical, mental and psychological well-being of each resident. Social services must be provided either directly by a qualified social worker or by arrangement with an appropriate health or social service agency or through consultation with a qualified social worker who would supervise a social work designee appointed by the administrator.
1.Services shall pertain to no less than the following:
a.Identification of social and emotional needs of residents through a comprehensive psychosocial assessment including a social history;
b.Establishment of a plan of care based on residents' needs;
c.Procedures for referral of residents, when indicated, to appropriate social agencies and discharge planning as indicated
B.A qualified social worker is defined as an individual with a minimum of a BSW from an accredited School of Social Work. A social work designee is defined as a staff member appointed by the administrator who is suited by training or experience to implement plans and procedures enumerated in accordance with § 1.17.8(A)(1) of this Part.
C.Notwithstanding any provisions in R.I. Gen. Laws Chapter 5-39.1 or any other general or public law to the contrary, any nursing facility licensed under R.I. Gen. Laws Chapter 23-17 that employs a social worker or social worker designee who meets all of the criteria in § 1.17.8(D) of this Part shall be granted a variance to the "qualified social worker" provisions stated in this Part.
D.Such criteria shall be limited to:
1.Meets the Centers for Medicare and Medicaid requirements for long-term care facilities under 42 C.F.R. Part 483, subpart B (or any successor Regulation);
2.Is currently employed by a nursing facility licensed under R.I. Gen. Laws Chapter 23-17; and
3.Has been continuously employed in a nursing facility licensed under R.I. Gen. Laws Chapter 23-17 commencing on or before July 1, 2003.
E.Sufficient supportive personnel shall be available to meet resident needs.
F.Appropriate records shall be maintained of all social services rendered, including consultation services, and reports shall be included in the resident's medical record.
G.Policies and procedures shall be established to assure confidentiality of all resident information consistent with the requirements of R.I. Gen. Laws Chapter 5-37.3.
1.17.9Specialized Rehabilitative Services
A.Each nursing facility shall provide directly or per written agreement with outside providers specialized rehabilitative and supportive services as needed by residents to improve, restore or maintain functioning.
1.Residents shall not be admitted or retained in a nursing facility not providing either directly or per contractual arrangement, those rehabilitative or other specialized services required to meet individual medical care needs of residents.
B.The specialized rehabilitative services, which include physical therapy, speech pathology, audiology and occupational therapy shall be provided per written order of the attending physician and in accordance with accepted professional practice by licensed therapists or assistants.
C.Written administrative and resident care policies and procedures shall be developed for rehabilitative services by appropriate therapists and representatives of the medical, administrative and professional staff.
D.Rehabilitative services shall be provided under a written plan of care initiated by the attending physician and developed in consultation with appropriate therapist(s) and nursing personnel.
E.Entries of all rehabilitative or supportive services rendered, including evaluation of progress and other pertinent information, shall be recorded in the resident's medical record and signed by personnel rendering the service(s).
F.Safe and adequate space and equipment shall be available commensurate with the scope of services provided.
1.17.10Resident Activities
A.Each nursing facility shall provide for an ongoing activities program that is person-centered, appropriate to the needs and interests of each individual resident, encourages self-care, and engages residents in activities that are important to the resident, and that will assist in the maintenance of an optimal level of psychosocial functioning, socialization, and quality of life for the resident.
B.The activities program must be directed by a qualified professional as defined in Requirements for Long Term Care Facilities," 42 C.F.R. Part 483.
C.The ongoing activities program shall make provisions to:
1.Promote opportunities for engaging in normal pursuits including religious activities of the resident's choice;
2.Promote the physical, social and mental well-being of each resident;
3.Promote independent as well as group activities; and
4.Harmonize with each resident's needs and medical treatment plan, subject to approval by the resident's attending physician.
D.Adequate space, supplies and equipment shall be available to meet resident care needs in accordance with the activities program and as stipulated in § 1.19.9 of this Part.
E.Each resident must have an activities plan, and all pertinent observations and information must be recorded in the medical record.
1.17.11Equipment
A.Each nursing facility shall maintain sufficient and appropriate types of equipment consistent with resident needs and sufficient to meet emergency situations.
B.All equipment to meet the needs of the residents shall be maintained in safe and good operational condition.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.18** Environmental and Maintenance Services {#sec-216-ricr-40-10-1-1.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.18}
1.18.1Housekeeping
A.A full-time employee of the nursing facility shall be designated responsible for housekeeping services, supervision and training of housekeeping personnel.
B.Sufficient housekeeping and maintenance personnel shall be employed to maintain a comfortable, safe, clean, sanitary and orderly environment in the nursing facility.
1.Housekeeping personnel qualified in accordance with § 1.14.6(A)(1) of this Part may assist in food distribution and food preparation. Careful hand washing shall be done prior to assisting in food distribution and/or food preparation.
2.Housekeeping personnel may provide assistance with eating and hydration of residents in accordance with § 1.16.11(B) of this Part
C.Written housekeeping policies and procedures shall be established in accordance with § 1.16.2(A) of this Part, for the operation of housekeeping services throughout the nursing facility. Copies shall be available for all housekeeping personnel.
D.All parts of the nursing facility and its premises shall be kept clean, neat and free of litter and rubbish and offensive odors.
E.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition and shall be properly stored.
F.Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other cleaning materials.
G.Cleaning shall be performed in a manner which will minimize the development and spread of pathogenic organisms in the home environment.
H.Exhaust ducts from kitchens and other cooking areas shall be equipped with proper filters and cleaned at regular intervals. The ducts shall be cleaned as often as necessary and inspected by the nursing facility no less than twice a year.
I.Nursing facilities contracting with outside resources for housekeeping services shall require conformity with existing Regulations.
J.Each nursing facility shall be maintained free from insects and rodents through the operation of a pest control program.
1.18.2Laundry Services
A.Each nursing facility shall make provisions for the cleaning of all linens and other washable goods.
B.Nursing facilities providing laundry service shall have adequate space and equipment for the safe and effective operation of laundry service and, in unsewered areas, shall obtain approval of the sewage system by the licensing agency to ensure its adequacy.
C.Written policies and procedures for the operation of the laundry service including special procedures for the handling and processing of contaminated linens, shall be established in accordance with § 1.16.2 of this Part.
D.There shall be distinct areas for the separate storage and handling of clean and soiled linens.
1.The soiled linen area and the washing area shall be negatively pressurized or otherwise protected to prevent introduction of airborne contaminants.
2.The clean linen area and the drying area shall be physically divorced from the soiled linen area and the washing area.
E.All soiled linen shall be placed in closed containers prior to transportation.
F.To safeguard clean linens from cross-contamination they shall be transported in containers used exclusively for clean linens which shall be kept covered at all times while in transit and stored in areas designated exclusively for this purpose.
G.A quantity of linen equivalent to three (3) times the number of beds including the set of linen which is actually in use shall be available and in good repair at all times.
H.Facilities contracting for services with an outside resource in accordance with § 1.15.3(C) shall require conformity with this Part.
1.18.3Emergency Operations and Continuity of Operations Plan [EOP/COOP]
A.Each nursing facility shall develop and maintain a written emergency operations plan (EOP) that shall include plans and procedures to be followed in response to any situation, event or other emergency that impacts or threatens the normal operation of the nursing and/or the general health and safety of the residents, and shall include a Continuity of Operations Plan (COOP) detailing how essential functions shall be maintained and restored. The plan shall include provisions for evacuation of the nursing facility in the event of a natural disaster or any time or circumstance where the general health and safety of the residents cannot be maintained or provided for while remaining in place. The plan and procedures shall be developed with the assistance of qualified safety, emergency management, and/or other appropriate experts and shall be coordinated with the local emergency management agency.
B.The EOP plan shall include procedures to be followed pertaining to no less than the following:
1.Fire, explosion, severe weather, loss of power and/or water, flooding, failure of internal systems and/or equipment, and/or any other unforeseen circumstance that impacts or threatens the routine operation of services at the nursing facility;
2.Transfer of casualties;
3.Transfer, backup, and/or storage of records;
4.Location and use of alarm systems, signals and firefighting equipment;
5.Containment of fire;
6.Notification of appropriate persons inside and outside the operation of the home (i.e., local authorities);
7.Internal and external relocations of residents and potential evacuation scenarios, as coordinated with local and State emergency planning authorities;
8.The continuation of meals and hydration needs for residents;
9.Handling of all medications and biologicals;
10.Elopement and/or missing residents;
11.Back-up or contingency plans to address possible internal systems (e.g., food, power, water, sewage disposal) and/or equipment failures; and
12.Any other essentials as required by the local emergency management agency.
C.A copy of the EOP plan shall be available at every residential area.
D.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the nursing facility.
E.Simulated drills testing the effectiveness of the EOP plan shall be conducted at least annually and/or in conjunction with local emergency preparedness drills. Written reports and evaluation of all drills shall be developed and maintained by the nursing facility.
F.All personnel shall receive training in disaster preparedness and response as part of their employment orientation, consistent with current standards of practice (i.e., ICS 100, 200, 700).
G.The administrator of the nursing facility shall notify the licensing agency (Office of Facilities Regulation) immediately by telephone of any unscheduled implementation of any part of the nursing facility’s emergency operations plan and shall provide a follow-up report in writing within five (5) business days using a reporting form designated by the licensing agency.
H.Each nursing facility shall agree to enter into a memorandum of agreement, upon written request, with the local municipality in which the nursing facility is geographically located to participate in a distribution and dispensing plan for medications and/or vaccines in the event of a public health emergency or disease outbreak.
1.The memorandum of agreement shall, at a minimum, include the following components:
a.A plan by the nursing facility to assess residents for medical appropriateness of medication or vaccine to be administered;
b.A plan outlining the process for receipt and management of medications and/or vaccines when transferred to the nursing facility by the municipality;
c.Review of the dispensing and distribution plan and memorandum of agreement by the nursing facility medical director; and
d.An agreement by the nursing facility to participate in trainings/exercises conducted by the municipality regarding distribution of medications and/or vaccines in the event of a public health emergency or disease outbreak.
I.Each nursing facility shall establish and maintain a health care facility specific electronic mail address (i.e., e-mail address) to be provided to the licensing agency for the purposes of contacting a high managerial agent for the nursing facility with both routine communications and emergency notices. The nursing facility shall be responsible for providing notice to the licensing agency at any time that the nursing facility’s specific electronic mail address is changed or updated.
J.In the event of an onsite, local area, or statewide emergency or natural disaster, the nursing facility will respond to requests for information and/or status reports as requested by the Department and/or designated situation/incident commander.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.19** Physical Plant {#sec-216-ricr-40-10-1-1.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.19}
1.19.1New Construction, Addition or Modification
A.All new construction, alterations, extensions or modifications of an existing nursing facility, as defined in the “Rules and Regulations for Determination of Need for New Health Care Equipment and New Institutional Health Services,” shall be subject to the following provisions:
1.R.I. Gen. Laws Chapter 23-15 (Certificate of Need).
2.R.I. Gen. Laws Chapter 23-1 (Department of Health).
3.Part 50-10-1 of this Title, Rhode Island Food Code
4.FGI “Guidelines for Design and Construction of Residential Health, Care and Support Facilities, 2018 edition.
5.R.I. Gen. Laws Chapter 23-28.1 (Fire Safety Code – General Provisions)
6.250-RICR-150-10-6, Rules Establishing Minimum Standards Relating to Location, Design, Construction and Maintenance of Onsite Wastewater Treatment Systems
7.ICC A117.1-2009
8.R.I. Gen. Laws Chapter 23-27.3 (State Building Code)
9.Americans with Disabilities Act
10.In addition, any other applicable State and local laws, codes and Regulations shall apply. Where there is a difference between codes, the code having the higher standard shall apply.
B.All plans for new construction or the renovation, alteration, extension, modification or conversion of an existing nursing facility that may affect compliance with §§ 1.19.4, 1.19.6, 1.19.7, 1.19.8, 1.19.9, and 1.19.15 of this Part, and "Guidelines for Design and Construction of Residential Health, Care and Support Facilities, 2018 edition, shall be reviewed by a Rhode Island licensed architect. Said architect shall certify that the plans conform to the construction requirements of §§ 1.19.4, 1.19.6, 1.19.7, 1.19.8, 1.19.9, and 1.19.15 of this Part, and "Guidelines for Design and Construction of Hospital and Health Care Facilities," 2010 Edition, prior to construction. The nursing facility shall maintain a copy of the plans reviewed and the architect’s signed certification, for review by the licensing agency upon request.
1.In the event of non-conformance for which the nursing facility seeks a variance, the general procedures outlined in § 1.20.2 of this Part shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as detailing the basis upon which the request is made. The Department may request additional information while evaluating variance requests.
2.In the event where plans are designed to meet resident-directed operation models per §§ 1.40 and 1.41 of this Part, and are non-compliant to the required construction requirements, the nursing facility may request a variance and the Department shall consider such alternative models in evaluation of the request.
3.If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of §§ 1.19.4, 1.19.6, 1.19.7, 1.19.8, 1.19.9 and 1.19.15 of this Part, and "Guidelines for Design and Construction Residential Health, Care and Support Facilities,” 2018edition, except those for which variances were granted, prior to construction. The nursing facility shall maintain a copy of the plans reviewed, the variance(s) granted and the architect’s signed certification, for review by the Department upon request.
C.Upon completion of construction, the nursing facility shall provide written notification to the Department describing the project, and a copy of the architect's certification. The nursing facility shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.
1.19.2General Provisions – Physical Environment
A.Each nursing facility shall be constructed, equipped and maintained to protect the health and safety of residents, personnel and the public. All equipment and furnishings shall be maintained in good condition, properly functioning and replaced when necessary.
B.All steps, stairs and corridors shall be suitably lighted, both day and night. Stairs used by residents shall have banisters, handrails or other types of support. All stair treads shall be well maintained to prevent hazards.
C.All rooms utilized by residents shall have proper ventilation and shall have outside openings with satisfactory screens. Shades or Venetian blinds and draperies shall be provided for each window.
D.Grounds surrounding the nursing facility shall be accessible to and usable by residents and shall be maintained in an orderly and well-kept manner.
1.19.3Fire and Safety
A.Each nursing facility shall meet the provisions of R.I. Gen. Laws Chapter 23-28.1 (Fire Safety Code – General Provisions).
B.Each nursing facility shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and Regulations. Such a program shall include written procedures for the implementation of said Rules and Regulations and logs shall be maintained.
1.19.4Emergency Power
A.An emergency electrical system shall be provided and installed in accordance with the applicable requirements as specified in the NFPA 99, 2012 Edition. The source of supply shall be an on-site fuel-fired generator.
1.Such emergency power system shall supply power adequate at least for:
a.Lighting all means of egress;
b.Equipment to maintain fire detection, alarm and extinguishing systems;
c.Life support systems, where applicable or of high probability of need to ensure an emergency response to health and safety; and
d.Continuation of normal health and safety operations of the nursing facility until normal operations resume or implementation of the ’s EOP plan and safe evacuation of all residents.
2.The nursing facility is responsible for ensuring appropriate testing and preventive maintenance of the generator in accordance with the NFPA 99, 2012 Edition and NFPA 110, 2010 Edition, including:
a.Generator is maintained and serviced in accordance with its manufacturer’s requirements;
b.Generator is inspected weekly and exercised (tested) under routine operational load for thirty (30) minutes each month.
c.In addition to its own internal resources, each nursing facility shall also have agreements with contracted service providers for emergency services, should the generator fail during testing or unscheduled use.
d.The nursing facility will maintain documentation of all testing and preventive maintenance of the generator system, and
e.The nursing facility will notify the licensing agency when the system is or is expected to be off-line for more than eight (8) hours for maintenance or when there is a significant failure of the equipment during testing or unscheduled use, or an inability of the equipment to provide for fifty (50) per cent of the operational load at any time of its operation.
B.A nursing facility without a generator upon promulgation of this Part must submit a written plan to the licensing agency within thirty (30) days detailing a time line to acquire, install, test, and place on-line a generator as required by § 1.19.4(A) of this Part no later than six (6) months after the effective date of this Part, or any extended time line acceptable to the Department.
1.Prior to the installation and availability of a generator as outlined in § 1.19.4(A) of this Part, the nursing facility shall provide an emergency source of electrical power necessary to protect the health and safety of residents in the event the normal electrical supply is interrupted.
C.In the event of a catastrophic failure or inability of a nursing facility’s emergency electrical system to protect the health and safety of residents, the nursing facility may be subject to a civil money penalty of up to ten thousand dollars ($10,000.00) if the incident or injuries are determined to be resulting from the nursing facility’s failure to routinely test and/or maintain the nursing facility’s emergency electrical system.
1.19.5Nursing Facility Requirements for the Physically Handicapped
A.Each nursing facility shall be accessible to, and functional for, residents, personnel and the public. All necessary accommodations shall be made to meet the needs of persons with mobility disabilities, or sight, hearing and coordination or perception disabilities in accordance with ICC A117.1-2009
B.Blind, non-ambulatory, physically handicapped or residents with mobility disabilities which limit self-preservation capability shall not be housed above the street level floor unless the nursing facility is equipped with an elevator and meets other requirements of ICC A117.1-2009. Further, the nursing facility must meet one (1) of the following as defined in NFPA Standard 220:
1.Is of fire resistive construction, one (1) hour protected non-combustible construction; or
2.Is fully sprinklered one (1) hour protected ordinary construction; or
3.Is fully sprinklered one (1) hour protected wood frame construction.
1.19.6Residential Area
A.Each residential area, as defined this Part, shall have at least the following:
1.A nurses' area or office of sufficient space for the materials and work of nursing services, with adjacent hand washing facilities for all staff;
2.Storage and preparation area(s) for drugs and biologicals;
3.Storage rooms for walkers, wheelchairs and other equipment;
4.Appropriate clean and soiled utility space; and
5.A telephone or a cell phone with outside line.
B.In addition, each residential area shall be equipped with a communication system which, as a minimum, shall be:
1.Electrically activated;
2.Operated from the bedside of each occupant and from all areas used by occupants, including multipurpose rooms, toilet and bathing facilities;
3.Capable of alerting the responsible person or persons on duty twenty-four (24) hours a day, wherever their station may be; and
4.Capable of providing for calls both internal and external to the nursing facility.
1.19.7Resident Rooms and Toilet Facilities
A.Resident rooms shall be designed and equipped for adequate nursing care, the individual resident’s comfort and privacy with no more than two (2) beds per room, and amenable to resident-directed furnishings and personal property. At least five percent (5%) of the total beds (per unit or per nursing facility) shall be located in single-bed rooms, each with a private bathing facility and toilet.
1.Single bedrooms shall be no less than one hundred (100) square feet in area and no less than eight feet (8’) wide exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules. In new construction, single bedrooms shall be no less than one hundred and twenty (120) square feet in area.
2.Multi-bedrooms shall be no less than one hundred and sixty (160) square feet in area and no less than ten feet (10’) wide, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules. In new construction, multi-bedrooms shall be no less than two hundred (200) square feet in area.
B.Each room shall have a window which can be easily opened. The window sill shall not be higher than three feet zero inches (3'0") above the floor and shall be above grade level.
C.The size of each window shall be no less than two feet six inches (2'6") wide by four feet five inches (4'5") high, double hung or an approved equivalent.
D.Each room shall have direct access to a corridor and outside exposure with the window at or above grade level.
E.Lavatories and bathing areas to be used by the handicapped shall be equipped with grab-bars for the safety of the residents and shall meet the requirements of "Guidelines for Design and Construction of Residential Health, Care and Support Facilities, 2018 edition.
F.All facilities constructed after March 20, 1977 shall have as a minimum, connecting toilet rooms between residents' rooms in accordance with the requirements of § 1.19.1 of this Part.
G.In all facilities constructed after August 1, 2001, patient toilet rooms shall be equipped with facilities for cleaning bedpans.
1.However, in facilities constructed prior to March 20, 1977, there shall be no less than one (1) toilet per eight (8) beds or fraction thereof on each floor where resident rooms are located.
H.Separate lavatory and toilet facilities shall be provided for employees and the general public commensurate with the needs of the facility.
I.A minimum of one (1) bathtub or shower shall be provided for every twelve (12) residents, not otherwise served by bathing facilities in resident rooms. At least one (1) bathtub shall be provided in each residential area.
J.Each bathtub or shower shall be in an individual room or enclosure which provides space for the private use of the bathing fixture, for drying and dressing and for a wheelchair and an attendant.
K.Complete privacy shall be provided to each resident in semi-private rooms by the use of overhead type fire resistive screens and/or cubicle fire resistive curtains suspended by inset overhead tracks in accordance with R.I. Gen. Laws Chapter 23-28.1 (Fire Safety Code – General Provisions).
L.When overhead type screens and/or cubicle curtains are not provided, each semi-private room shall be equipped with a fire resistive portable screen.
M.Each resident must be provided with a bed of proper size and height for the convenience of the resident, with a clean, comfortable mattress, bedside stand, comfortable chair, dresser and individual closet space for clothing with clothes racks and shelves accessible to residents in each room, and a reading lamp equipped with bulb of adequate candlepower.
N.Bedding including bedspread, shall be seasonally appropriate.
O.In all situations where physical configuration is not comfortable to adequate nursing care, comfort or privacy in the application of the above standards, the licensing agency shall be the ultimate authority in determining standards to be applied.
1.19.8Special Care Unit
A.A resident room shall be designated for isolation purposes. Such room shall be properly identified with precautionary signs, shall have outside ventilation, private toilet and hand washing facilities, and shall conform to other requirements established for the control of infection in accordance with § 1.16.2 of this Part.
1.19.9Dining & Resident Activities Rooms
A.The facility shall provide one or more clean, orderly, appropriately furnished and easily accessible room(s) of adequate size designed for resident dining and resident activities.
1.These areas shall be appropriately lighted and ventilated with non-smoking areas identified.
2.If a multipurpose room is used, there must be sufficient space to accommodate dining and resident activities and prevent interference with each other.
3.The total area set aside for these purposes shall be not less than thirty (30) square feet per bed for the first one hundred (100) beds and twenty-seven (27) square feet per bed for all beds in excess of one hundred (100).
4.Storage shall be provided for recreational equipment and supplies.
1.19.10Plumbing
A.All plumbing shall be installed in such a manner as to prevent back siphonage or cross connections between potable and non-potable water supplies in accordance with R.I. Gen. Laws Chapter 23-27.3 (State Building Code).
B.Fixtures from which grease is discharged may be served by a line in which a grease trap is installed in accordance with standards of R.I. Gen. Laws Chapter 23-27.3 (State Building Code).The grease trap shall be cleaned sufficiently often to sustain efficient operation.
1.19.11Waste Disposal
A.Medical Waste: Medical waste, as defined in 250-RICR-140-15-1, Medical Waste Regulations, shall be managed in accordance with the provisions of the aforementioned Regulations.
B.Other Waste: Wastes which are not classified as infectious waste, hazardous wastes or which are not otherwise regulated by law or Rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
1.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be at a waste disposal facility approved by the Rhode Island Department of Environmental Management or a waste disposal facility located outside Rhode Island which has been approved by the appropriate regulatory agency.
2.Load packers must conform to the same restrictions required for dumpsters and in addition, load packers shall be:
a.High enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment; and
b.The loading section shall be constructed and maintained to prevent rubbish from blowing from said area site.
3.Recyclable waste: Containers for recyclable waste, including paper and cardboard, shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required.
1.19.12Water Supply
A.Water shall be distributed to conveniently located taps and fixtures throughout the building and shall be adequate in volume and pressure for all purposes including firefighting.
1.In resident areas, hot water temperatures shall not be less than one hundred degrees Fahrenheit (100 ºF) nor exceed one hundred and eighteen degrees Fahrenheit (118 ºF). Thermometers [accuracy of which can be plus or minus two degrees Fahrenheit (±2 ºF)] shall be provided in each residential area to check water temperature periodically on that unit and at each site where residents are immersed or showered.
2.Thermostatic or pressure balanced mixing valves are required at each site or fixture used for immersion or showering of residents. Thermometers and tactical (skin sense) method shall be used to verify the appropriateness of the water temperature prior to each use.
3.In addition to temperature regulating devices controlling the generation of domestic hot water, hot water supply(ies) to resident care areas shall be regulated by anti-scalding, water tempering or mixing valves (approved by the director or their designee) in order to maintain the temperature standards of § 1.19.12(A)(1) of this Part.
1.19.13Waste Disposal Systems
A.Any new nursing facility shall be connected to a public sanitary sewer if available, or otherwise shall be subject to the requirements of 250-RICR-150-10-6, Rules Establishing Minimum Standards Relating to Location, Design, Construction and Maintenance of Onsite Wastewater Treatment Systems.
1.19.14Maintenance
A.All essential mechanical, electrical and resident care equipment shall be maintained in safe operating condition and logs or records shall be maintained of periodic inspections.
1.19.15Other Provisions
A.Nursing facilities shall make provisions to ensure that the following are maintained:
1.Lighting levels in all areas to ensure an adequate and comfortable work environment for both the employees and for residents in accordance with acceptable community standards for workplace safety and lighting standards for the elderly;
2.Limitation of sounds at comfort levels;
3.Comfortable temperature levels for the residents in all parts of resident occupied areas with a centralized heating system to maintain a minimum of seventy degrees Fahrenheit (70° F) during the coldest periods;
4.Adequate ventilation through windows or by mechanical means; and
5.Corridors equipped with firmly secured handrails on each side.
6.Heat relief: Pursuant to R.I. Gen. Laws § 23-17.5-27, any nursing facility which does not provide air conditioning in every patient room shall provide an air conditioned room or rooms in a residential section(s) of the nursing facility to provide relief to patients when the outdoor temperature exceeds eighty degrees Fahrenheit (80° F).
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.20** Confidentiality – Variance and Appeal Procedure {#sec-216-ricr-40-10-1-1.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.20}
1.20.1Confidentiality
A.Disclosure of any health care information relating to individuals shall be subject to all the statutory and regulatory provisions pertaining to confidentiality including but not limited to the provisions of R.I. Gen. Laws Chapter 5-37.3.
1.20.2Variance Procedure
A.The licensing agency may grant a variance from the provisions of a Rule or Regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of residents.
1.Variances shall not be granted for the provisions of this Part found in §§ 1.4, 1.11, 1.15, 1.15.5, 1.16.2, 1.16.6, 1.16.8, 1.17.3(K), 1.19.11, 1.19.12, 1.19.14, and 1.20.1 of this Part.
B.A request for a variance shall be filed by a high managerial agent of the nursing facility in writing, and set forth in detail the basis upon which the request is made, including:
1.Identification of the specific regulatory section(s) of the Regulations;
2.Alternative actions, processes, or procedures that through the facility’s implementation will facilitate compliance with the specific regulatory intent, and how the home will ensure staff awareness and training regarding the variance, when appropriate.
3.A variance period shall not exceed the nursing facility’s license period. A nursing facility must request renewal of the variance when it submits its license renewal application.
4.Upon the filing of each request for variance with the licensing agency, and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the nursing facility appeals the denial.
C.At a hearing held in furtherance of an appeal from a denial for a variance in accordance with § 1.20.2(B)(1) of this Part, the applicant shall present his case to the Director or his designee for quasi-judicial matters, and shall have the burden of persuading the Director or his designee as aforesaid, through the introduction of clear and convincing evidence, that a literal enforcement of the Rules will result in unnecessary hardship, and that a variance will not be contrary to the public interest, public health and/or health and safety of residents.
D.Nursing facilities that provide care in accordance with alternative service delivery models that facilitate resident-directed care may be eligible for a variance in accordance with any of the requirements contained in this Part.
1.20.3Deficiencies and Plans of Correction
A.The procedures in § 1.20.3 of this Part are exclusive of those required in accordance with § 1.16.7(B) of this Part and of those procedures required to be performed as a result of inspections and investigations conducted in accordance with R.I. Gen. Laws Chapter 23-17.
B.The licensing agency shall notify the governing body or other legal authority of a nursing facility of violations of individual standards through a statement of deficiencies which shall be forwarded to the nursing facility within fifteen (15) days of the inspection team formally exiting the nursing facility unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
C.A nursing facility which received a statement of deficiencies (SOD) report must submit a plan of corrections, signed by a high managerial agent of the nursing facility, to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of corrections shall include and detail any requests for variances as well as document the reasons therefore, in accordance with § 1.20.2 of this Part.
D.The licensing agency will be required to approve or reject the plan of corrections submitted by a nursing facility in accordance with § 1.20.3(C) of this Part within fifteen (15) days of receipt of the plan of corrections.
1.To be deemed acceptable by the licensing agency, a plan of correction shall:
a.Address how corrective action will be accomplished for those residents found to have been affected by the deficient practice(s);
b.Address how the nursing facility will identify other residents having the potential to be affected by the same deficient practice(s);
c.Address what measures will be put into place or systemic changes made to ensure that the deficient practice(s) will not recur;
d.Indicate how the nursing facility plans to monitor its performance to ensure that solutions are sustained;
e.Include dates when corrective action will be completed; and
f.Include any additional components deemed necessary by the licensing agency.
2.The nursing facility shall develop a plan for ensuring that correction is achieved and sustained. This plan shall be implemented and the corrective action(s) evaluated for effectiveness. The plan of correction shall be integrated into the quality assurance system.
3.All deficiencies shall be fully and wholly corrected within thirty (30) days of the date of notice of the deficiencies, unless an extension is granted for good cause shown, but in no case shall an extension exceed fifteen (15) days.
E.If the licensing agency rejects the plan of corrections, or if the nursing facility does not provide a plan of corrections within the fifteen (15) day period stipulated in § 1.20.3(C) of this Part, or if a nursing facility whose plan of corrections has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 1.12 of this Part. If the nursing facility is aggrieved by the action of the licensing agency, the nursing facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
F.The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws § 42-35-10. The hearing shall in all respects comply with R.I. Gen. Laws §§ 42-35-9, 42-35-10, and 42-35-12.
G.A nursing facility’s SOD is a public record upon Departmental approval of the corresponding plan of correction.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.21** Exception and Severability {#sec-216-ricr-40-10-1-1.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.21}
1.21.1Exception
A.Modification of any individual standard in this Part, for experimental or demonstration purposes, or as deemed appropriate by the licensing agency, provided that such modification will not be contrary to the public interest and the public health, or to the health and safety of residents, shall require advance written approval by the licensing agency and should be requested in accordance with the format outlined in § 1.20.2 of this Part.
1.21.2Judicial Review and Rules Governing Practices and Procedures
A.Judicial Review. Any person adversely affected by any final decision of the Department may seek judicial review of the decision in accordance with the provisions of R.I. Gen. Laws § 42-35-15.
B.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17 shall be held in accordance with the provisions of Part 10-05-4 of this Title, Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health, and Part 10-05-1 of this Title, Access to Public Records.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-1 § 1.22** Licensing Procedures, Definitions, and Conditions for Resident-Directed Homes {#sec-216-ricr-40-10-1-1.22 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-1#1.22}
1.22.1Purpose
A.Section 1.22 of this Part establishes requirements to implement the provisions of R.I. Gen. Laws § 23-17-44(d). For the purpose of this Part, the expansion of the bed capacity of a nursing facility pursuant to R.I. Gen. Laws § 23-17-44(d) shall be designated as a “Resident-directed Home.”
1.22.2Scope
A.Only those nursing facilities that propose to adopt a resident-directed model of care in accordance with the following provisions of this Part shall be licensed to expand their bed capacity:
1.Except for any variance(s) granted pursuant to § 1.20.2 of this Part, the provisions of § 1.22 of this Part shall be in addition to other applicable provisions of this Part.
2.A nursing facility that adopts a resident-directed home model of care shall have such a designation listed on the nursing facility’s license. No separate license shall be issued by the Department for a bed expansion and adoption of the model, as provided in this Part.
3.A nursing facility may implement resident-directed home model of care either in its existing nursing facility setting, in campus-based homes or in-home settings within the community.
4.Only nursing facilities licensed in Rhode Island are eligible to expand under the culture change initiative.
5.Any nursing facility seeking to expand its licensed bed capacity under this initiative, that will result in an expenditure that meets or exceeds the criteria for determination of need review under R.I. Gen. Laws § 23-15-2(10)(ii), shall be required to receive approval under R.I. Gen. Laws Chapter 23-15.
6.Each residential area of a resident-directed Home shall have a minimum of six (6) and a maximum of twelve (12) residents.
1.22.3Application for a Resident-directed Home
A.The Department shall develop an open and competitive process for a resident-directed Home and Requests for Applications for a resident-directed Home, to determine the licensure of expansion beds for a culture change initiative, the form and content of which shall be determined as the Department shall deem appropriate.
B.Complete Application Required. Only applications that the Department has determined to be complete shall be eligible for review. An applicant who submits an incomplete application shall receive written notification from the Department regarding the specific deficiencies and shall be allowed to resubmit a revised application to address these deficiencies within the timeframes stipulated in the Request for Applications.
C.Approval Not Implied. The announcement of an open application period does not imply that the Department will approve any or all of the submitted applications, even if the number of beds requested in the application(s) is less than the total number of available beds. The Department reserves the right to deny, or request modifications to, any and all applications consistent with its duly established statutory and regulatory authority.
D.Decision. After completion of the review process, the Department shall issue a decision granting or denying an application for a resident-directed Home. The decision of the Department is final, unless judicial review is sought in accordance with § 1.21.2 of this Part.
E.Acceptance of the Department’s decision by the applicant includes acceptance of all conditions attached thereto. Failure to comply with all conditions attached to the approval may result in the Department canceling or withdrawing an approval in accordance with § 1.21.2 of this Part.
F.Cancellation or Withdrawal of an Approval. The Department may cancel or withdraw an approval for good cause. The Department shall provide written notification to the applicant detailing the basis for cancellation or withdrawal of an approval. Within thirty (30) days from the date of notification, the applicant shall provide written justification to the Department as to why the approval should not be canceled or withdrawn. Upon receipt of this written justification or following the expiration of the allowed thirty (30) day period, the Department shall render a decision, as applicable. The decision of the Department is final, unless judicial review is sought in accordance with § 1.21.2 of this Part.
G.Application(s). Applications shall only be accepted during an open application period announced by the Department. The frequency of an open application period shall be determined by the Department.
H.Application for a resident-directed Home shall be on forms provided by the Department and shall include, but not be limited to, the following criteria:
1.A non-returnable, non-refundable application fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health;
2.The legal name and license number of the applicant, as stated on the current nursing facility license issued by the licensing agency;
3.The total number of beds requested in the resident-directed Home application;
4.Estimated total capital expenditures, including construction and financing, and all other capital costs to implement the resident-directed Home;
5.Projected incremental annual operating expenses, for the start-up year and two (2) full years following implementation of the resident-directed Home;
6.Written evidence of financing commitment from a qualified lender for the capital expenditures to construct the resident-directed Home and working capital requirements for the first twelve (12) months of operation;
7.If no debt financing is involved, evidence that the applicant has sufficient capital to fund the proposed construction of the resident-directed Home and working capital requirements for the first twelve (12) months of operation;
8.The proposed physical address of the resident-directed Home, including a scale drawing showing the spatial relationship to the licensee’s existing nursing facility;
9.A building/floor plan (to scale), prepared in accordance with § 1.19.1 of this Part, including any proposed variances, and ensuring;
a.The floor plan shall demonstrate that residents’ rooms are constructed around a central, communal, family-style living area where residents and staff may socialize, prepare meals, and dine together;
b.The central communal area shall, at a minimum, include:
(1)A living room seating area;
(2)An open residential-style full kitchen capable to prepare and cook resident meals;
(3)A dining area large enough for a single table, where possible, serving all residents in the home plus two (2) staff members;
c.Provide a private bedroom for each resident;
(1)Rooms shall only be shared at the request of a resident to accommodate a spouse, partner, family member, or friend;
(2)A spouse, partner, family member or friend who does not meet medical criteria for placement in the resident-directed Home may reside in the room assigned to the individual who is admitted to the resident-directed Home and who does meet the medical criteria for admission, and the nursing facility may charge room and board (and other appropriate nursing facility charges) for the spouse, partner, family member or friend who does not meet medical criteria for admission;
(3)Each resident room shall have a full, accessible private bathroom that contains at a minimum, a toilet, sink, and shower, and
(4)The entrance for each resident room shall be visible from the central communal area.
d.Be designed to be fully independent, handicapped accessible, and have overhead lift tracks that run from the bed into the bathroom in each resident bedroom.
e.Includes a secured exterior patio, garden or other outdoor space that:
(1)Allows residents to ambulate, with accommodations for assistive devices such as wheelchairs or walkers;
(2)Provides for outdoor activities;
(3)Provides seating for each resident-directed Home to protect from sun and elements under a covered area; and.
(4)Where feasible, provide a space to accommodate limited overnight guests
f.Projected staffing, by staffing classifications, for the entire nursing facility, and separately for the resident-directed Home, for the start-up year and two (2) full years following implementation of the resident-directed Home;
g.A written operations manual that describes in detail the operational systems and structure that will support and facilitate that resident-directed and person-centered care is provided to residents of the resident-directed Home, and minimally includes the following components:
(1)Procedures for the establishment, training, and operationally maintaining the following:
(AA)Routinely, at least fifty percent (50%) of direct-care staff qualified as Universal Workers;
(BB)Self-directed work team(s), assigned to the day-to-day management of the resident-directed Home; and
(CC)Personnel scheduling practice of consistent assignment of direct-care staff, as defined in this Part.
(2)Procedures for the implementation of a learning culture for staff and residents that identifies and facilitates participation by the residents in making personal and group choices in the operation of the resident-directed Home;
(3)A policy for the provision of person-centered services at the highest level of care required by a resident;
(4)A policy for the provision of services to Medicaid residents at the Medicaid reimbursement rate;
(5)Such other information or documents as deemed relevant by the Department
I.Review Criteria. The Department shall use an open and competitive process to determine the licensure of expansion beds under this culture change initiative and shall evaluate applications in accordance with the criteria and considerations contained in this Part.
J.Such evaluation shall be based upon a review of the items submitted in accordance with § 1.22.3(I) of this Part. The Department may also consider any prior experience with, or knowledge of, the applicant’s provision of long-term care services and licensure record.
K.Additionally, in reviewing resident-directed Home applications, the Department shall consider the applicant’s regulatory compliance history, available quality and performance measurements, including resident and family satisfaction reports, and the impact of the licensure of expansion beds on the regional distribution of, and access to, nursing facility beds in Rhode Island. In analyzing the statewide impact of the expansion beds, the Department may consider any available plans or studies related to the geographical distribution of nursing facility beds, including measures of bed need, levels-of-care, and accessibility.
L.Certificate of Need Review. A resident-directed Home, whose implementation requires prior Certificate of Need review and approval pursuant to R.I. Gen. Laws Chapter 23-15 shall, within one (1) year of the approval date of the application for a resident-directed Home, submit a Certificate of Need application in a form deemed acceptable by the Department. Failure to submit an application within the specified time frame may result in the Department canceling or withdrawing an approval in accordance with § 1.22.3(F) of this Part.
M.Approved Applications. All nursing facilities whose resident-directed Home applications are approved by the Department and whose implementation shall not require a prior Certificate of Need review and approval, shall comply with the following conditions:
1.The applicant shall implement the project at or under the total proposed cost;
2.The applicant shall complete the project in accordance with the proposed application;
3.The applicant shall provide information to the Department upon request; including results of studies and/or reports describing the resident-directed Home’s “lessons learned” with innovative approaches to long term care, such as the culture change model of care;
4.The applicant shall obtain needed zoning approval(s) within one (1) year of the date of approval of the application;
5.The applicant shall execute a contract to initiate construction within one (1) year of the date of approval of the application and expeditiously initiate development;
6.The applicant shall file a summary progress report, including a description of costs incurred, with the Department at three (3) month intervals from the date of final Department decision until full implementation;
7.The applicant shall comply with all applicable laws, codes and Regulations unless a variance therefrom shall have been granted by the appropriate agency; and
8.Any other factors deemed relevant by the Department.
1.22.4Additional Organization and Management Requirements for a Resident – Directed Home
A.In addition to the requirements of §§ 1.5 through 1.19 of this Part, the following is required for a resident-directed Home:
1.Governing Body of Other Legal Authority: The governing body or other legal authority, through the Administrator, shall be responsible for ensuring the management and operation of the resident-directed Home routinely conforms to resident-directed and person-centered practices as defined in this Part.
2.Quality Improvement: Monitoring and review of the resident-directed Home shall be added to the review criteria for the nursing facility’s Quality Improvement Plan.
3.For QI issues related to the resident-directed Homes, a member of the resident-directed Home’s self-directed work team shall participate on the Home’s Quality Improvement Committee.
B.Administrator
1.The Nursing Home Administrator is responsible for establishing the organizational supports and operational structure for a resident-directed Home that ensures and facilitates the control and management of the day to day activities and flow-of-life in the home is resident-directed and coordinated through self-directed work teams with appropriate medical and nursing other professional supports as would be provided in any private home or residential environment.
2.Include a central administration unit for the resident-directed Home that does not contain or utilize commercial and institutional elements and products such as physical nursing stations, medication carts, hospital or office type florescent lighting, acoustical tile ceilings, institutional style railings and corner guards, room numbering, labeling and signage that would not normally be found in a private home setting. Where Regulations require specific institutional elements, every effort shall be made to provide the institutional elements in a manner that is consistent with a private home environment (e.g., residential wall sconces used for required nurse call lights). Where Regulations require specific institutional elements, every effort shall be made to provide the institutional elements in a manner that is consistent with a resident-directed environment.
C.Personnel
1.Staffing model for a resident-directed Home shall be by consistent assignment.
2.Staffing of self-directed work teams for a resident-directed Home shall be scheduled based on the service needs of the residents and adjusted as needed to continually meet the needs of residents at all times, and should be determined for each individual resident-directed Home and not the nursing facility as a whole.
a.Self-directed work teams shall be composed of universal workers and any support staff consistently assigned to the functions of the resident-directed Home and responsible for the general administrative day-to-day activities and work functions for the home, and
b.Self-directed work teams shall collaborate with and include residents, residents’ family members, and guardians in the decision making regarding the flow and content of daily living and coordination of all resident’s care needs.
3.Staff Training: In addition to any State or Federal training requirements pertaining to long term care facilities, or training deemed appropriate by the nursing facility, each universal worker in a resident-directed Home shall annually and/or as needed receive in-service training on topics directly related to:
a.Resident-directed and person-centered care practices;
b.Communication and workplace conflict management; and
c.Self-directed work teams.
D.Resident Care Services
1.All resident care services shall be person-centered in their development and implemented with a full commitment to the resident-directed Home being a restraint-free environment.
2.Professional services (i.e., physician, nursing, dietetic, social, and specialized rehabilitative) shall be organized and provided by or arranged by the nursing facility for residents of the resident-directed Home and at the convenience of the residents and coordinated with the Home’s self-directed work teams, similar to services that would be provided to residents in their private home; either as outpatient, or home nursing care.
a.Professional services provided in the nursing facility by licensed nursing facility staff shall not be construed as providing “outpatient” or “home nursing care” services for the residents of the resident-directed Home for purposes of health care facility licensing.
b.The nursing facility’s Dietary Manager and/or consulting Dietitian shall provide staff of the resident-directed Home with consultation and in-service in the development of resident-directed menus, meal planning, and meal preparation.
E.Nothing in this Part shall prohibit the consumption of foods that are:
1.Prepared outside the resident-directed Home by family, acquaintances, or social organization, such as churches, schools, etc.;
2.Grown in or on the grounds of the resident-directed Home by residents and/or staff for residents; or
3.Prepared by appropriately licensed local retail or established eating establishments.
F.The resident-directed Home shall have at least one (1) lift motor and separate slings for each resident who requires use of a lift.
G.Environmental and Maintenance Services
1.The resident-directed Home should be designed to provide for normal housekeeping and laundry services from within the home, however, as needed or as circumstance require, such services may be provided for under the umbrella of the nursing facility’s available services in terms of emergency support services; including the adoption or inclusion in the nursing facility’s emergency operations plan.
H.Physical Environment
1.The resident-directed Home shall:
a.Have built-in safety features (e.g., magnetic locks on cabinets with chemicals or knives) to allow all areas of the house, including the kitchen, to be accessible to the residents during the majority of the day and night.
b.Utilize a wireless communication and notification system that shall provide for escalation of response if a signal is unanswered for a designated period of time. The signal shall be repeated and sent to other staff who were not designated to receive the original signal.
(1)Wired call or alert systems and overhead paging shall not be permitted.
c.Provide ample natural light in each habitable space provided through exterior windows.
d.Provide staff and public access to bathroom facilities.
2.Have available at least one (1) portable functional fire extinguisher accessible in the kitchen area. All fire extinguishers shall be installed, inspected and maintained in accordance with applicable National Fire Protection Association (NFPA) standards.
**History**
- *Amendment — effective from 2025-05-07 to current*
- *Amendment — effective from 2024-03-07 to 05/07/2025*
- *EMERGENCY RULE Amendment — effective from 2023-10-02 to 03/07/2024*
- *Amendment — effective from 2022-08-25 to 10/02/2023*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 04/29/2021*
- *EMERGENCY RULE Amendment — effective from 2020-09-28 to 01/12/2021*
- *EMERGENCY RULE Amendment — effective from 2020-05-26 to 09/28/2020*
- *Technical Revision — effective from 2018-03-29 to 07/03/2022*
- *Amendment — effective from 2018-03-29 to 03/29/2018*
- *Technical Revision — effective from 2013-08-01 to 03/29/2018*
- *Amendment — effective from 2013-08-01 to 08/01/2013*
- *Amendment — effective from 2012-12-10 to 08/01/2013*
- *Amendment — effective from 2006-11-07 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 11/07/2006*
- *Amendment — effective from 2003-05-01 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 05/01/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-2** Licensing Assisted Living Residences
##### **216-RICR-40-10-2 § 2.1** Authority {#sec-216-ricr-40-10-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-2#2.1}
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapter 23-17.4, and are established for the purpose of defining the minimum standards for licensed assisted living residences in Rhode Island; for the care of residents in an assisted living residence; for the maintenance and operation of assisted living residences which will:
1.Promote the dignity, individuality, independence, privacy, and autonomy of residents;
2.Provide a safe and home-like environment; and
3.Protect the safety, health and welfare of residents; for the encouragement of quality of life for all residents; and for the encouragement of quality in all aspects of the operations of assisted living residences.
**History**
- *Amendment — effective from 2024-03-18 to current*
- *Amendment — effective from 2022-08-25 to 03/18/2024*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2020-12-23 to 04/29/2021*
- *Amendment — effective from 2018-04-30 to 07/03/2022*
- *Amendment — effective from 2015-06-01 to 04/30/2018*
- *Amendment — effective from 2012-12-10 to 06/01/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-16 to 10/18/2007*
- *Amendment — effective from 2002-08-14 to 02/16/2004*
- *EMERGENCY RULE Adoption — effective from 2002-07-12 to 08/14/2002*
- *EMERGENCY RULE Adoption — effective from 2002-03-15 to 07/12/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/15/2002*
##### **216-RICR-40-10-2 § 2.2** Incorporated Materials {#sec-216-ricr-40-10-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-2#2.2}
A.These Regulations hereby adopt and incorporate Dietary Reference Intakes: The Essential Guide to Nutrient Requirements, National Academies Press, 2006, by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate ANSI A117.1 – 2009 Accessible and Usable Buildings and Facilities, International Code Council, 2009 by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate Kroger, Andrew, et al. “General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” Morbidity and Mortality Weekly Report Recommendations and Reports, vol. 60, no. RR02, 2011, , by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2024-03-18 to current*
- *Amendment — effective from 2022-08-25 to 03/18/2024*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2020-12-23 to 04/29/2021*
- *Amendment — effective from 2018-04-30 to 07/03/2022*
- *Amendment — effective from 2015-06-01 to 04/30/2018*
- *Amendment — effective from 2012-12-10 to 06/01/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-16 to 10/18/2007*
- *Amendment — effective from 2002-08-14 to 02/16/2004*
- *EMERGENCY RULE Adoption — effective from 2002-07-12 to 08/14/2002*
- *EMERGENCY RULE Adoption — effective from 2002-03-15 to 07/12/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/15/2002*
##### **216-RICR-40-10-2 § 2.3** Definitions {#sec-216-ricr-40-10-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-2#2.3}
A.Whenever used in these Regulations, the following terms shall be construed as follows:
1."Abuse" means any assault as defined in R.I. Gen. Laws Chapter 11-5 including, but not limited to hitting, kicking, pinching, slapping or the pulling of hair, provided however, unless such is required as an element of offense, it shall not be necessary to prove that the patient or resident was injured thereby, or any assault as defined in R.I. Gen. Laws Chapter 11-37 or any offense under R.I. Gen. Laws Chapter 11-10; or
a.Any conduct which harms or is likely to physically harm the resident except where the conduct is a part of the care and treatment, and in furtherance of the health and safety of the resident; or
b.Intentionally engaging in a pattern of harassing conduct which causes or is likely to cause emotional or psychological harm to the resident, including but not limited to ridiculing or demeaning a patient or resident, making derogatory remarks to a patient or resident or cursing directed towards a patient or resident, or threatening to inflict physical or emotional harm on a patient.
2."Act" means R.I. Gen. Laws Chapter 23-17.4, entitled "Assisted Living Residence Licensing Act."
3."Activities of daily living" means bathing, dressing, eating, toileting, mobility and transfer.
4."Administrator" means the person who has responsibility for day to day administration or operation of an assisted living residence.
5.“Alzheimer Dementia Special Care Unit/Program” means a distinct living environment within an assisted living residence that has been physically adapted to accommodate the particular needs and behaviors of those with dementia. The unit provides increased staffing, therapeutic activities designed specifically for those with dementia and trains its staff on an ongoing basis on the effective management of the physical and behavioral problems of those with dementia. The residents of the unit or program have had a standard medical diagnostic evaluation and have been determined to have a diagnosis of Alzheimer's dementia or another dementia.
6."Assisted living residence" means a publicly or privately operated residence that provides directly or indirectly by means of contracts or arrangements personal assistance and may include the delivery of limited health services, as defined under R.I. Gen. Laws § 23-17.4-2(12), to meet the resident's changing needs and preferences, lodging, and meals to six (6) or more adults who are unrelated to the licensee or administrator, excluding however, any privately operated establishment or facility licensed pursuant to R.I. Gen. Laws Chapter 23-17 and those facilities licensed by or under the jurisdiction of the Department of Behavioral Healthcare, Development Disabilities and Hospitals, the Department of Children, Youth, and Families, or any other State agency.
7."Capable of self-preservation" means the physical mobility and judgmental ability of the individual to take appropriate action in emergency situations. Residents not capable of self-preservation are limited to facilities that meet more stringent Life Safety Code requirements as provided under R.I. Gen. Laws § 23-17.4-6(b)(3).
8.“Center for Acute Infectious Diseases Epidemiology” means Center for Acute Infectious Diseases Epidemiology (CAIDE); Division of Emergency Preparedness, and Infectious Disease; Rhode Island Department of Health.
9.“Center for Food Protection” means the Center for Food Protection, Division of Environmental Health, Rhode Island Department of Health.
10.“Center for Health Facilities Regulation” means the Center for Health Facilities Regulation, Division of Healthcare Quality and Safety, Rhode Island Department of Health.
11."Change in operator" means a transfer by the licensee or operator of an assisted living residence to any other person (excluding delegations of authority to the administrative employees of the residence) of the licensee's authority to:
a.Hire or fire the Chief Executive Officer of the assisted living residence;
b.Maintain and control the books and records of assisted living residence;
c.Dispose of assets and incur liabilities on behalf of the assisted living residence; or
d.Adopt and enforce policies regarding operation of the assisted living residence.
e.This definition is not applicable to circumstances wherein the licensee of an assisted living residence for adults retains the immediate authority and jurisdiction over the activities enumerated in §§ 2.3(A)(11)(a) through (d) of this Part above.
12."Change in owner" means:
a.In the case of an assisted living residence which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of an assisted living residence which is an unincorporated solo proprietorship, the transfer of the title and property to another person;
c.In the case of an assisted living residence which is a corporation:
(1)A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)In the case of an assisted living residence which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of an assisted living residence which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
13."Declaration of disaster emergency" means a disaster emergency declared by the Governor pursuant to R.I. Gen. Laws § 30-15-9.
14.“Department” means the Rhode Island Department of Health. The Department is also the “licensing agency” designated pursuant to R.I. Gen. Laws Chapter 23-17.
15."Director" means the Director of the Rhode Island Department of Health.
16."Elopement," means leaving the premises without notice when the residence has assumed responsibility for the resident’s whereabouts.
17.“Employee” means any individual, whether paid or unpaid, directly employed by or under contract with the residence, who provides or delivers direct care services to residents and/or who has routine contact with residents without the presence of other employees.
18.“Essential caregiver” means an individual, whether a family member or friend of a resident of a nursing home or long-term care facility, who is designated by the resident or appointed by an individual with decision-making authority for the resident to provide physical or emotional support to the resident during a declaration of disaster emergency.
19.“Fiduciary agent” means one who holds a fiduciary relation or acts in a fiduciary capacity.
20."Health oversight agency" means a public authority or other agency or organization authorized by law to investigate or otherwise oversee the reporting of allegations of failure to meet professional practice standards or misconduct.
21."High managerial agent" means an officer of a residence, the administrator and assistant administrator of the residence, the director and assistant director of nursing services, or any other agent in a position of comparable authority with respect to the formulation of policies of the residence or the supervision in a managerial capacity of subordinate employees.
22."Level of licensure" means the licensed authority to admit residents according to the following classifications: [Note that residences must have both an "F" (fire) and an "M" (medication) classification].
23."Licensee" means any person who holds an assisted living residence license from the Department.
24."Life Safety Code" means the current applicable Rhode Island Fire Safety Code, R.I. Gen. Laws Chapter 23-28.1.
25."Limited health services" means health services provided by a licensed assisted living residence, as ordered by a resident's physician or other authorized health care provider acting within his/her scope of practice, and provided by qualified licensed assisted living staff members under supervision. Limited health services includes the following:
a.Stage I and stage II pressure ulcer treatment and prevention;
b.Simple wound care including postoperative suture care/removal and stasis ulcer care;
c.Ostomy care including appliance changes for residents with established stomas;
d.Urinary catheter care.
26.“Medication aide” means a nursing assistant who has had additional training in the administration of medications and is licensed with the Department pursuant to R.I. Gen. Laws Chapter 23-17.9 and Subchapter 05, Part 22 of this Chapter, Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs.
27."Mistreatment" means the inappropriate use of medications, isolation, or use of physical or chemical restraints as punishment, for employee convenience, as a substitute for treatment or care, in conflict with a physician's order, or in quantities which inhibit effective care of treatment, which harms or is likely to harm the patient or resident.
28."Neglect" means the intentional failure to provide treatment, care, goods and services necessary to maintain the health and safety of the patient or resident, or the intentional failure to carry out a plan of treatment or care prescribed by the physician of the patient or resident, or the intentional failure to report patient or resident health problems or changes in health conditions to an immediate supervisor or nurse, or the intentional lack of attention to the physical needs of a patient or resident including, but not limited to toileting, bathing, meals and safety.
a.“Neglect” also means failure to promptly act upon any change in a resident’s condition that would disqualify that resident from admission to the residence pursuant to § 2.4.14(A)of this Part, including but not limited to, the transfer of the resident to a health care facility. Provided, however, no person shall be considered to be neglected for the sole reason that he or she relies or is being furnished treatment in accordance with the tenets and teachings or a well-recognized church or denomination by a duly-accredited practitioner thereof.
29."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies, or limited liability companies) State or political subdivision or instrumentality of a State.
30."Personal assistance" means the provision of one (1) or more of the following services, as required by the resident or as reasonably requested by the resident, on a scheduled or unscheduled basis, including:
a.Assisting the resident with personal needs, including activities of daily living;
b.Assisting the resident with self-administration of medication; or administration of medications by appropriately licensed staff;
c.Providing or assisting the resident in arranging for health and supportive services as may be reasonably required;
d.Monitoring the activities of the resident while on the premises of the residence to ensure his/her health, safety, and well-being; and
e.Reasonable recreational, social and personal services.
31.“Qualified designee” means a licensed registered nurse, licensed practical nurse, or licensed medication aide.
32."Qualified licensed assisted living staff members" means a nursing assistant as provided under R.I. Gen. Laws § 23-17.9-2(a)(3), a licensed practical nurse as provided under R.I. Gen. Laws § 5-34-3(13) and/or a registered nurse as provided under R.I. Gen. Laws § 5-34-3(14).
33."Resident" means an individual not requiring medical or nursing care as provided in a health care facility but who as a result of choice and/or physical or mental limitation requires personal assistance, lodging and meals and may require the administration of medication and/or limited health services. A resident must be capable of self-preservation in emergency situations, unless the facility meets a more stringent Life Safety Code as required under R.I. Gen. Laws § 23-17.4-6(b)(3).
a.Persons needing medical or skilled nursing care, including daily professional observation and evaluation, as provided in a health care facility, and/or persons who are bedbound or in need of the assistance of more than one (1) person for ambulation are not appropriate to reside in assisted living residences. However, a resident may receive daily skilled nursing care or therapy from a licensed health care provider for a condition that results from a temporary illness or injury for up to forty-five (45) days subject to an extension of additional days as approved by the Department, or if the resident is under the care of a Rhode Island licensed hospice agency provided the assisted living residence assumes responsibility for ensuring that the required care is received.
b.Residents who are bed bound or in need of assistance of more than one (1) staff person for ambulation may reside in a residence if they are receiving hospice care in accordance with these Regulations. "Resident" shall also mean the resident's agent as designated in writing or legal guardian.
34."Significant change" means an improvement or decline in the resident's health status, behavior, or cognitive and/or functional abilities that results in a change in the resident's independence or quality of life, including but not limited to:
a.Resident's ability to perform activities of daily living;
b.A change in the resident’s behavior or mood resulting in behavioral symptoms that present a threat to the resident's self or others;
c.The elimination of problematic behavior on a sustained basis;
d.Requirements for resident’s level of service.
35.“State Fire Marshal” means the Division of the State Fire Marshal, Department of Public Safety, State of Rhode Island.
36."Supervision" means the supervision requirements of qualified licensed assisted living staff delivering limited health services.
**History**
- *Amendment — effective from 2024-03-18 to current*
- *Amendment — effective from 2022-08-25 to 03/18/2024*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2020-12-23 to 04/29/2021*
- *Amendment — effective from 2018-04-30 to 07/03/2022*
- *Amendment — effective from 2015-06-01 to 04/30/2018*
- *Amendment — effective from 2012-12-10 to 06/01/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-16 to 10/18/2007*
- *Amendment — effective from 2002-08-14 to 02/16/2004*
- *EMERGENCY RULE Adoption — effective from 2002-07-12 to 08/14/2002*
- *EMERGENCY RULE Adoption — effective from 2002-03-15 to 07/12/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/15/2002*
##### **216-RICR-40-10-2 § 2.4** Licensure Requirements {#sec-216-ricr-40-10-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-2#2.4}
2.4.1General Requirements for Licensing
A.No person, acting alone or jointly with any other person, shall conduct or maintain an assisted living residence in Rhode Island without a license in accordance with the requirements of R.I. Gen. Laws § 23-17.4-4 and in conformity with these Regulations.
1.All assisted living residences are subject to and must meet the requirements of § 2.4 of this Part to obtain and renew an assisted living residence license.
2.Any assisted living residence which offers to provide or provides services to residents with Alzheimer disease or other dementia by means of an Alzheimer Dementia/Special Care Unit/Program is also subject to the requirements of § 2.5 of this Part to obtain and renew a license endorsement which authorized these activities.
3.Any assisted living residence which offers to provide or provides limited health services to residents is also subject to the requirements of § 2.6 of this Part to obtain and renew a license endorsement which authorized these activities.
4.Any assisted living residence that offers to provide or provides services for residents receiving hospice services who are bed-bound or in need of assistance from more than one staff person for ambulation is required to be licensed at the F1 level, as defined in § 2.4.2(A)(1)(a) of this Part, and must have a license endorsement, issued pursuant to these regulations, to provide limited health services, and shall, at a minimum provide services for stage I and stage II pressure ulcer treatment and prevention and meet the requirements of § 2.6 of this Part.
B.No person, acting severally or jointly with any other person, shall admit or retain a resident in an assisted living residence which residence:
1.Does not meet the definition and requirements of the Act; or
2.Is not able to provide the services needed by a resident as agreed to in the service plan required under R.I. Gen. Laws § 23-17.4-15.6.
C.Each license shall specify the licensed resident capacity of the residence. The occupancy of the residence shall never exceed the licensed resident capacity.
1.The residence shall identify to the Department the location of beds and shall maintain proper space and furnishings for such locations.
2.The residence may not house more assisted living residents than the licensed capacity at any given time.
D.Proposed changes in bed capacity within a residence shall be submitted to the Department in writing and shall be subject to the approval of the Department.
E.No person and/or combination per area of residence shall represent itself as an assisted living residence or use the term residential care or any other similar term in its title, advertising, publication or other form of communication, unless licensed as an assisted living residence in accordance with the provisions herein.
2.4.2Levels of Licensure
A.An assisted living residence shall only admit and retain residents according to the level of licensure for which the residence has been licensed. A residence may have areas which are licensed separately.
1.Fire Code Classifications
a.Level F1 licensure: for residents who are not capable of self-preservation. This level requires a more stringent Life Safety Code, as defined in § 2.3(A)(25) of this Part; or
b.Level F2 licensure: for residents who are capable of self-preservation.
2.Medication Classifications
a.Level M1 licensure: for one (1) or more residents who require central storage and/or administration of medications; or
b.Level M2 licensure: for residents who require assistance (as elaborated in § 2.4.25(A)(3)(a) of this Part) with self-administration of medications;
3.Dementia Care
This category of licensure shall be required when one (1) or more resident's dementia symptoms impact their ability to function as demonstrated by any of the following:
a.Safety concerns due to elopement risk or other behaviors;
b.Inappropriate social behaviors that adversely impact the rights of others;
c.Inability to self-preserve due to dementia;
d.A physician's recommendation that the resident needs dementia support consistent with this level; or if the residence advertises or represents special dementia services or if the residence segregates residents with dementia. In addition to the requirements for the basic license, licensing requirements for the "dementia care" level shall include the following:
(1)Staff training and/or requirements specific to dementia care as determined by the Department;
(2)A registered nurse on staff and available for consultation at all times;
(3)The residence shall provide for a secure environment appropriate for the resident population.
e.A residence licensed at the "dementia care" level shall:
(1)Be licensed as an "F1 – M1" residence in accordance with the requirements of §§ 2.4.2(A)(1)(a) and (2)(a) of this Part; and
(2)Meet the requirements of §§ 2.4 and 2.5 of this Part.
4.Limited Health Care Services
a.This category of licensure shall be required for any assisted living residence that provides or offers to provide services in a manner as defined in § 2.3(A)(26) of this Part.
2.4.3Quality Assurance
A.In accordance with R.I. Gen. Laws § 23-17.4-10.1, each assisted living residence shall develop, implement and maintain a documented, ongoing quality assurance program.
1.The purpose of this program shall be to attain and maintain a high quality assisted living residence through an on-going process of quality improvement that monitors quality, identifies areas to improve, methods to improve them, and evaluates the progress achieved.
2.Each licensed residence shall establish a quality improvement committee which shall include at least the following: assisted living administrator, registered nurse and a representative of dietary services.
3.The quality improvement committee shall meet at least quarterly; shall maintain records of all quality improvement activities; and shall keep records of committee meetings that shall be available to the Department during any on-site visit.
4.The quality improvement committee shall review and approve the quality improvement plan for the residence at intervals not to exceed twelve (12) months. Said plan shall be available to the public upon request.
5.Each assisted living residence shall establish a written quality improvement plan that includes:
a.Program objectives;
b.Oversight responsibility (e.g., reports to the governing body, QI records);
c.Includes methods to identify, evaluate, and correct identified problems;
d.Provides criteria to monitor personal assistance and resident services, including, but not limited to:
(1)Resident/family satisfaction;
(2)Medication administration/errors;
(3)Reportable incidents as specified in § 2.4.17 of this Part;
(4)Resident falls;
(5)Plans of correction developed in response to the Department’s inspection reports.
B.In addition to the requirements of §§ 2.4.3(A)(1) through (5) of this Part, all assisted living residences with a “dementia care” license and/or a “limited health services license” shall also address the following areas in their quality improvement plan:
1.Prevention and treatment of decubitus ulcers;
2.Dehydration, and nutritional status and weight loss or gain; and
3.Changes in mental or psychological status.
4.Quality improvement documentation shall be kept on file for a minimum of five (5) years.
2.4.4Informal Dispute Resolution Process
A.In accordance with R.I. Gen. Laws § 23-17.4-10.3, the licensee or its designee has the right to an informal dispute resolution process to dispute any violation found or enforcement remedy imposed by the licensing agency during an inspection or complaint investigation. The purpose of the informal dispute resolution process is to provide an opportunity for an exchange of information that may lead to the modification, deletion, or removal of a violation, or parts of a violation, or enforcement remedy imposed by the licensing agency.
B.A request for an informal dispute resolution shall be made to the licensing agency within ten (10) business days from the receipt of a written finding of a violation or enforcement remedy. The request shall identify the violation or violations and enforcement remedy or remedies being disputed.
C.The licensing agency shall convene a meeting with the licensee within ten (10) business days of receipt of the request for informal dispute resolution, unless by mutual agreement a later date is agreed upon.
D.The licensee shall submit to the licensing agency, within fifteen (15) days, a plan of correction to address any undisputed violations, and including any violations that still remain following the informal dispute resolution.
2.4.5Financial Interest Disclosure
A.Any licensed assisted living residence that refers residents to any health care facility licensed pursuant to R.I. Gen. Laws Chapter 23-17, or to another assisted living residence licensed pursuant to the Act, or to a licensed adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose the following information to the resident:
1.That the referring entity has a financial interest in the residence or provider to which the referral is being made; and
2.That the resident has the option of seeking care from a different residence or provider which is also licensed and/or certified by the State of Rhode Island to provide similar services to the resident.
B.The referring entity shall also offer the resident a written list prepared by the Department of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting the Department as specified in § 2.4.6 of this Part.
C.Non-compliance with §§ 2.4.4(A) and (B) of this Part shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with R.I. Gen. Laws Chapter 23-17.10.
2.4.6Safe Resident Handling
A.Each licensed assisted living residence with an “Alzheimer’s Dementia Special Care Unit or Program” license and/or offers to provide or provides coordination of hospice services for residents who are bed-bound or in need of assistance from more than one (1) staff person for ambulation shall comply with the provisions of §§ 2.4.5(B) through (E) of this Part as a condition of licensure.
1.A currently licensed assisted living residence who applies for a new level of licensure must meet the requirements of §§ 2.4.6(B) through (E) of this Part prior to a new license level being approved.
B.Each licensed assisted living residence must maintain a safe resident handling committee, which shall be chaired by a professional nurse or other appropriate licensed health care professional. An assisted living residence may utilize any appropriately configured committee to perform the responsibilities of this section. At least half of the members of the committee shall be hourly, non-managerial employees who provide direct resident care.
C.Each licensed assisted living residence must have a written safe resident handling program, with input from the safe handling committee, to prevent musculoskeletal disorders among health care workers and injuries to residents. As part of this program, each licensed assisted living residence shall:
1.Implement a safe resident handling policy for all shifts and units of the residence that will achieve the maximum reasonable reduction of manual lifting, transferring, and repositioning of all or most of a resident's weight, except in emergency, life-threatening, or otherwise exceptional circumstances;
2.Conduct a resident handling hazard assessment. This assessment should consider such variables as handling-handling tasks, types of units, resident populations, and the physical environment of resident care areas;
3.Develop a process to identify the appropriate use of the safe resident handling policy based on the resident’s physical and mental condition, the resident's choice, and the availability of lifting equipment or lift teams. The policy shall include a means to address circumstances under which it would be medically contraindicated to use lifting or transfer aids or assistive devices for particular residents;
4.Designate and train a registered nurse or other appropriate licensed health care professional to serve as an expert resource, and train all direct care staff on safe resident handling policies, equipment, and devices before implementation, and at intervals not to exceed twelve (12) months, or as changes are made to the safe handling policies, equipment and/or devices being used; and
5.Conduct a performance evaluation of the safe resident handling policy at intervals not to exceed twelve (12) months, with the results of the evaluation reported to the safe resident handling committee or other appropriately designated committee. The evaluation shall determine the extent to which implementation of the program has resulted in a reduction in musculoskeletal disorder claims and days of lost work attributable to musculo-skeletal disorder caused by resident handling, and include recommendations to increase the program's effectiveness.
D.Nothing in § 2.4.5(A) of this Part precludes lift team members from performing other duties as assigned during their shift.
E.An employee may, in accordance with established residence protocols, report to the committee, as soon as possible, after being required to perform a resident handling activity that he/she believes in good faith exposed the resident and/or employee to an unacceptable risk of injury. Such employee reporting shall not be cause for discipline or be subject to other adverse consequences by his/her employer. These reportable incidents shall be included in the residence's annual performance evaluation.
2.4.7Communications
A.All communications and reports required to be submitted to the Department pursuant to these Regulations shall be sent to:
Rhode Island Department of Health, Center for Health Facilities Regulation
3 Capitol Hill, Room 306
Providence, RI 02908 401.222.2566 (phone)
401.222.3999 (FAX) or 401.222.5901 (FAX)
[email protected]
B.The information in § 2.4.6(A) of this Part shall be displayed in a conspicuous public area of the residence and shall be identified as the Department point of contact for complaints concerning potential violations of the Act or these Regulations.
C.Each assisted living residence shall establish and maintain a facility specific electronic mail address (i.e., e-mail address) to be provided to the Department for the purposes of contacting a high managerial agent for the residence with both routine communications and emergency notices. The residence shall be responsible for providing notice to the Department at any time that the residence’s specific electronic mail address is changed or updated.
D.In the event or in the preparation of an onsite, local area, or statewide emergency or natural disaster, the assisted living residence must respond to requests for information and/or status reports as requested by the Department and/or designated situation/incident commander.
2.4.8Application for License
A.Application for a license to conduct, maintain or operate an assisted living residence shall be made to the Department upon forms provided by the Department and shall contain such information as the Department reasonably requires which may include affirmative evidence of ability to comply with the provisions of the Act, these Regulations and compliance with Federal, State, and local laws and Rules and Regulations pertaining to, but not limited to: the management and operation of assisted living residences, fire, safety, zoning, building codes, sanitation, food service, communicable and reportable diseases, and other relevant health and safety requirements. The licensing application shall include evidence from the applicant that criminal background checks on owners and operators of licensed assisted living residences have been completed.
1.Each application shall be accompanied by a non-refundable application fee per license plus an additional fee per licensed bed, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
2.Each application for a license endorsement to provide an Alzheimer Dementia/Special Care Unit/Program or limited health services shall be accompanied by a non-refundable application fee, per license endorsement, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
B.A notarized listing of the names and addresses of direct and indirect owners whether individual, partnership, or corporation, with percentages of ownership designated, shall be provided with the application for licensure and shall be updated at intervals not to exceed twelve (12) months. If a corporation, the list shall include all officers, directors and other persons or any subsidiary corporation owning stock.
2.4.9Issuance and Renewal of License
A.Upon receipt of an application for a license, the Department shall issue a license if the applicant meets the requirements of the Act and these Regulations. The license issued, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year subject to inspection and approval by the Department.
1.All renewal applications shall be accompanied by a non-refundable application fee per license plus an additional fee per licensed bed, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
2.A renewal application for a license endorsement to provide an Alzheimer Dementia/Special Care Unit/Program or limited health services shall be accompanied by a non-refundable application fee, per license endorsement, as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
B.Each license shall be issued only for the premises and persons named in the application, and shall not be transferable or assignable except with the written approval of the Department.
C.The license will specify names of the owner and operator, the level of licensure or combination of services that the residence may provide, and the area where service can be provided (i.e., residents requiring assistance with self-preservation, and/or medication may only be admitted to facilities [or areas] with appropriate licensing level).
D.A license issued pursuant to these Regulations shall be the property of the State of Rhode Island and loaned to such licensee and it shall be kept posted in a conspicuous place on the premises.
E.In cases where a building has a mixed population of independent and assisted living residents, the location of the units on the assisted living license shall be documented in a roster available at all times and certified by the administrator, or his/her designee, and kept current on a daily basis.
2.4.10Inspections
A.The Department shall make or cause to be made such inspections and investigations as it deems necessary by duly authorized agents of the Director at such time and frequencies as determined by the Department.
B.A duly authorized representative of the Department shall have the right to enter at any time without prior notice, to inspect the premises and services for which an application has been received, or for which a license has been issued.
1.Refusal to permit inspection or investigation shall constitute a valid ground for suspension or revocation of license or curtailment of activities.
C.Every residence shall be given notice by the Department of all deficiencies reported as a result of an inspection or investigation.
2.4.11Change of Ownership, Operation and/or Location
A.When a change of ownership or operation or location of an assisted living residence or when discontinuation of services is contemplated, the Department shall be given written notice of pending changes.
B.A license shall immediately expire and become void and shall be returned to the Department when operation of an assisted living residence is discontinued or when any changes in ownership occur.
1.Prior to operating under a new owner or operator, the prospective licensee shall apply for a new license in accordance with § 2.4.7 of this Part, “Application for License.” Upon receipt of a complete application and if there are no changes in existing operations of the residence, including:
a.Resident capacity,
b.Level of licensure,
c.Modifications or construction of the physical plant,
2.The Department may, following a review of the complete application, issue a license to the prospective licensee without first inspecting the premises.
3.When there is a change in ownership or in the operation or control of the residence, and provided a complete application is submitted in accordance with § 2.4.10(B)(1) of this Part, the Department reserves the right to extend the expiration date of the existing license, allowing the residence to operate under the same license which applied to the prior licensee for such time as shall be required for the processing of a new application or reassignment of residents, not to exceed six (6) weeks.
C.When a change of certified administrator is contemplated, the Department shall be given written notice prior to the change and at the time of the actual change.
D.The Department shall be notified immediately when a licensee/owner determines to cease operations and close an assisted living residence. A meeting shall be conducted with the Department and prior to notice or notification to residents and the public to ensure there is a formal and comprehensive plan for an orderly closure, sixty (60) days or more notice to residents, their guardian, or relative so appointed or elected to be his/her decision maker, and the safe, orderly discharge and transfer of residents.
1.The assisted living residence closure plan shall include, but is not limited to the following:
a.Letter of intent and/or determining factors/justification for the closure (i.e., voluntary, financial), to include:
(1)Proposed closure date;
(2)Contact information for staff member responsible for implementing the closure plan;
(3)Projected fiscal management plan covering operations during the closure period.
b.Staffing plan(s)
(1)By unit/program/location;
(2)Time line for individual closures of any unit/program/service location;
(3)Staff scale-down process as appropriate given planned transition/reduction of patients/residents.
c.Plans for providing notification and estimated implementation of notices
(1)Any required notice to third (3rd) party payers (i.e., Medicaid, long-term care insurance);
(2)Notice to Accreditation entities – if appropriate;
(3)Notice to staff/union – meeting date(s);
(4)Public notice;
(5)Community/public meetings – if appropriate and/or planned.
d.Storage/access to medical records
(1)Location for self-storage, or
(2)Company/agency providing contract storage services.
2.4.12Denial, Suspension, Revocation of License or Curtailment of Activities
A.The Department is authorized to deny, suspend or revoke the license or curtail activities of any assisted living residence which:
1.Has failed to comply with these Regulations;
2.Has offered or provided service to residents outside of the scope of its appropriate level of license;
3.Has failed to correct deficiencies or complete corrective action plan; or
4.Has failed to comply with the provisions of the Act.
B.Reports of deficiencies shall be maintained on file in the Department and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of the assisted living residence.
C.Whenever an action shall be proposed to deny, suspend or revoke an assisted living residence license, or curtail its activities, the Department shall notify the residence by certified or registered mail or by personal service setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17.4-8 and 42-35-9, and the provisions of § 2.4.36 of this Part.
1.However, if the Department finds that the safety and welfare of residents requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
D.The appropriate state and federal agencies shall be notified of any action taken by the Department pertaining to either denial, suspension, or revocation of license, or curtailment of activities.
2.4.13Administrative Management
A.All licensees shall provide staffing which is sufficient to provide the necessary care and services to attain or maintain the highest practicable physical, mental and psychosocial well-being of the residents, according to the appropriate level of licensing. At least one (1) staff person who has completed employee training as outlined in § 2.4.12(G) of this Part shall be on the premises at all times.
B.Each licensee shall have responsible adult(s) who are employee(s) or who have a contractual relationship with the residence to provide the services required by these Regulations who is at least eighteen (18) years of age and
1.Awake and on the premises at all times,
2.Designated in charge of the operation of the residence; and
3.Physically and mentally capable of communication with emergency personnel.
C.Pursuant to R.I. Gen. Laws §§ 23-17.4-15.1.1 and 23-17.4-15.2, each assisted living residence shall have an administrator who is licensed by the Department in accordance with Regulations established pursuant to R.I. Gen. Laws § 23-17.4-21.1, in charge of the maintenance and operation of the residence and the services to the residents. The name and contact information for the current administrator shall be displayed in a conspicuous public area of the residence. The administrator is responsible for the safe and proper operation of the residence at all times by competent and appropriate employee(s) and shall be responsible for no less than the following:
1.The management and operation of the residence and services to the residents;
2.Compliance with federal, state, and local laws and Rules and Regulations pertaining to, but not limited to: the management and operation of assisted living residences, fire, safety, zoning, building codes, sanitation, food service, communicable and reportable diseases, Americans with Disabilities Act, employee health and safety, other relevant health and safety requirements, and these Regulations.
3.Staffing the residence with adequate and qualified personnel to attend to the food preparation, general housekeeping, assistance with personal care, medication administration, if applicable, and other such services;
4.Establishment of written policies and procedures governing the operation of the residence which are aimed, to the extent possible, at maintaining the independence of residents. Such policies shall include provisions to implement no less than the following:
a.The appropriate provisions of § 2.4.18 of this Part and other applicable provisions pertaining to admission, transfer, discharge, visitation privileges, availability and utilization of community resources, leisure time and such other;
b.Accountability of the residence when acting as a fiduciary agent for the resident pursuant to § 2.4.18 of this Part;
c.Notification of next of kin or other responsible person designated by the resident in the event of illness, accident or death; and
d.Such other provisions as may be deemed appropriate.
5.Compliance with all requirements appropriate to the service level for which the residence is licensed.
D.Cardiopulmonary Resuscitation
1.At all times, one (1) person on-site shall have successfully completed instruction by the American Heart Association, the American Red Cross, or the National Safety Council at the minimal ("Heartsaver") level to perform cardiopulmonary resuscitation.
E.A licensed administrator shall be in charge of no more than three (3) residences with an aggregate resident total of no more than one hundred twenty (120) residents.
F.The licensed administrator shall not leave the premises without delegating necessary authority for operation of the residence to a competent employee(s).
G.Employee Training
1.The administrator shall ensure that all new employees shall receive at least two (2) hours of orientation and training within ten (10) days of hire and prior to beginning work alone in the assisted living residence, in addition to any training that may be required for a specific job classification at the residence. Such areas include:
a.Fire prevention;
b.Recognition and reporting of abuse, neglect, and mistreatment;
c.Assisted living philosophy (goals/values: dignity, independence, autonomy, choice);
d.Resident's rights;
e.Confidentiality;
f.Emergency preparedness and procedures;
g.Medical emergency procedures;
h.Infection control policies and procedures; and
i.Resident elopement.
2.The administrator shall ensure that all new employees who will have regular contact with residents and provide residents with personal care shall receive at least ten (10) hours of orientation and training within thirty (30) days of hire and prior to beginning work alone in the assisted living residence, in addition to the areas stipulated in § 2.4.12(G) of this Part. Such areas include:
a.Basic sanitation;
b.Food service;
c.Basic knowledge of cultural differences;
d.Basic knowledge of aging-related behaviors including dementia and Alzheimer’s disease;
e.Personal assistance;
f.Assistance with medications;
g.Safety of residents;
h.Body Mechanics;
i.Resident Transfers (required for residences licensed at the F1 level for fire safety);
j.Record-keeping;
k.Service plans; and
l.Internal reporting.
H.In-service Training
1.Employees shall have on-going, at intervals not to exceed twelve (12) months, in-service training as appropriate for their job classifications and including the topics cited in § 2.4.12(G) of this Part.
2.All new employee orientation and on-going in-service training shall be documented in the employee's personnel file, and maintained onsite at the licensed residence.
I.Personnel Records
1.The residence shall maintain comprehensive personnel records for each employee. Personnel records shall be maintained onsite of the licensed residence and/or electronically available at all times.
2.Said personnel records shall be reviewed and updated at intervals not to exceed twelve (12) months and shall include, but not be limited to, all of the following components:
a.Completed job application and/or resume;
b.Written statements of references or documentation of verbal reference check;
c.Written functional job descriptions;
(1)These descriptions shall be updated at intervals not to exceed twelve (12) months and shall include, but not be limited to, minimal qualifications for the position, major duties and responsibilities, and shall be signed and dated by the individual employee.
d.Evidence of credentials, current professional licensure and/or certification;
e.Documentation of education and/or continuing training, including continuing education units (CEUs) related to administrator certification, food management, etc., medication administration, and dementia care;
f.Documentation of attendance at in-service training and/or orientation;
g.Documentation of at least one (1) performance evaluation at intervals not to exceed twelve (12) months;
h.Signed copy of employee’s awareness of resident’s rights;
i.Results of the criminal record (BCI) check.
J.Personnel Criminal Records Check
1.Pursuant to R.I. Gen. Laws § 23-17.4-27, all employees of assisted living residences licensed under the Act, hired after September 30, 2014, and having routine contact with a resident or having access to a resident's belongings or funds shall undergo a national criminal background records check which shall include fingerprints submitted to the Federal Bureau of Investigation (FBI) by the Bureau of Criminal Identification of the Department of Attorney General. The national criminal records check shall be processed, prior to, or within one (1) week of employment.
2.Said employee, through the employer, shall apply to the Bureau of Criminal Identification of the Department of Attorney General for a national criminal records check.
3.In those situations in which no disqualifying information has been found, the Bureau of Criminal Identification of the Department of Attorney General shall inform the applicant and the employer in writing of this fact.
4.Upon the discovery of any disqualifying information, as defined in R.I. Gen. Laws § 23-17.4-30 and in these Regulations, the Bureau of Criminal Identification of the Department of Attorney General will inform the applicant in writing of the nature of the disqualifying information; and, without disclosing the nature of the disqualifying information, will notify the employer in writing that disqualifying information has been discovered.
5.The employer shall maintain on file, subject to inspection by the Department, evidence that the statewide criminal records checks have been initiated on all employees seeking employment between October 1, 1991 and September 30, 2014, and the results of those checks.
6.The employer shall maintain on file, subject to inspection by the Department, evidence that national criminal records checks have been initiated on all employees seeking employment on or after October 1, 2014, and the results of those checks.
7.Failure to maintain this evidence shall be grounds to revoke the license or registration of the employer.
8.An employee against whom disqualifying information has been found may provide a copy of the national criminal records check to the employer. The administrator shall make a judgment regarding the continued employment of the employee.
9.Due to the fact that juvenile proceedings before the Rhode Island Family Court are exempt from disclosure, the requirement for a statewide criminal records check shall be waived for residence employees under the age of eighteen (18). Provided, however, the residence must perform a reference check for employees under age eighteen (18). Once the employee turns eighteen (18) years old, the required criminal records check must be completed within seven (7) days of his or her eighteenth (18th) birthday.
2.4.14Management of Services
A.Each residence shall provide services with adequate professional and ancillary employees and in accordance with applicable state law. Further, the residence shall assure that all services are rendered in a safe and effective manner and consistent with the requirements herein. The residence shall provide all care and services to all residents in accordance with the prevailing community standard of care.
B.The residence shall have a policy and procedure manual that is reviewed and updated by the administrator at intervals not to exceed twelve (12) months, and shall include, but not be limited to, the following items:
1.A written description of all services available to residents that shall be designed to promote the resident’s efforts to maintain independence;
2.A written statement of admission criteria that shall include, at a minimum, the following information regarding the resident population:
a.Nature and extent of disabling condition(s) served; and
b.Restrictions (if any).
(1)The statement of admission criteria shall include a statement that no otherwise qualified applicant shall be denied admission to the residence solely on the basis of age, sex, gender identity or expression, race, creed, color, religion, sexual orientation, marital status, familial status, disability, source of income, source of payment or profession, or national origin.
C.The residence shall develop and maintain written admission procedures that shall include no less than the following components:
1.Procedures for informing residents of house rules (e.g., necessary information, tour of residence);
2.A resident assessment process;
3.Provision of information to each resident related to:
a.Results of initial assessment;
b.Procedures for involuntary transfer within the residence;
c.Procedures for involuntary discharge;
d.Procedures for advanced directives;
e.Grievance procedures;
f.Availability of nursing services, if any.
4.Policies and procedures on elopement;
5.Procedures to be followed, including those for referral (in those cases where an applicant is found to be ineligible for admission);
D.Prior to admission, the resident and/or legal guardian shall be informed of any charges for services rendered, including charges for special diets, if any.
E.The residence shall develop, maintain, and enforce written policies and procedures for employee documentation of personal care services/activities of daily living (ADLs) rendered to residents.
F.The residence shall maintain a written policy and procedures for assisting a resident in locating and/or obtaining needed services, as appropriate.
G.The residence shall maintain a written policy regarding reportable incidents and events in accordance with § 2.4.17 of this Part.
H.The residence shall develop and maintain a statement of discharge criteria that specifies the conditions under which a resident is considered to be ineligible for continued residency and conditions under which a resident’s advanced rental fees are refunded.
I.Policies and procedures pertaining to the provision of services, and supported by appropriate manuals or reference materials where applicable, shall be established by a designated professional employee or administrator and approved by the licensee. Such policies shall pertain to no less than the following:
1.Residence staffing patterns;
2.Employee responsibility(ies) for the provision of services;
3.A statement that services rendered shall be performed in accordance with all applicable laws and Regulations for each service provided;
4.A description of services that are included in the monthly charge(s) and the additional cost(s), if any, for other available services or amenities;
5.Policies/procedures regarding medication management and/or assistance with medication(s);
6.A policy that medical waste, as defined in the Department of Environmental Management’s Medical Waste Regulations (250-RICR-140-15-1) shall be managed in accordance with the provisions of the aforementioned Regulations;
7.A policy regarding compliance with food service and Part 50-10-1 of this Title, Rhode Island Food Code, requirements;
8.Disclosure of resident information in accordance with the requirements of R.I. Gen. Laws § 23-3-26;
9.The procedure(s) for resolution of resident grievances, including the inclusion of the name, address, and telephone number of all pertinent resident advocacy groups, the State Ombudsman, and the Department.
10.Quality assurance program.
J.Smoking Policy
1.If the residence permits smoking, it shall have a policy that includes the following:
a.Location of designated smoking area(s) separate from the common area;
b.Prohibition of smoking in any area other than the designated area(s);
c.Adequate ventilation in smoking areas;
d.Assessment (upon admission, quarterly, and when a significant change in function occurs) of all residents that smoke to ensure safe smoking capabilities.
K.Advance Directives
1.The residence shall have written policies and procedures that address advanced directives that shall include, but not be limited to, sufficient instructions for employees to follow in the event of emergencies and the resuscitation of residents.
L.Medical Orders for Life Sustaining Treatment (MOLST)
1.The residence shall have written policies/procedures to accept, update if appropriate, and offer each qualified patient the opportunity to complete a MOLST in accordance with Part 20-15-4 of this Title, Medical Orders for Life Sustaining Treatment.
2.4.15Residency Requirements
A.Each licensee, or his/her designee, through the assessment and evaluation procedures delineated in these Regulations (see § 2.4.16(C) of this Part) shall be responsible to ensure that admission to and residency in an assisted living residence be limited to those individuals who meet the definition of "resident" in accordance with § 2.3(A)(34) of this Part.
B.Disclosure
1.Each assisted living residence shall disclose certain information about the residence to each potential resident, the resident's interested family, and the resident's agent as early as practical in the decision-making process and at least prior to the admission decision being made. The disclosed information shall be in print format and shall include at a minimum:
a.Identification of the residence and its owner and operator;
b.Level of license and an explanation of each level of licensure;
c.Admission and discharge criteria;
d.Services available;
e.Financial terms to include all fees and deposits, including any first (1st) month rental arrangements, and the residence's policy regarding notification to tenants of increases in fees, rates, services and deposits;
f.Terms of the residency agreement, including the process used in the event that a resident can no longer afford the cost of care being provided.
g.The names, addresses, and telephone numbers of: the Department; the Medicaid Fraud and Patient Abuse Unit of the Department of Attorney General; the State ombudsperson, and local police offices.
C.Residency Agreement or Contract
1.Pursuant to R.I. Gen. Laws § 23-17.4-16, prior to exchange of any funds and prior to admission, the residence shall execute a residency agreement or contract, signed by both the residence and the resident, that defines the services the residence will provide and the financial agreements between the residence and the resident or the resident's representative.
a.Any advanced deposit, application fee, or other pre-admission payment shall be subject to a signed document explaining fully the terms of the payment.
b.In cases of emergency placement, the residency agreement or contract shall be executed within five (5) working days of admissions.
2.The residency agreement or contract shall include (or reference other documents that include) no less than the following items:
a.Resident's rights;
b.Admission criteria;
c.Discharge criteria;
d.Discharge policies;
e.Description of the unit to be rented by the resident;
f.Description of shared space and facilities;
g.Services to be provided;
h.Services that can be arranged;
i.Financial terms between resident and residence;
(1)Basic rates;
(2)Extra charges at signing;
(3)Extra charges that may apply in the future;
(4)Deposits and advanced fees;
(5)Rate increase policy.
j.Special care provisions (as applicable);
k.Resident's responsibilities and house rules;
l.Initial and on-going assessment and service plan;
m.Grievance procedure.
D.The minimum prior notification time for changes in rates, fees, service charges, or any other payments required by the residence shall be thirty (30) days written notice to the resident.
2.4.16Resident Records
A.Each residence shall, at a minimum, maintain the following information for each resident:
1.The resident's name;
2.The resident's last address;
3.The name of the person or agency referring the resident to the home;
4.The name, specialty (if any), telephone number, and emergency telephone number of each physician who is currently treating the resident;
5.The date the resident began residing in the home;
6.A list of medications taken by the resident, including dosage, and specific records of medication administration as required by the Department;
a.In residences licensed at the M2 level, if a resident refuses to provide the information cited in § 2.4.15(A)(6) of this Part, this fact shall be documented in the resident’s service agreement.
7.Written acknowledgments that the resident has signed and received copies of the rights as provided in R.I. Gen. Laws § 23-17.4-16;
8.Information about any specific health problems of the resident, which may be useful in a medical emergency, including diagnostic and/or therapeutic orders;
9.A record of personal property and funds which the resident has entrusted to the residence;
10.The name, address, and telephone number of a person identified by the resident who should be contacted in the event of an emergency or death of the resident and the name, address, and telephone number of the legal guardian;
11.Any other health-related emergency, or pertinent information which the resident requests the residence to keep on record;
12.A copy of the initial and periodic assessments described in § 2.4.16 of this Part;
13.A copy of the service plan and nurse review as described in § 2.4.16 of this Part;
14.A copy of the residency agreement as described in § 2.4.14(C) of this Part.
B.Entries in the resident’s record relating to treatment, medication and diagnostic tests shall be made by the responsible persons at the time of administration and/or service. Only physicians shall enter or authenticate medical opinions or judgment.
1.Detailed descriptions of all pressure ulcers, or other skin lesions, shall be recorded in the resident's record.
C.At time of discharge, a discharge summary, summarizing the resident's stay, shall be completed promptly and signed by the residence’s administrator or registered nurse.
D.Resident records of discharged residents shall be completed within a reasonable period of time (not to exceed sixty (60) days) with all clinical information pertaining to the resident's stay made part of the resident's record.
E.Confidentiality of resident records shall be governed by the provisions of R.I. Gen. Laws Chapter 5-37.3 and the following;
1.Only authorized personnel shall have access to the records.
2.The residence shall release resident's medical information only with the written consent of the resident, parent, guardian or legal representative in accordance with R.I. Gen. Laws Chapter 5-37.3.
F.Such information shall be contained in record formats appropriate to the efficient and effective delivery of resident services and accessible for review upon request by the licensure agency or other appropriate health oversight agency.
G.The licensee shall retain resident records for seven (7) years from the date of discharge in accordance with the provisions of R.I. Gen. Laws § 23-3-26.
H.Statement of Resident's Rights
1.In accordance with R.I. Gen. Laws § 23-17.4-16.1, each resident and/or legal guardian shall be given a written statement of the resident’s rights and responsibilities in the residence that shall be signed by the resident and/or guardian attesting to his/her comprehension of these rights and responsibilities as explained by the employee who shall witness the resident’s signature. A copy of the signed document shall also be placed in the resident’s record.
2.4.17Resident Assessments and Service Plans
A.Prior to the admission of a resident, or the signing of a residency agreement with a resident, the administrator shall have a comprehensive assessment of the resident's health, physical, social, functional, activity, and cognitive needs and preferences conducted and signed by a registered nurse.
B.This assessment shall be used to determine if the resident's needs and preferences can be met by the assisted living residence within the range of services offered by the residence at its licensure level. The conclusions shall be shared with the resident or the resident's representative. If a reasonable accommodation can enable a resident to live in an assisted living residence, the nature of that accommodation and a plan for implementation or reason for denial should be included in the assessment. Provided, however, any reasonable accommodation provided to a resident shall be provided within the range of services offered by the residence at its licensure level.
1.As part of the initial resident admission and assessment process, the residence shall review and consider any notice provided to the facility as required in R.I. Gen. Laws § 42-56-10(23) concerning the resident's or prospective resident's status on parole and recommendations, if any, from the Department of Corrections regarding safety and security measures.
C.The Department-approved assessment form, or such other assessment form as approved by the Department, shall be utilized in completing the assessment on each resident who is admitted to the residence. (Approved Department form is available for downloading online at http://health.ri.gov/forms/assessment/AssistedLivingResident.pdf).
1.Assisted living residences not intending to use the Department’s assessment form shall submit their proposed assessment forms with a cover letter of intent to the Center for Health Facilities Regulation as specified in § 2.4.6(A) of this Part.
2.All assessment forms shall report information appropriate to determine compatibility and compliance with the residency criteria, and shall indicate that the resident’s needs can be met by the assisted living residence within its licensure level, and shall gather information appropriate for the development of an individualized service plan.
a.The assessment form shall be designed to demonstrate compliance with the assisted living residence’s criteria for residency.
b.The assessment form shall also be designed to demonstrate that the assisted living residence can meet the resident’s needs and preferences.
3.The assessment form shall also be designed to provide information appropriate for the development of an individualized service plan in accordance with § 2.4.16(G)(1) of this Part.
D.The assessment shall be reviewed and at intervals not to exceed twelve (12) months and each time a resident's condition changes significantly.
E.In the event a resident has an admission to a health care facility and is scheduled to return to the residence without a significant change in status, then the assessment shall be updated within five (5) working days of readmission.
1.In case of an emergency admission, the required assessment shall take place within five (5) working days and shall include the following:
a.An immediate admission necessitated by natural disaster, crisis, or threat to public safety at another licensed assisted living residence, independent living situation, community residential facility, or private residence;
b.An immediate admission necessitated by the unanticipated incapacitation of the primary caregiver of the person to be admitted;
c.Conditions or circumstances warranting emergency admission and as approved by Center for Health Facilities Regulation staff within forty-eight (48) hours.
F.Nurse Review
1.Nurse review is necessary for all levels of licensure.
a.A registered nurse shall visit the residence at least once every thirty (30) days except as provided in § 2.4.16(F)(1)(b) of this Part and shall complete a review to include the following:
(1)Monitor the medication regimen for all residents;
(2)Review any new physician orders and evaluate the health status of all residents by identifying symptoms of illness and/or changes in mental/physical health status;
(3)Evaluate the appropriateness of placement for each resident;
(4)Make any necessary recommendations to the administrator;
(5)Follow up on previous recommendations;
(6)Provide a signed, written report in the residence documenting:
(AA)Date and time of assessment;
(BB)Recommendations for follow-up;
(CC)Progress on previous recommendations;
(DD)Verification that the medication listed by the pharmacist on the mediset, blister pack or medication container is current with physician orders (M-1 level only);
(EE)Physical assessment identifying symptoms of illness and/or changes in mental or physical health status and appropriateness of placement;
(FF)Such reports shall be on file at the residence.
(7)Complete the quarterly evaluation of the residence’s registered medication aide(s) administration of medication. (Approved Department form is available for downloading online).
b.In those residences that have one (1) or more licensed registered nurses (i.e., at least one (1) full-time equivalent equal to thirty-five (35) hours) on-site, the nurse review shall be completed at least once every ninety (90) days.
G.Service Plans
1.Within a reasonable time after move-in, not to exceed seven (7) days, the Administrator shall be responsible for the development of a written service plan based on the initial assessment. The service plan shall include at least:
a.The services and interventions needed, including all services provided by outside healthcare agencies (e.g., home nursing care, hospice);
b.Description, frequency, duration relating to the service or intervention, including personal assistance, medication, special diets, recreational activities, and other similar services rendered;
c.Party responsible for arranging and/or providing the service; and
d.The resident’s requested and/or therapeutically needed recreational and social activities.
2.The service plan shall be developed by a registered nurse and/or the certified assisted living residence administrator, and shall be signed, approved, and dated by both parties.
3.The service plan shall be reviewed by both parties at intervals not to exceed twelve (12) months and each time a resident's condition changes significantly and all changes shall be acknowledged in writing by both parties.
4.A copy of the service plan shall be placed in the resident's record.
2.4.18Reporting Requirements
A.The person responsible for the operation of the residence shall promptly notify the next of kin as instructed or other responsible person designated by the resident or guardian of any illness, injury or death of a resident.
B.Accidents, incidents, and medication errors resulting in out-of-residence emergency medical services resulting in a hospital admission of any resident shall be reported to the Center for Health Facilities Regulation in writing, via facsimile or electronic transmission to [email protected] by the end of the next working day. A copy of each report shall be retained by the residence for review during subsequent inspections by the Department.
C.The death of any resident of an assisted living residence occurring on the premises within twenty-four (24) hours of assuming residency shall be reported to the Office of the State Medical Examiners and the Center for Health Facilities Regulation. Also, all deaths occurring in the residence which are sudden or unexpected, suspicious or unnatural, the result of trauma, remote or otherwise, or when unattended by a physician or are otherwise reportable in accordance with the provisions of R.I. Gen. Laws Chapter 23-4 shall be reported to the State Medical Examiner’s Office and the Center for Health Facilities Regulation.
D.Any employee of an assisted living residence who has reasonable cause to believe that a resident has been abused, exploited, neglected, or mistreated shall immediately, but not later than four (4) hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than twenty-four (24) hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, report such to the Director and to the Office of the Long-Term Care Ombudsman. Any person required to make a report pursuant to this section shall be deemed to have complied with these requirements if a report is made to a high managerial agent. Once notified, said agent shall be required to meet the above reporting requirements. The residence shall establish a written policy or procedure for reporting abused, exploited or neglected residents that complies with the provisions of this section. The report may be submitted by telephone but shall be followed up in writing.
1.Upon receipt of such information or allegation, the Director shall forthwith conduct such investigation as may be necessary and submit a report of findings of the investigation(s) to the Attorney General of the State of Rhode Island.
E.Unscheduled implementation of the residence’s fire, evacuation, and/or disaster plan shall be reported immediately via telephone (401) 222-5200, and shall be followed up in writing, on forms supplied by the Department, and faxed to the Department within three (3) business days.
F.Any elopement of a resident that results in police being called must be reported in writing to the Department within twenty-four (24) hours or by the end of the next business day.
G.All reports, as required by these Regulations, shall be provided to the Department in writing via facsimile or electronic transmission to [email protected] on forms supplied by the Department. A copy of each report shall be retained by the residence for review during subsequent inspections by the Department.
H.The residence shall maintain evidence that all reportable incidents have been thoroughly investigated and that actions have been taken to prevent further incidents while the investigation is in progress. Appropriate corrective action shall be taken, as necessary. The results of said investigation shall be reported to the Department, within five (5) business days, on forms supplied by the Department.
I.Reporting requirements, pursuant to R.I. Gen. Laws Chapter 23-17.8 must be posted in the residence in plain view of all residents and employees.
J.The administrator shall notify the Department in writing of any emergency admissions in accordance with § 2.4.16(E)(1)(c) of this Part within forty-eight (48) hours.
K.The administrator shall be responsible for the investigation and documentation of incidents that involve residence operations, resident services, or related event(s) that directly or indirectly jeopardize the health and safety of residents, or that results in a resident injury that requires assessment by a licensed practitioner or where the injury was not witnessed or explained by the resident.
1.Documentation of incidents shall include:
a.Date and time of incident;
b.Reporter’s name;
c.Name of resident(s) involved or affected;
d.Any injury(ies) to resident(s); and
e.Action taken by the residence in response to the incident.
2.Such documentation shall be made available for review during a survey inspection by the licensing agency Department or as required by any health oversight agency.
3.Such documentation shall be retained by the licensee for no less than seven (7) years after the event or incident.
2.4.19Rights of Residents
A.Every assisted living residence for adults licensed pursuant to these Regulations shall observe the standards stated in R.I. Gen. Laws § 23-17.4-16, “Rights of Residents” and such other appropriate standards as may be prescribed in Rules and Regulations promulgated by the Department with respect to each resident of the residence.
B.For purposes of the following standards stated in §§ 2.4.18(B)(1) through (7) of this Part the term "resident" shall also mean the resident's agent as designated in writing or legal guardian.
1.Upon request have access to all records pertaining to the resident, including clinical records, within the next business day or immediately in emergency situations;
2.Upon admission and during the resident's stay be fully informed in a language the resident understands, of all resident rights and rules governing resident conduct and responsibilities;
a.Each resident shall receive a copy of their rights.
b.Each resident shall acknowledge receipt in writing; and
c.Each resident shall be informed promptly of any changes.
3.Be informed in writing, prior to, or at the time of admission or at the signing of a residential contract or agreement of:
a.The scope of the services available through the residence's service program, including health services, and of all related fees and charges, including charges not covered either under Federal and/or State programs by other third (3rd) party payers or by the residence's basic rate;
b.The residence's policies regarding overdue payment including notice provisions and a schedule for late fee charges;
c.The residence's policy regarding acceptance of State and Federal government reimbursement for care in the residence both at time of admission and during the course of residency if the resident depletes his/her own private resources;
d.The residence's criteria for occupancy and termination of residency agreements;
e.The residence's capacity to serve residents with physical and cognitive impairments;
f.Support any health services that the residence includes in its service package or will make appropriate arrangements to provide these services;
4.Upon provision of at least thirty (30) days’ notice, if a resident chooses to leave a residence, the resident shall be refunded any advanced payment made provided that the resident is current in all payments;
5.The residence can discharge a resident only for the following reasons and within the following guidelines:
a.Except in life-threatening emergencies and for nonpayment of fees and costs, the residence gives thirty (30) days' advance written notice of termination of residency agreement with a statement containing the reason, the effective date of termination, the resident's right to an appeal under State law, and the name/address of the State Ombudsperson’s office;
b.If resident does not meet the requirements for residency criteria stated in the residency agreement or requirements of state or local laws or Regulations;
c.If resident is a danger to self or the welfare of others; and the residence has attempted to make a reasonable accommodation without success to address resident behavior in ways that would make termination of residency agreement or change unnecessary; which would be documented in the resident's records;
d.For failure to pay all fees and costs stated in the contract, resulting in bills more than thirty (30) days outstanding. A resident who has been given notice to vacate for nonpayment of rent has the right to retain possession of the premises, up to any time prior to eviction from the premises, by tendering to the provider the entire amount of fees for services, rent, interest, and costs then due. The provider may impose reasonable late fees for overdue payment; provided that the resident has received due notice of such charges in accordance with the residence's policies. Chronic and repeated failure to pay rent is a violation of the lease covenant. However the residence must make reasonable efforts to accommodate temporary financial hardship and provide information on government or private subsidies available that may be available to help with costs; and
e.The residence makes a good faith effort to counsel the resident if the resident shows indications of no longer meeting residence criteria or if service with a termination notice is anticipated;
6.To be able to share a room or unit with a spouse or other consenting resident of the residence in accordance with terms of the resident contract;
7.To live in a safe and clean environment.
C.In addition to the standards stated in R.I. Gen. Laws § 23-17.4-16, residents are entitled to the following:
1.Receive dental services from a dentist of his/her choice;
2.Each resident shall be given, in writing, the names, addresses, and telephone numbers of: the Department; the Medicaid Fraud and Patient Abuse Unit of the Department of Attorney General; the State Ombudsperson; and local police offices.
D.The residence must:
1.Implement written policies and procedures to ensure that all residence employees are aware of and protect the resident's rights contained in these Regulations;
2.Have prominently displayed a posting of the most recent State licensing survey of the assisted living residence; and
3.Provide each resident or his/her representative upon admission, a copy of the provisions of § 2.4.18 of this Part and shall display in a conspicuous place on the premises a copy of the "Rights of Residents."
2.4.20Essential Caregivers During a Declared Emergency
A.The provisions of this section shall apply for the period commencing fifteen (15) days after a declaration of disaster emergency and last until sixty (60) days after the termination or expiration of the declaration of disaster emergency by executive order, proclamation, or operation of law.
B.Each residence shall allow a resident of an assisted living residence, or an individual with decision-making authority for the resident, to designate an individual as the resident's essential caregiver during a declaration of a disaster emergency.
C.Qualifications and Caregiver Designation
1.In order to be designated as an essential caregiver to provide in-person physical or emotional support to a resident during a declaration of disaster emergency, the individual must be at least eighteen (18) years old.
2.One (1) essential caregiver may be designated at any given time for each resident.
D.Safety Measures
1.Each residence shall develop and implement safety protocols for essential caregivers within fifteen (15) days of a declaration of disaster emergency. Such protocols must be consistent with the Department, state and federal guidance. Residences must update safety protocols in the event of any new guidance from state or federal partners within seventy-two (72) hours.
2.The safety protocols for an essential caregiver, shall include, but not be limited to, procedures on:
a.Restrictions on travel;
(1)Restrictions on travel must not be more restrictive than travel restrictions for all Rhode Island residents for the declaration of disaster emergency.
b.Enhanced testing for communicable diseases, as applicable; and
(1)Enhanced testing, also known as surveillance testing, for essential caregivers must not be more stringent than surveillance testing required for residence staff.
c.Use of personal protective equipment (PPE)
(1)The required PPE for essential caregivers will vary depending on tasks, actions, and nature of emergency.
(2)A residence is not required to provide personal protective equipment (PPE) to essential caregivers.
2.An essential caregiver must comply with routine surveillance testing during the course of a declared disaster emergency.
3.The residence shall be responsible for verifying/tracking the testing status, as applicable, of essential caregivers.
4.The essential caregiver must adhere to face-masking, hand hygiene, social distancing, and other safety measures at the direction of residence staff.
5.In accordance with R.I. Gen. Laws § 23-17.5-37(b)(4), a residence that enters a lock down phase to establish safety measures for residents and essential caregivers shall not exceed a period of thirty (30) days. During the lock-down phase, essential caregivers are not permitted to enter.
6.A residence may establish additional safety requirements to protect the residents of the residence if the requirements meet all of the following criteria:
a.The requirements are directly linked to a declaration of disaster emergency.
b.The requirements are not so burdensome and onerous as to substantially prevent an essential caregiver from being able to physically or emotionally support a resident of the assisted living residence in person.
E.Administration
1.The residence must establish and implement policies and procedures for designating and utilizing essential caregivers during the period of a declared disaster emergency.
2.The residence must allow an essential caregiver to have regular and sustained in-person visitation and physical access to an assisted living residence resident.
a.The residence must ensure visits with essential caregivers are conducted with a reasonable degree of privacy.
3.The essential caregiver may sign an agreement with the residence that outlines what support and activities will be provided by the essential caregiver.
4.An essential caregiver visit may be suspended in the event of the essential caregiver's failure to comply with the residence's requirements or these Regulations during a visit.
5.A residence must have a policy or procedure in place for a resident or an individual with decision making authority for the resident, to immediately designate a replacement essential caregiver in the event an essential caregiver is suspended.
7.The residence must have a policy or procedures in place to replace an essential caregiver due to necessary circumstances, including but not limited to, illness or death of the essential caregiver.
8.Assisted living residences shall provide training to essential caregivers that includes, but is not limited, to the following:
a.Infection prevention and control, including proper donning and doffing of PPE, hand hygiene, and mask use;
b.Signs and symptoms of any communicable disease(s) that are associated with the declared disaster emergency;
c.Safety and efficacy of any available vaccination(s) for communicable disease(s) associated with the declared disaster emergency.
2.4.21Accessibility to the Residence and Residents
A.Access to assisted living residences for adults and its residents by individuals other than relatives and friends of the residents shall be pursuant to R.I. Gen. Laws § 23-17.4-11.
2.4.22Illness and Emergencies
A.Each residence shall have written procedures for residents in the event of temporary illness and emergencies which shall include procedures for the evacuation of the premises.
B.Residents shall not be restricted from obtaining community health services at any time or when confined to the residence for a temporary illness.
C.Reporting of Communicable Diseases
1.Each residence shall report promptly to the Center for Acute Infectious Diseases Epidemiology (IDE), cases of communicable diseases designated as "reportable diseases" when such cases are diagnosed in the residence in accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental and Occupational Diseases.
2.When infectious diseases present a potential hazard to residents or personnel, these shall be reported to the Center for Acute Infectious Diseases Epidemiology (IDE) even if not designated as "reportable diseases."
3.When outbreaks of food-borne illness are suspected, such occurrences shall be reported immediately to the Center for Acute Infectious Diseases Epidemiology (IDE) or to the Center for Food Protection.
4.Residences must comply with the provisions of R.I. Gen. Laws § 23-28.36-3, which requires notification of fire fighters, police officers and emergency medical technicians after exposure to infectious diseases.
5.Infection Control
Infection control provisions shall be established for the mutual protection of residents, employees, and the public. The residence shall be responsible for no less than the following:
a.Establishing and maintaining a residence-specific infection prevention program;
b.Establishing policies governing the admission and isolation of residents with known or suspected infectious diseases;
c.Developing, evaluating and revising on a continuing basis infection control policies, procedures and techniques for all appropriate areas of the residence;
d.Developing and implementing protocols for:
(1)Discharge planning to home that include full instructions to the family or caregivers regarding necessary infection control measures; and
(2)Hospital and/or nursing facility transfer of residents with infectious diseases which may present the risk of continuing transmission. Examples of such diseases include, but are not limited to, tuberculosis (TB), Methicillin resistant staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE), and clostridium difficile;
6.Resident Immunization Policies/Practices
Except as provided in § 2.4.21(C)(6)(e) of this Part, every residence in Rhode Island shall request that residents be immunized for influenza virus and pneumococcal disease. Influenza, pneumococcal, and other adult vaccination policies and protocols shall be developed and implemented by the residence and shall contain no less than the following provisions:
a.Notice to Resident. Upon admission, the residence shall notify the resident and legal guardian of the immunization requirements and request that the resident agree to be immunized against influenza virus and pneumococcal disease.
b.Records and Immunizations. Every residence shall document the annual immunization against influenza virus and immunization against pneumococcal disease for each resident which includes written evidence from a health care provider indicating the date and location the vaccine was administered.
c.Other Immunizations. An individual who becomes a resident shall have his status for influenza and pneumococcal immunization determined by the residence, and, if found to be deficient, the residence shall assist the resident in obtaining the necessary immunizations.
d.Vaccinations must be provided in accordance with “General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” incorporated above at § 2.2(C) of this Part.
e.Exceptions. No resident shall be required to receive either the influenza or pneumococcal vaccine if any of the following apply:
(1)The vaccine is contraindicated;
(2)It is against his/her religious beliefs; or
(3)The resident or the resident's legal guardian refuses the vaccine after being fully informed of the health risks of such action.
2.4.23Dietetic Services
A.Residents shall be provided three (3) balanced, varied meals each day (refer to Dietary Reference Intakes: The Essential Guide to Nutrient Requirements incorporated above at § 2.2(A) of this Part).
B.Food shall be served on dinnerware of good quality, such as ceramic, plastic or other materials that are durable.
C.The food service in each residence shall comply with the appropriate requirements of R.I. Gen. Laws Chapters 21-27 and 21-31, Part 50-10-1 of this Title, Rhode Island Food Code, and such other applicable statutory or regulatory provisions.
D.In the event of any construction, addition or alteration, the residence shall comply with the requirements of R.I. Gen. Laws § 23-1-31.
E.Weekly menus shall be posted in each residence and followed accordingly.
F.Residences must provide residents with a diet appropriate to their medical regime.
G.All food services shall be conducted in accordance with Part 50-10-2 of this Title, Certification of Managers in Food Safety that include but are not limited to the following provisions:
1.Each residence where potentially hazardous foods are prepared shall employ at least one (1) full-time, on-site manager certified in food safety who is at least eighteen (18) years of age.
2.Residences that primarily serve the elderly and individuals with diminished immune systems shall have a manager certified in food safety present during preparation of all hot potentially hazardous foods.
3.Residences that have a licensed capacity of twenty-six (26) or more residents and that employ ten (10) or more full-time equivalent employees directly involved in food preparation shall employ at least two (2) full time, on-site managers certified in food safety.
4.Residences that have a licensed capacity of twenty-five (25) or fewer residents and that employ five (5) or fewer full-time equivalent employees involved in preparation and serving of food, shall only be required to employ one (1) full time manager certified in food safety.
5.Once a manager certified in food safety terminates employment, establishments shall have sixty (60) days to employ a new manager certified in food safety, or have an individual enrolled in a Center for Food Protection approved food manager certification program in food safety. However, said time period may be extended by the Center for Food Protection.
a.Residences that have a licensed capacity of twenty-five (25) or fewer residents and that employ five (5) or fewer full-time equivalent employees involved in preparation and serving of food shall only have fifteen (15) days to employ a new manager certified in food safety. However, said time period may be extended by the Center for Food Protection.
6.Department certificates for managers certified in food safety shall be prominently posted in the residence next to the license to operate. The certificate shall be removed when the individual is no longer employed by the residence.
7.No person shall use the title "Manager Certified in Food Safety," or in any way represent himself as a manager certified in food safety unless they hold a current certificate pursuant Part 50-10-2 of this Title, Certification of Managers in Food Safety.
H.All menus including alternate choices shall be planned at least one (1) week in advance, to meet the standards for nutritional care in accordance with Dietary Reference Intakes: The Essential Guide to Nutrient Requirements, incorporated above at § 2.2(A) of this Part, and to provide for a variety of foods, adjusted for seasonal changes, and reflecting the dietary preferences of residents.
1.Menus shall indicate nourishments available to residents between evening meal and bedtime.
2.Menus shall be posted in a conspicuous place in the dietary department and in resident areas.
3.Records of menus actually served shall be retained for thirty (30) days.
2.4.24Housekeeping
A.The residence shall maintain a comfortable, safe, clean, sanitary and orderly environment, free of litter, rubbish and offensive odors.
2.4.25Laundry Services
A.Each residence shall make provisions for the cleaning of personal laundry of residents and all linens and other washable goods either directly or through other suitable arrangement.
2.4.26Medication Services
A.Medication Services
1.For M1 and M2 licensure levels, each resident shall have the right to:
a.Retain the services of his/her own personal physician and dentist;
b.Select the pharmacy or pharmacist of his/her choice provided that the pharmacy or pharmacist supplies medications suitably packaged for the residence's program;
c.Refuse any or all medications;
d.Retain possession and control of his/her medications, provided that such possession and control is deemed safe by the resident, the resident's guardian, if appropriate, and the administrator or his/her designee in consultation with the resident's physician(s).
2.For M1 and M2 licensure levels, the residence shall have the right:
a.To inform family, guardian, physician, or other party designated by the resident or guardian if a resident has refused medication(s).
b.Not to accept, and/or to evict a resident who refuses assistance with medications if the residence reasonably feels that the resident cannot safely possess and control medications without danger to self or others, in accordance with the requirements of the Resident’s Rights statement.
3.Each residence shall provide medication services only in accordance with the appropriate level of licensure for which the residence is licensed, which shall be as follows:
a.For assisted living residences licensed at the M2 Level, assistance with self- administration by unlicensed employees means that the residence shall only be responsible for reminding residents to take medications, and:
(1)The resident or guardian must provide written authorization for the residence to provide assistance with the self-administration of medications;
(2)The residence must provide, in writing, a description of services provided by the residence to each physician prescribing for a resident, including limitations on services;
(3)Employees may only remind the resident and observe the self-administration of medication;
(4)The resident shall not require nursing assessment of health status before receiving the medication, nor nursing assessment of the therapeutic or side effects after the medication is taken;
(5)Except as provided in § 2.4.25(A)(3)(a)(7) of this Part, the medication shall be in the original pharmacy-dispensed container with proper label and directions attached;
(6)Unlicensed employees shall not monitor health indicators, make medication decisions, adjust medications or provide other medical or nursing decisions;
(7)For residents capable of self-administration of medication but who wish to ask assisted living residence employees to use a medi-set (pre-poured packaging distribution system), only registered medication aide, licensed nurse, or pharmacist shall organize the medications for up to one (1) week;
(8)All medication in the residence, regardless of whether controlled by employees or by the resident, shall be stored securely. All medications shall be stored in a manner to prevent spoilage, dosage errors, administration errors or inappropriate access by other residents, visitors, or unauthorized employees. Provisions for safe storage may include lockable containers, secure spaces, or lockable units, as appropriate to the residence and the resident population.
(9)There shall be documented policies or procedures regarding medication disposal and inventory procedures in the policies and procedures manual.
(10)Each person assisting residents with self-administration of medications shall:
(AA)Be an employee of the residence;
(BB)Be literate in English; and
(CC)Receive orientation, instruction and on-the-job training regarding relevant policies and procedures; or
(DD)Be a licensed nurse.
(EE)M2 level facilities may limit record keeping for residents who retain possession and control of medications to the requirements of § 2.4.15(A)(6) of this Part.
b.For assisted living residences licensed at the M1 level, licensed employees (registered medication aides, registered nurses, licensed practical nurses) may administer oral or topical drugs and monitor health indicators. However, schedule II medications shall only be administered by licensed personnel. The physician or nurse supervisor shall conduct and document quarterly evaluations of the registered medication aides who are administering drugs and place a copy in the employee's personnel record.
c.For the first three (3) months of employment, a licensed nurse designated by the health care facility, adult day care program, or assisted living residence, as appropriate, shall conduct and document monthly evaluations (in accordance with the evaluation checklist on the Department website) of a medication aide who administers medication. After the first three (3) months, the evaluation shall be conducted no less than quarterly. Copies of said evaluations shall be placed in the medication aides’ personnel records.
B.Administration of Medications
1.Residences licensed at the M1 level may administer medications to residents including, but not limited to, removing medication containers from storage, assisting with the removal of a medication from a container for residents with disability which prevents independence in this act, and/or administering the medication directly to the resident.
a.The resident or guardian must provide written authorization for the residence to provide administration of medications.
b.Medications shall be administered in accordance with written orders of a physician. The residence must provide in writing, a description of services provided by the residence to each physician, including limitations on service.
c.All medications must be checked against a physician's orders by a licensed nurse, or pharmacist.
d.The resident must be identified prior to administration of any medication.
e.The medication must be in the original pharmacy-dispensed container with proper label and directions attached and be administered in accordance with such label.
f.Injectable medications, including but not limited to insulin, which cannot be self-administered by the resident, must be administered by a licensed nurse.
g.There shall be written a policy/procedure for the disposal of hypodermic needles, syringes and other such instruments that is in compliance with Part 20-15-6 of this Title, Hypodermic Needles, Syringes, and Other Such Instruments.
(1)The legal destruction of hypodermic needles, syringes or other such instruments is the responsibility of the last entitled or authorized possessor.
(AA)All personnel or residents legally authorized to use disposal syringes and needles, shall destroy them after one (1) use.
(BB)Excess and undesired needles, syringes and other such instruments shall be stored in impervious, rigid, puncture-resistant container for disposal. Intact needles shall be placed directly into the collection containers.
(CC)Personnel handling disposal waste materials such as needles, syringes, and other such instruments may treat and destroy such waste by a DEM-approved alternative treatment/destruction technology or prepare the regulated medical waste for off-site transport by a DEM-permitted medical waste transporter.
h.Individual medication records must be retained for each resident to whom medications are being administered and each dose administered to the resident must be properly recorded.
i.Any medication administered by the residence and refused by a resident shall be documented and reported, as appropriate.
j.Medications shall be stored securely and in such a manner to prevent spoilage, dosage errors, administration errors, and/or inappropriate access. Provisions for safe storage may include lockable containers, secure spaces, or lockable units, as appropriate to the residence and the resident population.
k.All medication in the residence, regardless of whether controlled by employees or by the resident, shall be stored securely as stated in § 2.4.25(A)(3)(a)(8) of this Part.
l.All centrally stored medications shall be maintained in accordance with manufacturer’s labeling and administered by authorized personnel.
2.For M1 and M2 licensure levels, unused or discontinued prescription medications that are left with a residence shall be inventoried and disposed of in accordance with the following requirements:
a.Disposal of Controlled Substances
(1)M1 residences that are lawfully in possession of excess and undesired controlled substances that are centrally stored shall inventory and dispose of all such controlled substances in accordance with all applicable Federal, State, and local laws and Regulations.
(2)Only centrally stored medications in M1 residences may be disposed of in the following manner:
(AA)The residence’s registered nurse and either another registered nurse, a licensed practical nurse, or the residence’s administrator may carry out flushing destruction activity, and appropriate records shall be maintained at the residence for two (2) years, as permitted by State and local laws and Regulations. The Director is authorized to enter any premises and inspect any and all aspects of the disposal process and related records.
b.Disposal of All Other Legend Drugs (i.e., Non-Controlled Substances)
(1)All other legend drugs (i.e., those not classified as controlled substances) shall be the responsibility of the resident or authorized personnel to dispose of as provided in Part 20-20-1 of this Title, Disposal of Drugs:
(AA)Legend drugs may be disposed of as solid waste provided that all of the following conditions are met:
(i)The legend drugs are rendered unrecognizable;
(ii)The legend drug would not pose a threat to the public or to the environment; and
(iii)The legend drugs cannot be recycled; or
(BB)The legend drugs may be disposed of as regulated medical waste through the use of an entity holding a regulated medical waste transporter permit issued pursuant to the requirements and in compliance with 250-RICR-140-15-1, Medical Waste Regulations.
3.Ordering medications
a.In M1 and M2 facilities, when assistance is needed, the certified administrator, or his/her qualified designee, shall assist with ordering medications. Assistance shall include coordinating prescriptions and delivery of medications, reorders of prescriptions, and receiving deliveries.
2.4.27Recreational and Other Services
A.Reasonable recreational and social activities and/or services shall be offered to each resident to:
1.Promote opportunities for engaging in normal pursuits including religious activities of the resident's choice;
2.Promote the physical, social and mental well-being of each resident;
3.Promote independent as well as group activities;
4.Harmonize with each resident's needs.
B.The residence shall post a calendar or schedule of social and recreational events offered to the residents and shall keep a record of the events that were actually presented to the residents. Said calendars and records shall be retained for at least one (1) year by the residence.
C.Personal assistance shall be provided as necessary, pursuant to the provisions of § 2.3(A)(31) of this Part and shall consist of activities such as bathing, oral hygiene, fingernail care, shampooing, shaving, dressing or assistance with ambulation or nutrition and hydration.
2.4.28New Construction, Modification, Additions, or Room Conversions
A.All new construction, modification, additions, or room conversions of an existing residence shall be subject to the provisions of Fire Safety Code – General Provisions (R.I. Gen. Laws Chapter 23-28.1), State Building Code (R.I. Gen. Laws Chapter 23-27.3), ANSI A117.1 – 2009 Accessible and Usable Buildings and Facilities (incorporated above at § 2.2(B) of this Part), Americans with Disabilities Act (42 U.S.C. §§ 12101 through 12213), and such other applicable State and local laws, codes and Regulations as may be applicable. Where there is a difference between codes, the code having the more stringent or higher standard shall apply.
2.4.29General Provisions
A.Fire Code and Structural Requirements
1.Existing facilities shall be constructed, equipped and maintained to protect the safety and well-being of residents, and shall provide a comfortable, sanitary environment, and shall furthermore comply with the applicable requirements of the Fire Safety Code – General Provisions (R.I. Gen. Laws Chapter 23-28.1), as determined by the State Fire Marshal and the Regulations.
a.Pursuant to R.I. Gen. Laws § 23-17.4-6, a residence with Fire Code deficiencies may be granted a license which may be renewed subject to the submission of a plan of correction acceptable to the State Fire Marshal and provided the nature of the deficiencies are such that they do not jeopardize the health, safety, and welfare of the residents.
b.A residence with residents who are blind, deaf, and physically disabled shall be subject to the applicable requirements of ANSI A117.1 – 2009 Accessible and Usable Buildings and Facilities (incorporated above at § 2.2(B) of this Part), and any other provisions that may be required by these Regulations.
c.Resident occupancy shall be permitted only in those areas where building design or structural limitations do not prevent, delay or reduce a resident from exercising self-preservation in an emergency.
d.A residence that elects to comply with a higher Life Safety Code (F1) and is so approved by the State Fire Marshal and meets the Department's requirements for the appropriate level of licensure may admit residents not capable of self-preservation.
e.Facilities must have an annual inspection to assess compliance with the Fire Safety Code. The inspection shall be conducted under the authority of the State Fire Marshal.
(1)Documentation of the State Fire Marshal inspection required under § 2.4.28(A)(1)(e) of this Part must be submitted with the application for renewal of licensure. The documentation must reflect compliance with the Fire Safety Code or be in accordance with § 2.4.28 (A)(1)(a) of this Part.
B.Assisted living residences shall not be utilized for any other purposes, unless such purposes are compatible with the objectives and the nature of an assisted living residence and are approved by the Department.
C.All rooms utilized by resident(s) shall have proper ventilation and shall have an outside opening with satisfactory screening.
D.All steps, stairs and corridors shall be suitably lighted, both day and night. Stairs used by residents shall have banisters, hand rails or other types of support. All stair treads shall be well maintained to prevent hazards.
E.Requirements for heat relief are pursuant to R.I. Gen. Laws § 23-17.4-16.4.
2.4.30Residents Rooms, Toilets and Bathing Fixtures
A.The bedroom of residents shall be designed and equipped with suitable furnishings for the safety, comfort and privacy of each resident and with no more than two (2) beds per room.
1.Single rooms shall be no less than one hundred (100) square feet in area and no less than eight feet (8’) wide, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules.
2.Double bedrooms shall be no less than one hundred sixty (160) square feet in area and no less than ten feet (10’) wide, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules.
B.Provisions shall be made for an area within the resident's bedroom and/or residence to be under lock for the safe keeping of personal possessions.
C.Each bedroom shall have a window which can be easily opened. The window sill shall not be higher than three feet (3’) above the floor and shall be above ground level.
D.Comfortable temperature levels shall be maintained in all parts of the residence occupied by residents with a centralized heating system to maintain a minimum of seventy degrees Fahrenheit (70° F) during the coldest periods.
E.There shall be no less than one (1) bath per ten (10) beds and one (1) toilet per eight (8) beds or fraction thereof on each floor where residents rooms are located and which are not otherwise serviced by bathing facilities within the resident's room.
1.Policies and procedures shall be in place to ensure resident comfort and safety regarding water temperature at each site in the residence where residents shower or bathe. Provided, however, such policies/procedures shall state that in resident areas hot water temperatures shall not be less than one hundred degrees Fahrenheit (100° F) nor exceed one hundred eighteen degrees Fahrenheit (118° F). Thermometers shall be provided in resident areas to check water temperature periodically at each site where residents bathe or shower.
2.4.31Dining and Living Areas
A.Each residence shall provide one (1) or more clear, orderly and appropriately furnished and easily accessible room of adequate size to include all residents for resident dining and activity, which shall be appropriately lighted.
1.If a multi-purpose room is used, there must be sufficient space to accommodate all residents for dining and activities and to prevent interference between activities.
2.4.32Safety Requirements
A.Halls and exit ways shall be free from all encumbrances and/or impediments.
B.All locks on bedrooms shall be operable by a master key, under the control of the person in charge in accordance with §§ 2.4.12(B) and (C) of this Part.
C.Every closet door latch shall be a type that cannot be locked from the inside.
D.Every bathroom door shall be designed to permit the opening of the locked door from outside in an emergency.
E.There shall be no portable cooking equipment (employing flame, gasoline, kerosene or exposed electrical heating elements) used in residents' rooms.
F.Portable space heaters shall not be permitted.
G.Proper safeguards shall be taken at all times against the fire hazards involved in smoking.
H.A telephone shall be easily accessible to residents in the event of emergencies. (Pay phones shall not be acceptable substitutes). The telephone number of the local fire department and law enforcement agencies serving the residence shall be posted by each telephone.
I.Each residence shall develop and maintain a written plan and procedure for the evacuation of the premises in case of fire or other emergency, based on F1/F2 licensure requirements, Fire Safety Code – General Provisions (R.I. Gen. Laws Chapter 23-28.1) requirements.
1.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the residence.
2.Drills simulating fire emergencies, testing the effectiveness of the fire evacuation plan shall be conducted at least six (6) times per year on a bimonthly basis with a minimum of two (2) drills conducted during the night when residents are sleeping with documentation of observed ability of residents to carry out evacuation procedures. At least fifty percent (50%) of these drills shall be obstructed drills, as defined in Fire Safety Code – General Provisions (R.I. Gen. Laws Chapter 23-28.1).
3.The drills shall be permitted to be announced in advance to the residents. The drills shall involve the actual evacuation of all residents to an assembly point as specified in the emergency plan and shall provide residents with experience in egressing through all exits and means of escape required by the Fire Safety Code – General Provisions (R.I. Gen. Laws Chapter 23-28.1). Exits and means of escape not used in any fire drill shall not be credited in meeting the requirements of the Fire Safety Code – General Provisions (R.I. Gen. Laws Chapter 23-28.1).
a.Documentation of fire drills shall be maintained and shall include no less than the following information:
(1)Name of the person conducting the drill;
(2)Date and time of the drill;
(3)Amount of time taken to evacuate the building or unit;
(4)Type of drill (i.e., obstructed or unobstructed);
(5)Record of problems encountered and steps taken to rectify them;
(6)Employee observation of each resident’s ability to carry out evacuation procedures.
4.Residents shall be instructed in all alternative methods of escape since the primary exit may be unusable due to fire and/or smoke. Such instruction shall be documented in the record described in § 2.4.31(I)(3)(a) of this Part.
5.Each new resident shall be oriented to the fire drill procedure on admission, with documentation of the orientation placed in the resident’s record.
J.Appropriate fire extinguishers shall be installed on each occupied level and maintained in a usable condition, inspected at specified intervals as stipulated by manufacturers and the State Fire Marshal.
K.Each residence shall develop written emergency plans related to internal and external disasters.
L.Disaster Preparedness
1.Each residence shall develop back-up or contingency plans to address possible internal systems and/or equipment failures.
2.4.33COVID-19 Practices and Procedures
A.Assisted Living Residents
1.Upon the identification of residents who test positive for COVID19, the residence shall take proper actions to prevent the transmission of COVID19 in accordance with Department guidance.
2.Assisted living residences shall have policies and procedures in place for addressing residents who refuse testing or unable to be tested.
3.The assisted living residence shall document all COVID19 testing, which documentation shall include at minimum the individual's name, date of test, and test result.
B.Assisted Living Personnel
1.For the purposes of § 2.4.32 of this Part, "personnel" means employees, as well as volunteers, students, trainees, and any individuals, whether paid or unpaid, directly employed by or under contract with the assisted living residence on a part time or fulltime basis.
2.Upon the identification of personnel who test positive for COVID19, the residence shall take proper actions to prevent the transmission of COVID19.
3.The assisted living residence shall develop and implement policies and procedures for ongoing tracking of personnel who are employed outside of the assisted living residence. Tracking shall include the name and location of the establishment and any other pertinent information.
2.4.34Variance Procedure
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any Rule or Regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of residents.
B.A request for a variance shall be filed by a high managerial agent of the assisted living residence in writing, and must set forth in detail the basis upon which the request is made including:
1.Identification of the specific regulatory section(s) herein;
2.Alternative actions, processes, or procedures that through the facility’s implementation will facilitate compliance with the specific regulatory intent, and how the Residence will ensure staff awareness and training regarding the variance, when appropriate.
3.A variance period shall not exceed the assisted living residence’s license period. An assisted living residence must request renewal of the variance when it submits its annual license renewal application.
4.Upon the filing of each request for variance with the Department, and within a reasonable time thereafter, the Department shall notify the applicant of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the residence appeals the denial and held in accordance with the provisions of § 2.4.35 of this Part.
C.Variances may be granted as follows (to be submitted on a RIDOH form):
1.Residents with in-dwelling Foley catheters will be granted a six (6) month variance and the resident may remain in the residence as long as there are no signs or symptoms of infection; and the residence assumes responsibility for ensuring that the required care is received.
2.Residents with chronic, non-pressure related ulcers, such as venous stasis ulcers, may remain in the residence as long as there are no signs or symptoms of infection; and the residence assumes responsibility for ensuring that the required care is received.
3.Hospice variances are granted on a six (6) month basis.
2.4.35Deficiencies and Plans of Correction
A.The Department shall notify the licensee and the residence's administrator or other legal authority of the residence of violations of individual standards through a notice of deficiencies which shall be forwarded to the residence within fifteen (15) days of inspection of the residence unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A licensee, or their designee, who receives a notice of deficient practices must submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficient practices. The plan of correction shall detail any requests for variances as well as document the reasons therefor.
1.An acceptable plan of correction shall include, for each individual standard cited:
a.How the licensee or their designee intends to correct each deficiency and comply with the stated regulation;
b.What measures will be put in place, or what systemic changes will be made to ensure that the deficient practice does not reoccur; and
c.The date the deficiency shall be corrected.
2.The criteria for acceptability shall be whether the submitted plan shall achieve compliance with the Act and these Regulations.
3.The plan of correction shall detail any requests for variances in accordance with § 2.4.33 of this Part.
C.The Department will be required to accept or reject the plan of correction submitted by a residence in accordance with §§ 2.4.33(B)(1) and (2) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the Department rejects the plan of correction, or if the residence does not provide a plan of correction within the fifteen (15) day period stipulated in § 2.4.33(B) of this Part, or if a residence whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 2.4.11 of this Part. If the residence is aggrieved by the sanctions of the Department, the residence may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing shall in all respects comply therein.
2.4.36Rules Governing Practices and Procedures
A.All hearings and reviews required by these Regulations shall be held in accordance with the provisions of R.I. Gen. Laws Chapter 42-35 and Part 10-05-4 of this Title, Practices and Procedures Before the Rhode Island Department of Health.
2.4.37Violations and Sanctions
A.Any person establishing, conducting, managing or operating an assisted living residence without a license pursuant to the provisions of the Act and these Regulations shall be liable for the penalty contained in R.I. Gen. Laws § 23-17.4-14.
B.Any person who obtains access to an assisted living residence or to its residents under false representation shall be subject to the provisions of R.I. Gen. Laws § 23-17.4-12.
C.The penalty for violation of R.I. Gen. Laws § 23-17.4-10 shall be in accordance with R.I. Gen. Laws § 23-17.4-10.2.
**History**
- *Amendment — effective from 2024-03-18 to current*
- *Amendment — effective from 2022-08-25 to 03/18/2024*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2020-12-23 to 04/29/2021*
- *Amendment — effective from 2018-04-30 to 07/03/2022*
- *Amendment — effective from 2015-06-01 to 04/30/2018*
- *Amendment — effective from 2012-12-10 to 06/01/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-16 to 10/18/2007*
- *Amendment — effective from 2002-08-14 to 02/16/2004*
- *EMERGENCY RULE Adoption — effective from 2002-07-12 to 08/14/2002*
- *EMERGENCY RULE Adoption — effective from 2002-03-15 to 07/12/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/15/2002*
##### **216-RICR-40-10-2 § 2.5** Alzheimer Dementia Special Care Unit/Program License Requirements {#sec-216-ricr-40-10-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-2#2.5}
2.5.1Applicability
A.Any assisted living residence that offers to provide or provides services to residents with Alzheimer disease or other dementia by means of an Alzheimer Dementia/Special Care Unit/Program shall be required to meet all requirements of §§ 2.4 and 2.5 of this Part.
2.5.2Specific Requirements
A.A residence licensed at the "dementia care" level shall be licensed as an "F1 – M1" residence in accordance with the requirements of § 2.4.10(B) of this Part; and
B.Any assisted living residence which offers to provide or provides services to residents with Alzheimer disease or other dementia by means of an Alzheimer Dementia Special Care Unit/Program shall be required to disclose in writing the type of services provided.
C.The disclosure shall be made to the Department and to any person seeking placement in an Alzheimer Dementia Special Care Unit/Program of an assisted living residence.
D.The information disclosed shall explain the additional care that is provided in each of the following areas:
1.Philosophy: The Alzheimer Dementia Special Care Unit's/Program’s written statement of its overall philosophy and mission which reflects the needs of residents afflicted with dementia;
2.Pre-Occupancy, Occupancy, and Termination of Residence: The process and criteria for occupancy, transfer or termination of residency from the unit;
3.Assessment, Service Planning & Implementation: The process used for assessment and establishing the plan of service and its implementation, including the method by which the plan of service evolves and is responsive to changes in condition;
4.Staffing Patterns & Training Ratios: Staff training and continuing education practices;
5.Physical Environment: The physical environment and design features appropriate to support the functioning of cognitively impaired adult residents;
6.Resident Activities: The frequency and types of resident activities;
7.Family Role in Providing Support and Services: The involvement in families and family support programs;
8.Program Costs: The cost of care and any additional fees, and the process used in the event that a resident can no longer afford the cost of care being provided.
E.The Department shall develop a standard disclosure form and shall review the information provided on the disclosure form by the assisted living residence to verify the accuracy of the information reported on it. Any significant changes in the information provided by the assisted living residence shall be reported to the Department at the time the changes are made.
F.Any residence that provides care for residents with Alzheimer disease or other dementia by means of an Alzheimer Dementia Special Care Unit/Program shall maintain written policies and procedures that detail specific services, including admission and discharge criteria, for residents and/or their responsible parties on the Unit/Program.
G.The Alzheimer Dementia Special Care Unit/Program shall operate and provide services to all residents of the unit/program in accordance with the prevailing community standard of care for residents with the particular needs and behaviors with dementia.
H.Staff assigned to provide direct care services to residents of the Alzheimer Dementia Special Care Unit/Program shall be a qualified licensed assisted living staff member as defined in § 2.3(A)(33) of this Part. Notwithstanding this requirement, staff hired before January 1, 2015, that are not qualified licensed assisted living staff members, may continue to provide direct care services to residents residing in existing Alzheimer Dementia Special Care Unit/Programs.
I.The Alzheimer Dementia Special Care Unit/Program shall have on staff, at a minimum, a registered nurse(s) with appropriate training and/or experience with dementia to manage and supervise all resident dementia-related health and behavioral issues. The nurse shall be on-site full-time (minimum of thirty-five (35) hours per week), and shall be available for consultation at all times.
J.Menus for the Alzheimer Dementia Special Care Unit/Program shall be developed under the direction of a nutritionist or registered dietician licensed by the Department.
K.All menus including alternate choices shall be planned at least one (1) week in advance, to meet the standards for nutritional care in accordance with Dietary Reference Intakes: The Essential Guide to Nutrient Requirements, incorporated above at § 2.2(A) of this Part, and to provide for a variety of foods, adjusted for seasonal changes, and reflecting the dietary preferences of residents.
1.Menus shall indicate nourishments available to residents between evening meal and bedtime.
2.Menus shall be posted in a conspicuous place in the dietary department and in resident areas.
3.Records of menus actually served shall be retained for thirty (30) days.
L.The Alzheimer Dementia Special Care Unit/Program shall provide a secure distinct living environment appropriate for the resident population. This requirement may include, but not be limited to, a locked unit, secured perimeter, or other mechanism to ensure resident safety and quality of life. The residence shall have elopement policies in place, specific to the Unit/Program.
M.Upon completion of the disclosures required pursuant to this section, a person who does not otherwise meet the requirements for the special care unit or program may choose to reside in the unit or area in accordance with § 23-17.4-16.
N.Staff Training – Dementia Care Level
1.The administrator shall ensure that all new employees who will assist residents with personal care at the dementia level of care receive at least four (4) hours of orientation and training in the areas listed below prior to beginning work alone in the assisted living residence, in addition to the areas stipulated in § 2.4.12(G) of this Part. Staff will be provided no less than twelve (12) hours of continued education in the following areas at intervals not to exceed twelve (12) months.
a.Understanding various dementias;
b.Communicating effectively with dementia residents;
c.Managing behaviors;
d.Elopement procedures for the Unit/Program;
e.Creating a safe environment for residents;
f.Medications commonly prescribed for resident residing in the unit/program and potential side effects.
2.5.3Emergency Power
A.The residence shall provide an emergency source of electrical power necessary to protect the health and safety of residents in the event the normal electrical supply is interrupted.
1.Such emergency power system shall supply power adequate at least for:
a.Lighting all means of egress; and
b.Equipment to maintain detection, alarm and extinguishing systems.
**History**
- *Amendment — effective from 2024-03-18 to current*
- *Amendment — effective from 2022-08-25 to 03/18/2024*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2020-12-23 to 04/29/2021*
- *Amendment — effective from 2018-04-30 to 07/03/2022*
- *Amendment — effective from 2015-06-01 to 04/30/2018*
- *Amendment — effective from 2012-12-10 to 06/01/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-16 to 10/18/2007*
- *Amendment — effective from 2002-08-14 to 02/16/2004*
- *EMERGENCY RULE Adoption — effective from 2002-07-12 to 08/14/2002*
- *EMERGENCY RULE Adoption — effective from 2002-03-15 to 07/12/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/15/2002*
##### **216-RICR-40-10-2 § 2.6** Limited Health Services License Requirements {#sec-216-ricr-40-10-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-2#2.6}
2.6.1Applicability
A.Any assisted living residence that offers to provide or provides limited health services to residents shall be required to meet all requirements of §§ 2.4 and 2.6 of this Part.
2.6.2Specific Requirements
A.All limited health services provided by a licensed assisted living residence shall be ordered by the resident’s physician, and provided by qualified licensed assisted living staff members.
B.Assisted living residences licensed to provide limited health services may provide any or all of the following services:
1.Stage I and stage II pressure ulcer treatment and prevention;
2.Simple wound care including postoperative suture care/removal and stasis ulcer care;
3.Ostomy care including appliance changes for residents with established stomas;
4.Urinary catheter care.
C.An assisted living residence licensed to provide limited health services and offers to provide services to residents receiving hospice services that are bed-bound or in need of assistance from more than one (1) staff person for ambulation is required to be licensed at the F1 licensure level as defined in § 2.4.2(A)(1)(a) of this Part.
D.When it is identified that a resident requires a limited health services as defined in § 2.6.2(B) of this Part, the residence must inform the resident in writing of his/her right to access a licensed home nursing care agency or hospice provider for the services needed.
E.Assisted living residences licensed to provide limited health services are required to disclose in writing all services offered.
F.The disclosure shall be made to the licensing agency and to any person seeking placement in an assisted living residence licensed to provide limited health services.
G.The information disclosed shall explain the care that is provided in each of the following areas:
1.Philosophy: Written statement of its overall philosophy and mission which reflects how the assisted living provides limited health services;
2.Pre-Occupancy, Occupancy, and Termination of Residence: The process and criteria for occupancy, transfer or termination of residency;
3.Assessment, Service Planning and Implementation: The process used for assessment and establishing the plan of services and its implementation, including the method by which the plan of services evolves and is responsive to changes in condition;
4.Family Role in Providing Support and Services: The involvement with families and family support programs;
5.Program Costs: The cost of care and any additional fees and the process used in the event that a resident can no longer afford the cost of care being provided.
H.Any significant changes in the disclosure information provided by the assisted living residence shall be reported to the Department at the time the changes are made.
I.An assisted living residence that determines to cease offering a limited health service(s) shall notify, in writing, the Department, all residents, their guardian, or relative so appointed or elected to be his/her decision maker, every resident’s physician and to the Office of the Long-Term Care Ombudsman of its intent thirty (30) days or more before ceasing to offer a limited health service.
1.The written notification shall include, but is not limited to the following:
a.Letter of intent and/or determining factors/justification for stopping the service(s);
b.Proposed date that services would be discontinued;
c.Plan for ensuring that residents continue to receive services until other acceptable arrangements are made; and
d.Contact information of staff member responsible for implementing plan.
J.Based upon approval by the Department, an assisted living residence that that does not provide all limited health services, as defined in § 2.6.2(B) of this Part, may add additional service(s) under its license one (1) time per annual licensing period.
K.Assisted living residences licensed to provide limited health services are required to develop and maintain written policies and procedures that detail the services offered, including:
1.Admission and discharge criteria for residents requiring limited health services;
2.Stage I and stage II pressure ulcer treatment and prevention;
3.Simple wound care including postoperative suture care/removal and stasis ulcer care;
4.Ostomy care including appliance changes for residents with established stomas;
5.Urinary catheter care;
6.Chronic, non-pressure related ulcers, such as venous stasis ulcers;
7.In-dwelling Foley catheters;
8.If applicable, coordination of hospice services for residents who are bed-bound or in need of assistance from more than one (1) staff person for ambulation.
L.All written policies and procedures for limited health services shall be developed under the direction of a licensed physician which shall be reviewed and approved at intervals not to exceed twelve (12) months.
M.Assisted living residences licensed to provide limited health services are required to have a licensed physician, a certified nurse practitioner or a licensed physician assistant as a member of the Quality Improvement Committee as defined in § 2.4.3 of this Part.
N.All limited health services shall be delivered in accordance with the prevailing community standard of care.
O.Evidence of Pre-employment and Ongoing Health Screening
1.Upon hire and prior to delivering services, employment health screenings shall be required for each individual who has or may have direct contact with a resident receiving limited health services. Such health screening shall be conducted in accordance with Part 20-15-7 of this Title, Immunization, Testing, and Health Screening for Health Care Workers.
P.All staff providing direct care services to residents receiving limited health services and/or hospice services for residents who are bed-bound or in need of assistance from more than one (1) staff person for ambulation shall be qualified licensed assisted living staff members and may only perform duties and services as permitted by their respective license and/or certificate of registration.
Q.Assisted living residences licensed to provide limited health services are required to have on staff, at a minimum, a registered nurse(s). The nurse shall be on-site full-time (minimum of thirty-five (35) hours per week), and shall be available for consultation at all times.
R.Staff Training – Limited Health Services. All employees, including those who will assist residents with personal care must receive at least four (4) hours of orientation and training in the areas listed below prior to beginning work alone with a resident receiving limited health services. Staff will be provided no less than two (2) hours of continued education in the following areas at intervals not to exceed twelve (12) months.
1.Pressure ulcer treatment and prevention;
2.Simple wound care including postoperative suture care/removal and stasis ulcer care;
3.Ostomy care including appliance changes for residents with established stomas;
4.Urinary catheter care;
5.In-dwelling Foley catheters;
6.Reporting changes in condition;
7.Signs and symptoms of infection(s); and
8.Signs and symptoms of dehydration.
2.6.3Emergency Power
A.The residence shall provide an emergency source of electrical power necessary to protect the health and safety of residents in the event the normal electrical supply is interrupted.
1.Such emergency power system shall supply power adequate at least for:
a.Lighting all means of egress; and
b.Equipment to maintain detection, alarm and extinguishing systems.
**History**
- *Amendment — effective from 2024-03-18 to current*
- *Amendment — effective from 2022-08-25 to 03/18/2024*
- *Amendment — effective from 2022-07-03 to 08/25/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-31 to 02/27/2022*
- *EMERGENCY RULE Amendment — effective from 2021-08-20 to 08/31/2021*
- *EMERGENCY RULE Amendment — effective from 2021-07-10 to 08/20/2021*
- *EMERGENCY RULE Amendment — effective from 2021-04-29 to 07/10/2021*
- *EMERGENCY RULE Amendment — effective from 2020-12-23 to 04/29/2021*
- *Amendment — effective from 2018-04-30 to 07/03/2022*
- *Amendment — effective from 2015-06-01 to 04/30/2018*
- *Amendment — effective from 2012-12-10 to 06/01/2015*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2004-02-16 to 10/18/2007*
- *Amendment — effective from 2002-08-14 to 02/16/2004*
- *EMERGENCY RULE Adoption — effective from 2002-07-12 to 08/14/2002*
- *EMERGENCY RULE Adoption — effective from 2002-03-15 to 07/12/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/15/2002*
#### **216-RICR-40-10-3** Organized Ambulatory Care Facilities
##### **216-RICR-40-10-3 § 3.1** Authority {#sec-216-ricr-40-10-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17-10, and are established for the purpose of adopting minimum requirement for the licensure of organized ambulatory care facilities in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.2** Incorporated Materials {#sec-216-ricr-40-10-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.2}
A.These regulations hereby adopt and incorporate the Facility Guidelines Institute’s "Guidelines for Design and Construction of Hospital and Outpatient Facilities" (2014) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the U.S. Department of Health & Human Services, Office of Minority Health’s “National Standards on Culturally and Linguistically Appropriate Services (CLAS)” (2013) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.3** Definitions {#sec-216-ricr-40-10-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-17, entitled "Licensing of Health Care Facilities."
2."Ambulatory and urgent health care" means health care services provided to outpatients whose condition does not require emergency medical care as defined herein, by or under the supervision of a physician/dentist licensed in Rhode Island pursuant to R.I. Gen. Laws Chapters 5-37 and 5-31.1 respectively.
3."Change in operator" means a transfer by the governing body or operator of an OACF to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.Hire or fire the chief executive officer of the OACF;
b.Maintain and control the books and records of the OACF;
c.Dispose of assets and incur liabilities on behalf of the OACF; or
d.Adopt and enforce policies regarding operation of the OACF.
e.The definition is not applicable to circumstances wherein the governing body of an OACF retains the immediate authority and jurisdiction over the activities enumerated in §§ 3.3(A)(3)(a) through (d) of this Part.
4."Change in owner" means:
a.In the case of an OACF which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of an OACF which is an unincorporated sole proprietorship, the transfer of the title and property to another person;
c.In the case of an OACF which is a corporation:
(1)A sale, lease, exchange other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations resulting in the creation of a new corporation; or
(4)In the case of an OACF facility which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of an OACF facility which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote is such corporation.
5.“Department” means the Rhode Island Department of Health. The Department is also the “licensing agency” designated pursuant to R.I. Gen. Laws Chapter 23-17.
6."Director" means the Director of the Rhode Island Department of Health.
7."Emergency medical care" means those services provided after the onset of a medical condition that is manifested by symptoms of sufficient severity that, in the absence of immediate medical attention, could reasonably be expected to result in placing health in jeopardy, serious impairment to bodily functions, serious dysfunction of any bodily organ or part, or development or continuance of severe pain.
8."Equity" means non-debt funds contributed towards the capital costs related to an initial licensure or change in owner or change in operator of an OACF which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
9.“Initial licensure” means a review conducted pursuant to the provisions contained in § 3.4.5 of this Part.
10."Institution based, non-public premises" means premises where the OACF provides direct care services solely to individuals who are members of a defined institution as determined by the Director.
11."Organized ambulatory care facility" hereinafter referred to as OACF means a structurally distinct public or private health care establishment, institution or facility, primarily constituted, staffed and equipped to deliver ambulatory and urgent health care services as defined herein, to the general public and known by such terms as central service facility, treatment center, diagnostic center, rehabilitation center (outpatient), infirmary, outpatient clinic or health center which is not a part of a hospital, excluding however, OACFs owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-5.1, (the "Professional Services Corporation Law"), or to a private practitioner's (physician, dentist or other health care provider) office, and/or operated by an individual practitioner, alone or as an member of a partnership, professional service corporation, organization or association), and those health care facilities otherwise licensed by or under the jurisdiction of the Department of Health and/or the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, or other governmental agency.
12."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivisions or instrumentally or the state.
13."Premises" means a tract of land and the buildings thereon where direct patient care services are provided.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.4** Licensing Procedures {#sec-216-ricr-40-10-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.4}
3.4.1General Requirements for Licensure
A.No person or governmental unit acting severally or jointly with any other person or governmental unit shall conduct, maintain or operate or hold itself out as an OACF in Rhode Island without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4, and shall meet the requirements of this Part.
1.Notwithstanding the requirements of § 3.4.1 of this Part, a health care facility licensed as an OACF in Rhode Island, may provide services at other locations (premises) operated by that licensed OACF, without the requirement of a separate OACF license for such other locations.
2.Each premises proposed for addition to an OACF license pursuant to § 3.4.1(A)(1) of this Part shall be approved by the Department prior to the inclusion of that premises on the OACF license and commencement of operations at that location.
B.Each premise of a licensed OACF shall comply with all pertinent provisions of this Part consistent with the scope of services provided at such premise.
C.Any initial licensure or any change in owner, operator, or lessee of a licensed OACF shall require prior review by the Health Services Council and approval of the Department as provided in §§ 3.4.5(A) and (B) of this Part, or for expedited reviews conducted pursuant to §§ 3.4.5(E) and (F) of this Part, as a condition precedent to the transfer, assignment or issuance of a new license.
D.Any OACF that utilizes latex gloves shall do so in accordance with the provisions of rules and regulations pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
E.Each OACF shall establish and maintain a health care facility specific electronic mail address (i.e., e-mail address) to be provided to the Department for the purposes of contacting the OACF with both routine communications and emergency notices. The OACF shall be responsible for providing notice to the Department at any time that the OACF’s specific electronic mail address is changed or updated.
3.4.2Application for License
A.Application for Initial License
1.Application for an initial license to conduct, maintain or operate an OACF shall be made to the Department upon forms provided by it, and shall contain such information as the Department reasonably requires, including but not limited to, evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and this Part.
2.Application to add a premises to an existing OACF license, pursuant to § 3.4.1(A)(1) of this Part, shall be made to the Department upon forms provided by it, and shall contain such information as the Department reasonably requires, including but not limited to, evidence of ability to comply with the provisions of the Act and this Part.
3.Licenses will expire at the end of each calendar year unless a renewal application is completed prior to the expiration date. Renewal applications are completed electronically on the Department web site and will be available for on-line renewal sixty (60) days prior to the expiration date.
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership, or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) by the OACF or any of the property or assets of the OACF. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the OACF is organized as a corporation, and all partners if the OACF is organized as a partnership.
3.4.3Issuance and Renewal of License
A.Upon receipt of an application for a license, the Department shall issue a license of renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and this Part. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection, approval and payment of all fees.
1.All applications for licenses shall be accompanied by a non-refundable, non-returnable fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) provided that not-for-profit entities operating more than one (1) such facility shall be subject to a single annual licensure fee for all such licenses; provided, further, that non-profit charitable community health centers shall be exempt from said fee.
B.A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator, or lessee or to the corporate entity responsible for its governance.
C.At least thirty (30) days prior to voluntary cessation of any OACF license, the Department shall be notified and provided with an acceptable plan for orderly closure, which shall include but is not limited to, notification and transfer of patients, transfer, storage or proper disposal of medical records, and notification of the public.
D.A license shall become void and shall be returned to the Department when the OACF ceases delivering patient care.
3.4.4Application for Initial Licensure or Changes in Owner, Operator, or Lessee
A.Application for review for initial licensure or changes in the owner, operator, or lessee of an OACF shall be made on forms provided by the Department and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 3.4.5(B) of this Part. Three (3) paper copies and one electronic copy (as a single pdf file) of such applications are required to be provided.
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-refundable, non-returnable application fee, as set forth the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
3.4.5Initial Licensure and Change in Owner, Operator, or Lessee Review
A.Except for expedited reviews conducted pursuant to §§ 3.4.5(E) and (F) of this Part, reviews of applications for initial licensure or for changes in the owner, operator, or lessee of licensed OACF's shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure or for a license in connection with a change in the owner, operator or lessee of an existing OACF, the Department will notify and afford the public thirty (30) days to comment on such application.
2.The decision of the Department will be rendered within ninety (90) days from acceptance of the application.
3.The decision of the Department shall be based upon the findings and recommendations of the Health Services Council unless the Department shall afford written justification for variance therefrom.
4.All applications reviewed by the Department and all written materials pertinent to Department review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.
B.Except as otherwise provided in R.I. Gen. Laws Chapter 23-17, a review by the Health Services Council of an application for an initial license or for a license in the case of a proposed change in the owner, operator, or lessee of a licensed OACF may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws Chapter 23-17-3. In conducting reviews of such applications, the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence, and standing in the community of the proposed owners, operators or directors of the OACF as evidenced by:
a.In cases where the proposed owners, operators, or directors of the OACF currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
(3)In providing appropriate access to health care facility services for traditionally underserved populations, which include but are not limited to Medical Assistance beneficiaries and uninsured and underinsured populations;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the OACF.
2.The extent to which the OACF will provide or will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the OACF's services as evidenced by:
a.The immediate and long term financial feasibility of the proposed financing plan:
(1)The proposed amount and sources of owner's equity to be provided by the applicant;
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the OACF;
(3)The relative availability of funds for capital and operating needs;
(4)The applicant's demonstrated financial capability; and
(5)Such other financial indicators as may be requested by the state agency.
3.The extent to which the facility will provide or will continue to provide safe and adequate treatment for individuals receiving the OACF's services and the extent to which the OACF will encourage quality improvement in all aspects of the operation of the OACF as evidenced by:
a.The applicant’s demonstrated record in providing safe and adequate treatment to individuals receiving services at facilities owned, operated, or directed by the applicant; and
b.The credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs.
4.The extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the OACF currently own, operate, or direct a health care facility, or in the past five (5) years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations, which include but are not limited to Medical Assistance beneficiaries and uninsured and underinsured populations, to its health care facilities; and
b.The proposed immediate and long-term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the OACF for traditionally underserved populations, which include but are not limited to Medical Assistance beneficiaries and uninsured and underinsured populations.
5.In consideration of the proposed continuation or termination of primary care and/or other core health care services by the OACF:
a.The effect(s) of such continuation or termination on the provision of access to safe and adequate treatment of individuals, including but not limited traditionally underserved populations.
6.And, in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long-term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
C.Subsequent to reviews conducted under §§ 3.4.5(A), (B), (E), and (F) of this Part, the issuance of a license by the Department may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the review criteria set forth in § 3.4.5(B) of this Part. This shall not limit the authority of the Department to require correction of conditions or defects which existed prior to the proposed change in owner, operator, or lessee and of which notice had been given to the OACF by the Department.
D.A license issued under this Part shall be the property of the State of Rhode Island and loaned to such licensee, and it shall be kept posted in a conspicuous place on the licensed premises.
E.Applicants for initial licensure may, at the sole discretion of the Department, be reviewed under expedited review procedures established in § 3.4.5(F) of this Part if the Department determines:
1.That the legal entity seeking licensure is the licensee for one or more health care facilities licensed in Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 23-17 whose records of compliance with licensure standards and requirements are deemed by the Department to demonstrate the legal entity’s ability and commitment to provide quality health services; and
2.That the licensure application demonstrates complete and satisfactory compliance with the review criteria set forth in § 3.4.5(B) of this Part.
F.Expedited reviews of applications for initial licensure of OACFs shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure the Department will determine if such application will be granted expedited review and the Department will notify the public of the Department’s initial assessment of the application materials with respect to the review criteria in § 3.4.5(B) of this Part as well as the Department’s intent to afford the application expedited review. At the same time the Department will afford the public a twenty (20) day period during which the public may review and comment on the application and the Department’s initial assessment of the application materials and the proposal to afford the application expedited review.
2.Written objections from affected parties directed to the processing under the expedited procedures and/or the satisfaction of the review criteria shall be accepted during the twenty (20) day comment period. Objections must provide clear, substantial and unequivocal rationale as to why the application does not satisfy the review criteria and/or why the application ought not to be processed under the expedited review mechanism. The Department may propose a preliminary report on such application provided such proposed report incorporates findings relative to the review criteria set forth in § 3.4.5(B) of this Part. The Health Services Council may consider such proposed report and may provide its advisory to the Director by adopting such report in amended or unamended form. The Health Services Council, however, is not bound to recommend to the Director that the application be process under the provisions for expedited review as delineated in §§ 3.4.5(E) and (F) of this Part. The Health Services Council shall take under advisement all objections both to the merits of the application and to the proposed expedited processing of the proposed application and shall make a recommendation to the Director regarding each. Should the Health Services Council not recommend to the Director that the application be processed under expedited review procedures as initially proposed, such application may continue to be processed consistent with the time frames and procedures for applications not recommended for expedited review. If expedited review is not granted, then the comment period may be forthwith extended consistent with the time frames in § 3.4.5(A) of this Part for applications not proposed for expedited review. The Director, with the advice of the Health Services Council, shall make the final decision either to grant or to deny expedited review and shall make the final decision to grant or to deny the application on the merits within the expedited review mechanism and time frames. The final decision either to grant or to deny expedited review cannot be appealed.
3.4.6Inspections
A.The Department shall make or cause to be made such inspections and investigations as it deems necessary, including health care records, in accordance with R.I. Gen. Laws § 23-17-10 and this Part.
B.A duly authorized representative of the Department shall have the right to enter at any time without prior notice to inspect the entire premises and services, including all records of any OACF for which an application has been received or for which a license has been issued. Any application shall constitute permission for and willingness to comply with such inspections.
C.Refusal to permit inspections shall constitute a valid ground for license revocation.
D.Every OACF shall be given notice within fifteen (15) business days by the Department of any deficiencies reported as a result of an inspection or investigation.
E.Written reports and recommendations of inspections and inspection logs or journals shall be maintained on file in each OACF for a period of no less than three (3) years.
3.4.7Denial, Suspension, Revocation of License or Curtailment of Activities
A.The Department is authorized to deny, suspend or revoke the license of or to curtail the activities of any OACF which:
1.Has failed to comply with this Part; and
2.Has failed to comply with the provisions of R.I. Gen Laws Chapter 23-17.
3.Reports of deficiencies noted in inspections conducted in accordance with § 3.4.6 of this Part shall be maintained on file in the Department, and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of an OACF.
B.Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the activities of an OACF, the Department shall notify the OACF by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9 and pursuant to the provisions of § 3.8.1 of this Part.
1.However, if the Department finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
C.The appropriate state and federal agencies shall be notified of any action taken by the Department pertaining to either denial, suspension, or revocation of license or curtailment of activities of any OACF.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.5** Organization and Management {#sec-216-ricr-40-10-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.5}
3.5.1Governing Body or Other Legal Authority
A.Each OACF shall have an organized governing body or other legal authority, ultimately responsible for:
1.The management and fiduciary control of the operation and maintenance of the OACF;
2.The conformity of the OACF with all federal, state and local laws and rules and regulations pertaining to fire, safety, sanitation, communicable and reportable diseases, patient care and other relevant health and safety requirements and this Part.
3.The administration of a policy of non-discrimination in the provision of services to patients and the employment of persons without regard to race, color, creed, national origin, gender, religion, sexual orientation, age, handicapping condition or degree of handicap, in accordance with Title VI of the Civil Rights Act of 1964; U.S. Executive Order #11246 entitled “Equal Employment Opportunity”, U.S. Department of Labor regulations; Title V of the Rehabilitation Act of 1973, the Rhode Island Fair Employment Practices Act, R.I. Gen. Laws Chapter 28-5 et seq.; the Americans with Disabilities Act; and any other federal or state laws relating to discriminatory practices.
B.The governing body or other legal authority shall provide appropriate personnel, physical resources, and equipment to facilitate the delivery of ambulatory health care services, during established hours of operation.
C.The governing body or other legal authority shall adopt by-laws defining the responsibilities for the operation and performance of the OACF and identifying purposes and means of fulfilling such. In addition, the governing body or equivalent legal authority shall establish administrative/clinical policies pertaining to no less than the following:
1.The qualifications and responsibilities of the administrator;
2.The scope of health and medical services to be provided;
3.Maintain linkages and referrals with other health care facilities to assure continuity of care;
4.Quality assurance for patient care and services;
5.Provisions for a program permitting selected individuals other than physicians or other licensed, registered or certified personnel to perform extended, defined patient care functions. Said functions shall not otherwise require a license, certification or registration by state law. Such program shall include written systems of credentials review, selection, training, formal authorization of specific functions, and maintenance of a current register; and
6.Such other matters as may be relevant to the organization and operation of the OACF.
D.The governing body shall be responsible to establish a mechanism through the organization's by-laws or policies and procedures to assure that duly qualified physicians and other professionals are assigned to agency services based on appropriate education, training, experience and evidence of current professional practice and licensure as may be required by law.
3.5.2Quality Improvement Program
A.The governing body shall ensure that there is an effective, ongoing, OACF-wide quality improvement program to evaluate the provision of patient care.
B.The organized OACF-wide quality improvement program shall be ongoing and shall have a written plan of implementation. The written quality improvement plan shall include at least the following:
1.Program objectives;
2.Organization(s) involved;
3.Oversight responsibility (e.g., reports to the governing body);
4.Facility-wide scope;
5.Program administration and coordination;
6.Involvement of all patient care disciplines/services;
7.Methodology for monitoring and evaluating quality of care;
8.Priority setting and problem resolution;
9.Determination of the effectiveness of action(s) taken;
10.Documentation of the quality improvement plan review.
C.All patient care services, including services rendered by a contractor, shall be evaluated.
D.Nosocomial infections and medication therapy shall be evaluated.
E.All medical and surgical services performed in the OACF shall be evaluated for appropriateness in diagnosis and treatment.
F.The OACF shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented.
G.The provisions of §§ 3.5.2(A) through (F) of this Part (“Quality Improvement”) shall be deemed to have been met if the OACF has met similar requirements of a national accrediting body, as approved by the Director.
3.5.3Pending and Actual Labor Disputes/Actions
OACFs shall provide the Department with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. OACFs shall provide a plan, acceptable to the Director, for continued operation of the facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action.
3.5.4Administrator
A.The governing body or other legal authority of the OACF shall appoint an administrator who shall be operationally responsible for:
1.The management and operation of the OACF;
2.The compliance with policies, rules and regulations and statutory provisions pertaining to the health and safety of patients;
3.Serving as liaison between the governing body or equivalent legal authority and the staff; and
4.The planning, organizing and directing of such other activities as may be delegated by the governing body.
3.5.5Medical or Dental Director
The governing body or other legal authority of the OACF shall appoint a medical or dental director (as appropriate), licensed in Rhode Island to ensure the achievement and maintenance of the quality of health care services and the establishment of policies and procedures for health care services based on recognized standards of practice in accordance with this Part.
3.5.6Personnel
A.The OACF shall be staffed with appropriate professional and ancillary personnel who shall be assigned duties and responsibilities which are consistent with licensure/ certification requirements, their training and experience, and services rendered. Staff performing functions requiring certification and/or licensure shall be duly licensed in Rhode Island as required by statute.
B.National criminal background checks shall be conducted in accordance with R.I. Gen. Laws §§ 23-17.7.1-17 and 23-17.7.1-20 for OACF personnel whose employment involves routine contact with a patient.
C.Each OACF shall have at least one appropriate qualified health professional staff person on duty at all times during the hours of operation when services are provided.
D.The OACF shall have a physician or dentist, as appropriate, licensed in Rhode Island, who is accessible during hours of operation.
E.An OACF shall require all persons, including students, who examine, observe, or treat a patient of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
F.Health Screening
1.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the OACF. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title).
3.5.7Rights of Patients
A.Each OACF shall observe the standards of R.I. Gen. Laws § 23-17-19.1 with respect to each patient.
B.In accordance with R.I. Gen. Laws § 23-17-19.2 each OACF shall display in a conspicuous place in the licensed OACF a copy of the "Rights of Patients” as defined in R.I. Gen. Laws § 23-17-19.1.
3.5.8Administrative Records
A.Each OACF shall maintain such administrative records as may be deemed necessary by the Department. These records shall include but not be limited to:
1.Monthly statistical summary of numbers of visits and number of patients seen;
2.An administrative record, log book or appointment book containing pertinent data such as patient's name, record number, age, sex, date and stated reason for the appointment and time of visit and the name of the provider of service; and
3.A triage plan for the screening and classification of patients to determine priority needs and to utilize staff personnel and equipment efficiently.
3.5.9Uniform Reporting System
A.Each OACF shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of the regulation may be met shall be prescribed from time to time in directives promulgated by the Director.
B.Each OACF shall make available for review upon request of the Department detailed statistical data pertaining to its operation, services provided, including numbers of patients, range of problems presented and treated, and facility. Such reports and data shall be made at such intervals and by such dates as determined by the Director.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.6** Health Care Services {#sec-216-ricr-40-10-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.6}
3.6.1Management of Services
A.Each OACF shall be organized to provide services with adequate professional and ancillary staff to ensure that all persons are treated and released within a reasonable and appropriate length of time. No patients shall be held overnight.
B.Policies and procedures pertaining to the provision of services and supported by appropriate manuals and reference material shall be established by the appropriate professional staff and approved by the administrator and the governing body. Such policies and procedures shall pertain to no less than the following:
1.The responsibility of the physician(s) or dentist, as appropriate, for the provision of health care services;
2.The designation of personnel authorized to deliver health care services in accordance with licensure and/or certification requirements and the provisions of § 3.5.1(C)(5) of this Part;
3.Standards of practice for each health care service provided;
4.Procedures that may and may not be performed;
5.Procurement and storage of drugs and medications in accordance with R.I. Gen. Laws Chapters 21-28 and 21-31;
6.Designation of personnel authorized to prescribe, administer, or dispense drugs;
7.Disposal of hypodermic needles, syringes and instruments in accordance with the requirements of the rules and regulations for Hypodermic Needles, Syringes, and Other Such Instruments (Part 20-15-6 of this Title);
8.Delineation of clinical privileges of non-physician practitioners;
9.Disclosure of patient information in accordance with federal and state law; and
10.Such other conditions as may be deemed appropriate.
C.Financial Interest Disclosure
1.Any OACF licensed pursuant to R.I. Gen. Laws Chapter 23-17, which refers clients to another such licensed health care facility or to a residential care/assisted living facility licensed pursuant to R.I. Gen. Laws Chapter 23-17.4 or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client:
a.That the referring entity has a financial interest in the facility or provider to which the referral is being made; and
b.That the client has the option of seeking care from a different facility or provider which is also licensed and/or certified by the state to provide similar services to the client.
2.The referring entity shall also offer the client a written list prepared by the Department of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting:
Rhode Island Department of Health,
Center for Health Facilities Regulation, 3 Capitol Hill, Room 306
Providence, RI 02908
401.222.2566
3.Non-compliance with §§ 3.6.1(C)(1) and (2) of this Part shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with R.I. Gen. Laws Chapter 23-17.10.
3.6.2Radiology and Laboratory Services
A.Any OACF providing diagnostic radiology services must meet the requirements of the regulations for Radiation (Subchapter 40-20 of this Title).
1.Mammography:
a.All aspects of mammography services shall be managed in accordance with the requirements of the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900.
b.Pursuant to R.I. Gen. Laws § 23-4.9-1, each mammographic imaging facility that takes a mammography x-ray of any individual within Rhode Island shall keep and maintain that mammography x-ray for the life of the individual. However, any mammography x-ray may be destroyed if the individual has had no contact with the mammographic imaging facility for a period exceeding fifteen (15) years.
B.Clinical laboratory services may be provided on the premises of the OACF subject to the provisions of R.I. Gen. Laws § 23-16.2-3 and Federal CLIA requirements (42 C.F.R. § 493).
3.6.3Infection Control
A.An OACF shall establish policies and procedures governing infection control and reporting techniques which address §§ 3.6.3(B) through (F) of this Part, as applicable.
B.The medical/dental director in cooperation with other disciplines shall establish a team which shall be responsible for no less than the following:
1.Establishing and maintaining a facility-wide infection surveillance program which shall include an infection surveillance officer to conduct all infection surveillance activities;
2.Developing and implementing written policies and procedures for the surveillance, prevention, and control of infections;
3.Developing, evaluating and revising on a continuing basis infection control policies, procedures and techniques for all appropriate phases of facility operation and services.
C.Infection control provisions shall be established for the mutual protection of patients, employees and the public.
D.A continuing education program on infection control shall be conducted at intervals not to exceed twelve (12) months for all staff.
E.Reporting of Communicable Diseases:
1.The OACF shall promptly report to the Department cases of communicable diseases designated as "reportable diseases" by the Director, when such cases are diagnosed in the OACF in accordance with the rules and regulations pertaining to the Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).
2.When infectious diseases present a potential hazard to patients or personnel, these shall be reported to the Department, even if not designated as "reportable diseases."
F.Reporting by Laboratories:
1.Laboratories shall report communicable diseases and submit specimens in accordance with the Department’s Clinical Specimen Submission Guidance(available on-line http://www.health.ri.gov/programs/laboratory/biological/about/specimensubmission/) .
2.Facilities must, in addition, comply with all other laboratory reporting requirements for TB, HIV/AIDS, sexually transmitted diseases, childhood lead poisoning and occupational diseases as outlined in the rules and regulations pertaining to the Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).
3.6.4Health Care Records
A.Each OACF shall maintain a health care record on every patient seeking health care services.
B.For each visit to the OACF the health care record shall contain documentation relating to the following:
1.Patient identification (name, address, age and sex);
2.Pertinent health history and physical findings;
3.Diagnostic and therapeutic orders;
4.Reports of procedures, tests and findings of each visit;
5.Diagnostic impressions; and
6.Such other pertinent data as may be necessary to insure continuity of patient care.
C.Each OACF shall make provisions for the appropriate release or transfer of patient care information in accordance with the legal requirements governing confidentiality of health care information.
D.All medical records, either originals or accurate reproductions, shall be preserved for a minimum of five (5) years, except that records of minors shall be kept for at least five (5) years after such minor shall have reached the age of eighteen (18) years.
3.6.5Medical and/or Dental Equipment
Medical and/or dental equipment and supplies for the reception, appraisal, examination, treatment and observation of patients shall be determined by the amount, type and extensiveness of services provided.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.7** Ph y sical Plant and Equipment {#sec-216-ricr-40-10-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.7}
3.7.1Physical Facility
A.All construction shall be subject to the laws, rules, regulations and codes of R.I. Gen. Laws Chapters 23-17, 23-28.1, and “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 3.2(A) of this Part, and all other appropriate state and local laws, codes, regulations and ordinances. Where there is a difference between codes, the code having the more stringent standard shall apply.
B.All plans for new construction or the renovation, alteration, extension, modification or conversion of an existing facility that may affect compliance with “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 3.2(A) of this Part shall be reviewed by a licensed architect, acceptable to the Director. Said architect shall certify that the plans conform to the construction requirements of “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 3.2(A) of this Part, prior to construction. The facility shall maintain a copy of the plans reviewed and the architect’s signed certification, for review by the Department upon request.
1.In the event of non-conformance for which the facility seeks a variance, the general procedures outlined in § 3.8.1 of this Part shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as detailing the basis upon which the request is made. The Department may request additional information while evaluating variance requests.
2.If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 3.2(A) of this Part, except those for which variances were granted, prior to construction. The facility shall maintain a copy of the plans reviewed, the variance(s) granted and the architect’s signed certification, for review by the Department upon request.
C.Upon completion of construction, the facility shall provide written notification to the Department, describing the project, and a copy of the architect's certification. The facility shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.
3.7.2Environmental Maintenance
A.The OACF shall be maintained and equipped to provide a sanitary, safe and comfortable environment with all furnishings in good repair, and the premises shall be kept free of hazards.
B.Written policies and procedures shall be established to assure a comfortable, safe and sanitary environment and appropriate lighting throughout the facility.
C.Appropriate equipment and supplies to clean the facility shall be maintained in a safe, sanitary condition.
D.Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place and kept in an enclosed section separate from other cleaning materials.
E.Smoking shall be permitted only in areas designated pursuant to R.I. Gen. Laws Chapter 23-20.10.
F.Waste Disposal
1.Regulated Medical Waste:
a.Regulated medical waste, as defined in the Medical Waste Regulations (250-RICR-140-15-1.2(C)) shall be managed in accordance with the provisions of the aforementioned regulations.
2.Other Waste:
a.Wastes which are not classified as infectious waste, hazardous wastes or which are not otherwise regulated by law or rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
3.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management.
4.Load packers must conform to the same restrictions required for dumpsters and, in addition, load packers shall be:
a.High enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment; and
b.The loading section shall be constructed and maintained to prevent rubbish from blowing from said area site.
3.7.3Disaster Preparedness
A.Each facility shall develop and maintain a written disaster preparedness plan which shall include plans and procedures to be followed in case of fire and/or other emergencies.
B.The plan and procedures shall be developed with the assistance of qualified safety, emergency management, and/or other appropriate experts.
C.The plan shall include procedures to be followed pertaining to no less than the following:
1.Fire, explosion, hurricane, loss of power and/or water, flooding, failure of internal systems or equipment, and other calamities;
2.Transfer of casualties;
3.Location and use of alarm systems, signals and firefighting equipment;
4.Containment of fire;
5.Notification of appropriate persons;
6.Relocation of patients and evacuation routes;
7.Handling of drugs and biologicals; and
8.Any other essentials as may be warranted.
D.A copy of the plan shall be available to all personnel.
E.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the facility.
F.Simulated drills testing the effectiveness of the plan shall be conducted for all personnel at least twice a year. Written reports and evaluation of all drills shall be maintained by the facility.
G.All personnel shall receive training in disaster preparedness as part of their employment orientation.
3.7.4Fire Safety
A.Each facility shall meet the requirements of R.I. Gen. Laws Chapter 23-28.1 pertaining to fire and safety.
B.A monitoring program for the internal enforcement of all applicable fire safety laws and regulations shall be established. Such program shall include written procedures for the implementation of policies, regulations, and statutes. A log of such monitoring shall be maintained.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-3 § 3.8** Practices and Procedures, Confidentiality {#sec-216-ricr-40-10-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-3#3.8}
3.8.1Variance Procedures
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of patients.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the Department, and within a reasonable time thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial and in accordance with the provisions of § 3.8.2 of this Part.
3.8.2Deficiencies and Plans of Correction
A.The Department shall notify the governing body or other legal authority of an OACF of violations of individual standards through a notice of deficiencies which shall be forwarded to the OACF f within fifteen (15) days of inspection of the OACF unless the director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.An OACF which received a notice of deficiencies must submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The Department will be required to approve or reject the plan of correction submitted by an OACF in accordance with § 3.8.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the Department rejects the plan of correction, or if the OACF does not provide a plan of correction within the fifteen (15) day period stipulated in § 3.8.2(C) of this Part, or if an OACF whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 3.4.7 of this Part. If the OACF is aggrieved by the action of the Department, the OACF may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35 .
E.The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35 . The hearing shall in all respects comply with the provisions therein.
3.8.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17, shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
3.8.4Confidentiality
Disclosure of any health care information relating to individuals shall be subject to the provisions of the Confidentiality Act of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and federal requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2018-08-29 to 08/29/2018*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-01-07 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 01/07/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-4** Licensing of Hospitals
##### **216-RICR-40-10-4 § 4.1** Authority {#sec-216-ricr-40-10-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-17-10 and 23-17.14-31, as amended, and are established for the purpose of adopting prevailing standards for licensed hospitals in this state.
B.The Director of the Department of Health is authorized to establish as part of these regulations quality and volume-related standards to be achieved and maintained for specific tertiary health care services offered by individual licensed health care facilities where peer reviewed medical and health literature establishes significant relationships between desired quality related outcomes and volume of services provided. (See R.I. Gen. Laws § 23-17-45). Pursuant to the provisions of R.I. Gen. Laws § 42-35-2.9, the following were given consideration in arriving at the regulations: alternative approaches to the regulations; and duplication or overlap with other state regulations. Based on the available information, no known alternative approach, duplication or overlap was identified.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.2** Incorporated Materials {#sec-216-ricr-40-10-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.2}
A.These regulations hereby adopt and incorporate the following by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations:
1.21 C.F.R. §§ 50.20 through 50.27 (2017).
2.21 C.F.R. Part 900 (2017).
3.42 C.F.R. Part 2 (2017).
4.45 C.F.R. § 46.101 (2017).
5.45 C.F.R. §§ 46.116 through 46.117 (2017).
6.Blyth, Pamela. Health Care Environmental Services: Housekeeping Departmental Training Manual. American Hospital Association, 1996.
7.Bozzi, Carmine, et al. “Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities.” Morbidity and Mortality Weekly Report Recommendations and Reports, vol. 43, no. RR13, 1994, .
8.Brodsky, Allen. Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions as Low as Reasonably Achievable. U.S. Nuclear Regulatory Commission, 1982.
9.“Bylaws.” United Network for Organ Sharing, 2015, https://www.unos.org/wp-content/uploads/unos/UNOS_Bylaws.pdf.
10.Guidelines for Design and Construction of Hospital and Health Care Facilities. American Institute of Architects, 2006.
11.Lighting for Hospitals and Healthcare Facilities. Illuminating Engineering Society, 2006.
12.National Research Council. Recommended Dietary Allowances. National Academies Press, 1989.
13.NFPA 1: Fire Code. National Fire Protection Association, 2015.
14.NFPA 99: Health Care Facilities Code. National Fire Protection Association, 2015, section 5.1.14.1.1.
15.NFPA 99: Health Care Facilities Code. National Fire Protection Association, 2015, section 15.4.
16.NFPA 232: Standard for the Protection of Records. National Fire Protection Association, 2017.
17.“Recommendations for Preventing the Spread of Vancomycin Resistance: Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC).” Morbidity and Mortality Weekly Report Recommendations and Reports, vol. 44, no. RR12, 1995, .
18.Rogers, Martha, et al. “Guidelines for Preventing Transmission of HIV through Transplantation of Human Tissue and Organs.” Morbidity and Mortality Weekly Report Recommendations and Reports, vol. 43, no. RR8, 1994, .
19.Shefer, Abigail, et al. “Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP).” Morbidity and Mortality Weekly Report Recommendations and Reports, no. 60, vol. RR07, 2011, .
20.Standards and Recommendations for Hospital Care of Newborn Infants. American Academy of Pediatrics, 1977.
21.Standards for Blood Banks and Transfusion Services. American Association of Blood Banks, 2016.
22.Standards for Obstetric-Gynecological Services. American College of Obstetricians and Gynecologists, 1985.
23.Joint Commission. Comprehensive Accreditation Manual for Hospitals. Joint Commission Resources, 2017. (As pertains to central service functions, disaster plan, and medical records.)
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.3** Definitions {#sec-216-ricr-40-10-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.3}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1.“Advanced practice clinician,” as used in these regulations, means an advanced practice nurse licensed in accordance with R.I. Gen. Laws Chapter 5-34, and/or a certified registered nurse anesthetist licensed in accordance with R.I. Gen. Laws Chapter 5-34.2; and/or a midwife licensed in accordance with R.I. Gen. Laws § 23-13-9; and/or a physician assistant licensed in accordance with R.I. Gen. Laws Chapter 5-54.
2.“After-care,” as used in § 4.6.33 of this Part, means any assistance provided by a caregiver to a patient after the patient’s discharge from a hospital that is related to the patient’s condition at the time of discharge. Such assistance may include, but is not limited to, assisting with basic activities of daily living, instrumental activities of daily living, or other tasks as determined to be appropriate by the discharging physician or other health care professional.
3."The bed complement" of a hospital refers to the number of beds a hospital has in actual use, equal to or less than the licensed capacity.
4.“Bilingual” means having fluency in English and in another language.
5."Birth center service" means a distinct and identifiable unit in a hospital with an obstetrical service, staffed, equipped and operated to provide services to low risk mothers-to-be (as defined in § 4.6.23(B)(1) of this Part), or mothers during pregnancy, labor, birth and puerperium.
6.“Caregiver” means any individual duly designated as a caregiver by a patient under § 4.6.33 of this Part who provides after-care assistance to a patient living in his or her residence. A designated caregiver may include, but is not limited to, a relative, partner, friend, or neighbor who has a significant relationship with the patient.
7."Change in operator" means a transfer by the governing body or operator of a hospital to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.hire or fire the chief executive officer of the hospital;
b.maintain and control the books and records of the hospital;
c.dispose of assets and incur liabilities on behalf of the hospital; or
d.adopt and enforce policies regarding operation of the hospital.
e.This definition is not applicable to circumstances wherein the governing body of a hospital retains the immediate authority and jurisdiction over the activities enumerated in §§ 4.3(A)(7)(a) through (d) of this Part above.
8."Change in owner" means:
a.in the case of a hospital which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.in the case of a hospital which is an unincorporated solo proprietorship, the transfer of the title and property to another person;
c.in the case of a hospital which is a corporation:
(1)a sale, lease, exchange or other disposition of all, or substantially all, of the property and assets of the corporation; or
(2)a merger of the corporation into another corporation; or
(3)the consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)in the case of a hospital which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)in the case of a hospital which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
9.“Charity care” means health care services provided by a hospital without charge to a patient and for which the hospital does not and has not expected payment. Said health care services shall be rendered to patients determined to be uninsured, underinsured or otherwise deemed to be eligible at the time of delivery of services. Charity care services are those health care services that are not recognized as either a receivable or as revenue in the hospital’s financial statements. Charity care shall not include health care services provided to individuals for the purpose of professional courtesy without charge or for reduced charge. Under no circumstances shall bad debt be deemed to be charity care. Charity care shall be cost adjusted by applying a ratio of cost to charges from the hospital’s Medicare Cost Reports to charity care charges-foregone.
10."Clinician" means a physician licensed under R.I. Gen. Laws Chapter 5-37; a nurse licensed under R.I. Gen. Laws Chapter 5-34; a psychologist licensed under R.I. Gen. Laws Chapter 5-44, a social worker licensed under R.I. Gen. Laws Chapter 5-39.1; a physical therapist licensed under R.I. Gen. Laws Chapter 5-40; and a speech language pathologist or audiologist licensed under R.I. Gen. Laws Chapter 5-48.
11."Conscious sedation" means a drug-induced depression of consciousness during which patients respond purposefully (reflex withdrawal from a painful stimulus is not considered a purposeful response) to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
12.“Conversion” means any transfer by a person or persons of an ownership or membership interest or authority in a hospital, or the assets thereof, whether by purchase, merger, consolidation, lease, gift, joint venture, sale, or other disposition which results in a change of ownership or control or possession of twenty percent (20%) or greater of the members or voting rights or interests of the hospital or of the assets of the hospital or pursuant to which, by virtue of such transfer, a person, together with all persons affiliated with such person, holds or owns, in the aggregate, twenty percent (20%) or greater of the membership or voting rights or interests of the hospital or of the assets of the hospital, or the removal, addition or substitution of a partner which results in a new partner gaining or acquiring a controlling interest in the hospital, or any change in membership which results in a new person gaining or acquiring a controlling vote in the hospital.
13.“Coronary artery bypass graft,” as used in these regulations, pertains to surgical operations for the purpose of constructing new pathways around stenosing or obstructing lesions in segments of coronary arteries for the purpose of bringing blood to the myocardium that is otherwise made ischemic by these lesions. These grafted conduits shall include autologous blood vessels, allograft vessels, and synthetic tubes.
14.“Degradation (of performance)” means an undesired departure in the operational performance of any equipment and/or system from its intended performance. “Degradation” can apply to temporary or permanent failure.
15.“Director” shall mean the Director of the Rhode Island Department of Health.
16.“Discharge” means a patient’s exit or release from a hospital to the patient’s residence following an inpatient admission.
17.“Door-to-balloon time,” as used in these regulations, means the time that elapses from the point in time at which the patient arrives at the percutaneous coronary intervention (PCI) hospital to the point in time at which there is balloon inflation in patients who receive primary angioplasty or primary coronary intervention. Reported statistics shall follow applicable guidelines issued by the American College of Cardiology and the American Heart Association.
18.“Elective percutaneous coronary intervention,” as used in these regulations, means all percutaneous coronary intervention procedures except primary percutaneous coronary intervention.
19.“Electromagnetic compatibility” or “EMC” means the ability of an equipment and/or system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance (EMD) to anything in that environment.
20.“Electromagnetic disturbance” or “EMD” means any electromagnetic phenomenon that may degrade the performance of an equipment and/or system. An EMD may be an electromagnetic noise, an unwanted signal, or a change in the propagation medium itself.
21.“Electromagnetic interference” or “EMI” means degradation of the performance of a piece of equipment, transmission channel, or system caused by an EMD.
22.“Entry” means a patient’s admission into a hospital for the purpose of medical care.
23.“Esophageal cancer surgery,” as used in these regulations, means esophageal surgical procedures, performed for the purpose of treating known or suspected cancer, including esophageal resection, partial or total esophagectomy, esophageal anastomosis, and other related procedures excluding endoscopic procedures.
24.“Equity” means non-debt funds contributed towards the capital costs related to a change in owner or change in operator of a hospital which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
25.“Fluency” means the ability to converse freely in a language.
26.“Health care provider” means any person licensed by this state to provide or otherwise lawfully providing health care services, including, but not limited to, a physician, hospital, intermediate care facility or other health care facility, dentist, nurse, optometrist, podiatrist, physical therapist, psychiatric social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health services.
27."Health Services Council" shall mean the advisory body to the Rhode Island Department of Health established in accordance with R.I. Gen. Laws § 23-17-13.1, appointed and empowered in accordance with R.I. Gen. Laws § 23-15-7 to serve as the advisory body to the state agency in its review functions.
28.“Heart transplant,” as used in these regulations, shall include the grafting of a replacement heart into a person with a heart obtained from another person. These standards do not apply to xenografts, nor to artificial or mechanical replacement organs.
29.“High managerial agent” means an officer of the hospital, the chief executive officer, director of risk management, director of nursing services, or any other agent designated by the hospital in a position of comparable authority with respect to the formulation of hospital policies or the supervision of subordinate employees.
30.“Home care services” shall mean a program which is currently administered, and through coordinated planning, evaluation, and follow-up procedures, provides for physician-directed medical, nursing, social, and related services made available either directly or through participating agencies to selected patients having a nexus with a hospital at their place of residence.
31.“Hospital” shall mean a facility with a governing body, an organized medical staff and a nursing service providing equipment and services primarily for inpatient care to persons who require definitive diagnosis and treatment for injury, illness or other disabilities or pregnancy. A hospital shall provide psychiatric and/or medical and/or surgical care and at least the following services: dietetic, infection control, medical records, laboratory, pharmaceutical and radiology, except that a psychiatric facility need not provide radiology services.
32.“Laboratory station” means a facility for the collection, processing and transmission of specimens derived from the human body.
33.“The licensed capacity” of a hospital refers to the number of beds a hospital is licensed to operate.
34.“Licensing agency” shall mean the Rhode Island Department of Health.
35.“Lift team” means hospital employees specially trained to perform patient lifts, transfers, and repositioning in accordance with safe patient handling policy.
36.“Liver transplant,” as used in these regulations, shall include the grafting of a replacement liver into a person with a liver obtained from another person. These standards do not apply to xenografts, nor to artificial or mechanical replacement organs.
37.“Local anesthesia” means the injection of a local anesthetic agent (e.g., Lidocaine) into and around the operative site to achieve numbness in the area where a painful procedure is to be performed. This type of anesthesia does not involve any systemic sedation.
38.“Musculoskeletal disorders” means conditions that involve the nerves, tendons, muscles, and supporting structures of the body.
39.“Neonatal intensive care unit” or “NICU” means a unit that provides a comprehensive range of specialty and subspecialty services to severely ill infants, including infants who have an elevated risk of mortality as a consequence of very low birth weight (less than or equal to 1500 grams), surgical conditions, or other forms of severe illness in full-term newborns.
40.“Net operating revenue” means net patient revenue plus other operating revenue.
41.“Non-English speaker” means a person who cannot speak or understand, or has difficulty in speaking or understanding, the English language, because he/she uses only or primarily a spoken language other than English, and/or a person who uses a sign language and requires the use of a sign language interpreter to facilitate communication.
42.“Pancreatic cancer surgery”, as used in these regulations, means pancreatic surgical procedures, performed for the purpose of treating known or suspected cancer, including resection of the pancreas, partial or total pancreatectomy, radical pancreaticoduodenectomy, and other related procedures excluding endoscopic procedures.
43.“Percutaneous coronary intervention” or “PCI”, as used in these regulations, shall include not only conventional balloon angioplasty but also non-balloon procedures including, but not limited to, directional antherectomy, excimer laser, transluminal extraction catheter, rotablation, and coronary stenting and thrombus aspiration.
44.“Person” shall mean any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability companies, state, or political subdivision or instrumentality of a state.
45.“Physician” means any person licensed to practice allopathic or osteopathic medicine pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
46.“Premises” means a tract of land and the buildings thereon where direct patient care services are provided.
47.“Primary percutaneous coronary intervention”, as used in these regulations, means percutaneous coronary intervention used as the primary reperfusion strategy, with or without thrombolysis, for known or suspected acute myocardial infarction.
48.“Qualified interpreter" means a person who, through experience and/or training, is able to translate/interpret a particular foreign language into English with the exception of sign language interpreters who must be licensed in accordance with R.I. Gen. Laws Chapter 5-71.
49.“Qualified sign language interpreter" means one who has been licensed in accordance with the provisions of R.I. Gen. Laws Chapter 5-71.
50.“Radio frequency” means a frequency in the portion of the electromagnetic spectrum that is between the audio-frequency portion and the infrared portion. The present practical limits of radio frequency are roughly 9 kHz to 3000 GHz.
51.“Regional anesthesia” means the use of local anesthetic agents to block nerves leading to the area where a painful procedure is to be done. There are many examples of regional anesthesia, including, but not limited to, spinal, interscalene, ankle, etc. Generally, regional anesthesia involves more of a physiological reaction because of the larger area blocked and/or the dose of local anesthesia. This type of anesthesia may or may not involve sedation.
52.“Renovation” means moving a wall or otherwise changing a structure such that life safety codes or other structural requirements are affected. Normal maintenance of an existing structure is excluded from this definition.
53.“Reportable event” means:
a.fire or internal disaster in the facility which disrupts the provision of patient care services or causes harm to patients or personnel;
b.poisoning involving patient(s) of the facility;
c.infection outbreak as may be defined by and in accordance with rules and regulations pertaining to the Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title);
d.kidnapping;
e.elopements from inpatient psychiatric units and elopements by minors who are inpatients, (reportable to the Department of Health at the time the local municipal police are informed); elopements of psychiatric patients from outpatient or emergency departments who are reasonably thought to be a danger to themselves or to others;
f.strikes, official strike notices, or other personnel actions that may disrupt services;
g.disasters or other emergency situations external to the hospital environment which adversely affect facility operations; and
h.unscheduled termination of any health care service or utilities vital to the continued safe operation of the facility or to the health and safety of its patients and personnel (including any unanticipated interruption in power to a facility, as well as any event that triggers the use of a backup generator).
54.“Reportable incidents” are those which result in patient injury as defined in §§ 4.3(A)(53)(a) though (j) or which involve matters described in §§ 4.3(A)(53)(k) through (o):
a.brain injury;
b.mental impairment;
c.paraplegia;
d.quadriplegia;
e.any paralysis;
f.loss of use of limb or organ;
g.any serious or unforeseen complication, that is not expected or probable, resulting in an extended hospital stay or death of the patient;
h.birth injury;
i.impairment of sight or hearing;
j.surgery on the wrong patient;
k.subjecting a patient to a procedure/treatment not ordered or intended by the patient's attending physician, excluding procedures not requiring a physician's order, medication errors, and collection of specimen, for laboratory study, obtained by non- invasive means or routine phlebotomy;
l.suicide of a patient during treatment or within five (5) days of discharge from inpatient or outpatient units (if known);
m.blood transfusion error;
n.medication error that necessitates a clinical intervention other than monitoring; or
o.any other incident reported to the malpractice insurance carrier or self-insurance program.
55.“Residence” means a dwelling that the patient considers to be his or her home. A “residence” for the purposes of § 4.6.33 of this Part shall not include any rehabilitation facility, hospital, nursing home, assisted-living facility, or group home licensed by Rhode Island.
56.“R.I. Gen. Laws” means General Laws of Rhode Island, as amended.
57.“Root cause analysis” means a process for identifying the causal factor(s) that underlie variation in performance.
58.“Safe patient handling” means the use of engineering controls, transfer aids, or assistive devices whenever feasible and appropriate instead of manual lifting to perform the acts of lifting, transferring, and/or repositioning health care patients and residents.
59.“Safe patient handling policy” means protocols established to implement safe patient handling.
60.“State agency” shall mean the Rhode Island Department of Health.
61.“Tertiary care” means services provided by highly specialized providers (e.g.,neonatologists, neurosurgeons, thoracic surgeons). Such services frequently require highly sophisticated equipment and support facilities. As used in these regulations, this care is defined as including, but is not limited to, those services provided in a neonatal intensive care unit.
62.“These Regulations” means this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.4** Licensing Procedures {#sec-216-ricr-40-10-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.4}
4.4.1General Requirements for Licensure
A.No person acting severally or jointly with any other person, shall establish, conduct or maintain a hospital in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4.
B.A certificate of need is required as a precondition to the establishment of a new hospital, and such other activities in accordance with “Rules and Regulations for Determination of Need for New Health Care Equipment and New Institutional Health Services.”
C.Each premises and the related operations of a licensed hospital shall be approved by the Department of Health prior to the inclusion of that premises on the hospital license and commencement of operations at that location.
1.The hospital shall have a written lease, contract, or other legal document in place for use of space on premises not owned by the hospital.
D.The hospital shall maintain current accreditation by any organization granted deeming authority by the federal Centers for Medicare and Medicaid Services (CMS).
E.The hospital shall be subject to the provisions of R.I. Gen. Laws Chapter 23-17.17, and the Rules and Regulations Related to the Health Care Quality Program (Part 10-10-7 of this Title) promulgated by the Department. Nothing in these regulations should be construed to be inconsistent with the Rules and Regulations Related to the Health Care Quality Program.
4.4.2Application for License or Changes in the Owner, Operator, or Lessee
A.Application for a license to conduct, maintain or operate a hospital shall be made to the licensing agency upon forms provided by it one (1) month prior to expiration date of license and shall contain such information as the licensing agency reasonably requires which may include affirmative evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and these regulations.
1.Each application shall be accompanied by a non-refundable, non-returnable application fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Application for changes in the owner, operator, or lessee of a hospital shall be made on forms provided by the licensing agency and shall contain but not be limited to: information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 4.4.3(E) of this Part. An application for a proposed conversion pursuant to the provisions of R.I. Gen. Laws § 23-17.14 shall contain all information required pursuant to R.I. Gen. Laws § 23-17.14 as may be determined by the state agency. Further, when review of a proposed change in owner, operator or lessee of a hospital and review of a proposed conversion are both required pursuant to the provisions of R.I. Gen. Laws Chapters 23-17 and 23-17.14, respectively, a conversion application shall be filed with the Department of Health which contains all information required pursuant to R.I. Gen. Laws Chapter 23-17.14 as may be determined by the state agency; and a separate application for a change in effective control shall be filed containing all information required under the provisions of R.I. Gen. Laws Chapter 23-17 and § 4.4.2 of this Part. Twenty-five (25) copies of the change in effective control application are required to be provided.
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-refundable, non-returnable application fee, as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
4.4.3Issuance & Renewal of License
A.Upon receipt of an application for a license, the licensing agency shall issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and these regulations. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection and approval by the licensing agency.
1.All renewal applications shall be accompanied by a non-refundable, non-returnable annual inspection fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.A license shall be issued to a specific licensee for a specific location(s) and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance, as identified in the application.
1.Any change in owner, operator, or lessee of a licensed hospital shall require prior advisory review by the Health Services Council and approval of the licensing agency as provided in §§ 4.4.3(D) through 4.4.3(E) of this Part as a condition precedent to the transfer, assignment or issuance of a new license.
2.Any conversion of a licensed hospital shall require prior approval of the licensing agency as provided in the “Rules and Regulations Pertaining to Hospital Conversions.”
3.Any change or addition in premises shall require prior review and approval by the Department of Health and amendment of the hospital license.
C.A license issued hereunder shall be the property of the State of Rhode Island and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
D.Reviews of applications for changes in the owner, operator, or lessee of licensed hospitals shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for a license in connection with a change in the owner, operator or lessee of an existing hospital, the licensing agency will notify and afford the public thirty (30) days to comment on such application.
2.The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application.
3.The Health Services Council shall transmit its advisory to the state agency in writing. The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the licensing agency shall afford written justification for variance therefrom.
4.All applications reviewed by the licensing agency and all written materials pertinent to licensing agency review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.
E.Except as otherwise provided in these regulations, a review by the Health Services Council of an application for a license, in the case of a proposed change in the owner, operator, or lessee of a licensed hospital, shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence and standing in the community of the proposed owners, operators or directors of the hospital as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)in providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)in encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
(3)in providing appropriate access to health care facility services;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the health care facility.
2.The extent to which the facility will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individual's receiving the facility's services as evidenced by:
a.The immediate and long term financial feasibility of the proposed financing plan;
(1)The proposed amount and sources of owner's equity to be provided by the applicant;
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;
(3)The relative availability of funds for capital and operating needs;
(4)The applicant's demonstrated financial capability;
(5)Such other financial indicators as may be requested by the state agency;
3.The extent to which the facility will continue to provide safe and adequate treatment for individuals receiving the facility's services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:
a.The applicant’s demonstrated record in providing safe and adequate treatment to individuals receiving services at facilities owned, operated, or directed by the applicant; and
b.The credibility and demonstrated or potential effectiveness of the applicant’s proposed quality assurance programs.
4.The extent to which the facility will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities; and
b.The proposed immediate and long term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility.
5.In consideration of the proposed continuation or termination of emergency, primary care and/or other core health care services by the facility:
a.The effect(s) of such continuation or termination on access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations.
6.And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
F.Subsequent to reviews conducted under §§ 4.4.3(D) through 4.4.3(E) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in § 4.4.3(E) of this Part. This shall not limit the authority of the licensing agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the facility by the licensing agency.
G.Any new hospital licensee shall meet the statewide community standard for the provision of charity care as a condition of initial and continued licensure, pursuant to § 4.5.2 of this Part.
H.Those entities engaged in a hospital conversion shall be subject to the provisions of the “Rules and Regulations Pertaining to Hospital Conversions” promulgated by the Department. Nothing in these regulations should be construed to be inconsistent with the “Rules and Regulations Pertaining to Hospital Conversions.”
4.4.4Capacity & Classification
A.Each license shall be issued for the specified licensed bed capacity of the hospital. No hospital shall have more inpatients than the number of beds for which it is licensed, except in cases of short term seasonal fluctuations, local epidemics, or multiple casualty emergencies.
1.The number of women in active labor admitted at any point in time to the birth center service shall be no greater than the number of birth rooms in the center.
4.4.5Inspections
A.The licensing agency shall make, or cause to be made, such inspections and investigations as it deems necessary in accordance with R.I. Gen. Laws § 23-17-10 and these regulations.
B.Every hospital shall be given prompt notice by the licensing agency of all deficiencies reported as a result of an inspection or investigation.
C.Written reports and recommendations of inspections shall be maintained on file in each hospital for a period of no less than three (3) years.
4.4.6Denial, Suspension, Revocation of License, Curtailment of Activities or Cessation of Operation
A.The licensing agency is authorized to deny, suspend or revoke the license or curtail activities of any hospital which: has failed to comply with the rules and regulations pertaining to licensing of hospitals; and has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
1.Lists of deficiencies noted in inspections conducted in accordance with § 4.4.5 of this Part shall be maintained on file in the licensing agency and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or curtail activities of a hospital.
B.Where the licensing agency deems that operation of a hospital results in undue hardship to patients as a result of deficiencies, the licensing agency is authorized to deny licensure to facilities not previously licensed, or to suspend for a stipulated period of time or revoke the license of a hospital already licensed or curtail activities of the hospital.
C.Whenever an action shall be proposed to deny, suspend or revoke a hospital license, or curtail its activities, the licensing agency shall notify the hospital by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9.
1.However, if the licensing agency finds that public health, safety, or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
D.The appropriate state and federal placement and reimbursement agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license or curtailment of activities.
E.A license shall immediately become void and shall be returned to the licensing agency whenever the hospital ceases delivering patient care.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.5** Organization & Management {#sec-216-ricr-40-10-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.5}
4.5.1Governing Body
A.Each hospital shall have an organized governing body or other legal authority, responsible for:
1.the management and control of the operation of the hospital; and
2.the conformity of the hospital with all federal, state and local laws and regulations relating to fire, safety, sanitation, communicable and reportable diseases; and
3.other relevant health and safety requirements and with these regulations.
B.The governing body shall define the population and communities to be served and the scope of services to be provided.
1.The governing body, through the chief executive officer, shall provide for institutional planning to meet the health needs of the community, in accordance with R.I. Gen. Laws § 23-17-10.
C.The governing body, through its chief executive officer, shall provide appropriate resources and personnel, and shall determine the qualifications of personnel as required in these regulations, considering such factors as education, training, experience, board certification, eligibility to sit for examination of specialty board, evidence of current professional practice and licensure as may be required by law or regulation and such other relevant factor(s) as may be deemed necessary to meet the needs of the patients as well as the health needs of the community.
D.The governing body shall adopt and maintain written by-laws, rules and regulations in accordance with legal requirements and with its defined community responsibility, identifying the purpose of the hospital and the means of fulfilling them. A copy of said by-laws, rules and regulations including amendments or revisions thereto, shall be filed with the licensing agency.
1.Each hospital shall provide the licensing agency written notice of any changes to the hospital's corporate documents, including, but not limited to: charters/articles of incorporation and by-laws, and their equivalents for partnerships and limited liability corporations (LLCs), immediately but no more than thirty (30) days of making such change. Materials provided shall be deemed to be public records.
2.Each hospital shall provide the licensing agency written notice of any changes to the corporate documents of any entity that owns, operates, and/or controls the licensed hospital, including, but not limited to: charters/articles of incorporation and by-laws, and their equivalents for partnerships and limited liability corporations (LLCs), immediately but no more than thirty (30) days of making such change. Materials provided shall be deemed to be public records.
E.The by-laws, rules and regulations shall include:
1.a statement of purpose;
2.a statement of qualifications for membership and method of selecting members of the governing body;
3.provisions for the establishment, selection and term of office of committee members and officers;
4.a description of the functions and duties of the governing body, officers, and committees;
5.specifications for the frequency of meetings, attendance requirements, provisions for the order of business and the maintenance of written minutes;
6.a statement of the authority and responsibility delegated to the chief executive officer and to the medical staff;
7.provision for the selection and appointment of medical staff and the granting of clinical privileges. Such provisions shall include the appointment of a credentialing committee that shall include advance practice clinicians.
a.Physician Contracts
(1)Pursuant to R.I. Gen. Laws § 23-17-53, a hospital, by contract or otherwise, may not refuse or fail to grant or renew medical staff membership or, staff privileges, or condition or otherwise limit or restrict staff privileges, based in whole or in part on the fact that the physician or a partner, associate, or employee of the physician is providing medical or health care services at a different hospital, hospital system or on behalf of a health plan; provided, however, that a hospital may condition or otherwise limit or restrict staff privileges for reasons related to the availability of limited resources as determined in advance by the hospital's governing body. Nor shall a hospital by contract, or otherwise limit a physician's participation or staff privileges or the participation or staff privileges of a partner, associate, or employee of the physician at a different hospital, hospital system or health plan.
(2)This section does not prevent a hospital from entering into contracts with physicians to ensure physician availability and coverage at the hospital or to comply with regulatory requirements or quality of care standards established by the governing body of the hospital, if contracts, requirements or standards do not require that a physician join, participate in or contract with a physician-hospital organization or similar organization as a condition of the grant or continuation of staff privileges at the hospital.
(3)This section does not prevent the governing body of a hospital from limiting the number of physicians granted medical staff membership or privileges at the hospital based on a medical staff development plan that is unrelated to a physician or a partner, associate, or employee of a physician having medical staff membership or privileges at another hospital or hospital system; or
(4)A contract provision that violates this section shall be void and of no force and effect.
8.provision for the approval of the medical staff by-laws, rules and regulations;
9.provision of guidelines for the relationships among the governing body, the chief executive officer, the medical staff and the community;
10.a policy statement concerning the development and implementation of short and long range plans in accordance with R.I. Gen. Laws Chapter 23-17;
11.a policy statement concerning the publication of an annual report, including a certified financial statement;
12.a policy statement relating to conflict of interest on the part of members of the governing body, medical staff and employees who may influence corporate decisions;
13.provision that contracts with outside providers of services be restricted to those which comply with federal, state and local laws and these regulations; and
14.a policy statement relating to the protection of any physician or any other person or employee for non-participation in abortion or sterilization procedures in accordance with R.I. Gen. Laws § 23-17-11.
F.The governing body or other appropriate authority of a hospital is authorized to suspend, deny, revoke or curtail staff privileges of any staff member for good cause in accordance with R.I. Gen. Laws § 23-17-21.
4.5.2Statewide Standard for the Provision of Charity Care, Uncompensated Care, and Community Benefits
Hospital charity care, uncompensated care, and community benefits standards shall be consistent with the requirements provided in the “Rules and Regulations Pertaining to Hospital Conversions.”
4.5.3Quality Improvement
A.The governing body shall ensure that there is an effective, ongoing, hospital-wide quality improvement program to evaluate the provision of patient care.
B.The organized hospital-wide quality improvement program shall be ongoing and shall have a written plan of implementation. The written quality improvement plan shall include at least the following:
1.program objectives;
2.organization(s) involved;
3.oversight responsibility (e.g., reports to the governing body);
4.hospital-wide scope;
5.program administration and coordination;
6.involvement of all patient care disciplines/services;
7.methodology for monitoring and evaluating quality of care;
8.priority setting and problem resolution;
9.determination of the effectiveness of action(s) taken;
10.documentation of the quality improvement plan review.
C.All patient care services, including services rendered by a contractor, shall be evaluated.
D.Nosocomial infections and medication therapy shall be evaluated.
E.All medical and surgical services performed in the hospital shall be evaluated for appropriateness in diagnosis and treatment. The evaluation shall include peer review of individual cases. The hospital shall maintain records of peer reviews, documenting the case(s) reviewed, focus of each review, findings, conclusions, any actions taken, and any follow-up on actions taken.
F.The hospital shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented.
4.5.4Chief Executive Officer
The chief executive officer shall be directly responsible to the governing body for the management and operation of the hospital and shall provide liaison between the governing body and the medical staff.
4.5.5Medical Staff
A.Each hospital shall have an organized medical staff responsible for the quality of medical services and accountable to the governing body of the hospital.
B.The medical staff shall be responsible for its organized governance and for all medical care provided to patients.
C.The medical staff shall maintain standards of professional performance through staff appointment criteria, delineation of staff privileges, continuing peer review and other appropriate mechanisms.
D.The medical staff, subject to the approval of the governing body of the hospital, shall adopt by-laws incorporating details of its general powers, duties, and responsibilities including:
1.methods of selection, election or appointment of all officers and other executive committee members and officers;
2.provisions for the selection and appointment of officers of departments or services specifying required qualifications;
3.the type, purpose, composition and organization of standing committees;
4.frequency and requirements for attendance at staff departmental meetings;
5.an appeal mechanism for denial of staff appointments, reappointments and privileges;
6.delineation of clinical privileges of non-physician practitioners;
7.designation of personnel qualified to prescribe or administer drugs;
8.requirements regarding medical records;
9.a mechanism for utilization and medical care review;
10.such provisions as shall be required by hospital or governmental rules and regulations; and
11.provisions for a program permitting selected individuals other than physicians or other licensed, registered or certified personnel to perform extended, defined patient care functions. Said functions shall not otherwise require a license, certification or registration by state law. Such program shall include written systems of credentials review, selection, training, formal authorization of specific functions and maintenance of a current register.
E.A copy of approved medical staff by-laws and regulations and revisions thereto, shall be submitted to the licensing agency.
4.5.6Organization
A.Each hospital shall maintain clearly written definitions of its organization, authority, responsibility and relationships.
B.Each hospital department and service shall maintain:
1.clearly written definitions of its organization, authority, responsibility and relationships;
2.written patient care policies and procedures; and
3.written provision for systematic evaluation of programs and services.
C.Every licensed hospital and its insurance carrier shall cooperatively, as part of their administrative function, establish an internal risk management program in accordance with the requirements of R.I. Gen. Laws § 23-17-24.
D.All hospitals shall comply with the requirements of R.I. Gen. Laws Chapter 23-18.6.1 and Rhode Island Health Department Rules and Regulations Relating to Procurement of Anatomical Gifts from Persons with Unknown Intent by establishing protocols related to anatomical gifts and all other relevant requirements.
E.Any hospital that utilizes latex gloves shall do so in accordance with the provisions of the Rules and Regulations Pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title) promulgated by the Department of Health.
4.5.7Personnel
A.The hospital shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services.
B.There shall be written personnel policies and procedures which shall be made available to personnel.
C.Provisions shall be made for orientation and ongoing education programs for all personnel. There shall be written evidence that staff demonstrate competencies necessary to work in specific areas and/or with specific patient populations.
D.There shall be a job description for each position which delineates the qualifications, duties, authority and responsibilities inherent in each position.
1.For those authorized to perform defined functions in accordance with § 4.5.5(D)(11) of this Part, a job description delineating qualifications, duties, authority and responsibilities shall be provided.
2.For every individual within the hospital who is licensed, certified or registered by the state of Rhode Island, a mechanism shall be in place to verify currency of licensure electronically via the Department's licensure database.
E.There shall be work performance evaluation programs with appropriate records maintained.
F.Non-employee staff (including but not limited to volunteers, per diem staff and contractees) who are working in the hospital must adhere to policies and procedures of the hospital. The hospital must provide for adequate orientation, supervision and evaluation of the activities of non-employee staff.
G.If the hospital does not employ personnel to render required services, or obtains services from an outside source, arrangements for such services shall be made through written agreements or contracts.
1.The responsibilities, functions, objectives, terms of agreement, financial arrangements, charges and other pertinent requirements shall be clearly delineated in the terms of any contract negotiated by the hospital.
2.All contracts or agreements negotiated by the hospital shall be consistent with the provisions established in accordance with §§ 4.5.1(E)(12) through (13) of this Part.
H.Pursuant to R.I. Gen. Laws § 23-17-2, any hospital licensed pursuant to R.I. Gen. Laws Chapter 23-17, shall provide to all patients and staff, through posted notices in conspicuous places throughout the hospital, the current Center for Health Facility Regulations telephone number to call with concerns. Such notices shall be written in English and, at a minimum, the three most common languages used by patients served by each hospital as determined by such hospital, and shall include the internationally-recognized symbol for sign language (including a relay number for access by hearing/speech impaired (TTY)).
I.In accordance with R.I. Gen. Laws § 23-17-47, a health care facility shall require all persons, including students, who examine, observe or treat a patient or resident of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure registration status, if any, and staff position of such person. For hospital designated interpreters and bilingual clinicians, include fluency in sign languages or language other than English, if any, and staff position of such person on the badge. This badge shall be worn in a manner that makes the badge easily seen and read by the patient or visitor.
J.Health Screening
Upon hire and prior to delivering services, pre-employment health screenings shall be required for each individual who has or may have direct contact with a patient in the hospital. Such health screening shall be conducted in accordance with the Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title) promulgated by the Department of Health.
K.Safe Patient Handling
Each licensed hospital shall comply with the following as a condition of licensure:
1.Each licensed hospital shall establish a safe patient handling committee, which shall be chaired by a professional nurse or other appropriate licensed health care professional. A hospital may utilize any appropriately configured committee to perform the responsibilities of this section. At least half of the members of the committee shall be hourly, non-managerial employees who provide direct patient care.
2.Each licensed hospital shall develop a written safe patient handling program, with input from the safe patient handling committee, to prevent musculoskeletal disorders among health care workers and injuries to patients. As part of this program, each licensed health care facility shall:
a.Implement a safe patient handling policy for all shifts and units of the facility that will achieve the maximum reasonable reduction of manual lifting, transferring, and repositioning of all or most of a patient's weight, except in emergency, life-threatening, or otherwise exceptional circumstances;
b.Conduct a patient handling hazard assessment. This assessment should consider such variables as patient-handling tasks, types of nursing units, patient populations, and the physical environment of patient care areas;
c.Develop a process to identify the appropriate use of the safe patient handling policy based on the patient's physical and mental condition, the patient's choice, and the availability of lifting equipment or lift teams. The policy shall include a means to address circumstances under which it would be medically contraindicated to use lifting or transfer aids or assistive devices for particular patients;
d.Designate and train a registered nurse or other appropriate licensed health care professional to serve as an expert resource, and train all clinical staff on safe patient handling policies, equipment, and devices before implementation, and at least annually or as changes are made to the safe patient handling policies, equipment and/or devices being used;
e.Conduct an annual performance evaluation of the safe patient handling with the results of the evaluation reported to the safe patient handling committee or other appropriately designated committee. The evaluation shall determine the extent to which implementation of the program has resulted in a reduction in musculoskeletal disorder claims and days of lost work attributable to musculoskeletal disorder caused by patient handling, and include recommendations to increase the program's effectiveness; and
f.Submit an annual report to the safe patient handling committee of the facility, which shall be made available to the public upon request, on activities related to the identification, assessment, development, and evaluation of strategies to control risk of injury to patients, nurses and other health care workers associated with the lifting, transferring, repositioning, or movement of a patient.
3.Nothing in this section precludes lift team members from performing other duties as assigned during their shift.
4.An employee may, in accordance with established facility protocols, report to the committee, as soon as possible, after being required to perform a patient handling activity that he/she believes in good faith exposed the patient and/or employee to an unacceptable risk of injury. Such employee reporting shall not be cause for discipline or be subject to other adverse consequences by his/her employer. These reportable incidents shall be included in the facility's annual performance evaluation.
L.Overtime Requirement
All hospitals shall be in compliance with the provisions of R.I. Gen. Laws Chapter 23-17.20.
M.Credentialing of Advanced Practice Clinicians
1.All advanced practice clinicians shall be appropriately credentialed by the hospital.
2.All advanced practice clinicians shall be credentialed through the medical staff appointment process and shall be subject to continuing quality assurance review by medical staff mechanisms.
3.The medical staff shall delineate clinical privileges granted to advanced practice clinicians and shall communicate same in accordance with hospital policies.
4.The hospital shall document clinical privileges granted to advance practice clinicians. These documents shall be reviewed no less than every two (2) years by the medical staff so as to reflect current operations within the hospital and the continued competency of the advanced practice clinician.
4.5.8Professional Library
A.The hospital shall provide appropriate library services for the professional and technical needs of hospital personnel including:
1.current books, periodicals and other pertinent materials;
2.appropriate computer resources for literature search and retrieval;
3.adequate facilities; and
4.adequate personnel to maintain the library service.
4.5.9Rights of Patients
A.Every hospital shall observe the following standards with respect to each patient who is admitted to its facility as enumerated in R.I. Gen. Laws §§ 23-17-19.1 and 40.1-5-5.
1.The hospital shall inform the patient of the right to include a written durable power of attorney and/or living will into his/her medical record.
B.A copy of the Rights of Patients shall be given to each patient or his/her representative upon admission and shall be posted in a conspicuous place on the premises.
C.Patient Visitation Rights
1.All health care providers, as licensed under the provisions of R.I. Gen. Laws Chapters 5-29 and 5-37 and all health care facilities, as defined in R.I. Gen. Laws § 23-17-2, shall be required to note in their patients’ permanent medical records, the name of individual(s) not legally related by blood or marriage to the patient, who the patient wishes to be considered as immediate family member(s), for the purpose of granting extended visitation rights to said individual(s), so said individual(s) may visit the patient while he or she is receiving inpatient health care services in a health care facility.
a.The patient visitation provisions set forth in this section shall not prohibit a hospital from establishing reasonable policies related to the number of visitors each patient may have at any one time.
2.A patient choosing to designate said individual(s) as immediate family members for the purpose of extending visitation rights may choose up to five (5) individuals and do so either verbally or in writing. This designation shall be made only by the patient and can be initiated and/or rescinded by the patient at any time, either prior to, during, or subsequent to an inpatient stay at the health care facility.
3.The full names of individual(s) so designated, along with their relationship to the patient, shall be recorded in the patient’s permanent medical records, both at the inpatient health care facility and with the patient’s primary care physician.
4.In the event the patient has not had the opportunity to have said designation recorded in his or her medical records, a signed statement in the patient’s own handwriting attesting to the designation of said individual(s) as an immediate family member for the purpose of extending visitation right during the provision of health care services in an inpatient health care facility, along with their relationship to said individual(s) shall meet all the requirements of this section. The patient’s signature on said signed statement shall be witnessed by two individuals, neither of whom can be the designated individual(s). In the event such signed statement is not available, those designated as agents on a durable power of attorney for health care form shall be allowed visitation privileges.
5.This section shall not be construed to prohibit legally recognized members of the patient’s family from visiting the patient if they have not been so designated through the provisions of this section. No patient shall be required to designate individual(s) under the provisions of this section.
D.Concern Line
1.Pursuant to R.I. Gen. Laws § 23-17-52, any hospital licensed pursuant to R.I. Gen. Laws Chapter 23-17, shall provide to all patients and staff, through posted notices in conspicuous places throughout the hospital, the current Center for Health Facility Regulations telephone number to call with concerns.
2.Such notices shall be written in English and, at a minimum, the three most common languages used by patients and staff served by each hospital as determined by such hospital, and shall include the internationally-recognized symbol for sign language (including a relay number for access by hearing/speech impaired (TTY)).
4.5.10Research Involving Human Subjects
A.A hospital that conducts research involving human subjects shall comply with all applicable state and federal laws, rules and regulations, including any required review and approval by an Institutional Review Board (IRB). The hospital shall have written polices and procedures governing research activities.
B.If the hospital conducts research involving human subjects who are not otherwise patients of the hospital (i.e., not receiving inpatient, outpatient, or emergency services) the following requirements shall be met:
1.There shall be a written protocol for each research study which, at a minimum, describes the nature and purpose of the study, the procedures to be utilized, the extent and type of assessment/testing of subjects, the risks of participation, the content of and subject's access to records to be maintained, and provisions regarding confidentiality and disclosure of information.
2.Each subject shall be advised of the items listed in § 4.5.10(B)(1) of this Part, as well as his/her rights and responsibilities, and shall agree to participate in the research study. The use of written consent shall apply to all research participants, except those identified in the federal regulations that guide IRBs in the protection of human subjects (45 C.F.R. §§ 46.116 through 46.117 (2017)), and where the requirement for written consent has been explicitly waived by the hospital's IRB. Also, written consent shall not be required for studies that are exempt from IRB review (45 C.F.R. § 46.101 (2017)). Studies conducted using information abstracted from existing records in anonymous form shall not have a requirement of directly contacting individuals involved in the research.
a.In accordance with R.I. Gen. Laws § 23-17-19(10), except as otherwise provided in this subparagraph, if the health care facility proposes to use the patient in any human subjects research, it shall first thoroughly inform the patient of the proposal and offer the patient the right to refuse to participate in the project.
b.No facility shall be required to inform prospectively the patient of the proposal and the patient's right to refuse to participate when:
(1)the facility's human subjects research involves the investigation of potentially lifesaving devices, medications and/or treatments and the patient is unable to grant consent due to a life-threatening situation and consent is not available from the agent pursuant to R.I. Gen. Laws. Chapter 23-4.10 or the patient's decision maker if an agent has not been designated or an applicable advanced directive has not been executed by the patient; and
(2)the facility's institutional review board approves the human subjects research pursuant to the requirements of 21 C.F.R. §§ 50.20 through 50.27 (2017) and/or 45 C.F.R. §§ 46.116 through 46.117 (2017) (relating to the informed consent of human subjects).
c.Any health care facility engaging in research pursuant to the requirements of this section shall file a copy of the relevant research protocol with the Department, which filing shall be publicly available.
3.Hospital standards and procedures shall be observed in all clinical activities involving research subjects (e.g., phlebotomy or other specimen collection, EKG, etc.) unless deviation from standard procedures is integral to the research, in which case this shall be described in the written study protocol.
4.There shall be written procedures pertaining to the control, accountability, security, administration, and maintenance of records of receipt and disposition of all drugs and biologicals utilized in each research study.
5.If research staff become aware of any clinical condition/concern which may warrant further assessment or treatment, he/she shall promptly notify the subject and advise follow-up with a health care provider.
6.Records regarding a subject are exempt from the requirements of § 4.6.10 of this Part (medical records) but shall be maintained in conformance to the written study protocol. Subject records, either original or accurate reproduction, shall be maintained for a minimum of five (5) years.
7.In addition to the requirements of § 4.5.7 of this Part, there shall be evidence that all staff participating in a research study have received training in the specific protocols to be applied.
8.Research activities involving human subjects who are not otherwise patients of the hospital shall be exempt from the requirements of § 4.5.3 of this Part. However, there shall be a quality assurance program in effect to ensure conformance to the written study protocols. Quality assurance activities may be documented in the study protocol.
4.5.11Uniform Reporting System
A.Each hospital shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director with the advice of the Health Services Council.
B.Each hospital shall report to the licensing agency detailed financial and statistical data pertaining to its operations, services, and facilities. Such reports shall be made at such intervals and by such dates as determined by the Director and shall include but not be limited to the following:
1.utilization of inpatient and outpatient hospital facility and services;
2.unit cost of hospital services;
3.charges for rooms and services;
4.audited financial statements for both hospital and any parent corporation/foundation; and
5.quality of hospital care.
C.The licensing agency is authorized to make the reported data available to any state agency concerned with or exercising jurisdiction over the reimbursement or utilization of hospitals.
D.The directives promulgated by the Director pursuant to these regulations shall be sent to each hospital to which they apply. Such directives shall prescribe the form and manner in which the financial and statistical data required shall be furnished to the licensing agency.
4.5.12Inpatient, Emergency Department, and Observation Unit Data
A.All licensed hospitals in this state shall be subject to the uniform reporting of financial and statistical data on hospital inpatient services, emergency department services, and observation unit services in accordance with the technical and data specifications contained in Rhode Island Hospital Discharge Data Reporting Manual, Rhode Island Emergency Department Data Reporting Manual, and Rhode Island Observation Services Data Reporting Manual.
1.Data submitted in accordance with § 4.5.12 of this Part shall contain only the medical record number or the hospital assigned number and no other patient identifying information to ensure anonymity of the reported data.
2.The Department shall provide licensed hospitals with no less than a twenty (20) day comment period after issuing or changing the reporting requirements.
a.Licensed hospitals shall have a period of at least ninety (90) days after the comment period to comply with new or changed reporting requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.6** Patient Care Services {#sec-216-ricr-40-10-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.6}
4.6.1Admission, Transfer & Discharge
A.Each hospital shall have written admission, transfer and discharge policies and procedures pertaining to at least the following:
1.types of clinical conditions acceptable for admission to specific levels of care and appropriate clinical departments or services;
2.informing and offering advance directives to all patients upon admission;
3.constraints imposed by limitations of services, physical facilities or staff coverage;
4.emergency admissions;
5.requirements for informed consent signed by patient or legal representatives for diagnostic and treatment procedures;
6.internal transfer of patients from one level or type of care to another;
7.discharge and termination of services; and
8.provisions for a mechanism for recording, transmitting patient-specific information to other health care providers and receiving information essential to the continuity of patient care. (This mechanism shall include the required use of the Department's Continuity of Care form. See also § 4.6.1(C)(3)(c) of this Part); and
B.In addition to the above policies in § 4.6.1(A) of this Part each hospital shall adopt the following:
1.no person shall be denied admission to the hospital because of race, color, religion, ancestry, sexual orientation, or national origin;
2.every patient admitted to the hospital shall be and remain under the care of a member of the medical staff as specified under the by-laws;
3.no suspected or actually infected non-obstetric patient shall be admitted to the obstetric department or unit;
4.transfer agreements or contracts shall clearly delineate responsibilities of parties involved; and
5.pursuant to R.I. Gen. Laws § 23-17.14-15 not discourage persons who cannot afford to pay from seeking essential medical services; and not encourage persons who cannot afford to pay to seek essential medical services from other providers.
C.Discharge Planning
The hospital shall have a discharge planning process for all inpatients. Discharge planning policies and procedures must be in writing and shall include a mechanism for discharge planners to receive regular updates regarding new offerings of community programs and the complete range of current options available at discharge.
1.The hospital shall identify, at an early stage in hospitalization, all inpatients who are likely to suffer adverse health consequences on discharge if there is no adequate discharge planning.
2.A discharge planning evaluation shall be provided to all inpatients identified in § 4.6.1(C)(1) of this Part above, to other patients on patient request, the request of the person acting on the patient’s behalf, or upon the request of the physician.
a.The evaluation shall be timely to avoid unnecessary delays in discharge and must be part of the patient's medical record.
b.The evaluation shall include a needs assessment, the patient's capacity for self-care, and the availability of post-hospital services to meet the needs of the patient.
c.A registered nurse or social worker shall develop or supervise the development of the evaluation.
d.The results of the evaluation shall be discussed with the patient or the individual acting on the patient's behalf.
e.The evaluation shall be used to establish an appropriate discharge plan.
3.A registered nurse or social worker shall develop or supervise the development of a discharge plan if the discharge planning evaluation indicates the need for a discharge plan.
a.The hospital shall arrange for implementation of the discharge plan.
b.The hospital shall transfer or refer inpatients and outpatients to appropriate facilities, agencies, or outpatient services, as needed, for follow-up care.
c.Designated hospital personnel shall complete the “Continuity of Care” form approved by the Department for each patient who is discharged to another health care facility licensed under the provisions of R.I. Gen. Laws Chapter 23-17 (e.g., nursing facility). The Continuity of Care form and instructions for its use should be downloaded from the Department's website: http://health.ri.gov
4.The hospital shall reassess its discharge planning process on an on-going basis. The reassessment shall include a review of discharge plans, as well as a review of patients who were discharged without plans, to ensure that the process is responsive to discharge needs.
D.Discharge Planning: Substance Use Disorder, Opioid Use Disorder, and Chronic Addiction
1.Evaluation
a.The hospital must administer a standardized evaluation to all patients with an indication of substance use disorder, opioid use disorder, or chronic addiction. If the patient declines evaluation this must be documented in the medical record. If the patient is determined after an evaluation to have a substance use disorder or opioid use disorder then appropriate medical services will be offered to the patient. Services offered to the patient shall include, but are not limited, to clinically appropriate inpatient and outpatient services.
b.Hospitals shall have a written policy for evaluation available upon request, inspection, or related to investigation of complaint.
2.Laboratory Screening
For every patient presenting to the hospital with an opioid overdose, the hospital must order a laboratory screening to determine what substance(s) caused the overdose. If the patient refuses the laboratory screening, the hospital is still in compliance as long as the test was ordered. If the patient declines screening this must be documented in the medical record.
3.Education
a.The hospital must educate all patients who are prescribed opioids on the risks and benefits of prescribed opioids as well as safe storage and disposal in accordance with the section titled “Patient Education/Consent” in Rules and Regulations for Pain Management, Opioid Use and the Registration of Distributors of Controlled Substances in Rhode Island.
b.When patients present with indications of illicit drug use (including but not limited to the use of illegal substances or the use of diverted prescription drugs), the hospital must educate such patients on illicit drug use, including evidence-based harm reduction strategies such as proper syringe disposal and how to obtain non-prescription syringes.
c.If the Department issues a health advisory (either statewide or for the particular geographic area in which the hospital is contained) regarding an increase in overdoses or overdose deaths, the hospital is required to educate illicit drug use and diverted overdose patients with evidence-based harm reduction strategies.
4.Naloxone
a.The hospital must have a written policy that outlines when a prescriber should dispense or prescribe naloxone to patients. This policy must include a list of conditions that would prompt the dispensing or prescribing of naloxone. A sample list of conditions is found in the Department’s guidance document “Levels of Care for Emergency Departments and Hospitals for Treating Overdose and Opioid Use Disorder.”
b.For patients meeting the conditions set out in the hospital’s policy, a prescriber must dispense or prescribe naloxone.
c.For those patients who are dispensed or prescribed naloxone, education regarding how to administer naloxone shall be provided to patients prior to discharge.
d.Hospitals shall have a written policy for naloxone available upon request, inspection or related to investigation of complaint.
5.Peer Recovery
a.The hospital shall offer all patients the opportunity to speak with a peer recovery support specialist, if those patients:
(1)are diagnosed with substance use disorder or opioid use disorder using then evaluation protocol required by § 4.6.1(D)(1) of this Part, or
(2)are treated for an opioid overdose.
b.To fulfill the above requirement, at a minimum the hospital must inform the patient that the hospital will contact a peer recovery support specialist on the patient’s behalf.
c.Hospitals shall have a written policy for peer recovery available upon request, inspection or related to investigation of complaint.
6.Treatment Services
a.The hospital shall provide information to patients about appropriate inpatient and outpatient services, including but not limited to medication assisted treatment and biopsychosocial treatment, if those patients:
(1)are diagnosed with substance use disorder or opioid use disorder using then evaluation protocol required by § 4.6.1(D)(1) of this Part, or
(2)are treated for an opioid overdose.
b.Hospitals must make a good faith effort to assist the patient in obtaining an appointment with a qualified licensed professional. To fulfill the above requirement, at a minimum the hospital must present a list of names, addresses, and phone numbers of appropriate inpatient and outpatient services. This list shall include information about medication-assisted treatment. If the patient declines to receive information or assistance about treatment services this must be documented in the medical record.
c.Hospitals shall have a written policy for treatment services available upon request, inspection or related to investigation of complaint.
7.Notification of Emergency Contact
a.Prior to discharge and with patient consent, the hospital will attempt to notify the patient’s emergency contacts and peer recovery support specialist (if any of these individuals have been identified) pursuant to R.I. Gen. Laws § 23-17.26-3(iii). If the patient declines notification of an emergency contact or recovery coach, the treating provider will document this refusal in the medical record.
b.Hospitals shall have a written policy for notification of emergency contact available upon request, inspection, or related to investigation of complaint.
8.Right to Refuse Treatment
Pursuant to R.I. Gen. Laws § 23-17-19.1(4), a patient has the right to refuse any screening, treatment, or service described in §§ 4.6.1(D)(1) through (7) of this Part.
9.Overdose Reporting
Hospitals shall comply with the reporting requirements found in Rules and Regulations Pertaining to Opioid Overdose Prevention and Reporting (Part 20-20-5 of this Title).
E.Financial Interest Disclosure
1.Any health care facility licensed pursuant to R.I. Gen. Laws Chapter 23-17, which refers clients to another such licensed health care facility or to a residential care/assisted living facility licensed pursuant to R.I. Gen. Laws Chapter 23-17.4, or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client:
a.that the referring entity has a financial interest in the facility or provider to which the referral is being made;
b.that the client has the option of seeking care from a different facility or provider which is also licensed and/or certified by the state to provide similar services to the client.
2.The referring entity shall also offer the client a written list prepared by the Department of Health of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting:
Rhode Island Department of Health, Center for Health Facility Regulations 3 Capitol Hill, Room 306Providence, RI 02908401.222.2566
3.Non-compliance with §§ 4.6.1(E)(1) through (2) of this Part shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with R.I. Gen. Laws § 23-17.10.
4.6.2Patient Care Management
A.A mechanism shall be established for the periodic review and revision of patient care policies and procedures.
B.There shall be evidence that medical, nursing and other services are provided under an integrated written plan of care for each patient. Written care plans shall identify problems, goals, and interventions. Goals shall be measurable.
C.All orders for medications or treatments must be in writing. An order is considered to be in writing if: it is written and signed by a lawfully authorized person; or it is dictated to and transcribed by a registered nurse or other appropriately licensed person onto the order form. Additionally, the registered nurse or other appropriately licensed person must: date the order and identify the telephone or verbal order by the name and title of the authorized individual who gave the order; and sign the order entry with his/her own name and title. All verbal or telephone orders must be appropriately signed by a practitioner involved in the care of the patient no later than the end of the next calendar day.
1.Hospitals may implement a standing orders program authorizing licensed nurses and other licensed health care professionals acting within their scopes of practice to administer influenza and/or pneumococcal vaccines without a physician signature in accordance with an institution-approved or physician-approved protocol. The standing orders shall be in accordance with “Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” incorporated above at § 4.2(A)(19) of this Part.
D.There shall be a written policy for appropriate minimum, specific testing for all surgical inpatients and for all patients who are undergoing specific procedures requiring anesthesia in the inpatient and outpatient settings.
E.The hospital shall assure that drugs and biologicals are only administered by appropriately licensed professionals, including but not limited to, physicians, nurses, or physician assistants. Medication administration technicians shall not administer drugs or biologicals under any circumstances.
F.The hospital shall provide care and services to all patients in accordance with the prevailing community standard of care.
G.Medical Restraints:
In acute medical and pre/post-surgical care, a patient shall be free from physical and chemical restraint that is not medically necessary. A restraint shall only be used if needed to improve the patient's well-being and only if less restrictive interventions have been determined to be ineffective to protect the patient or others from harm.
H.Behavioral Restraints:
A patient shall be free from seclusion or restraint imposed as a means of coercion, discipline, convenience or retaliation by staff. Seclusion or restraint employed for behavior management shall only be used in emergency situations if needed to ensure the patient's or other's physical safety and less restrictive interventions have been determined to be ineffective.
1.Restraints/seclusion use shall be prescribed in writing and signed by a physician or other licensed practitioner acting within his/her scope of practice and permitted by the hospital to order restraints/seclusion. The type and duration of restraints/seclusion shall be specified. Standing or "on an as needed basis" (i.e., PRN) orders shall not be permitted.
2.Restraints/seclusion, if used, shall be addressed in the written treatment plan for the patient.
3.Restraints/seclusion use shall be based on an assessment of the patient, implemented in the least restrictive manner possible, implemented in accordance with safe and appropriate restraining techniques, and discontinued at the earliest possible time.
4.The condition of a restrained/secluded patient shall be continually assessed, monitored, and reevaluated.
I.Pain Assessment
All health care providers licensed by this state to provide health care services and all health care facilities licensed under R.I. Gen. Laws Chapter 23-17, shall assess patient pain in accordance with the requirements of the “Rules and Regulations Related to Pain Assessment” promulgated by the Department.
4.6.3Provision of Interpreter Services
A.Every hospital shall, as a condition of initial or continued licensure, provide a qualified interpreter, if an appropriate bilingual clinician is not available to translate, in connection with all services provided to every non-English speaker who is a patient or seeks appropriate care and treatment and is not accompanied or represented by an appropriate qualified interpreter or a qualified sign language interpreter who has attained at least sixteen (16) years of age.
B.No later than 1 July 2002, each hospital shall develop, establish and maintain a formal plan for the provision of language interpretation with respect to the provision of hospital services in all licensed settings.
1.Each hospital shall establish criteria for the qualification of interpreters. In addition to fluency in a language other than English, interpreters shall have demonstrated competency in the following topics, at a minimum:
a.the appropriate role of a medical interpreter;
b.the confidentiality of health care information;
c.the ethical issues involved in serving as a medical interpreter;
d.common medical terminology; and
e.relevant hospital policies and procedures.
2.Each hospital shall review the qualifications of and designate individuals as interpreters in specific languages. Such reviews and designations shall be documented.
3.Each hospital shall establish criteria for the qualification of bilingual clinicians. In addition to being bilingual, clinicians shall have knowledge of the following topics:
a.the appropriate role of a medical interpreter;
b.the ethical issues involved in serving as a medical interpreter;
c.common medical terminology; and
d.relevant hospital policies and procedures.
4.Each hospital, for the purposes of providing interpretive services, shall review the qualifications of and designate clinicians as bilingual in specific languages. Such reviews and designations shall be documented.
5.Each hospital may also contract with appropriate off-site interpreter service providers for the provision of qualified interpreter services provided that hospital has received the prior written approval of such arrangements from the state agency.
C.Each hospital shall post a multi-lingual notice in conspicuous places setting forth the requirements of § 4.6.3(A) of this Part in English, include the internationally-recognized symbol for sign language (including a relay number for access by hearing/speech impaired (TTY)) and include, at minimum, three (3) most common foreign languages used by the hospital as determined by the hospital.
4.6.4Central Service Functions
A.Hospitals with central service functions shall operate, under the supervision of a qualified person, a central service for the processing, sterilization, storing and dispensing of clean and sterile supplies and equipment.
B.Adequate facilities shall be provided for the cleaning, preparation, sterilization, aeration, storage and dispensing of supplies and equipment for patient care.
C.Areas for the processing of clean and dirty supplies and equipment shall be separated by physical barriers.
D.Written procedures shall be established for all central service functions including:
1.procedures for all sterilization and for monitoring the effectiveness thereof;
2.appropriate disposal of wastes and contaminated supplies; and
3.compliance with the provisions of Comprehensive Accreditation Manual for Hospitals, incorporated above at § 4.2(A)(23) of this Part.
E.Such procedures shall be subject to the approval of a multidisciplinary hospital group.
F.Reports of bacteriological tests and dated recordings of thermometer charts and inspection records shall be maintained in accordance with written procedures.
G.Central service procedures shall apply wherever sterilization is performed.
4.6.5Dietary Service
A.Each facility shall maintain a dietary service directed by a full-time person qualified by training and experience in organization and administration of food service.
B.Each hospital shall have at least one Registered Dietitian, licensed by the state, to direct nutritional aspects of patient care and to advise on food preparation and service.
C.Adequate space, equipment and supplies shall be provided for the efficient, safe and sanitary receiving, storage, refrigeration, preparation and service of food and other related aspects of the food service operation.
1.Any construction, addition, alterations affecting food service operations shall be in conformity with the requirements of R.I. Gen. Laws § 23-1-31.
D.Each hospital food service operation shall comply with the applicable standards of the Rhode Island Food Code (Part 50-10-1 of this Title).
E.Foods shall be prepared by methods that conserve nutritive value, flavor and appearance.
F.Foods served shall be palatable, attractive and at proper temperature.
G.Written policies and procedures shall be established for dietary services, pertaining to but not limited to the following:
1.responsibilities and functions of personnel;
2.standards for nutritional care in accordance with Recommended Dietary Allowances, incorporated above at § 4.2(A)(12) of this Part;
3.identifying patients at nutritional risk;
4.precise delivery of patient's dietary order;
5.alterations or modifications to diet orders or schedules;
6.food purchasing, storage, preparation and service;
7.safety and sanitation relative to personnel and equipment;
8.ancillary dietary services, including food storage and preparation in satellite kitchens, and vending operations;
9.ice making in accordance with Good Manufacturing Practices for Food (Part 50-10-4 of this Title); and
10.standards for enteral nutritional care.
H.Any hospital engaged in processing, handling, or both, of frozen foods shall be subject to standards of Good Manufacturing Practices for Food (Part 50-10-4 of this Title).
I.There shall be a diet manual maintained by the dietary service which shall be reviewed, revised as necessary and approved by a multidisciplinary group at least every five (5) years and more often as necessary. Diets served to patients shall comply with the principles set forth in the diet manual.
J.All patient diets shall be ordered in writing by the physician.
K.Assessments, observations and information pertinent to dietetic treatment shall be recorded in the patient's medical record by the dietitian.
L.A hospital contracting for food service shall require, as part of the contract, that the contractor comply with the provisions of these regulations.
4.6.6Disaster & Mass Casualty Program
A.Each hospital shall develop and maintain a written disaster plan which shall include provisions for complete evacuation of the facility and for the timely care of casualties arising from both external and internal disasters based on the guidelines of Comprehensive Accreditation Manual for Hospitals, incorporated above at § 4.2(A)(23) of this Part.
B.The plan shall also include provisions for:
1.disaster-site triage and distribution of patients to ensure the most efficient use of available facilities and services;
2.a mechanism for physician identification as well as route access and entrance to the hospital; and
3.back-up or contingency plans to address internal systems, electronic disasters, including a backup system for an electronic medical record file system, and/or equipment failures.
C.The plan(s) shall be developed and coordinated with the appropriate state and local agencies and representatives concerned with emergency, safety, rescue and disaster preparedness.
D.The disaster plan shall be rehearsed at least twice a year preferably as part of a coordinated drill in which other community emergency services agencies participate with hospital, medical, administrative, nursing and other personnel.
E.Written reports and evaluation of all drills shall be maintained.
F.A copy of the plan(s) and any revision thereto shall be submitted to the licensing agency.
4.6.7Emergency Service
A.Each hospital shall have a well-defined plan for emergency services based on community need and on the capability of the hospital and its specialized supportive services.
1.The hospital plan for emergency services shall be developed in cooperation with representatives of community emergency medical service agencies or groups (e.g., emergency medical service councils).
2.Hospitals without an emergency department or service shall have written policies and procedures governing the handling of emergencies.
3.Pursuant to R.I. Gen. Laws § 23-17-26, every hospital with an emergency medical care unit shall provide to every person prompt lifesaving medical treatment in an emergency:
a.without discrimination based on economic status or source of payment; and
b.without delaying treatment for the purpose of prior discussion of source of payment;
c.unless such delays can be imposed without material risk to the health of the person.
B.Each hospital emergency department or service shall be organized to provide twenty-four (24) hour services with adequate professional and ancillary staff coverage to ensure that all persons are treated within a reasonable length of time, commensurate with the priority for treatment.
C.Every emergency department or service shall have a person qualified by training and experience in the department twenty-four (24) hours a day who shall determine the nature, level and urgency of care required of all persons seeking treatment and to categorize them accordingly, assuring that serious cases are accorded priority treatment. If such person is a non-physician, he or she shall serve under the supervision of the physician-in-charge and in accordance with policies and procedures acceptable to the medical staff and hospital administration.
D.Every hospital emergency department or service shall have a qualified member of the medical staff assigned as physician-in-charge or made responsible for the emergency medical services, to ensure that emergency patient care services meet the standards of these regulations and for the coordination of physician coverage according to a plan established by the medical staff and approved by the governing authority.
E.At least one (1) physician on duty in the emergency department of a general hospital shall be certified by the American Board of Emergency Medicine or the American Board of Osteopathic Emergency Medicine or shall be eligible to sit for examination of one of the aforementioned boards; or shall be Board certified or eligible in Family Practice, Internal Medicine or General Surgery with at least one (1) year of practice in emergency medicine; or those physicians who have practiced in an emergency department setting for at least seven thousand (7,000) hours in sixty (60) months with two thousand (2,000) of said practice hours having been completed in the last twenty-four (24) months.
1.At least one physician on duty or immediately available "on call" in the emergency department of a psychiatric hospital shall be certified by the American Board of Psychiatry and Neurology or shall be eligible to sit for the examination of the aforementioned board.
F.Additional staff in the emergency department or service of a general hospital shall meet the following qualifications:
1.a physician who is Board certified or eligible in Family Practice, Internal Medicine, General Surgery or Pediatrics;
2.a physician with more than two (2) years of practice following full licensure; or
3.in those hospitals having approved residency training programs, by residents with more than two (2) years of training in the specialties of internal medicine, surgery, pediatrics, and/or emergency medicine, when such emergency department training is part of their formal residency training program.
G.In addition, hospitals shall have available on call twenty-four (24) hours a day, physicians in specialties appropriate to the scope of services provided by the hospital.
H.A current roster of physicians, medical specialists or consultants on emergency call, including alternates, shall be kept posted at all times in the emergency department or service.
I.The staffing pattern of nursing and allied health personnel shall be consonant with the scope and complexity of the emergency services provided. No less than one registered nurse who has training and experience in emergency care shall be assigned to the emergency services at all times.
J.A continuing inservice education training program in emergency medical care, including prehospital care protocols and standing orders in accordance with the provisions of the Department’s “Rules and Regulations Relating to Emergency Medical Services”, shall be conducted for all categories of health personnel in the emergency department or service in accordance with § 4.5.7 of this Part.
K.There shall be written policies governing emergency patient care services, supported by appropriate procedure manuals and reference materials. The policies and procedures shall pertain to at least the following:
1.medical staff and obligation for emergency patient care in accordance with § 4.6.7(A)(3) of this Part;
2.circumstances under which definitive care shall not be provided and procedures to be followed in referrals;
3.assignment of clinical privileges according to levels of professional competence;
4.procedures that may or may not be performed in the emergency department or service area;
5.handling of persons who are emotionally ill, under the influence of drugs or alcohol, dead on arrival, or other categories of special cases as determined necessary;
6.procedures for early transfer of severely ill or injured to special in-house treatment areas or to other facilities;
7.written instructions to be given for follow-up care and disposition of all cases;
8.notification of patient's personal physician and transmission of relevant reports;
9.disclosure of patient information in accordance with federal and state law;
10.communication with police, health authorities and emergency vehicle operators;
11.appropriate utilization of observation beds;
12.procurement of equipment and drugs; and
13.operation of the emergency department or service in times of disaster.
L.A list of poison antidotes and the telephone number of the Rhode Island Poison Control Center shall be available in the emergency department or service area.
M.The emergency service shall have necessary supportive services available on a twenty-four (24) hour basis. These services shall include, in accordance with these regulations, anesthesia service (§ 4.6.20 of this Part); clinical laboratory service with arterial blood gas analysis capability (§ 4.6.9(E)(1) of this Part); blood transfusion services (§ 4.6.9(H) of this Part); pharmaceutical service (§ 4.6.14 of this Part); radiology service including protocol to govern the interpretation by a radiologist, of diagnostic images produced by x-ray or other modalities, including a procedure for the prompt communication of the radiologist's interpretation (§ 4.6.15(A) of this Part); and surgical service (§ 4.6.19 of this Part).
N.Facilities, equipment, supplies and drugs for the reception, appraisal, examination, treatment and observation of emergency room patients shall be determined by the amount, type and extensiveness of services provided.
O.No less than the following special supplies and equipment shall be available and located within the general hospital emergency department or service:
1.oxygen;
2.electrocardiograph;
3.cardiac monitor and defibrillator with battery pack;
4.pacemaker;
5.central venous catheter set-up;
6.gastric lavage equipment;
7.suction device;
8.intravenous fluids and administration devices;
9.endotracheal intubation, pericardiocentesis, thoracostomy, and cricothyrotomy trays;
10.mechanical ventilator (readily available);
11.emergency obstetrical pack; and
12.pulse oximeter for measuring carboxyhemoglobin levels.
P.The emergency drug cart(s) and adjunctive emergency equipment shall be checked by an appropriate, designated individual at least once per shift to assure that all items required for immediate availability are actually contained in the cart and are in usable condition.
1.A signed record of such periodic inspections shall be maintained by the appropriate emergency department staff.
Q.A medical record shall be maintained on every patient seeking emergency care. For each visit to the emergency service, the medical record shall contain documentation relating to the following:
1.patient identification (name, address, age and sex);
2.time and means of arrival;
3.pertinent medical history of the illness or injury and physical findings;
4.emergency care given before arrival;
5.diagnostic and therapeutic orders;
6.reports of procedures, tests, treatments and findings;
7.diagnostic impression;
8.conclusion at termination of evaluation/treatment, including final disposition of patient, condition on discharge or transfer, and any instructions given for follow-up care;
9.a patient's leaving against medical advice; and
10.origin of incoming patient and destination of patient at discharge.
11.the standardized Rhode Island EMS Ambulance Run Report ("run report") provided, prepared and signed by the licensed emergency medical technician who completed the form.
R.A mechanism shall be developed to include the emergency department record into the patient's medical record in accordance with § 4.6.10(C) of this Part.
S.Those hospitals which have provisions for Mobile Intensive Care Communications manned by technical personnel shall comply with the requirements of R.I. Gen. Laws Chapter 23-17.6.
T.The standards of § 4.5.9 of this Part pertaining to "Rights of Patients" shall be observed for all patients treated in the emergency department or service. In addition, hospitals shall:
1.provide access to a physically separate room, office or chapel, wherein privacy can be guaranteed, for families when circumstances shall warrant (such room may have alternative uses); and
2.inform emergency service patients, by posting in an easily visible location, that the routine cost for use of the emergency service does not include additional professional service charges except in the case where residents who perform the service are employed by the hospital.
U.Restocking of Municipal Ambulance Supplies
1.Pursuant to R.I. Gen. Laws § 23-4.1-7.1, every hospital licensed in accordance with R.I. Gen. Laws Chapter 23-17, is required to restock supplies listed by the Director of Health that are used by a licensed emergency medical services provider in transporting emergency patients to such hospital.
a.Restocking will not be required:
(1)in the absence of documentation of supply usage on the emergency patient’s R.I. EMS ambulance run report, or
(2)if the licensed emergency medical services provider bills any third party payer for the supplies which were used.
b.The listing of supplies that are subject to mandatory restocking in accordance with § 4.6.7(U)(1) of this Part is available by contacting:
Rhode Island Department of Health, Office of Emergency Medical Services 3 Capitol Hill, Room 105Providence, RI 02908401-222-2401
V.Diversion Plan – Disaster Planning and Response
Hospitals with an emergency department or service shall maintain participation in and compliance with the Rhode Island Diversion Plan. Such compliance shall include retaining all required communication devices (e.g., Nextel system) in good operating condition and training of an adequate number of staff in the use of communication equipment as it relates to disaster planning/response and the proper execution of the Diversion Plan.
4.6.8Home Care Services
A.Hospitals with home care services as defined in § 4.3 of this Part, shall have an organizational structure designed in accordance with the provisions of § 4.5.6 of this Part.
B.A qualified person shall be responsible for the administrative and coordinating functions of the home care program. Such a person may be the physician responsible for the general direction of the medical services of the program.
C.A multidisciplinary group with representatives of the services provided shall be established to serve in an advisory capacity. The group shall meet as frequently as necessary, maintain written documented reports of its proceedings, and shall be responsible for no less than the following:
1.develop and recommend policies as required under §§ 4.6.1 through 4.6.2 of this Part, and such other policies as may be required pertaining to professional and ancillary services provided by and through the program;
2.assist in maintaining liaison with other health care providers;
3.assist in quality improvement program;
4.review annually all program policies and make recommendations; and
5.such other related functions as may be deemed advisable within the scope of responsibility of said group.
D.The general responsibility for the medical services provided in connection with the home care program shall be vested in an appropriately designated member of the medical staff in accordance with hospital policy.
1.Regularly scheduled meetings of personnel responsible for the provision of services (such as program staff, hospital personnel and representatives of participating community agencies) shall be held to affect coordination of patient care services.
E.Home health care program personnel shall be qualified to perform their respective duties in accordance with state licensure and acceptable professional qualification standards.
F.A policy and procedure manual shall be established which shall contain guidelines specifically related to the program such as:
1.definition of the scope of services offered;
2.admission and discharge policies;
3.procedures to be performed in the home;
4.circumstances that may require the patient to return to the hospital for treatment;
5.care of patients in an emergency; and
6.other such related policies and procedures.
G.A medical record shall be maintained for every patient receiving services in accordance with the provisions of § 4.6.10 of this Part.
H.Arrangements for the provision of services by a participating community agency or individual provider shall be documented by means of a written signed agreement or contract which shall include specific terms governing the mutual responsibilities for the nature, scope and cost of service to be provided.
4.6.9Laboratory Service
A.The director of laboratory service shall be a member of the medical staff, preferably a pathologist certified by the American Board of Pathology.
B.Staff personnel shall be sufficient in number and adequately qualified and licensed, as applicable, pursuant to R.I. Gen. Laws Chapter 23-16.3.
C.Laboratories shall have adequate space, equipment and supplies to perform the required volume of work with accuracy, efficiency and shall conform with the fire safety requirements found in section 15.4 of NFPA 99: Health Care Facilities Code, incorporated above at § 4.2(A)(15) of this Part.
D.Provisions shall be made to assure continuous availability of emergency laboratory services, including blood transfusion services.
E.Clinical Laboratory Services
1.Examination in the fields of hematology, chemistry, microbiology, immunology, urinalysis, immunohematology and other services necessary to meet patient care needs shall be provided within the institution in accordance with standard medical practice and these regulations.
2.Hospital clinical laboratory services shall be provided in accordance with Section 10.0 “Records and Reports,” Section 12.0 “Procedural Manual,” Sections 13.1 and 13.2 of “Collection, Identification and Examination of Specimens,” Section 14.0 “Radiobioassay, Pathological, and Cytological Examinations,” and Sections 15.1, 15.2, and 15.2.1 of “Methodologies for Quality Control” of “Rules and Regulations for Licensing Clinical Laboratories and Stations.”
F.Other Services
1.Other services not specifically required by these regulations to be provided on-site may be provided either by the hospital directly or by contractual arrangement with a Rhode Island licensed laboratory. Such services may include tissue pathology, cytotechnology, cytogenetics, etc.
2.In the latter instance, written policies and procedures shall be established governing prompt transportation of specimens and submission of reports; and all surgically removed tissues shall be examined by a pathologist and signed reports shall be included in the patient's medical record.
3.There shall be a written mechanism for internal and/or external professional review of tissue pathology services as needed.
G.Autopsy Service
1.An autopsy service shall be provided either directly by the hospital or by contractual arrangement with another licensed institution.
2.In either case, the facility shall have adequate space, equipment and personnel for the expected workload; autopsies on reportable death cases shall be subject to the requirements of rules and regulations pertaining to Medical Examiner System (Part 60-10-1 of this Title).
H.Blood Banks & Transfusion Services:
1.Each hospital shall provide appropriate facilities and equipment for the procurement, storage and administration of whole blood and blood products either directly or through participation in a multi-facility community blood collection, testing, storage and processing system. Psychiatric hospitals not providing this service shall be exempt from this requirement.
2.Written policies and procedures for all phases of operation of blood banks and transfusion services shall be established and periodically revised to comply with standards of Standards for Blood Banks and Transfusion Services, incorporated above at § 4.2(A)(21) of this Part.
I.Reports
Authenticated and dated reports of all pathological and clinical laboratory examinations including autopsies shall be made part of the patient's medical record in a timely manner as determined by hospital policy.
4.6.10Medical Records
A.The medical record service shall be under the full-time direction of a registered medical record administrator or a registered health information administrator (RHIA) who is certified by the American Health Information Management Association or who possesses equivalent training and experience.
B.The medical record department shall be adequately staffed and equipped to facilitate the accurate processing, checking, indexing, filing and retrieval of all medical records.
C.A medical record shall be established and maintained for every person treated on an inpatient, outpatient (ambulatory) or emergency basis, in any unit of the hospital. The record shall be available to all other units.
D.Written policies and procedures shall be established regarding content and completion of medical records by an appropriate multidisciplinary group. Also, this group shall be responsible for ongoing review.
E.Entries in the medical record shall be made by the responsible person in accordance with hospital policies and procedures.
F.The medical record shall contain sufficient information to identify the patient and the problem, to describe the treatment and document the results.
G.The content of all medical records (inpatient, outpatient, ambulatory and emergency) shall conform with applicable standards of Comprehensive Accreditation Manual for Hospitals, incorporated above at § 4.2(A)(23) of this Part. Further, medical records shall document the primary language of the patient; shall document any hospital provision of interpretive services by bilingual clinicians, qualified interpreters, or qualified sign language interpreters; and shall document the inability to provide interpretive services by bilingual clinicians, qualified interpreters, or qualified sign language interpreters as required by the patient.
H.The medical record, including the discharge summary, shall be completed within thirty (30) days of the patient's discharge.
I.Provisions shall be made for the safe storage of medical records in accordance with NFPA 99: Standard for the Protection of Records, incorporated above at § 4.2(A)(16) of this Part.
J.All medical records either original or accurate reproductions shall be preserved for a minimum of five (5) years following discharge of the patient in accordance with R.I. Gen. Laws § 23-3-26.
1.Records of minors shall be kept for at least five (5) years after such minor shall have reached the age of 18 years.
K.A mechanism shall be established to ensure confidentiality of all medical records, including computerized or electronic records.
L.Patient Access to Medical Records
1.Medical records, even though the property of the facility, may be requested by the patient or an authorized representative. All medical record requests shall be made in writing.
2.Charges shall not be made if the record is requested for continuity of care purposes or for immunization records required for school admission or by the applicant or beneficiary or individual representing an applicant or beneficiary for the purposes of supporting a claim or appeal under the provision of the Social Security Act or any federal or state needs-based benefit program such as Medical Assistance, RIte Care, Temporary Disability Insurance and Unemployment Compensation.
3.No fees shall be charged to applicants for benefits in connection with a Civil Court Certification Proceeding or a claim under the Worker’s Compensation Act R.I. Gen. Laws Chapter 28-29 as reflected in R.I. Gen. Laws § 23-17-19.1(16).
4.Records must be provided within thirty (30) days of the request or within thirty (30) days of completion of the medical record (whichever is later).
M.Hospital Closure/Change in Ownership and Medical Records
1.A hospital that voluntarily closes or changes ownership shall initiate a multimedia press release, within thirty (30) days, notifying the public of the facility closure. Such notice shall include the procedure by which individuals may obtain their medical records. In addition, written notification of facility closure and a plan for disposition of medical records shall be provided to the Department at least thirty (30) days prior to the closure/change of ownership of the hospital.
2.If a hospital changes ownership, all medical records in original, electronic, or microfilm form shall remain in the hospital or related institution, become part of the ownership agreement, and it shall be the responsibility of the new owner to protect and maintain these records.
3.If any hospital shall be finally closed, its medical records may be delivered to any other hospital(s) in the vicinity willing to accept and retain same, or may be delivered to any other lawfully permitted agency.
4.Medical records not claimed that are beyond five (5) years of the last date of discharge may be destroyed, provided that the requirements of § 4.6.10(J)(1) of this Part are met. Patients or their representatives shall be provided with an opportunity to claim their records prior to destruction of the records in the event of closure or change in ownership of the hospital.
4.6.11Nursing Service
A.Each hospital shall have an organized nursing department. A registered nurse qualified on the basis of education, experience and clinical ability shall be responsible for the nursing service.
B.There shall be a sufficient number of registered nurses on duty at all times to plan, assign, supervise and evaluate nursing care as well as to provide direct patient care as required.
1.There shall be a registered nurse on each inpatient unit at all times.
C.The number and type of registered nurses and ancillary nursing personnel shall be based on evaluation of patient care needs and staff capabilities for each patient care unit.
1.The hospital shall designate a registered nurse responsible for development of a written nursing staffing plan. This plan shall be:
a.specific by nursing unit;
b.developed in collaboration with nursing representation from each unit; and
c.flexible to respond to changes in patient acuity and/or census.
D.Nursing personnel shall be assigned to patient care units in a manner that minimizes the risk of cross-infection and accidental contamination.
E.There shall be written evidence that the nursing service provides safe and effective nursing care, through the comprehensive assessment and planning of each patient's care based upon such assessment and the implementation of the plan.
4.6.12Nuclear Medicine
A.Hospitals with nuclear medicine service may provide such services either directly or per contractual arrangement with another facility having a licensed program in accordance with “Rules and Regulations for the Control of Radiation.”
B.The direction of the nuclear service shall be provided by a member of the medical staff who through education and experience is qualified in nuclear medicine.
C.Policies and procedures shall be adopted for the receiving, handling, use, storage and disposition of radioactive isotopes based on the guidelines of Brodsky, Allen, Principles and Practices for Keeping Occupational Radiation Exposures at Medical Institutions as Low as Reasonably Achievable, incorporated above at § 4.2(A)(8) of this Part.
D.The type, quantity and quality of equipment for the nuclear medicine service shall be adequate to conduct reliable diagnostic studies and treatment.
E.There shall be quality control procedures and a quality management program as required under Part C of the “Rules and Regulations for the Control of Radiation.”
F.Records of services rendered shall be maintained and incorporated in the patient's medical record. Other records as required by law shall be maintained.
G.Radiobioassay Examinations
A nuclear medicine department performing radiobioassay examinations shall comply with the “Rules and Regulations for the Control of Radiation.” Furthermore, the nuclear medicine department shall be registered with the Office of Occupational and Radiological Health and conform to such directives as may be promulgated by the Department of Health for possession and use of radioactive materials.
4.6.13Outpatient (Ambulatory Care) Services
All hospital outpatient (ambulatory care) services shall conform to all applicable regulations, since such services are an integral part of the hospital and covered under its license.
4.6.14Pharmaceutical Service
Each hospital shall provide pharmaceutical services either directly within the institution or by contractual arrangement. In either instance, there shall be evidence of a current pharmacy license in compliance with R.I. Gen. Laws § 5-19.1-8. Pharmaceutical services shall be provided in accordance with “Rules and Regulations Pertaining to Pharmacists, Pharmacies & Manufacturers, Wholesalers & Distributors.”
4.6.15Medical Imaging Services
A.Each hospital, except those psychiatric hospitals who elect not to provide medical imaging services, shall maintain such services including provisions for emergency coverage, directed by a qualified radiologist, preferably one certified by the American Board of Radiology or having the equivalent in training and experience.
B.Hospitals maintaining radiotherapy services shall provide for their safe and effective operation under a director qualified by training and experience in therapeutic radiology.
C.X-ray equipment facilities and services shall be registered with the Office of Occupational and Radiological Health in accordance with Part B of “Rules and Regulations for the Control of Radiation.”
D.Sufficient technical personnel shall be available, consistent with the scope of services provided.
E.Adequate space and equipment shall be provided for medical imaging services including facilities for processing and storage of films and records.
F.Authenticated reports of the radiologist's interpretation, consultation and therapy shall be part of the patient's medical record.
G.Reports and films shall be preserved in accordance with § 4.6.10(I) of this Part.
H.All aspects of mammography services shall be managed in accordance with the provisions of the Rules & Regulations Related to Quality Assurance Standards for Mammography of the Rhode Island Department of Health and the applicable U.S. Food and Drug Administration (USFDA) regulations in 21 C.F.R. Part 900 (2017).
4.6.16Radiation Safety
A.The requirements of Parts A and F of “Rules and Regulations for the Control of Radiation” pertaining to x-ray equipment, safety precautions, monitoring of personnel and areas, administrative procedures, maintenance of records and other requirements shall apply to medical imaging services.
B.The requirements of Part H of “Rules and Regulations for the Control of Radiation” pertaining to particle accelerators shall apply to radiotherapy services utilizing particle accelerators.
4.6.17Reporting of Hospital Events & Incidents
A.Reportable Deaths:
1.All patient deaths occurring within the hospital, which are reportable in accordance with Rules and Regulations Pertaining to Medical Examiner System (Part 60-10-1 of this Title), shall be reported to the Office of State Medical Examiners.
2.In addition to the above, hospitals shall be subject to the appropriate requirements of Rules and Regulations Pertaining to Medical Examiner System (Part 60-10-1 of this Title).
B.Reportable Events
1.The hospital shall, within twenty-four (24) hours of receipt of such information, notify the licensing agency of any reportable event as defined in § 4.3 of this Part on a form and in a manner specified by the Department.
2.In cases of kidnapping or elopement, the report to the licensing agency shall include: patient medical record number; date and circumstances of the kidnapping/elopement; and outcome (e.g., return to hospital, adverse effect, etc.). Peer review and follow-up reporting shall be conducted as required in §§ 4.6.17(C)(5) through (6) of this Part.
3.Health care facilities shall provide the licensing agency with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. Health care facilities shall provide a plan, acceptable to the Director, for continued operation of the facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action.
C.Reportable Incidents
1.The hospital shall ensure that any employee who has reasonable cause to believe a reportable incident, as defined in § 4.3 of this Part, has occurred reports such information to a high managerial agent within twenty-four (24) hours of receipt of such information on a form and in a manner specified by the Department.
2.The hospital must maintain records of such reports including all subsequent actions taken.
3.Any reportable incident occurring on or after June 30, 1994 shall be reported in writing to the Department of Health within seventy-two (72) hours of when the hospital has reasonable cause to believe an incident has occurred. Any incident(s) occurring prior to June 30, 1994 need not be reported.
4.Written report shall be in compliance with § 4.9.1 of this Part and shall include a patient medical record number but no personal identifier.
5.The hospital shall ensure an appropriate committee or multidisciplinary group conducts peer review for all reportable incidents. The hospital shall notify the licensing agency of the outcome of the internal review as soon as this information is available but in no case later than six (6) months after the initial report and if the findings determine that the incident was within the normal range of outcomes, no further action shall be required.
6.If findings conclude that the incident was not within said normal range, the hospital shall conduct a root cause analysis or other appropriate process for incident investigation to identify causal factors that may have led to the incident and shall develop a performance improvement plan to prevent similar incidents from occurring in the future. The hospital shall provide the licensing agency the following information:
a.an explanation of the circumstances surrounding the incident;
b.an updated assessment of the effect of the incident on the patient;
c.a summary of current patient status including follow-up care and post incident diagnosis;
d.a summary of all actions taken to correct identified problems to prevent recurrence of the incident and/or improve overall patient care; and
e.a copy of the performance improvement plan developed as a result of the incident investigation.
D.Other Reporting Requirements
1.The hospital shall forward to the licensing agency copies of all hospital notifications and reports made in compliance with the federal Safe Medical Devices Act of 1990, 21 U.S.C. § 360i (2017).
2.The hospital shall report within 24 hours, to the licensing agency, allegations of patient abuse, neglect or mistreatment as defined in R.I. Gen. Laws Chapter 23-17-8.
4.6.18Social Services
A.Every hospital shall provide social services within the scope of a defined plan.
B.A social worker qualified on the basis of education, training and experience in accordance with the provisions of R.I. Gen. Laws Chapter 5-39.1 shall supervise the delivery of social services on a full, part-time, or consultative basis.
C.The service shall be staffed by a sufficient number of social workers, qualified on the basis of education, training and experience in accordance with the provisions of R.I. Gen. Laws Chapter 5-39.1.
D.Appropriate records shall be maintained and included in the patient's medical record.
4.6.19Surgical Service
A.Hospitals in which surgery is performed shall maintain an operating suite and a surgical department/service.
B.The surgical department/service shall be governed under rules and regulations which include surgical staff privileges, supporting services of other professional and paramedical personnel, provisions for emergency coverage and operating suite procedures, including standards of Rules and Regulations for the Termination of Pregnancy (Part 20-10-6 of this Title).
C.The operating suite shall be:
1.under the supervision of a person qualified by training and experience in operating room service;
2.adequately designed, to include operating and recovery rooms, proper scrubbing, sterilization and dressing room facilities, storage for anesthetic agents and shall be adequately equipped as required by the scope and complexity of services;
3.in compliance with safety requirements of section 5.1.14.1.1 NFPA 99: Health Care Facilities Code, incorporated above at § 4.2(A)(14) of this Part, and all other codes and regulations of §§ 4.7.4 and 4.8.1(A) of this Part; and
4.provided with prominently posted policies and procedures pertaining to safety controls.
D.A roster of current surgical privileges of every surgical staff member shall be maintained on file in the operating suite.
E.An operating room register shall be maintained which shall include as a minimum: patient's name, hospital number; pre- and post-operative diagnosis; complications, if any; name of surgeon; first assistant, anesthetist, scrub and circulating nurse; operation performed; and type of anesthesia.
F.The medical staff shall develop a policy acceptable to the Director identifying which tissue/specimens removed at surgery shall be submitted for pathological examination.
G.Policies and procedures governing infection control and reporting techniques shall be established in accordance with § 4.7.2(A)(4) of this Part.
H.The patient's medical record shall be available in the surgical suite at time of surgery and shall contain no less than the following information which shall be documented prior to surgery:
1.a medical history, physical examination and laboratory studies in accordance with § 4.6.2(C) of this Part;
2.a signed consent for surgical procedure except in emergencies; and
3.a pre-operative diagnosis.
I.An accurate and complete description of operative procedure including post-operative diagnosis shall be recorded by the operating surgeon within 48 hours following completion of surgery.
4.6.20Anesthesia Service
A.In hospitals with an anesthesia department/service, said department/service shall be under the direction of a board-certified anesthesiologist and shall be organized under written policies and procedures regarding staff privileges, emergency coverage on a twenty-four (24) hour basis, the administration of anesthetics, the maintenance of safety controls and qualifications and supervision of non-physician anesthetists and trainees.
B.Policies shall include provisions, in addition to the above, for the following:
1.pre-anesthesia evaluation by a physician;
2.safety of the patient during the anesthesia period;
3.review of patient's condition prior to induction of anesthesia and post anesthetic evaluation;
4.recording of all events related to each phase of anesthesia care, including the development of an intraoperative anesthesia record; and
5.the administration of anesthetics, including conscious sedation, in any setting in the hospital.
C.With respect to inpatients, a post-anesthesia evaluation shall be documented within forty-eight (48) hours after surgery by the individual who administered the anesthesia. If the person who administered the anesthesia is on leave (e.g., holiday, vacation, sick), an exception to this requirement shall be permitted.
D.With respect to outpatients, a post-anesthesia evaluation to assess proper anesthesia recovery shall be performed prior to discharge. All post-anesthesia evaluations shall be performed by the individual who administered the anesthesia or another qualified anesthesia provider.
E.Anesthesia shall only be administered by:
1.a qualified anesthesiologist;
2.a doctor of medicine or osteopathy (other than an anesthesiologist);
3.a dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state law or regulation;
4.a certified registered nurse anesthetist (CRNA) acting within his/her scope of practice and as authorized by the governing body;
5.a physician assistant acting within his/her scope of practice and as authorized by the governing body;
6.a certified nurse-midwife acting within his/her scope of practice and as authorized by the governing body;
7.a certified registered nurse practitioner acting within his/her scope of practice and as authorized by the governing body.
4.6.21Obstetric Service
A.Hospitals with an obstetric service shall provide adequate and comprehensive care to mothers and their newborn infants in an environment which provides protection from infection and cross-infection.
B.Written policies and procedures shall be developed to cover alternative use of obstetrical beds. These may include, but need not be restricted to patients undergoing "clean" gynecologic surgery.
C.The obstetric unit shall be under the general supervision of a registered nurse with training and experience in obstetric nursing.
D.The practice of midwifery shall be governed by the statutory and regulatory provisions of “Rules and Regulations for Licensing of Midwives;” all policies, procedures and protocols shall be approved by the medical staff and the governing body.
E.Hospitals with an obstetric service shall have no less than the following supportive services available on a twenty-four (24) hour basis:
1.diagnostic x-ray;
2.blood or blood component transfusion service;
3.clinical laboratory; and
4.anesthesia service in accordance with § 4.6.20 of this Part.
F.Satisfactory provisions shall be made for the care of patients in labor in adequately equipped labor rooms, conveniently located to the delivery room.
G.The delivery room(s) shall be of sufficient number and size to accommodate expected case load, personnel and equipment.
H.The delivery room shall meet applicable codes and regulations §§ 4.8.1 through 4.8.2 of this Part.
I.Hospitals performing both surgery and obstetric services shall maintain individually identified surgical and obstetric suites. Shared overflow facilities may be considered under special circumstances with advance approval of the licensing agency.
J.Provisions shall be made within the delivery area for the immediate care of emergencies with all necessary emergency equipment available.
K.An acceptable method and procedure shall be established for the positive associative identification of mother and child in the delivery room.
L.Facilities shall be available and policies and procedures established for maternity patients requiring isolation in accordance with § 4.7.2 of this Part.
M.A medical record shall be maintained for each mother and newborn and the applicable standards of Standards for Obstetric-Gynecological Services, incorporated above at § 4.2(A)(22) of this Part, shall serve as guidelines in determining minimum content.
1.A record of any prenatal care rendered shall be on file at the hospital and become part of the patient's medical record.
N.Where not otherwise covered in these regulations, the standards of Standards for Obstetric-Gynecological Services, incorporated above at § 4.2(A)(22) of this Part, shall serve as a guide in defining adequacy of the practices, facilities and equipment in the obstetric unit.
O.A policy and procedure manual shall be established which contains guidelines specifically related to the administration and management of clinical services pertaining to no less than the following:
1.definition of the limits of practice and services provided;
2.a signed informed consent which attests to the patient's full awareness of the type of services provided, and the hospital's recognition of parental choice for specific care services, except in emergency situations and provisions required by law;
3.the orientation and childbirth education program for expectant mothers;
4.plan of care to be developed by staff with the participation of the patient; such plan shall be mutually acceptable to the patient and staff but must include those provisions required by law. Furthermore, the plan shall identify parental choices pertaining to such services as the use of anesthesia; breast-feeding; circumcision of newborn male; and need for postpartum supportive services;
5.medical consultation (pediatric, OB/GYN or other);
6.the use of controlled substances;
7.accessibility to diagnostic services including laboratory, sonography, medical imaging, electronic monitoring, intensive care;
8.permitting the attendance of partners and/or family members during labor and delivery;
9.postpartum care based on acceptable standards for follow-up and evaluation after discharge which includes no less than:
a.provisions for the immediate postpartum care and assessment of newborn; eye prophylaxis to newborn; Rhogam test; metabolic screening and other tests for the newborn as may be required by law; postpartum examination; assessment of mother-child relationship including breast-feeding; follow-up care and family planning; preparation and submission of birth certificates; instruction in child care; immunizations and such other intrapartum and postpartum care as may be appropriate; and
10.such other as may be deemed necessary and appropriate.
P.Mothers may be discharged only if prenatal, perinatal and infant risk factors have been identified and documented according to the perinatal screening protocol of the Department (see § 4.10 of this Part) and the discharge plan includes confirmed arrangements for appropriate home and community follow-up services to address those risks. (See also §§ 4.6.22(G), (H), (J) and (N) of this Part).
4.6.22Newborn Service
A.Hospitals with a newborn service shall have a registered nurse with experience in the care of the newborn and shall be responsible for the nursing care of newborn infants. The appropriate nursing personnel shall be present in the nursery at all times.
B.Access to the nursery shall be limited to parents and personnel who are immediately concerned with the care of the newborn and the nursery environment and who are free of communicable infections.
C.The nursery shall be located and arranged to provide complete protection of newborn infants from infection and cross-infection and nursery accommodations shall include but shall not be limited to:
1.A regular nursery for the care of healthy infants, excluding:
a.infants with transmissible disease;
b.infants born to a mother who is a carrier or is infected by transmissible disease;
c.infants born outside the hospital or readmitted with suspected transmissible disease;
d.infants who are exposed to or have been infected; and
e.other infants excluded by the medical staff.
2.An isolation facility for the care of newborn infants with a suspected or confirmed diagnosis of infection.
3.A premature nursery for the care of premature infants or other high risk and seriously ill infants with non-infectious conditions. Vigorous healthy premature infants may be cared for in their own protected environment, such as in a standard incubator in the regular nursery.
D.A defined policy for the care of infants born outside the hospital, for infants born of a mother who has had no prenatal care, or for infants suspected of harboring an infectious disease.
E.The ventilation system shall maintain positive pressure in the nursery and shall be installed in accordance with section 7.31 of Guidelines for Design and Construction of Hospital and Health Care Facilities, incorporated above at § 4.2(A)(10) of this Part.
F.Prophylactic treatment to the eyes of newborn infants shall be administered in accordance with R.I. Gen. Laws § 23-13-4.
G.The physician attending a newborn child shall cause said child to be subject to the tests listed in the Rules and Regulations Pertaining to the Newborn Metabolic, Endocrine, and Hemoglobinopathy Screening Program (Part 20-05-1 of this Title).
H.An adequate record of the pertinent facts of the gestation and immediate neonatal period shall accompany the infant to the nursery and become part of the infant's medical record and may be used to assist in conducting risk assessments for discharge planning and public health services.
I.Where otherwise not covered in these regulations, the standards of Standards and Recommendations for Hospital Care of Newborn Infants, incorporated above at § 4.2(A)(20) of this Part, shall serve as a guide in defining the adequacy of facilities, equipment, furnishings and practices in the newborn nursery and formula room.
J.Hospital staff shall develop a multidisciplinary discharge plan for any drug exposed baby, pursuant to R.I. Gen. Laws § 42-72-5.
K.Infants may be discharged only if prenatal, perinatal and infant risk factors have been identified and documented according to the perinatal screening protocol of the Department (see § 4.10 of this Part) and the discharge plan includes confirmed arrangements for appropriate home and community follow-up services to address those risks. (See also §§ 4.6.22(G), (H), (J) and (N) of this Part.)
L.Each hospital that provides newborn/obstetrical services shall report to the Department the following data for each fiscal year:
1.the number of births;
2.the number of very low birth weight neonates (501 –1500 grams);
3.the number of low birth weight neonates (1501 – 2500 grams);
4.neonatal mortality rates by birth weight class;
5.admissions and transfers to neonatal intensive care units.
M.Each hospital that provides newborn/obstetrical services shall maintain records of morbidity rates of neonates for nosocomial infections, necrotizing enterocolitis, bronchopulmonary dysplasia, and intraventricular hemorrhage.
N.Each hospital that provides newborn/obstetrical services shall report annually to the Department its survival rates for the hospital fiscal year as compared with the most recent rates reported by the National Institute of Child Health and Human Development Neonatal Network and the morbidity rates specified in § 4.6.22(M) of this Part. If the survival rate for the hospital’s newborn unit is lower than the survival rates reported by the National Institute of Child Health and Human Development Neonatal Network by more than twenty-five percent (25%), the newborn unit shall file a written plan with the Department for the identification of the cause(s) of excess mortality and a plan for correction, if indicated.
4.6.23Birth Center Service
A.Hospitals with an obstetric service may elect to have a birth center service as defined in § 4.3 of this Part. An organizational structure for such service shall be designed in accordance with § 4.5.6 of this Part.
B.The birth center service shall be under the direction of a medical director who is a board certified obstetrician/gynecologist, with full obstetrical privileges, and who shall be responsible for all the clinical and medical matters pertaining to the management of pregnancy, birth, postpartum, newborn and gynecological health care of low-risk women, including the approval of written policies and procedures and protocols for midwifery care management where appropriate and applicable.
1."Low-Risk" refers to expected normal, uncomplicated prenatal course, assisted by adequate prenatal care and prospects for a normal uncomplicated birth based on continual screening for high risk factors which would preclude admission to the center, or require referral and/or transfer from the center in accordance with the transfer policies pursuant to § 4.6.1(A)(6) of this Part.
C.A midwife licensed in this state or a physician with obstetric privileges may be designated to direct the administrative operation of the center and the management of clinical services.
D.An appropriate number of qualified professionals and ancillary personnel shall be assigned to the birth center service. Two (2) staff members shall be in attendance at each birth, one of the two shall be a physician with hospital obstetric privileges or a midwife with delivery privileges and licensed in this state. The other member may be a licensed midwife with delivery privileges, an obstetric physician, or licensed physician assistant with training and experience in obstetric care and resuscitation of the newborn, or a licensed nurse with training and experience in obstetric care and resuscitation of the newborn.
1.The practice of midwifery shall be governed by the statutory and regulatory provisions of “Rules and Regulations for Licensing of Midwives;” all policies, procedures and protocols shall be approved by the medical director and the governing body.
2.There shall be on the premises at all times, when a woman is in labor, a staff person who holds a current certificate in cardiopulmonary resuscitation from a recognized program such as the American Heart Association.
3.Whenever one or more women in labor are on the premises, there shall be one staff member in excess to the number of women in labor.
E.A policy and procedure manual shall be established which contains guidelines specifically related to the administration and management of clinical services pertaining to no less than the following:
1.definition of the limits of practice and services provided;
2.the criteria for the selection of clients based on established medical and social risk factors associated with possible poor outcomes and utilizing as guidelines no less than the risk factors of “Rules and Regulations for Licensing Birth Centers,” which would preclude admission to the center;
3.the criteria for the referral and/or transfer of clients and/or newborn utilizing as guidelines the high risk factors of “Rules and Regulations for Licensing Birth Centers;”
4.a signed informed consent which attests to the client's full awareness of the type of services provided at the birth center, and the birth center's recognition of parental choice for specific care services, except in emergency situations and provisions required by law;
5.the orientation and childbirth education program for expectant mothers, based on the provisions of “Rules and Regulations for Licensing Birth Centers;”
6.plan of care to be developed by staff with the participation of the client; such plan shall be mutually acceptable to the client and staff but must include those provisions required by law. Furthermore, the plan shall identify parental choices pertaining to such services as the use of anesthesia in accordance with “Rules and Regulations for Licensing Birth Centers;” breast-feeding, circumcision of newborn male, and need for postpartum supportive services. Such plan shall be based on the provisions of “Rules and Regulations for Licensing Birth Centers;”
7.prenatal care to be provided either directly at the birth center or in another setting as approved by the medical director and the governing body; and provided, the professional staff providing the prenatal care meets the staff requirements of these regulations, and policies are established by the medical director governing the prenatal care practices and admission criteria of a woman in active labor, which are consistent with the birth center services practice;
8.medical consultation (pediatric, OB/GYN or other);
9.the use of controlled substance;
10.the use of anesthesia in accordance with “Rules and Regulations for Licensing Birth Centers;”
11.accessibility to diagnostic services including laboratory, sonography, medical imaging, electronic monitoring, intensive care;
12.labor and delivery (including provisions pertaining to § 4.4.4(A)(1) of this Part);
13.permitting the attendance of partners and/or family members during labor and delivery;
14.the provision of services on a twenty-four (24) hour basis;
15.postpartum care based on acceptable standards for follow-up programs of care and postpartum evaluation after discharge which includes no less than:
a.discharge of mother and newborn generally within twenty-four (24) hours after birth;
b.accessibility by telephone, twenty-four (24) hours a day of center's physician, midwife or nurse to assist mothers in case of need during postpartum period;
c.home visitation within twenty-four (24) hours of discharge by a member of the center's professional staff to insure continuity of care and assessment of mother and newborn;
d.provisions for the immediate postpartum care and assessment of newborn; eye prophylaxis to newborn; Rhogam test; metabolic screening and other tests for the newborn as may be required by law; postpartum examination; assessment of mother-child relationship including breast-feeding; follow-up care and family planning; preparation and submission of birth certificates; instruction in child care; immunizations and such other intrapartum and postpartum care as may be appropriate; and
16.such other as may be deemed necessary and appropriate.
F.A mechanism shall be established for the systematic review of professional and administrative services and the quality improvement program.
G.A clinical record shall be maintained for every client and newborn in accordance with the appropriate provisions of § 4.6.10 of this Part.
H.Food Services
Provisions shall be made for the availability of appropriate nourishments and light snacks for clients and family members.
I.Physical Setting and Equipment
Birth center service shall be provided in a home-like environment, designated and equipped to protect the health and safety of clients and personnel, and to facilitate emergency exit for the transfer of mothers and/or newborns in the event of emergency.
1.Reception areas, examination room, family rooms and other supportive areas shall be provided and designed to give privacy and comfort to clients and their families.
2.The birth room shall be spacious enough to accommodate staff to move freely and to include at least:
a.a large bed or double bed;
b.chairs (lounge and straight-back);
c.a bassinet;
d.space for birth room supplies and equipment and family belongings; and
e.access to a sink with hot and cold running water with elbow-wrist controls.
3.Acceptable toilet facilities shall be available to each laboring woman and adequate shower facilities shall also be available.
4.Provisions shall be made for areas such as medication and storage areas, utility areas and such others as may be necessary.
5.Equipment in the birth center shall be limited to those items needed to provide low risk maternity care and shall include equipment to initiate emergency procedures in life threatening events to mothers and newborns. Such equipment shall include:
a.oxygen and positive pressure masks;
b.delee trap suction and infant laryngoscope and airways;
c.IV equipment;
d.blood expanders;
e.medications identified in protocols for emergency needs; and
f.infant transport equipment and infant warmers.
J.Mothers and infants may be discharged only if prenatal, perinatal and infant risk factors have been identified and documented according to the perinatal screening protocol of the Department (see § 4.10 of this Part) and the discharge plan includes confirmed arrangements for appropriate home and community follow-up services to address those risks. (See also §§ 4.6.22(G), (H), (J) and (N) of this Part.)
4.6.24Tertiary Care Services: Neonatal Intensive Care Units (NICUs)
A.Approval to Operate a NICU and General Requirements
1.In order to use the designation “neonatal intensive care unit” or “NICU”, a hospital shall obtain approval from the Department’s Center for Health Facility Regulations. Said approval shall be issued by the Department if the NICU meets the requirements defined in these regulations.
a.Each hospital shall renew this NICU designation annually.
2.Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described in these regulations, the Department shall approve the hospital’s designation as a NICU.
3.A hospital that has not received approval by the Department under this section shall not use the designation “neonatal intensive care unit” or “NICU” or any substantially similar phrase to describe any such services provided and shall not provide neonatal intensive care unit services.
4.A hospital that operates a neonatal intensive care unit approved by the Department shall maintain capabilities and provide services that include, but are not limited to, those capabilities and services described in §§ 4.6.24(D), (E), and (F) of this Part. A hospital that operates a neonatal intensive care unit approved by the Department shall upgrade its capabilities and services as needed to meet the recommendations of the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.
5.A hospital that operates a NICU and determines that the NICU no longer meets minimum standards of these regulations shall notify the Department of Health and file a plan of correction within fifteen (15) days of such determination by a hospital. The plan of correction shall be subject to § 4.9.3 of this Part.
6.A NICU shall provide consultation, transportation, and professional educational offerings to staff of other obstetrical facilities in the state.
7.A hospital that operates a neonatal intensive care unit approved by the Department shall have written protocols in place that incorporate the following components:
a.continuous involvement of parents in an infant’s care to maximize pre-discharge education regarding care of the infant;
b.nursing orientation and ongoing inservice education in the theory and skills necessary to function in a neonatal intensive care unit environment;
c.emergency transport of infants to the neonatal intensive care unit from other facilities;
d.administration, credentialing of staff, and staffing patterns of the neonatal intensive care unit.
B.Minimum Standards: Volume
1.An existing neonatal intensive care unit shall maintain an average daily census of at least fifteen (15) neonates.
2.As part of the approval process for a new (or proposed) neonatal intensive care unit, the hospital shall provide data to the Department demonstrating a reasonable expectation of referrals of high risk maternity patients so that an average daily census of at least fifteen (15) neonates is achievable within two (2) years of its opening date.
3.As part of the approval process for a new (or proposed) neonatal intensive care unit, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed neonatal intensive care unit is likely to result in the average daily census falling below fifteen (15) neonates at any existing neonatal intensive care unit(s) in the state. If this outcome is likely, the proposal shall describe how the overall quality of care for all very low birth weight neonates in the state will be improved with the addition of the proposed unit.
C.Minimum Standards: Survival Rates
1.Each hospital that has an approved neonatal intensive care unit shall maintain a record of the neonatal survival rate (i.e., the rate at twenty-eight [28] days after delivery) and survival rate at discharge for very low birth weight neonates by 250 gram weight groups (i.e., 501 – 750 grams, 751 – 1000 grams, 1001 – 1250 grams, 1251 – 1500 grams).
2.Each hospital shall maintain records of morbidity rates of neonates for nosocomial infections, necrotizing enterocolitis, bronchopulmonary dysplasia, and intraventricular hemorrhage.
3.Each hospital shall report annually to the Department its survival rates for the hospital fiscal year as compared with the most recent rates reported by the National Institute of Child Health and Human Development Neonatal Network and the morbidity rates specified in § 4.6.24(C)(2) of this Part. If the survival rate for the hospital’s neonatal intensive care unit is lower than the survival rates reported by the National Institute of Child Health and Human Development Neonatal Network by more than twenty-five percent (25%), the neonatal intensive care unit shall file a written plan with the Department for the identification of the cause(s) of excess mortality and for correction of the rates.
D.Staffing Requirements
1.A hospital that operates a neonatal intensive care unit approved by the Department shall be in compliance with the following staffing requirements:
a.A board-certified neonatologist licensed in Rhode Island shall be designated as the medical director of the neonatal intensive care unit;
b.The registered nurse who has responsibility and accountability for the twenty-four (24) hour nursing management of the neonatal intensive care unit shall, at a minimum, be licensed in Rhode Island, have earned a bachelor’s degree in nursing with additional education in neonatology, and have three (3) years of clinical experience, two (2) of which are in the specialty area of neonatology;
c.A registered dietitian licensed in Rhode Island with experience in neonatal nutrition shall actively participate in the management of neonates in the neonatal intensive care unit;
d.A respiratory therapist licensed in Rhode Island and trained in the neonatology specialty area shall be available to the neonatal intensive care unit twenty-four (24) hours per day.
E.Service Requirements
A hospital that operates a neonatal intensive care unit approved by the Department shall provide services that include but are not limited to the following:
1.twenty-four (24) hour emergency transport team for transferring sick newborns from the birth facility to the neonatal intensive care unit;
2.ventilatory assistance and/or complex respiratory management;
3.capability of continuous intravenous administration of vasopressor agents;
4.insertion and maintenance of all types of venous and arterial lines;
5.phototherapy;
6.exchange transfusions;
7.continuous cardiorespiratory monitoring;
8.complex nutritional and metabolic management including total parenteral nutrition;
9.extensive pediatric radiology, diagnostic imaging, and subspecialty services;
10.full range of laboratory services including microchemistry available on a twenty-four (24) hour basis;
11.pharmacy services experienced in neonatal medications and dosage;
12.surgical therapies and post-surgical care for the neonate;
13.access to pediatric subspecialty consultation;
14.availability of developmental consultation;
15.organized interdisciplinary process for continuous quality monitoring;
16.crisis-oriented support and ongoing psychosocial services, including social work services and the availability of psychiatric consultation for the parents of the neonate.
F.Equipment Requirements
A hospital that operates a neonatal intensive care unit approved by the Department shall maintain equipment in good working order that includes but is not limited to the following:
1.incubators;
2.cardiorespiratory monitors with high/low alarm and oximeters;
3.warming tables;
4.infusion pumps;
5.oxygen humidification and warming systems;
6.oxygen analyzer;
7.transcutaneous blood gas monitors;
8.arterial and venous catheterization equipment;
9.resuscitation and other life support medications and equipment;
10.ventilators with heated humidity and alarm systems;
11.transducers for invasive cardiac monitoring;
12.transport incubators.
G.Penalties for Noncompliance
The penalties for violations of the standards set forth in § 4.6.24 of this Part shall be in accordance with those set forth in R.I. Gen. Laws Chapter 23-17 and § 4.4.6 of this Part. Failure to maintain the minimal neonatal intensive care unit standards set forth in these regulations may result in the revocation or suspension of the hospital’s neonatal intensive care unit designation and/or cessation of its activities. A hospital shall post notices for patients and shall notify physicians if its designation as an approved neonatal intensive care unit has been revoked or suspended.
4.6.25Tertiary Care Services: Primary and/or Elective Percutaneous Coronary Intervention Programs
A.Approval to Operate a Primary and/or Elective Percutaneous Coronary Intervention Program and General Requirements
1.In order to use the designation “primary percutaneous coronary intervention program" and/or “elective percutaneous coronary intervention program,” a hospital shall obtain approval from the Department’s Center for Health Facility Regulations. Said approval shall be issued by the Department if the primary and/or elective percutaneous coronary intervention program meets the requirements defined in these regulations.
a.Each hospital shall renew primary and/or elective percutaneous coronary intervention program designation annually.
2.Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described in these regulations, the Department shall approve the hospital’s designation as a primary and/or elective percutaneous coronary intervention program.
3.A hospital that has not received approval by the Department under this section shall not use the designation “primary percutaneous coronary intervention program,” or “elective percutaneous coronary intervention program,” or any substantially similar phrase, to describe any such services provided and shall not perform primary and/or elective percutaneous coronary interventions.
4.A hospital that operates a primary and/or elective percutaneous coronary intervention program approved by the Department shall maintain capabilities and provide services that include, but are not limited to, those capabilities and services described in §§ 4.6.25(D), (E), (F) of this Part. A hospital that operates a primary and/or elective percutaneous coronary intervention program approved by the Department shall maintain its capabilities and services as needed to meet the recommendations of the American College of Cardiology and the American Heart Association.
5.A hospital that operates a primary and/or elective percutaneous coronary intervention program and determines that primary and/or elective percutaneous coronary intervention program no longer meets minimum standards of these regulations shall notify the Department of Health and file a plan of correction within fifteen (15) days of such determination by a hospital. The plan of correction shall be subject to the provisions of § 4.9.3 of this Part.
6.A hospital that operates an approved elective percutaneous coronary intervention program shall have an approved primary percutaneous coronary intervention program available on-site.
B.Minimum Standards: Volume
1.An existing primary percutaneous coronary intervention program shall maintain an annual minimum volume of at least thirty-six (36) primary percutaneous coronary intervention procedures.
2.An existing elective percutaneous coronary intervention program shall maintain an annual minimum volume of at least two hundred (200) percutaneous coronary intervention procedures.
3.As part of the approval process for a new (or proposed) primary percutaneous coronary intervention program, the hospital shall provide data to the Department demonstrating a reasonable expectation of attaining and maintaining a minimum volume of thirty-six (36) primary percutaneous coronary intervention procedures per year within one (1) year of its opening date.
4.As part of the approval process for a new (or proposed) elective percutaneous coronary intervention program, the hospital shall provide data to the Department demonstrating a reasonable expectation of attaining and maintaining a minimum volume of two hundred (200) elective angioplasty procedures per year within two (2) years of its opening date.
5.As part of the approval process for a new (or proposed) primary percutaneous coronary intervention program, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed primary coronary angioplasty program is likely to result in the annual volume of procedures performed by existing primary percutaneous coronary intervention programs falling below thirty-six (36) primary percutaneous coronary intervention procedures per year. If this outcome is likely, the proposal shall describe how the overall quality of care for all primary percutaneous coronary intervention patients in the state will be improved with the addition of the proposed program.
6.As part of the approval process for a new (or proposed) elective percutaneous coronary intervention program, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed elective percutaneous coronary intervention program is likely to result in the annual volume of procedures performed by existing elective percutaneous coronary intervention programs falling below two hundred (200) percutaneous coronary intervention procedures per year. If this outcome is likely, the proposal shall describe how the overall quality of care for all elective percutaneous coronary intervention patients in the state will be improved with the addition of the proposed program.
C.Minimum Standards: Survival Rates and Door-to-Balloon Times
1.Each hospital that has an approved primary and/or elective percutaneous coronary intervention program shall maintain a record of the inhospital mortality rate and emergency coronary artery bypass graft (CABG) rate (i.e., bypass operation during the same hospital stay) for patients having percutaneous coronary intervention procedures.
2.Each hospital that has an approved primary and/or elective percutaneous coronary intervention program shall participate in a nationally recognized database acceptable to the Director. To the extent possible, risk adjusted rates, based on data from nationally recognized databases and methods acceptable to the Director, shall be used.
3.Each hospital that has an approved primary percutaneous coronary intervention program shall maintain a record of door-to-balloon times for each patient.
4.Each hospital shall report the following data to the Department annually:
a.the emergency coronary artery bypass (CABG) rate for patients having percutaneous coronary intervention;
b.the hospital’s risk-adjusted PCI mortality rate, based on a nationally recognized database and methods acceptable to the Director;
c.the 95% confidence interval around the hospital’s PCI mortality rate;
d.the national average PCI mortality rate from the national PCI database in which the hospital participates; and
e.the 95% confidence interval around the national PCI mortality rate. If the hospital’s annual risk-adjusted PCI mortality rate is statistically significantly higher than the national rate at the 95% level of confidence, then the hospital shall file a corrective action plan.
D.Staffing Requirements
A hospital that operates a primary and/or elective percutaneous coronary intervention program approved by the Department shall be in compliance with the following staffing requirements:
1.A board-certified cardiologist licensed in Rhode Island shall be designated as the director of the cardiac catheterization laboratory that includes the primary and/or elective percutaneous coronary intervention program.
2.Physicians doing primary and/or elective percutaneous coronary intervention procedures shall have training in adult or pediatric interventional cardiology,
3.Each hospital that has an approved primary and/or elective percutaneous coronary intervention program shall have a written procedure for granting and renewing privileges for physician-operators that specifies the required training, experience, board certification, annual volume of procedures, and other factors which will indicate acceptable proficiency.
4.The hospital shall monitor annual procedural volume, complication rates, emergency CABG rates, and inhospital mortality for each operator.
a.For the purpose of counting procedures, an interventional procedure is defined as a single session with a patient in the procedure room, irrespective of how many or what types of interventions are performed during the session. Only one physician may claim credit for a particular procedure. A physician-operator who claims credit for a procedure is the physician in charge of it. In a teaching program, the trainee will take an active role in the procedure under the direction of the supervising physician, who is responsible. The attending physician who takes primary responsibility for the procedure shall be credited with performing it.
5.The nursing supervisor shall be a registered nurse licensed in Rhode Island familiar with the overall function of the cardiac catheterization laboratory with critical care experience, knowledge of cardiovascular medications, ability to start intravenous solutions, and experience in operating room techniques.
6.At least one (1) technologist, who may or may not be a certified radiological technologist, shall be skilled in radiographic and angiographic imaging principles and techniques.
7.Physicians performing primary percutaneous coronary intervention procedures shall have an annual minimum volume of at least seventy-five (75) percutaneous coronary intervention procedures of which at least eleven (11) are primary percutaneous coronary intervention procedures across all hospitals where he/she practices and has privileges.
8.Physicians performing elective percutaneous coronary intervention procedures shall have an annual minimum volume of at least seventy-five (75) percutaneous coronary intervention procedures across all hospitals where he/she practices and has privileges.
E.Service Requirements for Primary and/or Elective Percutaneous Coronary Intervention Programs Without On-Site Coronary Artery Bypass Graft Surgery Program
1.A hospital that operates an approved primary and/or elective percutaneous coronary intervention program without on-site coronary artery bypass graft surgery program shall establish a memorandum of understanding, acceptable to the Director, with a hospital that has an on-site coronary artery bypass graft surgery program for transfer of patients requiring emergency cardiac surgery.
2.A hospital that operates an approved primary and/or elective percutaneous coronary intervention program without on-site coronary artery bypass graft surgery program shall develop rapid transfer protocols, acceptable to the Director, with the area emergency medical services provider for transfer of patients requiring emergency cardiac surgery.
F.Equipment Requirements
A hospital that operates a primary and/or elective percutaneous coronary intervention program approved by the Department shall have a catheterization laboratory that shall have proper equipment that is appropriate for the types of procedures performed in the laboratory and is in accordance with the guidelines issued periodically by the American College of Cardiology and the American Heart Association.
G.Quality of Care
1.The primary and/or elective percutaneous coronary intervention program shall have regular, frequent, and formal review in a multidisciplinary conference of all deaths and major complications.
2.The primary and/or elective percutaneous coronary intervention program shall maintain a database, acceptable to the Director, that collects and analyzes patient data sufficient to analyze utilization and outcome data and to determine the reasons for substantial deviations from the average utilizations and outcomes reported by nationally recognized databases.
H.Reporting Requirements
Each hospital with an approved primary and/or elective percutaneous coronary intervention program shall report to the Department for each hospital calendar year:
1.the number of primary and/or elective percutaneous coronary intervention procedures;
2.the number of primary and/or elective percutaneous coronary intervention by primary operator and the number of transfers from another hospital;
3.the number of emergency coronary artery bypass graft surgeries in the same hospital stay following primary and/or elective percutaneous coronary intervention procedures;
4.the number of transfers to another hospital for emergency coronary artery bypass graft surgeries following a primary and/or elective percutaneous coronary intervention;
5.the inhospital mortality rate for primary and/or elective percutaneous coronary intervention patients;
6.the number of primary and/or elective percutaneous coronary intervention procedures by indication for performing the procedure;
7.the door-to-balloon times for primary percutaneous coronary intervention procedures; and
8.such other data as specified by the Director.
I.Penalties for Noncompliance
The penalties for violations of the standards set forth in § 4.6.25 of this Part shall be in accordance with those set forth in R.I. Gen. Laws Chapter 23-17, and § 4.4.6 of this Part. Failure to maintain the minimal primary and/or elective percutaneous coronary intervention program standards set forth in these regulations may result in the revocation or suspension of the hospital’s primary and/or elective percutaneous coronary intervention program designation and/or cessation of its activities. A hospital shall post notices for patients and notify physicians if its designation as an approved primary and/or elective percutaneous coronary intervention program has been revoked or suspended.
4.6.26Tertiary Care Services: Coronary Artery Bypass Graft Surgical Programs
A.Approval to Operate a Coronary Artery Bypass Graft Surgical Program and General Requirements
1.In order to use the designation “coronary artery bypass graft surgical program,” a hospital shall obtain approval from the Department’s Center for Health Facility Regulations. Said approval shall be issued by the Department if the coronary artery bypass graft surgical program meets the requirements defined in these regulations.
a.Each hospital shall renew this coronary artery bypass graft surgical program designation annually.
2.Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described in these regulations, the Department shall approve the hospital’s designation as a coronary artery bypass graft surgical program.
3.A hospital that has not received approval by the Department under this section shall not use the designation “coronary artery bypass graft surgical program”, or any substantially similar phrase, to describe any such services provided and shall not perform coronary artery bypass graft surgeries.
4.A hospital that operates a coronary artery bypass graft surgical program approved by the Department shall maintain capabilities and provide services that include, but are not limited to, those capabilities and services described in §§ 4.6.26(D), (E) and (F) of this Part. A hospital that operates a coronary artery bypass graft surgical program approved by the Department shall maintain its capabilities and services as needed to meet the recommendations of the Society of Thoracic Surgery, American College of Cardiology, and the American Heart Association.
5.A hospital that operates a coronary artery bypass graft surgical program and determines the that coronary artery bypass graft surgical program no longer meets minimum standards in these regulations shall notify the Department and file a plan of correction within fifteen (15) days of such determination by a hospital. The plan of correction shall be subject to the provisions of § 4.9.3 of this Part.
B.Minimum Standards: Volume
1.An existing coronary artery bypass graft surgical program shall maintain an annual minimum volume of at least two hundred and fifty (250) surgical patients who require cardiopulmonary bypass capability, the majority of whom have coronary artery bypass grafts. Patients who have minimally-invasive coronary artery bypass graft operations shall be included in the counted patients.
2.As part of the approval process for a new (or proposed) coronary artery bypass graft surgical program, the hospital shall provide data to the Department demonstrating a reasonable expectation, within two (2) years of its opening date, of attaining and maintaining a minimum volume of at least two hundred and fifty (250) surgical patients per year who require the availability of cardiopulmonary bypass.
3.As part of the approval process for a new (or proposed) coronary artery bypass graft surgical program, the hospital shall also provide any available data to the Department regarding whether the addition of the proposed coronary artery bypass graft surgical program is likely to result in the annual volume of procedures performed by existing coronary artery bypass graft surgical programs falling below two hundred and fifty (250) procedures per year. If this outcome is likely, the proposal shall describe how the overall quality of care for all coronary artery bypass graft patients in the state will be improved with the addition of the proposed program.
C.Minimum Standards: Survival Rates
1.Each hospital that has an approved coronary artery bypass graft surgical program shall maintain a record of the inhospital mortality rate for patients having coronary artery bypass graft surgery and shall participate in a nationally recognized database acceptable to the Director. To the extent possible, risk adjusted rates, based upon data from nationally recognized databases and methods acceptable to the Director, shall be used.
2.Each hospital shall report the following data to the Department annually:
a.the hospital’s risk-adjusted mortality rate for isolated CABG, based on a nationally recognized database and methods acceptable to the Director;
b.the 95% confidence interval around the hospital’s isolated CABG mortality rate;
c.the national average isolated CABG mortality rate from the national open heart surgery database in which the hospital participates;
d.the 95% confidence interval around the national isolated CABG mortality rate.
3.If the hospital’s annual risk-adjusted isolated CABG mortality rate is statistically significantly higher than the national rate at the 95% level of confidence, then the hospital shall file a plan for identification of the cause of the excess mortality and a plan for correction, in accordance with the requirements set forth in § 4.9.3 of this Part.
D.Staffing Requirements
A hospital that operates a coronary artery bypass graft surgical program approved by the Department shall be in compliance with the following staffing requirements:
1.A cardiac surgeon certified by the American Board of Thoracic Surgery or equivalent certifying body shall be designated as director of the coronary artery bypass graft surgical program.
2.A hospital coronary artery bypass graft surgical program should have a minimum of two (2) qualified cardiac surgeons.
3.Each hospital that has an approved coronary artery bypass graft surgical program shall have a written procedure for granting and renewing privileges for surgeons that specifies the required training, experience, board certification, annual volume of open heart procedures, and other factors that will indicate acceptable proficiency. The hospital shall monitor annual procedural volume, complication rates, and inhospital mortality for each surgeon.
4.Other specially trained physicians assisting the cardiac surgeon shall be cardiac surgical assistants, cardiac anesthesiologists, cardiologists, and other qualified consultants.
5.Nursing personnel shall include surgical nurses specially trained in cardiac surgical nursing, cardiac surgery intensive care nursing, and cardiac nurse educators.
6.Perfusionists shall be trained in the preparation, maintenance, and operation of pump-oxygenators and related equipment during open heart surgery and shall be knowledgeable about red blood cell-saving procedures and circulatory assist devices. The perfusionist shall work under the direction of the cardiac surgeon or the cardiac anesthesiologist or both.
7.Other personnel required shall be a full complement of hospital professionals including pharmacists, dietitians, respiratory therapists, social workers and physical therapists with cardiac rehabilitation skills.
E.Service Requirements
Coronary angiography of diagnostic quality shall be available. Facilities that treat pediatric patients shall provide for biplane angiography.
F.Equipment Requirements
1.The cardiac operating room shall be a room with requisite space and equipment for open heart surgery. It shall have adequate electrical grounding, oxygen and vacuum supply, proper illumination, and capability of supporting the technical equipment used in cardiopulmonary bypass, including the pump-oxygenators, heat exchange equipment, cell saver, anesthetic apparatus and assist devices.
2.The cardiac intensive care units shall be operated under the direction of a qualified physician and have a unit nurse director. It shall have typical intensive care capabilities including continuous electrocardiographic and hemodynamic monitoring and recording and equipment and personnel for full ventilatory support. The space shall accommodate multiple life support systems, such as intraaortic balloon pumps, ventricular and total circulatory assist devices, and hemodialysis machines. Portable chest x-rays should be available twenty-four (24) hours per day. The unit shall be able to obtain immediate reports on blood gas analysis, serum electrolyte measurements, and certain other lab tests. The number of beds shall be one-half (1/2) the number of open heart operations performed each week.
G.Quality of Care
1.The cardiac surgery program shall have regular, frequent, and formal review in a multidisciplinary conference of all deaths and major complications.
2.The cardiac surgery program shall maintain a registry, acceptable to the Director, that collects and analyzes patient data sufficient to analyze utilization and outcome data and to determine the reasons for substantial deviations from the average utilizations and outcomes reported by nationally recognized databases. The database shall be sufficient to perform adequate risk stratification.
H.Reporting Requirements
Each hospital with an approved coronary artery bypass graft surgical program shall report to the Department for each hospital calendar year:
1.the number of surgical patients requiring cardiopulmonary bypass capability;
2.the number of coronary artery bypass graft surgeries by principal surgeon;
3.the number of emergency coronary artery bypass graft surgeries in the same hospital stay following percutaneous coronary intervention;
4.the inhospital mortality rate for coronary artery bypass graft surgical patients;
5.the number of coronary artery bypass graft operations by indication for performing the surgery; and
6.such other data as specified by the Director.
I.Penalties for Noncompliance
The penalties for violations of the standards set forth in § 4.6.26 of this Part shall be in accordance with those set forth in R.I. Gen. Laws Chapter 23-17 and § 4.4.6 of this Part. Failure to maintain the minimal coronary artery bypass graft surgical program standards set forth in these regulations may result in the revocation or suspension of the hospital’s coronary artery bypass graft surgical program designation and/or cessation of its activities. A hospital shall post notices for patients and shall notify physicians if its designation as an approved coronary artery bypass graft surgical program has been revoked or suspended.
4.6.27Tertiary Care Services: Heart and/or Liver Transplant Programs
A.Approval to Operate a Heart and/or Liver Transplant Program and General Requirements
1.In order to use the designation “heart transplant program” or “liver transplant program”, a hospital shall obtain approval from the Department’s Center for Health Facility Regulations. Said approval shall be issued by the Department if the heart and/or liver transplant program meets the requirements defined in these regulations.
a.Each hospital shall renew this heart and/or liver transplant program designation annually.
2.Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described in these regulations, the Department shall approve the hospital’s designation as a heart and/or liver transplant program.
3.A hospital that has not received approval by the Department under this section shall not use the designation “heart transplant program” or “liver transplant program”, or any substantially similar phrase, to describe any such services provided and shall not perform heart and/or liver transplant procedures.
4.A hospital that operates a heart and/or liver transplant program approved by the Department shall maintain capabilities and provide services in accordance with the requirements described in these regulations.
5.A hospital that operates a heart and/or liver transplant program approved by the Department shall maintain its membership in good standing with the United Network for Organ Sharing (UNOS).
6.A hospital that operates a heart and/or liver transplant program shall perform mandatory HIV testing, and counseling, as appropriate, in accordance with the regulations for Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title) and “Guidelines for Preventing Transmission of HIV through Transplantation of Human Tissue and Organs,” incorporated above at § 4.2(A)(18) of this Part, for the prevention of HIV transmission.
7.A hospital that operates a heart and/or liver transplant program and determines that the heart and/or liver transplant program no longer meets minimum standards in these regulations shall notify the Department of Health and file a plan of correction within fifteen (15) days of such determination by a hospital. The plan of correction shall be subject to the provisions of § 4.9.3 of this Part.
B.Minimum Standards: Volume
1.A new or proposed heart transplant program shall provide data showing a reasonable expectation of attaining and maintaining a minimum volume of nine (9) transplant procedures per year within two (2) years of its opening. If a second or subsequent program is proposed, it shall also report whether the addition of the new heart transplant program is likely to result in the annual volume of procedures performed by existing heart transplant programs falling below nine (9) heart transplants per year. If this outcome is likely, it will explain how the overall quality of care for all heart transplant patients in the state will be improved by the addition of the proposed program.
2.A new or proposed liver transplant program shall provide data showing a reasonable expectation of attaining and maintaining a minimum volume of twenty (20) transplant procedures per year within two (2) years of its opening. If a second or subsequent program is proposed, it shall also report whether the addition of the new liver transplant program is likely to result in the annual volume of procedures performed by existing liver transplant programs falling below twenty (20) liver transplants per year. If this outcome is likely, it will explain how the overall quality of care for all liver transplant patients in the state will be improved by the addition of the proposed program.
C.Minimum Standards: Survival Rates
1.Each hospital that has a heart transplant program shall maintain a record of the rates of mortality at three (3) months, one (1) year and three (3) years. Risk-adjusted rates, based on data from the UNOS database and methods acceptable to the Director of Health, shall be used. If patient or graft outcomes decline to a level mandating UNOS review, then the hospital shall notify the Department of Health and file a plan of correction.
2.Each hospital that has a liver transplant program shall maintain a record of the rates of mortality at three (3) months, one (1) year and three (3) years. Risk-adjusted rates, based on data from the UNOS database and methods acceptable to the Director of Health, shall be used. If patient or graft outcomes decline to a level mandating UNOS review, then the hospital shall notify the Department of Health and file a plan of correction.
D.Quality of Care
1.Each hospital that has a heart transplant program and/or a liver transplant program shall become a member of the UNOS and shall maintain its membership in good standing. The program shall follow the procedures designated by the current bylaws of UNOS (“Bylaws,” incorporated above at § 4.2(A)(9) of this Part).
2.The personnel and facilities used by the transplant program shall conform to the bylaws of UNOS for heart transplantation and/or for liver transplantation, as appropriate.
3.The program shall document its acceptance as a member of UNOS before commencing transplantation and shall inform the Department immediately in writing if it has been notified by UNOS that the program is in jeopardy of becoming a member not in good standing.
E.Reporting Requirements
Each hospital that provides heart transplantation and/or liver transplantation services shall report to the Department for each hospital fiscal year:
1.the number of heart and/or liver transplants, respectively;
2.the number of heart and/or liver transplants by principal surgeon;
3.the mortality rate for heart and/or liver patients at three (3) months, one (1) year, and three (3) years.
F.Penalties for Noncompliance
The penalties for violations of the standards set forth in § 4.6.27 of this Part shall be in accordance with those set forth in R.I. Gen. Laws Chapter 23-17 and § 4.4.6 of this Part. Failure to maintain the minimal heart and/or liver transplant program standards set forth in these regulations may result in the revocation or suspension of the hospital’s heart and/or liver transplant program designation and/or cessation of its activities. The hospital shall post notices for patients and notify physicians if its status as an approved heart and/or liver transplant program has been revoked or suspended.
4.6.28Tertiary Care Services: Esophageal and/or Pancreatic Cancer Surgery Programs
A.Approval to Operate an Esophageal and/or Pancreatic Cancer Surgery Programs and General Requirements
1.In order to use the designation “Esophageal Cancer Surgery Program” and/or “Pancreatic Cancer Surgery Program,” a hospital shall obtain approval from the Department’s Center for Health Facility Regulations. Said approval shall be issued by the Department if the esophageal and/or pancreatic cancer surgery program meets the requirements defined in these regulations.
a.Within six (6) months of the effective date of these regulations, any hospital operating an esophageal and/or pancreatic cancer surgery program shall file an application with the Department for approval as a “Esophageal Cancer Surgery Program” and/or “Pancreatic Cancer Surgery Program,” as applicable.
b.Each hospital shall renew this esophageal and/or pancreatic cancer surgery program designation annually.
2.Upon satisfactory review of all requested documentation and upon the determination that the hospital has achieved the volume/quality standards described in these regulations, the Department shall approve the hospital’s designation as esophageal and/or pancreatic cancer surgery program.
3.A hospital that has not received approval by the Department under this section shall not use the designation “Esophageal Cancer Surgery Program” and/or “Pancreatic Cancer Surgery Program,” or any substantially similar phrase, to describe any such services provided and shall not perform esophageal and/or pancreatic cancer surgery.
4.A hospital that operates an esophageal and/or pancreatic cancer surgery program approved by the Department shall maintain capabilities and provide services in accordance with the requirements described in these regulations.
5.A hospital that operates an esophageal and/or pancreatic cancer surgery program and determines that the esophageal and/or pancreatic cancer surgery program no longer meets minimum standards in these regulations shall notify the Department and file a plan of correction within fifteen (15) days of such determination by a hospital. The plan of correction shall be subject to the provisions of § 4.9.3 of this Part.
B.Minimum Standards: Volume
1.An existing esophageal cancer surgery program approved by the Department shall maintain an annual minimum volume of seven (7) operations.
2.An existing pancreatic cancer surgery program approved by the Department shall maintain an annual minimum volume of eleven (11) operations.
3.Each hospital that has an approved esophageal and/or pancreatic cancer surgery program shall participate in a nationally recognized database acceptable to the Director, if such database exists. To the extent possible, risk adjusted rates, based on data from nationally recognized databases and methods acceptable to the Director, shall be used.
4.A new or proposed esophageal cancer surgery program shall provide data to the Department showing a reasonable expectation of attaining and maintaining a minimum volume of seven (7) operations per year within two (2) years of its designation. It shall also report whether the addition of the new esophageal cancer surgery program is likely to result in the annual volume of operations performed by existing esophageal cancer surgery programs falling below seven (7) operations per year. If this outcome is likely, it will explain how the overall quality of care for all esophageal cancer patients in the state will be improved by the addition of the proposed program.
5.A new or proposed pancreatic cancer surgery program shall provide data to the Department showing a reasonable expectation of attaining and maintaining a minimum volume of eleven (11) operations per year within two (2) years of its designation. It shall also report whether the addition of the new pancreatic cancer surgery program is likely to result in the annual volume of operations performed by existing pancreatic cancer surgery programs falling below eleven (11) operations per year. If this outcome is likely, it will explain how the overall quality of care for all pancreatic cancer patients in the state will be improved by the addition of the proposed program.
C.Reporting Requirements
Each hospital that provides esophageal cancer surgery and/or pancreatic cancer surgery shall report to the Department for each hospital fiscal year:
1.the number of esophageal and/or pancreatic cancer operations, respectively;
2.the number of esophageal and/or pancreatic cancer operations by principal surgeon;
3.the mortality rate for esophageal and/or pancreatic cancer patients at three (3) months, and the readmission rates.
D.Penalties for Noncompliance
The penalties for violations of the standards set forth in § 4.6.28 of this Part shall be in accordance with those set forth in R.I. Gen. Laws Chapter 23-17, and § 4.4.6 of this Part. Failure to maintain the minimal esophageal and/or pancreatic cancer surgery program standards set forth in these regulations may result in the revocation or suspension of the hospital’s esophageal and/or pancreatic cancer surgery program designation and/or cessation of its activities. The hospital shall post notices for patients and shall notify physicians, if its status as an approved esophageal and/or pancreatic cancer surgery program has been revoked or suspended.
4.6.29Special Care Units
A.As used in this section, special care units may be multi-purpose or include but not be limited to units for: burn, critical care, observation, pulmonary care, rehabilitation and hemodialysis.
B.Special care units shall have a defined organization and shall be integrated with other departments and services of the hospital.
C.The units shall be designed and equipped for the defined special functions with provisions for effectiveness and safety in operation.
D.Hospitals shall develop and define standards for the operation of the specialized units.
E.The services shall be governed by written policies and procedures specifically defining admission and discharge criteria.
F.Each unit shall be under the direction of a physician qualified by training and experience in the specialty care.
G.A sufficient number of specially qualified personnel shall be provided based on the scope and complexity of the services provided.
H.There shall be specific written policies defining the scope of responsibilities assigned to staff personnel.
I.A continuing education program developed specifically for personnel of special care units shall be provided to insure an optimum level of skills and performance.
4.6.30Psychiatric Service
A.Hospitals with psychiatric services shall have such services under the supervision of a clinical director who is certified by the American Board of Psychiatry and Neurology or who has equivalent training and experience.
B.There shall be a sufficient number of qualified professional, technical and supporting personnel and consultants to carry out a diagnostic and treatment program that includes no less than:
1.the evaluation of individual needs of patients; and
2.the establishment and implementation of written treatment and rehabilitation plans involving psychiatric, medical, surgical, nursing, social work, psychological therapies and other such services.
C.Medical records shall include:
1.patient's legal status;
2.psychiatric diagnosis as well as diagnoses of intercurrent diseases;
3.psychiatric evaluation which includes a medical history, records mental status, notes onset of illness and circumstances leading to admission, describes attitude and behaviors, and estimates intellectual and cognitive functioning, memory functioning and orientation;
4.complete neurological examination when indicated;
5.social service records of interviews with patient, family and others, assessments of home plans, contacts with community resources, as well as a social history;
6.treatment plans that include measurable goals and specific treatment modalities to be utilized;
7.documentation of all treatment provided;
8.at least weekly progress notes, by the physician, physician assistant, nurse, social worker, and when appropriate, others significantly involved in treatment, that provide an assessment of the patient's progress in accordance with the treatment plan;
9.discharge summary and aftercare plan.
D.Hospitals with psychiatric services shall maintain patient-identifiable information in confidence in accordance with all applicable state and federal statutes and regulations, including, but not limited to, R.I. Gen. Laws Chapter 40.1-5 ("Mental Health Law").
E.In addition to the above, the requirements of § 4.6.29 of this Part and all applicable sections of these regulations shall apply to a hospital providing inpatient diagnostic and therapeutic care to persons with mental disorders.
4.6.31Rehabilitation Services
A.If a hospital provides rehabilitation, physical therapy, occupational therapy, audiology or speech pathology services, such services shall have a defined organizational structure with established lines of authority and responsibility that ensures accountability in patient care and administrative matters. Such services shall be integrated with other departments and services of the hospital.
B.The director(s) of the service or services (may be single discipline departments or multi- discipline departments) shall be qualified by training, experience, and capability to properly supervise and administer the services. The director retains responsibility for the personnel providing the service.
C.Services shall be provided by staff who meet the qualifications specified by the medical staff and hold current licensure, certification or registration as may be required by law (see R.I. Gen. Laws Chapters 5-40, 5-40.1, and 5-48).
D.The director of the service(s) shall ensure there are a sufficient number of qualified staff to:
1.evaluate each patient requiring services;
2.initiate a plan of treatment;
3.provide treatment services;
4.instruct and supervise support staff when they are used to render services.
E.Services shall be provided in accordance with written orders by persons who are authorized by the medical staff to order such services. Orders shall be incorporated into the patient’s clinical record.
F.Services shall be furnished in accordance with a written plan of treatment, which is established by the practitioner ordering the service in collaboration with an individual qualified to provide the service.
1.Treatment plans shall include treatment goals, as well as type, amount, frequency and duration of services.
2.Treatment plans shall be revised as necessary. Changes in the treatment plan shall be documented in writing and supported by clinical record information such as evaluations, test results, or orders.
G.Treatment shall be documented in the clinical record by the responsible person at the time services are provided. Progress notes (to note the patient’s status in relationship to goal attainment) shall be recorded periodically in accordance with hospital policy.
H.In addition to the above, the requirements of § 4.6.29 of this Part and all applicable sections of these regulations shall apply to inpatient rehabilitation units.
4.6.32Substance Abuse Treatment Services/Programs
A.Hospitals with substance abuse treatment programs shall have such program(s) under the direction of a physician who has experience and training in the treatment of individuals with chemical dependency.
B.Each program shall have a clinical supervisor to oversee counseling activities directly and provide clinical supervision. The clinical supervisor shall have a minimum of a master’s degree in a clinically related field, and a minimum of three (3) years supervisory experience; be licensed as a chemical dependency clinical supervisor by the Rhode Island Board for Licensing of Chemical Dependency Professionals; or be a licensed chemical dependency professional and, at a minimum, have taken a state Department of Behavioral Healthcare, Developmental Disabilities and Hospitals (BHDDH) approved course in clinical supervision.
C.The substance abuse program shall be staffed with a sufficient number of specially qualified professional and ancillary personnel who shall be assigned duties and responsibilities consistent with their education and experience.
D.There shall be sufficient number of staff to carry out the treatment program, that includes no less than:
1.initial evaluation, including medical and psychosocial assessment; and
2.the establishment and implementation of written treatment plans.
E.Medical records shall include:
1.Medical assessment including medical history and history of drugs prescribed;
2.History of alcohol and/or other drug use, including age of onset, duration, patterns, and consequences or resultant effects (to include medical, physical, psychosocial, employment, educational, legal, financial, family, social, recreational and other pertinent areas);
3.Special exams, tests, or evaluations necessary for complete initial and on-going assessment;
4.Individualized treatment plan, including problem list, short- and long- term goals expressed in measurable behaviors, treatment interventions, and timeframes;
5.Documentation of all treatment provided, at the time of provision;
6.At least weekly progress notes, describing progress, or lack thereof, toward goal achievement;
7.Discharge summary and aftercare plan; and
8.Post-discharge follow-up contacts.
F.Hospitals with substance abuse treatment programs shall maintain identifiable patient information in confidence in accordance with all applicable state and federal statutes and regulations, including, but not limited to, 42 C.F.R. Part 2 (2017).
G.In addition to the above, the requirements of § 4.6.29 of this Part and all applicable regulations contained in these regulations shall apply to the substance abuse treatment program.
4.6.33Caregiver Services
A.Any hospital licensed pursuant to § 4.4 of this Part, shall provide each patient or, if applicable, the patient’s legal guardian with an opportunity to designate at least one caregiver under R.I. Gen. Laws Chapter 23-17 following the patient’s entry to the hospital.
1.Unconscious or Incapacitated Patient
In the event that the patient is unconscious or otherwise incapacitated upon entry into the hospital, the hospital shall adhere to the following requirements:
a.Provide the patient or the patient’s legal guardian with an opportunity to designate a caregiver within a given timeframe, at the discretion of the attending physician, following the patient’s recovery of consciousness or capacity; and
b.Notify the patient that the purpose of providing a caregiver’s identity is to include that caregiver in discharge planning and sharing of post-discharge care information or instruction.
2.Patient Designates Caregiver
In the event that the patient or the patient’s legal guardian designates an individual as a caregiver pursuant to R.I. Gen. Laws Chapter 23-17, the hospital shall adhere to the following requirements:
a.Record the patient’s designation of the caregiver in the patient’s medical record along with the caregivers; relationship to the patient, name, telephone number and address;
b.Promptly request the written consent of the patient, or the patient’s legal guardian, to release medical information to the patients designated caregiver following the hospitals established procedures for releasing personal health information and in compliance with all federal and state laws;
c.If the patient or the patient’s legal guardian declines to consent to release medical information to the patients designated caregiver, the hospital is not required to:
(1)Provide notice to the caregiver in accordance with R.I. Gen. Laws § 23-17.27-4 and § 4.6.33(C) of this Part; or
(2)Provide information contained in the patients discharge plan in accordance with R.I. Gen. Laws § 23-17.27-5 and § 4.6.33(E) of this Part.
3.Patient Declines to Designate Caregiver
In the event that the patient, or the patient’s legal guardian, declines to designate a caregiver, the hospital shall promptly document this in the patient’s medical record.
4.Patient Elects to Change Caregiver
A patient, or a patient’s legal guardian, may elect to change the patient’s caregiver at any time, and the hospital must record this change in the patient’s medical record before the patient’s discharge.
5.The designation of a caregiver by a patient, or a patient’s legal guardian, in accordance with § 4.6.33(A) of this Part does not obligate any individual to perform any after-care tasks for any patient.
6.The requirements set forth in § 4.6.33(A) of this Part shall not be construed to require a patient, or a patient’s legal guardian, to designate any individual as a caregiver as defined by R.I. Gen. Laws Chapter 23-17.27 and these Regulations.
B.Notice of Patient Discharge to Designated Caregiver
Any hospital licensed pursuant to § 4.4 of this Part shall notify the patient's designated caregiver of the patient's discharge or transfer to another facility licensed by the State of Rhode Island as soon as possible, in any event, upon issuance of a discharge order by the patient's attending physician or other health care professional.
1.In the event that the hospital is unable to contact the designated caregiver, the lack of contact shall not interfere with, delay or otherwise affect the medical care provided to the patient or an appropriate discharge of the patient. The hospital shall promptly document the attempt to contact the patient’s designated caregiver in the patient’s medical record.
C.Instruction to Designated Caregiver
As soon as possible and prior to a patient’s discharge from a hospital, the hospital shall consult with the designated caregiver and the patient regarding the caregiver’s capabilities and limitations. The hospital will then issue a discharge plan that describes the patient’s after-care needs at his or her residence in accordance with the provisions set forth in §§ 4.6.33(C)(1) through (4) of this Part.
1.Caregiver Consultation Session and Assessment
The consultation session will include an assessment of the caregiver’s capability to provide after care and any limitations the caregiver foresees in providing after care. The hospital shall adhere to the following requirements regarding the consultation and assessment:
a.At its discretion, determine which hospital staff are best qualified to conduct the caregiver assessment; and
b.If, upon assessment, the hospital determines a caregiver may have difficulty supplying the needed care safely, the discharge plan may be adjusted accordingly and alternate care arrangements may be made in consultation with the caregiver.
2.Discharge Plan Schedule
The consultation and the issuance of a discharge plan shall occur on a schedule that takes into consideration the following:
a.The severity of the patient’s condition;
b.The setting in which care is to be delivered; and
c.The urgency of the need for caregiver services.
3.Unable to Contact Caregiver
In the event that the hospital is unable to contact the designated caregiver, the lack of contact shall not interfere with, delay, or otherwise affect the medical care provided to the patient, or an appropriate discharge of the patient. The hospital shall promptly document the attempt in the patient's medical record.
4.Discharge Plan Content
At minimum, a discharge plan shall include:
a.The name and contact information of the caregiver designated in accordance with § 4.6.33(A) of this Part;
b.A description of all after-care tasks recommended by the patient’s physician or other health care professional, taking into account the capabilities and limitations of the caregiver;
c.Contact information for any health care, community resources, and long-term services and support necessary to successfully carry out the patients discharge plan.
D.Caregiver Training
The hospital issuing the discharge plan must offer to provide caregivers with instruction in all after-care tasks described in the discharge plan. Any training or instructions provided to a caregiver shall be provided, to the extent possible, in non-technical language and in the caregiver’s native language.
1.At minimum, any training or instructions provided to a caregiver shall include the following:
a.A live or recorded demonstration of the tasks performed by the hospital employee or individual with whom the hospital has a contractual relationship authorized to perform the after-care task; and
b.An opportunity for the caregiver and patient to ask questions about the after-care tasks; and
c.Answers to the caregiver’s and the patient’s questions provided in a culturally competent manner and in accordance with the hospitals requirements to provide language access services under state and federal law.
2.Any instruction required under § 4.6.33(C) of this Part shall be documented in the patient’s medical record, including the date, time and contents of the instruction.
E.Non-Interference with Powers of Existing Health Care Directives
1.Nothing in R.I. Gen. Laws Chapter 23-17.27 or these regulations shall be construed to interfere with the rights of an agent operating under a valid directive pursuant to R.I. Gen. Laws Chapter 23-4.10 (Health Care Power of Attorney) or R.I. Gen. Laws § 23-4.11-3.1 (Medical Orders for Life Sustaining Treatment).
2.A patient may designate a caregiver in an advance directive.
F.Nothing in R.I. Gen. Laws Chapter 23-17.27 or these regulations shall delay the discharge of a patient, or the transfer of a patient from a hospital to another facility.
G.Caregiver Reimbursement
1.A caregiver shall not be reimbursed by any government or commercial payer for after-care assistance that is provided pursuant to R.I. Gen. Laws Chapter 23-17.27 or these regulations, with the sole exception that R.I. Gen. Laws Chapter 23-17.27 shall not supersede the applicability of wage replacement benefits paid to workers under Rhode Island's temporary disability insurance program, pursuant to R.I. Gen. Laws § 28-41-35.
2.Nothing in to R.I. Gen. Laws Chapter 23-17.27 or these regulations shall be construed to impact, impede or otherwise disrupt or reduce the reimbursement obligations of an insurance company, health service corporation, hospital service corporation, medical service corporation, health maintenance organization, or any other entity issuing health benefits plans.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.7** Environmental & Maintenance Services {#sec-216-ricr-40-10-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.7}
4.7.1Housekeeping and Maintenance Services
A.Written housekeeping and maintenance procedures shall be established for the cleaning of all areas in the hospital based on the guidelines of Health Care Environmental Services: Housekeeping Departmental Training Manual, incorporated above at § 4.2(A)(6) of this Part. Copies shall be made available to housekeeping personnel.
B.All parts of the hospital and its premises shall be kept clean, neat, free of litter and rubbish, and all furnishings maintained in good repair.
C.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition.
D.Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other cleaning materials.
E.Cleaning shall be performed in a manner which will minimize the spread of pathogenic organisms in the hospital atmosphere.
F.Exhaust ducts from kitchens and other cooking areas shall be equipped with proper filters and cleaned at regular intervals. The ducts shall be cleaned and inspected no less than twice a year.
4.7.2Infection Control
A.The medical staff in cooperation with other disciplines shall establish a multidisciplinary group which shall report to the governing body and which shall be responsible for no less than the following:
1.establishing and maintaining a hospital-wide infection surveillance program which shall include an infection surveillance officer to conduct all infection surveillance activities;
2.developing and implementing written policies and procedures for the surveillance, prevention, and control of infections in all patient care departments/services;
3.establishing policies governing the admission and isolation of patients with known or suspected infectious diseases;
4.developing, evaluating and revising on a continuing basis infection control policies, procedures and techniques for all appropriate phases of hospital operation and services;
5.developing and implementing a system for evaluating and recording the occurrences of all infections among personnel and patients; such records shall be made available to the licensing agency upon request;
6.implementing a TB infection control program requiring risk assessment and development of a TB infection control plan; early identification, treatment and isolation of strongly suspected or confirmed infectious TB patients; effective engineering controls; an appropriate respiratory protection program; health care worker TB training, education, counseling and screening; and evaluation of the program's effectiveness, per guidelines in “Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities,” incorporated above at § 4.2(A)(7) of this Part.
7.developing and implementing an institution-specific strategic plan for the prevention and control of vancomycin resistance, with a special focus on vancomycin-resistant enterococci, per guidelines in “Recommendations for Preventing the Spread of Vancomycin Resistance: Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC),” incorporated above at § 4.2(A)(17) of this Part.
8.developing and implementing protocols for discharge planning of patients with infectious diseases which may present the risk of continuing transmission in the community or congregate living environment. Examples of such diseases include, but are not limited to, tuberculosis (TB), Methicillin resistant staphylococcus aureus (MRSA), clostridium difficile, etc.
9.assuring that patient care support departments (i.e., central services, laundry, etc.) are available to assist in the prevention and control of infectious diseases and are provided with adequate direction, training, staffing and facilities to perform all required infection surveillance, prevention and control functions.
B.Infection control provisions shall be established for the mutual protection of patients, employees and the public.
C.A continuing education program on infection control shall be conducted periodically for all staff.
D.Reporting of Communicable Diseases
1.The hospital shall promptly report to the Rhode Island Department of Health cases of communicable diseases designated as "reportable diseases" by the Director of Health, when such cases are admitted to or are diagnosed in the hospital in accordance with the most current rules and regulations pertaining to the reporting of communicable diseases (Reporting and Testing of Infectious, Environmental and Occupational Diseases, Part 30-05-1 of this Title).
2.When infectious diseases present a potential hazard to hospitalized patients or personnel, these shall be reported to the Rhode Island Department of Health, even if not designated as "reportable diseases."
3.Reporting by Hospital Laboratories
Hospital laboratories shall report communicable diseases and submit specimens in accordance with the requirements in the most current version of the Rhode Island Epidemiological and Laboratory Reporting and Surveillance Manual issued by the Division of Disease Prevention and Control at the Department of Health.
4.Hospitals must, in addition, comply with all other laboratory reporting requirements for TB, HIV/AIDS, sexually transmitted diseases, childhood lead poisoning and occupational diseases as outlined in Reporting of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).
4.7.3Laundry Service
A.Each hospital shall make provisions for the cleaning of all linens and other washable goods.
B.Hospitals providing laundry service shall have adequate facilities and equipment for the safe and effective operation of a laundry service.
C.There shall be distinct areas for the separate storage and handling of clean and soiled linens. Those areas used for the storage and handling of soiled linens shall be negatively pressurized.
D.Special procedures shall be established for the handling and processing of contaminated linens.
E.All soiled linen shall be placed in closed containers prior to transportation.
F.To safeguard clean linens from cross-contamination they shall be:
1.transported in containers used exclusively for clean linens and shall be kept covered at all times while in transit; and
2.stored in areas designated exclusively for this purpose (e.g., linen closets, enclosed carts, etc.).
4.7.4Electromagnetic Interference and Medical Devices
A.The facility's governing body, or its designee (e.g., Safety Committee), shall develop and implement policies and procedures that achieve electromagnetic compatibility, including, but not limited to, the designation of areas of the facility where the use of common hand-held radio frequency transmitters (e.g., cellular and PCS telephones, two-way radios) by staff, visitors, and/or patients is to be managed and/or restricted. Said policies and procedures shall require no less than the following:
1.Each facility shall perform an assessment of the radiated electromagnetic environment in the facility and implement the actions needed to minimize radiated electromagnetic interference and promote electromagnetic compatibility.
2.Each facility shall actively manage its equipment to foster electromagnetic compatibility and to mitigate the risks of electromagnetic interference
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.8** Physical Plant {#sec-216-ricr-40-10-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.8}
4.8.1New Construction, Addition or Modification
A.All new construction, alterations, extensions or modifications of an existing facility shall be subject to the laws, rules, regulations and codes:
1.Guidelines for Design and Construction of Hospital and Health Care Facilities, incorporated above at § 4.2(A)(10) of this Part.
2.Rhode Island State Fire Safety Code, R.I. Gen. Laws Chapter 23-28.1.
3.Rhode Island State Building Code, R.I. Gen. Laws Chapter 23-27.3.
4.Department of Environmental Management’s Air Pollution Control Regulation No. 12: Incinerators (250-RICR-120-05-12).
5.NFPA 1: Fire Code, incorporated above at § 4.2(A)(13) of this Part.
6.Lighting for Hospitals and Healthcare Facilities, incorporated above at § 4.2(A)(11) of this Part.
7.“Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities,” incorporated above at § 4.2(A)(7) of this Part.
8.All other appropriate state and local laws, codes, regulations, and ordinances.
B.Where there is a difference between codes, the code having the more stringent standard shall apply.
C.All plans for new construction or the renovation, alteration, extension, modification or conversion of an existing facility that may affect compliance with Guidelines for Design and Construction of Hospital and Health Care Facilities, incorporated above at § 4.2(A)(10) of this Part, shall be reviewed by a licensed architect, acceptable to the Director. Said architect shall certify that the plans conform to the construction requirements of Guidelines for Design and Construction of Hospital and Health Care Facilities, incorporated above at §4.2(A)(10) of this Part, prior to construction. The facility shall maintain a copy of the plans reviewed and the architect’s signed certification, for review by the Department of Health upon request.
1.In the event of non-conformance for which the facility seeks a variance, the general procedures outlined in § 4.9.2 shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as detailing the basis upon which the request is made. The Department may request additional information while evaluating variance requests.
2.If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of Guidelines for Design and Construction of Hospital and Health Care Facilities, incorporated above at § 4.2(A)(10) of this Part, except those for which variances were granted, prior to construction. The facility shall maintain a copy of the plans reviewed, the variance(s) granted and the architect’s signed certification, for review by the Department upon request.
D.Upon completion of construction, the facility shall provide written notification to the Department, describing the project, and a copy of the architect's certification. The facility shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.
E.In addition to the above requirements, the following requirements of §§ 4.8.2 through 4.8.6 of this Part shall apply.
4.8.2Fire Safety
Each hospital shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations and such a program shall include written procedures for the implementation of said rules and regulations, and logs shall be maintained.
4.8.3Incinerators
A.Incinerators within hospitals shall be segregated from other parts of the building by non-combustible construction, with walls, floors and ceilings having a fire resistance rating of not less than two hours. Openings to such rooms shall be protected by Class B fire doors, and equipped with positive self-closing devices in accordance with R.I. Gen. Laws Chapter 23-28.1.
B.Incinerators shall be gas, electric, or oil fired and capable of destroying pathological and other types of waste.
1.An incinerator installed to handle pathological waste materials shall have the capability of completely burning the waste material and shall meet the air emission requirements of the Department of Environmental Management’s Air Pollution Control Regulation No. 12: Incinerators (250-RICR-120-05-12).
2.Refuse incinerators shall be capable of burning rubbish containing 50 percent wet materials, and shall meet the air emission requirements of the Department of Environmental Management’s Air Pollution Control Regulation No. 12: Incinerators (250-RICR-120-05-12).
3.A multi-purpose incinerator shall meet the requirements of both §§ 4.8.3(B)(1) and (2) of this Part above.
C.Hospital incinerators shall be designed and installed in accordance with the air emission requirements of the Department of Environmental Management’s Air Pollution Control Regulation No. 12: Incinerators (250-RICR-120-05-12).
4.8.4Lighting & Electrical Services
A.Policies and procedures shall be established to govern the use and operation of all electrical equipment.
B.The standards of Lighting for Hospitals and Healthcare Facilities, incorporated above at § 4.2(A)(11) of this Part, shall serve as a guide to determine the lighting levels within each area of the hospital.
C.All electrical appliances used by hospitals shall be listed or labeled by an approved testing agency or be approved by local electrical inspection authorities.
D.Each hospital shall continuously evaluate (i.e., not less than every two (2) years) the essential electrical system's demand and compare that to the capacity of their emergency generation system. This evaluation shall be conducted by a qualified electrical consultant acceptable to the Director. A report on the results of the evaluation(s) shall be provided to the Director upon request.
E.Each hospital shall have a plan for responding to electrical system problems and failures in a timely manner. The plan shall include procedures for diagnosing and alleviating electrical problems or failures that may develop. Emergency generators and automatic transfer switches shall be tested in accordance with the most current applicable NFPA code. In addition to its own internal resources, each hospital shall also have agreements with contracted service providers for emergency services.
4.8.5Plumbing
A.All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of State Building Code regulations “RISBC-3 Rhode IslandPlumbing Code.”
B.All plumbing shall be installed in such a manner as to prevent back siphonage or cross connections between potable and non-potable water supplies.
C.Fixtures from which grease is discharged shall be served by a line in which a grease trap is installed. The grease trap shall be cleaned sufficiently often to sustain efficient operation.
4.8.6Waste Water Disposal
Any new facility shall be connected to a public sanitary sewer.
4.8.7Waste Disposal
A.Medical Waste
Medical waste as defined in the Department of Environmental Management’s Medical Waste Regulations (250-RICR-140-15-1) shall be managed in accordance with the provisions of the aforementioned regulations.
B.Other Waste
Wastes which are not classified as medical waste, hazardous wastes or which are not otherwise regulated by law or rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
1.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management.
2.Load packers must conform to the same restrictions required for dumpsters and, in addition, load packers shall be:
a.high enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment; and
b.the loading section shall be constructed and maintained to prevent rubbish from blowing from said area site.
4.8.8Water Supply
A.Water shall be obtained from a community water system as defined in “Rules and Regulations Pertaining to Public Drinking Water.”
B.The water shall be distributed to conveniently located taps and fixtures throughout the buildings and shall be adequate in volume and pressure for all hospital purposes, including firefighting.
4.8.9Existing Structures
In all instances, where exceptions are not granted by the licensing agency, the same standards as specified for new construction shall apply.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.9** Confidentiality, Variance & Severability {#sec-216-ricr-40-10-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.9}
4.9.1Confidentiality
Disclosure of any health care information relating to individuals shall be subject to the provisions of all relevant statutory and federal requirements governing confidentiality of health care information including but not limited to the provisions of R.I. Gen. Laws Chapter 5-37.3.
4.9.2Variance Procedure
A.The licensing agency may grant a variance upon request of the applicant from the provisions of any these regulations, if it finds in specific cases, that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon filing of each request for variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial. Such hearing must be held in accordance with the provisions of § 4.9.4 of this Part.
4.9.3Deficiencies & Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a facility in accordance with § 4.9.3(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 4.9.3(B) of this Part, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 4.46 of this Part. If the facility is aggrieved by the sanctions of the licensing agency, the facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department of Health shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing shall in all respects comply with the provisions therein.
4.9.4Rules Governing Practices & Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17, as amended, shall be held in accordance with the provisions of the Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
4.9.5Severability
If any provision of these regulations or the application thereof to any facility or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provisions of the regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
##### **216-RICR-40-10-4 § 4.10** Appendix A: Universal Perinatal Screening Protocol {#sec-216-ricr-40-10-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-4#4.10}
A.Discharge after Delivery of a Normal Newborn
1.A perinatal hospitalization is unique in that proper medical care involves two patients at the beginning of a crucial long-term relationship. The medically necessary care of the mother and infant at birth includes the assessment, documentation and management of patient needs in the domains of maternal health, infant health and development and nurturance. Early perinatal discharge is only appropriate if an assessment is complete, all significant patient needs have been addressed and a mechanism is in place to ensure follow-up. Discharge of mothers and infants should be coordinated so that the pair leave the hospital together, unless the medical condition of one requires a significantly longer hospital stay.
2.The following risk factors shall be evaluated and appropriate follow-up care plans and/or referrals documented in the medical record prior to discharge.
a.Maternal Health
(1)The mother has stable vital signs, is ambulatory, eating and voiding;
(2)The uterus is firm, the perineum intact or sutured and there is no significant active post-partum bleeding;
(3)Post-partum exam and lab work completed, treatment and instructions given;
(4)Rhogam and/or rubella vaccine given, if required;
(5)Other maternal health problems documented and addressed.
b.Infant Health & Development
(1)Successful feeding x 3, voiding and defecating;
(2)Vital signs stable for at least 12 hours;
(3)Physical examination completed;
(4)Metabolic, hemoglobinopathy, Level 1, and hearing screening and other lab work completed;
(5)Eye prophylaxis, hepatitis B vaccine and Vitamin K given as required;
(6)Other infant health and development issues documented and addressed, parent instructions given, follow-up appointments arranged;
(7)Birth certificate completed.
c.If the infant weighs less than 2,500 grams or has a 5-minute APGAR score less than seven, or if the mother is known to have a risk factor (e.g., diabetes, streptococcal carrier, hepatitis or illicit drug use) for early post-natal complications, discharge in less than 48 hours after birth may be contraindicated.
d.Nurturance:
(1)There is a responsible adult available to assist the mother and infant at home for at least twenty-four hours;
(2)There is a telephone in the home, and a caregiver who speaks the mother's language is available to provide telephone assistance;
(3)The home is reasonably safe, food, and heat if needed, is available;
(4)Appointments for follow-up care are complete, including home visits, family support referrals and primary care visits;
(5)If the mother is under 17 years of age, has less than a high school education, has other impairments, a history of neglect or other significant risk for poor nurturance or developmental problems such as those identified by Universal Level 1 Newborn Screening, appropriate family support arrangements have been completed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2021-01-12 to 07/11/2021*
- *Technical Revision — effective from 2017-09-28 to 01/04/2022*
- *Amendment — effective from 2017-09-28 to 09/28/2017*
- *Amendment — effective from 2017-03-14 to 09/28/2017*
- *Amendment — effective from 2012-12-10 to 03/14/2017*
- *Amendment — effective from 2009-05-14 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 05/14/2009*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2004-09-14 to 04/07/2005*
- *Amendment — effective from 2003-01-15 to 09/14/2004*
- *Amendment — effective from 2002-08-04 to 01/15/2003*
- *Amendment — effective from 2002-03-27 to 08/04/2002*
- *Periodic Refile — effective from 2002-01-02 to 03/27/2002*
#### **216-RICR-40-10-5** Licensing of Freestanding Ambulatory Surgical Centers
##### **216-RICR-40-10-5 § 5.1** Authority {#sec-216-ricr-40-10-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17-10 and are established for the purpose of adopting minimal standards for licensed freestanding ambulatory surgical centers in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.2** Definitions {#sec-216-ricr-40-10-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.2}
A.Wherever used in these rules and regulations the following terms shall be construed as follows:
1."Change of operator" means a transfer by the governing body or operator of a licensed freestanding ambulatory surgical center (“FASC”) to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.Hire or fire the chief executive officer of the FASC;
b.Maintain and control the books and records of the FASC;
c.Dispose of assets and incur liabilities on behalf of the FASC;
d.Adopt and enforce policies regarding operation of the FASC.
e.This definition is not applicable to circumstances wherein the governing body of a FASC retains the immediate authority and jurisdiction over the activities enumerated in §§ 5.2(A)(1)(a) through (d) of this Part.
2."Change in owner" means:
a.In the case of a FASC which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership.
b.In the case of a FASC which is a corporation:
(1)A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a FASC which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of a FASC which is a non-business corporation, and change in membership which results in a new person acquiring a controlling vote in such corporation.
3."Director" means the Director of the Rhode Island Department of Health.
4.“Equity” means non-debt funds contributed towards the capital costs related to a change in owner or change in operator of a freestanding ambulatory surgical center which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
5."Freestanding Ambulatory Surgical Center," also referred to as the “FASC”, means an establishment or place which may be a public or private organization equipped and operated exclusively for ambulatory patients for the purpose of performing surgical procedures which have the approval of the governing body and which in the opinion of the surgeon and anesthesiologist can be performed safely without requiring extensive anesthesia or overnight stay.
6."Health Services Council" means the advisory body to the Rhode Island State Department of Health established in accordance with R.I. Gen. Laws Chapter 23-16, appointed and empowered in accordance with R.I. Gen. Laws Chapter 23-17, to serve as the advisory body to the state agency in its review functions.
7.The “licensed capacity," of the FASC, means the number of operating rooms and recovery beds that the facility is licensed to operate.
8."Licensing agency" or "state agency" means the Rhode Island Department of Health.
9."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivisions or instrumentality of a state.
10."R.I. Gen. Laws" means the General Laws of Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.** 3 Licensing Procedures and Definitions {#sec-216-ricr-40-10-5-5. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.}
5.3.1General Requirements for Licensure
A.No person acting severally or jointly with any other person, shall establish, conduct or maintain a FASC in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4.
B.A certificate of need is required as a precondition to the establishment of a new FASC and such other activities in accordance with R.I. Gen. Laws Chapter 23-15.
5.3.2Application for License or for Changes in Owner, Operator, or Lessee
A.Application for License and Renewal.
1.Application for an initial license to conduct, maintain or operate a FASC shall be made to the licensing agency upon forms provided by it and shall contain such information as the licensing agency reasonably requires which may include affirmative evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and this Part.
2.Licenses will expire at the end of the calendar year unless renewed (prior to the expiration date of licensure).
a.Renewal applications must be submitted one month prior to the expiration date.
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust, note or other obligation.
C.Application for changes in the owner, operator, or lessee of a FASC shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 5.3.3(D)(5) of this Part. Three (3) paper copies and an electronic copy of such applications are required to be provided.
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-refundable, non-returnable application fee, as set forth in the Fee Structure for Licensing, Laboratory, and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
5.3.3Issuance and Renewal of License
A.Upon receipt of an application for a license, the licensing agency shall issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and this Part. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection and approval by the licensing agency.
B.A license shall be issued to a specific licensee for a specific location and shall not be transferable except with the written approval of the licensing agency. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance.
1.Any change in owner, operator, or lessee of a licensed FASC shall require prior review by the Health Services Council and approval of the licensing agency as provided in § 5.3.3(D) of this Part as a condition precedent to the transfer, assignment or issuance of a new license.
C.A license issued hereunder shall be the property of the state loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
D.Reviews of applications for changes in the owner, operator, or lessee of licensed FASC shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for a license in connection with a change in the owner, operator or lessee of an existing FASC, the licensing agency will notify and afford the public thirty (30) days to comment on such application.
2.The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application.
3.The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the licensing agency shall afford written justification for variance therefrom.
4.All applications reviewed by the licensing agency and all written materials pertinent to licensing agency review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.
5.Except as otherwise provided in R.I. Gen. Laws Chapter 23-17, a review of the Health Services Council of an application for a license in the case of a proposed change in the owner, operator, or lessee of a licensed FASC may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws Chapter 23-17-3. In conducting reviews of such applications the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
6.The character, commitment, competence and standing in the community of the proposed owners, operators, or directors of the FASC as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
(3)In providing appropriate access to health care facility services;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the health care facility;
7.The extent to which the facility will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the facility's services as evidenced by:
a.The immediate and long term financial feasibility of the proposed financing plan;
(1)The proposed amount and sources of owner's equity to be provided by the applicant;
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;
(3)The relative availability of funds for capital and operating needs;
(4)The applicant's demonstrated financial capability;
(5)Such other financial indicators as may be requested by the state agency;
8.The extent to which the facility will continue to provide safe and adequate treatment for individuals receiving the facility's services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:
a.The applicant’s demonstrated record in providing safe and adequate treatment to individuals receiving services at facilities owned, operated, or directed by the applicant; and
b.The credibility and demonstrated or potential effectiveness of the applicant’s proposed quality assurance programs;
9.The extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities; and
b.The proposed immediate and long term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility;
10.In consideration of the proposed continuation or termination of health care services by the facility:
a.The effect(s) of such continuation or termination on access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations.
11.And, in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long-term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
E.Subsequent to reviews conducted under §§ 5.3.3(D) and (D)(6) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in § 5.3.3(D)(6) of this Part. This shall not limit the authority of the licensing agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the facility by the licensing agency.
5.3.4Capacity
A.The license for a FASC shall be issued for a specified number of operating rooms and recovery beds. The numerical capacity of the FASC shall be determined by the number of recovery beds provided.
B.The post-surgical occupancy of a facility shall not exceed the determined capacity for which a FASC is licensed.
5.3.5Inspections
A.The licensing agency shall make or cause to be made such inspections and investigations as it deems necessary and in accordance with R.I. Gen. Laws § 23-17-10 and this Part.
B.Every FASC shall be given prompt notice by the licensing agency of any deficiencies reported as a result of an inspection or investigation.
C.Written reports and recommendations of inspections shall be maintained on file in each FASC for a period of no less than three (3) years.
5.3.6Denial, Suspension, Revocation of License or Curtailment of Activities
A.The licensing agency is authorized to deny, suspend or revoke the license or curtail activities of any FASC which:
1.has failed to comply with the rules and regulations pertaining to the licensing of FASC; and
2.has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3.Lists of deficiencies noted in inspections conducted in accordance with § 5.3.5 of this Part shall be maintained on file in the licensing agency, and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or to curtail activities of a FASC.
B.Where the licensing agency deems that operation of a FASC results in undue hardship to patients as a result of deficiencies, the licensing agency is authorized to deny licensure to a FASC not previously licensed, or to suspend for a stipulated period of time or revoke the license of a FASC already licensed or curtail activities of the FASC.
C.Whenever an action shall be proposed to deny, suspend or revoke a FASC license, or curtail its activities, the licensing agency shall notify the FASC by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35.9.
1.However, if the licensing agency finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21, and 42-35-14(c).
D.The appropriate state and federal placement and reimbursement agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension or revocation of license, or curtailment of activities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.** 4 Organization and Management {#sec-216-ricr-40-10-5-5. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.}
5.4.1Governing Body and Management
A.Each facility shall have an organized governing body or other legal authority, responsible for:
1.The management and control of the operation;
2.The assurance of the quality of care and services;
3.The conformity of the facility with all federal, state and local laws and regulations relating to fire, safety, sanitation, infection control; and
4. Other relevant health and safety requirements and with all the rules and regulations of this Part.
B.The governing body or other legal authority shall provide appropriate personnel, physical resources, and equipment based on the scope of services provided.
C.The governing body or other legal authority shall designate:
1.An administrator who shall be responsible for the management and operation of the facility; and
2.A medical director to ensure achievement and maintenance of quality standards of professional practice.
D.The governing body shall adopt and maintain by-laws defining responsibilities for the operation and performance of the organization, identifying purposes and means of fulfilling such, and in addition the by-laws shall include but not be limited to:
1.A statement of qualifications and responsibilities of the medical director and administrator;
2.A statement of the governing body's responsibility for the quality of care and services;
3.A statement relating to development and implementation of long and short range plans;
4.A statement of policy establishing the criteria for the selection and admission of patients;
5.A statement relating to conflict of interest on the part of the governing body, medical staff and employees;
6.A policy statement concerning the publication of an annual report, including a certified financial statement; and
7.Such other matters as may be relevant to the organization of the FASC.
E.When a majority of the members of the governing body are physicians, the governing body, either directly or by delegation, shall make initial appointments, and assignment or curtailment of surgical privileges, based on the education, training, experience and evidence of competence of the physician, dentist or podiatrist consistent with state law; or when a majority of the members of the governing body are not physicians the organization's by-laws or similar rules and regulations shall specify a procedure for establishing medical review for the purpose of making initial appointments, reappointments, and assignment or curtailment of medical privileges, based on the education, training, experience and evidence of current competence of the physician, dentist or podiatrist, and consistent with state law.
F.A health care facility shall require all persons, including students, who examine, observe, or treat a patient or resident of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
5.4.2Administrator
A.The governing body shall appoint a qualified administrator who may be the medical director, who shall be responsible for:
1.The management and operation of the FASC;
2.The enforcement of policies, rules and regulations and statutory provisions pertaining to the health and safety of patients;
3.Serving as liaison between the governing body and the staff; and
4.The planning, organizing and directing of such other activities as may be delegated by the governing body.
5.4.3Medical Director
A.The surgical services of the FASC shall be under the direction of a physician licensed in Rhode Island, who meets the qualifications set forth by the governing body in accordance with § 5.4.1 of this Part, and who shall be responsible for no less than the following.
1.The coordination, supervision and functioning of services;
2.The establishment of provisions for infection control;
3.The achievement and maintenance of quality assurance of professional practices through a mechanism of peer review; and
4.The establishment of policies and procedures for surgical and anesthesia services and other related health care services.
B.Personnel Health Requirements
1.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the freestanding ambulatory surgical center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-17 of this Title) promulgated by the Department of Health.
5.4.4Rights of Patients
A.Each FASC shall observe the standards enumerated in R.I. Gen. Laws § 23-17-19.1 with respect to each patient admitted on its facility.
B.Each facility shall display in a conspicuous place in the licensed FASC a copy of the "Rights of Patients.”
5.4.5Disaster Preparedness
A.Each FASC shall develop and maintain a written disaster preparedness plan which shall include specific provisions and procedures for the emergency care of patients in the event of fire, natural disaster or functional failure of equipment.
1.Such a plan shall be developed and coordinated with appropriate state and local agencies and representatives concerned with emergency safety and rescue;
2.A copy of the plan shall be submitted to the licensing agency;
3.Simulated drills testing the effectiveness of the plan shall be conducted at least semi-annually. Written reports and evaluation of all drills shall be maintained by the FASC and available for review by the licensing agency;
B.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the facility.
5.4.6Administrative Records
A.Each FASC shall maintain such administrative records as may be deemed necessary for the business operation of the facility, in addition to the following;
1.Monthly statistical summary of numbers of surgical procedures performed, appropriately classified;
2.Narcotic register;
3.An operating room log book maintained in chronological sequence of admissions which shall include pertinent information such as patient's name, name of surgeon and anesthetist, circulating nurse, surgical procedures performed, type of anesthesia and complications (if any); and
4.A record of all transfers to a hospital for post-surgical care.
5.4.7Uniform Reporting System
A.Each FASC shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director with the advice of the Health Services Council.
B.Each FASC shall report to the licensing agency detailed financial and statistical data pertaining to its operations, services, and facility. Such reports shall be made at such intervals and by such dates as determined by the Director and shall include but not be limited to the following:
1.Utilization of FASC services;
2.Unit cost of services;
3.Charges for services;
4.Financial condition of the FASC; and
5.Quality of care.
C.The licensing agency is authorized to make the reported data available to any state agency concerned with or exercising jurisdiction over the reimbursement of the FASC.
D.The directives promulgated by the Director pursuant to these regulations shall be sent to each FASC to which they apply. Such directives shall prescribe the form and manner in which the financial and statistical data required shall be furnished to the licensing agency.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.** 5 Patient Care Services {#sec-216-ricr-40-10-5-5. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.}
5.5.1Admission, Transfer and Discharge
A.Each FASC shall have written admission, transfer and discharge policies and procedures pertaining to at least the following:
1.Types of surgical procedures and conditions acceptable for admission;
2.Emergency admission;
3.Requirements for pre-admission history in accordance with § 5.5.5(C) of this Part;
4.Transfer of patients for continuity of care or emergency care;
5.Discharge of patient with responsible adult, as indicated;
6.Constraints imposed by limitations of services, physical facilities; and
7.Instruction of patients on self-care upon discharge.
5.5.2Patient Care Management
A.Each patient shall be under the continuing supervision of a physician and provisions shall be made to assure the availability of a physician through the period of a patient's stay in the FASC.
B.A mechanism shall be established for the development and periodic review and revision of patient care policies and procedures which shall pertain to no less than:
1.Scope of services provided either directly or per contractual arrangements;
2.Criteria for admission, transfer and discharge;
3.Physician services and consultation services;
4.Radiology and laboratory services; and
5.Counseling services, if indicated.
C.The names and telephone number(s) of physicians to be called in an emergency including rescue or ambulance services shall be posted and easily accessible.
D.No medication shall be given except on the signed order of a lawfully authorized person. Emergency telephone orders shall be signed within twenty-four (24) hours.
5.5.3Anesthesia Service
A.A qualified anesthesiologist shall be on the staff.
B.There shall be written policies and procedures regarding:
1.Privileges of staff for anesthesiology established in accordance with § 5.4.1(E) of this Part;
2.Emergency coverage;
3. Administration of anesthetics;
4. The maintenance of safety controls; and
5.Qualifications and supervision of non-physician anesthetists. In addition, the policies shall include provisions for at least the following:
a.Pre-anesthesia evaluation by a physician;
b.Safety of the patient during the anesthesia period;
c.Review of patient's condition prior to induction of anesthesia and post-anesthetic evaluation; and
d.Recording of all events related to each phase of anesthesia care.
5.5.4Counseling and Referral Service
When irreversible procedures are to be performed, such as human sterilization or termination of pregnancy, or when indicated in other situations, counseling service shall be provided through physicians, qualified nurses, social workers or trained counselors or a list of counseling agencies shall be made available to patients.
5.5.5Nursing Care Service
A.Nursing care service shall be under the direction of a full time licensed registered nurse who has training and experience in surgical nursing, and who shall be responsible for the supervision of nursing care needs of patients in preparation for and during the surgical procedure, and during the recovery period until discharged from the FASC by the responsible physician.
B.The number and type of registered nurses and ancillary personnel shall be based on the scope of services provided and staff capabilities, to ensure direct patient care as needed throughout the period of the patient(s) stay.
C.It shall be the responsibility of the registered nurse to obtain directly from the patient, per telephone if possible, a pre-admission history, distinct from the history obtained by the private physician.
5.5.6Infection Control
A.A mechanism shall be established by the Medical Director for the development of infection control policies which shall pertain to no less than:
1.Infection surveillance activities
2.Sanitation and asepsis;
3.Isolation of patients with known or suspected infectious diseases;
4.Handling and disposal of waste and contaminants;
5.Sterilization, disinfection and laundry;
6.Reporting, recording and evaluation of occurrences of infections; and
7.Documentation of infection rate.
B.The facility shall report promptly to the licensing agency infectious diseases which may present a potential hazard to patients, personnel and the public. Included are the reportable diseases and the occurrences of other diseases in outbreak form.
5.5.7Surgical Service
A.Written staff rules and regulations and policies shall be established to govern surgical services which shall include surgical staff privileges, supporting services of professional and paramedical personnel, provisions for emergency coverage and operating suite procedures.
B.Surgical procedures shall be performed only by physicians, dentists or podiatrists who are licensed in the state and who have been granted privileges to perform those procedures by the governing body of the FASC in accordance with § 5.4.1(E) of this Part.
C.Each FASC shall have a written transfer agreement for transferring patients to a nearby hospital when hospitalization is indicated, or shall permit elective surgery only by licensed practitioners who have similar privileges at a nearby licensed hospital and approved by the governing body of the FASC.
D.Surgical procedures performed in the FASC shall be limited to those procedures and approved by the governing body.
E.If termination of pregnancy procedures are performed in a FASC the requirements of the rules and regulations for the Termination of Pregnancy (Part 20-10-6 of this Title) shall apply.
F.An anesthesiologist or another physician qualified in resuscitative technique shall be present or immediately available until all patients operated on a given day have been discharged.
G.Each operating room suite shall be:
1.Under the supervision of a person qualified by training and experience in operating room service;
2.Designed and equipped so that the types of surgery conducted and the type of anesthesia utilized (general or local) shall meet the fire and safety requirements of §§ 5.7.2(C) and/or (D) of this Part;
3.Designed to include recovery rooms, proper scrubbing, sterilizing and dressing room facilities, storage for anesthetic agents;
4.Equipped to carry out all necessary and emergency procedures; and
5.Provided with prominently posted policies and procedures pertaining to safety controls.
H.All tissues/specimens removed at surgery shall be submitted for pathological examination except those exempted by the surgeon in writing.
I.Procedures shall be established to obtain blood or blood substitutes on a timely basis.
J.The patient's medical record shall be available in the operating room at the time of surgery and shall contain no less than the following information:
1.A medical history and physical examination;
2.A signed consent form for surgical procedure; and
3.A pre-operative diagnosis.
K.An accurate and complete description of operative procedure shall be recorded by the operating surgeon immediately following completion of surgery.
L.Areas for the processing of clean and dirty supplies and equipment shall be separated by physical barriers.
M.Written procedures shall be established for all sterilization and for the appropriate disposal of wastes and contaminated supplies.
N.Reports of bacteriological tests and dated recordings of thermometer charts and inspection records shall be maintained on the premises.
5.5.8Supplies and Equipment
A.Supplies of appropriate sterile linens, gloves, dressings and so forth, shall be maintained in sufficient quantities for regular and emergency use.
B.Such surgical instruments, accessory and operating room lights and resuscitation equipment as are appropriate for the types of surgery and surgical risks which may be encountered in a FASC shall be provided and maintained in clean and sterile condition.
C.Supplies of appropriate drugs, medications, fluids, electrolyte solutions, etc. shall be maintained in sufficient quantities for regular and emergency use.
5.5.9Deficiencies and Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a facility within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 5.3.6 of this Part. If the facility is aggrieved by the action of the licensing agency, the facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
5.5.10Laboratory and Radiology Services
A.Each FASC may perform on the premises limited procedures such as urinalysis and CBC, provided that personnel are qualified by training and are under supervision of a physician.
B.The requirements of the "Rules and Regulations for the Control of Radiation [R23-1.3-RAD]" pertaining to radiology shall apply to those FASC providing such services.
5.5.11Medical Records
A.A member of the professional staff shall be designated to supervise the medical records and to ensure proper documentation, completion, indexing, filing, retrieval and safe storage.
B.A medical record shall be established and maintained for every patient cared for in the FASC.
C.Each medical record shall contain sufficient information and data to support the diagnosis, plan of treatment and shall contain no less than the following:
1.Patient identification, (name, address, birth date, etc.);
2.Medical history and physical examination;
3.Pre-operative and final diagnosis;
4.Nurses' notes;
5.Anesthesiologists reports, medical consultation, and counseling (if any);
6.Surgeon's operative notes, progress report and discharge notes;
7.Instructions given patient upon discharge; and
8.Other related reports.
5.5.12Medical Consultation
Consultation and assistance in specialty fields shall be readily available and used as indicated prior to and when necessary following a surgical procedure. A facility shall maintain a current list of consultants available.
5.5.13Emergency Transfer
Each FASC shall have resources available for the emergency transfer of patients to a hospital. When indicated, a physician, physician assistant, or nurse shall accompany the patient.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.** 6 Environmental Maintenance {#sec-216-ricr-40-10-5-5. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.}
5.6.1Environment
A.The FASC shall be maintained and equipped to provide a functional sanitary, safe and comfort- able environment, with all furnishings in good repair, and the premises shall be kept free of hazards.
B.Written policies and procedures shall be established pertaining to environmental controls to assure comfortable, safe and sanitary environment with well-lighted space for the services provided.
C.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition.
D.Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place and kept in an enclosed section separate from other cleaning materials.
E.Cleaning shall be performed in a manner which minimizes the spread of pathogenic organisms in the atmosphere.
F.Operating rooms shall be thoroughly cleaned after each operation.
G.Smoking shall be permitted only in restricted areas.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.** 7 Physical Plant and Equipment {#sec-216-ricr-40-10-5-5. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.}
5.7.1New Construction
A.All new construction shall be subject to the provisions of R.I. Gen. Laws Chapters 23-28-1, 23-27.3, and The American National Standard - Specifications for Making Buildings and Facilities Accessible to and Usable by, The Physically Handicapped," American National Standards Institute, Inc., 1430 Broadway, New York, New York 10013.
B.In addition, any other applicable state and local laws, codes and regulations shall apply. Where there is a difference between codes, the code having the higher standard shall apply.
5.7.2Physical Facility
A.Patient examination, waiting, procedure and recovery rooms shall be designed and equipped to provide good and safe care, as well as to provide privacy and comfort for patients.
B.Sufficient space shall be provided in the patient recovery areas to accommodate the patient load with a planned recovery period and to accommodate emergency equipment and staff to move freely.
C.If flammable agents are present in an operating room, the room shall be constructed and equipped in accordance with the standards of publication No. 56A, (1973) of the "National Fire Protection Association," 470 Atlantic Avenue, Boston, Massachusetts 02110.
D.If only non-flammable agents are present in an operating room, the room shall be constructed and equipped in compliance with standards of publication No. 56G, (1975) of the "National Fire Protection Association," 470 Atlantic Avenue, Boston, Massachusetts 02110.
E.Heating and ventilation systems shall be capable of maintaining comfortable temperatures.
F.Each FASC shall meet the fire and safety provisions of R.I. Gen. Laws 23-28.1 and shall conform with all state and local building codes.
G.An elevator shall be provided where patient care is provided at different floor levels. The cab size of the elevator shall be large enough to accommodate a stretcher and an attendant.
H.Medication and storage areas shall be provided and equipped with locks to ensure the safe keeping of drugs and biologicals.
5.7.3Emergency Power
A.Each FASC shall be equipped with an alternate emergency power source.
B.The emergency electrical power system shall have a sufficient capacity to supply power to maintain the operation of the operating room and other life-support systems, and lighting of egress, fire detection equipment, alarm and extinguishing systems.
C.Monthly testing of emergency power shall be documented and reports retained for at least three (3) years.
5.7.4Lighting and Electrical Services
All electrical and other equipment used in the FASC shall be maintained free of defects which could be a potential hazard to patients or personnel. Periodic calibration and/or preventive maintenance of equipment shall be provided and documentation of all testing shall be maintained.
5.7.5Plumbing
A.All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of R.I. Gen. Laws Chapter 23-27.3.
B.All plumbing shall be installed in such a manner as to prevent back siphonage or cross-connections between potable and non-potable water supplies.
5.7.6Water Supply
Water shall be obtained from a community water system and shall be distributed to conveniently located taps and fixtures throughout the facility and shall be adequate in volume and pressure for all purposes including firefighting.
5.7.7Waste Disposal
A.Medical Waste
1.Medical waste as defined in the Medical Waste Regulations (250-RICR-140-15-1), promulgated by the Rhode Island Department of Environmental Management, shall be managed in accordance with the provisions of the aforementioned regulations.
B.Other Waste:
1.Wastes which are not classified as infectious waste, hazardous wastes, or which are not otherwise regulated by law or rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
a.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management.
b.Load packers must conform to the same restrictions required for dumpsters and in addition, load packers shall be:
(1)High enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment; and
(2)The loading section shall be constructed and maintained to prevent rubbish from blowing from said area site.
5.7.8Waste Water Disposal
If a municipal sanitary sewer system is available, the facility shall be connected to the system, if feasible. If a municipal sanitary sewer system is not available the facility shall meet the standards set forth by the Department of Environmental Management.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-5 § 5.** 8 Exception {#sec-216-ricr-40-10-5-5. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-5#5.}
5.8.1Exception
Modification of any individual standards herein, for experimental or demonstration purposes, or any other purpose, shall require advance written approval from the licensing agency.
5.8.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17, shall be held in accordance with the provisions of the rules and regulations regarding "Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health [R42-35-PP]" and "Rules and Regulations Pertaining to Access to Public Records of the Rhode Island Department of Health [R38-2-APRA]".
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-03-22 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/22/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-6** Patient Safety Organizations
##### **216-RICR-40-10-6 § 6.1** Authority {#sec-216-ricr-40-10-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.1}
These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17.21-5(c), for the purpose of adopting standards for certification of patient safety organizations and operational requirements for both a reporting entity and a patient safety organization.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.2** Incorporated Materials {#sec-216-ricr-40-10-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.2}
These regulations hereby adopt and incorporate 45 C.F.R. Parts 160 through 164 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.3** Definitions {#sec-216-ricr-40-10-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.3}
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-17.21, entitled “The Rhode Island Patient Safety Act of 2008.”
2.“Bona fide contract” means a written contract between a reporting entity and a PSO that is executed in good faith by officials authorized to execute such contract.
3.“Component organization” means an entity that is either:
a.A unit or division of a corporate organization or of a multi-organizational enterprise; or
b.A separate organization, whether incorporated or not, that is owned, managed or controlled by one or more other organization(s), i.e., its parent organization(s).
4.“Component PSO” means a patient safety organization certified by the Director that is a component organization.
5.“Department” means the Rhode Island Department of Health.
6.“Director" means the Director of the Rhode Island Department of Health.
7.“Document log” means an inventory or record, required pursuant to R.I. Gen. Laws § 23-17.21-6(b), which itemizes the types of documents submitted to the PSO without indicating the content of such documents.
8.“Entity” means any organization or organizational unit, regardless of whether the organization is public, private, for-profit or not-for-profit.
9.“Health care facility” means any corporation, limited liability company, facility, or institution licensed by this state to provide health care or professional services, or an officer, employee or agent thereof acting in the course and scope of his or her employment.
10.“Identifiable patient safety work product” means patient safety work product that:
a.Is presented in a form and manner that allows the identification of any provider or reporting entity that is a subject of the work product, or any providers or reporting entities that participate in activities that are a subject of the work product;
b.Constitutes individually identifiable health information as that term is defined in the Health Insurance Portability and Accountability Act, 42 U.S.C. § 1320d-6 and its implementing regulations; or
c.Is presented in a form and manner that allows the identification of an individual.
11.“Near misses” means circumstances in which a patient safety event is narrowly averted.
12.“Nonidentifiable patient safety work product” means patient safety work product that is not identifiable patient safety work product as defined in these regulations.
13.“Patient safety activities” means:
a.Efforts to improve patient safety and the quality of health care delivery;
b.The collection and analysis of patient safety work product;
c.The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;
d.The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;
e.The maintenance of procedures to preserve confidentiality with respect to patient safety work product; and
f.The provision of appropriate security measures with respect to patient safety work product.
14.“Patient safety event” means those events as defined by the national quality forum, institute of medicine, Center for Medicare and Medicaid Services (CMS), and as further defined by the Quality of Care Advisory Committee, as established in this Part pursuant to RI Gen Laws § 23-17.21-5(b), and shall include near misses.
15.“Patient safety organization (PSO)” means any entity certified by the Director whose activity is to improve patient safety and the quality of health care delivery for patients receiving care through the collection, aggregation, analysis, investigation, and/or processing of medical or health care related information submitted to it by reporting entities. A PSO shall not mean any agency or public body as defined in R.I. Gen. Laws § 38-2-2(1).
16.“Patient safety work product" means all reports, records, memoranda, analyses, statements, root cause analyses, and written or oral statements, that:
a.A health care facility or provider prepares for the purpose of disclosing a patient safety event, and is disclosed, to a patient safety organization;
b.Is received from a reporting entity, and is created and analyzed by a patient safety organization; or
c.Directly or indirectly contains deliberations, analytical process, recommendations, conclusions, or other communications of a patient safety organization and between a patient safety organization and health care providers or facilities.
17.“Quality of Care Advisory Committee” means the committee established by the Director, pursuant to R.I. Gen. Laws § 23-17.21-5(b), to advise the Department on PSO-related issues.
18.“Reporting entity” means any hospital, nursing facility or freestanding ambulatory surgical center licensed pursuant to R.I. Gen. Laws § 23-17.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.4** General Provisions {#sec-216-ricr-40-10-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.4}
A.Ineligible Entities
1.Entities that may not seek certification as a PSO include:
a.Health insurance issuers or components of health insurance issuers.
2.Any other entity, public or private, that conducts regulatory oversight of health care providers, such as accreditation or licensure, may not seek certification, except that a component of such an entity may seek listing as a component PSO.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.5** Privilege and Confidentiality Protections {#sec-216-ricr-40-10-6-6.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.5}
6.5.1Privilege
Privilege of patient safety work product and document log is pursuant to R.I. Gen. Laws § 23-17.21-8(a).
6.5.2Confidentiality of Patient Safety Work Product and Document Log
Confidentiality of patient safety work product and document log is pursuant to R.I. Gen. Laws § 23-17.21-8(b).
6.5.3Exceptions
A.Exceptions from privilege and confidentiality are pursuant to R.I. Gen. Laws § 23-17.21-8(c)(1).
B.Exceptions from confidentiality are pursuant to R.I. Gen. Laws § 23-17.21-8(c)(2).
C.Continued protection of information after disclosure is pursuant to R.I. Gen. Laws §§ 23-17.21-8(d)(1) through 23-17.21-8(d)(3).
1.Limitations on actions are pursuant to R.I. Gen. Laws § 23-17.21(8)(d)(4).
D.Reporter protection is pursuant to R.I. Gen. Laws § 23-17.21-8(e).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.6** Reporting Entity Requirements {#sec-216-ricr-40-10-6-6.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.6}
Reporting entity requirements are pursuant to R.I. Gen. Laws § 23-17.21-6.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.7** Patient Safety Organization Requirements {#sec-216-ricr-40-10-6-6.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.7}
6.7.1Maintenance of Reports
Maintenance of reports is pursuant to R.I. Gen. Laws § 23-17.21-7(b).
6.7.2Dissemination of Information
Dissemination of information is pursuant to R.I. Gen. Laws § 23-17.21-7(c).
6.7.3Safeguards and Security Measures
A.General Requirements
1.A PSO shall have in place appropriate physical, technical and procedural safeguards and security measures to ensure the technical integrity, physical safety, and confidentiality of any patient safety work product. These safeguards and security measures shall be in place at all times and at any location at which the PSO, its workforce members, or its contractors hold patient safety work product. Such safeguards and security measures shall comply with state and federal confidentiality laws including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations 45 C.F.R. Parts 160 through 164 (2017) incorporated at § 6.2 of this Part and R.I. Gen. Laws Chapter 5-37.3 (Confidentiality of Health Care Communications and Information Act).
2.Nothing in the Act or this Part shall be construed to prohibit a PSO from choosing to disclose patient safety work product, or portions of patient safety work product, solely to a reporting entity, in conformity with the PSO's mission and within its contractual obligations to the reporting entity who submitted the information. No patient safety organization shall release protected health information or patient identifying information without meeting the requirements of R.I. Gen. Laws § 5-37.3 (Confidentiality of Health Care Communications and Information Act) and the federal Health Insurance Portability and Accountability Act of 1996, and its implementing regulations 45 C.F.R. Parts 160 through 164 (2017) incorporated at § 6.2 of this Part.
B.Security Framework. PSOs shall consider the following framework for the security of patient safety work product. The framework includes security management, separation of systems, security monitoring and control, and system assessment. To address the four elements of this framework, a PSO shall develop appropriate and scalable security standards, policies, and procedures that are suitable for the size and complexity of its organization.
1.Security Management. A PSO shall address:
a.Maintenance and effective implementation of written policies and procedures that conform to the requirements of this section to protect the confidentiality, integrity, and availability of the patient safety work product that is processed, stored, and transmitted; and to monitor and improve the effectiveness of such policies and procedures, and
b.Training of the PSO workforce and PSO contractors who access or hold patient safety work product regarding the requirements of the Act, this Part, and the PSO's policies and procedures regarding the confidentiality and security of patient safety work product.
2.Separation of Systems. A PSO shall address:
a.Maintenance of patient safety work product, whether in electronic or other media, physically and functionally separate from any other system of records;
b.Protection of the media, whether in electronic, paper, or other format, that contain patient safety work product, limiting access to authorized users and sanitizing and destroying such media before disposal or release for reuse; and
c.Physical and environmental protection, to control and limit physical and virtual access to places and equipment where patient safety work product is stored or used.
3.Security Control and Monitoring. A PSO shall address:
a.Identification of those authorized to have access to patient safety work product and an audit capacity to detect unlawful, unauthorized or inappropriate access to patient safety work product, and
b.Measures to prevent unauthorized removal, transmission or disclosure of patient safety work product.
4.Security Assessment. A PSO shall address:
a.Periodic assessments of security risks and controls, as determined appropriate by the PSO, to establish if its controls are effective, to correct any deficiency identified, and to reduce or eliminate any vulnerabilities.
b.System and communications protection, to monitor, control, and protect PSO uses, communications, and transmissions involving patient safety work product to and from reporting entities and any other responsible persons.
6.7.4Required Notifications
A.A PSO shall meet the following notification requirements:
1.Notification Regarding PSO Compliance With Minimum Contract Requirement. No later than forty-five (45) calendar days prior to expiration of the PSO’s certification, as specified in § 6.8.3(A) of this Part, the PSO shall submit to the Director an attestation as to whether it has met the requirement of § 6.8.2(A)(4)(c) of this Part regarding two (2) bona fide contracts.
2.Notification Regarding a PSO's Relationships With Its Contracting Reporting Entities. A PSO shall submit a disclosure statement to the Director regarding its relationships with each reporting entity with which the PSO has a contract pursuant to the Act and this Part if the circumstances described in either §§ 6.7.4(A)(2)(a) or 6.7.4(A)(2)(b) of this Part are applicable. The Director shall receive a disclosure statement within forty-five (45) days of the date on which a PSO enters a contract with a reporting entity if the circumstances are met on the date the contract is entered. During the contract period, if a PSO subsequently enters one or more relationships with a contracting reporting entity that create the circumstances described in § 6.7.4(A)(2)(a) of this Part or a reporting entity exerts any control over the PSO of the type described in § 6.7.4(A)(2)(b) of this Part, the Director shall receive a disclosure statement from the PSO within forty-five (45) days of the date that the PSO entered each new relationship or of the date on which the reporting entity imposed control of the type described in § 6.7.4(A)(2)(b) of this Part.
a.Taking into account all relationships that the PSO has with the reporting entity, other than the bona fide contract entered into pursuant to the Act and this Part, the PSO shall fully disclose any other contractual, financial, or reporting relationships described below that it has with that reporting entity.
(1)Contractual relationships which are not limited to relationships based on formal contracts but also encompass relationships based on any oral or written agreement or any arrangement that imposes responsibilities on the PSO.
(2)Financial relationships including any direct or indirect ownership or investment relationship between the PSO and the contracting reporting entity, shared or common financial interests or direct or indirect compensation arrangement, whether in cash or in-kind.
(3)Reporting relationships including any relationship that gives the reporting entity access to information or control, directly or indirectly, over the work of the PSO that is not available to other contracting reporting entities.
b.Taking into account all relationships that the PSO has with the reporting entity, the PSO shall fully disclose if it is not independently managed or controlled, or if it does not operate independently from, the contracting reporting entity. In particular, the PSO shall further disclose whether the contracting reporting entity has exercised or imposed any type of management control that could limit the PSO's ability to fairly and accurately perform patient safety activities and fully describe such control(s).
c.PSOs may also describe or include in their disclosure statements, as applicable, any agreements, stipulations, or procedural safeguards that have been created to protect the ability of the PSO to operate independently or information that indicates the limited impact or insignificance of its financial, reporting, or contractual relationships with a contracting reporting entity.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.8** Application For Certification {#sec-216-ricr-40-10-6-6.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.8}
6.8.1General Requirements
A.Certification Required. A patient safety organization (PSO) shall be certified by the Director pursuant to this Part before entering into a contract with a reporting entity.
B.Submission of Application. Any entity, except as specified in § 6.4(A) of this Part may request an initial or renewal certification as a PSO by submitting a completed application form to the Director on forms provided by the Department. An individual with authority to make commitments on behalf of the entity seeking certification will be required to acknowledge each of the certification requirements, attest that the entity meets each requirement, provide contact information for the entity, and certify that the PSO will promptly notify the Department during its period of certification if it can no longer comply with any of the criteria in this Part.
C.Notification of Changes. Any PSO certified pursuant to this section shall notify the Department in writing before making any change which would render the information contained in their application for certification no longer accurate.
D.Federal Certification Required. Any entity requesting certification as a PSO pursuant to this Part shall also obtain and maintain certification/listing as a PSO pursuant to the Patient Safety and Quality Improvement Act, 42 U.S.C. §§ 299b-21 through 299b-26, and any implementing regulations promulgated by the U.S. Agency for Healthcare Quality and Research.
1.Any PSO certified pursuant to this Part prior to the establishment of a federal PSO certification/listing program shall be required to obtain such certification when it becomes available. The PSO shall provide copies of all federal PSO certification/listing documents to the Director pursuant to § 6.8.1(C) of this Part.
2.Any entity requesting certification as a PSO pursuant to this Part after the establishment of a federal PSO certification/listing program shall be required to provide copies of all federal PSO certification/listing documents with their application.
3.Renewal. A PSO seeking renewal of certification after the establishment of a federal PSO certification/listing program shall include documentation that the PSO maintains current certification/listing pursuant to that federal PSO program.
6.8.2Certification Application
A.An application for certification as a PSO shall include, as a minimum, the following information for review by the Department:
1.Certification Regarding Patient Safety Activities. An entity seeking initial certification as a PSO shall attest that it has written policies and procedures in place to perform each of the following eight (8) patient safety activities:
a.Efforts to improve patient safety and the quality of health care delivery;
b.Collection and analysis of patient safety work product;
c.Development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;
d.Utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;
e.Maintenance of procedures to preserve confidentiality with respect to patient safety work product;
f.Provision of appropriate security measures with respect to patient safety work product;
g.Utilization of qualified staff; and
h.Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.
2.The policies and procedures referenced in § 6.8.2(A)(1) of this Part shall provide for compliance with the privilege and confidentiality provisions of § 6.5 of this Part and the appropriate safeguards and security measures required by § 6.7.3 of this Part.
3.Renewal. A PSO seeking renewal of certification shall attest that it is performing, and will continue to perform, each of the eight (8) patient safety activities referenced in § 6.8.2(A)(1) of this Part, and is and will continue to comply with the privilege and confidentiality provisions of § 6.5 of this Part and the appropriate safeguards and security measures required by § 6.7.3 of this Part.
4.Certification Regarding PSO Criteria. An entity seeking initial certification as a PSO shall attest that it will comply with each of the following seven (7) criteria:
a.The mission and primary activity of a PSO shall be to conduct activities that are to improve patient safety and the quality of health care delivery.
b.The PSO shall have appropriately qualified workforce members, including licensed or certified medical professionals.
c.The PSO, within the initial two (2) year certification period, and within each sequential two (2) year certification renewal period, shall have entered into at least two (2) bona fide contracts, each of a reasonable period of time, each with a different reporting entity for the purpose of receiving and reviewing patient safety work product.
d.The PSO is not a health insurance issuer, and is not a component of a health insurance issuer.
e.The PSO shall make disclosures to the Director as required under § 6.7.4 of this Part.
f.To the extent practical and appropriate, the PSO shall collect patient safety work product from reporting entities in a standardized manner that permits valid comparisons of similar cases among similar reporting entities.
g.The PSO shall utilize patient safety work product for the purpose of providing direct feedback and assistance to reporting entities to effectively minimize patient risk.
h.Renewal. A PSO seeking renewal of certification shall also attest that it is complying with, and will continue to comply with, each of the seven (7) PSO criteria referenced in § 6.8.2(A)(4) of this Part.
5.Additional Certifications Required of Component Organizations. An entity seeking initial certification as a PSO, that is a component of another organization or enterprise, shall also attest that it will comply with the following requirements:
a.Separation of Patient Safety Work Product. A component PSO shall:
(1)Maintain patient safety work product separately from the rest of the parent organization(s) of which it is a part; and
(2)Not have a shared information system that could permit access to its patient safety work product to an individual(s) in, or unit(s) of, the rest of the parent organization(s) of which it is a part.
b.Notwithstanding the requirements of paragraph § 6.8.2(A)(5)(a) of this Part, a component PSO may provide access to identifiable patient safety work product to an individual(s) in, or a unit(s) of, the rest of the parent organization(s) of which it is a part if the component PSO enters into a written agreement with such individuals or units that requires that:
(1)The component PSO will only provide access to identifiable patient safety work product to enable such individuals or units to assist the component PSO in its conduct of patient safety activities, and
(2)Such individuals or units that receive access to identifiable patient safety work product pursuant to such written agreement will only use or disclose such information as specified by the component PSO to assist the component PSO in its conduct of patient safety activities, will take appropriate security measures to prevent unauthorized disclosures and will comply with the other certifications the component has made pursuant to §§ 6.8.2(A)(5)(c) through (d) of this Part regarding unauthorized disclosures and conflicts with the mission of the component PSO.
c.Nondisclosure of Patient Safety Work Product. A component PSO shall require that members of its workforce and any other contractor staff, or individuals in, or units of, its parent organization(s) that receive access in accordance with § 6.8.2(A)(5)(b) of this Part to its identifiable patient safety work product, not be engaged in work for the parent organization(s) of which it is a part, if the work could be informed or influenced by such individuals' knowledge of identifiable patient safety work product, except for individuals whose other work for the rest of the parent organization(s) is solely the provision of clinical care.
d.Conflict of Interest. The pursuit of the mission of a component PSO shall not create a conflict of interest with the rest of the parent organization(s) of which it is a part.
e.Renewal. A component PSO seeking renewal of certification shall also certify that it is complying with, and will continue to comply with, each of the additional requirements referenced in §§ 6.8.2(A)(5)(a) through (d) of this Part.
6.8.3Issuance and Renewal of Certification.
A.Issuance of Certification. Pursuant to the provisions of R.I. Gen. Laws § 23-17.21-5(a), the Director shall grant certification to a PSO which meets the certification requirements set forth in this Part. The certification shall expire on the last day of the month two (2) years from the date of issue, unless sooner suspended or revoked.
B.Renewal of Certification. A PSO may renew a certification every two (2) years upon submission of an application in accordance with the provisions of §§ 6.8.2(A)(3), 6.8.2(A)(4)(h), and 6.8.2(A)(5)(e) (if applicable) of this Part. In any case in which the responsible individual of a PSO has filed a renewal application in proper form, including compliance with the notification requirements of § 6.7.4(A)(1) of this Part, not less than forty-five (45) calendar days prior to expiration of its existing certification, the existing certification shall not expire until final action on the renewal application has been taken by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.9** Complaints and Enforcement {#sec-216-ricr-40-10-6-6.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.9}
A.Complaints and Routine Correspondence.
1.Complaints. Any person who desires to register a complaint citing a violation of the Act or this Part shall submit a written and signed letter of complaint to the Director. All complaints shall be directed to:
Rhode Island Department of Health
3 Capitol Hill
Providence, RI 02908-5097
Phone: (401) 222-5200
2.Routine Correspondence. Routine correspondence, including all required notifications and reports, shall also be directed to the address specified above.
B.Penalties.
1.Civil Monetary Penalty. Subject to § 6.5.3(C)(3) of this Part, a person who discloses identifiable patient safety work product and/or document log in a knowing or reckless violation of § 6.5.2 of this Part shall be subject to a civil monetary penalty of not more than ten thousand dollars ($10,000) for each act constituting such violation.
2.Relation to Health Insurance Portability and Accountability Act. Penalties shall not be imposed both under this Part and under the regulations issued pursuant to the Health Insurance Portability and Accountability Act, 42 U.S.C. § 1320d-5 for a single act or omission.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
##### **216-RICR-40-10-6 § 6.10** Rules Governing Practices and Procedures {#sec-216-ricr-40-10-6-6.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-6#6.10}
Upon due notice in accordance with R.I. Gen. Laws § 42-35, all hearings and reviews required under the provisions of the Act and this Part shall be held in accordance with requirements of the Rules and Regulations of the Rhode Island Department of Health Regarding Practices and Procedures Before the Department of Health and Access to Public Records of the Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-30 to 04/30/2018*
- *Adoption — effective from 2009-01-27 to 04/30/2018*
#### **216-RICR-40-10-7** Licensing Adult Day Care Programs
##### **216-RICR-40-10-7 § 7.1** Authority {#sec-216-ricr-40-10-7-7.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.1}
These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1-52(a), and are established for the purpose of defining the prevailing standards for licensed adult day care programs in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-40-10-7 § 7.2** Incorporated Materials {#sec-216-ricr-40-10-7-7.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.2}
A.These regulations hereby adopt and incorporate "The American National Standard - Specifications for Making Buildings and Facilities Accessible to and Usable by, the Physically Handicapped" (1980) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate "The Americans with Disabilities Act" 42 U.S.C § 12101-12213; 47 U.S.C §§ 152, 221, 225, 611; 29 U.S.C § 706 (1991) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-40-10-7 § 7.3** Definitions {#sec-216-ricr-40-10-7-7.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.3}
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1."Adult day care program" means a comprehensive, nonresidential program designed to address the biological, psychological, and social needs of adults through individual plans of care that incorporate, as needed, a variety of health, social and related support services in a protective setting.
2.“Alzheimer dementia or other dementia special care services” means a program that offers services to one or more participants with a diagnosis of Alzheimer dementia or other dementia.
3.“Building Code” means the current Rhode Island State Building Code, contained in R.I. Gen. Laws Chapter 23-27.3.
4.“Case management services” means a collaborative process of assessment, planning, facilitation and advocacy for options and services to meet an individual’s health needs through communication and available resources to promote quality cost-effective outcomes.
5.“Department” means the Rhode Island Department of Health.
6.“Direct care staff” means the program director and all other staff who work directly with program participants.
7.“Director” means the Director of the Rhode Island Department of Health.
8.“Disqualifying information” for criminal records check purposes, and as used herein, means any conviction for murder, voluntary manslaughter, involuntary manslaughter, first degree sexual assault, second degree sexual assault, third degree sexual assault, assault on persons sixty (60) years of age or older, assault with intent to commit specified felonies (murder, robbery, rape, burglary, or the abominable and detestable crime against nature) felony assault, patient abuse, neglect or mistreatment of patients, burglary, first degree arson, robbery, felony drug offenses, larceny, or felony banking law violations.
9.“Elderly” means any person who is fifty-five (55) years or older.
10."Elopement", as used herein, means leaving the premises without notice when the adult day care program has assumed responsibility for the participant’s whereabouts.
11.“Executive director” means the top administrative staff member, however named, at the adult day care program.
12.“Interdisciplinary team” means at least three (3) professionals, with training in one of each of the following disciplines: nursing, activities, and case management or social work.
13.“Life Safety Code” means the current Rhode Island State Fire Safety Code, as contained in R.I. Gen. Laws Chapter 23-28.1.
14.“Medication aide” means a nursing assistant who has had additional training in the administration of medications and is registered with the Department in accordance with the “Rules and Regulations Pertaining to Rhode Island Certificates of Registration for Nursing Assistants, Medication Aides, and the Approval of Nursing Assistants and Medication Aide Training Programs”.
15.“Nurse” means a person who is licensed to practice professional or practical nursing in accordance with R.I. Gen. Laws Chapter 5-34.
16.“Other authorized provider working within the scope of his/her practice”, as used herein, means a physician assistant, dentist, registered nurse practitioner, or other person duly authorized by law to prescribe.
17.“Participant”, as used herein, means a person who is 18 years of age and enrolled in an adult day care program.
18.“Person” means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability companies, state, or political subdivision or instrumentality of a state.
19.“Social worker” means a person licensed under R.I. Gen. Laws Chapter 5-38.1 and the “Rules and Regulations for Licensing Clinical Social Workers and Independent Clinical Social Workers”.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-40-10-7 § 7.4** Licensure Requirements {#sec-216-ricr-40-10-7-7.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.4}
7.4.1General Requirements
A.These rules and regulations shall apply to all adult day care programs that provide services to the elderly who are in need of supportive care and supervision during the daytime.
B.A license issued to a new adult day care program, unless sooner suspended or revoked, shall expire by limitation on March 31st of each odd-numbered year and may be renewed upon application to the Department.
C.No person, acting alone or jointly with any other person, shall establish, conduct or maintain an adult day care program in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-1-52, and in conformity with this Part.
D.No facility or program shall represent itself as an adult day care program or use the term “adult day care program” or any other similar term in its title, advertising, publication or other form of communication, unless licensed as an adult day care program in accordance with the provisions herein.
E.An application for a license shall be made to the Department, upon forms provided by the Department and shall contain such information as the Department reasonably requires.
F.Upon receipt of a completed application for a license, the Department may issue a license if the applicant meets the requirements of R.I. Gen. Laws § 23-1-52, and this Part.
G.A license issued hereunder shall be the property of the state and loaned to such licensee.
H.The license shall be posted in a conspicuous place on the premises.
I.Each license shall be issued only for the premises and person(s) named in the application and shall not be transferable or assignable except with the written approval of the Department.
J.Each program shall be responsible for complying with all local, state, and federal laws, codes, rules and regulations that apply to the program.
K.Each program shall be responsible for maintaining a policy of nondiscrimination in the provision of services to participants and in the employment of staff without regard to race, color, creed, national origin, sex, sexual orientation, age, handicapping condition or degree of handicap, in accordance with all applicable state and federal statutes and regulations.
7.4.2Responsibilities of the Governing Body/Program
A.Each adult day care program shall have an organized governing body or other legal authority, responsible for:
1.The management and control of the operation of the program;
2.The conformity of the program with:
a.All federal, state and local laws and regulations relating to fire, safety, sanitation, communicable and reportable diseases;
b.Other relevant health and safety requirements; and
c.With all of the requirements contained in this Part.
B.The program shall:
1.Maintain names and affiliations of members of the agency’s governing body;
2.Describe structure of the agency’s governing body;
3.Provide functional and staff organizational charts;
4.Maintain a copy of the organization's charter, constitution or by-laws, that include but are not limited to:
a.A definition of goals, purposes, objectives;
b.A statement of compliance with civil rights act and other federal, state, local laws safe guarding civil rights;
c.Appropriate standing committees;
d.A statement of asset disbursement in case of corporate liquidation;
e.Evidence of consumer involvement or input into program policies.
5.Provide documentation that the governing body does the following:
a.Provides for annual evaluation;
b.Oversees contracts, adopts and operates annual budget, maintains financial records, provides annual audit by an independent certified public accountant;
c.Adheres to accepted standards of accounting;
d.Employs a director and gives said person the authority to manage the daily affairs according to established personnel and corporate policies;
e.Meets at least quarterly and maintains minutes of proceedings.
C.The governing body shall review, approve, and revise a current, written plan of operation, including a service description for providing adult day care services to frail elderly persons. This description shall be reviewed at least annually, updated as needed, and made available to the Department, upon request.
D.The program shall demonstrate that it has the capacity to carry out this plan of operation and perform various operational functions needed to oversee and support the program, including the ability to:
1.Manage ongoing operations;
2.Coordinate across multiple sites, as applicable;
3.Maintain partnerships with entities and programs; and
4.Demonstrate an effective approach to program management.
E.The program shall present a clear and concise annual summary statement of activities and scope of service (e.g., an annual report).
F.The program shall develop written policies and procedures, consistent with Department regulations, for providing services to participants.
G.Written protocols shall be developed to specify exactly when the program will be cancelled due to weather conditions and other emergencies and the participants will be evacuated due to power outage and other emergencies. These protocols shall be easily accessible in the facility and in all program vehicles that transport participants and shall include at least the following:
1.Means by which participants and families are notified of cancellations and early closings.
2.Description of location to which participants will be moved in case of evacuation and letter of agreement if this location is not affiliated with the program.
H.An organization chart shall be developed to illustrate the lines of authority and communication channels, and shall be provided to all program staff.
I.The director shall have full authority and responsibility to plan, staff, direct, implement, and evaluate the program.
J.The director or designee shall be on site to provide the program’s day-to-day management during hours of operation.
K.The program shall have a policy assuring that it follows all applicable federal and state requirements including, but not limited to:
1.Title V of the Civil Rights Act of 1964, 42 U.S.C. § 2000e;
2.Drug-Free Workplace Act of 1988, 41 U.S.C. § 81;
3.The Rhode Island Lobbying Reform Act (R.I. Gen. Laws Chapter 42-139.1).
L.Each program shall inform its staff and participants of the general content of the Department’s regulations; and shall develop and implement written plans, policies and procedures to ensure compliance with the Department’s regulations. These documents shall be reviewed by the program’s governing body at least annually and revised as needed.
M.The program shall have at least the following written documents:
1.Plan for community education and involvement;
2.Statement of program philosophy and objectives;
3.Mission statement;
4.Contracts and agreements with other agencies and individuals.
N.The program shall have a policy and procedure manual that is written in a format that can be updated, as needed, and shall include date(s) of revision. Each policy shall be signed by the executive director. This manual shall include at least the following areas of program operation:
1.Mission and philosophy;
2.Organization structure;
3.Personnel, including staffing requirements and responsibilities;
4.Program description, including program evaluation;
5.Participant policies, including admission and discharge; and
6.Environmental issues.
O.Upon request, copies of all policies, procedures and statements adopted by the program pursuant to § 7.4.2(N) of this Part shall be provided to participants, their representatives, and members of the general public.
7.4.3Program Evaluation
A.The program shall have a self-evaluation and continuous improvement system. This self-evaluation shall include a statement of the program’s goals and objectives and shall be conducted at least annually.
B.The self-evaluation system shall measure the program’s success in achieving the stated goals and objectives and shall review the effectiveness of the program’s policies and procedures.
C.Goals, objectives, policies and procedures shall be revised as needed based on the results of the self-evaluation.
D.All revised goals, objectives, policies and procedures shall be made available to the program’s employees, interns, trainees and volunteers.
E.The self-evaluation and any changes that result from it shall be documented.
7.4.4Personnel Requirements
A.The program shall maintain written personnel policies and procedures that shall include, but not be limited to, the following topics:
1.Hiring, training, and supervising all paid and unpaid personnel;
2.Use of outside service providers;
3.Use of volunteers;
4.Notification of employees, consultants, interns, trainees, and volunteers of their responsibilities, rights, benefits, and conditions of employment;
5.Written job descriptions:
a.Each staff member shall receive a copy of his/her job description that shall include: educational and work qualifications; major job duties; numbers and titles of persons supervised; and title of the supervisor for the position;
b.Supervision and job performance;
c.Required education and training;
d.Records, including maintenance of records;
e.Current salary/wage schedules;
f.Fringe benefits and any conditions attached to the benefits;
g.Disciplinary procedures and grounds for dismissal; and
h.Equal opportunity plan that shall include a statement guaranteeing that hiring and promotion shall be free from unlawful discrimination on the basis of race, color, creed, national origin, sex, sexual orientation, age, physical or mental handicap, or degree of handicap.
B.Each program shall have a written plan for no less than ten (10) hours of staff training and development. Training shall include at least the following:
1.Orientation for all staff at the start of employment. This initial training shall include orientation to the program’s policies, procedures, rules, and regulations;
2.Current first aid training, including cardiopulmonary resuscitation (CPR) and Heimlich Maneuver, for direct program staff (including drivers). Evidence of current first aid training shall be maintained on file and shall be available to the Department upon request.
3.Universal precautions and latex safety;
4.Participants’ rights, with a focus on dignity, choice, diversity, and cultural sensitivity;
5.Reporting abuse, mistreatment, and neglect;
6.Fire safety;
7.Safe patient handling and body mechanics;
8.Developing, implementing, and evaluating individual plans of care, as applicable;
9.Specialized services offered by the program;
10.Identifying participants who abuse alcohol and/or other substances, suffer from depression, or are victims of elder abuse or self-neglect;
11.Services available to participants from community programs or agencies;
12.Medications prescribed for participants, the benefits of the medications, common side effects and risks, and the laws governing administration of prescribed medications; and
13.Confidentiality of participant information and records. Each employee, consultant, intern, trainee and volunteer shall sign a statement agreeing to abide by the rules and regulations governing participant confidentiality. This signed statement shall be included in the individual’s personnel record.
C.Alzheimer Dementia or Other Dementia Special Care Services: The executive director, or his/her designee, shall ensure that all new employees who assist participants with personal care at the Alzheimer Dementia or Other Dementia Special Care Services level of care receive at least twelve (12) hours of orientation and training in the areas listed below within thirty (30) days of hire and prior to beginning work alone in the adult day care program, in addition to the areas stipulated in § 7.4.4(B) of this Part. Such areas shall include, but not be limited to:
1.Understanding various dementias;
2.Communicating effectively with persons with dementia;
3.Managing behaviors.
D.Training shall be completed within thirty (30) days of hire and prior to working without direct supervision.
E.All staff shall receive no less than (10) ten hours of training annually, and as needed, in the topics stipulated in § 7.4.4(B) of this Part.
F.The program director or his/her designee shall evaluate the performance of each employee at the end of his/her probationary period and at least annually thereafter. The governing body or designee shall evaluate the program director. Performance evaluations shall be in writing, and a copy shall be filed in the individual’s personnel record. The individual shall be notified, in writing, of the evaluation results.
G.The program shall maintain confidential personnel records for each employee including time sheets or other records showing all dates and hours worked by each employee and holidays, sick leave, vacation, and unpaid leave taken. Each individual shall have access to his/her personnel record. Each record shall contain at least the following:
1.A complete job application; and when appropriate, a resume.
2.References, which may be documented verbal references or letters of reference.
3.For every individual within the program who is licensed, certified or registered by the state of Rhode Island, a mechanism shall be in place to verify currency of licensure electronically via the Department's licensure database.
4.Documentation of any participation in job related training, while employed by the program, including the date(s) of training, the provider, the topic, and proof of attendance and completion.
5.Performance evaluations.
6.Statement signed by the individual agreeing to abide by the rules and regulations regarding the confidentiality of participant information and records.
7.The program shall have an adequate number of qualified staff to meet the needs of its participants.
8.The program shall comply with local, state, and federal laws governing hours and conditions of employment and wages.
9.The program shall assign a staff member to oversee the development, implementation, and periodic review of each participant’s individual plan of care; and to monitor and evaluate the participant’s progress in achieving his/her treatment goals and objectives.
10.The program shall have a written agreement with any agency, program, or other service provider that provides essential services not provided directly by and otherwise the responsibility of the program. This written agreement shall be updated annually. The nature and extent of the services provided shall be documented.
11.Programs that use volunteers shall have a screening procedure to select volunteers with appropriate skills to work with the participants. The nature and extent of volunteer services shall be documented.
H.Staffing Requirements
1.The program shall employ a nurse who shall be on site daily for a minimum of six (6) hours.
2.The program shall designate one full-time staff member as the program director. The program director shall designate a staff member to act in his/her absence.
3.Each program shall employ at least one (1) nursing assistant licensed by the Department.
4.Aides shall be nursing assistants licensed by the Department, or shall be employees who have completed the employee orientation program set forth in § 7.4.4(B) of this Part, prior to providing direct care to participants.
5.Aides shall be responsible for assisting professional program staff members as required in implementing services and meeting the needs of individual participants.
6.The program shall identify a staff person responsible for the functions of an activities director who shall be on site daily for a minimum of four (4) hours. The activities director shall have the ability to develop and implement therapeutic activities for specific participants and for groups.
7.Programs whose daily enrollment is twenty-four (24) or more participants shall provide case management services on-site or shall make them available for a minimum of twenty (20) hours each week.
8.The program shall have at least one (1) staff member trained in first aid, including cardiopulmonary resuscitation (CPR) and the Heimlich maneuver on site during all operating hours.
I.Health Screening
1.Upon hire and prior to delivering services, employment health screenings shall be required for each individual who has or may have direct contact with a program participant. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title) promulgated by the Department.
J.Criminal Background Checks
1.Criminal record review requirements are pursuant to R.I. Gen. Laws § 23-17-34.
2.If an applicant has undergone a criminal records check within eighteen (18) months of an application for employment, an employer may request from the BCI a letter indicating if any disqualifying information was discovered. The BCI will respond without disclosing the nature of the disqualifying information. This letter must be maintained on file to satisfy the requirements of this section.
7.4.5Inspections
A.The Department shall make or cause to be made such inspections and investigations, as it deems necessary by duly authorized agents of the Director at such time and frequencies as determined by the Department.
B.A duly authorized representative of the Director shall have the right to enter at any time without prior notice, to inspect the premises and services for which an application has been received, or for which a license has been issued.
C.Refusal to permit inspection or investigation shall constitute a valid ground for suspension or revocation of license or curtailment of activities.
D.Each program shall be given notice by the Department of its level of compliance with this Part, including a list of all deficiencies reported as a result of an inspection or investigation.
7.4.6Denial, Suspension or Revocation of License or Curtailment of Activities
A.The Department is authorized to deny, suspend or revoke the license or curtail activities of any adult day care program which:
1.Has failed to comply with the rules and regulations of this Part;
2.Has offered or provided services to participants outside of the scope of its license;
3.Has failed to correct deficiencies or complete corrective action plan; or
4.Has failed to comply with the provisions of R.I. Gen. Laws § 23-1-52.
B.Reports of deficiencies shall be maintained on file in the Department and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of the adult day program.
C.Noncompliance with this Part may constitute grounds to revoke, suspend, curtail the activities of, deny an application for licensure, or otherwise discipline the licensee by the Director.
7.4.7Deficiencies and Plans of Correction
A.The Department shall notify the governing body or other legal authority of a program of violations of these regulations through a notice of deficiencies which shall be forwarded to the program within fifteen (15) days of inspection of the program unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-52.
B.A program which received a notice of deficiencies shall submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficiencies.
C.The Department shall approve or reject the plan of correction submitted by a program in accordance with § 7.4.7(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the Department rejects the plan of correction, or if the program does not provide a plan of correction within the fifteen (15) day period stipulated in § 7.4.7(B) of this Part, or if a program whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 7.4.6 of this Part.
7.4.8Change of Ownership, Operation and/or Location
A.When a change of ownership or operation or location of an adult day program is planned or when discontinuation of services is contemplated, the Department shall be given written notice of pending changes within forty-five (45) days of such pending changes.
B.A license shall immediately expire and become void and shall be returned to the Department when operation of an adult day program is discontinued or when any changes in ownership occur.
C.Prior to operating under a new owner or operator, the prospective licensee shall apply for a new license in accordance with § 7.4.1 of this Part.
D.When there is a change in ownership or in the operation or control of the program, the Department reserves the right to extend the expiration date of such license, allowing the program or program to operate under the same license which applied to the prior licensee for such time as shall be required for the processing of a new application or reassignment of participants, not to exceed six (6) weeks.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-40-10-7 § 7.5** Requirements for Adult Day Care Programs {#sec-216-ricr-40-10-7-7.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.5}
7.5.1Admission Policies and Procedures
A.Each adult day care program shall define the target population(s) it serves.
B.Each adult day care program shall have a written policy on participants who are appropriate for enrollment.
C.Each adult day care program shall have a mission and philosophy statement that reflects the needs of the participants and the care and services it provides.
D.Each participant shall have a physical/mental condition that indicates a need for nursing care, supervision, therapeutic services, support services, and/or socialization.
E.Each adult day care program shall serve only participants whose needs are compatible with the program’s resources.
F.No less than fifty-one percent (51%) of the program’s average daily number of participants shall be fifty-five (55) years of age or older.
G.Prior to an individual’s acceptance as a participant, the program shall require a notice from the applicant’s primary care physician (or other authorized provider acting within the scope of his/her practice) including a medical history and documentation that a physical examination has taken place within the past year. Physician’s (or other authorized provider acting within the scope of his/her practice) documentation shall include, but not be limited to, the following:
1.A list of current medications and treatments;
2.A list of immunizations (e.g., tetanus, pneumococcal, influenza) with dates; and indication of TB test results, if test has been given;
3.Any special dietary requirements;
4.A statement indicating any limitations to the individual’s participation in program activities;
5.Recommendations for therapy, when applicable.
H.In a documented crisis situation, the program may allow up to thirty (30) days after enrollment in the program for receipt of the complete physician’s documentation as required in § 7.5.1(G) of this Part.
I.The program shall have procedures for orientation of the participant and/or family to policies, services, and facilities.
J.The program shall assure that all participants or their authorized representatives review all consents and permission documents and either sign where indicated or state in writing that they have read and understand the documents and are unwilling to sign them. Copies of these signed documents shall be filed in the participant’s individual record.
K.The participant (or their authorized representative) and family shall be informed of the program’s procedures for advance directives.
L.Program policies shall define the target population, admission criteria, discharge criteria, medication policy, participant rights, confidentiality, and grievance procedures.
7.5.2Participant Policies
A.All programs shall promote a restraint-free environment. The use of chemical and/or physical restraints shall be restricted to those participants whose physicians (or other authorized provider acting within the scope of his/her practice) have ordered such restraints.
B.The rights listed in § 7.5.3(A) of this Part shall be posted. These rights shall be explained to all participants or their representatives, families, staff, and volunteers in the language understood by the individual.
C.A grievance procedure shall be established to enable participants and their families/caregivers to have their concerns addressed without fear of recrimination.
D.The program shall comply with the state mandatory procedures for reporting suspected elder abuse to the Department as outlined in R.I. Gen. Laws Chapter 23-17.8. Any employee of a licensed adult day care program who has reasonable cause to believe that a participant has been abused, exploited, neglected, or mistreated shall, within twenty-four (24) hours of the receipt of said information, transfer such to the Director. Staff shall be trained in signs and symptoms of potential abuse.
7.5.3Participant Rights and Responsibilities
A.Adult day care programs shall assure that all participants are afforded the following rights, as well as any others deemed appropriate by the specific program:
1.The right to be treated with consideration, respect, and dignity, including privacy in treatment;
2.The right to participate in program of services and activities designed to encourage independence, learning, growth and awareness of constructive ways to develop one’s interests and abilities;
3.The right to self-determination within the adult day care setting, including the opportunity to:
a.Participate in developing or changing one’s plan for services;
b.Decide whether or not to participate in any given activity;
c.Be involved to the extent possible in program planning and operation;
d.Refuse treatment and be informed of the consequences of such refusal;
e.End participation in the adult day care program at any time.
4.The right to a thorough initial assessment, development of an individualized plan of care, and a determination of the required level of care;
5.The right to be cared for in an atmosphere of sincere interest and concern in which needed support and services are provided;
6.The right to a safe, secure, and clean environment;
7.The right to receive nourishment and assistance with meals as necessary to maximize functional abilities and quality of life;
8.The right to confidentiality and the guarantee that no personal or medical information will be released to persons not authorized under law to receive it without the participant’s written consent, in accordance with R.I. Gen. Laws Chapter 5-37.3;
9.The right to voice grievances about care or treatment without discrimination or reprisal;
10.The right to be fully informed, as documented by the participant’s written acknowledgment, of all participants’ rights and of all rules and regulations regarding participant conduct and responsibilities;
11.The right to be free from harm, including unnecessary physical or chemical restraint, isolation, excessive medication, abuse, or neglect;
12.The right to be fully informed, at the time of acceptance into the program, of services and activities available and related charges;
13.The right to communicate with others to the extent of the participant’s capability.
7.5.4Program Services
A.Programs shall offer, or make available through arrangements with community agencies, the services specified below in order to meet the needs of the participant population:
1.Nursing services shall be provided in accordance with the particular needs of each participant and shall include, but not be limited to, the following:
a.Supervision of and/or administration of medications and treatments as prescribed by the participant’s physician (or other authorized provider working within the scope of his/her practice);
b.Participation in the development and implementation of the individual participant’s plan of care;
c.Ongoing monitoring of each participant’s health status;
d.Maintenance-therapy treatment as recommended by a therapist; and
e.Coordination of orders from the participant’s physician (or other authorized provider working within the scope of his/her practice).
2.Programs shall provide or arrange for health education, which may include promotion, prevention, screening and detection.
B.Therapeutic services shall be provided to, or coordinated for, each participant, as needed, when recommended by a therapist or prescribed by a physician (or other authorized provider working within the scope of his/her practice).
1.Therapeutic services shall include occupational, physical, and/or speech therapy.
C.The program shall establish written agreements with occupational, physical, and speech therapists to define the nature and extent of the working relationship.
D.Program staff members shall provide therapeutic services to participants following a plan of care devised by a therapist.
E.Program staff members shall provide maintenance therapy to meet the particular needs of a participant when indicated by the program therapy consultants or the participant’s physician (or other authorized provider acting within the scope of his/her practice). The program’s nurse, or other licensed professional, shall supervise the administration of maintenance therapy to participants.
F.Program staff members shall provide individual and group activity programs that offer social, recreational, and educational events.
G.The dignity, interests, and therapeutic needs of individual participants shall be considered in the development of activity programs.
H.Nursing assistants and aides, under the supervision of a nurse, shall provide personal care services and shall offer training and assistance in dressing, grooming, personal hygiene, use of special aids, accident prevention, and activities of daily living.
I.Personal care services and assistance with activities of daily living shall be provided in a safe and hygienic manner, with recognition of each individual participant’s dignity and right to privacy, and in a manner that encourages the maximum level of independence.
J.Programs shall provide a noon meal and make available two (2) snacks per day for each participant every full day he/she attends the program.
K.Menus shall be developed under the direction of a nutritionist or registered dietician licensed by the Department.
L.The noon meal shall be equivalent to at least one-third the recommended daily dietary allowance established by the U.S. Department of Agriculture (USDA).
M.The program shall provide or arrange for any special diets, if required by a participant and prescribed by his/her physician (or other authorized provider working within the scope of his/her practice).
N.The program shall offer or arrange for nutritional counseling, as necessary.
O.Food shall be prepared in accordance with the Rhode Island Food Code (Part 50-10-1 of this Title).
P.The program shall assist participants and their families with personal and social issues.
Q.The program shall provide or arrange for mental health and substance abuse services for participants when indicated by a physician (or other authorized provider working within the scope of his/her practice).
R.Mental health and substance abuse services shall be documented in the individual participant’s plan of care.
S.The program shall establish written emergency policies and procedures. Emergency procedures shall include, but not be limited to, the following:
1.A written plan and/or agreement for emergency care;
2.A written plan and/or agreement for emergency transportation;
3.A file readily located for each participant containing at least the following:
a.Name and telephone number of his/her physician;
b.Hospital preference;
c.Insurance information;
d.Medications and allergies;
e.Current diagnoses and history;
f.Name and telephone number of emergency contact;
g.Copy of any advance directive, power of health care attorney, etc.; and
h.Photograph (for participant identification);
4.A conspicuously displayed notice indicating emergency fire procedures in accordance with local and state fire department regulations;
5.Training for participants in emergency procedures, written records of which shall be kept; and
6.Annual training for direct program staff members, including drivers, in emergency procedures, written records of which shall be kept.
T.The program shall provide a balance of purposeful activities to meet the participants’ needs and interests (i.e., social, intellectual, cultural, economic, emotional, physical, and spiritual).
U.Program activities and services shall be designed to promote personal growth and enhance the self-image, and/or improve and maintain the functioning level of participants to the extent possible.
V.Activity opportunities shall be available whenever the program is in operation.
W.If a participant receives services from several community agencies, the program shall coordinate with the participant’s case manager to ensure that services are not duplicated.
X.Programs shall arrange for ancillary services to meet needs identified through the assessment and individual care planning process.
Y.Ancillary services shall include education for the participant and/or family caregiver and may be delivered on a one-to-one basis or in a group setting.
Z.Ancillary services shall be provided within the framework of the individualized plan of care and as part of the overall array of services the participant receives.
AA.Services shall be rendered in accordance with the prevailing community standard of practice.
7.5.5Alzheimer Dementia or Other Dementia Special Care Services Disclosure
A.Any adult day care program that offers to provide or provides services to participants with Alzheimer dementia or other dementia shall be required to disclose on a standard disclosure form provided by the Department the type of services provided, in addition to those services required by this Part.
B.Said disclosure shall be made to the Department and to any person seeking placement in an Alzheimer Dementia or other dementia special care services component of an adult day care program.
C.The information disclosed shall explain the additional care that is provided in each of the following areas:
1.Philosophy: the Alzheimer Dementia or other Dementia special care services written statement of its overall philosophy and mission which reflects the needs of participants affected by dementia;
2.Termination from the Program: the process and criteria for transfer or termination from the program/unit;
3.Assessment, Service Planning and Implementation: the process used for assessment and establishing the plan of service and its implementation, including the method by which the plan of service evolves and is responsive to changes in condition;
4.Staffing Patterns and Training Ratios: staff training and continuing education practices;
5.Physical Environment: the physical environment and design features appropriate to support the functioning of cognitively impaired adults;
6.Participant Activities: the frequency and types of activities for participants;
7.Family Role in Providing Support and Services: the involvement in families and family support programs;
8.Program Costs: the cost of care and any additional fees.
D.The Department shall review the information provided on the disclosure form by the adult day care program to verify the accuracy of the information reported on it. Any significant changes in the information provided by the adult day care program on its disclosure form shall be reported to the Department at the time the changes are made.
E.Any adult day care program that provides care for participants with Alzheimer disease or other dementia shall maintain written policies and procedures that detail specific services, including admission and discharge criteria for participants and/or their responsible parties in the program.
F.Training for employees who work in an Alzheimer Dementia or other dementia special care services program shall meet all of the requirements of §§ 7.4.4(B) and (C) of this Part.
G.The adult day care program that has an Alzheimer Dementia or other dementia special care services program shall have no less than one (1) registered nurse on staff and available for consultation at all times with appropriate training and/or experience with dementia to manage and supervise all participant dementia-related health and behavioral issues.
H.The adult day care program with an Alzheimer Dementia or other dementia special care services program shall provide a secure environment appropriate for the participant population. This requirement may include, but not be limited to, a locked unit, secured perimeter, or other protocol to ensure participant safety and quality of life. The adult day care program shall have elopement policies in place.
7.5.6Individual Assessments, Plans of Care, and Participant Records
A.Each adult day services program shall conduct an assessment of each potential participant in order to determine whether or not that participant is suitable for enrollment in the program.
B.This assessment shall be conducted by a licensed staff member working within the scope of his/her practice, shall be reviewed by a registered nurse, and shall include interviews of family members, as appropriate.
C.Initial assessment information and information provided by the applicant’s physician (or other authorized provider acting within the scope of his/her practice) shall be reviewed by at least one registered nurse member of the program.
D.The assessment shall include no less than the following components:
1.Participant’s ability to self-preserve including cognitive and physical considerations;
2.Assistance with medications that may be required;
3.Health status including medical and nursing needs;
4.Dementia care needs;
5.Assistance with personal needs, including activities of daily living;
6.Providing or arranging for health and supportive services;
7.Monitoring activities to ensure health, safety, and well–being;
8.Cognitive needs;
9.Functional needs; and
10.Social needs.
E.Written documentation of this initial assessment shall be maintained by the program in the participant’s record.
F.Upon admission to the program, program staff shall negotiate a written agreement with the participant (or their authorized representative), and if appropriate, with the participant’s legal guardian. This agreement shall specify at least the following:
1.A disclosure statement that describes the program’s range of care and services;
2.Basic services offered to the participant by the program;
3.Staffing profile;
4.Participant confidentiality policies and procedures;
5.Admission, discharge, and/or transfer criteria;
6.Fees and arrangements for reimbursement and payment;
7.Identification of and authorization for third party payers;
8.Any non-financial obligations of the participant and his/her family, such as a commitment by the participant to attend the program a specified number of days per week;
9.Days and hours of program operation;
10.Schedule of holidays when the program is closed;
11.Announcement procedures for unexpected closing of the program due to disaster or severe weather conditions.
G.Each participant shall designate a health care provider to contact in the event of an emergency and for ongoing care.
H.Each program shall maintain a participant record system, including a separate record for each participant.
I.Programs shall conduct the assessment as required herein and utilize the results of this assessment to develop an individual written plan of care for each participant within thirty (30) days after the individual enters the program.
J.Each plan of care shall be drafted by an interdisciplinary team, with input from nursing assistants. The participant, caregiver, and other service providers shall have the opportunity to contribute to the development, implementation, and evaluation of his/her care plan.
K.If coordination of care is needed and if the participant is a client of another agency, the care plan shall be developed in conjunction with the services provided by that agency. The participant’s case manager or other appropriate staff member from that agency shall be invited to participate in the care-planning meeting.
L.The individual plan of care shall consist of these elements:
1.Specific problems, needs or challenges faced by the participant;
2.Realistic goals and/or objectives for the participant for each item identified in § 7.5.7(L)(1) of this Part;
3.Measurable action steps to be taken during the coming quarter to achieve the goals and/or objectives identified in § 7.5.7(L)(2) of this Part;
4.Specific observations to be made and/or data to be collected to measure progress toward achieving the goals and/or objectives identified in § 7.5.7(L)(2) of this Part; and
5.Specific timelines for making observations and collecting data as identified in § 7.5.7(L)(4) of this Part.
M.There shall be a care plan review quarterly conducted by one of the three members of the interdisciplinary team, including the participant and/or family/ caregiver, that reassesses the individual participant’s needs and reevaluates the appropriateness of service plans. At least the following items shall be reviewed:
1.Scheduled days of attendance;
2.Services, objectives, and goals of the plan of care;
3.Progress, or lack thereof, in achieving objectives and goals of the plan of care; and
4.Conditions of participation.
N.Progress notes shall be written no less than monthly by a licensed member of the interdisciplinary team and shall be maintained as part of each participant’s record.
O.The program shall maintain individual participant records arranged for ready access by staff.
P.Each individual participant record shall contain at least the following sections:
1.Progress notes no less than monthly and quarterly;
2.Assessment information;
3.Summary of quarterly plan of care meetings, including names and titles of all in attendance and documentation of any person(s) invited who did not attend;
4.Medical and other health-related information, including physician’s (or other authorized health care provider’s) orders;
5.Medication records; and
6.Financial records, including eligibility and payment documents.
Q.Emergency information about each participant and a recent photograph of each participant shall be maintained for ready access.
R.Individual participant records and all other documents associated with identifiable individual participants shall be maintained as confidential materials in accordance with current state and federal laws, rules and regulations. Storage of all participant records and documents shall assure their safety from inappropriate use and from fire and other unplanned destruction.
S.The program shall develop and follow written policies establishing guidelines for storage and retention of participant records, including but not limited to the following:
1.The required participant information shall be contained in record formats appropriate to the efficient and effective delivery of services and accessible for review upon request by the Department or other appropriate health oversight agency.
2.Guidelines for the removal of participant records from file.
3.Retention of participant records for five (5) years from the date of discharge in accordance with R.I. Gen. Laws Chapter 23-3.
7.5.7Discharge Planning
A.The program shall develop a re-evaluation protocol that specifies:
1.Those changes in medical and/or behavioral status that trigger an unscheduled reassessment of the participant;
2.Observational and data-gathering procedures—including inquiries made of the family concerning the participant’s status outside program hours—to yield measurable status changes;
3.Procedures to be followed by the treatment team to attempt to modify status changes so that the participant may continue in the program;
4.Description of criteria to be followed to determine that discharge procedures should be initiated.
B.Steps taken under the re-evaluation protocol shall be documented in the individual participant record.
C.The program shall develop a discharge protocol that includes criteria and notification procedures.
D.Discharge/transition plans shall be developed for participants that describe changes in service needs and changes in functional status that prompted another level of care.
E.Each participant and/or family/caregiver shall be given written notice if the participant is to be discharged from the program.
F.Discharge procedures shall include at least the following:
1.A discharge summary;
2.Recommendations for continuing care;
3.In consultation with the participant, family member or guardian, referral to community service agencies for any appropriate services, if the participant is returning to more independent living.
G.The program shall complete and maintain on file a discharge form indicating a discharge plan for each participant leaving the program.
H.The program shall discuss and agree upon the discharge plan with the participant and his/her family as far in advance of discharge as possible.
I.Any adult day care program that refers participants to any health care facility licensed pursuant to R.I. Gen. Laws Chapter 23-17, to an assisted living residence licensed pursuant to R.I. Gen. Laws Chapter 23-17.4, or to an adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose and document that the following information was provided to the participant:
1.That the referring entity has a financial interest in the program or provider to which the referral is being made;
2.That the participant has the option of seeking care from a different program or provider that is also licensed by the state to provide similar services to the participant.
J.The adult day care program shall offer the participant a written list prepared by the Department of all alternative licensed health care facilities, assisted living residences, and adult day services programs. Said written list may be obtained by contacting:
Rhode Island Department of Health Office of Facilities Regulation
3 Capitol Hill, Room 305
Providence, RI 02908
(401) 222-2566
www.health.ri.gov
7.5.8Medication Services
A.The program shall store and administer medications to participants as required and in accordance with all applicable state and federal laws and regulations.
B.Participants shall have the right to refuse any and all medications.
C.The program shall inform the participant’s family or a participant’s authorized representative when a participant has refused medication(s). The nurse shall inform the participant’s physician (or other authorized provider acting within the scope of his/her practice), as she/he deems appropriate.
D.The program shall have the right not to accept, and/or to discharge a participant who refuses assistance with medications if the program reasonably feels that the participant cannot safely possess and control his/her medications.
E.The program shall record each instance of medication refusal by a participant in the participant’s individual record.
F.All medications shall be stored securely and in a manner to prevent spoilage, dosage errors, administrative errors, inappropriate access, or diversion. Provided, further, medications stored in a refrigerator shall be stored separately from the food in a secured container.
G.Licensed nurses and medication aides may administer medications and monitor health indicators.
H.All medications shall be checked against a physician’s (or other authorized provider working within the scope of his/her practice) orders by a nurse or pharmacist.
I.All medications shall be in the original pharmacy-dispensed container with a proper label and directions attached and shall be administered in accordance with such label.
J.Injectable medications, including but not limited to insulin, shall be administered by a nurse.
K.Individual medication records shall be retained for each participant to whom medications are being administered and each dose administered to the participant shall be properly recorded.
L.Such records shall be retained by the program for no less than five (5) years after discharge from the program.
M.A nurse shall monitor the medication regimen for all participants.
N.Unused or discontinued prescription medications shall be the property of the participant and shall be given to the participant’s family or authorized representative, whenever possible.
O.Any unused or discontinued prescription medications that are left with a program shall be disposed of in accordance with the Rules and Regulations Governing the Disposal of Legend Drugs.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-40-10-7 § 7.6** Environmental Requirements {#sec-216-ricr-40-10-7-7.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.6}
7.6.1Environment
A.The facility housing the program shall be constructed, equipped, and maintained to protect the safety and well-being of participants.
B.The facility shall comply with applicable state and local building regulations and zoning, fire, and health codes and ordinances, including Rhode Island State Fire Safety Code ( R.I. Gen. Laws Chapter 23-28.1) and the Rhode Island State Building Code (R.I. Gen. Laws Chapter 23-27.3).
C.The program shall comply with the requirements of the federal Americans with Disabilities Act incorporated above at § 7.2(B) of this Part.
D.A program with participants who are blind, deaf and /or physically disabled shall be subject to all applicable requirements of “The American National Standard - Specifications for Making Buildings and Facilities Accessible to and Usable by, the Physically Handicapped” incorporated above at § 7.2(A) of this Part.
E.The program shall obtain annual certification from its local fire department approving the facility for program operation. Such certification shall indicate the maximum daily occupancy.
F.The program shall submit copies of such certifications to the Department with application for license.
G.The sign for the program shall be visible, and the entrance to the program shall be clearly identified.
H.The program, when it is co-located in a facility housing other services, shall have its own separate identifiable space for activity areas during operating hours.
I.The facility shall have sufficient space to accommodate the full range of program activities, services, and equipment.
J.Each program shall have the following areas:
1.A dining area;
2.A food preparation area in compliance with the Rhode Island Food Code (Part 50-10-1 of this Title);
3.A project area equipped with adequate table and seating space (a dining area may be used);
4.A group activity area;
5.A private, enclosed space, free from disruption, for individual nursing services and counseling;
6.A properly equipped rest area; and
7.Properly equipped, handicapped-accessible bathrooms.
K.There shall be private space to permit staff to work effectively and without interruption.
L.Identified space shall be available for participants and/or family/ caregivers to have private discussions with staff.
M.There shall be storage space for program and operating supplies.
N.Outside space that is used for outdoor activities shall be safe, accessible to indoor areas, and accessible to persons with a disability.
O.The program shall provide a comfortable, sanitary environment for the population it serves.
P.All rooms utilized by participants shall have proper ventilation.
Q.All steps, stairs, and corridors shall be suitably lighted. Stairs used by participants shall have banisters, hand rails or other types of support. All stair treads shall be well maintained to prevent hazards.
R.Halls and exit ways shall be free from all encumbrances and/or impediments.
S.Space shall be available for the safe arrival and departure of participants.
T.Illumination in all areas shall be adequate and glare shall be avoided.
U.Sound transmission shall be controlled.
V.Conditions shall be maintained within a comfortable temperature range to accommodate the population served.
W.Sufficient, appropriate furnishings shall be available for the entire participant population present.
X.Program restrooms shall be located as near the activity area as possible.
1.Restrooms shall meet current Americans With Disabilities Act (ADA) requirements.
2.Every restroom door shall be designed to permit the opening of the locked door from the outside.
Y.Each program shall have at least one (1) shower or other accommodation for bathing.
Z.The overall design of the program shall facilitate participants’ movement throughout the facility and encourage involvement in activities and services.
7.6.2Construction and Renovations
A.Any licensee or applicant desiring to make alterations or additions to its facility or to construct a new facility shall, before commencing such alteration, addition, or new construction, inform the Department. The Department may conduct preliminary inspection and approval or make recommendations with respect to compliance with the regulations herein.
B.All new construction, modification, additions, or room conversions shall be subject to the provisions of R.I. Gen. Laws Chapters 23-28.1 and 23-27.3, ”The American National Standard - Specifications for Making Buildings and Facilities Accessible to and Usable by, the Physically Handicapped" incorporated above at § 7.2(A) of this Part and "The Americans with Disabilities Act" incorporated above at § 7.2(B) of this Part and such other applicable federal, state and local laws, codes and regulations as may be applicable. Where there is a difference between codes, the code having the more stringent standard shall apply.
7.6.3Transportation Services
A.The program shall provide transportation and/or assist in arranging transportation services for participants and maximize the use of transportation arranged by the participant’s family.
B.When transportation is provided to participants through program operated vehicles, the operation of each vehicle shall be in conformity with all applicable state and federal regulations related to the driver, vehicle, and transportation services.
C.Programs that operate their own vehicle(s) shall employ drivers who possess the appropriate current motor vehicle license(s) for the size and seating capacity of the vehicle(s).
D.Drivers shall have experience in transporting passengers and shall be sensitive to the needs of aged individuals and individuals with handicapping conditions.
7.6.4Safety and Sanitation
A.The facility and grounds shall be safe, clean and accessible to all participants.
B.Smoking shall not be permitted in the facility.
C.At least two (2) well-identified exits shall be available to participants.
D.Universal precautions shall be practiced by all staff.
E.The program shall comply with rules and regulations pertaining to the use of latex gloves by health care workers promulgated by the Department and as contained in the rules and regulations for the Use of Latex Gloves by Health Care Workers, In Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
F.The program shall be free of hazards, such as exposed electrical cords, loose area rugs and steep grades.
G.Steps and curbs shall be painted and the edges of stairs marked appropriately to highlight them.
H.Procedures for fire safety as approved by the state and local fire authorities shall be adopted and posted.
I.Appropriate fire extinguishers shall be installed on each occupied level of the facility and maintained in a usable condition, inspected at specified intervals as stipulated by manufacturers and local and state fire authorities.
J.The program shall develop and maintain a written plan and procedure for the evacuation of the premises in case of fire or other emergency.
K.An evacuation plan shall be posted in each room.
L.Emergency procedures shall be clearly outlined and posted in conspicuous locations throughout the facility.
M.Drills simulating emergency conditions to test the effectiveness of the plan shall be conducted in accordance with the requirements of the Office of the State Fire Marshal with documentation of observed ability of participants and staff to carry out evacuation procedures.
N.Emergency first aid kits shall be accessible to staff.
O.There shall be sufficient maintenance and housekeeping personnel to assure that the facility is clean, sanitary, and safe at all times.
P.Toxic substances, whether for activities or cleaning, shall be stored in a locked area not accessible to participants.
Q.A safety guide for dealing with spills of toxic substances, chemicals, and other liquids including blood shall be posted and followed by all staff.
R.Insect infestation control shall be scheduled at a time when participants are not in the facility.
S.Equipment shall be adequately and safely maintained.
T.The program shall have a sufficient budget for equipment maintenance, repair, or replacement of all equipment.
U.Programs shall have on-site at least the following health care and safety equipment:
1.An emergency first aid kit;
2.A scale for weighing participants;
3.A blood pressure cuff and stethoscope;
4.A thermometer;
5.A proper, secure storage space (including refrigeration, as needed) for medications;
6.Sufficient number of blankets; and
7.A portable oxygen tank for emergencies.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
##### **216-RICR-40-10-7 § 7.7** Variance, Practices, and Procedures {#sec-216-ricr-40-10-7-7.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-7#7.7}
7.7.1Variance Process
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health or safety of the participants.
B.A request for a variance shall be submitted in writing by the applicant or licensee to the Department for review.
C.Within a reasonable time thereafter, the Department will review the application and return a written decision to the applicant.
D.If the applicant is dissatisfied with the decision of the Department, an appeal may be made through the process outlined in § 7.7.2 of this Part.
7.7.2Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws § 23-1-52, shall be held in accordance with the provisions of the “Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health” and “Rules and Regulations Pertaining to Access to Public Records of the Rhode Island Department of Health”.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-06-09 to 10/07/2020*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Adoption — effective from 2008-12-10 to 04/30/2018 Click here to view previous versions of this Part.*
#### **216-RICR-40-10-8** Birth Centers
##### **216-RICR-40-10-8 § 8.1** Authority {#sec-216-ricr-40-10-8-8.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.1}
A.These regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws § 23-17-10, and are established for the purpose of adopting minimum standards for Birth Centers which are consistent with acceptable standards of practice and which ensure that, while providing pregnant women with a maternity care alternative, the Birth Centers will provide services in such a manner as to safeguard the health, safety, and welfare of mothers and newborns.
B.A hospital birth center service, maintained and operated by a hospital on its licensed premises shall be subject to the standards for birth center services as set forth in the rules and regulations for Licensing of Hospitals (Part 4 of this Subchapter) and shall operate under the hospital license.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.2** Incorporated Materials {#sec-216-ricr-40-10-8-8.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.2}
A.These regulations hereby adopt and incorporate the Facility Guidelines Institute’s "Guidelines for Design and Construction of Hospital and Outpatient Facilities" (2014) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the U.S. Department of Health & Human Services, Office of Minority Health’s “National Standards on Culturally and Linguistically Appropriate Services (CLAS)” (2013) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.3** Definitions {#sec-216-ricr-40-10-8-8.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-17, entitled "Licensing of Health Care Facilities."
2."Birth center", or “Center,” means any public or private establishment, place or facility, geographically distinct and separate from a hospital or the mother's residence, staffed, equipped and operated to provide services to low-risk mothers as defined in § 8.3(A)(9) of this Part during pregnancy, labor, birth and puerperium.
3."Change of operator" means a transfer by the governing body or operator of a Birth Center to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.Hire or fire the chief executive officer of the Center;
b.Maintain and control the books and records of the Center;
c.Dispose of assets and incur liabilities on behalf of the Center;
d.Adopt and enforce policies regarding operation of the Center.
e.This definition is not applicable to circumstances wherein the governing body of a Birth Center retains the immediate authority and jurisdiction over the activities enumerated in §§ 8.3(A)(3)(a) through (d) of this Part.
4."Change in owner" means:
a.In the case of a Birth Center which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of a Birth Center which is an unincorporated sole proprietorship, the transfer of the title and property to another person;
c.In the case of a Birth Center which is a corporation;
(1)A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a Birth Center which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of a Birth Center which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
5.“Department” means the Rhode Island Department of Health. The Department is also the “licensing agency” designated pursuant to R.I. Gen. Laws Chapter 23-17.
6."Director" means the Director of the Rhode Island Department of Health.
7.“Equity” means non-debt funds contributed towards the capital costs related to an initial licensure or change in owner or change in operator of a Birth Center which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
8."Licensed capacity" means the number of birthing rooms a Center is licensed to operate.
9."Low-risk" means expected normal, uncomplicated prenatal course assisted by adequate prenatal care and prospects for a normal uncomplicated birth based on continual screening for prenatal high-risk factors (see § 8.10 of this Part) which preclude admission to the Center for childbirth.
10."Midwife" means an individual licensed to practice midwifery in Rhode Island pursuant to the provisions of R.I. Gen. Laws § 23-13-9 and the rules and regulations for Midwives (Subchapter 05 Part 23 of this Chapter).
11."Mother" or "women" or "client", means a pregnant individual, or a mother-to-be, or a mother, as the case may be.
12."Obstetrical physician" means an individual licensed pursuant to the provisions of R.I. Gen. Laws Chapter 5-37 to practice medicine and with current admitting obstetrical privileges in a licensed hospital nearby the admitting Center.
13."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivision or instrumentality of the state.
14."Practice of midwifery" means the authorization provided by rules and regulations for Midwives (Subchapter 05 Part 23 of this Chapter), which allow a licensed midwife to attend cases of normal childbirth, to provide prenatal, intrapartum and post-partum care including immediate care of the newborn, in continual collaboration with a physician (as defined therein) and in accordance with acceptable standards of practice.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.4** Licensing Procedures {#sec-216-ricr-40-10-8-8.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.4}
8.4.1General Requirements for Licensure
A.No person or governmental unit acting severally or jointly with any other person or governmental unit shall establish, conduct, maintain or operate or hold itself out as a Birth Center in Rhode Island without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4 and this Part.
B.Each license shall specify the licensed capacity of the Center.
C.The number of women in active labor, admitted to birth rooms at any given point in time shall be no greater than the number of birth rooms in the Center.
D.Centers shall be limited to those practices normally accomplished in uncomplicated childbirth, including simple episiotomies and repairs. Any other surgical procedures such as tubal ligation, termination of pregnancy or such other would require the Center to be specifically licensed as a Freestanding Ambulatory Surgical Center in accordance with the rules and regulations for Licensing of Freestanding Ambulatory Surgical Centers (Part 5 of this Subchapter).
E.Proposed changes in birth room capacity shall be submitted in writing to the Department and shall be subject to the approval of the Department.
F.Any Birth Center that utilizes latex gloves shall do so in accordance with the provisions of Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
G.Each Birth Center shall establish and maintain a health care facility specific electronic mail address (i.e., e-mail address) to be provided to the Department for the purposes of contacting the Birth Center with both routine communications and emergency notices. The Birth Center shall be responsible for providing notice to the Department at any time that the Birth Center’s specific electronic mail address is changed or updated.
8.4.2Application for License, Initial License or Changes in Owner, Operator, or Lessee
A.Application for a license to conduct, maintain or operate a Birth Center shall be made to the Department upon forms provided by it, and shall contain such information as the Department reasonably requires, including but not limited to evidence of ability to comply with the provisions of R.I. Gen. Laws § 23-17-4 and this Part.
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust, note or other obligation secured (in whole or in part) by the Center of any of the property or assets of the Center. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the Center is organized as a corporation, and all partners if the Center is organized as a partnership.
C.Application for initial licensure or changes in the owner, operator, or lessee of a Center shall be made on forms provided by the Department and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 8.4.3(D) of this Part. Three (3) paper copies and an electronic copy of such applications are required to be provided.
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-returnable, non-refundable application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
8.4.3Issuance and Renewal of License
A.Upon receipt of an application for license, the Department shall issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws § 23-17-4 and this Part. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection and approval by the Department.
B.A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance.
1.Any initial license or any change in owner, operator, or lessee of a licensed Center shall require prior review by the Health Services Council and approval of the Department as provided in §§ 8.4.3(D) and (E) of this Part or for expedited review conducted pursuant to § 8.4.3(H) of this Part, as a condition precedent to the transfer, assignment or issuance of a new license.
C.A license issued hereunder shall be the property of the State of Rhode Island loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
D.Except for expedited review conducted pursuant to § 8.4.3(H) of this Part, reviews of applications for initial licensure or for changes in owner, operator, or lessee of licensed Center shall be conducted according to the procedures stated in R.I. Gen. Laws § 23-17-14.4. The Department will notify and afford the public thirty (30) days to comment on such application.
E.The limits on licensing criteria are stated in R.I. Gen. Laws § 23-17-14.3. In conducting reviews of such applications, the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence and standing in the community of the proposed owners, operators, or directors of the Center as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five (5) years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
(3)In providing appropriate access to health care facility services;
b.A complete disclosure of all individuals and entities comprising the applicant and
c.The applicant’s proposed and demonstrated financial commitment to the health care facility.
2.The extent to which the facility will provide or will continue without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the facility's services as evidenced by:
a.The immediate and long term financial feasibility of the proposed financing plan;
b.The proposed amount and sources of owner's equity to be provided by the applicant;
c.The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;
d.The relative availability of funds for capital and operating needs;
e.The applicant's demonstrated financial capability;
f.Such other financial indicators as may be requested by the state agency;
3.The extent to which the facility will provide or will continue to provide safe and adequate treatment for individuals receiving the facility's service and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:
a.The credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs;
4.The extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities; and
b.The proposed immediate and long term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility.
5.In consideration of the proposed continuation or termination of emergency, primary care and/or other core health care services by the facility.
a.The effect(s) of such continuation or termination on the provision of access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations.
6.And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
F.Subsequent to reviews conducted under §§ 8.4.3(D), (E), (G) and (H) of this Part, the issuance of a license by the Department may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. laws § 23-17-3 or to the review criteria set forth in § 8.4.3(E) of this Part. This shall not limit the authority of the Department to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the facility by the Department.
G.Applicants for initial licensure may, at the sole discretion of the Department, be reviewed under expedited review procedures established in § 8.4.3(H) of this Part if the Department determines:
1.That the legal entity seeking licensure is the licensee for one or more health care facilities licensed in Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 23-17 whose records of compliance with licensure standards and requirements are deemed by the Department to demonstrate the legal entity’s ability and commitment to provide quality health services; and
2.That the licensure application demonstrates complete and satisfactory compliance with the review criteria set forth in § 8.4.3(E) of this Part.
H.Expedited reviews of applications for initial licensure of Birth Centers shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure the Department will determine if such application will be granted expedited review and the Department will notify the public of the Department’s initial assessment of the application materials with respect to the review criteria in § 8.4.3(E) as well as the Department’s intent to afford the application expedited review. At the same time the Department will afford the public a twenty (20) day period during which the public may review and comment on the application and the Department’s initial assessment of the application materials and the proposal to afford the application expedited review.
2.Written objections from affected parties directed to the processing under the expedited procedures and/or the satisfaction of the review criteria shall be accepted during the twenty (20) day comment period. Objections must provide clear, substantial and unequivocal rationale as to why the application does not satisfy the review criteria and/or why the application ought not to be processed under the expedited review mechanism.
3.The Department may propose a preliminary report on such application provided such proposed report incorporates findings relative to the review criteria set forth in § 8.4.3(E) of this Part.
4.The Health Services Council may consider such proposed report and may provide its advisory to the Director of Health by adopting such report in amended or unamended form.
a.The Health Services Council, however, is not bound to recommend to the Director that the application be processed under the provisions for expedited review as delineated in §§ 8.4.3(G) and (H) of this Part.
5.The Health Services Council shall take under advisement all objections both to the merits of the application and to the proposed expedited processing of the proposed application and shall make a recommendation to the Director regarding each.
6.Should the Health Services Council not recommend to the Director that the application be processed under expedited review procedures as initially proposed, such application may continue to be processed consistent with the time frames and procedures for applications not recommended for expedited review.
7.If expedited review is not granted, then the comment period may be forthwith extended consistent with the time frames in § 8.4.3(D) for applications not proposed for expedited review.
8.The Director, with the advice of the Health Services Council, shall make the final decision either to grant or to deny expedited review and shall make the final decision to grant or to deny the application on the merits within the expedited review mechanism and time frames.
8.4.4Inspections
A.The Department shall make or cause to be made such inspections and investigations, as it deems necessary, in accordance with R.I. Gen. Laws § 23-17-10 and this Part.
B.Every Center shall be given notice within fifteen (15) business days by the Department of any deficiencies reported as a result of an inspection or investigation.
C.A duly authorized representative of the Department shall have the right to enter at any time without prior notice to inspect the entire premises and services, including all records of any Center for which an application has been received or for which a license has been issued. Any application shall constitute permission for and willingness to comply with such inspections.
D.Refusal to permit inspections shall constitute a valid ground for license revocation.
8.4.5Denial, Suspension, Revocation of License or Curtailment of Activities
A.The Department is authorized to deny, suspend or revoke the license of or to curtail the activities of any Center which:
1.Has failed to comply with the rules and regulations pertaining to the licensing of Birth Centers; and
2.Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3.Reports of deficiencies noted in inspections conducted in accordance with § 8.4.4 of this Part shall be maintained on file in the Department, and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of a Center.
B.Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the activities of a Center, the Department shall notify the Center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9 and in accordance with the provisions of § 8.9.2 of this Part.
1.However, if the Department finds that public health, safety, or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
C.The appropriate state and federal agencies shall be notified of any action taken by the Department pertaining to denial, suspension, revocation of license, or curtailment of activities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.5** Organization and Management {#sec-216-ricr-40-10-8-8.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.5}
8.5.1Governing Body and Management
A.Each Center shall have an organized governing body or equivalent legal authority ultimately responsible for:
1.The management and control of the operation;
2.The assurance of quality care and services;
3.Compliance with all federal, state and local laws and regulations; and
4.Other relevant health and safety requirements, including the rules and regulations of this Part.
B.The governing body or equivalent legal authority shall be responsible to provide a sufficient number of appropriately qualified personnel, physical resources and equipment, supplies and services for the provision of safe, effective and efficient delivery of care services for normal uncomplicated pregnancies to low-risk mothers as defined in this Part.
C.The governing body or equivalent legal authority shall appoint and assure the competence of:
1.An individual responsible for the administrative operation of the Center;
2.A Director of Medical Affairs, responsible for professional practices and services and for the achievement and maintenance of quality care services; and
3.A Director of the Birth Center responsible for the day to day management of the clinical services.
4.The governing body or equivalent legal authority shall furthermore be responsible to establish a mechanism through the organization's by-laws and/or policies to assure that the Director of Medical Affairs, the Director of the Birth Center and other clinical staff are duly qualified by education, training and experience and meet the requirements of this Part.
D.The governing body or equivalent legal authority shall adopt and maintain by-laws defining responsibilities for the operation and performance of the organization, identifying purposes and means of fulfilling such, and in addition the by-laws shall include but not be limited to:
1.A statement of qualifications and responsibilities of the Director of Medical Affairs and the Director of the Center;
2.A statement of the governing body's responsibility for the quality care and services;
3.A statement of policy pertaining to the criteria for the selection, admission and transfer or referral of mothers and/or newborns in accordance with the requirements of this Part;
4.A statement relating to development and implementation of long and short range plans;
5.A statement relating to conflict of interest on the part of the governing body and staff;
6.A policy statement concerning the publication of an annual report, including a certified financial statement; and
7.Such other matters as may be relevant to the organization of the Center.
E.Furthermore, the governing body or equivalent legal authority in consultation with the Director of Medical Affairs shall be ultimately responsible to develop policies governing no less than the following:
1.Modalities of health and medical services to be provided;
2.Involvement of mother and whenever possible, partner, in the development and assessment of plan of care;
3.Signed consent for the provision of services;
4.Referrals and written agreements with other health care facilities, community agencies and medical personnel to insure back-up services and continuity of care in accordance with § 8.5.5 of this Part;
5.Effective review of professional practices;
6.Quality assurance for care and services; and
7.Such other matters as may be relevant to the organization and operation of the Center, the delivery of services and as may be required under the rules and regulations of this Part.
8.5.2Director of Medical Affairs
A.The Director of Medical Affairs shall be appointed by and responsible to the governing body or equivalent legal authority, and shall be a board-certified obstetrician/ gynecologist, with full obstetrical privileges in a licensed hospital nearby the Center. The Director of Medical Affairs may also be designated as the Director of the Birth Centers and may also be designated as the individual responsible for the administrative operation of the Center. Furthermore, the Director of Medical Affairs shall be responsible for:
1.Advising and consulting with the staff of the Center on all matters related to medical management of pregnancy, birth, postpartum, newborn and gynecologic health care and infection control;
2.The approval of written policies and procedures and protocols for midwifery care management where appropriate or applicable;
3.The coordination of all professional medical consultants to the Center (i.e., consulting obstetrical physicians, pediatricians, family practice physicians, etc.); and
4.Such other functions as may be deemed appropriate.
5.In addition, it shall be the responsibility of the Director of Medical Affairs to determine if a mother and/or newborn found to have clinically significant risk factors (see §§ 8.10, 8.11, and 8.12 of this Part) should be admitted to the Center, or whether or not the Center should continue to provide care to the mother and/or newborn during the puerperium period.
8.5.3Birth Center Director
The Birth Center Director, who may also be the designated individual responsible for the administrative operation of the Center, shall be either an obstetrical physician as defined in this Part, or a midwife licensed in Rhode Island.
8.5.4Personnel
A.Each Center shall be staffed with an appropriate number of professional and ancillary personnel whose education, training and experience is commensurate with assigned duties and responsibilities.
1.There shall be on the premises at all times when a woman is in labor, a staff person who hold a current certificate in cardiopulmonary resuscitation from a recognized program such as the American Heart Association or the American Red Cross.
B.There shall be at least two (2) staff members attending each birth; one of the two must be an obstetrical physician or a midwife, licensed in Rhode Island. The other member may be a midwife, or an obstetrical physician licensed in Rhode Island, or a nurse, nurse practitioner, or physician assistant licensed in Rhode Island, who has training and experience in obstetrical care and resuscitation of the newborn. Furthermore:
1.Whenever one or more women in active labor are on the premises there shall be at least one staff member on the premises in excess of the number of women in labor.
2.Each Center shall establish a mechanism to enable professional staff of the Center to make immediate telephone contact with an obstetrical physician and a pediatrician on a twenty-four (24) hour basis, seven (7) days a week. Mechanical answering services shall not be acceptable.
3.Each Center must ensure all qualified personnel and clinical staff shall be trained in infant and adult resuscitation. Clinical staff or qualified personnel who have demonstrated the ability to perform neonatal resuscitation procedures must be present during each birth.
C.Each Center shall establish a job description for each classification of position, which clearly delineates qualifications, duties, authority and responsibilities inherent in each position.
D.Records shall be maintained on the premises for all personnel which shall contain no less than:
1.Current background information pertaining to qualifications, including evidence of national criminal background checks for Center personnel whose employment involves routine contact with a patient;
2.Evidence of registration, certification or licensure as may be required by law; and
3.Signed contracts for those employees employed on a part-time basis.
4.Each Center shall require all persons, including students, who examine, observe, or treat a patient to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/ registration status, if any, and staff position of such person.
E.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the birth Center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title) .
8.5.5Written Agreements
A.Each Center shall enter into signed written agreements to ensure accessibility to supportive services, and such agreement must clearly delineate the mutual responsibilities of the undersigned parties to ensure the provision of services as agreed upon. Such agreements shall be entered into with no less than:
1.A hospital licensed in Rhode Island which is nearby the Center and which has an obstetrical service, in order to provide emergency back-up services to a mother and/or infant in need of emergency obstetrical and/or pediatric hospital services;
2."Obstetrical physician(s)" as defined in this Part to ensure availability to the staff and mothers at the Center, twenty-four (24) hours a day, seven (7) days a week, in accordance with agency policies and this Part;
3.A board certified pediatrician, with pediatric privileges in a hospital licensed in Rhode Island;
4.An ambulance service licensed in Rhode Island to ensure the immediate transfer of mothers and/or newborns in emergencies, when appropriate;
5.A clinical laboratory licensed in Rhode Island to ensure accessibility to a full range of clinical laboratory testing, as may be required;
6.A radiological service agreement with a provider licensed in Rhode Island to ensure accessibility to a full range of radiological services, as may be required; and
7.Such other, as may be required for the provision of supportive services (see § 8.6.9 of this Part) which are not provided directly by the Center.
8.5.6Rights of Clients
A.Each Center shall observe applicable provisions of R.I. Gen. Laws § 23-17-19.1 with respect to each client.
B.In accordance with R.I. Gen. Laws § 23-17-19.2, each Center shall display in a conspicuous place on the premises, a copy of the "Rights of Patients" as defined in R.I. Gen. Laws § 23-17-19.1.
8.5.7Disaster Preparedness
A.Each Center shall develop and maintain a written disaster preparedness plan which shall include specific provisions and procedures for the emergency care of mothers and infants in the event of fire, natural disaster or functional failure of equipment.
1.Such a plan shall be developed and coordinated with appropriate state and local agencies and representatives concerned with emergency safety and rescue.
2.A copy of the plan shall be submitted to the Department.
3.Simulated drills testing the effectiveness of the plan shall be conducted at least semi-annually. Written reports and evaluation of all drills shall be maintained by the Center and available for review by the Department.
B.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the Center.
8.5.8Administrative Records
A.Each Center shall maintain such administrative records as may be deemed necessary by the Department. These records shall include but not be limited to:
1.Monthly statistical summary of numbers of visits, deliveries appropriately classified;
2.An administrative record, log book or appointment book maintained in chronological sequence of admissions, which shall include pertinent information such as mother's name, age, address, parity, expected delivery date, date of each visit, reason for appointment, complications, date of admission, date of discharge or transfer, morbidity and mortality data, and such other data as may be relevant;
3.A record of all transfers to hospitals or other sources, and consultation; and
4.Such other reports or records as may be deemed appropriate.
8.5.9Uniform Reporting System
A.Each Center shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this Part may be met shall be prescribed from time to time in directives promulgated by the Director.
B.Each Center shall report to the Department detailed statistical data pertaining to its operation, services and facility. Such reports and data shall be made at such intervals and by such dates as determined by the Director.
C.The Department is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the Center.
D.The directives promulgated by the Director pursuant to this Part shall be sent to each Center to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.6** Management of Clinical Services {#sec-216-ricr-40-10-8-8.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.6}
8.6.1Selection of Clients
A.Each Center shall clearly delineate in its policy and procedure manual the medical and social risk factors which exclude women from the low-risk intrapartum group. At a minimum, mothers with problems and conditions considered to be high-risk as listed in § 8.10 of this Part, must be precluded from admission to the Center's services, except mothers with problems and conditions identified with an asterisk in § 8.10 of this Part shall require in each particular case for the Director of Medical Affairs to make a determination as to whether or not the mother may be admitted to the Center for services in accordance with § 8.5.2 of this Part.
B.Therefore, only those mothers who have no abnormal findings or findings declared insignificant (see § 8.6.1(A) of this Part) and demonstrate the potential for an uncomplicated course of pregnancy and labor, may be accepted for childbirth at the Center.
C.An initial assessment shall be made of every woman seeking Birth Center services. Such assessment shall be made by a professional staff member (obstetrician and/or midwife) to determine eligibility of the women for admission to the Center in accordance with the provisions of § 8.6.1(A) of this Part. All findings of the assessment shall be recorded into the clinical record, signed by the responsible person and countersigned by the Director of Medical Affairs.
D.Women who fail to register with the Center before the end of first trimester shall be excluded from admission unless a written, signed exception is made by the Director of Medical Affairs on an individual basis.
8.6.2Orientation and Childbirth Education
A.Each Center shall assure that each woman and family registering for care at the Center shall be given an orientation to the Center which includes information pertaining to no less than:
1.The philosophy and goals of the Center;
2.Services available directly at the Center;
3.Services provided through consultation and referrals;
4.Policies and procedures;
5.Requirement for signed written consent for care and services, attesting to full awareness of care and services to be provided;
6.Involvement of mother (and partner whenever possible) in the development and assessment of plan of care in accordance with § 8.6.10 of this Part;
7.Charges for required care and potential additional charges;
8.Risk factors associated with possible poor outcomes which are subject to the Director of Medical Affairs’ final determination; and
9.Such other matters as may be deemed appropriate.
B.A childbirth education program shall be provided or made available by each Center. The program shall consist of a course of instruction to expectant mothers pertaining to prenatal care and its outcome, care of the newborn, and to provide an understanding of labor and delivery, self-care and preparation for their participation in the childbirth process.
1.All women who have not previously attended a basic childbirth education program must attend a program of childbirth education and preferably with a support person.
8.6.3Prenatal Care
A.The Center shall ensure that mothers have adequate prenatal care in accordance with the Center's written policies and procedures and acceptable standards of practice. The policies shall require:
1.Every mother to be enrolled in the development and assessment of plan of care.
2.Every mother to be evaluated within two (2) weeks of the initial request for care in order to establish a data base of risk assessment, identification of problems and needs, and to develop a protocol of car which must include:
a.Data from history, physical examination;
b.Laboratory findings, (results of gestational diabetes test at appropriate time - 26 weeks);
c.Social, nutritional and health assessments; and
d.Frequency of prenatal visits.
3.Every mother accepted for care at the Center shall be evaluated on a regular basis for the presence of any high-risk factor listed in § 8.10.2 of this Part. Mothers who develop problems or conditions considered to be high-risk shall require in each particular case that the Director of Medical Affairs makes a determination as to whether or not the Center may continue to provide care to the mother. Findings shall be entered in the clinical record and signed by the Director of Medical Affairs.
8.6.4High-Risk Factors Requiring Transfer of Mother and/or Newborn
A.Any risk factor pertaining to labor, delivery or postpartum periods as outlined in §§ 8.11 and 8.12 of this Part shall be cause to preclude continuation of care of the mother and/or newborn at the Center with the exception of those risk factors identified with an asterisk which shall be subject to the Director of Medical Affairs’ final determination in accordance with § 8.5.2 of this Part.
1.If a clinical complication occurs in the course of labor, delivery or postpartum, it is the responsibility of the obstetrical physician or midwife to have the mother and/or newborn transferred promptly to a licensed hospital obstetrical service and notify the Director of Medical Affairs. When indicated, a physician, nurse, nurse practitioner, or physician assistant, or midwife shall accompany the patient.
2.Consultation with the Board Certified OB/GYN and/or Pediatrician as the case may indicate shall be required in doubtful cases to ascertain referral and/or transfer to the hospital obstetrical and/or newborn service and/or other.
3.Appropriate records shall accompany a mother and/or newborn upon transfer.
8.6.5Postpartum Care
A.In general, mothers and newborns shall be discharged within twenty-four (24) hours after birth in accordance with written policies and procedures established by the Center. If a mother or newborn is not in satisfactory condition for discharge within twenty-four (24) hours following birth, the mother and/or newborn shall be transferred to a hospital licensed in Rhode Island which has an obstetrical and nursery service. (See § 8.5.5(A)(1) of this Part).
B.Furthermore, the written policies and procedures established by the Director of Medical Affairs for a follow-up program of care and postpartum evaluation after discharge from the Center shall include no less than:
1.The Center's physician, midwife or nurse must be accessible by telephone, twenty-four (24) hours a day to mothers, to assist mothers in case of need during the postpartum period;
2.A home visit within twenty-four (24) to forty-eight (48) hours of discharge by the Center's professional staff personnel to insure continuity of care, and assessment of mother and newborn; and
3.The Center's postpartum program must include provisions for the assessment of mother and infant, including physical examination, laboratory screening tests at appropriate times, maternal postpartum status, instructions in child care, including immunization, referral to sources of pediatric care, provisions for family planning services, and assessment of mother-child relationship including breast feeding.
8.6.6Analgesia and Anesthesia
A.Inhalation or intravenous anesthesia shall not be administered at any Birth Center.
B.Local anesthesia for episiotomies and/or repair of lacerations may be performed in accordance with written procedures established by the Director of Medical Affairs.
C.Systemic non-narcotic analgesia may be administered but pain control should depend primarily on emotional support and adequate preparation for the birth experience.
8.6.7Food Service
A.Each Center shall have the capacity to provide mothers and families with appropriate nourishment and light snacks. The minimum equipment shall include refrigerator, stove, sink, cupboard and counter space or equivalent.
B.Food may be prepared by the family or prepared in the Center. When meals are prepared and served by the Center, the Center will be subject to the Rhode Island Food Code (Part 50-10-1 of this Title).
8.6.8Laboratory Services
Each Center must have assurance of accessibility to a full range of clinical laboratory tests in accordance with the provisions of written agreements as required in § 8.5.5 of this Part.
8.6.9Other Services
Each Center shall have assurance of access to a full range of diagnostic services including laboratory, sonography, radiology, electronic monitoring, intensive care and emergency transportation in accordance with the requirements of § 8.5.5(A)(5) of this Part.
8.6.10Plan of Care
A.A written plan of care shall be established by professional staff for each mother accepted for care at the Center, including the newborn.
1.After assessment and discussion of the mother's needs, the plan of care shall be developed with the participation of the mother, and partner whenever possible. A plan which is mutually acceptable to staff and mother, shall include those provisions required by law and shall clearly identify parental choices for those care services available at the Center, such as: local anesthesia for episiotomies or for repair of laceration, breast feeding, circumcision of newborn male, need for postpartum supportive services.
2.Furthermore, the mother shall be involved in the continuous assessment and revision as may be required of the plan of care. In addition to the above, the plan of care shall include provisions pertaining to the following:
a.Prenatal Care.
(1)Personal and family history;
(2)Findings of physical examination(s) and laboratory tests; and
(3)Continuous assessment of mother for high-risk factors.
b.Labor.
(1)Documentation of progress in labor and findings of examinations; and
(2)Ensuring that clinical staff or qualified personnel who have demonstrated the ability to perform neonatal resuscitation procedures are present, pursuant to § 8.5.4(B)(3) of this Part.
c.Intrapartum and postpartum care.
(1)Immediate postpartum care and newborn assessment;
(2)Eye prophylaxis to newborn;
(3)Test for appropriate use of RH immune globulin, and metabolic screening and other tests for the newborn as may be required by law;
(4)Postpartum examination and family planning and follow-up care;
(5)Preparation and submission of birth certificates; and
(6)Such other care as may be deemed necessary and appropriate.
8.6.11Clinical Records
A.The Center shall maintain a clinical record for every mother and newborn serviced at the Center. Such record shall contain accurate documentation of significant clinical information pertaining to the mother and newborn sufficiently detailed and organized in such a manner to enable:
1.The responsible practitioners to provide effective continuing care to determine retrospectively the condition of the mother and newborn infant and to review procedures performed and individual's responses to the care;
2.A consultant to render an opinion after examination and review of clinical record;
3.Another practitioner to assume the care of the mother or the newborn at any time;
4.Pertinent information for quality assurance assessments to be retrieved;
5.The clinical staff to utilize the record to instruct mother and family.
B.The clinical records shall contain significant documented data to assist the clinical staff in their determinations of high-risk factors throughout the course of the mother's pregnancy, labor and delivery including the newborn in accordance with the risk-factors identified in §§ 8.10, 8.11, and 8.12 of this Part. Clinical records shall furthermore contain no less than:
1.Admitting identification data, including history, physical examination and risk assessment;
2.Signed consent;
3.Prenatal record containing blood serology, rubella screening and RH factor, blood typing and screening for irregular antibodies;
4.Labor and delivery records;
5.Clinical observations during prenatal care, labor and delivery, postpartum care, including laboratory reports, medical orders, consultation reports, signed entries by professionals rendering care;
6.Newborn record including all pertinent data of assessment and other care;
7.Complications, transfers, referrals;
8.Report of postpartum home visits;
9.Discharge summary; and
10.Such other information, data and reports as may be deemed necessary.
C.All entries in the clinical records shall be signed by the responsible person in accordance with the Center's policies and procedures.
D.All clinical records either original or accurate reproductions shall be preserved for a minimum of five (5) years following discharge of the mother and/or newborn in accordance with R.I. Gen. Laws § 23-3-26.
1.Records of minors shall be kept for at least five (5) years after such minor shall have reached the age of eighteen (18) years.
8.6.12Infection Control
A.A mechanism shall be established by the Director of Medical Affairs for the development of infection control policies which shall pertain to no less than:
1.Infection surveillance activities;
2.Sanitation and asepsis;
3.Handling and disposal of waste and contaminants;
4.Sterilization, disinfection and laundry;
5.Reporting, recording and evaluation of occurrences of infections; and
6.Documentation of infection rate.
B.The Center shall report promptly to the Department infectious diseases which may present a potential hazard to patients, personnel and the public. Included are reportable diseases and the occurrences of other diseases in outbreak form.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.7** Environmental Management {#sec-216-ricr-40-10-8-8.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.7}
8.7.1Housekeeping
A.The Center shall be maintained and equipped to provide functional, sanitary, safe and comfortable environment, with all furnishings in good repair, and the premises shall be kept free of hazards.
B.Written policies and procedures shall be established pertaining to environmental controls to assure comfortable, safe and sanitary environment with well-lighted space.
C.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe and sanitary condition.
D.Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place and kept in an enclosed section separated from other cleaning materials.
E.Cleaning shall be performed in a manner which minimizes the spread of pathogenic organisms in the atmosphere.
F.Birth rooms shall be thoroughly cleaned after each delivery in accordance with the Center’s infection control policies.
G.Smoking shall be permitted only in areas designated pursuant to R.I. Gen. Laws Chapter 23-20.10.
8.7.2Laundry Service
A.Each Center shall make provisions for the cleaning of all linens and other washable goods provided either on the premises or per contractual arrangement.
B.A Center having laundry service on the premises shall have adequate space and equipment for the safe and effective operation of a laundry service, and in unsewered areas shall obtain approval of the sewage system to ensure adequacy in accordance with the “Rules Establishing Minimum Standards Relating to Location, Design, Construction and Maintenance of Onsite Wastewater Treatment Systems.”
C.There shall be distinct areas for the separate storage and handling of clean and soiled linens.
D.All soiled linen shall be placed in closed containers prior to transporting to laundry.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.8** Physical Plant and Equipment {#sec-216-ricr-40-10-8-8.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.8}
8.8.1Physical Facility
A.All construction shall be subject to the laws, rules, regulations and codes of R.I. Gen. Laws Chapters 23-17 and 23-28.1, and “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 8.2(A) of this Part, and all other appropriate state and local laws, codes, regulations and ordinances. Where there is a difference between codes, the code having the more stringent standard shall apply.
B.All plans for new construction or the renovation, alteration, extension, modification or conversion of an existing Birth Center that may affect compliance with “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 8.2(A) of this Part shall be reviewed by a licensed architect, acceptable to the Director. Said architect shall certify that the plans conform to the construction requirements of “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 8.2(A) of this Part, prior to construction. The Birth Center shall maintain a copy of the plans reviewed and the architect’s signed certification, for review by the Department upon request.
1.In the event of non-conformance for which the Birth Center seeks a variance, the general procedures outlined in § 8.9.1 of this Part shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as detailing the basis upon which the request is made. The Department may request additional information while evaluating variance requests.
2.If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of “Guidelines for Design and Construction of Hospital and Outpatient Facilities” incorporated above at § 8.2(A) of this Part, except those for which variances were granted, prior to construction. The Birth Center shall maintain a copy of the plans reviewed, the variance(s) granted and the architect’s signed certification, for review by the Department upon request.
C.Upon completion of construction, the Birth Center shall provide written notification to the Department, describing the project, and a copy of the architect's certification. The Birth Center shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.
8.8.2General Provisions for Physical Facility (Including Existing Facilities)
A.Each Center shall be constructed, designed, planned, equipped and maintained to protect the health and safety of mothers, newborns, personnel and the public, and to facilitate emergency exit of mothers and/or newborns in the event of emergency.
B.Reception areas, examination rooms, birth rooms, family rooms and other supportive areas shall be designed and equipped to provide good and safe care as well as to provide privacy and comfort to mothers and their families.
C.The birth room(s) shall be located to provide unimpeded, rapid access to an exit of the building where emergency transportation vehicles may be accommodated.
1.Hallways and doors providing access and entry into the birth room shall be of adequate width to accommodate ambulance stretchers and wheelchairs.
2.The birth room shall be spacious enough to accommodate staff to move freely and to include at least:
a.A large bed or double bed;
b.Chairs - lounge and straight-back;
c.Bedside/procedure tables;
d.A bassinet;
e.Space for birth room supplies and equipment and for family belongings; and
f.Access to a sink with hot and cold running water with elbow-wrist controls.
D.Acceptable toilet facilities shall be available to each laboring mother and adequate shower facilities shall also be available to accommodate mothers.
E.Utility, storage and laundry areas shall be designed and equipped for washing, sterilizing and storage of equipment, linens and medical supplies in a manner which insures segregation of clean linen and sterile supplies and equipment from those that are soiled and/or contaminated.
F.Medication and storage areas shall be provided and equipped with locks to ensure the safekeeping of drugs and biologicals.
G.Heating and ventilation systems shall be capable of maintaining comfortable temperatures.
H.Lighting and electrical services: Each Center shall be adequately lighted with appropriate lighting for examination in the birth room(s).
1.An emergency source of electrical light shall be available for the protection of mothers and families in the event the normal electrical power is interrupted.
2.All electrical and other equipment used in the Center shall be maintained free of defects which could be a potential hazard to mother/newborns, their families and staff.
I.An elevator shall be provided where care is provided at different floor levels. The cab size of the elevator shall be large enough to accommodate a stretcher, an attendant and such equipment as may be needed.
8.8.3Equipment
A.Each Center shall be equipped with those items needed to provide low-risk maternity care and shall include equipment to initiate emergency procedures in life threatening events to mother and newborn. Such equipment shall include no less than:
1.Oxygen and positive pressure masks;
2.DeLee trap suction and infant laryngoscope and airways;
3.IV equipment;
4.Blood expanders;
5.Medications identified in protocols for emergency needs;
6.Infant transport equipment and infant warmers.
B.In addition, the Center shall be equipped with standard equipment which includes no less than:
1.Equipment for standard screening;
2.Laboratory tests; and
3.Sterilization of instruments.
8.8.4Plumbing
All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of R.I. Gen. Laws Chapter 23-27.3.
8.8.5Water Supply
Water shall be obtained from an approved water system and shall be distributed to conveniently located taps and fixtures throughout the facility and shall be adequate in volume and pressure for all Center purposes, including fire safety in accordance with R.I. Gen. Laws Chapter 23-27.3.
8.8.6Waste Disposal
Waste disposal methods shall be provided that are acceptable to the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.9** Practices and Procedures, Confidentiality {#sec-216-ricr-40-10-8-8.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.9}
8.9.1Variance Procedure
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case, if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of patients.
B.A request for a variance shall be filed by any applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the Department, and within thirty (30) days thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial and in accordance with the provisions of § 8.9.2 of this Part.
8.9.2Deficiencies and Plans of Correction
A.The Department shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The Department will be required to approve or reject the plan of correction submitted by a facility in accordance with § 8.9.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the Department rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 8.9.2(C) of this Part, or if a facility whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 8.4.5 of this Part. If the facility is aggrieved by the sanctions of the Department, the facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department of Health shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing in all respects shall comply with all provisions therein.
8.9.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17, shall be held in accordance with the provisions of Part 10-05-4 of this Title [Practices and Procedures Before the Department of Health].
8.9.4Confidentiality
Disclosure of any health care information relating to individuals shall be subject to the provisions of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and federal requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.10** Prenatal High-Risk Factors {#sec-216-ricr-40-10-8-8.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.10}
8.10.1Reproductive History
A.* Signifies that the risk factor could be clinically significant and, therefore, subject to the Director of Medical Affairs’ final determination.
B.Maternal Characteristics.
1.Age: <16 and >40 years
2.*Height: <60 inches
3.*Weight: <100 lbs. and >200 lbs.
4.Parity: Four (4) or more
C.Past Obstetrical History.
1.*Habitual Abortion: more than two (2) consecutive spontaneous or two (2) or more induced abortions
2.Post Partum Hemorrhage or 3rd Stage problem(s), e.g., severe lacerations, inverted uterus, retained placenta, etc.
3.*Pre-Eclampsia
4.Hypertension - all hypertensive disorders of pregnancy
5.*Previous Second Stage Labor greater than two (2) hours
6.Previous Delivery:
a.Other than spontaneous or low forceps; and
b.Caesarian Section
7.Baby:
a.*Prematurity <37 weeks or <2500 grams or >4500 grams
b.*Respiratory Distress
c.*Congenital abnormality
d.*Known genetic disorders
e.*Any Neonatal death
f.*Fetal death
g.*Significant birth injury
D.Associated Conditions.
1.Scarred uterus - vaginal plastic surgery - * Urinary tract surgery
2.Adrenal disease
3.Cardiovascular disease except for mild asymptomatic Class I without hemodynamic abnormality
4.Collagen disease
5.Renal disease (albuminuria, hematuria, casts)
6.Chronic or acute liver disease
7.Diabetes Mellitus
8.Gestational diabetes - (blood or plasma screening test or abnormal glucose tolerance test or equivalent)
9.*Gastrointestinal disorders, e.g., regional ileitis, ulcerative colitis, etc.
10.Genetic Disorder
11.Hematologic disease
12.Hypertension
13.*Pulmonary disease, (not requiring treatment) e.g., asthma, chronic bronchitis, etc.
14.*Pulmonary disease, requiring treatment
15.*Psychiatric
16.Neurologic disorder
17.Hyperthyroidism
18.Venereal and Related diseases
19.*Thrombophlebitis
20.*Alcohol abuse
21.*Drug abuse
22.*Smoking - (> 1 pkg. a day)
23.Such other medial/obstetrical/or surgical problem or condition as determined to be significant risk to the mother or fetus.
8.10.2Prenatal Course of Current Pregnancy
A.Late Registration (see § 8.6.1(D) of this Part)
B.Anemia (less than ten (10) gm Hgb concentration and not responding to therapy)
C.Uterine Bleeding (except for threatened abortion in first trimester)
D.Any presentations except vertex position at 37 weeks or beyond
E.Intra-uterine fetal growth retardation or fetus small for gestational age
F.Pre-Eclampsia
G.Hypertension - resting BP140/90 or an increase of 30 systolic or fifteen (15) diastolic over the patient's base line pressure
H.Known Multiple gestation
I.Premature Labor at less than thirty-seven (37) weeks
J.Premature rupture of membranes under thirty-seven (37) weeks
K.Prolonged rupture of membranes:
1.For fourteen (14) hours without regular contractions; or
2.For twenty-four (24) hours with contractions unless delivery is imminent.
L.Prolonged Pregnancy - (at 42 completed weeks or more)
M.Polyhydramnios
N.Significant isoimmunization against RH or other antigen which may affect the fetus
O.Development of any condition listed above under § 8.10.1 of this Part
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.11** High-Risk Factors Requiring Transfer of Mother from the Center {#sec-216-ricr-40-10-8-8.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.11}
8.11.1Labor – Delivery – Post Partum
A.Abnormal Bleeding
B.Cord Prolapse
C.Dystocia Labor (at term)
D.Prolonged latent phase with ruptured membranes
1.(20 hrs. nulliparous)
2.(14 hrs. multiparous)
E.Protraction or arrest in the active stage
F.Prolonged second stage greater than two (2) hours
G.Secondary arrest
H.Extensive perineal or cervical laceration
I.Fever above 100.4 F on two (2) occasions four (4) hours apart
J.Fetal Distress -
1.Fetal heart rate < 100 or > 180 or any audible decelerations of heart beat
K.Meconium (stain of the amniotic fluid)
L.Hypertension or Hypotension Maternal Tachycardia
M.More than 24 hours in active labor unless delivery is imminent
N.Presentation (any other than vertex)
O.Retained placenta (greater than one hour)
P.Any other condition requiring more than twelve (12) hours observation post delivery
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-8 § 8.12** Criteria Requiring Transfer of Newborn {#sec-216-ricr-40-10-8-8.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-8#8.12}
A.* Signifies that the risk factor could be clinically significant and, therefore, subject to the Director of Medical Affairs’ final determination.
B.Apgar score of:
1.Five (5) or less at one (1) min.; or
2.Seven (7) or less at five (5) min.
C.Exaggerated tremors
D.Failure to take feeding
E.Instability of vital signs which includes T.P.R.
F.Jaundice
G.Major congenital anomaly
H.Neonatal sepsis or infection
I.Respiratory distress
J.*Signs of pre or post maturity
K.Shock or asphyxia
L.*Weight (<2500 grams)
M.Any other condition requiring more than twelve (12) hours observation post delivery
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-11-25 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 11/25/2018*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-9** Licensing of Freestanding Emergency Care Facilities
##### **216-RICR-40-10-9 § 9.1** Authority {#sec-216-ricr-40-10-9-9.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17-10, as amended, and are established for the purpose of adopting minimal standards for the licensing of freestanding emergency care facilities in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.2** Incorporated Materials {#sec-216-ricr-40-10-9-9.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.2}
A.These regulations hereby adopt and incorporate the following by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations:
1.NFPA 56A: Standard for Fire and Explosion Prevention During Cleaning and Purging of Flammable Gas Piping Systems. National Fire Protection Association, 1975.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.3** Definitions {#sec-216-ricr-40-10-9-9.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.3}
A."Freestanding Emergency Care Facility" hereinafter referred to as FECF, means an establishment, place or facility which may be a public or private organization, structurally distinct and separate from a hospital, staffed, equipped and operated to provide prompt emergency medical care as defined herein.
B."Emergency Medical Care" means services provided for a medical condition that is manifested by symptoms of sufficient severity that, in the absence of immediate medical attention, could result in placing health in jeopardy, serious impairment to bodily functions, serious dysfunction of any bodily organ or part, or development or continuance of severe pain.
C."Director" means the Director of the Rhode Island Department of Health.
D."Licensing Agency" means the Rhode Island Department of Health.
E."Person" means any individual, trust or state, partnership, corporation (including associations, joint stock companies) state, or political subdivisions or instrumentality of the state.
F."Physician" means an individual licensed under the provisions of R.I. Gen. Laws Chapter 5-37, to practice medicine or osteopathy in this state.
G."Change in owner" means:
1.In the case of an FECF which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
2.In the case of an FECF which is an unincorporated solo proprietorship, the transfer of the title and property to another person;
3.In the case of an FECF which is a corporation;
a.A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
b.A merger of the corporation into another corporation; or
c.The consolidation of two or more corporations, resulting in the creation of a new corporation; or
d.In the case of an FECF which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
e.In the case of an FECF facility which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
H."Change in operator" means a transfer by the governing body or operator of an FECF to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
1.Hire or fire the chief executive officer of the FECF;
2.Maintain and control the books and records of FECF;
3.Dispose of assets and incur liabilities on behalf of the FECF; or
4.Adopt and enforce policies regarding operation of the FECF.
5.This definition is not applicable to circumstances wherein the governing body of an FECF retains the immediate authority and jurisdiction over the activities enumerated above.
I.“Equity” means non-debt funds contributed towards the capital costs related to an initial licensure or change in owner or change in operator of a freestanding emergency care facility which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.4** Licensing Procedures {#sec-216-ricr-40-10-9-9.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.4}
9.4.1General Requirements for Licensure
A.No person acting severally or jointly with any other person, shall establish, conduct or maintain a FECF in this state without a license in accordance with the requirements of R.I. Gen. Laws §§ 23-17-4 and 23-15-4, and shall meet the requirements of the rules and regulations herein.
B.No person or facility shall represent itself as a Freestanding Emergency Care Facility or except in the case of licensed hospitals, shall use the term "emergency" in its title, advertising, publications or other form of communication, unless licensed as a freestanding emergency care facility in accordance with the provisions herein.
C.A facility licensed as a Freestanding Emergency Care Facility must include in a prominent manner in all its advertising, publications, signs or other forms of communication the following:
1.The term "freestanding," to distinguish the emergency care facility from that of a hospital emergency care service of Rules and Regulations for Licensing of Hospitals; and
2.Days and hours of the facility's operation.
D.Pursuant to R.I. Gen. Laws § 23-17-26, a freestanding emergency care facility shall provide to every person prompt lifesaving medical care treatment in an emergency without discrimination on account of economic status or source of payment and without delaying treatment for the purpose of prior discussion of source of payment unless such delay can be imposed without material risk to the health of the person.
9.4.2Application for License, Initial License, or Changes in Owner, Operator, or Lessee
A.Application for a license to conduct, maintain or operate, a FECF shall be made to the licensing agency upon forms provided by it, and shall contain such information as the licensing agency reasonably requires, including but not limited to evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and the rules and regulations herein.
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust, note or other obligation secured (in whole or in part) by the FECF or any of the property or assets of the FECF. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the FECF is organized as a corporation, and all partners if the FECF is organized as a partnership.
C.Application for initial licensure or change in owner, operator, or lessee of an FECF shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or the considerations enumerated in § 9.4.3(E) of this Part. Twenty-five (25) copies of such applications are required to be provided.
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-returnable, non-refundable application fee, as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
9.4.3Issuance and Renewal of License
A.Upon receipt of an application for a license, the licensing agency shall issue a license or renewal thereof for a period of no more than one (1) year, if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and the rules and regulations herein. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year subject to inspection and approval by the licensing agency.
B.A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance.
C.Any initial license or any change in owner, operator, or lessee of a licensed FECF shall require prior review by the Health Services Council and approval of the licensing agency as provided in §§ 9.4.3(D) and (E) of this Part, or for expedited reviews conducted pursuant to §§ 9.4.3(H) and (I) of this Part, as a condition precedent to the transfer, assignment, or issuance of a new license.
D.Except for expedited reviews conducted pursuant to §§ 9.4.3(H) and (I) of this Part, reviews of applications for initial licensure or for changes in the owner, operator, or lessee of licensed FECF shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure or for a license in connection with a change in the owner, operator or lessee of an existing FECF, the licensing agency will notify and afford the public thirty (30) days to comment on such application.
2.The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application.
E.Except as otherwise provided in R.I. Gen. Laws Chapter 23-17, a review by the Health Services Council of an application for an initial license or for a license in the case of a proposed change in the owner, operator, or lessee of a licensed Freestanding Emergency Care Facility may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3. In conducting reviews of such applications the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence, and standing in the community of the proposed owners, operators, or directors of the FECF as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
(3)In providing appropriate access to health care facility services;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the health care facility;
2.The extent to which the facility will provide or will continue without material effect on its viability at the time of change of owner, operator, or lessee to provide safe and adequate treatment for individuals receiving the FECF services as evidenced by:
a.The immediate and long term financial feasibility of the proposed financing plan;
(1)The proposed amount and sources of owner's equity to be provided by the applicant;
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;
(3)The relative availability of funds for capital and operating needs;
(4)The applicant's demonstrated financial capability;
(5)Such other financial indicators as may be requested by the state agency;
3.The extent to which the facility will provide or will continue to provide safe and adequate treatment for individuals receiving the FECF services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:
a.The credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs;
4.The extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities; and
b.The proposed immediate and long term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility.
5.In consideration of the proposed continuation or termination of emergency, primary and/or other core health care services by the FECF:
a.The effect(s) of such continuation or termination on the provision of access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations.
6.And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
F.Subsequent to reviews conducted under §§ 9.4.3(C), (D), (G), and (H) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in § 9.4.3(E) of this Part. This shall not limit the authority of the licensing agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice has been given to the FECF by the licensing agency.
G.A license issued hereunder shall be the property of the state and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
H.Applicants for initial licensure may, at the sole discretion of the licensing agency, be reviewed under expedited review procedures established in § 9.4.3(I) of this Part if the licensing agency determines:
1.That the legal entity seeking licensure is the licensee for one or more health care facilities licensed in Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 23-17 whose records of compliance with licensure standards and requirements are deemed by the licensing agency to demonstrate the legal entity’s ability and commitment to provide quality health services; and
2.That the licensure application demonstrates complete and satisfactory compliance with the review criteria set forth in set forth in § 9.4.3(E) of this Part.
I.Expedited reviews of applications for initial licensure of freestanding emergency care facilities shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure the licensing agency will determine if such application will be granted expedited review and the licensing agency will notify the public of the licensing agency’s initial assessment of the application materials with respect to the review criteria in § 9.4.3(E) of this Part as well as the licensing agency’s intent to afford the application expedited review. At the same time the licensing agency will afford the public a twenty (20) day period during which the public may review and comment on the application and the licensing agency’s initial assessment of the application materials and the proposal to afford the application expedited review.
2.Written objections from affected parties directed to the processing under the expedited procedures and/or the satisfaction of the review criteria shall be accepted during the twenty (20) day comment period. Objections must provide clear, substantial and unequivocal rationale as to why the application does not satisfy the review criteria and/or why the application ought not to be processed under the expedited review mechanism. The licensing agency may propose a preliminary report on such application provided such proposed report incorporates findings relative to the review criteria set forth in § 9.4.3(E) of this Part. The Health Services Council may consider such proposed report and may provide its advisory to the Director of Health by adopting such report in amended or unamended form. The Health Services Council, however, is not bound to recommend to the Director that the application be process under the provisions for expedited review as delineated in and §§ 9.4.3(H) and (I) of this Part. The Health Services Council shall take under advisement all objections both to the merits of the application and to the proposed expedited processing of the proposed application and shall make a recommendation to the Director regarding each. Should the Health Services Council not recommend to the Director that the application be processed under expedited review procedures as initially proposed, such application may continue to be processed consistent with the time frames and procedures for applications not recommended for expedited review. If expedited review is not granted, then the comment period may be forthwith extended consistent with the time frames in § 9.4.3(D) for applications not proposed for expedited review. The Director, with the advice of the Health Services Council, shall make the final decision either to grant or to deny expedited review and shall make the final decision to grant or to deny the application on the merits within the expedited review mechanism and time frames.
9.4.4Inspections
A.The licensing agency shall make or cause to be made such inspections and investigations, as it deems necessary, in accordance with R.I. Gen. Laws § 23-17-10 and the rules and regulations herein.
B.Every FECF shall be given prompt notice by the licensing agency of any deficiencies reported as a result of an inspection or investigation.
9.4.5Denial, Suspension, Revocation of License or Curtailment of Activities
A.The licensing agency is authorized to deny, suspend or revoke the license of or to curtail the activities of any FECF which:
1.Has failed to comply with the rules and regulations pertaining to the licensing of FECFs; and
2.Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
B.Reports of deficiencies noted in inspections conducted in accordance with § 9.4.4 of this Part shall be maintained on file in the licensing agency, and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or to curtail activities of a FECF.
C.Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the activities of a FECF, the licensing agency shall notify the FECF by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9 and in accordance with the provisions of § 9.8.2 of this Part.
1.However, if the licensing agency finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
D.The appropriate state and federal agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license or curtailment of activities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.5** Organization and Management {#sec-216-ricr-40-10-9-9.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.5}
9.5.1Governing Body and Management
A.Each facility shall have an organized governing body or equivalent legal authority ultimately responsible for:
1.The management and control of the operation;
2.The assurance of the quality of care and services;
3.The compliance with all federal, state and local laws and regulations; and
4.Other relevant health and safety requirements including the rules and regulations herein.
B.The governing body or equivalent legal authority shall provide appropriate personnel, physical resources, and equipment for the delivery of safe and effective emergency medical care.
C.The governing body or equivalent legal authority shall designate;
1. An administrator who shall be responsible for the management and operation of the facility; and
2.A medical director to ensure achievement and maintenance of quality standards of professional practice.
D.The governing body or equivalent legal authority shall adopt and maintain by-laws defining responsibilities for the operation and performance of the organization, identifying purposes and means of fulfilling each. In addition, the governing body shall establish administrative policies pertaining to no less than the following:
1.Qualifications and responsibilities of the medical director and administrator;
2.The plan of the governing body for the implementation of long- and short-range plans as prescribed by the Director in accordance with R.I. Gen. Laws Chapter 23-17; and
3.Such other matters as may be relevant to the organization and operation of the FECF.
E.The governing body or other legal authority shall be responsible through the organization's by-laws, policies, or other mechanism to determine the qualifications of physicians and other professionals as required herein, considering such factors as education, training, experience, board certification, eligibility to sit for examination of specialty board, evidence of current professional practice and licensure as may be required by law or regulation, the relevant qualifications required in § 9.5.4 of this Part and such other relevant factors as may be deemed necessary.
9.5.2Administrator
A.The governing body or equivalent legal authority shall appoint an administrator (who may also be the medical director), who shall be operationally responsible for:
1.The management and operation of the FECF;
2.The compliance with policies, rules and regulations and statutory provisions pertaining to the health and safety of patients;
3.Serving as liaison between the governing body and the staff; and
4.The planning, organizing and directing of such other activities as may be delegated by the governing body.
9.5.3Medical Director
A.The FECF shall have a physician licensed in this state, who shall serve as Medical Director and be responsible for no less than the following:
1.Coordination and supervision of emergency medical care services;
2.The achievement and maintenance of quality assurances of professional practice through a mechanism of peer review; and
3.The establishment of policies and procedures for emergency medical care services and other related emergency health care services.
9.5.4Personnel
A.Each FECF shall be staffed by a licensed physician(s) who has certification, as defined in § 9.5.4(B) of this Part, and full licensure and who shall be present within the facility during the hours of operation.
B.At least one physician on duty during the hours of operation shall be:
1.Certified or Board Eligible by the American Board of Emergency Medicine or the American Board of Osteopathic Emergency Medicine; OR
2.Certified or Board Eligible to sit for the examination of one of the following boards: Internal Medicine, Family Practice, or Surgery; AND must hold a certificate from the following approved programs: Advanced Coronary Life Support; Advanced Trauma Life Support; Pediatric Advanced Life Support.
C.No less than one licensed registered nurse who has training and experience in emergency care shall be on duty during the hours of operation.
D.Every freestanding emergency care facility shall have a person qualified by training and experience on the premises during the hours of operation who shall determine the nature, level and urgency of care required of all persons seeking treatment and to categorize them accordingly, assuring that serious cases are accorded priority treatment. If such person is a non-physician, he or she shall serve under the supervision of the physician-in-charge and in accordance with policies and procedures acceptable to the governing body or other legal authority.
E.Each FECF shall establish a protocol to govern the interpretation by a radiologist, of diagnostic images produced by x-ray or other modalities, including a procedure for the prompt communication of the radiologist's interpretation to the facility.
F.A health care facility shall require all persons, including students, who examine, observe, or treat a patient or resident of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
G.Health Screening
Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the freestanding emergency care facility. Such health screening shall be conducted in accordance with the Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care Workers promulgated by the Department of Health.
9.5.5Rights of Patients
A.Each FECF shall observe the standards of R.I. Gen. Laws § 23-17-19.1 with respect to each patient.
B.Each facility shall display in a conspicuous place in the licensed FECF a copy of the "Rights of Patients."
9.5.6Disaster Preparedness
A.Each FECF shall develop and maintain a written disaster preparedness plan which shall include specific provisions and procedures for the emergency medical care of patients in the event of an external disaster or internal functional failure of equipment.
1.Such plan shall be developed in cooperation with appropriate state and local agencies.
2.A copy of the plan shall be submitted to the licensing agency.
9.5.7Administrative Records
A.Each FECF shall maintain such administrative records as may be deemed necessary by the licensing agency. These records shall include but not be limited to:
1.Monthly statistical summary of numbers of patients seen appropriately classified as to the nature of the conditions;
2.A copy of the long and short range plans;
3.An administrative record of log book containing pertinent data such as patient's name, record number, age, sex, date and time of arrival and discharge, type of care, diagnosis and disposition, and provider of service; and
4.A record of all transfers to other health facilities.
9.5.8Uniform Reporting System
A.Each FECF shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director.
B.Each FECF shall make available for review upon request of the licensing agency detailed statistical data pertaining to its operations, services, and facility. Such reports and data shall be made at such intervals and by such dates as determined by the Director.
C.The licensing agency is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the FECF.
D.The directives promulgated by the Director pursuant to these regulations shall be sent to each FECF to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the licensing agency.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.6** Emergency Care Services {#sec-216-ricr-40-10-9-9.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.6}
9.6.1Management Services
A.Each FECF shall provide emergency care service with professional and ancillary staff to ensure that all persons treated are released or transferred within a reasonable and appropriate length of time. No patient shall be held overnight.
B.Policies and procedures pertaining to the provision of emergency medical care services and supported by appropriate manuals and reference material shall be established by the Medical Director and approved by the governing body. Such policies and procedures shall pertain to no less than the following:
1.The responsibility of the medical staff for emergency patient care;
2.Medical circumstances under which definitive care cannot be provided and procedures for referral;
3.Procedures that may and may not be performed in the FECF;
4.Procurement, storage and administration of drugs and medications in accordance with R.I. Gen. Laws Chapters 21-28 and 21-31;
5.Disposal of hypodermic needles, syringes and instruments in accordance with the requirements of the Rules and Regulations for Governing Hypodermic Needles, Syringes and Other Such Instruments;
6.Handling of persons who are emotionally ill, under the influence of drugs or alcohol, dead on arrival, or other categories of special care;
7.Procedures for early transfer of severely ill or injured to hospital;
8.Written instructions to be given to the patient to assure continuity of care;
9.Notification of patient's personal physician and transmission of relevant reports per written consent of patient;
10.Disclosure of patient information in accordance with federal and state law;
11.Location and storage of supplies and special equipment; and
12.Pursuant to R.I. Gen. Laws § 23-17-26 the provision of prompt emergency medical care for every person in an emergency without discrimination on account of economic status or source of payment and without delaying treatment for the purpose of prior discussion of source of payment unless such delay can be imposed without material risk to the health of the person.
9.6.2Supportive Services
A.Each FECF shall provide on the premises during hours of operation, the following:
1.Clinical laboratory services must be provided on the premises of the FECF subject to the provisions of R.I. Gen. Laws § 23-16.2-3; and
2.Diagnostic radiology services which meet the requirements of § 9.5.4(D) of this Part and Rules and Regulations for the Control of Radiation.
a.Mammography
(1)All aspects of mammography services shall be managed in accordance with the provisions of the Rules and Regulations Related to Quality Assurance Standards for Mammography of the Rhode Island Department of Health.
9.6.3Medical Records
A.A medical record shall be maintained on every patient provided emergency care.
B.For each visit to the emergency facility the medical record shall contain documentation relating to the following:
1.Patient identification (name, address, age and sex);
2.Time and means of arrival;
3.Pertinent medical history of the illness or injury and physical findings;
4.Emergency care given before arrival;
5.Diagnostic and therapeutic orders;
6.Reports of procedures, tests and findings;
7.Diagnostic impression;
8.Conclusion at termination of evaluation/treatment, including final disposition of patient's condition on discharge or transfer and any instructions given for follow-up care;
9.A patient's leaving against medical advice; and
10.Origin of incoming patient and destination of patient at discharge.
C.All medical records either original or accurate reproductions shall be preserved for a minimum of five (5) years, except that records of minors shall be kept for at least five (5) years after such minor shall have reached the age of 18 years.
9.6.4Medical Equipment and Supplies
A.No less than the following special supplies and equipment shall be available and located within the emergency service area:
1.Oxygen;
2.Electrocardiograph;
3.Cardiac monitor and defibrillator with battery pack;
4.Pacemaker insertion set-up; external pacemaker
5.Central venous catheter set-up;
6.Gastric lavage equipment;
7.Suction device;
8.Intravenous fluids and administration devices;
9.Endotracheal intubation, and tracheostomy trays; and
10.Emergency obstetrical pack.
B.Medical equipment and supplies for the reception, appraisal, examination, treatment and observation of patients shall be determined by the amount, type and extensiveness of services provided.
C.The emergency drug cart(s) and adjunctive emergency equipment shall be checked by an appropriate, designated individual as per written procedures after each use to assure that all items required for immediate availability are actually contained in the cart and are in usable condition.
9.6.5Discharge Planning: Substance Use Disorder, Opioid Use Disorder, and Chronic Addiction
A.Evaluation
1.The FECF must administer a standardized evaluation to all patients with an indication of substance use disorder, opioid use disorder, or chronic addiction. If the patient declines evaluation this must be documented in the medical record. If the patient is determined after an evaluation to have a substance use disorder or opioid use disorder then appropriate medical services will be offered to the patient. Services offered to the patient shall include, but are not limited to clinically appropriate inpatient and outpatient services.
2.FECFs shall have a written policy for evaluation available upon request, inspection, or related to investigation of complaint.
B.Laboratory Screening
For every patient presenting to the FECF with an opioid overdose, the FECF must order a laboratory screening to determine what substance(s) caused the overdose. If the patient refuses the laboratory screening, the FECF is still in compliance as long as the test was ordered. If the patient declines screening this must be documented in the medical record.
C.Education
1.The FECF must educate all patients who are prescribed opioids on the risks and benefits of prescribed opioids as well as safe storage and disposal in accordance with the section titled “Patient Education/Consent” in Rules and Regulations for Pain Management, Opioid Use and the Registration of Distributors of Controlled Substances in Rhode Island.
2.When patients present with indications of illicit drug use (including but not limited to the use of illegal substances or the use of diverted prescription drugs), the FECF must educate such patients on illicit drug use, including evidence-based harm reduction strategies such as proper syringe disposal and how to obtain non-prescription syringes.
3.If the Department issues a health advisory (either statewide or for the particular geographic area in which the FECF is contained) regarding an increase in overdoses or overdose deaths, the FECF is required to educate illicit drug use and diverted overdose patients with evidence-based harm reduction strategies.
D.Naloxone
1.The FECF must have a written policy that outlines when a prescriber should dispense or prescribe naloxone to patients. This policy must include a list of conditions that would prompt the dispensing or prescribing of naloxone. A sample list of conditions is found in the Department’s guidance document “Levels of Care for Emergency Departments and Hospitals for Treating Overdose and Opioid Use Disorder.”
2.For patients meeting the conditions set out in the FECF’s policy, a prescriber must dispense or prescribe naloxone.
3.For those patients who are dispensed or prescribed naloxone, education regarding how to administer naloxone shall be provided to patients prior to discharge.
4.FECFs shall have a written policy for naloxone available upon request, inspection or related to investigation of complaint.
E.Peer Recovery
1.The FECF shall offer all patients the opportunity to speak with a peer recovery support specialist, if those patients:
a.are diagnosed with substance use disorder or opioid use disorder using then evaluation protocol required by § 9.6.5(A) of this Part, or
b.are treated for an opioid overdose.
2.To fulfill the above requirement, at a minimum the FECF must inform the patient that the FECF will contact a peer recovery support specialist on the patient’s behalf.
3.FECFs shall have a written policy for peer recovery available upon request, inspection or related to investigation of complaint.
F.Treatment Services
1.The FECF shall provide information to patients about appropriate inpatient and outpatient services, including but not limited to medication assisted treatment and biopsychosocial treatment, if those patients:
a.are diagnosed with substance use disorder or opioid use disorder using then evaluation protocol required by § 9.6.5(A) of this Part, or
b.are treated for an opioid overdose.
2.FECFs must make a good faith effort to assist the patient in obtaining an appointment with a qualified licensed professional. To fulfill the above requirement, at a minimum the FECF must present a list of names, addresses, and phone numbers of appropriate inpatient and outpatient services. This list shall include information about medication-assisted treatment. If the patient declines to receive information or assistance about treatment services this must be documented in the medical record.
3.FECFs shall have a written policy for treatment services available upon request, inspection or related to investigation of complaint.
G.Notification of Emergency Contact
1.Prior to discharge and with patient consent, the FECF will attempt to notify the patient’s emergency contacts and peer recovery support specialist (if any of these individuals have been identified) pursuant to R.I. Gen. Laws § 23-17.26-3(iii). If the patient declines notification of an emergency contact or recovery coach, the treating provider will document this refusal in the medical record.
2.FECFs shall have a written policy for notification of emergency contact available upon request, inspection, or related to investigation of complaint.
H.Right to Refuse Treatment
Pursuant to R.I. Gen. Laws § 23-17-19.1(4), a patient has the right to refuse any screening, treatment, or service described in §§ 9.6.5(A) through (G) of this Part.
I.Overdose Reporting
FECFs shall comply with the reporting requirements found in Rules and Regulations Pertaining to Opioid Overdose Prevention and Reporting.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.7** Physical Plant and Equipment {#sec-216-ricr-40-10-9-9.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.7}
9.7.1New Construction
A.All new construction shall be subject to the provisions of NFPA 56A: Standard for Fire and Explosion Prevention During Cleaning and Purging of Flammable Gas Piping Systems, incorporated above at § 9.2(A)(1), and R.I. Gen. Laws Chapters 23-28.1 and 23-27.3.
B.In addition, any other applicable state and local laws, codes and regulations shall apply. (Where there is a difference between codes, the code having the more stringent standard shall apply.)
9.7.2Physical Facility
A.The FECF shall be designed and equipped to facilitate the reception, examination, treatment and observation of patients, in accordance with prevailing standards, safeguarding the dignity and privacy of patients and their families to the extent consistent with providing emergency medical care and with efficient administration.
B.In existing facilities, unless a variance is granted by the licensing agency, the same standards as specified above in § 9.7.1 of this Part for new construction shall apply.
C.The entrance of the FECF shall be clearly identified externally and shall be accessible to emergency vehicles and pedestrian traffic. All entrance doors shall be well lighted, wide enough to accommodate patients, attendants and equipment. A ramp shall be provided for wheelchair and stretcher patients when the use of stairs would be required otherwise.
9.7.3Environmental Maintenance
A.The FECF shall be maintained and equipped to provide a sanitary, safe and comfortable environment, with all furnishings in good repair, and the premises shall be kept free of hazards.
B.Written policies and procedures shall be established to assure comfortable, safe and sanitary environment and appropriate lighting throughout the facility.
C.Appropriate equipment and supplies to clean the facility shall be maintained in a safe, sanitary condition.
D.Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place and kept in an enclosed section separate from other cleaning materials.
E.Smoking shall be permitted only in designated areas.
9.7.4Waste Disposal
A.Infectious Waste
Infectious waste as defined in the Department of Environmental Management’s Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island, shall be managed in accordance with the provisions of the aforementioned regulations.
B.Other Waste
Wastes which are not classified as infectious waste, hazardous wastes, or which are not otherwise regulated bylaw or rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
1.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management.
2.Load packers must conform to the same restrictions required for dumpsters and in addition, load packers shall be:
a.High enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment; and
b.The loading section shall be constructed and maintained to prevent rubbish from blowing from said area site.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-9 § 9.8** Practices and Procedures, Confidentiality and Severability {#sec-216-ricr-40-10-9-9.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-9#9.8}
9.8.1Variance Procedure
A.The licensing agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rules and regulation herein, if it finds in specific cases, that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of patients.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon filing of each request for variance with the licensing agency and within thirty (30) days thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial. Such hearing must be held in accordance with the provisions of § 9.8.2 of this Part.
9.8.2Deficiencies and Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a facility within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in herein. If the facility is aggrieved by the action of the licensing agency, the facility may appeal the decision regarding sanctions and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
9.8.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17 shall be held in accordance with the provisions of the rules and regulations promulgated by the Rules and Regulations Pertaining to Practices and Procedures Before the Department of Health.
9.8.4Confidentiality
Disclosure of any health care information relating to individuals shall be subject to the provisions of the Confidentiality Act and other relevant statutory and federal requirements.
9.8.5Severability
If any provision of the rules and regulations herein or the application to any facility or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end the provisions of the rules and regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2017-09-26 to 01/04/2022*
- *Amendment — effective from 2017-09-26 to 09/26/2017*
- *Amendment — effective from 2012-12-10 to 09/26/2017*
- *Amendment — effective from 2005-04-07 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-10** Licensing Nursing Service Agencies
##### **216-RICR-40-10-10 § 10.1** Authority {#sec-216-ricr-40-10-10-10.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-17.7.1-3, 23-17.7.1-10, and 23-17.7.1-19, and are established for the purpose of adopting prevailing standards for the licensing of nursing service agencies in this state.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.2** Definitions {#sec-216-ricr-40-10-10-10.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.2}
A.Wherever used in these rules and regulations the following terms shall be construed as follows:
1.“Accreditation agency” means an entity, approved by the Director, that grants accreditation to nursing service agencies.
2."Act" means R.I. Gen. Laws Chapter 23-17.7.1 entitled, "Licensing of Nursing Service Agencies."
3."Branch office" means a location from which a licensed nursing service agency provides services within a portion of the total geographic area served by the licensed central office.
4."Client" means the facility or agency to which the registered nurse, licensed practical nurse, or nursing assistant is assigned on a temporary basis.
5."Director" means the Director of the Rhode Island Department of Health.
6."Employees" means those individuals (registered nurses, licensed practical nurses, or nursing assistants) which a nursing service agency supplies on a temporary basis.
7."Employers" means nursing service agencies as defined herein.
8."Licensing agency" means the Rhode Island Department of Health.
9."Nursing assistant" means as defined in R.I. Gen. Laws § 23-17.7.1-2(c).
10."Nursing service agency" means as defined in R.I. Gen. Laws § 23-17.7.1-2(d) and also means temporary nursing service agency.
11."Person" means any individual, trust or estate, partnership, corporation (including association, joint stock companies) state or political subdivision or instrumentality of a state.
12."Service record" means as defined in R.I. Gen. Laws § 23-17.7.1-2(e).
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.3** General Requirements for Licensing {#sec-216-ricr-40-10-10-10.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.3}
A.No person shall establish, conduct or maintain a nursing service agency in this state without a license in accordance with R.I. Gen. Laws Chapter 23-17.7.1 and this Part. In addition to the requirements of R.I. Gen. Laws Chapter 23-17.7.1:
1.Unless otherwise exempt, no agency shall hold itself or represent itself as a nursing service agency or use the term “nursing service agency” or other similar term in its advertising, publicity or any other form of communication, unless licensed with the Department of Health as a nursing service agency in accordance with the provisions of this Part.
2.A nursing service agency shall maintain a licensed central office within the geographical boundaries of the state.
3.Within twenty-four (24) months of initial licensure, the nursing service agency shall attain appropriate certification from an accreditation agency, as defined in § 10.2(A)(1) of this Part.
a.Each nursing service agency, having obtained accreditation pursuant to § 10.3(A)(3) of this Part, shall maintain such certification as a condition of licensure.
B.Exemptions
1.The provisions of the Act and this Part shall not be construed to apply to those agencies identified in R.I. Gen. Laws §§ 23-17.7.1-13, 23-17.7.1-14, and 23-17.7.1-15. However, the agencies shall be subject to the same training requirements for nursing assistants and the duties of the individuals shall be the same as those prescribed by regulations.
C.Nursing service agencies who may be exempt from the requirements contained in this Part (in accordance with § 10.3(B) of this Part) shall submit a written request for exemption to the licensing agency setting forth the reasons for such exemption.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.4** Application for Licensing and Fee {#sec-216-ricr-40-10-10-10.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.4}
A.Application for a license to conduct, maintain or operate a nursing service agency shall be made pursuant to R.I. Gen. Laws § 23-17.7.1-5. In addition to the requirements of R.I. Gen. Laws § 23-17.7.1-5:
1.A license shall be required for each central office of a nursing service agency operation. Each branch shall be subject to the requirements of this Part, with the exception of the licensing fee.
2.Each nursing service agency that maintains a branch office shall indicate on the application the location of the central office as well as the location(s) of the branch office(s).
B.In addition to the requirements of R.I. Gen. Laws Chapter 23-17.7.1, a notarized list of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensing and shall be updated annually. The list shall include each owner (in whole or in part), any mortgage, deed or trust, or other obligation secured (in whole or in part) by the nursing service agency or any of the property or assets of same.
1.This list shall also include all officers, directors and other persons of any subsidiary corporation owning stock, if the nursing service agency is organized as a partnership.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.5** Issuance and Renewal of License {#sec-216-ricr-40-10-10-10.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.5}
A.The licensing agency shall issue a license to the applicant(s) that meets the requirements of R.I. Gen. Laws Chapter 23-17.7.1 and this Part.
B.The license issued, unless sooner suspended or revoked, shall expire on the thirty-first (31st) day of December following its issuance and may be renewed from year to year in accordance with R.I. Gen. Laws § 23-17.7.1-7. The licensing fee is set forth in R.I. Gen. Laws § 23-17.7.1-3(c).
C.A license shall not be transferable or assignable except with the prior written approval of the licensing agency.
D.Upon receipt of an application for a license, the licensing agency shall issue a license in accordance with R.I. Gen. Laws § 23-17.7.1-6. In addition to the requirements of R.I. Gen. Laws § 23-17.7.1-6, a license issued under this Part shall be the property of the state and loaned to such registrant and it shall be kept posted in a conspicuous place on the premises.
E.The location of the agency and the location where required in-service training is conducted shall conform to all local and state building codes, and laws.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.6** Change of Ownership, Operation and/or Location {#sec-216-ricr-40-10-10-10.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.6}
A.When a change of ownership or location, any interruption in delivery of nursing service agency services of three (3) consecutive months or longer duration, or closure of the nursing service agency is contemplated, the licensing agency shall be notified in writing.
1.Thirty (30) days prior to voluntary cessation of service, the licensing agency shall be notified and provided with a plan for orderly closure; notification to clients; transfer, storage, or proper disposal of records; and notification to the public.
2.Thirty (30) days prior to a change in the location of a nursing service agency premises, the licensing agency shall be notified in writing.
B.Upon closure or changes of ownership or cessation in service of three (3) consecutive months or longer in duration, the license shall immediately become void and shall be returned to the licensing agency, unless deemed otherwise by the Director, pursuant to § 10.5(C) of this Part.
1.When there is a change in ownership or in the operation or control of the nursing service agency, the licensing agency reserves the right to extend the expiration date of such license allowing the nursing service agency to operate under the same license which applied to the prior registrant for such time as shall be required for the processing of a new application.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.7** Inspections {#sec-216-ricr-40-10-10-10.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.7}
A.The licensing agency shall make or cause to be made, any inspections and investigations in accordance with R.I. Gen. Laws § 23-17.7.1-10(a).
1.If an employee of a staffing agency is directly connected to a quality of care or a substandard quality of care deficiency in a facility, a subsequential investigation by the licensing agency shall be conducted in accordance with R.I. Gen. Laws § 23-17.7.1-10.
B.Refusal to permit inspections of the nursing service agency shall constitute valid grounds for licensing denial, suspension or revocation.
C.Every nursing service agency shall be given notice by the licensing agency of all deficiencies reported as a result of an inspection or investigation.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.8** Denial, Suspension, Revocation of Certificate of Licensing {#sec-216-ricr-40-10-10-10.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.8}
A.The licensing agency is authorized to deny, suspend or revoke the license of any nursing service agency which has failed to comply with the statutory provisions of the Act and with this Part.
B.Whenever an action shall be proposed to deny, suspend, or revoke a nursing service agency license, the licensing agency shall notify the nursing service agency in accordance with the provisions of R.I. Gen. Laws § 23-17.7.1-8.
1.However, if the licensing agency finds that public health, safety or welfare of clients requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of licensing pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
C.The appropriate state and federal agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of the license.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.9** Operational Requirements/Organization and Management {#sec-216-ricr-40-10-10-10.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.9}
10.9.1Governing Body
A.The staffing agency shall maintain insurance coverage for workers' compensation in accordance with R.I. Gen. Laws § 23-17.7.1-10(e). In addition to the requirements of R.I. Gen. Laws Chapter 23-17.7.1-10(e), each nursing service agency shall have an organized governing body or equivalent legal authority ultimately responsible for:
1.The management and operation of the agency including fiscal management;
2.Assuring employees are appropriately credentialed, including a mechanism to verify currency of licensure electronically via the licensing agency’s licensure database;
3.Appropriate placement of qualified personnel (employees) and delineation of provisions for supervision;
4.A mechanism to resolve client complaints or other difficulties;
5.Acquiring and maintaining employee bonding insurance (theft and damage) (a minimum amount of ten thousand dollars ($10,000.00) per loss) and liability insurance (a minimum amount of five hundred thousand dollars ($500,000.00) per occurrence); and
6.Assuring compliance with all applicable state and federal statutory and regulatory provisions thereof, including the rules and regulations of this Part.
B.The governing body or equivalent legal authority shall:
1.Establish policies delineating administrative responsibilities for the operation and management of the agency;
2.Provide an appropriate mechanism for the selection, screening of personnel (employees) credentials, and placement of personnel (employees);
3.Ensure that nursing assistants rendering services to clients are supervised by professional (registered) nurses in accordance with R.I. Gen. Laws Chapter 23-17.9;
4.Provide photo identification for each employee in accordance with § 10.9.3(A)(2) of this Part; and
5.Designate in writing the person responsible for the management and operation of the agency and services in the absence of the administrator.
C.Uniform Reporting System
1.Each nursing service agency shall establish and maintain records and data in such a manner as to make uniform a system of periodic reporting. The manner in which the requirements of this Part may be met shall be prescribed from time to time in directives promulgated by the Director.
2.Each nursing service agency shall report to the licensing agency detailed statistical data pertaining to its operation and services. Such reports and data shall be made at such intervals and by such dates as determined by the Director.
3.The licensing agency is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the nursing service agency.
4.The directives promulgated by the Director pursuant to this Part shall be sent to each nursing service agency to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the licensing agency.
D.Nursing service agencies shall provide the licensing agency with a statistical report of the information required by R.I. Gen. Laws § 23-17.7.1-23. In accordance with R.I. Gen. Laws § 23-17.7.1-23(c), these reports shall be submitted by the employment agencies no later than thirty (30) days after the end of the calendar year.
10.9.2Administrative Management
A.The designated person responsible for the management and operation of the agency shall furthermore be responsible for no less than the following:
1.The implementation of agency policies and procedures pertaining to the administration and operation of the agency, the hiring and placement of personnel (employees), and the implementation of appropriate state and federal statutory and regulatory requirements including the regulatory provisions of this Part;
2.The selection of employees, documentation and verification of current certification, licensing and/or licensure of employees as may be required by law;
3.The maintenance of administrative and personnel (employee) records and files;
4.Policies and procedures pertaining to patient care;
5.Assuring that employees wear their photo identification during working hours;
6.Provisions to assure that appropriate supervision is provided to nursing assistants;
7.The establishment of a mechanism for the recording and follow-up of all complaints;
8.An operational twenty-four (24) hour on-call system; appropriate agency staff must be accessible by pager or phone; and
9.Such other matters as may be relevant to the organization and operation of the agency.
10.9.3Personnel
A.Each nursing service agency shall establish personnel policies and procedures which shall be made available to each employee.
1.Such policies and procedures shall include provisions pertaining to conditions for employment, selection, credentials and placement of employees, supervision as may be required, reporting to clients, reporting to the nursing service agency, employee evaluation, and such other provisions as deemed necessary.
a.An evaluation of employee performance shall be performed annually for each employee and shall be reviewed with and signed by the employee within forty- five (45) days of the evaluation.
2.As a condition of employment, the nursing service agency shall require employees to wear a photo identification at all times while the employee is working in accordance with R.I. Gen. Laws § 23-17.7.1-12.
3.There shall be a job description for each classification of position which delineates qualifications, duties, authority and responsibilities inherent in each position.
4.An in-service educational program for direct patient care personnel shall be provided in accordance with R.I. Gen. Laws § 23-17.7.1-11.
a.If an employee has been found to have provided a quality-of-care violation or substandard quality of care deficiency, the nursing service agency must provide re-education related to the deficient practice, and in accordance with the nursing service agency's policy and must include a re-evaluation of the policies.
B.Personnel files shall be maintained for each employee and shall be available at all times for inspection by the licensing agency. Such files shall be available at all times for inspection and shall include findings of a criminal records check in accordance with R.I. Gen. Laws § 23-17.7.1-17(e). In addition to the requirements of R.I. Gen. Laws § 23-17.7.1-17(e), the files must also contain no less than the following:
1.Resume or application form that includes qualifications for employment, completion of required training and educational programs, and previous employment;
2.Evidence of current licensing, certification or licensure of personnel (employees) as may be required by law;
3.Records of required health examination which shall be kept confidential and in accordance with provisions of § 10.9.3(C) of this Part;
4.Documentation of complaints and follow-up;
5.Employee orientation, evaluation (90-day and annual) and documentation of in-service education; and
6.Such other matters as may be relevant to the organization and operation of the agency.
C.Health Requirements
1.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct patient contact. Such health screening shall be conducted in accordance with Part 20-15-7 of this Title.
D.Criminal Records Check
1.Criminal records checks will be conducted pursuant to R.I. Gen. Laws § 23-17.7.1-17. The Nursing service agency employer is responsible for following the requirements for disqualifying information pursuant to R.I. Gen. Laws § 23-17.7.1-20.
E.Employment Prohibitions
1.No nursing service agency shall recruit potential employees from a client to which it actively provides services in any contract in accordance with R.I. Gen. Laws § 23-17.7.1-22.
2.Nursing service agencies shall not penalize current employees should the employee be hired as a permanent employee of a client facility, in accordance with R.I. Gen. Laws § 23-17.7.1-22.
10.9.4Administrative Records and Reports
A.Each nursing service agency shall maintain appropriate administrative records documenting administrative management of the operation, including but not limited to charter of incorporation, by-laws or administrative policies approved by the governing body or equivalent legal authority, and fiscal records. In addition, the following administrative records/reports shall be maintained and kept current:
1.Contract(s) and/or agreements entered into with other agency(ies);
2.Personnel file and folder for each employee; which includes documented evidence of credentials and other appropriate data, including documentation of orientation, and quarterly in-service education, records of completion of required training and educational programs;
3.Documentary evidence of workers compensation, bonding and liability insurance;
4.Evidence of compliance with all U.S. Occupational Safety and Health Administration (OSHA) requirements;
5.Payroll records; and
6.Such other administrative and personnel records as deemed necessary and appropriate for the operation of the agency.
10.9.5Contractual Agreements
A.When contractual agreements or arrangements are entered into with another agency, such contract must be signed by the parties involved and shall include no less than the following terms:
1.Identification of the services requested and type(s) of personnel (employees);
2.Compliance with contracting agency personnel (employee) policies which includes assurance that the photo identification be worn on the employee's person at all times while the employee is working;
3.Provisions for employee supervision;
4.A mechanism to resolve client complaints or other difficulties;
5.Fiscal arrangements;
6.Duration and severability provisions; and
7.Such other provisions as are mutually acceptable to parties involved.
10.9.6Confidentiality
A.Each nursing service agency and all persons employed by the service agency must comply with all applicable federal and state laws and regulations regarding confidentiality of patient information including but not limited to the provisions of R.I. Gen. Laws Chapter 5-37.3.
10.9.7Reporting of Patient Abuse/Neglect
A.Reporting of patient abuse/neglect shall be pursuant to R.I. Gen. Laws § 23-17.8-2.
10.9.8Agency Rates
A.In accordance with R.I. Gen. Laws § 23-17.7.1-10, the nursing service agency’s maximum rate for services provided to a nursing facility and/or assisted living residence by a nurse or certified nurse shall not exceed two hundred percent (200%) of the regional hourly wage of each position. These positions shall include, but not be limited to: registered nurses, licensed practical nurses, certified nurse assistants, and medication aides pursuant to R.I. Gen. Laws § 23-17.7.1-10(b).
1.The maximum rate shall include all charges in accordance with R.I. Gen. Laws § 23-17.7.1-10(b).
B.The regional hourly wage shall be determined in accordance with R.I. Gen. Laws § 23-17.1-10.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.10** Nursing/Nursing Assistant/Services/Duties/Training Programs {#sec-216-ricr-40-10-10-10.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.10}
10.10.1Services
A.Each nursing service agency shall establish policies and procedures governing services, which shall include policies pertaining to no less than the following:
1.Hours of service, availability of weekend services and accessibility of services;
2.Provisions for crisis or emergency services; and
3.Such other as may be deemed necessary and appropriate.
B.Nursing Services
1.All services performed by registered nurses shall be in accordance with the provisions of R.I. Gen. Laws Chapter 5-34 and the rules and regulations promulgated thereunder, relating to the practice of nursing.
C.Nursing Assistant Services
1.All nursing assistant services performed by registered nursing assistants shall be in accordance with the provisions of R.I. Gen. Laws Chapter 23-17.9, and the rules and regulations promulgated thereunder, relating to the services, duties and training of a nursing assistant.
2.A nursing assistant shall be registered with the licensing agency and shall conform to all requirements of registration.
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
##### **216-RICR-40-10-10 § 10.11** Variance, Violations and Sanctions, Practices and Procedures and Severability {#sec-216-ricr-40-10-10-10.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-10#10.11}
10.11.1Variance Procedure
A.The licensing agency may grant a variance either upon its own motion or upon request of the applicant from any of the provisions of this Part, if it finds in specific cases, that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health, and/or health and safety of the public.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon filing of each request for a variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial. Such hearing must be held in accordance with the provisions of § 10.11.4 of this Part.
10.11.2Deficiencies and Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefor.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a facility in accordance with § 10.11.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 10.11.2(B) of this Part, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 10.11.3 of this Part. If the facility is aggrieved by the sanctions of the licensing agency, the facility may appeal the decision and request a hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing shall in all respects comply therein.
10.11.3Denial, Suspension, or Revocation of License
A.The licensing agency, after notice and opportunity for a hearing to the applicant or licensee, is authorized to deny, suspend, or revoke a license in any case in which it finds that there has been failure to comply with R.I. Gen. Laws Chapter 23-17.7.1 and this Part.
B.The notice shall be effected in accordance with R.I. Gen. Laws § 23-17.7.1-8.
C.A copy of the determination shall be sent by registered or certified mail or served personally upon the applicant or licensee. The decision denying, suspending, or revoking the license or application shall be in accordance with R.I. Gen. Laws § 23-17.7.1-8.
D.The procedure governing hearings authorized by this Section shall be in accordance with R.I. Gen. Laws §§ 42-35-9 through 42-35-13 as stipulated in R.I. Gen. Laws § 42-35-14(a).
E.A full and complete record shall be kept of all proceedings, and all testimony shall be reported in accordance with R.I. Gen. Laws § 23-17.7.1-8.
F.A copy or copies of the transcript may be obtained by an interested party in accordance with R.I. Gen. Laws § 23-17.7.1-8.
G.Any person, firm, partnership or corporation establishing, conducting, managing or operating a nursing service agency without licensing, or who shall operate such business after revocation or suspension of a certificate of licensing or after an order to curtail any or all activities or who violates any of the statutory or regulatory provisions of this Part, shall be subject to the sanctions of the Act.
10.11.4Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of the Act shall be held in accordance with the provisions of Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Amendment — effective from 2024-06-20 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/20/2024*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Adoption — effective from 2006-02-27 to 12/10/2012*
#### **216-RICR-40-10-11** Licensing Hospice Care
##### **216-RICR-40-10-11 § 11.1** Authority {#sec-216-ricr-40-10-11-11.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.1}
A.These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-17-2(9) and 23-17-10(a)(1), and are established for the purpose of adopting minimum standards for licensed hospice care in this state.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.2** Incorporated Materials {#sec-216-ricr-40-10-11-11.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.2}
A.These regulations hereby adopt and incorporate the American Institute of Architects Academy of Architecture for Health’s "Guidelines for Design and Construction of Hospital and Health Care Facilities" (2006) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the National Research Council National Academy of Sciences’ "Recommended Dietary Allowances" (1989), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate the National Tuberculosis Center’s "Policy and Procedures for Tuberculosis Screening of Health-Care Workers” (2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
D.These regulations hereby adopt and incorporate "Recommendations for Preventing the Spread of Vancomycin Resistance: Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC)" (1995) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
E.These regulations hereby adopt and incorporate "The American National Standard - Specifications for Making Buildings and Facilities Accessible to and Usable by the Physically Handicapped” (1961) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
F.These regulations hereby adopt and incorporate "The Americans with Disabilities Act" 42 U.S.C §§ 12101-12213; 47 U.S.C §§ 152, 221, 225, 611; 29 U.S.C § 706 (1990) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
G.These regulations hereby adopt and incorporate “Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC)” (1997) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
H.These regulations hereby adopt and incorporate the U.S. Department of Health & Human Services, Public Health Services, Centers for Disease Control & Prevention’s “Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities” (1994) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.3** Definitions (Applies to All Facilities and Programs) {#sec-216-ricr-40-10-11-11.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.3}
A.Wherever used in these rules and regulations the following terms shall be construed as follows:
1."Attending practitioner" means a physician, as defined in R.I. Gen. Laws Chapter 5-37, or a certified nurse practitioner, as defined in R.I. Gen. Laws Chapter 5-34, (who may or may not be on the hospice staff) identified by the terminally ill patient/family as having a significant role in the determination and delivery of the patient’s medical care. Attending practitioner also means a physician assistant (who may or may not be on the hospice staff), as long as the physician assistant’s role is providing medical and surgical services in collaboration with physicians, as set forth in the provisions of R.I. Gen. Laws Chapter 5-54.
2."Bereavement" means the extended period of grief preceding the death and following (usually for one year) the death of a loved one, during which individuals experience, respond, and adjust emotionally, physically, socially, and spiritually to the loss of a loved one.
3."Branch office" means a fixed and established geographical location from which a licensed hospice program provides services within a portion of the total geographic area served by the licensed central office.
4."Certified nurse practitioner” means an advanced practice nurse utilizing independent knowledge of physical assessment, diagnosis, and management of health care and illnesses. The practice includes prescriptive privileges. Certified nurse practitioners are members of the health care delivery system practicing in areas including, but not limited to family practice, pediatrics, adult health care, geriatrics, and women’s health care in primary, acute, long-term, and critical care settings in health care facilities and the community. Certified nurse practitioners may be recognized as the primary care provider or acute-care provider of record.
5."Change in operator" means a transfer by the governing body or operator of a hospice program to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.Hire or fire the chief executive officer of the hospice program;
b.Maintain and control the books and records of the hospice program;
c.Dispose of assets and incur liabilities on behalf of the hospice program; or
d.Adopt and enforce policies regarding operation of the hospice program.
e.This definition is not applicable to circumstances wherein the governing body of a hospice program retains the immediate authority and jurisdiction over the activities enumerated in §§ 11.3(A)(6)(a) through (d) of this Part.
6."Change in owner" means:
a.In the case of a hospice program that is a partnership, the removal, addition, or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of a hospice program that is an unincorporated sole proprietorship, the transfer of the title and property to another person;
c.In the case of a hospice program that is a corporation:
(1)A sale, lease, exchange, or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a hospice program that is a business corporation, any transfer of corporate stock that results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of a hospice program that is a non-business corporation, any change in membership that results in a new person acquiring a controlling vote in such corporation.
7.“Collaboration” means the physician assistant shall, as indicated by the patient’s condition, the education, competencies, and experience of the physician assistant, and the standards of care, consult with or refer to an appropriate physician or other healthcare professional. The degree of collaboration shall be determined by the practice and includes decisions made by a physician employer, physician group practice, and the credentialing and privileging systems of a licensed hospital, health center, or ambulatory care center. A physician must be accessible at all times for consultation by the physician assistant.
8.“Department” means the Rhode Island Department of Health.
9."Director" means the Director of the Rhode Island Department of Health.
10.“Disqualifying information” means that information produced by a criminal record check, pertaining to conviction, for the following crimes will result in a letter to the employee and employer disqualifying the applicant from said employment: murder, voluntary manslaughter, involuntary manslaughter, first degree sexual assault, second degree sexual assault, third degree sexual assault, assault on persons sixty (60) years of age or older, child abuse, assault with intent to commit specified felonies (murder, robbery, rape, burglary, or the abominable and detestable crime against nature), felony assault, patient abuse, neglect or mistreatment of patients, burglary, first degree arson, robbery, felony drug offenses, larceny or felony banking law violations.
11.“Equity” means non-debt funds contributed toward the capital costs related to a change in owner or change in operator of a hospice facility which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
12."General inpatient care" means hospice care provided to terminally ill patients in an inpatient setting.
13."Hospice care" (hereinafter referred to as “hospice program”) means a program of palliative care that provides for the physical, psychological, social and spiritual needs of a terminally ill patient and his/her family, both in the home and in an inpatient setting.
14.“Hospice inpatient facility” means a health care facility that cares for hospice and palliative care patients requiring short-term, general inpatient, respite care, or routine home care and is operated directly by a hospice program under a license issued by the Department.
15."Inpatient respite care" means short-term inpatient care provided to terminally ill patients to provide relief to family members or others caring for the patient.
16."Licensing agency" means the Rhode Island Department of Health.
17.“Medication aide”, as used herein, means selected unlicensed personnel who have satisfactorily completed a state-approved course in drug administration who may administer oral or topical drugs (with the exception of Schedule II drugs) in accordance with the requirements of § 11.5.8(J) of this Part.
18."Nurse" means an individual licensed to practice as a professional (registered) (RN) or licensed practical nurse (LPN) in this state under the provisions of R.I. Gen. Laws Chapter 5-34.
19."Nursing assistant" means a nurse's aide, orderly, or home health aide who is a paraprofessional, and who holds a Rhode Island certificate of registration pursuant to the provisions of R.I. Gen. Laws Chapter 23-17.9, and the rules and regulations promulgated thereunder, who is trained to give personal care and related health care and assistance based on his/her level of preparation to individuals who are sick, disabled, dependent, or infirm, and who are patients of or who are receiving services from health care facilities.
20."Palliative care" means patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and facilitates patient autonomy, access to information, and choice.
21."Person" means an individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state or political subdivision or instrumentality of a state.
22."Physician" means any individual licensed to practice medicine in this state under the provisions of R.I. Gen. Laws Chapter 5-37.
23.“Physician assistant” means a person who is qualified by academic and practical training to provide medical and surgical services in collaboration with physicians, as set forth in the provisions of R.I. Gen. Laws Chapter 5-54.
24.“Residential area” means a distinct living environment within an inpatient hospice facility that includes no more than sixty (60) beds.
25.“Social worker” means a person licensed under R.I. Gen. Laws Chapter 5-38.1 and the Rules and Regulations Pertaining to Licensing Clinical Social Workers and Independent Clinical Social Workers.
26.“Spiritual counselor” means clergy (individual ordained for religious service), pastoral or another similar counselor.
27."Terminally ill" means that an individual has a medical prognosis of a life expectancy of six months or less if the illness runs its normal course.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.4** Licensure Procedures {#sec-216-ricr-40-10-11-11.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.4}
11.4.1General Requirements for Licensure
A.No person acting alone or jointly with any other person, shall establish, conduct, or maintain a hospice program in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4 and in accordance with the rules and regulations of this Part.
1.However, pursuant to R.I. Gen. Laws § 23-17-2(7), any provider of hospice care who provides hospice care without charge shall be exempt from the licensing provisions above, but shall meet applicable standards of the National Hospice and Palliative Care Organization.
B.A certificate of need is required as a precondition to licensure of any hospice program, unless exempt under R.I. Gen. Laws § 23-15-2(4)(ii), in accordance with the Rules and Regulations Pertaining to Determination of Need for New Health Care Equipment and New Institutional Health Care Services.
C.Any change in owner, operator, or lessee of a licensed hospice program shall require prior review by the Health Services Council and approval of the licensing agency as provided in §§ 11.4.5(A) and (B) of this Part, as a condition precedent to the transfer, assignment or issuance of a new license.
D.No facility shall hold itself or represent itself as a hospice program or use the term "hospice" or other similar term in its advertising, publicity or any other form of communication, unless licensed as a hospice program in accordance with the provisions herein.
E.A hospice program shall organize, manage, and administer its hospice care services to attain and maintain the highest obtainable quality of life for each patient and address issues related to care at the end of life in a manner consistent with acceptable standards of practice.
F.Upon notification by the Department, any licensed hospice program that holds a nursing facility license shall be issued a new license as a hospice inpatient facility and shall surrender its nursing facility license to the Department.
G.Each hospice program that maintains a branch office shall disclose to the licensing agency the location of agency records (i.e., central office or branch office). At a minimum, all clinical records shall be maintained at the branch office for those patients served by the branch office.
11.4.2Application for License
A.Application for a license to conduct, maintain or operate a hospice program shall be made to the licensing agency upon forms provided by the licensing agency and shall contain such information as the licensing agency reasonably requires which may include affirmative evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and the rules and regulations of this Part.
1.Each application shall be accompanied by an application fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership, or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust, note or other obligation secured (in whole or in part) by the hospice care program or any of the property or assets of the hospice program.
C.The list shall also include all officers, directors, and other persons of any subsidiary corporation owning stock, if the hospice program is organized as a corporation and all partners if organized as a partnership.
11.4.3Issuance and Renewal of License
A.Upon receipt of an application for a license, the licensing agency shall issue a license for a period of no more than one (1) year, if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and the rules and regulations of this Part. The license issued, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year subject to inspection and approval by the licensing agency.
1.All renewal applications shall be accompanied by a renewal fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.In accordance with R.I. Gen. Laws § 23-17-38, nonprofit hospice programs with current home nursing care provider licenses shall be exempt from the annual licensure fee stated herein.
3.Each hospice program that maintains a branch office shall indicate on the application the location of the central office as well as the location(s) of the branch office(s).
B.Hospice programs operating under a single license may establish branch offices under that same single license and such license shall be maintained and posted in the central office.
C.A license issued shall not be transferable or assignable except with the written approval of the licensing agency.
11.4.4Application for Changes in Owner, Operator, or Lessee
A.Application for review for changes in the owner, operator, or lessee of a hospice program shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 11.4.5(B) of this Part. Three (3) paper copies and an electronic copy of such applications are required to be provided.
1.Each application filed pursuant the provisions of this Section shall be accompanied by a non-refundable, non-returnable application fee, as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
11.4.5Change in Owner, Operator, or Lessee Review
A.Reviews of applications for changes in the owner, operator, or lessee of a licensed hospice program shall be conducted according to the procedures stated in R.I. Gen. Laws § 23-17-14.4. The licensing agency will notify and afford the public thirty (30) days to comment on such applications.
B.The limits on licensing criteria are stated in R.I. Gen. Laws § 23-17-14.3. In conducting reviews of such applications, the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence, and standing in the community of the proposed owners, operators or directors of the hospice program as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated, or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting, and effecting quality improvement in all aspects of health care facility services; and
(3)In providing appropriate access to health care facility services;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the health care facility.
2.The extent to which the program will provide or will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the hospice services as evidenced by:
a.The immediate and long-term financial feasibility of the proposed financing plan;
(1)The proposed amount and sources of owner's equity to be provided by the applicant;
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator, or lessee of the health care facility,
(3)The relative availability of funds for capital and operating needs,
(4)The applicant's demonstrated financial capability, and
(5)Such other financial indicators as may be requested by the state agency.
3.The extent to which the program will provide or will continue to provide safe and adequate treatment for individuals receiving the hospice services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:
a.The applicant’s demonstrated record in providing safe and adequate treatment to individuals receiving services at facilities owned, operated, or directed by the applicant; and
b.The credibility and demonstrated or potential effectiveness of the applicant’s proposed quality assurance programs.
4.The extent to which the program will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five (5) years owned, operated, or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities; and
b.The proposed immediate and long-term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility.
5.In consideration of the proposed continuation or termination of health care services by the hospice program:
a.The effect(s) of such continuation or termination on access to safe and adequate treatment of individuals, including but not limited to traditionally underserved populations.
6.And, in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long-term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
C.Subsequent to reviews conducted under §§ 11.4.5(A), (B), (E), and (F) of this Part, the issuance of a license by the licensing agency may be made subject to any consideration, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the review criteria set forth in § 11.4.5(B) of this Part. This shall not limit the authority of the licensing agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice has been given to the hospice program by the licensing agency.
D.A license issued hereunder shall be the property of the state and loaned to such licensee, and it shall be kept posted in a conspicuous place.
11.4.6Change of Ownership, Operation and/or Location
A.When a change of ownership or operation or location of a hospice program or when discontinuation or addition of a service(s) is contemplated, the licensing agency shall be notified in writing.
B.The Department shall be notified immediately when a licensee/owner determines to cease operations and close a hospice agency.
1.A meeting shall be conducted between the Department and the licensee/owner prior to issuance of any closure notification to patients and the public to ensure there is a formal and comprehensive plan for an orderly closure.
C.At least sixty (60) days prior to the proposed closure date the hospice agency shall provide the Department a plan for orderly closure. This Closure Plan must include, but is not limited to, the following:
1.Letter of intent and/or determining factors/justification for the closure (i.e., voluntary, financial), which must include:
a.Proposed closure date;
b.Contact information for the staff member(s) responsible for implementing the closure plan; and
c.Last day new patients will be accepted.
2.Detailed plan and proposed timeline for patient discharge or transition of care to another licensed agency, including:
a.List of patients, including patient name, address, phone number, insurer/guarantor, and contact information for guardian and/ or emergency contact;
b.Appointment schedule and acuity/level of care of each patient receiving services; and
c.Staff scale-down process as appropriate, given planned transition/reduction of patients/residents.
3.Plan for the retention, storage, and access to medical records in accordance with R.I. Gen. Laws Chapter 5-37.3 and applicable federal laws, including:
a.Name and contact information of agency/company or legally authorized person who will be storing the records and address where records will be stored.
4.Detailed plan for providing notification and estimated implementation of notices to the following:
a.Patients, Staff/union, and Public
(1)Patients, their guardians, or relatives so appointed or elected to be their decision makers must be provided at least thirty (30) days’ notice prior to closure;
b.Medicaid, Medicare, and other third-party insurers;
c.Accreditation entities (if applicable); and
d.Other agencies as required by law.
5.Plan for the removal and/or disposal of any controlled or non-controlled substances (if applicable).
6.Plan for removal, transfer, or disposal of clinical/medical equipment and/or oxygen tanks (if applicable).
7.Projected fiscal management plan covering payroll, benefits, and operations during the closure period, including but not limited to:
a.Employee retirement plans currently in effect or under the control of the agency.
D.No implementation of any discontinuation of the operation of a hospice program shall be in effect without prior approval of the Department.
E.A license shall immediately become void and shall be returned to the licensing agency when operation of a hospice program is discontinued or when any changes in ownership occur in accordance with the rules and regulations of this Part and R.I. Gen. Laws § 23-17-6.
1.When there is a change in ownership or in the operation or control of the hospice program, the licensing agency reserves the right to extend the expiration date of such license, allowing the program to operate under the same license which applied to the prior license for such time as shall be required for the processing of a new application or reassignment of patients, not to exceed six (6) weeks.
11.4.7Inspections
A.The licensing agency shall make, or cause to be made, such inspections and investigations, as deemed necessary in accordance with R.I. Gen. Laws § 23-17-10 and the Rules and Regulations of this Part.
1.Such inspections and investigations may include on-site visits to patients, either in their homes, in the hospital, hospice inpatient facility, or nursing facilities, provided however, that a signed statement of approval for home visitation has been obtained by the licensing agency from the patient/family.
B.Refusal to permit inspections, other than in-home visits referred to in § 11.4.7(A)(1) of this Part, shall constitute a valid ground for license denial, suspension, or revocation.
C.Every hospice program shall be given notice by the licensing agency of all deficiencies reported as a result of an inspection or investigation.
11.4.8Denial, Suspension, Revocation of License or Curtailment of Activities
A.The licensing agency is authorized to deny, suspend, or revoke the license or curtail activities of any hospice program which:
1.Has failed to comply with the Rules and Regulations Pertaining to the Licensing of Hospice Care Programs; or
2.Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3.Reports of deficiencies shall be maintained on file in the licensing agency and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or to curtail activities of a hospice program.
B.Whenever an action shall be proposed to deny, suspend or revoke a license for any hospice program or to curtail its activities, the licensing agency shall notify the hospice program by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9, and in accordance with the provisions of § 11.8.4 of this Part.
1.However, if the licensing agency finds that public health, safety or welfare of patients requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
C.The appropriate state and federal agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license, or curtailment of activities.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.5** Organization and Management {#sec-216-ricr-40-10-11-11.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.5}
11.5.1Governing Body
A.There shall be an organized governing body or equivalent legal authority ultimately responsible for:
1.The management, fiscal affairs, and operation of the hospice program;
2.The assurance of quality care and services; and
3.The compliance with all federal, state and local laws and regulations pertaining to a hospice program and the rules and regulations of this Part.
B.The governing body or other legal authority shall furthermore be responsible to:
1.Make services available on a twenty-four (24) hour basis to meet the needs of patients/family as required under the provisions of §§ 11.5.5(F)(2) and 11.5.5(G)(1) of this Part;
2.Provide a sufficient number of appropriate personnel, physical resources and equipment to facilitate the delivery of prescribed services;
3.Ensure conformity of the facility with all Federal, State, and local Rules and Regulations Pertaining to Fire, Safety, Sanitation, Communicable and Reportable Diseases, other relevant health and safety requirements, and all Rules and Regulations of this Part; and
4.Implement a policy of non-discrimination in the provision of services to patients and the employment of persons without regard to race, color, creed, national origin, gender, religion, sexual orientation, age, gender identity or expression, handicapping condition or degree of handicap, in accordance with Title VI of the Civil Rights Act of 1964, U.S. Executive Order #11246 entitled “Equal Employment Opportunity,” U.S. Department of Labor Regulations, Title V of the Rehabilitation Act of 1973, the Rhode Island Fair Employment Practices Act, R.I. Gen. Laws Chapter 28-5, the Americans with Disabilities Act, and any other applicable Federal or State laws relating to discriminatory practices.
C.The governing body or other legal authority shall designate:
1.An administrator who shall be responsible for the management and operation of the hospice program; and
2.A medical director who assumes overall responsibility for the medical component of patient care and to ensure achievement and maintenance of quality standards of professional practice.
D.The governing body or equivalent legal authority shall adopt and maintain bylaws or acceptable equivalent which defines responsibilities for the operation and performance of the organization, identifies purposes and means of fulfilling such. In addition, the governing body or equivalent legal authority shall establish administrative policies pertaining to no less than the following:
1.Responsibilities of the administrator and the medical director;
2.Conflict of interest on the part of the governing body, professional staff, and employees;
3.The services to be provided;
4.Criteria for the selection, admission and transfer of terminally ill patient/families;
5.Patient/family consent and involvement in the development of patient care plan;
6.Developing support network when relatives are not available and patient needs and wants that support;
7.Linkages and referrals with community and other health care facilities or agencies that shall include a mechanism for recording, transmitting, and receiving information essential to the continuity of patient/family care. Such information must contain no less than:
a.Patient identification data such as name, address, age, gender, name of next of kin, health insurance coverage,
b.Diagnosis and prognosis, medical status of patient, brief description of current illness, medical and nursing plans of care including such information as medications, treatments, dietary needs, baseline laboratory data,
c.Functional status,
d.Special services such as physical therapy, occupational therapy, speech therapy and similar services,
e.Psychosocial needs,
f.Such other information pertinent to ensure continuity of patient care,
g.Any additional information as cited in the “continuity of care” form available on the department’s website: www.health.ri.gov. Designated licensed personnel shall complete the “continuity of care” form approved by the department for each patient who is discharged to another health care facility, such as a hospital, or who is discharged home with follow-up home care required. Said form shall be provided to the receiving facility or agency prior to or upon transfer of the patient,
8.Professional management responsibilities for contracted services,
9.Reports of patient's condition and transmission thereof to the patient’s physician, and
10.Such other matters as may be relevant to the organization and operation of hospice care.
11.5.2Organization of Services
A.The governing body or other legal authority shall organize hospice program services to provide an integrated continuum of care for terminally ill patients/families and to ensure that such care is rendered under the professional management responsibility of the hospice program.
1.An organizational chart with written description of the organization, authorities, responsibilities, accountabilities, and relationships shall be maintained, that shall include but not be limited to:
a.A description of each level of care and services;
b.Policies and procedures pertaining to hospice care and services that are consistent with professionally recognized standards of practice;
c.A description of the system for the maintenance of patient records; and
d.Such other related provisions as deemed appropriate.
11.5.3Quality Improvement
A.Each hospice program shall establish a written quality improvement plan that shall be reviewed by the Department during the facility’s annual survey and that includes:
1.Program objectives;
2.Oversight responsibility (e.g., reports to the governing body);
3.Hospice-wide scope;
4.Involvement of all patient care disciplines/services;
5.Provides criteria to monitor nursing care, including medication administration;
6.Prevention and treatment of decubitus ulcers;
7.Accidents and injuries, resulting in unexpected death;
8.Any other data necessary to monitor quality of care; and
9.Methods to identify, evaluate, and correct problems.
B.All patient care services, including services rendered by a contractor, shall be evaluated.
C.Each licensed hospice program administrator shall designate a qualified individual to coordinate and manage the hospice program’s quality improvement program.
D.A quality improvement committee for a hospice program shall be established and shall annually review and approve the quality improvement plan for the hospice program. Said plan shall be available to the public upon request.
E.The hospice program’s quality improvement committee shall include at least the following members:
1.The hospice program administrator;
2.The director of nursing;
3.The medical director; and
4.A social worker.
F.The quality improvement committee shall meet at least quarterly; shall maintain records of all quality improvement activities; and shall keep records of committee meetings that shall be available to the Department during any on-site visit.
G.The Director may not require the quality improvement committee to disclose the records and the reports prepared by the committee except as necessary to assure compliance with the requirements of this Part.
H.Good faith attempts by the quality improvement committee to identify and correct quality deficiencies will not be used as a basis for hospice licensure sanctions.
I.If the Department determines that a hospice program is not implementing its quality improvement program effectively and that quality improvement activities are inadequate, the Department may impose sanctions on the hospice program to improve quality of patient care.
J.The program shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented and submitted to the governing body for their consideration.
11.5.4Written Agreements
A.There shall be written agreements for the provision of those services required in § 11.5.5(B) of this Part, not provided directly by the hospice program. The agreements shall clearly delineate the responsibilities of the parties involved and shall include no less than the following provisions:
1.A stipulation that services may be provided only with the express authorization of the hospice program;
2.The responsibility of the licensed hospice program for the admission of patients/families to the hospice service;
3.Identification of services to be provided that must be within the scope and limitations set forth in the plan of care and that must not be altered in type, amount, frequency or duration (except in case of adverse reaction) by the individual, agency, or institution;
4.The manner in which the services are coordinated, supervised and evaluated by the hospice program;
5.Assurance of compliance with the patient care policies of the licensed hospice program;
6.Establishment of procedures for, and frequency of, patient/family care assessment;
7.Furnishing the hospice plan of care to other health care facilities upon transfer of patient;
8.Assurance that personnel and services meet the requirements specified herein pertaining to personnel and services, including licensure, personnel qualifications, functions, supervision, hospice training and orientation, in-service training, and attendance at case conferences;
9.Reimbursement mechanism, charges, and terms for the renewal or termination of the agreement;
10.Such other provisions as may be mutually agreed upon or as may be relevant and deemed necessary;
11.Assurance that the inpatient provider has established policies consistent with those of the hospice program and that the inpatient care facility agrees to abide by the patient care plan and protocol established by the hospice program;
12.Assurance the medical record shall include a record of all inpatient services and events, and a copy of the discharge summary and, if requested, a copy of the medical record to be provided to the hospice program; and
13.The party responsible for the implementation of the provisions of the agreement.
B.The hospice program shall retain professional management responsibility for contracted services to ensure that they are furnished in a safe and effective manner by persons meeting the qualifications stated herein, in accordance with the patient’s plan of care.
11.5.5Minimum Services Required/Availability and Accessibility of Services
A.Any service available through a hospice program shall be provided to patients/families, with the consent of the terminally ill patient and family.
B.Services that are to be provided directly through staff personnel of a hospice program shall include the following core services:
1.Physician services (may include attending physicians' or certified nurse practitioners’ services in accordance with § 11.5.8(A) of this Part);
2.Nursing services;
3.Social services;
4.Counseling services, including spiritual counseling, when required;
5.Pain assessment; and
6.Availability of drugs and biologicals on a twenty-four (24) hour basis.
C.A hospice program may use contracted staff if necessary to supplement hospice staff personnel in order to meet the needs of patients during periods of peak patient loads or under extraordinary circumstances. If contracting is used, the hospice shall maintain professional management responsibility for the services and shall assure that the qualifications of staff and services provided meet the requirements herein.
D.In addition to the minimum services listed in § 11.5.5(B) of this Part, a hospice program shall ensure that the following services are provided, as applicable, to patients/families directly by hospice staff personnel or under written arrangement as specified in § 11.5.4 of this Part.
1.Home health aide and homemaker services;
2.Short-term respite care, and general inpatient care;
3.Physical therapy, occupational therapy, and speech-language pathology services;
4.Medical supplies and appliances; and
5.Nutritional counseling.
E.Pain Assessment
1.All health care providers licensed by this state to provide health care services and all health care facilities licensed under R.I. Gen. Laws, shall assess patient pain in accordance with the requirements of the Rules and Regulations Pertaining to Pain Assessment promulgated by the Department.
F.Availability of Services
1.A hospice program shall make:
a.Nursing services, physician services, drugs and biologicals routinely available on a twenty-four (24) hour basis, seven (7) days a week, as may be required in accordance with the plan of care;
b.All other services available on a twenty-four (24) hour basis to the extent necessary to meet the needs of individuals for care that is reasonable and necessary for the palliation and management of terminal illness and related conditions in accordance with the plan of care; and
c.Patient visiting and assessment capability available on a twenty-four (24) hour basis, seven (7) days a week to respond to acute and urgent patient/family needs.
2.Additional health services or related services, including palliative care, may be provided as may be deemed appropriate to meet patient/family needs and such services must be rendered in a manner consistent with acceptable standards of practice.
G.Accessibility to Hospice Care
1.Each hospice program shall establish a mechanism to enable patients/families to make telephone contact with responsible staff personnel on a twenty-four (24) hour basis, seven (7) days a week. Mechanical answering devices shall not be acceptable.
H.Accessibility to Pharmacy Services
1.Each hospice program shall provide on a twenty-four (24) hour basis, seven (7) days a week, accessibility to pharmacy services to enable patient/family to obtain prescription drugs and biologicals, for the palliative care and management of the terminally ill patient.
I.Continuity of Care. The hospice program shall assure the continuity of patient/family care in the home and inpatient settings through written policies, procedures, and criteria pertaining to no less than the following:
1.Admission criteria and initial assessment of the patient/family need and decision for care;
2.Signed informed consent;
3.Ongoing assessment of patient/family needs;
4.Development and review of the plan of care by the interdisciplinary team;
5.Transfer of patients to inpatient care facilities for inpatient respite care and general inpatient care;
6.The provision of appropriate patient/family information at the point of transfer between levels of care settings;
7.Community or other resources to insure continuity of care and meet patient/family needs;
8.Management of symptom control through palliative care and utilization of therapeutic services (see § 11.5.5(E)(1) of this Part);
9.Provision of continuing care for patients transferred to inpatient care facilities;
10.Constraints imposed by limitations of services, family conditions; and
11.Such other criteria as may be deemed appropriate.
11.5.6Plan of Care
A.After an initial assessment of patient/family needs, a written plan of care shall be established by the medical director or physician designee, the attending physician and the interdisciplinary team for each patient/family admitted to the hospice program. Such plan of care shall be developed with the participation of the patient and family, and shall include only those services that are acceptable to the patient and family. Furthermore, the family shall be involved whenever possible in the implementation and continuous assessment of the plan of care. The hospice program shall ensure that each patient and family/primary caregiver(s) receive education and training provided by the hospice appropriate to the care and services identified in the plan of care.
B.The plan of care shall include, but not be limited to, provisions pertaining to:
1.Pertinent diagnosis and prognosis;
2.Interventions to facilitate the management of pain and symptoms;
3.Measurable targeted outcomes anticipated from implementing and coordinating the plan of care;
4.A detailed statement of the patient/family needs addressing the physical, psychological, social, and spiritual needs of the patient/family; the scope of services required; the frequency of visits; the need for inpatient care (respite and/or general inpatients); nutritional needs; medications; management of discomfort and symptom control; management of grief;
5.Drugs and treatments necessary to meet the needs of the patient;
6.Medical supplies and appliances necessary to meet the needs of the patient;
7.The interdisciplinary group’s documentation of patient and family understanding, involvement, and agreement with the plan of care, in accordance with the hospice’s own policies, in the clinical record;
8.Consent of patient/patient’s designated agent/family; and
9.Such other relevant modalities of care and services as may be appropriate to meet patient/family care needs.
C.The plan of care shall be reviewed and updated at periodic intervals by the interdisciplinary team.
D.A revised plan of care shall include information from the patient’s updated comprehensive assessment and the patient’s progress toward outcomes specified in the plan of care.
11.5.7Levels of Care
A.Home Care: Home care services shall be provided to hospice patients/families either as routine home care or continuous home care during periods of crisis, in order to maintain the terminally ill patient at home.
B.General Inpatient Care: Short-term general inpatient care for the control of pain or management of acute and severe clinical conditions that cannot be managed in the current setting shall be provided only in licensed hospitals, licensed nursing facilities, or hospice inpatient facilities that meet the requirements of §§ 11.6.1 through 11.7.15(A) of this Part. Hospice care provided in a nursing facility or hospital shall have a binding written agreement with a hospice program that includes the provisions of § 11.5.4 of this Part.
C.Inpatient Respite Care: Inpatient respite care may be provided for short periods of time to relieve family members or others caring for the terminally ill patient in the home. Such care shall be provided only in a licensed hospital, nursing facility or hospice inpatient facility that meets the requirements of §§ 11.6.1 through 11.7.15(A) of this Part, and with whom the hospice program has entered into a binding agreement as provided in § 11.5.4 of this Part.
11.5.8Hospice Services
A.Attending Practitioner Services: Attending practitioner services shall be provided by a physician, as defined in R.I. Gen. Laws Chapter 5-37, or a certified nurse practitioner, as defined in R.I. Gen. Laws Chapter 5-34, to meet the general medical needs of patients for the management of the terminal illness and related conditions, through palliative and supportive care and in accordance with hospice policies. Attending practitioner services may also be provided by a physician assistant, as long as the physician assistant’s role is providing medical and surgical services in collaboration with physicians, as set forth in the provisions of R.I. Gen. Laws Chapter 5-54.
1.Such policies shall include provisions governing the relationship of the attending physician or the certified nurse practitioner, or physician assistant, to the medical director, and the interdisciplinary team.
2.In addition to palliation and management of terminal illness and related conditions, staff physician(s) and/or certified nurse practitioner(s) of the hospice program, including the physician member(s), certified nurse practitioner member(s), and/or physician assistant member(s) of the interdisciplinary group shall also meet the general medical needs of the patients to the extent that these needs are not met by the attending physician, certified nurse practitioner, and/or physician assistant.
B.Nursing Services: Nursing services shall be provided under the direction of a licensed professional (registered) nurse to meet the nursing care needs of patients/families as prescribed in the plan of care and in accordance with acceptable standards of practice and hospice policies.
C.Social Services: Social services shall be offered by a person licensed under R.I. Gen. Laws Chapter 5-39.1 and the Rules and Regulations Pertaining to Licensing Clinical Social Workers and Independent Clinical Social Workers. Such services shall be provided as prescribed in the plan of care and in accordance with acceptable standards of practice and hospice care policies.
D.Bereavement Counseling Services: Bereavement counseling services shall be offered to meet the needs of the members of families both before and after the death of the patient. Such services shall be provided by a professional person qualified by training and experience for the development, implementation, and assessment of a plan of care to meet the needs of the bereaved.
E.Spiritual Counseling Services: Spiritual counseling services shall be available. Patients/families shall be notified of the availability of such services.
F.Nutritional Counseling: Dietary counseling services for the patient/family shall be available as may be required, while the individual is in hospice care.
G.Home-Health Aide/Nursing Assistant Services: Each hospice program shall provide home-health aide/nursing assistant services pursuant to § 11.5.5(E)(1) of this Part and as prescribed by the patient/family plan of care and consistent with policies of the hospice program.
1.The home-health aide/nursing assistant shall provide personal care and other related support services under the supervision of a registered nurse from the licensed hospice program and/or a therapist when the aide carries out simple procedures as an extension of physical, speech, or occupational therapy or social services. Duties of home-health aides/nursing assistants shall include, but not be limited to:
a.Performance of simple procedures as an extension of therapy services;
b.Personal care;
c.Ambulation and exercise;
d.Assistance with medications that are ordinarily self-administered, in accordance with state and federal laws and regulations;
e.Preparing meals and assisting patients with eating;
f.Household services that are essential to the patient's health care at home;
g.Reporting changes in patient's condition and needs; and
h.Completing appropriate records.
H.Volunteer Services: The development and utilization of trained lay and professional volunteers shall be required of a hospice program. Direct patient care rendered by volunteers shall be provided under the supervision of a qualified and experienced staff member of the hospice program and shall be consistent with the established patient/family plan of care. Furthermore, direct patient care volunteers shall:
1.Have the necessary qualifications and skills to provide the prescribed service;
2.Have participated in an appropriate orientation and training program of hospice care; and
3.Be responsible to record patient care services rendered.
I.Medical Supplies: Medical supplies and appliances, including drugs and biologicals, as may be needed, shall be provided (either directly or by arrangement) for the palliation and management of the terminal illness and related conditions in accordance with § 11.5.5(E)(1) of this Part.
J.Administration of Drugs and Biologicals. Drugs and biologicals as prescribed by the physician or other practitioner working within the scope of his/her practice in the plan of care may be administered by the following individuals:
1.A licensed nurse, certified nurse practitioner, physician, and/or physician assistant;
2.Selected non-licensed personnel with demonstrated competence who have satisfactorily completed a State-Approved Program on Drug Administration may administer oral or topical drugs in accordance with the Rules and Regulations Pertaining to Rhode Island Certificates of Registration for Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs if adequate medical and nursing supervision is provided in accordance with R.I. Gen. Laws Chapter 5-34, agency policies, and applicable federal laws and regulations.
3.The patient may self-administer drugs, or a member of the family/caregiver may also administer drugs to the patient in accordance with the plan of care, upon written approval of the attending physician, certified nurse practitioner, or, as appropriate, physician assistant.
K.Pharmacy Services: Hospice programs shall have policies pertaining to the disposal of controlled substances and legend drugs that are consistent with the Rules and Regulations Pertaining to the Disposal of Legend Drugs.
L.Other Services: such as physical, occupational, speech, and hearing therapy services must be available and when provided, such services must be rendered in accordance with the plan of care and in a manner consistent with accepted standards of practice.
M.Clinical Records
1.A clinical record shall be established for every patient receiving care and services. The record shall be completed promptly and accurately documented, readily accessible and systematically organized to facilitate retrieval.
2.Each clinical record shall include a comprehensive compilation of information. Entries shall be made for all services provided, signed by the staff providing the services. The record shall include entries on all services rendered whether furnished directly or under arrangements with the hospice. Each patient’s record shall contain no less than:
a.The initial and subsequent assessment;
b.The plan of care;
c.Identification data;
d.Consent form;
e.Any advance directives;
f.Pertinent medical history; and
g.Complete documentation of all services and events (including evaluations, treatment, progress notes).
3.Records shall be maintained by the agency for a period of at least five (5) years following the date of discharge and shall be safeguarded against loss or unauthorized use.
4.Each program shall establish policies and procedures to govern the use and removal of records and determine the conditions for release of information in accordance with statutory provisions pertaining to confidentiality.
11.5.9Personnel
A.A registered nurse with training and experience in hospice care shall be designated to coordinate the overall plan of care for each patient/family.
B.Each hospice program shall designate a sufficient number of staff personnel (including volunteers) with training and experience in hospice care and whose qualifications are commensurate with their duties and responsibilities to provide care services to patients/families.
1.Staff personnel shall provide evidence of current registration, certification or licensure as may be required by law. For every person employed by the hospice program who is licensed, certified, or registered by the Department, a mechanism shall be in place to electronically verify such licensure via the Department's electronic licensure database.
C.A job description for each classification of position shall be established clearly delineating qualifications, duties, authority, and responsibilities inherent in each position.
D.An ongoing program for the training of all personnel shall be conducted by the hospice program, that shall include:
1.An orientation program for new staff personnel (including volunteers); and
2.A continuing program for the development and improvement of skills of staff to ensure the delivery of quality hospice care services.
E.Administrator
1.The governing body or other legal authority shall appoint an individual who possesses appropriate education and experience to serve as administrator of the hospice program, and who shall be responsible for:
a.The management and operation of the program;
b.The enforcement of policies, rules and regulations, and statutory provisions pertaining to the program;
c.Serving as liaison between the governing body and staff; and
d.The planning, organizing, and directing of such other activities as may be delegated by the governing body.
2.A hospice inpatient facility shall have a full-time administrator. Any change in administrators shall be reported in writing to the Department within fifteen (15) days. The administrator shall designate in writing the person to act in his/her absence in order to provide the hospice inpatient facility with administrative direction at all times.
F.Medical Director
1.The overall responsibility for the medical component of patient care shall be under the direction of a physician, qualified by training and experience in hospice care, who shall also be responsible for no less than the following:
a.Coordination of medical care provided by the hospice program;
b.Ensuring and maintaining quality standards of professional practice;
c.Implementation of patient care policies;
d.The achievement and maintenance of quality assurance of professional practices through a mechanism for the assessment of patient/family care outcomes;
e.Ensuring completion of health care worker screening and immunization requirements as contained in the Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title);
f.The certification of terminally ill patients admitted to the hospice program;
g.Participation as a member of the interdisciplinary team, in the development, implementation, and assessment of patient/family plan of care; and
h.Consulting with attending physicians and/or certified nurse practitioners regarding patient care plans.
2.Upon appointment, the name of the medical director shall be submitted to the Department. Each time a new medical director is appointed, the name of said physician shall be reported promptly to the Department. The medical director's Rhode Island medical license number, medical office address, telephone number, emergency telephone number, hospital affiliation and other credentialing information shall be maintained on file by the hospice program and updated as needed.
G.Criminal Records Check
1.Criminal records checks shall be in accordance with R.I. Gen. Laws § 23-17-34.
2.If an applicant has undergone a national criminal records check within eighteen (18) months of an application for employment, then an employer may request from the bureau a letter indicating if any disqualifying information was discovered. The bureau will respond without disclosing the nature of the disqualifying information. This letter must be maintained on file to satisfy the requirements of R.I. Gen. Laws § 23-17-34.
H.Photo Identification
1.A hospice program shall require all persons, including students, who examine, observe, or treat a patient to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
I.Hospice Inpatient Facilities
1.In additional to the personnel requirements contained above, each hospice inpatient facility shall have a registered nurse on the premises twenty-four (24) hours a day. In addition, the necessary nursing service personnel (licensed and non-licensed) shall be in sufficient numbers on a twenty-four (24) hour basis, to assess patients’ needs, to develop and implement patient care plans, to provide direct patient care services, and to perform other related activities to maintain the health, safety, and welfare of patients.
J.In-Service Education
1.An in-service educational program shall be conducted on an ongoing basis, that shall include an orientation program for new personnel and a program for the development and improvement of skills of all personnel. The in-service program shall be geared to the needs of the population and shall include annual programs on prevention and control of infection, food services and sanitation (as appropriate), fire prevention and safety, confidentiality of patient information, patient rights and any other areas related to hospice care.
a.Provisions shall be made for written documentation of in-service educational programs, including attendance.
K.Health Screening
1.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the hospice. Such health screening shall be conducted in accordance with the Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title) promulgated by the Department.
L.Latex
1.Any hospice program that utilizes latex gloves shall do so in accordance with the provisions of the Rules and Regulations Pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part of this Title) promulgated by the Department.
11.5.10Interdisciplinary Team
A.The governing body or other legal authority shall designate an interdisciplinary team composed of staff personnel that includes:
1.Attending practitioner;
2.Professional (registered) nurse;
3.Social worker;
4.Spiritual counselors; and
5.Such other staff and non-staff personnel as may be deemed appropriate.
B.The interdisciplinary team shall be responsible to develop, implement and assess patient/family plans of care, and in addition:
1.The supervision of care, personnel and services provided;
2.The provision of direct patient care as may be required and appropriate;
3.The development of a patient/family plan of care, and the revision of such plan of care as may be required;
4.The development of policies and procedures governing patient/family care and services; and
5.Such other duties as may be deemed appropriate by the governing body.
11.5.11Rights of Patients
A.Each hospice program shall adopt applicable "rights of patients" pursuant to the provisions of R.I. Gen. Laws § 23-17-19.1 and shall make such available to patients/patient’s designated agent/families.
B.In addition to the rights stated in R.I. Gen. Laws § 23-17-19.1, the patient shall be offered treatment without discrimination as to creed, gender, sexual orientation, age, gender identity or expression, handicapping condition or degree of handicap.
C.No charge shall be made for furnishing a health record or part of a health record to a patient, his or her attorney or authorized representative if the record or part of the record is necessary for the purpose of supporting an appeal under any provision of the Social Security Act, 42 U.S.C. § 301 et seq., and the request is accompanied by documentation of the appeal or a claim under the provisions of the Workers' Compensation Act, R.I. Gen. Laws Chapters 28-29 through 28-38. Additionally, charges shall not be made if the record is requested for immunization records required for school admission or by the applicant or beneficiary or individual representing an applicant or beneficiary for the purposes of supporting a claim or appeal under the provision of the Social Security Act or any federal or state needs-based benefit program such as Medical Assistance, RIte Care, Temporary Disability Insurance, or unemployment compensation.
D.The hospice program shall provide the patient/patient’s designated agent/family with written information concerning its policies on advance directives, including a description of any applicable state law.
11.5.12Reporting of Patient Abuse or Neglect, Accidents and Death
A.Any physician, nurse, or other employee of a hospice program who has reasonable cause to believe that a patient has been abused, exploited, mistreated, or neglected shall within twenty-four (24) hours of the receipt of said information, transfer such to the Director. Any person required to make a report pursuant to this Section shall be deemed to have complied with these requirements if a report is made to a high managerial agent. Once notified, the administrator or the director of nursing services shall be required to meet the above reporting requirements.
B.The hospice program shall maintain evidence that all allegations of abuse, neglect, and/or mistreatment have been thoroughly investigated and that further potential abuse has been prevented while the investigation is in progress. The results of said investigation shall be reported to the Department. Appropriate corrective action shall be taken, as necessary.
C.Accidents resulting in hospitalization or death of any patient shall be reported in writing to the licensing agency before the end of the next working day. A copy of each report shall be retained by the facility for review during subsequent surveys.
D.All patient deaths occurring within a hospice program or in a hospice inpatient facility that are under the following categories shall be reported to the program medical director and to the Office of the State Medical Examiners in accordance with R.I. Gen. Laws Chapter 23-4:
1.Suspicious or unnatural;
2.The result of trauma, remote or otherwise;
3.The decedent is less than eighteen (18) years of age;
4.As a result of a drug overdose or poisoning, remote or otherwise, and
5.As a result of an infectious disease with epidemic potential.
E.The death of any hospice patient occurring within twenty-four (24) hours of admission to a hospice program providing care in the home or a program at an inpatient hospice unit shall be reported to the Office of the State Medical Examiners, unless declared exempt by the Chief Medical Examiner.
F.Reporting requirements shall be posted, pursuant to R.I. Gen. Laws Chapter 23-17.8
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.6** General Requirements for Inpatient Hospice Settings {#sec-216-ricr-40-10-11-11.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.6}
11.6.1Hospice Inpatient Facilities
A.A licensed hospital, a licensed nursing facility, or a hospice inpatient facility with whom a hospice program enters into a written agreement for the provision of inpatient care (general inpatient, or respite care, as described above) for hospice patients shall be required to meet the following provisions pertaining to:
1.Staffing (see also §§ 11.5.9(I)(1) and 11.5.9(J)(1) of this Part); and
2.Patient areas pursuant to § 11.6.1(B) of this Part.
3.Additionally, said facilities providing general inpatient care or inpatient respite care shall be required to meet the provisions of §§ 11.6.2 through 11.7.15(A) of this Part.
B.Patient Areas
1.The patient areas must be designed and equipped for the comfort and privacy of each patient/family that includes:
a.Physical space for private patient/family visiting;
b.Accommodations for family members, including children, if they wish to remain with patient overnight;
c.Accommodation for family privacy after a patient's death; and
d.Home-like interior.
2.Patients shall be permitted to receive visitors, including small children and pets, at any hour, provided that a therapeutic environment is maintained for all patients.
11.6.2Dietetic Services
A.Each facility shall maintain a dietetic service under the supervision of a full-time person who, as a minimum, is a graduate of a state approved course that provided instruction in food service supervision and nutrition and has experience in the organization and management of food service.
1.When the dietary manager is absent, a responsible person shall be assigned to supervise dietetic service personnel and food service operations.
B.The facility's food service operation shall comply with all appropriate standards of the Rhode Island Food Code (Part 50-10-1 of this Title).
1.Diet kitchens, nourishment stations, and any other related areas shall be the responsibility of the dietetic service.
C.There shall be a supply of staple foods for a minimum of seven (7) days and of perishable foods for a minimum of two (2) days in the facility.
11.6.3Infection Control
A.Infection control provisions shall be established for the mutual protection of patients, employees, and the public.
B.The facility shall be responsible for no less than the following:
1.Establishing and maintaining a facility-wide infection surveillance program;
2.Developing and implementing written policies and procedures for the surveillance, prevention, and control of infections in all patient care departments/services;
3.Establishing policies governing the admission and isolation of patients with known or suspected infectious diseases;
4.Developing, evaluating, and revising on a continuing basis infection control policies, procedures, and techniques for all appropriate areas of facility operation and services;
5.Developing and implementing a system for evaluating and recording the occurrences of all infections relevant to employment (e.g., skin rash) among personnel and infections among patients; such records shall be made available to the licensing agency upon request;
6.Consistent with “Policy and Procedures for Tuberculosis Screening of Health-Care Workers” incorporated above at § 11.2(C) of this Part, implementing a tuberculosis (TB) infection control program requiring risk assessment and development of a TB infection control plan; early identification, treatment and isolation of strongly suspected or confirmed infectious TB patients; effective engineering controls; an appropriate respiratory protection program; health care worker TB training, education, counseling and screening; and evaluation of the program's effectiveness, per guidelines in “Policy and Procedures for Tuberculosis Screening of Health-Care Workers” incorporated above at § 11.2(C) of this Part.
7.Developing and implementing an institution-specific strategic plan for the prevention and control of vancomycin resistance, with a special focus on vancomycin-resistant enterococci, per guidelines in “Guidelines for the Control of Vancomycin Resistant Enterococci (VRE) in Nursing Homes and Extended Care Facilities” (1996). (See also “Recommendations for Preventing the Spread of Vancomycin Resistance: Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC)” incorporated above at § 11.2(D) of this Part for additional information on this issue).
8.Developing and implementing protocols for:
a.Discharge planning that includes full instruction to the family or caregivers regarding necessary infection control measures, and
b.Hospital transfer of patients with infectious diseases which may present the risk of continuing transmission. Examples of such diseases include, but are not limited to, TB, methicillin resistant staphylococcus aureus (MRSA), VRE, and clostridium difficile.
9.Assuring that all patient care staff are available in order to assist in the prevention and control of infectious diseases and are provided with adequate direction, training, staffing and facilities to perform all required infection surveillance, prevention and control functions.
C.A continuing education program on infection control shall be conducted periodically for all staff.
D.Reporting of Communicable Diseases
1.Each facility shall report promptly to the Department, cases of communicable diseases designated as "reportable diseases" when such cases are diagnosed in the facility in accordance with the Rules and Regulations Pertaining to the Reporting of Infectious, Environmental and Occupational Diseases (Part of this Title).
2.When infectious diseases present a potential hazard to patients or personnel, these shall be reported to the Department, Center for Acute Infectious Diseases and Epidemiology even if not designated as "reportable diseases."
3.When outbreaks of food-borne illness are suspected, such occurrences shall be reported immediately to the Department, Center for Acute Infectious Diseases and Epidemiology or to the Center for Food Protection.
4.Facilities shall comply with the provisions of R.I. Gen. Laws § 23-28.36-3, which require notification of fire fighters, police officers, and emergency medical technicians after exposure to infectious diseases.
11.6.4Pharmaceutical Services
A.Each facility shall provide pharmaceutical services either directly within the facility or per contractual arrangement. Such services shall be provided in accordance with the requirements of the Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
1.In either instance, appropriate methods and procedures for the procurement and the dispensing of drugs and biologicals shall be established in accordance with appropriate federal and state laws and regulations.
B.There shall be written policies and procedures relating to the pharmaceutical service that shall require no less than:
1.The authority, responsibility, and duties of the registered pharmacist;
2.The selection, procurement, distribution, storage, dispensing or other disposition of drugs and biologicals in accordance with appropriate federal and state laws and regulations;
3.Maintenance of records of all transactions, including recording of receipt and dispensing or other disposition of all drugs and biologicals;
4.Inspection of all drug and biological storage and medication areas and documented evidence of findings;
5.Automatic stop orders for drugs or biologicals;
6.The use of only approved drugs and biologicals;
7.Control of medications from any source;
8.A requirement that when automated storage and distribution devices are utilized, all pertinent provisions of the Rules and Regulations Pertaining to Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors shall be met;
9.A monitoring program to identify adverse drug reactions, interactions and incompatibilities and antibiotic antagonisms; and
10.Drugs and biological stored outside of an automated storage and distribution device shall be labeled with the name of the patient, name of the physician, drug dosage, cautionary instructions, and expiration date.
C.Adequate space, equipment, supplies and locked storage areas shall be provided for the storage of drugs and biologicals based on the scope of services provided.
D.Refrigerated food storage units shall not be utilized for storage of drugs and/or biologicals except in facilities of thirty (30) beds or less, provided they are locked in an appropriate container.
E.Drugs may be administered to patients from bulk inventories of non-legend and non-controlled substance items such as aspirin or milk of magnesia, as ordered by a licensed physician.
F.An emergency medication kit, approved by the pharmaceutical service committee or its equivalent, shall be kept at each nursing station.
G.There shall be adequate drug and biological preparation areas with provisions for locked storage in accordance with federal and state laws and regulations.
H.The pharmaceutical service committee or its equivalent, consisting of not less than a registered pharmacist, a registered nurse, a physician, and the administrator, shall:
1.Serve as an advisory body on all matters pertaining to pharmaceutical services;
2.Establish a program of accountability for all drugs and biologicals;
3.Develop and review periodically all policies and procedures for safe and effective drug therapy; and
4.Monitor the pharmaceutical service.
I.A registered pharmacist shall assist in developing, coordinating, and supervising all pharmaceutical services in conjunction with the pharmaceutical services committee. In addition, a registered pharmacist shall:
1.Review the drug and biological regimen of each patient at least monthly;
2.Report any irregularities to the attending physician and/or medical director. These reports shall show documentation of review and response; and
3.Document in writing the performance of such review, which documentation shall be kept on file by the facility and shall be made accessible to the Department upon request.
11.6.5Laboratory and Radiologic Services
A.All facilities shall make provisions for laboratory, x-ray, and other services to be provided either directly by the facility or per contractual arrangements with an outside provider.
B.If the facility provides its own laboratory and x-ray services, these shall meet all applicable statutory and regulatory requirements.
C.All services shall be provided only per order of the attending physician who shall be promptly notified of the findings in accordance with a protocol established by the facility. Such a protocol shall describe which laboratory values mandate a call to the patient’s attending physician.
D.Signed and dated reports of all findings shall become part of the patient's medical record.
11.6.6Equipment
A.Each facility shall maintain sufficient and appropriate types of equipment consistent with patient needs and sufficient to meet emergency situations.
B.All equipment to meet the needs of the patients shall be maintained in safe and effective operational condition.
11.6.7Housekeeping
A.An employee of the facility shall be designated responsible for housekeeping services, supervision, and training of housekeeping personnel.
B.Sufficient housekeeping and maintenance personnel shall be employed to maintain a comfortable, safe, clean, sanitary, and orderly environment in the facility.
C.Written housekeeping policies and procedures shall be established in accordance with § 11.6.3 of this Part on infection control, for the operation of housekeeping services throughout the facility. Copies shall be made available to all housekeeping personnel.
D.Housekeeping personnel may assist in food distribution but not food preparation. Careful hand washing should be done prior to assisting in food distribution.
E.All parts of the facility and its premises shall be kept clean, neat, and free of litter and rubbish and offensive odors.
F.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition and shall be properly stored.
G.Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other cleaning materials.
H.Cleaning shall be performed in such a manner so as to minimize the development and spread of pathogenic organisms in the facility environment.
I.Exhaust ducts from kitchens and other cooking areas shall be equipped with proper filters and cleaned at regular intervals. The ducts shall be cleaned as often as necessary and inspected by the facility no less than twice per year.
J.Facilities contracting with outside resources for housekeeping services shall require conformity with the regulations contained herein.
K.Each facility shall be maintained free from insects and rodents through the operation of a pest control program.
11.6.8Laundry Services
A.Each facility shall make provisions for the cleaning of all linens and other washable goods.
B.Facilities providing laundry service shall have adequate space and equipment for the safe and effective operation of laundry service and, in unsewered areas, shall obtain approval of the sewage system by the licensing agency to ensure its adequacy.
C.Written policies and procedures for the operation of the laundry service including special procedures for the handling and processing of contaminated linens, shall be established in accordance with § 11.6.3 of this Part on infection control.
D.There shall be distinct areas for the separate storage and handling of clean and soiled linens.
1.The soiled linen area and the washing area shall be negatively pressurized or otherwise protected to prevent introduction of airborne contaminants.
2.The clean linen area and the drying area shall be physically separated from the soiled linen area and the washing area.
E.All soiled linen shall be placed in closed containers prior to transportation.
F.To safeguard clean linens from cross-contamination they shall be transported in containers used exclusively for clean linens which shall be kept covered at all times while in transit and stored in areas designated exclusively for this purpose.
G.A quantity of linen equivalent to three (3) times the number of beds including the set of linen that is in use shall be available and in good repair at all times.
H.Facilities contracting for services with an outside resource in accordance with § 11.5.4 of this Part shall require conformity with these regulations as part of the contract.
11.6.9Disaster Preparedness
A.Each facility shall develop and maintain a written disaster preparedness plan that shall include plans and procedures to be followed in case of fire or other emergencies. The plan and procedures shall be developed with the assistance of qualified safety, emergency management, and/or other appropriate experts and shall be coordinated with the local emergency management agency.
B.The plan shall include procedures to be followed pertaining to no less than the following:
1.Fire, explosion, severe weather, loss of power and/or water, flooding, failure of internal systems and/or equipment, and other calamities;
2.Transfer of casualties;
3.Transfer of records;
4.Location and use of alarm systems, signals, and firefighting equipment;
5.Containment of fire;
6.Notification of appropriate persons;
7.Relocations of patients and evacuation routes;
8.Feeding of patients;
9.Handling of drugs and biologicals;
10.Missing patients; and
11.Any other essentials as required by the local emergency management agency.
C.A copy of the plan shall be available to the staff and to the public.
D.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the facility.
E.In-service training related to the disaster preparedness plan shall be conducted for all shifts at least semi-annually. Written documentation of all drills shall be maintained by the facility.
F.All personnel shall receive training in disaster preparedness as part of their employment orientation.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.7** Physical Plant {#sec-216-ricr-40-10-11-11.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.7}
11.7.1New Construction, Addition or Modification
A.All new construction, alterations, extensions or modifications of an existing facility, as defined in rules and regulations pursuant to R.I. Gen. Laws Chapter 23-15, shall be subject to the following provisions:
1.R.I. Gen. Laws Chapter 23-15 (Certificate of Need);
2.R.I. Gen. Laws Chapter 23-1 (Department of Health);
3.Rhode Island Food Code (Part 50-10-1 of this Title);
4.Guidelines for Design and Construction of Hospital and Health Care Facilities incorporated above at § 11.2(A) of this Part;
5.R.I. Gen. Laws Chapter 23-28.1 (State Fire Code);
6.Rhode Island Department of Environmental Management Rules and Regulations Establishing Minimum Standards Relating to Location, Design, Construction and Maintenance of Individual Sewage Disposal Systems (Sewage regulations);
7.The American National Standard - Specifications for Making Buildings and Facilities Accessible to and Usable by, the Physically Handicapped incorporated above at § 11.2(E) of this Part;
8.R.I. Gen. Laws Chapter 23-27.3 (State Building Code); and
9.The Americans with Disabilities Act incorporated above at § 11.2(F) of this Part.
B.In addition, any other applicable State and local laws, codes, and Regulations shall apply. Where there is a difference between codes, the code having the higher standard shall apply.
C.All plans for new construction or the renovation, alteration, extension, modification, or conversion of an existing facility that may affect compliance with §§ 11.7.4, 11.7.6, 11.7.7, 11.7.8, 11.7.9, and 11.7.14 of this Part, and “Guidelines for Design and Construction of Hospital and Health Care Facilities” incorporated above at § 11.2(A) of this Part shall be reviewed by a Rhode Island licensed architect. Said architect shall certify that the plans conform to the construction requirements of §§ 11.7.4, 11.7.6, 11.7.7, 11.7.8, 11.7.9, and 11.7.14 of this Part, and “Guidelines for Design and Construction of Hospital and Health Care Facilities” incorporated above at § 11.2(A) of this Part, prior to construction. The facility shall maintain a copy of the plans reviewed and the architect’s signed certification, for review by the Department upon request.
1.In the event of non-conformance for which the facility seeks a variance, the general procedures outlined in § 11.8.1 of this Part shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as details explaining the basis upon which the request is made. The Department may request additional information while evaluating variance requests.
2.If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of §§ 11.7.4, 11.7.6, 11.7.7, 11.7.8, 11.7.9, and 11.7.14 of this Part, and “Guidelines for Design and Construction of Hospital and Health Care Facilities” incorporated above at § 11.2(A) of this Part, except those for which variances were granted, prior to construction. The facility shall maintain a copy of the plans reviewed, the variance(s) granted, and the architect’s signed certification, for review by the Department upon request.
D.Upon completion of construction, the facility shall provide written notification to the Department describing the project, and a copy of the architect's certification. The facility shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.
11.7.2General Provisions – Physical Environment
A.Each facility shall be constructed, equipped, and maintained to protect the health and safety of patients, personnel, and the public. All equipment and furnishings shall be maintained in good condition, properly functioning, and replaced when necessary.
B.All steps, stairs, and corridors shall be suitably lighted, both day and night. Stairs used by patients shall have banisters, handrails, or other types of support. All stair treads shall be well maintained to prevent hazards.
C.All rooms utilized by patients shall have proper ventilation and shall have outside openings with satisfactory screens. Shades or Venetian blinds and draperies shall be provided for each window.
D.Grounds surrounding the facility shall be accessible to and usable by patients/families and shall be maintained in an orderly and well-kept manner.
11.7.3Fire Safety
A.Each facility shall meet the provisions of R.I. Gen. Laws Chapter 23-28.1.
B.Each facility shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations. Such a program shall include written procedures for the implementation of said rules and regulations and logs shall be maintained.
11.7.4Emergency Power
A.The facility shall provide an emergency source of electrical power necessary to protect the health and safety of patients in the event the normal electrical supply is interrupted.
1.Such emergency power system shall supply power adequate at least for:
a.Lighting all means of egress;
b.Equipment to maintain detection, alarm, and extinguishing systems; and
c.Life support systems, where applicable.
2.Where life support systems are used, emergency electrical service shall be provided by an emergency generator located on the premises.
11.7.5Facility Requirements for the Physically Handicapped
A.Each facility shall be accessible to, and functional for, patients, personnel, and the public. All necessary accommodations shall be made to meet the needs of persons with mobility disabilities, or sight, hearing, and coordination or perception disabilities in accordance with "The Americans with Disabilities Act” incorporated above at § 11.2(F) of this Part.
B.Blind, non-ambulatory, or physically handicapped patients or patients with mobility disabilities that limit self-preservation capability shall not be housed above the street- level floor unless the facility is equipped with an elevator and meets other requirements of R.I. Gen. Laws Chapter 23-28.1. Further, the facility must meet one of the following as defined in the National Fire Protection Association Standards No. 220:
1.Is of fire-resistive, one (1) hour-protected non-combustible construction;
2.Is fully-sprinklered, one (1) hour-protected, ordinary construction; or
3.Is fully-sprinklered, one (1) hour-protected, wood frame construction.
11.7.6Residential Area
A.Each residential area, as defined in § 11.3.24 of this Part, shall have at least the following:
1.Staff areas with adjacent hand-washing facility;
2.Storage rooms for walkers, wheelchairs, and other equipment;
3.Appropriate clean and soiled utility space; and
4.A telephone with an outside line.
B.In addition, each residential area shall be equipped with a communication system which, at a minimum, shall be:
1.Electrically activated;
2.Operated from the bedside of each occupant and from all areas used by occupants, including multipurpose rooms, toilet, and bathing facilities; and
3.Capable of alerting the responsible person or persons on duty twenty-four (24) hours a day, regardless of the location of the person on duty.
11.7.7Patient Rooms and Toilet Facilities
A.Patient rooms shall be designed with a personalized, homelike environment, and equipped for adequate nursing care, comfort, and privacy of patients with no more than one (1) bed per room.
B.Bedrooms shall be no less than one hundred (100) square feet in area and no less than eight (8) feet wide exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules. In new construction, single bedrooms shall be constructed in accordance with the American Institute of Architects Academy of Architecture for Health guidelines of “Guidelines for Design and Construction of Hospital and Health Care Facilities” incorporated above at § 11.2(A) of this Part.
C.Each room shall have a window that can be easily opened. The windowsill shall not be higher than three feet (3'0") above the floor and shall be above grade level.
D.The size of each window shall be no less than two feet, six inches (2'6") wide by four feet, five inches (4'5") high, double hung or an approved equivalent.
E.Each room shall have direct access to a corridor and outside exposure with the window at or above grade level.
F.Lavatories and bathing areas to be used by the handicapped shall be equipped with grab-bars for the safety of the patients and shall meet the requirements of “Guidelines for Design and Construction of Hospital and Health Care Facilities” incorporated above at § 11.2(A) of this Part.
G.All facilities constructed after March 20, 1977 shall have at, a minimum, connecting toilet rooms between patients' rooms in accordance with the requirements of § 11.7.1 of this Part. In addition, in facilities constructed prior to March 20, 1977, there shall be no less than one (1) toilet per eight (8) beds or fraction thereof on each floor where patient rooms are located.
H.In all facilities constructed after August 1, 2001, patient toilet rooms shall be equipped with facilities for cleaning bedpans.
I.Separate lavatory and toilet facilities shall be provided for employees and the general public commensurate with the needs of the facility.
J.A minimum of one (1) bathtub or shower shall be provided for every twelve (12) patients, not otherwise served by bathing facilities in patient rooms. At least one (1) bathtub shall be provided in each residential area.
K.Each bathtub or shower shall be in an individual room or enclosure which provides space for the private use of the bathing fixture, for drying and dressing and for a wheelchair and an attendant.
L.Complete privacy shall be provided to each patient in semi-private rooms by the use of overhead type fire resistive screens and/or cubicle fire resistive curtains suspended by inset overhead tracks in accordance with R.I. Gen. Laws Chapter 23-28.1.
1.When overhead-type screens and/or cubicle curtains are not provided, each semi-private room shall be equipped with a fire-resistant, portable screen.
M.Each patient shall be provided with a bed of proper size and height for the convenience and comfort of the patient, box spring and clean, comfortable mattress, bedside stand, straight-back chair, comfortable chair, dresser, and individual closet space for clothing with clothes racks and shelves accessible to patients in each room, and a reading lamp equipped with bulb of adequate candlepower.
1.Bedding including bedspread, shall be seasonally appropriate.
11.7.8Special Care Unit
A.A patient room shall be designated for isolation purposes. Such room shall be properly identified with precautionary signs, shall have outside ventilation, private toilet, and hand washing facilities, and shall conform to other requirements established for the control of infection in accordance with § 11.6.3 of this Part.
11.7.9Dining and Patient Activity Rooms
A.The facility shall provide one or more clean, orderly, appropriately furnished and easily accessible room(s) of adequate size designed for patient and family dining, as applicable.
1.These areas shall be appropriately lighted and ventilated with non-smoking areas identified.
2.If a multipurpose room is used, there must be sufficient space to accommodate dining to prevent interference with each other.
11.7.10Plumbing
A.All plumbing shall be installed in such a manner as to prevent back siphonage or cross connections between potable and non-potable water supplies in accordance with R.I. Gen. Laws Chapter 23-27.3.
B.Fixtures from which grease is discharged may be served by a line in which a grease trap is installed in accordance with standards of R.I. Gen. Laws Chapter 23-27.3. The grease trap shall be cleaned sufficiently often to sustain efficient operation.
11.7.11Water Supply
A.Water shall be distributed to conveniently located taps and fixtures throughout the building and shall be adequate in volume and pressure for all purposes including firefighting.
1.In patient areas, hot water temperatures shall not be less than one hundred (100) degrees Fahrenheit nor exceed one hundred ten (110) degrees Fahrenheit (plus or minus two degrees). Thermometers (accuracy of which can be plus or minus two degrees) shall be provided in each residential area to check water temperature periodically on that unit and at each site where patients are immersed or showered.
2.Thermostatic or pressure balanced mixing valves are required at each site or fixture used for immersion or showering of patients. Thermometers and tactical (skin sense) method shall be used to verify the appropriateness of the water temperature prior to each use.
3.In addition to temperature-regulating devices controlling the generation of domestic hot water, hot water supplies to patient care areas shall be regulated by anti-scalding, water tempering or mixing valves (approved by the Director or his/her designee) in order to maintain the temperature standards of § 11.7.11(A)(1) of this Part.
11.7.12Waste Disposal Systems
A.Any new facility shall be connected to a public sanitary sewer, if available, or otherwise shall be subject to the requirements of Rhode Island Department of Environmental Management Rules Establishing Minimum Standards Relating to Location, Design, Construction and Maintenance of Onsite Wastewater Treatment Systems.
11.7.13Maintenance
A.All essential mechanical, electrical, and patient care equipment shall be maintained in safe operating condition and logs/records shall be maintained of periodic inspections.
11.7.14Other Provisions
A.Facilities shall make provisions to ensure that the following are maintained:
1.Adequate and comfortable lighting levels in all areas in accordance with “Guidelines for Design and Construction of Hospital and Health Care Facilities” incorporated above at § 11.2(A) of this Part;
2.Limitation of sounds at comfort levels;
3.Comfortable temperature levels for the patients in all parts of patient occupied areas with a centralized heating system to maintain a minimum of seventy (70) degrees Fahrenheit during the coldest periods;
4.Adequate ventilation through windows or by mechanical means; and
5.Corridors equipped with firmly secured handrails on each side.
6.Heat relief: any hospice inpatient facility that does not provide air conditioning in every patient room shall provide an air-conditioned room or rooms in a residential section(s) of the facility to provide relief to patients when the outdoor temperature exceeds eighty (80) degrees Fahrenheit.
11.7.15Waste Disposal
A.Medical waste
1.Medical waste as defined in the Rhode Island Department of Environmental Management Medical Waste Regulations, 250-RICR-140-15-1, shall be managed in accordance with the provisions of the aforementioned regulations.
B.Other Waste
1.Wastes which are not classified as infectious wastes, hazardous wastes, or which are not otherwise regulated by law or rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
a.Dumpsters shall be tightly covered, leak-proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be in sanitary landfills approved by the Rhode Island Department of Environmental Management.
b.Load packers must conform to the same restrictions required for dumpsters and, in addition, load packers shall be:
(1)High enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment; and
(2)The loading section shall be constructed and maintained to prevent rubbish from blowing from said area site.
c.Recyclable waste: Containers for recyclable waste, including paper and cardboard, shall be tightly covered, leak-proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-11 § 11.8** Practices and Procedures, Confidentiality, and Severability {#sec-216-ricr-40-10-11-11.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-11#11.8}
11.8.1Variance Procedure
A.The licensing agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such variance will not be contrary to the public interest.
B.A request for a variance shall be filed by an applicant in writing setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time, and place may be scheduled if the hospice program appeals the denial.
11.8.2Deficiencies and Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility that received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefor.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a facility in accordance with § 11.8.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 11.8.2(B) of this Part, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 11.4.8 of this Part. If the facility is aggrieved by the action of the licensing agency, the facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35. The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing shall in all respects comply with the provisions therein.
11.8.3Uniform Reporting System
A.Each hospice program shall establish and maintain records and data in such a manner as to make uniform a system of periodic reporting. The manner in which the requirements of this Part may be met shall be prescribed from time to time in directives promulgated by the Director.
B.Each hospice program shall report to the licensing agency detailed statistical data pertaining to its operation and services. Such reports and data shall be made at such intervals and by such dates as determined by the Director.
C.The licensing agency is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the hospice program.
D.The directives promulgated by the Director pursuant to these regulations shall be sent to each hospice program to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the licensing agency.
11.8.4Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17 shall be held in accordance with the provisions of Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
11.8.5Confidentiality
A.Disclosure of any health care information relating to individuals shall be subject to the provisions of R.I. Gen. Laws Chapter 5-37.3, the Confidentiality of Health Care Information Act, and other relevant state and federal statutory and regulatory requirements.
**History**
- *Amendment — effective from 2025-11-03 to current*
- *Amendment — effective from 2023-03-21 to 11/03/2025*
- *Periodic Refile — effective from 2022-01-04 to 03/21/2023*
- *Amendment — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 03/07/2018*
- *Amendment — effective from 2007-08-16 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 08/16/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-13** Licensure of Physician Ambulatory Surgery Centers and Podiatry Ambulatory Surgery Centers
##### **216-RICR-40-10-13 § 13.1** Authority {#sec-216-ricr-40-10-13-13.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17-10, and are established for the purpose of adopting minimal standards for the licensure of physician ambulatory surgery centers and podiatry ambulatory surgery centers in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.2** Incorporated Materials {#sec-216-ricr-40-10-13-13.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.2}
A.These regulations hereby adopt and incorporate American National Standards Institute, Inc.’s “Specifications for Making Buildings and Facilities Accessible to and Usable by, The Physically Handicapped” (1980) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the American Society of Anesthesiologists’ “The ASA Physical Status Classification System” (1999) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate the American Society of Anesthesiologists’ “Basic Standards for Preanesthesia Care, Standards for Basic Anesthetic Monitoring, and Standards for Postanesthesia Care” (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
D.These regulations hereby adopt and incorporate the American Society of Anesthesiologists’ “Guidelines for Office-Based Anesthesia,” (2014) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
E.These regulations hereby adopt and incorporate the American Institute of Architects Academy of Architecture for Health’s “Guidelines for Design and Construction of Hospital and Health Care Facilities” (2001), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.3** Definitions {#sec-216-ricr-40-10-13-13.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.3}
A.Wherever used in these rules and regulations the following terms shall be construed to mean:
1.“Accreditation agency” means an entity, approved by the Director, which grants accreditation to physician ambulatory surgery centers and podiatry ambulatory surgery centers. Accreditation agencies approved by the Director include: the Joint Commission on Accreditation of Healthcare Organizations, the American Association for Accreditation of Ambulatory Surgery Facilities, Inc., and the Accreditation Association for Ambulatory Health Care, Inc.
2."Anesthesiologist" means a physician licensed in Rhode Island who is board certified, or becoming so, in anesthesia and has privileges to administer anesthesia in a Rhode Island licensed health care facility.
3."Certified registered nurse anesthetist" means a registered nurse who has successfully met the requirements for licensure which are set forth in the "Rules and Regulations for Licensing of Nurses and Standards for the Approval of Basic Nursing Education Programs".
4."The practice of certified registered nurse anesthesia" means providing certain health care services under the supervision of anesthesiologists, licensed physicians, or licensed dentists, in accordance with R.I. Gen. Laws § 5-31.1-1(g) which requires substantial specialized knowledge, judgement and skill related to the administration of anesthesia, including pre-operative and post-operative assessment of patients; administration of anesthetics; monitoring patients during anesthesia; management of fluid in intravenous therapy and respiratory care.
5."Conscious sedation" means a drug-induced depression of consciousness during which patients respond purposefully (reflex withdrawal from a painful stimulus is not considered a purposeful response) to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
6."Director" means the Director of the Rhode Island Department of Health.
7."Employee", as used in § 13.4.1(E) of this Part, means an individual who is required to comply with instructions about when, where, and how to work, both as to the final results and as to the details of when, where, and how the work is to be done. The employer need not actually exercise this control; it is sufficient that he has the right to do so. When the employer does not possess this control, the individual involved is not an employee, but an independent contractor.
8.“Exempt procedures” means:
a.Minor surgical procedures such as excision of skin lesions, moles, warts, lipomas and repair of lacerations, incision and drainage of superficial abscesses, or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug induced alteration of consciousness other than minimal pre-operative tranquilization of the patient;
b.Procedures not requiring or using conscious sedation techniques or pre-operative medications other than minimal pre-operative tranquilization of the patient;
c.Procedures requiring or using only local, topical, or no anesthesia.
9."General anesthesia" means a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.
10."The licensed capacity" of the physician ambulatory surgery center and/or podiatry ambulatory surgery center means the number of operating/procedure rooms that the physician ambulatory surgery center and/or podiatry ambulatory surgery center is licensed to operate.
11."Licensing agency" or "state agency" means the Rhode Island Department of Health.
12."Local anesthesia" means the injection of a local anesthetic agent (e.g., Lidocaine) into and around the operative site to achieve numbness in the area where a painful procedure is to be performed. This type of anesthesia does not involve any systemic sedation.
13.“Operating room or procedure room” means the area of the office operatory wherein a surgical treatment is performed.
14."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivisions or instrumentality of a state.
15.“Physician” means a person licensed to practice allopathic or osteopathic medicine in this state, pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
16."Physician ambulatory surgery center," means an office or portion thereof owned and/or operated by a physician-controlled professional services corporation as defined in R.I. Gen. Laws Chapter 7-5.1 or a private physician’s office or group of physicians’ offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association) which is utilized for the purpose of furnishing surgical services to said owner and/or operator’s own patients on an ambulatory basis.
17.“Podiatrist” means a person with a license to practice podiatric medicine and surgery in this state under the provisions of R.I. Gen. Laws Chapter 5-29.
18.“Podiatry ambulatory surgery center” means an office or portion of an office owned and/or operated by a podiatrist controlled professional service corporation as defined in R.I. Gen. Laws Chapter 7-5.1 or a private podiatrist’s office or group of the podiatrists’ offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association) which is utilized for the purpose of furnishing surgical services to the owner and/or operator’s own patients.
19."Regional anesthesia" means the use of local anesthetic agents to block nerves leading to the area where a painful procedure is to be done. There are many examples of regional anesthesia, including, but not limited to, spinal, interscalene, ankle, etc. Generally, regional anesthesia involves more of a physiological reaction because of the larger area blocked and/or the dose of local anesthesia. This type of anesthesia may or may not involve sedation.
20."Registered nurse" means a person licensed under the provisions of R.I. Gen. Laws Chapter 5-34.
21."Surgery" means the excision or resection partial/complete, destruction, incision or other structural alteration of human tissue by any means. Surgery shall have the same meaning as "operate."
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.4** Licensure Procedures {#sec-216-ricr-40-10-13-13.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.4}
13.4.1General Requirements for Licensure
A.No person acting severally or jointly with any other person, shall establish, conduct or maintain a physician ambulatory surgery center in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4. Physician ambulatory surgery center licensure shall not be required for the performance of exempt procedures as defined herein.
B.On or after January 6, 2003 , no person acting severally or jointly with any other person, shall establish, conduct or maintain a podiatry ambulatory surgery center in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4. Podiatry ambulatory surgery center licensure shall not be required for the performance of exempt procedures as defined herein.
C.Exemption from the requirements of certificate of need for a single-practice physician or podiatry ambulatory surgery center is pursuant to R.I. Gen. Laws § 23-15-2(4)(i).
D.Initial licensure and/or changes in owner, operator or lessee of a physician ambulatory surgery center or podiatry ambulatory surgery center are subject to approval of the licensing agency.
E.Surgery provided within the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be provided solely by physicians or podiatrists, respectively, who are or who comprise, or are employees of, the person to whom the license is issued.
13.4.2Application for License
A.Application for a license to conduct, maintain or operate a physician ambulatory surgery center/ podiatry ambulatory surgery center shall be made to the licensing agency upon forms provided by it one (1) month prior to expiration date of license and shall contain such information as the licensing agency reasonably requires which may include affirmative evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and the rules and regulations herein.
1.Each application shall be accompanied by a non-refundable application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.A listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated upon any change to such ownership information.
1.The licensing agency shall be informed forthwith of any change in owner of a licensed physician ambulatory surgery center/ podiatry ambulatory surgery center.
13.4.3Issuance and Renewal of License
A.Upon receipt of an application for a license, the licensing agency shall issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and the rules and regulations herein. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December beginning in the year 2001 (2003 for podiatry ambulatory surgery centers) and may be renewed from year to year after inspection and approval by the licensing agency.
1.All renewal applications shall be accompanied by a non-refundable application fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.A license shall be issued to a specific licensee for a specific location and shall not be transferable.
C.A license issued hereunder shall be the property of the state loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
13.4.4Capacity
A.The license for a physician ambulatory surgery center/ podiatry ambulatory surgery center shall be issued for a specified number of operating/procedure rooms.
B.The post-surgical recovery area of a physician ambulatory surgery center/ podiatry ambulatory surgery center shall be adequate to meet patients’ needs.
13.4.5Inspections
A.The licensing agency shall make or cause to be made such inspections and investigations as it deems necessary and in accordance with R.I. Gen. Laws § 23-17-10 and the rules and regulations herein.
1.Within nine (9) months of initial licensure, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall file an acceptable application with an accreditation agency, as defined herein.
2.Within twenty four (24) months of initial licensure, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall attain appropriate certification from an accreditation agency, as defined in herein.
3.Each physician ambulatory surgery center/ podiatry ambulatory surgery center, having obtained accreditation pursuant to § 13.4.5(A)(2) of this Part, shall maintain such certification as a condition of licensure.
4.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall provide the state agency with complete copies of all correspondence received from or mailed to any accreditation agency related to certification from the accreditation agency. Said copies shall be supplied to the state agency within three (3) days of receipt or mailing of the correspondence.
B.Every physician ambulatory surgery center/ podiatry ambulatory surgery center shall be given prompt notice by the licensing agency of any deficiencies reported as a result of an inspection or investigation.
C.Written reports and recommendations of inspections, including such materials from the state agency and the accreditation agency, shall be maintained on file in each physician ambulatory surgery center/ podiatry ambulatory surgery center for a period of no less than three (3) years. Physician ambulatory surgery center/ podiatry ambulatory surgery center plans for the correction of identified deficiencies shall also be maintained on file for a period of no less than three (3) years.
D.All materials required pursuant to § 13.4.5 of this Part shall be deemed to be public records and shall be made available by the physician ambulatory surgery center/ podiatry ambulatory surgery center to members of the public on request.
13.4.6 Denial, Suspension, Revocation of License or Curtailment of Activities
A.The licensing agency is authorized to deny, suspend or revoke the license or curtail activities of any physician ambulatory surgery center/ podiatry ambulatory surgery center which:
1. Has failed to comply with the rules and regulations pertaining to the licensing of physician ambulatory surgery center/ podiatry ambulatory surgery centers; and
2. Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3.Lists of deficiencies noted in inspections conducted in accordance with § 13.4.5 of this Part shall be maintained on file in the licensing agency, and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or to curtail activities of a physician ambulatory surgery center/ podiatry ambulatory surgery center.
B.Where the licensing agency deems that operation of a physician ambulatory surgery center/ podiatry ambulatory surgery center results in undue hardship to patients as a result of deficiencies, the licensing agency is authorized to deny licensure to a physician ambulatory surgery center/ podiatry ambulatory surgery center not previously licensed, or to suspend for a stipulated period of time or revoke the license of a physician ambulatory surgery center/ podiatry ambulatory surgery center already licensed or curtail activities of the physician ambulatory surgery center/ podiatry ambulatory surgery center.
C.Whenever an action shall be proposed to deny, suspend or revoke a physician ambulatory surgery center/ podiatry ambulatory surgery center license, or curtail its activities, the licensing agency shall notify the physician ambulatory surgery center/ podiatry ambulatory surgery center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9.
D.However, if the licensing agency finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
E.The appropriate state and federal placement and reimbursement agencies and the relevant accreditation agency(ies) shall be notified of any action taken by the licensing agency pertaining to denial, suspension or revocation of license, or curtailment of activities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.5** Organization and Management {#sec-216-ricr-40-10-13-13.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.5}
13.5.1Control and Management
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall be responsible for:
1. The management and control of the operation;
2.The assurance of the quality of care and services;
3.The conformity of the physician ambulatory surgery center/ podiatry ambulatory surgery center with all federal, state and local laws and regulations relating to fire, safety, sanitation, infection control; and
4.Other relevant health and safety requirements and with all the rules and regulations herein.
B.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall provide appropriate personnel, physical resources, and equipment based on the scope of services provided.
C.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall designate:
1.an administrator who shall be responsible for the management and operation of the physician ambulatory surgery center/ podiatry ambulatory surgery center; and
2.a medical director to assure achievement and maintenance of quality standards of professional practice.
3.The administrator and the medical director may be the same individual.
D.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall adopt and maintain policies/procedures defining responsibilities for the operation and performance of the physician ambulatory surgery center/ podiatry ambulatory surgery center, identifying purposes and means of fulfilling such, and in addition the policies/procedures shall include but not be limited to:
1.A statement of qualifications and responsibilities of the medical director and administrator;
2.A statement of the physician ambulatory surgery center/ podiatry ambulatory surgery center’s responsibility for the quality of care and services;
3.A statement of physician ambulatory surgery center/ podiatry ambulatory surgery center’s policy establishing the criteria for the selection and admission of patients;
4.Such other matters as may be relevant to the organization of the physician ambulatory surgery center/ podiatry ambulatory surgery center.
E.All policies and procedures adopted by the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be reviewed annually.
13.5.2Personnel Requirements
A.The appointment of all personnel shall be documented in writing. The job description of each member of the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be documented in writing and shall include directives related to responsibilities and discipline.
B.A timely written performance evaluation shall be required for all employees.
C.The number and type of registered nurses and ancillary personnel shall be based on the scope of services provided and staff capabilities, to ensure direct patient care as needed throughout the period of the patient’s stay. All personnel, such as nurses, shall be licensed as required by the R.I. Gen. Laws.
D.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall make initial appointments, and assignment or curtailment of surgical privileges, based on the education, training, experience and evidence of competence of the licensed professional staff person providing surgical services, consistent with state law. (See also § 13.6.5(B) of this Part).
E.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall clearly define in writing the responsibilities and supervision of any student personnel utilized in the physician ambulatory surgery center/ podiatry ambulatory surgery center.
F.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall adhere to a written procedure for granting and renewing privileges for anesthesiologists or certified registered nurse anesthetists that specifies the required training, experience, board certification, and/or other factors that indicate acceptable proficiency.
G.A physician ambulatory surgery center/ podiatry ambulatory surgery center shall require all persons, including students, who examine, observe, or treat a patient of such office operatory to wear photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
H.All surgical personnel, pre-operative, and recovery personnel shall be trained in basic life support (CPR) at least every two (2) years.
I.All surgical personnel shall be trained in basic aseptic techniques.
J.All surgical personnel shall wear suitable attire.
K.Administrator. The physician ambulatory surgery center/ podiatry ambulatory surgery center shall appoint a qualified administrator who may be the medical director, who shall be responsible for:
1.The management and operation of the physician ambulatory surgery center/ podiatry ambulatory surgery center;
2.The enforcement of policies, rules and regulations and statutory provisions pertaining to the health and safety of patients;
3. Serving as liaison between the physician ambulatory surgery center/ podiatry ambulatory surgery center and the staff; and
4. The planning, organizing and directing of such other activities as may be delegated by the physician ambulatory surgery center/ podiatry ambulatory surgery center.
L.Medical Director
1.The surgical services of the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be under the direction of a physician licensed under the provisions of R.I. Gen. Laws Chapter 5-37, or a podiatrist licensed under the provisions of R.I. Gen. Laws Chapter 5-29, respectively, who meets the qualifications set forth by the physician ambulatory surgery center/ podiatry ambulatory surgery center in accordance with § 13.5.1 of this Part, and who shall be responsible for no less than the following.
a.The coordination, supervision and functioning of services;
b.The establishment of provisions for infection control;
c.The achievement and maintenance of quality assurance of professional practices through a mechanism of peer review acceptable to the Director; and
d.The establishment of policies and procedures for surgical and anesthesia services and other related health care services.
M.Health Screening
1.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the physician ambulatory surgery center/ podiatry ambulatory surgery center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title) promulgated by the Department of Health.
13.5.3Quality Assurance
The office operatory shall establish a formal mechanism for quality assurance for all surgical services provided by all physicians or podiatrists performing surgical procedures in the physician ambulatory surgery center/ podiatry ambulatory surgery center. The quality assurance mechanism shall be in accordance with the requirements established by the accreditation agency.
13.5.4Peer Review
A.An organized process of peer review shall be conducted in accordance with the requirements of the accreditation agency. At a minimum, peer review shall provide for:
1.Regular review of reportable events (see § 13.6.3(E) of this Part) with formal determination of strategies to improve outcomes and assessment of change accomplished; and
2.Formal review of credentials and privileges of all surgeons, certified registered nurse anesthetists, and anesthesiologists.
B.Medical peer review shall be conducted in accordance with R.I. Gen. Laws §§ 5-37-1(10)(a) and (b) and subject to the confidentiality provisions of R.I. Gen. Laws § 5-37.3-7.
13.5.5Administrative Records
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall maintain such administrative records as may be deemed necessary for the business operation of the physician ambulatory surgery center/ podiatry ambulatory surgery center, in addition to the following:
1.Monthly statistical summary of numbers of surgical procedures performed, appropriately classified;
2.Controlled substances register if such are maintained at the physician ambulatory surgery center/ podiatry ambulatory surgery center;
3.An operating/procedure room log book maintained in chronological sequence of admissions which shall include pertinent information such as patient's name, pre-op and post-op diagnosis, name of operating physician and person administering anesthesia, circulating nurse, surgical procedures performed, specimen sent for pathological examination, type of anesthesia and complications (if any); and
4.A record of all transfers to a hospital for post-surgical care.
13.5.6Disaster Preparedness
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall develop and maintain a written disaster preparedness plan that shall include specific provisions and procedures for the emergency care of patients in the event of fire, loss of utilities, bomb threat, natural disaster or functional failure of equipment.
1.Such a plan shall be developed and coordinated with appropriate state and local agencies and representatives concerned with emergency safety and rescue;
2.A copy of the plan shall be submitted to the licensing agency;
3.Simulated drills testing the effectiveness of the plan shall be conducted at least semi-annually. Written reports and evaluation of all drills shall be maintained by the physician ambulatory surgery center/ podiatry ambulatory surgery center and available for review by the licensing agency.
B.Emergency action steps shall be clearly outlined and posted in conspicuous locations throughout the physician ambulatory surgery center/ podiatry ambulatory surgery center.
13.5.7Uniform Reporting System
Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.6** Patient Care Services {#sec-216-ricr-40-10-13-13.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.6}
13.6.1Rights of Patients
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall observe the standards enumerated in R.I. Gen. Laws § 23-17-19.1 with respect to each patient admitted to its physician ambulatory surgery center/ podiatry ambulatory surgery center.
B.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall display in a conspicuous place in the licensed physician ambulatory surgery center/ podiatry ambulatory surgery center a copy of the "Rights of Patients.”
13.6.2Admission, Transfer and Discharge
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall have and implement written admission, transfer and discharge policies and procedures pertaining to at least the following:
1.Types of surgical procedures and conditions acceptable for admission;
2.Requirements for pre-admission history;
3.Transfer of patients for continuity of care or emergency care accompanied by the "Rhode Island Department of Health Continuity of Care Short Form" available on-line: www.healthri.org;
4.Emergency instructions shall be posted at each telephone. The names and telephone numbers to be called in an emergency shall be posted and easily accessible (including, but not limited to, "911", physicians to be called in an emergency, nearest hospital emergency department).
5.Emergency transfer of patients to the nearest full-service emergency department of an acute care hospital. When indicated, a physician, physician assistant, or nurse shall accompany the patient.
6.Discharge of patient with responsible adult, as indicated;
7.Constraints imposed by limitations of services, physical facilities; and
8.Instruction of patients on self-care upon discharge.
13.6.3Patient Care Management
A.Each patient shall be under the continuing supervision of a physician or podiatrist on-site throughout the period of a patient's stay in the physician ambulatory surgery center/ podiatry ambulatory surgery center.
B.A physician, podiatrist, registered nurse, physician assistant, advanced practice nurse, or midwife shall care for the patient at all times while in the recovery area.
C.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall have and implement written patient care management policies and procedures pertaining to at least the following:
1.Scope of services provided either directly or per contractual arrangements;
2.Criteria for admission, transfer and discharge;
3.Management of patients with known or suspected infectious diseases, including the exclusion of patients who are known or suspected of having airborne infectious diseases;
4.Physician services and consultation services;
5.Staffing plan that delineates the personnel required to be present in the physician ambulatory surgery center/ podiatry ambulatory surgery center in order to provide effective safe patient care and all other related services;
6.Radiology and laboratory services, including the facility's required minimum specific testing; and
7.Counseling services, if indicated.
D.All orders for medications or treatments must be in writing. An order is considered to be in writing if:
1.It is written and signed by a lawfully authorized person; or
2. It is dictated to and transcribed by a registered nurse or other appropriately licensed person onto the order form. Additionally, the registered nurse or other appropriately licensed person must:
a.Date the order and identify the verbal order by the name and title of the authorized individual who gave the order; and
b.Sign the order entry with his/her own name and title. All verbal orders must be appropriately signed within twenty-four (24) hours.
E.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall, within seventy-two (72) hours of receipt of such information, notify the licensing agency of any reportable event as follows:
1.Transfer of the patient from the physician ambulatory surgery center/ podiatry ambulatory surgery center to a hospital emergency department;
2.Unscheduled hospital admission of the patient within seventy-two (72) hours of discharge from the physician ambulatory surgery center/ podiatry ambulatory surgery center;
3.Extension of the surgical procedure beyond four (4) hours;
4.Unplanned readmission to the physician ambulatory surgery center/ podiatry ambulatory surgery center within seventy-two (72) hours;
5.Death of the patient within thirty (30) days;
6.Subjecting a patient to a procedure not ordered or intended by the patient's physician, excluding: procedures not requiring a physician's order, medication errors, and collection of specimens, for laboratory study, obtained by non-invasive means or routine phlebotomy;
7.Or any other incident reported to the malpractice insurance carrier.
13.6.4Anesthesia Service
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall have and implement written anesthesia service policies and procedures pertaining to at least the following:
1.Staff privileges for anesthesia services established in accordance with §§ 13.5.2(D) and (F) of this Part;
2.Emergency coverage;
3.Administration of anesthetics;
4.The maintenance of safety controls, including, but not limited to, inspection, maintenance, and calibration of equipment;
5.Qualifications and supervision of non-physician anesthetists;
6.Qualifications of the supervising physician;
7.Anesthesia monitoring standards of § 13.2(C) of this Part.
B.In addition, the policies shall include provisions for at least the following:
1.Pre-anesthesia evaluation by a physician;
2.Safety of the patient during the anesthesia period;
3.Review of patient's condition prior to induction of anesthesia and post-anesthetic evaluation in accordance with the standards cited in § 13.2(C) of this Part; and
4.Recording of all events related to each phase of anesthesia care.
C.A board-certified anesthesiologist or a board-certified anesthesiologist, in conjunction with a certified registered nurse anesthetist, if the facility utilizes certified registered nurse anesthetists to administer anesthesia shall be responsible for developing the policies and procedures cited in §§ 13.6.4(A) and (B) of this Part.
D.General anesthesia shall be permitted only in those licensed physician ambulatory surgery centers/ podiatry ambulatory surgery centers that meet the requirements of §§ 13.6.4(E), (G), and 13.6.7(D) of this Part. If any type of anesthesia is administered that may fail mid-procedure necessitating the use of general anesthesia, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be in compliance with §§ 13.6.4(E), (G), and 13.6.7(D) of this Part at all times.
E.No explosive anesthetics shall be utilized in any physician ambulatory surgery center/ podiatry ambulatory surgery center.
F.The administration of anesthesia, with or without sedation or a dissociative drug, shall be under the direct supervision of a qualified physician.
G.In a licensed physician ambulatory surgery center/ podiatry ambulatory surgery center administering general anesthesia, an anesthesiologist or a certified registered nurse anesthetist shall administer the anesthesia.
H.In a licensed physician ambulatory surgery center/ podiatry ambulatory surgery center administering all types of anesthesia, other than general anesthesia, an anesthesiologist, a certified registered nurse anesthetist, or a physician shall administer anesthesia.
I.The person administering anesthesia shall not function in any other capacity during the surgical procedure.
13.6.5Surgical Service
A.Written staff rules and regulations and policies shall be established and implemented to govern surgical services that shall include surgical staff privileges, supporting services of professional and paramedical personnel, provisions for emergency coverage and operating suite procedures.
B.Surgical procedures shall be performed only by physicians or podiatrists who have current surgical privileges for the same or a similar class of procedures at a nearby hospital.
C.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall schedule elective surgery only.
D.Discharge of the patient shall be the responsibility of the operating physician or podiatrist and shall take place only after direct evaluation by the physician or podiatrist, determining the patient is adequately recovered to function independently (i.e., vital signs stable, full responsiveness and orientation, ability to move voluntarily). If sedation, regional block, or general anesthesia has been utilized, a responsible adult shall accompany the patient and be instructed about the patient's care.
E.Surgical procedures performed in the physician ambulatory surgery center/ podiatry ambulatory surgery center shall:
1.Be performed only on patients determined in writing by the operating physician or podiatrist prior to surgery to be classified as ASA Class 1, ASA Class 2, or ASA Class 3 under the American Society of Anesthesiology “Physical Status Classification”. For ASA Class 3 patients, surgical procedures utilizing planned general anesthesia, or planned epidurals, spinals, or brachial plexus blocks, may be performed only when the operating physician or podiatrist and a board-certified anesthesiologist concur (in writing prior to the surgery) that the patient is an acceptable candidate for a surgical procedure in the physician ambulatory surgery center/ podiatry ambulatory surgery center setting;
2.Not exceed an expected duration of two (2) hours, as documented in writing prior to the initiation of the procedure by the operating physician or podiatrist; Surgical procedures exceeding two (2) hours in duration shall be peer-reviewed and documented in accordance with the requirements set forth in § 13.5.4(A) of this Part.
3.Be permitted only when at least one (1) physician, podiatrist, or a certified registered nurse anesthetist currently trained in Advanced Cardiac Life Support (ACLS) is available and will continue to be available in the recovery area until the patient is discharged from the physician ambulatory surgery center/ podiatry ambulatory surgery center.
F.No overnight stays shall be permitted in the physician ambulatory surgery center/ podiatry ambulatory surgery center under any circumstances.
G.If termination of pregnancy procedures are performed in a physician ambulatory surgery center, the requirements of the rules and regulations for the Termination of Pregnancy (Part 20-10-6 of this Title) shall also apply.
H.Each operating/procedure room suite shall have policies and procedures pertaining to safety controls prominently posted.
I.All tissues/specimens removed at surgery shall be submitted for pathological examination except those exempted in writing by the operating physician or podiatrist.
J.The patient's medical record shall be available in the operating/procedure room at the time of surgery.
K.An accurate and complete description of operative procedure shall be recorded by the operating physician or podiatrist within a timely fashion following completion of surgery.
L.Areas for the processing of clean and dirty supplies and equipment shall be separated by physical barriers.
M.Written procedures shall be adhered to for all sterilization and for the appropriate disposal of wastes and contaminated supplies.
N.Reports of bacteriological tests and inspection records shall be maintained on the premises.
13.6.6Infection Control
A.A mechanism shall be established by the medical director for the development of infection control policies that shall pertain to no less than:
1.Infection surveillance activities;
2.Sanitation and asepsis;
3.Handling and disposal of waste and contaminants;
4.Sterilization, disinfection, and laundry;
5.Reporting, recording and evaluation of occurrences of infections; and
6.Documentation of infection rate.
B.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall report promptly to the licensing agency infectious diseases that may present a potential hazard to patients, personnel, and the public. Included are the reportable diseases cited in the rules and regulations regarding "Rules and Regulations Pertaining to Reporting of Infectious, Environmental and Occupational Diseases [R23-10-DIS]" and the occurrences of other diseases in outbreak form.
13.6.7Supplies and Equipment
A.Supplies of appropriate sterile linens, gloves, dressings and so forth, shall be maintained in sufficient quantities for routine and emergency use.
B.Such surgical instruments, accessory and operating/procedure room lights, and resuscitation equipment as are appropriate for the types of surgery and surgical risks that may be encountered in a physician ambulatory surgery center/ podiatry ambulatory surgery center shall be provided and maintained in clean, safe, and sterile condition.
1.An adequately-stocked cardiopulmonary resuscitative cart shall be available for emergencies and shall include, at a minimum, an Ambu Bag, a laryngoscope, airway management equipment, and a medication kit. The medication kit shall include appropriate medications for the treatment of anaphylaxis, cardiac arrhythmias, cardiac arrest, and malignant hyperthermia.
C.When anesthesia is utilized, appropriate monitoring equipment shall be available, shall be maintained in proper working condition, shall meet the requirements of the guidelines of § 13.2(D) of this Part incorporated above in this Part, and shall include monitors for pulse oximeter, non-invasive blood pressure, and EKG.
D.In those physician ambulatory surgery centers/ podiatry ambulatory surgery centers administering general anesthesia, the following monitoring equipment shall be present in the facility: blood pressure apparatus, EKG oscilloscope, defibrillator, pulse oximeter with alarm, oxygen analyzer with alarm, and CO2 monitor.
E.Defibrillating equipment shall be available.
F.Supplies of appropriate drugs, medications, fluids, electrolyte solutions, etc. shall be maintained in sufficient quantities for routine and emergency use.
G.Any physician ambulatory surgery center/ podiatry ambulatory surgery center that utilizes latex gloves shall do so in accordance with the provisions of the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title) promulgated by the Department of Health.
13.6.8Laboratory, Radiology, and Pharmaceutical Services
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center may perform on the premises limited procedures such as urinalysis and CBC, provided that personnel are qualified by training and are under the supervision of a physician.
B.The requirements of the "Rules and Regulations for the Control of Radiation" pertaining to radiology shall apply to those office operatory providing such services.
C.Each physician ambulatory surgery center/ podiatry ambulatory surgery center performing laboratory testing shall be in compliance with the requirements of 42 C.F.R. Part 493.
D.Pharmaceutical services, if provided by the physician ambulatory surgery center/ podiatry ambulatory surgery center, shall be provided in accordance with prevailing standards of professional practice and shall be supervised by a pharmacist licensed in Rhode Island, by an operating physician, or by a podiatrist who is qualified to assume professional, organization, and administrative responsibility for the quality of services rendered.
E.Record-keeping and security measures shall be maintained to assure the control and safe dispensing of drugs in compliance with all state and federal laws.
F.Provisions for secure storage and proper record-keeping of all controlled substances shall be in accordance with R.I. Gen. Laws Chapter 21-28.
G.Dispensing and labeling of all pharmaceuticals shall be in accordance with R.I. Gen. Laws Chapter 21-31.
H.The quality and appropriateness of medication usage shall be monitored and evaluated as part of the quality assurance program required herein.
13.6.9Medical Records
A.An individual shall be designated to supervise the medical records and to ensure proper documentation, completion, indexing, filing, retrieval, and safe storage.
B.A medical record shall be established and maintained for every patient cared for in the physician ambulatory surgery center/ podiatry ambulatory surgery center. Said medical record may be the same patient record maintained in the physician's/podiatrist’s office, provided that the information stipulated in § 13.6.9(C) of this Part is included.
C.Each medical record shall contain sufficient information and data to support the diagnosis, plan of treatment, and shall contain no less than the following:
1.Patient identification, (name, address, birth date, etc.);
2.Medical history and physical examination;
3.Pre-operative and final diagnosis;
4.Results of all appropriate, minimum specific tests for the procedure(s) to be performed;
5.A signed consent form for surgical procedure;
6.A signed consent form for anesthesia;
7.The expected duration of the surgical procedure(s);
8.The type(s) of anesthesia to be used and the expected duration of each;
9.The patient’s pre-operative ASA classification(s) as determined by:
a.the operating physician;
b.any consulting physician(s);
c.physician assistant(s) in collaboration with a physician; and
d.the anesthesiologist or certified registered nurse anesthetist;
e.For ASA Class 3 patients who are undergoing surgical procedures utilizing planned general anesthesia, or planned epidurals, spinals, or brachial plexus blocks, a written statement from a board-certified anesthesiologist concurring that the patient is an acceptable candidate for a surgical procedure in the physician ambulatory surgery center/ podiatry ambulatory surgery center setting shall also be required. (See § 13.6.5(E)(1) of this Part).
10.Nurses' notes;
11.Anesthesiologist’s and/or certified registered nurse anesthetist’s reports, including pre- anesthesia evaluation, intra-operative anesthesia record, and post-anesthesia evaluation;
12.Medical consultation, and counseling (if any);
13.Operating physician's/podiatrist’s operative notes, progress reports, and discharge notes;
14.Instructions given patient upon discharge; and
15.Other related reports.
D.Medical Consultation
1.Consultation and assistance in specialty fields shall be readily available and used as indicated prior to and/or following a surgical procedure. A physician ambulatory surgery center/ podiatry ambulatory surgery center shall maintain a current list of consultants available.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.7** Environmental Maintenance {#sec-216-ricr-40-10-13-13.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.7}
13.7.1Environment
A.The physician ambulatory surgery center/ podiatry ambulatory surgery center shall be maintained and equipped to provide a functional sanitary, safe and comfortable environment, with all furnishings in good repair. The premises shall be kept free of hazards.
B.Written policies and procedures shall be established pertaining to environmental controls to assure comfortable, safe and sanitary environment with well-lighted space for the services provided.
C.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition.
D.Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place and kept in an enclosed section separate from other cleaning materials.
E.Cleaning shall be performed in a manner that minimizes the spread of pathogenic organisms in the atmosphere.
F.Operating/procedure rooms shall be thoroughly cleaned after each operation.
G.Smoking shall not be permitted.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.8** Physical Plant and Equipment {#sec-216-ricr-40-10-13-13.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.8}
13.8.1New Construction
A.All new construction shall be subject to the provisions of R.I Gen. Laws Chapters 23-28.1 and 23-27.3, and § 13.2(A) of this Part above.
B.In addition, any other applicable state and local laws, codes and regulations shall apply. Where there is a difference between codes, the code having the more stringent standard shall apply.
C.All plans for new construction or the renovation, alteration, extension, modification or conversion of an existing facility that may affect compliance with § 13.8.2 of this Part shall be reviewed by a licensed architect, acceptable to the Director. Said architect shall certify that the plans conform to the construction requirements of § 13.8.2 of this Part, prior to construction. The facility shall maintain a copy of the plans reviewed and the architect’s signed certification, for review by the Department of Health upon request.
1.In the event of non-conformance for which the facility seeks a variance, the general procedures outlined in § 13.9.2 of this Part shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as detailing the basis upon which the request is made. The Department may request additional information while evaluating variance requests.
2.If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of § 13.8.2 of this Part, except those for which variances were granted, prior to construction. The facility shall maintain a copy of the plans reviewed, the variance(s) granted and the architect’s signed certification, for review by the Department upon request.
D.Upon completion of construction, the facility shall provide written notification to the Department describing the project, and a copy of the architect's certification. The facility shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.
13.8.2Physical Facility
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall meet the fire and safety provisions of R.I Gen. Laws Chapters 23-28.1 and shall conform to all state and local building codes.
B.A building entrance shall be located at grade level and able to accommodate wheelchairs.
C.An elevator shall be provided where patient care is provided at other than street level. The cab size shall be large enough to accommodate a stretcher and an attendant.
D.Administrative and public areas shall include at least the following:
1.A lobby area including a waiting area, conveniently accessible wheelchair storage;
2.Reception/information desk, accessible public toilets, public telephone(s) and drinking fountain(s);
3.Interview space for private interviews relating to admission, credit, etc.;
4.General and individual office space for business transactions, records and administrative and professional staff. These shall be separate from public and patient areas with provisions for confidentiality of records. Enclosed office spaces for administration and consultation shall be provided.
5.General storage facilities.
E.A system for sterilizing equipment and supplies shall be provided. When sterilization is provided off-site, adequate sterile supplies shall be provided. If on-site processing facilities are provided, they shall include the following:
1.Soiled workroom: This room shall be physically separated from all other areas of the facility. Work space shall be provided to handle the cleaning and terminal sterilization/disinfection of all medical/surgical instruments and equipment. The soiled workroom shall contain work table(s), sink(s), flush-type device(s) and washer/sterilizer decontaminator(s) or other decontamination equipment. Pass-through doors and washer/sterilizer decontaminators should deliver into clean processing areas/workrooms.
2.Clean Assembly/Workroom and Sterilization Area: Clean and soiled work areas should be physically separated. This room is exclusively for the inspection, assembly and packaging and sterilization of medical/surgical supplies and equipment. The room shall contain handwashing facilities, work space and equipment for terminal sterilizing of medical and surgical equipment and supplies. The assembly work area should contain work tables, counter, storage facilities for back-up supplies and a drying cabinet or equipment. Access to the sterilization room should be restricted.
3.Alternatively, based on the scope of the practice, a single utility room may be adequate for clean and soiled activities, provided the room includes a sink for cleaning instruments/equipment, a hand wash sink, adequate work counter space, and allow for instrument/equipment processing to flow from soiled area, to clean area, to sterilization, and finally to storage, without crossing paths.
a.Clean/Sterile Supplies – Storage: Storage for packs, etc., shall include provisions for ventilation, humidity, and temperature control.
F.Provisions shall be made to separate pediatric from adult patients. This shall include pre- and post-operative care areas and should allow for parental presence.
G.At least one room shall be provided for examination and testing of patients prior to surgery, assuring both visual and audible privacy. Exam rooms shall have a minimum floor area of 80 square feet, excluding vestibules, toilets and closets. Room arrangement should permit at least 2 feet 8 inches clearance at each side and the foot of the examination table. A handwashing fixture and a counter or shelf space for writing shall be provided.
H.Each operating room shall have a minimum clear area of 250 square feet, exclusive of cabinets and shelves. Additional clear area may be required to accommodate the functional plan, which may require additional staff or equipment. There shall be at least one x-ray film illuminator in each room.
I.A room for post-anesthesia recovery shall be provided as required by volumes and procedure type. At least 3 feet shall be provided at each side and at the foot of each bed. If pediatric surgery is part of the program, separation from the adult section and space for parents shall be provided. Bedpans and bedpan-cleaning facilities shall be provided in this area.
J.A designated supervised recovery lounge shall be required for patients who do not require post-anesthesia recovery but need additional time for their vital signs to stabilize before safely leaving the facility. This lounge shall contain space for staff and family members and provisions for privacy. It shall have convenient access to toilets. Hand washing and nourishment facilities must be provided.
K.The surgical service area must include a drug distribution station. Provisions shall be made for storage and preparation of medications administered to patients. Locked storage, including a refrigerator and double-locked storage for controlled substances shall be provided. Convenient access to handwashing facilities shall be provided.
L.Scrub facilities shall be provided near the entrance to each operating room and may service two operating rooms if needed. Scrub facilities shall be arranged to minimize incidental splatter on nearby personnel or supplies.
M.The surgical service area must include a soiled work area, containing a clinical sink or equivalent flushing-type fixture, a work counter sink for handwashing and waste receptacle(s).
N.Fluid waste disposal facilities shall be provided, convenient to operating rooms. A clinical sink or equivalent equipment in a soiled workroom shall meet this standard.
O.Provisions shall be made for cleaning, testing, and storing anesthesia equipment. If a separate workroom, it shall contain a work counter, sink and racks for cylinders. Provisions shall be made for the separate storage of clean and soiled items. Provisions shall be made for the separate storage of reserve gas cylinders.
1.If flammable agents are present in an operating/procedure room, the room shall be constructed and equipped in accordance with the standards of publication number 56A, (1975) of the National Fire Protection Association.
2.If only non-flammable agents are present in the operating/procedure room, the room shall be constructed and equipped in accordance with the standards of publication number 56G, (1975) of the National Fire Protection Association.
P.Equipment storage area(s) for equipment and supplies used in the surgical service shall be provided.
Q.Appropriate change areas shall be provided for staff working within the surgical area. Change area(s) shall contain toilets, lavatories for handwashing, and space for donning scrub attire.
R.Provisions shall be made for patients to change from street clothing into hospital gowns, if required by the functional program, and prepare for surgery. This should include waiting areas, toilets, changing areas, and space for administration of medication. Provisions shall be made for securing patients’ clothing and personal effects.
S.If stretcher storage provided, at least the following minimal facilities shall be provided:
1.Laboratory work counter with sink, vacuum, gas and electrical services.
2.Lavatory or counter sink equipped for handwashing. shall be provided, convenient for use and out of the way of normal traffic.
T.Physician ambulatory surgery centers/ podiatry ambulatory surgery centers having three (3) or more operating rooms shall provide a lounge area for surgical staff and a staff toilet room shall be provided near the recovery area.
U.Space containing a floor receptacle or service sink and storage space for housekeeping supplies and equipment shall be provided.
V.Provisions shall be made for convenient access to and use of emergency equipment at both surgical and recovery areas.
1.If laboratory services are
2.Storage cabinet(s) or closet(s).
3.Specimen collection facilities.
W.If radiology services are provided, at least the following minimal facilities shall be provided:
1.Radiographic room(s)
2.Film processing facilities
3.Viewing areas
4.Storage facilities for exposed film
5.Dressing rooms, as required by services provided, with convenient toilet access.
X.Heating and ventilation systems shall be capable of maintaining adequate ventilation and temperature for the comfort and safety of patients and staff.
Y.If the physician ambulatory surgery center/ podiatry ambulatory surgery center includes an endoscopy suite, the following minimal facilities must be provided:
1.Each procedure room shall have a minimum clear area of 200 square feet, exclusive of fixed cabinets and built-in shelves, and be designed for visual and acoustical privacy. Oxygen, vacuum and medical air shall be provided.
2.Dedicated processing room(s) for cleaning and disinfecting instrumentation must be provided. Cleaning rooms should allow for the flow of instrumentation from the contaminated area to the clean area, and, finally, to storage.
3.The decontamination room shall be equipped with the following: two utility sinks remote from each other; freestanding handwashing fixture; work counter space: space and plumbing for automatic endoscope cleaners, sonic processor and flash sterilizer (where required); and outlets for vacuum and compressed air. Negative pressure shall be maintained in the decontamination room and all air should be vented to the outside to avoid recirculation within the physician ambulatory surgery center/ podiatry ambulatory surgery center.
13.8.3Emergency Power
A.Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall be equipped with an alternate emergency energy power source with a minimum two (2) hour capability.
B.The emergency electrical power system shall have a sufficient capacity to supply power to maintain the operation of the operating/procedure room and other life-support systems, and lighting of egress, fire detection equipment, alarm and extinguishing systems.
C.Monthly testing of emergency power shall be documented and reports retained for at least three (3) years.
13.8.4Lighting and Electrical Services
All electrical and other equipment used in the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be maintained free of defects that could be a potential hazard to patients or personnel. Periodic calibration and/or preventive maintenance of equipment shall be provided and documentation of all testing shall be maintained for at least three (3) years.
13.8.5Plumbing
A.All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of R.I. Gen. Laws Chapter 23-27.3.
B.All plumbing shall be installed in such a manner as to prevent back siphonage or cross-connections between potable and non-potable water supplies.
13.8.6Water Supply
Water shall be obtained from a community water system and shall be distributed to conveniently located taps and fixtures throughout the physician ambulatory surgery center/ podiatry ambulatory surgery center and shall be adequate in volume and pressure for all purposes including fire fighting.
13.8.7Medical Waste Disposal
Medical waste as defined in the Medical Waste Regulations, 250-RICR-140-15-1, promulgated by the Rhode Island Department of Environmental Management, shall be managed in accordance with the provisions of the aforementioned regulations.
13.8.8Waste Water Disposal
If a municipal sanitary sewer system is available, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be connected to the system, if feasible. If a municipal sanitary sewer system is not available, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall meet the standards set forth by the Department of Environmental Management.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-13 § 13.9** Deficiencies, Variance, and Severability {#sec-216-ricr-40-10-13-13.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-13#13.9}
13.9.1Deficiencies and Plans of Correction
A.The licensing agency shall notify the physician ambulatory surgery center/ podiatry ambulatory surgery center of violations of individual standards through a notice of deficiencies which shall be forwarded to the physician ambulatory surgery center/ podiatry ambulatory surgery center within fifteen (15) days of inspection of the physician ambulatory surgery center/ podiatry ambulatory surgery center unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A physician ambulatory surgery center/ podiatry ambulatory surgery center that received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefor.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a physician ambulatory surgery center/ podiatry ambulatory surgery center within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the physician ambulatory surgery center/ podiatry ambulatory surgery center does not provide a plan of correction or if a physician ambulatory surgery center/ podiatry ambulatory surgery center whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 13.9 of this Part. If the physician ambulatory surgery center/ podiatry ambulatory surgery center is aggrieved by the action of the licensing agency, the physician ambulatory surgery center/ podiatry ambulatory surgery center may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
13.9.2Variance Procedure
A.The licensing agency may grant a variance upon request of the applicant from the provisions herein, if it finds in specific cases, that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon filing of each request for variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial. Such hearing must be held in accordance with the provisions of § 13.9.3 of this Part.
13.9.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17 shall be held in accordance with the provisions of the "Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health [R42-35-PP]".
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-04 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/04/2018*
- *Amendment — effective from 2002-12-26 to 12/10/2012*
- *Amendment — effective from 2002-08-04 to 12/26/2002*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-14** Registration of Body Piercing Technicians and Body Piercing Establishments
##### **216-RICR-40-10-14 § 14.1** Authority {#sec-216-ricr-40-10-14-14.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-14#14.1}
These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1-39, as amended, and are established for the purpose of adopting minimum requirements for the registration of body piercing technicians and body piercing establishments in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-14 § 14.2** Incorporated Materials {#sec-216-ricr-40-10-14-14.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-14#14.2}
These regulations hereby adopt and incorporate 29 C.F.R. § 1910.1030 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-14 § 14.3** Definitions {#sec-216-ricr-40-10-14-14.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-14#14.3}
A.Wherever used in these rules and regulations, the terms listed below shall be construed as follows:
1.“Act” means R.I. Gen. Laws § 23-1-39 entitled “Tattooing/and/or Body Piercing.”
2.“Aseptic technique” means the practice of preventing the transmission of infectious agents into the human body by using standard aseptic procedures.
3.“Body piercing” means the act of penetrating the skin, excluding the earlobes, to make, generally permanent in nature, a hole or mark.
4.“Body piercing establishment” means any establishment operated by any person for the purpose of offering or conducting body piercing.
5.“Body piercing technician” means an individual who is registered in this state to practice body piercing in accordance with the requirements herein.
6.“Communicable disease” means any disease caused by an infectious agent which may be transmitted directly or indirectly from one individual to another.
7.“Director” means the Director of the Rhode Island Department of Health.
8.“Division” means the Division of Professional Regulation at the Rhode Island Department of Health.
9.“Instruments” means body piercing equipment. Such equipment includes, but is not limited to, piercing needles, forceps, hemostats, tweezers, or other implements used to pierce, puncture, or be inserted into any part of the human body for the intended purpose of making a permanent hole. Such equipment also includes studs, hoops, rings or other decorative jewelry, materials or apparatuses inserted into any part of the human body for the intended purpose of placement in the hole resulting from piercing.
10.“Jewelry” means any personal ornament inserted into a pierced area.
11.“Needle” means the implement used to pierce or puncture a hole in any part of the human body.
12.“Permanent hole” means a hole produced by piercing or puncturing any part of the human body, with instruments intended to leave an opening in body tissue(s) into which an appropriate device or apparatus may be inserted. Permanent hole would include any body part newly pierced or punctured which is undergoing a healing process; and, any piercing whether or not removal of a device or apparatus from the perforation would result in fusing or healing of the tissue or skin structures.
13.“Person” means any individual, trust or estate, partnership, corporation (including but not limited to associations and joint stock companies), state, or political subdivision or instrumentality of the state.
14.“Registration agency” means the Rhode Island Department of Health. “Registration agency” and “licensing agency” are synonymous.
15.“Sharps” means any object that can penetrate the skin, including but not limited to, needles, scalpel blades, lancets, glass tubes that could be broken during handling that have been removed from their original sterile containers.
16.“Sterilization” means the use of procedures that destroy all microbial life, including viruses, on the equipment or device.
17.“Universal precautions” means a set of guidelines and controls, published by the Centers for Disease Control (CDC) that outline certain practices that health care workers should employ in order to prevent parenteral, mucous-membrane, and no intact skin exposure to blood borne pathogens. The method of infection control requires the employer and employee to assume that all human blood and specified human body fluids are infectious for HIV, HBV, and other blood borne pathogens. Precautions include: hand washing, gloving, personal protective equipment, injury prevention, proper handling and disposal of needles and other sharp instruments and blood and body fluid contaminated products.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-14 § 14.4** Registration Requirements for Body Piercing Technicians {#sec-216-ricr-40-10-14-14.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-14#14.4}
14.4.1Registration Requirements
Pursuant R.I. Gen. Laws § 23-1-39 of the Act, no person shall engage in the practice of body piercing or hold himself/herself as a body piercing technician in this state unless he/she is registered in this state under the statutory and regulatory provisions herein. Provided, that physicians duly licensed to practice medicine in the state of Rhode Island under the provisions of R.I. Gen. Laws Chapter 5-37 shall be exempt from this registration requirement. However, a physician engaged in the practice of body piercing in his/her private office shall be required to register the site as a body piercing establishment and meet the requirements of § 14.5 of this Part. Nothing in these regulations shall be construed to alter the scope of practice of any licensed health care practitioner otherwise defined by rule or statute.
14.4.2Qualifications
A.Any applicant seeking registration in this state must:
1.Be over 18 years of age;
2.Be of good moral character; and
3.Demonstrate knowledge of body piercing techniques or procedures, based upon the requirements of § 14.4.5 of this Part.
B.Applicants who have not satisfactorily met the registration requirements stated in § 14.4.2(A) shall be given two (2) additional opportunities to demonstrate body piercing technique. Failure to meet all technique requirements will result in denial of registration.
14.4.3Application and Registration Fee
A.Application for registration shall be made on forms provided by the Division of Professional Regulation, Rhode Island Department of Health, which shall be completed and submitted to the Division. Such application shall be accompanied by the following documents:
1.For US citizens: a certified copy of birth certificate;
2.For non-US citizens: proof of lawful entry into the United States;
3.A registration fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title; and
4.A recent identification photograph of the applicant, head and shoulders, front view, approximately 2x3 inches in size.
14.4.4Issuance & Renewal of Registration & Fee
A.The Director shall issue to applicants who have satisfactorily met the application and qualification requirements herein a registration to practice body piercing in the state. This registration, unless sooner suspended or revoked, shall expire on December 31st of each year.
B.On or before the first day of November in each year, an application for renewal of registration shall be mailed to every person to whom a registration has been issued during the current year.
C.Every person so registered who desires to renew his/her registration shall file with the Division:
1.Such renewal application, completed and signed by the applicant; and,
2.The fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title.
D.Lapsed Registration
1.Any registrant who allows the registration to lapse for less than two (2) years may have same reinstated by submitting to the registration agency the fee and application as required in § 14.4.4(C) of this Part.
2.Any registrant whose registration lapses for two (2) or more years shall be required to submit to the demonstration of aseptic body piercing technique described in § 14.4.2(A) of this Part.
14.4.5Body Piercing Practice
A.A registered body piercing technician shall maintain sanitary and safe practice in accordance with prevailing standards and the regulations herein.
B.Body Piercing Procedures. A body piercing technician shall conduct his/her body piercing practice so as to prevent the transmission of communicable diseases from client to client, technician to client, and client to technician. Body piercing technicians shall maintain at least the following minimum standards in the practice of body piercing:
1.Immediately before and after body piercing, the body piercing technician shall advise the client – both verbally and in writing – on the proper care of the body piercing site and shall instruct the client to consult a physician at the first sign of infection (such as excessive pain, redness, swelling, or discharge) in the area of the body piercing.
a.A signed copy of the aftercare sheet shall be retained by the body piercing technician.
2.The area of the body to be pierced, and all parts of the body which are visible, shall be examined for signs of intravenous drug use, open sores, lesions, oozing wounds, and skin diseases. If such are found, or suspected, the person shall not be pierced.
3.At a minimum, the skin shall be prepared first by thoroughly cleansing it with an antiseptic soap or seventy percent (70%) isopropyl alcohol. Following this cleaning, a betadine solution or surgical scrub (i.e., hibiclens for the iodine sensitive) shall be applied to the skin using a sterile swab. Surface contact time shall be a minimum of one (1) minute. Following the drying time, the residue shall be removed by utilizing a sterile swab in a circular motion beginning at the piercing site. Following the removal of any residue, the area of the skin that is to be pierced shall be marked by a single use sterile skin skribe. After the piercing, the skin shall be thoroughly cleaned with an antiseptic solution.
4.Only jewelry that is made of surgical stainless steel of at least 316L grade quality, solid gold of at least 14K weight, niobium, titanium, platinum, and/or only rings with rounded edges, shall be used in body piercing. Invoices from jewelry manufacturers and/or distributors shall be available for inspection upon request.
5.Needles and other sharps shall be immediately deposited into a puncture-resistant infectious waste sharps container. Needles shall not be reused.
6.All needles and any blood soaked material shall be handled and discarded according to the Department of Environmental Management’s Medical Waste Regulations, 250-RICR-140-15-1. All other material shall be discarded appropriately.
7.Each body piercing technician shall wear a clean outer garment. If the garment is visibly contaminated with blood, it shall be changed between clients.
8.Before working on each client, each body piercing technician shall clean his/her own fingernails with a brush and shall thoroughly wash and scrub hands with hot running water, using germicidal soap from a dispenser. Hands must also be washed after each rest room use, before putting on gloves and after taking off gloves.
9.Non-sterile gloves may be used for body piercing preparations. Prior to commencing the body piercing, the body piercing technician shall put on sterile gloves, which shall be used for a single body piercing procedure only. Sterile gloves shall be removed and discarded in accordance with the requirements of the Department of Environmental Management’s Medical Waste Regulations, 250-RICR-140-15-1.
10.Technicians shall wear eye goggles, shields, and/or a mask if blood or saliva spattering is likely to occur while providing services.
11.All work surfaces and non-autoclaved equipment used in the body piercing process shall be cleaned with an EPA-approved bactericidal, virucidal, fungicidal, tuberculocidal surface disinfectant/decontaminant cleaner between clients. Gloves shall be used in the cleaning process. Subsequently, the body piercing technician shall wash his/her hands with a germicidal soap after cleaning work surfaces and equipment.
C.Body Piercing Equipment:
1.All tools used in the piercing process (e.g., ring openers/closers, forceps, clamps, needle pushers, receiver tubes) shall be cleaned utilizing an ultrasonic cleaner. Immersion time for all equipment shall be five (5) minutes. Ultrasonic cleaning tank detergent shall be changed daily. An ultrasonic cleaning tank shall be scrubbed thoroughly with isopropyl alcohol between detergent changes.
2.Body piercing technicians shall properly sterilize all instruments that pierce the skin, that directly aid in piercing the skin, or that may come in contact with instruments that pierce the skin, through such means as storage in trays with other instruments or contact with forceps, in accordance with the sterilization procedures described below.
3.Body piercing technicians shall disinfect all equipment indirectly used in body piercing, including any beds, tables, headrests, armrests, legrests, or handrails.
4.Storage cabinets shall be maintained in a sanitary condition and all instruments, jewelry, and other equipment, when not in use, shall be stored in an orderly manner.
D.Sterilization of Instruments and/or Equipment:
1.Operational sterilizers shall be available in each body piercing establishment. All instruments shall be sterilized after each use by autoclaving under fifteen (15) pounds of pressure for twenty (20) minutes. Autoclave temperature shall not be less than two hundred seventy-three (273?) degrees Fahrenheit or one hundred thirty-six (136?) degrees Celsius, or according to manufacturer's specifications.
2.Autoclave units shall be checked monthly, using a standard spore test, with results maintained on file for inspection. Autoclave units shall be maintained in accordance with manufacturer’s specifications. Records of said monthly checks shall be maintained for a minimum of two (2) years.
a.A log book shall be maintained for the results of said monthly inspections and shall include no less than the following items: date of inspection, results of inspection, and the signature of the body piercing technician who conducted the inspection.
3.The sterilizing date shall be noted, and evidence of sterilization shall be demonstrated by color indicator or equivalent. Packs shall be used within thirty (30) days or resterilized.
E.Restrictions:
1.R.I. Gen. Laws § 23-1-39 prohibits the body piercing of minors (persons under the age of eighteen (18)) in this state except if the minor is accompanied by his/her parent or guardian, and said parent or guardian gives written consent to the body piercing. Proper photographic identification of the parent or legal guardian shall be required (e.g., driver’s license).
14.4.6Denial, Suspension or Revocation of Registration
A.The Director is authorized to deny an application, or revoke a registration for cause (e.g., conviction of crimes) or for failure of an applicant or registrant to comply with the provisions of these rules and regulations.
B.Whenever an action shall be proposed to deny an application, or suspend a registration, the Director shall notify the person by registered mail setting forth the reason(s) for the proposed action.
C.The applicant or registrant shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35 as amended, and Practices and Procedures Before the Rhode Island Department of Health, Part 10-05-4 of this Title, and Access to Public Records, Part 10-05-1 of this Title.
D.If it is determined that a person is violating any provisions of the rules and regulations herein, the Director may issue an order to ensure compliance in accordance with the provisions of R.I. Gen. Laws §§ 23-1-20 through 23-1-25.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-14 § 14.5** Registration Requirements for Body Piercing Establishments {#sec-216-ricr-40-10-14-14.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-14#14.5}
14.5.1Administration
The Director shall be responsible for the administrative functions required to implement the provisions of R.I. Gen. Laws § 23-1-39 and the rules and regulations herein as they apply to the registering of body piercing establishments.
14.5.2Registration Requirements
A.No person, acting severally or jointly with any other person, shall conduct, maintain, or operate a body piercing establishment in the state without a registration issued by the registration agency.
B.No person, firm, partnership or corporation shall describe its services in any manner under the title “Body Piercing Establishment” unless such services as defined herein are performed in an establishment that is registered with the Department of Health in accordance with the provisions of the rules and regulations for registering of body piercing establishments.
14.5.3Application for Registration and Fee
A.Application for a registration to conduct, maintain, or operate a body piercing establishment shall be made in writing on forms provided by the Division of Facilities Regulation and shall be submitted at least ninety (90) days prior to the opening of the body piercing establishment.
B.The application for registration shall include:
1.the address of the place of business;
2.the address of the owner and/or manager;
3.the name of the manager (and if a physician’s office, the name of the physician) who shall be registered with the Rhode Island Department of Health;
4.written documentation that the owner and/or manager is at least eighteen (18) years of age;
5.criminal convictions of the corporation, owner and/or manager, if any, except minor traffic violations;
6.a list of all owners and partners;
7.a list of owners holding fifty percent (50%) or more stock;
8.the fee as set forth in Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title;
9.a list of all equipment;
10.a floor plan of the body piercing establishment;
11.appropriate certificates of compliance with all applicable local and state codes; and
12.written operating policies and procedures pertaining to such matters as hours of business operation, nature of services, sanitation, and safety procedures established for the protection of clients and employees.
14.5.4Issuance & Renewal of Registration and Fee
A.Upon approval, the Division of Facilities Regulation shall issue a registration. Said registration, unless sooner suspended or revoked, shall expire by limitation on March 31st following its issuance and may be renewed from year to year after inspection and/or approval by the registration agency, provided the applicant meets the appropriate statutory and regulatory requirements herein.
B.A registration shall be issued only to a specific applicant for any licensed location, and shall not be transferable.
C.The annual registration renewal fee as set forth in Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, Part 10-05-2 of this Title, shall accompany the application for the annual license renewal.
D.Any registrant who allows the registration to lapse may have the same reinstated by submitting an application, the accompanying documents, the fee as required in § 14.5.4 of this Part, and other such documentation as deemed appropriate.
14.5.5Change of Ownership, Operation and/or Location
A.When a change of ownership, operation, location, or discontinuation of business of a body piercing establishment is contemplated, the owner and/or manager shall notify the registration agency in writing prior to the proposed action.
B.When there is a change in ownership, or in the operation or control of a registered body piercing establishment, the registration shall immediately become void and shall be returned to the registration agency. However, the registration agency reserves the right to extend the expiration date of such registration, allowing the facility to operate under the same conditions which applied to the prior registrant for such time as shall be required for the processing of a new application, but not to exceed thirty (30) days.
14.5.6Inspections
A.Duly authorized representatives of the Director shall, at all reasonable times, have the authority to enter upon any and all parts of the premises on which any body piercing establishment is located (and of the premises appurtenant thereto) to make any investigation or inspection to determine conformity with the statutory and regulatory provisions herein.
B.Refusal to permit inspection or investigation shall constitute valid grounds for registration denial or revocation.
C.Applicants who have not satisfactorily met the requirements herein related to the inspection described above will be given one (1) additional facility inspection. Failure to meet all requirements will result in denial of registration.
14.5.7General Operational Requirements
A.Personnel
1.Each facility shall submit to the registration agency the name of the owner and/or manager who shall be responsible for:
a.The management and control of the operation and the maintenance of the facility;
b.The facility's conformity with state and local laws and regulations pertaining to fire, safety, building sanitation, personnel and other relevant statutory and regulatory provisions; and
c.The establishment of policies and procedures, including but not limited to, the practice of body piercing, sanitation protocols, infection control, universal precautions, the nature of services provided and other such policies and procedures as may be required.
2.Persons engaged in the practice of body piercing shall comply with the Occupational Safety and Health Administration's (OSHA) Blood Borne Pathogen Standards of 29 C.F.R. § 1910.1030 (2017), incorporated in § 14.2 of this Part, in order to protect themselves (and any employees) against occupational exposure to bloodborne pathogens. Compliance shall include, but not be limited to:
a.a written exposure control plan;
b.staff training;
c.engineering and work practice controls;
d.adoption of universal precautions;
e.personal protective equipment;
f.hepatitis b vaccinations; and
g.a protocol for evaluation in the event that an exposure occurs.
3.Only individuals who hold current Rhode Island registration as a body piercing technician or a duly licensed physician shall practice body piercing and/or use the title “body piercing technician” in accordance with the regulatory provisions of the rules and regulations herein.
4.If the owner and/or manager of a facility is not a registered body piercing technician, a registered body piercing technician shall be designated as the agent of the manager and/or owner, responsible for the direct supervision of all personnel and services related to the practice of body piercing. The name of said designated individual shall be submitted to the registration agency.
B.Environment & Maintenance
1.Each body piercing establishment shall be required to meet the following provisions:
a.The facility shall be maintained in a sanitary condition free from hazards.
b.All walls and floors shall be smooth and easily cleanable. There shall be no carpeting in the body piercing area. Walls and ceilings are to be painted in a light color. Walls and floors shall be kept clean and in good repair, free from dust and debris. Floors or walls shall not be swept or cleaned while body piercing is being performed.
c.Adequate light and ventilation shall be provided.
d.Each body piercing establishment shall contain a hand sink in the body piercing area for the exclusive use of the body piercing technician. The sink shall have hot and cold running water. At the sink, there shall also be available: a soap dispenser, disposable towels and refuse containers.
(1)In facilities in which there are multiple body piercing workstations, there shall be a minimum of one sink per every two workstations. Each sink shall meet the requirements of § 14.5.7(B)(1)(d) of this Part.
e.Toilets and hand-washing facilities shall be provided in convenient locations in conformity with the Rhode Island State Building Code of R.I. Gen. Laws Chapter 23-27.3.
f.All work surfaces shall be smooth, non-porous and easily cleanable.
g.The facility shall be arranged so that work areas are separated from waiting customers by providing a separate room for body piercing or by providing at least ten (10) feet between work areas and partitioning the areas with panels (or other barriers) at least six (6) feet high. The panel may be constructed of solid opaque plastic or similar material.
h.Equipment and supplies shall be properly stored in designated storage cabinets.
i.No smoking, eating, or drinking shall be permitted in the body piercing area.
C.Waste Disposal
1.Medical waste shall be managed in accordance with the Department of Environmental Management’s Medical Waste Regulations, 250-RICR-140-15-1.
14.5.8Retention of Records
A.The owner of a body piercing establishment shall maintain proper records for each client. A record of each client shall include:
1.the date on which he/she was body pierced;
2.the signed aftercare sheet;
3.his/her name, address, telephone number and age;
a.Photo identification as proof of age (e.g., driver’s license, military identification), a copy of which shall be maintained for each client;
4.if the client is a minor, a copy of the written consent from the parent/guardian and a copy of the parent/guardian’s proper photo identification;
5.the location where the body was pierced; and
6.the name of the body piercing technician.
B.These records shall be permanently entered in a book with pre-numbered pages, kept solely for this purpose. Records that cannot be physically stored in this pre-numbered book (e.g., copies of proof of age as required in § 14.5.8(A)(3)(a) may be stored elsewhere in the facility. These records shall be available for inspection by the Department of Health. These records shall be maintained for a minimum of five (5) years after the date on which the client was body pierced.
14.5.9Denial, Suspension or Revocation of Registration
A.The Director is authorized to deny an application, revoke or suspend a registration for failure of an applicant or registrant to comply with the provisions of the rules and regulations herein.
B.Whenever an action shall be proposed to deny an application, revoke or suspend a registration, the Director shall notify the person by certified mail, setting forth the reason(s) for the proposed action.
C.The applicant or registrant shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35, and the Practices and Procedures Before the Rhode Island Department of Health, Part 10-05-4 of this Title, and Access to Public Records, Part 10-05-1 of this Title.
D.If it is determined that a person is violating any provisions of the rules and regulations herein, the Director may issue an order to secure compliance in accordance with the provisions of R.I. Gen. Laws §§ 23-1-20 through 23-1-25.
14.5.10Deficiencies and Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of these rules and regulations through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility. If the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public, she/he may issue an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility that has received a notice of deficiencies shall submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The licensing agency shall be required to approve or reject the plan of correction submitted by a facility in accordance with § 14.5.10(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 14.5.10(B) of this Part, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions referenced in § 14.5.9 of this Part.
E.If the facility is aggrieved by the sanctions of the licensing agency, the facility may appeal the decision and request a hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35, and Practices and Procedures Before the Rhode Island Department of Health, Part 10-05-4 of this Title, and Access to Public Records, Part 10-05-1 of this Title.
14.5.11Variance Procedures
A.The licensing agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of clients.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the licensing agency, and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial and in accordance with the provisions of § 14.5.10 of this Part.
14.5.12Severability
If any provision of these rules and regulations or the application thereof to any individual, facility or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end, the provisions of the regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2012-12-10 to 01/04/2022*
- *Technical Revision — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
#### **216-RICR-40-10-15** Tattoo Artists and Tattoo Parlors
##### **216-RICR-40-10-15 § 15.1** Authority {#sec-216-ricr-40-10-15-15.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-1-39(a) and 23-1-39(b), and are established for the purpose of adopting minimum requirements for the registration of tattoo artists and tattoo parlors in this state.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.2** Incorporated Materials {#sec-216-ricr-40-10-15-15.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.2}
These regulations hereby adopt and incorporate 29 C.F.R. § 1910.1030 (1994) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.3** Definitions {#sec-216-ricr-40-10-15-15.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.3}
A.Wherever used in these rules and regulations, the terms listed below shall be construed as follows:
1."Act" means R.I. Gen. Laws § 23-1-39, entitled "Tattooing and/or Body Piercing"
2.“Apprentice” means a trainee tattoo/permanent makeup artist working under the supervision of a Rhode Island licensed tattoo/permanent makeup artist within a Rhode Island licensed tattoo parlor.
3."Aseptic technique" means the practice of preventing the transmission of infectious agents into the human body by using standard aseptic procedures.
4."Communicable disease" means any disease caused by an infectious agent which may be transmitted directly or indirectly from one individual to another.
5."Director" means the Director of the Rhode Island Department of Health.
6."Division" means the Division of Customer Services at the Rhode Island Department of Health.
7."Person" means any individual, trust or estate, partnership, corporation (including but not limited to associations, joint stock companies,) state, or political subdivision or instrumentality of the state.
8."Registration agency" means the Rhode Island Department of Health.
9.“Repigmentation” means recoloration of the skin as a result of the following:
a.Dermabrasion, chemical peels, removal or resolution of birthmarks, vitiligo or other skin conditions which result in the loss of melanin to the skin;
b.Scars as a result of surgical procedures, such as cosmetic facial surgery, mole or wart removal, cauterization, etc.;
c.Recoloration to burn grafts and other skin irregularities as a result of burns or photo- damage;
d.Recreation of an areola or nipple, following mastectomy; or
e.Irregularly pigmented skin which may require cheek blush or other blending of pigments into the skin to camouflage.
10."Tattoo" means to mark or color the skin by introduction of non-toxic dyes or pigments into the skin. For the purposes of these rules and regulations, “tattooing” includes cosmetic procedures such as eye lining, lip lining, microblading, or repigmentation, as defined in this Part.
11."Tattoo artist" means an individual who is registered in this state to practice tattooing or permanent makeup in accordance with the requirements of this Part.
12."Tattoo parlor/shop" means any establishment operated by any person for the purpose of offering or conducting tattooing and/or permanent makeup procedures.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.4** Registration Requirements for Tattoo/Permanent Makeup Artists {#sec-216-ricr-40-10-15-15.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.4}
Pursuant to R.I. Gen. Laws § 23-1-39, no person shall engage in the practice of tattooing or hold himself/herself as a tattoo artist in this state unless he/she is registered in this state under the statutory and regulatory provisions of this Part. Provided, that physicians duly licensed to practice medicine in the state of Rhode Island under the provisions of R.I. Gen Laws Chapter 5-37, shall be exempt from this registration requirement. However, a physician engaged in the practice of tattooing in his/her private office shall be required to register the site as a tattoo parlor/shop and meet the requirements of § 15.5 of this Part.
15.4.1Qualifications
A.Any applicant seeking registration in this state must:
1.Be over 18 years of age;
2.Be of good moral character;
3.Demonstrate knowledge of aseptic tattooing technique via inspection, as indicated in § 15.4.3 of this Part; and
4.Have completed an apprenticeship program as outlined in this Part or has shown equivalent documentation of education/experience in the art of tattooing/permanent makeup.
15.4.2Application and Registration Fee
A.Application for registration shall be made on forms provided by the Division including, if applicable, a request for inspection form, which shall be completed and submitted to the Division. Such application shall be accompanied by the following documents:
1.For U.S citizens: a certified copy of birth certificate;
2.For non-U.S. citizens: proof of lawful entry into the United States and proof of lawful eligibility for employment in the United States;
3.A registration fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
4.A recent identification photograph of the applicant, head and shoulders, front view, approximately 2x3 inches in size; and,
5.A completed "Inspection Request" form.
a.Said inspection will be completed within ninety (90) days of application.
B.Any applicant who has not previously been issued a registration by the registration agency will be required to submit to a technique inspection, as set forth in § 15.4.3 of this Part, before a registration shall be issued.
15.4.3Registration of Tattoo/ Permanent Makeup Artists and Apprentices
A.By Examination
1.Applicants and apprentices who have completed an apprenticeship program, seeking registration as a tattoo/permanent makeup artist, shall be required to demonstrate aseptic tattooing technique via an examination administered by the registration agency, to test the applicant's fitness to engage in the practice of tattooing/permanent makeup. Such examination shall test the applicant's knowledge and practices of infection control and such other areas as may be deemed necessary, and shall be administered upon completion and review of the application.
a.Applicants who have not satisfactorily met the application requirements of this Part relating to the examination described in § 15.4.3(A)(1) of this Part will be given two (2) additional opportunities to demonstrate tattooing technique. Failure to meet all technique requirements will result in denial of registration.
b.Applicants wishing to reapply for registration may do so after a six (6) month waiting period between attempts at the examination.
B.Apprenticeships
1.Persons wishing to begin an apprenticeship program at an established tattoo parlor must register with the registration agency within thirty (30) days of beginning a tattoo parlor’s apprenticeship training program.
2.A tattoo parlor’s apprenticeship training program must span eighteen (18) months from the apprentice registration date and should be inclusive of the following:
a.Practical Operation: 150 hours
b.Aseptic Tattooing Technique: 50 hours
c.Anatomy and Physiology: 30 hours
d.Skin and Skin Disorders: 20 hours
e.Aftercare Instruction: 10 hours
f.Equipment and Supplies: 20 hours
g.Rhode Island Rules and Regulations for Tattoo Artists and Tattoo Parlors: 20 hours
3.Upon completion of a tattoo parlor’s training program, documentation of training must be presented with the tattoo license application to the registration agency for review and processing.
4.Parlor patrons receiving a tattoo/permanent make up procedure from an apprentice must be informed prior to the tattoo/permanent makeup procedure in writing, and acknowledge via a dated signature, that they willfully accept the tattoo/permanent makeup procedure to be performed by an apprentice.
5.The licensed tattoo artist trainer must be present at all times during procedures performed by the apprentice.
15.4.4Issuance and Renewal of Registration and Fee
A.The Director shall issue to applicants who have satisfactorily met the application and examination requirements of this Part, a registration to practice tattooing in the state. This registration, unless sooner suspended or revoked, shall expire on December 31st of each year.
B.On or before the first day of December in each year, an application for online renewal of registration shall be mailed to every person to whom a registration has been issued during the current year.
C.Every person so registered who desires to renew his/her registration shall electronically file with the Division:
1.An online renewal acknowledgement of adherence to the requirements of this Part.
2.The fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
D.Lapsed Registration
1.Any registrant who allows the registration to lapse may have same reinstated by submitting to the registration agency, an application and accompanying documents, as required in § 15.4.2 of this Part.
2.Any registrant whose registration lapses for two (2) or more years shall be required to submit to the practical examination of aseptic tattooing technique administered by the registration agency.
15.4.5Tattooing Practice
A.A registered tattoo artist shall maintain sanitary and safe practice in accordance with prevailing standards contained in this Part.
1.Dyes, Pigments, Transfer Paper, and Stencils:
a.All dyes and pigments shall be manufactured for the purpose of tattooing and used according to the manufacturer’s specifications.
b.In preparing dyes or pigments, non-toxic materials shall be used.
c.Single-use, sterile, individual containers for dyes or pigments shall be used for each patron.
d.The stencil, unless composed of acetate, shall be used for a single tattoo procedure only. Acetate stencils may be disinfected and re-used.
e.Transfer paper shall be one time use and shall be used per manufacturer’s specifications.
2.Tattoo Procedures:
a.A tattoo artist shall conduct his/her tattooing practice so as to prevent the transmission of communicable diseases from client to client and from artist to client. Tattoo artists shall maintain at least the following minimum standards in the practice of tattooing:
(1)The area of the body to be tattooed, and all parts of the body which are visible, shall be examined for signs of intravenous drug use, open sores, lesions, oozing wounds, and skin diseases. If such are found, or suspected, the person shall not be tattooed.
(2)Each tattoo artist shall wear a clean outer garment. If the garment is visibly contaminated with blood, it shall be changed between clients.
(3)Before working on each client, each tattoo artist shall clean his/her own fingernails with a brush and shall thoroughly wash and scrub hands with hot running water, using germicidal soap from a dispenser. Hands must also be washed after each rest room use, before putting on gloves and after taking off gloves.
3.Tattoo Materials:
a.All materials necessary for the tattooing process shall be set up on a single-use disposable sterile cloth (e.g., polycloth). All autoclaved/sterile packs shall be opened ready for use without touching the interior of the pack. Single-use or collapsible tubes shall be used for lubricants.
b.Any shaving shall be done with a single use razor blade or razor.
c.The skin shall be prepared first by thoroughly soaping with an antiseptic soap and rinsing with tap water. Following this cleansing, a germicidal solution (such as 70% isopropyl alcohol) shall be applied to the skin using a sterile swab.
d.Stencil transfer medium shall be applied (if applicable) using sterile swabs and prepared clean transfer paper/stencil shall be applied to the skin.
e.After applying the stencil, the tattoo artist shall remove and discard gloves and again wash and scrub his/her hands with soap and water and dry hands using paper towels.
f.Prior to commencing application of the tattoo, the tattoo artist shall then re-glove.
g.If there is a need to rinse the tube and needle between colors, this shall be done with ninety-one percent (91%) isopropyl alcohol or sterile water in sterile single-use disposable containers or non-disposable sterilized containers.
h.As the tattoo operation progresses, any excess dye or pigment applied to the skin shall be removed with sterile, lint-free material.
i.The tattoo shall be allowed to dry. After drying, a sterile lubricant shall be applied from a collapsible metal or plastic tube, and the entire area covered with a piece of sterile gauze or similar sterile porous material.
j.Needles and microblades shall be immediately deposited into a puncture-resistant infectious waste sharps container. Needles and microblades shall not be reused.
k.All used sharps and any blood soaked material shall be handled and discarded according to the Medical Waste Regulations (250-RICR-140-15-1). All other material shall be discarded appropriately.
l.Unless one time use and disposable, all tubes must be rinsed with tap water and then placed in a germicidal solution (e.g., Cidex) or directly into an ultrasonic cleaner.
m.Gloves shall be removed and discarded in accordance with the requirements of the Medical Waste Regulations (250-RICR-140-15-1) .
n.Immediately after tattooing, the tattoo artist shall advise the patron, both verbally and in writing, on the care of the tattoo and shall instruct the patron to consult a physician at the first sign of infection (such as excessive pain, redness, swelling, or discharge) in the area of the tattoo.
o.All work surfaces and non-autoclaved equipment (e.g., tattoo machine and pliers) used in the tattoo process shall be cleaned with an EPA-approved bactericidal, virucidal, fungicidal, tuberculocidal surface disinfectant/decontaminant cleaner between clients. Gloves shall be used in the cleaning process. Subsequently, the artist shall wash his/her hands with a germicidal soap after cleaning work surfaces and equipment.
p.After tattooing, the remaining unused dye or pigment shall be discarded in accordance with the requirements of the Medical Waste Regulations (250-RICR-140-15-1). Non-disposable individual containers shall be resterilized, according to specifications in § 15.4.5(A)(5) of this Part.
4.Tattoo Equipment:
a.A set of individual, single-use sterilized needle bars shall be used for each new patron. Before each use, the open end of the reusable needle tube of the tattooing machine shall be cleaned and sterilized in an approved manner as set forth in § 15.4.5(A)(5) of this Part.
b.Unless one time use and disposable, the needle tubes shall be cleaned by use of an ultrasonic cleaner and sterilizer. Immersion time for all equipment shall be five (5) minutes. Ultrasonic cleaning tank detergent shall be changed daily. The tank shall be scrubbed thoroughly with a ninety-one percent (91%) solution of isopropyl alcohol between detergent changes.
c.Adequate numbers of sterilized needles, tubes and/or microblades shall be on hand for each operator for the entire day or night operation, based on the average number of clients per day. Failure to maintain an adequate number of sterilized needles, tubes, and/or microblades shall require the artist to cease operations until such time as an adequate number becomes available.
d.All items of equipment which may be touched during the tattoo process, such as clip cords, machine heads, spray bottles, etc., shall be capable of being sheathed easily with a disposable impervious covering.
e.Storage cabinets shall be maintained in a sanitary condition and all instruments, dyes, pigments, stencils and other equipment, when not in use, shall be stored in an orderly manner.
5.Sterilization:
a.Sterilizing of instruments: Operational sterilizers shall be available in each tattoo parlor unless all materials are one time use and disposable. All multiuse grips and needle tubes shall be sterilized after each use by autoclaving per manufacturer's specifications.
b.If in use, autoclave units shall be checked monthly, using a standard spore test, with results maintained on file for inspection. Autoclave units shall be maintained in accordance with manufacturer’s specifications. Records of said monthly checks shall be maintained for a minimum of two (2) years.
c.A log book shall be maintained for the results of said monthly inspections and shall include no less than the following items:
(1)Date of inspection;
(2)Results of inspection; and
(3)The signature of the tattoo artist who conducted the inspection.
d.The sterilizing date shall be noted, and evidence of sterilization shall be demonstrated by color indicator or equivalent. Packs shall be used within thirty (30) days or resterilized.
B.Restrictions: All tattoo patrons must meet the age eligibility requirements of R.I. Gen. Laws § 11-9-15.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.5** Registration Requirements for Tattoo Parlors/Shops {#sec-216-ricr-40-10-15-15.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.5}
15.5.1Registration Requirements
A.No person, acting severally or jointly with any other person, shall conduct, maintain, or operate a tattoo parlor/shop in the state without a registration issued by the registration agency.
B.No person, firm, partnership or corporation shall describe its services in any manner under the title "Tattoo" unless such services as defined in this Part are performed in a parlor/shop that is registered with the registration agency in accordance with the provisions of this Part.
15.5.2Application for Registration and Fee
A.Application for a registration to conduct, maintain, or operate a tattoo parlor/shop shall be made in writing on forms provided by the Division and shall be submitted at least ninety (90) days prior to the opening of the tattoo parlor/shop.
B.The application for registration shall include:
1.The address of the place of business;
2.The address of the owner and/or manager;
3.The name of the manager who shall be registered with the registration agency;
4.Written documentation that the owner and/or manager is at least eighteen (18) years of age;
5.Criminal convictions of the corporation, owner and/or manager, if any, except minor traffic violations;
6.A list of all owners and partners;
7.A list of owners holding fifty percent (50%) or more stock;
8.The fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
9.A list of all equipment;
10.A floor plan of the tattoo parlor/shop;
11.Appropriate certificates of compliance with all applicable local and state codes;
12.Written operating policies and procedures pertaining to such matters as hours of business operation, nature of services, sanitation, and safety procedures established for the protection of patrons and employees.
15.5.3Issuance and Renewal of Registration and Fee
A.Upon approval, the Division shall issue a registration. Said registration, unless sooner suspended or revoked, shall expire by limitation on March 31st following its issuance and may be renewed from year to year after inspection and/or approval by the registration agency, provided the applicant meets the appropriate statutory and regulatory requirements herein.
B.A registration shall be issued only to a specific applicant for a specific location, and shall not be transferable.
C.The annual registration renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2) shall accompany the application for the annual license renewal.
D.Any registrant who allows the registration to lapse may have the same reinstated by submitting an application, the accompanying documents, the fee as required in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) and other such documentation as deemed appropriate.
15.5.4Change of Ownership, Operation and/or Location
A.When a change of ownership, operation, location, or discontinuation of business of a tattoo parlor/shop is contemplated, the owner and/or manager shall notify the registration agency in writing prior to the proposed action.
B.When there is a change in ownership, or in the operation or control of a registered tattoo parlor/shop, the registration shall immediately become void and shall be returned to the registration agency. However, the registration agency reserves the right to extend the expiration date of such registration, allowing the facility to operate under the same conditions which applied to the prior registrant for such time as shall be required for the processing of a new application, but not to exceed thirty (30) days.
15.5.5Inspections
A.Duly authorized representatives of the registration agency shall, at all reasonable times, have the authority to enter upon any and all parts of the premises on which any tattoo parlor/shop is located (and of the premises appurtenant thereto) to make any investigation or inspection to determine conformity with the statutory and regulatory provisions of this Part.
B.Refusal to permit inspection or investigation shall constitute valid grounds for registration denial or revocation.
C.Applicants who have not satisfactorily met the requirements of this Part related to the inspection described in § 15.5.5 of this Part will be given one (1) additional facility inspection. Failure to meet all requirements will result in denial of registration.
1.Applicants wishing to reapply for registration may do so after a one (1) year waiting period.
15.5.6General Operational Requirements
A.Personnel
1.Each facility shall submit to the registration agency the name of the owner and/or manager who shall be responsible for:
a.The management and control of the operation and the maintenance of the facility;
b.The facility's conformity with state and local laws and regulations pertaining to fire, safety, building sanitation, personnel and other relevant statutory and regulatory provisions; and,
c.The establishment of policies and procedures, including but not limited to, the practice of tattooing, sanitation protocols, infection control, the nature of services provided and other such policies and procedures as may be required.
2.Persons engaged in the practice of tattooing shall comply with the Occupational Safety and Health Administration's (OSHA) Blood Borne Pathogen Standards, incorporated above at § 15.2(A) of this Part, in order to protect themselves (and any employees) against occupational exposure to bloodborne pathogens. Compliance shall include, but not be limited to:
a.A written exposure control plan;
b.Staff training;
c.Engineering and work practice controls;
d.Adoption of universal precautions;
e.Personal protective equipment;
f.Hepatitis B vaccinations; and,
g.A protocol for evaluation in the event that an exposure occurs.
3.Only individuals who hold current Rhode Island registration as a tattoo artist or a duly licensed physician shall practice tattooing and use the title "tattoo artist" in accordance with the regulatory provisions of this Part.
4.If the owner and/or manager of a facility is not a registered tattoo artist, a registered tattoo artist shall be designated as the agent of the manager and/or owner, responsible for the direct supervision of all personnel and services related to the practice of tattooing. The name of said designated individual shall be submitted to the registration agency.
B.Environment and Maintenance
1.Each tattoo parlor/shop shall be required to meet the following provisions:
a.The facility shall be maintained in a sanitary condition free from hazards.
b.All walls, ceilings, and floors shall be smooth and easily cleanable and have a non-absorbent surface. There shall be no carpeting in the tattooing area. Walls and ceilings are to be painted in a light color. Walls, ceilings and floors shall be kept clean and in good repair, free from dust and debris. Floors, walls or ceilings shall not be swept or cleaned while tattooing is being performed.
c.Adequate light and ventilation shall be provided.
d.Each tattoo parlor/shop shall contain a hand sink in the tattooing area for the exclusive use of the tattoo artist. The sink shall have hot and cold running water. At the sink, there shall also be available:
(1)A soap dispenser;
(2)Disposable towels; and
(3)Refuse containers.
(4)In facilities in which there are multiple tattooing workstations, there shall be a minimum of one (1) sink per every two (2) workstations. Each sink shall meet the requirements of § 15.5.6(B)(1)(d) of this Part.
e.Toilets and hand-washing facilities shall conform with the Rhode Island State Building Code, R.I. Gen. Laws Chapter 23-27.3.
f.All work surfaces shall be smooth, non-porous and easily cleanable.
g.The facility shall be arranged so that work areas are separated from waiting customers by providing a separate room for tattooing or by providing at least ten (10) feet between work areas and partitioning the areas with panels (or other barriers) at least six (6) feet high. The panel may be constructed of solid opaque plastic or similar material.
h.Equipment and supplies shall be properly stored in designated storage cabinets.
i.No smoking, eating or drinking shall be permitted in the tattooing area.
C.Waste Disposal
1.Medical waste shall be managed in accordance with the Medical Waste Regulations (250-RICR-140-15-1).
15.5.7Retention of Records
A.The owner of a tattooing parlor/shop shall maintain proper records for each patron. A record of each patron shall include:
1.The date on which he/she was tattooed;
2.His/her name, address, telephone number and age;
a.Photo identification as proof of age (e.g., driver’s license, military identification), a copy of which shall be maintained for each patron;
3.The location and design of the tattoo; and,
4.The name of the tattoo artist.
B.These records shall be permanently entered in a book with pre-numbered pages, kept solely for this purpose. Records that cannot be physically stored in this pre-numbered book (e.g., copies of proof of age as required in § 15.5.7(A)(2)(a) of this Part) may be stored elsewhere in the facility. These records shall be available for inspection by the registration agency. These records shall be maintained for a minimum of five (5) years after the date on which the patron was tattooed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.** 6 Denial, Suspension or Revocation of Registration {#sec-216-ricr-40-10-15-15. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.}
A.The Director is authorized to deny an application, revoke or suspend a registration for failure of an applicant or registrant to comply with the provisions of the rules and regulations herein.
B.Whenever an action shall be proposed to deny an application, revoke or suspend a registration, the Director shall notify the person by certified mail, setting forth the reason(s) for the proposed action.
C.The applicant or registrant shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35, and the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
D.If it is determined that a person is violating any provisions of this Part, the Director may issue an order to secure compliance in accordance with the provisions of R.I. Gen. Laws §§ 23-1-20 through 23-1-25.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.** 7 Deficiencies and Plans of Correction {#sec-216-ricr-40-10-15-15. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.}
A.The registration agency shall notify the governing body or other legal authority of a facility of violations of this Part through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility. If the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public, she/he may issue an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility that has received a notice of deficiencies shall submit a plan of correction to the registration agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The registration agency shall be required to approve or reject the plan of correction submitted by a facility in accordance with § 15.7(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the registration agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 15.7(B) of this Part, or if a facility whose plan of correction has been approved by the registration agency fails to execute its plan within a reasonable time, the registration agency may invoke the sanctions referenced in § 15.6 of this Part.
E.If the facility is aggrieved by the sanctions of the registration agency, the facility may appeal the decision and request a hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35, and the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1)..
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
##### **216-RICR-40-10-15 § 15.** 8 Variance Procedures {#sec-216-ricr-40-10-15-15. omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-15#15.}
A.The registration agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of clients.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
C.Upon the filing of each request for variance with the registration agency, and within thirty (30) days thereafter, the registration agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial and in accordance with the provisions of § 15.7 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-06-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 06/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2006-01-11 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/11/2006*
#### **216-RICR-40-10-16** Rehabilitation Hospital Centers
##### **216-RICR-40-10-16 § 16.1** Authority {#sec-216-ricr-40-10-16-16.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17-10 and are established for the purpose of adopting minimum standards for rehabilitation hospital centers in Rhode Island.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.2** Incorporated Materials {#sec-216-ricr-40-10-16-16.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.2}
A.These regulations hereby adopt and incorporate the Commission on Accreditation of Rehabilitation Facilities’ “Standards for Facilities Serving People with Disabilities” (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate NFPA 232: Standard for the Protection of Records. National Fire Protection Association (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate NFPA 99: Health Care Facilities Code, National Fire Protection Association, (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
D.These regulations hereby adopt and incorporate the American National Standards “Specifications for Making Buildings and Facilities Accessible and Usable by the Physically Handicapped” (1980), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
E.These regulations hereby adopt and incorporate the Facility Guidelines Institute’s "Guidelines for Design and Construction of Hospital and Outpatient Facilities" (2014) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.3** Definitions {#sec-216-ricr-40-10-16-16.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1.“Bed complement" of a rehabilitation hospital center means the number of beds a center has in actual use, equal to or less than the licensed capacity.
2.“Capacity" of a rehabilitation hospital center means the maximum potential number of beds which may be accommodated within the center.
3."Change in operator" means a transfer by the governing body or operator of a center to any other person (excluding delegations of authority to the medical or administrative staff of the center) of the governing body's authority to:
a.Hire or fire the chief executive officer (administrator) of the center;
b.Maintain and control the books and records of the center;
c.Dispose of assets and incur liabilities on behalf of the center; or
d.Adopt and enforce policies regarding operation of the center.
(1)This definition is not applicable to circumstances wherein the governing body of a center retains the immediate authority and jurisdiction over the activities enumerated in §§ 16.3(A)(3)(a) through (d) of this Part.
4."Change in owner" means:
a.In the case of a center which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership;
b.In the case of a center which is an unincorporated sole proprietorship, the transfer of the title and property to another person;
c.In the case of a center which is a corporation;
(1)A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a center which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of a center which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
5."Director" means the Director of the Rhode Island Department of Health.
6.“Discharge” means a patient’s exit or release from a Center to the patient’s residence following an inpatient admission.
7.“Equity” means non-debt funds contributed towards the capital costs related to a change in owner or change in operator of a rehabilitation hospital center which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
8."Health Services Council" means the advisory body to the Rhode Island Department of Health established in accordance with R.I. Gen. Laws § 23-17-13.1 appointed and empowered in accordance with R.I. Gen. Laws § 23-15-7 to serve as the advisory body to the state agency in its review functions.
9.“Licensed capacity" of a rehabilitation hospital center means the number of beds a center is licensed to operate.
10.“Lift team” means Rehabilitation hospital center employees specifically trained to perform patient lifts, transfers, and repositioning in accordance with safe patient handling policy.
11.“Musculoskeletal disorders” means conditions that involve the nerves, tendons, muscles, and supporting structures of the body.
12."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivision or instrumentality of a state.
13."Physician" means an individual licensed to practice medicine or osteopathy in Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 5-37.
14."Progressive levels" means inpatient, day patient and outpatient or other levels of rehabilitation programs and services through which a patient progresses based on established criteria for each level of care and on the individual patient's plan of care.
15."Rehabilitation" means the process of providing through an interdisciplinary team, coordinated comprehensive services deemed appropriate to the needs of a person with a disability, in a program designed to achieve objectives of improved functional ability, health, welfare and the realization of one's maximum physical, social, psychological and vocational potential for useful and productive activity and to enhance independent and self-sufficiency.
16."Rehabilitation hospital center", or “Center” means a facility which has a distinct organizational entity, an organized medical staff, nursing service and a range of rehabilitation services, which provides progressive levels of functional rehabilitation services to persons who require diagnosis and treatment for non-acute chronic injury, illness or other disabilities, excluding substance mental and/or rehabilitation facilities licensed by other state agencies. Such rehabilitation hospital centers however, shall not be construed to have the same meaning as the term “hospital” as defined in the rules and regulations for Licensing of Hospitals (Part 4 of this Subchapter), nor to imply the provisions of a range of acute care as could be provided under the aforementioned regulations.
17.“State Fire Marshal” means the Division of the State Fire Marshal, Department of Public Safety, State of Rhode Island.
18.“Safe patient handling” means the use of engineering controls, transfer aids, or assistive devices whenever feasible and appropriate instead of manual lifting to perform the acts of lifting, transferring, and/or repositioning health care patients and residents.
19.“Safe patient handling policy” means protocols established to implement safe patient handling.
20."State agency" means the Rhode Island Department of Health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.4** General Requirements for Licensure {#sec-216-ricr-40-10-16-16.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.4}
A.No person acting severally or jointly with any other person, shall establish, conduct or maintain a rehabilitation hospital center in this state without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4.
B.A certificate of need is required as a precondition to the establishment of a new rehabilitation hospital center in accordance with R.I. Gen. Laws Chapter 23-15.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.5** Application for License or Changes in Owner, Operator, or Lessee {#sec-216-ricr-40-10-16-16.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.5}
A.Application for a license to conduct, maintain or operate a rehabilitation hospital center shall be made to the state agency upon forms provided by it one month prior to expiration date of license and shall contain such information as the state agency reasonably requires which may include affirmative evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and this Part.
1.Each application shall be accompanied by an application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) per facility plus an additional fee per licensed bed as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Application for changes in the owner, operator, or lessee of a rehabilitation hospital center shall be made on forms provided by the state agency and shall contain, but not be limited to, information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 16.6(E) of this Part. Three (3) copies of such applications are required to be provided.
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-refundable, non-returnable application fee, as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.6** Issuance and Renewal of License {#sec-216-ricr-40-10-16-16.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.6}
A.Upon receipt of an application for a license, the state agency issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and this Part. Said license, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year after inspection and approval by the state agency.
1.All renewal applications shall be accompanied by an annual inspection fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) per facility plus an additional fee per licensed bed as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance, as identified in the application.
1.Any change in owner, operator, or lessee of a licensed rehabilitation hospital center shall require prior review by the Health Services Council and approval of the state agency as provided in § 16.6(E) of this Part as a condition precedent to the transfer, assignment or issuance of a new license.
C.A license issued hereunder shall be the property of the state and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
D.Reviews of applications for changes in the owner, operator, or lessee of licensed rehabilitation hospital centers shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form, of an application for a license in connection with a change in the owner, operator or lessee of an existing rehabilitation hospital center, the state agency will notify and afford the public thirty (30) days to comment on such application.
2.The decision of the state agency will be rendered within ninety (90) days from acceptance of the application.
3.The Health Services Council shall transmit its advisory to the state agency in writing. The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the state agency shall afford written justification for variance therefrom.
4.All applicants reviewed by the state agency and all written materials pertinent to the state review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.
E.Except as otherwise provided in the Act (R.I. Gen. Laws Chapter 23-17), a review by the Health Services Council of an application for a license, in the case of a proposed change in the owner, operator, or lessee of a licensed rehabilitation hospital center may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 . In conducting reviews of such applications the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence, and standing in the community of the proposed owners, operators or directors of the rehabilitation hospital center as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
(3)In providing appropriate access to health care facility services;
b.A complete disclosure of all individuals and entities comprising the applicant; and
c.The applicant’s proposed and demonstrated financial commitment to the health care facility.
2.The extent to which the center will continue, without material effect on its viability at the time of change of owner, operator or lessee, to provide safe and adequate treatment for individuals receiving the rehabilitation hospital center's services as evidenced by:
a.The immediate and long term financial feasibility of the proposed financing plan;
(1)The proposed amount and sources of owner's equity to be provided by the applicant;
(2)The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;
(3)The relative availability of funds for capital and operating needs;
(4)The applicant's demonstrated financial capability;
(5)Such other financial indicators as may be requested by the state agency.
3.The extent to which the center will continue to provide safe and adequate treatment for individuals receiving the rehabilitation hospital center's services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by:
a.The applicant’s demonstrated record in providing safe and adequate treatment to individuals receiving services at facilities owned, operated, or directed by the applicant; and
b.The credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs.
4.The extent to which the center will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally under served populations to its health care facilities; and
b.The proposed immediate and long-term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility.
5.In consideration of the proposed continuation or termination of health care services by the rehabilitation hospital center:
a.The effect(s) of such continuation or termination on access to safe and adequate treatment of individuals, including but not limited traditionally underserved populations.
b.And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
F.Subsequent to reviews conducted under §§ 16.6(D) and (E) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in § 16.6(E) of this Part. This shall not limit the authority of the state agency to require correction of conditions or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the facility by the licensing agency.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.7** Capacity {#sec-216-ricr-40-10-16-16.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.7}
Each license shall be issued for the specified licensed bed capacity of the rehabilitation hospital center. No center shall have more inpatients than the number of beds for which it is licensed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.8** Inspections {#sec-216-ricr-40-10-16-16.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.8}
A.The state agency shall make, or cause to be made, such inspections and investigations as it deems necessary in accordance with R.I. Gen. Laws § 23-17-10 and this Part.
B.Every center shall be given prompt notice by the state agency of all deficiencies reported as a result of an inspection or investigation.
C.Written reports and recommendations of inspections shall be maintained on file in each center for a period of no less than thee (3) years.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.9** Denial, Suspension, Revocation of License, Curtailment of Activities or Closure {#sec-216-ricr-40-10-16-16.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.9}
A.The state agency is authorized to deny, suspend or revoke the license or curtail activities of any center which:
1.Has failed to comply with the rules and regulations pertaining to licensing of rehabilitation hospital centers; and
2.Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3.Lists of deficiencies noted in inspections conducted in accordance with § 16.8 of this Part shall be maintained on file in the state agency, and shall be considered by the state agency in rendering determinations to deny, suspend or revoke the license or curtail activities of a center.
B.Where the state agency deems that operation of a center results in undue hardship to patients as a result of deficiencies, the state agency is authorized to deny licensure to centers not previously licensed, or to suspend for a stipulated period of time or revoke the license of a center already licensed or curtail activities of the center.
C.Whenever an action shall be proposed to deny, suspend or revoke a center's license, or curtail its activities, the state agency shall notify the center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9.
1.However, if the licensing agency finds that public health, safety, or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the state agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
D.The appropriate state and federal placement and reimbursement agencies shall be notified of any action taken by the state agency pertaining to either denial, suspension, or revocation of license or curtailment of activities.
E.The state agency shall be notified immediately when a licensee/owner determines to cease operations and close a center.
F.At least (30) days prior to voluntary cessation of any facility license, the Department of Health shall be provided with an acceptable plan for orderly closure which shall include, but is not limited to the following; notification and transfer of patients, transfer, storage, or proper disposal of medical records; and notification of the public.
G.A license shall immediately become void and shall be returned to the state agency whenever the center ceases delivering patient care.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.10** Organization and Management {#sec-216-ricr-40-10-16-16.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.10}
16.10.1Governing Body
A.There shall be an organized governing body or equivalent legal authority ultimately responsible for:
1.The management, fiscal affairs, and operation of the rehabilitation hospital center;
2.The assurance of quality care and services; and
3.Compliance with all federal, state and local laws and regulations pertaining to rehabilitation, fire, safety, sanitation, communicable and reportable diseases, and other relevant health and safety requirements and with all rules and regulations of this Part.
B.The governing body or other legal authority shall furthermore be responsible to define the population and communities to be served and the scope of services to be provided.
C.The governing body or other legal authority shall also be responsible to:
1.Provide physical resources and equipment to facilitate the delivery of prescribed services and to ensure that the entire center is accessible to the disabled;
2.Provide a sufficient number of trained, experienced and competent personnel to provide appropriate care and supervision for all patients and to ensure that patients’ needs are met; and
3.Determine that qualifications of personnel, including consultants, as may be required in this Part, and to consider such qualifications as education, training, experience, board certification, and evidence of current professional practice and licensure as may be required by law or regulation, and such other relevant factors.
D.The governing body or other legal authority shall designate:
1.an administrator who shall be responsible for the management and operation of the center; and
2.a medical director who assumes overall responsibility for the health and rehabilitation care and to ensure achievement and maintenance of quality standards of professional practice.
E.The governing body shall adopt and maintain written by-laws and rules and regulations or acceptable equivalent which defines responsibilities for the operation and performance of the organization, identified purposes, and means of fulfilling such. Such by-laws, rules and regulations shall include:
1.A statement of purpose;
2.A statement of qualifications for membership and method of selecting members of the governing body;
3.A statement of the authority and responsibility delegated to the administrator, the medical director and to the medical staff;
4.Provision for the selection and appointment of medical director and medical staff;
5.Provision for the approval of the medical staff by-laws and/or rules and regulations;
6.Provision of guidelines for the relationships among the governing body, the administrator, the medical director and medical staff;
7.A policy statement concerning the development and implementation of short and long range plans in accordance with R.I. Gen. Laws Chapter 23-17;
8.A policy statement concerning the publication of an annual report, including a certified financial statement; and
9.Provision that contracts with outside providers of services be restricted to those which comply with federal, state and local laws and regulations and in accordance with § 16.10.8 of this Part.
F.In addition, the governing body or other legal authority shall establish administrative policies pertaining to no less than the following:
1.Responsibilities of the administrator and the medical director;
2.Conflict of interest on the part of the governing body, professional staff and employees;
3.The services to be provided;
4.Criteria for the selection, admission, discharge and transfer of patients from one level of care to another (inpatient - day patient - outpatient) or transfer to another facility; (see § 16.11.1(B) of this Part)
5.Patient/family consent and involvement in the development of patient care plan;
6.Developing support network as may be deemed appropriate;
7.Linkages and referrals with community and other health care facilities or agencies to assure continuity of patient care and to support services of the center; and
8.Such other matters as may be relevant.
16.10.2Administrator
The administrator shall be directly responsible to the governing body for the management and operation of the center and shall provide liaison between the governing body and the medical staff.
16.10.3Medical Director
A.The overall responsibility for the rehabilitation and health care needs and services of patients shall be under the direction of a physician who is licensed in the State of RI and certified by the American Board of Physical Medicine and Rehabilitation, or who has specific education and experience in rehabilitation and who shall be responsible for:
1.The coordination and supervision of holistic health care and rehabilitation programs and services:
2.The achievement and maintenance of quality assurance of professional practices through a mechanism for the assessment of patient care outcomes;
3.Participation in the interdisciplinary team and in the development, implementation and assessment of patient of care;
4.Establishment and maintenance of a quality assurance program in accordance with the provisions of § 16.11.9 of this Part; and such other responsibilities as may be deemed appropriate.
16.10.4Medical Staff
A.Each center shall have an organized medical staff responsible to the governing body who shall be responsible to maintain standards of professional performance through staff appointment criteria, continuing peer review and other appropriate evaluation mechanisms.
B.The medical staff, subject to the approval of the governing body, shall adopt by-laws and/or rules and regulations incorporating details of its general powers, duties and responsibilities including the types of committees, delineation and clinical privileges of non-physician practitioners and designation of personnel qualified to prescribe or administer drugs.
C.A copy of approved medical staff by-laws and/or rules and regulations and revisions thereto, shall be submitted to the state agency.
16.10.5Organization
A.The internal organization of the center shall be structured to include appropriate clinical programs and services consonant with the health and rehabilitative needs of its defined population.
B.Each center shall maintain clearly written definitions of its organization authority, responsibilities and relationships.
C.Each clinical program and service shall maintain:
1.Clearly written definitions of its organization, authority, responsibilities and relationships;
2.Written patient care policies and procedures; and
3.Written provision for systematic evaluation of programs and services.
D.Every licensed center and its insurance carrier shall cooperatively, as a part of their administrative function, establish an internal risk management program in accordance with the requirements of R.I. Gen. Laws § 23-17-24.
16.10.6Personnel and Safe Patient Handling
A.The center shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services.
1.Various categories of personnel working in patient care areas shall be clearly identifiable to patients and the public.
B.There shall be written personnel policies and procedures which shall be made available to personnel.
C.There shall be a job description for each position which delineates the qualifications, duties, authority and responsibilities inherent in each position.
1.For those selected non-licensed personnel authorized to administer drugs in accordance with § 16.11.4(B)(3) of this Part, a job description delineating qualifications, duties and responsibilities shall be provided.
D.Provisions shall be made for orientation and continuing in-service education for personnel.
E.There shall be written evidence that staff demonstrate competencies necessary to work in specific areas and/ or with specific patient populations.
F.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the rehabilitation hospital. Such health screening shall be conducted in accordance with the rules and regulations pertaining to Immunization, Testing, and Health Screening for Health Care Workers (Part 20-15-7 of this Title).
G.National criminal background checks shall be conducted in accordance with R.I. Gen. Laws §§ 23-17.7.1-17, 23-17-62 and 23-17.7.1-20 for Center personnel whose employment involves routine contact with a patient.
H.Personnel records shall be maintained for each employee, shall be available at all times for inspection and shall include:
1.Current and background information covering qualifications for employment;
2.Records of completion of required training and educational programs;
3.Records of all required health examinations which shall be kept confidential; and
4.Evidence of current registration, certification or licensure for all personnel subject to statutory requirements.
I.An in-service educational program shall be conducted on an ongoing basis, which shall include an orientation program for new personnel and a program for the development and improvement of skills of all personnel. The in-service program shall be geared to the rehabilitation needs of patients, food service sanitation, fire prevention and safety, confidentiality of patient information, rights of patients and any other area related to rehabilitation.
1.Provision shall be made for written documentation of programs, including attendance. Flexible program schedules shall be formulated at least two months in advance.
J.A health care facility shall require all persons, including students, who examine, observe, or treat a patient or resident of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
K.Safe Patient Handling. Each licensed center hospital shall establish a safe patient handling committee, which shall be chaired by a professional nurse or other appropriate licensed health care professional. A center may utilize any appropriately configured committee to perform the responsibilities of this section. At least half of the members of the committee shall be hourly, non-managerial employees who provide direct patient care.
1.Each licensed center shall develop a written safe patient handling program, with input from the safe patient handling committee, to prevent musculoskeletal disorders among health care workers and injuries to patients. As part of this program, each licensed health care facility shall:
a.Implement a safe patient handling policy for all shifts and units of the facility that will achieve the maximum reasonable reduction of manual lifting, transferring, and repositioning of all or most of a patient's weight, except in emergency, life-threatening, or otherwise exceptional circumstances;
b.Conduct a patient handling hazard assessment. This assessment should consider such variables as patient-handling tasks, types of nursing units, patient populations, and the physical environment of patient care areas;
c.Develop a process to identify the appropriate use of the safe patient handling policy based on the patient's physical and mental condition, the patient's choice, and the availability of lifting equipment or lift teams. The policy shall include a means to address circumstances under which it would be medically contraindicated to use lifting or transfer aids or assistive devices for particular patients;
d.Designate and train a registered nurse or other appropriate licensed health care professional to serve as an expert resource, and train all clinical staff on safe patient handling policies, equipment, and devices before implementation, and at least annually or as changes are made to the safe patient handling policies, equipment and/or devices being used;
e.Conduct an annual performance evaluation of the safe patient handling with the results of the evaluation reported to the safe patient handling committee or other appropriately designated committee. The evaluation shall determine the extent to which implementation of the program has resulted in a reduction in musculoskeletal disorder claims and days of lost work attributable to musculoskeletal disorder caused by patient handling, and include recommendations to increase the program's effectiveness; and
f.Submit an annual report to the safe patient handling committee of the facility, which shall be made available to the public upon request, on activities related to the identification, assessment, development, and evaluation of strategies to control risk of injury to patients, nurses and other health care workers associated with the lifting, transferring, repositioning, or movement of a patient.
2.Nothing in this section precludes lift team members from performing other duties as assigned during their shift.
3.An employee may, in accordance with established facility protocols, report to the committee, as soon as possible, after being required to perform a patient handling activity that he/she believes in good faith exposed the patient and/or employee to an unacceptable risk of injury. Such employee reporting shall not be cause for discipline or be subject to other adverse consequences by his/her employer. These reportable incidents shall be included in the facility's annual performance evaluation.
16.10.7Interdisciplinary Team
A.The governing body or other legal authority shall designate an interdisciplinary team composed of staff personnel which includes:
1.Patient/family;
2.Physician(s) (to include physician(s) who are experts in the treatment of specific conditions and also in the rehabilitation of the patient as a whole);
3.Professional (registered) nurse;
4.Social worker;
5.Physical, occupational, speech and hearing, psychologists; and
6.Such other staff and non-staff personnel as may be deemed necessary.
B.The interdisciplinary team shall be responsible for patient education, the development, implementation and assessment of patient/family plans of care, and in addition:
1.The supervision of care, clinical health and rehabilitation services provided;
2.The provision of direct patient care as may be required and appropriate;
3.The review on an ongoing regularly scheduled basis of patient/family plans of care, and the revision of such plans of care, and development of a discharge plan as may be required;
4.The development of policies and procedures governing patient/family care and services; and
5.Such other duties as may be deemed appropriate.
16.10.8Contracts or Agreements
A.There shall be written contract(s) or agreement(s) for the provisions of those services which are not provided directly by the center. The contract(s) or agreement(s) shall clearly delineate the responsibilities of the parties involved and shall include no less than the following provisions:
1.The responsibilities, functions, objectives, terms of agreement, financial arrangements, charges and other pertinent requirements shall be clearly delineated in the terms of the contract or agreement negotiated between the parties involved;
2.Assurance that the services to be provided are in accordance with the plan of care;
3.The manner in which the contracted services are coordinated, supervised and evaluated;
4.Establish the frequency of patient care assessment; and
5.Such other provision as may be deemed appropriate.
16.10.9Clinical Records
A.A clinical record shall be established and maintained for every person admitted to any level of care (inpatient, day patient or outpatient). Such record shall follow the patient at each level of care in order to insure continuity of care.
B.Written policies and procedures shall be established regarding content and completion of clinical records.
C.Entries in the clinical record shall be made by the responsible person providing care or services in accordance with the center's policies and procedures.
D.The clinical record shall contain sufficient information to identify the patient and the problem and to describe the rehabilitation treatment modalities of care and the patient's response to the rehabilitation care and services.
E.The content of the clinical records (inpatient, day patient, outpatient) shall conform with applicable standards of § 16.2(A) of this Part
F.Provisions shall be made for the safe storage of clinical records of reproduction in accordance with § 16.2(B) of this Part.
G.All clinical records either original or accurate reproductions shall be preserved for a minimum of five (5) years following discharge of the patient in accordance with R.I. Gen. Laws § 23-3-26.
1.Records of minors shall be kept for at least five (5) years after such minor shall have reached the age of 18 years.
16.10.10Rights of Patients
A.Every center shall observe the standards as enumerated in R.I. Gen. Laws Chapter 23-17-19.1 with respect to each patient who is admitted to its center.
B.A copy of the Rights of Patients shall be given to each patient or his/ her representative upon admission and shall be posted in a conspicuous place on the premises in accordance with R.I. Gen. Laws § 23-17-19.2.
16.10.11Financial Disclosure
A.Any health care facility licensed pursuant to R.I. Gen. Laws Chapter 23-17, which refers clients to another such licensed health care facility or to a residential care/assisted living facility licensed pursuant to R.I. Gen. Laws Chapter 23-17.4, or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client:
1.That the referring entity has a financial interest in the facility or provider to which the referral is being made; and
2.That the client has the option of seeking care from a different facility or provider which is also licensed and/or certified by the state to provide similar services to the client.
3.The referring entity shall also offer the client a written list prepared by the Department of Health of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting:
Rhode Island Department of Health
Center for Health Facility Regulations
3 Capitol Hill, Room 306 Providence, RI 02908
401.222.2566
16.10.12Abuse, Neglect, or Mistreatment
A.The center shall report within 24 hours, to the state agency, allegations of patient abuse, neglect or mistreatment as defined in R.I. Gen. Laws Chapter 23-17-8.
1.The center shall maintain evidence that all allegations of abuse, neglect, and/or mistreatment have been thoroughly investigated and that further potential abuse has been prevented while the investigation is in progress. Appropriate corrective action shall be taken, as necessary. The results of said investigation shall be reported to the state agency within five (5) business days.
16.10.13Uniform Reporting System
A.Each center shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director with the advice of the Health Services Council.
B.Each center shall report to the state agency detailed financial and statistical data pertaining to its operations, services, and facilities. Such reports shall be made at such intervals and by such dates as determined by the Director and shall include but not be limited to the following:
1.Utilization of the center and its services;
2.Unit cost of center services;
3.Charges for rooms and services;
4.Financial condition of the center; and
5.Quality of rehabilitative care.
C.The state agency is authorized to make the reported data available to any state agency concerned with or exercising jurisdiction over the reimbursement or utilization of the center.
D.The directives promulgated by the Director pursuant to this Part shall be sent to each center to which they apply. Such directives shall prescribe the form and manner in which the financial and statistical data required shall be furnished to the state agency.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.11** Patient Care Services {#sec-216-ricr-40-10-16-16.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.11}
16.11.1Management Responsibility
A.The rehabilitation hospital center through its Medical Director shall be responsible to ensure that all health and holistic rehabilitation services and programs, including services provided per contract or arrangement are rendered in a safe and effective manner consistent with acceptable standards of practice, policies of the center and the requirements of this Part.
1.Furthermore, the Medical Director shall be responsible to ensure that all patients receive adequate medical/surgical treatment, as may be required for specific conditions, in an appropriate facility.
B.The center shall assure the continuity of patient care in the inpatient, day patient and outpatient settings through written policies, procedures and criteria pertaining to no less than the following:
1.Criteria and policies and procedures for admissions to each level of care and initial assessment of patient care needs;
2.Signed informed consent;
3.Ongoing assessment of patient/family needs;
4.Development and review of the plan of care by the interdisciplinary team;
5.Transfer of patients for acute medical-surgical problems; (see § 16.11.1(A) of this Part)
6.The provision of appropriate information to patient/family at the points of transfer between levels of care;
7.Community or other resources, including consultation services, to insure continuity of care to meet patient care needs;
8.Constraints imposed by limitations of services, patient and home conditions, or other; and
9.Such other criteria as may be deemed appropriate.
16.11.2Plan of Care
A.After initial assessment of patient rehabilitative needs, a written plan of care shall be established by the interdisciplinary team for each patient admitted to the center and at each level of care and with the participation of the patient or responsible party. Such plan shall designate the intensity of services required in relation to the disability and the individual's response to treatment and shall include provisions pertaining to:
1.Pertinent diagnosis and prognosis;
2.Identification of the intensity of patient care needs including:
a.The range of rehabilitation services required;
b.The level of care required;
c.The frequency of therapeutic services required;
d.Medications;
e.Management of discomfort and pain control; and
f.Other rehabilitative needs and prescribed therapies;
3.Such other relevant modalities of care, training and services as may be appropriate to meet the patient's rehabilitative needs.
B.Patient care plans shall be reviewed and updated at periodic intervals as specified in the plan of care by the multidisciplinary team.
16.11.3Levels of Care
A.Inpatient Care: shall be for the provision of intensive functional rehabilitation services through the interdisciplinary team, for patients who require uninterrupted rehabilitation and nursing care services including a range of intensive rehabilitation services referred to in § 16.11.4 of this Part as related to patient's disability and response to treatment.
B.Day Care: shall be for the provision of rehabilitation services through the Interdisciplinary Team to patients whose condition continues to require intensive functional rehabilitation services as provided in the inpatient setting, but who can accommodate to a less protective environment such as his or her home, without interrupting the rehabilitation process.
C.Outpatient: shall refer to the provision of coordinated and integrated assessment and/or rehabilitation services with emphasis on continuity of care, education and training to individuals with disabling impairments requiring less intensive rehabilitation, supervision and support services.
16.11.4Rehabilitation Services
A.Physician Services: shall be available and/or on call on a twenty-four (24) hour basis and be provided by physician(s) who shall be responsible for the diagnosis and treatment of disabled patients, and who shall participate with members of the interdisciplinary team in the development, implementation and assessment of patient care plans.
B.Nursing Services: shall be provided on a twenty-four (24) hour basis under a licensed professional (registered) nurse in accordance with R.I. Gen. Laws Chapter 5-34, who has training and experience in rehabilitation nursing and who shall be responsible to meet the rehabilitative nursing needs of patients as prescribed in the patient's plan of care and in accordance with acceptable standards of practice.
1.There shall be a sufficient number of licensed professional (registered) nurses on duty at all times to plan, assign, supervise, implement and evaluate nursing care as well as to provide direct patient care as required.
2.The number and type of licensed nurses and ancillary nursing personnel shall be based on evaluation of patient care needs and staff capabilities for each patient care unit.
3.Administration of drugs by non-licensed personnel, selected non-licensed personnel with demonstrated competency, who have satisfactorily completed a state approved training program in drug administration may administer oral or topical drugs, if adequate medical and nursing supervision is provided in accordance with R.I. Gen. Laws Chapter 5-34.
C.Social Services: shall be provided as prescribed in the plan of care and in accordance with acceptable standards of practice and center policies. Social Workers hired after January 1, 2019 shall be qualified on the basis of education, training and experience in accordance with the provisions of R.I. Gen. Laws Chapter 5-39.1. Staff providing social services hired before December 31, 2018 shall have at least a bachelor's degree in social work from a school accredited or approved by the Council on Social Work Education.
D.Therapeutic Services: All therapeutic services shall be provided as prescribed by the interdisciplinary team in the plan of care. Such therapeutic services shall be provided by appropriate staff or consultants in accordance with the center's policies and procedures and consistent with prevailing standards of practice. Furthermore, therapists staff or consultants shall participate in the development, implementation and assessment of patient care plans.
1.Therapists and assistants (physical, occupational, speech, audiologist) shall furthermore hold current licensure, certification or registration as may be required under R.I. Gen. Laws Chapters 5-34, 5-40, and 5-40.1.
E.Psychological Services: shall be provided by qualified psychologists who are certified in the State of Rhode Island in accordance with R.I. Gen. Laws Chapter 5-44. Such services shall be provided as prescribed in the plan of care and the psychologist(s) shall also participate in the development, implementation and assessment of the patient's plan of care.
F.Pastoral Care: Clergymen or members of various denominational organizations or churches shall have access to patients. Patients shall be notified of the availability of such services.
G.Prosthetic/Orthotic Services: shall be rendered as prescribed in the plan of care and provided by individuals with training and experience in prosthetics and/or orthotic services, who shall also participate in the development, implementation and assessment of the plan of care.
H.Allied Rehabilitation Services: such as pre-vocational, vocational, driver training shall also be provided in accordance with center policies and through written agreement with agencies providing vocational training or driver education.
I.Other Rehabilitation Services: all other rehabilitation services, including recreation services, provided by the center shall be provided by individuals with appropriate qualifications and rendered in accordance with acceptable standards or practice.
16.11.5Infection Control
A.The center shall make provisions through patient care and personnel policies for the control of infection and for the protection of patients and personnel. Policies shall pertain to no less than the following:
1.Sanitation and medical asepsis;
2.Disposal of solid waste materials;
3.Admission and isolation of patients with known or suspected infections, diseases and other protective isolation;
4.The establishment of a center-wide surveillance program which shall include an infection surveillance officer to conduct all infection surveillance activities. This shall include a system of periodic reporting, evaluation and recording of the occurrence of infections among personnel and patients;
5.The monitoring of staff personnel to insure the implementation of policies and procedures for the control of infection control.
B.Reporting of Communicable Diseases: Each center shall report promptly to the Rhode Island Department of Health, Division of Disease Control, cases of communicable diseases designated as "reportable diseases" in accordance with the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental, and Occupational Diseases (Part 30-05-1 of this Title) when such cases are diagnosed.
1.When outbreaks of food borne illness are suspected, such occurrences shall be updated immediately to the Rhode Island Department of Health, Division of Disease Control or to the Division of Food Protection and Sanitation.
16.11.6Dietary Services
A.A center shall maintain a dietary service directed by a full-time person qualified by training and experience in organization and administration of food service.
B.Each center shall have at least one Registered Dietitian, licensed by the state and certified by the Commission on Dietetic Registration, employed on either a full-time, or regular part-time basis to direct nutritional aspects of patient care and to advise on food preparation and service.
C.Adequate space, equipment and supplies shall be provided for the efficient, safe and sanitary receiving, storage, refrigeration, preparation and service of food and other related aspects of the food service operation in accordance with the Rhode Island Food Code (Part 50-10-1 of this Title)
1.Any construction, addition, alteration affecting food service operations shall be in conformance with the requirements of R.I. Gen. Laws § 23-1-31.
D.The food service operation shall comply with applicable standards of the Rhode Island Food Code (Part 50-10-1 of this Title).
E.Written policies and procedures shall be established for dietary services, pertaining to but not limited to the following:
1.Responsibilities and functions of personnel;
2.Advising the administrator on all nutritional aspects of patient care, food service and preparation;
3.Alterations or modification to diet orders;
4.Food purchasing, storage preparation and service;
5.Safety and sanitation relative to personnel and equipment;
6.Ancillary dietary services, including food storage and preparation in satellite kitchens, and vending operations;
7.Providing dietary counseling to patients when necessary; and
8.Ice making in accordance with Good Manufacturing Practices for Food (Part 50-10-4 of this Title).
F.Any center engaged in processing or handling or both, of frozen foods shall be subject to standards of Good Manufacturing Practices for Food (Part 50-10-4 of this Title).
G.There shall be a diet manual maintained by the dietary service which shall be reviewed, periodically revised as necessary and approved by the medical staff. Diets served to patients shall comply with the principles set forth in the diet manual.
H.All patient diets shall be ordered in writing by the physician.
I.A dining room shall be available for those patients who wish to participate in group dining in accordance with § 16.13.3(A)(5) of this Part.
J.Self-help feeding program shall be available to those patients who need them to maintain maximum independence in the activities of daily living.
K.A center contracting for food service shall require as a part of the contract, that the contractor comply with the provisions of the rules and regulations of this Part.
L.All menus shall be planned at least one week in advance and shall provide for a variety of foods, adjusted for seasonal changes, and reflecting the dietary preferences of patients. Menus shall be posted in a conspicuous place in the dietary department and records of such shall be retained for thirty (30) days.
16.11.7Laboratory and Radiology Services
A.Clinical laboratory services shall be in accordance with the provisions of R.I. Gen. Laws § 23-16.2-3 and the Federal CLIA regulation: 42 C.F.R. § 439. The Center must also maintain the appropriate CLIA certificate to the level of testing being performed.
B.A center providing radiology services must meet the requirements of regulations regarding Radiation (Subchapter 20 of this Chapter).
1.Authentication reports of radiological interpretations, consultations shall be part of the patient's clinical record.
C.Centers contracting with outside resources for laboratory and/or radiology services shall contract only with:
1.Laboratories which meet the requirements of the rules and regulations for Clinical Laboratories and Stations (Part 60-05-4 of this Title); and
2.Radiation facilities which meet the requirements of the rules and regulations for Radiation (Subchapter 20 of this Chapter).
16.11.8Pharmacy
A.Each Rehabilitation Hospital Center shall provide pharmaceutical services either directly within the institution or by contractual arrangement. In either instance, there shall be evidence of a current pharmacy license in compliance with R.I. Gen. Laws § 5-19.1-8. Pharmaceutical services shall be provided in accordance with the rules and regulations pertaining to Pharmacists, Pharmacies, and Manufacturers, Wholesalers and Distributors (Subchapter 15 Part 1 of this Chapter).
B.An emergency medication kit, approved by the pharmaceutical service committee or its equivalent, shall be kept at each nursing station.
16.11.9Quality Assurance Program
A.Each center shall establish and maintain on an ongoing basis a Quality Assurance Program which involves assessment of all quality assurance activities conducted in the provision of its health care and rehabilitation program and services at all levels which shall include no less than:
1.Establishment of standards and criteria for the assessment of the quality of health and rehabilitation program and services provided and the appropriateness of the resources utilized;
2.Assessment of rehabilitation outcomes;
3.Ongoing review of rehabilitation programs and services by physicians and other health professionals;
4.A mechanism to assure the utilization of systematic data collection based on valid samples of the total patient population to measure performance and patient results, and to make recommendations to physicians and centers of needed changes;
5.Provisions for combining utilization data and financial data into management reports which shall be available to the Director of Health;
6.Arrangements of routine reporting of results of quality assurance program activities to the governing body, administration, providers, and the Director of Health; and
7.Written procedures for taking appropriate remedial action whenever, as determined under the quality assurance program, inappropriate or substandard services have been provided or services which should have been furnished have not been provided.
16.11.10Equipment
A.Each center shall have an assortment of styles and sizes of adaptive equipment for patient evaluation and training in the following areas:
1.Beds - e.g., beds & accessories, mattresses, waterproof bed protection, enuresis, alarms, self-fitting aids, bed and cantilever tabled, protective devices for incontinency.
2.Pressure relief -e.g., beds and cushions designed for pressure relief, sheepskins.
3.Chairs -e.g., geriatric, adjustable and mobile chairs, self-lift seats, therapeutic training wheelchairs.
4.Communication -e.g., reading aids, writing and speech aids, deaf aids, remote control apparatus.
5.Eating and Drinking Aids -e.g., non-slip materials, trays, cutlery.
6.Electro Diagnostic - EMG
7.Hoists and Lifting Equipment -e.g., portable, fixed and electric hoists, manual lifting aids, car hoists, stair climbers.
8.Leisure Activities - e.g., music, sports, hobbies, crafts, sewing.
9.Sport & Physical Recreation -e.g., (facilities for disabled people) clubs concerned with sports for disabled.
10.Personal Toilet and Personal Care -e.g., commodes, hair washing, showers, aids for incontinency.
11.Prosthetics and Orthotics - adjustable models.
12.Walking Aids and Wheelchairs
13.Household equipment/fittings
14.Clothing/footwear
15.Therapeutic Devices: nerve muscle stimulators; exercise equipment -e.g., weight/pulleys, ergometer, treadmill; Modalities: mv/heat/ microwave, traction; Positioning; Hydrotherapy (whirlpool and therapeutic pool)
16.Other Diagnostic: E.K.G.; Pulmonary function; Biofeedback & video feedback; audio and visual equipment; and prevocational, e.g. adjustable heights and accessible work stations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.12** Environmental and Maintenance Services {#sec-216-ricr-40-10-16-16.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.12}
16.12.1Disaster Preparedness
A.Each center shall develop and maintain a written disaster preparedness plan which shall include plans and procedures to be followed in case of fire or other emergencies.
B.The plan and procedures shall be developed and coordinated with assistance of qualified safety and other appropriate experts, including the appropriate state and local agencies and representatives concerned with emergency, safety, rescue and disaster preparedness.
C.The plan shall include procedures to be followed pertaining to no less than the following:
1.Fire, explosion, hurricane, loss of power and/or water, flooding and other calamities;
2.Transfer of casualties;
3.Location and use of alarm systems, signals and fire fighting equipment;
4.Containment of fire;
5.Notification of appropriate persons;
6.Relocation of patients and evacuation routes;
7.Handling of drugs and biologicals; and
8.Any other essentials as may be warranted.
D.A copy of the plan shall be available at every nursing unit.
E.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the center.
F.Simulated drills testing the effectiveness of the plan shall be conducted for all shifts at least twice a year. Written reports and evaluation of all drills shall be maintained by the facility.
G.All personnel shall receive training in disaster preparedness as part of their employment orientation.
16.12.2Housekeeping
A.A full-time employee of the center shall be designated responsible for housekeeping services, supervision and training of housekeeping personnel.
B.Sufficient housekeeping and maintenance personnel shall be employed to maintain a comfortable, safe, clean, sanitary and orderly environment in the center.
1.Housekeeping personnel may assist in food distribution but not food preparation. Careful hand washing should be done prior to assisting in food distribution.
C.Written housekeeping policies and procedures shall be established for the operation of housekeeping services throughout the facility. Copies shall be available for all housekeeping personnel.
D.All parts of the center and its premises shall be kept clean, neat and free of litter and rubbish and offensive odors.
E.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition and shall be properly stored.
F.Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other cleaning materials.
G.Cleaning shall be performed in a manner which will minimize the development and spread of pathogenic organisms in the environment.
H.Exhaust ducts from kitchens and other cooking areas shall be equipped with proper filters and cleaned at regular intervals. The ducts shall be cleaned as often as necessary and inspected by the facility no less than twice a year.
I.Centers contracting with outside resources for housekeeping services shall require conformance with existing regulations
16.12.3Laundry Service
A.Each center shall make provisions for the cleaning of all linens and other washable goods.
B.A center providing laundry service shall have adequate space and equipment for the safe and effective operation of a laundry service. In unsewered areas, approval shall be obtained of the sewage system from the state agency to ensure its adequacy.
C.Written policies and procedures for the operation of the laundry service, including special procedures for the handling and processing of contaminated linens, shall be established.
D.There shall be distinct areas for the separate storage and handling of clean and soiled linens.
1.The soiled linen area and the washing area shall be negatively pressurized or otherwise protected to prevent introduction of airborne contaminants.
2.The clean linen area and the drying area shall be physically divorced from the soiled linen area and the washing area.
E.All soiled linen shall be placed in closed containers prior to transportation.
F.To safeguard clean linens from cross-contamination they shall be transported in containers used exclusively for clean linens which shall be kept covered at all times while in transit and stored in areas designated exclusively for this purpose.
G.Centers contracting for services with an outside resource shall require conformance with this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.13** Physical Plant {#sec-216-ricr-40-10-16-16.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.13}
16.13.1New Construction, Additions or Modifications
A.All construction, as defined in rules and regulations pursuant to R.I. Gen. Laws Chapter 23-15 shall be subject to the following provisions:
1.R.I. Gen. Laws Chapter 23-15.
2.Rhode Island Food Code (Part 50-10-1 of this Title).
3.R.I. Gen. Laws § 23-1-31.
4.R.I. Gen. Laws Chapter 23-28.1.
5.R.I. Gen. Laws Chapter 23-27.3.
6.Incorporated materials at § 16.2(D) of this Part.
7.Facility Guidelines Institute’s "Guidelines for Design and Construction of Hospital and Outpatient Facilities" (2014). “
8.Incorporated materials at § 16.2(A) of this Part.
9.In addition, any other applicable state and local law, codes and regulations shall apply. Where there is a difference between codes, the code having the higher standard shall apply.
16.13.2General Provisions - Physical Environment
A.Each center shall be constructed, equipped and maintained to protect health and safety of disabled patients, personnel and the public. All equipment and furnishings shall be maintained in good condition, properly functioning and replaced when necessary.
B.The entire physical plan, including functional units of the center, service areas, shall be accessible to, and functional for disabled patients, personnel and the public. All necessary accommodations shall be made to meet the needs of persons with mobility disabilities or sight, hearing and coordination or perception disabilities in accordance with “The American Nation Standard-Specifications for Making Buildings and Facilities Accessible to and Usable by the Physically Handicapped (ANSI)”, incorporated above in § 16.2(D) of this Part and the Facility Guidelines Institute’s "Guidelines for Design and Construction of Hospital and Outpatient Facilities" (2014).
C.Blind non-ambulatory, physically handicapped or patients with mobility disabilities which limit self-preservation capability shall not be housed above the street level floor unless the center is equipped with an elevator and meets other requirements of ANSI as incorporated above in in § 16.2(D) of this Part. Furthermore, the center must meet R.I. Gen. Laws § 23-28.1.
D.All rooms utilized by patients shall have proper ventilation and shall have outside opening with satisfactory screens. Grounds surrounding the center shall be accessible to and usable by patients and shall be maintained in an orderly and well-kept manner.
16.13.3Functional Units and Service Areas
A.All functional units and service areas of the rehabilitation hospital center shall be based on the guidelines for rehabilitation facilities in the Facility Guidelines Institute’s "Guidelines for Design and Construction of Hospital and Outpatient Facilities" (2014) and Standards for Facilities Serving People with Disabilities” incorporated above in § 16.2(A) of this Part. Such functional units and service areas shall include:
1.Nursing unit (for Inpatients);
2.Day Patient and Out Patient units;
3.Dietary Unit pursuant to § 16.11.6 of this Part;
4.Psychological/Social or Vocational Services Unit;
5.Patients' Dining, Recreation and Day Spaces.
a.If a multi-purpose room is used, there must be sufficient space to accommodate dining and patient activities of both inpatient and day patients and present interference with each other;
b.Storage shall be provided for recreational equipment and supplies.
6.Unit for Teaching Activities of Daily Living: bathing, dressings, going to toilet, continence, feeding and transfer;
7.Physical and Occupational Units, Prosthetics and Orthotics; and
8.Such other units as may be required in accordance with the aforementioned rules and regulations.
16.13.4Special Care Unit
A patient room shall be designated for isolation purposes. Such room shall be properly identified with precautionary signs, shall have outside ventilation, private toilet and hand washing facilities.
16.13.5Therapeutic Pools
Centers providing therapeutic pool services shall be subject to the applicable rules and regulations of Aquatic Venues (Part 50-05-4 of this Title).
16.13.6Fire and Safety
A.Each center shall meet the requirements of R.I. Gen. Laws Chapter 23-28.1 pertaining to fire and safety.
B.A monitoring program for the internal enforcement of all applicable fire and safety laws and regulations shall be established. Such program shall include written procedures for the implementation of policies, regulations and statutes. A log of such monitoring shall be maintained.
16.13.7Lighting and Electrical Services/Emergency Power
A.All electrical and other equipment used in the center shall be maintained free of defects which could be a potential hazard to patients or personnel. Periodic calibration and/or preventive maintenance of equipment shall be provided and documentation of all testing shall be maintained.
B.All electrical appliances used by centers shall have the Underwriters Laboratories label or be approved by local electrical inspection authorities.
C.Each center shall be equipped with an alternate emergency power source. The emergency electrical power system shall have a sufficient capacity to supply power to maintain the operation of any life-support systems, lighting egress, fire detection equipment, alarm and extinguishing system.
1.Monthly testing of emergency power shall be documented and reports retained for at least three (3) years.
16.13.8Incinerators
A.Incinerators within hospitals shall be segregated from other parts of the building by non-combustible construction, with walls, floors and ceilings having a fire resistance rating of not less than two hours. Openings to such rooms shall be protected by Class B fire doors, and equipped with positive self-closing devices in accordance with R.I. Gen Laws Chapter 23-28.1.
B.Incinerators within the center shall meet the Department of Environmental Management’s "Air Pollution Control Regulation No. 12 - Incinerators".
16.13.9Plumbing
A.All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of R.I. Gen. Laws Chapter 23-27.3. The local codes will supersede the aforementioned only if they are more stringent.
B.All plumbing shall be installed in such a manner as to prevent back siphonage or cross connections between potable and non-potable water supplies.
C.Fixtures from which grease is discharged shall be served by a line in which a grease trap is installed. The grease trap shall be cleaned sufficiently often to sustain efficient operation.
16.13.10Waste Water Disposal
Any new center shall be connected to a public sanitary sewer.
16.13.11Waste Disposal
A.Medical Waste. Medical waste as defined in the Rhode Island Department of Environmental Management’s Medical Waste Regulations (250-RICR-140-15-1) shall be managed in accordance with the provisions of the aforementioned regulations.
1.Such hazardous waste materials shall be placed in watertight and durable containers in accordance with acceptable practices for transportation.
B.Other Waste. Wastes which are not classified as medical waste, hazardous wastes or which are not otherwise regulated by law or rule may be disposed in dumpsters or load packers provided the following precautions are maintained:
1.The recommendations of the United States Consumer Product Safety Commission, subchapter B-Consumer Product Safety Commission Regulations, should serve as guidelines in establishing protective measures against hazardous dumpsters and load packers.
2.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pick-up schedule shall be maintained with more frequent pick-ups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management.
3.Load packers must conform to the same restrictions required from dumpsters and in addition, load packers shall be: high enough off the ground to facilitate the cleaning of the underneath area of the stationary equipment; and the loading section should be constructed and maintained to prevent rubbish from blowing from said area site.
16.13.12Water Supply
A.Water for consumption shall be obtained from a community water system defined in rules and regulations pertaining to Public Drinking Water (Part 50-05-1 of this Title) approved by the Department of Health.
B.The water shall be distributed to conveniently located taps and fixtures throughout the buildings and shall be adequate in volume and pressure for all center purposes, including firefighting.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-16 § 16.14** Practices and Procedures, Confidentiality {#sec-216-ricr-40-10-16-16.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-16#16.14}
16.14.1Variance Procedure
A.The state agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such variance will not be contrary to the public interest, public health and/or health and safety of patients.
B.A request for a variance shall be filed by an applicant in writing setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the state agency and within thirty (30) days thereafter, the state agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the center appeals the denial.
16.14.2Deficiencies and Plans of Correction
A.The state agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the state agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The state agency will be required to approve or reject the plan of correction submitted by a facility in accordance with § 16.14.2 of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the state agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 16.14.2 of this Part, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the state agency may invoke the sanctions enumerated in § 0 of this Part. If the facility is aggrieved by the action of the state agency, the facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department of Health shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 23-45. The hearing shall in all respects comply with the provisions therein.
16.14.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17 shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
16.14.4Confidentiality
Disclosure of any health care information relating to individuals shall be subject to the provisions of the "Confidentiality of Health Care Information" of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and federal requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/29/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2002-08-04 to 04/07/2005*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-17** Licensing Home Nursing Care Providers and Home Care Providers
##### **216-RICR-40-10-17 § 17.1** Authority {#sec-216-ricr-40-10-17-17.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.1}
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-17-10 and 23-17-42 and are established for the purpose of adopting minimum standards for licensed home nursing care and home care providers in this State.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.2** Reserved {#sec-216-ricr-40-10-17-17.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.2}
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.3** Definitions {#sec-216-ricr-40-10-17-17.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.3}
A.Wherever used in these Rules and Regulations the following terms shall be construed to mean:
1."Abuse" means:
a.Any assault as defined in R.I. Gen. Laws Chapter 11-5, including, but not limited to, hitting, kicking, pinching, slapping, or the pulling of hair; provided, however, unless it is required as an element of the offense charged, it shall not be necessary to prove that the patient or resident was injured by the assault;
b.Any assault as defined in R.I. Gen. Laws Chapter 11-37;
c.Any offense under R.I. Gen. Laws Chapter 11-10;
d.Any conduct which harms or is likely to physically harm the patient or resident except where the conduct is a part of the care and treatment, and in furtherance of the health and safety of the patient or resident;
e.Intentionally engaging in a pattern of harassing conduct which causes or is likely to cause emotional or psychological harm to the patient or resident, including but not limited to, ridiculing or demeaning a patient or resident, making derogatory remarks to a patient or resident or cursing directed towards a patient or resident, or threatening to inflict physical or emotional harm on a patient or resident.
2."Administrator" means an individual who:
a.Is a licensed physician; or
b.Has training and experience in health service administration and at least one (1) year of supervisory or administrative experience in home nursing care or home care or related health programs; or
c.Is a registered nurse who meets qualifications of as set forth in 42 C.F.R. Part 484 (2022).
3.“Advanced practice registered nurse” or “APRN” means the title given to an individual licensed to practice advanced practice registered nursing with one (1) of the following roles: Certified Nurse Practitioner (CNP), Certified Registered Nurse Anesthetist (CRNA) as defined in R.I. Gen. Laws Chapter 5-34.2, or Certified Clinical Nurse Specialist (CNS) and who functions in a population focus. An APRN may serve as a primary or acute-care provider of record.
4."Attending clinician" means a physician, physician assistant, advanced practice registered nurse, certified nurse midwife, certified midwife, or certified clinical nurse specialist identified by the patient/client/family as having a significant role in the determination and delivery of the individual's medical care.
5."Branch office" means a location from which a licensed home nursing care provider or licensed home care provider provides services within a portion of the total geographic area served by the licensed central office.
6."Change in operator" means a transfer by the governing body or operator of a home nursing care or home care provider to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.Hire or fire the Chief Executive Officer of the home nursing care provider or home care provider;
b.Maintain and control the books and records of the home nursing care provider or home care provider;
c.Dispose of assets and incur liabilities on behalf of the home nursing care provider or home care provider; or
d.Adopt and enforce policies regarding operation of the home nursing care provider or home care provider.
e.This definition is not applicable to circumstances wherein the governing body of a home nursing care provider or home care provider retains the immediate authority and jurisdiction over the activities enumerated above.
7."Change in owner" means:
a.In the case of a home nursing care provider or home care provider which is a partnership, the removal, addition, or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership.
b.In the case of a home nursing care provider or home care provider which is an unincorporated solo proprietorship, the transfer of the title and property to another person;
c.In the case of a home nursing care provider or home care provider which is a corporation:
(1)A sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two (2) or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a home nursing care provider or home care provider which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or
(5)In the case of a home nursing care provider or home care provider which is a non- business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation.
8.“Certified clinical nurse specialist” means an advance practice registered nurse who independently provides care to clients; facilitates attainment of health goals; and provides innovation in nursing practice based on clinical expertise, evidence-based decision making, and leadership skills. The Clinical Nurse Specialist practices with individual clients and populations; nurses and other multidisciplinary team members; and organizations to effect system-wide changes to improve programs of care. The practice may include prescriptive privileges.
9.“Certified nurse midwife” means a person who has successfully completed an accredited education program in midwifery, holds a current certification as a nurse-midwife by the American Midwifery Certification Board (AMCB) and is licensed to practice midwifery in Rhode Island.
10.“Department” means the Rhode Island Department of Health.
11."Director" means the Director of the Rhode Island Department of Health.
12.“Equity” means non-debt funds contributed towards the capital costs related to an initial licensure or change in owner or change in operator of a home nursing care provider or home care provider which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
13."Fluency" means the ability to converse freely in a language.
14."Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including, but not limited to, hospitals; nursing facilities; home nursing care providers (which shall include skilled nursing services and may also include activities allowed as a home care provider or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services); rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care and physician office settings providing surgical treatment and podiatry ambulatory-surgery centers providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities that are not part of a hospital but that are organized and operated to provide health care services to outpatients such as central services facilities serving more than one (1) health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school-based health centers, and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-5.1 (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation organization, or association). Facilities licensed by the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals and clinical laboratories licensed in accordance with R.I. Gen. Laws Chapter 23-16.2, as well as Christian Science institutions, also known as Christian Science Nursing Facilities, listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of this Part.
15.“Health care provider” means any person licensed by the State of Rhode Island to provide or otherwise lawfully providing health care services, including, but not limited to, a physician, hospital, intermediate care facility or other health care facility, dentist, nurse, APRN, Certified Clinical Nurse Specialist, physician assistant, optometrist, podiatrist, physical therapist, psychiatric social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health services.
16.“High managerial agent" means an officer of a licensee, the administrator and assistant administrator of the facility, the Director and Assistant Director of Nursing Services, or any other agent in a position of comparable authority with respect to the formulation of policies of the facility or the supervision in a managerial capacity of subordinate employees.
17."Home care provider" means any person that provides, arranges to provide, offers to provide, or in any other way provides for the delivery of any direct health care services in the home requiring supervision by a Registered Nurse (RN), but excludes the delivery of direct nursing care by a Registered (RN) or Licensed Practical (LPN) Nurse on an on-going basis; Also as used in this Part, "home care provider" includes homemaker services as defined in this Part. Nursing service agency services may also be provided under this license provided such services are rendered in accordance with Part 10 of this Subchapter, Licensing Nursing Service Agencies.
18."Home nursing care provider" means any person that provides, arranges to provide, offers to provide, or in any other way provides for the delivery of direct nursing services in the home by a Registered (RN) or licensed Practical (LPN) Nurse or therapeutic services provided by an applicable, licensed healthcare provider. As used in this Part, “home nursing care provider” may include home care provider services. Nursing service agency services may also be provided under this license provided such services are rendered in accordance with Part 10 of this Subchapter, Licensing Nursing Service Agencies.
19.“Home health aide” means “nursing assistant.”
20.“Homemaker” means a trained non-professional worker who performs related housekeeping services in the home for the sick, disabled, dependent or infirm.
21.“Homemaker services” means housekeeping services performed in the home for the sick, disabled, dependent, or infirm by a trained non-professional worker who is supervised in accordance with the requirements of § 17.5.3(H)(2) of this Part.
22.“Licensing agency” means the Rhode Island Department of Health.
23.“Medical services” means such professional services and supplies rendered by or under the direction of persons duly licensed under the laws of the State of Rhode Island to practice medicine or to provide medical and surgical services in collaboration with physicians, or podiatry, or advanced practice nursing as may be specified by any medical service plan. Medical services shall not be construed to include hospital services.
24.“Mistreatment” means the inappropriate use of medications, isolation, or use of physical or chemical restraints:
a.As punishment;
b.For staff convenience;
c.As a substitute for treatment or care;
d.In conflict with a physician’s order; or
e.In quantities which inhibit effective care or treatment, or which harms or is likely to harm the patient or resident.
25.“Neglect” means the intentional failure to provide treatment, care, goods, and services necessary to maintain the health and safety of the patient or resident, or the intentional failure to carry out a plan of treatment or care prescribed by the physician of the patient or resident, or the intentional failure to report patient or resident health problems or changes in health problems or changes in health conditions to an immediate supervisor or nurse, or the intentional lack of attention to the physical needs of a patient or resident including, but not limited to toileting, bathing, meals, and safety. No person shall be considered to be neglected for the sole reason that he or she relies on or is being furnished treatment in accordance with the tenets and teachings of a well-recognized church or denomination by a duly-accredited practitioner of a well-recognized church or denomination.
26.“Nursing assistant” means a nurse’s aide, or home health aide, who is a paraprofessional, registered, pursuant to the provisions of R.I. Gen. Laws Chapter 23-17.9, and who is trained to give personal care and related health care and assistance based on his/her level of preparation to individuals who are sick, disabled, dependent or infirm, and who are residents of or receive services from health care facilities licensed pursuant to R.I. Gen. Laws Chapter 23-17, or who are receiving services from agencies licensed pursuant to R.I. Gen. Laws Chapter 23-17.7.1.
27.“Patient” means a person who receives home nursing care or home care provider services or who is judged to need home nursing care or home care provider services based upon the results of an initial screening. The terms “patient” and “client” are synonymous in the context of this Part.
28.“Person” means any individual, trust or estate, partnership, corporation (including associations, joint stock companies, and insurance companies) state or political subdivision or instrumentality of a State.
29.“Personal care services” means those services provided to a patient that do not require the skills of a licensed nurse. These services may include, but are not limited to: bathing, dressing, grooming, caring for hair/nails, and assistance with ambulation.
30.“Physician” means any individual licensed to practice medicine in Rhode Island.
31.“Physician assistant” means a person who is qualified by academic and practical training to provide medical and surgical services in collaboration with physicians and licensed in Rhode Island.
32.“Plan of care” or “care plan,” means the comprehensive written plan for the patient’s care. The plan shall include attending clinician orders for medications, treatments, procedures, or therapeutic services, where indicated; and shall also encompass patient assessments and treatment goals/objectives, including provisions for personal care and social needs. (For further requirements related to the patient’s plan of care, see §§ 17.4.4(A)(4) and 17.6.2(C) of this Part.
33.“Supervision” means clinical guidance provided by a qualified person for the assessment and monitoring of patient care management.
a.Registered Nurses and other appropriate professionals of the health care team, licensed, registered and/or certified as may be required by the laws of Rhode Island, shall supervise (directly or indirectly) Nursing Assistants. A registered nurse shall supervise any acts, functions or tasks performed by a Nursing Assistant that are nursing-related.
34.“Therapeutic services”, as used in this Part, means those treatments provided by a licensed health care professional that have medicinal or healing properties, such as, but not limited to, infusion, respiratory, occupational, speech, or physical therapy and that are included in the patient’s care plan.
35."Uncompensated care" means health care services provided by a home nursing care or home care provider for which the home nursing care or home care provider does not and has not expected payment and which health care services are not recognized as either a receivable or as revenue in the home nursing care or home care provider's financial statements.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.4** General Requirements for Licensure and Certificate of Need Requirements {#sec-216-ricr-40-10-17-17.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.4}
17.4.1General Requirements
A.No person acting alone or jointly with any other person, shall establish, conduct or maintain a home nursing care provider or home care provider in Rhode Island without a license in accordance with the requirements of R.I. Gen. Laws § 23-17-4 and in conformity with this Part. Provided, however, that any person, firm, corporation or other entity which provides volunteer registered and licensed practical nurses to the public shall not be required to have a license as a health care facility.
B.A certificate of need is required as a precondition to the establishment and initial licensure of any home nursing care provider or home care provider and such other activities in accordance with Part 22 of this Subchapter, Determination of Need for New Health Care Equipment and New Institutional Health Care Services.
1.Any certificate of need required as a precondition to the establishment and initial licensure or any change in owner, operator, or lessee of a licensed home nursing care provider or home care provider shall require prior review by the Health Services Council and approval of the licensing agency in accordance with §§ 17.2.2(C) and (E) of this Part, as a condition precedent to the issuance, transfer, or assignment of a new license.
C.No facility shall hold itself or represent itself as a home nursing care provider or home care provider or use the term "home nursing care provider or home care provider", "home health care provider" or other similar term in its advertising, publicity or any other form of communication, unless licensed as a home nursing care provider or home care provider in accordance with the provisions of this Part.
1.Any person establishing, conducting, managing, or operating any home nursing care provider or home care provider without a license shall be fined not more than five thousand dollars ($5,000.00) or imprisoned not more than one (1) year or both, in the discretion of the court, for each offense.
D.Each home nursing care provider or home care provider that maintains a branch office shall disclose to the licensing agency the location of their records (i.e., central office or branch office). At a minimum, all clinical records shall be maintained at the branch office for those patients served by the branch office.
E.Financial Interest Disclosure
1.Any health care facility licensed pursuant to R.I. Gen. Laws Chapter 23-17 which refers clients/patients to another such licensed health care facility or to a residential care/assisted living facility licensed pursuant to R.I. Gen. Laws Chapter 23-17.4, or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client/patient:
a.That the referring entity has a financial interest in the facility or provider to which the referral is being made;
b.That the patient/client has the option of seeking care from a different facility or provider which is also licensed and/or certified by the State to provide similar services to the patient/client.
2.The referring entity shall also offer the patient/client a written list prepared by the Department of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting: Rhode Island Department of Health Center for Health Facilities Regulation(CHFR)Capitol Hill, Room 306Providence, RI 02908
F.Non-compliance with §§ 17.4.1(E)(1) and (2) of this Part shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with R.I. Gen. Laws Chapter 23-17.10.
17.4.2Application for Certificate of Need or Changes in the Owner, Operator, or Lessee
A.Application for a Certificate of Need for a home nursing care provider or home care provider shall be made on forms provided by the licensing agency, and shall contain, but not be limited to. information pertinent to the statutory purpose expressed in R.I. Gen. Laws Chapter 23-15 or to the considerations enumerated in Part 22 of this Subchapter, Determination of Need for New Health Care Equipment and New Institutional Health Care Services.
1.Each application for Certificate of Need filed pursuant the provisions of § 17.4.2 of this Part shall be accompanied by an application fee, made payable to the General Treasurer, State of Rhode Island, in the amount specified in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
B.Application for changes in the owner, operator, or lessee of a home nursing care provider or home care provider shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3 or to the considerations enumerated in § 17.4.3(G) of this Part.
1.Each application for changes in the owner, operator, or lessee filed pursuant the provisions of § 17.4.2 of this Part shall be accompanied by a non-returnable, non-refundable application fee, made payable to the Rhode Island General Treasurer, in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
C.Review of an application for Certificate of Need for a home nursing care provider or a home care provider shall be conducted according to the procedures and criteria set forth in Part 22 of this Subchapter, Determination of Need for New Health Care Equipment and New Institutional Health Care Services. Review of an application for changes in the owner, operator, or lessee of licensed home nursing care provider or home care provider shall be conducted according to the following procedures:
1.Within ten (10) working days of receipt, in acceptable form of an application for initial licensure or for a license in connection with a change in the owner, operator or lessee of an existing home nursing care provider or home care provider, the licensing agency will notify and afford the public thirty (30) days to comment, when practicable, on such application.
2.The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application.
3.The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the licensing agency shall afford written justification for variance therefrom.
4.All applications reviewed by the licensing agency and all written materials pertinent to licensing agency review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request.
D.Except as otherwise provided in R.I. Gen. Laws Chapter 23-17, a review by the Health Services Council on an application for changes in the owner, operator, or lessee of a licensed home nursing care provider or home care provider may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3. In conducting reviews of such an application the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate:
1.The character, commitment, competence, and standing in the community of the proposed owners, operators or directors of the home nursing care provider or home care provider, including but not limited to the following:
a.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five (5) years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s):
(1)In providing safe and adequate treatment to the individuals receiving the health care facility's services;
(2)In encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and
b.In providing appropriate access to health care facility services;
2.A complete disclosure of all individuals and entities comprising the applicant; and
3.The applicant’s proposed and demonstrated financial commitment to the health care facility.
4.Any other factors deemed relevant by the Health Services Council and the Director.
E.The extent to which the facility will provide or will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the home nursing care provider or home care provider's services, including but not limited to the following:
1.The immediate and long-term financial feasibility of the proposed financing plan;
a.The proposed amount and sources of owner's equity to be provided by the applicant;
b.The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the implementation of the change in owner, operator or lessee of the health care facility;
c.The relative availability of funds for capital and operating needs;
d.The applicant's demonstrated financial capability; and
e.Any other factors deemed relevant by the Health Services Council or the Director.
F.The extent to which the facility will provide or will continue to provide safe and adequate treatment for individuals receiving the home nursing care provider or home care provider's services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility, including but not limited to the following:
1.The credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs; and
2.Any other factors deemed relevant by the Health Services Council or the Director.
G.The extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations, including but not limited to the following:
1.In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five (5) years owned, operated, or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally underserved populations to its health care facilities;
a.The proposed immediate and long-term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility; and
b.Any other factors deemed relevant by the Health Services Council or the Director.
H.In consideration of the proposed continuation or termination of emergency, primary care and/or other core health care services by the facility:
1.The effect(s) of such continuation or termination on the provision of access to safe and adequate treatment of individuals, including but not limited traditionally underserved populations.
2.And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two (2) or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation.
17.4.3Application, Issuance and Renewal of License
A.Application for a license to conduct, maintain or operate a home nursing care provider or home care provider shall be made to the licensing agency upon forms provided by it, and shall contain such information as the licensing agency reasonably requires, including but not limited to, evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and this Part.
1.Each application shall be accompanied by a non-returnable, non-refundable application fee, made payable to the Rhode Island General Treasurer, in the amount specified in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. No additional licensure fee shall be charged when a home nursing care provider or home care provider changes location during any calendar year for which an annual license fee has already been paid for that home nursing care provider or home care provider.
2.Each home nursing care or home care provider that maintains a branch office shall indicate on the application the location of the central office as well as the location(s) of the branch office(s).
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership, or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust, note or other obligation secured (in whole or in part) by the home nursing care provider or home care provider or any of the property or assets of the home nursing care provider or home care provider.
1.This list shall also include all officers, directors and other persons of any subsidiary corporation owning stock, if the home nursing care provider or home care provider is organized as a corporation and all partners if the home nursing care provider or home care provider is organized as a partnership.
C.Upon receipt of an application for a home nursing care provider license or a home care provider license, the licensing agency shall issue the applicable license or renewal thereof for a period of no more than one (1) year, if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17 and this Part.
1.Home care provider licenses are exempt from the requirements of § 17.8 of this Part.
D.The license issued, unless sooner suspended or revoked, shall expire by limitation on the thirty-first (31st) day of December following its issuance and may be renewed from year to year subject to inspection and approval by the licensing agency.
1.All renewal applications shall be accompanied by a non-returnable, non-refundable renewal fee, made payable to the Rhode Island General Treasurer, in the amount specified in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
E.Each license shall be issued only for the premises and persons named in the application and shall not be transferable or assignable except with the written approval of the licensing agency. Home nursing care providers and home care providers operating under a single license may establish branch offices under that same single license and such license shall be maintained and posted in the central office.
F.A license issued pursuant to this Part shall be the property of the State and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
G.Subsequent to reviews conducted under §§ 17.4.2(C) and (D) of this Part, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in R.I. Gen. Laws § 23-17-3, or to the review criteria set forth in § 17.4.2(C) of this Part. This shall not limit the authority of the licensing agency to require correction of condition or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the facility by the licensing agency.
H.Each home nursing care provider shall meet the statewide community standard for the provision of uncompensated care, established by § 17.4.4 of this Part, as a condition of initial and continued licensure.
17.4.4Statewide Standard for the Provision of Uncompensated Care
A.In accordance with R.I Gen. Laws § 23-17-42, the statewide community standard for uncompensated care shall be one percent (1%) of net patient revenue earned on an annual basis. Uncompensated care shall be cost adjusted by applying a ratio of costs to charges from the licensee's Medicare Cost Report. Licensees not filing Medicare Cost Reports shall submit an audited financial report or such other report as deemed acceptable to the Director.
17.4.5Change of Ownership, Operation and/or Location
A.When a change of ownership or operation or location of a home nursing care provider or home care provider or when discontinuation or addition of a service(s) is contemplated, the licensing agency shall be notified in writing.
B.Sixty (60) days prior to voluntary cessation of any facility license, the Department of Health shall be notified and provided with a plan for orderly closure; notification and transfer of patients; transfer, storage, or proper disposal of medical records; and notification of the public.
C.A license shall immediately become void and shall be returned to the licensing agency when a home nursing care provider or home care provider discontinues services or when any changes in ownership occur in accordance with this Part and R.I. Gen. Laws § 23-17-6.
1.When there is a change in ownership or in the operation or control of the home nursing care provider or home care provider, the licensing agency reserves the right to extend the expiration date of such license, allowing the home nursing care provider or home care provider to operate under the same license which applied to the prior licensee for such time as shall be required for the processing of a new application or reassignment of patients, not to exceed six (6) weeks.
17.4.6Inspections
A.The licensing agency shall make, or cause to be made, such inspections and investigations, including medical records, as deemed necessary in accordance with R.I. Gen. Laws § 23-17-10 and this Part.
B.Refusal to permit inspections shall constitute a valid ground for license denial, suspension or revocation.
C.Every home nursing care provider or home care provider shall be given notice by the licensing agency of all deficiencies reported as a result of an inspection or investigation.
17.4.7Deficiencies and Plans of Correction
A.The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A facility which received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore.
C.The licensing agency will be required to approve or reject the plan of correction submitted by a facility in accordance with § 17.4.7(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in § 17.4.7(C) of this Part, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in § 17.4.8 of this Part. If the facility is aggrieved by the sanctions of the licensing agency, the facility may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
17.4.8Denial, Suspension, Revocation of License or Curtailment of Activities
A.The licensing agency is authorized to deny, suspend or revoke the license or curtail activities of any home nursing care provider or home care provider which:
1.Has failed to comply with the Rules and Regulations pertaining to the licensing of a home nursing care provider or home care provider; or
2.Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
B.Reports of deficiencies shall be maintained on file in the licensing agency and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or to curtail activities of a home nursing care provider or home care provider.
C.Whenever an action shall be proposed to deny, suspend or revoke a home nursing care provider or home care provider license, or curtail its activities, the licensing agency shall notify the home nursing care provider or home care provider by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9, and in accordance with the provisions of § 17.9.2 of this Part. However, if the licensing agency finds that public health, safety or welfare of patients requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
D.The appropriate state and federal agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license, or curtailment of activities.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.5** Organization and Management {#sec-216-ricr-40-10-17-17.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.5}
17.5.1Governing Body
A.Each home nursing care provider or home care provider shall have an organized governing body or equivalent legal authority ultimately responsible for:
1.The management, fiscal affairs and operation of the home nursing care provider or home care provider;
2.The assurance of quality care and services; and
3.Compliance with all federal, state, and local laws and Regulations pertaining to a home nursing care provider or home care provider and this Part.
B.The governing body, or equivalent legal authority, shall provide appropriate personnel, physical resources and equipment to facilitate the delivery of prescribed services and shall furthermore:
1.Appoint an Administrator and/or Director of Nursing Services in accordance with the provisions of § 17.5.2(O) of this Part;
2.Identify the range of services to be provided which must include no less than those services required in §§ 17.5.2(D) and 17.8.1(B) of this Part as applicable;
3.Define the geographic areas to be served; and
4.Carry out such other functions as may be relevant to the organization and operation of the home nursing care provider or home care provider.
C.The governing body, or equivalent legal authority, shall adopt and maintain by-laws or acceptable equivalent which defines responsibilities for the operation and performance of the organization, and shall identify purposes and means of fulfilling same. In addition, the governing body or equivalent legal authority, shall establish administrative policies pertaining to no less than the following:
1.Responsibilities of the Administrator and/or Director of Nursing Services;
2.Acquiring and maintaining employee bonding insurance (theft and damage) (a minimum amount of ten thousand dollars ($10,000.00) per loss) and liability insurance (a minimum amount of five hundred thousand dollars ($500,000.00) per occurrence);
3.The modalities of services to be provided;
4.Circumstances under which definitive care cannot be provided and procedures for referral;
5.Linkages and referrals with other health care facilities, which shall include a mechanism for recording, transmitting and receiving information essential to the continuity of patient care. Such information shall contain no less than the following:
a.Patient identification data such as: name, address, age, gender, name of next-of-kin, health insurance coverage, etc.
b.Diagnosis and prognosis, medical status of patient, brief description of current illness, plan of care, including such information as medications, treatments, dietary needs, baseline laboratory data;
c.Functional status;
d.Therapeutic services such as: physical therapy, infusion therapy, occupational therapy, or speech therapy;
e.Psychosocial needs; and
f.Such other information pertinent to ensure continuity of patient care.
6.Reports of patient's condition and transmission thereof to the patient's attending clinician;
7.Policies and procedures regarding persons employed by the facility; Said policies shall include, but not be limited to, the following:
a.Compliance with health screening and in-service education requirements of § 17.5.3 of this Part;
b.Timely completion of the Bureau of Criminal Identification (BCI) check in accordance with R.I. Gen. Laws § 23-17-34;
c.Timely judgment regarding continued employment of an employee upon whom disqualifying information has been found (see § 17.5.3(L) of this Part.
8.Accreditation by a nationally recognized accrediting body must be achieved within two (2) years of the date on which the home care provider/home nursing care provider is initially licensed. Further, such accreditation must be maintained in order to remain licensed in good standing.
9.Such other matters as may be relevant to the organization and operation of the home nursing care provider or home care provider.
D.The governing body or other legal authority shall organize services to ensure an integrated continuum of patient care. An organizational chart with written description of the organization, authorities, responsibilities, accountability, and relationships shall be maintained which shall include but not be limited to:
1.A description of each service offered;
2.Policies and procedures pertaining to each service;
3.A description of the system for the maintenance of the patient's clinical record; and
4.Standards of clinical practice.
E.Quality Improvement
1.The governing body shall ensure that there is an effective, ongoing, agency-wide quality improvement program to evaluate the provision of patient care. Further, the home nursing care provider or home care provider shall have written policies and procedures establishing a mechanism for the annual evaluation of professional standards of practice and administrative practices, conducted by professional personnel, including home nursing care provider or home care provider staff.
a.Such evaluation shall assess the extent to which the home nursing care provider’s or home care provider’s programs and services are appropriate, adequate, effective and efficient based on data such as: number of patients on services, patient visits, reasons for discharge, diagnoses, sources of referral, patients denied services, community needs, staff days for each service offered and such other criteria as may be deemed appropriate.
2.The organized agency-wide quality improvement program shall be ongoing and shall have a written plan of implementation. The written quality improvement plan shall include at least the following:
a.Program objectives;
b.Organization(s) involved;
c.Oversight responsibility (e.g., reports to the governing body);
d.Home nursing care provider-wide or home care provider-wide scope;
e.Program administration and coordination;
f.Involvement of all patient care disciplines/services;
g.Methodology for monitoring and evaluating quality of care;
h.Priority setting and problem resolution;
i.Determination of the effectiveness of action(s) taken;
j.Documentation of the quality improvement plan review.
3.All patient care services, including services rendered by a contractor, shall be evaluated.
4.The home nursing care provider or home care provider shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented and submitted to the governing body for their consideration.
5.The provisions of § 17.5.1(E)(2) of this Part shall be deemed to have been met if the agency has met similar requirements of a national accrediting body, as approved by the Director.
F.Uniform Reporting System
1.Each home nursing care provider or home care provider shall establish and maintain records and data in such a manner as to make uniform a system of periodic reporting. The manner in which the requirements of this Part may be met shall be prescribed from time to time in directives promulgated by the Director.
2.Each home nursing care provider or home care provider shall report to the licensing agency detailed statistical data pertaining to its operation and services. Such reports and data shall be made at such intervals and by such dates as determined by the Director.
3.The licensing agency is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the home nursing care provider or home care provider.
4.The directives promulgated by the Director pursuant to this Part shall be sent to each home nursing care provider or home care provider to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the licensing agency.
G.Disaster/Emergency Planning
1.Each home nursing care provider or home care provider shall develop and maintain an emergency preparedness plan that is reviewed and updated annually.
a.At a minimum, the emergency preparedness plan must include all of the provisions contained in 42 C.F.R. § 484.102 that include but are not limited to:
(1)Emergency preparedness policies and procedures;
(2)Communications plan that is in conformity with all federal, state, and local laws and regulations;
(3)Training and testing program.
b.Any home nursing care provider or home care provider that is part of a healthcare system consisting of multiple separately licensed healthcare facilities may participate in the healthcare system’s coordinated emergency preparedness program, provided that it meets the requirements of 42 C.F.R. § 484.102.
2.The emergency preparedness plan shall be developed with the assistance of qualified safety, emergency management, and/or other appropriate experts.
3.Each home nursing care provider or home care provider shall develop back-up or contingency plans to address possible internal systems and/or equipment failures.
H.Pending and Actual Labor Disputes/Actions
1.Health care facilities shall provide the licensing agency with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. Health care facilities shall provide a plan, acceptable to the Director, for continued operation of the facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action.
I.Latex
1.Any home nursing care provider or home care provider that utilizes latex gloves shall do so in accordance with the provisions of the rules and regulations pertaining to Part 20-15-3 of this Title, Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department.
J.Reporting of Resident Abuse, Mistreatment, or Neglect
1.Duty to Report resident abuse, mistreatment, or neglect is pursuant to R.I. Gen. Laws § 23-17.8-2. The report shall be on forms provided by the licensing Agency and shall contain information as outlined in R.I. Gen. Laws § 23-17.8-2.
17.5.2Service Accessibility
A.Accessibility to agency: Each home nursing care provider or home care provider shall establish a mechanism to enable patients to make telephone contact with responsible staff of the home nursing care provider or home care provider on a twenty-four (24) hour basis, seven (7) days a week.
B.Medical supplies and equipment: Each home nursing care provider or home care provider shall assist patients in arranging for the procurement of medical supplies and equipment as may be prescribed in the plan of care.
C.Written Agreements
1.There shall be written agreements for the provision of service(s) not provided directly by the home nursing care provider or home care provider which clearly delineate the responsibilities of the parties involved and shall include no less than the following provisions:
a.Designation of service(s) to be provided which must be within the scope and limitations set forth in the plan of care and which must not be altered in type, amount, frequency, or duration (except in case of adverse reaction) by the individual or home nursing care provider or home care provider;
b.The responsibility of the licensed home nursing care provider or home care provider for the provision of services to the patient;
c.Assurance of compliance with the patient care policies of the licensed home nursing care provider or home care provider;
d.Establishment of procedures for and frequency of patient care assessment and attendance at case conferences;
e.Mechanism for submission of clinical progress notes on patient care;
f.Documented evidence that personnel and services under contract meet the requirements specified in this Part for home nursing care provider or home care provider personnel and services, including licensure, health screenings, and criminal background checks. In instances where the contracted services are provided by another Department CHFR licensee, said license shall suffice to meet the requirements of § 17.5.2(C) of this Part.
g.Reimbursement mechanism, charges and terms for renewal or termination of the agreement; and
h.Such other provisions as may be mutually agreed upon.
D.Scope of Services
1.Each home nursing care/home care provider shall provide either directly, or by written contractual agreement with another Department-licensed agency, homemaker, nursing assistant services or other therapeutic service(s) (e.g., physical/occupational therapy).
2.Additional health services or related services may be provided by agencies as may be deemed appropriate to meet community needs in a manner consistent with professionally-recognized standards of practice and all applicable current laws and Regulations.
17.5.3Personnel
A.Each home nursing care provider or home care provider shall employ a sufficient number of qualified personnel to provide effective patient care and other related services.
B.A job description for each classification of position shall be established, clearly delineating qualifications, duties, authority and responsibilities inherent in each position.
C.Written personnel policies supporting sound patient care and personnel practices shall be made available to all full-time or part-time personnel and shall include provisions for:
1.Annual evaluation of employee performance that is reviewed with and signed by the employee within forty-five (45) days of the evaluation; and
2.Such other matters as deemed appropriate.
D.An inservice educational program shall be conducted on an ongoing basis, which shall include an orientation program for staff personnel employed by the home nursing care provider or home care provider providing direct care and a continuing program for the development and improvement of skills of staff to ensure the delivery of quality home care services. The inservice program shall include but not be limited to, infection control measures, Health Insurance Portability and Accountability Act (HIPAA) general provisions, recognition and reporting of abuse, neglect, mistreatment, and exploitation.
E.A mechanism to establish an audit trail of employees shall be implemented and shall include, at a minimum, for each employee:
1.Date of employment by the home nursing care provider or home care provider agency; and
2.Date(s), name(s), and address(es) of each assignment.
F.For every person employed by the home nursing care provider or home care provider who is licensed, certified, or registered by the Department, a mechanism shall be in place to electronically verify such licensure via the Department's licensure database.
G.Personnel files shall be maintained for each employee and shall be available at all times for inspection by the licensing agency. Such files shall include no less than the following documentation:
1.A certified copy of birth certificate or copy of the U.S. Immigration and Naturalization Service Employment Eligibility Verification form (“I-9”); or immigration papers or resident alien card;
2.Information pertaining to qualifications for employment;
3.Records of completion of required training and educational programs;
4.Evidence of current licensure or certification as may be required by law;
5.Resume of previous employment;
6.Records of required health examination which shall be kept confidential and in accordance with provisions of § 17.5.3(K) of this Part;
7.Documentation of complaints and follow-up;
8.Findings of a criminal records check, if employed after July 26,1993;
9.Reference check prior to employment;
10.Employee orientation, evaluation (annual) and documentation of in-service education; and
11.Such other matters as may be relevant to the organization and operation of the agency.
H.Supervision of Homemakers
1.All homemaker services performed by a homemaker shall be in accordance with the provisions of R.I. Gen. Laws Chapter 23-17, and this Part.
2.Homemaker services shall be rendered in accordance with a plan of care and shall be supervised by a nurse, licensed in Rhode Island, or by an individual with a bachelor's degree in social work, home economics, gerontology or other related field of study, and who shall be responsible for no less than the following:
a.Conducting the initial in-home assessment and assessments no less than every three (3) months thereafter or more frequently as the condition of the patient/client may require;
b.Monitoring the performance of the homemakers and maintaining appropriate clinical records;
c.Coordinating management of services (inter and intra-agency);
d.Assigning only delegable duties in accordance with § 17.5.3(J) of this Part;
e.Maintaining a record for each patient/client with appropriate documentation of services rendered which is signed by the homemaker rendering services;
f.Such other functions and activities as may be deemed necessary and appropriate.
I.Training Program for Homemakers
1.Homemakers shall be required to have successfully completed a basic training program of twenty (20) hours of classroom instruction, and with no less than five (5) hours of practical experience in addition to the required classroom instruction.
2.The course of instruction shall be designed to provide skill in all the duties listed in § 17.5.3(J) of this Part and to provide homemaker skills, information, and an orientation to basic human needs. The course of instruction curriculum must include, but is not limited to:
a.Orientation to homemaker agency, including policies and procedures, ethical responsibilities/accountability, confidentiality, and the function of the homemaker as a team member;
b.Understanding basic human needs, including the needs of children/older persons, physically/disabled people, people with terminal illness, and people with mental illness/dementia;
c.Infection control, including hand washing, cross contamination, and universal precautions appropriate to the homemaker;
d.Emergency procedures; and
e.Care of the home, including planning and serving meals, shopping, food preparation, basic nutrition, cleanliness/general housekeeping, accident prevention, care of food preparation areas/dishes, laundry and ironing, making unoccupied beds, and disposal of trash/medical waste.
3.Upon completion of the homemaker training program, each homemaker must satisfactorily pass the final examination of the training program in order to be eligible to function as a homemaker.
J.Duties of Homemakers
1.A homemaker who has satisfactorily completed a training program approved by the Director, as described in § 17.5.3(I) of this Part, may perform the following duties under an established plan of care and under the supervision of a qualified person in accordance with § 17.5.3(H) of this Part:
a.Change bed linens (unoccupied);
b.Grocery shopping;
c.General housekeeping (washing dishes, cleaning kitchen, bathroom, patient’s/client's room);
d.Laundry and ironing;
e.Meal preparation;
f.Shopping, errand-running;
g.Recording services rendered.
2.Notwithstanding the provisions of § 17.5.3(J)(1) of this Part, additional duties may be assigned to homemakers provided such duties do not include the duties of a nursing assistant, as listed in Subchapter 05 Part 22 of this Chapter, Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs.
a.Such additional duties must be clearly delineated in agency policies and procedures, but may not be in conflict with other state regulations.
3.A health care facility shall require all persons, including students, who examine, observe, or treat a patient or resident of the facility to wear a photo identification badge which states, in a reasonably legible manner:
a.The first name;
b.Licensure registration status, if any;
c.Fluency in languages other than English, if any; and
d.Staff position of that person.
4.A home nursing care provider or home care provider shall be considered for all purposes an employer and those persons that it supplies on a temporary basis shall be considered employees and not independent contractors and home nursing care providers or home care providers shall be subject to all state and federal laws which govern employer/employee relationships.
K.Health Screening
1.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient of the home care provider/home care nursing provider. Such health screening shall be conducted in accordance with Immunization, Part 20-15-7 of this Title, Testing, and Health Screening for Health Care Workers, promulgated by the Department of Health.
L.Criminal Records Check
1.Criminal records checks shall be in accordance with R.I. Gen. Laws § 23-17-34.
M.Administrator and/or Director of Nursing Services
1.A full-time administrator as defined in this Part shall be appointed by and be responsible to the governing body or other legal authority for no less than the following:
a.The management and operation of the agency;
b.The implementation of policies, statutory and regulatory provisions;
c.Acting as liaison between the governing body and the professional and paraprofessional staff and the community;
d.The preparation and implementation of an effective budgeting, accounting and reporting system;
e.The establishment of standards of professional practice developed in cooperation with the governing board and staff;
f.The establishment of policies and procedures governing the range of health care services provided by the home nursing care provider or home care provider;
g.The establishment of a quality improvement program which includes a review mechanism for patient care management;
h.The preparation of an annual report;
i.The employment of qualified professional and paraprofessional staff; and
j.For such other related functions as may be delegated by the governing body or other legal authority.
2.In the event that a non-nurse is appointed administrator of the home nursing care provider or home care provider, the nursing service shall be under the direction of a Registered Nurse who is licensed in Rhode Island and who shall be responsible to the Administrator for the management of professional services, the standards of practice, and other related professional aspects of patient care services.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.6** Patient Care Management {#sec-216-ricr-40-10-17-17.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.6}
17.6.1Rights of Patients
A.Each patient/client of a home nursing care provider or home care provider has the right to be informed of his or her rights under R.I. Gen. Laws § 23-17-19.1 and the home nursing care provider or home care provider must protect and promote the exercise of these rights.
B.The home nursing care provider or home care provider must provide the patient/client with a written notice of the patient/client rights in § 17.6.1(E) of this Part in advance of furnishing care to the patient/client or during the initial evaluation visit before the initiation of treatment.
C.A copy of the written notice of rights signed by the patient/client will be maintained in the patient/client record by the home nursing care provider or home care provider and in the patient/client's home. The home nursing care provider or home care provider must maintain documentation showing that it has complied with the requirements of this Section.
D.The provisions of § 17.6 of this Part shall not apply to nursing services or home health services conducted by and for those who rely exclusively upon spiritual means through prayer alone in accordance with the creed or tenets of a recognized church or religious denomination.
E.In addition to the rights stated in R.I. Gen. Laws § 23-17-19.1:
1.No charge shall be made for furnishing a health record or part thereof to a patient, his/her attorney or authorized representative if the record or part thereof is necessary for the purpose of supporting an appeal under any provision of the Social Security Act (42 U.S.C. § 301 et seq.) and the request is accompanied by documentation of the appeal. A provider shall furnish a health record requested pursuant to this Section within thirty (30) days of the request.
17.6.2Confidentiality
A.Disclosure of any health care information relating to individuals shall be subject to the provisions of the "Confidentiality of Health Care Communication and Information Act", R.I. Gen. Laws Chapter 5-37.3, and other relevant statutory and federal requirements.
17.6.3Admission and Discharge Policies
A.Providers shall establish policies pertaining to eligibility for admission to and discharge from home nursing care provider or home care provider services. Such policies shall be based on the following criteria:
1.Pre-admission assessment of patient care needs;
2.Reasonable expectations of the home nursing care provider’s or home care provider’s capability to respond to the medical and nursing needs of the patient;
3.Plan of care;
4.Constraints imposed by limitation of services, family conditions;
5.Community or other resources to ensure continuity of patient care; and
6.Such other criteria as may be deemed appropriate.
17.6.4Alzheimer’s Operational Plan
A.Every healthcare facility as defined in R.I. Gen. Laws § 23-17-2 shall complete and implement an operational plan for the recognition and management of patients with Alzheimer's disease or dementia.
1.Such plan shall include a protocol for the following:
a.Identifying the signs and symptoms of cognitive impairments, including Alzheimer’s disease;
b.Management of clients/patients with Alzheimer’s disease;
c.Training of clinical and non-clinical staff; and
d.Advance care planning and resources for family members.
2.Such plan shall be maintained by the healthcare facility and made available to the licensing agency upon request.
17.6.5Clinical Records
A.Accurate and complete clinical records maintained in accordance with accepted professional standards shall be kept on each patient and filed in an accessible location within the home nursing care provider or home care provider. Such records shall contain no less than the following information:
1.Identifying data (name, address, date of birth, gender, date of admission or readmission);
2.Sources of patient referral;
3.Name of attending clinician (including address and telephone number);
4.Original plan of care for services provided;
a.Personal care objectives;
b.Homemaker objectives, as appropriate;
5.Documentation of each patient contact;
6.Changes in and reviews of the patient's plan of care, signed by responsible professional;
7.Documentation of an executed advance directive (if any) and a copy of the advance directive, if provided to the facility by the patient; and
8.Discharge summaries.
B.Home nursing care provider or home care provider personnel involved in the care of patients shall participate, to the extent possible, in developing care plans. When practical, designated home nursing care provider or home care provider personnel shall complete a “Continuity of Care” form as approved by the Director for each patient who is discharged to another health care facility, such as a hospital or nursing facility, or other facility licensed under the provisions of R.I. Gen. Laws Chapter 23-17. Said form shall be provided to the receiving facility, agency, or provider prior to, upon transfer, or discharge of the patient. (See the Department’s website for the approved form: health.ri.gov).
C.Records shall be maintained by the home nursing care provider or home care provider for a period of at least seven (7) years following the date of discharge and shall be safeguarded against loss or unauthorized use. This requirement shall also apply to computerized or electronic records.
1.Records shall be maintained by the home nursing care provider or home care provider for a minimum of seven (7) years after a minor patient turns eighteen (18) years of age.
D.Each home nursing care provider or home care provider shall have written policies and procedures to govern the use and removal of records and determine the conditions for release of information in accordance with statutory provisions pertaining to confidentiality.
17.6.6Nursing Assistant Services
A.Each home nursing care provider or home care provider that chooses to provide home nursing care and home care as provided in this Part shall be subject to the same training requirements for nursing assistants and the duties of the individuals shall be the same as those prescribed in Subchapter 05 Part 22 of this Chapter, Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs.
B.Supervision of Nursing Assistants
1.Supervision of nursing assistants shall be directed to the management of patients’/clients' care and services, the performance of duties, and shall be available at all times during the established hours of operation of the home nursing care provider or home care provider and at such other times as they are providing services to patients/clients.
2.Supervision of nursing assistants as employees of a home nursing care provider or home care provider:
3.Nursing assistant services shall be:
a.Provided in accordance with a plan of care; and
b.Monitored/supervised no less than once every three (3) months by a professional (registered) nurse or other appropriate health care professional who is licensed in Rhode Island; and
c.Provided in accordance with Subchapter 05 Part 22 of this Chapter, Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs.
d.Such supervision shall include the following duties:
(1)Conducting the initial in-home assessment prior to commencement of service, unless documented extraordinary circumstances prevent such timing. In these cases the initial in-home assessment must be conducted within forty-eight (48) hours. Subsequent assessments and direct supervision of the Nursing Assistant (at least one supervisory session) must be conducted no less than every three (3) months thereafter or more frequently as the condition of the patient/client may require;
(2)Involving other professional disciplines where personal care is provided, as may be deemed necessary to ensure the provision of quality care;
(3)Developing, reviewing and revising the plan of care, as the condition of the patient/client may require but no less than once every three (3) months;
(4)Assigning only delegable duties as set forth in Subchapter 05 Part 22 of this Chapter, Nursing Assistants, Medication Aides, and the Approval of Nursing Assistant and Medication Aide Training Programs for Nursing Assistants;
(5)On-site monitoring the performance of Nursing Assistants no less than once every three (3) months and maintaining appropriate records of such monitoring;
(6)Coordinating the management of services (inter- and intra-agency);
(7)Monitoring the clinical record for each patient/client which includes appropriate recording of the plan of care, services rendered, and which is signed by the person rendering services; and
(8)Such other functions and activities as may be deemed necessary and appropriate.
17.6.7Reporting of Communicable Diseases
A.Each facility shall report promptly to the Rhode Island Department of Health, Division of Disease Control, cases of communicable diseases designated as "reportable diseases" by the Director, when such cases are diagnosed in accordance with the most current Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental, and Occupational Diseases.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.7** Physical Plant {#sec-216-ricr-40-10-17-17.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.7}
17.7.1General Provisions
A.Each licensed home nursing care provider or home care provider shall maintain an office(s) located in Rhode Island with adequate space and equipment to accommodate staff personnel to carry out their professional and administrative responsibilities in an efficient manner within a safe environment.
B.Adequate space shall be provided for the storage and maintenance of equipment, supplies and records necessary for patient care services and for the operation of the home nursing care provider or home care provider.
C.All equipment and furnishings shall be maintained in good condition, properly functioning and replaced as necessary.
D.Each home nursing care provider or home care provider shall maintain an effective telephone communication system accessible to patients and personnel on a twenty-four (24) hour basis, seven (7) days a week, in accordance with § 17.5.2(A) of this Part.
E.Medical Waste Disposal
1.In accordance with the Medical Waste Regulations, 250-RICR-140-15-1, medical waste generated by individuals on the premises of a single-family home or single-family dwelling unit or by members of households residing in single and multiple residences, hotels, and motels which serve as a residence for individuals, provided the dwelling is not serving as a commercial or professional office where individuals who are not members of the family residing at such dwelling are receiving medical care by a health care professional is specifically excluded from the definition of regulated medical waste and the requirements of the aforementioned regulations. Medical waste generated by health care providers in private homes where they provide medical services to individuals residing in said homes is also exempt from the requirements of the Medical Waste Regulations, 250-RICR-140-15-1, promulgated by the Rhode Island Department of Environmental Management.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.8** Additional Requirements – Home Nursing Care Providers {#sec-216-ricr-40-10-17-17.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.8}
A.In addition to meeting the General Requirements as set forth in §§ 17.1 through 17.7.1 of this Part, home nursing care providers shall meet the additional requirements of § 17.8.1 of this Part.
17.8.1Governing Body & Management Professional Advisory Committee
A.An advisory group of professional personnel ("Professional Advisory Committee") shall be established by the governing body or other legal authority which shall include at least:
1.One (1) physician and a registered nurse; and
2.A representative of each therapeutic service offered by the home nursing care provider or home care provider, which may also include appropriate representation from other professional disciplines.
3.The administrator of the home nursing care provider or home care provider shall be ex-officio member of the committee.
4.At least one (1) member shall neither be an owner nor an employee of the home nursing care provider or home care provider.
5.The Professional Advisory Committee shall meet at least twice per year to advise the agency on professional issues and to establish and annually review the home nursing care provider’s or home care provider’s policies pertaining to:
a.The scope of services offered;
b.Admission and discharge policies;
c.Plans of care;
d.Clinical records;
e.Personnel qualifications;
f.Program evaluation; and
g.Such other matters as may be deemed appropriate by the governing body or other legal authority.
6.The physician member of the Professional Advisory Committee shall attend at least one (1) meeting per year and show evidence of participation (e.g., review of agenda/minutes) in any other Professional Advisory Committee meetings.
B.Scope of Services
1.Each home nursing care provider shall provide direct nursing services in the home, or by contractual agreement with another Department-licensed agency, delivered by a Registered (RN) or Licensed Practical (LPN) Nurse.
2.Each home nursing care provider may provide homemaker and Nursing Assistant services, either directly or by contractual agreement with another Department-licensed agency; and may provide other therapeutic service(s), to be provided either directly or by contractual agreement.
3.Additional health services or related services may be provided by a home nursing care provider as may be deemed appropriate to meet community needs in a manner consistent with acceptable standards of practice.
C.Medical Services
1.Patients admitted for medical services shall be under the care of an attending clinician responsible for the development of the plan of care.
a.A care plan prescribed by the attending clinician, if appropriate, shall contain no less than the following:
(1)Pertinent diagnosis, including mental status, level of consciousness, ability to communicate including language, speech and hearing;
(2)Types of services and equipment required, frequency of visits, prognosis, rehabilitative potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, safety measures (if any), instructions for continuing care, referral or discharge; dates/times of any follow-up appointment(s), when known;
(3)Medical diagnosis and nursing assessment, therapeutic goals, prognosis and all conditions relevant to the plan of care, including any known allergies and reactions; and
(4)Surgical procedures, surgical complications, infections, prior diagnoses, presence of pressure ulcers, incontinence, disabilities;
2.The attending clinician’s orders for any services which shall specify the procedures and modalities to be used including the amount, frequency and duration of therapy and/or care, including therapeutic services, such as physical therapy, occupational therapy, speech therapy, clinical social work, nutritional assessment, audiology, intravenous (IV) therapy, percutaneous endoscopic gastrostomy (PEG) feeding, wound/dressing, surgical drains, central line, oxygen, diet, all medications prescribed.
3.The plan of care shall not be modified without consent of the attending clinician and shall furthermore be reviewed by the attending clinician and home nursing care provider or home care provider staff as often as the severity of the patient's condition requires but no less than once every sixty (60) days beginning with the start of care date.
4.Direct Nursing Services Direct nursing services shall be provided by Registered and/or Practical Nurses duly licensed in Rhode Island and in accordance with the written plan of care, acceptable standards of nursing practice and Subchapter 05 Part 3 of this Chapter, Licensing of Nurses and Standards for the Approval of Basic Nursing Education Programs.
5.Copies of the plan of care and the number of service hours scheduled shall be provided to the patient upon admission and as revised.
17.8.2Supervision of Therapeutic Services
A.Therapeutic services may include, but are not limited to, speech pathology/audiology, physical therapy, occupational therapy and respiratory care. Supervision of therapeutic services shall be in accordance with applicable Rules and Regulations for licensing of said therapists.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-17 § 17.9** Variance Procedure, Practices and Procedures, and Severability {#sec-216-ricr-40-10-17-17.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-17#17.9}
17.9.1Variance Procedure
A.The licensing agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such variance will not be contrary to the public interest, public health and/or health and safety of patients.
B.A request for a variance shall be filed by an applicant in writing setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant of its approval, or in the case of a denial, a hearing date, time and place may be scheduled if the home nursing care provider or home care provider appeals the denial.
17.9.2Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17 shall be held in accordance with the provisions of Part 10-05-4 of this Title, Practices and Procedures Before the Rhode Island Department of Health.
**History**
- *Amendment — effective from 2024-05-06 to current*
- *Amendment — effective from 2022-03-24 to 05/06/2024*
- *Periodic Refile — effective from 2022-01-04 to 03/24/2022*
- *Technical Revision — effective from 2018-03-07 to 01/04/2022*
- *Amendment — effective from 2018-03-07 to 03/07/2018*
- *Amendment — effective from 2012-12-23 to 03/07/2018*
- *Amendment — effective from 2012-12-10 to 12/23/2012*
- *EMERGENCY RULE Amendment — effective from 2012-02-06 to 09/03/2012*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-04-07 to 10/18/2007*
- *Amendment — effective from 2003-04-02 to 04/07/2005*
- *Amendment — effective from 2002-08-04 to 04/02/2003*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-18** School Based Health Centers
##### **216-RICR-40-10-18 § 18.1** Authority {#sec-216-ricr-40-10-18-18.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.1}
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-17-10 and 23-17-4.1, and are established for the purpose of adopting minimum standards for licensed school-based health centers in this State.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.2** Incorporated Materials {#sec-216-ricr-40-10-18-18.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.2}
A.These Regulations hereby adopt and incorporate "Clinical Laboratory Improvement Amendments of 1988" Department of Health and Human Services (1992) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the School-Based Health Alliance, Core Competencies, June 2017, by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.3** Definitions {#sec-216-ricr-40-10-18-18.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.3}
A.Wherever used in these Rules and Regulations, the following terms shall be construed as follows:
1."Certified nurse-teacher" means those personnel certified by the Department of Elementary and Secondary Education and employed pursuant to the provisions of R.I. Gen. Laws §§ 16-21-7 and 16-21-8.
2."Department" means the Rhode Island Department of Health.
3."Director" means the Director of the Rhode Island Department of Health.
4."Health care facility" means a facility as defined in R.I. Gen. Laws § 23-17-2.
5."Limited function test" means those tests listed in the Federal Register under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests.
6."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies) State, or political subdivisions or instrumentally of the State.
7."Premises" means a tract of land and the buildings thereon where direct patient care services are provided.
8."School-based health center" means a facility located in an elementary or secondary school licensed as a school-based health center that delivers primary and/or preventive health care services to individuals.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.4** Licensing Procedures {#sec-216-ricr-40-10-18-18.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.4}
18.4.1General Requirements
A.No person acting severally or jointly with any other person shall establish, conduct, or maintain a school-based health center in this State without a license in accordance with the requirements of R.I. Gen. Laws §§ 23-17-4 and 23-17-4.1, and shall meet the requirements of this Part.
B.In order to apply for and/or to maintain a school-based health center license, a person must possess a current license as a health care facility under the provisions of R.I. Gen. Laws § 23-17-56.
C.No person shall represent itself as a school-based health center unless licensed as a school-based health center pursuant to the provisions of this Part.
D.School health services provided to students in accordance with this Part shall not require licensure as a school-based health center. Nothing in these Regulations shall be construed as prohibiting school health personnel from rendering school health services in accordance with this Part.
E.School-based health centers shall be exempt from the provisions of R.I. Gen. Laws §§ 23-17-14.3 and 23-17-14.4.
18.4.2Application for License
A.Application for a license to conduct, maintain or operate a school-based health center shall be made to the Department upon forms provided by it, and shall contain such information as the Department reasonably requires, including but not limited to, evidence of ability to comply with the provisions of R.I. Gen. Laws Chapter 23-17 and this Part.
B.A notarized listing of names and addresses of direct and indirect owners of the licensed health care facility (see requirements of § 18.4.1(B) of this Part) whether individual, partnership, or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of the facility or any of the property or assets of the facility. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the facility is organized as a corporation, and all partners if the facility is organized as a partnership.
C.There shall be a current, written memorandum of understanding in place that delineates the responsibilities of both the facility and the public school district.
18.4.3Issuance and Renewal of License
A.Application for a license to conduct, maintain, or operate a School-Based Health Center shall be made to the Department upon forms provided by the Department and shall contain such information as the Department reasonably requires, including, but not limited to a staffing/personnel plan in accordance with § 18.5.1(C)(4).
1.Each application filed pursuant the provisions of this section shall be accompanied by a non-returnable, non-refundable application fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
B.A notarized listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of the School Based Health Center or any of the property or assets of the School Based Health Center. The list shall also include all officers, directors and other persons or any subsidiary corporation owning stock, if the School Based Health Center is organized as a corporation, and all partners in the School Based Health Center if organized as a partnership.
C.Upon receipt of an application for a license, the Department shall issue a license or renewal thereof for a period of no more than one (1) year if the applicant meets the requirements of R.I. Gen. Laws Chapter 23-17. Said license, unless sooner suspended or revoked, shall expire by limitation on the thirty-first (31st) day of December following its issuance and may be renewed from year to year after inspection and approval.
1.All renewal applications shall be accompanied by a non-refundable application fee per license as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
D.A license shall be issued to a specific licensee for a specific location and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator, or lessee or to the corporate entity responsible for its governance.
E.A licensed issued pursuant to these Regulations shall be the property of the State of Rhode Island and loaned to such licensee and it shall be kept posted in a conspicuous place on the premises.
F.Thirty (30) days prior to voluntary cessation of any school-based health center license, the Department shall be notified and provided with a plan for orderly closure, notification and transfer of patients, transfer and storage of medical records, and notification of the public.
18.4.4Inspections
A.The Department shall make or cause to be made such inspections and investigations as it deems necessary, including health care records, in accordance with R.I. Gen. Laws § 23-17-10 and this Part.
B.Every school-based health center shall be given prompt notice by the Department of any deficiencies reported as a result of an inspection or investigation.
18.4.5Denial, Suspension, Revocation of License or Curtailment of Activities
A.The Department is authorized to deny, suspend or revoke the license of or to curtail the activities of any school-based health center which:
1.Has failed to comply with the Rules and Regulations pertaining to the licensing of a school-based health center; and
2.Has failed to comply with the provisions of R.I. Gen. Laws Chapter 23-17.
3.Reports of deficiencies noted in inspections conducted in accordance with § 18.8.2 of this Part shall be maintained on file in the Department, and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of a school-based health center.
B.Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the activities of a school-based health center, the Department shall notify the school-based health center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws §§ 23-17-8 and 42-35-9 and pursuant to the provisions of § 18.8.3 of this Part.
1.However, if the Department finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
C.The appropriate State Agencies shall be notified of any action taken by the Department pertaining to either denial, suspension, or revocation of license or curtailment of activities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.5** Organization and Management {#sec-216-ricr-40-10-18-18.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.5}
18.5.1Governing Body and Management
A.Each facility shall have an organized governing body or equivalent legal authority, ultimately responsible for:
1.The program and operation of the school-based health center;
2.The appointment of an administrator who shall be directly responsible for the management and operation of the school-based health center;
3.The assurance of the quality of care and services; and
4.The compliance with all Federal, State and local laws and Regulations pertaining to safety, sanitation, communicable and reportable diseases, smoking policies and other health and safety requirements relevant to school-based health centers and all Rules and Regulations of this Part.
B.The governing body or equivalent legal authority shall ensure appropriate personnel, physical resources, and equipment to facilitate the delivery of school-based health center services, during established hours of operation.
C.The governing body or equivalent legal authority shall adopt written policies defining the responsibilities for the operation and performance of the school-based health center and identifying purposes and means of fulfilling such. In addition, the governing body or equivalent legal authority shall establish administrative/clinical policies pertaining to no less than the following:
1.The scope of health and medical services to be provided, as described in the School-based Health Alliance, Core Competencies, June 2017, incorporated by reference at § 18.2(B) of this Part;
2.Maintain linkages and referrals with other health care facilities to assure continuity of care;
3.Quality assurance for patient care and services;
4.Development and implementation of a staffing/personnel plan, which must include a description of the school's certified nurse-teacher role in the procedures for patient referrals, student and family communication, care coordination and delivery of services;
5.Any written agreements, memoranda of understanding and/or other terms and conditions agreed to between the school-based health center or the entity operating the school-based health center and the school district and/or collective bargaining agent; and
a.Such written agreements, memoranda of understanding and/or other terms and conditions agreed upon by the school-based health center and the school district and/or collective bargaining agent must be submitted to the Department for review.
6.Such other matters as may be relevant to the organization and operation of the school-based health center.
18.5.2Quality Improvement
A.The governing body shall ensure that there is an effective, ongoing, school-based health center wide quality improvement program to evaluate the provision of patient care. The quality improvement activities at the school-based health center shall be coordinated with and integrated into the quality improvement activities for similar services at other health care facilities operated by the licensee.
B.The organized school-based health center wide quality improvement program shall be ongoing and shall have a written plan of implementation.
C.The school-based health center shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented.
18.5.3Pending and Actual Labor Disputes/Actions
Health care facilities shall provide the Department with prompt notice of pending and actual labor disputes/actions pursuant to R.I. Gen. Laws § 23-17-48.
18.5.4Medical Oversight
Each school-based health center shall have a physician licensed in this State who shall be responsible for the achievement and maintenance of the quality of health care services and the establishment of policies and procedures for health care services based on recognized standards of practice.
18.5.5Personnel
A.A certified nurse-teacher must be employed and present in any elementary or secondary school with a school-based health center on-site and/or available for consultation either in-person or remotely during the school-based health center hours of operation.
B.The school-based health center shall be staffed with appropriate professional and ancillary personnel who shall be assigned duties and responsibilities that are consistent with licensure/certification requirements, their training and experience, and services rendered. Staff performing functions requiring certification and/or licensure shall be duly licensed in Rhode Island as required by statute.
C.Each school-based health center shall have at least one (1) appropriately qualified health professional staff person on duty at all times when services are provided.
D.A health care facility shall require all persons who examine, observe, or treat a patient of such facility to wear a photo identification badge which includes the information required by R.I. Gen. Laws § 23-17-47. This badge shall be worn in a manner that makes the badge easily seen and read by the patient or visitor.
E.The school-based health center shall have written job descriptions that define qualifications, responsibilities, and supervision of all school-based health center personnel.
18.5.6Health Screening
Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient of the school-based health center. Such health screening shall be conducted in accordance with Part 20-15-7 of this Title, Immunization, Testing, and Health Screening for Health Care Workers.
18.5.7Rights of Patients
A.Consistent with R.I. Gen. Laws § 23-17-19.1(16), each school-based health center shall observe each of the following age-appropriate rights with respect to each patient who utilizes the facility.
B.Each patient can expect to:
1.Be treated respectfully.
2.Receive the information needed to make intelligent choices about the health care received.
3.Receive information concerning treatment and be informed of the medical consequences of refusing treatment.
4.Receive private, confidential care.
5.Have the ability to refuse the release of medical records.
6.Receive referrals for care that the provider is unable to meet.
7.Have the ability to register complaints regarding the care received or lack thereof.
8.Have school-based health center respond in a reasonable manner to the request of a patient’s physician for medical services to the patient. The school-based health center shall also respond in a reasonable manner to the patient’s request for other services customarily rendered by the school-based health center to the extent the services do not require the approval of the patient’s physician or are not inconsistent with the patient’s treatment;
9.Be furnished with the identities of all other health care and educational institutions that the school-based health center has authorized to participate in the patient’s treatment and the nature of the relationship between the institutions and the school-based health center;
10.Upon request, be informed of any research project, and be offered the right to refuse to participate in the project. The school-based health center shall also comply with any additional provisions for research stipulated by the school department.
11.Have the ability to examine any pertinent school-based health center Rules and Regulations that specifically govern the patient’s treatment;
12.Be offered treatment without discrimination as to race, color, religion, national origin, sexual orientation, disability, or source of payment.
C.Each school-based health center shall display in a conspicuous place in the licensed school-based health center a copy of the "Rights of Patients”, including but not limited to, the patient rights stated above.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.6** Health Care Services {#sec-216-ricr-40-10-18-18.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.6}
18.6.1Management of Services
A.Policies and procedures pertaining to the provision of services and supported by appropriate manuals and reference material shall be established by the appropriate professional staff and approved by the governing body. Such policies and procedures shall pertain to no less than the following:
1.The responsibility of the physician(s) for the provision of health care services;
2.The designation of personnel authorized to deliver health care services in accordance with licensure and/or certification requirements;
3.Standards of practice for each health care service provided;
4.Procedures that may and may not be performed;
5.Procurement and storage of all drugs and medications in accordance with R.I. Gen Laws Chapters 21-28 and 21-31 and disposal of all drugs and medications in accordance with Part 20-20-1 of this Title, Disposal of Drugs;
6.Designation of personnel authorized to prescribe, administer, dispense, or dispose of drugs in accordance with licensure and/or certification requirements;
7.Disposal of hypodermic needles, syringes and instruments in accordance with the requirements of Part 20-15-6 of this Title, Hypodermic Needles, Syringes, and Other Such Instruments ;
8.Disclosure of patient information in accordance with Federal and State law; and
9.Such other conditions as may be deemed appropriate.
18.6.2Laboratory Services
A.Clinical laboratory services may be provided on the premises of the school-based health center.
1.If the laboratory services only consist of limited function tests, as defined by this Part, these services shall be subject to the “Clinical Laboratory Improvement Amendments of 1988” incorporated above at § 18.2(A) of this Part.
2.If the laboratory services consist of tests more complex than limited function tests, the laboratory shall be additionally subject to the provisions of R.I. Gen. Laws Chapters 23-16.2 and 23-16.3, and the Regulations adopted thereunder.
18.6.3Infection Control
A.Policies and procedures governing infection control and reporting techniques shall be established in accordance with this section.
B.Infection control provisions shall be established for the mutual protection of patients, employees, and the public.
C.Reporting of Communicable Diseases
1.School-based health center personnel who are charged with reporting communicable diseases (e.g., physicians, physician assistants, registered nurse practitioners, midwives) shall promptly report to the Department cases of communicable diseases designated as "reportable diseases" by the Director of Health, when such cases are diagnosed in the school-based health center in accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental, and Occupational Diseases.
2.When infectious diseases present a potential hazard to patients or personnel, these shall be reported to the Department, even if not designated as "reportable diseases."
3.School-based health centers must, in addition, comply with all other laboratory reporting requirements for tuberculosis, HIV/AIDS, sexually transmitted diseases, childhood lead poisoning, and occupational diseases as outlined in Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental, and Occupational Diseases.
18.6.4Health Care Records
A.Each school-based health center shall maintain a health care record on every patient seeking health care services.
B.For each visit to the school-based health center, the health care record shall contain documentation relating to the following:
1.Patient identification (name, address, age and sex);
2.Pertinent health history and physical findings;
3.Diagnostic and therapeutic orders;
4.Reports of procedures, tests and findings of each visit;
5.Diagnostic impressions; and
6.Such other pertinent data as may be necessary to ensure continuity of patient care.
C.Procedures shall be established to ensure confidentiality of all medical records, including computer or electronic records.
D.Each school-based health center shall make provisions for the appropriate release or transfer of patient care information in accordance with the legal requirements governing confidentiality of health care information.
E.All medical records, either originals or accurate reproductions, shall be preserved for a minimum of five (5) years, except that records of minors shall be kept for at least five (5) years after such minor shall have reached the age of eighteen (18) years.
18.6.5Medical Equipment
Medical equipment and supplies for the reception, appraisal, examination, treatment and observation of patients shall be determined by the amount, type and extensiveness of services provided.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.7** Physical Plant and Equipment {#sec-216-ricr-40-10-18-18.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.7}
18.7.1Physical Facility
A.All construction shall be subject to the laws, Rules, Regulations and codes of R.I. Gen. Laws Chapters 23-17, 23-28.1, 23-27.3 and all other appropriate State and local laws, codes, Regulations and ordinances. Where there is a difference between codes, the code having the more stringent standard shall apply.
B.Provisions shall be made for all of the areas listed below, some of which may be multipurpose in order to provide the following:
1.At least one (1) examining room with provisions that each examining room include hand-washing facilities that include a sink and running water, and that each examining room is private such that conversations cannot be overheard;
2.A counseling room that is private such that conversations cannot be overheard;
3.A bathroom with hand-washing facilities;
4.Office and administrative space where staff can work privately with records;
5.Secure areas for the protection of medical records, pharmaceuticals, and supplies;
6.Waiting room area.
C.The school-based health center building shall also conform with the following:
1.Fire protection standards that meet local codes;
2.Water and waste disposal systems conforming with local codes, Narragansett Bay Commission and Federal OSHA requirements;
3.Separate telephone lines with voice mail telling students how to obtain emergency services after hours;
4.Adequate lighting;
5.Proper ventilation;
6.Provisions for patients with special needs, as appropriate.
18.7.2Environmental Maintenance
A.The school-based health center shall be maintained and equipped to provide a sanitary, safe and comfortable environment with all furnishings in good repair, and the premises shall be kept free of hazards.
B.Appropriate equipment and supplies to clean the school-based health center shall be maintained in a safe, sanitary condition.
C.Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place and kept in an enclosed section separate from other cleaning materials.
18.7.3Waste Disposal
A.Medical Waste
Medical waste, as defined in the Medical Waste Regulations, 250-RICR-140-15-1, shall be managed in accordance with the provisions of the aforementioned Regulations.
B.Other Waste
Wastes which are not classified as medical waste, hazardous wastes or which are not otherwise regulated by law or Rule may be disposed in dumpsters or load packers.
18.7.4Disaster Preparedness
A.Each school-based health center shall develop and maintain a written disaster preparedness plan that shall include plans and procedures to be followed in case of fire and/or other emergencies. This disaster preparedness plan shall be coordinated with the school's plan for fire and/or other emergencies.
B.Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the school-based health center.
C.Simulated drills testing the effectiveness of the plan shall be conducted for all personnel at least twice a year. Written reports and evaluation of all drills shall be maintained by the school-based health center.
18.7.5Fire Safety
Each school-based health center shall meet the requirements of R.I. Gen. Laws Chapter 23-28.1 pertaining to fire and safety.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
##### **216-RICR-40-10-18 § 18.8** Practices and Procedures, Confidentiality and Severability {#sec-216-ricr-40-10-18-18.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-18#18.8}
18.8.1Variance Procedures
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any Rule or Regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of patients.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the Department, and within a reasonable time thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the facility appeals the denial and in accordance with the provisions of § 18.8.3 of this Part.
18.8.2Deficiencies and Plans of Correction
A.The Department shall notify the governing body or other legal authority of a school-based health center of violations of individual standards through a notice of deficiencies which shall be forwarded to the school-based health center within fifteen (15) days of inspection of the school-based health center unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A school-based health center which received a notice of deficiencies must submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefor.
C.The Department will be required to approve or reject the plan of correction submitted by a school-based health center in accordance with § 18.8.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the Department rejects the plan of correction, or if the school-based health center does not provide a plan of correction within the fifteen (15) day period stipulated in § 18.8.2(C) of this Part, or if a school-based health center whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 18.4.5 of this Part. If the school-based health center is aggrieved by the action of the Department, the school-based health center may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing shall in all respects comply with the provisions therein.
18.8.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-17, shall be held in accordance with Part 10-05-4 of this Title, Practices and Procedures Before the Rhode Island Department of Health and Part 10-05-1 of this Title, Access to Public Records.
18.8.4Confidentiality
Disclosure of any health care information relating to individuals shall be subject to the provisions of the Confidentiality Act of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and Federal requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2021-12-19 to 01/04/2022*
- *Amendment — effective from 2018-07-02 to 12/19/2021*
- *Amendment — effective from 2002-08-04 to 07/02/2018*
- *Periodic Refile — effective from 2002-01-02 to 08/04/2002*
#### **216-RICR-40-10-19** Nursing Facility Receivership
##### **216-RICR-40-10-19 § 19.1** Authority {#sec-216-ricr-40-10-19-19.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-19#19.1}
These rules and regulations are promulgated under the authority of R.I. Gen. Laws § 23-17.11-4(a) and are established for the purpose of establishing a process for notification of quality of care concerns, survey results and enforcement actions to residents and their families, residents’ legal representative and health care providers, the long-term care ombudsman, and the public.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2006-06-12 to 07/02/2018*
- *EMERGENCY RULE Adoption — effective from 2006-03-08 to 06/12/2006*
##### **216-RICR-40-10-19 § 19.2** Notification Process {#sec-216-ricr-40-10-19-19.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-19#19.2}
Any nursing facility being managed pursuant to R.I. Gen. Laws Chapter 23-17.11 shall comply with all reporting and notification requirements and processes for licensed nursing facilities pursuant to R.I. Gen. Laws 23-17 and the rules and regulations for Licensing of Nursing Facilities (Part 1 of this Subchapter).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Amendment — effective from 2006-06-12 to 07/02/2018*
- *EMERGENCY RULE Adoption — effective from 2006-03-08 to 06/12/2006*
#### **216-RICR-40-10-23** Hospital Conversions
##### **216-RICR-40-10-23 § 23.1** Authority {#sec-216-ricr-40-10-23-23.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.1}
This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-17.14-31 for the purpose of establishing minimal standards for the review of hospital conversions in this state, and to fulfill those purposes set forth in R.I. Gen. Laws § 23-17.14-3.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.2** Incorporated Materials {#sec-216-ricr-40-10-23-23.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.2}
These regulations hereby adopt and incorporate the Title VI of the Civil Rights Act of 1964, 42 U.S.C. § 2000d, ("Title VI”) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations, in order to ensure that communications and language assistance is offered, individuals are informed about the availability of language assistance, competence of individuals providing language assistance is assured, and easy-to-understand materials and signage are provided.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.3** Definitions {#sec-216-ricr-40-10-23-23.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.3}
A.Wherever used in these rules and regulations, the terms listed below shall be construed as follows:
1."Acquiree" means the person or persons which lose(s) any ownership or control in the new hospital, as the terms "new hospital" and "person(s)" are defined within the Act.
2."Acquiror" means the person or persons which gain(s) an ownership or control in the new hospital, as the terms "new hospital" and "person(s)" are defined within the Act.
3.“Act” means R.I. Gen. Laws Chapter 23-17.14, entitled “The Hospital Conversions Act.”
4."Affected community" means any city or town within the state of Rhode Island wherein an existing hospital is physically located and/or those cities and towns whose inhabitants are regularly served by the existing hospital.
5."Affiliate" means a legal entity as defined in R.I. Gen. Laws § 23-17-2(1).
6.“Assets” means cash, cash-equivalents and other hard assets that can be converted into cash, including: cash on hand, savings accounts, checking accounts, Certificates of Deposit (CDs), money market accounts, stocks (common and preferred), bonds, mutual funds, IRAs, 401(k)s, 403(b)s, 457s, cash-in-value of life insurance policies, personal property, motor vehicles other than for personal use, second homes and rental properties. Excluded from assets are a primary residence and a motor vehicle for personal use.
7.“Assets protection threshold” means the maximum amount of assets that may be held and still allow the patient/guarantor to be eligible for full charity care. The assets protection threshold shall be $8,000 for singles and $12,000 for family units for 2006 and thereafter increased annually by the most current Consumer Price Index. Provided, however, that in instances in which an individual may be eligible for the state’s Medical Assistance Program, a hospital may apply a lower threshold consistent with a threshold utilized by the state’s Medical Assistance Program for the purpose of that individual qualifying for the state’s Medical Assistance Program(s).
8.“Bad debt” means services provided and billed, but reported to be uncollectible, and demonstrated as such in the audited financial statements. Bad debt shall be cost-adjusted by applying a ratio of cost to charges from the hospital’s Medicare Cost Reports to the “Provision for Bad Debts” (or equivalent) in the “Statements of Operations” (or equivalent) in the hospital’s Audited Financial Statements.
9."Charity care" means health care services provided by a hospital without charge to a patient and for which the hospital does not and has not expected payment. Said health care services shall be rendered to patients determined to be uninsured, underinsured or otherwise deemed to be eligible at the time of delivery of services. Charity care services are those health care services that are not recognized as either a receivable or as revenue in the hospital’s financial statements. Charity care shall not include health care services provided to individuals for the purpose of professional courtesy without charge or for reduced charge. Under no circumstances shall bad debt be deemed to be charity care. Charity care shall be cost-adjusted by applying a ratio of cost to charges from the hospital’s Medicare Cost Reports to charity care charges-foregone.
10."Community benefit" means the provision of hospital services that meet the ongoing needs of the community for primary and emergency care in a manner that enables families and members of the community to maintain relationships with persons who are hospitalized or are receiving hospital services, and shall also include, but not be limited to, charity care and uncompensated care. Community benefit activities may also include the following:
a.Programs, procedures, and protocols that meet the needs of the medically indigent;
b.Linkages with community partners that focus on improving the health and well-being of community residents;
c.Contribution of non-revenue producing services made available to the community, such as fitness programs, health screenings, or transportation services;
d.Public advocacy on behalf of community health needs;
e.Scientific, medical research, or educational activities.
11."Conversion" means any transfer by a person or persons of an ownership or membership interest or authority in a hospital, or the assets thereof, whether by purchase, merger, consolidation, lease, gift, joint venture, sale, or other disposition which results in a change of ownership or control or possession of twenty percent (20%) or greater of the members or voting rights or interests of the hospital or of the assets of the hospital or pursuant to which, by virtue of such transfer, a person, together with all persons affiliated with such person, holds or owns, in the aggregate, twenty percent (20%) or greater of the membership or voting rights or interests of the hospital or of the assets of the hospital, or the removal, addition or substitution of a partner which results in a new partner gaining or acquiring a controlling interest in the hospital, or any change in membership which results in a new person gaining or acquiring a controlling vote in the hospital.
12."Department" means the Department of Health.
13."Director" means the Director of the Rhode Island Department of Health.
14.“Emergency care” means care provided in situations or circumstances involving the sudden onset of a medical, dental, mental or substance abuse condition manifesting itself by acute symptoms of sufficient severity (e.g., severe pain) where the absence of immediate medical attention could reasonably be expected to result in placing the patient’s health in serious jeopardy, serious impairment to bodily or mental functions, or serious dysfunction of any body organ or part.
15.“Equity” means non-debt funds contributed towards the capital costs related to a change in owner or change in operator of a hospital which funds are free and clear of any repayment obligation or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.
16.“Essential services” means hospital services that are reasonably required to diagnosis, correct, cure, alleviate, or prevent the worsening of conditions that endanger life or cause suffering or pain, or result in illness or infirmity, or threaten to cause or aggravate a handicap, or cause physical deformity or malfunction, and there is no other equally effective more conservative or substantially less costly course of treatment available or suitable for the person requesting the service.
17."Existing hospital" means the hospital as it exists prior to the acquisition.
18.“Family unit” means a group of two or more persons related by birth, adoption, marriage, or other legal means who either live together or who live apart and are claimed as dependents.
19.“Federal poverty levels" or "FPL” mean the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. § 9902(2).
20."For-profit corporation" means a legal entity formed for the purpose of transacting business which has as any one of its purposes pecuniary profit.
21.“Free care” and "no cost care" means charity care.
22."Guarantor" means a person or persons who has accepted or is required to accept responsibility for the patient’s hospital bills.
23."Hospital" means a person or governmental entity licensed in accordance with R.I. Gen. Laws Chapter 23-17 to establish, maintain and operate a hospital, for-profit and not-for-profit.
24.“Income” means the actual or estimated total annual cash receipts before taxes from: salaries, wages, self-employment income, child care income, rental income, unemployment compensation, temporary disability insurance, child support, alimony, workers’ compensation, veterans’ benefits, social security payments, dividend and interest income, royalties, private and public pensions, and public assistance. Also included in income are: strike benefits, net lottery and gambling winnings and one-time insurance payments or injury compensation received in the calendar year in which the financial aid is sought for the hospital services.
25."Incumbent" or "Recently incumbent" means those individuals holding the position at the time the application is submitted and any individual who held a similar position within one (1) year prior to the application's acceptance.
26.“New hospital" means the hospital as it exists after the completion of a conversion.
27."Not-for-profit corporation” means a legal entity formed for some charitable or benevolent purpose and not-for-profit which has been exempted from taxation pursuant to Internal Revenue Code Section 501(C)(3) [26 U.S.C. § 501(c)(3)].
28."Outpatient care areas” means outpatient clinical space and/or programs for which the hospital charges a facility fee or other hospital billing.
29."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies, and insurance companies), state or political subdivision or instrumentality of the state.
30.“Primary care services” means the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. In most instances, primary care is focused on the point at which a patient first seeks assistance from the health care system for non-emergency services. Primary care services include, but are not limited to, such services as family practice, pediatrics, internal medicine, obstetrics/gynecology, and mental health services.
31."Rhode Island resident" means an individual whose primary permanent residence is within the State of Rhode Island, regardless of citizenship or immigration status.
32.“State agency” means the Rhode Island Department of Health.
33."Transacting parties" means any person or persons who seeks either to transfer or acquire ownership or a controlling interest or controlling authority in a hospital which would result in a change of ownership, control, or authority of twenty percent (20%) or greater.
34."Uncompensated care" means a combination of free care, which the hospital provides at no cost to the patient, bad debt, which the hospital bills for but does not collect, and less than full Medicaid reimbursement amounts.
35.“Uninsured” means those individuals who do not have coverage under private or employer-sponsored health insurance or another government health plan, and who continue to lack such coverage.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.4** General Requirements and Procedures {#sec-216-ricr-40-10-23-23.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.4}
A.Any hospital conversion, as defined in in this Part, requires review and approval from the Department of Health in accordance with the provisions of R.I. Gen. Laws § 23-17.14-5.
B.All hospitals, including all new hospitals as defined in § 23.3 of this Part, shall be subject to the provisions of the rules and regulations for Licensing of Hospitals (Part 4 of this Subchapter) promulgated by the Rhode Island Department of Health.
C.Any effect on hospital licensing fees is pursuant to R.I. Gen. Laws § 23-17.14-20.
D.Concurrent approval of proposed conversions and proposed change in owner, operator or lessee is pursuant to R.I. Gen. Laws § 23-17.14-28.
1.Reviews of applications for changes in the owner, operator, or lessee of licensed hospitals shall be conducted in accordance with the requirements set forth in the rules and regulations for Licensing of Hospitals (Part 4 of this Subchapter).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.5** Conversion Application {#sec-216-ricr-40-10-23-23.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.5}
A.Information required in the initial application for conversions is pursuant to R.I. Gen. Laws § 23-17.14-6. Additionally, hospitals must provide:
1.All information relevant to the criteria that the Department is required to consider pursuant to §§ 23.6 and 23.7 of this Part.
2.Any additional information pertaining to the conversion that the state agency may deem necessary for analysis of the applicable considerations outlined in §§ 23.6 and 23.7 of this Part.
3.With respect to all information required pursuant to § 23.6 of this Part, the transacting parties shall upgrade and update said information through to the time of the Director's decision and the transacting parties shall have a continuing duty to supplement previously submitted information with supplemental, updated, and upgraded information.
B.Two (2) copies of the initial application shall be provided to the Department of Health by United States mail, certified, return receipt requested, pursuant to R.I. Gen. Laws § 23-17.14-6(b);
C.Except for information determined in accordance with R.I. Gen. Laws § 23-17.14-32 to be confidential and/or proprietary, or otherwise required by law to be maintained as confidential, the initial application and supporting documentation shall be considered a public record and shall be available for inspection upon request.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.6** Review of For-profit Conversions {#sec-216-ricr-40-10-23-23.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.6}
A.Review process is pursuant to R.I. Gen. Laws § 23-17.14-7.
B.In reviewing an application for a conversion involving hospitals in which one (1) or more of the transacting parties is a for-profit corporation as the acquiror, the Department shall consider the criteria stated in R.I. Gen. Laws § 23-17.14-8 and:
1.Issues of market share especially as they affect quality, access, and affordability of services.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.7** Review of Not-for-Profit Conversions {#sec-216-ricr-40-10-23-23.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.7}
A.All conversions which are limited to not-for-profit corporations which involve the establishment, maintenance, or operation of a hospital shall require prior approval of the Department. The review shall proceed pursuant to R.I. Gen. Laws § 23-17.14-9. The transacting parties shall file an initial application pursuant to the provisions set forth in R.I. Gen. Laws § 23-17.14-6 and § 23.5 of this Part.
B.The Department shall adhere to the process set forth in R.I. Gen. Laws § 23-17.14-10 in reviewing an application of a conversion involving a hospital in which the transacting parties are limited to not-for-profit corporations.
C.In reviewing an application of a conversion involving a hospital in which the transacting parties are limited to not-for-profit corporations, the Department shall consider the criteria stated in R.I. Gen. Laws § 23-17.14-11 and:
1.Issues of market share especially as they affect quality, access, and affordability of services.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.8** Review of Other Conversions {#sec-216-ricr-40-10-23-23.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.8}
Review of conversions involving a for-profit hospital as the acquiree is conducted pursuant to R.I. Gen. Laws § 23-17.14-12.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.9** Expedited Review {#sec-216-ricr-40-10-23-23.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.9}
Expedited review is conducted pursuant to R.I. Gen. Laws § 23-17.14-12.1.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.10** Reports, Use of Experts, Costs, and Investigations {#sec-216-ricr-40-10-23-23.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.10}
A.Engaging the use of experts, receiving reports, and their associated costs during review are pursuant to R.I. Gen. Laws § 23-17.14-13.
B.The conduction of investigations is pursuant to R.I. Gen. Laws § 23-17.14-14.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.11** Limits to Subsequent Acquisitions {#sec-216-ricr-40-10-23-23.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.11}
Limits to acquisitions are pursuant to R.I. Gen. Laws § 23-17.14-19.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.12** Concurrent Review {#sec-216-ricr-40-10-23-23.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.12}
A.The Director may consider the requirements of the Act and the requirements of R.I. Gen. Laws §§ 23-17-1 through 23-17-45 together upon completion of the initial application. The Director may approve, approve with conditions, or disapprove one or both requests filed pursuant to the Act and R.I. Gen. Laws §§ 23-17-1 through 23-17-45.
B.The decision of the Director approving or denying a conversion application required by the Act shall be subject to judicial review in accordance with the provisions of R.I. Gen. Laws §§ 42-35-15 and 42-35-16. For any conversion subject to the Act, the Director may combine any hearings required by the Act with any hearings on similar or related matters required by R.I. Gen. Laws §§ 23-17-1 through 23-17-45 and shall consider issues of market share especially as they affect quality, access, and affordability of services.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.13** Elimination or Reduction in Emergency Department and Primary Care Services {#sec-216-ricr-40-10-23-23.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.13}
A.No hospital emergency department or primary care services which existed for at least one (1) year and which significantly serve uninsured or underinsured individuals shall be eliminated or significantly reduced without the prior approval of the Director in accordance with R.I. Gen. Laws § 23-17.14-18.
1.Prior to the elimination or significant reduction of an emergency department or primary care services which existed for at least one (1) year, a hospital shall provide the Director a written plan whereby it proposes to do any of the following:
a.Eliminate its emergency department;
b.Reduce the operation of its emergency department to less than twenty-four (24) hours per day;
c.Make material reductions in emergency department staff providing emergency health care services;
d.Eliminate the delivery of primary care services;
e.Reduce by twenty-five percent (25%) or more its hours of operation for delivery of primary care services (including, but not limited to, family practice, pediatrics, internal medicine, obstetrics/gynecology, or mental health services);
f.Make material reductions in the number or qualifications of staff which affects access to or continuity of primary care services; or
g.Take other actions which result in a significant reduction in primary care services.
2.The written plan describing the impact of such proposal and describing the proposed reduction or elimination will be provided to the Director in a form acceptable for review prior to the implementation of the proposed reduction or elimination, as required in § 23.13(A)(1) of this Part, and shall include, at a minimum, the following information:
a.A description of the services to be reduced or eliminated;
b.The proposed change in hours of operation, if any;
c.The proposed changes in staffing, if any;
d.The documented length of time the services to be reduced or eliminated have been available at the facility;
e.The number of patients utilizing those services that are to be reduced or eliminated annually during the most recent three (3) years;
f.Aggregate data delineating the insurance status of the individuals served by the facility during the most recent three (3) years;
g.Data describing the insurance status of those individuals utilizing those services that are to be reduced or eliminated annually during the most recent three (3) years;
h.The geographical area for which the facility provides services;
i.Identification and description, including supporting data and statistical analyses, of the impact of the proposed elimination or reduction on:
(1)Access to health care services for traditionally underserved populations, including but not limited to, Medicaid, uninsured and underinsured patients, and racial and ethnic minority populations;
(2)The delivery of such services on the affected community: emergency and/or primary care in the cities and towns whose residents are regularly served by the hospital (the “affected” cities and towns);
(3)Other licensed hospitals or health care providers in the affected community or cities and towns; and,
(4)Other licensed hospitals or health care providers in the state; and,
j.Such other information as the Director deems necessary.
3.Upon receipt of the completed plan, as described above, in a form acceptable for review, the Director shall determine based upon the public interest in light of attendant circumstances whether the services affected by the proposed elimination or reduction significantly serve uninsured and/or underinsured individuals. If the Director determines that the services affected by the proposed elimination or reduction do significantly serve uninsured and/or underinsured individuals, the written plan shall be reviewed in accordance with the requirements of § 23.13(A)(4) of this Part below and must be approved by the Director prior to the elimination or reduction of said services.
4.Notwithstanding any other provision in the General Laws, the Director shall have the sole authority to review all plans submitted under this section and the Director shall issue a decision within ninety (90) days from the receipt of the written plan in form and content acceptable for review by the Department or the request shall be deemed approved. If deemed appropriate, the Director may issue public notice and allow a written comment period within sixty (60) days of receipt of the receipt of the proposal.
a.If the Director disapproves the proposal within ninety (90) days of receipt of the written plan in a form acceptable for review, he/she shall afford written expressed reason(s) for disapproval.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.14** Provision of Charity Care, Uncompensated Care, and Community Benefits {#sec-216-ricr-40-10-23-23.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.14}
A.All hospitals shall, as a condition of initial and/or continued licensure:
1.Meet the statewide standards for the provision of charity care as provided in this Part;
2.Meet the statewide standards for the provision of uncompensated care as provided in this Part;
3.Meet the statewide standards for the provision of community benefits as provided in this Part;
4.Not discourage persons who cannot afford to pay from seeking essential medical services; and,
5.Not encourage persons who cannot afford to pay to seek essential medical services from other providers.
B.The Director shall, on an annual basis, review each licensed hospital's level of performance in providing charity care and uncompensated care.
C.The Director shall consider the appropriate amount of charity and uncompensated care necessary to provide safe and adequate treatment, appropriate access and balanced health care delivery to the residents of the state.
23.14.1Statewide Standards for the Provision of Charity Care
A.Every licensed hospital shall be in full compliance with the following statewide standards for the provision of charity care:
1.A hospital may expand its financial assistance beyond this Part but it shall not reduce the assistance nor restrict the qualifications further than this Part.
2.These standards apply to uninsured, low-income Rhode Island residents ineligible for state, federal or employer sponsored health insurance, and shall cover all inpatient and outpatient essential medical services routinely billed by the hospital and provided under the hospital’s license, and routinely reimbursed by the Rhode Island Medicaid program(s).
3.Hospitals shall provide full charity care (i.e., a 100% discount) to patients/guarantors whose annual income is up to and including 200% of the Federal Poverty Levels (FPL), taking into consideration family unit size.
4.In addition, in order to qualify a patient/guarantor for full charity care (§ 23.14.1(A)(3) of this Part), a hospital may or may not also apply an assets criterion requiring that the patient’s/guarantor’s assets not exceed the assets protection threshold.
5.If a hospital applies the assets criterion (§ 23.14.1(A)(4) of this Part) in addition to the income criterion (§ 23.14.1(A)(3) of this Part) in determining eligibility for full charity care only, in cases where a patient/guarantor qualifies for full charity care under the income criterion but does not meet the assets criterion (i.e., has assets in excess of the assets protection threshold), the hospital must provide the patient/guarantor the highest discount offered by the hospital under § 23.14.1(A)(6) of this Part on the whole hospital bill, and the maximum amount that the hospital may pursue for collection shall be the patient/guarantor’s actual assets less the assets protection threshold.
6.Hospitals shall provide partial charity care (i.e., a discount less than 100%) to patients/guarantors whose annual income is between 200% and up to and including 300% of the Federal Poverty Levels (FPLs), taking into consideration family unit size. This partial charity care shall be on a sliding scale discount basis determined by each individual hospital pursuant to its own evaluation of its service area needs and financial resources. For purposes of determining eligibility for partial charity care only, hospitals may or may not also apply the assets criterion under § 23.14.1(A)(4) of this Part. Should a hospital apply the assets criterion, it has the discretion in how this criterion is evaluated in determining eligibility for partial charity care.
7.Hospitals may deny charity care if the patient/guarantor does not provide the information and documentation necessary to apply for charity care or other existing financial resources that may be available to pay for the healthcare services. If a patient/guarantor is denied charity care, the hospital may place the outstanding account in bad debt status and pursue collections consistent with §§ 23.14.1(A)(14) and 23.14.2 of this Part.
8.The hospital shall provide public ‘Notice of Hospital Financial-Aid’ on forms provided by the Department. This public Notice shall be approved by the Director, no less than standard ‘letter’ size (8.5” x 11”), and be prominently posted in Emergency Departments, admission areas, outpatient care areas and on the hospital’s website. The hospital shall also make this notice available in other languages in accordance with the applicable provisions of the “Standards for Culturally and Linguistically Appropriate Services in Health Care” incorporated in § 23.2 of this Part.
9.The hospital shall provide that same public ‘Notice of Hospital Financial-Aid’ on each hospital patient bill. This public notice shall be approved by the Director and may be in a size less than 8.5” x 11”.
10.The hospital shall provide its ‘Financial-Aid Criteria’ on forms provided by the Department for qualifying patients/guarantors for charity care including information on the sliding scale discount schedule for partial charity care under § 23.14.1(A)(6) of this Part. This Financial-Aid Criteria shall be approved by the Director and be made available to all persons on request. The hospital shall also make this Financial-Aid Criteria available in other languages in accordance with the applicable provisions of the “Standards for Culturally and Linguistically Appropriate Services in Health Care” incorporated in § 23.2 of this Part.
11.The hospital shall use a standardized ‘Application for Hospital Financial-Aid’ on forms provided by the Department or as approved by the Director in determining eligibility for full and partial charity care. With the exception of the deletion of the “Assets” Section on the Application (in cases where the hospital does not apply the assets criterion), any material changes to the Application (additions and/or deletions) must first be approved by the Director.
12.Within fourteen (14) days after receipt of a completed Application for Hospital Financial-Aid, the hospital shall render a decision on charity care and notify the patient/guarantor of its decision in writing.
13.The hospital shall have a timely Appeals Process in place should a patient/guarantor be denied charity care. This appeal process shall be set forth in writing and adopted as formal hospital policy and be made available to all persons on request.
14.The hospital shall have a Collections Process in place with this process set forth in writing and adopted as formal hospital policy, and be made available to all persons on request.
15.The hospital shall provide the Department on an annual basis or as required by the Director information including, but not be limited to:
a.The ‘Annual Financial-Aid Data Filing’ on forms provided by the Department or as determined by the Director;
b.The public Notice of Hospital Financial-Aid pursuant to § 23.14.1(A)(8) of this Part;
c.A copy of a hospital bill including the public Notice of Hospital Financial-Aid pursuant to § 23.14.1(A)(9) of this part;
d.The Financial-Aid Criteria for charity care including full disclosure of the discount schedule for partial charity care and, if applicable, how the assets criterion is evaluated in determining eligibility for partial charity care under § 23.14.1(A)(10) of this Part;
e.The Application for Hospital Financial-Aid under § 23.14.1(A)(11) of this Part;
f.The hospital’s adopted Appeals Process under § 23.14.1(A)(13) of this Part;
g.The hospital’s adopted Collections Process pursuant to § 23.14.1(A)(14) of this Part.
23.14.2Statewide Standards for the Provision of Uncompensated Care
A.The statewide standards for the provision of uncompensated care shall be that the hospital (or its agent(s)) may attach, but shall not force foreclosure of a patient’s/guarantor’s primary residence for non-payment of amounts owed (bad debt).
1.Hospitals shall report the amounts of Medicaid Shortfalls, Charity Care, and Bad Debt to the Department, as well as other financial information as determined by the Director.
23.14.3Statewide Standards for the Provision of Community Benefits
A.The statewide standards for the provision of community benefits shall be full compliance with the following:
1.Each licensed hospital shall provide on or before March 1st of each calendar year (as practicable), a report in a form acceptable to the Director, a detailed description with supporting documentation, evidence of compliance of this section including, but not limited to, the cost of charity care; bad debt; contracted Medicaid shortfalls; and any additional information demonstrating compliance with this section.
2.On and after 1 January 2001, each licensed hospital shall have a formal, Board-approved plan for the provision of community benefits. This plan shall be updated and Board-approved, at a minimum, every three (3) years. The plan shall incorporate, at a minimum, the following principles:
a.The governing body shall adopt/affirm and make public a community benefits mission statement setting forth the hospital’s commitment to a formal community benefits plan;
b.The governing body, the chief executive officer, and senior management shall be responsible for the oversight of the development and implementation of the community benefits plan, the methods to be followed, the resources to be allocated, and the mechanism for regular evaluation of the plan on no less than an annual basis;
c.The governing body shall delineate the specific community or communities, including racial or ethnic minority populations, that will be the focus of its community benefits plan and shall involve representatives of that designated community or communities in the planning and implementation process;
d.The community benefits plan shall include a comprehensive assessment of the health care needs of the identified community or communities, which shall include, but not be limited to, needs related to the goals articulated in A Healthier Rhode Island by 2010: A Plan for Action, as well as a statement of priorities consistent with the hospital’s resources; and
e.The community benefits plan shall specify the actual or planned dates for implementation of the activities and/or proposals included therein.
B.If the Department receives sufficient information indicating that a licensed hospital is not in compliance with § 23.14 of this Part, the Director shall hold a hearing upon ten (10) days notice to the licensed hospital and shall issue in writing findings and appropriate penalties as set forth in § 23.17 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.15** Gag Rules Prohibited {#sec-216-ricr-40-10-23-23.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.15}
Gag rules are prohibited pursuant to R.I. Gen. Laws § 23-17.14-16.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.16** Perjury {#sec-216-ricr-40-10-23-23.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.16}
The penalty for perjury is pursuant to R.I. Gen. Laws § 23-17.14-17.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.17** Failure to Comply {#sec-216-ricr-40-10-23-23.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.17}
The penalties for failure to comply with this Part will be applied pursuant to R.I. Gen. Laws § 23-17.14-30.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.18** Whistleblower Protections {#sec-216-ricr-40-10-23-23.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.18}
Whistleblower protections are pursuant to R.I. Gen. Laws § 23-17.14-29.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
##### **216-RICR-40-10-23 § 23.19** Judicial Review {#sec-216-ricr-40-10-23-23.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-23#23.19}
Judicial review is pursuant to R.I. Gen. Laws § 23-17.14-34.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-29 to 01/04/2022*
- *Amendment — effective from 2007-01-30 to 08/29/2018*
- *Amendment — effective from 2006-06-25 to 01/30/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/25/2006*
#### **216-RICR-40-10-24** Tanning Facilities
##### **216-RICR-40-10-24 § 24.1** Authority {#sec-216-ricr-40-10-24-24.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.1}
This Part is promulgated pursuant to the authority conferred by R.I. Gen. Laws § 23-68-8, and is established for the purpose of regulating tanning facilities to minimize the risks associated with tanning by artificial ultraviolet light.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.2** Purpose {#sec-216-ricr-40-10-24-24.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.2}
A.The purpose of this Part is to regulate tanning facilities to minimize the risks associated with tanning by artificial ultraviolet light. These risks include, but may not be limited to:
1.Sunburn;
2.Premature aging of the skin;
3.Skin cancer;
4.Retinal damage;
5.Formation of cataracts;
6.Suppression of the immune system;
7.Damage to the vascular system; and
8.Communication of disease due to improper sanitation of tanning devices.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.3** Incorporated Materials {#sec-216-ricr-40-10-24-24.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.3}
A.This Part hereby adopts and incorporates 21 C.F.R. § 878.4635(b)(6)(i)(A) (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.This Part hereby adopts and incorporates 21 C.F.R. § 1010.3 (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
C.Except as provided in this Part, the requirements of 21 C.F.R. § 1040.20 (2018) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.4** Definitions {#sec-216-ricr-40-10-24-24.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.4}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-68 entitled, "Tanning Facility Safety Standard Act."
2."Department" means the Rhode Island Department of Health.
3."Director" means the Director of the Rhode Island Department of Health or their designee.
4."EPA" means the United States Environmental Protection Agency.
5."FDA" means the United States Food and Drug Administration.
6."Minor" means any individual under the age of eighteen (18).
7."Other compensation" means the payment or exchange of goods, services or anything of value for use of the tanning device or devices.
8."Patron" means any member of the public who is provided access to a tanning device in exchange for a fee or other compensation, or any individual who, in exchange for a fee or other compensation, is afforded use of a tanning device as a condition or benefit of membership or access.
9."Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent or agency of these entities.
10."Protective eyewear" means any device designed to be worn by users of a product to reduce exposure of the eyes to radiation emitted by the product.
11."Registrant" means any person who is registered with the Department as required by provisions of this Part.
12."Registration" means registration with the Department in accordance with provisions of this Part.
13."Safe level" means not more than fifty (50) colonies of microorganisms per four (4) square inches of equipment surface.
14."Sanitize" means the effective bactericidal treatment of surfaces of equipment and devices by an EPA or FDA registered product which provides a sufficient concentration of chemicals, allowing enough time to reduce the bacterial count, including pathogens, to a safe level. Chemical germicides that are registered with the EPA as hospital disinfectants, when used at recommended dilutions and directions, may be approved for sanitizing tanning devices.
15."Sunlamp product" means any electronic product designed to incorporate one (1) or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between two hundred (200) and four hundred (400) nanometers, to induce skin tanning.
16."Tanning device" means any equipment used during the process of skin tanning with a sunlamp product, such as any sunlamp product and any accompanying equipment, including, but not limited to, timers, ballasts, starters, lamps, reflectors, cooling fans, acrylics, comfort pillows and handrails.
17."Tanning facility" means any location, place, area, structure, or business that either as a sole service or in conjunction with other services, provides patrons with access to sunlamps, ultraviolet lamps or other equipment intended to induce skin tanning through the irradiation of any part of the human body for cosmetic or non-medical purposes.
18."Timer" means a device provided to terminate the exposure at a preset time interval.
19."Ultraviolet lamp" means any lamp that produces ultraviolet radiation in the wavelength interval of two hundred (200) to four hundred (400) nanometers in air and that is intended for use in any sunlamp product.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.5** Registration Requirements {#sec-216-ricr-40-10-24-24.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.5}
24.5.1Application and Registration Fee
A.It shall be unlawful for any person, corporation, or other entity to own, maintain, conduct, or operate a tanning facility in Rhode Island without having been registered with the Department pursuant to the provisions of R.I. Gen. Laws § 23-68-6 and this Part.
B.Each tanning facility shall be registered prior to operation. The registrant shall file an application with the Department and pay applicable fee(s) specified in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) to register each tanning facility.
1.If the registrant owns or operates more than one (1) such tanning facility, the registrant shall file a separate application for each tanning facility owned or operated.
C.Registrations are issued to one (1) person for one (1) tanning facility and are non-transferable.
D.As a requirement for registration, each tanning facility shall maintain evidence of holding liability insurance.
E.Registration application shall be made on forms furnished by the Department and shall contain all the information required by the form and accompanying instructions.
F.A certificate of registration will be issued by the Department upon a determination that the applicant has provided all the information required by the application meets the requirements of the Act and this Part, and has paid the application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.The certificate of registration expires annually on the thirty-first (31st) day of August.
2.No person shall operate or maintain a tanning facility without a current and valid certificate of registration.
3.The certificate shall be displayed in a conspicuous place on the premises of the tanning facility.
G.The registrant shall notify the Department in writing before making any change which would render the information contained in the application for registration or the validation of registration no longer accurate. This requirement shall not apply for changes involving replacement of designated original equipment lamp types with lamps which have been certified with the FDA as “equivalent” replacement of the lamps. The registrant shall maintain manufacturer’s literature demonstrating the equivalency of any replacement lamps.
24.5.2Renewal of Registration
A.A registration issued under the provisions of this Part shall be for a period of no longer than twelve (12) months and is required to be renewed annually by the registrant.
1.A registration, unless sooner suspended or revoked, shall expire by limitation on the thirty-first (31st) day of August following its issuance. Said registration may be renewed from year to year after approval by the Department, provided the applicant meets the appropriate requirements of the Act and this Part.
B.Registration renewal application shall be made on forms furnished by the Department and shall contain all the information required by the form and accompanying instructions.
C.An annual tanning facility registration renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) shall accompany the application renewal form provided by the Department.
D.The application for registration renewals and renewal fees shall be received by the Department on or before the expiration date of said registration.
24.5.3Inspections
A.The Department shall make, or cause to be made, such inspections and investigations as it deems necessary in accordance with R.I. Gen. Laws § 23-68-5 and this Part.
B.The Department shall notify the registrant of violations of individual standards through a statement of deficiencies (SOD), which shall be forwarded to the tanning facility within fifteen (15) days of the inspection team formally exiting the tanning facility, unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
1.A tanning facility which received an SOD report must submit a plan of corrections, signed by an authorized representative of the registrant’s management, to the Department within fifteen (15) days of the date of the notice of deficiencies.
C.All written reports, statements of deficiencies and plans of correction shall be maintained on file in each tanning facility for a period of no less than five (5) years.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.6** Protection of Patrons {#sec-216-ricr-40-10-24-24.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.6}
24.6.1Warning Statement
A.At each patron's initial visit to a tanning facility, and at intervals not to exceed twelve (12) months thereafter, the patron shall be provided a written statement containing the following information to review and sign:
1.Not wearing protective eyewear while tanning may cause injury to the eyes;
2.Overexposure to the tanning process may cause burns;
3.Repeated exposure to the tanning process may cause skin cancer or premature aging of the skin or both;
4.Abnormal skin sensitivity or burning may result from the tanning process if the patron is also consuming or using certain:
a.Foods;
b.Cosmetics; or
c.Medications, such as tranquilizers, antibiotics, diuretics, high blood pressure medication, antineoplastic or birth control pills.
5.Any person taking a prescription or over-the-counter drug should consult a physician or a registered pharmacist before using a sunlamp product; and
6.During pregnancy, a woman should consult with her healthcare provider before tanning.
B.A copy of this signed statement shall be maintained in the patron's record, as described in § 24.8.3 of this Part.
C.The registrant shall be responsible for complying with the requirements of § 24.6.1 of this Part.
24.6.2Warning Sign
A.Pursuant to R.I. Gen. Laws § 23-68-4(4), the registrant shall conspicuously post the warning sign described in § 24.6.2(B) of this Part within one (1) meter (39.37 inches) of each sunlamp product and in such a manner that the sign is clearly visible, not obstructed by any barrier, equipment or other object, and can be easily viewed by the patron before operating the sunlamp product.
1.A similar sign containing at least the information listed in § 24.6.2(B) of this Part that complies with all other applicable state and federal laws, codes and regulations may be used instead.
B.This warning sign shall use upper and lower-case letters which are at least ten (10) millimeters (0.39 inches) and five (5) millimeters (0.20 inches) in height, as follows:
DANGER - Ultraviolet Radiation
Follow instructions
Avoid overexposure
As with natural sunlight, overexposure may cause eye and skin injury and allergic reactions.
Repeated overexposure may cause premature aging of the skin and skin cancer.
WEAR FDA COMPLIANT PROTECTIVE EYEWEAR. FAILURE TO USE PROTECTIVE EYEWEAR MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES.
Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult a physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight.
If you do not tan in the sun, you are unlikely to tan from the use of this product.
If you believe that you have been injured by this tanning equipment, you should contact RI Department of Health, Radiation Control Program, 3 Capitol Hill, Room 305, Providence, RI 02908-5097
(401) 222-2566 or [email protected]
1.Pursuant to 21 C.F.R. § 878.4635(b)(6)(i)(A), the warning sign required by § 24.6.2(B) of this Part shall also include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years.
24.6.3Protective Eyewear
A.The registrant shall require that each patron wear protective eyewear during the use of sunlamp products.
1.The registrant shall provide such protective eyewear, unless the patron furnishes their own protective eyewear which meets the requirements of this Part.
2.Tanning facility operators shall instruct the consumer in the proper utilization of the protective eyewear required by § 24.6.3 of this Part.
B.The tanning facility registrant shall ensure that patrons have the protective eyewear required by § 24.6.3 of this Part before each tanning session and shall make a reasonable effort to ensure that this eyewear is worn during tanning.
C.The protective eyewear required by § 24.6.3 of this Part shall meet the requirements of 21 C.F.R. § 1040.20(c)(4).
D.Any reusable protective eyewear furnished by the registrant shall be sanitized in accordance with § 24.7.1(B) of this Part.
24.6.4Policy and Procedural Requirements Related to Patron Safety
A.The registrant shall maintain a list of the common photosensitizing agents as provided by the FDA, or other appropriate authorities, available for review by patrons.
B.At each tanning facility, the registrant shall keep a list of emergency contact numbers appropriate for the community in which the facility is located. This list shall be easily accessible and shall include, but not be limited to, contact numbers for:
1.The nearest hospital;
2.The nearest fire department; and
3.Emergency 911 service.
C.At least one (1) trained staff member is required on-site at all times when the tanning facility is in operation.
D.Only one (1) patron may be in a tanning room at one (1) time, with the following exceptions:
1.If two (2) or more sunlamp products are used in the same room, in which case only those patrons using sunlamp products may be present in the room; and
2.If a patron using a sunlamp product needs aid or assistance from another person, in which case that individual shall also be provided with and wear protective eyewear.
E.Exposure of Minors
1.No patron under the age of eighteen (18) shall be allowed to use a sunlamp product.
2.Infants and other minors are not permitted to be in the sunlamp product room during exposure of parents or guardians.
F.Exposure Limits and other Controls against Overexposure
1.The registrant shall ensure that each patron using a sunlamp product shall be instructed on the maximum exposure time and proper exposure distance, as recommended by the manufacturer of the product.
2.The registrant shall ensure that each patron does not exceed the maximum exposure time indicated by the sunlamp product manufacturer.
a.The registrant shall limit exposure time to the recommended maximum exposure time provided by the product manufacturer on the sunlamp product or in the product operating manual. The maximum exposure time recommended by the manufacturer of the product shall not be exceeded in any twenty-four (24)-hour period.
b.Initial tanning sessions (three (3) to five (5)) are limited to one (1) tanning session per forty-eight (48)-hour period or as recommended by the sunlamp product manufacturer, whichever is less frequent, to allow adequate time for melanin activation and transit to occur prior to subsequent exposures. Patrons shall be advised of the manufacturer's recommended exposure schedule as posted on the sunlamp product or listed in the operating manual for the product prior to the initial tanning sessions.
c.After the initial (three (3) to five (5)) tanning exposures, tanning sessions are limited to one (1) tanning session per twenty-four (24)-hour period or as recommended by the sunlamp product manufacturer, whichever is less frequent. Patrons shall be advised of the manufacturer's exposure schedule as posted on the sunlamp product or listed in the operating manual for the sunlamp product prior to tanning.
d.For patrons with annual tanning packages, package maximums shall not exceed the maximum amount of exposure recommended by the product manufacturer.
3.Tanning facilities are prohibited from controlling the use of sunlamp products with token timer control systems, in the absence of trained staff.
4.The registrant shall ensure that the patron is instructed as to the location and proper operation of the sunlamp product's emergency shut-off switch.
5.The registrant shall establish and use a procedure manual that will aid in the protection of the patron from excessive or unnecessary exposure to ultraviolet light.
a.This manual shall be specific to the facility and shall include at least documentation of the requirements detailed in this Part.
b.A copy of this manual shall be kept on-site and readily available at all times when the tanning facility is in operation.
c.This procedure manual may be developed as part of the training manual described in § 24.8.2 of this Part, provided the above requirements are met.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.7** Physical Plant and Equipment {#sec-216-ricr-40-10-24-24.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.7}
24.7.1Construction, Sanitation and Maintenance of Tanning Facilities
A.Each tanning facility shall be constructed to meet the following minimum requirements:
1.All tanning facilities shall be equipped with convenient toilet facilities and dressing rooms. At a minimum, such toilet facilities shall include a water closet, a hand-washing sink and a safe and sanitary supply of water. Such toilet and dressing rooms shall be properly maintained, as well as meet all federal, state and local laws, codes and regulations.
2.The sunlamp products shall meet the requirements of § 24.7.2 of this Part and all other applicable federal and state requirements.
3.The physical facility shall be constructed such that:
a.All areas of the tanning facility shall be ventilated with at least six (6) air changes per hour or as otherwise required by local code; and
b.Tanning booth temperature shall be maintained below one hundred degrees Fahrenheit (100° F) (thirty-eight degrees Centigrade (38° C)) during sunlamp product operation.
4.Except as otherwise required by this Part, each tanning facility shall be constructed in accordance with all applicable local and state codes.
B.Each tanning facility shall be cleaned and maintained to meet the following minimum requirements:
1.All areas of the tanning facility, including tanning devices, equipment and apparatus, shall be maintained in a clean and sanitary manner and in accordance with manufacturer's instructions.
2.The tanning device(s) and protective eyewear shall be cleaned with an EPA-approved sanitizer after each use, unless the facility provides sanitary disposable clear plastic sheets for application before and disposal after each patron use of a tanning device. Suitable written instructions shall be posted to provide adequate guidance to patrons using sanitary sheets.
a.Facilities using disposable clear plastic sheets to cover the surface of a tanning device shall be required to clean and sanitize those tanning devices periodically throughout each day the tanning devices are being used by patrons.
b.Disposable eyewear designed for one (1) use only are exempt from this requirement provided that they are disposed of and not reused by any other patron.
c.Tanning devices shall be cleaned and sanitized according to the following minimum provisions:
(1)A clean paper or cloth towel shall be used each time the tanning device is cleaned and sanitized;
(2)The sanitizer used shall be one specifically manufactured for sanitizing ultraviolet light-emitting equipment and protective eyewear and that does not damage the acrylic lamp covers of the sunlamp product.
(3)The ultraviolet light produced by a sunlamp product itself is not considered an adequate sanitizing agent.
3.A test kit or other device that accurately measures the concentration of the sanitizing solution in parts per million (ppm) shall be used to measure the strength of the sanitizing solution when the concentrate and water dilution is initially prepared and at least weekly thereafter to ensure sufficient strength of the sanitizing solution.
a.If a suitable test kit is not available for an approved sanitizer, the laboratory analysis data shall be provided by the product manufacturer, and a copy shall be on file with the Department.
4.Written procedures maintained at the facility shall include proper mixing and handling instructions for each sanitizer used, so as to ensure proper concentration of the sanitizer.
5.Except as otherwise required by this Part, each tanning facility shall be cleaned and maintained in accordance with all applicable local and state codes.
C.Clean sanitary towels shall be available to all patrons using tanning facilities.
D.A hamper or other receptacle shall be provided for all soiled towels and linen.
E.No pets or other animals shall be permitted in tanning rooms at any time, except for service animals accompanying a qualified individual with a disability in accordance with R.I. Gen. Laws §§ 40-9.1-1, et seq. and 42-87-1, et seq. and/or the Americans with Disabilities Act, 42 U.S.C. 12101, et seq.
24.7.2Equipment
A.The registrant shall use only sunlamp products manufactured in accordance with the specifications set forth in 21 C.F.R. § 1040.20. Sunlamp products which do not meet the provisions of 21 C.F.R. § 1040.20 shall not be operated.
1.The sunlamp products shall meet the National Fire Protection Association's National Electrical Code, or be approved by the Underwriter Laboratories (UL) or Electrical Testing Laboratories (ETL). Compliance shall be based on the standard in effect at the time of manufacture as shown on the device identification label required by 21 C.F.R. § 1010.3.
B.Each sunlamp product or ultraviolet lamp used in tanning facilities shall not emit measurable ultraviolet C radiation.
C.Each ultraviolet lamp contained within the sunlamp product shall be shielded so as to not come into contact with the patron.
D.The construction of the sunlamp product shall be such that it will have the strength to withstand the stress of use and the impact of a falling person.
1.Entry to stand-up sunlamp products shall be of rigid construction with doors which are non-locking and open outwardly.
E.The appropriate position the patron is to assume prior to operation shall be clearly marked on each sunlamp product.
F.Each sunlamp product shall prominently display a label which contains the information required by § 24.6.2(B) of this Part or an equivalent warning/information label.
G.Reasonable means shall be provided to enable a patron to summon assistance from the exposure position.
H.Original Equipment Manufacturer (OEM) replacement parts (or their equivalent) shall be used, if available, to prevent UL/ETL de-listing of sunlamp products. All local, state and national electrical codes shall be observed during installation.
I.Defective or non-lighting filters or lamps at the end of their useful UV-emitting life shall be replaced with a type intended for use in the sunlamp product, shall be of the same ultraviolet range (A or B) as specified by the manufacturer, and shall be the original lamp type as specified by the manufacturer, or shall be certified as an equivalent lamp per 21 C.F.R. § 1040.20(c)(5).
1.If equivalent lamps are used instead of the required OEM lamps, a copy of the equivalency certification provided by the lamp supplier shall be maintained on file for review by the Department.
J.Defective or burned out tanning lamps and tanning lamps which have been operated in a sunlamp product for the manufacturer's maximum rated lamp hour life shall be disposed of in a safe and proper manner to prevent unauthorized and unsafe use as lighting devices. Used tanning lamps are prohibited from being resold for any purpose.
K.Each sunlamp product shall have a timer which complies with the requirements of 21 C.F.R. § 1040.20(c)(2).
1.The maximum timer interval shall not exceed the manufacturer's maximum recommended exposure time.
2.Each timer shall be functional and accurate to within ± ten percent (10%) of the maximum timer interval of the product as required by 21 C.F.R. § 1040.20(c)(2)(iii).
3.The registrant shall ensure that the timer is tested for accuracy at intervals not to exceed twelve (12) calendar months.
4.Sunlamp product timers shall be controlled by properly trained staff.
5.Tanning facilities shall install remote timer controls prior to the operation of sunlamp products.
6.The time shall not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle when emission from the tanning device has been interrupted.
L.In addition to a timer, each sunlamp product shall be equipped with a control on the product to enable the person being exposed to terminate manually radiation emission from the product at any time without disconnecting the electrical plug or removing the ultraviolet lamp, as required by 21 C.F.R. § 1040.20(c)(3).
M.The minimum requirements of the manufacturer shall be maintained for all sunlamp products.
N.Each sunlamp product shall be equipped with an hour meter to accurately determine lamp hour use.
1.Lamp hour use as indicated by the hour meter shall be recorded at each episode of maintenance service for each product, as specified in § 24.8.3(H)(3) of this Part.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.8** Administrative Requirements {#sec-216-ricr-40-10-24-24.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.8}
24.8.1General Administrative Requirements
A.The registrant shall be responsible for directing the operation of the tanning facility which has been registered with the Department. That registrant shall assure that the provisions of this Part are met in the operation of a tanning facility.
B.The registrant shall ensure that the tanning facility complies with all applicable federal, state and local codes, laws and regulations.
C.Each registrant shall establish and maintain a tanning facility specific electronic mail address (i.e., e-mail address) to be provided to the Department for the purposes of contacting the registrant with both routine communications and emergency notices. The registrant shall be responsible for providing notice to the Department at any time that the tanning facility’s specific electronic mail address is changed or updated.
24.8.2Training of Personnel
A.The registrant shall certify that all tanning facility staff are adequately trained and have been issued a training manual established for that facility. This training and manual shall include, but not be limited to, coverage of the following provisions:
1.The requirements of this Part;
2.Procedures for correct operation of the tanning facility and sunlamp products;
3.Guidelines for the recognition of injury or overexposure to ultraviolet radiation;
4.The sunlamp product manufacturer's procedures for operation and maintenance of the sunlamp products;
5.Guidelines for the determination of skin type of customers and appropriate determination of duration of exposure to sunlamp products;
6.Procedures for the use of patron consent forms;
7.Emergency procedures to be followed in case of injury;
8.Potential photosensitizing foods, cosmetics, and medications;
9.Requirements for the proper use of protective eyewear;
10.Proper sanitizing procedures for eyewear, facility, and devices; and
11.Instructions for use of sunlamp product to avoid or to minimize potential injury to the patron, as required by 21 C.F.R. § 1040.20(e).
B.The registrant may use vendor-provided information in establishing the facility's training manual, provided that this material contains all of the above information.
C.Staff training shall be documented by the registrant. Such documentation shall include the dates and times of the training, as well as the subjects covered in each training session
D.Tanning equipment shall only be operated when a trained tanning operator is present at the tanning facility.
24.8.3Records and Reports
A.The registrant shall be responsible for maintaining all records as described in this Part.
B.All required records shall be maintained at the tanning facility for a minimum of three (3) years and shall be available for review by the Department.
C.All required records may also be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete copies of the records. If records are stored electronically, they shall be maintained in a manner that will allow retrieval of records for any specified time period.
D.Patron Records
1.The registrant shall maintain a record of each patron's total number of tanning visits, dates and durations of tanning exposures.
2.The registrant shall maintain a record of each patron's signature and acknowledgment that they understand the potential risks involved with exposure and overexposure to ultraviolet radiation and they have reviewed a photosensitizing drug list.
E.Within five (5) working days after occurrence or knowledge thereof, the registrant shall submit to the Department a written or electronic report of each actual or alleged accident or injury that results from the use of registered sunlamp products for which medical attention was sought or obtained. The report shall include:
1.The name of the affected individual(s);
2.The name, location and phone number of the tanning facility involved;
3.The nature of the actual or alleged injury(ies); and
4.Any other information relevant to the actual or alleged injury(ies) to include the date and duration of exposure and any documentation of medical attention sought or obtained.
F.The registrant shall maintain a record of staff training as required in § 24.8.1 of this Part.
G.The registrant shall maintain records showing the results of timer tests required by § 24.7.2(K)(3) of this Part.
H.The registrant shall maintain the following information for each sunlamp product:
1.Manufacturer's equipment manual and any other service-related material or instruction;
2.The exposure schedule provided by the manufacturer; and
3.Records of surveys, inspections, maintenance and modifications performed on the sunlamp product, including the names of persons performing such services, the date of service and the hour meter reading of the product serviced.
I.The registrant shall maintain records showing the receipt, transfer, repair and disposal of all sunlamp products and lamps.
24.8.4Advertising and Promotion
A.No person or establishment registered under the Act and this Part shall use or cause or promote the use of any advertising, promotional literature, testimonial, guarantee, warranty, label, brand, insignia or any other representation, however disseminated or published, which is misleading, deceptive or untruthful.
B.No person or facility shall advertise or promote tanning packages labeled as "unlimited" unless information regarding maximum exposure schedules is included in such advertisements.
1.Promotion of annual tanning packages shall include a written statement listing the total number of sessions allowed per person per year, as listed in § 24.6.4(F)(2) of this Part.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-40-10-24 § 24.9** Penalties, Practices and Procedures {#sec-216-ricr-40-10-24-24.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-24#24.9}
24.9.1Denial, Revocation or Suspension of Registration
A.The Department is authorized to deny an application for the issuance of a registration or to revoke or suspend any registration issued if the provisions of the Act and this Part are not met.
B.Whenever an action shall be proposed to deny, revoke or suspend a registration, the Department shall notify the applicant by certified mail, setting forth reasons for the proposed action. The applicant shall be given an opportunity for a prompt and fair hearing, in accordance with Practices and Procedures before the Rhode Island Department of Health (Part 10-05-4 of this Title).
C.If the Department finds that the health, safety or welfare of the public requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of a registration pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.
24.9.2Violations and Penalties
Penalties for violations are in accordance with R.I. Gen. Laws § 23-68-7.
**History**
- *Amendment — effective from 2025-06-05 to current*
- *Periodic Refile — effective from 2022-01-04 to 06/05/2025*
- *Amendment — effective from 2018-08-27 to 01/04/2022*
- *Amendment — effective from 2014-08-12 to 08/27/2018*
- *Amendment — effective from 2012-12-10 to 08/12/2014*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2007-06-19 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
#### **216-RICR-40-10-25** Harm Reduction Centers
##### **216-RICR-40-10-25 § 25.1** Authority {#sec-216-ricr-40-10-25-25.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.1}
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapter 23-12.10 for the purpose of establishing minimum standards for Harm Reduction Centers that are consistent with acceptable international standards of practice and that will provide services in such a manner as to safeguard the health, safety, and welfare of clients.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.2** Definitions {#sec-216-ricr-40-10-25-25.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.2}
A.Wherever used in this Part the following terms shall be construed as follows:
1."Change in owner" means a transfer by the governing body or operator of a harm reduction center to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to:
a.Hire or fire the Harm Reduction Center Director and/or the Medical Director;
b.Maintain and control the books and records of the Harm Reduction Center;
c.Dispose of assets and incur liabilities on behalf of the Harm Reduction Center; or
d.Adopt and enforce policies regarding operation of the Harm Reduction Center.
2.“Case manager” means a person that coordinates and links care across community-based health and social services organizations. A case manager identifies and secures the necessary resources, equipment, and supplies from formal and informal sources including professionals, paraprofessionals, volunteers, family and friends.
3."Client" means a person who utilizes the services of a Harm Reduction Center.
4.“Department” or “RIDOH” means the Rhode Island Department of Health.
5."Director" means the Director of the Rhode Island Department of Health or his or her designee.
6."Drug consumption" means smoking, injecting, snorting, inhaling, swallowing, or otherwise consuming pre-obtained, controlled substances.
7."Harm reduction center" or "Center" means a community-based resource for health screening, disease prevention, and recovery assistance where persons may consume pre-obtained controlled substances in a non-judgmental, supportive environment.
8.“Harm reduction education” means education on practical strategies aimed to reduce behaviors associated with negative consequences associated with drug use including but not limited to infections, overdose, other illness and death.
9.“Harm reduction services” means practical strategies and evidence-based approaches aimed at reducing behaviors associated with negative consequences associated with drug use, such as: safe smoking practices, safe injection practices, using with others, use of clean needles and syringes, etc.
10."Licensed capacity" means the number of drug consumption stations a center is licensed to operate within the Center.
11."Medical director" means a physician licensed to practice medicine in Rhode Island in accordance with R.I. Gen. Laws Chapter 5-37.
12.“Mental health counselor” means a person who has been licensed to provide clinical counseling in accordance with R.I. Gen. Laws Chapter 5-63.2.
13."Temporary service site" means a non-permanent, temporary location where a Harm Reduction Center operates using a mobile unit or short-term unit.
14.“Mobile unit” means a Harm Reduction Center that can move location, such as a van or a bus.
15.“Municipal authorization and approval” means an express affirmative vote by the city or town council, or the equivalent governing body, of any municipality where a fixed, mobile, or short-term Harm Reduction Center is proposed to be located, which the affirmative vote approves the opening and operation of the Harm Reduction Center.
16.“Nurse” means an individual licensed to practice as a professional (registered)(RN) or licensed practical nurse (LPN) in Rhode Island pursuant the provisions of R.I. Gen. Laws Chapter 5-34.
17.“Opioid” means any opiate, synthetic or natural, or opium derivative, listed in R.I. Gen. Laws § 21-28-2.08.
18.“Opioid antagonist” means a drug used to reverse the effects of opioids, such a naloxone hydrochloride, commonly referred to as naloxone, which is a competitive antagonist that binds to opioid receptors with higher affinity than agonists but does not activate the receptors. For the purposes of this Part, opioid antagonist does not include any drugs, such as naltrexone hydrochloride, used for addiction treatment.
19.“Overdose” means a condition including, but not limited to, extreme physical illness, decreased level of consciousness, respiratory depression, coma, or death resulting from the consumption or use of an opioid, or another controlled substance. This would include an overdose that requires medical assistance, clinical suspicion for drug overdose (respiratory depression, unconsciousness, altered mental status) and either a urine toxicology screen positive for opiates or negative urine toxicology screen without other conditions to explain the clinical condition.
20.“Peer” is a person with lived experience with substance use.
21."Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, State, or political subdivision or instrumentality of the State.
22."Premises" means a tract of land and the buildings thereon where harm reduction services are provided.
23."Smoking" or "smoke" means inhaling, exhaling, burning, vaporizing, or carrying any lighted or heated cigar, cigarette, pipe, plant, tobacco product, pharmacologically active chemical, or other combustible substance in any manner or in any form. "Smoking" or "smoke" also includes the use of electronic cigarettes, electronic cigars, electronic pipes, and any other electronic vaporization devices.
24.“Short-term unit” (less than one hundred eighty (180) days) means a Harm Reduction Center or component of a Harm Reduction Center thereof that does not have a permanent, fixed location, such as a tent.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.3** Licensing Procedures {#sec-216-ricr-40-10-25-25.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.3}
25.3.1General Requirements for Licensure
A.No person or governmental unit acting severally or jointly with any other person or governmental unit shall establish, conduct, maintain or operate or hold itself out as a Harm Reduction Center in Rhode Island without a license in accordance with the requirements of R.I. Gen. Laws Chapter 23-12.10 and this Part.
B.Each Harm Reduction Center application shall specify the licensed capacity within the Center.
C.Proposed changes in Center licensed capacity shall be submitted in writing to the Department and shall be subject to the approval of the Department.
D.Notwithstanding the requirements of § 25.3 of this Part, an entity licensed as a Harm Reduction Center in Rhode Island, may provide services at other premises or by use of Temporary Service Sites operated by that licensed Harm Reduction Center, without the requirement of a separate Harm Reduction Center license for such other locations.
E.Each premises or Temporary Service Site proposed for addition to a Harm Reduction Center license pursuant to § 25.3.6 of this Part shall be approved by the Department prior to the inclusion of that premises or Temporary Service Site on the Harm Reduction Center license and commencement of operations at such location.
F.Each premises, Mobile Unit, or Short-term Unit of a licensed Harm Reduction Center shall comply with all pertinent provisions of this Part consistent with the scope of services provided.
25.3.2Application for License, Initial License or Changes in Owner, Operator, or Lessee
A.Application for a license to conduct, maintain or operate a Harm Reduction Center shall be made to the Department upon provided forms, and shall contain such information as the Department reasonably requires, including but not limited to evidence of ability to comply with this Part.
1.Each Harm Reduction Center shall establish and maintain a center specific electronic mail address (i.e., e-mail address) and physical mail address to be provided to the Department for the purposes of contacting the Harm Reduction Center with both routine communications and emergency notices. The Harm Reduction Center shall be responsible for providing notice to the Department at any time that the Center’s specific electronic mail address or physical mail address is changed or updated.
B.A listing of names and addresses of direct and indirect owners whether individual, partnership or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall also include all Officers, Directors and other persons or any subsidiary corporation owning stock, if the Center is organized as a corporation, and all partners if the Center is organized as a partnership. If the Center is organized as a not-for-profit corporation, the list shall include the names of all Officers and Directors of the non-profit corporation.
C.When a change of ownership or operation or location of a Harm Reduction Center is planned or when discontinuation of services is contemplated, the Department shall be given written notice of pending changes within thirty (30) days of such pending changes.
D.A license shall immediately expire and become void and shall be returned to the Department when operation of a Harm Reduction Center is discontinued or when any changes in ownership occur.
E.Prior to operating under a new owner or operator, the Harm Reduction Center shall apply for a new license in accordance with § 25.3.3 of this Part.
F.When there is a change in operation or ownership of the Harm Reduction Center, the Department reserves the right to extend the expiration date of such license, allowing the Harm Reduction Center to operate under the same license which applied to the prior licensee for such time as shall be required for the processing of a new application or reassignment of participants, not to exceed six (6) weeks.
25.3.3Issuance and Renewal of License
A.Upon receipt of an application for license, the Department shall issue a license if the applicant meets the requirements of this Part.
B.The Harm Reduction Center licensee must submit written documentation of municipal authorization and approval in the form of a copy of the affirmative resolution from the municipal vote with the licensure application. An initial license or additional premises or Temporary Service Site approval will not be issued without written documentation of municipal authorization.
1.Mobile routes must have municipal authorization, such authorization shall also include, but not be limited to:
a.Specific addresses or blocks where the Mobile Unit or Short-term Unit will be operating with specific schedule outlined.
b.If partnering with a property owner, a letter must be obtained agreeing to host the Mobile Unit or Short-term Unit or to operate on their premises, including hours of operation.
2.If the routes/locations change, a municipal designee must be notified prior to the new route/location, and official approval must be obtained as soon as practicable for the new location and/or route. A copy of the affirmative resolution must be submitted to the Department within thirty (30) days.
C.The licensee must develop, in collaboration with local public safety officials, a plan to address public safety and order for the Center. Such plan must be made available to the Department upon request and submitted to the municipality.
D.Prior to issuing a license, RIDOH will conduct an inspection of the Center.
E.A license shall be issued to a specific licensee for a specific premise and/or Temporary Service Site(s) and shall not be transferable. The license shall be issued only for the premises and the individual owner, operator or lessee, or to the corporate entity responsible for its governance.
F.A license issued hereunder shall be the property of the State of Rhode Island loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises.
25.3.4Inspections
A.The Department shall make or cause to be made such inspections and investigations as it deems necessary.
B.Every Center shall be given notice within fifteen (15) business days by the Department of any deficiencies reported as a result of an inspection or investigation.
C.A duly authorized representative of the Department shall have the right to enter at any time without prior notice to inspect the entire premises and services, including all records of any Center for which an application has been received or for which a license has been issued. Any application shall constitute permission for and willingness to comply with such inspections.
D.Refusal to permit inspections shall constitute a valid ground for license revocation.
25.3.5Denial, Suspension, Revocation of License, or Curtailment of Activities
A.The Department is authorized to deny, suspend, or revoke the license of or to curtail the activities of any Center that:
1.Failed to comply with the provisions of R.I. Gen. Laws Chapter 23-12.10 and these Regulations promulgated thereunder.
B.Reports of deficiencies noted in inspections conducted in accordance with § 25.3.4 of this Part shall be maintained on file in the Department and shall be considered by the Department in rendering determinations to deny, suspend or revoke the license or to curtail activities of a Center.
C.Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the activities of a Center, the Department shall notify the Center by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9 and in accordance with the provisions of § 25.8.3 of this Part.
1.However, if the Department finds that public health, safety, or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
25.3.6Licensing of Mobile Units & Short-Term Units
A.A Harm Reduction Center that only provides service through a mobile unit or Short-term Unit must have a physical address, but services are not required to be provided at the physical address. Existing, physical Harm Reduction Centers must receive prior approval of the Department prior to operating a Mobile Unit or Short-Term Unit.
B.The provider must comply with the following additional requirements and codes for the Mobile Unit. Variances are not permitted for these items:
1.The unit must have a current motor vehicle registration and inspection sticker.
2.The driver of the Mobile Unit shall maintain an appropriate State-issued driver’s license in good standing.
3.The provider must obtain and maintain appropriate levels of motor vehicle insurance as recommended by their insurance carrier.
4.Compliance with the Rhode Island State Fire Safety Code as evidence by inspection report from the State Fire Marshal or designee.
5.All electrical material and equipment shall be installed with applicable sections of RISBC-5, Rhode Island Electrical Code (510-RICR-00-00-5).
C.Short-term units must comply with Rhode Island State Fire Safety Code as evidence by inspection report from the State Fire Marshal or designee.
D.All electrical material and equipment within short-term units shall be installed with applicable sections of RISBC-5, Rhode Island Electrical Code (510-RICR-00-00-5).
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.4** Organization and Management {#sec-216-ricr-40-10-25-25.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.4}
25.4.1Governing Body and Management
A.Each Center shall have an organized governing body or equivalent legal authority ultimately responsible for:
1.The management and control of the operation;
2.The assurance of quality care and services;
3.Compliance with all State and local laws and Regulations; and
4.All relevant health and safety requirements, including compliance with this Part.
B.The governing body or equivalent legal authority shall be responsible to provide a sufficient number of appropriately qualified personnel, physical resources, equipment, supplies, and services for the provision of safe, effective, and efficient delivery of care services to clients as defined in this Part.
C.The governing body or equivalent legal authority shall appoint and assure the competence of:
1.A Medical Director who is responsible for overseeing clinical practices and services and for achieving and maintaining quality services; and
2.A Harm Reduction Center Director who is responsible for the day-to-day administrative management of the Center.
D.The governing body or equivalent legal authority shall furthermore be responsible to establish a mechanism through the organization's by-laws and/or policies to assure that the Medical Director, the Center Director, and other staff are duly qualified by education, training, and experience and meet the requirements of this Part.
E.The governing body shall be responsible for ensuring that the perspectives of persons with current or former lived experience of substance use are part of the design, implementation, operations, and evaluation of the Harm Reduction Center.
F.The governing body or equivalent legal authority shall adopt and maintain by-laws defining responsibilities for the operation and performance of the organization, identifying purposes and means of fulfilling such, and in addition the by-laws shall include but not be limited to:
1.A statement of qualifications and responsibilities of the Medical Director;
2.A statement of the responsibilities of the Center Director;
3.A statement of the governing body's responsibility for the quality care and services;
4.A statement of policy pertaining to the criteria for the selection, and transfer or referral of clients in accordance with the requirements of this Part;
5.A statement relating to development and implementation of long and short-range plans;
6.A statement relating to conflict of interest on the part of the governing body and staff;
7.A statement describing how the perspectives of persons with current or former lived experience of substance use will be or were included in the design, implementation, evaluation, and operations of the Harm Reduction Center;
8.A statement relating to confidentiality of information and right to anonymity of clients using the Center;
9.A policy statement concerning the publication of an annual report; and
10.Such other matters as may be relevant to the organization of the Center.
G.Furthermore, the governing body or equivalent legal authority in consultation with the Medical Director shall be ultimately responsible to develop and implement policies governing no less than the following:
1.Harm reduction services to be provided;
2.Client consent for the provision of services;
3.Referrals to community providers and organizations in accordance with § 25.5 of this Part;
4.Effective review of clinical practices;
5.Quality assurance for care and services; and
6.Such other matters as may be relevant to the organization and operation of the Center, the delivery of services, and as may be required under the Rules and Regulations of this Part.
25.4.2Personnel
A.All staff shall be trained in:
1.Cardiopulmonary resuscitation from a recognized program such as the American Heart Association or the Red Cross;
2.Overdose response;
3.Opioid antagonist administration;
4.Disposal and transportation of sharps and hazardous medical waste; and
5.Confidentiality of medical information and anonymity for Harm Reduction Center clients.
B.Harm Reduction Centers must have appropriately qualified personnel to provide Center services. Such personnel may include, but are not limited to, the following:
1.Peers;
2.Case managers;
3.Nurses; and
4.Mental health counselors.
C.Each Center shall establish a job description for each classification of all positions, whether paid or volunteer, which clearly delineates qualifications, duties, authority and responsibilities inherent in each position.
D.Records shall be maintained on the premises for all personnel which shall contain no less than:
1.Current background information pertaining to qualifications, including evidence of a State criminal background check obtained upon hire and prior to delivering services for Center personnel whose employment involves routine contact with a client.
a.Any person who has a prior criminal conviction may be considered for employment, at the discretion of the employer.
2.Evidence of registration, certification or licensure as may be required by law; and
3.Each Center shall require all persons, including students, who examine or observe a client to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.
E.Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a client in the Harm Reduction Center. Such health screening shall be conducted in accordance with Part 20-15-7 of this Title, Immunization, Testing, and Health Screening for Health Care Workers. Each Center shall also assure that staff members are in compliance with all applicable laws and Regulations.
F.Each Center must ensure that staff competence to perform job responsibilities is assessed, demonstrated, maintained, and documented in a training file.
1.Each Center must conduct staff performance evaluations no less than once annually per staff member and retain a copy of the evaluation in a personnel file for paid staff.
G.Each Center must develop and implement employee wellness policies and practices that are reflective of working in a potentially traumatic setting. Staff must be made aware of these policies and practices upon hire, and policies must be posted in an area regularly accessed by staff.
25.4.3Medical Director
A.The Medical Director shall be appointed by and be responsible to the governing body or equivalent legal authority and who has appropriate clinical experience to provide effective clinical oversight. The Medical Director shall be responsible for:
1.Advising and consulting with the Center staff on all matters related to medical management of clients with health-related conditions including overdose, or other health related matters;
2.The approval of written policies, procedures, and protocols for client clinical care where appropriate or applicable;
3.The coordination of all professional medical consultants to the Center (i.e., consulting physicians, nurses, and other clinical staff); and
4.Such other functions deemed necessary and appropriate for the Center’s operation under the Rules and Regulations of this Part.
B.Depending on needs of the Center and its resources, the Medical Director may be engaged in a consulting role and need not be a full-time employee of the Center.
25.4.4Harm Reduction Center Director
A.The Harm Reduction Center Director shall be the designated individual responsible for the administrative operation of the Center. The Center Director shall be responsible for:
1.Daily Center operations;
2.Staff hiring, supervision, and support;
3.Meeting the Center's stated goals and objectives;
4.Reporting to Center’s governing body or equivalent legal authority;
5.Reporting (§§ 25.4.7 and 25.4.8 of this Part); and
6.Other functions deemed necessary and appropriate for the Center’s operation under the Rules and Regulations of this Part, as directed by the Center’s governing body or equivalent legal authority.
25.4.5Rights of Clients & Code of Conduct
A.Each Harm Reduction Center shall develop a Code of Client Rights & Responsibilities for Harm Reduction Services and shall include people with current or former lived experience of substance use in the development of the Code of Client Rights & Responsibilities.
B.The Harm Reduction Center shall establish a system to inform clients of their rights and responsibilities and must include the right to lodge a complaint using the RIDOH electronic submission process: Submit A Complaint: Department of Health (ri.gov).
C.Language assistance must be provided for clients who do not communicate using English.
25.4.6Confidentiality
A.Disclosure of any health care information relating to individuals shall be subject to the provisions of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and regulatory requirements.
25.4.7Reporting of Client Deaths & Overdoses within the Center
A.The Harm Reduction Center must develop and implement policies/protocols which address reporting of deaths and overdoses within the Harm Reduction Center to the Center's Medical Director and to the Department.
B.Client deaths as a result of a drug overdose or other cause within the Center shall be reported to the Director within twenty-four (24) hours by phone at 401-222-5200 or 401-276-8046. All reports, as required by this Part, shall be provided to the licensing agency in writing via facsimile or electronic transmission to [email protected] on forms supplied by the Department. A copy of each report shall be retained by the Harm Reduction Center for review during subsequent inspections by the Department.
C.Client deaths as a result of a drug overdose or other cause within the Center shall also be reported to the Office of State Medical Examiners in accordance with R.I. Gen. Laws Chapter 23-4.
D.Nonfatal opioid overdose incidents within the Center shall be reported to the Department within forty-eight (48) hours as specified by Part 20-20-5 of this Title, Opioid Overdose Prevention and Reporting.
25.4.8Administrative Records and Reporting
A.Each Center shall maintain administrative records and reporting as may be deemed necessary by the Department. These records must include but are not limited to, the following:
1.A deidentified, daily record of:
a.Number of client visits, including
(1)Total visits; and
(2)Unique client visits.
b.Number and type of services utilized, including stratification of consumption service by method of consumption (e.g., smoking);
c.Time of visit;
d.Number of overdoses (fatal & non-fatal), including stratification of location of overdose (e.g., smoking space, other consumption space, etc.);
e.Use of an opioid antagonist or other opioid resuscitation method, including stratifying by location and method (e.g., smoking space, other consumption space, etc.); and
f.Amount of opioid antagonists administered per overdose.
2.Each Center shall also report to the Department statistical data pertaining to its operations and services utilized. Such reports shall be made at such intervals, by such dates, and in a format as determined by the Director.
3.The directives issued by the Director pursuant to this Part shall be sent to each Center to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the Department.
4.The Center shall provide other reports or records as deemed necessary and appropriate to document the Center’s compliance with this Part or deemed necessary by RIDOH for the evaluation of the scope and effectiveness of the Harm Reduction Center Pilot Program under R.I. Gen. Laws Chapter 23-12.10.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.5** Management of Services {#sec-216-ricr-40-10-25-25.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.5}
25.5.1Selection of Clients
A.Each Center must have a policy and procedure that includes, at minimum, the following:
1.Client eligibility criteria;
2.Client termination criteria and process; and
3.Client denial of services criteria.
B.Clients shall be anonymous and shall not be asked to present identification to utilize Center drug consumption services.
C.Clients are only permitted to consume drugs they have brought to the Center. Clients are prohibited from sharing, exchanging, or selling drugs at the Center.
D.Staff are prohibited from assisting clients with consumption of drugs that the client has brought into the Center. Clients are prohibited from assisting other clients with drug consumption.
25.5.2Client Orientation
A.The Center must have a process to ensure each person using the Center has information pertaining to no less than:
1.The philosophy and goals of the Center;
2.Services available directly at the Center;
3.Services provided through consultation and referrals;
4.Policies and procedures including:
a.Drug usage and sharing policy;
b.Disposal of paraphernalia;
c.Confidentiality and anonymity; and
d.Client termination criteria and process.
5.Client denial of services criteria.
25.5.3Services & Referrals
A.The Harm Reduction Center must provide at a minimum the following services:
1.Drug consumption;
2.Harm reduction education/training and supplies; and
3.Needle exchange.
B.The Harm Reduction Center must provide referrals for counseling or other medical treatment that may be appropriate for clients utilizing the Harm Reduction Center.
C.Harm Reduction Centers must make available additional referrals and information to serve the needs of their client population, such as, but not limited to, the following:
1.Basic needs (clothes, food, COVID-19 supplies, etc.) referrals and supplies;
2.Referrals to housing services;
3.Referrals to employment services; and
4.Referrals to legal services.
25.5.4Drug Checking
A.Harm Reduction Centers are permitted to offer drug checking/testing of client's pre-acquired substances. Drug checking/testing includes the use of fentanyl test strips or other means of drug testing as available. Clients are permitted to utilize their own drug checking/testing supplies, and Center staff may assist as needed.
1.Unless using tests that have been approved to detect quantity and potency, clients utilizing the Center’s drug checking resource must be notified at the time of testing that testing methods measure the presence of certain types of drugs, depending on the test being used, but do not measure the quantity or potency of the drug present in a sample and that even if the test returns a negative result, the sample may nonetheless contain an undesirable substance at a lower concentration than can be detected or an analog of the substance not detected by the test.
25.5.5Client Records
A.Clients shall be anonymous for Harm Reduction Center Services. Centers are required to assign a non-identifying ID to allow for population-level tracking and reporting of service utilization as prescribed by the Department.
25.5.6Infection Control
A.A mechanism shall be established by the Medical Director for the development of infection control policies and procedures which shall pertain to no less than:
1.Infection surveillance activities;
2.Sanitation and disinfection of all client areas;
3.Handling and disposal of medical waste and contaminants;
4.Reporting, recording, and evaluating occurrences of infections.
B.The Center shall report promptly to the Department infectious diseases which may present a potential hazard to clients, personnel, and the public in accordance with Part 30-05-1 of this Title, Reporting and Testing of Infectious, Environmental, and Occupational Diseases.
25.5.7Emergencies
A.Each Center must have policies and procedures for responding to life-threatening emergencies such as drug overdose, respiratory arrest, and cardiac arrest and other emergencies such as fire, loss of power, and hurricanes.
1.In the event of a life-threatening emergency or death the Center must call 911.
B.The Harm Reduction Center Director must develop rapid response protocols for addressing community/neighborhood concerns and must have designated community liaison representatives.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.6** Environmental Management {#sec-216-ricr-40-10-25-25.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.6}
A.The Center shall be maintained and equipped to provide functional, sanitary, safe and comfortable environment, with all furnishings in good repair, and the premises shall be kept free of hazards.
B.Written policies and procedures shall be established pertaining to environmental controls to assure comfortable, safe and sanitary environment with well-lighted space. Policies and procedures must address cleaning of surfaces that may be contaminated with leftover drug residue and/or trash that may contain hazards such as needles or biomedical waste.
C.Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe and sanitary condition.
D.Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place and kept in an enclosed section separated from other cleaning materials.
E.Cleaning shall be performed in a manner which minimizes the spread of pathogenic organisms in the atmosphere.
F.Drug consumption spaces shall be thoroughly cleaned after each client use, in accordance with the Center’s infection control policies and procedures. Staff must be provided access to adequate personal protective equipment for cleaning.
G.Smoking shall be permitted only in designated areas, as specified under § 25.7.1(D) of this Part.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.7** Physical Plant and Equipment {#sec-216-ricr-40-10-25-25.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.7}
25.7.1General Provisions for Physical Center
A.Each Center shall be equipped and maintained to protect the health and safety of clients, personnel and the public, and to facilitate emergency exit of clients and personnel in the event of emergency.
B.Each Center shall have at least the following areas:
1.An intake space where potential clients can learn about the Harm Reduction Center services and its operation;
2.Smoking drug consumption area;
3Drug consumption areas for other consumption methods; and
4.An aftercare area where clients receive referrals, education, and counseling, as applicable.
C.Each area of the center must allow for unimpeded, rapid access to an exit where emergency transportation vehicles may be accommodated.
1.There shall be adequate space for staff or volunteers to perform opioid antagonist administration and artificial respiration, if necessary.
2.Hallways and doors providing access and entry into the reception, drug consumption and after care areas shall be of adequate width to accommodate ambulance stretchers and wheelchairs.
D.The drug consumption area(s) shall be spacious enough to accommodate staff to move freely and include, but not be limited to:
1.Mirrors strategically placed to facilitate monitoring and self-injection.
2.Accessible sharps and biohazardous waste disposals for each consumption station/room/booth and washrooms.
3.Non-permeable, non-flammable chairs, counters/tables, floor surfaces, and privacy partitions that can be easily cleaned with hospital grade cleaning supplies.
a.No carpeting is permitted in the Center.
b.The station/room/booth must allow for observation by Center staff.
c.Handwashing stations must be readily available.
4.Smoking of tobacco products and drugs are only allowed in specifically designated smoking areas that meet the following criteria:
a.The drug consumption area must be well-ventilated with outdoor air through the use of adequate mechanical ventilation that is designed to run at all times that the building is occupied.
b.Smoking areas must be physically separated from non-smoking areas, including any staff-only areas.
c.Signs shall clearly indicate what areas allow smoking and what areas are non-smoking areas.
d.Smoking areas shall be ventilated in such a way that the air from that area shall not enter any other areas of the center.
e.The exhaust system shall run at all times that the smoking area is occupied and for at least one (1) hour afterwards.
f.Air from smoking areas shall be exhausted outdoors to a location secure from public access, such as the roof.
E.The Harm Reduction Center must have adequate security policies and procedures to ensure the safety of both staff and clients.
F.Acceptable toilet facilities shall be available to clients and staff.
G.Secure utility and storage areas shall be designed and equipped for washing, sterilizing and storage of equipment, and supplies in a manner that ensures segregation of clean and sterile supplies and equipment from those that are soiled and/or contaminated.
H.Heating and ventilation systems shall be capable of maintaining comfortable temperatures.
I.Each Harm Reduction Center shall be adequately lighted with appropriate lighting in the drug consumption area(s).
1.An emergency source of electrical lighting shall be available in the event the normal electrical power is interrupted.
2.All electrical and other equipment used in the Harm Reduction Center shall be maintained free of defects which could be a potential hazard to clients and staff.
J.An elevator shall be available where Harm Reduction Service resources are provided at different floor levels. The cab size of the elevator shall be large enough to accommodate a stretcher, an attendant and such equipment as may be needed.
25.7.2Initial licensure, New Construction, Modification, Additions, or Room Conversions
A.All initial licenses, new construction, modification, additions, or room conversions of an existing center shall be subject to the provisions of Fire Safety Code-General Provisions (R.I. Gen. Laws Chapter 23-28.1), State Building Code (R.I. Gen. Laws Chapter 23-27.3), ANSI A117.1 – 2009 Accessible and Usable Buildings and Facilities, Americans with Disabilities Act (42 U.S.C. §§ 12101 through 12213), and such other applicable State and local laws, codes and Regulations as may be applicable. Where there is a difference between codes, the code having the more stringent or higher standard shall apply.
25.7.3Equipment and Supplies
A.Each Harm Reduction Center shall be equipped with a sufficient supply of those items needed to initiate emergency procedures in life threatening events. Such equipment shall include no less than the following:
1.Self-inflating bag valve mask;
2.Mouth barriers for rescue breathing;
3.Oral glucose;
4.Oxygen and AMBU-bags;
5.Automated External Defibrillator (AED);
6.Opioid Antagonist; and
7.Fire extinguisher
B.The Harm Reduction Center shall be equipped with a sufficient supply of harm reduction supplies for safe drug use practices within the Center and/or for take home supplies, included but not limited to:
1.Fentanyl test strips;
2.Nitrile gloves;
3.Safe injection supplies;
4.Safe snorting supplies; and
5.Safe smoking supplies.
C.Any Harm Reduction Center that utilizes latex gloves shall do so in accordance with the provisions of Part 20-15-3 of this Title, Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department.
D.The Harm Reduction Center must provide sharps containers at each consumption station and biohazard disposal containers and arrange for the disposal/removal of containers according to the R.I. Department of Environmental Management’s Medical Waste Regulations, 250-RICR-140-15-1, for disposal of hazardous medical waste.
E.Each Center must identify a person(s) to intervene whenever conditions immediately threaten life or health or threaten damage to equipment or the Center.
F.Each Center must ensure that all equipment is maintained appropriately and in proper working condition.
25.7.4Plumbing
A.All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of R.I. Gen. Laws Chapter 23-27.3.
25.7.5Water Supply
A.Water shall be obtained from an approved water system and shall be distributed to conveniently located taps and fixtures throughout the Center and shall be adequate in volume and pressure for all Center purposes, including fire safety in accordance with R.I. Gen. Laws Chapter 23-27.3.
25.7.6Drug Disposal
A.The Harm Reduction Center must develop and implement written policies and procedures for management and disposal of drugs and unknown substances in accordance with Part 20-20-1 of this Title, Disposal of Drugs.
25.7.7Design and Layout of Mobile Units and Short-term Units
A.Each mobile unit or short-term unit shall be constructed, equipped, and maintained to protect the health and safety of clients and staff. All equipment and furnishings shall be maintained in good condition, properly functioning and replaced when necessary.
B.The design of the Mobile Unit or Short-Term Unit shall comply with § 25.7.1 of this Part. In the event of non-conformance for which the provider seeks a variance from this Section, the general procedures outlined in § 25.8.1 of this Part shall be followed.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.8** Practices and Procedures {#sec-216-ricr-40-10-25-25.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.8}
25.8.1Variance Procedure
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any Rule or Regulation in a specific case, if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of clients.
B.A request for a variance shall be filed by any applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the Department, and within thirty (30) days thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the center appeals the denial and in accordance with the provisions of § 25.8.3 of this Part.
25.8.2Deficiencies and Plans of Correction
A.The Department shall notify the governing body or other legal authority of a center of violations of individual standards through a notice of deficiencies which shall be forwarded to the Center within fifteen (15) days of inspection of the Harm Reduction Center unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with R.I. Gen. Laws § 23-1-21.
B.A Harm Reduction Center that received a notice of deficiencies must submit a plan of correction to the Department within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefor.
C.The Department will be required to approve or reject the plan of correction submitted by a Harm Reduction Center in accordance with § 25.8.2(B) of this Part within fifteen (15) days of receipt of the plan of correction.
D.If the Department rejects the plan of correction, or if the Harm Reduction Center does not provide a plan of correction within the fifteen (15) day period stipulated in § 25.8.2(B) of this Part, or if a Harm Reduction Center whose plan of correction has been approved by the Department fails to execute its plan within a reasonable time, the Department may invoke the sanctions enumerated in § 25.3.5 of this Part. If the Harm Reduction Center is aggrieved by the sanctions of the Department, the Harm Reduction Center may appeal the decision and request a hearing in accordance with R.I. Gen. Laws Chapter 42-35.
E.The notice of the hearing to be given by the Department shall comply in all respects with the provisions of R.I. Gen. Laws Chapter 42-35. The hearing in all respects shall comply with all provisions therein.
25.8.3Rules Governing Practices and Procedures
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-12.10 shall be held in accordance with Part 10-05-4 of this Title, Practices and Procedures Before the Rhode Island Department of Health.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
##### **216-RICR-40-10-25 § 25.9** Severability {#sec-216-ricr-40-10-25-25.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-10-25#25.9}
A.If any provisions of these Regulations or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of these Regulations which can be given effect, and to this end the provisions of these Regulations are declared severable.
**History**
- *Amendment — effective from 2024-08-15 to current*
- *Adoption — effective from 2022-02-16 to 08/15/2024*
### **Subchapter 15** Pharmacy
#### **216-RICR-40-15-1** Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors
##### **216-RICR-40-15-1 § 1.1** Authority {#sec-216-ricr-40-15-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.1}
A.These Regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws §§ 5-19.1-5(6), 27-18-93(e), and 23-25.6-7 and Chapter 5-19.2 for the purpose of establishing administrative procedures and pharmaceutical practices consistent with current standards of practice.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.2** Incorporation by Reference {#sec-216-ricr-40-15-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.2}
A.This Part hereby adopts and incorporates the Center for Disease Control and Prevention’s “Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update” (2021) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.This Part hereby adopts and incorporates the Center for Disease Control and Prevention’s “Updated Guidelines for Antiretroviral Postexposure Prophylaxis after Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016” (2025) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
C.This Part hereby adopts and incorporates the Center for Disease Control and Prevention’s “Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use” (2024) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
D.This Part hereby adopts and incorporates United States Pharmacopoeia Chapter 797, Pharmaceutical Compounding – Sterile Preparations (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
E.This Part hereby adopts and incorporates United States Pharmacopoeia Chapter 795, Pharmaceutical Compounding – Non-sterile Preparations (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
F.This Part hereby adopts and incorporates United States Pharmacopoeia Chapter 800, Hazardous Drugs-Handling in Healthcare Settings (2020) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
G.This Part hereby adopts and incorporates United States Pharmacopoeia Chapter 659, Packaging and Storage Requirements (2021) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
H.This Part hereby adopts and incorporates United States Pharmacopoeia Chapter 825, Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging (2024) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.3** Definitions {#sec-216-ricr-40-15-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.3}
A.Wherever used in this Part the following terms shall be construed as follows:
1.“ACPE” means Accreditation Council for Pharmacy Education.
2."Act" means R.I. Gen. Laws Chapter 5-19.1 entitled, "Pharmacies."
3.“Active ingredient” means any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body of man or animals.
4.“Active Pharmaceutical Ingredient (API)” for the purposes of compounding, means any substance or mixture of substances intended to be used in the compounding of a preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body. Also referred to as Bulk Drug Substance. A conventionally manufactured drug product is not an API but is typically manufactured from an API(s).
5.“Actively reports” means reporting all dispensing errors and analyses of such errors to a patient safety organization as soon as practical but no later than thirty (30) days of identification of the error.
6.“Administer” or “Administration” means the direct application of – medications to the body of a patient or research subject by a practitioner by injection, inhalation, ingestion, or any other means.
7.“Adverse drug reaction” means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.
8.“Assisted living residence licensed at the M-1 level” or “Assisted living residence” means a publicly or privately operated residence that provides directly or indirectly by means of contracts or arrangements personal assistance to meet the resident's changing needs and preferences, including central storage and/or administration of medications, lodging, and meals, to six (6) or more adults who are unrelated to the licensee or administrator, excluding however, any privately operated establishment or facility licensed pursuant to R.I. Gen. Laws Chapter 23-17 and those facilities licensed by or under the jurisdiction of the Department of Behavioral Healthcare, Developmental Disabilities and Hospitals, the Department of Children, Youth, and Families, or any other state agency. Assisted living residences include sheltered care homes, board and care residences, and any other entity by any other name providing the above services.
9."Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.
10.“Auto-substitute” means the replacing of the prescribed product with either a generic product, another brand of the prescribed product, a product with the same active ingredient but different inactive ingredients or a different drug within the same therapeutic class as the prescribed product, without being required to obtain prescriber authorization.
11.“Automated dispensing system” means a computerized system for dispensing prepackaged medications in manufacturer labeled, unit-of-use doses.
12.“Automated filling system” means an automated system used within a pharmacy to assist in filling a prescription drug order by selecting, labeling, filling, or sealing medication for dispensing. An “automated filling system” shall not include automated devices used solely to count medication or vacuum tube drug delivery systems.
13.“Automated pharmacy system” means a mechanical system, located within or adjacent to the prescription department, or at a remote location, that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all transaction information.
14.“Automated storage and distribution devices” means a mechanical device that delivers drugs other than by administration, and uses automated data processing technology to:
a.Provide effective storage and security of drugs contained in the device;
b.Limit access to authorized individuals;
c.Record the identity of all personnel who access the drugs stored within the device;
d.Provide documentation of storage and removal of contents;
e.Provide ongoing documentation that monitors proper delivery of drugs to ensure patient safety;
f.Comply with Rhode Island General Laws and Regulations.
15.“Batch compounding” means the act of compounding multiple containers/doses of a drug product or other material with uniform character and quality, within specified limits, that are prepared in anticipation of physician/prescription drug orders or approved protocol/procedure based on routine, regularly observed prescribing patterns.
16.“Beyond use date” means:
a.The date or time beyond which a compounded drug preparation is not recommended to be dispensed, administered, stored, or transported.
b.Beyond use date shall be determined from the date and time the drug preparation is compounded.
17.“Biological product”' means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings as defined in the Public Health Service Act, 42 U.S.C. § 262.
18.“Biosimilar” means a product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
19.“Blister packages” means multi-dose containers of a specific medication repackaged by the pharmacy and intended for a specific patient.
20."Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
21."Blood component" means that part of blood separated by physical or mechanical means.
22."Board" means the Board of Pharmacy within the Department of Health established pursuant to R.I. Gen. Laws § 5-19.1-3.
23.“Call center operation” means any operation that functions as a shared order processing facility but is not licensed as a pharmacy.
24."Cancer drug" means as defined in R.I. Gen. Laws § 23-25.6-2(1).
25.“Central fill pharmacy” means the pharmacy that fills the prescription order for delivery in accordance with an agreement with another pharmacy or pharmacies.
26."Change of ownership" means:
a.In the case of a pharmacy, manufacturer or wholesaler which is a partnership which results in a new partner acquiring a controlling interest in the partnership;
b.In the case of a pharmacy, manufacturer or wholesaler which is a sole proprietorship, the transfer of the title and property to another person;
c.In the case of a pharmacy, manufacturer or wholesaler which is a corporation:
(1)A sale, lease exchange, or other disposition of all, or substantially all of the property and assets of the corporation; or
(2)A merger of the corporation into another corporation; or
(3)The consolidation of two (2) or more corporations, resulting in the creation of a new corporation; or
(4)In the case of a pharmacy, manufacturer or wholesaler which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in the corporation; or
(5)In the case of a pharmacy, manufacturer or wholesaler which is a nonbusiness corporation, any change in membership which results in a new person acquiring a controlling vote in the corporation.
27.“Clinic” means a health facility providing healthcare services to individuals associated with a college or university.
28."Collaborative pharmacy practice" means as defined in R.I. Gen. Laws § 5-19.2-2(a).
29."Collaborative practice agreement" means as defined in R.I. Gen. Laws § 5-19.2-2(b).
30.“Compounded sterile preparations” or “CSPs” means a preparation intended to be sterile that is created by combining, admixing, diluting, pooling, reconstituting, repackaging other than as provided in the manufacturer’s labeling, or otherwise altering a drug product or bulk drug substance.
31.“Compounded non-sterile preparations” or "CNSPs" means a preparation intended to be non-sterile by combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug product or bulk drug substance to create a nonsterile preparation.
32."Compounding" shall be the act of combining two (2) or more sterile or non-sterile ingredients as a result of a practitioner's prescription or medication order occurring in the course of professional practice based upon the individual needs of a patient and a relationship between the practitioner, patient, and pharmacist. Compounding does not mean the routine preparation, mixing, reconstitution or assembling of drug products that are essentially copies of a commercially available product. Pharmacy compounding includes the preparation of drugs or devices pursuant to a prescription or medication order or in anticipation of prescription or medication orders based upon routine, regularly observed prescribing patterns. Addition of vitamins, nutrients, and/or medications to intravenous fluid bags is compounding. The flavoring of commercially available oral liquids, tablets, and capsules to facilitate patient dosing is not considered compounding under this Part and exempt from following USP 795 standards.
33."Confidential information" means healthcare and other information maintained by the pharmacist in the patient's records, which is deemed confidential by virtue of the provisions of R.I. Gen. Laws Chapter 5-37.3, and any other Federal or State law.
34.“Contact hour” means a unit of measure of educational credit as defined by ACPE.
35.“Consultant pharmacist” means a pharmacist licensed to engage in the practice of pharmacy in this State who is responsible for developing, coordinating, and supervising pharmaceutical services in a nursing facility, assisted living residence, medical institution, or hospice care facility.
36.“Continuing education” means accredited or approved post-licensure professional pharmaceutical education designed to maintain and improve competence in the practice of pharmacy, pharmacy skills, and preserve pharmaceutical standards for the purpose of protecting public health, safety, and welfare. Continuing education programs shall address topics and subject matter areas which are pertinent to the contemporary practice of pharmacy.
37.“Continuing education unit” (CEU) means a unit of measure of educational credit which is equivalent to ten (10) hours.
38.“Controlled substance" means a drug or substance, or an immediate precursor of such drug or substance, so designated under or pursuant to the provisions of R.I. Gen. Laws Chapter 21-28.
39.“Correctional facility” means any facility in the State of Rhode Island for the confinement or rehabilitation of offenders or individuals charged with or convicted of criminal offenses.
40."Counseling" means the oral communication by the pharmacist of information, as defined in the rules of the Board, to the patient or care giver, in order to improve therapy by ensuring proper use of drugs and devices.
41.“COVID-19” means the disease cause by the novel coronavirus SARS-CoV-2.
42."Deliver" or "Delivery" means the actual, constructive, or attempted transfer from one (1) person to another of a drug or device whether or not there is an agency relationship.
43."Department" means the Rhode Island Department of Health.
44.“Digital signature” means an electronic signature based upon cryptographic methods of originator authentication, and computed by using a set of rules and a set of parameters that identify the signer so that the integrity of the data can be verified.
45.“Delivery pharmacy” means the pharmacy that delivers the filled prescription medication to the patient.
46."Device" means an instrument, apparatus, and contrivances, including their components, parts and accessories, intended:
a.For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or
b.To affect the structure or any function of the body of man or other animals.
47.“Director" means the Director of the Rhode Island state Department of Health or their subordinates to whom the Director has delegated the powers and duties vested in the Director by this Part. The terms Department or Director may be used interchangeably unless clearly indicated otherwise by the context of the sentence in which it appears.
48.“Dispensary” shall have the same meaning as “clinic.”
49."Dispense" or "Dispensing" means the interpretation of a prescription or order for a drug, biological, or device and, pursuant to that prescription or order, the proper selection, measuring, compounding, labeling, or packaging necessary to prepare that prescription or order for delivery or administration.
50."Dispensing error" means one (1) or more of the following discovered after the final verification by the pharmacist and after receipt of the drug by the patient:
a.Variation from the prescriber's prescription drug order, including but not limited to:
(1)Incorrect drug;
(2)Incorrect drug strength;
(3)Incorrect dosage form;
(4)Incorrect patient; or
(5)Inadequate or incorrect packaging, labeling, or directions.
b.Failure to exercise professional judgment in identifying and managing:
(1)Known therapeutic duplication;
(2)Known drug-disease contraindications;
(3)Known drug-drug interactions;
(4)Incorrect drug dosage or duration of drug treatment;
(5)Known drug-allergy interactions;
(6)A clinically significant, avoidable delay in therapy; or
(7)Any other significant, actual, or potential problem with a patient's drug therapy.
c.Delivery of a drug to the incorrect patient.
d.Variation in bulk repackaging or filling of automated devices, including but not limited to:
(1)Incorrect drug;
(2)Incorrect drug strength;
(3)Incorrect dosage form; or
(4)Inadequate or incorrect packaging or labeling.
51.“Dispensing error analysis" means a review of the findings collected and documented on each dispensing error, assessment of the cause and any factors contributing to the dispensing error, and any recommendation for remedial action to improve pharmacy systems and workflow processes to prevent or reduce future errors.
52."Distribute" means the delivery of a drug other than by administering or dispensing.
53.“Distributor” means a person defined in R.I. Gen. Laws § 21-28-1.02.
54.“Donation” means the act or instance of donating an item or currency as a free contribution to a person or institution.
55."Donor," for the purposes of the Pharmaceutical Redistribution Program, means as defined in R.I. Gen. Laws § 23-25.6-2(5).
56."Drug" means:
a.Articles recognized in the official United States Pharmacopeia, or the official Homeo-pathic Pharmacopeia of the United States;
b.Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, woman or other animals;
c.Substances (other than food) intended to affect the structure of any function of the body of man, woman or other animals;
d.Substances intended for use as a component of any substances specified here above or as a “Prescription drug” or “Legend drug” defined in these Regulations, but not including devices or their component parts or accessories;
e.For the purposes of this Part “drug” means “medication” and “medication” means “drug.”
57.“Drug regimen review" includes, but is not limited to, the following activities:
a.Evaluation of the prescriptions and patient records for:
(1)Known allergies;
(2)Rational therapy-contraindications;
(3)Reasonable dose and route of administration;
(4)Reasonable directions for use, and
(5)Evaluation of the prescriptions and patient records for duplication of therapy.
b.Evaluation of the prescriptions and patient records for interactions:
(1)Drug-drug;
(2)Drug-food;
(3)Drug-disease;
(4)Adverse drug reactions, and
(5)Idiosyncratic reactions.
c.Evaluations of the prescriptions and patient records for proper utilization (including over-and under-utilization), and optimum therapeutic outcomes.
58.“DEM” means the Rhode Island Department of Environmental Management.
59."Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
60."Drug" has the same meaning set forth in R.I. Gen. Laws § 5-19.1-2(k).
61."Drug therapy management" means as defined in R.I. Gen. Laws § 5-19.2-2(d).
62.“Electronic medical record” (eMAR) is an electronically stored report that serves as a record of the drugs administered to a patient at a facility by a health care professional. The eMAR is a part of a patient's permanent record on their medical chart.
63.“Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.
64.“Electronic transmission prescription” means any prescription, other than an oral or written prescription, that is electronically transmitted from a practitioner authorized to prescribe to a pharmacy without alteration by a third (3rd) party unless authorized by the prescribing practitioner or from one (1) pharmacy to another pharmacy.
65."Emergency drug kit" means a select supply of drugs and/or biologicals located at a nursing facility, assisted living residence, medical institution, or hospice care facility, except as prohibited by other statutes or Regulations, for the immediate administration to patients upon the medical order of an authorized prescriber.
66."Equivalent and interchangeable" means having the same generic name, dosage form, and labeled potency, meeting standards of the United States Pharmacopoeia or National Formulary, or their successors, if applicable, and not found in violation of the requirements of the United States Food and Drug Administration, or its successor agency, or the Rhode Island Department of Health.
67.“Facsimile (FAX) prescription” means a written prescription or order that is transmitted by an electronic device that sends the exact image to the receiver (pharmacy) in a hard copy form.
68.“FDA-approved product” means any drug or device that has received United States Food and Drug Administration (FDA) approval, including being manufactured in an FDA-approved facility.
69."Financial interest" means financial benefit gained by any practitioner with authority to prescribe drugs and includes such benefit derived by a spouse or dependent child.
70.“Foreign pharmacy graduate" is a pharmacist whose undergraduate pharmacy degree was conferred outside the United States by a pharmacy school listed in the World Directory of Schools of Pharmacy published by the World Health Organization. The United States, as used here, includes the fifty (50) States, the District of Columbia, and Puerto Rico.
a."FPGEC" means the Foreign Pharmacy Graduate Equivalency Commission.
b."FPGEE" means the Foreign Pharmacy Graduate Equivalency Examination.
c."TOEFL" is the Test of English as a Foreign Language, as given by the American College Testing (ACT), or its successor, and certified by the FPGEC.
d."Test of Spoken English (TSE)" means the test of spoken English administered by the Educational Testing Service.
71.“Hazardous drug” means any drug identified on the NIOSH or DEM lists that has the potential to cause carcinogenicity, teratogenicity, developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.
72.“Hospice care facility” means an inpatient setting where palliative and supportive services to the terminally ill and their families are provided.
73.“Hospital” means a facility with a governing body, an organized medical staff and a nursing service providing equipment and services primarily to inpatient care to persons who require definitive diagnosis and treatment for injury, illness or other disabilities or pregnancy, licensed pursuant to R.I. Gen. Laws Chapter 23-17.
74.“Immunizing pharmacist” means a pharmacist who is certified to administer adult and pediatric vaccinations in accordance with these Regulations.
75.“Injectable hormonal contraceptive” means an FDA approved medication composed of a hormone(s) used to prevent pregnancy.
76.“Institutional pharmacy” means any pharmacy:
a.Located within or
b.Off-site and contracted with any hospital, clinic or dispensary in which drugs are compounded or dispensed to its patients or patients of another licensed in-patient healthcare facility with whom it has a contract.
77.“Interchangeable biological product” means biosimilar to an FDA-approved reference product and meets additional standards for interchangeability. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.
78."Intern" means a graduate of an Accreditation Council for Pharmaceutical Education (ACPE)-accredited program of pharmacy, or a student enrolled in a professional ACPE-accredited program of pharmacy or a graduate of a foreign college of pharmacy who has obtained full certification from the FPGEC (Foreign Pharmacy Graduate Equivalency Commission) administered by the National Association of Boards of Pharmacy.
79."Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.
80."Internship" means that period of training of an intern, under the direction of the preceptor, which is required for licensure to engage in the practice of pharmacy.
81."Investigational drug" means any drug which has not been approved for use in the United States, but for which an investigational drug application has been approved by the Food and Drug Administration (FDA).
82.“ISO” means an air quality classification from the International Organization for Standardization.
83."Legend drugs" means any drugs that are required by any applicable Federal or State law or Regulation to be dispensed on prescription only or are restricted to use by practitioners only.
84.“Limited-function test” means as defined in R.I. Gen. Laws § 5-19.2-2(e).
85."Live hours” means hours acquired through attendance or participation at programs that provide for direct interaction between faculty and participants and may include lectures, symposia, live teleconferences or workshops.
86.“Manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance or device or the packaging or repackaging.
87.“Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug or poisons.
88."Manufacturing" means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substances or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacists, practitioners, or other persons.
89.“Medical institution” means any hospital, clinic or dispensary.
90."Medication error" means any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems including, but not limited to: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
91.“Medication administration record” or “MAR” is a report that serves as a record of the drugs administered to a patient at a facility by a health care professional. The MAR is a part of a patient's permanent record on their medical chart.
92.“Medication orders” or “Orders” means a written, verbal or electronically transmitted order for drugs and devices from an authorized practitioner in the State of Rhode Island for the dispensing and administration of a drug.
93."Most in need," for the purposes of the Pharmaceutical Redistribution Program, means as defined in R.I. Gen. Laws § 23-25.6-2(6).
94.“Multi-drug single-dosing container” means a container that is a customized single-dosing package labeled by a pharmacy for a specific patient, and such package contains one (1) or more solid, oral dosage form drugs to be administered to or taken by a specific patient at the same dosage time from a single container.
95.“NABP” means National Association of Boards of Pharmacy.
96.“NIOSH” means National Institute for Occupational Safety and Health.
97."Non-controlled substance prescription drugs," for the purposes of the Pharmaceutical Redistribution Program, as defined in R.I. Gen. Laws § 23-25.6-2(7).
98."Non-legend" or "Non-prescription drugs" means any drugs that may be lawfully sold without a prescription.
99."Non-resident pharmacy" means a pharmacy located outside Rhode Island in any State in the United States or any Province or Territory of Canada that ships, mails, or delivers prescription drugs and/or devices to a patient or person in Rhode Island.
100."Nuclear pharmacy" means a pharmacy providing radiopharmaceutical services.
101."Nuclear/radiologic pharmacy practice" refers to a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.
102.“Nursing facility” means a place, however named, or an identifiable unit or distinct part thereof that provides twenty-four (24) hour in-resident nursing, therapeutic, restorative or preventive and supportive nursing care services for two (2) or more residents unrelated by blood or marriage whose condition requires continuous nursing care and supervision.
103."Out-of-state redistributor," for the purposes of the Pharmaceutical Redistribution Program, means a redistributor that is based outside of this state in accordance with R.I. Gen. Laws Chapter 21-28.
104.“Outsourcing facility” means a facility at one (1) geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all of the requirements of § 503B of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 353b.
105."Patient profile" means a patient record system that is maintained by all pharmacies for patients for whom prescriptions are dispensed. The patient profile shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing.
106."Patient safety organization" (PSO) means an organization that has as its primary mission continuous quality improvement under the Patient Safety and Quality Improvement Act of 2005 (Pub. Law 109-41) and is credentialed by the Agency for Healthcare Research and Quality.
107."Person" means an individual, corporation, government, subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity.
108.“Pharmaceutical assistance program (PAP) medication” means a non-controlled manufacturer-prepared medication that is shipped to a practitioner for a specific “medically indigent" patient, generally defined as those with low income, without insurance, and ineligible for public programs.
109."Pharmaceutical care" is the provision of drugs and other pharmaceutical services intended to achieve outcomes related to cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. Pharmaceutical care includes the judgment of a pharmacist in dispensing an equivalent and interchangeable drug or device in response to a prescription after appropriate communication with the patient.
110.“Pharmaceutical organization” means any profit or non-profit organization that advocates, lobbies, solicits business, or provides support services to any private or public sector organization, or business within the various disciplines of the pharmacy profession, including but not limited to State pharmacy associations, national pharmacy associations, accrediting organizations and suppliers.
111."Pharmaceutical redistribution program" means as defined in R.I. Gen. Laws § 23-25.6-2(9).
112."Pharmacist" means an individual licensed to engage in the practice of pharmacy in the State of Rhode Island pursuant to R.I. Gen. Laws § 5-19.1-14.
113."Pharmacist-in-charge" means a pharmacist licensed in the State of Rhode Island designated by the owner as the person responsible for the operation of a pharmacy in conformance with all laws and Regulations pertinent to the practice of pharmacy and who is personally in full and actual charge of such pharmacy and personnel.
114."Pharmacist with advanced training and experience relevant to the scope of collaborative practice" means as defined in R.I. Gen. Laws § 5-19.2-2(f).
115."Pharmacy" means that portion or part of a premises where prescriptions are compounded and dispensed, including that portion utilized for the storage of prescription or legend drugs.
116.“Pharmacy and therapeutics committee” means the active standing committee in the hospital, nursing or hospice care facility which is the organizational line of communication and liaison between the medical and pharmacy staff which acts to review and promote rational drug therapy and utilization in the licensed facility.
117."Pharmacy technician" means an individual who meets minimum qualifications established by the Board, that are less than those established by the Act as necessary for licensing as a pharmacist; and who work under the direction and supervision of a licensed pharmacist. There shall be two (2) levels of licensure for Pharmacy Technicians:
a.Pharmacy Technician I; and
b.Pharmacy Technician II. (See also § 1.13.2 of this Part). As used in these Regulations, a “Pharmacy Technician II” is one who is licensed by the Board as a Pharmacy Technician and who is also currently certified by the Pharmacy Technician Certification Board (PTCB) of the American Pharmacists' Association or other national certifying organization as may be approved by the Board.
118.“Post-exposure prophylaxis” or “PEP” means a drug or drug combination that meets the same clinical eligibility recommendations provided in the incorporated reference in § 1.2(B) of this Part.
119."Practice of pharmacy" means as defined in R.I. Gen. Laws § 5-19.1-2(x). In addition to the provisions stated in in R.I. Gen. Laws § 5-19.1-2(x), “Practice of pharmacy” shall include the provision of medication therapy management (MTM), the participation in collaborative practice, and the administration of medications.
120."Practitioner" means a physician, physician assistant, dentist, veterinarian, nurse or other person duly authorized by law in the State in which they practice to prescribe drugs.
121."Preceptor" means a pharmacist licensed to engage in the practice of pharmacy in the State of Rhode Island or a licensed pharmacist in the USA who has the responsibility for training interns.
122.“Pre-exposure prophylaxis” or “PrEP” means a drug or drug combination that meets the same clinical eligibility recommendations provided in the incorporated reference in § 1.2(A) of this Part.
123."Prescriber" means any person who has occupational licensing by relevant boards to prescribe a medication. Prescribers include, but are not limited to, physicians, or any other person legally permitted to prescribe medications.
124.“Prescription” means an order for drugs or devices issued by the practitioner duly authorized by law in the State in which they practice to prescribe drugs or devices in the course of their professional practice for a legitimate medical purpose.
125.“Prescription sample” means a complimentary drug packaged in accordance with federal and state statutes and provided to a licensed practitioner free of charge by manufacturers.
126.“Prescription drug” or "Legend drug” means a drug which, under Federal law, is required, prior to being dispensed or delivered, to be labeled with either of the following statements:
a.“Rx only”;
b."Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; or
c.A drug which is required by any applicable Federal or State law or Rule to be dispensed pursuant only to a prescription, or is restricted to use by practitioners only, and includes finished dosage forms and active ingredients subject to § 503(b) of the Federal Food, Drug, and Cosmetic Act, including all medical gases.
127."Product liability", as used herein, means insurance coverage protecting the Canadian pharmacy against legal liability resulting from a defective condition causing bodily injury, or damage, to any individual or entity, associated with the use of the product.
128."Prospective drug review" means a review of the patient's drug therapy record and prescription, as established in the rules of the Board, prior to dispensing the drug as part of a drug regimen review.
129.“PTCB” means Pharmacy Technician Certification Board.
130."Qualified nuclear pharmacist" means a currently licensed pharmacist in the state of Rhode Island, who is identified as an Authorized Nuclear Pharmacist on a radioactive materials license issued pursuant to § 216-RICR-40-20-9.5.12 or equivalent Regulations of the U.S. Nuclear Regulatory Commission or another Agreement State.
131."Reasonable effort" includes collecting patient information with printed data forms provided to the patient by the pharmacist, the pharmacist interviewing the patient to develop a patient's medication history, or similar patient-pharmacist interactions where the pharmacist assumes responsibility to collect, record, and maintain information necessary to properly dispense a prescription and counsel a patient. Collection of patient information may be appropriately delegated by the responsible pharmacist.
132."Radiopharmaceuticals" are radioactive drugs as defined by the FDA and regulated pursuant to R.I. Gen. Laws Chapter 23-1.3 and the “Rules and Regulations for the Control of Radiation [R23-1.3-RAD].”
133."Radiopharmaceutical service" means, but is not limited to, the procurement, storage, handling, preparation, labeling, quality assurance testing, dispensing, delivery, record keeping, and disposal of radiopharmaceuticals and other drugs.
134."Receiver" means any person or institution who or that receives a donated drug, including, but not limited to: a wholesaler, a drug manufacturer, a re-packager, a returns processor, a third-party logistics provider, a healthcare facility, a pharmacy, a hospital, or a patient. Donated medications shall be obtained legally, with informed consent of the donor, and without coercion.
135.“Recognized provider” means any person, corporation or association approved either by the Board, the Accreditation Council for Pharmaceutical Education (ACPE), or American Medical Association (AMA) Category I Programs, to conduct continuing education programs.
136."Redistributor," for the purposes of the Pharmaceutical Redistribution Program, means as defined in R.I. Gen. Laws § 23-25.6-2(12). Redistributors shall also include out-of-state redistributors engaged in redistribution of medications pursuant to the provisions of R.I. Gen. Laws Chapter 23-25.6. Redistributors must be licensed by the Department as distributors in accordance with the provisions of R.I. Gen. Laws Chapter 21-28, as amended.
137.“Restricted pharmacy” is a facility established pursuant to R.I. Gen. Laws § 5-19.1-10, and the provisions of the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001 et seq., for the purposes of dispensing drugs to the beneficiaries of any trust, fund, pension plan, combination plan, or profit sharing plan.
138.“Retail pharmacy” means any pharmacy where drugs are compounded, dispensed, stored or sold or where prescriptions are filled or dispensed to the general public.
139.“Self-administered hormonal contraceptive” means a drug composed of a hormone(s) that is approved by the FDA to prevent pregnancy and that the patient to whom the drug is prescribed may self-administer.
140.“Shared order filling” means that the functions of: preparation, packaging, compounding, or labeling of an order or any combination of these functions by an authorized person located at a pharmacy on behalf of and at the request of another pharmacy; and returning the filled order to the requesting pharmacy for delivery to the patient or patient’s agent or, at the request of the delivery pharmacy, directly delivering the filled order to the patient, or an alternate location of the patient’s choosing.
141.“Shared order processing” means that the functions of: interpreting and entering the order, performing drug utilization reviews, refill authorizations, or therapeutic interventions, or any combination of these functions are performed in accordance with the Act and these Regulations, and are performed at a licensed pharmacy at the request of, and on behalf of, another pharmacy.
142.“Shared services pharmacy” means both central fill and delivery pharmacies that have the same owner, or have a written contract outlining the services provided and the shared responsibilities of each party in accordance with the Act and this Part, and that participate in shared order filling or shared order processing, or both.
143.“Standing order” means a prewritten medication, medical supply(ies) or equipment order with specific instructions from a licensed independent practitioner to administer, prescribe or dispense a medication, supplies, or equipment to a person in clearly defined circumstances.
144.“Sterile compounding” means any manipulation of a sterile or non-sterile preparation intended to produce a sterile final preparation.
145.“Supply” means the delivery of a non-controlled medication to a patient by a practitioner by one (1) of the following methods and in accordance with the requirements stated herein:
a.Pre-packaged prescription sample medication;
b.Automated dispensing system;
c.Administration of a stock medication;
d.Dispensing of a manufacturer-prepared pap medication;
e.Dispensing of oral and transdermal contraceptives.
146."Tamper-evident packaging" means a package that has an outer or secondary seal that must be broken to access the inner package and shall include clear messaging that the package had previously been opened after its seal date. Tamper-evident packaging includes, but is not limited to, blister packs and sealed manufactured bottles.
147."Temperature-sensitive drug" means prescription drugs that are deemed by the manufacturer to be susceptible to decomposition if not stored at temperatures in accordance with the following United States Pharmacopeia (USP) standards: room temperature range of sixty-eight to seventy-seven degrees Fahrenheit (68° to 77° F), refrigeration range of thirty-six to forty-six degrees Fahrenheit (36° to 46° F) and freezer range of minus thirteen to positive fourteen degrees Fahrenheit (-13° to +14° F). Improperly stored temperature-sensitive drugs may affect the drugs potency and efficacy. Common examples of temperature-sensitive drugs include drugs that must be refrigerated, such as biologics or insulin.
148."Transaction date" means the date on which the drug was transferred from the donor to the pharmaceutical redistribution program or to the redistributor.
149.“Trauma informed care” means a service delivery approach focused on an understanding of and responsiveness to the impact of trauma on an individual.
150."Underinsured," for the purposes of the Pharmaceutical Redistribution Program, means any person as defined by R.I. Gen. Laws § 23-25.6-2(16).
151."Unit-dose container" is one that is designed to hold a quantity of drug intended for use as a single dose and used promptly after the container is opened. The immediate container, and/or the outer container or protective packaging shall be designed to show evidence of any tampering with the contents. Each individual container shall be fully identifiable containing a single dose of a single entity and shall protect the integrity of the dosage form. Labeling shall be in accordance with USP standards compendia and Federal and State law and shall include the identity, quantity, and strength of the product, name of the manufacturer, and lot number and expiration date of the article.
152.“USP” means the United States Pharmacopeia.
153.“Value of redistributed drug” means drugs in this category shall be valued at fifty percent (50%) of the industry established maximum acquisition cost (MAC) listed in credible databases utilized by Centers for Medicaid & Medicare Services (CMS).
154."Wholesale distribution" means distribution of prescription drugs to person other than a consumer or patient, but does not include:
a.Intracompany sales;
b.The purchase or other acquisition by a hospital or other healthcare entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or healthcare entities that are members of such organizations;
c.The sale, purchase or trade of a drug of an offer to sell, purchase, or trade a drug by a charitable organization to a non-profit affiliate of the organization to the extent otherwise permitted by law;
d.The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other healthcare entities that are under common control. For purposes of this Section, “common control” means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract or otherwise;
e.The sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons. For purposes of this Section, "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
f.The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;
g.The lawful distribution of drug samples by manufacturers' representatives or distributors' representatives;
h.The sale, purchase, or trade of blood and blood components intended for transfusion;
i.Every hospital licensed in accordance with R.I. Gen. Laws Chapter 23-17 that is required to restock supplies listed by the Director of Health that are used by a licensed emergency medical services provider in transporting emergency patients to such hospital, pursuant to R.I. Gen. Laws § 23-4.1-7.1.
j.Every hospital licensed in accordance with R.I. Gen. Laws Chapter 23-17 that accepts vaccine from the Department and distributes such vaccine as part of the Department's immunization program.
155."Wholesale distributor" means anyone engaged in wholesale distribution of drugs, including, but not limited to, manufacturers, repackers, own-label distributors, private-label distributors, jobbers, brokers, warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses, independent wholesale drug traders, and retail pharmacies that conduct wholesale distribution.
156."Wholesaler" means a person who buys drugs or devices for resale and distribution to corporations, individuals, or entities other than consumers.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.4** Code of Professional Conduct for Pharmacists and Pharmacies {#sec-216-ricr-40-15-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.4}
A.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall follow the Code of Professional Conduct to include, but not be limited to the following:
1.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall at all times conduct professional activities in conformity with Federal, State and municipal laws, ordinances and/or Regulations, including the Regulations of the Board.
2.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not dispense drugs, devices, or other substances in a manner which is intended, either directly or indirectly, to circumvent the law.
3.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall observe the standards of the United States Pharmacopoeia Chapters 795, 797, and 800, incorporated by reference in §§ 7.2(D) – (F) of this Part above, in addition to State laws and Regulations.
4.While on duty, a pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall be responsible for the proper preservation and security of all drugs in the pharmacy or pharmacy department, including the proper refrigeration and storage of said drugs.
5.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not engage in any fraudulent or deceptive act.
6.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not in any way aid or abet the unlawful practice of pharmacy.
7.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not knowingly dispense or distribute expired, outdated or otherwise substandard drugs or devices or counterfeit drugs or devices to any person or entity.
8.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not knowingly dispense or distribute drugs or devices to any person or entity who is not licensed or legally authorized to receive such drugs or devices.
9.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department may dispense prescription drugs by mail or common carrier in a manner consistent with Federal and State laws and Regulations, including the Regulations of the Board. All pharmacists shall have available sufficient information to contact the patient and the prescribing practitioner.
10.A pharmacist, pharmacy, pharmacy department, pharmaceutical organization or pharmacy corporation shall not provide any practitioner with prescription blanks which refer to any pharmacist, pharmacy or pharmacy department.
11.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not purchase drug samples for the purpose of compounding, dispensing, or in any way reselling these samples.
12.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall comply with the mandatory counseling provisions contained in State and Federal laws.
13.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall maintain patient confidentiality at all times. Confidential information shall include information maintained by the pharmacist in the patient’s records or information which is communicated to the patient as part of patient counseling, which is privileged and may be released only to the patient or to those practitioners and other pharmacists where, in the pharmacist’s professional judgment, such release is necessary to protect the patient’s health and well-being; and to such other persons or governmental agencies authorized by law to receive such confidential information.
14.A pharmacist-in-charge, registered pharmacist, pharmacy, or anyone acting on behalf of a pharmacy or pharmacy department shall not obtain any remuneration by fraud, misrepresentation, or deception, including, but not limited to, receiving remuneration for amending or modifying, or attempting to amend or modify, a patient’s pharmaceutical services, absent a clear benefit to the patient.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.5** Pharmacists/Licensure Requirements {#sec-216-ricr-40-15-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.5}
1.5.1Licensure Requirements
A.No person, unless a licensed pharmacist shall retail, compound or dispense drugs, medicine or poisons, except as provided pursuant to statutory provisions of R.I. Gen. Laws § 5-19.1-8.
B.The Director has determined that, in the interest of public health, a waiver of the requirements of § 1.5.1 of this Part is necessary under limited circumstances. Specifically, the waiver shall only be applicable when such medication will be dispensed by a licensed healthcare professional at the Block Island Health Center or, in the event that the Block Island Health Center ceases to exist, to another pharmacy licensed in the Town of New Shoreham, Rhode Island, and it is necessary to dispense medication before the medication can be delivered to the island. The waiver shall be subject to the following provisions:
1.Medication to be dispensed shall be limited to legend drugs included in a written policy established by the Block Island Health Center. A full instruction on the use of the product in plain language shall be provided to the patient.
2.The Block Island Health Center shall keep a written log of all medications dispensed pursuant to the waiver authorized by this Part. The dispensing log shall contain, as a minimum, the following information:
a.The name of the prescriber;
b.The full name of the patient;
c.The name of the drug dispensed in accordance with R.I. Gen. Laws Chapter 21-31;
d.Quantity and strength of the drug dispensed; and
e.The date of dispensing.
3.Copies of the dispensing logs shall be maintained for twenty-four (24) months from the date the legend drug was dispensed and shall be made available to the Department upon request.
4.Each medication dispensed pursuant to the waiver authorized by this Part shall have a label attached which meets the requirements of § 1.6.17(A) of this Part.
5.When required, the healthcare provider who dispenses medication pursuant to the waiver authorized by § 1.5.1 of this Part shall be responsible for ensuring that all necessary data is entered into the Department’s Prescription Monitoring Program (PMP) database in accordance with the Rules and Regulations for the Prescription Drug Monitoring Program (Part 20-20-3 of this Title).
6.Any waiver utilized pursuant to this Part shall not relieve the licensed healthcare provider of record-keeping or other requirements of this Part.
C.A licensee must provide current contact information to the Department. Furthermore, licensees will have a continuing obligation to inform the Department of any change in their contact information.
D.All licensees subject to provisions of this Part shall conduct themselves in a professional manner and must adhere to conduct mentioned above in § 1.4(A) of this Part.
1.5.2Authorized Practices
A.In accordance with R.I. Gen. Laws § 5-19.1-22, nothing in the Act or this Part shall apply to any practitioner with authority to prescribe who does not maintain an open shop for the retailing, dispensing of medicines and poisons, nor prevent them from administering or supplying to his patients such articles as he or she may deem fit and proper.
B.Nothing in the Act or this Part shall apply to, nor in any manner interfere with the business of, a general merchant in selling and distributing non-narcotic, non-prescription medicines or drugs which are prepackaged, fully prepared by the manufacturer for use by the consumer, and labeled in accordance with the requirements of the State (R.I. Gen. Laws Chapter 21-31) and Federal Food and Drug Acts.
C.A licensed pharmacist may decline to dispense a drug or device, pursuant to an order or prescription, on ethical, moral, or religious grounds only if the licensed pharmacist has previously notified the pharmacy owner, in writing, of the device(s), drug or class of drugs to which they object, and the pharmacy owner can, without creating undue hardship, provide a reasonable accommodation of the licensed pharmacist's objection. The licensed pharmacy owner shall establish protocols to ensure that the patient has timely access to the prescribed drug or device despite the licensed pharmacist's refusal to dispense the prescription or order. For the purpose of this Section, "reasonable accommodation" shall mean the pharmacy owner has demonstrated that they explored any available reasonable alternative means of accommodating the licensed pharmacist’s ethical, moral, or religious objections, including the possibilities of excusing the licensed pharmacist from those duties or permitting those duties to be performed by another person, but is unable to reasonably accommodate the ethical, moral, or religious objections without undue hardship on the conduct of the pharmacy owner’s business.
1.5.3Qualifications for Licensure: Pharmacists
A.In addition to the provisions of R.I. Gen. Laws § 5-19.1-14, every person in order to be a licensed pharmacist shall:
1.If the applicant is a foreign pharmacy graduate, have obtained full certification from the FPGEC.
2.Have satisfactorily completed the internship in accordance with § 1.5.13 of this Part; and
3.Have successfully passed such examination as the Board and the Director may require in accordance with § 1.5.5(A) of this Part.
4.Not have been convicted of any felony for violations involving controlled substances subject to waiver by the Board upon presentation of satisfactory evidence that such conviction does not impair the ability of the person to conduct with safety to the public the practice of pharmacy.
5.Obtain and report an eProfile number from NABP.
6.Meet such additional requirements as may be established in this Part.
1.5.4Application for Licensure and Fee
A.Application for licensure shall be made on forms provided by the Department, and which may be obtained at:
The Rhode Island Department of Health
Three Capitol Hill, Room 103
Providence, Rhode Island 02908
1.Said forms shall be completed and signed by the applicant, and submitted to the Department no sooner than thirty (30) days prior to the scheduled date of graduation. Such application shall be accompanied by the following documents and fee (non-returnable):
a.A true copy of certificate of birth;
b.One (1) unmounted recent photograph, head and shoulders, front view, approximately two inches by three inches (2” x 3”) in size, of the applicant. Such photograph must be certified by a member of the faculty of the college of pharmacy at which the applicant matriculated;
c.Proof of graduation from an accredited College of Pharmacy;
d.The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Application and supporting documents shall be verified and reviewed by the Department. Eligibility for examinations shall not be granted until after the applicant's date of graduation.
C.No applicant shall be approved or accepted for examination until they have met all requirements of internship as set forth in § 1.5.13 of this Part. Affidavit of internship hours shall be submitted to the Department prior to application for licensure.
D.Applications shall be completed (including the submission of all supporting documents) within six (6) months of the date of initial submission. Any application that is not completed within this six (6) month time frame shall be deemed to be invalid, shall be denied, and the applicant shall be required to submit a new application. No fees shall be refunded.
1.5.5Examination for Licensure
A.By Examination: Applicants shall be required to pass a written examination, conducted in English, as the Board deems most practical and expeditious to test the applicant's knowledge and skills to engage in the practice of pharmacy in the State of Rhode Island, pursuant to R.I. Gen. Laws § 5-19.1-14.
1.For written examination the Board requires applicants to successfully pass the following examinations:
a.The North American Pharmacists Licensure Examination (NAPLEX) or its successor examination of the National Association of Boards of Pharmacy (NABP) which may be:
(1)Administered in the State of Rhode Island with the passing grade as determined by NABP and approved by the Board; or
(2)Administered in another State by the licensing authority of the respective State, and provided the requirements of § 1.5.5(B) of this Part on transfer of grades are met; and
b.The Multistate Pharmacy Jurisprudence Examination (MPJE) with a passing grade as determined by NABP.
B.Transfer of Grades
1.Applicants wishing to participate in the National Association of Boards of Pharmacy Transfer of Scores Program must comply with all the requirements of the National Association of Boards of Pharmacy regarding the transfer of scores including but not limited to the submission to the National Association of Boards of Pharmacy the completed and signed NAPLEX SCORE TRANSFER FORM with accompanying fee (non-refundable).
2.For individuals seeking licensure in Rhode Island, the Board of Pharmacy will only accept scores submitted directly by the National Association of Boards of Pharmacy. Furthermore, each individual seeking licensure in the State of Rhode Island must submit an application for licensure to the Department in accordance with § 1.5.11 of this Part and must meet all other statutory and regulatory requirements in this Part.
3.Applicants participating in the Transfer of Scores Program shall complete the Multistate Jurisprudence Examination, as described in § 1.5.5(A) of this Part, within six (6) months of application to the Rhode Island Board of Pharmacy.
1.5.6Re-Examination
A.In case of failure of any applicant to satisfactorily pass the NAPLEX Examination, and/or the Multistate Pharmacy Jurisprudence Examination (MPJE), such applicant shall be entitled to re-examination(s) in accordance with NABP guidelines.
B.Application for re-examination shall be submitted to the Department and accompanied by the required fees in accordance with § 1.5.4 of this Part.
1.5.7Without Examination by Reciprocity
A.The Department shall, without examination other than those required in § 1.5.5 of this Part relating to the practice of pharmacy, license as a pharmacist any individual who has been duly licensed by examination as a pharmacist under the laws of another State, Territory or Possession of the United States, if, in the opinion of the Board, the applicant meets the qualifications required of professional pharmacists in the State of Rhode Island.
1.The Board of Pharmacy in each State in which the applicant holds or has held a registration or license submits to the Board in the State of Rhode Island a statement confirming the applicant to be or have been in good standing.
2.The applicant shall have passed the Multistate Pharmacy Jurisprudence Examination and the examination of the National Association of Boards of Pharmacy in accordance with the provisions of § 1.5.5 of this Part.
3.The applicant shall submit to the Department the Official Transfer of Pharmaceutic Licensure Application of the NABP, a copy of their birth certificate, and the application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.5.8Temporary Ninety (90) Day License
A.In accordance with R.I. Gen. Laws § 5-19.1-8 persons who provide acceptable evidence of being currently licensed by examination or endorsement under the laws of other States of the United States and the District of Columbia, shall not be prevented from practicing in the State of Rhode Island for a period of ninety (90) days from the date on the application receipt, provided that they become duly licensed in the State of Rhode Island within ninety (90) days. This original privilege to work ninety (90) days shall not be extended or renewed and shall only be granted to an applicant on a one (1) time basis.
B.The licensing agency in each State in which the applicant holds or has held a registration or license shall submit to the Board a statement confirming the applicant to be or have been in good standing in that state.
1.5.9Internship: Pharmacy Interns
A.General Requirements
1.Any person who is a graduate of an accredited program of pharmacy or who is a student enrolled in an accredited program of pharmacy, or any graduate of a foreign College of Pharmacy who has obtained FPGEC certification, may file with the Department an application for licensure as a pharmacy intern. They shall be required to furnish such information as the Department may prescribe and, simultaneously with the filing of said application, shall pay to the Department a fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.All pharmacy intern licenses issued must be in accordance with R.I. Gen. Laws § 5-19.1-15(a) and shall be valid for a period of five (5) years. In addition to the requirements of R.I. Gen. Laws § 5-19.1-15(a), if an intern is no longer actively enrolled in a college of pharmacy, they must apply for a new intern license and pay the required fee upon reestablishing active status in the college of pharmacy program.
3.It shall be the responsibility of the licensee to notify the Department of any changes in their enrollment status as a pharmacy student and this information may also be provided by colleges of pharmacy.
4.No pharmacy student may serve an internship with a preceptor without holding a valid limited license from the Board.
5.To assure adequate practical instruction, pharmacy internship experience as required under the Act and this Part shall be obtained after licensure as a pharmacy intern by practice in any licensed pharmacy or other program meeting the requirements promulgated in this Part, and shall include such instruction in the practice of pharmacy as the Board shall prescribe.
6.Licensed pharmacy interns shall practice only under the immediate supervision of a licensed pharmacist.
B.No pharmacy student enrolled in a professional program of an accredited college of pharmacy may serve an internship in the State of Rhode Island with a preceptor without holding a valid limited license by the Board of Pharmacy pursuant to the provisions of R.I. Gen. Laws § 5-19.1-15.
C.Prior to commencing internship, the applicant must obtain a limited license from the Department. A limited license shall be granted to an applicant who:
1.Is eighteen (18) years of age or older;
2.Has satisfied the Board that they exhibit professional integrity and ethical standards."
3.Is enrolled in a professional program of an accredited College of Pharmacy.
D.Pharmacy intern licenses are non-transferrable.
1.5.10Foreign Graduates
A.Foreign graduates shall have obtained full FPGEC certification prior to commencing internship.
1.5.11Application and Fee
A.Application for limited licensure shall be made on forms provided by the Department and which may be obtained at:
The Rhode Island Department of Health
Three Capitol Hill, Room 103
Providence, Rhode Island 02908
1.Said forms shall be completed and signed by the applicant and submitted to the Department prior to accruing any hours. Such application shall be accompanied by the following documents and fee (non-returnable and non-refundable):
a.A copy of certificate of birth to verify that the applicant is eighteen (18) years of age or older;
b.Documented evidence that the student is enrolled in a professional program of an accredited college of pharmacy, and signed by the Dean of the College of Pharmacy or his appointed designee;
c.The application fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
2.Foreign Interns: The license application requirement of a documented Social Security Number (SSN) may only be waived for the initial license year. Subsequent license renewal shall require a documented SSN. A foreign pharmacy intern may practice under a limited license without a registered SSN at the discretion of the preceptor.
1.5.12Internship
A.The internship required of applicants for licensure as pharmacists shall consist of one thousand five hundred (1,500) hours, and shall be carried out under the supervision of a U.S. registered or licensed pharmacist who shall act as a preceptor.
B.Applicants seeking licensure as a pharmacist by reciprocity (§ 1.5.6 of this Part) shall have satisfied the requirements of internship in the State of initial licensure.
C.Prior to application for examination, the pharmacy intern shall submit, on forms provided by the Department, verification of their practical experience under the supervision of a licensed pharmacist. Any hours accrued prior to the issuance of the limited license shall not be accepted as part of the internship requirement.
1.5.13Duties and Responsibilities of Pharmacy Interns
A.Pharmacy interns may perform only those tasks in which they have proficiency, in the professional judgment of the pharmacist-in-charge, but in no case shall ever exceed what is permitted by Regulation or law.
B.A pharmacy intern may not perform a final review or exercise final decision-making with respect to any of the following without the prior review and approval of the licensed pharmacist: drug utilization review; clinical conflict resolution, or dispensing process validation.
C.A pharmacy intern shall wear a name tag that indicates the intern's name and the intern's licensure designation.
1.5.14Issuance and Renewal of the Pharmacist License
A.Upon completion of the requirements, a license shall be issued by the Department to an applicant found to have satisfactorily met all the requirements herein. Said license shall be renewed every two (2) years and will expire on the thirty-first (31st) day of December unless sooner suspended or discontinued.
B.Every person licensed as a pharmacist in the State of Rhode Island who desires to renew their license shall file such renewal application with the Department by the thirty-first (31st) day of December of each even year. Said renewal shall be duly executed together with the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) and shall not exceed the amount set forth in R.I. Gen. Laws § 5-19.1-20.
1.Upon receipt of such application and payment of such fee, the accuracy of the application shall be verified and a license renewal shall be granted effective for up to two (2) years unless sooner suspended or discontinued.
C.Every person licensed as a pharmacist in this State who desires to renew their license must obtain an eProfile number from the National Association of Boards of Pharmacy (NABP).
D.Any person who allows their license to lapse by failing to renew it on or before the thirty-first (31st) day of December of each even year may be reinstated upon filing an application with payment of the renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.Any pharmacist license that has lapsed, been revoked or suspended and the pharmacist has not practiced pharmacy, as defined by the Board, for three (3) years requires that they take and pass the same examinations required for initial licensure.
1.5.15Continuing Education
A.Pursuant to the provisions of R.I. Gen. Laws § 5-19.1-14, any pharmacist, licensed to practice pharmacy in Rhode Island, who seeks licensure renewal, shall be required to have satisfactorily completed at least fifteen (15) hours (one and a half (1.5) continuing education units) of continuing education courses sponsored by a recognized provider between January 1st and December 31st of each calendar year. One (1) hour or one tenth (0.1) continuing education units of the required fifteen (15) hours of continuing education between January 1st and December 31st of each calendar year shall be in the area of the law as classified by ACPE. Furthermore, five (5) hours or one half (0.5) continuing education units between January 1st and December 31st of each calendar year must be live hours. In addition:
1.Immunizing pharmacists shall complete one (1) hour or one tenth (0.1) continuing education units of the required fifteen (15) hours of continuing education.
2.Any pharmacist participating in a collaborative pharmacy practice agreement shall earn at least five (5) additional contact hours or one half (0.5) continuing education units of board-approved continuing education that addresses areas of practice generally related to collaborative practice agreements each year and shall maintain documentation of these hours at the practice site to be made available for inspection by the Boards of Medical Licensure and Discipline and Pharmacy.
3.Any pharmacist who has not participated in a collaborative pharmacy practice arrangement for a period of two (2) years and seeks to enter into such an arrangement, must have obtained and/or maintained the certification set forth in this Part, as applicable, or have earned fifteen (15) hours of relevant continuing education within the prior year in the area of practice covered by the agreement.
4.For the first (1st) year of licensure following graduation from a College of Pharmacy, a pharmacist shall not be subject to the continuing education requirements of this Part, with the exception of the continuing education requirement contained in § 1.12.1(B)(7) of this Part; and
5.In emergency or hardship cases, a licensed pharmacist may apply to the Board on forms provided by the Department for an exemption from the continuing education requirements of this Part.
6.The annual application for license renewal shall include affidavits signed by the applicant attesting to the fact that they have satisfactorily completed an approved course(s) of continuing education provided by a recognized provider, as defined in this Part. Furthermore:
a.Certificates of continuing education courses must be retained and safeguarded by each pharmacist for review by the Department, if required and requested. Such certificate need not be submitted with the application for licensure renewal; however, documentation must be retained for two (2) years following the date of completion of the course.
b.Any pharmacist whose license has not been renewed for one (1) or more years must demonstrate compliance with continuing education Regulations for the licensure period immediately prior to application.
c.Pharmacists failing to comply with the requirements of § 1.5.17(A)(6) of this Part.
1.5.16Recognized Provider
A.A “recognized provider” is any person, group or organization approved by the Board as responsible and competent to provide continuing education courses and includes providers accredited by an appropriate national, regional or state accreditation agency. Any provider approved the Accreditation Council for Pharmaceutical Education (ACPE), the Board of Pharmacy in another State or jurisdiction, or the provider of American Medical Association (AMA) Category I programs shall be considered recognized providers.
1.5.17Continuing Education Credit for Postgraduate Pharmacy Curriculum/Program
A.A licensed pharmacist who is enrolled in a postgraduate Doctor of Pharmacy program shall be awarded CEUs for satisfactory completion of courses within said curriculum or program, provided that the sponsor of the postgraduate curriculum or program is an accredited College of Pharmacy. A licensed pharmacist enrolled in other postgraduate pharmacy programs may seek continuing education credit provided that the application satisfies all requirements under this Section and provided further that the course provides instruction in one (1) or more of the following areas: pharmacy, pharmaceutical sciences, pharmacy practice or pharmacy law.
B.Students seeking continuing education credit for postgraduate pharmacy education must maintain official course transcripts for two (2) years after completion of the course work.
1.5.18Return or Exchange of Drugs
A.Drugs, medicines, sick room supplies, and items for personal hygiene, shall not be accepted for return or exchange by any pharmacist, after such drugs, medicines, sick room supplies, or items for personal hygiene have been taken from the premises where sold, distributed, or dispensed, except under the following conditions:
1.Recalls or Errors. Prescription drugs may be returned in the event the drug is subject to a manufacturer’s recall or FDA recall, or if the drug is associated with a medication error.
2.Prescription Drugs. Unused prescription drugs may be accepted by wholesalers or pharmacies, from which they were purchased, for return from nursing facilities, assisted living residences, residential care facilities, community health organizations and State correctional facilities that centrally store prescription drugs and are licensed at the M1 licensure level by the Department, within forty-five (45) days of dispensing.
a.The wholesaler or pharmacy to which the following categories of prescription drugs are returned may repackage, restock, and redistribute such medication:
(1)Unopened sections of blister pack prescription medication, with seal intact;
(2)Unopened unit-dose containers of liquids with the safety seal intact;
(3)Unopened unit-dose containers of powders for oral solution with safety seal intact; and
(4)Unused injectables, with safety seal intact.
b.Exceptions. Notwithstanding the provisions of § 1.5.18(B)(1) of this Part, the unused prescription drug shall not be accepted, repackaged or redispensed if:
(1)The prescription drug is expired or beyond use date;
(2)The pharmacist accepting or redispensing the drug, in their judgment has reason to believe that the prescription drug is adulterated, mislabeled, or has been improperly stored;
(3)The prescription drug is defined as controlled substances in R.I. Gen. Laws § 21-28-1.02; or
(4)It is a drug that can only be dispensed to a patient registered with the drug’s manufacturer in accordance with Federal Food and Drug Administration requirements.
3.Recording: The wholesaler or pharmacy shall maintain a record of the receipt of each drug, medicine, or device showing the prescription number for which the material was acquired, and quantity. Such records shall be kept on file in the pharmacy for a period of two (2) years and shall be made available to the Department upon request.
4.The wholesaler or pharmacy shall be required to reimburse or credit the purchaser for any such returned prescription drugs at original invoice price plus a restocking fee not to exceed five dollars ($5.00).
5.Sick Room Supplies/Equipment: A pharmacist may accept for return sick room supplies/equipment provided such can be sanitized. If the surfaces of the sick room supplies or equipment cannot be cleansed or sterilized, the articles are not returnable. However, sick room supplies are not to be construed to mean nor include hospital beds, wheelchairs, crutches and such other major equipment used in the care and treatment of the sick and injured.
1.5.19Multi-Drug Single-Dosing Systems
A.General Requirements
1.Requirements related to the utilization of multi-drug single-dosing containers include the following:
a.The number of drugs placed in one package cannot exceed the capacity of the container in order to prevent damage to the individual dosage forms;
b.The multi-drug single-dosing container may include controlled medications from Schedule IV and V if such medications are prescribed for the patient on a routine, customary basis;
c.The labels must be of sufficient size to properly and clearly label each container with all information required by State and Federal law and Rules
d.The integrity of each individual multi-drug single-dosing container shall be maintained until the last drug dose is administered to or taken by the patient.
2.A multi-drug single-dosing container shall be designed to prevent the container from being re-closed, designed to show evidence of having been opened, and designed in such a manner that the label cannot be altered.
3.Once a multi-drug single-dosing container has been properly labeled and dispensed to a patient, and said container is returned to the pharmacy for any reason, the drugs packaged in such container shall be considered adulterated and shall not be returned to the pharmacy stock. Provided, however, drugs in multi-drug single-dosing containers may be redispensed to the same patient to whom the drugs were originally dispensed.
4.Whenever a drug(s) in a multi-drug single-dosing container has/have been discontinued, the remaining container(s) may be returned to the dispensing pharmacy for the removal of the discontinued drug(s) for destruction. Under no circumstances shall any of the remaining or discontinued drug(s) be returned to the drug stock of the pharmacy or dispensed to any patient other than the patient to whom the drugs were originally dispensed.
5.Nothing contained in this Part is meant to prevent a nurse or a patient-specified caregiver from removing a discontinued drug(s) from a container at the time of administration in order to be wasted as directed by a pharmacist or from retaining up to a seventy-two (72) hour supply of the continued drug(s) in the original container in order to maintain a patient on their continuing drug administration schedule.
B.Labeling Requirements
1.Each individual, customized, multi-drug single-dosing container shall bear a label, which, at a minimum, contains the following:
a.The name of the patient;
b.The name of the prescribing practitioner of each drug;
c.The identifying serial number assigned to the prescription drug order for each drug contained therein;
d.The name, strength, exact physical description, and total quantity of each drug contained therein;
e.The directions for use, and/or time of administration or time to be taken for each individual multi-drug single-dosing container;
f.Either the dispensing or preparation date, as well as a beyond-use (expiration) date for each drug contained in the multi-drug single-dosing container. The expiration date of each drug included therein shall not be longer than one (1) year from the date of preparation of the multi-drug single-dosing container. All drugs shall be packaged in accordance with USP Chapter 659 incorporated by reference in § 1.2(G) of this Part.
2.The name, address, and telephone number of the pharmacy issuing the multi-drug single dosing container and any cautionary statements necessary for the proper administration or storage of the medication shall appear on the individualized patient container.
C.Exclusions. Multi-drug single-dosing containers shall not include drug(s) that have the following characteristics:
1.USP-DI monograph or official labeling requires dispensing in the original container;
2.Are incompatible with packaging components or with each other;
3.Require special packaging;
4.Are controlled medications from Schedules II and III.
D.Requirements for Nursing Facilities and Assisted Living Residences
1.Requirements related to the utilization of multi-drug single-dosing containers in a nursing facility or assisted living residence include the following:
a.The name, address, and telephone number of the pharmacy issuing the multi-drug single dosing container and any cautionary statements necessary for the proper administration or storage of the medication shall appear on the medication administration record (MAR).
2.In a nursing facility or assisted living residence licensed at the M-1 level, only a nurse, other licensed person acting within their scope of practice, or selected non-licensed personnel who have satisfactorily completed a State-Approved Course in Drug Administration and have demonstrated competency in accordance with the State-approved protocol in drug administration shall remove a discontinued drug(s) from a container in order to be wasted in accordance with policies and procedures of the facility.
E.Prescriptions. A prescription shall contain the following information, at a minimum:
1.Full name and street address of the patient;
2.Name, address, and if required by law or Rules of the Board, DEA registration number of the prescribing practitioner;
3.Date of issuance;
4.Name, strength, dosage form and quantity of drug prescribed;
5.Directions for use;
6.Refills authorized, if any;
7.If a written prescription, prescribing practitioner’s signature;
8.If an electronically transmitted prescription, prescribing practitioner’s electronic or digital signature;
9.If a hard copy prescription is generated from a facsimile or a prescribing practitioner’s electronic or manual signature, such prescription shall be applied to paper that utilizes features that will ensure the prescription is not subject to any form of copying and/or alteration;
10.Oral prescriptions shall be reduced promptly to writing and stored either electronically or in hard copy format.
1.5.20Prescription Refill Information
A.No pharmacist shall fill or refill any prescription after one (1) year from the date of issuance by the practitioner without authorization from the practitioner.
B.Authorization for prescription refills is presumed to be within the prescribed dosage or normal therapeutic use. Refiling prescriptions more frequently than the prescribed dosage would require, or refiling prescriptions in significant excess of normal therapeutic use, may constitute unprofessional conduct based on drug utilization requirements in § 1.19 of this Part.
C.If deemed appropriate in the pharmacist’s professional judgement, a patient may receive, upon request, drug quantities in excess of the face amount written on the prescription for a non-controlled substance only, up to the total amount authorized by refills. The pharmacist shall not dispense in excess of the face amount of a prescription for controlled substance without authorization from the prescriber for each prescription.
D.A pharmacist may refill a prescription for a patient written by a practitioner who has expired or has had their license to practice or controlled substance registration revoked, suspended, or discontinued, for a period not to exceed ninety (90) days, if the prescription was written by the practitioner prior to their death or action against license and the prescription contains authorizations for refills.
E.Pharmacists shall only compound prescriptions for a drug product(s) not included in the official compendium (The U.S. Pharmacopoeia, N.F.) if the prescription clearly delineates in writing all the ingredients to be included in the drug product. All such prescriptions, drugs and ingredients must conform to the requirements of R.I. Gen. Laws Chapters 21-31, 21-28, 5-19.1 and such other applicable statutory requirements.
1.5.21Electronic Transmission
A.Technological devices for the transmission or communication of prescriptions between licensed prescribers and pharmacists may be used in accordance with the following requirements:
1.The transmission of prescriptions for controlled substances shall comply with the provisions of R.I. Gen. Laws Chapters 21-28 (“Controlled Substances Act”), 21 C.F.R. § 1306.08, R.I. Gen. Laws Chapter 5-37.3 (“Confidentiality of Healthcare Information Act”), and all other Federal or State laws.
2.Unless otherwise prohibited by law, prescriptions may be transmitted by electronic means or facsimile from the prescriber as defined in R.I. Gen. Laws Chapter 21-28 and 21 C.F.R. § 1306.08, for transmission of prescriptions to the dispensing pharmacy. The facsimile copy of the prescription may serve as the hard copy of the prescription except for prescription orders for Schedule II drugs in accordance with the provisions of R.I. Gen. Laws Chapter 21-28.
3.In addition to all other information required to be included on a prescription, an electronically transmitted prescription and facsimile prescriptions shall include the date of transmission.
4.A pharmacy receiving an electronic transmission prescription shall either receive the prescription in hard copy form or have the capacity to retrieve an electronic copy of the prescription from the pharmacy’s computer memory.
5.The patient shall have the right to choose the manner in which their prescription is transmitted to the pharmacy.
6.The patient shall have the right to choose the pharmacy to which their prescription is transferred.
7.The pharmacist shall exercise professional judgment regarding the accuracy or authenticity of the transmitted prescription consistent with existing laws and Regulations.
8.Technological devices shall not be used to circumvent documentation, verification, or any provisions of the Act. Neither shall they be used to commit any other action that may be deemed unprofessional conduct.
9.Technological devices shall be located within the pharmacy.
1.5.22Emergency Prescription Refill
A.In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one (1) time emergency refill of up to a ninety (90) day supply of the prescribed medication, providing that:
1.The prescription is not for a drug in Schedule II, III, IV, and V appearing in R.I. Gen. Laws Chapter 21-28;
2.The medication is essential to the maintenance of life or to the continuation of therapy of a chronic condition
3.In the pharmacist’s professional judgment, the interruption of therapy might reasonably produce undesirable health consequences or may cause physical or mental discomfort; and
4.The dispensing pharmacist notifies the prescriber of the emergency dispensing within a reasonable time after such dispensing.
5.For an emergency prescription refill, there shall be appropriate documentation in the patient profile or on the hard copy of the prescription that an emergency refill has been dispensed.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.6** Pharmacies: Licensure Requirements {#sec-216-ricr-40-15-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.6}
1.6.1Licensure Requirements: Pharmacies
A.Pursuant to R.I. Gen. Laws § 5-19.1-9, no person shall conduct, maintain, or operate a pharmacy in the State of Rhode Island without first obtaining and having in force a pharmacy license in accordance with the statutory provisions of the Act and the regulatory requirements of this Part.
B.Restricted Pharmacies: Pursuant to R.I. Gen. Laws § 5-19.1-10, upon application of the plan administrator or trustee of any trust, fund, pension plan, combination plan, or profit sharing plan, which is subject to the provisions of the Employee Retirement Income Security Act of 1974, 29 U.S.C. § 1001 et seq., the Board may license a facility, hereinafter called a restricted pharmacy, for the purpose of dispensing pharmacy services to beneficiaries; provided, however, that no such license shall be granted unless the said trust, fund or plan demonstrates to the satisfaction of the Board that it is associated with another such trust, fund or plan already licensed in another State to own and operate a restricted pharmacy for the purpose of dispensing pharmacy services to its beneficiaries. Charges for such serviced shall be determined by the trustee or plan administrator. A restrictive pharmacy may, after written notice to the Board, limit its operation to a specific schedule of drugs.
1.Nothing in this Section shall prohibit a restricted pharmacy from accepting or filling prescriptions by mail; provided, that the prescribing physician is verified, according to the procedures established by R.I. Gen. Laws Chapter 5-37, as licensed to practice in the State of Rhode Island or in any New England State.
C.Any pharmacy that utilizes latex gloves shall do so in accordance with the provisions of the Rules and Regulations pertaining to the Use of Latex Gloves by Healthcare Workers, in Licensed Healthcare Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (Part 20-15-3 of this Title).
D.A mechanism shall be in place to verify current licensure for every individual within the pharmacy who is licensed, certified, or registered by the State of Rhode Island. Documentation of current licensure shall be maintained by the pharmacy.
E.All pharmacies shall maintain an adequate number of pharmacists and pharmacy technicians to meet pharmacy workload demands, including but not limited to, administration of immunizations and medications, prescribing of medications and any future pharmaceutical care functions as allowed by law, provide for adequate rest periods for personnel, and maintain public safety. Pharmacy staffing information shall be provided to the Department upon request, including but not limited to number of pharmacists and pharmacy technicians, prescription volume, pharmacy hours of operation, and staff schedules. Should the Department deem the pharmacy is inadequately staffed to provide all services, they shall be subjected to disciplinary actions by the Board. Such disciplinary action shall follow the applicable requirements outlined in § 1.19 of this Part. All hearings and reviews required by this Part shall be held in accordance with the provisions of R.I. Gen. Laws Chapter 42-35.
1.“Inadequately staffed” means an insufficient number of pharmacists and technicians to safely carry out the practice of pharmacy and meeting workload demands, including but not limited to, administration of medications and immunizations, and all future functions of pharmacy practice as required by laws and regulations. Inadequately staffed may be determined in a number of ways, including but not limited to, on-site observations of current staffing, pharmacy sales/volume reports, pharmacy staffing schedules, and payroll reports.
1.6.2Application for License and Fee
A.Application for a license (retail pharmacy, pharmacy within a medical institution, or restricted pharmacy) to conduct, maintain or operate a pharmacy in the State of Rhode Island shall be made in writing on forms provided by the Department and shall be submitted to the Department at least thirty (30) days prior to the expected operating date of the establishment for the transaction of business as a pharmacy.
B.The initial application must include the following:
1.Name and address of owner and/or manager and a notarized declaration of ownership and location;
2.Name of pharmacist-in-charge of the pharmacy;
3.Proposed location and address of place of business and blueprint or drawings of proposed floor plans;
4.For all pharmacies, the initial licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
5.An eProfile number from the national association of boards of pharmacy.
6.Pharmacies that compound sterile preparations shall provide an inspection report performed by the Board of Pharmacy from the pharmacy’s home State, an independent organization such as NABP, or other similar agency as approved by the Board. Inspection shall be:
a.At the expense of the applicant;
b.Performed as a condition of initial licensure and annually thereafter; and
c.As deemed necessary by the Department to protect the public health and safety.
7.Such other information as the Board may deem necessary.
C.Applications for license renewal shall be made on forms provided by the Department and shall include such information as the Board may require, and the application must be accompanied by the license renewal fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.6.3Issuance and Renewal of License
A.Upon receipt of an application for a license the Board shall issue a license or renewal thereof for a period of one (1) year if the applicant meets the requirements of the Act and this Part. Said license, unless sooner suspended or discontinued, shall expire annually on the thirtieth (30th) day of September following its issuance and may be renewed from year to year upon submission of application and license renewal fee. The applicant for renewal must obtain and submit an eProfile from the national association of boards of pharmacy.
B.A license shall be issued to a pharmacy in the name of the owner of the pharmacy. The license shall be issued for a specific location and shall not be transferable.
1.No pharmacist shall be a pharmacist-in-charge at more than one (1) pharmacy at the same time. Provided, however, a pharmacist may be designated as the pharmacist-in-charge at a maximum of two (2) pharmacies for a period not to exceed sixty (60) days for the purpose of transitioning to a new pharmacist-in-charge.
C.A license issued under this Part is the property of the State of Rhode Island and loaned to such licensee. It shall be kept posted in a conspicuous place in the licensed pharmacy.
1.The name of the pharmacist-in-charge shall be conspicuously displayed in the pharmacy.
1.6.4Change of Ownership and/or Location
A.When a change of ownership or location or when discontinuation of services is contemplated, the owner shall notify the Department in writing at least fourteen (14) days prior to the proposed action.
B.The pharmacy owner shall give the Department fourteen (14) days notice in writing prior to terminating services of a pharmacist-in-charge of a pharmacy, unless the pharmacist-in-charge vacates the position without notice. In this instance, the Department shall be notified in writing immediately of the change in pharmacist-in-charge.
C.When there is a change in ownership and/or location, the license shall immediately become void and shall be delivered to the Department.
1.The Board, or its designee, reserves the right to extend the expiration date of such license, allowing the pharmacy to operate, but under conditions stipulated by the Board for such time as shall be required for the processing of a new application.
2.The new applications must be filed in accordance with the provisions of § 1.6.2 of this Part and be accompanied by the initial licensure fee pursuant to R.I. Gen. Laws § 5-19.1-9 and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
D.Pharmacy renovations or remodeling: Any renovations or remodeling of an existing pharmacy shall not be considered a change of location.
E.Patient records shall be retained and shall be capable of being retrieved, in a reasonable time period, for no less than two (2) years after a change of ownership is completed.
1.6.5General Requirements: All Pharmacies
A.Personnel: A licensed pharmacist shall be physically accessible at the address listed on the license in order to operate and manage the pharmacy at all times during the hours of operation when the pharmacy is open to the public. The pharmacist(s) shall be subject to all the statutory and regulatory provisions of this Part pertaining to the practice of pharmacy.
1.The owner shall ensure that a sufficient number of qualified, trained, competent and adequately supervised pharmacists and supportive personnel are employed to provide technical services, as well as ensuring that all such functions and activities are performed competently, safely, and without risk of harm to patients. The relationship between the supervising pharmacist and the supportive personnel shall be such that the pharmacist is fully aware of and responsible for all activities involved in the preparation and dispensing of medications prior to the release to the patient, including the maintenance of appropriate records.
2.The pharmacy shall be directed by a licensed pharmacist, hereinafter referred to as the pharmacist-in-charge, who shall be responsible for meeting the requirements set forth by Federal and State law, this Section, and other applicable Regulations of the Board. The pharmacist-in-charge shall be thoroughly familiar with the specialized functions of pharmacy practice.
3.The pharmacist-in-charge of any pharmacy licensed in the State of Rhode Island and located in the State of Rhode Island or in another State, shall be licensed as a registered pharmacist in the State where the pharmacy is located.
4.The pharmacist-in-charge shall ensure that a sufficient number of pharmacists and supportive personnel are available to operate such pharmacy competently, safely, and to meet the needs of patients. All pharmacists shall be properly identified by name and licensure designation.
5.The owner shall develop and implement written policies and procedures to specify the duties to be performed by such pharmacists.
6.The pharmacist-in-charge of a pharmacy shall be responsible for no less than the following:
a.Provide to the Department a beginning inventory of all controlled substances, Schedules II-V, upon commencement of duties, and an ending inventory of same upon termination of duties as pharmacist-in-charge;
b.Maintain adequate controls to prohibit the diversion of controlled substances and promptly execute DEA Form 106 (or its successor form) to the Drug Enforcement Administration and the Department in the event of a theft or loss of a controlled substance;
c.Report prescription forgeries, or attempted forgeries, as deemed necessary in the professional judgment of the pharmacist-in-charge, to the appropriate law enforcement authorities;
d.Ensure that the pharmacy dispensing area and equipment is in clean and orderly condition, that all licenses and registrations are current, that the “top ten” list and prices are conspicuously posted, and that the expiration dates of the pharmaceutical stock are periodically checked to ensure that no expired medications are dispensed;
e.Remove all controlled and non-controlled drugs from any pharmacy or institution upon sale or closure of the facility;
f.Comply with the Rules and Regulations for Disposal of Drugs (Part 20-20-1 of this Title), to utilize an alternative drug destruction mechanism for expired, excess/undesired controlled substances consistent with all Federal and State laws and Regulations;
g.Contact the Department whenever a concern arises that would affect the pharmacy’s practice;
h.Ensure adherence to all policies and procedures for the operation of the pharmacy in accordance with the Act and this Part;
i.Be administratively responsible for the overall operation and conduct of the pharmacy.
B.Nothing in this Part shall prohibit a pharmacist from practicing pharmacy and providing pharmaceutical care outside of a pharmacy, including into Rhode Island, if the following conditions are met:
1.The pharmacist is licensed in Rhode Island or an employee of a non-resident pharmacy licensed in Rhode Island;
2.The pharmacist has real-time electronic access to prescription records, patient profiles, or other relevant medical information and appropriately reviews the information;
3.Such records are protected from unauthorized access and use;
4.The pharmacist maintains the records or other patient-specific information created, collected, or used electronically; and
5.A pharmacy can permit pharmacists to work remotely, as operationally feasible and in accordance with applicable State and Federal law to conduct prescription data entry, prescription verification, clinical pharmacy and other functions that are normally performed in a pharmacy. Pharmacists shall only be permitted to work remotely as long as licensing reciprocity exists and the pharmacist resides in the United States or United States’ Territory.
1.6.6Security
A.Every pharmacy must have and maintain proper security to limit accessibility of unauthorized personnel on the premises and to safeguard against the diversion of drugs, biologicals and medications.
B.Each pharmacy shall, at least while closed, utilize an alarm or other comparable monitoring system.
C.The Board shall deem additional security requirements necessary for the protection of the pharmacy and of the public.
D.The pharmacy shall place security cameras at multiple vantage points in the drug storage area within the pharmacy, including other adjacent areas of the building and pharmacy as deemed necessary by the Department and Board, which actively record and store video data for a minimum of 30 (thirty) days.
E.The pharmacy shall establish policies and procedures to address disasters and emergencies in order to protect the integrity of drugs and prevent unauthorized access to prescription medication.
1.6.7Facilities, Equipment and Stock
A.Every pharmacy must be properly secured, equipped with facilities, apparatus, utensils, adequate reference materials relevant to the practice site, and a representative stock of pharmaceuticals, chemicals, drugs and preparations, so that prescriptions can be properly filled.
B.Each pharmacy shall adhere to written policies and procedures that require all stocks of medications to be inspected routinely for outdated, unusable or mislabeled products. Any outdated, unusable, or mislabeled medication or products shall be segregated to ensure that no such medications or products are dispensed.
1.6.8Space
A.The pharmacy shall be adequate in size and space to enable the pharmacist(s) to discharge all pharmaceutical functions and duties in a safe and effective manner, and to contain all required equipment, utensils, storage areas, including prescription compounding counter, and an area with adequate privacy to conduct patient counseling as well as other practice of pharmacy functions defined in this Part. The pharmacy shall be equipped with proper sanitary appliances and kept in a clean, sanitary and orderly manner.
1.6.9Pharmaceutical Services – Drug Recall
A.The pharmacist-in-charge shall ensure that a written procedure to handle drug product recalls. The procedure shall include, but is not limited to, the following:
1.A process for review of documents (i.e., prescriptions, drug orders, etc.) of the recalled lots;
2.Notification to the recipients and prescribers of the recalled product, when appropriate;
3.Personal inspection of all areas where drugs are stored to determine presence of recalled products;
4.Quarantine of all recalled products to be marked “Quarantined-Do Not Use” until returned to manufacturer; and,
5.Maintenance of written log of all recalls, the actions taken, and the results.
1.6.10Emergency Kits
A.Drugs and devices may be provided in emergency kits for use by authorized personnel in nursing facilities, assisted living residences, medical institutions, or hospice care facilities (collectively “institutions”) provided that:
1.The pharmacist-in-charge or designee, and the qualified health care staff shall jointly determine the drugs to be included in the kit by identity and quantity.
2.The emergency kit shall be sealed with a non-reusable, easily removable seal to prevent unauthorized access, and to ensure a proper environment for preservation of the drugs.
3.The exterior of the emergency kit shall be labeled so as to clearly indicate that it is an emergency drug kit. A listing of the drugs contained therein including name, strength and quantity of each drug or device shall be attached. Each emergency kit shall be inspected by a pharmacist or his designee monthly to check for expiration dates and the integrity of the seal.
4.All drugs within the emergency kit shall be labeled, if applicable, with the name, strength, lot number, manufacturer and expiration date.
5.Drugs and devices shall be removed from the emergency kit for administration to a patient only pursuant to a valid physician’s order, by personnel authorized by the medical institution.
6.The pharmacy shall be notified whenever an emergency kit is opened. The pharmacist or designee shall re-stock, reseal and return the kit to the unit within a reasonable length of time.
7.The pharmacy may use automated storage and distribution devices as an emergency kit so long as the automated storage and distribution device complies with the provisions of this Section.
1.6.11Repackaging
A.Drugs which are repackaged within a pharmacy for subsequent dispensing or administration shall be labeled to include:
1.The generic or trade name, strength, and quantity of drug
2.Control number assigned by the pharmacy which corresponds to the identification of the manufacturer, manufacturer’s expiration date, lot number of the drug, quantity repackaged, date repackaged and pharmacist responsible for repackaging;
3.The expiration date of the drug being repackaged shall be one (1) year from the date the drug is repackaged or the expiration date on the manufacturer’s container, whichever is earlier.
B.The pharmacy shall have and use facilities, personnel, operational practices, packaging material, and control procedures to assure that the purity, integrity, safety, and effectiveness of the drugs are not affected by such repackaging. All repackaging must be performed by or under the supervision of a pharmacist.
C.A pharmacy may repackage a patient’s previously dispensed medication provided that the pharmacy implements policies and procedures that include but are not limited to the following requirements:
1.The patient or patient’s responsible party requests that the pharmacy repackage the medication for ease of administration in unit dose containers.
2.The pharmacy receiving the previously dispensed medication records the prescription medication received, all label information, and stores the medication separate from the pharmacy’s inventory.
3.The medication is repackaged in an appropriate USP approved multi-unit, unit-of-use, or single-unit dose container.
4.The pharmacy records the previously repackaged medication quantity, includes all information on the original prescription label, and a pharmacist verifies the medication that was repackaged is correctly labeled by the pharmacy.
1.6.12Investigational Drugs
A.The pharmacist-in-charge and the medical staff shall be responsible for developing policies and procedures for ensuring proper labeling pursuant to R.I. Gen. Laws Chapter 21-31, Storage, Distribution, administration and Control of Investigational Drugs.
1.Investigational drugs shall be relabeled “For Investigational Use Only.”
2.A perpetual inventory record for investigational drugs shall be maintained. The record shall contain:
a.Drug’s name, dosage form and strength, lot number, expiration date;
b.Name, address, telephone number of the sponsor;
c.Protocol number;
d.Information on disposition of the drug; and,
e.Recording dispenser’s initials.
3.Investigational drugs shall be segregated from commercial products.
4.The pharmacist-in-charge shall be responsible for the provision of staff education regarding investigational drugs.
5.Prior to dispensing, any investigational drug, dose and treatment schedule should be verified against the protocol.
B.Any information pertaining to potential adverse effects, precautions, compounding and preparation requirements, etc., of the investigational drug shall be reviewed by the pharmacist.
1.6.13Adverse Drug Reactions (ADRs) and Medication Errors
A.Medication Use Evaluation Program:
1.The pharmacist-in-charge shall establish policies and procedures to increase the effectiveness and minimize the risk of drug use. Policies and procedures shall include defining, monitoring, detecting, reporting and reviewing medication errors and adverse drug reactions (ADRs). ADRs deemed to be significant by the pharmacist shall be reported to the FDA’s MedWatch Program. Vaccine-related adverse events shall be reported to the CDC using VAERS and adverse events involving Dietary Supplements shall be reported to https://www.safetyreporting.hhs.gov.
B.Patient Profile
1.A patient record system shall be maintained by all pharmacies for patients for whom prescriptions are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing. The pharmacist shall make a reasonable effort to obtain, record, and maintain the following information:
a.Full name of the patient for whom the drug is intended
b.Address and telephone number of the patient
c.Patient’s age or date of birth
d.Patient’s gender
e.A list of all prescriptions obtained by the patient at the pharmacy maintaining the patient record during the twelve (12) months immediately preceding the most recent entry showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the practitioner, and
f.Pharmacist comments relevant to the individual’s drug therapy and drug allergies, including any other information peculiar to the specific patient or drug.
C.The pharmacist shall make a reasonable effort to obtain from the patient or the patient’s agent any known allergies, drug reactions, idiosyncrasies, and chronic conditions of the patient and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review, and shall record this information in the patient’s profile.
D.The patient record shall be maintained for a period of not less than two (2) years from the date of the last entry in the patient profile record. This record may be a hard copy or in a computerized form.
E.Prospective Drug Review
1.A pharmacist shall review the patient record and each prescription presented for dispensing for purposes of promoting therapeutic appropriateness by identifying:
a.Over-utilization or under-utilization
b.Therapeutic duplication
c.Drug-disease contraindications
d.Drug-drug interactions
e.Incorrect drug dosage or duration of drug treatment
f.Drug-allergy interactions
g.Clinical abuse/misuse
h.Food-drug interaction
2.Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the practitioner or other appropriate persons.
F.Continuous quality improvement programs
1.Notwithstanding practices constituting unprofessional practice indicated in this Part, any pharmacy that actively reports dispensing errors and the analysis of such errors to a patient safety organization shall be deemed in compliance with this Section.
2.Pharmacies not actively reporting to patient safety organizations shall implement a program for continuous quality improvement in compliance with this Section.
a.Notification requirements
(1)A pharmacy intern or pharmacy technician who identifies or learns of a dispensing error shall immediately notify a pharmacist on duty of the dispensing error.
(2)A pharmacist on duty shall appropriately respond to the dispensing error in a manner that protects the health and safety of the patient.
(3)A pharmacist on duty shall immediately notify the patient or the person responsible for administration of the drug to the patient and communicate steps to avoid injury or mitigate the error if the patient is in receipt of a drug involving a dispensing error that may cause patient harm or affect the efficacy of the drug therapy. Additionally, reasonable efforts shall be made to determine if the patient self-administered or was administered the drug involving the dispensing error. If it is known or reasonable to believe the patient self-administered or was administered the drug involving the dispensing error, the pharmacist shall immediately assure that the prescriber is notified.
b.Documentation and record requirements; remedial action:
(1)Documentation of the dispensing error must be initiated as soon as practical, not to exceed three (3) days from identifying the error. Documentation shall include, at a minimum, a description of the event that is sufficient to allow further investigation, categorization, and analysis of the event.
(2)The pharmacist-in-charge or designee shall perform a systematic, ongoing analysis, as defined in these Regulations, of dispensing errors. An analysis of each dispensing error shall be performed within thirty (30) days of identifying the error.
(3)The pharmacist-in-charge shall inform pharmacy personnel of changes made to pharmacy policies, procedures, systems, or processes as a result of the analysis.
(4)Documentation associated with the dispensing error need only to be maintained until the systematic analysis has been completed. Prescriptions, dispensing information, and other records required by Federal or state law shall be maintained accordingly.
(5)A separate record shall be maintained and available for inspection to ensure compliance with this Section for twelve (12) months from the date of the analysis of dispensing errors and shall include the following information:
(AA)Dates the analysis was initiated and completed;
(BB)Names of the participants in the analysis;
(CC)General description of remedial action taken to prevent or reduce future errors; and
1.6.14Patient Counseling
A.After receipt of a new prescription and following a review of the patient’s record, a pharmacist or pharmacy intern, as defined in the Act, shall initiate discussion of matters which will enhance or optimize drug therapy with each patient or care giver of such patient. Such discussion shall be in person whenever practicable, by telephone or electronic means, and shall include appropriate elements of patient counseling, as is appropriate for the patient in the professional judgment of the pharmacist. The offer to counsel may be delegated by the pharmacist. Nothing in this Section will prohibit a pharmacist from counseling a patient on a refill prescription when deemed necessary in the professional judgment of the pharmacist. Such elements may include the following:
1.The name and description of the drug;
2.The dosage form, dose, route of administration, dosing schedule, and duration of drug therapy;
3.Intended use of the drug and expected action;
4.Special directions and precautions for preparation, administration, and use by the patient;
5.Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
6.Techniques for self-monitoring drug therapy;
7.Proper storage;
8.Prescription refill information;
9.Action to be taken in the event of a missed dose; and
10.Pharmacist comments relevant to the individual’s drug therapy, including any other information peculiar to the specific patient or drug.
B.Alternative forms of patient information shall be used, when deemed necessary in the professional judgment of the pharmacist, to supplement patient counseling when appropriate. Examples to include written information leaflets, pictogram labels, video programs, etc.
C.Patient counseling and patient profiles, as described above and defined in this Act shall not be required for inpatients of a hospital or institution, or any other licensed health-care facility, where other licensed healthcare professionals are authorized to administer the drugs.
D.A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation. Such refusal shall be documented in writing.
1.6.15Prescription Transfer
A.Prescriptions may be transferred an unlimited amount of times for the purposes of filling or refilling between pharmacies by any means either verbally, electronically, or via fax provided that the pharmacies adhere to the following requirements:
1.The prescription is for a drug that is lawfully able to be filled.
2.The pharmacist, or supportive personnel, as permitted, transferring the prescription cancels the original prescription in their records, and indicates in the prescription record to whom the prescription was transferred, including the name of the pharmacy, the date of the transfer, and the name or initials of the transferring pharmacist or supportive personnel.
3.The pharmacist, or supportive personnel, as permitted, receiving the transferred prescription shall:
a.Note that it is a transferred prescription
b.Record all of the following information in the prescription records, in addition to other information required by law:
(1)Date of issuance of the original prescription
(2)Original number of refills authorized on prescription
(3)Complete refill record from original prescription
(4)Number of valid refills remaining
c.File number of the original prescription
d.Name of the pharmacy and pharmacist or supportive personnel from whom the prescription was transferred
4.A pharmacist, or supportive personnel, as permitted, may transfer a prescription to another pharmacist or supportive personnel employed by the same corporation without regard to the requirements of §§ 1.6.15(A)(2) and (3) of this Part, provided that both have access to the same computerized prescription transfer system which contains the prescription and refill records and incorporates procedures to prevent unauthorized refills.
5.If the prescription is for a controlled substance in Schedules II, III, IV, or V, the pharmacies shall comply with 21 C.F.R. §§ 1306.25 and 1306.08(e).
B.The requirements of §§ 1.6.15(A)(2) through (4) of this Part are excepted when an offsite pharmacy that provides pharmaceutical services to a nursing facility, assisted living residence, mental health institution, medical institution, hospital, or hospice care facility pursuant to a valid medication order or prescription directly transmits and shares the quantity of a prescription or medication order with another pharmacy if:
1.The transmission and sharing of the prescription or medication order is for the limited purpose of ensuring that drugs or devices are attainable to meet the immediate needs of patients for up to a seventy-two (72) hour supply or the originating pharmacy cannot provide services for the institutional facility on an ongoing basis due to a State of Emergency declared by an authorized government official or agency or unforeseen circumstances requiring that the pharmacy temporarily cease operations;
2.The originating pharmacy obtains consent from the facility, home health agency or hospice agency to share the pharmacy services for its residents;
3.The originating pharmacy provides a copy of a valid verbal, electronic, or written prescription or medication order to the receiving pharmacy prior to dispensing by the receiving pharmacy; and
4.The receiving pharmacy maintains responsibility for performing all requirements under applicable pharmacy statutes and Regulations when dispensing the portion of the prescription or medication order.
1.6.16Beyond-Use Dating on Labels
A.It shall be the responsibility of the dispenser, taking into account the nature of the drug repackaged, the characteristics of the container, and the storage conditions to which the article may be subject, to determine a suitable beyond-use date to be placed on the label. In addition:
1.The maximum beyond-use date that may be placed on the prescription container label shall be one (1) year from the date the drug is dispensed or the expiration date on the manufacturer’s container, whichever is earlier.
2.Where an expiration date on a product is dated only by the month and year, the intended expiration date shall be considered to be the last day of the stated month.
1.6.17Necessity of Prescription Label
A.In accordance with R.I. Gen. Laws § 5-19.1-18, to every box, bottle, jar, tube or other container of a prescription which is dispensed, a label shall be attached, the contents of which shall include:
1.The name of the prescriber;
2.The full name of the patient;
3.The name and address of the pharmacy;
4.The name of the drug dispensed in accordance with R.I. Gen. Laws Chapter 21-31;
5.Quantity and strength of the drug dispensed;
6.The date of dispensing;
7.The prescription number;
8.The expiration date of the prescription in accordance with § 1.6.16 of this Part; and
9.A full instruction on the use of the product in plain language.
B.Said label shall be printed, typed, or a combination of printed and typed, but shall not be handwritten, except in the case of an emergency.
C.No person shall alter, deface, or remove any label so affixed.
D.The requirements of this Section shall not apply to an order to dispense a drug for immediate administration to a licensed hospital, nursing facility, or hospice facility in-patient.
1.6.18Generic Substitutions
A.Pharmacists when dispensing a prescription shall, unless requested otherwise by the individual presenting the prescription in writing, substitute drugs containing all the same active chemical ingredients of the same strength, quantity, and dosage form as the drug requested by the prescriber from approved prescription drug products in accordance with the provisions of R.I. Gen. Laws §§ 21-31-16 and 21-31-15(l)(1), unless ordered by the prescribing physician to dispense as brand name necessary on the prescription form, or if the prescriber gives oral direction to that effect to the dispensing pharmacist.
B.The requirements of § 1.6.18(A) of this Part shall not apply to an order to dispense a drug for immediate administration to a licensed hospital, nursing facility or hospice facility in-patient.
C.The pharmacist shall make a product selection from approved prescription drug products and shall pass the savings on to the ultimate consumer. When a drug product selection is made, the pharmacist shall indicate the product dispensed on the written prescription or on the oral prescription, which has been reduced to writing or product information may be maintained on a computerized system if information is readily retrievable.
1.6.19Biosimilar Interchange
A.Pharmacists when dispensing a biological product shall, unless requested otherwise by the patient, interchange with a less expensive product that is a highly similar product to the FDA-approved biological product, known as a reference product, which has no clinically meaningful differences in terms of safety and effectiveness from the reference product, and the FDA has:
1.Licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4) or lists of licensed, biological products with reference product exclusivity and biosimilarity or interchangeability evaluations; or
2.Determined is therapeutically equivalent as set forth in the latest edition of or supplement to, the United States Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations.
1.6.20Central Database – Operation
A.In accordance with R.I. Gen. Laws § 5-19.1-17, pharmacies operated by a person pursuant to the Act may refill prescriptions which have been previously dispensed by an affiliated pharmacy, provided, that prior to dispensing a refill the pharmacy refilling the prescription verifies the appropriateness of the refill through a centralized database.
B.Clinic pharmacies operated by a health maintenance organization licensed under R.I. Gen. Laws Chapter 27-41 and the Act may refill prescriptions which have been previously dispensed by another health maintenance organization clinic pharmacy, provided that prior to dispensing a refill the pharmacy refilling the prescription verifies the appropriateness of the refill through a centralized database of that health maintenance organization.
C.Disclosure of prescription information to any other person(s) other than agents of properly licensed pharmacies pursuant to §§ 1.6.20(A) and (B) of this Part is prohibited.
D.Disclosure of prescription information is permitted only to those directly involved in patient care consistent with R.I. Gen. Laws Chapter 5-37.3, the “Healthcare Communications and Information Act” and other applicable Federal and State laws.
E.The disclosure of prescription information to researchers may only be authorized in accordance with Federal policy for the protection of human subjects.
1.6.21Product Selection
A.A pharmacist may alter the prescribed dosage form of a medication, if in the professional judgment of the pharmacist, the form dispensed meets the bio-equivalency of the dose prescribed and it is appropriate for the patient.
1.6.22Poison Prevention Packaging
A.All drugs and substances cited in the Federal Poison Prevention Packaging Act Regulations, 15 U.S.C. § 1471 et seq., shall be packaged and dispensed in accordance with said Regulations.
B.Documentation shall be maintained by the pharmacy to record those instances when a non-child-resistant safety cap container has been requested by a consumer.
1.6.23Product Verification
A.Verification by a pharmacist of a filled prescription must include a verification of the prescription label and product against the original or scanned prescription.
1.6.24Therapeutic Substitution
A.Therapeutic substitutions by pharmacists are permitted in situations requiring compliance with a formulary prepared by the pharmacy and therapeutics committee, and agreed to by the staff physicians of the facility:
1.In a hospital, licensed pursuant to R.I. Gen. Laws Chapter 23-17; or
2.In a nursing facility, medical institution, or hospice care facility with contracted pharmaceutical services pursuant to § 1.7.1 of this Part and licensed under R.I. Gen. Laws Chapter 23-17.
1.6.25Return to Stock of Undelivered Medications
A.Prescriptions that have not been picked up by or delivered to patients may be returned to stock. The pharmacist shall be responsible for the development of written policies and procedures that shall include, but not be limited to, the following:
1.Drugs returned to stock have been maintained to assure their integrity;
2.No drugs returned to stock have expirations dates that exceed twelve (12) months from the date of dispensing of original prescription;
3.Patient information on prescription labels have been redacted to protect patient confidentiality; and
4.Given a manufacturer or FDA recall for a drug product, pharmacist shall assume products held in containers without lot numbers are included in the recall and proceed accordingly.
1.6.26General Requirements: Retail Pharmacies
A.Space. Any new pharmacy shall have an area of not less than two hundred and fifty square feet (250’).
B.List of Drugs Posted. Each pharmacy:
1.Shall conspicuously display the list of the ten (10) prescribed health maintenance prescription drugs compiled by the Director at or adjacent to the place in the pharmacy where prescriptions are presented for compounding and dispensing;
2.Shall, upon request, provide to a consumer who possesses a prescription for any listed prescription drug, the current selling price of that drug; and
3.May change the current selling price and the posting of that price on the list at any time.
C.Each pharmacy shall post, in a clear and legible form, on that list, the current selling price of each prescription drug listed. Current selling price means the actual price to be paid by a retail purchaser to the pharmacy for any prescription drug listed at the usual strength and amount listed.
D.The requirements of this Section do not apply to an order to dispense a drug for immediate administration to a hospital patient.
1.6.27General Requirements: Institutional Pharmacies
A.Physical Requirements. An institutional pharmacy shall have sufficient floor space allocated to it to ensure that drugs are prepared in sanitary, well-lighted and enclosed places. It shall have sufficient equipment, supplies and physical facilities for proper compounding, dispensing and storage of drugs, including parenteral preparations and for the provision of pharmaceutical care. All work surfaces shall be free of equipment, supplies, records and labels unrelated to the preparation of medications. The equipment and physical facilities shall include, but are not limited to, the following:
1.Compounding and dispensing areas;
2.Physically separate parenteral solution additive area when solutions are compound in the pharmacy as described in § 1.8 of this Part;
3.Receiving and storage areas;
4.Packaging and repackaging areas;
5.Office space sufficient to allow for administrative functions without interference with the safe compounding and dispensing of medications and security of the pharmacy.
B.After-hours Pharmacy Services. The pharmacist-in-charge shall establish policies and procedures for the provision of a limited supply of medications for filling of urgent orders to patients of the medical institution after the scheduled hours of operation of the pharmacy. The pharmacist-in-charge shall provide for the provision of pharmaceutical care after normal working hours by use of an “on call” pharmacist accessible to the medical institution after hours. The institutional pharmacy may enter into a contractual arrangement with another pharmacy or pharmacist for the provision of such services. Medications may be accessed from a pharmacy-designated area. The policies and procedures shall address:
1.A list of those individuals authorized by the pharmacist-in-charge to remove medications from the pharmacy-designated area
2.A list of medications authorized for removal from the pharmacy-designated area determined by the pharmacist-in-charge or designee, and the medical staff of the medical institution. The pharmacist in charge shall limit the number of medications, quantity and dosage forms to maximize patient safety. Medications shall be removed from the designated area in unit-of-use packaging, whenever possible. If a non-unit-dosed medication is needed when the pharmacy is closed, the bulk medication container shall be signed out. When the pharmacy re-opens, the pharmacist shall retrieve the bottle and dispense the necessary amount of medication. The bottle shall be returned to the pharmacy within twenty-four (24) hours after the pharmacy re-opens.
3.Documentation of medications removed from the pharmacy-designated area, which shall include, but not be limited to, medication name, strength, signature of authorized person removing medications, quantity and name of patient
4.Methods for performing a periodic review of those policies and procedures
C.Medication Distribution and Control. The pharmacist-in-charge shall establish policies and procedures relating to the procurement, distribution and control of all drug products used in the medical institution.
1.Medication Orders
a.Medications are to be prescribed, dispensed and administered only upon orders of authorized practitioners and medication orders transmitted to the pharmacy in an appropriate manner.
b.A licensed pharmacist in the institutional pharmacy shall review all medication orders for appropriateness upon receipt in the pharmacy prior to dispensing, except orders initiated in the operating room, emergency room, procedural rooms, and ambulatory care centers. Medication orders written when the pharmacy is closed shall be reviewed within twenty-four (24) hours after the pharmacy re-opens.
c.All patient medication orders shall be contained in the patient’s medical record.
d.Medication orders shall contain:
(1)Full name and street address of the patient;
(2)Name, address, and if required by law or rules of the Board, DEA registration number of the prescribing practitioner;
(3)Date of issuance;
(4)Name, strength, dosage form of drug prescribed;
(5)Directions for use;
(6)If a written prescription, prescribing practitioner’s signature;
(7)If an electronically transmitted prescription, prescribing practitioner’s electronic signature or type written signature; and
(8)Oral prescriptions shall be reduced promptly to writing by the pharmacist or intern and stored either electronically or in hard copy format.
e.Medication orders for controlled substances must comply with all applicable Federal and State laws.
f.A valid medication order may be transmitted to a licensed pharmacy by the following means:
(1)Delivery of the original, signed written medication order.
(2)Electronically by a nurse or authorized agent of the prescriber in a hospital, nursing facility, medical institutions, or hospice care facilities via a secure, interoperable information technology system that exchanges data accurately, effectively and in compliance with applicable laws.
(3)Verbally by an authorized prescriber or the prescriber’s authorized designated agent. For the purposes of this Section, nurses in nursing facilities shall be considered authorized designated agents.
(4)Via facsimile by a prescriber or the prescriber’s authorized designated agent. If the order was initially received verbally, the transmitted document shall include the name of the prescriber, the name of the agent who received and transcribed the medication order.
2.Medication Storage and Security
a.All areas designated for medication storage shall have and shall maintain proper security to limit accessibility of unauthorized personnel on the premises and to safeguard against diversion of drugs, biologicals and medications.
b.All medications shall be stored in designated areas under proper conditions of sanitation, temperature, light, moisture, ventilation, and segregation to ensure medication integrity. Medications shall be stored in accordance with medication labeling pursuant to the Federal and State Food Drug and Cosmetic Acts, 21 U.S.C. § 301 et seq. and R.I. Gen. Laws Chapter 21-31.
c.Each pharmacy shall adhere to written policies and procedures that require all stocks of medications to be inspected routinely for outdated, unusable or mislabeled products.
d.Floor stock of medications shall be limited to medications for emergency use, non-legend medications that are routinely used, and limited medications as designated by the facility.
e.All medication areas including auxiliary drug supplies, unit dose carts and emergency kits, shall remain secured at all times. All medications must be adequately secured to restrict access by unauthorized personnel.
f.Sample medications shall be procured, stored, dispensed and/or donated to charitable institutions in accordance with the Federal Food Drug and Cosmetic Act.
3.Labeling
a.All drugs dispensed within a medical institution shall be labeled and identified up to the point of administration.
b.Whenever a drug is added to a parenteral admixture, it shall be labeled with a supplementary label indicating the name and amount of the drug added, expiration date and expiration time, if applicable. For admixtures prepared outside the pharmacy, the pharmacist-in-charge shall develop policies and procedures for preparation and labeling.
c.Labels for outpatient medications shall comply with R.I. Gen. Laws § 21-31-15(l)(l).
4.Records. The pharmacist-in-charge shall develop a system of daily accountability for medication compounding and dispensing that shall permit the identification of the responsible pharmacist. Readily retrievable records of accountability shall be maintained for at least two (2) years. At a minimum, this system shall identify all personnel who perform these activities and the pharmacist responsible for:
a.Interpretation and appropriateness of new medication orders;
b.Profile entry of new medication orders;
c.Dispensing of new medication orders including “stat” doses;
d.Daily cart fills;
e.Compounding medications; and
f.Periodically assessing the quality of pharmacy procedures for preparation and release of drugs for replenishment of floor stock, ancillary drug supplies, emergency kits and automated dispensing devices in locations outside the pharmacy.
5.Patient’s personal medications may be administered to the patient in the event that the hospital does not stock the medication, and shall be arranged per hospital policy.
a.Notwithstanding the provision of § 1.6.27(C)(5) of this Part, or any other provision of this Part to the contrary, a hospital may refuse to store its patients’ personal medication in its pharmacy and may direct that personal medications be stored securely in the patients’ rooms or returned to the patients’ homes. A patient’s personal medication may be administered to the patient during a hospital stay, if necessary.
6.Emergency Outpatient Medications
a.The pharmacist-in-charge and medical staff shall establish policies and procedures for the dispensing of medications from the emergency room.
(1)Only a licensed prescriber shall be authorized to dispense medications to patients in an emergency situation.
(2)Emergency medications shall be labeled in accordance with R.I. Gen. Laws § 21-31-15(l)(l).
7.Monitoring Drug Therapy. The pharmacist shall review the appropriateness of the choice of medications for the patient and the patient’s therapeutic regimen, pursuant to § 1.6.13(C) of this Part.
a.Pharmacists shall have access to the following information:
(1)Admission diagnosis;
(2)Age, weight, height and sex;
(3)History of allergies and/or previous adverse drug reactions;
(4)Current and discontinued medications;
(5)Co-morbid disease states;
(6)Pertinent laboratory information.
b.The pharmacist shall review each medication order and, in the case of an identified, significant problem or opportunity for improvement, the pharmacist shall contact the prescribing practitioner. All such communications shall be documented electronically or in writing. Pharmacy interventions shall be reviewed with appropriate staff committees on a routine basis.
c.Medication Use Evaluation Program: The pharmacist-in-charge and medical staff shall establish policies and procedures to increase the effectiveness and minimize the risk of drug use. Policies and procedures shall include defining, monitoring, detecting, reporting and reviewing the following:
(1)Adverse Drug Reactions (ADR): ADRs that the pharmacist deems to be significant shall be reported to the FDA’s MedWatch Program. Vaccine-related adverse events shall be reported to the CDC.
(2)Medication Errors: Special consideration shall be given to measures to prevent medication administration errors associated with preparing parenteral and sterile products.
(3)Medication Use Evaluation: The system shall identify, and resolve actual and potential medication-related problems, and prevent potential medication problems that could interfere with optimum patient outcomes from medication therapy.
1.6.28Standing Orders
A.A Rhode Island licensed pharmacist may engage in a standing order pursuant to a signed standing order by a Rhode Island licensed physician or other practitioner. More than one (1) pharmacist may engage in a standing order signed by a Rhode Island licensed physician or other prescriber.
1.The signed standing order must be kept on file and readily retrievable at the site where the engagement in said order is taking place.
2.All standing orders must be approved by the BOP, the BMLD and the Director, each party listed herein may request revisions to any proposed standing order as a condition of approval. Each proposed standing order must first be submitted to the BOP. Upon BOP approval, the proposed standing order will be forwarded to the BMLD. Upon BMLD approval the standing order will be sent to the Director for approval.
3.No proposed standing order may commence until it is approved by the Director. The Director may also terminate a standing order at any time.
B.Standing orders must include, but are not limited to the following:
1.An explanation of the standing order;
2.The criteria for the standing order;
3.The training requirements for the individuals participating in the standing order, if any;
4.The medicine, medical supply, and/or medical equipment that may be supplied and/or administered per the standing order;
5.The indications for which the medicine, medical supply, and/or medical equipment is to be administered, prescribed, or dispensed;
6.The number of dose(s) of the medicine, medical supply or equipment per the standing order;
7.The route of administration or use;
8.Record of the clinical documentation in paper or electric form and any other documentation per State or Federal requirements;
9.The effective dates of the standing order.
C.If a standing order lists more than one (1) medicine, medical supply, and/or equipment for the treatment of a condition, the purpose of each medicine medical supply or equipment must be listed on the standing order.
D.The standing order must not exceed a two (2) year time period. If a renewal is requested, a review per § 1.13.1(A)(2) prior to the anniversary date of the standing order is required.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.7** Specialized Pharmacy Practice {#sec-216-ricr-40-15-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.7}
1.7.1Pharmaceutical Services: Nursing, Hospice Care, and Correctional Facilities
A.Any licensed pharmacy or licensed pharmacist that provides pharmaceutical services by contract to a nursing, hospice, or correctional facility shall comply with the following requirements:
1.Unless the nursing, hospice care, or correctional facility operates a licensed pharmacy and employs a director of pharmacy services, the nursing, hospice care, or correctional facility shall have a written agreement with a licensed resident or non-resident pharmacy to provide pharmaceutical services. The pharmacist-in-charge of the pharmacy shall supervise the entire spectrum of pharmaceutical services in the nursing, hospice care, or correctional facility.
a.If pharmaceutical services are provided by a non-resident pharmacy in a correctional facility, a State licensed pharmacist shall supervise those services.
2.The pharmacy and therapeutics committee, or its equivalent, shall consist of not less than a licensed pharmacist, a registered nurse, a physician and the administrator or a representative from administration and shall review all policies and procedures for the provision of pharmaceutical services to patients.
3.The pharmacist shall be responsible for the development of written policies and procedures that shall include, but not be limited to, the following:
a.Procedures for administering the services outlined in the written agreement with the facility
b.Policies and procedures necessary to ensure the safe use, administration, control and accountability of all drugs throughout the nursing, hospice care, or correctional facility in compliance with Federal and State laws. The pharmacist shall:
(1)Ensure that a valid medication or prescription order is received prior to the dispensing of any drug pursuant to § 1.6.27(C) of this Part.
(2)Ensure that the drugs for each patient are kept and stored in the originally received containers and that the medication of one (1) patient shall not be transferred to another patient.
(3)Ensure that each cabinet, cart or other area utilized for the storage of drugs is locked and accessible only to authorized personnel.
(4)Provide for the timely delivery of drugs and biologicals from the pharmacy so a practitioner’s orders for drug therapy can be implemented without undue delay.
c.Policies and procedures outlining the return or destruction on-site of wastage for all controlled substances and the proper disposal of legend drugs.
d.Policies governing appropriate storage of medications, an effective drug recall procedure, and labeling of all prescription drugs and biologicals in accordance with Federal and State requirements.
e.The pharmacist shall:
(1)Report any irregularities to the attending physician, medical director, and director of nurses. Reports shall show evidence of review and response; and
(2)Document in writing the performance of such review, which documentation shall be kept on file by the facility and shall be made accessible to inspectors upon request.
f.For nursing facilities, policies and procedures governing patient drug regimen reviews shall include procedures for reporting irregularities, and documenting that such reviews have been performed. The contracted pharmacy consultant shall review all medication orders or prescription orders with information on the patient profiles. The consultant pharmacist shall review the drug and biological regimen of each resident monthly.
4.A unit dose drug dispensing system or automated storage and distribution device may be utilized for the dispensing of drugs to patients in a licensed hospital, nursing, hospice care, or correctional facility. Such systems or devices shall be utilized in accordance with this Part.
5.Secure Delivery Area: Filled prescriptions may be delivered to health care facilities by pharmacy employees or authorized agents. Prescription medication may be accepted for delivery from a pharmacy during normal business hours under the general supervision of a pharmacist. However, when the pharmacy is closed for business prescription medication may only be accepted for delivery or dropped off at the pharmacy if:
a.The prescriptions are placed in a secured delivery area equipped with adequate security, including an alarm or comparable monitoring system, to prevent unauthorized entry, theft and diversion;
b.The secured delivery area appropriately safeguards product integrity in accordance with USP-NF requirements;
c.The secured delivery area is on the same premises as the pharmacy that filled the prescriptions;
d.The pharmacy and the approved agent solely have access to the secure delivery area;
e.The pharmacy maintains records of all persons who have accessed the secured delivery area and each prescription stored and removed for delivery;
f.The pharmacy maintains written policies and procedures for secured delivery area storage and removal of prescriptions;
g.A pharmacist or a pharmacy, by means of its agent, may accept the return of the following drugs or devices to the secured delivery area:
(1)Emergency kits;
(2)Prescriptions that were unsuccessfully delivered by the pharmacy, a pharmacist, or its agent; and
(3)Those deemed qualified for return pursuant to the requirements of this Part.
1.7.2Pharmaceutical Services: Nuclear/Radiologic Pharmacies
A.The practice of nuclear/radiologic pharmacy is hereby recognized as a specialty of pharmacy practice, regulated by the Department and the Board. This Section applies only to pharmacies which are preparing and distributing, or redistributing radioactive material, not simply handling such material.
B.Policies and Procedures
1.This Part shall not apply to a nuclear medicine department within a medical institution which is licensed by another agency.
2.Nuclear pharmacies shall maintain records of acquisition, inventory, and disposition of all radioactive drugs and other radioactive materials, in accordance with the provisions of the “Rules and Regulations for the Control of Radiation [R23-1.3-RAD].”
3.All pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area. Detailed floor plans shall be submitted to the Department and the Rhode Island Radiation Control Agency before approval of the license.
4.Radiopharmaceuticals are to be dispensed only upon a prescription drug order, from a practitioner authorized to possess, use and administer radiopharmaceuticals.
5.The permit to operate a nuclear pharmacy is conditional upon an approved Rhode Island Radiation Control Agency license. Copies of the Rhode Island Radiation Control Agency inspection reports shall be made available upon request for Board inspection.
C.Personnel
1.A license to operate a pharmacy providing radiopharmaceutical services shall only be issued to a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of a qualified nuclear pharmacist. A qualified nuclear pharmacist shall be responsible for all operations of the pharmacy and shall be in personal attendance at all times that the pharmacy is open for business.
2.The nuclear pharmacy area shall be secured from unauthorized personnel.
D.Physical Requirements
1.Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided, meeting minimal space requirements established for all pharmacies in the State or as otherwise defined by the Board.
1.7.3Nonresident Pharmacies
A.Licensure: In order to ship, mail, or deliver prescription drugs and/or devices to a patient in Rhode Island, a non-resident pharmacy must be licensed by the Board and shall comply with all statutory requirements and this Part.
B.Agent of record: Each non-resident pharmacy that ships, mails, or delivers prescription drugs and/or devices to a patient in Rhode Island shall designate a resident agent in Rhode Island for service of process. Any such non-resident pharmacy that does not so designate a registered agent and that ships, mails, or delivers prescription drugs and/or devices in Rhode Island, shall be deemed an appointment by such non-resident pharmacy of the Rhode Island Secretary of State to be its true and lawful attorney upon whom may be served all legal process in any action or proceeding against such pharmacy growing out of or arising from such delivery. A copy of any such service of process shall be mailed to the non-resident pharmacy by the complaining party by certified mail, return receipt requested, postage prepaid, or by international certified mail, return receipt requested, postage prepaid, at the address of such non-resident pharmacy as designated on the pharmacy's application for licensure in Rhode Island. If any such pharmacy is not licensed in Rhode Island, service on the Rhode Island Secretary of State only shall be sufficient service.
C.Conditions of Licensure: As conditions of licensure, the non-resident pharmacy must comply with the following:
1.Maintain, at all times a valid unexpired license, permit or registration to operate the pharmacy in compliance with the laws of any other State in the United States or any Province or Territory of Canada in which it is located;
2.Provide a description of any final disciplinary action(s) by licensing boards in other states in the United States, United States Territories or Possessions, or any Provinces or Territories of Canada; as defined as discipline in those States, Provinces, or Territories and
3.Provide all information requested by the Board.
D.A pharmacy license will be issued to the owner who meets the requirements established pursuant to the Act and this Part. On and after December 1, 2024, for licenses issued or renewed, the owner of each pharmacy shall receive a license of location, which shall entitle the owner to operate such pharmacy at the location specified, or such other temporary location as the Director may approve, for the period ending on the thirtieth (30th) day of September of the current licensing cycle. Each such owner shall at the time of filing provide proof of payment of the fee established in R.I. Gen. Laws § 5-19.1-11(b), file with the Department on a provided form, a declaration of ownership and location. Such declaration of ownership and location filed with the Department shall be deemed presumptive evidence of ownership of the pharmacy specified on the license.
E.A license shall be issued to the owner and premise listed on the form and shall not be transferred. A license issued pursuant to this Part shall be the property of the Department and loaned to the licensee, and it shall be kept posted in a conspicuous place on the licensed premises. If a change in owner or premise listed in said firm occurs, the license becomes null and void.
F.It shall be the duty of the owner to immediately notify the Department of any proposed change of location or ownership.
G.In the event such license fee remains unpaid on the date due, no renewal or new license shall be issued except upon payment of the license renewal fee.
H.Reports and Complaints – Upon receipt of a complaint against the non-resident pharmacy, the Department shall forward the complaint to the other State (in the United States) or Canadian Provincial or Territorial boards where the non-resident pharmacy is licensed.
1.7.4Canadian Pharmacies
A.A Canadian pharmacy seeking licensure in Rhode Island shall, as a condition of licensure, comply at all times with the following requirements:
1.Only ship into Rhode Island products that have been approved by the United States Food and Drug Administration (FDA);
2.Provide written documentation acceptable to the Board that the Canadian pharmacy’s importation of prescription drugs to Rhode Island residents is in compliance with all FDA and other applicable Federal laws and Regulations.
3.Provide a certificate of insurance in the name of the Department as certificate holder showing evidence of five million dollars ($5,000,000.00) of product liability insurance or other equivalent means of security acceptable to the Board.
a.The product liability insurance policy shall include U.S. Territories and shall be issued by an insurer that maintains at least an “A” rating from A.M. Best and a financial size category of at least Class “X.”
b.Failure to maintain product liability insurance shall result in the revocation of the Canadian pharmacy’s license to do business in Rhode Island.
c.The product liability insurance policy shall include a provision that stipulates that the Director shall be notified of the cancellation or failure to renew the insurance. Further, the policy shall be required to continue in effect for ten (10) days after written notice of the cancellation is given to the Director of the cancellation or termination of the product liability insurance policy by the issuing insurance company or companies in addition to any other notices which may be required by law.
4.Not perform therapeutic substitution (i.e., substitution of medications within a class) without the approval of the prescriber;
5.Provide patients with an opportunity to discuss matters that will enhance or optimize drug therapy with each patient or care giver of such patient. Such discussion, by telephone, electronic, or other acceptable means, shall include appropriate elements of patient counseling, as is appropriate for the patient in the professional judgment of the pharmacist.
6.Provide for the secure and confidential storage of confidential patient healthcare information with restricted access, including policies and procedures implemented to protect the integrity and confidentiality of patient healthcare information. Except as provided in R.I. Gen. Laws Chapter 5-37.3 or as specifically provided by State and Federal law, a patient's confidential healthcare information shall not be released or transferred without the written authorization of the patient or their authorized representative, on a consent form meeting the requirements set forth in R.I. Gen. Laws Chapter 5-37.3. Further, under no circumstances shall a patient’s confidential healthcare information be provided to a third (3rd) party for marketing, fundraising, or research purposes. Anyone who violates the provisions of R.I. Gen. Laws Chapter 5-37.3 may be held liable for actual and exemplary damages and other penalties set forth in R.I. Gen. Laws Chapter 5-37.3.
7.Provide and maintain all appropriate inventory controls in order to detect and document any theft, counterfeiting, or diversion of drugs or devices.
8.Have a procedure in place for handling recalls and withdrawals of drugs and devices, including the tracking of lot numbers, consistent with the requirements of § 1.14 of this Part. Such procedure shall be adequate to deal with recalls and withdrawals due to:
a.Any action initiated at the request of the U.S. FDA or any other Federal, State, or local law enforcement or other governmental agency, including the Board;
b.Any volunteer action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or
c.Any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.
9.Provide the patient with written documentation that indicates the country(ies) where the patient’s medication(s) were manufactured.
10.Ensure that all drug labels are written in English and meet all requirements set forth in Rhode Island law and this Part.
B.A non-resident Canadian pharmacy shall not ship, mail, deliver, or otherwise dispense to a Rhode Island patient any of the following:
1.A controlled substance as defined in R.I. Gen. Laws § 21-28-1.02(7);
2.A biological product as defined in this Part;
3.An infused drug including peritoneal dialysis solution;
4.An intravenously injected drug;
5.A drug that is inhaled during surgery;
6.A parenteral drug;
7.A drug manufactured through one or more biotechnology processes including:
a.A therapeutic DNA plasmid product;
b.A therapeutic synthetic peptide product of not more than forty (40) amino acids;
c.A monoclonal antibody product for in-vivo use; and
d.A therapeutic recombinant DNA-derived product.
8.A drug required to be refrigerated at any time during manufacturing, packaging, processing, or holding;
9.A photoreactive drug.
C.The Canadian pharmacy shall provide the name and address of a Rhode Island resident upon whom notices or orders of the Department or process affecting the Canadian pharmacy may be served.
D.As a condition of licensure, a Canadian pharmacy shall agree that the statutes and Regulations of the State of Rhode Island will apply to all matters. Further, the Canadian pharmacy agrees that exclusive jurisdiction for any dispute with any Rhode Island citizen resides in the courts of the State of Rhode Island and further agrees and expressly consents to the exercise of personal jurisdiction in the courts of the State of Rhode Island in connection with any dispute, including any claim involving any Rhode Island citizen.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.8** Compounding of Pharmaceuticals {#sec-216-ricr-40-15-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.8}
A.General Requirements: Non-sterile and Sterile Compounding
1.A pharmacist/patient/prescriber relationship shall exist in order for a pharmacist to prepare compounds that are not commercially available, except as applied to Outsourcing Facilities.
2.Pharmacists, interns, or Technician IIs engaged in compounding shall operate in conformity with all applicable State and Federal laws and Regulations regulating the practice of pharmacy.
3.The requirements in § 1.8 of this Part shall not apply to the preparation of medications by licensed healthcare professionals in emergency situations for immediate administration to patients.
4.A practitioner’s prescription shall be required for the compounding of all pharmaceuticals except as applied to Outsourcing Facilities.
5.Retail pharmacies shall only prepare compounded preparations in limited quantities (i.e., stock preparation, batch processing) prior to receiving a valid prescription based on a history of receiving valid prescriptions that have been generated solely within an established pharmacist/patient/practitioner relationship, provided that the prescriptions are maintained on file for all such preparations prepared at the pharmacy.
a.Hospital and institutional pharmacies shall only prepare compounded preparations in limited quantities (i.e., batch compounding) in anticipation of receiving a valid practitioner order/prescription or as part of an established hospital or institutionally approved protocol/procedure. Such anticipated compounding shall be based upon a history of receiving valid practitioner orders/prescriptions/protocol/procedure that have been generated solely within an established pharmacist/patient/practitioner relationship provided that the practitioner order/prescription/protocol/procedure is maintained on file in the pharmacy or in the patient’s medical record for all such preparations prepared at the pharmacy.
6.All compounded preparations shall be labeled using USP 797 guidelines, incorporated in § 1.2(D) above, and in accordance with applicable state and federal laws.
7.All compounded preparations shall be stored under conditions dictated by composition and stability characteristics (e.g., in a clean, dry place, on a shelf, or in the refrigerator) to ensure strength, quality, and purity.
8.Pharmacists shall not offer pharmaceutically prepared compounded preparations to other State-licensed persons or commercial entities for subsequent resale, except as applied to Outsourcing Facilities.
9.Compounding personnel shall be responsible for ensuring that compounded preparations are accurately identified, measured, diluted, and mixed; are correctly packaged, sealed, labeled, stored, dispensed, and distributed. Ingredients shall be of the correct identity, quality, and purity. Appropriate cleanliness shall be maintained. Proper labeling and supplementary instructions for the clinical administration of CSPs and CNSPs shall be provided by a pharmacist. Beyond-use dates shall be determined based upon USP Chapters 795 and 797 incorporated by reference in §§ 1.2(D) and (E) of this Part, documented testing or literature and professional judgment.
10.Bulk and Active Pharmaceutical Ingredients (APIs) used in the preparation of compounded sterile preparations (CSPs), and compounded non-sterile preparations shall be USP or National Formulary (NF) certified and shall be accompanied by a certificate of analysis for inspection by the Department upon request.
B.General Requirements: Sterile Compounding. The pharmacist-in-charge or designated person(s) acting on behalf of the pharmacist-in-charge shall ensure the following activities are accomplished for all sterile compounding as outlined in USP Chapter 797 incorporated by reference in § 1.2(D) of this Part:
1.All CSPs shall be prepared in a manner that maintains sterility and minimizes the introduction of particulate matter;
a.All CSPs shall be accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed as appropriate. This requirement includes maintaining appropriate cleanliness and providing labeling and supplementary instructions for the proper clinical administration of CSPs;
b.Through appropriate information sources, specific CSPs maintain their labeled strength according to USP guidelines until their beyond-use dates;
c.A written quality assurance procedure includes the following in-process checks that are applied, as is appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients; bacterial endotoxins, particulate matter, and pH; labeling and storage requirements;
d.Upon discovery of potential contamination, the pharmacist-in-charge shall immediately notify any patient(s) to whom a potentially contaminated CSP was administered. In an institutional setting, the pharmacist-in-charge shall immediately notify the patient’s physician of the potential risk. Positive sterility test results shall prompt a rapid and systematic investigation of aseptic techniques, environmental controls, and other sterility assurance controls to identify sources of contamination and correct problems in the methods or processes.
C.Responsibilities of Compounding Personnel: Sterile Compounding
1.The pharmacist-in-charge shall be responsible for the overall operation of the compounding pharmacy.
2.The pharmacist-in-charge or designated person(s) acting on behalf of the pharmacist-in-charge shall ensure the following are achieved:
a.Compounding personnel shall have demonstrated competencies (including but not limited to media-fill) on file following United States Pharmacopoeia Chapter 797, Pharmaceutical Compounding – Sterile Preparations (2023) incorporated by reference in § 1.2(D) of this Part.
D.Facility Requirements - Sterile Compounding: Clean Room Suite (Secondary engineering control (SEC))
1.Pharmacies that engage in the pharmaceutical preparation of CSPs shall have a specifically designed space that is adequately sized for the orderly placement of equipment and the materials used to prepare sterile preparations in accordance with USP Chapter 797, incorporated by reference in § 1.2(D) of this Part. This area shall be separate and distinct from other areas within the pharmacy and no other activity other than the preparation of sterile preparations shall occur in this area.
2.Pharmacies shall employ the use of Primary Engineering Controls (PECs) or a barrier isolator system to prepare CSPs as defined by United States Pharmacopoeia Chapter 797, Pharmaceutical Compounding – Sterile Preparations (2023) incorporated by reference in § 1.2(D) of this Part. These devices shall be located in accordance with the USP standards incorporated in § 1.2(D) of this Part.
3.Pharmacies that compound hazardous preparations shall do so in accordance with USP Chapter 800, incorporated by reference in § 1.2(F) of this Part.
4.Sinks or water sources shall be located in compliance with United States Pharmacopoeia Chapter 797, Pharmaceutical Compounding – Sterile Preparations (2023) incorporated by reference in § 1.2(D) of this Part.
E.Facility Requirements – Sterile Compounding Segregated Compounding Area (SCA)
1.SCAs shall be designed and used following United States Pharmacopoeia Chapter 797, Pharmaceutical Compounding – Sterile Preparations (2023) incorporated by reference in § 1.2(D) of this Part. PECs or barriers isolator systems shall be located following the USP standards incorporated in § 1.2(D) of this Part.
a.BUDs will be assigned using the USP standards incorporated in § 1.2(D) of this Part.
F.Quality Assurance and Environmental Monitoring
1.Quality Assurance
a.Pharmacies that compound CSPs shall implement a formal quality assurance program for monitoring, evaluating, correcting, and improving the activities, systems and processes that support the preparation of CSPs.
b.A written quality assurance procedure includes the following in-process checks that are applied to specific CSPs: accuracy and precision of measuring and weighing (if using Active Pharmaceutical Ingredient or API); the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients; bacterial endotoxins, particulate matter, and pH; labeling and storage requirements.
c.Upon discovery of confirmed CSP contamination, the pharmacist-in-charge or designated person(s) shall immediately notify any patient(s) and their providers to whom a potentially contaminated CSP was administered. Documentation of this notification shall be recorded and kept on file. Positive CSP sterility test results shall prompt a rapid and systematic investigation of aseptic techniques, environmental controls, and other sterility assurance controls to identify sources of contamination and correct problems in the methods or processes.
d.CSPs shall have the following:
(1)Quality assurance practices that shall include, at a minimum: routine disinfections and air quality testing of the direct compounding environment; visual confirmation that personnel are properly garbed; orders reviewed to ensure the correct identity and amount of the ingredients used; and a visual inspection of the CSP to ensure proper labeling, accuracy and the absence of particulate matter and leakage.
(2)In the absence of sterility testing, storage periods (before administration) shall not exceed the USP standards incorporated in § 1.2(D) of this Part.
G.Environmental Monitoring: Sterile Compounding
1.Certification that each PEC working properly and meets the air quality requirement of ISO Class 5 shall be conducted every six (6) months and whenever the PEC is relocated. Such certification shall be performed and documented by qualified operator(s) using current industry standard equipment.
2.The air quality of the SEC shall be in conformity with ISO Class 7 and ISO Class 8 requirements, as appropriate. Certification inspections shall be conducted every six (6) months and whenever renovations occur. Such certification shall be performed and documented by a qualified operator(s) with calibrated industry standard equipment.
3.The pharmacist-in-charge or designated person(s) acting on behalf of the pharmacist-in-charge shall be responsible for reviewing and maintaining the certification records required in §§ 1.8(D)(5) and (E)(1) of this Part for a period of no less than two (2) years.
4.A written plan and schedule for the environmental monitoring procedures for viable micro-organisms shall be established and followed. The plan shall be adequate to evaluate the various PEC and SECs classified air environment areas of the designated sterile compounding area(s). Minimum frequencies for sampling shall exceed the USP standards incorporated in § 1.2(D) of this Part as follows: Category I and Category II CSPs shall occur monthly and Category III CSPs shall occur weekly.
5.When above action level results for viable sampling are discovered, the pharmacy shall keep records of viable sampling reports and remediation actions and have such records readily retrievable for Board inspection for a period of two (2) years.
6.In the event of sample results being above the USP action levels in a PEC or SEC stated in the USP standards incorporated in § 1.2(D) of this Part the following shall occur:
a.The pharmacy shall conduct a risk assessment to continue safe sterile compounding activities which may include but not be limited to the following:
(1)Thorough terminal cleaning of all impacted compounding spaces.
(2)Reducing BUD
(3)Consideration of alternate locations for sterile compounding.
(4)Notification of the Board of Pharmacy for all instances of repeat actionable growth consisting of more than two (2) consecutive tests and shall provide the Board of Pharmacy with a corrective action plan.
(5)The Department of Health shall have the authority to order a clean room to cease operations if it determines there is significant risk to public health.
1.8.1Equipment: Sterile Compounding
A.Written procedures outlining required calibration, annual maintenance, monitoring for proper function, and controlled procedures for use shall be established and followed for all equipment, apparatuses, and devices used in the preparation of CSPs. Results from calibration, annual maintenance reports, and routine maintenance shall be kept on file for the lifetime of the equipment.
1.8.2Record Keeping Requirements: Sterile Compounding
A.All records required to be retained under this Part, or copies of such records, shall be readily retrievable for inspection by the Department during the retention period at the establishment where activities described in such records occurred.
B.Records required under this Part may be retained either as the original records or as true copies, such as photocopies, electronic image or other accurate reproductions of the original records.
1.8.3Radiopharmaceuticals as CSPs
A.Compounding of radiopharmaceuticals for Positron Emission Tomography (PET) shall be performed in accordance with USP Chapter 825, incorporated by reference in § 1.2(H) of this Part.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.9** Automated Storage and Distribution Devices {#sec-216-ricr-40-15-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.9}
1.9.1Automated Storage and Distribution Devices
A.Automated storage and distribution devices may be utilized by nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities who maintain contracts for pharmaceutical services with licensed pharmacies and which provide contractual pharmaceutical services to patients or licensed pharmacies, in the case of prescriptions available for delivery; and shall comply with the following provisions:
1.Drugs stored in an automated storage and distribution device servicing nursing facilities, medical institutions, assisted living, rehabilitation centers, hospitals, hospice care or correctional facilities are part of the inventory of the pharmacy providing pharmaceutical services to that facility.
2.Documentation as to type of equipment, serial numbers, content, policies and procedures and location shall be maintained on-site in the pharmacy. Such documentation shall include:
a.Name and address of the pharmacy where the automated storage and distribution device is being used;
b.Manufacturer’s name and model;
c.Description of how the device is used;
d.Quality assurance procedures to determine continued appropriate use of the automated device;
e.Policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access and malfunction.
3.Automated storage and distribution devices shall have adequate security systems and procedures to prevent unauthorized access, to comply with Federal and State Regulations and maintain patient confidentiality.
4.Records and/or electronic data kept by automated storage and distribution devices shall meet the following requirements:
a.All events involving the contents of the automated storage and distribution device shall be recorded electronically
b.Records shall be maintained by the pharmacy and shall be readily available to the Department. Such records shall include:
(1)Identity of system accessed;
(2)Identification of the individual accessing the system;
(3)Type of transaction;
(4)Name, strength, dosage form, and quantity of the drug accessed;
(5)Name of the patient for whom the drug was accessed;(6) Such additional information as the pharmacist-in-charge may deem necessary.
c.A record of medications filled/stocked into an automated storage and distribution device shall be maintained and shall include identification of the persons filling/stocking and checking for accuracy.
B.All containers of medications stored in the automated storage and distribution device shall be packaged and labeled in accordance with Federal and State laws and Regulations.
C.The pharmacy operating an automated storage and distribution device shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated storage and distribution device in accordance with existing Regulations.
D.The automated storage and distribution device shall provide a mechanism for storing and accounting for wasted medications or discarded medications in accordance with existing State and Federal law.
E.The pharmacist-in-charge shall establish policies and procedures that shall:
1.Assure that the automated storage and distribution device is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record-keeping and security safeguards.
2.Assure access to medications for the purposes of administration by authorized licensed personnel only, and provides a method to identify the patient and to release that patient’s prescriptions correctly.
3.Authorize individuals and determine levels of access to automated storage and distribution devices and ensure security of the system.
4.Assure that the filling/stocking of all medications in the system shall be accomplished by qualified personnel as defined by pharmacy policy and procedure.
5.Implement an ongoing quality assurance program that monitors compliance to the established policies and procedures of the automated pharmacy system.
6.Assure that a pharmacist is available at all times to fulfill any patient counseling as required by law and Regulation during the operating hours of the pharmacy or telephonically during any hours that prescriptions are available for pick-up.
7.If an automated self-serve prescription delivery kiosk is located at the pharmacy, the kiosk shall be located either in a wall of a properly licensed pharmacy or within twenty feet (20’) of a properly licensed pharmacy. The automated storage/distribution system shall be secured against a wall or floor in such a manner as to prevent the unauthorized removal of the system.
F.The pharmacist-in-charge shall establish policies and procedures for the process of dispensing and/or administering medications pursuant to a medication order.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.10** Provision of Medications by Non-Pharmacists {#sec-216-ricr-40-15-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.10}
A.Samples
1.A practitioner, or their authorized agent, may supply prescription sample medications to their patients.
B.Automated Dispensing Systems
1.A practitioner may dispense legend medications, excluding controlled substances, in accordance with their scope of practice, through the use of an automated dispensing system. The practitioner shall perform drug utilization review prior to the medication being dispensed.
2.If a practitioner utilizes an automated dispensing system for dispensing medications to their patients, the following requirements shall apply:
a.Entering the patient’s medication order into the system shall be done by the practitioner;
b.Labeling of medication containers shall be in accordance with all applicable State and Federal statutes and Regulations;
c.Loading medication into the automated system shall be the responsibility of the practitioner.
C.Pharmaceutical Assistance Program (PAP) Medications
1.PAP medications may be dispensed from stock supplies provided that the following requirements are met:
a.Packaging and labeling of medication containers shall be in accordance with all applicable State and Federal statutes and Regulations;
b.Practitioner performs drug utilization review and dispensing process validation (“final check”) prior to the medication being dispensed.
2.Delivery of the PAP medication to the patient may be delegated by the practitioner.
D.Stock Medications
1.In a hospital, nursing facility, medical institution, clinic, assisted living residence, or hospice care facility where the facility or practitioner does not hold an institutional pharmacy license, administration of stock medications is permitted. The practitioner shall perform drug utilization review and medication validation (“final check”) prior to the medication being administered. Provided, however, the practitioner may delegate the medication validation (“final check”) to the registered nurse administering the medication.
2.In substance abuse facilities, that include detoxification services and residential treatment services, stock medications shall be administered in accordance with a protocol approved by the Board.
E.Oral Contraceptives
1.In entities receiving Title X funding for family planning services pursuant to 42 C.F.R. Part 59(A)(1001) of the Public Health Services Act (42 U.S.C. § 300), any practitioner may authorize a registered nurse to dispense oral and transdermal contraceptives to their patients for the purposes of birth control, pursuant to criteria established by the Board.
F.Emergency Dispensing of Pharmaceuticals
1.Notwithstanding any other provision of this Part to the contrary, any practitioner authorized to deliver healthcare services at a facility licensed pursuant to the Rules and Regulations for the Licensing of Organized Ambulatory Care Facilities, Part 10-3 of this Chapter, may dispense pharmaceuticals provided by the Director only during a period covered by a Federal or State emergency declaration. However, all such emergency dispensing shall only be performed in accordance with specific written protocols provided by the Director for these pharmaceuticals.
2.Notwithstanding any other provision of this Part to the contrary, any practitioner in a hospital emergency department who treats a patient for sexual assault, needle stick or other incident involving potential exposure to Human Immunodeficiency Virus (HIV) may provide the patient with up to the entire recommended course of medication for prophylaxis against potential HIV exposure. Any such dispensing of HIV prophylaxis medication shall be conducted in accordance with protocols established by the hospital’s institutional pharmacy, and shall include written instructions to be given to the patient regarding the use of the medication, which shall contain, as a minimum, the information required by §§ 1.10(G)(1)(a) through (f) of this Part.
G.Distribution of Remaining Doses of Prescriptions Drugs
1.A practitioner in a hospital emergency room, hospital clinic or ambulatory surgical center who administers to a patient a single dose of a medication from a multi-dose unit of use package may distribute any remaining doses of the prescription drug to the patient, provided the practitioner gives the patient sufficient instructions regarding the prescription drug, which instructions may include, but not be limited to:
a.The name and description of the drug;
b.Intended use of the drug and expected action;
c.Special directions and precautions for preparation, administration, and use by the patient;
d.Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
e.Proper storage; and
f.Action to be taken in the event of a missed dose.
2.For the purposes of § 1.10(G) of this Part, “sufficient instructions” shall include the receipt by the patient of appropriate written information such as a drug monograph.
3.A label shall be affixed to each dispensed medication that shall include:
a.The full name of the patient;
b.The name of the prescriber;
c.The name of the drug dispensed;
d.Quantity and strength of the drug dispensed;
e.Date of dispensing; and
f.Directions for use.
4.Medication dispensing and labeling shall be limited to prescribers only and may not be delegated to other personnel.
5.In a hospital setting, the pharmacist/pharmacy shall be responsible to determining which medicines can be dispensed from the Emergency Department and/or hospital clinic in this manner.
6.Under no circumstances shall any drug designated as a controlled substance pursuant to R.I. Gen. Laws Chapter 21-28, be dispensed to a patient by a practitioner in a hospital emergency room or ambulatory surgery center.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.11** Central Fill Operations {#sec-216-ricr-40-15-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.11}
A.A shared services pharmacy shall be licensed by the Board as either a resident or non-resident pharmacy.
B.Shared services pharmacies shall meet no less than the following requirements:
1.Share a common electronic file or appropriate technology to allow access to sufficient information necessary to fill, refill, or perform shared services in conformity with the Act and this Part;
2.Report to the Board, as soon as practical, the results of any disciplinary action taken against a shared services pharmacy by an alternate jurisdiction;
3.Maintain a mechanism for tracking the order during each step of the processing and filling functions performed at the pharmacy;
4.Maintain a mechanism for placing a unique identifier, identifying on the prescription label the names of the delivery and central fill pharmacies involved in filling the order;
5.Provide adequate security to protect the confidentiality and integrity of patient information, in accordance with all applicable Federal and State laws and Regulations;
6.Ensure that all controlled medications not claimed at the delivery pharmacy are returned to the central fill pharmacy within thirty (30) days;
7.Ensure that patient counseling is performed in accordance with all applicable Regulations;
8.Ensure that the pharmacist-in-charge at each shared services pharmacy shall be responsible for all storage and shipping procedures to ensure drug integrity and to prohibit drug tampering.
C.Any pharmacy participating in shared order processing or shared order filling shall adopt a policy/procedures manual that shall be maintained at each shared services pharmacy and shall describe methods by which the pharmacies shall achieve compliance with the Act and this Part while engaging in shared services.
D.Prior to filling patients’ prescriptions, the delivery pharmacy shall provide a one (1) time written notification to patients informing them that their prescription medications may be processed at an alternate site. Signage conspicuously displayed at the delivery pharmacy notifying patients that their prescription medications may be processed at an alternate site shall meet this requirement for patient notification.
E.A call center operation may perform the functions listed in §§ 1.11(B)(1) through (3), (5), (7) of this Part (as appropriate), and § 1.11(C) of this Part.
F.No person shall perform the duties of a pharmacist or Pharmacy Technician unless the person is licensed to do so by the Department under the provisions of the Act and this Part.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.12** Administration of Immunizations and Performance of Limited-Function Tests by Pharmacists {#sec-216-ricr-40-15-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.12}
1.12.1Administration of Immunizations
A.An immunizing pharmacist shall follow a written protocol from a prescriber or have obtained a valid prescription for immunization administration to a patient.
B.Qualifications
1.A pharmacist may administer immunizations to persons who are at least eighteen (18) years of age, as provided in § 1.12 of this Part.
2.A pharmacist may administer influenza vaccine to a person between the ages of nine (9) and eighteen (18) years old inclusive.
3.A pharmacist may administer any immunization, pursuant to §§ 1.12(B)(1) and (2) of this Part, available in accordance with manufacturers’ guidelines or established guidelines issued by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) or American Academy of Pediatrics (AAP) for administration to patients.
4.A pharmacist who is administering immunizations to a student eighteen (18) years of age or older shall do so in accordance with the Regulations for Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities (Part 30-05-3 of this Title).
5.A pharmacist may administer immunizations if the pharmacist has completed either:
a.Immunization training within an accredited College of Pharmacy program and possesses documentation of same; or
b.A twenty (20) hour course of training recognized by the Board and in accordance with the following:
(1)The course of study for the training program shall include current guidelines and recommendations of the Centers for Disease Control and Prevention and the American Pharmacists Association.
(2)The training course of study shall include, at a minimum, the following components:
(AA)Mechanisms of action of immunizations, contraindications, drug interactions, and monitoring after immunizations administration;
(BB)Immunization schedules;
(CC)Immunization screening questions, informed consent, recordkeeping, registries and State/Federal reporting mechanisms;
(DD)Vaccine storage and handling in accordance with the guidelines of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices Recommendations and Guidelines;
(EE)Biohazard waste disposal;
(FF)Sterile techniques;
(GG)Establishing protocols and standing orders;
(HH)Immunization coalitions and other community resources available;
(II)Identifying, managing, and responding to adverse events associated with immunization administration;
(JJ)Mechanism for reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS);
(KK)Reimbursement procedures and immunization coverage by Federal, State, and local entities;
(LL)Administration techniques.
6.The pharmacist shall possess evidence of current basic cardiopulmonary resuscitation (CPR) training issued by the American Heart Association, the American Red Cross, or other such similar training organization.
7.The pharmacist shall complete at least one (1) hour of continuing education in the area of immunizations each year.
8.A pharmacist shall not delegate the administration of immunizations to another person, except;
a.A licensed pharmacy intern who has completed a recognized immunization certificate training program and holds a current basic cardiopulmonary resuscitation (CPR) training certificate, shall carry out the same functions as an immunizing pharmacist pursuant to this Part and shall do so under the direct supervision and with the authorization of an immunizing pharmacist.
b.A Technician II who has completed a recognized certificate training course on appropriate immunization administration technique and holds a current basic cardiopulmonary resuscitation (CPR) training certificate, shall be permitted to administer vaccinations under the direct supervision and with the authorization of an immunizing pharmacist when;
(1)The immunizing pharmacist has completed all of the requirements pursuant to § 1.12 of this Part prior to administration of the vaccination.
(2)The immunizing pharmacist is on the premises for post-immunization monitoring of the patient.
C.Immunization Administration Policies and Procedures: All immunizing pharmacists shall adhere to written policies and procedures that include no less than the following:
1.A statement of the procedures, decision criteria, or plan the pharmacist will follow when exercising the administration authority, including when to refer the patient to the physician/prescriber
2.A statement of the procedures for emergency situations
3.A statement of record keeping and documentation procedures
4.A statement related to the handling and disposal of used or contaminated equipment and supplies
5.A statement requiring that the pharmacy give the appropriate Vaccine Information Statement (VIS) to the patient or legal representative with each dose of immunization covered by these forms
6.A statement that the pharmacy report adverse events to the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider, as identified by the patient
7.If a patient is immunized pursuant to a valid prescription, a notation of such prescription shall be made in the patient’s pharmacy profile.
D.Prescriber Protocols
1.Prior to administering immunizations to adults, pharmacists who have not obtained a valid prescription for immunization administration shall follow written protocols established between either a pharmacy or individually by a pharmacist and a protocol prescriber.
2.The protocol shall include, at a minimum:
a.A statement identifying the person authorized to prescribe drugs who has delegated the activity;
b.A statement identifying either the pharmacy or the individual pharmacist(s) authorized to administer immunizations and a copy of said pharmacist’s documentation of completion of the recognized immunization training program;
c.A statement identifying the routes and types of immunizations that a pharmacist is authorized to administer (e.g., injectable and nasally administered).
3.The protocol shall be reviewed no less than every two (2) years by the prescriber and an immunizing pharmacist.
4.An immunizing pharmacist shall provide written notification of a patient’s immunization to the primary care provider, if known, within seven (7) days.
E.Record-Keeping and Reporting
1.The pharmacist who administers any immunization shall maintain the following information in the pharmacy records regarding each immunization administration:
a.Patient’s name, address, and date of birth;
b.Date of the administration and site of injection of the immunization;
c.Name, dose, manufacturer, lot number, and expiration date of the immunization;
d.Name and address of the patient’s primary healthcare provider, as identified by the patient, if known;
e.Name or identifiable initials of the immunizing pharmacist, intern or Technician II if applicable;
f.Publication date of the Vaccine Information Statement (VIS);
g.Date that the VIS was provided to the patient.
2.The immunization records shall be maintained for no less than two (2) years in accordance with all applicable State and Federal statutes and Regulations pertaining to confidentiality.
3.Pharmacists authorized to administer influenza immunizations to individuals between the ages of nine (9) and eighteen (18) years, inclusive, shall be required to electronically report to the Department all immunizations administered within seven (7) days of administration in the format and for the populations required by the Department.
1.12.2Limited-Function Tests
A.Performing a Limited-Function Test. A pharmacist may perform a limited-function test, as defined in this Part, only in accordance with instructions provided in the kit manufacturer’s package insert, and in accordance with guidance published by the Centers for Disease Control and Prevention, Division of Laboratory Programs, Standards, and Services.
B.Reporting Limited-Function Test Results
1.A report of a limited-function test shall contain, at a minimum, the following information:
a.Patient name;
b.Patient date of birth, sex and age;
c.Test performed;
d.Test results;
e.Interpretation, according to instructions in the product insert;
f.Reference range of lab results;
g.Comments or qualifying statement, if applicable;
h.Date completed or reported; and
i.Name of pharmacist performing the test.
2.Upon receiving consent from the patient, a pharmacist performing a limited-function test shall report test results to the patient’s primary care practitioner, if known, within a reasonable timeframe.
3.In the event that a patient with an abnormal test result does not have an existing relationship with a primary care practitioner, the pharmacist shall make efforts to refer the patient to a primary care practitioner practice, health center, or clinic.
4.The pharmacist shall inform the patient that the limited-function test results are intended for informational & educational purposes, rather than diagnostic purposes.
5.The requirements of this Section shall not apply to tests performed through a collaborative practice agreement, as defined in this Part.
C.Required Documents and Records. Each pharmacy where a pharmacist performs one or more limited-function tests shall maintain, at a minimum, the following:
1.Name of test;
2.Test procedures or site-specific work instructions;
3.Records of testing materials used, test system and equipment function checks, and maintenance;
4.Test results, including the results of any confirmatory or supplemental testing required by the kit manufacturer’s package insert;
5.Records of any test system failures, troubleshooting, and corrective action taken when problems are identified, including related communication with testing personnel;
6.Unless a different interval is specified by applicable statute or Regulation, records and documents required by this Part shall be maintained for three (3) years from the date of completion.
1.11.3Administration of Medications
A.In accordance with R.I. Gen. Laws § 5-19.1-1, a pharmacist can administer medications in the drug classes listed in § 1.11.3(B) of this Part, to any age group, pursuant to a valid prescription or physician-approved protocol, including, but not limited to, a standing order, and under the following conditions:
1.The route(s) are FDA approved; and
2.The medication is administered privately.
a.The pharmacist must administer the medication in an area that provides for patient privacy, particularly for medications administered to sites that require removal of clothing (e.g., intramuscular injections into the gluteal muscles).
B.A pharmacist is authorized to administer medications in the following drug classes:
1.Anti-infectives
2.Anti-HIV
3.Purified Protein Derivative
4.Vaccines
5.Antipsychotics
6.Epinephrine
7.Buprenorphine
8.Vitamins
9.Hormones and Hormone Analogs
10.Fertility Agents
11.Contraceptives
12.Androgens
13.Biologics
14.Monoclonal Antibodies
15.Interferons
16.Calcium Regulating Agents
17.Immunologic Agents
18.Hematopoietic Agents
19.Dermatologic Agents
20.Colony Stimulating Factors
21.Antirheumatic Agents
22.Anticoagulants
23.Steroids
24.Opioid Antagonists
25.Topicals
C.Pharmacists shall not administer drugs in the following routes:
1.Intravenous Injections
2.Intravenous Infusions
a.Exception. If allowed at a code and per hospital policy, a pharmacist may administer intravenous infusions.
3.Intrathecal
4.Rectal
5.Intraocular
E.Pharmacists shall not administer the following drugs or drug classes:
1.Chemotherapy agents; and
2.Controlled Substances, except for those used for addiction treatment and hormones and hormone analogs.
F.A pharmacist who refuses to administer a medication based on professional judgment shall notify the prescriber of this decision within the earliest practicable time.
G.A pharmacist shall not administer medications to animals.
H.The pharmacist must document all medications administered in either the patient’s paper or electronic prescription profile.
I.Training and Qualifications
1.Medication administration training within an accredited college of Pharmacy program or other organizations including but not limited to APhA, AMA, ASCP, ASHP or other accredited professional training organizations; or
2.Certification as an immunizing pharmacist.
J.The pharmacist must develop policies and procedures for medication administration services. Such policies must include no less than the following:
1.A statement of the procedures, decision criteria or plan that will be followed when exercising the administration authority, including when to refer the patient to the physician/prescriber;
2.A statement of the procedures for emergency situations;
3.A statement of record keeping and documentation procedures;
4.A statement related to the handling and disposal of used or contaminated equipment and supplies; and
5.A statement that the pharmacy report adverse events to the FDA and to the primary care provider, as identified by the patient
H.Record-Keeping and Reporting
1.The pharmacist who administers any medication shall keep a record either as a hard copy or electronic record (e.g., prescription profile of electronic health record) to maintain, at minimum, the following information regarding each medication administration:
a.Patient’s name, address, and date of birth;
b.Medication name and dosage;
c.Date of the administration and route of administration;
d.Name and address of the patient’s primary healthcare provider, as identified by the patient, if known; and
e.Name or identifiable initials of the administering pharmacist.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.13** Pharmacy Technicians {#sec-216-ricr-40-15-1-1.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.13}
1.13.1Pharmacy Technicians
A.General Requirements
1.In accordance with R.I. Gen. Laws § 5-19.1-16, a Pharmacy Technician license will be issued to any individual who meets the requirements established under the Act and this Part.
2.No person shall perform the duties set forth in §§ 1.13.1(F)(1)(a) and (2) of this Part unless such person is licensed as a Pharmacy Technician.
3.There shall be two (2) levels of licensure for a Pharmacy Technician: Pharmacy Technician I and Pharmacy Technician II.
4.The Pharmacy Technician shall file with the Department an application for licensure (see below) and shall be required to furnish such information as the Board may prescribe and, simultaneously with the filing of said application, shall pay to the Department the required non-refundable fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
5.A Pharmacy Technician license shall be issued by the Department to an applicant found to have satisfactorily met all the requirements herein. Said license shall be renewed every two (2) years and will expire on the thirty-first (31st) day of December unless sooner suspended or discontinued.
6.No individual may serve as a Pharmacy Technician without holding a valid Pharmacy Technician license from the Board.
7.A Pharmacy Technician shall wear a name tag that indicates the technician's name and the appropriate licensure designation.
8.A pharmacy can permit Pharmacy Technicians to work remotely, as operationally feasible and in accordance with applicable State and Federal law, to conduct order entry and other functions that are normally performed in a pharmacy. Pharmacy Technicians shall only be permitted to work remotely as long as licensing reciprocity exists, and the Pharmacy Technician resides in the United States or United States’ Territory.
B.Licensure by Endorsement
1.A Pharmacy Technician currently licensed or registered and in good standing in another State or jurisdiction may be licensed by the Board. Provided, however, the requirements for licensure or registration in the State of original and current licensure shall be equivalent to the requirements established by the Board.
C.Exemption for High-School Career Exploration Programs
1.High school students working in pharmacies as part of school or community sponsored career exploration programs shall be exempt from the requirements of § 1.13.1 of this Part and shall not be required to be licensed as Pharmacy Technicians.
D.Licensure of Pharmacy Technicians
1.There shall be two (2) levels of licensure for Pharmacy Technicians. An applicant for licensure as a Pharmacy Technician shall be licensed as one (1) of the following:
a.Pharmacy Technician I: A person licensed by the Board as a Pharmacy Technician I and who performs any pharmacy function or duties under the supervision of a pharmacist as defined in § 1.13.1(E)(1) of this Part.
b.Pharmacy Technician II: A person licensed by the Board as a Pharmacy Technician II and who performs any pharmacy functions and duties under the supervision of a pharmacist as defined in § 1.13.1(E)(2) of this Part.
E.Qualifications
1.Pharmacy Technician I. An applicant for licensure as a Pharmacy Technician I must:
a.Has satisfied the Board that they exhibit professional integrity and ethical standards.
b.Be eighteen (18) years of age or older with the exception of those high school students working in pharmacies as part of school or community sponsored career exploration programs;
c.Be a high-school graduate or the equivalent, or currently enrolled in a high school or vocational training program that awards such degree or certificate;
d.Not have been convicted of any felony for violations involving controlled substances subject to waiver by the Board upon presentation of satisfactory evidence that such conviction does not impair the ability of the person to conduct with safety to the public the duties of a Pharmacy Technician I;
e.Be currently enrolled in or successfully completed a Board-approved Pharmacy Technician I training program defined in § 1.13.1(G) of this Part.
f.Obtain an eProfile number from the national association of boards of pharmacy.
2.Pharmacy Technicians II. An applicant for licensure as a Pharmacy Technician II must:
a.Has satisfied the Board that they exhibit professional integrity and ethical standards;
b.Be eighteen (18) years of age or older;
c.Be a high-school graduate or the equivalent;
d.Not have been convicted of any felony for violations involving controlled substances subject to waiver by the Board upon presentation of satisfactory evidence that such conviction does not impair the ability of the person to conduct with safety to the public the duties of a Pharmacy Technician;
e.Have successfully passed a nationally-recognized certification examination acceptable to the Board, including, but not limited to, the Pharmacy Technician Certification Examination (PTCE) or the National Healthcare Association’s “ExCPT” examination.
f.Obtain an eProfile number from the national association of boards of pharmacy.
F.Duties and Responsibilities
1.Pharmacy Technician I
a.A Pharmacy Technician I may perform only those tasks for which they have been trained and in which there is proficiency as determined by the pharmacist-in-charge, but in no case, shall ever exceed what is permitted by Regulation, law or scope of practice, and as set forth below:
(1)A Pharmacy Technician I may request refill authorizations for patients from a prescriber who uses a voice mail response system and/or when an agent of the prescriber transcribes the requested information for a follow-up phone call to the pharmacy after reviewing the request with the prescriber. The Pharmacy Technician I may accept authorization for refills from the prescriber or prescriber's agent provided that no information has changed from the previous prescription.
(2)A Pharmacy Technician I may not perform drug utilization review; clinical conflict resolution, prescriber contact concerning prescription drug order clarification or therapy modification; patient counseling or dispensing process validation; or receive new prescription drug orders or conduct prescription transfers.
2.Pharmacy Technician II
a.A Pharmacy Technician II may perform only those tasks for which they have been trained and in which there is proficiency as determined by the pharmacist-in-charge, but in no case, shall ever exceed what is permitted by Regulation, law, or scope of practice. In addition to performing the duties and responsibilities stipulated above for Pharmacy Technician I, a Pharmacy Technician II may perform the following duties:
(1)A Pharmacy Technician II may request refill authorizations from the prescriber or prescriber's agent and, with the approval of the pharmacist on duty, transfer and receive new prescription information and changes to prescriptions from the prescriber or agent, except where otherwise prohibited by Federal or State laws and Regulations, provide immunizations, perform sterile and non-sterile compounding, and clarify prescription or medication orders.
b.When a licensed pharmacist is not physically accessible at the address listed on the license, there shall be a sign posted that a licensed pharmacist is not available and that the pharmacy is not opened to the public. Such sign shall be legible and easily viewed by patients or customers. In this circumstance, only Pharmacy Technician II(s) may be present in the pharmacy and the pharmacy shall be closed to the public.
c.With the approval of the pharmacist-in-charge, a Pharmacy Technician II may be present in the pharmacy without a pharmacist present in order to prepare medications and to perform other duties and activities as authorized by statute, Regulation, and the Pharmacy Technician II's scope of practice. Provided, however, a Pharmacy Technician II may not perform drug utilization review; clinical conflict resolution; therapy modification; patient counseling; or dispensing process validation.
G.Board-approved Training Programs for Pharmacy Technician I(s)
1.Training programs for Pharmacy Technicians I(s) that are approved by the Board include:
a.An employer-based Pharmacy Technician training program that includes theoretical and practical instruction as described herein;
(1)Said employer-based Pharmacy Technician training program shall:
(AA)Include written guidelines, policies, and procedures that define the specific tasks the technician shall be expected to perform that include but are not limited to the following:
(i)Orientation;
(ii)Job descriptions;
(iii)Communication techniques;
(iv)Laws and Rules;
(v)Security and safety;
(vi)Prescription drugs;
(vii)Basic pharmaceutical nomenclature;
(viii)Dosage forms;
(ix)Drug orders;
(x)Prescribers;
(xi)Directions for use;
(xii)Commonly used abbreviations and symbols;
(xiii)Number of dosage units;
(xiv)Strengths and systems of measurement;
(xv)Routes of administration;
(xvi)Frequency of administration;
(xvii)Interpreting directions for use;
(xviii)Drug order preparation;
(xix)Creating or updating patient medication records;
(xx)Entering drug order information into the computer or typing the label in a manual system;
(xxi)Selecting the correct stock bottle;
(xxii)Accurately counting or pouring the appropriate quantity of drug product;
(xxiii)Selecting the proper container;
(xxiv)Affixing the prescription label;
(xxv)Affixing auxiliary labels, if indicated; and
(xxvi)Preparing the finished product for inspection and final check by pharmacists.
(BB)Stipulate how the technician's competency is to be assessed.
(2)A copy of the training program shall be kept in the pharmacy at all times.
(3)The pharmacist-in-charge shall certify that the Pharmacy Technician has successfully completed the training program. Documentation of the training shall be maintained at the pharmacy by the pharmacist-in-charge.
b.Any other training program as approved by the Board.
2.In specialty pharmacies (e.g., compounding pharmacies), the pharmacist-in-charge shall ensure that Pharmacy Technicians receive any training necessary to perform specialty functions and duties. Such training shall be documented by the pharmacist-in-charge.
H.Application
1.Application for licensure as a Pharmacy Technician I or II shall be made on the form provided by the Department that may be obtained at:
The Rhode Island Department of Health
Three Capitol Hill, Room 103
Providence, RI 02908
2.Said form shall be completed and signed by the applicant and accompanied by the non-refundable, non-returnable fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
a.On the above application, the pharmacist-in-charge shall also attest to the following:
(1)That the applicant will receive documented on-the-job training with the duties of employment; and
(2)That the applicant will only be assigned duties for which competency has been demonstrated.
3.Each Pharmacy Technician I applicant shall specify the name of the employer on the application and shall notify the Department when there is a change in employer.
I.Issuance of License
1.A Pharmacy Technician license shall be issued by the Department to an applicant found to have satisfactorily met all the requirements herein. Said license must be renewed every two (2) years and will expire on the thirty-first day (31st) of December unless sooner suspended or discontinued.
2.Every person licensed as a Pharmacy Technician in this State must obtain an eProfile number from the National Association of Boards of Pharmacy in order to renew their license.
3.A Pharmacy Technician II, licensed by national certification, shall maintain their certification in order to renew said license.
J.Continuing Education Requirement
1.A Pharmacy Technician II who seeks annual licensure renewal shall be required to:
a.Satisfactorily complete at least ten (10) hours (one (1) continuing education unit) of continuing education courses, sponsored by a recognized provider between January 1st and December 31st of each year.
b.Maintain documentation of all required continuing education for a period of at least two (2) years from the date the training was completed.
2.A Pharmacy Technician I and II license shall be transferable to different practice locations within the State of Rhode Island.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.14** Collaborative Pharmacy Practice {#sec-216-ricr-40-15-1-1.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.14}
A.All collaborative practice agreements (CPAs) must be approved by the Director in accordance with R.I. Gen. Laws § 5-19.2-3(a).
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.15** Wholesalers Distributors, Redistributors, and Manufacturers {#sec-216-ricr-40-15-1-1.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.15}
1.15.1Licensure Requirements
A.General Licensure Requirements
1.Pursuant to the provisions of R.I. Gen. Laws §§ 5-19.1-12, 5-19.1-13, and 23-25.6-1, et seq.:
a.If Rhode Island is the State in which a prescription drug is distributed or is the State from which or into which a prescription drug is distributed by a wholesale distributor or redistributor, that wholesale distributor or redistributor may not distribute in or into or out of Rhode Island unless each facility of such wholesale distributor or redistributor is licensed in Rhode Island.
b.If Rhode Island is the State into which a prescription drug is shipped by a wholesale distributor or redistributor, that wholesale distributor or redistributor shall also be licensed as a wholesale distributor or redistributor by the State from which that wholesale distributor or redistributor ships.
c.If Rhode Island is the State in which a prescription drug is manufactured or is the State from which or into which a prescription drug of a manufacturer is shipped, this prescription drug may not be manufactured in and/or shipped into or out of Rhode Island unless each facility of such manufacturer is licensed in Rhode Island.
2.Federal Licensure
a.A manufacturer shall also be licensed as a manufacturer by the Secretary of the U.S. Department of Health and Human Services, Food and Drug Administration;
3.The Board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be consistent with the public health and safety.
4.A wholesale distributor, redistributor, or manufacturer license is only valid for the name, ownership and location listed on the license. Changes of name, ownership or location shall require a new license.
5.When wholesale distribution, redistribution, or manufacturing facility operations are conducted at more than one (1) location, each location shall be licensed by the Board.
6.A wholesale distributor, redistributor, or manufacturer shall not operate from a place of residence.
7.A wholesale distributing, redistributing, or manufacturing facility shall be located apart and separate from any retail pharmacy licensed by the Board.
8.Changes in any information required for a wholesale distributor, redistributor, or manufacturer must be reported to the Board, in writing, within ten (10) days (e.g. facility manager, designated representative, telephone number, etc.).
9.Each wholesale distributor, redistributor, or manufacturer facility must publicly display all licenses and have readily available the most recent State and/or Federal inspection reports.
10.Each wholesale distributor or manufacturer shall ship only to the address listed on the purchaser’s license
11.Compliance with Federal, State and Local Laws. Each wholesale distributor, redistributor, or manufacturer shall operate in compliance with applicable Federal, State and local laws and Regulations.
a.Each wholesale distributor, redistributor, or manufacturer shall permit the Department, Board and authorized Federal, State and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, at reasonable times, and in a reasonable manner, to the extent authorized by law.
b.Each wholesale distributor or manufacturer that deals in controlled substances shall register with the Department, and with the Drug Enforcement Administration (DEA), and shall comply with all applicable State, local and DEA Regulations.
B.Wholesale Distributor Licensure
1.The Department and Board requires the following from each wholesale distributor or redistributor as part of the initial licensing procedure, and as part of any renewal of such license:
a.The applicant’s full name, full business address, and telephone number;
b.All trade or business names used by the applicant;
c.The type of ownership (e.g., individual, partnership, limited liability company or corporation);
d.Name(s) of the owner(s) of the applicant including:
(1)If a person; the name, address, Social Security Number and date of birth;
(2)If other than a person; the name, address, and Social Security Number and date of birth of each partner, limited liability company member, or corporate officer and corporate director, and the Federal Employer Identification Number [FEIN];
(3)If a corporation, the State of incorporation; and
(4)If a publicly traded corporation, the information in § 1.15.1(B)(1)(d) of this Part is not required for corporate officers and corporate directors.
e.Names of designated representatives and facility managers of the applicant, their Social Security Numbers and date of birth;
f.Proof of licensure by the U.S. Secretary of Health and Human Services, Food and Drug Administration and, if applicable, by the State where the applicant is located (home State);
g.Upon the Board’s written request, a list of all manufacturers, wholesale distributors, and dispensers for whom the manufacturer provides services at such facility;
h.Any other information the Board deems necessary to protect the public health and safety; and
i.The initial or renewal licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Criteria for Renewal of Licensure for Wholesale Distributors or Redistributors
1.The Board shall consider, at a minimum, the following factors in determining the eligibility for, and renewal of, licensure of wholesale distributors:
a.Engaging in any unprofessional conduct as defined in § 1.19 of this Part;
b.Any finding by a law enforcement agency or regulatory agency that the applicant or any of its owners have violated any Federal, State, or local laws or foreign laws;
c.Suspension, revocation or any other sanction against a license currently or previously held by the applicant or any of its owners for violations of State or Federal laws;
d.Any finding that the applicant or any of its owners are guilty of or pleaded guilty or nolo contendere to violating Federal, State, or local criminal laws;
e.The furnishing by the applicant of false or fraudulent material in any application;
f.Failure to maintain and/or make available to the Board or to Federal, State, or local law enforcement officials those records required to be maintained by wholesale distributers;
g.Any licensee who has no record of wholesaler distributions, or of redistributions in programs established under R.I. Gen. Laws § 23-25.6-1, during routine inspection may have its subsequent renewal application referred to the Board for review and possible approval or disapproval, and such review may require the licensee to appear before the Board; and
h.Any other factors or qualifications that the Board considers relevant to and consistent with the public health and safety.
D.Manufacturer Licensure
1.The Board requires the following from each manufacturer as part of the initial licensing procedure, and as part of any renewal of such license:
a.The applicant’s full name, full business address, and telephone number;
b.All trade or business names used by the applicant;
c.The type of ownership (e.g., individual, partnership, limited liability company or corporation);
d.Name(s) of the owner(s) of the applicant including:
(1)If a person; the name, address, Social Security Number and date of birth;
(2)If other than a person; the name, address, and Social Security Number and date of birth of each partner, limited liability company member, or corporate officer and corporate director, and the Federal Employer Identification Number [FEIN];
(3)If a corporation, the State of incorporation; and
(4)If a publicly traded corporation, the information in § 1.15.1(D)(1)(d) is not required for corporate officers and corporate directors.
e.Names of designated representatives and facility managers of the applicant, their Social Security Numbers and date of birth;
f.Proof of licensure by the U.S. Secretary of Health and Human Services, Food and Drug Administration and, if applicable, by the State where the applicant is located (home State);
g.Upon the Board’s written request, a list of all manufacturers, wholesale distributors and dispensers for whom the manufacturer provides services at such facility;
h.Any other information the Board deems necessary to protect the public health and safety; and
i.The initial or renewal licensure fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
E.Criteria for Renewal of Licensure for Manufacturers
1.The Board shall consider, at a minimum, the following factors in determining the eligibility for, and renewal of, licensure of manufacturers:
a.Engaging in any unprofessional conduct as defined in § 1.19 of this Part;
b.Any finding by a law enforcement agency or regulatory agency that the applicant or any of its owners have violated any Federal, State, or local laws or foreign laws;
c.Suspension, revocation or any other sanction against a license currently or previously held by the applicant or any of its owners for violations of State or Federal laws;
d.Any finding that the applicant or any of its owners are guilty of or pleaded guilty or nolo contendere to violating Federal, State, or local criminal laws;
e.The furnishing by the applicant of false or fraudulent material in any application;
f.Failure to maintain and/or make available to the Board or to Federal, State, or local law enforcement officials those records required to be maintained by manufacturers;
g.Any licensee who has no record of manufacturing during routine inspection may have its subsequent renewal application referred to the Board for review and possible approval or disapproval, and such review may require the licensee to appear before the Board; and
h.Any other factors or qualifications that the Board considers relevant to and consistent with the public health and safety.
1.15.2Operational Procedures
A.Diversion Detection and Prevention Plan. Each wholesale distributor or manufacturer shall have and follow a diversion detection and prevention plan that includes all prescription drugs.
B.Written Policies and Procedures. Each wholesale drug distributor or manufacturer shall establish, maintain and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Each wholesale distributor or manufacturer shall include, as a minimum, the following items in their written policies and procedures:
1.A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.
2.A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:
a.Any action initiated at the request of the Food and Drug Administration or other Federal, State or local law enforcement or other government agency, including the Board;
b.Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market, or
c.Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.
3.A procedure to ensure that each wholesale distributor or manufacturer prepares for, protects against, and handles any crisis that affects security for operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, State, or national emergency.
4.A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two (2) years after disposition of the outdated drugs.
C.Personnel. A wholesale distributor or manufacturer shall:
1.Establish and maintain for Board inspection a list of each partner, limited liability company member or corporate officer and corporate director, as well as designated representatives and facility managers, including a description of their duties and a summary of their qualifications;
2.Designate, in writing, a person to serve as the designated facility manager of the wholesale distributor or manufacturer (as appropriate) for each location licensed;
3.Not have as an owner, designated representative, facility manager, or supervising pharmacist anyone:
a.Convicted of any felony for conduct relating to compounding prescription drugs, any felony for violation of 21 U.S.C. §§ 331(i) or (k) or any felony for violation of 18 U.S.C. § 1365 relating to product tampering; or
b.Who has violated Federal or State requirements for licensure that presents a threat of serious adverse health consequences or death to humans.
4.Employ adequate personnel with the education and experience necessary to safely and lawfully engage in acting as a wholesale distributor or manufacturer as applicable.
D.Facilities. Each wholesale distributor or manufacturer at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:
1.Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
2.Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
3.Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;
4.Be maintained in a clean and orderly condition; and
5.Be free from infestation by insects, rodents, birds, or vermin of any kind.
E.Security
1.Each wholesale distributor or manufacturer shall be secure from unauthorized entry:
a.Access from outside the premises shall be kept to a minimum and be well-controlled;
b.The outside perimeter of the premises shall be well-lighted;
c.Entry into areas where prescription drugs are held shall be limited to authorized personnel.
2.Each wholesale distributor or manufacturer shall be equipped with an alarm system to detect entry after hours.
3.Each wholesale distributor or manufacturer shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
F.Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs or with the requirements in the current edition of an official compendium, such as the United States Pharmacopeia, and National Formulary, or their successor agency.
1.If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected;
2.Appropriate manual, electro-mechanical, or electronic temperature and humidity recording equipment, devices and/or logs shall be utilized to document proper storage or prescription drugs;
3.The record keeping requirements in § 1.15.2(I) of this Part shall be followed for all stored drugs; and
4.Storage shall not include temporary or incidental possession for the purpose of delivery and/or shipment of prescription drugs.
G.Examination of Materials
1.Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs, or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
2.The contents of each outgoing shipment shall be carefully inspected for identity of the prescription drug products, and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.
3.The record keeping requirements in § 1.15.2(I) of this Part shall be followed for all incoming and outgoing prescription drugs.
H.Salvaging, Reprocessing, Returned, Damaged and Outdated Prescription Drugs
1.Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.
2.Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used, shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.
3.If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return, and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.
4.The record keeping requirements in § 1.15.2(I) of this Part shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.
5.Salvaging and Reprocessing. Each wholesale distributor or manufacturer shall be subject to the provisions of any applicable Federal, State, or local laws or Regulations that relate to prescription drug product salvaging or reprocessing, including 21 C.F.R. Parts 207, 210(d), and 211.
I.Record keeping
1.Each wholesale distributor or manufacturer shall establish and maintain inventories and records of all transactions regarding the receipt and distribution of prescription drugs. These records shall include the following information:
a.The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;
b.The identity and quantity of the drugs received and distributed or disposed of, and
c.The dates of receipt and distribution or other disposition of the drugs.
2.Inventories and records shall be made available for inspection and photocopying by any authorized official of any governmental agency charged with enforcement of this Part for a period of two (2) years following disposition of the drugs.
3.Records described in § 1.15.2(I) of this Part that are kept at the inspection site, or that can be immediately retrieved by computer or other electronic means, shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of any governmental agency charged with enforcement of this Part.
1.15.3Drug Redistribution Program
A.Drug Donation Conditions
1.All participation in the donation program shall be voluntary pursuant to R.I. Gen. Laws § 23-25.6-4(a).
2.All prescription drugs, excluding controlled substances, that have been approved for medical use in the United States, that are listed in the United States Pharmacopoeia (USP) or National Formulary (USP/NF) and that meet the criteria for donation established in this Part may be accepted for donation under the pharmaceutical redistribution program.
3.Any person who is eighteen (18) years of age or older may donate legally obtained prescription drugs to a redistributor if the drugs meet the requirements of this Part, as determined by a pharmacist who is employed by or under contract with a drug redistributor.
4.For the donation of a prescription drug to occur, the conditions stated in R.I. Gen. Laws § 23-25.6-4(b) must be met. In addition to the conditions stated in R.I. Gen. Laws § 23-25.6-4(b), the following conditions must also be met:
a.The donor’s name, address, and phone contact must be provided to the redistribution program and verified as accurate by the redistribution program prior to accepting donated drug(s).
b.If the donor is a facility such as a pharmacy, institution, manufacturer, wholesale distributor or any other authorized donor it must provide their resident state and applicable Rhode Island and federal registrations to the redistribution program in order for donated drug(s) to be accepted.
c.The donor must sign and date a form provided by the redistribution program which attests that the donated drug(s) have been stored in temperature-controlled environments, as applicable.
d.Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or the USP must not be donated or accepted as part of the drug redistribution program;
e.The donated drug(s) has been stored according to manufacturer or USP storage requirements;
f.The packaging contains the lot number and expiration date of the donated drug(s);
g.The drug does not have any signs of tampering, misbranding, deterioration, compromised integrity, or adulteration.
5.All drugs must be inventoried at the redistribution facility. The inventory must include the name, strength, and quantity of the drug, and the date of donation if the drug has been continually under the control of a healthcare professional. If the drug has not been continually under the control of a healthcare professional, the redistributor must collect a donation form that is signed by the person making the donation.
6.Drugs must be donated on the premises of the redistributor. A drop box must not be used to deliver or accept donated drugs.
7.A drug that is the subject of a U.S. Food and Drug Administration (FDA) managed risk evaluation and mitigation strategy pursuant to 21 U.S.C. § 355-1 must not be donated if the inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the drug manufacturer.
8.The following drugs:
May be Donated
May NOT be Donated
Cancer drugs
Controlled substances
Creams
Drugs that are only approved for use in other countries or are from foreign non-FDA approved sources
Drugs donated by a manufacturer
Drugs that the pharmacist deems may not be donated
Drugs from out-of-state
Empty bottles
Eye drops
Insulin syringes
Drugs that have a clear expiration date
Medical supplies and devices
Drugs that have lot numbers displayed
Non-FDA-approved drugs
Drugs within three (3) months of expiration
Open vials, bottles, or packages
Inhalers (in packaging)
Over-the-counter drugs (“OTCs”)
FDA-approved drugs from FDA-approved sources
Temperature sensitive drugs (cannot be stored at normal room temperature)
Non-controlled substance prescription drugs
Veterinary drugs
Patches
Compounded drugs
Samples
Sealed liquids
Sealed mail order pharmacy bottles
Sealed manufacturer bottles
Drugs stored in accordance with USP guidelines
Surplus products
Tamper-proof products (e.g., blister packs)
Unopened stock bottles
B.Handling of Drugs to be Redistributed
1.A pharmacist must adhere to standard pharmacy practices, as required by State and Federal law, when dispensing all drugs.
2.A licensed pharmacist employed by or under contract with the redistributor must inspect donated prescription drugs to determine, to the extent reasonably possible in the judgment of the pharmacist, that the drugs are not adulterated or misbranded, are safe and suitable for dispensing, and are not ineligible drugs. The pharmacist who inspects the drugs must sign an inspection record stating this inspection has been completed and attach it to the copy of the inventory or donor record provided with the drugs.
3.The redistributor must be responsible for drug recalls and must have an established mechanism to notify recipients in the event of a drug recall.
4.Donated drugs may be dispensed only if the drugs are prescribed by a healthcare prescriber for use by an eligible person and are dispensed by a pharmacist or other person permitted to dispense.
5.Donated drugs shall not be stored with non-donated inventory.
6.The drug redistribution facility must have a quarantine area for drugs that are expired, adulterated, recalled, misbranded, or deteriorated such that these drugs are separated from drugs to be dispensed or redistributed.
7.If any one of the conditions contained in § 1.15.3(A) of this Part is not satisfied, the donated drugs shall not be distributed pursuant to R.I. Gen. Laws § 23-25.6-4(c).
8.The redistributor must remove the original donor’s identification and the name of the dispensing pharmacy from the package prior to dispensing the drugs.
9.The drugs must be labeled properly with a serial number or other effective label in accordance with § 1.6.17(A) of this Part.
10.Drug diversion and theft prevention measures plan must be in place at the drug redistribution location.
11.Security measures, including but not limited to, an alarm system monitored 24/7, security cameras, and motion detectors must be in place at the redistribution location. Entry to areas where drugs are stored must be limited to authorized personnel only.
12.Drugs donated under the drug redistribution program must not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or waste hauler.
13.Drugs donated to a Receiver cannot be re-donated.
14.When donated drugs are destroyed, records of their destruction must be retained by the drug redistribution program and readily retrievable upon request of any state board of pharmacy or federal regulatory agency.
a.Documentation must include, and not be limited to, a record of the drug(s) destroyed, drug dosage, drug quantity, the name of the person or reverse distributor destroying the drug(s), and the names of donors of the drug(s) destroyed.
15.Drug redistributors must maintain compliance with all applicable requirements of the DQSA (Drug Quality & Security Act) and DSCSA (Drug Supply Chain Security Act) 21 U.S.C. § 301.
C.Redistributor Requirements
1.Conditions of redistribution of donated medications are pursuant to R.I. Gen. Laws § 23-25.6-5.
2.Redistributors must be licensed by the Department as distributors in accordance with the provisions of R.I. Gen. Laws Chapter 21-28, as amended and this Part.
3.A separate distributor license is required for each redistribution location.
4.A name change of a licensed drug redistributor shall require a new license.
5.A pharmacist licensed in Rhode Island must be responsible for ensuring donated drugs meet the criteria for redistribution. If in the licensed pharmacist’s professional judgment, the safety, identity, strength, quality, or purity of the donated drug makes it unsuitable for redistribution, the drug must not be redistributed and may be destroyed.
6.A pharmacist licensed in Rhode Island must be responsible for developing a formulary of drugs appropriate for the redistribution program.
7.The Board shall have the right to deny an application for a drug redistribution program license if it determines that approving the application would not be consistent with public health and safety. Appeals may be made in accordance with § 1.19.5 of this Part.
8.Pursuant to R.I. Gen. Laws § 23-25.6-3(b), the donation and redistribution of drugs is not categorized as wholesale distribution and does not warrant licensing as a drug wholesale distributor.
9.A drug redistributor must employ a sufficient number of personnel who are educated and experienced to safely and lawfully engage in the operation of a drug redistribution facility.
10.A pharmacy that solely operates a drug redistribution program may repackage a reasonable quantity of donated drugs in anticipation of dispensing the drugs to its patient population. The pharmacy must have repackaging policies and protocols in place for identifying and recalling drugs.
11.A pharmaceutical redistribution program must not be operated from a person’s residence.
12.The cost to any person for a redistributed drug must not exceed the current established Rhode Island Medicaid dispensing fee that is paid to retail pharmacies for a non-redistributed prescription drug dispensed to a Medicaid recipient; this fee is a separate fee and does not include the usual and customary cost, acquisition cost or any similar industry standard drug acquisition costs that Rhode Island Medicaid would reimburse to a licensed retail pharmacy for a covered prescription.
13.A designated facility manager responsible for the operation of the redistribution program must be employed by the redistributor.
14.Written policies and procedures that address no less than the following items must be documented and implemented:
a.Receipt of drugs;
b.Security;
c.Storage;
d.Inventory management;
e.Redistribution of drugs;
f.Reporting of drug loss or theft;
g.Handling drugs that have been recalled;
h.Pharmacist methodology for accepting drugs that will be redistributed;
i.Handling drug recalls;
j.Emergency/disaster plan for facility; and,
k.Segregation of outdated drugs from working inventory.
15.A drug redistributor must dispense donated prescription drugs in compliance with all applicable federal and state laws and regulations for dispensing prescription drugs, including all requirements related to packaging, labeling, record-keeping, drug utilization review, and patient counseling.
16.A drug redistributor licensed in Rhode Island must prioritize the dispensing of redistributed drugs to citizens of Rhode Island (“Rhode Islanders”) in most need and other eligible Rhode Islanders under the following conditions:
a.Rhode Island patients must receive no less than ninety-five percent (95%) of the redistributed drugs, by value. Licensed drug redistributors must retain readily producible documents demonstrating this prioritization.
b.Prior to redistributing drugs to any institution, the drug redistributor must prioritize individual Rhode Islanders who are most in need, do not have health insurance, are underinsured, would face enormous financial hardship to pay the full price or co-pay for a non-redistributed prescription drug, or are reliant on public health programs and must retain readily producible documents demonstrating this prioritization.
17.A redistributor must notify a patient if the patient is receiving a drug that has been donated. While acceptance of a redistributed drug is voluntary, the patient shall always have the option to refuse this type of medication.
D.Physical Plant
1.The drug redistribution facility must be of suitable size and construction to facilitate operations, cleaning, maintenance, and storage of drugs. Additionally, the drug redistribution program must maintain:
a.An appropriate HVAC system to control the facility’s temperature and humidity;
b.Appropriate temperature conditions as specified by the USP as follows:
(1)Room temperature drugs must be stored at a temperature range of sixty-eighty to seventy-seven degrees Fahrenheit (68° to 77° F);
(2)An automated temperature monitoring system that records temperatures and provides continuous readings 24/7;
c.Appropriate lighting and adequate space with shelving for drug products so that no products are stored on floors.
d.The drug redistribution facility must be free of infestation of birds, rodents, insects, and vermin of any kind.
E.Drug Storage
1.Storage of donated drugs shall be in accordance with R.I. Gen. Laws § 23-25.6-5(e).
F.Record Keeping
1.A paper or electronic log for tracking redistributed drugs must be maintained at the redistribution facility.
2.The log must document the transaction date, drug name, strength, and quantity, date the drug left the donor, date the drug was received at the redistribution facility, name and contact information of the donor, location of the drug’s origin, expiration date of the drug, date pharmacist approved the drug to be redistributed, date the drug was released to Receiver, and the pharmacist’s initials.
3.The drug redistributor must retain readily producible records in paper or electronic form for every drug that is redistributed with no less than the following information:
a.Name of person that received a redistributed drug;
b.Name, strength, and quantity of redistributed drug;
c.Name of State where the redistributed drug was dispensed;
d.Price paid for each drug that was sold by the drug redistributor pursuant to R.I. Gen. Laws § 23-25.6-5(c) and §§ 1.15.3(C)(13) and 1.15.3 (H)(4) of this Part;
e.Proof of prioritization of need for person who received the redistributed drug;
f.Readily producible data breakdowns which demonstrate the locations where redistributed drugs were dispensed; and,
g.Readily producible data breakdowns which demonstrate the persons in need and other populations where redistributed drugs were dispensed.
h.Patient records that contain Protected Health Information (PHI) must be stored and maintained following all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
4.All records required pursuant to the provisions of R.I. Gen. Laws Chapter 23-25.6 and this Part must be retained in hard copy or electronic format for a period of no less than two (2) years.
G.Drug Destruction/Disposal
1.Donated drugs that cannot be utilized by the redistributor must be destroyed in accordance with the requirements of R.I. Gen. Laws § 23-25.6-5(d).
2.A drug disposal log must be maintained in hard-copy or electronic form at the facility that consists of drug name, strength, quantity, date the drug left the donor, date the drug was received at the redistribution facility, the name and contact information of the donor, location of the drug’s origin, expiration date of the drug, reason the drug was disposed and the pharmacist’s initials.
3.A hazardous drug disposal service must be in place for the safe disposal of any such drugs.
H.Patient Eligibility Criteria shall be in accordance with the provisions of R.I. Gen. Laws § 23-25.6-3(a).
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.16** Medications for Human Immunodeficiency Virus (HIV) Preexposure (PrEP) and Post-exposure (PEP) Prophylaxis {#sec-216-ricr-40-15-1-1.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.16}
A.In accordance with R.I. Gen. Laws §§ 27-18-93, 27-19-85, 27-20-81, 27-41-98, and 23-6.3-2, Dispensing and Administration of HIV PrEP or PEP Drugs, a licensed pharmacist may prescribe, dispense, and administer HIV PrEP or PEP drugs. Pharmacists shall order laboratory testing for HIV infection. In addition to the requirements of R.I. Gen. Laws § 27-18-93(c)(1), the pharmacist, where practicable, may order laboratory tests consistent with the CDC guidelines incorporated by reference in §§ 1.2(A) and (B) of this Part, as allowed by law. Pursuant to R.I. Gen. Laws 27-18-93(a), a pharmacist may obtain a standing order or enter into a collaborative practice agreement to fulfill the requirements of this Part.
B.Before furnishing an HIV PrEP or PEP drug to a patient, a pharmacist shall complete a training program approved by the board as outlined in R.I. Gen. Laws § 27-18-93(b). In addition to those requirements outlined in R.I. Gen. Laws § 27-18-93(b), the training program must contain the following:
1.Ordering, interpreting, and documenting laboratory testing for HIV infection and any other laboratory testing needed for prescription adherence,
2.Guidelines on PrEP and PEP selection provided by the CDC guidelines incorporated by reference in §§ 1.2(A) and (B) of this Part,
3.Available formulations, regimens, pharmacology, and pharmacotherapy of PrEP and PEP medications, including use in vulnerable populations (e.g., pregnant people, adolescents, LGBTQIA+) and algorithms for medication selection,
4.Factors and considerations required for patient-centered medication selection including assessment of advantages and disadvantages of various approved medication options,
5.Best practices on PrEP and PEP medication adherence and counseling for recipients,
6.Monitoring considerations of approved medications including management of potential adverse events and follow-up care,
7.Identification of patients that should be referred to a primary care or other provider at any point during the protocol, or at follow-up,
8.Use and documentation of a standardized referral process including other sexually transmitted infection (STI) screening, testing, and treatment,
9.Trauma-informed care, and
10.Billing for testing, prescribing, dispensing, counseling, and monitoring services as necessary.
C.Patient eligibility for PrEP and PEP must be determined using the CDC guidelines incorporated by reference in §§ 1.2(A) and (B) of this Part.
D.A pharmacist shall dispense or administer a PrEP or PEP drug pursuant to R.I. Gen. Laws §§ 27-18-93(c)(1)-(7). In addition to the requirements outlined in R.I. Gen. Laws §§ 27-18-93(c)(1)-(7), the following must be completed:
1.Additional laboratory testing as recommended in the CDC guidelines incorporated by reference in §§ 1.2(A) and (B) of this Part.
2.Ensuring the patient meets eligibility criteria for either HIV PrEP or PEP as outlined by CDC guidelines incorporated by reference in §§ 1.2(A) and (B) of this Part.
E.A pharmacist shall dispense or administer a complete course of a PEP drug under the conditions outlined in R.I. Gen. Laws §§ 27-18-93(d)(1)-(4).
F.Record Keeping and Reporting
1.The pharmacist must document the services provided as outlined in R.I. Gen. Laws § 27-18-93(c)(5). In addition to the requirements outlined in R.I. Gen. Laws § 27-18-93(c)(5), the pharmacist must also keep a record, either as a hard copy or electronic record, and maintain the following information:
a.Patient’s name, address, and date of birth;
b.Medication name and dose;
c.Date of the administration and route of administration;
d.Name and address of the patient’s primary medical provider, as identified by the patient, if known;
e.Name or identifiable initials of the administering pharmacist;
f.Indication for use (i.e., sexual risk, IDU);
g.HIV test result and date of result;
h.Other laboratory tests ordered and the results thereof; and
i.Name of the medical practice or medical provider to whom the patient was referred.
2.Patient records that contain Protected Health Information (PHI) must be stored and maintained following all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.17** Contraceptives {#sec-216-ricr-40-15-1-1.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.17}
A.In accordance with R.I. Gen. Laws § 5-19.1-36, a pharmacist may prescribe and dispense all short-term, FDA-approved hormonal contraceptives.
B.Pharmacies should display signs in stores and on websites indicating on-site, behind the counter availability of contraceptives in accordance with R.I. Gen. Laws § 5-19.1-36(g).
C.Requirements for Pharmacists to Prescribe and Dispense Short-term FDA-Approved Hormonal Contraceptives
1.Training
a.A pharmacist who prescribes injectable hormonal contraceptives and self-administered hormonal contraceptives must complete educational training in accordance with R.I. Gen. Laws § 5-19.1-36(c)(1).
b.A pharmacist prescribing short-term, FDA-approved hormonal contraceptives must make available their initial training documentation to the Department.
c.A pharmacist who prescribes injectable hormonal contraceptives and self-administered hormonal contraceptives must stay current with established and new clinical parameters through continuing education and related programs. These continuing education programs are in accordance with § 1.5.15 of this Part.
2.Prescribing
a.Prescribing must be done in accordance with R.I. Gen. Laws § 5-19.1-36.
b.A pharmacist shall have the option to not participate in the prescribing of injectable hormonal contraceptives and self-administered hormonal contraceptives but must make every reasonable effort to find a pharmacist to accommodate the patient’s needs.
c.A pharmacist who prescribes injectable hormonal contraceptives or self-administered hormonal contraceptives may prescribe to a minor in accordance with R.I. Gen. Laws § 23-4.6-1.
d.In addition to the requirements of R.I. Gen. Laws § 5-19.1-36(c)(2), the pharmacist must review the self-screening risk assessment tool to ensure there are no contraindications prior to prescribing self-administered hormonal contraceptives, including injectable forms, as well as screen for high blood pressure and other relevant parameters as established by the Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use document incorporated by reference in § 1.2(C) of this Part.
D.Reimbursement and Fee for Service
1.All reimbursement and fee for service coverage of contraceptives prescribed by a pharmacist are outlined in R.I. Gen. Laws §§ 5-19.1-36(d) and (e).
E.Record Keeping
1.The pharmacist shall document the patient encounter with the following information:
a.Patient’s name, address, and date of birth;
b.Medication name and dose;
c.Date of the administration;
d.Name and address of the patient’s primary medical provider, as identified by the patient, if known;
e.If unknown, name of the medical practice or medical provider to whom the patient was referred; and
f.Name or identifiable initials of the administering pharmacist.
2.A pharmacy shall maintain records of the encounter, including, but not limited to, the self-screening risk assessment tool, based on the Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use document incorporated by reference in § 1.2(C) of this Part.
3.Patient records that contain Protected Health Information (PHI) must be stored and maintained following all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.18** Emergency Response Related to Pharmacy Practice and Procedures {#sec-216-ricr-40-15-1-1.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.18}
A.Notwithstanding any other provision of this Part to the contrary, during a State of Emergency declared by the Governor pursuant to R.I. Gen. Laws § 30-15-9 and with approval from the Director, the practice of pharmacy shall include and permit the following practices and procedures:
1.Notwithstanding the provisions of § 1.6.18 of this Part, or any other provision of this Part to the contrary, any pharmacist is authorized to auto-substitute a prescribed medication product without having to adhere to a dispense-as-written directive.
2.Notwithstanding the provisions of § 1.5.9 of this Part, or any other provision of this Part to the contrary, an intern holding a valid, active intern license from another State, as verified by the hiring pharmacy, is permitted to work in any pharmacy located in Rhode Island.
3.Notwithstanding the provisions of § 1.8 of this Part, or any other provision of this Part to the contrary, compounding personnel are permitted to adhere to current recommendations of the Centers for Disease Control and Prevention (CDC) or other nationally recognized public health agency for use of Personal Protective Equipment (PPE) during non-hazardous sterile compounding for the purpose of conserving PPE resources.
4.Notwithstanding the provisions of § 1.8(E)(2) of this Part, or any other provision of this Part to the contrary, pharmacies that engage in the pharmaceutical preparation of CSPs are permitted to extend the period for certification inspections beyond six (6) months, subject to approval by the Director.
5.Notwithstanding the provisions of § 1.7.1(A)(3) of this Part, which sets forth certain responsibilities of licensed pharmacies and pharmacists providing pharmaceutical services by contract to nursing, hospice, or correctional facilities to be set forth in written policies and procedures, the responsibilities referenced in § 1.7.1(A)(3)(e) and (f) of this Part are suspended.
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
##### **216-RICR-40-15-1 § 1.19** Violations, Complaints, and Sanctions {#sec-216-ricr-40-15-1-1.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-15-1#1.19}
1.19.1Grounds for Denial or Discontinuation of License
A.The Board, with the approval of the Director, may deny, suspend, revoke the license of, or otherwise discipline the licensee upon proof of the conduct described in R.I. Gen. Laws § 5-19.1-21, including failure of a pharmacy, pharmacy owner, corporation, or anyone acting on behalf of a pharmacy to prevent the loss of controlled substances in accordance with the Controlled Substances Act.
B.Failure to comply with Department and/or board investigations constitutes a violation of this Part and may result in disciplinary action.
C.Penalties for unlawful practices are pursuant to R.I. Gen. Laws § 5-19.1-23.
1.19.2Violations and Sanctions
A.Any licensed pharmacist who shall have been convicted of a violation of the provisions of Chapter 28 of the Title 21 of the United States Code approved October 27, 1970, as amended entitled "Comprehensive Drug Abuse Prevention and Control Act of 1970" (21 U.S.C. § 84(1236)), and all Regulations pertaining thereto shall be deemed to have forfeited their right to licensure, and the Board of Pharmacy shall thereupon discontinue their license.
1.19.3Complaints
A.Any person, pharmacist, business entity or public officer, including a licensee, may submit a complaint to the Board against any licensee or person believed to be engaged in activity which violates the Act or this Part.
B.All complaints must be submitted to the Department by the complainant or an authorized representative of the complainant. A complaint must state the grounds for the complaint, including a statement of facts or circumstances upon which the complaining party relies for the charge. A complaint shall state the name, address, and telephone number or email address of the complainant or representative to be contacted by the Board or its investigative designees for purposes of investigation or issuance of notice.
C.Within twenty-one (21) calendar days of receipt of notice that a complaint has been filed, the licensee or person against whom the complaint has been filed must respond in writing to the Board and the Department.
1.19.4Variance Procedure
A.The Department may grant a variance from the provisions of a Rule or Regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest and/or health and safety of the public.
1.Variances may be granted only for the provisions of §§ 1.7 through 1.12 of this Part and shall be for a limited period of time, generally not to exceed one (1) year.
B.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the Department, and within a reasonable time thereafter, the Department shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the person appeals the denial.
C.At a hearing held in furtherance of an appeal from a denial for a variance in accordance with § 1.7.3(B)(1) of this Part, the applicant shall bear the burden of proof that a literal enforcement of the Rules will result in unnecessary hardship, and that a variance will not be contrary to the public interest and/or health and safety of the public.
1.19.5Rules Governing Practices and Procedures
A.Upon due notice in accordance with R.I. Gen. Laws Chapter 42-35 (the Administrative Procedures Act), all hearings and reviews required under the provisions of the Act shall be held in accordance with the Rules and Regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Amendment — effective from 2026-04-12 to current*
- *Amendment — effective from 2022-12-08 to 04/12/2026*
- *Periodic Refile — effective from 2022-01-04 to 12/08/2022*
- *Amendment — effective from 2021-05-17 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-27 to 05/17/2021*
- *Amendment — effective from 2018-10-31 to 04/27/2020*
- *Amendment — effective from 2015-11-23 to 10/31/2018*
- *Amendment — effective from 2014-04-23 to 11/23/2015*
- *Amendment — effective from 2012-12-10 to 04/23/2014*
- *Amendment — effective from 2012-05-10 to 12/10/2012*
- *Amendment — effective from 2010-02-04 to 05/10/2012*
- *EMERGENCY RULE Amendment — effective from 2009-07-22 to 02/17/2010*
- *Amendment — effective from 2009-05-14 to 02/04/2010*
- *Amendment — effective from 2008-02-14 to 05/14/2009*
- *Amendment — effective from 2007-08-16 to 02/14/2008*
- *Amendment — effective from 2007-05-17 to 08/16/2007*
- *Amendment — effective from 2006-07-13 to 05/17/2007*
- *Amendment — effective from 2005-11-17 to 07/13/2006*
- *Amendment — effective from 2005-07-21 to 11/17/2005*
- *Amendment — effective from 2005-01-19 to 07/21/2005*
- *Amendment — effective from 2004-03-08 to 01/19/2005*
- *Amendment — effective from 2003-12-23 to 03/08/2004*
- *EMERGENCY RULE Adoption — effective from 2003-10-16 to 12/23/2003*
- *Amendment — effective from 2003-06-19 to 06/18/2003*
- *EMERGENCY RULE Adoption — effective from 2003-06-18 to 10/16/2003*
- *Amendment — effective from 2003-01-27 to 06/19/2003*
- *Amendment — effective from 2002-07-28 to 01/27/2003*
- *Amendment — effective from 2002-02-05 to 07/28/2002*
- *Periodic Refile — effective from 2002-01-02 to 02/05/2002*
### **Subchapter 20** Radiation
#### **216-RICR-40-20-1** General Provisions and Standards for Protection Against Radiation
##### **216-RICR-40-20-1 § 1.1** Authority {#sec-216-ricr-40-20-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes generally applicable provisions, including standards for protection against radiation hazards. Except as otherwise specifically provided, this Part applies to persons licensed or registered by the Agency to receive, possess, use, transfer, or dispose of any source of radiation; provided, however, that nothing in this Part shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission. The limits in this Part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released under § 9.5.16 of this Subchapter, or to voluntary participation in medical research programs.
C.The requirements of this Part are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant in such a manner that the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this Part. However, nothing in this Part shall be construed as limiting actions that may be necessary to protect health and safety.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.2** Incorporated Material {#sec-216-ricr-40-20-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 20 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 1.2(A) of this Part, §§ 20.1001, 20.1002, 20.1006, 20.1007, 20.1008, 20.1009, 20.1205, 20.1401, 20.1406(b), 20.1905(g), 20.2109, 20.2202, 20.2203(c), 20.2206(a)(1), (3), (4) and (5), 20.2205, 20.2206, 20.2301, 20.2302, 20.2401, 20.2402, Appendix D to Part 20 and Appendix F to 10 C.F.R. Part 20 are not incorporated by reference.
C.Effect of incorporation of 10 C.F.R. Part 20. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 20, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 20 as follows:
1.Any reference to NRC or Commission shall be deemed to be a reference to the Agency.
2.Any reference to NRC or agreement State shall be deemed to be a reference to the Agency, NRC, or agreement State.
3.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
4.Any notifications, reports or correspondence referenced in the incorporated sections of 10 C.F.R. Part 20 shall be directed to the Agency using contact information specified in § 1.4 of this Part.
5.Any reference to licensee shall be deemed to include registrant.
6.Any reference to license shall be deemed to include registration.
7.Any reference to licensed shall be deemed to include registered.
8.Any requirement to utilize NRC Form 4 may also be satisfied by use of Agency Form RCA-2.
9.Any requirement to utilize NRC Form 5 may also be satisfied by use of Agency Form RCA-3.
10.10 C.F.R. Part 20 notwithstanding, exposures involving the use of X-rays may be weighted, in a manner specified by the Agency, so that, with Agency approval, the effective dose equivalent may be substituted for the deep dose equivalent in determining compliance with occupational exposure limits for specified groups of individuals.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.3** Definitions {#sec-216-ricr-40-20-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.3}
A.In addition to the definitions contained in 10 C.F.R. § 20.1003, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3, entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Annual” means an interval not to exceed twelve (12) months.
4.“NARM” means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.
5.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
6.“Registrant” means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this Subchapter and the Act.
7.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.4** Communications {#sec-216-ricr-40-20-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.4}
A.All communications and reports concerning this Subchapter, and applications filed thereunder, should be addressed to the Agency at its office located at:
Rhode Island Department of Health
Center for Health Facilities Regulation
Radiation Control Program
Three Capitol Hill – Room 305
Providence, RI 02908-5097
B.During normal business hours, the Agency may be contacted at (401) 222-2566. At other times, this number will allow you to leave a message on the answering machine. In case of an emergency when it is necessary to immediately contact the Agency, utilize the Rhode Island Department of Health's twenty-four (24) hour number (401) 276-8046 and indicate the nature of your emergency. FAX communications may be sent twenty-four (24) hours a day to (401) 222-3999. For non-emergency situations, any required report or other routine correspondence may also be submitted via e-mail to [email protected].
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.5** General Provisions {#sec-216-ricr-40-20-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.5}
1.5.1Implementation
A.Any existing license or registration condition that is more restrictive than this Part remains in force until there is an amendment or renewal of the license or registration.
B.If a license or registration condition exempts a licensee or registrant from a provision of this Part in effect on or before January 1, 1994, it also exempts the licensee or registrant from the corresponding provision of this Part.
C.If a license or registration condition cites provisions of this Part in effect prior to January 1, 1994, which do not correspond to any provisions of this Part, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition.
1.5.2Exemptions and Additional Requirements
A.The Agency may, upon application by a licensee or registrant or upon its own initiative, grant an exemption from the requirements of this Subchapter if it determines the exemption is authorized by law and would not result in undue hazard to life or property.
B.The Agency may, by Rule, Regulation, or order, impose requirements on a licensee or registrant, in addition to those established in this Subchapter, as it deems appropriate or necessary to protect health or to minimize danger to life or property.
1.5.3Inspections
A.Each licensee and registrant shall afford the Agency at all reasonable times the opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored, and the cooperation and assistance of the registrant or licensee, or his staff, if needed.
B.Each licensee and registrant shall make available to the Agency for inspection, upon reasonable notice, records maintained pursuant to this Subchapter.
1.5.4Tests
A.Each licensee and registrant shall perform upon instructions from the Agency, or shall permit the Agency to perform such reasonable tests as the Agency deems appropriate or necessary including, but not limited to, tests of:
1.Sources of radiation;
2.Facilities wherein sources of radiation are used or stored;
3.Radiation detection and monitoring instruments; and
4.Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.
1.5.5Violations
An injunction or other court order may be obtained prohibiting any violation of any provision of the Act or any Regulation or order issued thereunder. Any person who willfully violates any provision of the Act or any Regulation or order issued thereunder may be guilty of a misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law.
1.5.6Units of Radiation Dose
For the purpose of this Part, the units of radiation dose are defined by 10 C.F.R. § 20.1004.
1.5.7Units of Radioactivity
For the purpose of this Part, the units of radioactivity are defined by 10 C.F.R. § 20.1005.
1.5.8Deliberate Misconduct
A.Any licensee, certificate of registration holder, applicant for a license or certificate of registration, employee of a licensee, certificate of registration holder or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or certificate of registration holder or applicant for a license or certificate of registration, who knowingly provides to any licensee, applicant, certificate holder, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee’s, certificate holder’s or applicant’s activities in this Part, may not:
1.Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate of registration holder, or applicant to be in violation of any Rule, Regulation, or order; or any term, condition, or limitation of any license issued by the Agency; or
2.Deliberately submit to the Agency, a licensee, certificate of registration holder, an applicant, or a licensee’s, certificate holder’s or applicant’s, contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Agency.
B.A person who violates §§ 1.5.8(A)(1) or (2) of this Part may be subject to enforcement action in accordance with the procedures in § 2.11 of this Subchapter.
C.For the purposes of § 1.5.8(A)(1) of this Part, deliberate misconduct by a person means an intentional act or omission that the person knows:
1.Would cause a licensee, certificate of registration holder or applicant to be in violation of any Rule, Regulation, or order; or any term, condition, or limitation, of any license issued by the Agency; or
2.Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.6** Radiation Protection Programs {#sec-216-ricr-40-20-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.6}
For the purpose of this Part, the required radiation protection program is defined by 10 C.F.R. § 20.1101.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.7** Occupational Dose Limits {#sec-216-ricr-40-20-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.7}
1.7.1Occupational Dose Limits for Adults
A.For the purpose of this Part, the occupational dose limits for adults are defined by 10 C.F.R. § 20.1201.
B.For sources of radiation other than radioactive material, when a protective apron is worn and monitoring is conducted as specified in § 1.10.3(B) of this Part, the effective dose equivalent for external radiation shall be determined as follows:
1.When only one individual monitoring device is used and it is located at the neck outside the protective apron, and the reported dose exceeds twenty-five percent (25%) of the limit specified in § 1.7.1(A) of this Part, the reported deep dose equivalent value multiplied by three tenths (0.3) shall be the effective dose equivalent for external radiation; or
2.When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by one and one half (1.5) and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by four one hundredths (0.04).
1.7.2Compliance with Requirements for Summation of External and Internal Doses
For the purpose of this Part, compliance with requirements for summation of external and internal doses is defined by 10 C.F.R. § 20.1202.
1.7.3Determination of External Dose from Airborne Radioactive Material
For the purpose of this Part, determination of external dose from airborne radioactive material is defined by 10 C.F.R. § 20.1203.
1.7.4Determination of Internal Exposure
For the purpose of this Part, determination of internal exposure is defined by 10 C.F.R. § 20.1204.
1.7.5Determination of Prior Occupational Dose
A.For the purpose of this Part, determination of prior occupational dose is defined by 10 C.F.R. § 20.2104.
B.The licensee or registrant shall retain the records of prior occupational dose and exposure history as specified in § 1.7.5(A) of this Part on Agency Form RCA-2 or equivalent until the Agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing Agency Form RCA-2 or equivalent for three (3) years after the record is made.
C.Upon termination of the license or registration, the licensee or registrant shall make arrangements, satisfactory to the Agency, for permanent storage of records contained on Agency Form RCA-2 or equivalent.
1.7.6Planned Special Exposures
For the purpose of this Part, planned special exposures are defined by 10 C.F.R. § 20.1206.
1.7.7Occupational Dose Limits for Minors
For the purpose of this Part, occupational dose limits for minors are defined by 10 C.F.R. § 20.1207.
1.7.8Dose Equivalent to an Embryo/Fetus
For the purpose of this Part, dose equivalent to an embryo/fetus is defined by 10 C.F.R. § 20.1208.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.8** Radiation Dose Limits for Individual Members of the Public {#sec-216-ricr-40-20-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.8}
1.8.1Dose Limits for Individual Members of the Public
A.For the purpose of this Part, dose limits for individual members of the public are defined by 10 C.F.R. § 20.1301.
B.Each registrant shall conduct operations so that the total effective dose equivalent to individual members of the public does not exceed the original design criteria of five (5) mSv (one half (0.5) rem) in a year at locations within registered facilities where only radiation machines were installed prior to January 1, 1994 and which continue to meet the original design criteria (e.g. workload, type and use of radiation machine, room configuration, etc.) on or after January 1, 1994.
1.8.2Compliance with Dose Limits for Individual Members of the Public
For the purpose of this Part, compliance with dose limits for individual members of the public is defined by 10 C.F.R. § 20.1302.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.9** Radiological Criteria for License Termination {#sec-216-ricr-40-20-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.9}
1.9.1General Provisions and Scope
A.Applicability. The criteria in §§ 1.9.1 through 1.9.6 of this Part apply to the decommissioning of facilities licensed under Parts 7, 9, 10 and 11 of this Subchapter, as well as other facilities subject to the Agency’s jurisdiction.
B.After a site has been decommissioned and the license terminated in accordance with the criteria in §§ 1.9.1 through 1.9.6 of this Part, the Agency will require additional cleanup only if, based on new information, it determines that the criteria in §§ 1.9.1 through 1.9.6 of this Part were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety.
C.When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand (1,000) years after decommissioning.
1.9.2Radiological Criteria for Unrestricted Use
For the purpose of this Part, compliance with radiological criteria for unrestricted use is defined by 10 C.F.R. § 20.1402.
1.9.3Criteria for License Termination Under Restricted Conditions
For the purpose of this Part, criteria for license termination under restricted conditions is defined by 10 C.F.R. § 20.1403.
1.9.4Alternate Criteria for License Termination
For the purpose of this Part, alternate criteria for license termination is defined by 10 C.F.R. § 20.1404.
1.9.5Public Notification and Public Participation
For the purpose of this Part, requirements for public notification and public participation are defined by 10 C.F.R. § 20.1405.
1.9.6Minimization of Contamination
For the purpose of this Part, requirements for minimization of contamination are defined by 10 C.F.R. § 20.1406, excluding 10 C.F.R. § 20.1406(b).
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.10** Surveys and Monitoring {#sec-216-ricr-40-20-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.10}
1.10.1Testing for Leakage or Contamination of Sealed Sources
A.The licensee in possession of any sealed source shall assure that:
1.Each sealed source, except as specified in § 1.10.1(B) of this Part, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within six (6) months before transfer to the licensee.
2.Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six (6) months or at alternative intervals approved by the Agency, after evaluation of information specified by § 7.6.17 of this Subchapter, another Agreement State or the U.S. Nuclear Regulatory Commission.
3.Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three (3) months or at alternative intervals approved by the Agency, after evaluation of information specified by § 7.6.17 of this Subchapter, another Agreement State or the U.S. Nuclear Regulatory Commission.
4.For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee shall assure that the sealed source is tested for leakage or contamination before further use.
5.Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of one hundred eighty-five (185) Bq (five one thousandths (0.005) µCi) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the "off" position.
6.The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of thirty-seven (37) Bq (one one thousandth (0.001) µCi) of radon-222 in a twenty-four (24) hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume and time.
7.Tests for contamination from radium daughters shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of one hundred eighty-five (185) Bq (five one thousandths (0.005) µCi) of a radium daughter which has a half-life greater than four (4) days.
B.A licensee need not perform test for leakage or contamination on the following sealed sources:
1.Sealed sources containing only radioactive material with a half-life of less than thirty (30) days;
2.Sealed sources containing only radioactive material as a gas;
3.Sealed sources containing three and seven tenths (3.7) MBq (one hundred (100) µCi) or less of beta or photon-emitting material or three hundred seventy (370) kBq (ten (10) µCi) or less of alpha-emitting material;
4.Sealed sources containing only hydrogen-3;
5.Seeds of iridium-192 encased in nylon ribbon; and
6.Sealed sources, except teletherapy and brachytherapy sources, which are stored, not being used and identified as in storage. The licensee shall, however, test each such sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within six (6) months before the date of use or transfer. No sealed source shall be stored for a period of more than ten (10) years without being tested for leakage and/or contamination.
C.Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the Agency, another Agreement State or the U.S. Nuclear Regulatory Commission to perform such services.
D.Records of tests for leakage or contamination of sealed sources required by § 1.10.1 of this Part shall be kept in units of becquerel or microcurie and maintained for inspection by the Agency for five (5) years after the records are made.
E.The following shall be considered evidence that a sealed source is leaking:
1.The presence of one hundred eighty-five (185) Bq (five one thousandths (0.005) µCi) or more of removable contamination on any test sample; or
2.Leakage of thirty-seven (37) Bq (one one thousandth (0.001) µCi) of radon-222 per twenty-four (24) hours for brachytherapy sources manufactured to contain radium.
F.The licensee shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this Part.
G.The licensee shall file a report within five (5) working days with the Agency if the test for leakage or contamination indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results and the corrective action taken.
1.10.2General Survey and Monitoring Requirements
A.For the purpose of this Part, general survey and monitoring requirements are defined by 10 C.F.R. § 20.1501.
B.Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.
1.10.3Conditions Requiring Individual Monitoring of External and Internal Occupational Dose
A.For the purpose of this Part, conditions requiring individual monitoring of external and internal occupational dose are defined by 10 C.F.R. § 20.1502.
B.Individuals wearing a protective apron, when personnel monitoring is otherwise required by this Subchapter, shall position their individual monitoring devices as follows:
1.An individual monitoring device used for the dose to an embryo/fetus of a declared pregnant woman, pursuant to § 1.7.8 of this Part, shall be located under the protective apron at the waist.
a.It is recognized that, in the specific work environment of medical fluoroscopic equipment, the dose to the embryo/fetus is overestimated by the individual monitoring device because of the overlying tissue of the pregnant individual. A medical physicist who is registered with the Agency pursuant to § 3.6 of this Subchapter as a Provider of Diagnostic X-Ray Physics Services should be consulted to determine the dose to the embryo/fetus for the rare occasion in which this individual monitoring device has a monthly reported dose equivalent value in excess of five tenths (0.5) mSv (fifty (50) mrem). Therefore, for purposes of this Part, the value to be used for determining the dose to an embryo/fetus pursuant to § 1.7.8 of this Part for occupational exposure to radiation from medical fluoroscopic equipment may be the value reported by the individual monitoring device worn at the waist underneath the protective apron which has been corrected for the particular individual and her work environment by the above referenced medical physicist.
2.An individual monitoring device used for eye dose equivalent shall be located at the neck, or an unshielded location closer to the eye, outside the protective apron.
3.When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to § 1.7.1(B) of this Part, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used, for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.
C.An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with § 1.7.1(A) of this Part, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.11** Control of Exposure from External Sources in Restricted Areas {#sec-216-ricr-40-20-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.11}
1.11.1Control of Access to High Radiation Areas
A.For the purpose of this Part, control of access to high radiation areas is defined by 10 C.F.R. § 20.1601.
B.The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in § 1.11.1(A) of this Part if the registrant has met all the specific requirements for access and control specified in other applicable Parts of this Subchapter.
1.11.2Control of Access to Very High Radiation Areas
A.For the purpose of this Part, control of access to very high radiation areas is defined by 10 C.F.R. § 20.1602.
B.The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in § 1.11.2(A) of this Part if the registrant has met all the specific requirements for access and control specified in other applicable Parts of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.12** Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas {#sec-216-ricr-40-20-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.12}
1.12.1Use of Process or Other Engineering Controls
For the purpose of this Part, use of process or other engineering controls is defined by 10 C.F.R. § 20.1701.
1.12.2Use of Other Controls
For the purpose of this Part, use of other controls is defined by 10 C.F.R. § 20.1702.
1.12.3Use of Individual Respiratory Protection Equipment
A.For the purpose of this Part, use of individual respiratory protection equipment is defined by 10 C.F.R. § 20.1703.
B.For the purpose of this Part, further restrictions on the use of respiratory protection equipment are defined by 10 C.F.R. § 20.1704.
C.For the purpose of this Part, authorization for use of higher assigned protection factors is required by 10 C.F.R. § 20.1705.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.13** Storage and Control of Licensed Material {#sec-216-ricr-40-20-1-1.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.13}
1.13.1Security of Stored Material
For the purpose of this Part, security of stored material is defined by 10 C.F.R. § 20.1801.
1.13.2Control of Material Not in Storage
A.For the purpose of this Part, control of material not in storage is defined by 10 C.F.R. § 20.1802.
B.The registrant shall maintain control of radiation machines that are in an unrestricted area and that are not in storage.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.14** Precautionary Procedures {#sec-216-ricr-40-20-1-1.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.14}
1.14.1Caution Signs
For the purpose of this Part, caution signs are defined by 10 C.F.R. § 20.1901.
1.14.2Posting Requirements
For the purpose of this Part, posting requirements are defined by 10 C.F.R. § 20.1902.
1.14.3Exceptions to Posting Requirements
A.For the purpose of this Part, exceptions to posting requirements are defined by 10 C.F.R. § 20.1903.
B.A room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.
1.14.4Labeling Containers and Radiation Machines
A.For the purpose of this Part, labeling of containers is defined by 10 C.F.R. § 20.1904.
B.Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.
1.14.5Exemptions to Labeling Requirements
For the purpose of this Part, exemptions to labeling requirements are defined by 10 C.F.R. § 20.1905, excluding 10 C.F.R. § 20.1905(g).
1.14.6Procedures for Receiving and Opening Packages
For the purpose of this Part, procedures for receiving and opening packages are defined by 10 C.F.R. § 20.1906.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.15** Waste Disposal {#sec-216-ricr-40-20-1-1.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.15}
1.15.1General Requirements for Waste Disposal
For the purpose of this Part, general requirements for waste disposal are defined by 10 C.F.R. § 20.2001.
1.15.2Method for Obtaining Approval of Proposed Disposal Procedures
For the purpose of this Part, the method for obtaining approval of proposed disposal procedures is defined by 10 C.F.R. § 20.2002.
1.15.3Disposal by Release into Sanitary Sewerage
For the purpose of this Part, disposal by release into sanitary sewerage is defined by 10 C.F.R. § 20.2003.
1.15.4Treatment or Disposal by Incineration
For the purpose of this Part, treatment or disposal by incineration is defined by 10 C.F.R. § 20.2004.
1.15.5Disposal of Specific Wastes
For the purpose of this Part, disposal of specific wastes is defined by 10 C.F.R. § 20.2005.
1.15.6Transfer for Disposal and Manifests
For the purpose of this Part, transfer for disposal and manifests are defined by 10 C.F.R. § 20.2006.
1.15.7Compliance with Environmental and Health Protection Regulations
For the purpose of this Part, compliance with environmental and health protection regulations is defined by 10 C.F.R. § 20.2007.
1.15.8Disposal of 11e(3) and 11e(4) Byproduct Material
For the purpose of this Part, disposal of 11e(3) and 11e(4) Byproduct Material is defined by 10 C.F.R. § 20.2008.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.16** Records {#sec-216-ricr-40-20-1-1.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.16}
1.16.1General Provisions
A.For the purpose of this Part, general recordkeeping provisions are defined by 10 C.F.R. § 20.2101.
B.Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. All records required by this Subchapter shall be maintained indefinitely unless otherwise specified in this Subchapter.
1.16.2Records of Radiation Protection Programs
For the purpose of this Part, requirements for maintenance of records of radiation protection programs are defined by 10 C.F.R. § 20.2102.
1.16.3Records of Surveys
For the purpose of this Part, requirements for maintenance of records of surveys are defined by 10 C.F.R. § 20.2103.
1.16.4Records of Tests for Leakage or Contamination of Sealed Sources
Records of tests for leakage or contamination of sealed sources required by § 1.10.1(A) of this Part shall be kept in units of becquerel or microcurie and maintained for inspection by the Agency for five (5) years after the records are made.
1.16.5Records of Planned Special Exposures
For the purpose of this Part, requirements for maintenance of records of planned special exposures are defined by 10 C.F.R. § 20.2105.
1.16.6Records of Individual Monitoring Results
For the purpose of this Part, requirements for maintenance of records of individual monitoring results are defined by 10 C.F.R. § 20.2106.
1.16.7Records of Dose to Individual Members of the Public
For the purpose of this Part, requirements for maintenance of records of dose to individual members of the public are defined by 10 C.F.R. § 20.2107.
1.16.8Records of Waste Disposal
For the purpose of this Part, requirements for maintenance of records of waste disposal are defined by 10 C.F.R. § 20.2108.
1.16.9Form of Records
For the purpose of this Part, requirements regarding the form of records are defined by 10 C.F.R. § 20.2110.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.17** Reports {#sec-216-ricr-40-20-1-1.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.17}
1.17.1Reports of Theft or Loss of Licensed Material
For the purpose of this Part, requirements regarding reports of theft or loss of licensed material are defined by 10 C.F.R. § 20.2201.
1.17.2Notification of Incidents
A.Immediate Notification. Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:
1.Immediately notify the Agency of each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:
a.An individual to receive:
(1)A total effective dose equivalent of twenty-five one hundredths (0.25) Sv (twenty-five (25) rem) or more; or
(2)A lens dose equivalent of seventy-five one hundredths (0.75) Sv (seventy-five (75) rem) or more; or
(3)A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of two and one half (2.5) Gy (two hundred fifty (250) rad) or more; or
b.The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for twenty-four (24) hours, the individual could have received an intake five (5) times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.
2.Immediately notify the Agency as soon as possible, but not later than four (4) hours after the discovery, of an event (e.g., fire, explosion, toxic gas release, etc.) that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits.
B.Twenty-Four Hour Notification. Each licensee or registrant shall, within twenty-four (24) hours of discovery of the event, report to the Agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:
1.An individual to receive, in a period of twenty-four (24) hours:
a.A total effective dose equivalent exceeding five one hundredths (0.05) Sv (five (5) rem); or
b.A lens dose equivalent exceeding fifteen one hundredths (0.15) Sv (fifteen (15) rem); or
c.A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding one half (0.5) Sv (fifty (50) rem); or
2.The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for twenty-four (24) hours, the individual could have received an intake in excess of one (1) occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.
3.An unplanned contamination event that:
a.Requires access to the contaminated area, by workers or the public, to be restricted for more than twenty-four (24) hours by imposing additional radiological controls or by prohibiting entry into the area; and
b.Involves a quantity of material greater than five (5) times the lowest annual limit on intake specified for the material in § 1.19 of this Part; and
c.Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than twenty-four (24) hours to decay prior to decontamination.
4.An event in which equipment is disabled or fails to function as designed when:
a.The equipment is required by regulation or license/registration condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and/or radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident; and
b.The equipment is required to be available and operable when it is disabled or fails to function; and
c.No redundant equipment is available and operable to perform the required safety function.
5.An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.
6.An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:
a.The quantity of material involved is greater than five (5) times the lowest annual limit on intake specified for the material in § 1.19 of this Part; and
b.The damage affects the integrity of the licensed material or its container.
C.The licensee or registrant shall prepare each report filed with the Agency pursuant to § 1.17.2 of this Part so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.
D.Licensees or registrants shall make the reports required by §§ 1.17.2(A) and (B) of this Part to the Agency by telephone, telegram, mailgram, or facsimile to the Agency. To the extent that the information is available at the time of notification, the information provided in these reports shall include:
1.The name of the person making the report and their call-back telephone number;
2.A description of the event, including time and date;
3.The exact location of the event;
4.The levels of radiation and the isotopes, quantities, and chemical and physical form of the licensed material involved; and
5.Any personnel radiation exposure data available.
E.The provisions of § 1.17.2 of this Part do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported pursuant to § 1.17.4 of this Part.
1.17.3Reports of Exposures, Radiation Levels, and Concentrations of Radioactive Material Exceeding the Constraints or Limits
For the purpose of this Part, requirements regarding reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits are defined by 10 C.F.R. § 20.2203, excluding 10 C.F.R. § 20.2203(c).
1.17.4Reports of Planned Special Exposures
For the purpose of this Part, requirements regarding reports of planned special exposures are defined by 10 C.F.R. § 20.2204.
1.17.5Notifications and Reports to Individuals
When a licensee or registrant is required pursuant to §§ 1.17.3 or 1.17.4 of this Part to report to the Agency any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the Agency.
1.17.6Reports of Transactions Involving Nationally Tracked Sources
For the purpose of this Part, requirements regarding reports of transactions involving nationally tracked sources are defined by 10 C.F.R. § 20.2207.
1.17.7Vacating Premises
Each specific licensee shall, no less than thirty (30) days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of his or her activities, notify the Agency in writing of intent to vacate. When deemed necessary by the Agency, the licensee shall decontaminate the premises in such a manner as the Agency may specify.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.18** Assigned Protection Factors for Respirators {#sec-216-ricr-40-20-1-1.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.18}
For the purpose of this Part, assigned protection factors for respirators are defined in Appendix A to 10 C.F.R. Part 20.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.19** Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage {#sec-216-ricr-40-20-1-1.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.19}
For the purpose of this Part, Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of radionuclides for occupational exposure; effluent concentrations; and concentrations for release to sewerage are defined in Appendix B to 10 C.F.R. Part 20.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.20** Quantities of Licensed Material Requiring Labeling {#sec-216-ricr-40-20-1-1.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.20}
For the purpose of this Part, quantities of licensed material requiring labeling are defined in Appendix C to 10 C.F.R. Part 20.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.21** Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests {#sec-216-ricr-40-20-1-1.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.21}
For the purpose of this Part, requirements for transfers of low-level radioactive waste intended for disposal at licensed land disposal facilities and manifests are defined in Appendix G to 10 C.F.R. Part 20.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
##### **216-RICR-40-20-1 § 1.22** Nationally Tracked Source Thresholds {#sec-216-ricr-40-20-1-1.22 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-1#1.22}
For the purpose of this Part, requirements for nationally tracked source thresholds are defined in Appendix E to 10 C.F.R. Part 20.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Adoption — effective from 2019-01-01 to 01/01/2019*
#### **216-RICR-40-20-2** Notices, Instructions, and Reports to Workers; Inspections and Compliance Procedures
##### **216-RICR-40-20-2 § 2.1** Authority and Purpose {#sec-216-ricr-40-20-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes requirements for notices, instructions and reports by licensees or registrants to individuals engaged in work under a license or registration and options available to such individuals in connection with Agency inspections of licensees or registrants to ascertain compliance with the provisions of the Act and Regulations, orders, licenses and certificates of registration issued thereunder regarding radiological working conditions. Except as otherwise specifically provided, this Part applies to persons licensed or registered by the Agency to receive, possess, use, transfer, or dispose of any source of radiation; provided, however, that nothing in this Part shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.2** Incorporated Material {#sec-216-ricr-40-20-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 19 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 2.2(A) of this Part, 10 C.F.R. §§ 19.3 (definition of “regulated entities” only), 19.4, 19.5, 19.8, 19.11(b) and (e), 19.14(a), 19.18, 19.20, 19.30, 19.31, 19.32 and 19.40 are not incorporated by reference.
C.Effect of incorporation of 10 C.F.R. Part 19. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 19, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 19 as follows:
1.Any reference to NRC or Commission shall be deemed to be a reference to the Agency.
2.Any reference to NRC or agreement state shall be deemed to be a reference to the Agency, NRC or agreement State.
3.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
4.Any notifications, reports or correspondence referenced in the incorporated sections of 10 C.F.R. Part 19 shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
5.Any reference to licensee shall be deemed to include registrant.
6.Any reference to license shall be deemed to include registration.
7.Any reference to licensed shall be deemed to include registered.
8.Any reference to NRC Form 3 shall be deemed to be a reference to Agency Form RCA-1.
9.Any requirement to utilize NRC Form 4 may also be satisfied by use of Agency Form RCA-2.
10.Any requirement to utilize NRC Form 5 may also be satisfied by use of Agency Form RCA-3.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.3** Definitions {#sec-216-ricr-40-20-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.3}
A.In addition to the definitions contained in 10 C.F.R. § 19.3, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
4.“Registrant” means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this Subchapter and the Act.
5.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
6.“Regulated entities” means any individual person, organization or corporation that is subject to the regulatory jurisdiction of Rhode Island.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.4** Posting of Notices to Workers {#sec-216-ricr-40-20-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.4}
A.For the purpose of this Part, requirements for posting of notices to workers are defined in 10 C.F.R. § 19.11, excluding 10 C.F.R. §§ 19.11(b) and (e).
B.Notwithstanding the requirements of § 2.4(A) of this Part, Agency licensees and registrants shall post Agency Form RCA-1 in lieu of NRC Form 3.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.5** Instruction to Workers {#sec-216-ricr-40-20-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.5}
A.For the purpose of this Part, requirements for instruction to workers are defined in 10 C.F.R. § 19.12.
B.Use of Latex Gloves. Persons, firms or corporations licensed or registered by the Agency that utilize latex gloves are subject to Part 20-15-3 of this Title, Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department, and the posting and employee notification requirements contained therein.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.6** Notifications and Reports to Individuals {#sec-216-ricr-40-20-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.6}
For the purpose of this Part, requirements for notifications and reports to individuals are defined in 10 C.F.R. § 19.13.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.7** Presence of Representatives of Licensees and Regulated Entities, and Workers During Inspections {#sec-216-ricr-40-20-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.7}
For the purpose of this Part, requirements for presence of representatives of licensees and regulated entities and workers during inspections are defined in 10 C.F.R. § 19.14, excluding 10 C.F.R. § 19.14(a).
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.8** Consultation with Workers During Inspections {#sec-216-ricr-40-20-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.8}
For the purpose of this Part, requirements for consultation with workers during inspections are defined in 10 C.F.R. § 19.15.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.9** Requests by Workers for Inspections {#sec-216-ricr-40-20-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.9}
For the purpose of this Part, requirements for requests by workers for inspections are defined in 10 C.F.R. § 19.16.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-2 § 2.10** Inspections Not Warranted; Informal Review {#sec-216-ricr-40-20-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-2#2.10}
For the purpose of this Part, requirements for inspections not warranted; informal review are defined in 10 C.F.R. § 19.17.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-3** Registration of X-Ray Equipment Facilities and Radiation Physics Services
##### **216-RICR-40-20-3 § 3.1** Authority {#sec-216-ricr-40-20-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part requires the registration of X-ray equipment facilities and the registration of persons providing installation and/or servicing of X-ray equipment to Agency registrants or radiation physics services to Agency registrants or licensees. For purposes of this Part, particle accelerator facilities, whether used primarily for X-ray production or other purposes, shall be considered X-ray equipment facilities.
C.In addition to the requirements of this Part, all registrants are subject to the applicable provisions of other Parts of this Subchapter.
D.Any notifications, reports or correspondence referenced in this Part shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.2** Incorporation by Reference {#sec-216-ricr-40-20-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.2}
A.This Part hereby adopts and incorporates the National Council on Radiation Protection and Measurements’ (NCRP) Report 144 “Radiation Protection for Particle Accelerator Facilities” (2003) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.This Part hereby adopts and incorporates the National Council on Radiation Protection and Measurements’ (NCRP) Report 145, “Radiation Protection in Dentistry” (2003) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
C.This Part hereby adopts and incorporates the National Council on Radiation Protection and Measurements’ (NCRP) Report 147, “Structural Shielding Design for Medical X-ray Imaging Facilities” (2004) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
D.This Part hereby adopts and incorporates the National Council on Radiation Protection and Measurements’ (NCRP) Report 148, “Radiation Protection in Veterinary Medicine” (2004) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.3** Prohibitions and Exemptions {#sec-216-ricr-40-20-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.3}
A.Prohibitions. All registrants shall prohibit any person from furnishing X-ray equipment servicing or radiation physics services as described in § 3.6 of this Part to their X-ray equipment facility until such person provides evidence that they are registered with the Agency as a provider of services in accordance with § 3.6 of this Part.
B.Exemptions
1.Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and certification requirements of this Part, providing dose equivalent rate averaged over an area of ten square centimeters (10 cm2) does not exceed five tenths (0.5) mrem (five (5) uSv) per hour at five (5) cm from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.
2.X-ray equipment while in transit or in storage incident to transit are exempt from the requirements of this Part. This exemption does not apply to the providers of X-ray equipment for mobile services.
3.Domestic television receivers and video display terminals are exempt from the requirements of this Part.
4.Inoperable X-ray equipment is exempt from the requirements of this Part. For the purposes of this Part, an inoperable X-ray equipment means X-ray equipment that cannot be energized when connected to a power supply without repair or modification.
5.Financial institutions that take possession of operable X-ray equipment as the result of foreclosure, bankruptcy, or other default of payment are subject to the requirements in this Part. X-ray equipment which is operable for the sole purpose of selling, leasing or transferring shall be registered in the Storage category.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.4** Definitions {#sec-216-ricr-40-20-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.4}
A.Whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3."Facility" means the location, building, vehicle, or complex under one (1) administrative control, at which one (1) or more radiation machines are installed, located and/or used.
4.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.5** General Regulatory Requirements {#sec-216-ricr-40-20-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.5}
3.5.1Shielding Plan Review
A.Except as otherwise provided in § 3.5.1(C) of this Part, all new X-ray equipment (as defined by Part 4 of this Subchapter, Diagnostic X-Rays and Associated Imaging Systems in the Healing Arts) facilities and modifications of existing X-ray equipment facilities utilizing ionizing radiation machines shall require shielding plan review by the Agency.
B.Prior to construction, the floor plans, shielding specifications, and equipment arrangement shall be submitted to the Agency for review and approval. The required information for all ionizing radiation machines, except therapeutic radiation machines, is denoted in § 3.13 of this Part. The required information for therapeutic radiation machines is contained in § 5.13 of this Subchapter.
C.The Agency may require the applicant to utilize the services of a person registered to provide General Radiation Physics Services in developing the information required by § 3.13 of this Part.
D.Shielding plan review by the Agency is not required for the following type of X-ray equipment facilities:
1.Any type of X-ray equipment which provides sufficient self-shielding to reduce the radiation levels at all external surfaces of the equipment below those levels required by §§ 1.7.1, 1.7.7 and 1.8.1 of this Subchapter.
2.Any X-ray equipment facility performing only dental intraoral and/or panoramic procedures whose estimated workload has been evaluated in accordance with NCRP Report 145 [“Radiation Protection in Dentistry” (2003)], and it has been documented that existing structural configuration will provide sufficient shielding to reduce the radiation levels to those required by §§ 1.7.1, 1.7.7 and 1.8.1 of this Subchapter.
3.5.2Submission of Application
A.Each person who owns or possesses and administratively controls an X-ray equipment facility, unless specifically exempted in § 3.3 of this Part, shall apply for registration of such facility with the Agency prior to the operation of an X-ray equipment facility. Application for registration shall be completed on forms furnished by the Agency and shall contain all the information required by the form and accompanying instructions, including a designated e-mail address for receipt of official Agency correspondence in electronic format. The issuance of a Certificate of Registration for an X-ray equipment facility shall not preclude the Agency from subsequently reassigning the registered X-ray equipment to a more appropriate registration category and/or requiring the facility to periodically reregister all X-ray equipment at the facility. The registration category for an X-ray equipment facility will be determined in accordance with the provisions of § 15.4.6 of this Subchapter.
B.Designation of Individual Responsible for Radiation Protection. An individual to be responsible for radiation protection shall be designated on each application form. The qualifications of that individual shall be submitted to the Agency with the application. The Radiation Safety Officer (RSO) shall meet the applicable requirements of § 3.15 of this Part and carry out the responsibilities in § 3.16 of this Part.
C.Designation of Facility Supervisor
1.An individual responsible for directing the operation of the X-ray equipment facility shall be designated on each application form.
2.The designation of a licensed practitioner of the healing arts shall be required on each healing arts application.
3.The designation of an individual licensed in accordance with R.I. Gen. Laws Chapter 5-25 to engage in veterinary medicine shall be required on each veterinary medicine application.
D.Additional Requirements for Medical Research on Humans. In addition to the requirements of §§ 3.5.2(A), (B) and (C) of this Part, the applicant shall submit, as a minimum, the following information:
1.A detailed description of the proposed medical research, including a copy of the form that will be used to obtain informed consent from the human subjects and an evaluation of the potential radiation exposure to individuals participating in the medical research; and
2.The following documentation:
a.Documentation that the research is conducted, funded, supported, or regulated by a Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects; or
b.Documentation of prior review and approval of the research activities by an "Institutional Review Board" as required by 45 C.F.R. Part 46 and 21 C.F.R. Part 56.
E.Additional Requirements for Mobile Service Operations. In addition to the requirements of §§ 3.5.2(A), (B) and (C) of this Part, the applicant shall submit the following information:
1.The location where the X-ray equipment, records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.
2.A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and
3.A current copy of the applicant's operating and safety procedures including radiological practices for protection of patients, operators, employees, and the general public.
F.Signature. Each application shall be signed by the applicant or a person duly authorized to act on their behalf.
3.5.3Shielding Evaluation Required
A.Prior to routine use, but in no case later than thirty (30) days subsequent to installation of the radiation producing equipment and/or modification of the existing facility, the shielding shall be reviewed and evaluated by a person registered with the Agency to provide General Radiation Physics Services.
B.A written report of the shielding evaluation shall be provided to the facility within ten (10) days of the evaluation. The report shall specifically address any shielding and/or radiation protection deficiencies that were discovered during the evaluation and shall include recommendations for correcting these deficiencies. Any noted deficiencies shall be adequately addressed by the facility.
C.Facilities shall provide the Agency with a copy of the shielding evaluation report within ten (10) days of receipt of said report.
D.An Agency finding that an X-ray equipment facility meets appropriate radiation protection standards shall not preclude the requirement of additional modifications, should a subsequent analysis of operating conditions and/or a radiation survey indicate that an individual is likely to receive a dose in excess of the limits prescribed in §§ 1.7.1, 1.7.7 and 1.8.1 of this Subchapter.
E.Retention of Information Used to Develop Shielding Plan. After installation of radiation producing equipment, the registrant shall maintain for inspection by the Agency:
1.The maximum rated technique factors of each machine;
2.A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:
a.The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or
b.The type and thickness of materials, or lead equivalency, of each protective barrier.
3.All information required by § 3.5.3(E) of this Part shall be retained until disposal is authorized by the Agency. All required information shall be retained in an active file from at least the time of generation until the next Agency inspection. Information generated prior to the last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of said information can be retrieved until such time as the Agency authorizes final disposal.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.6** Application for Registration of X-Ray Equipment Servicing and Radiation Physics Services {#sec-216-ricr-40-20-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.6}
A.Each person who is engaged in the business of installing or offering to install X-ray radiation equipment in this State, or is engaged in the business of furnishing or offering to furnish X-ray equipment servicing to an Agency registrant, or is engaged in the business of furnishing or offering to furnish radiation physics services to an Agency registrant or licensee shall apply for registration of such installation and/or servicing or radiation physics services with the Agency prior to furnishing or offering to furnish any such servicing or services.
B.Application for Registration shall be completed on forms furnished by the Agency and shall contain all information required by the Agency as indicated on the forms and accompanying instructions, including a designated e-mail address for receipt of official Agency correspondence in electronic format.
1.An application for registration to provide X-ray equipment servicing will be accepted from either a firm or an individual.
2.An application for registration to provide radiation physics services will only be accepted from an individual. If a firm employs more than one (1) individual to provide radiation physics services, each individual shall be required to obtain a separate registration.
C.Education and Experience Requirements for Providers of Radiation Physics Services. In addition to the other requirements contained in this section, applicants for Radiation Physics Services must include documentation of the education and experience that qualify the applicant to discharge the Radiation Physics Services being requested. The minimum acceptable education and experience requirements are contained in § 3.14 of this Part. Applicants who do not explicitly meet the requirements contained in § 3.14 of this Part, but who believe they have a combination of training and/or practical experience equivalent to these requirements, may request special consideration of their situation and/or issuance of a limited Certificate of Registration by the Agency.
D.For the purpose of this Part, X-ray equipment servicing and/or radiation physics services may include but shall not be limited to:
1.Installation and/or servicing of X-ray equipment, and associated components;
2.Calibration of X-ray equipment used by Agency registrants or radiation survey instruments used by Agency registrants or licensees;
3.Radiation protection and/or radiation physics consultations or surveys, performed for Agency registrants or licensees;
4.Personnel dosimetry services.
E.Restrictions on Provision of Services
1.Persons offering the services described in § 3.6(D) of this Part shall not provide such services to any operational X-ray equipment facility or any facility utilizing radioactive materials in this State until such facility provides evidence that it has been registered or licensed with the Agency in accordance with § 3.5 of this Part or Parts 7 or 9 of this Subchapter. Persons providing the services described in § 3.6(D) of this Part to a preoperational X-ray facility or facility intending to utilize radioactive material shall inform the facility of the registration or licensing requirements of this Subchapter.
2.An individual registered with the Agency as a provider of services in accordance with § 3.6 of this Part shall only perform services that are specifically authorized for that individual on the Certificate of Registration issued by the Agency.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.7** Certificate of Registration {#sec-216-ricr-40-20-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.7}
A.No person who is required to be registered under this part shall operate an X-ray equipment facility or radiation physics service without a valid Certificate of Registration.
B.The Agency may incorporate in the Certificate of Registration at the time of issuance or thereafter by appropriate Rule, Regulation, or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use, and transfer of radiation equipment as it deems appropriate or necessary.
C.A current Certificate of Registration or legible copy thereof shall be posted conspicuously at each registered facility.
D.Except as provided by § 3.7(F) of this Part, each Certificate of Registration shall expire at the end of the specified day in the month and year stated therein.
E.Application for renewal of registration shall be filed in accordance with §§ 3.5 or 3.6 of this Part.
F.In any case in which a registrant not less than thirty (30) days prior to the expiration of his existing Certificate of Registration has filed an application in proper form for renewal, and has remitted the renewal fee, such existing Certificate of Registration shall not expire until the application status has been finally determined by the Agency.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.8** Report of Changes {#sec-216-ricr-40-20-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.8}
The registrant shall notify the Agency in writing before making any change which would render the information contained in the Application for Registration and/or the Certificate of Registration no longer accurate. In the case of disposition of an X-ray system, such notification should specify the recipient of the system. In the case of modifications involving a structural change, or the addition or relocation of an X-ray system, the Agency may require the registrant to submit the information contained in § 3.13 of this Part.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.9** Approval Not Implied {#sec-216-ricr-40-20-3-3.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.9}
No person, in any advertisement, shall refer to the fact that he or his facility is registered with the Agency pursuant to the provisions of §§ 3.5 or 3.6 of this Part and no person shall state or imply that any activity under such registration has been approved by the Agency.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.10** Assembler and/or Transfer Obligation {#sec-216-ricr-40-20-3-3.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.10}
A.Any person who sells, leases, transfers, lends, disposes, assembles, or installs X-ray equipment in this State shall notify the Agency within fifteen (15) days of:
1.The name and address of persons who have received this equipment.
2.The manufacturer, model, and serial number of each X-ray system transferred; and
3.The date of transfer of each X-ray system.
4.In the case of diagnostic X-ray systems which contain certified components, a copy of RCA Form 2579 shall be submitted to the Agency within fifteen (15) days following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.
B.No person shall make, sell, lease, transfer, lend, assemble, or install X-ray systems or the supplies used in connection with such system unless such supplies and equipment when properly placed in operation and used in this State shall meet the requirements of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.11** Waiver of Registration for Temporary Use {#sec-216-ricr-40-20-3-3.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.11}
A.Whenever any X-ray system is to be brought into the State, for any temporary use, the person proposing to bring such system into the State shall give written notice to the Agency at least two (2) working days before such machine is to be used in the State. The notice shall include:
1.The type of X-ray system;
2.The nature, duration, and scope of use;
3.The exact location(s) where the X-ray system is to be used; and
4.The State(s) in which the X-ray system is registered.
5.Upon receipt of such notification, the Agency shall determine whether a waiver of registration will be granted.
B.In addition, the out-of-State person shall:
1.Comply with all applicable Regulations of the Agency;
2.Supply the Agency with such other information as the Agency may reasonably request; and
3.Not operate within the State on a temporary basis in excess of one hundred eighty (180) calendar days per year.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.12** Registration Fees {#sec-216-ricr-40-20-3-3.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.12}
In accordance with authority granted to the Agency in R.I. Gen. Laws § 23-1.3-5(i), registration fees are payable to the Treasurer, State of Rhode Island by persons applying for registration. A current schedule of fees is available in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health. Upon approval of the application, the Agency will notify the applicant of the correct fee which is due. A Certificate of Registration will not be issued or renewed until the correct fee has been remitted. Fees which remain unpaid beyond the expiration date of the current Certificate of Registration may result in suspension of registration.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.13** Information on Radiation Shielding Required for Plan Reviews {#sec-216-ricr-40-20-3-3.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.13}
A.All X-Ray Equipment Facilities must submit the following information for plan reviews:
1.Basic facility information including:
a.Name;
b.RPS registration number and telephone number of the individual responsible for the shielding specifications;
c.Name and telephone number of the facility supervisor; and
d.The street address [including room number(s)] of the facility.
e.The plan should also indicate whether this is a new structure or a modification to existing structure(s). If the facility is currently registered, the Agency registration number must be provided.
2.All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers.
3.Secondary barriers, when required, shall be provided in all wall, floor, and ceiling areas.
4.Shielding in walls of diagnostic X-ray facilities shall extend to a minimum height of seven feet (7’) above the floor.
B.X-Ray Equipment Facilities Up To 150 kV
1.In addition to the requirements listed in § 3.13(A) of this Part, the plans for all X-ray equipment facilities which produce only photons with a maximum energy less than or equal to one hundred fifty (150) kV shall contain, as a minimum, the following additional information:
a.Equipment specifications including the make and model of the X-ray equipment, the maximum technique factors and the energy waveform (single phase, three phase, etc.).
b.The maximum design workload for the facility in terms of milliamp-minutes or milliamp-seconds per week. The total anticipated number of patients per week or number of exposures per week, as well as the type of examination(s) or treatment(s) which will be performed with the equipment, shall also be provided.
c.A facility blueprint/drawing indicating:
(1)Scale (one quarter inch (0.25”) = one foot (1’) is typical);
(2)Direction of North;
(3)Normal location of the X-ray system's radiation port(s);
(4)The port's travel and traverse limits;
(5)General direction(s) of the useful beam;
(6)Locations of any windows and doors; and
(7)The location of the X-ray control panel.
(8)If the control panel is located inside the X-ray room, the location of the operator's station shall be noted in the plan and the operator's station at the control panel shall be in compliance with § 1.7.1 of this Subchapter.
d.In X-ray facilities designed for medical use, a window (of lead equivalent at least equal to that required for the adjacent barrier), mirror or other remote viewing system shall be provided and so placed that the operator can see the patient during the exposure without having to leave the protected area.
e.The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
f.The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present.
g.At least one (1) example calculation which shows the methodology used to determine the amount of shielding required for each physical condition [i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze] and shielding material in the facility. If commercial software is used to generate shielding requirements, also identify the software used and the version/revision date.
C.X-Ray Equipment Facilities Over 150 kV
1.In addition to the requirements listed in §§ 3.13(A) and (B) of this Part, the plans for all X-ray equipment/accelerator facilities which produce photons with a maximum energy in excess of one hundred fifty (150) kV and/or electrons and/or protons or other subatomic particles shall also contain the following information:
a.Equipment specifications including: manufacturer and model number of the unit; rad (or rem) per minute at the isocenter; and the energy(s) and type(s) of radiation produced [ie: photon, electron, neutron]. The source to isocenter distance must be specified.
b.Maximum design workload for the facility including total weekly radiation output [expressed in rad (or rem)/week at one (1) meter], total beam-on time per day or week.
c.Facility blueprint/drawing (including both floor plan and elevation views) indicating:
(1)Position and orientation of the X-ray/accelerator unit, scale (one quarter inch (0.25”) = one foot (1’) is typical);
(2)Type(s) and thickness of shielding material(s);
(3)Direction of North; and
(4)The locations and size of all penetrations through each shielding barrier (ceiling, walls and floor), as well as details of the door(s) and maze.
d.The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
e.The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present.
f.Description of all assumptions that were used in shielding calculations including, but not limited to:
(1)Design energy [i.e.: room may be designed for six (6) MV unit although only a four (4) MV unit is currently proposed];
(2)Presence of integral beam-stop in unit;
(3)Workload, occupancy and use(s) of adjacent areas;
(4)Fraction of time that primary beam will intercept each permanent barrier (walls, floor and ceiling); and
(5)"Allowed" radiation exposure in both restricted and unrestricted areas.
g.At least one (1) example calculation which shows the methodology used to determine the amount of shielding required for each physical condition [i.e.: primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze] and shielding material in the facility. If commercial software is used to generate shielding requirements, also identify the software used and the version/revision date.
D.Neutron Shielding
1.In addition to the requirements listed in §§ 3.13(A) and (C) of this Part, X-ray equipment/accelerator facilities which are capable of operating above ten (10) MV shall submit shielding plans which contain, as a minimum, the following additional information:
a.The structural composition, thickness, minimum density and location of all neutron shielding material.
b.Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas.
c.At least one (1) example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition [i.e.: restricted and unrestricted areas, entry door(s) and maze] and neutron shielding material utilized in the facility. If commercial software is used to generate shielding requirements, also identify the software used and the version/revision date.
d.The method(s) and instrumentation which will be used to verify the adequacy of all neutron shielding installed in the facility.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.14** Education and Experience Requirements for Radiation Physics Services {#sec-216-ricr-40-20-3-3.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.14}
A.Radiotherapy Physics Services. Calibration and surveys of: therapeutic X-ray equipment; medical accelerators; teletherapy units, remote afterloader brachytherapy units and/or stereotactic radiosurgery units utilizing sealed radioactive sources.
1.Documentation of training sufficient to qualify as:
a.An Authorized Medical Physicist pursuant to § 9.5.11 of this Subchapter in the modality(s) for which registration is being requested; or
b.A Qualified Medical Physicist pursuant to § 5.3.4 of this Subchapter.
B.Diagnostic X-ray Physics Services. Calibration and surveys of diagnostic X-ray equipment.
1.Certification by the American Board of Radiology in:
a.Radiological physics;
b.Roentgen-ray and gamma-ray physics; or
c.X-ray and radium physics; or
d.Diagnostic radiological physics; or
e.Diagnostic medical physics; or
2.Certification by the American Board of Medical Physics in Diagnostic Imaging Physics; or
3.Hold a master's or doctor's degree in radiological physics and submit documentation of appropriate experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide Diagnostic X-ray Physics Services; or
4.Hold a master's or doctor's degree in health physics or other related radiation discipline and submit documentation of at least one (1) year of appropriate full time experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide Diagnostic X-ray Physics Services; or
5.Hold a master's or doctor's degree in a physical science and submit documentation of at least two (2) years of appropriate full time training and experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide Diagnostic X-ray Physics Services; or
6.Hold a bachelor's degree in health physics or other related radiation discipline and submit documentation of at least two (2) years of appropriate full time experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide Diagnostic X-ray Physics Services; or
7.Hold a bachelor's degree in a physical science and submit documentation of at least three (3) years of appropriate full time training and experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide Diagnostic X-ray Physics Services.
C.General Radiation Physics Services. All radiation physics services (except calibration of health physics instrumentation) for Agency registrants and/or radioactive materials licensees not covered in §§ 3.14(A) and (B) of this Part including:
1.Comprehensive certification by the American Board of Health Physics; or
2.Certification by the American Board of Radiology in
a.Radiological Physics or
b.Roentgen-ray and gamma-ray physics; or
c.X-ray and radium physics; or
d.Diagnostic radiological physics; or
e.Medical nuclear physics or nuclear medical physics; or
3.Certification by the American Board of Medical Physics in Nuclear Medicine Physics or Medical Health Physics; or
4.Hold a master's or doctor's degree in radiological physics or health physics or other related radiation discipline and submit documentation of appropriate experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide General Radiation Physics Services; or
5.Hold a master's or doctor's degree in a physical science and submit documentation of at least one (1) year of appropriate full time training and experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide General Radiation Physics Services; or
6.Hold a bachelor's degree in health physics or other related radiation discipline and submit documentation of at least one (1) year of appropriate full time experience in the area(s) for which registration is being requested. This experience must have been obtained under the supervision of an individual qualified to provide General Radiation Physics Services; or
D.Instrument Calibration Services. Calibration of health physics instrumentation for Agency registrants and/or radioactive materials licensees.
1.Compliance with the criteria required to perform any of the services contained in §§ 3.14(A), (B) or (C) of this Part; or
2.Hold at least a bachelor's degree in physics (or a closely related field such as electrical engineering) and submit documentation of at least six (6) months of appropriate full time training and experience in the calibration of health physics instrumentation.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.15** Radiation Safety Officer (RSO) Requirements {#sec-216-ricr-40-20-3-3.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.15}
3.15.1General Requirements
A.An RSO shall meet the following general requirements, as well as any applicable facility-specific requirements of § 3.15.2 of this Part.
1.Knowledge of potential radiation hazards and emergency precautions;
2.Completed educational courses related to ionizing radiation safety or a radiation safety officer course;
3.Experience in the use and familiarity of the type of equipment used.
3.15.2Facility Specific Requirements
A.Specific RSO requirements by facility are as follows.
1.Healing arts facilities subject to Part 4 of this Subchapter shall have:
a.A licensed practitioner RSO with documentation of a current unrestricted Rhode Island license; or
b.A non-practitioner RSO who meets the following requirements:
(1)An individual who has a current unrestricted license, issued in accordance with R.I. Gen. Laws Chapter 5-68.1, as a radiologic technologist, and has at least two (2) years of supervised use for the type(s) of radiation machines covered by the registration; or
(2)An individual who has a current unrestricted license, issued in accordance with R.I. Gen. Laws Chapter 5-34, as a nurse practitioner, and has at least two (2) years of supervised use for the type(s) of radiation machines covered by the registration; or
(3)An individual who has a current unrestricted license, issued in accordance with R.I. Gen. Laws Chapter 5-54, as a physician assistant, and has at least two (2) years of supervised use for the type(s) of radiation machines covered by the registration; or
(4)An individual who has a current unrestricted license, issued in accordance with R.I. Gen. Laws Chapter 5-31.1, as a dental hygienist, and has at least two (2) years of performing radiologic procedures under a dentist's instruction and direction; or
(5)An individual who has a bachelor's (or higher) degree in a natural or physical science, health physics, radiological science, nuclear medicine, or nuclear engineering.
2.Healing Arts facilities subject to Part 5 of this Subchapter shall have an individual who meets the requirements for either an Authorized User physician or qualified medical physicist, as specified in Part 5 of this Subchapter.
3.Academic institutions and/or research and development facilities shall have an RSO who is a faculty or staff member with appropriate training in radiation protection, radiation engineering, or related disciplines. (If properly qualified, this individual may also serve as the RSO over the healing arts section of the facility.)
4.Industrial radiography facilities shall have an RSO who meets the requirements specified in § 10.6.2 of this Subchapter.
5.Other industrial facilities shall have an RSO whose training and experience is sufficient to identify and control the anticipated radiation hazards.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-3 § 3.16** Duties and Responsibilities of The Radiation Safety Officer (RSO) {#sec-216-ricr-40-20-3-3.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-3#3.16}
A.Specific duties and responsibilities of the Radiation Safety Officer (RSO) include, but are not limited to, the following:
1.Establishment and oversight of operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA), and periodic review to ensure that the procedures are current and conform with this Subchapter;
2.Ensure that individual monitoring devices are properly used by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by Part 1 of this Subchapter;
3.Investigate and report to the Agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this Subchapter and each theft or loss of source(s) of radiation, determining the cause, and taking steps to prevent its recurrence;
4.Maintain a thorough knowledge of relevant management policies and administrative procedures of the registrant and keep management informed on a periodic basis of the performance of the registrant's radiation protection program, if applicable;
5.Authority to institute corrective actions including shut-down of operations when necessary in emergency situations or unsafe conditions;
6.Maintain records as required by this Subchapter; and
7.Ensure that personnel are adequately trained and complying with this Subchapter, the conditions of the Certificate of Registration, and the operating and safety procedures of the registrant.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-4** Medical Diagnostic and Interventional X-Ray and Imaging Systems
##### **216-RICR-40-20-4 § 4.1** Authority {#sec-216-ricr-40-20-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes requirements, for which a registrant is responsible, for use of diagnostic and interventional X-ray equipment and imaging systems by, or under the supervision of, an individual authorized by and licensed in accordance with applicable provisions of the R.I. Gen. Laws to engage in the healing arts or veterinary medicine. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of this Subchapter.
C.Any notifications, reports or correspondence required by this Part shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
4.1.1Incorporation by Reference
A.Except as provided in this Part, these Regulations hereby adopt and incorporate the requirements of 21 C.F.R. Part 900 (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the requirements of ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (2021) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the requirements of NCRP Report 168, Radiation Dose Management for Fluoroscopically-Guided Interventional Medical Procedures (2010) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.2** Definitions {#sec-216-ricr-40-20-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.2}
A.Whenever used in this Part, the following terms shall be construed as follows:
1."Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.
2.“Act” means R.I. Gen. Laws Chapter 23-1.3, entitled "Radiation Control."
3.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
4."Air kerma" means kerma in air (see definition of Kerma).
5."Air kerma rate” or “AKR" means the air kerma per unit time.
6."Alert value" means a dose index (e.g., of CTDIvol(mGy) or DLP(mGy-cm)) that is set by the registrant to trigger an alert to the CT operator prior to scanning within an ongoing examination. The Alert value represents a universal dose index value well above the registrant's established range for the examination that warrants more stringent review and consideration before proceeding.
7."Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. [The nominal chemical composition of type 1100 aluminum is ninety-nine percent (99.00%) minimum aluminum, twelve one hundredths of one percent (0.12%) copper.]
8."Articulated joint" means a joint between two (2) separate sections of a tabletop which joint provides the capacity of one (1) of the sections to pivot on the line segment along which the sections join.
9."Attenuation block" means a block or stack of type 1100 aluminum alloy, or aluminum alloy having equivalent attenuation, with dimensions twenty centimeters (20 cm) or larger by twenty centimeters (20 cm) or larger by three and eight tenths centimeters (3.8 cm), that is large enough to intercept the entire X-ray beam.
10."Automatic exposure control” or “AEC)" means a device which automatically controls one (1) or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation.
11."Automatic exposure rate control” or “AERC)" means a device which automatically controls one (1) or more technique factors in order to obtain, at a preselected location(s), a required quantity of radiation per unit time.
12."Barrier" (See "Primary protective barrier").
13."Beam axis" means a line from the source through the centers of the X-ray fields.
14."Beam-limiting device" means a device which provides a means to restrict the dimensions of the X-ray field.
15."Bone densitometry" means a noninvasive measurement of certain physical characteristics of bone that reflect bone strength. Test results are typically reported as bone mineral content or density and are used for diagnosing osteoporosis, estimating fracture risk, and monitoring changes in bone mineral content.
16."Bone densitometer" means a device intended for medical purposes to measure bone density and mineral content by X-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
17."C-arm fluoroscope" means a fluoroscopic X-ray system in which the image receptor and the X-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
18."Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be extended at least one hundred centimeters (100 cm) beyond the support.
19."Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the position of the image receptor during a radiographic exposure.
20."Coefficient of variation (C)" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:
where: s = Estimated standard deviation of the population
= Mean value of observations in sample
xi = ith observation in sample
and n = Number of observations in sample.
21."Computed radiography" or "CR" (also see "DR") means a digital X-ray imaging method in which a photo-stimulable phosphor is used to capture and store a latent image. The latent image is read out by stimulating the phosphor with a laser. Computed radiography systems may use cassettes to house the phosphor, or it may be integrated into a digital radiography system.
22."Computed tomography” or “CT" means the production of a tomogram by the acquisition and computer processing of X-ray transmission data.
23."Computed tomography dose index" or “CTDI” means the average absorbed dose, along the z-axis, from a series of contiguous irradiations. It is measured from one (1) axial CT scan (one (1) rotation of the X-ray tube) and is calculated by dividing the integrated absorbed dose by the nominal total beam collimation. The scattering media for CTDI consist of two (2) (sixteen (16) and thirty-two (32) centimeters in diameter) polymethylmethacrylate (PMMA, e.g., acrylic or Lucite) cylinders of fourteen centimeters (14 cm) length. The equation is:
where:
D(z) = the radiation dose profile along the z-axis,
N = the number of tomographic sections imaged in a single axial scan. This is equal to the number of data channels used in a particular scan. The value of N may be less than or equal to the maximum number of data channels available on the system, and
T = the width of the tomographic section along the z-axis imaged by one (1) data channel. In multiple-detector-row (multislice) CT scanners, several detector elements may be grouped together to form one (1) data channel. In single-detector-row (single-slice) CT, the z-axis collimation (T) is the nominal scan width.
24."CTDI100" means the accumulated multiple scan dose at the center of a one hundred millimeter (100 mm) scan and underestimates the accumulated dose for longer scan lengths. It is thus smaller than the equilibrium dose. The CTDI100, requires integration of the radiation dose profile from a single axial scan over specific integration limits. In the case of CTDI100, the integration limits are + fifty millimeters (50 mm), which corresponds to the one hundred millimeters (100 mm) length of the commercially available “pencil” ionization chamber. CTDI100 is acquired using a one hundred millimeter (100 mm) long, three (3) cc active volume CT “pencil” ionization chamber and one (1) of the two (2) standard CTDI acrylic phantoms (sixteen (16) and thirty-two (32) centimeters diameter) and a stationary patient table. The equation is:
25."Cone beam computed tomography” or “CBCT" means a volumetric imaging modality. Volumetric data are acquired using two-dimensional digital detector arrays, and a cone-shaped X-ray beam (instead of fan-shaped) that rotates around the patient. Reconstruction algorithms can be used to generate images of any desired plane.
26."Control panel" means that part of the X-ray control upon which are mounted the switches, knobs, pushbuttons, keypads, touchscreens, and other hardware necessary for manually setting the technique factors.
27."Cradle" means:
a.A removable device which supports and may restrain a patient above an X-ray table; or
b.A device:
(1)Whose patient support structure is interposed between the patient and the image receptor during normal use;
(2)Which is equipped with means for patient restraint; and
(3)Which is capable of rotation about its long (longitudinal) axis.
28."CT conditions of operation" means all selectable parameters governing the operation of a CT X-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in § 4.2 of this Part.
29."CT gantry" means tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components within a computed tomography system.
30."CT number" means the number used to represent the X-ray attenuation associated with each elemental area of the CT image:
where: k = A constant, a normal value of one thousand (1,000) when the Hounsfield scale of CT number is used;
ux = Linear attenuation coefficient of the material of interest; and
uw = Linear attenuation coefficient of water.
31."Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.
32."Detector" (See "Radiation detector").
33."Diagnostic reference level” or “DRL” means an investigational level used to identify unusually high radiation doses or dose rates for common medical X-ray imaging procedures. DRLs are suggested action levels above which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses. DRLs should not be applied to an individual patient.
34."Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.
35."Diagnostic X-ray system" means an X-ray system designed for irradiation of any part of the human [or animal] body for the purpose of diagnosis or visualization.
36."Digital radiography” or “DR" means an X-ray imaging method (or radiography) which produces a digital rather than analog image. DR includes both computed radiography and direct digital radiography.
37."Direct digital radiography” or “DDR” (also see "CR" and "DR") means an X-ray imaging method in which a digital sensor, usually incorporating a thin-film transistor, is used to capture an X-ray image. Some DDR systems use a scintillator to convert X-rays to light and a photodiode array to convert light to charge, while others use a photoconductor to convert X-rays directly to charge, which is stored on the thin-film transistor.
38."Direct scattered radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").
39."Direct supervision" means a qualified licensed practitioner must exercise general supervision and be present in the facility and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the licensed practitioner must be present in the room when the procedure is being performed.
40."Dose" means the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name of the unit of absorbed dose is gray (Gy).
41."Dose area product," “DAP,” a/k/a "kerma-area product," or “KAP” means the product of the air kerma and the area of the irradiated field and is typically expressed in Gy-cm2, so it does not change with distance from the X-ray tube.
42."Dose length product" or “DLP” means the indicator of the integrated radiation dose from a complete CT examination. It addresses the total scan length by the formula: DLP (mGy-cm) = CTDIvol (mGy) x scan length (cm).
43."Dose profile" means the dose as a function of position along a line.
44."Effective dose" or "E" means the sum of the tissue-weighted equivalent doses for the radiosensitive tissues and organs of the body. It is given by the expression E = ST (wT HT), in which HT is the equivalent dose in tissue or organ T and wT is the tissue weighting factor for tissue or organ T. The unit of E and HT is joule per kilogram (J·kg-1), with the special name sievert (Sv).
45."Equipment" (See "X-ray equipment") means X-ray equipment.
46."Exposure" or "X" means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg. A second meaning of exposure is the process or condition during which the X-ray tube produces X-ray radiation.
47."Field emission equipment" means equipment which uses an X-ray tube in which electron emission from the cathode is due solely to the action of an electric field.
48."Filter" means material placed in the useful beam to preferentially absorb selected radiations.
49."Fluoroscopic imaging assembly" means a subsystem in which X-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
50."Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling X-ray tube activation in any fluoroscopic mode of operation.
51."Fluoroscopically-guided interventional procedures" or "FGI procedures" means an interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy.
52."Fluoroscopy" means a technique for generating X-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term “radioscopy” in the standards of the International Electrotechnical Commission.
53."Focal spot (actual)" means the area projected on the anode of the X-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.
54."General purpose radiographic X-ray system" means any radiographic X-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.
55."General supervision" means the procedure is performed under the overall direction and control of the qualified licensed practitioner but who is not required to be physically present during the performance of the procedure.
56."Half-value layer" or "HVL" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one half (1/2) of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
57."Healing arts screening" means the testing of human beings using X-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such X-ray tests for the purpose of diagnosis or treatment.
58."Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.
59."Image intensifier" means a device, installed in its housing, which instantaneously converts an X-ray pattern into a corresponding light image of higher intensity.
60."Image receptor" means any device, such as a fluorescent screen, radiographic film, X-ray image intensifier tube, solid-state detector, or gaseous detector which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term “image receptor” shall mean the preselected portion of the device.
61."Irradiation" means the exposure of matter to ionizing radiation.
62."Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.
63."Kerma" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged particles liberated by uncharged particles in a mass dm of material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as "air kerma."
64."Kerma-area product” or “KAP" (See "dose area product").
65."Kilovolts peak" (See "Peak tube potential").
66."kV" means kilovolts.
67."kWs" means kilowatt second.
68."Last-image hold radiograph" or "LIH radiograph" means an image obtained either by retaining one (1) or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.
69."Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
70."Leakage radiation" means radiation emanating from the diagnostic source assembly except for:
a.The useful beam; and
b.Radiation produced when the exposure switch or timer is not activated.
71."Leakage technique factors" means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:
a.For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being ten (10) millicoulombs (or ten (10) mAs) or the minimum obtainable from the unit, whichever is larger;
b.For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of X-ray pulses in an hour for operation at the maximum-rated peak tube potential; and
c.For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.
72."Light field" means that area of the intersection of the light beam from the beam-limiting device and one (1) of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one fourth (1/4) of the maximum in the intersection.
73."Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential; that is, Percent line-voltage regulation = 100 (Vn-Vl)/Vl, where: Vn = No-load line potential; and Vl = Load line potential.
74."mA" means milliampere.
75."mAs" means milliampere second.
76."Mode of operation" means, for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, X-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.
77."Multiple tomogram system" means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.
78.“Noise” means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
where µx = Linear attenuation coefficient of the material of interest, µw = Linear attenuation coefficient of water, and s = Estimated standard deviation of the CTN of picture elements in a specified area of the CT image.
79."Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which X-ray transmission data are collected.
80."Notification value" means a protocol-specific dose index (e.g., CTDIvol(mGy) or of DLP(mGy-cm)) that is set by the registrant to trigger a notification to the CT operator prior to scanning when the dose index exceeds the established range for the examination.
81."Patient" means an individual or animal subjected to healing arts examination, diagnosis or treatment.
82."Picture element" means an elemental area of a tomogram.
83."PBL” (See "Positive beam limitation").
84."Peak tube potential" means the maximum value of the potential difference across the X-ray tube during an exposure.
85."Personal supervision" means a qualified practitioner must exercise General Supervision and be present in the room or adjacent control area during the performance of the procedure.
86."Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.
87."Photostimulable storage phosphor” or “PSP" means a material used to capture and store radiographic images in computed radiography systems.
88."Pitch" means the table incrementation, in CT, per X-ray tube rotation, divided by the nominal X-ray beam width at isocenter.
89."Position indicating device” or “PID" means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
90."Positive beam limitation" means the automatic or semi-automatic adjustment of an X-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.
91."Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure (beyond the patient and cassette holder) for protection purposes.
92."Protective garment" means a garment made of radiation absorbing materials used to reduce radiation exposure.
93."Protocol" means a collection of settings and parameters that fully describe an examination.
94."Pulsed mode" means operation of the X-ray system such that the X-ray tube current is pulsed by the X-ray control to produce one or more exposure intervals of duration less than one half (1/2) second.
95."Quality assurance" means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities as required.
96.“Qualified medical physicist” or “QMP” (for activities authorized pursuant to this Part) means an individual registered to provide Radiation Physics Services (Diagnostic X-ray Physics Services) in accordance with § 3.6 of this Subchapter.
97."Radiation detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one (1) or more quantities of incident radiation.
98.“Radiation medical event” means an event that meets the criteria in § 4.4.14(A) of this Part.
99."Radiation protocol committee” or “RPC" means the representative group of qualified individuals in a CT or FGI facility responsible for the ongoing review and management of CT or FGI protocols to ensure that exams being performed achieve the desired diagnostic image quality at the lowest radiation dose possible while properly exploiting the capabilities of the equipment being used.
100."Radiation therapy simulation system" means a radiographic or fluoroscopic X-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
101."Radiograph" means an image receptor on which the image is created directly or indirectly by an X-ray pattern and results in a permanent record.
102."Radiography" means a technique for generating and recording an X-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.
103."Recording" means producing a retrievable form of an image resulting from X-ray photons.
104."Reference plane" means a plane which is parallel to and which can be offset (as specified in manufacturer information provided to users) from the location of the tomographic plane(s).
105.“Registrant” means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this Subchapter and the Act.
106.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
107."Scan" means the complete process of collecting X-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one (1) or more tomograms.
108."Scan increment" means the amount of relative displacement of the patient with respect to the CT X-ray system between successive scans measured along the direction of such displacement.
109."Scan sequence" means a pre-selected set of two (2) or more scans performed consecutively under pre-selected CT conditions of operation.
110."Scan time" means the time elapsed during the accumulation of X-ray transmission data for a single scan.
111."Scattered radiation" means radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").
112."Sensitivity profile" means the relative response of the CT X-ray system as a function of position along a line perpendicular to the tomographic plane.
113."Single tomogram system" means a CT X-ray system which obtains X-ray transmission data during a scan to produce a single tomogram.
114."Shutter" means a device attached to the tube housing assembly which can intercept the entire cross-sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
115."Size-specific dose estimate" or “SSDE” means a patient dose estimate which takes into consideration corrections based on the size of the patient, using linear dimensions measured on the patient or patient images.
116."Source" means the focal spot of the X-ray tube.
117."Source-image receptor distance" or “SID” means the distance from the source to the center of the input surface of the image receptor.
118."Source-skin distance" or “SSD” means the distance from the source to the center of the entrant X-ray field in the plane tangent to the patient skin surface.
119."Spot-film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure. Digital image receptors used in place of film with spot-film devices should be considered "spot-film."
120."Spot-film device" means a device intended to transport and/or position a radiographic image receptor between the X-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph.
121."Stray radiation" means the sum of leakage and scattered radiation.
122."Substantial radiation dose level” or “SRDL” means an appropriately-selected dose used to trigger additional dose-management actions during a procedure and medical follow-up for a radiation level that might produce a clinically-relevant injury in an average patient.
123.“Technique factors” means the following conditions of operation:
a.For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);
b.For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of X-ray pulses;
c.For CT X-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, X-ray pulse width in seconds, and the number of X-ray pulses per scan, or the product of tube current, X-ray pulse width, and the number of X-ray pulses in mAs;
d.For CT X-ray systems not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and
e.For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.
124."Tomogram" means the depiction of the X-ray attenuation properties of a section through the body.
125."Tomographic plane" means that geometric plane which the manufacturer identified as corresponding to the output tomogram.
126."Tomographic section" means the volume of an object whose X-ray attenuation properties are imaged in a tomogram.
127."Tube" means an X-ray tube, unless otherwise specified.
128."Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
129."Unintended" (radiation dose in diagnostic or interventional X-ray) means a patient radiation dose resulting from a human error or equipment malfunction during the procedure.
130."Useful beam" means the radiation which passes through the tube housing port and the aperture of the beam limiting device when the exposure switch or timer is activated.
131."Visible area" means that portion of the input surface of the image receptor over which incident X-ray photons are producing a visible image.
132."Volume computed tomography dose index” or “CTDIvol" means a radiation dose parameter derived from the CTDIw (weighted or average CTDI given across the field of view). The formula is: CTDIvol = (N)(T)(CTDIw)/I, where N = number of simultaneous axial scans per X-ray source rotation, T = thickness of one axial scan (mm), and I = table increment per axial scan (mm). Thus, CTDIvol = CTDIw / pitch.
133."Weighted computed tomography dose index” or “CTDIwa” means the estimated average CTDI100 across the field of view (FOV). The equation is: CTDIw = 1/3 CTDI100,center + 2/3 CTDI100,edge
Where one third (1/3) and two thirds (2/3) approximate the relative areas represented by the center and edge values derived using the sixteen (16) or thirty-two (32) centimeters acrylic phantom. CTDIw uses CTDI100 and an f-factor for air (0.87 rad/R or 1.0 mGy/mGy).
134."X-ray control" means a device which controls input power to the X-ray high-voltage generator and/or the X-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an X-ray exposure.
135."X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The X-ray exposure control may include such associated equipment as timers and back-up timers.
136."X-ray equipment" means an X-ray system, subsystem, or component thereof. Types of X-ray equipment are as follows:
a."Mobile X-ray equipment" means X-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled;
b."Portable X-ray equipment" means X-ray equipment designed to be hand-carried; and
c."Stationary X-ray equipment" means X-ray equipment which is installed in a fixed location.
d."Hand-held X-ray equipment" means X-ray equipment that is designed to be hand-held during operation.
137."X-ray field" means that area of the intersection of the useful beam and any one of a set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one fourth (1/4) of the maximum in the intersection.
138."X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the X-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the X-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.
139."X-ray system" means an assemblage of components for the controlled production of X-rays. It includes minimally an X-ray high-voltage generator, an X-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.
140."X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop.
141."X-ray tube" means any electron tube which is designed for the conversion of electrical energy into X-ray energy.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.3** General and Administrative Requirements {#sec-216-ricr-40-20-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.3}
4.3.1Administrative Controls
A.The registrant shall be responsible for directing the operation of the X-ray system(s) under their administrative control. The registrant or the registrant's agent shall assure that the requirements of this Subchapter are met in the operation of the X-ray system(s).
B.The registrant shall have a radiation safety program. The radiation safety program shall include but not be limited to the following:
1.The use of ionizing radiation within its purview is performed in accordance with the Act and Agency Regulations.
2.All persons are protected as required by Part 1 of this Subchapter.
C.The registrant shall have a mechanism in place for the referring physician to access information on selecting the most appropriate diagnostic procedure to answer the clinical question.
D.The registrant shall utilize nationally recognized diagnostic reference levels (DRLs) when applicable.
E.The registrant shall select the appropriate technique and employ available dose reduction methods and technologies across all patient sizes and clinical indications.
F.Each registrant shall have a documented procedure in place for verification of patient identity and exam to be performed, including identification of the appropriate body part.
G.All X-ray equipment shall be installed and used in accordance with the equipment manufacturer’s specifications.
4.3.2Operation Prohibited
An X-ray system which does not meet the provisions of this Part shall not be operated for diagnostic purposes unless the Agency or a Qualified Medical Physicist determines that the non-compliance will not pose a significant radiation risk or significantly affect image quality, and arrangements have been made to correct the non-compliance within thirty (30) days.
4.3.3Individuals Operating X-ray Systems for Healing Arts Use
A.Individuals who will be operating the X-ray systems for healing arts use shall possess a current license in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, and Radiation Therapists, unless the individual is specifically exempted from licensure by said Regulations. Individuals who will be operating the X-ray systems and who are not subject to licensure under Subchapter 05 Part 34 of this Chapter shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. As a minimum, such instruction shall consist of subjects outlined in § 4.12 of this Part.
B.The names and qualifications of all personnel operating X-ray equipment for healing arts use must be kept on file for Agency inspection at each facility location.
C.All individuals operating, or supervising the operation of, fluoroscopic X-ray systems shall have completed a minimum of four (4) hours training, prior to performing fluoroscopy procedures that includes but is not limited to the following:
1.Biological effects of X-ray;
2.Radiation protection methods for patients and staff;
3.Factors affecting fluoroscopic outputs;
4.Dose management including dose reduction techniques, monitoring, and recording;
5.Principles and operation of the specific fluoroscopic X-ray system(s) to be used;
6.Fluoroscopic and fluorographic outputs of each mode of operation on the system(s) to be used clinically;
7.Basic properties of radiation;
8.Units of measurement and dose, including DAP (dose-area product) values and air kerma;
9.High level control options; and
10.Applicable requirements of this Subchapter.
D.All persons operating, or supervising the operation of, fluoroscopy systems during fluoroscopically-guided interventional (FGI) procedures shall have completed a minimum of eight (8) hours of training approved by the Agency. The training shall include, but not be limited to:
1.The topics provided in § 4.3.3(C) of this Part;
2.Methods to reduce patient dose using advanced imaging and recording features;
3.Procedures for recording pertinent data specified in § 4.5.13 of this Part; and
4.A minimum of one (1) hour of hands-on fluoroscopic machine training demonstrating application of topics required in § 4.3.3(D) of this Part.
E.The training required §§ 4.3.3(C) and (D) of this Part shall be provided by a Qualified Medical Physicist or another individual approved by the Agency.
F.The registrant shall either provide a minimum of two (2) hours in-service training for all individuals operating or supervising the operation of fluoroscopy systems used, at intervals not to exceed twenty-four (24) months or require evidence of continuing medical education, in fluoroscopic radiation safety and patient dose management at intervals not to exceed twenty-four (24) months.
G.Documentation pertaining to the requirements of §§ 4.3.3(B), (C) and (D) of this Part shall be maintained for review for three (3) years.
H.A dental facility registrant shall provide initial training and shall ensure that X-ray operators have completed a course in dental radiography offered by an educational institution with a program accredited by the commission on dental accreditation (§ 05-2.10.3(A)(11) of this Chapter). Annual evaluations of X-ray operators to include but not limited to: positioning of the X-ray tube, image processing, operator location during X-ray exposure, source to skin distance, radiation protection, appropriate radiographic protocol, and applicable regulatory requirements. Records of training and annual evaluations shall be maintained for inspection by the Agency for three (3) years.
4.3.4Technique Protocols
A.For general radiographic systems not equipped with an operational anatomic programming option, protocols shall be documented and readily available to the operator. At a minimum, these protocols shall include the following information:
1.Patient's (adult or pediatric, as applicable) body part and anatomical size;
2.Technique factors;
3.Type of the image receptor to be used;
4.Source to image receptor distance to be used (except for dental intraoral radiography, which shall list cone length to be used); and
5.Type of grid, if any.
4.3.5Written Safety Procedures
The registrant of a facility shall create and make available to X-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with these procedures.
4.3.6Room Occupancy During Radiographic Exposure
A.The registrant shall restrict the presence of individuals in the immediate area of the patient being examined, while the X-ray tube is energized, to those required and, as applicable, those in training for the medical procedure, or the parent or guardian of a patient. The following applies to all individuals, other than the patient being examined:
1.All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than one half millimeter (0.5 mm) lead equivalent material.
2.All individuals shall be protected from the secondary radiation by protective garments or whole-body protective barriers of not less than twenty-five one hundredths of one quarter millimeter (0.25 mm) lead equivalent material.
3.Instances may warrant having human patients other than the one being examined in the room during the exam. If the procedure results in scatter radiation in excess of two one hundredths (0.02) mSv (2 mR) in any one (1) hour at the position of these patients, such patients shall be protected from the direct scatter radiation by whole body protective barriers of not less than twenty-five one hundredths of one quarter millimeter (0.25 mm) lead equivalent material or shall be positioned so that the two one hundredths (0.02) mSv (2 mR) in any one (1) hour limit is met.
4.Written safety procedures, as required by § 4.3.5 of this Part, shall describe how the requirements of this section will be met when using mobile or portable X-ray systems.
4.3.7[Reserved]
4.3.8Non-Healing Arts Exposure Prohibited
Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes, and exposure of an individual for the purpose of healing arts screening except as authorized by § 4.3.12 of this Part.
4.3.9When a Patient or Image Receptor Must be Provided with Auxiliary Support During a Radiation Exposure
A.In cases where a patient or image receptor must be provided with auxiliary support, mechanical support devices shall be used whenever possible. The written safety procedures, required by § 4.3.5 of this Part, shall list individual projections where holding devices cannot be utilized;
B.Written safety procedures, as required by § 4.3.5 of this Part, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;
C.The human holder shall be instructed in personal radiation safety and protected as required by § 4.3.6 of this Part;
D.No individual shall be used routinely to hold image receptor or patients during a radiation exposure; and
E.Each facility shall have protective garments (e.g., aprons, gloves, collars) and shields available in sufficient numbers to provide protection for all personnel who are involved with X-ray operations and who are otherwise not shielded.
1.All protective apparel and auxiliary shields shall be evaluated annually for integrity and clearly labeled with their lead equivalence.
F.A record shall be made of the examination and shall include the name of the human holder, date of the examination, number of exposures and technique factors utilized for the exposure(s).
4.3.10Procedures and Auxiliary Equipment Designed to Minimize Patient and Personnel Exposure Commensurate with The Needed Diagnostic Information Shall Be Utilized
A.The fastest imaging system consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.
B.The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality. The registrant shall use auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.
C.Portable or mobile X-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary X-ray installation.
D.X-ray Film Processing Facilities. A registrant using analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions.
1.Manually Developed Film
a.The temperature of solutions in the tanks shall be maintained within the range of sixty degrees Fahrenheit (60º F) to eighty degrees Fahrenheit (80º F) (sixteen degrees Celsius (16º C) to twenty-seven degrees Celsius (27º C)). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart:
Manual Film Developing Technique Chart
Developer Temperature °C/°F
Developing Time (Minutes)
Developer Temperature °C/°F
Developing Time (Minutes)
26.7/80
2.0
20.6/69
4.5
26.1/79
2.0
20.0/68
5.0
25.6/78
2.5
19.4/67
5.5
25.0/77
2.5
18.9/66
5.5
24.4/76
3.0
18.3/65
6.0
23.9/75
3.0
17.8/64
6.5
23.3/74
3.5
17.2/63
7.0
22.8/73
3.5
16.7/62
8.0
22.2/72
4.0
16.1/61
8.5
21.7/71
4.0
15.6/60
9.5
21.1/70
4.5
b.Devices shall be utilized which will:
(1)Indicate the actual temperature of the developer; and
(2)Give an audible or visible signal indicating the termination of a preset time.
c.Developing tanks shall be constructed of mechanically rigid, corrosion resistant material.
d.Developing solutions shall be prepared, replenished, and replaced following manufacturer recommendations.
2.Automatic Developers and Other Closed Developing Systems
a.Films shall be developed in accordance with the time temperature relationships recommended by the film manufacturer or, in the absence of such recommendations, with the following time-temperature chart; and
Developer Temperature
Minimum Immersion Timea/
°C
°F
Seconds
35.5
96
19
35
95
20
34.5
94
21
34
93
22
33.5
92
23
33
91
24
32
90
25
31.5
89
26
31
88
27
30.5
87
28
30
86
29
29.5
85
30
a/ Immersion time only, no crossover time included.
b.Developing deviations from the requirements of § 4.3.10(D)(2)(a) of this Part shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).
c.Automatic developers shall be operated and maintained following manufacturer specifications.
E.Additional Requirements for Facilities Using Analog Image Receptors
1.Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.
2.Facilities shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six (6) months and after any change that may impact film fog.
3.Darkrooms typically used by more than one (1) individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.
4.Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light-tight container.
5.Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to assure radiographs of good diagnostic quality.
6.Outdated X-ray film shall not be used for diagnostic radiographs.
7.The film and intensifying screen shall be spectrally compatible.
8.Facilities other than dental, podiatry, and veterinary facilities shall:
a.Have a continuous and documented sensitometric quality control program, including quality control tests for speed, contrast and fog. These tests shall be performed according to specifications of the manufacturer, a Qualified Medical Physicist, or a nationally recognized organization.
b.Maintain a light-tight darkroom and use proper safelighting such that any film type in use exposed in a cassette to X-ray radiation sufficient to produce an optical density from one (1) to two (2) when developed shall not suffer an increase in density greater than one tenth (0.1) when exposed in the darkroom for two (2) minutes with all safelights on. If used, daylight film handling systems shall preclude fogging of the film.
c.Limit the base plus fog of unexposed film to an optical density less than twenty-five one hundredths (0.25) when developed by the routine procedure used by the facility.
F.Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR).
1.When exposure indicators are available, the facility shall establish and document an acceptable range for the exposure values for examinations routinely performed at the facility. The indicated exposure values for each image shall be compared to the established range. Consistent deviations from established ranges shall be investigated, corrective actions taken as necessary, and results documented.
2.CR facilities shall perform at least weekly erasure of all CR cassettes.
G.Dental Facilities
1.If using film, the facility shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six (6) months and after any change that may impact film fog.
2.If using a filmless system, the facility shall maintain and operate photostimulable storage phosphor (PSP) and DDR systems according to manufacturer specifications.
4.3.11Additional Compliance Required
All individuals who are associated with the operation of an X-ray system are subject to the applicable requirements of Parts 1 and 2 of this Subchapter.
4.3.12Healing Arts Screening
Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in § 4.11 of this Part. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified.
4.3.13Information and Maintenance Record and Associated Information
A.The registrant shall maintain the following information. The information shall be maintained in a separate file or package in chronological order for each X-ray system, for a minimum of five (5) years or as noted below:
1.Maximum rating of technique factors;
2.Model and serial numbers of all major components, and user's manuals for those components, including software, shall be maintained for the life of the system;
3.Aluminum equivalent filtration in the useful beam, including any routine variation;
4.Tube rating charts and cooling curves;
5.Records of surveys, calibrations, maintenance, and modifications (e.g., major software and hardware upgrades) performed on the X-ray system(s), with the names of the persons who performed such services;
6.A scale drawing of the room in which a stationary X-ray system is located with such drawing indicating the current use of areas adjacent to the room and an estimate of the extent of occupancy by an individual in such areas. In addition, the drawing shall include the results of a survey for radiation levels present at the operator's position, and at pertinent points outside the room at specified test conditions; or the type and thickness of materials, or lead equivalency, of each protective barrier.
7.A copy of all correspondence with this Agency regarding that X-ray system.
4.3.14X-ray Utilization Log
A.Except for veterinary facilities, each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed. The record shall also include the following information:
1.Name of the licensed practitioner of the healing arts ordering the examination.
2.Name(s) of individuals who performed the examination.
3.Any deviation from the standard procedure as specified on the technique chart, including all repeat exposures.
4.When applicable, the X-ray system used.
5.When the patient or image receptor must be provided with human auxiliary support, the name of the human holder.
B.X-ray utilization logs shall be maintained for a minimum of five (5) years following the examination or treatment of adult patients. Records of examination or treatment of minors shall be maintained for a minimum of five (5) years beyond the age of majority.
C.If X-ray utilization logs are stored electronically, records shall be maintained in a manner that will allow retrieval of records for any specified time period.
D.Each veterinary facility shall maintain a record containing the type of examinations and the dates the examinations were performed. The record shall also include the following information:
1.Name(s) of individuals who performed the examination;
2.Any deviation from the standard procedure as specified on the technique chart, including all repeat exposures;
3.When applicable, the X-ray system used; and
4.When the patient or image receptor must be provided with human auxiliary support, the name of the human holder.
4.3.15Report and Notification of a Dose to an Embryo/Fetus
A.A registrant shall report any dose to an embryo/fetus that is greater than fifty (50) mSv (five (5) rem) dose equivalent that is a result of an administration of radiation to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the prescribing physician.
B.The registrant shall notify the Agency by telephone no later than the next business day after discovery of a dose to the embryo/fetus that requires a report in § 4.3.15(A) of this Part.
C.The registrant shall submit a written report, prepared by a Qualified Medical Physicist, to the Agency within fifteen (15) business days after discovery of a dose to the embryo/fetus that requires a report in § 4.3.15(A) of this Part.
1.The written report must include:
a.The registrant's name and registration number;
b.The name of the prescribing physician;
c.A brief description of the event;
d.Why the event occurred;
e.The effect, if any, on the embryo/fetus;
f.What actions, if any, have been taken or are planned to prevent recurrence; and
g.Certification that the registrant notified the mother (or the mother's or child's responsible relative or guardian), and if not, why not.
2.The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.
D.The registrant shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than twenty-four (24) hours after discovery of an event that would require reporting under § 4.3.15(A) of this Part, unless the referring physician personally informs the registrant either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The registrant is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within twenty-four (24) hours, the registrant shall make the appropriate notifications as soon as possible thereafter. The registrant may not delay any appropriate medical care for the embryo/fetus, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the pregnant individual. If a verbal notification is made, the registrant shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested.
E.A registrant shall:
1.Annotate a copy of the report provided to the Agency with the:
a.Name of the pregnant individual who is the subject of the event; and
b.Identification number or if no other identification number is available, the Social Security Number of the pregnant individual who is the subject of the event; and
2.Provide a copy of the annotated report to the referring physician, if other than the registrant, no later than fifteen (15) days after the discovery of the event.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.4** General Requirements for All Diagnostic and Interventional X-ray Systems {#sec-216-ricr-40-20-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.4}
4.4.1Applicability
In addition to other requirements of this Part, all diagnostic and interventional X-ray systems shall meet the requirements of § 4.4 of this Part. Requirements specific to dental intra-oral, panoramic, cephalometric, volumetric dental imaging equipment are included in § 4.14 of this Part.
4.4.2Maintaining Compliance
Diagnostic and interventional X-ray systems and their associated components used on humans and certified pursuant to the Federal X-ray Equipment Performance Standard (21 C.F.R. Part 1020) shall be maintained in compliance with applicable requirements of that standard.
4.4.3Warning Label
A.On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear the following warning statement, or the warning statement in § 4.4.3(B) of this Part, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
B.On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the following warning statement, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."
4.4.4Battery Charge Indicator
On battery-powered X-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
4.4.5Leakage Radiation from the Diagnostic Source Assembly
The leakage radiation from the diagnostic source assembly measured at a distance of one meter (1 m) in any direction from the source shall not exceed eighty-eight one hundredths milligray (0.88 mGy) air kerma [one hundred milliroentgen (100 mR) exposure] in one (1) hour when the X-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum X-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).
4.4.6Radiation from Components Other Than the Diagnostic Source Assembly
The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of eighteen (18) µgray [two (2) milliroentgens exposure] in one (1) hour at five centimeters (5 cm) from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).
4.4.7Beam Quality
A.Half-Value Layer (HVL)
1.The HVL of the useful beam for a given X-ray tube potential shall not be less than the values shown in § 4.4.7(B) of this Part [Table 1], If it is necessary to determine such half-value layer at an X-ray tube potential which is not listed in § 4.4.7(B) of this Part [Table 1], linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one (1) thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent X-ray emissions if the minimum required filtration is not in place.
2.Optional Filtration on Fluoroscopic Systems. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an X-ray tube(s) with a continuous output of one (1) kilowatt or more and an anode heat storage capacity of one million (1,000,000) heat units or more shall provide the option of adding X-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions of § 4.4.7(A)(1) of this Part. The selection of this additional X-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the X-ray beam shall be provided.
B.Table 1 – X-Ray Tube Voltage (kilovolt peak)
Design Operating Range
Measured Operating Potential
Minimum HVL (mm in Aluminum)
Subject to § 4.4.7 of this Part and manufactured before June 10, 2006)
X-Ray Systems subject to § 4.4.7 of this Part and manufactured on or after June 10, 2006)
Below 51
30
0.3
0.3
40
0.4
0.4
50
0.5
0.5
51 to 70
51
1.2
1.3
60
1.3
1.5
70
1.5
1.8
Above 70
71
2.1
2.5
80
2.3
2.9
90
2.5
3.2
100
2.7
3.6
110
3.0
3.9
120
3.2
4.3
130
3.5
4.7
140
3.8
5.0
150
4.1
5.4
C.Measuring Compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.
D.Aluminum Equivalent of Material Between Patient and Image Receptor. Except when used in a CT X-ray system, the aluminum equivalent of each of the items listed in § 4.4.7(E) of this Part [Table 2], which are used between the patient and the image receptor, may not exceed the indicated limits. Compliance shall be determined by X-ray measurements made at a potential of one hundred (100) kilovolts peak and with an X-ray beam that has an HVL specified in § 4.4.7(B) of this Part [Table 1] for the potential. This requirement applies to front panel(s) of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.
E.Table 2 – Maximum Aluminum Equivalent (millimeters)
ITEM
Maximum Aluminum Equivalent (millimeters)
1. Front panel(s) of cassette holders (total of all)
1.2
2. Film panel(s) of film changer (total of all)
1.2
3. Cradle
2.3
4. Tabletop, stationary, without articulated joints
1.2
5. Tabletop, movable, without articulated joint(s) (including stationary subtop)
1.7
6. Tabletop, with radiolucent panel having one articulated joint
1.7
7. Tabletop, with radiolucent panel having two or more articulated joints
2.3
8. Tabletop, cantilevered
2.3
9. Tabletop, radiation therapy simulator
5.0
F.Modification of Certified Diagnostic X-ray Components and Systems
1.Diagnostic X-ray components and systems certified in accordance with 21 C.F.R. Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this Part.
2.The owner of a diagnostic X-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this Part. The owner who causes such modification need not submit the reports required by this Subchapter, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the X-ray system does not result in a failure to comply with this Subchapter.
4.4.8Multiple Tubes
Where two (2) or more radiographic tubes are controlled by one (1) exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the X-ray control panel and at or near the tube housing assembly which has been selected.
4.4.9Mechanical Support of Tube Head
The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.
4.4.10Technique Indicators
A.For X-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.
B.The requirement of § 4.4.10(A) of this Part may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.
C.The accuracy of the indicated kilovoltage peak (kVp) shall meet manufacturer specifications. In the absence of a manufacturer specification, kVp accuracy shall be within ± ten percent (10%).
4.4.11Structural Shielding
Structural shielding shall be provided whenever necessary to meet the requirements of §§ 1.7.1 and 1.8.1 of this Subchapter, in addition to specific requirements contained in other Parts of this Subchapter.
4.4.12Locks
All position locking, holding, and centering devices on X-ray system components and systems shall function as intended.
4.4.13Use of Calibrated Dosimetry System
Measurements required in §§ 4.10.1(A)(3), (4) and (5) of this Part shall be performed with a calibrated dosimetry system per manufacturer recommendations. The calibration of such a system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two (2) years and records of calibration maintained for five (5) years for inspection by the Agency.
4.4.14Reports and Notifications of Radiation Medical Events
A.Other than events that result from intervention by a patient or human research subject, a registrant shall report any event in which the administration of ionizing radiation from a diagnostic radiation machine meets one (1) or more of the following criteria:
1.A patient or human research subject receives an unintended skin dose to the same area in a single procedure greater than two (2) Gy [two hundred (200) rads].
2.A patient or human research subject receives an unintended dose other than skin dose in a single procedure greater than:
a.Five (5) times the facility’s established protocol, and > 0.5 Gy (50 rad) to any organ; or
b.Five (5) times the facility’s established protocol, and > 0.05 Sv (5 rem) total effective dose.
3.Wrong patient or wrong site for the entire procedure when the resultant dose:
a.> 0.5 Gy (50 rad) to any organ; or
b.Total Effective dose is greater than or equal to ( =) 0.05 Sv (5 rem).
B.Any wrong patient or wrong site imaged regardless of dose received shall be reported, documented and addressed internally within the facility.
C.The registrant shall notify the Agency by telephone no later than the next business day after discovery of the radiation medical event.
1.All required notifications shall use Agency contact information specified in § 1.4 of this Subchapter.
D.The registrant shall submit a written report to the Agency, prepared by a Qualified Medical Physicist, to the Agency within fifteen (15) business days after discovery of the radiation medical event. The written report shall include:
1.The registrant’s name;
2.Date of event and date discovered;
3.The estimated dose received;
4.The imaging procedure(s) performed;
5.The type of equipment in use (e.g., CT, fluoroscopy, radiographic, other);
6.The manufacturer and model of the unit used;
7.Why the event occurred;
8.How the event was discovered;
9.The effect, if any, on the individuals(s) who is the subject of the radiation medical event;
10.Actions, if any, that have been taken, or are planned, to prevent recurrence;
11.Certification that the registrant notified the individual (or the individual’s responsible relative or guardian), and if not, why not; and
12.If there was notification, what information was provided to the individual.
E.The registrant shall provide a clinical summary of the radiation medical event to the prescribing physician and patient within fifteen (15) business days.
4.4.15Records of Radiation Medical Events
The registrant shall retain a record of a radiation medical event reported in accordance with § 4.4.14 of this Part as part of the patient's permanent medical record.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.5** Fluoroscopic Equipment {#sec-216-ricr-40-20-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.5}
4.5.1Applicability
A.The provisions of § 4.5 of this Part apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor. X-ray systems subject to § 4.5 of this Part shall also meet the requirements of § 4.4 of this Part.
B.Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.
4.5.2Primary Protective Barrier
A.Limitation of Useful Beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The X-ray tube used for fluoroscopy shall not produce X-rays unless the barrier is in position to intercept the entire useful beam. The air kerma rate [AKR] due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34 x 10-3 percent of the entrance AKR, at a distance of ten centimeters (10 cm) from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor.
B.Measuring Compliance. The AKR shall be measured in accordance with § 4.5.6 of this Part. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm). If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned thirty centimeters (30 cm) above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than thirty centimeters (30 cm). Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam ten centimeters (10 cm) from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.
4.5.3Equipment Operation
A.All fluoroscopic images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.
B.The operation of mobile or portable fluoroscopic X-ray systems, by radiologic technologists, for positioning purposes only, shall be performed under the direct supervision of a licensed practitioner of the healing arts who meets the requirements of § 4.3.3(C) of this Part.
C.A medical resident or radiologic technology student in training shall not be allowed to operate fluoroscopic X-ray systems unless in the physical presence of a licensed practitioner of the healing arts and a radiologic technologist, as specified in § 4.3.3(C) of this Part.
D.Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.
E.Operators shall be competent in the standard operating procedures of the unit in use, including the use of available dose-saving features, and the relative radiation output rates of the various modes of operation.
F.Procedure planning for fluoroscopic procedures on pregnant patients shall include feasible modifications to minimize the dose to the conceptus.
G.Procedure planning for fluoroscopic procedures on pediatric patients shall include feasible modifications to minimize dose.
H.The registrant shall use all methods available on the fluoroscopy system to monitor dose during a fluoroscopic procedure.
I.The facility shall establish a written policy regarding patient dose management in fluoroscopically guided procedures in conformance with the ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (2021) incorporated above at § 4.1.1(B) of this Part or NCRP Report 168 Radiation Dose Management for Fluoroscopically-Guided Interventional Medical Procedures incorporated above at § 4.1.1(C) of this Part.
4.5.4Field Limitation
A.Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the X-ray beam is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor. Compliance with §§ 4.5.4(C) and (D) of this Part shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
B.Further Means for Limitation. Means shall be provided to permit further limitation of the X-ray field to sizes smaller than the limits of §§ 4.5.4(C) and (D) of this Part. Beam-limiting devices manufactured after May 22,1979 and incorporated in equipment with a variable SID and/or capability of a visible area of greater than three hundred square centimeters (300 cm2), shall be provided with means for stepless adjustment of the X-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than three hundred square centimeters (300 cm2) shall be provided with either stepless adjustment of the X-ray field or with a means to further limit the X-ray field size at the plane of the image receptor to one hundred twenty-five square centimeters (125 cm2) or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of five centimeters (5 cm) by five centimeters (5 cm).
C.Fluoroscopy and Radiography Using the Fluoroscopic Imaging Assembly with Inherently Circular Image Receptors
1.For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:
a.Neither the length nor width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three percent (3%) of the SID. The sum of the excess length and the excess width shall be no greater than four percent (4%) of the SID.
b.For rectangular X-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor.
2.For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation therapy simulation systems, the maximum area of the X-ray field in the plane of the image receptor shall conform with one (1) of the following requirements:
a.When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to thirty-four centimeters (34 cm) in any direction, at least eighty percent (80%) of the area of the X-ray field overlaps the visible area of the image receptor, or
b.When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than thirty-four centimeters (34 cm) in any direction, the X-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than two centimeters (2 cm).
D.Fluoroscopy and Radiography Using Fluoroscopic Imaging Assembly with Inherently Rectangular Image Receptors. For X-ray systems manufactured on or after June 10, 2006, the following applies:
1.Neither the length nor width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three percent (3%) of the SID. The sum of the excess length and the excess width shall be no greater than four percent (4%) of the SID.
2.The error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor.
E.Override Capability. If the fluoroscopic X-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the operator’s position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE.
4.5.5Activation of the Tube
X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial fluoroscopic images from the fluoroscopic image receptor, the operator shall be able to terminate the X-ray exposure(s) at any time but means may be provided to permit completion of any single exposure of the series in process.
4.5.6Air Kerma Rates (AKR)
A.For fluoroscopic equipment, the following requirements apply:
1.Fluoroscopic equipment manufactured before May 19, 1995.
a.Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight (88) mGy per minute (ten (10) R/min) exposure rate at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in § 4.5.6(A)(1)(e) of this Part.
b.Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of forty-four (44) mGy per minute (five (5) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in § 4.5.6(A)(1)(e) of this Part.
c.Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight (88) mGy per minute (ten (10) R/min exposure rate) in either mode at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in § 4.5.6(A)(1)(e) of this Part.
d.Equipment may be modified in accordance with § 4.4.7(F) of this Part to comply with § 4.5.6(A)(2) of this Part. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement: MODIFIED TO COMPLY WITH 21 C.F.R. § 1020.32(H)(2).
e.Exceptions:
(1)During recording of fluoroscopic images.
2.Fluoroscopic equipment manufactured on or after May 19, 1995
a.Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than forty-four (44) mGy per minute (five (5) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(3). Provision for manual selection of technique factors may be provided.
b.Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight (88) mGy per minute (ten (10) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(3), except as specified in § 4.5.6(A)(2)(c) of this Part.
c.Exceptions
(1)For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the X-ray source is operated in a pulsed mode.
(2)For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.
(3)Fluoroscopy equipment with optional high-level control. When high-level control is selected and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of one hundred seventy-six (176) mGy per minute (twenty (20) R/min exposure rate) at the measurement point specified in 21 C.F.R. § 1020.32(d)(3). Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the operator shall indicate that the high-level control is employed.
4.5.7Measurement of Entrance AKR
A.Compliance with § 4.5.6 of this Part shall be determined as follows:
1.If the source is below the X-ray table, the AKR shall be measured at one centimeter (1 cm) above the tabletop or cradle.
2.If the source is above the X-ray table, the AKR shall be measured at thirty centimeters (30 cm) above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
3.In a C-arm type of fluoroscope, the AKR shall be measured at thirty centimeters (30 cm) from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than thirty centimeters (30 cm) from the input surface of the fluoroscopic imaging assembly.
4.In a C-arm type of fluoroscope having a SID less than forty-five centimeters (45 cm), the AKR shall be measured at the minimum SSD.
5.In a lateral type of fluoroscope, the AKR shall be measured at a point fifteen centimeters (15 cm) from the centerline of the X-ray table and in the direction of the X-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral X-ray source, with the end of the beam-limiting device or spacer no closer than fifteen centimeters (15 cm) to the centerline of the X-ray table.
4.5.8Indication of Potential and Current
During fluoroscopy and cinefluorography, the X-ray tube potential and current shall be continuously indicated. Deviation of X-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.
4.5.9Source-Skin Distance
A.Means shall be provided to limit the source-skin distance to not less than thirty-eight centimeters (38 cm) on stationary fluoroscopes and to not less than thirty centimeters (30 cm) on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operating at shorter source-skin distances but in no case less than twenty centimeters (20 cm).
B.For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than forty-five centimeters (45 cm), means shall be provided to limit the source-skin distance to not less than nineteen centimeters (19 cm). Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distance specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than ten centimeters (10 cm).
4.5.10Fluoroscopic Irradiation Time, Display and Signal
A.Fluoroscopic equipment manufactured before June 10, 2006:
1.Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while X-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 C.F.R. § 1020.30(q) to comply with the requirements of § 4.5.10 of this Part. When the equipment is modified, it shall bear a label indicating the statement: MODIFIED TO COMPLY WITH 21 C.F.R. § 1020.32(h)(2).
B.For X-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:
1.A display of the fluoroscopic irradiation time at the fluoroscopist’s working position. This display shall function independently of the audible signal described § 4.5.10(B)(2) of this Part. The following requirements apply:
a.When the X-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six (6) seconds.
b.The fluoroscopic irradiation time shall also be displayed within six (6) seconds of termination of an exposure and remain displayed until reset.
c.Means shall be provided to reset the display to zero (0) prior to the beginning of a new examination or procedure.
2.A signal audible to the fluoroscopist shall sound for each passage of five (5) minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two (2) seconds.
4.5.11[RESERVED]
4.5.12Protection From Scattered Radiation
A.For stationary fluoroscopic systems, ancillary shielding, such as drapes, self-supporting curtains, or viewing shields, shall be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.
B.Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met:
1.Shielding required under § 4.5.12(A) of this Part shall be maintained to the degree possible under the clinical conditions;
2.All persons, except the patient, in the room where fluoroscopy is performed shall wear protective garments that provide a lead equivalent shielding of at least twenty-five one hundredths of one millimeter (0.25 mm);
3.The fluoroscopic field size shall be reduced to the minimum required for the procedure being performed (area of clinical interest); and
4.Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or non-use of the protective drapes.
4.5.13Additional Requirements for Facilities Performing Fluoroscopically-Guided Interventional (FGI) Procedures
A.A registrant utilizing fluoroscopically-guided interventional (FGI) procedures shall establish a Radiation Protocol Committee (RPC) in accordance with the following:
1.The registrant may establish a system-wide committee if the registrant has more than one (1) site;
2.Two (2) or more registrants may form a cooperative RPC as long as each facility has a representative on the committee; and
3.If the registrant has already established a radiation safety committee, the requirements of § 4.5.13(A) of this Part may be delegated to that committee if the members meet the requirements of § 4.5.13(E) of this Part.
B.A quorum of the RPC shall meet as often as necessary, but at intervals not to exceed twelve (12) months.
C.A record of each RPC meeting shall include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant shall maintain the record for inspection by the Agency for three (3) years.
D.The RPC shall provide an annual report to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee.
E.Members of the RPC shall include but not be limited to the following individuals:
1.A supervising physician of the healing arts who meets the requirements in § 4.3.3(C) of this Part;
2.A Qualified Medical Physicist;
3.The lead technologist; and
4.Other individuals as deemed necessary by the registrant.
F.The RPC shall establish and implement written FGI procedure protocols, or protocols documented in an electronic report system, that include but are not limited to the following:
1.Identification of individuals who are authorized to use fluoroscopic systems for interventional purposes;
2.A method to be used to monitor patient radiation dose during FGI;
3.Dose notification levels, as appropriate, at which the physician is notified, and appropriate actions are taken for patient safety;
4.Substantial radiation dose level (SRDL) values following nationally recognized standards;
5.Actions to be taken for cases when a SRDL is exceeded which may include patient follow-up; and
6.A review of the established protocols at an interval not to exceed twelve (12) months.
G.A record of each RPC protocol shall be maintained for inspection by the Agency. If the RPC revises a protocol, documentation shall be maintained that includes the justification for the revision and the previous protocol for inspection by the Agency.
H.A record of radiation output information shall be maintained, for three (3) years for inspection by the Agency so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include, but not be limited to, the following:
1.Patient identification;
2.Type and date of examination;
3.Identification of the fluoroscopic system used; and
4.Peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system. If the peak skin dose, cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records shall include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following as necessary:
a.Fluoroscopic mode, such as, high-level or pulsed mode of operation;
b.Cumulative fluoroscopic exposure time; and
c.Number of films or recorded exposures.
4.5.14Radiation Therapy Simulation Systems
A.Radiation therapy simulation systems shall be exempt from the requirements of § 4.5.2(A) of this Part, provided such systems are intended only for remote control operation.
B.Radiation therapy simulation systems shall be exempt from all the requirements of §§ 4.5.4(C), 4.5.6, and 4.6.12(A)(2) of this Part when used for therapy simulation purposes.
C.As an alternative to the requirements of § 4.5.10 of this Part, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which X-rays were produced, and which is capable of being reset between X-ray examinations.
4.5.15Display of Last-Image-Hold (LIH)
A.Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.
B.For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.
C.For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.
D.Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.
4.5.16Displays of Values of Air Kerma Rate (AKR) and Cumulative Air Kerma
A.Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist’s working position the AKR and cumulative air kerma. The following requirements apply for each X-ray tube used during an examination or procedure:
1.When the X-ray tube is activated and the number of images produced per unit time is greater than six (6) images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.
2.The cumulative air kerma in units of mGy shall be displayed either within five (5) seconds of termination of an exposure or displayed continuously and updated at least once every five (5) seconds.
3.The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.
4.The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.
a.For fluoroscopes with X-ray source below the X-ray table, X-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in §§ 4.5.7(A)(1), (2) or (5) of this Part.
b.For C-arm fluoroscopes, the reference location shall be fifteen (15) cm from the isocenter toward the X-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the X-ray beam with the patient’s skin.
5.Means shall be provided to reset to zero (0) the display of cumulative air kerma prior to the commencement of a new examination or procedure.
6.The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ± thirty-five percent (± 35%) over the range of six (6) mGy/min and one hundred (100) mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three (3) seconds.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.6** Radiographic Equipment {#sec-216-ricr-40-20-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.6}
4.6.1Applicability
The provisions of § 4.6 of this Part apply to all non-dental registrants using diagnostic X-ray equipment. X-ray systems subject to § 4.6 of this Part shall also meet the requirements of § 4.4 of this Part. Requirements specific to using dental intra-oral, hand held, panoramic, and cephalometric equipment are in §§ 4.13 and 4.14 of this Part. The useful beam shall be limited to the area of clinical interest.
4.6.2Radiation Exposure Control
A.Exposure Initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.
B.Exposure Indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
C.Operator Protection, Except Veterinary Systems
1.Stationary Radiographic Systems. Stationary radiographic systems shall be required to have the X-ray control, including the exposure switch, permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure.
2.Mobile and Portable Systems. Mobile and portable X-ray systems which are:
a.Used continuously for greater than one (1) week in the same location (i.e., a room or suite) shall meet the requirements of § 4.6.2(C)(1) of this Part;
b.Used for less than one (1) week at the same location shall be provided with either a protective barrier at least two meters (2 m) (six and one half feet (6.5’)) high for operator protection during exposures or means shall be provided to allow the operator to be at least two and seven tenths meters (2.7 m) (nine feet (9’)) from the tube housing assembly during the exposure.
3.Podiatry Systems. Podiatry facilities shall meet the protection requirements in § 4.6.2(C)(2)(b) of this Part.
D.Operator and Ancillary Personnel Protection for Veterinary Systems
1.All stationary, mobile or portable X-ray systems used for veterinary work shall be provided with either a two meter (2 m) (six and one half feet (6.5’)) high protective barrier for operator protection during exposures or shall be provided with means to allow the operator to be at least two and seven tenths meters (2.7 m) (nine feet (9’)) from the tube housing assembly during exposures. Otherwise, in cases where animals are held, the operator and ancillary personnel shall be protected by a minimum of twenty-five one hundredths millimeter (0.25 mm) lead equivalent from scatter radiation and one half millimeter (0.5 mm) from the useful beam. Refer to § 4.13 of this Part for hand-held intraoral dental radiographic units used in veterinary practice.
4.6.3Control and Indication of Technique Factors
A.Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.
1.Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one half (0.5) second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero (0). It shall not be possible to make an exposure when the timer is set to a zero (0) or off position if either position is provided.
2.During serial radiography, the operator shall be able to terminate the X-ray exposure(s) at any time but means may be provided to permit completion of any single exposure of the series in process.
B.Automatic Exposure Controls. When an automatic exposure control is provided:
1.Indication shall be made on the control panel when this mode of operation is selected;
2.When the X-ray tube potential is equal to or greater than fifty-one kilovolts peak (51 kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than one sixtieth of one (1/60) second or a time interval required to deliver five milliampere-seconds (5 mAs), whichever is greater;
3.Either the product of peak X-ray tube potential, current, and exposure time shall be limited to not more than sixty kilowatt-seconds (60 kWs) per exposure or the product of X-ray tube current and exposure time shall be limited to not more than six hundred (600) mAs per exposure, except when the X-ray tube potential is less than fifty-one (51) kVp, in which case the product of X-ray tube current and exposure time shall be limited to not more than two thousand (2,000) mAs per exposure; and
4.A visible signal shall indicate when an exposure has been terminated at the limits described in § 4.6.3(B)(3) of this Part, and manual resetting shall be required before further automatically timed exposures can be made.
C.Accuracy. Deviation of technique factors under § 4.6.3 of this Part from indicated values shall not exceed the limits given by the manufacturer.
4.6.4Positive Beam Limitation (PBL)
A.The requirements of § 4.6.4 of this Part shall apply to radiographic systems which contain PBL.
B.Field Size. When a PBL system is provided, it shall prevent X-ray production when:
1.Either the length or width of the X-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than three percent (3%) of the SID; or
2.The sum of the length and width differences stated in § 4.6.4(B)(1) of this Part without regard to sign exceeds four percent (4%) of the SID.
3.The beam-limiting device is at a SID for which PBL is not designed for sizing.
C.Conditions For PBL. When provided, the PBL system shall function as described in § 4.6.4(B) of this Part whenever all the following conditions are met:
1.The image receptor is inserted into a permanently mounted cassette holder;
2.The image receptor length and width are less than fifty centimeters (50 cm);
3.The X-ray beam axis is within ± three degrees (± 3°) of vertical and the SID is ninety centimeters (90 cm) to one hundred thirty centimeters (130 cm) inclusive; or the X-ray beam axis is within ± three degrees (± 3°) of horizontal and the SID is ninety centimeters (90 cm) to two hundred five centimeters (205 cm) inclusive;
4.The X-ray beam axis is perpendicular to the plane of the image receptor to within ± three degrees (± 3°); and
5.Neither tomographic nor stereoscopic radiography is being performed.
D.Measuring Compliance. Compliance with the requirements of § 4.6.4(B) of this Part shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of § 4.6.4(B) of this Part are met. Compliance shall be determined no sooner than five (5) seconds after insertion of the image receptor.
E.Operator Initiated Undersizing. The PBL system shall be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at a SID of one hundred centimeters (100 cm) shall be equal to or less than five centimeters (5 cm). Return to PBL function as described in § 4.6.4(B) of this Part shall occur automatically upon any change of image receptor size or SID.
F.Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE
1.The override capability is considered accessible to the operator if it is referenced in the operator’s manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.
G.Disabling of PBL. A facility has the option to permanently functionally disable a PBL system. When this option is chosen, the standards for manual collimation apply.
4.6.5Source-to-Skin Distance
The minimum source-skin distance shall not be less than thirty centimeters (30 cm), except intraoral dental equipment covered under § 4.14 of this Part and veterinary equipment.
4.6.6Air Kerma Reproducibility
A.Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than five one hundredths (0.05).
1.Measuring compliance. Determination of compliance shall be based on five (5) consecutive measurements taken within a time period of one (1) hour. An additional five (5) consecutive measurements may be taken (ten (10) consecutive measurements total) to determine compliance if the results of the initial five (5) measurements are not compliant. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be within one (± 1) of the mean value for all measurements.
2.For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of twelve (12) pulses on field emission equipment rated for pulsed operation or no less than one tenth of one (0.1) second per exposure on all other equipment.
4.6.7Radiation from Capacitor Energy Storage Equipment
A.Radiation emitted from the X-ray tube shall not exceed:
1.An air kerma of twenty-six one hundredths (0.26) µGy (three one hundredths (0.03) mR exposure) in one (1) minute at five centimeters (5 cm) from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2), with no linear dimensions greater than twenty centimeters (20 cm); and
2.An air kerma of eighty-eight one hundredths (0.88) mGy (one hundred (100) mR exposure) in one (1) hour at one hundred centimeters (100 cm) from the X-ray source, with beam-limiting device fully open, when the system is discharged through the X-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total projected number of discharges in one (1) hour (duty cycle). The measurements shall be averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).
4.6.8Hand-Holding Restrictions for Portable X-ray Systems
A.Except during veterinary field operations where it is impractical to do so, a tube stand or other mechanical support shall be used for portable X-ray systems, so that the X-ray tube housing assembly need not be hand-held during exposures.
B.Neither the X-ray tube housing nor the collimating device shall be held during an exposure. Exceptions are allowed for Agency-approved devices specifically designed to be hand-held.
4.6.9[RESERVED]
4.6.10Beam-on Indicators
The X-ray control shall provide visual indication whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
4.6.11[RESERVED]
4.6.12Field Limitation and Alignment for Mobile, Portable and Stationary General Purpose X-ray Systems
A.Except when spot-film devices are in service, mobile, portable and stationary general purpose radiographic X-ray systems shall meet the following requirements:
1.Variable X-ray Field Limitation. A means for stepless adjustment of the size of the X-ray field shall be provided. Each dimension of the minimum field size at a SID of one hundred centimeters (100 cm) shall be equal to or less than five centimeters (5 cm).
2.Visual Definition
a.Means for visually defining the perimeter of the X-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the X-ray field along either the length or width of the visually defined field shall not exceed two percent (2%) of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the X-ray beam.
b.When a light localizer is used to define the X-ray field, it shall provide an average illuminance of not less than one hundred sixty (160) lux (fifteen (15) footcandles) at one hundred centimeters (100 cm) or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field.
c.The edge of the light field at one hundred centimeters (100 cm) or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four (4) in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three (3) in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance three millimeters (3 mm) from the edge of the light field toward the center of the field; and I2 is the illuminance three millimeters (3 mm) from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of one millimeters (1 mm).
4.6.13Field Indication and Alignment on Stationary General Purpose X-ray Equipment
A.Except when spot-film devices are in service, stationary general purpose X-ray systems shall meet the following requirements in addition to those prescribed in § 4.6.12 of this Part:
1.Means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, to align the center of the X-ray field with respect to the center of the image receptor to within two percent (2%) of the SID, and to indicate the SID to within two percent (2%);
2.The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;
3.Indication of field size dimensions and SIDs shall be specified in centimeters and/or inches and shall be such that aperture adjustments result in X-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within two percent (2%) of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and
4.Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of one hundred (100), one hundred fifty (150), and two hundred (200) centimeters and/or thirty-six (36”), forty (40”), forty-eight (48”), seventy-two (72”) inches and nominal image receptor dimensions of thirteen (13), eighteen (18), twenty-four (24), thirty (30), thirty-five (35), forty (40), and forty-three (43) centimeters and/or five (5”), seven (7”), eight (8”), nine (9”), ten (10”), eleven (11”), twelve (12”), fourteen (14”), and seventeen (17”) inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic X-ray system is uniquely designed to operate.
4.6.14Linearity
A.The following requirements apply for any fixed X-ray tube potential within the range of forty percent (40%) to one hundred percent (100%) of the maximum rated:
1.Equipment Having Independent Selection of X-Ray Tube Current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two (2) consecutive tube current settings shall not differ by more than one tenth (0.10) times their sum: X1-X2 0.10 (X1+X2), where X1 and X2 are the average mGy/mAs values obtained at each of two (2) consecutive tube current settings, or at two (2) settings differing by no more than a factor of two (2) where the mA selector provides continuous selection.
2.Equipment Having Selection of X-Ray Tube Current-Exposure Time Product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two (2) consecutive mAs selector settings shall not differ by more than one tenth (0.10) times their sum: X1-X2 0.10 (X1 +X2), where X1 and X2 are the average mGy/mAs values obtained at any two (2) consecutive mAs selector settings, or at two (2) settings differing by no more than a factor of two (2) where the mAs selector provides continuous selection.
3.Measuring Compliance. Determination of compliance will be based on ten (10) exposures, made within one (1) hour. These two (2) settings may include any two (2) focal spot sizes except where one (1) is equal to or less than forty-five one hundredths of one millimeter (0.45 mm) and the other is greater than forty-five one hundredths of one millimeter (0.45 mm). For purposes of this requirement, focal spot size is the focal spot size specified by the X-ray tube manufacturer. All values for percent line-voltage regulation at any one (1) combination of technique factors shall be within one (± 1) of the mean value for all measurements at these technique factors.
4.6.15Field Limitation on Radiographic X-ray Equipment Other Than General Purpose Radiographic Systems
A.X-ray Systems Designed for One Image Receptor Size. Radiographic equipment designed for only one (1) image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the X-ray field with the center of image receptor to within two percent (2%) of the SID, or shall be provided with means to both size and align the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.
B.Other X-ray Systems. Radiographic systems not specifically covered in §§ 4.6.12, 4.6.13, or 4.6.15(A), of this Part which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the X-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two percent (2%) of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the X-ray field with the center of the image receptor to within two percent (2%) of the SID, or means shall be provided to both size and alignment the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:
1.A system which performs in accordance with §§ 4.6.12 and 4.6.13 of this Part; or when alignment means are also provided, may be met with either;
2.An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
3.A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.
4.6.16Field Limitation and Alignment for Spot-Film Devices
A.The following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system:
1.Means shall be provided between the source and the patient for adjustment of the X-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the X-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the X-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.
2.Neither the length nor width of the X-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than three percent (3%) of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed four percent (4%) of the SID. On spot film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
3.The center of the X-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within two percent (2%) of the SID.
4.Means shall be provided to reduce the X-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:
a.For spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the X-ray field, the minimum field size, at the greatest SID, does not exceed one hundred twenty-five square centimeters (125 cm2); or
b.For spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of five centimeters (5 cm) by five centimeters (5 cm).
5.A capability may be provided for overriding the automatic X-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the operator’s position shall indicate whenever the automatic X-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.7** Computed Tomography Equipment {#sec-216-ricr-40-20-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.7}
4.7.1Requirements for CT Equipment
A.Applicability. X-ray systems subject to § 4.7 of this Part shall also meet the applicable requirements of § 4.4 of this Part. Unless otherwise specified, the requirements for equipment contained in § 4.7.1 of this Part are applicable to CT X-ray systems manufactured or remanufactured on or after September 3, 1985.
1.Accreditation. All diagnostic CT X-ray equipment for human use shall be accredited by an accrediting organization recognized by the Agency unless otherwise authorized by the Agency.
2.Technical and Safety Information. The technical and safety information relating to the conditions of operation, dose information and imaging performance provided by the CT manufacturer shall be maintained by the facility.
B.Termination of Exposure
1.Means shall be provided to terminate the X-ray exposure automatically by either de-energizing the X-ray source or shuttering the X-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than one hundred ten percent (110%) of its preset value through the use of either a backup timer or devices which monitor equipment function.
2.A visible signal shall indicate when the X-ray exposure has been terminated through the means required by § 4.7.1(B) of this Part.
3.The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under CT system control, of greater than one half (0.5) second duration.
C.Tomographic Plane Indication and Alignment
1.For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.
2.For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.
3.If a mechanism using a light source is used to satisfy §§ 4.7.1(C)(1) or (2) of this Part, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to five hundred (500) lux.
D.Beam-On and Shutter Status Indicators and Control Switches
1.The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed.
2.Each emergency button or switch shall be clearly labeled as to its function.
E.Indication of CT Conditions of Operation. The CT X-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
F.Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry
1.The total error in the indicated location of the tomographic plane or reference plane shall not exceed five millimeters (5 mm).
2.If the X-ray production period is less than one half (0.5) second, the indication of X-ray production shall be actuated for at least one half (0.5) second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.
3.The deviation of indicated scan increment versus actual increment shall not exceed plus or minus one millimeter (± 1 mm) with any mass from zero (0) to one hundred (100) kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or thirty centimeters (30 cm), whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.
4.Premature termination of the X-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.
4.7.2CT Facility Design Requirements
A.Aural Communication. Provision shall be made for two (2) way aural communication between the patient and the operator at the control panel.
B.Viewing Systems
1.Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.
2.When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.
4.7.3Radiation Protection Survey, Routine Quality Control, and Operating Procedures
A.Radiation Protection Survey
1.All CT X-ray systems shall have a radiation protection survey completed by, or under the direct supervision of, a Qualified Medical Physicist within thirty (30) days of installation. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.
2.The registrant shall obtain a written report of the survey from the Qualified Medical Physicist, and a copy of the report shall be made available to the Agency upon request.
B.Routine Quality Control. A routine QC program on the CT system shall:
1.Be developed by a Qualified Medical Physicist and include acceptable tolerances for points evaluated.
2.Incorporate the use of a water equivalent phantom. At a minimum, noise, CT number, and artifacts shall be evaluated.
3.Be completed at time intervals and under system conditions specified by the Qualified Medical Physicist. The interval shall not exceed one (1) week.
4.The registrant shall maintain a record of each routine QC check required by § 4.7.3(B) of this Part for three (3) years.
C.Operating Procedures
1.The CT X-ray system shall not be operated except by an individual who has been specifically trained on the operational features of the unit by a manufacturer's applications specialist, Qualified Medical Physicist, or someone deemed qualified by the Agency.
2.The following information shall be readily available to the CT operator:
a.The results of at least the most recent routine QC completed on the system:
b.Instructions on performing routine QC, including the use of the CT phantom(s), a schedule of routine QC appropriate for the system, and allowable variations set by the Qualified Medical Physicist for the indicated parameters; and
c.Scanning protocols established by the RPC, including instructions on reporting deviations.
3.If the Qualified Medical Physicist evaluation or routine QC of the CT X-ray system identifies that a system operating parameter has exceeded a tolerance established by a Qualified Medical Physicist, use of the CT X-ray system on patients shall be limited to those uses permitted by established written instructions of the Qualified Medical Physicist.
4.7.4CT X-ray System Used for Treatment Planning in Radiation Oncology
A.A CT X-ray system used solely for treatment planning in radiation oncology is exempt from the specific requirements of §§ 4.7.1, 4.7.2, and 4.7.3 of this Part, and is only subject to the requirements of § 5.10 of this Subchapter.
B.A CT X-ray system used for both diagnostic X-ray and radiation therapy simulation is subject to the requirements of both § 4.7 of this Part and § 5.10 of this Subchapter.
4.7.5CT Radiation Protocol Committee (RPC)
A.The registrant shall develop and maintain an RPC in accordance with the following:
1.Members of the RPC shall include but not be limited to the:
a.Lead CT radiologist;
b.Lead CT technologist;
c.Qualified Medical Physicist; and
d.Other individuals as deemed necessary by the registrant (e.g., Radiation Safety Officer, Chief Medical or Administrative Officer, Radiology Department Administrator/Manager).
2.If the registrant has more than one (1) site with CT, the registrant may establish a system-wide RPC.
3.Two (2) or more registrants may form a cooperative RPC as long as each facility has a representative on the committee.
4.If the registrant has already established a radiation safety committee, the requirements of § 4.7.5 of this Part may be delegated to that committee if the members meet the requirements of § 4.7.5(A)(1) of this Part.
B.Responsibilities of the RPC. The RPC shall:
1.Review existing CT protocols along with the evaluation and implementation of new and innovative technologies that can improve image quality and/or lower patient dose in comparison with the older protocol.
2.Review the capabilities of the individual CT scanner to ensure maximum performance is achieved
3.Determine and review the protocols that are used frequently or could result in significant doses. This review shall include acquisition and reconstruction parameters, image quality, and radiation dose. At a minimum, the facility shall review the following clinical protocols, if performed, at intervals not to exceed twelve (12) months:
a.Pediatric Head;
b.Pediatric Abdomen;
c.Adult Head;
d.Adult Abdomen;
e.Adult Chest; and
f.Brain Perfusion.
4.Establish and implement written protocols, or protocols documented in an electronic reporting system, that include but are not limited to the following:
a.A method to be used to monitor the CT radiation output.
b.A standardized protocol naming policy.
c.A DRL, notification value, and alert value for CT procedures reviewed in § 4.7.5(B)(3) of this Part. Notification and alert values may be applied by using trigger values in conformance with NEMA XR-29 or facility-established values and procedures as defined by the Qualified Medical Physicist.
d.Actions to be taken for cases when the dose alert value was exceeded which may include patient follow-up.
e.A process determining who has access and authority to make changes to the protocol management systems, including a method to prevent inadvertent or unauthorized modifications to a CT protocol.
5.If CT fluoroscopy is performed, the RPC shall establish and implement operating procedures and training designed to minimize patient and occupational radiation exposure.
6.Provide an annual report to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee,
7.At a minimum the RPC members in §§ 4.7.5(A)(1)(a) through (c) of this Part shall meet as often as necessary to conduct business but at intervals not to exceed twelve (12) months.
C.Records
1.A record of each RPC meeting shall be maintained. The record shall include the date, names of individuals in attendance, minutes of the meeting, and any action taken.
2.The registrant shall maintain a record of RPC policies and procedures.
3.The registrant shall maintain a record of radiation output information so the radiation dose may be estimated in accordance with established protocols (e.g., SSDE). The record shall include:
a.Patient identification;
b.Type and date of examination;
c.Identification of the CT system used; and
d.The dose values the CT system provides (e.g., CTDIvol, DLP, SSDE).
4.7.6PET CT and SPECT CT System
A.A CT X-ray system used solely to calculate attenuation coefficients in nuclear medicine studies shall meet the applicable requirements in §§ 4.7.1, 4.7.2, 4.7.3, 4.7.5 and 4.10.1 of this Part unless otherwise exempted below:
1.§ 4.7.1(A)(1) of this Part – Accreditation
2.In lieu of § 4.10.1(A)(5) of this Part, a Qualified Medical Physicist shall complete a performance evaluation on the CT system following nationally recognized guidelines or those approved by the Agency at intervals not to exceed twelve (12) months.
3.In lieu of § 4.7.1(B) of this Part, routine QC checks shall be completed at intervals not to exceed one (1) week. These checks shall be established and documented by a Qualified Medical Physicist following nationally recognized guidelines or those approved by the Agency.
4.§ 4.7.3(C)(2)(c) of this Part – Scanning protocols established by the RPC.
4.7.7Veterinary CT System
A CT X-ray system, including a cone beam computed tomography system (CBCT), used solely in non-human imaging shall meet the requirements of § 4.7.3(A) of this Part [radiation protection surveys] and is otherwise exempt from the standards of § 4.7 of this Part.
4.7.8Cone Beam Computed Tomography System (CBCT)
A.A CBCT facility shall meet §§ 4.4, 4.6.2, 4.6.5, 4.7.1(A)(2), and 4.7.1(B), (C), (D), and (E) of this Part, as applicable.
1.Exemption. A registrant using fluoroscopy systems capable of CBCT shall meet § 4.7.8 of this Part except §§ 4.7.1(A)(2), and 4.7.1(B), (C), (D), and (E) of this Part.
B.Beam Alignment. The X-ray field in the plane of the image receptor shall not exceed beyond the edge of the image receptor by more than two percent (2%) of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, the center of the X-ray field shall be aligned with the center of the image receptor to within two percent (2%) of the SID.
C.The registrant or Radiation Protocol Committee (RPC), if established, shall implement and document a policy addressing deviations from established protocols.
D.A CBCT X-ray system shall only be operated by an individual who has been specifically trained in its operation.
E.The following information shall be readily available to the CBCT operator:
1.Instructions on performing routine QC, including the use of the CBCT phantom(s);
2.A schedule of routine QC appropriate for the system;
3.Allowable variations set by the Qualified Medical Physicist, if required, for the indicated parameters; and
4.The results of at least the most recent routine QC completed on the system.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.8** Mammography {#sec-216-ricr-40-20-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.8}
4.8.1Applicability
The provisions of this section are in addition to, and not in substitution for, other applicable provisions of this Subchapter.
4.8.2Certification Requirements
A.Only X-ray systems in compliance with the requirements of the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900 shall be used for screening and diagnostic mammography.
B.A facility performing mammography shall have a valid certificate issued by the U.S. Department of Health and Human Services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.
C.A facility performing mammography shall ensure that the additional mammography activities of processing the X-ray film, interpreting the image, and maintaining viewing conditions, wherever performed, meet all quality standards pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.
4.8.3Retention of Mammography X-rays
Pursuant to R.I. Gen. Laws § 23-4.9-1, each mammographic imaging facility that takes a mammography X-ray of any individual within Rhode Island shall keep and maintain that mammography X-ray pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.9** Dual-Energy X-ray Absorptiometry (DXA) (Bone Densitometry) {#sec-216-ricr-40-20-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.9}
4.9.1DXA Systems
A.DXA systems shall be:
1.Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C – Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;
2.Registered in accordance with Part 3 of this Subchapter; and
3.At a minimum, maintained and operated in accordance with the manufacturer’s specification and recommendations.
4.9.2[RESERVED]
4.9.3DXA System Operators
A.Operators of DXA systems shall be:
1.Licensed as a practitioner of the healing arts; or
2.Individuals who possess a current license in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, Radiation Therapists and Radiologist Assistants, unless the individual is specifically exempted from licensure by said Regulations; or
3.Individuals who are not subject to licensure under Subchapter 05 Part 34 of this Chapter and have been instructed in the proper use of the DXA system. As a minimum, such instruction shall include:
a.Basic radiation protection;
b.Operating procedures for DXA systems, to include use of various system functions, safety, and maintenance; and
c.Patient positioning for the types of examinations performed.
4.9.4DXA System Operation
A.During the operation of any DXA system:
1.In the absence of a survey performed by or under the supervision of a Qualified Medical Physicist determining the minimum distance the operator may be from the patient and radiation source, the operator, ancillary personnel, and members of the general public shall be positioned at least two meters (2 m) from the patient and DXA system during the examination.
2.The operator shall advise the patient that the DXA examination is a type of X-ray procedure.
4.9.5Maintenance of Records
The registrant shall keep maintenance and QC test records for DXA systems as prescribed by §§ 4.9.1(A)(3) and 4.10.1(A)(6) of this Part. These records shall be maintained for inspection by the Agency for a minimum of three (3) years from the date the maintenance action was completed.
4.9.6DXA Examination Requirements
A.DXA on human patients shall be conducted only:
1.Under a prescription of a licensed practitioner of the healing arts; or
2.Under a screening program approved by the Agency.
4.9.7Submission of Information
Any person proposing to conduct a DXA screening program shall submit the information outlined in § 4.11 of this Part and include the name and address of the licensed practitioner of the healing arts who will interpret the screening results.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.10** Quality Assurance Program {#sec-216-ricr-40-20-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.10}
4.10.1Quality Assurance
A.Except where otherwise specified by the provisions of § 4.10.1(A)(7) of this Part, all registrants of diagnostic X-ray imaging equipment shall establish and maintain a quality assurance program consisting of quality control assessments addressing at least the following items:
1.Administration
a.Written standard operating procedures on radiation protection are reviewed and updated by management at intervals not to exceed twelve (12) months (± thirty (30) days);
b.Employee review and written acknowledgement of standard operating procedures and policies on radiation protection at intervals not to exceed twelve (12) months (± thirty (30) days);
c.Maintenance of documentation of minimum qualifications for practitioners, medical physicists, and X-ray equipment operators; and
d.Record retention in accordance with applicable Rhode Island statutes and Regulations, but in no case less than three (3) years.
2.Image Processing
a.Facilities Using Analog Image Receptors
(1)Facilities shall establish and implement a quality assurance program for X-ray film developing, whether developing is manual or automatic, in accord with the recommendations of a Qualified Medical Physicist, the system manufacturer, or a nationally recognized organization.
(2)Facilities other than dental, podiatry, and veterinary shall have a continuous and documented sensitometric quality control program, including quality control tests for speed, contrast and fog. These tests shall be performed according to specifications of a Qualified Medical Physicist, the manufacturer, or a nationally recognized organization.
b.Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR).
(1)Facilities shall establish and follow an image quality control program in accordance with the recommendations of a Qualified Medical Physicist, the system manufacturer, or a nationally recognized organization;
(2)Facilities other than dental, podiatric and veterinary, shall quarterly complete phantom image evaluation using a phantom approved by a Qualified Medical Physicist, system manufacturer, or the Agency. At a minimum the analysis shall include: artifacts, spatial resolution, contrast/noise, workstation monitors, and exposure indicator constancy.
c.Dental Facilities
(1)Facilities using analog image receptors shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six (6) months and after a change that may impact film fog.
(2)Facilities using a filmless system shall maintain and operate PSP and DDR systems according to manufacturer specifications.
3.Radiographic Equipment
a.Facilities other than dental, podiatry, and veterinary shall have their digital radiographic systems evaluated by a Qualified Medical Physicist prior to initial clinical use after installation or relocation and by or under the direction of a Qualified Medical Physicist at intervals not to exceed twelve (12) months (± thirty (30) days) unless otherwise determined by the Agency. The evaluation shall follow nationally recognized procedures or those recognized by the Agency and shall include a review of any required QC tests.
b.Dental, podiatry, and veterinary facilities shall have their digital radiographic systems evaluated by a Qualified Medical Physicist prior to initial clinical use after installation or relocation. The evaluation shall follow nationally recognized procedures or those recognized by the Agency.
c.Measurement of the radiation output shall be performed at a specified distance and over a range of clinical kVp values and shall be made at intervals not to exceed twelve (12) months (± thirty (30) days) or after any maintenance of the system which might affect the radiation output. These measurements shall be performed in-air with minimum scatter conditions. Results of the measurements shall include the µGy/mAs (mR/mAs), as well as the technique factors used to determine such results.
(1)These measurements may be used to estimate entrance skin exposure (ESE) for the average adult patient for selected routine radiographic procedures. These values should be compared with available national reference values.
(2)The name and signature of the Qualified Medical Physicist performing the measurements, and the date the measurements were performed, shall be included in the results.
4.Fluoroscopic Equipment
a.Fluoroscopic equipment shall be evaluated by a Qualified Medical Physicist within thirty (30) days of installation and of any maintenance of the system that may affect the exposure rate. Thereafter, the measurements shall be made annually or at intervals not to exceed twelve (12) months (± thirty (30) days) from the date of the prior measurement by or under the direction of a Qualified Medical Physicist. The evaluation shall include a review of any required QC tests. At a minimum these evaluations shall include:
(1)A measurement of entrance exposure rates that covers the full range of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction and CINE, when available. For systems without automatic exposure control, these measurements shall be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system. For systems with automatic exposure control, these measurements shall be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system.
(2)A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with § 4.5.7(A) of this Part.
(3)An evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes.
(4)An evaluation of the operation of the five (5) minute timer, warning lights, interlocks, and collision sensors.
(5)An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.
(6)An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.
(7)An evaluation of any changes that may impact patient and personnel protection devices.
b.Results of these measurements shall be posted where any fluoroscopist may have ready access to such results during the fluoroscopic procedure and in the record required in § 4.3.13(A)(5) of this Part. Results of the measurements shall include the mGy per minute (R/min exposure rate), as well as the technique factors used to determine such results. The name of the Qualified Medical Physicist performing the measurements and the date the measurements were performed shall be included in the results.
5.Computerized Tomography Equipment
a.The evaluation of a CT X-ray system shall be performed after initial installation and before use on human patients, and at intervals not to exceed twelve (12) months (± thirty (30) days). In addition, the Qualified Medical Physicist shall complete an evaluation of the CT system within thirty (30) days or after any change or replacement of components which, in the opinion of the Qualified Medical Physicist, could cause a change in the radiation output or image quality;
b.The annual testing of the CT X-ray system shall be performed by, or under the personal supervision of, a Qualified Medical Physicist who assumes the responsibility and signs the final performance evaluation report;
c.Evaluation standards and tolerances shall be established by the Qualified Medical Physicist and maintained by the facility. These standards and tolerances shall meet nationally recognized standards and tolerances for the CT X-ray system;
d.The evaluation shall include but not be limited to:
(1)Geometric factors and alignment including alignment light accuracy and table increment accuracy;
(2)Image localization from scanned projection radiograph (localization image);
(3)Radiation beam width;
(4)Image quality including high-contrast (spatial) resolution and low-contrast resolution
(5)Image uniformity;
(6)Noise;
(7)Artifact evaluation;
(8)CT number accuracy;
(9)Image quality for acquisition workstation display devices;
(10)A review of the results of the routine QC required under § 4.7.3(B) of this Part;
(11)A safety evaluation of audible and visual signals, posting requirements;
(12)Dosimetry.
e.Cone Beam CT (CBCT) Systems
(1)Facilities other than dental shall have an evaluation performed by, or under the direct supervision of, a Qualified Medical Physicist. The evaluation shall follow nationally recognized standards and tolerances or those recognized by the Agency. The evaluation shall be performed within thirty (30) days of initial installation, at intervals not to exceed twelve (12) months (± thirty (30) days), and within thirty (30) days after any change or replacement of components which, in the opinion of the Qualified Medical Physicist, could cause a change in the radiation output or image quality. The facility shall maintain documentation of the established standards and tolerances and testing results. Exemption. A Qualified Medical Physicist performance evaluation on CBCT systems capable of operating at no greater than one hundred (100) kV or twenty (20) mA shall be performed at intervals not to exceed twenty-four (24) months, or an interval approved by the Agency.
(2)Facilities other than dental shall follow the QC recommendations provided by the CBCT manufacturer. In the absence of manufacturer provided QC recommendations, the registrant shall implement and document QC guidelines established by a Qualified Medical Physicist in accordance with nationally recognized guidelines or those recognized by the Agency.
(3)Dental facilities shall have an evaluation performed by, or under the direct supervision of, a Qualified Medical Physicist. The evaluation shall be performed within thirty (30) days of initial installation, at intervals not to exceed twelve (12) months (± thirty (30) days), and within thirty (30) days after any change or replacement of components which, in the opinion of the Qualified Medical Physicist, could cause a change in the radiation output or image quality. The evaluation shall include, at a minimum, the following elements (if applicable to the CBCT system):
Test
Standard
Scan Increment Accuracy
±1 mm
Scan Localization Light Accuracy
±5 mm
Patient Dose
CBCT equipment manufacturer’s specifications and scan protocol or phantom manufacturer’s specifications
Pre-Patient Collimation Accuracy
Manufacturer’s specifications
Contrast Scale
CBCT equipment or phantom manufacturer’s specifications
CT Number for Water
CBCT equipment or phantom manufacturer’s specifications
Slice Thickness
CBCT equipment or phantom manufacturer’s specifications
Field Uniformity
CBCT equipment or phantom manufacturer’s specifications
Low Contrast Resolution
CBCT equipment or phantom manufacturer’s specifications
High Contrast Resolution
CBCT equipment or phantom manufacturer’s specifications
Noise
CBCT equipment or phantom manufacturer’s specifications
Scan Protocol Review
As required by § 4.3.4 of this Part
Review of facility and technologist’s QC test
Review QC tests for proper procedure and corrective action
Medical physicist report and recommendations
Communicate results and recommendations to registrant
6.DXA Systems
a.Conform to the DXA system manufacturer recommendations and recommendations of recognized professional societies such as the International Society for Clinical Densitometry or the American College of Radiology.
7.Clarification of required quality assurance program elements for certain mammography X-ray facilities.
a.The requirements in § 4.10 of this Part do not pertain to diagnostic X-ray imaging equipment subject to the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.
4.10.2Availability of Quality Assurance Program
The registrant shall establish and maintain written quality assurance (QA) and quality control (QC) procedures, including evaluation frequencies and tolerances. The QA/QC procedures shall be available for review by the Agency.
4.10.3Implementation of Quality Assurance Program
A.The registrant shall designate an appropriately trained individual to manage the quality assurance program. Quality control assessments for §§ 4.10.1(A)(2), (3), (4) and (5) of this Part shall be conducted by, or under the direction of, a Qualified Medical Physicist.
B.A Qualified Medical Physicist shall determine the frequency and nature of QA/QC procedures, except when the frequency for a specific QA/QC procedure is defined by this Subchapter.
C.A Qualified Medical Physicist shall perform a review of the Quality Assurance Program at an interval not to exceed twelve (12) months (± thirty (30) days) and shall provide a written report which documents the results of this review.
D.The registrant shall maintain documentation showing the testing instruments used in determining compliance with the provisions of this Part are properly calibrated in accordance with § 4.4.13 of this Part and maintained in accordance with the Agency minimum standard or accepted professional standards when no Agency minimum is defined.
E.The registrant shall perform repeat/reject analysis of radiographic images at least quarterly following specifications of a nationally recognized organization.
F.The registrant shall complete preventative maintenance on the X-ray systems in accordance with manufacturer specifications at intervals not to exceed twelve (12) months.
G.The registrant shall check each study for artifacts. If an artifact is present, the source shall be identified, and appropriate action taken.
H.The registrant shall retain QA/QC records of evaluations and reviews in accordance with applicable provisions of the Rhode Island General Laws and this Subchapter, but in no case less than three (3) years.
I.Exemptions
1.Dental facilities. Dental facilities performing only intra-oral, panoramic, cephalometric or volumetric dental imaging are exempt from the following provisions of §§ 4.3 and 4.10.3 of this Part:
a.§ 4.3.1(C) of this Part – information available to referring physician;
b.§ 4.10.3(E) of this Part – repeat analysis
2.Podiatry facilities. Podiatry facilities are exempt from the following provisions of §§ 4.3 and 4.10.3 of this Part:
a.§ 4.3.1(C) of this Part – information available to referring physician;
b.§ 4.10.3(E) of this Part – repeat analysis
3.Veterinary facilities. Veterinary facilities are exempt from the following provisions of §§ 4.3 and 4.10.3 of this Part:
a.§ 4.3.1(C) of this Part – information available to referring physician;
b.§ 4.3.1(D) of this Part – use of reference levels;
c.§ 4.3.1(E) of this Part – use of dose reduction techniques;
d.§ 4.3.1(F) of this Part – patient identification;
e.§ 4.3.6(A)(3) of this Part (routine holding of patient);
f.§§ 4.3.10(E)(8)(a) through (c) of this Part – use of sensitometric equipment;
g.§ 4.3.12 of this Part – healing arts screening); and
h.§ 4.10.3(E) of this Part – repeat analysis.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.11** Information to Be Submitted by Persons Proposing to Conduct Healing Arts Screening {#sec-216-ricr-40-20-4-4.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.11}
A.Persons requesting that the Agency approve a healing arts screening program shall submit the following information for evaluation and approval:
1.Name and address of the applicant and, where applicable, the names and addresses of agents within Rhode Island.
2.Diseases or conditions for which the X-ray examinations are to be used in diagnoses.
3.A description of the X-ray examinations proposed in the screening program (i.e., type and number of views).
4.Description of the population to be examined in the screening program, (i.e., age range, gender, physical condition, and other appropriate information).
5.An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used in preference to the X-ray examinations.
6.An evaluation by a Qualified Medical Physicist of the X-ray system(s) to be used in the screening program. The evaluation shall include the following:
a.Documentation that such system(s) satisfy all requirements of this Subchapter; and
b.Measurement of appropriate patient exposures from the X-ray examinations to be performed.
7.A description of the X-ray quality control program.
8.A copy of the protocol information for the X-ray examination procedures to be used.
9.The name and Rhode Island license number of each radiologic technologist who will be operating the X-ray system(s).
10.The name and Rhode Island license number of each health care provider who will be supervising the operators of the X-ray system(s). The extent of supervision and the method of work performance evaluation shall be specified.
11.The name and address of the Rhode Island-licensed practitioner of the healing arts who will interpret the images.
12.Procedures to be used in advising the individuals screened and their health care provider(s) of the results of the screening procedure and any further medical needs indicated.
13.Procedures for the retention or disposition of the images and other records pertaining to the X-ray examinations.
14.Frequency of screening of individuals.
15.The duration of the screening program.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.12** Instruction of Users of X-ray Equipment in the Healing Arts {#sec-216-ricr-40-20-4-4.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.12}
A.Fundamentals of Radiation Safety
1.Characteristics of x-radiation
2.Units of radiation dose
3.Hazards of excessive exposure to radiation
4.Levels of radiation from sources of radiation
5.Methods of controlling radiation dose:
a.Working time
b.Working distances
c.Shielding
B.Radiation Detection Instrumentation to be Used:
1.Radiation survey instruments:
a.Operation
b.Calibration
c.Limitations
2.Survey, monitoring and spot-check techniques
3.Personnel monitoring devices
4.Interpretation of personnel monitoring reports
C.Operation and Control of X-ray Equipment:
1.Collimation and filtration
2.Exposure techniques for the equipment used
3.Image processing techniques
D.Anatomy and positioning:
1.Relevant human anatomy
2.Relevant human physiology
3.Radiographic positioning
E.The requirements of pertinent Federal and State Regulations
F.The licensee's or registrant's written operating and emergency procedures
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.13** Requirements for Use of Hand-Held Intraoral Dental Radiographic Unit {#sec-216-ricr-40-20-4-4.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.13}
A.In addition to the standards in this Part, the following requirements are specifically applicable to intraoral dental radiographic units designed to be operated as a hand-held device:
1.For All Uses:
a.The facility shall maintain documentation that each operator of hand-held X-ray equipment has completed training as specified by the manufacturer and approved by the Agency.
b.The use of a protective apron when operating a hand-held intraoral dental radiographic unit shall be in accordance with manufacturer’s specifications unless otherwise authorized by the Agency or recommended by a health physicist or Qualified Medical Physicist.
c.A hand-held intraoral dental radiographic unit shall be held with minimal motion during a patient examination. If the operator has difficulty in holding the device stationary during the exposure, the operator shall use a stand to immobilize the device.
d.A hand-held X-ray system shall be equipped with a backscatter shield of not less than one quarter of one millimeter (0.25 mm) lead equivalent and fifteen and two tenths centimeters (15.2 cm) (six inches (6”)) in diameter that is positioned as close as practicable to the distal end of the position indication device.
e.The operator shall ensure there are no bystanders within a radius of six feet (6’) from the patient being examined with a hand-held intraoral radiographic unit.
f.Hand-held intraoral dental radiographic units shall not routinely be used for patient examinations in hallways and waiting rooms.
g.The registrant shall comply with any facility-specific requirements established by the Agency.
h.The facility shall adopt and follow protocols provided by the manufacturer, and approved by the agency, regarding the safe operation of the device.
i.The registrant shall secure the hand-held device from unauthorized removal or use.
2.Additional Requirements for Operatories in Permanent Facilities:
a.When hand-held intraoral dental radiographic units are used for patient examinations in dental operatories, that facility shall meet the structural shielding requirements specified by the Agency or by a health physicist or Qualified Medical Physicist.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-4 § 4.14** Requirements for Dental Facilities {#sec-216-ricr-40-20-4-4.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-4#4.14}
4.14.1Applicability
In addition to the applicable requirements of §§ 4.3 and 4.4 of this Part, the requirements of § 4.14 of this Part apply to dental facilities using intraoral, panoramic, and cephalometric X-ray equipment. Dental facilities using cone beam computed tomography (CBCT) technology shall follow applicable provisions of § 4.7.8 of this Part.
4.14.2Warning Label
A.On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear the following warning statement or the warning statement in § 4.14.2(B) of this Part, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
B.On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."
4.14.3Radiation Exposure Control
Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.
4.14.4Exposure Control Location and Operator Protection
A.Except for units designed to be hand-held, the exposure control shall allow the operator to be:
1.Behind a protective barrier at least two meters (2 m) (six and one half feet (6.5’)) tall or
2.At least two meters (2 m) (six and one half feet (6.5’)) from the tube housing assembly, outside the path of the useful X-ray beam, while making exposures.
4.14.5Administrative Controls
A.Patient and image receptor holding devices shall be used when the techniques permit.
B.Except for units designed to be hand-held, the tube housing and position indicating device (PID) shall not be hand-held during an exposure.
C.Dental fluoroscopy without image intensification shall not be used.
4.14.6Beam-on Indicators
The X-ray control shall provide visual indication whenever X-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.
4.14.7Multiple Tubes
Where two (2) or more radiographic tubes are controlled by one (1) exposure switch, the tube which has been selected shall be clearly indicated prior to initiation of the exposure. Only the selected tube can be energized. This indication shall be both on the X-ray control panel and at or near the tube housing assembly which has been selected.
4.14.8Mechanical Support of Tube Head
The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.
4.14.9Battery Charge Indicator
On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
4.14.10Locks
All position locking, holding, and centering devices on X-ray system components and systems shall function as intended.
4.14.11Technique Indicators
A.For X-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.
B.The requirement of § 4.14.11(A) of this Part may be met by permanent markings on equipment having fixed technique factors.
4.14.12Exposure Reproducibility
For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than five one hundredths (0.05).
4.14.13Timers
Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.
4.14.14Kilovolt Peak
Deviation of technique factors from indicated values shall not exceed the limits provided by the manufacturer. (variation of 21 C.F.R. § 1020.31(a)(4)). At a minimum, the kVp on variable kVp units shall be accurate to within ten percent (10%) and within twenty percent (20%) on fixed kVp units.
4.14.15X-ray Beam Alignment
A.The useful X-ray beam shall be limited to the area of clinical interest.
BIntraoral Dental Units
1.X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-to-skin distance (SSD) to not less than eighteen centimeters (18 cm).
2.The X-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than seven centimeters (7 cm).
C.Extraoral, Panoramic and Cephalometric Units
1.X-ray systems designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the X-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two percent (2%) of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the X-ray field with the center of the image receptor to within two percent (2%) of the SID, or means shall be provided to both size and alignment of the X-ray field such that the X-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:
(a)An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
(b)A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.
4.14.16Beam Quality
A.The Half Value Layer (HVL) of the useful beam for a given X-ray tube potential shall not be less than the values shown in § 4.14.16(B) of this Part [Table 1]. If it is necessary to determine such half-value layer at an X-ray tube potential which is not listed in § 4.14.16(B) of this Part, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one (1) thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent X-ray emissions if the minimum required filtration is not in place.
B.Table 1 – X-Ray Tube Voltage (kilovolt peak)
Minimum HVL (mm in Aluminum)
Design Operating Range
Measured Operating Potential
Dental X-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980
Dental X-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980
All X-ray systems, except dental X-ray systems designed for use with intraoral image receptors, subject to § 4.14.16 of this Part and manufactured on or after June 10, 2006
Below 51
30
1.5
0.3
0.3
40
1.5
0.4
0.4
50
1.5
0.5
0.5
51 to 70
51
1.5
1.2
1.3
60
1.5
1.3
1.5
70
1.5
1.5
1.8
Above 70
71
2.1
2.1
2.5
80
2.3
2.3
2.9
90
2.5
2.5
3.2
100
2.7
2.7
3.6
110
3.0
3.0
3.9
120
3.2
3.2
4.3
130
3.5
3.5
4.7
140
3.8
3.8
5.0
150
4.1
4.1
5.4
4.14.17kVp Limitations
Intraoral dental X-ray machines with a measured kVp of less than fifty-one (51) kVp shall not be used to make diagnostic dental radiographs of humans.
4.4.18Modification of Certified Diagnostic X-ray Components and Equipment
A.Diagnostic X-ray components and equipment certified in accordance with 21 C.F.R. Part 1020 shall not be modified such that the component or equipment fails to comply with any applicable provision of 21 C.F.R. Part 1020.
B.The owner of a diagnostic X-ray equipment who uses the equipment in a professional or commercial capacity may modify the equipment provided the modification does not result in the failure of the equipment or component to comply with the applicable requirements of 21 C.F.R. Part 1020. The owner who causes such modification need not submit the reports required by 21 C.F.R. Part 1020, provided the owner records the date and the details of the modification in the equipment records and maintains this information, and provided the modification of the X-ray system does not result in a failure to comply with 21 C.F.R. Part 1020.
4.14.19Leakage Radiation from the Diagnostic Source Assembly
The leakage radiation from the diagnostic source assembly measured at a distance of one meter (1 m) in any direction from the source shall not exceed eighty-eight one hundredths milligray (0.88 mGy) air kerma (vice one hundred milliroentgen (100 mR) exposure) in one (1) hour when the X-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum X-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).
4.14.20Radiation from Components Other Than the Diagnostic Source Assembly
The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of eighteen (18) microgray (two (2) milliroentgens exposure) in one (1) hour at five centimeters (5 cm) from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).
4.14.21Maintaining Compliance
Diagnostic X-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 C.F.R. Part 1020) shall be maintained in compliance with applicable requirements of that standard.
**History**
- *Amendment — effective from 2023-11-28 to current*
- *Amendment — effective from 2022-05-25 to 11/28/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-5** Therapeutic Radiation Machines
##### **216-RICR-40-20-5 § 5.1** Authority and Incorporation by Reference {#sec-216-ricr-40-20-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.1}
5.1.1Authority
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes requirements, for which a registrant is responsible, for use of therapeutic radiation machines. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of this Subchapter.
C.The use of therapeutic radiation machines must be by, or under the supervision of, an Authorized Physician who meets the criteria established by § 5.3.3 of this Part.
D.Provisions for Research Involving Human Subjects. A registrant may conduct research involving human subjects using therapeutic radiation machines provided that:
1.If the research will be conducted, funded, supported, or regulated by a Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects (45 C.F.R. Part 46), the registrant must, before conducting research:
a.Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; and
b.Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject; or
2.If the research will not be conducted, funded, supported, or regulated by a Federal agency that has implemented the Federal Policy, the registrant must, before conducting research:
a.Apply for and receive approval of a specific amendment to its Agency registration; and
b.Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; and
c.Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject.
E.FDA, Other Federal and State Requirements. Nothing in this Part relieves the registrant from complying with applicable Agency, FDA, other Federal, and State requirements governing therapeutic radiation machines or auxiliary devices.
F.Electronic brachytherapy devices are subject to the requirements of § 5.8 of this Part and are exempt from the requirements of § 5.6 of this Part.
G.Any notifications, reports or correspondence required by this Part must be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
5.1.2Incorporation by Reference
A.These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements’ (NCRP) Report 49 “Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV” (1976) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements’ (NCRP) Report 79, “Neutron Contamination from Medical Electron Accelerators” (1984) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements’ (NCRP) Report 144, “Radiation Protection for Particle Accelerator Facilities” (2003) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate the National Council on Radiation Protection and Measurements’ (NCRP) Report 151, “Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy Facilities” (2006) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.2** Definitions {#sec-216-ricr-40-20-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.2}
A.Whenever used in this Part, the following terms must be construed as follows:
1.“Absorbed dose" or "D” means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The units of absorbed dose is the gray (Gy). One gray (Gy) is the international system of units (SI) equivalent of one hundred (100) rads, which is equal to an absorbed dose of one (1) joule/kilogram.
2.“Absorbed dose rate” means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for electrically generated radiation producing devices.
3.“Act” means R.I. Gen. Laws Chapter 23-1.3, entitled "Radiation Control."
4.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
5.“Air kerma" or "K” means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the name for the unit of kerma is the gray (Gy).
6."Authorized physician" means a physician who is qualified to be named on an Agency therapeutic radiation machine registration by satisfying the requirements of § 5.3.3 of this Part.
7.“Barrier” (See "Protective barrier").
8.“Beam axis” means the axis of rotation of the beam limiting device.
9.“Beam-limiting device” means a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimensions of the useful beam.
10.“Beam monitoring system” means a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.
11.“Beam scattering foil” means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.
12.“Bent beam linear accelerator” means a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.
13.“Changeable filters” means any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
14.“Contact therapy system” means a therapeutic radiation machine with a short target to skin distance (TSD), usually less than five (5) centimeters.
15.“Conventional simulator” means any X-ray equipment designed to reproduce the geometric conditions of the radiation therapy equipment.
16.“Detector” (See "Radiation detector").
17.“Dose monitor unit" or "DMU” means a unit response from the beam monitoring system from which the absorbed dose can be calculated.
18.“Dosimetry system” means an ion chamber and electrometer used as a dosimeter for measurement of clinical photon and electron beams with calibration coefficients determined either in air or in water and are traceable to a national primary standards dosimetry laboratory. Specialized dosimetry systems are available for detecting different radiation types.
19.“Electronic brachytherapy” means a method of radiation therapy where an electrically generated low-energy source of ionizing radiation is placed in or near the tumor or target tissue to deliver a therapeutic radiation dose.
20.“Electronic brachytherapy device” means the system used to produce and deliver therapeutic radiation including the X-ray tube, the control mechanism, the cooling system, and the power source.
21.“Electronic brachytherapy source” means the X-ray tube component used in an electronic brachytherapy device.
22.“External beam radiation therapy” means therapeutic irradiation in which the source of radiation is at a distance from the body.
23.“Field-flattening filter” means a filter used to homogenize the absorbed dose rate over the radiation field.
24.“Filter” means material placed in the useful beam to change beam quality in therapeutic radiation machines subject to § 5.6 of this Part.
25.“Gantry” means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.
26.“Gray" or "Gy" means the SI unit of absorbed dose, kerma, and specific energy imparted equal to one (1) joule per kilogram. The previous special unit of absorbed dose (rad) has been replaced by the gray. [one (1) Gy = one hundred (100) rad].
27.“Half-value layer" or "HVL" means the thickness of a specified material which attenuates X-ray radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one half (1/2) of the value measured without the material at the same point.
28.“Image guided radiation therapy” or “IGRT” means a method of radiation therapy where the treatment setup and delivery are verified through imaging-based system(s).
29.“Interlock” means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
30.“Interruption of irradiation” means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
31.“Irradiation” means the exposure of a living being or matter to ionizing radiation.
32.“Isocenter” means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.
33.“Kilovolt," "kV," "Kilo electron volt," or "keV” means the energy equal to that acquired by a particle with one (1) electron charge in passing through a potential difference of one thousand (1,000) volts in a vacuum. The current convention is to use kV for photons and keV for electrons.
34.“Lead equivalent” means the thickness of the material in question affording the same attenuation, under specified conditions, as lead.
35.“Leakage radiation” means radiation emanating from the radiation therapy system except for the useful beam.
36.“Light field” means the area illuminated by light, simulating the radiation field.
37.“mA” means milliampere.
38.“Medical health physicist” means an individual who meets the qualifications of § 5.3.4 of this Part or is certified by The American Board of Medical Physics in Medical Health Physics, or is certified by the American Board of Health Physics including a minimum three (3) years relevant experience in the subfield of medical health physics.
39.“Megavolt," "MV," "Mega electron volt," or "MeV" means the energy equal to that acquired by a particle with one (1) electron charge in passing through a potential difference of one million (1,000,000) volts in a vacuum. The current convention is to use MV for photons and MeV for electrons.
40.“Mobile electronic brachytherapy” means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.
41.“Mobile therapeutic radiation machine” means a machine that is transported from one address to be used at another address, or moveable within the facility of record.
42."Monitor unit (MU)" (See "Dose monitor unit").
43.“Moving beam radiation therapy” means radiation therapy with any planned displacement of radiation field or patient/human research subject relative to each other, or with any planned change of absorbed dose distribution. It includes, but is not limited to, arc, skip, conformal, intensity modulation and rotational therapy.
44.“Patient” means an individual subjected to machine produced radiation for the purpose(s) of medical therapy.
45.“Patient intervention” means any action by the patient or human research subject, whether intentional or unintentional, during the administration of radiation therapy that causes interference.
46.“Peak tube potential” means the maximum value of the potential difference across the X-ray tube during an exposure.
47.“Periodic quality assurance check” means a procedure which is performed to ensure that a previous parameter or condition continues to be valid.
48.“Phantom” means an object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.
49.“Prescribed dose” means the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic radiation machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique.
50.“Primary dose monitoring system” means a system which will monitor the useful beam during irradiation, and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.
51."Primary protective barrier" (see "Protective barrier").
52.“Protective barrier” means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:
a."Primary protective barrier" means the material, excluding filters, placed in the useful beam.
b."Secondary protective barrier" means the material which attenuates stray radiation.
53."Qualified medical physicist" means an individual qualified in accordance with § 5.3.4 of this Part.
54.“Quality management program” means a program providing for verification of process by written procedures addressing testing, auditing, and inspection to ensure that deficiencies, deviation, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities.
55.“Radiation detector” means a device that, in the presence of radiation provides, by either direct or indirect means a signal or other indication suitable for use in measuring one (1) or more properties or quantities of incident radiation.
56."Radiation field" (see "Useful beam").
57.“Radiation head” means the structure from which the useful beam emerges.
58.“Radiation oncology safety team” means a team that must include, but is not limited to, the authorized physician, qualified medical physicist, radiation oncology therapist, and other individuals as deemed necessary by the registrant (e.g., radiation safety officer, chief medical or administrative officer, department administrator/manager, nurse). The radiation oncology safety team is responsible for the registrant’s quality management program.
59.“Radiation protection program” means organizational, procedural, and technical arrangements for the designation of controlled areas and supervised areas, for local rules, and for monitoring of the workplace for occupational exposure.
60.“Redundant beam monitoring system” means a combination of two (2) independent dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.
61.“Registrant” means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this Subchapter and the Act.
62.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
63.“Safety assessment program” means a plan prepared by the registrant to address protection and safety for radiation practices within the facility and includes, but is not limited to, consideration of the design, construction, and operation of therapeutic radiation machines and related facilities and equipment as they pertain to normal and potential exposure. It also includes consideration of management systems and procedures to safely handle therapeutic radiation machines, to operate equipment, to monitor radiation protection, to implement a quality assurance program, and to handle emergencies.
64.“Scattered radiation” means ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.
65.“Secondary dose monitoring system” means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.
66.“Shutter” means a device attached to the tube housing assembly which can totally intercept the useful beam, and which has a lead equivalency not less than that of the tube housing assembly.
67.“Sievert" or "Sv" means the SI unit of dose equivalent. The unit of dose equivalent is the joule per kilogram. The previous special unit of dose equivalent (rem) is being replaced by the sievert. [one (1) Sv = one hundred (100) rem].
68.“Simulator (radiation therapy simulation system)” means any X-ray system intended for localizing the volume to be exposed during radiation therapy and establishing the position and size of the therapeutic irradiation field.
69.“Source” means the region and/or material from which the radiation emanates.
70.“Source-skin distance” or “SSD" (See "Target-skin distance").
71.“Stationary beam radiation therapy” means radiation therapy without displacement of one (1) or more mechanical axes relative to the patient/human research subject during irradiation.
72.“Stray radiation” means the sum of leakage and scattered radiation.
73.“Survey instruments” means detectors used for measuring radiation exposure levels. Specialized survey instruments are available for detecting different radiation types.
74.“Target” means that part of an X-ray tube or accelerator onto which is directed a beam of accelerated particles to produce ionizing radiation or other particles.
75.“Target-skin distance” or “TSD" means the distance measured along the beam axis from the center of the front surface of the X-ray target and/or electron virtual source to the surface of the irradiated object or patient/human research subject.
76.“Tenth-value layer” or “TVL" means the thickness of a specified material which attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate or absorbed dose rate is reduced to one-tenth (1/10) of the value measured without the material at the same point.
77.“Termination of irradiation” means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
78.“Therapeutic radiation machine” means X-ray or electron-producing equipment designed and used for external beam radiation therapy. For the purpose of this Part, devices used to administer electronic brachytherapy must also be considered therapeutic radiation machines.
79.“Treatment frequency” means fractions per calendar day, minimum interfraction interval, coordination with systemic therapy (if applicable), or plan delivery sequencing. Also known as fractionation schedule.
80.“Treatment modality” means electron, photon, or charged particle modes of delivery.
81.“Treatment site” means the anatomical description of the tissue intended to receive a therapeutic radiation dose, as prescribed in a written directive.
82.“Treatment technique” means a technique that includes, but is not limited to, anteroposterior [AP], posteroanterior [PA], right and/or left laterals, right and/or left anterior or posterior oblique, tangents, 4-field, 3-field, en face, dynamic conformal arc therapy [DCAT], intensity modulated radiation therapy [IMRT], volumetric modulated arc therapy [VMAT], stereotactic radiosurgery [SRS], stereotactic body radiation therapy [SBRT], or beam configuration approved by the authorized physician.
83.“Tube” means an X-ray tube, unless otherwise specified.
84.“Tube housing assembly” means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
85.“Useful beam” means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapeutic radiation machine to produce radiation.
86.“Virtual simulator” means an imaging unit used in conjunction with relevant software which recreates the treatment machine, and that allows import, manipulation, display, and storage of images from CT and/or other imaging modalities.
87.“Virtual source” means a point from which radiation appears to originate.
88.“Wedge filter” means a filter which effects continuous change in transmission over all or a part of the useful beam.
89.“Written directive” means an order in writing for the administration of radiation to a specific patient or human research subject, as specified in § 5.5.1 of this Part.
90.“X-ray tube” means any electron tube which is designed to be used primarily for the production of X-rays.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.3** General Administrative Requirements for Facilities Using Therapeutic Radiation Machines {#sec-216-ricr-40-20-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.3}
5.3.1Administrative Controls
The registrant must be responsible for directing the operation of the therapeutic radiation machines which have been registered with the Agency. The registrant or the registrant's agent must ensure that the requirements of this Part are met in the operation of the therapeutic radiation machine(s).
5.3.2Prohibition on Use
A therapeutic radiation machine which does not meet the provisions of this Part or has not received U.S. Food and Drug Administration (FDA) clearance or premarket approval, must not be used for irradiation of patients/human research subjects.
5.3.3Qualification Requirements for Therapeutic Radiation Machine Authorized Physicians
A.The registrant for any therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must require the Authorized Physician to be:
1.Currently certified in:
a.Radiation Oncology by the American Board of Radiology (ABR); or
b.Radiation Oncology by the American Osteopathic Board of Radiology(AOBR); or
c.Radiation Oncology by the Royal College of Physicians and Surgeons of Canada.
5.3.4Qualification Requirements for Medical Physicist
A.The registrant for any therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must require the Qualified Medical Physicist to:
1.Be registered with the Agency, under the provisions of Part 3 of this Subchapter, as a provider of clinical radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and
2.Be currently certified by the American Board of Radiology in:
a.Therapeutic Radiological Physics; or
b.Radiological Physics; or
c.Therapeutic Medical Physics; or
3.Be currently certified by the American Board of Medical Physics in Radiation Oncology Physics; or
4.Be currently certified by the Canadian College of Physicists in Medicine (CCPM) in Radiation Oncology Physics.
5.3.5Qualifications of Operators
A.Individuals who will be operating a therapeutic radiation machine for medical use must possess a current license as a Radiation Therapist in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, and Radiation Therapists, unless the individual is specifically exempted from licensure by said Regulations.
B.The names and training of all personnel currently operating a therapeutic radiation machine must be kept on file at the facility. Information on former operators must be retained for a period of at least two (2) years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.
5.3.6Written Safety Procedures
Written safety procedures, Rules, and posted emergency procedure must be developed by a radiation oncology safety team and must be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator must be able to demonstrate familiarity with these safety procedures, rules, and emergency procedures.
5.3.7Exposure Prohibited
Individuals must not be exposed to the useful beam except for medical therapy purposes and unless such exposure is justified and has been ordered in writing by a therapeutic radiation machine Authorized Physician. This provision specifically prohibits deliberate exposure of an individual for training, demonstration, or other non-healing-arts purposes.
5.3.8Visiting Authorized Physician
A.A registrant may permit any physician to act as a Visiting Authorized Physician under the term of the registrant's Certificate of Registration for up to sixty (60) days per calendar year under the following conditions:
1.The Visiting Authorized Physician has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and
2.The Visiting Authorized Physician meets the requirements established for Authorized Physician(s) in § 5.3.3 of this Part; and
3.The registrant must maintain copies of the written permission required in § 5.3.8(A)(1) of this Part and documentation that the Visiting Authorized Physician met the requirements of § 5.3.8(A)(2) of this Part for five (5) years from the date of the last visit.
5.3.9Quality Management Program Training
All individuals associated with the operation of a therapeutic radiation machine must be instructed in and must comply with the provisions of the registrant's safety assessment program, radiation protection program, and quality management program. In addition to the requirements of this Part, these individuals are also subject to the requirements of §§ 1.7.1, 1.7.5 and 1.10.3 of this Subchapter.
5.3.10Information and Maintenance Record and Associated Information
A.The registrant must maintain the following information in an auditable form in a separate file or package for each therapeutic radiation machine, for inspection by the Agency:
1.Report of acceptance testing and commissioning.
2.Records of all shielding designs and surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by this Part, as well as the date(s) and name(s) of person(s) who performed such activities.
3.Records of maintenance and/or modifications performed on the therapeutic radiation machine as well as the date(s) and name(s) of person(s) who performed such services.
4.Record of the approval process for authorizing the return of the therapeutic radiation machine to clinical use after service, repair, or upgrade, as determined by the radiation oncology safety team.
5.3.11Records Retention
All records required by this Part must be retained until disposal is authorized by the Agency unless another retention period is specifically authorized in this Part. All required records must be retained in an auditable form in an active file from at least the time of generation until the next Agency inspection. Any required record generated prior to the last Agency inspection may be archived as long as a complete copy of said record can be retrieved until such time as the Agency authorizes final disposal.
5.3.12Report and Notification of a Dose to an Embryo/Fetus
A.A registrant must report any dose to an embryo/fetus that is greater than fifty (50) mSv (five (5) rem) dose equivalent that is a result of an administration of radiation to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the prescribing physician.
B.The registrant must notify the Agency by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus that requires a report in § 5.3.12(A) of this Part.
C.The registrant must submit a written report to the Agency within fifteen (15) days after discovery of a dose to the embryo/fetus that requires a report in § 5.3.12(A) of this Part.
1.The written report must include:
a.The registrant's name and registration number;
b.The name of the prescribing physician;
c.A brief description of the event;
d.Why the event occurred;
e.The effect, if any, on the embryo/fetus;
f.What actions, if any, have been taken or are planned to prevent recurrence; and
g.Certification that the registrant notified the pregnant individual or mother (or the mother's responsible relative or guardian), and if not, why not.
2.The report must not contain the individual's or child's name or any other information that could lead to identification of the individual.
D.The registrant must provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than twenty-four (24) hours after discovery of an event that would require reporting under §§ 5.3.12(A) of this Part, unless the referring physician personally informs the registrant either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The registrant is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within twenty-four (24) hours, the registrant must make the appropriate notifications as soon as possible thereafter. The registrant may not delay any appropriate medical care for the embryo/fetus, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If an oral notification is made, the registrant must inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.
E.A registrant must:
1.Annotate a copy of the report provided to the Agency with the:
a.Name of the pregnant individual who is the subject of the event; and
b.Identification number or if no other identification number is available, the social security number of the pregnant individual who is the subject of the event; and
2.Provide a copy of the annotated report to the referring physician, if other than the registrant, no later than fifteen (15) days after the discovery of the event.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.4** General Technical Requirements for Facilities Using Therapeutic Radiation Machines {#sec-216-ricr-40-20-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.4}
5.4.1Shielding and Safety Designs Requirements
A.Each therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must be provided with such primary and/or secondary barriers as are necessary to ensure compliance with Part 1 of this Subchapter.
1.Facility shielding and safety designs must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies; and
2.By, or under the direction of, a Qualified Medical Physicist or a Medical Health Physicist.
3.Facility design information for all new installations of a therapeutic radiation machine, or installations of a therapeutic radiation machine of a different model with a different isocenter or higher energy or workload into a room not previously approved for that energy or isocenter or planned workload, must be submitted for Agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in § 5.14 of this Part.
B.Radiation Shielding Surveys
1.The registrant must ensure that radiation shielding surveys of all new facilities, and existing facilities not previously surveyed are performed:
a.With an operable radiation measurement survey instrument calibrated in accordance with § 5.11 of this Part; and
b.In accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed; and
c.By, or under the direction of, a Qualified Medical Physicist or a Medical Health Physicist; and
d.Must verify that radiation levels in restricted and unrestricted areas are not likely to cause personnel exposures in excess of the limits specified in Part 1 of this Subchapter.
C.In addition to the requirements of § 5.4.1(A) of this Part, a radiation shielding survey must also be performed prior to any subsequent medical use and:
1.After making any change in the treatment room shielding;
2.After making any change in the location of the therapeutic radiation machine within the treatment room;
3.After replacing or relocating the therapeutic radiation machine; or
4.Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.
D.The survey record must indicate all instances where the facility, in the opinion of the Qualified Medical Physicist or Medical Health Physicist, is in violation of applicable regulations. The survey record must also include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the therapeutic radiation machine, the instrument(s) used to measure radiation levels in accordance with § 5.11 of this Part, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over any one (1) hour for each restricted and unrestricted area, the calculated maximum level of radiation over a period of one (1) week for each restricted and unrestricted area, the signature of the individual responsible for conducting the survey, and date signed.
E.If the results of the surveys required by §§ 5.4.1(A) or (B) of this Part indicate any radiation levels in excess of the respective limit specified in § 5.4.1(A) of this Part, the registrant must lock the control in the "OFF" position and not use the unit:
1.Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or
2.Until the registrant has received a specific exemption from the Agency.
5.4.2Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program
A.If the survey required by § 5.4.1 of this Part indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by §§ 1.8.1(A) and (B) of this Subchapter, before beginning the treatment program the registrant must:
1.Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with §§ 1.8.1(A) and (B) of this Subchapter;
2.Perform the survey required by § 5.4.1 of this Part again; and
3.Include in the report required by § 5.4.4 of this Part the results of the initial survey, a description of the modification made to comply with § 5.4.2(A) of this Part and the results of the second (2nd) survey; or
4.Request and receive a registration amendment that authorizes radiation levels in unrestricted areas greater than those permitted by §§ 1.8.1(A) and (B) of this Subchapter.
5.4.3Radiation Measuring Equipment
The registrant must have appropriate and operable radiation measuring equipment available for use and calibrated in accordance with § 5.11 of this Part. Radiation measuring equipment includes, but is not limited to, dosimetry systems, survey instruments, and other radiation measuring devices used in planning, guiding, and administering radiation.
5.4.4Reports of External Beam Radiation Therapy Surveys and Measurements
The registrant for any therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must furnish a copy of the records of surveys required in §§ 5.4.1 and 5.4.2 of this Part to the Agency within thirty-six (36) days following completion of the action that initiated the record requirement.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.5** Quality Management Program {#sec-216-ricr-40-20-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.5}
5.5.1Scope and Applicability
A.Each applicant or registrant subject to §§ 5.6, 5.7 or 5.11 of this Part shall develop, implement, and maintain a written quality management program to provide high confidence that radiation will be administered as directed by the Authorized Physician. The quality management program must address, as a minimum, the following specific objectives:
1.Written Directives:
a.A written directive must be dated and signed by an Authorized Physician prior to the administration of radiation;
b.Notwithstanding § 5.5.1(A)(1)(a) of this Part, if, because of the patient's/human research subject's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's/human research subject's health, an oral revision to an existing written directive must be acceptable, provided that the oral revision is documented immediately in writing in the patient's/human research subject's record and a revised written directive is signed by an Authorized Physician within forty-eight (48) hours of the oral revision;
c.The written directive must contain the patient or human research subject’s name, the type and energy of the beam, the total dose, dose per fraction, treatment site, treatment technique, treatment frequency, and number of fractions.
d.A written revision to an existing written directive may be made provided that the revision is dated and signed by an Authorized Physician prior to the administration of the therapeutic radiation machine dose, or the next fractional dose.
e.The registrant must retain a copy of each written directive, in an auditable form, for in accordance with medical record retention requirements for comparable documents after the date of administration.
2.Procedures for Administrations. The registrant must develop, implement, and maintain documented policies, procedures, and rules to provide high confidence that:
a.Prior to the administration of radiation treatments, the patient's/human research subject's identity is verified, by more than one (1) method, as the individual named in the written directive.
b.Therapeutic radiation machine final plans of treatment and related calculations are in accordance with the respective written directives by:
(1)Checking the parameters and the results of the primary calculation with a secondary method to verify they are correct and in accordance with the written directive; and
(2)Verifying the planned parameters are correctly displayed on the consoles of therapeutic radiation machines;
c.Each administration is in accordance with the written directive; and
d.Any unintended treatment deviation from the written directive, or final plan of treatment utilized as a written directive, is identified, and evaluated, and appropriate action is taken.
e.At least two (2) radiation therapists per patient are required when non-emergent external beam radiation therapy is being delivered.
3.A registrant must retain a copy of the procedures required by § 5.5.1(A)(2) of this Part for the duration of the registration.
5.5.2Notifications of Medical Events
A.A registrant must report any medical event, except for a medical event resulting from intervention by a patient or human research subject, in which the administration of therapeutic radiation machine radiation results or will likely result in unintended permanent functional damage to an organ or a physiological system as determined by an Authorized Physician as defined in § 5.3.3 of this Part.
B.Other than events that result from intervention by a patient or human research subject, a registrant must report any event in which the administration of a therapeutic radiation machine therapy dose:
1.Involves the wrong patient, wrong treatment modality, wrong treatment technique, wrong treatment site; or
2.The administered dose differs from the prescribed dose as stated in the written directive by more than fifty percent (50%) for treatment courses consisting of a single fraction; or
3.The administered dose differs from the prescribed dose as stated in the written directive by more than ten percent (10%) for treatment courses consisting of five (5) fractions or less; or
4.The administered dose over any five (5) consecutive fractions differs from the prescribed dose by more than thirty percent (30%); or
5.The administered dose over the entire treatment course consisting of more than five (5) fractions differs from the prescribed dose by more than twenty percent (20%).
C.The registrant must notify the Agency no later than the next business day after the registrant ascertains that a medical event occurred.
1.All required notifications must use Agency contact information specified in § 1.4 of this Subchapter.
D.The registrant must submit a written report to the Agency within fifteen (15) days after the initial notification of a medical event. The written report must include:
1.The registrant’s name and registration number;
2.The name of the prescribing physician;
3.A brief description of the event;
4.Why the event occurred;
5.The effect, if any, on the individual(s);
6.Actions, if any, that have been taken, or are planned, to prevent recurrence; and
7.Certification that the registrant notified the individual (or the individual’s responsible relative or guardian), and if not, why not.
E.The report must not contain the individual’s name or any other information that could lead to the identification of the individual.
F.The prescribing Authorized Physician must provide notification of the event to the individual who is the subject of the medical event no later than twenty-four (24) hours after initial notification by the registrant to the Agency, unless the prescribing Authorized Physician determines that, based on medical judgement, telling the individual would be harmful. The prescribing Authorized Physician will also notify any other physician health care providers actively involved in the patient’s care for the disease that is being treated. If the health care providers or the affected individual cannot be reached within twenty-four (24) hours, the prescribing Authorized Physician must notify each as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification.
G.To meet the requirements of § 5.5.2 of this Part, the notification of the individual who is the subject of the medical event may be made instead to that individual’s responsible relative or guardian. If an oral notification is made, the registrant must inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.
H.Aside from the notification requirement, nothing in § 5.5.2 of this Part affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the medical event, or to that individual’s responsible relatives or guardians.
I.The registrant must retain a record of each medical event report with an identification link to the individual who is the subject of the medical event in accordance with § 5.5.3 of this Part.
5.5.3Records of Medical Events
A.A registrant must retain a record of medical events reported in accordance with § 5.5.2 of this Part for the duration of the registration. The identification link must include, as a minimum:
1.The name of the individual who is the subject of the medical event; and
2.The social security number or other identification number, if one has been assigned, of the individual who is the subject of the medical event.
B.A registrant must provide a copy of the annotated report to the referring physician, if other than the registrant, no later than fifteen (15) days after the registrant ascertains that a medical event occurred.
5.5.4Implementation of Quality Management Program
A.As a part of the quality management program, the registrant must:
1.Develop procedures for, and conduct a review of, the quality management program including, since the last review, an evaluation of a representative sample of patient/human research subject administrations, and all medical events to verify compliance with all aspects of the quality management program.
2.Conduct these reviews at intervals not to exceed twelve (12) months.
3.Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements of § 5.5.1 of this Part; and
4.Maintain records of each review, including the evaluations and findings of the review, in an auditable form, for three (3) years.
5.5.5[RESERVED]
5.5.6Modifications
The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.6** Therapeutic Radiation Machines of Less Than 500 kV {#sec-216-ricr-40-20-5-5.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.6}
Documentation from the manufacturer and installer that the therapeutic radiation machine was manufactured and installed in accordance with most current applicable International Electrotechnical Commission (IEC) standards in effect at the time of manufacturing/installation must be sufficient to demonstrate compliance with the applicable requirements of §§ 5.6.1 through 5.6.13 of this Part.
5.6.1Leakage Radiation
A.When the X-ray tube is operated at its maximum rated tube current for the maximum kV, the leakage air kerma rate must not exceed the value specified at the distance specified for that classification of therapeutic radiation machine:
1.Five to fifty (5 – 50) kV Systems. The leakage air kerma rate measured at any position five (5) centimeters from the tube housing assembly must not exceed one (1) mGy (one hundred (100) mrad) in any one (1) hour.
2.Greater than fifty (>50) and < five hundred (500) kV Systems. The leakage air kerma rate measured at a distance of one (1) meter from the target in any direction must not exceed one (1) cGy in any one (1) hour. This air kerma rate measurement may be averaged over areas no larger than one hundred square centimeters (100 cm2). In addition, the air kerma rate at a distance of five (5) centimeters from the surface of the tube housing assembly must not exceed thirty (30) cGy per hour.
3.For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in §§ 5.6.1(A)(1) and (2) of this Part for the specified operating conditions. Records on leakage radiation measurements must be maintained in an auditable form at the installation for inspection by the Agency.
5.6.2Permanent Beam Limiting Devices
Permanent diaphragms or cones used for limiting the useful beam must provide at least the same degree of attenuation as required for the tube housing assembly.
5.6.3Adjustable or Removable Beam Limiting Devices
A.All adjustable or removable beam limiting devices, diaphragms, cones or blocks must not transmit more than five percent (5%) of the useful beam for the most penetrating beam used.
B.When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.
5.6.4Filter System
A.The filter system must be so designed that:
1.Filters cannot be accidentally displaced at any possible tube orientation;
2.An interlock system prevents irradiation if the proper filter is not in place;
3.The air kerma rate escaping from the filter slot must not exceed one (1) cGy per hour at one (1) meter under any operating conditions; and
4.Each filter must be marked as to its material of construction and its thickness.
5.6.5Tube Immobilization
A.The X-ray tube must be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and
B.The tube housing assembly must be capable of being immobilized for stationary portal treatments.
5.6.6Source Marking
The tube housing assembly must be so marked that it is possible to determine the location of the source to within five (5) millimeters, and such marking must be readily accessible for use during calibration procedures.
5.6.7Beam Block
Contact therapy tube housing assemblies must have a removable shield of material, equivalent in attenuation to one half (0.5) millimeters of lead at one hundred (100) kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.
5.6.8Timer
A.A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval.
B.A timer which has a display must be provided at the treatment control panel. The timer must have a pre-set time selector and an elapsed time or time remaining indicator.
C.The timer must be a cumulative timer which activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator.
D.The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation.
E.The timer must permit accurate pre-setting and determination of exposure times as short as one (1) second.
F.The timer must not permit an exposure if set at zero (0).
G.The timer must not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and
H.Timer must be accurate to within one percent (1%) of the selected value or one (1) second, whichever is greater.
5.6.9Control Panel Functions
A.The control panel, in addition to the displays required by other provisions in § 5.6 of this Part, must have:
1.An indication of whether electrical power is available at the control panel and if activation of the X-ray tube is possible.
2.An indication of whether X-rays are being produced.
3.Means for indicating X-ray tube potential and current.
4.The means for terminating an exposure at any time.
5.An access control device which will prevent unauthorized use of the therapeutic radiation machine; and
6.A positive display of specific filter(s) in the beam.
5.6.10Multiple Tubes
A.When a control panel may energize more than one (1) X-ray tube:
1.It must be possible to activate only one (1) X-ray tube at any time;
2.There must be an indication at the control panel identifying which X-ray tube is activated; and
3.There must be an indication at the tube housing assembly when that tube is energized.
5.6.11Target-to-Skin Distance (TSD)
There must be a means of determining the central axis TSD to within one (1) centimeter and of reproducing this measurement to within two (2) millimeters thereafter.
5.6.12Shutters
Unless it is possible to bring the X-ray output to the prescribed exposure parameters within five (5) seconds after the X-ray "ON" switch is energized, the beam must be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter must be controlled by the operator from the control panel. An indication of shutter position must appear at the control panel.
5.6.13Low Filtration X-ray Tubes
Each therapeutic radiation machine equipped with a beryllium or other low-filtration window must be clearly labeled as such upon the tube housing assembly and must be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.
5.6.14Facility Design Requirements for Therapeutic Radiation Machines Capable of Operating in the Range 50 kV to 500 kV
A.In addition to shielding adequate to meet requirements of § 5.9.1 of this Part, the treatment room must meet the following design requirements:
1.Aural Communication. Provision must be made for continuous two (2) way aural communication between the patient/human research subject and the operator at the control panel.
2.Viewing Systems. Provision must be made to permit continuous observation of the patient/human research subject during irradiation and the viewing system must be so located that the operator can observe the patient/human research subject from the control panel. The therapeutic radiation machine must not be used for patient/human research subject irradiation unless at least one (1) viewing system is operational.
5.6.15Additional Requirements
A.Treatment rooms which contain a therapeutic radiation machine capable of operating above one hundred fifty (150) kV must meet the following additional requirements:
1.All protective barriers must be fixed except for entrance doors or beam interceptors.
2.The control panel must be located in a location that ensures compliance with Part 1 of this Subchapter.
3.Interlocks must be provided such that all entrance doors, including doors to any interior booths, must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it must not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and
4.When any door referred to in § 5.6.15(A)(3) of this Part is opened while the X-ray tube is activated, the air kerma rate at a distance of one (1) meter from the source must be reduced to less than one (1) mGy (one hundred (100) mrad) per hour.
5.6.16Acceptance Testing, Commissioning, and Full Calibration Measurements
A.Acceptance testing, commissioning, and full calibration of a therapeutic radiation machine subject to § 5.6 of this Part must be performed by, or under the direct supervision of, a Qualified Medical Physicist.
1.Acceptance testing and commissioning must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed. Acceptance testing and commissioning must be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.
2.Full calibration must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed. All applicable parameters (for all energies), and the calibration report, must be completed:
a.Before the first medical use following installation or reinstallation of the therapeutic radiation machine; and
b.At intervals not exceeding thirteen (13) calendar months; and
c.Before medical use under the following conditions:
(1)Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent (5%) from the value obtained at the last full calibration and the difference cannot be reconciled; and
(2)Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
3.Notwithstanding the requirements of § 5.6.16(A)(2)(c) of this Part:
a.Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and
b.If the repair, replacement or modification does not affect all energies, full calibration must be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in § 5.6.16(A)(2)(c)(1) of this Part.
B.The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include the calibration reports, the date of the calibration, the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the X-ray tube, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the Qualified Medical Physicist responsible for performing the calibration.
5.6.17Quality Assurance Checks
A.Periodic quality assurance checks must be performed on therapeutic radiation machines subject to § 5.6 of this Part, which are capable of operation at greater than or equal to fifty (50) kV.
B.To satisfy the requirement of § 5.6.17(A) of this Part, periodic quality assurance checks must meet the following requirements:
1.The registrant must perform periodic quality assurance checks in accordance with written procedures established by the Qualified Medical Physicist and must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed; and
2.The periodic quality assurance check procedures must specify the frequency at which tests or measurements are to be performed. The periodic quality assurance check procedures must specify that the periodic quality assurance check must be performed during the calibration specified in § 5.6.16(A) of this Part. The acceptable tolerance for each parameter measured in the periodic quality assurance checks, when compared to the value for that parameter determined in the calibration specified in § 5.6.16(A) of this Part, must be stated.
C.The cause for a parameter exceeding a tolerance set by the Qualified Medical Physicist and consistent with nationally recognized standards must be investigated and corrected before the system is used for patient/human research subject irradiation.
D.Whenever a periodic quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the Qualified Medical Physicist's periodic quality assurance check procedures, the system must be recalibrated, as required in § 5.6.16(A) of this Part.
E.The registrant must use the dosimetry system described in § 5.11.5 of this Part to make the periodic absolute dose measurement.
F.The registrant must have the Qualified Medical Physicist review and sign the results of each radiation output quality assurance check within fifteen (15) days of the date that the check was performed.
G.The registrant must ensure that monthly safety quality assurance checks of therapeutic radiation machines subject to § 5.6 of this Part are performed at intervals not to exceed thirty-six (36) days.
H.Notwithstanding the requirements of §§ 5.6.17(F) and (G) of this Part, the registrant must ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by §§ 5.6.17(F) and (G) of this Part have been performed at intervals not to exceed the thirty-six (36) day period immediately prior to said administration.
I.To satisfy the requirement of § 5.6.17(G) of this Part, monthly safety quality assurance checks must ensure proper operation of:
1.Electrical interlocks at each external beam radiation therapy room entrance;
2.Proper operation of the "BEAM-ON" and termination switches;
3.Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room;
4.Viewing and aural systems;
5.If applicable, electrically operated treatment room doors from inside and outside the treatment room;
J.The registrant must maintain a record of each quality assurance check in an auditable form for three (3) years. The record must include the date of the quality assurance check, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the manufacturer's name, model number, serial number, and calibration report of the instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the quality assurance check.
5.6.18Operating Procedures
A.The therapeutic radiation machine must not be used for irradiation of patients/human research subjects unless the requirements of §§ 5.6.16 and 5.6.17 of this Part have been met.
B.Therapeutic radiation machines must not be left unattended unless secured pursuant to § 5.6.9(A)(5) of this Part.
C.When a patient/human research subject must be held in position for radiation therapy, mechanical support or restraints devices must be used.
D.The tube housing or any other part of the imaging assembly must not be held by an individual or patient during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed fifty (50) kV. In such cases, the holder must wear protective gloves and apron of not less than one half (0.5) millimeters lead equivalency at one hundred (100) kV.
E.A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console; and
F.No individual other than the patient/human research subject must be in the treatment room during exposures from therapeutic radiation machines operating above one hundred fifty (150) kV. At energies less than or equal to one hundred fifty (150) kV, any individual, other than the patient/human research subject, in the treatment room must be protected by a barrier sufficient to meet the requirements of § 1.7.1 of this Subchapter.
5.6.19Possession of Survey Instrument(s)
Each facility location authorized to use a therapeutic radiation machine in accordance with § 5.6 of this Part must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) µSv (one (1) mrem) per hour to ten (10) mSv (one thousand (1,000) mrem) per hour or exposure rates over the range five hundred (500) uR/h to five (5) R/h. The survey instrument(s) must be operable and calibrated in accordance with § 5.11 of this Part.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.7** Therapeutic Radiation Machines – Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above) {#sec-216-ricr-40-20-5-5.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.7}
Documentation from the manufacturer and installer that the therapeutic radiation machine was manufactured and installed in accordance with most current applicable IEC standards in effect at the time of manufacturing/installation must be sufficient to demonstrate compliance with the applicable requirements of §§ 5.7.2 through 5.7.16 of this Part.
5.7.1[RESERVED]
5.7.2Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron Modes
A.For each therapeutic radiation machine subject to § 5.7 of this Part, the registrant must determine, or obtain from the manufacturer, the leakage radiation for the specified operating conditions. Records on leakage radiation measurements must be maintained in an auditable form at the installation for inspection by the Agency.
B.The absorbed dose due to leakage radiation (excluding neutrons) at any point outside the maximum-sized useful beam, but within a circular plane of radius two (2) meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance (i.e. patient/human research subject plane), must not exceed a maximum of two tenths of one percent (0.2%) and an average of one tenth of one percent (0.1%) of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding one hundred square centimeters (100 cm2) at a minimum of sixteen (16) points uniformly distributed in the plane.
C.Except for the area defined in § 5.7.2 of this Part, the absorbed dose due to leakage radiation (excluding neutrons) at one (1) meter from the electron path between the electron source and the target or electron window must not exceed one half of one percent (0.5%) of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding one hundred square centimeters (100 cm2).
D.The neutron absorbed dose outside the useful beam must be in compliance with the appropriate manufacturer specifications; and
E.For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in §§ 5.7.2(A) through (D) of this Part for the specified operating conditions. Records on leakage radiation measurements must be maintained in an auditable form at the installation for inspection by the Agency.
5.7.3Leakage Radiation Through Beam Limiting Devices
A.Photon Radiation. All adjustable or interchangeable beam limiting devices must attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) must not exceed two percent (2%) of the maximum absorbed dose on the central axis of the useful beam measured in a one hundred square centimeter (100 cm2) radiation field, or maximum available field size if less than one hundred square centimeters (100 cm2).
B.Electron Radiation. All adjustable or interchangeable electron applicators must attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance must not exceed:
1.A maximum of two percent (2%) and average of one half of one percent (0.5%) of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line seven (7) centimeters outside the periphery of the useful beam; and
2.A maximum of ten percent (10%) of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line two (2) centimeters outside the periphery of the useful beam.
C.Measurement of Leakage Radiation
1.Photon Radiation. Measurements of leakage radiation through the beam limiting devices must be made with the beam limiting devices closed and any residual aperture blocked by at least two (2) tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set must be measured independently at the depth of maximum dose. Measurements must be made using a radiation detector of area not exceeding ten square centimeters (10 cm2);
2.Electron Radiation. Measurements of leakage radiation through the electron applicators must be made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter (1 cm2) suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements must be made using one (1) centimeter of water equivalent build up material.
5.7.4Filters/Wedges
A.If applicable, each wedge filter which is removable from the system must be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle must appear on the wedge or wedge tray (if permanently mounted to the tray). If the wedge or wedge tray is significantly damaged, the wedge must be removed from clinical service.
B.If the absorbed dose rate information required by § 5.7.2 of this Part relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter must be removable only by the use of tools.
C.If applicable, for equipment which utilizes a system of wedge filters, inter-changeable field flattening filters, or interchangeable beam scattering foils:
1.Irradiation must not be possible until a selection of a filter or a positive selection to use "no filter" has been made at the treatment control panel, either manually or automatically;
2.An interlock system must be provided to prevent irradiation if the filter selected is not in the correct position;
3.A display must be provided at the treatment control panel showing the wedge filter(s), interchangeable field flattening filter(s), and/or interchangeable beam scattering foil(s) in use; and
4.An interlock must be provided to prevent irradiation if any filter and/or beam scattering foil selection operation carried out in the treatment room does not agree with the filter and/or beam scattering foil selection operation carried out at the treatment control panel.
5.7.5Stray Radiation in the Useful Beam
The registrant must obtain from the manufacturer data sufficient to ensure that stray X-ray radiation in the useful electron beam, absorbed dose at the surface during X-ray irradiation and stray neutron radiation in the useful X-ray beam are in compliance with the appropriate manufacturer specifications and perform as intended.
5.7.6Beam Monitors
A.All therapeutic radiation machines subject to § 5.7 of this Part must be provided with redundant beam monitoring systems. The detectors for these systems must be fixed and functional in the useful beam during treatment to indicate the dose monitor unit rate.
B.Equipment must be provided with at least two (2) independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.
C.Equipment must be provided with at least one (1) radiation detector. This detector must be incorporated into a useful beam monitoring system.
D.The detector and the system into which that detector is incorporated must meet the following requirements:
1.Each detector must be removable only with tools and, if movable, must be interlocked to prevent incorrect positioning;
2.Each detector must form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated;
3.Each beam monitoring system must be capable of independently monitoring, interrupting, and terminating irradiation; and
4.The design of the beam monitoring systems must ensure that the:
a.Malfunctioning of one system must not affect the correct functioning of the other system(s); and
b.Failure of either system must terminate irradiation or prevent the initiation of radiation.
5.Each beam monitoring system must have a legible display at the treatment control panel. Each display must:
a.Maintain a reading until intentionally reset;
b.Have only one (1) scale and no electrical or mechanical scale multiplying factors;
c.Utilize a design such that increasing dose is displayed by increasing numbers; and
d.In the event of power failure, the beam monitoring information required in § 5.7.6(D)(5)(c) of this Part displayed at the control panel at the time of failure must be retrievable in at least one system for a twenty (20) minute period of time.
5.7.7Beam Flatness and Symmetry
Beam flatness and symmetry must be in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed.
5.7.8Selection and Display of Dose Monitor Units
A.Irradiation must not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.
B.The pre-selected number of dose monitor units must be displayed at the treatment control panel until reset for the next irradiation.
C.After termination of irradiation, it must be necessary to reset the treatment delivery parameters before subsequent treatment can be initiated; and
D.After interruption of irradiation, it must be necessary for the operator to follow the manufacturer and facility procedures before irradiation can be re-initiated.
5.7.9Air Kerma Rate/Absorbed Dose Rate
A.A system must be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in § 5.7.6 of this Part may form part of this system. In addition:
1.The dose monitor unit rate must be displayed at the treatment control panel;
2.If the equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device must be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated must be a record maintained by the registrant;
3.If the equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten (10) times the maximum value specified by the manufacturer, a device must be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds four (4) Gy; and
4.For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the maximum value(s) specified in §§ 5.7.9(A)(2) and (3) of this Part for the specified operating conditions. Records of these maximum value(s) must be maintained in an auditable form at the installation for inspection by the Agency.
5.7.10Termination of Irradiation by the Beam Monitoring System or Systems During Stationary Beam Radiation Therapy
A.Each primary system must terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.
B.If the original design of the equipment included a secondary dose monitoring system, that system must be capable of terminating irradiation when not more than fifteen percent (15%) or forty (40) dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system; and
C.An indicator on the control panel must show which monitoring system has terminated irradiation.
5.7.11Termination of Irradiation
It must be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel and in the treatment room.
5.7.12Interruption of Irradiation
If a therapeutic radiation machine has an interrupt mode, it must be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it must be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements must be automatically terminated.
5.7.13Irradiation Control Device
A.A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval or pre-set number of monitor units.
B.If applicable, a timer must be provided which has a display at the treatment control panel. The timer must have a pre-set time selector and an elapsed time indicator.
C.The timer or monitor unit indicator must be a cumulative device which activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator.
D.The timer or monitor unit indicator must terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.
5.7.14Selection of Radiation Type
A.Equipment capable of both X-ray therapy and electron therapy must meet the following additional requirements:
1.Irradiation must not be possible until a selection of radiation type (X-rays or electrons) has been made at the treatment control panel;
2.The radiation type selected must be displayed at the treatment control panel before and during irradiation;
3.An interlock system must be provided to ensure that the equipment can principally emit only the radiation type which has been selected;
4.An interlock system must be provided to prevent irradiation with X-rays, except to obtain an image, when electron applicators are fitted;
5.An interlock system must be provided to prevent irradiation with electrons when accessories specific for X-ray therapy are fitted; and
6.An interlock system must be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.
5.7.15Selection of Energy
A.Equipment capable of generating radiation beams of different energies must meet the following requirements:
1.Irradiation must not be possible until a selection of energy has been made at the treatment control panel;
2.The nominal energy value selected must be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it must be necessary to reset the nominal energy value selected before subsequent treatment can be initiated;
3.Irradiation must not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location; and
4.The selection of energy must be in compliance with the appropriate manufacturer specifications and perform as intended.
5.7.16Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy
A.Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy must meet the following requirements:
1.Irradiation must not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel.
2.The mode of operation must be displayed at the treatment control panel.
3.An interlock system must be provided to ensure that the equipment can operate only in the mode which has been selected.
4.An interlock system must be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel.
5.Moving beam radiation therapy must be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement:
a.Where angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered must differ by less than five percent (5%) from the dose monitor unit value selected;
b.An interlock must be provided to prevent motion of more than five degrees (5°) or one (1) cm beyond the selected limits during moving beam radiation therapy;
c.An interlock must be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy.
d.An interlock system must be provided to terminate irradiation if the number of dose monitor units delivered in any ten degrees (10°) of rotation or one (1) cm of linear motion differs by more than twenty percent (20%) from the selected value;
e.Moving beam radiation therapy must be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement.
6.Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation must be as required by § 5.7.10 of this Part.
7.An interlock system must be provided to terminate irradiation if movement:
a.Occurs during stationary beam radiation therapy; or
b.Does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.
8.In addition to the above requirements, facilities using equipment where the radiation therapy source is mounted on a ring gantry must develop a quality assurance program in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed.
5.7.17Facility Design Requirements for Therapeutic Radiation Machines Operating above 500 kV
A.In addition to shielding adequate to meet requirements of § 5.9 of this Part, the following design requirements are also applicable:
1.Protective Barriers. All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors.
2.Control Panel. In addition to other requirements specified in this Part, the control panel must also:
a.Be in a location that ensures compliance with Part 1 of this Subchapter;
b.Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;
c.Provide an indication of whether radiation is being produced; and
d.Include an access control system which will prevent unauthorized use of the therapeutic radiation machine.
3.Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent viewing system must be provided to permit continuous observation of the patient/human research subject following positioning and during irradiation and must be so located that the operator may observe the patient/human research subject from the treatment control panel. The therapeutic radiation machine must not be used for patient/human research subject irradiation unless at least one (1) viewing system is operational.
4.Aural Communications. Provision must be made for continuous two (2) way aural communication between the patient/human research subject and the operator at the control panel. The therapeutic radiation machine must not be used for irradiation of patients/human research subjects unless continuous two (2) way aural communication is possible.
5.Room Entrances. Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF."
6.Entrance Interlocks. Interlocks must be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it must not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel.
7.Beam Interceptor Interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with §§ 1.8.1(A) and (B) of this Subchapter, interlocks must be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s).
8.Emergency Cutoff Switches. At least one (1) emergency power cutoff switch must terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination capability required by § 5.7.11 of this Part. All emergency power cutoff switches must include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch.
9.Safety Interlocks. All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine.
10.Surveys for Residual Radiation. Surveys for residual activity must be conducted on all therapeutic radiation machines capable of generating photon and electron energies above ten (10) MV prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.
5.7.18Qualified Medical Physicist Support
A.The services of a Qualified Medical Physicist must be required in facilities having therapeutic radiation machines with energies of five hundred (500) kV and above. The Qualified Medical Physicist must be responsible for:
1.Full calibration(s) required by § 5.7.20 of this Part and protection surveys required by § 5.4.1 of this Part;
2.Supervision and review of dosimetry;
3.Beam data acquisition and transfer for computerized dosimetry, and supervision of its use;
4.Quality assurance, including quality assurance check review required by § 5.7.21(C) of this Part;
5.Consultation with the Authorized Physician in treatment planning, as needed; and
6.Performing calculations/assessments regarding medical events and unintended treatment deviations.
B.If the Qualified Medical Physicist is not a full-time employee of the registrant, the operating procedures required by § 5.7.19 of this Part must also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.
5.7.19Operating Procedures
A.No individual, other than the patient/human research subject, must be in the treatment room during treatment or during any irradiation for testing or calibration purposes.
B.Therapeutic radiation machines must not be made available for medical use unless the requirements of §§ 5.4.1, 5.7.20 and 5.7.21 of this Part have been met.
C.Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized access and use.
D.When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field where applicable.
E.If a patient/human research subject must be held in position during treatment, mechanical support or restraint devices must be used.
F.A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.
5.7.20Acceptance Testing, Commissioning and Full Calibration Measurements
A.Acceptance testing, commissioning and full calibration of a therapeutic radiation machine subject to § 5.7 of this Part must be performed under the supervision of a Qualified Medical Physicist and reviewed and approved by a Qualified Medical Physicist.
B.Acceptance testing and commissioning must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed. Acceptance testing and commissioning must be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine.
C.Full calibration must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed. All applicable parameters (for all energies) must be completed at intervals not exceeding (13) calendar months.
1.Full calibration must include external validation of machine output accuracy for all energies prior to clinical use and at least annually thereafter for photons and protons, and every two (2) years for electrons.
D.The Qualified Medical Physicist must perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:
1.Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent (5%) from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi-energy and/or multi-mode capabilities must only require measurements for those modes and/or energies that are not within their acceptable range; and
2.Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes and/or energies, measurements must be performed on the affected mode/energy that is in most frequent clinical use at the facility. The remaining energies/modes may be validated with quality assurance check procedures against the criteria in § 5.7.20(D)(1) of this Part.
E.The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include the date of the calibration, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the model numbers, serial numbers, and calibration reports of the instruments used to calibrate the therapeutic radiation machine, and the signature of the Qualified Medical Physicist responsible for performance of the calibration.
F.Therapy-Related Computer Systems. The registrant must perform acceptance testing on the treatment planning system of therapeutic radiation machine-related computer systems in accordance with current published recommendations from a recognized national professional association (when available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer’s acceptance testing protocol must be followed.
1.Acceptance testing must be performed by, or under the direct supervision of, a Qualified Medical Physicist. At a minimum, the acceptance testing must include, as applicable, verification of:
a.The source-specific input parameters required by the dose calculation algorithm;
b.The accuracy of dose calculations at representative points;
c.The accuracy of isodose plots and graphic displays;
d.The accuracy of the software used to determine radiation source positions from radiographic images; and
e.If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.
2.Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the Authorized Physician and the Qualified Medical Physicist for correctness through means independent of that used for the determination of the parameters.
5.7.21Quality Assurance Checks
A.Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to § 5.7 of this Part, which are capable of operation at greater than or equal to five hundred (500) kV. Periodic quality assurance checks must meet the following requirements:
1.The registrant must use a dosimetry system which has calibrated in accordance with § 5.11.5 of this Part to make the periodic quality assurance checks required in § 5.7.21(A) of this Part.
2.The registrant must perform periodic quality assurance checks required by § 5.7.21(A) of this Part in accordance with written procedures established by the Qualified Medical Physicist and must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed.
B.The registrant must review the results of each periodic radiation output check according to the following procedures:
1.The Authorized Physician or Qualified Medical Physicist must be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine must not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances;
2.If all periodic radiation output quality assurance check parameters appear to be within their acceptable range, the periodic quality assurance check must be reviewed and signed by either the Authorized Physician or Qualified Medical Physicist within five (5) treatment days; and
3.The Qualified Medical Physicist must review and sign the results of each radiation output quality assurance check at intervals not to exceed thirty-six (36) days.
C.Therapeutic radiation machines subject to § 5.7 of this Part must have applicable safety quality assurance checks that meet the following requirements:
1.The registrant must perform safety quality assurance checks in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed; and
2.Safety quality assurance checks must be performed at intervals not to exceed one (1) week; and
3.Safety quality assurance checks must ensure proper operation of:
a.Proper operation of the "BEAM-ON", interrupt and termination switches;
b.Beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
c.Electrically operated treatment room door(s) from inside and outside the treatment room.
d.Viewing and aural systems.
e.Electrical interlocks at each external beam radiation therapy room entrance.
f.At least one (1) termination switch. If more than one (1) termination switch is installed and not all switches are tested at once, each switch must be tested on a rotating basis. Safety quality assurance checks of the emergency power cutoff switches may be conducted as recommended by the manufacturer in order to minimize possible stability problems with the therapeutic radiation machine.
D.The registrant must promptly repair any system identified in §§ 5.7.21(A) and (D) of this Part that is not operating properly.
E.The registrant must maintain a record of each quality assurance check required by §§ 5.7.21(A) and (D) of this Part for three (3) years. The record must include the date of the quality assurance check, the manufacturer's name, model number, serial number for the therapeutic radiation machine, the manufacturer's name, model number and serial number, and calibration report of the appropriate instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check.
5.7.22 Accreditation and External Audits
A.Each registrant providing radiation therapy with therapeutic radiation machines must:
1.Maintain an accreditation in radiation oncology by the American College of Radiology (ACR), American College of Radiation Oncology (ACRO), American Society for Radiation Oncology (ASTRO), or an accrediting organization that is recognized by the Agency; or
2.Conduct an external audit as described in § 5.7.22(B) of this Part.
B.An external audit must be completed by an Authorized Physician and Qualified Medical Physicist. This audit must be conducted at intervals not exceeding thirty-six (36) months and when new technology and/or features are used. The auditing Authorized Physician and Qualified Medical Physicist must be external.
1.The Authorized Physician audit requirement consists of a review of all the clinical aspects of the practice such as patient management (medical record review), including treatment response seen in follow-up visits if appropriate, and assessment of staffing levels including physician assistants, therapists and nurses based on patient volume and technology and complexity of services provided at the facility. The reviewing Authorized Physician must meet the requirements of § 5.3.3 of this Part.
2.The Qualified Medical Physicist audit requirement consists of a review of the QA manual and records, policies and procedures and an assessment of staffing, training and equipment needs. The reviewing Qualified Medical Physicist must meet the requirements of § 5.3.4 of this Part.
3.At a minimum, the external audit must address general questions about the practice including:
a.Therapy modalities;
b.Facility staffing;
c.Patient simulation and treatment;
d.A review of patient charts and images completed by an Authorized Physician who is active in the practice and type of radiation therapy offered by the registrant;
e.A physics component completed by a Qualified Medical Physicist who is active in the practice of the technology and modalities in use at the practice under audit;
f.An audit summary and recommendations as well as the facility's response.
4.Agency Form RCA-14 describes the minimum elements that must be included in an external audit.
C.For a newly registered facility, an initiation for accreditation or external audit must be no later than six (6) months after patient treatment begins.
D.The outcome of the accreditation survey or external audit or must be available for inspection and provided to the Agency upon request.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.8** Electronic Brachytherapy {#sec-216-ricr-40-20-5-5.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.8}
Documentation from the manufacturer and installer that the therapeutic radiation machine was manufactured and installed in accordance with most current applicable IEC standards in effect at the time of manufacturing/installation must be sufficient to demonstrate compliance with the applicable requirements of §§ 5.8.4 through 5.8.6 of this Part.
5.8.1Applicability
A.Electronic brachytherapy devices must be subject to the requirements of § 5.8 of this Part, and must be exempt for the requirements of § 5.6 of this Part.
B.An electronic brachytherapy device that does not meet the requirements of § 5.8 of this Part must not be used for irradiation of patients.
C.An electronic brachytherapy device must only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant’s Institutional Review Board (IRB).
5.8.2Possession of Survey Instrument(s)
Each facility location authorized to use an electronic brachytherapy device in accordance with § 5.8 of this Part must possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) µSv (one (1) mrem) per hour to ten (10) mSv (one thousand (1,000) mrem) per hour. The survey instrument(s) must be operable and calibrated in accordance with § 5.11 of this Part for the applicable electronic brachytherapy source energy.
5.8.3Facility Design Requirements for Electronic Brachytherapy Devices
A.In addition to shielding adequate to meet requirements of § 5.9 of this Part, the treatment room must meet the following design requirements:
1.If applicable, provision must be made to prevent simultaneous operation of more than one (1) therapeutic radiation machine in a treatment room.
2.Access to the treatment room must be controlled by a door at each entrance.
3.Provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device must not be used for patient irradiation unless the patient can be observed.
4.For electronic brachytherapy devices capable of operating at fifty (50) kV and below, radiation shielding for the staff in the treatment room must be available, either as a portable shield and/or as localized shielded material around the treatment site.
5.For electronic brachytherapy devices capable of operating at greater than one hundred fifty (150) kV:
a.The control panel must be located outside the treatment room;
b.Electrical interlocks must be provided for all doors to the treatment room that will:
(1)Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;
(2)Cause the source to be shielded or switched off when an entrance door is opened; and
(3)Prevent the source from being exposed or switched on following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.
5.8.4Electrical Safety for Electronic Brachytherapy Devices
A.The high voltage transformer must be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment.
B.The high voltage transformer must be isolated from personnel (e.g., operator) and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open.
C.The high voltage transformer must have appropriate safety labels warning personnel of potential electrical shock and/or heat related injuries.
D.Equipment must be in compliance with the appropriate manufacturer specifications and perform as intended:
5.8.5Control Panel Functions
A.The control panel, in addition to the displays required by other provisions in § 5.8 of this Part, must:
1.Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;
2.Provide an indication of whether X-rays are being produced;
3.Provide a means for indicating electronic brachytherapy source potential and current;
4.Provide the means for terminating an exposure at any time; and
5.Include an access control device that will prevent unauthorized use of the electronic brachytherapy device.
5.8.6Irradiation Control Device
A.A suitable irradiation control device (timer) must be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.
B.A timer must be provided at the treatment control panel. The timer must indicate the planned setting and the time elapsed or remaining.
C.The timer must not permit an exposure if set at zero (0).
D.The timer must be a cumulative device that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it must be necessary to reset the elapsed time indicator.
E.The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.
F.The timer must permit setting of exposure times as short as one tenth of one (0.1) second.
G.The timer must be accurate to within one percent (1%) of the selected value or one tenth of one (0.1) second, whichever is greater.
5.8.7Qualified Medical Physicist Support
A.The services of a Qualified Medical Physicist must be required in facilities having electronic brachytherapy devices. The Qualified Medical Physicist must be responsible for:
1.Evaluation of the output from the electronic brachytherapy source;
2.Generation of the necessary dosimetric information;
3.Supervision and review of treatment calculations prior to initial treatment of any treatment site;
4.Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in § 5.8.11 of this Part;
5.Consultation with the Authorized Physician in treatment planning, as needed; and
6.Performing calculations/assessments regarding patient treatments that may constitute a medical event.
B.If the Qualified Medical Physicist is not a full-time employee of the registrant, the operating procedures required by § 5.8.8 of this Part must also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.
5.8.8Operating Procedures
A.Only individuals approved by the Authorized Physician, Radiation Safety Officer, or Qualified Medical Physicist must be present in the treatment room during treatment.
B.Electronic brachytherapy devices must not be made available for medical use unless the requirements of §§ 5.4, 5.8.9 and 5.8.10 of this Part have been met.
C.The electronic brachytherapy device must be rendered inoperable, either by hardware or other access control system, when unattended by qualified staff or service personnel.
D.During operation, the electronic brachytherapy device operator must monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent unshielded exposure from the treatment beam.
E.If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used.
F.Written procedures must be developed, implemented, and maintained for responding to an abnormal situation. These procedures must include:
1.Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
2.The names and telephone numbers of the Authorized Physicians, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally.
G.A copy of the current operating and emergency procedures must be physically located at the electronic brachytherapy device control console.
1.If the control console is integral to the electronic brachytherapy device, the required procedures must be kept where the operator is located during electronic brachytherapy device operation.
H.Instructions must be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the Authorized Physicians, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally.
I.The Radiation Safety Officer, or his/her designee, and an Authorized Physician must be notified as soon as possible if the patient has a medical emergency, suffers injury or dies. The Radiation Safety Officer or the Qualified Medical Physicist must inform the manufacturer of the event.
5.8.9Safety Precautions for Electronic Brachytherapy Devices
A.A Qualified Medical Physicist must determine which persons in the treatment room require monitoring when the beam is energized;
B.An Authorized Physician and a Qualified Medical Physicist must be physically present during the initiation of all patient treatments involving the electronic brachytherapy device;
C.A Qualified Medical Physicist and either an Authorized Physician or a physician or electronic brachytherapy device operator, under the supervision of an Authorized Physician, who has been trained in the operation and emergency response for the electronic brachytherapy device, must be physically present during continuation of all patient treatments involving the electronic brachytherapy device;
D.When shielding is required by § 5.8.3(A)(4) of this Part, the electronic brachytherapy device operator must use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a Qualified Medical Physicist must designate shield locations sufficient to meet the requirements of § 1.7.1 of this Subchapter for any individual, other than the patient, in the treatment room; and
E.All personnel in the treatment room are required to remain behind shielding during treatment. A Qualified Medical Physicist must approve any deviation from this requirement and must designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.
5.8.10Electronic Brachytherapy Source Calibration Measurements
A.Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to § 5.8 of this Part must be performed by, or under the direct supervision of, a Qualified Medical Physicist;
B.Calibration of the electronic brachytherapy source output must be made for each electronic brachytherapy source, or after any repair affecting the X-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks;
C.Calibration of the electronic brachytherapy source output must utilize a dosimetry system as described in § 5.4.3 of this Part;
D.Calibration of the electronic brachytherapy source output must be in accordance with current published recommendations from a recognized national professional association with expertise in the use of electronic brachytherapy. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed.
E.The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include:
1.The date of the calibration;
2.The manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;
3.The model numbers, serial numbers, and calibration reports of the instrument(s) used to calibrate the electronic brachytherapy device; and
4.The name and signature of the Qualified Medical Physicist responsible for performing the calibration.
5.8.11Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy Devices
A.Quality assurance checks must be performed on each electronic brachytherapy device subject to § 5.8 of this Part:
1.At the beginning of each day of use.
2.Each time the device is moved to a new room or site. Site is intended to include each day of use at each operating location for a self-contained electronic brachytherapy unit transported in a van or trailer. See § 5.8.14 of this Part for additional clarification.
3.After each X-ray tube installation.
B.The registrant must perform periodic quality assurance checks required by § 5.8.11(A) of this Part consistent with manufacturer guidance and procedures established by the Qualified Medical Physicist.
C.To satisfy the requirements of § 5.8.11(A) of this Part, radiation output quality assurance checks must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of electronic brachytherapy. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed.
D.The registrant must use a dosimetry system that has been intercompared within the previous twelve (12) months with the dosimetry system described in § 5.4.3 of this Part to make the quality assurance checks required in § 5.8.11(C) of this Part;
E.The registrant must review the results of each radiation output quality assurance check according to the following procedures:
1.An Authorized Physician and Qualified Medical Physicist must be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device must not be made available for subsequent medical use until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances;
2.If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the Authorized Physician or Qualified Medical Physicist within two (2) days; and
3.The Qualified Medical Physicist must review and sign the results of each radiation output quality assurance check at intervals not to exceed thirty (30) days.
F.To satisfy the requirements of § 5.8.11(A) of this Part, safety device quality assurance checks must, at a minimum, assure:
1.Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;
2.Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;
3.Proper operation of radiation monitors, if applicable;
4.The integrity of all cables, catheters or parts of the device that carry high voltages; and
5.Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.
G.If the results of the safety device quality assurance checks required in § 5.8.11(F) of this Part indicate any malfunction, a registrant must secure the control console in the "OFF" position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.
H.The registrant must maintain a record of each quality assurance check required by §§ 5.8.11(C) and (F) of this Part in an auditable form for three (3) years.
1.The record must include the date of the quality assurance check, the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check and the name and signature of the Qualified Medical Physicist who reviewed the quality assurance check;
2.For radiation output quality assurance checks required by § 5.8.11(C) of this Part, the record must also include the unique identifier for the electronic brachytherapy source and the manufacturer's name; model number and serial number for the instrument(s) used to measure the radiation output of the electronic brachytherapy device.
5.8.12Therapy-Related Computer Systems
A.The registrant must perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in the use of electronic brachytherapy. In the absence of an acceptance testing protocol published by a recognized national professional association, the manufacturer’s acceptance testing protocol must be followed.
B.Acceptance testing must be performed by, or under the direct supervision of, a Qualified Medical Physicist. At a minimum, the acceptance testing must include, as applicable, verification of:
1.The source-specific input parameters required by the dose calculation algorithm;
2.The applicator-specific input parameters required by the dose calculation algorithm;
3.The accuracy of dose, dwell time, and treatment time calculations at representative points;
4.The accuracy of isodose plots and graphic displays;
5.The accuracy of the software used to determine radiation source positions from radiographic images; and
6.If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.
C.The position indicators in the applicator must be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.
D.Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the Authorized Physician and the Qualified Medical Physicist for correctness through means independent of that used for the determination of the parameters.
5.8.13Training
A.A registrant must provide instruction, initially and at intervals not to exceed twelve (12) months, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in § 5.8.8 of this Part. If the interval between patients exceeds twelve (12) months, retraining of the individuals must be provided before the next treatment is administered.
B.In addition to the requirements of § 5.3.3 of this Part for therapeutic radiation machine Authorized Physicians and § 5.3.4 of this Part for Qualified Medical Physicists, these individuals must also receive device specific instruction initially from the manufacturer, and at intervals not to exceed twelve (12) months from either the manufacturer or other qualified trainer. The training must be of a duration recommended by a recognized national professional association with expertise in the use of electronic brachytherapy. In the absence of any training protocol recommended by a recognized national professional association, the manufacturer’s training protocol must be followed. The training must include, but not be limited to:
1.Device-specific radiation safety requirements;
2.Device operation;
3.Clinical use for the types of use approved by the FDA;
4.Emergency procedures, including an emergency drill; and
5.The registrant’s Quality Assurance Program.
C.A registrant must retain a record of individuals receiving instruction required by §§ 5.8.13(A) and (B) of this Part in an auditable form for three (3) years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.
5.8.14Mobile Electronic Brachytherapy Service
A.A registrant providing mobile electronic brachytherapy service must, at a minimum:
1.Check each survey instrument for consistent response with a dedicated check source before medical use at each address of use or on each day of use, whichever is more restrictive. The registrant is not required to keep records of these checks.
2.Account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client’s address.
3.Perform, at each location on each day of use, all of the required quality assurance checks specified in § 5.8.11 of this Part to assure proper operation of the device.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.9** Shielding and Safety Design Requirements {#sec-216-ricr-40-20-5-5.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.9}
5.9.1Primary and Secondary Barriers
Each therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must be provided with such primary and/or secondary barriers as are necessary to ensure compliance with §§ 1.7.1 and 1.8.1 of this Subchapter and are in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies.
5.9.2Facility Design Information
Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of different model with a different isocenter or higher energy or workload into a room not previously approved for that energy or isocenter or planned workload must be submitted for Agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in § 5.14 of this Part.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.10** Quality Assurance for Radiation Therapy Simulation Systems and Imaging Systems Used for Guidance During Therapeutic Radiation {#sec-216-ricr-40-20-5-5.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.10}
A.Quality assurance for a conventional or virtual simulator and for imaging systems used for guidance during therapeutic radiation must include acceptance testing and periodic verification of system performance; and
B.Be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocols, must be followed.
C.Imaging systems used exclusively for simulation or guidance of therapeutic radiation must be exempt from the provisions of Part 4 of this Subchapter.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.11** Calibration of Survey Instruments and Dosimetry Systems {#sec-216-ricr-40-20-5-5.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.11}
5.11.1Survey Instruments
The registrant must ensure that the survey instruments used to show compliance with this Part have been calibrated before first use, at intervals not to exceed twelve (12) months, and following repair.
5.11.2Calibration Protocols
A.To satisfy the requirements of § 5.11.1 of this Part, the registrant must:
1.Calibrate all required scale readings up to ten (10) mSv (one thousand (1,000) mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST).
2.Calibrate at least two (2) points on each scale to be calibrated. These points should be at approximately one third (1/3) and two thirds (2/3) of full-scale.
B.To satisfy the requirements of § 5.11.2(A) of this Part, the registrant must:
1.Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than ten percent (10%).
2.Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than twenty percent (20%) if a correction factor or graph is conspicuously attached to the instrument.
5.11.3Record Retention
A.The registrant must retain a record of each calibration required in § 5.11.1 of this Part in an auditable form for three (3) years. The record must include:
1.A description of the calibration procedure; and
2.A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
5.11.4Use of Calibration Services
A.The registrant may obtain the services of individuals licensed by the Agency, the U.S. Nuclear Regulatory Commission or another Agreement State to perform calibrations of survey instruments. Records of calibrations which contain information required by § 5.11.3 of this Part must be maintained in an auditable form by the registrant.
B.The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include: the manufacturer’s name, model name, serial number, date of calibration and name of the laboratory where the calibration was performed.
5.11.5Dosimetry Systems
A.The registrant must have a calibrated dosimetry system available for use. The system must have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration must have been performed within the previous twenty-four (24) months and after any servicing that may have affected system calibration. A system may be cross-calibrated with another system that has been calibrated in accordance with this section. This cross-calibration must have been performed within the previous twelve (12) months and after each servicing that may have affected system calibration.
1.The dosimetry system must have been calibrated at an energy (energy range) appropriate for the radiation being measured.
2.Field sizes of less than three square centimeters by three square centimeters (3 cm x 3 cm) are considered to be small and require small volume micro-detector dosimetry systems.
B.The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include: the manufacturer’s name, model name, serial number, date of calibration and name of the lab where the calibration was performed.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.12** Other Use of Electronically-Produced Radiation To Deliver Therapeutic Radiation Dosage {#sec-216-ricr-40-20-5-5.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.12}
5.12.1Prohibition on Use
A.A person must not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:
1.The applicant or registrant has, at a minimum, provided the Agency with:
a.A detailed description of the device and its intended application(s);
b.Facility design requirements, including shielding and access control;
c.Documentation of appropriate training for Authorized Physician, qualified medical physicist(s) and other personnel who will be involved in performing quality assurance tasks and/or setting up patients for treatment or delivering treatment;
d.Methodology for measurement of dosages to be administered to patients or human research subjects;
e.Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for machine quality assurance radiation safety;
f.Radiation safety precautions and instructions; and
g.Other information requested by the Agency in its review of the application; and
2.The applicant or registrant has received written approval from the Agency to utilize the device in accordance with the regulations and specific conditions the Agency considers necessary for the medical use of the device.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.13** Emerging and Future Technologies {#sec-216-ricr-40-20-5-5.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.13}
A.Each registrant must develop, implement, and maintain a dedicated quality management program to control the processes used to administer therapeutic radiation with newly acquired, FDA-cleared emerging technologies or previously unused features of a future technology system.
B.Implementation and on-going clinical use of the emerging technology or new features must include:
1.An explicit strategy to ensure quality of processes and patient safety.
2.Approval from facility management and the radiation oncology safety team before the technology arrives and/or new features are used.
C.The quality management program must be developed by the radiation oncology safety team.
D.The quality management program must address, at a minimum:
1.Education and training about the new technology and/or features;
2.A system and timeline for on-going competency assessment of all registrant staff involved with the planning or administration of therapeutic radiation to patients or human research subjects;
3.A system for real-time recording of on-going issues related to the technology and clinical use of the new technology and/or features;
4.A strategy for timely investigation and adjudication of accidents and process deviations that may be captured in the system developed in § 5.13(B)(1) of this Part;
5.A strategy for routine review at intervals not to exceed thirteen (13) months of the clinical use of the new technology and/or features which includes an assessment of the current use compared to § 5.13(B) of this Part and plan to either update the clinical use plan or steps to bring the clinical use back into alignment with § 5.13(B) of this Part;
6.A strategy to ensure quality of equipment functions;
7.An explicit strategy for ensuring quality after hardware and software updates and after equipment repair.
E.The quality management program must be in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer’s protocol or equivalent quality, safety, and security protocol must be followed.
F.New technology issues should be reported through the vendor/manufacturer, applicable regulatory agency alerts, and/or customer service bulletins and be reviewed and addressed via a documented reporting system.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-5 § 5.14** Information on Radiation Shielding Required for Plan Reviews {#sec-216-ricr-40-20-5-5.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-5#5.14}
5.14.1All Therapeutic Radiation Machines
A.Basic facility information including:
1.Name, telephone number and Agency registration number of the individual responsible for preparation of the shielding plan;
2.Name and telephone number of the facility supervisor; and
3.The street address, including room number, of the therapeutic radiation machine facility.
4.The plan should also indicate whether this is a new structure or a modification to existing structure(s).
B.All wall, floor, and ceiling areas struck by the useful beam must have primary barriers.
C.Secondary barriers must be provided in all wall, floor, and ceiling areas not having primary barriers.
5.14.2Therapeutic Radiation Machines Up To 150 kV (Photons Only)
A.In addition to the requirements listed in § 5.14.1 of this Part, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to one hundred fifty (150) kV must submit shielding designs which contain, as a minimum, the following additional information:
1.Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors.
2.Maximum design workload for the facility including total weekly radiation output, [expressed in gray or air kerma at one (1) meter], total beam-on time per day or week, the average treatment time per patient/human research subject, along with the anticipated number of patients to be treated per day or week.
3.A facility blueprint/drawing indicating:
a.Scale [one quarter inch (0.25”) = one foot (1’) is typical];
b.Direction of North;
c.Normal location of the therapeutic radiation machine's radiation port(s);
d.The port's travel and traverse limits;
e.General direction(s) of the useful beam;
f.Locations of any windows and doors;
g.The location of the therapeutic radiation machine control panel; and
h.If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth must be noted on the plan and the operator's station at the control panel must be behind a protective barrier sufficient to ensure compliance with § 1.7.1 of this Subchapter.
4.The structural composition and thickness or lead/concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
5.The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present; and
6.The calculations which show the methodology used to determine the amount of shielding required for each physical condition [i.e., primary and secondary/leakage barriers, restricted and unrestricted areas, entry door(s)] and shielding material in the facility.
a.If commercial software is used to generate shielding requirements, the software and the version/revision date used must be identified.
b.If the software used to generate shielding requirements is not in the open literature, an explanation of the calculations used to verify the results obtained with the software must also be submitted.
5.14.3Therapeutic Radiation Machines Over 150 kV
A.In addition to the requirements listed in § 5.14.2 of this Part, therapeutic radiation machine facilities which produce photons with a maximum energy in excess of one hundred fifty (150) kV and/or electrons must submit shielding designs which contain, at a minimum, the following additional information:
1.Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray at the isocenter and the energy(s) and type(s) of radiation produced [i.e., photon, electron]. The target to isocenter distance must be specified.
2.Maximum design workload for the facility including total weekly radiation output [expressed in gray at one (1) meter], total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week.
3.Facility blueprint/drawing (including both floor plan and elevation views) indicating:
a.Relative orientation of the therapeutic radiation machine;
b.Scale [one quarter inch (0.25”) = one foot (1’) is typical];
c.Type(s), thickness and minimum density of shielding material(s);
d.Direction of North;
e.The locations and size of all penetrations through each shielding barrier (ceiling, walls and floor), as well as details of the door(s) and maze.
4.The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned.
5.The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present.
6.A description of all assumptions that were in shielding calculations including, but not limited to, design energy [i.e., room may be designed for six (6) MV unit although only a four (4) MV unit is currently proposed], work-load, presence of integral beam-stop in unit, occupancy and use(s) of adjacent areas, fraction of time that useful beam will intercept each permanent barrier [walls, floor and ceiling] and "allowed" radiation exposure in both restricted and unrestricted areas.
7.The calculations which shows the methodology used to determine the amount of shielding required for each physical condition [i.e., primary and secondary/leakage barriers, restricted and unrestricted areas, small angle scatter, entry door(s) and maze] and shielding material in the facility.
a.If commercial software is used to generate shielding requirements, the software and the version/revision date used must be identified.
b.If the software used to generate shielding requirements is not in the open literature, an explanation of the calculations used to verify the results obtained with the software must also be submitted.
5.14.4Neutron Shielding
A.In addition to the requirements listed in § 5.14.3 of this Part, therapeutic radiation machine facilities which are capable of operating at greater to or equal to ten (10) MV must submit shielding plans which contain, as a minimum, the following additional information:
1.The structural composition, thickness, minimum density and location of all neutron shielding material.
2.Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent (due to neutrons) in both restricted and unrestricted areas.
3.At least one (1) example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition [i.e., restricted and unrestricted areas, entry door(s) and maze] and neutron shielding material utilized in the facility.
a.If commercial software is used to generate shielding requirements, the software and version/revision date used must be identified.
b.If the software used to generate shielding requirements is not in the open literature an explanation of the calculations used to verify the results obtained with the software must also be submitted.
4.The method(s) and instrumentation which will be used to verify the adequacy of all neutron shielding installed in the facility.
**History**
- *Amendment — effective from 2023-11-27 to current*
- *Amendment — effective from 2022-05-25 to 11/27/2023*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-6** Radiation Safety Requirements for Industrial Radiation Machines
##### **216-RICR-40-20-6 § 6.1** Authority {#sec-216-ricr-40-20-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes special requirements for the use of industrial radiation machines not otherwise covered by this Subchapter. The requirements of this Part are in addition to, and not in substitution for, other applicable requirements of this Subchapter.
C.Any notifications, reports or correspondence required by this Part shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.2** Exemptions {#sec-216-ricr-40-20-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.2}
Uses of portable/handheld fluorescence X-ray (open beam) devices that are manufactured without safety devices are exempt from the requirements of § 6.5(A) of this Part.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.3** Definitions {#sec-216-ricr-40-20-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.3}
A.Whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3."Bomb detection radiation machine" means X-ray generating equipment used solely for the purpose of remotely detecting explosive devices. This definition does not include hand-held X-ray bomb detection equipment for the purposes of this Part.
4."Cabinet X-ray system” means an X-ray system with the X-ray tube installed in an enclosure (hereinafter termed "cabinet") that is independent of existing architectural structures except the floor. The cabinet X-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. Included are all X-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An X-ray tube used within a shielded part of a building, or X-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet X-ray system.
5.“Category A industrial radiation machine” means a device capable of generating or emitting fields of radiation in an open beam configuration during normal conditions of use. This includes, but is not limited to, portable/handheld fluorescence X-ray, fluoroscopy hand-held intensified, fluoroscopy X-ray, flash X-ray, flash X-ray for bomb detection, spectrography X-ray, diffraction X-ray and uncertified cabinet X-ray.
6.“Category B industrial radiation machine” means a device capable of generating or emitting fields of radiation where the beam is contained during normal conditions of use. This includes, but is not limited to, package X-ray, certified and certifiable cabinet X-ray, X-ray fluorescence units and similar devices.
7."Certifiable cabinet X-ray system" means an existing uncertified X-ray system that has been modified to meet the certification requirements specified in 21 C.F.R. § 1020.40.
8."Certified cabinet X-ray system" means an X-ray system which has been certified in accordance with 21 C.F.R. § 1010.2 as being manufactured and assembled pursuant to the provisions of 21 C.F.R. § 1020.40.
9."Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
10."Leakage radiation" means all radiation coming from within the source housing, except the useful beam.
11."Open-beam configuration" means an analytical X-ray system in which an individual could accidentally place some part of his body in the primary beam path during normal operation.
12.“Registrant” means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this Subchapter and the Act.
13.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.4** General Requirements – All Industrial Radiation Machines {#sec-216-ricr-40-20-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.4}
6.4.1Radiation Levels
The local components of an industrial radiation machine shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present in the area in excess of the dose limits given in § 1.8.1 of this Subchapter.
6.4.2Warning Devices
A.The X-ray control shall provide visual indication whenever X-rays are produced.
B.All ancillary warning devices shall be labeled so that their purpose is easily identified and shall have fail-safe characteristics.
C.Posting. Each area or room containing industrial radiation machines shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "CAUTION – X-RAY EQUIPMENT," or words having a similar intent.
D.Ports. Unused ports on industrial radiation machine source housings shall be secured in the closed position in a manner which will prevent inadvertent opening.
E.Labeling. Each registrant shall ensure that each industrial radiation machine is labeled in a conspicuous manner to caution individuals that radiation is produced when it is energized. This label shall be affixed in a clearly visible location on the face of the control unit. If the industrial radiation machine is not visible from the control unit, the industrial radiation machine shall have a visible indication that it is energized.
F.Radiation Source Housing. Each radiation source housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.5** Additional Requirements – Category A Industrial Radiation Machines {#sec-216-ricr-40-20-6-6.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.5}
A.Safety Device. A safety device shall be provided on all open-beam configurations which prevents the entry of any portion of an individual's body into the primary X-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations.
1.A registrant may apply to the Agency for an exemption from the requirement of a safety device. Such application shall include:
a.A description of the various safety devices that have been evaluated;
b.The reason each of these devices cannot be used; and
c.A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.
B.Warning Devices. Open-beam configurations shall be provided with a visible indication of:
1.X-ray tube status (ON – OFF) located near the radiation source housing, if the primary beam is controlled in this manner; and/or
2.Shutter status (OPEN – CLOSED) located near each port on the radiation source housing, if the primary beam is controlled in this manner.
C.Shutters. On open-beam configurations each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
D.Surveys
1.Radiation surveys, as required by § 1.10.2 of this Subchapter, of industrial radiation machines sufficient to show compliance with § 6.4.1 of this Part shall be performed:
a.Upon installation of the equipment, and at least once every twelve (12) months thereafter;
b.Following any change in the initial arrangement, number, or type of local components in the system;
c.Following any maintenance requiring the disassembly or removal of a local component in the system;
d.During the performance of maintenance and alignment procedures if the procedures require the presence of a primary X-ray beam when any local component in the system is disassembled or removed; and
e.Any time a visual inspection of the local components in the system reveals an abnormal condition.
f.Whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the radiation dose limits.
2.Radiation survey measurements shall not be required if a registrant can demonstrate, to the satisfaction of the Agency, compliance with § 6.4.1 of this Part in some other manner.
E.Generator Cabinet. Each X-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five (5) cm from its surface such that it is not capable of producing a dose in excess of one half (0.5) mrem (five (5) µSv) in any one (1) hour.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.6** Additional Requirements – Category B Industrial Radiation Machines {#sec-216-ricr-40-20-6-6.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.6}
A.All Category B industrial radiation machines shall be evaluated in accordance with the following requirements:
1.The registrant shall perform an evaluation of the radiation dose limits to determine compliance with §§ 1.8.1(A) and (B) of this Subchapter at intervals not to exceed twelve (12) months. The registrant shall ensure that radiation emitted five (5) centimeters from the external surface of the cabinet X-ray system does not exceed one half of one (0.5) millirem (five (5.0) µSv) in any one (1) hour;
2.Tests for proper operation of interlocks shall be conducted and recorded at intervals not to exceed twelve (12) months;
3.Records that demonstrate compliance with § 6.6(A) of this Part shall be maintained by the registrant for ten (10) years for inspection by the Agency.
B.Certified and Certifiable Cabinet X-ray Systems. Certified and certifiable cabinet X-ray systems, including those designed to allow admittance of individuals shall also be maintained in compliance with 21 C.F.R. § 1020.40, and no modification shall be made to the system unless prior Agency approval has been granted.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.7** Operating Requirements {#sec-216-ricr-40-20-6-6.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.7}
A.Procedures. Operating and safety procedures shall be written and made available to all industrial radiation machine operators. No individual shall be permitted to operate an industrial radiation machine in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer.
B.Bypassing. No individual shall bypass a safety device or interlock unless such individual has obtained the written approval of the radiation safety officer. Such approval shall be for a specified period of time. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing.
C.Repair or Modification of Industrial Radiation Machines. Except as specified in § 6.7(B) of this Part, no operation involving removal of covers, shielding materials or tube housing or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-6 § 6.8** Personnel Requirements {#sec-216-ricr-40-20-6-6.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-6#6.8}
A.Instruction. No individual shall be permitted to operate or maintain an industrial radiation machine unless the individual has received instruction in and demonstrated competence in the following:
1.Identification of radiation hazards associated with the use of the industrial radiation machine;
2.Radiation warning and safety devices incorporated into the industrial radiation machine, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;
3.Operating and safety procedures for the industrial radiation machine; and
4.Proper procedures for reporting an actual or suspected exposure in excess of the limits specified in § 1.8.1 of this Subchapter.
B.Instructions for Bomb Detection Radiation Machines. All personnel operating bomb detection radiation machines shall be trained in the set-up and operation of the radiation machine and in establishing a restricted area.
C.Individual Monitoring. In addition to the requirements of § 1.10.3(A)(1) of this Subchapter, finger dosimetric devices shall be provided to and shall be used by:
1.Industrial radiation machine workers using systems having an open-beam configuration and not equipped with a safety device; and
2.Personnel maintaining industrial radiation machines if the maintenance procedures require the presence of a primary X-ray beam when any local component in the X-ray system is disassembled or removed.
D.Reported dose values shall not be used for the purpose of determining compliance with § 1.7.1 of this Subchapter unless evaluated by an individual registered with the Agency to provide General Radiation Physics Services.
E.Records and Documentation. Records that demonstrate compliance with §§ 6.8(A) through (C) of this Part shall be maintained by the registrant for ten (10) years for inspection by the Agency. In addition to complying with the requirements of §§ 6.8(A) through (C) of this Part, records of individual monitoring results shall be maintained by the registrant in accordance with § 1.16.6 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-7** Licensing of Radioactive Material
##### **216-RICR-40-20-7 § 7.1** Authority {#sec-216-ricr-40-20-7-7.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part provides for the licensing of radioactive material. No person shall receive, possess, use, transfer, own or acquire radioactive material except as authorized in a specific or general license issued pursuant to this Part or as otherwise provided in this Part.
C.This Part establishes general licenses for the possession and use of radioactive material and a general license for ownership of radioactive material. The general licenses provided in this Part are subject to the provisions of §§ 7.4.3, 7.6.2, 7.6.3, 7.6.9 and 7.8.5 of this Part, and Parts 1 and 2 of this Subchapter unless indicated otherwise in the specific provision of the general license.
D.This Part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing radioactive material for sale or distribution to:
1.Persons generally licensed under this Part, 10 C.F.R. Part 31 or equivalent Regulations of another Agreement State (as defined by 10 C.F.R. § 40.4).
2.Persons licensed under Part 9 of this Subchapter.
E.This Part prescribes requirements for the issuance of specific licenses to persons who introduce radioactive material into a product or material owned by or in the possession of a licensee or another, and Regulations governing holders of such licenses.
F.This Part prescribes requirements for the issuance of specific licenses of broad scope for radioactive material (“broad licenses”).
G.This Part prescribes certain requirements governing holders of licenses to manufacture or distribute items containing radioactive material.
H.The requirements of this Part are in addition to, and not in substitution for, other applicable requirements of this Subchapter.
1.All licensees are subject to the requirements of Parts 1 and 2 of this Subchapter.
2.Licensees engaged in use of radionuclides in the healing arts are subject to the requirements of Part 9 of this Subchapter.
3.Licensees engaged in industrial radiographic operations are subject to the requirements of Part 10 of this Subchapter.
4.Licensees engaged in wireline and/or subsurface tracer studies are subject to the requirements of Part 11 of this Subchapter.
I.In any conflict between the requirements in this Part and a specific requirement in another Part of the Regulations in this Subchapter, the specific requirement governs.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.2** Incorporated Material {#sec-216-ricr-40-20-7-7.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.2}
7.2.1General Provisions for Radioactive Material
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 30 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 7.2.1(A) of this Part, 10 C.F.R. §§ 30.1, 30.2, 30.3, 30.4 (paragraph 2 of the definition of "Commencement of Construction" and paragraph 9ii of the definition of "Construction" only), 30.5, 30.6, 30.8, 30.9, 30.12, 30.21(c), 30.31, 30.32(e), 30.34(d), (e)(1) and (3), 30.37, 30.39, 30.41(b)(6), 30.52, 30.53, 30.55, 30.61, 30.63 and 30.64 are not incorporated by reference.
7.2.2General Licenses for Radioactive Material
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 31 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 7.2.2(A) of this Part, 10 C.F.R. §§ 31.1, 31.2, 31.4, 31.9, 31.13, 31.14, 31.15, 31.16, 31.17, 31.18, 31.19, 31.21, 31.22 and 31.23 are not incorporated by reference.
7.2.3Specific Licenses to Manufacture or Transfer Certain Items Containing Radioactive Material
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 32 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 7.2.3(A) of this Part, 10 C.F.R. §§ 32.1, 32.8, 32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.21(a), 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29, 32.30, 32.31, 32.32, 32.40, 32.201, 32.210, 32.211, 32.301 and 32.303 are not incorporated by reference.
7.2.4Specific Domestic Licenses of Broad Scope for Radioactive Material
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 33 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 7.2.4(A) of this Part, 10 C.F.R. §§ 33.1, 33.8, 33.12, 33.16, 33.21 and 33.23 are not incorporated by reference.
7.2.5Licensing of Source Material
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 40 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 7.2.5(A) of this Part, 10 C.F.R. §§ 40.1, 40.2, 40.4 (definition of "Reconciliation", paragraph 2 in the definition of Commencement of Construction and paragraph 9ii in the definition of Construction and definition of "Foreign obligations only), 40.5, 40.6, 40.7, 40.8, 40.9, 40.10, 40.11, 40.12, 40.13(c)(5)(iv), 40.14, 40.20, 40.21, 40.23, 40.26, 40.27, 40.28, 40.31, 40.32(d), (e), and (g), 40.33, 40.36(c), (e), and (g), 40.38, 40.41(d), (e)(1) and (3)(g) and (h), 40.43, 40.45, 40.51(b)(6), 40.52, 40.53, 40.56, 40.62, 40.63, 40.64, 40.65, 40.66, 40.67, 40.71, 40.81 and 40.82 are not incorporated by reference.
7.2.6Licensing of Special Nuclear Material
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 70 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 7.2.6(A) of this Part, 10 C.F.R. §§ 70.1, 70.2, 70.3, 70.4 (paragraph 2 in the definition of Commencement of Construction and paragraph 9ii in the definition of Construction only), 70.5, 70.6, 70.7, 70.8, 70.9, 70.10, 70.13, 70.14, 70.17, 70.18, 70.20, 70.20a, 70.20b, 70.21, 70.22, 70.23(a)(1), (a)(5) through (a)(12) and (b), 70.24, 70.25(a)(1), (c), (d), and (f), 70.31(c), (d) and (e), 70.32(a)(1), (4), (5), (6) and (7) and (b)(1), (3) and (4) and (c), (d), (e), (f), (g), (h), (i), (j) and (k), 70.33, 70.35, 70.37, 70.40, 70.42(b)(6), 70.44, 70.51(c), (d) and (e), 70.52, 70.53, 70.54, 70.55, 70.56, 70.57, 70.58, 70.59, 70.60, 70.61, 70.62, 70.64, 70.65, 70.66, 70.72, 70.73, 70.74, 70.76, 70.81 and 70.82, 70.91, 70.92 and Appendix A are not incorporated by reference.
C.Except as provided in this Part, the requirements of 10 C.F.R. § 150.11(b) (2019) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
7.2.7Effect of incorporation of 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70
A.To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70 the following words and phrases shall be substituted for the language in 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70 as follows:
1.Any reference to NRC or Commission shall be deemed to be a reference to the Agency.
2.Any reference to NRC or agreement State shall be deemed to be a reference to the Agency, NRC or agreement State.
3.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
4.Any reference to special nuclear material shall be deemed to be a reference to special nuclear material in quantities not sufficient to form a critical mass.
5.Any reference to “NRC Form 313, Application for Material License" shall be deemed to be a reference to Agency Form MAT-1, Application for Material License.
6.Any reference to “NRC Form 244, Registration Certificate – Use of Depleted Uranium Under General License" shall be deemed to be a reference to Agency Form GEN-1 "Registration Certificate – Use of Depleted Uranium Under General License."
7.Any reference to “NRC Form 483, Registration Certificate – In Vitro Testing with Byproduct Material Under General License" shall be deemed to be a reference to Agency Form GEN-3, Certificate – In Vitro Testing with Radioactive Material Under General License.
8.Any notifications, reports or correspondence referenced in the incorporated sections of 10 C.F.R. Parts 30, 31, 32, 33, 40 and 70 shall be directed to the Agency using Agency contact information specified in § 1.4 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.3** Definitions {#sec-216-ricr-40-20-7-7.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.3}
A.In addition to the definitions contained in 10 C.F.R. §§ 30.4, 32.2, 40.4 and § 70.4, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“NARM” means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.
4.“Offshore waters” means that area of land and water, beyond Rhode Island’s Submerged Lands Act jurisdiction, on or above the U.S. Outer Continental Shelf.
5.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
6.“Special nuclear material in quantities not sufficient to form a critical mass” means uranium enriched in the isotope U-235 in quantities not exceeding three hundred fifty (350) grams of contained U-235; uranium-233 in quantities not exceeding two hundred (200) grams; plutonium in quantities not exceeding two hundred (200) grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed "1" (i.e., unity). For example, the following quantities in combination would not exceed the limitation and are within the formula: (175 (grams contained U-235)/350) + (50 (grams U-233)/200) + (50 (grams Pu)/200) = 1.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.4** Exemptions {#sec-216-ricr-40-20-7-7.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.4}
7.4.1Persons Using Sources of Radiation Under Certain Department of Energy and Nuclear Regulatory Commission Contracts
A.Any prime contractor or subcontractor of the U.S. Department of Energy (DOE) or the U.S. Nuclear Regulatory Commission (NRC) operating within the State of Rhode Island is exempt from the requirements for a license set forth in this Subchapter to the extent that such prime contractor or subcontractor under his contract manufactures, produces, transfers, receives, acquires, owns, possesses, or uses sources of radiation:
1.The performance of work for the DOE at a United States Government-owned or controlled site, including the transportation of sources of radiation to or from such site and the performance of contract services during temporary interruptions of such transportation;
2.Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or
3.The use or operation of nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel.
B.In addition to the foregoing exemptions, any prime contractor or subcontractor of the DOE or the NRC is exempt from the requirements for a license set forth in this Subchapter to the extent that such prime contractor or subcontractor manufacturers, produces, transfers, receives, acquires, owns, possesses, or uses sources of radiation under his prime contract or subcontract when the State of Rhode Island and the NRC jointly determine that:
1.The exemption of the prime contractor or subcontractor is authorized by law; and
2.Under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.
7.4.2Carriers
Common and contract carriers, freight forwarders, warehousemen, and the U.S. Postal Service are exempt from the requirements in this Part to the extent that they transport or store radioactive material in the regular course of carriage for another or storage incident thereto.
7.4.3Exempt Concentrations
For the purpose of this Part, exempt concentrations are defined by 10 C.F.R. §§ 30.14 and 30.70, Schedule A [§ 7.9.1 of this Part].
7.4.4Exempt Quantities
For the purpose of this Part, exempt quantities are defined by 10 C.F.R. §§ 30.18 and 30.71, Schedule B [§ 7.9.2 of this Part].
7.4.5Certain Items Containing Radioactive Material
For the purpose of this Part, exemptions for certain items containing radioactive material are defined by 10 C.F.R. § 30.15.
7.4.6Self-luminous Products Containing Tritium, Krypton-85, or Promethium-147
For the purpose of this Part, exemptions for self-luminous products containing tritium, Krypton-85, or Promethium-147 are defined by 10 C.F.R. § 30.19.
7.4.7Gas and Aerosol Detectors Containing Radioactive Material
For the purpose of this Part, exemptions for gas and aerosol detectors containing radioactive material are defined by 10 C.F.R. § 30.20.
7.4.8Radioactive Drug: Capsules Containing C-14 Urea for "In Vivo" Diagnostic Use for Humans
For the purpose of this Part, exemptions for capsules containing C-14 urea for "in vivo" diagnostic use for humans are defined by 10 C.F.R. § 30.21, excluding 10 C.F.R. § 30.21(c).
7.4.9Certain Industrial Devices
For the purpose of this Part, exemptions for certain industrial devices are defined by 10 C.F.R. § 30.22.
7.4.10Unimportant Quantities of Source Material
For the purpose of this Part, unimportant quantities of source material are defined by 10 C.F.R. § 40.13, with the exception of § 40.13(c)(5)(iv).
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.5** Licenses {#sec-216-ricr-40-20-7-7.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.5}
A.Licenses for radioactive materials are of two (2) types: general and specific.
1.The Agency issues a specific license to a named person who has filed an application for the license under the provisions of this Subchapter.
2.A general license is provided by regulation, grants authority to a person for certain activities involving radioactive material, and is effective without the filing of an application with the Agency or the issuance of a licensing document to a particular person. However, registration with the Agency may be required by the particular general license.
B.Types of specific licenses of broad scope:
1.A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.
2.A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in the table referenced in § 7.9.6 of this Part, for any authorized purpose. The possession limit for a Type B broad license, if only one (1) radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column I of the table referenced in § 7.9.6 of this Part. If two (2) or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Column I of the table referenced in § 7.9.6 of this Part, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.
3.A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in the table referenced in § 7.9.6 of this Part, for any authorized purpose. The possession limit for a Type C broad license, if only one (1) radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column II of the table referenced in § 7.9.6 of this Part. If two (2) or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in Column II of the table referenced in § 7.9.6 of this Part, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.6** Specific Licenses {#sec-216-ricr-40-20-7-7.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.6}
7.6.1Application for Specific Licenses
A.Applications for specific licenses shall be filed in duplicate on a form prescribed by the Agency, and shall include a designated e-mail address for receipt of official Agency correspondence in electronic format.
B.The Agency may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Agency to determine whether the application should be granted or denied or whether a license should be modified or revoked.
C.Each application shall be signed by the applicant or licensee or a person duly authorized to act on their behalf.
D.An application for a license may include a request for a license authorizing one (1) or more activities.
E.In the application, the applicant shall submit the required information to the Agency without reference to previously submitted documents unless permission has been obtained from the Agency, in advance, to incorporate by reference information contained in previous applications, statements, or reports filed with the Agency. All references shall be clear and specific and shall contain all of the information needed for a particular item on the application.
F.Applications and documents submitted to the Agency may be made available for public inspection except that the Agency may withhold any document or part thereof from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned.
G.Specific License to Use Radioactive Material in the Form of a Sealed Source or in a Device That Contains the Sealed Source. For the purposes of this Part, requirements for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source are defined by 10 C.F.R. § 30.32(g).
H.Consideration of the Need for an Emergency Plan for Responding to a Release of Radioactive Materials. For the purpose of this Part, requirements for consideration of the need for an emergency plan for responding to a release of radioactive materials are defined by 10 C.F.R. § 30.32(i).
I.Production of PET Radioactive Drugs for Noncommercial Transfer. An application from a medical facility or educational institution to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part 9 of this Subchapter shall include:
1.A request for authorization for the production of PET radionuclides or evidence of an existing license issued under this Part, or equivalent Regulations of the U.S. Nuclear Regulatory Commission or another Agreement State, for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.
2.Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one (1) of the criteria in § 7.6.16(B) of this Part.
3.Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an Authorized Nuclear Pharmacist as specified in 10 C.F.R. § 32.72(b)(2) and § 7.6.16(C) of this Part.
4.Information identified in 10 C.F.R. § 32.72(a)(3) on the PET drugs to be noncommercially transferred to members of its consortium.
7.6.2General Requirements for Issuance of Specific Licenses
A.For the purposes of this Part, general requirements for issuance of specific licenses are defined by 10 C.F.R. §§ 30.33, 40.32 and 70.31.
B.Use of Radioactive Material at Property Not Owned by Applicant. In addition to the requirements set forth in § 7.6.2(A) of this Part and/or Part 9 of this Subchapter, a specific license for use of radioactive material where the proposed location of use is not owned by the applicant will be issued under the following conditions:
1.Each initial application shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use.
2.Each amendment request for an additional location of use shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use.
7.6.3Terms and Conditions of Licenses
For the purpose of this Part, terms and conditions of licenses are defined by 10 C.F.R. §§ 30.34 [excluding §§ 30.34(d), (e)(1), & (e)(3)], 40.41 [excluding §§ 40.41(d), (e)(1) and (3) and (g)] and § 70.32 [excluding §§ 70.32(a)(1), (4), (5), (6) and (7) and (b)(1), (3) and (4) and (c), (d), (e), (f), (g), (h), (i), (j) and (k)].
7.6.4Financial Assurance and Recordkeeping for Decommissioning
A.For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for a specific license authorizing the possession and use of unsealed radioactive material are defined by 10 C.F.R. § 30.35.
B.For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for licenses authorizing the receipt, possession and use of source material are defined by 10 C.F.R. §§ 40.36 (a), (b), (d) and (f).
C.For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for licenses authorizing the receipt, possession and use of special nuclear material in quantities not sufficient to form a critical mass are defined by 10 C.F.R. §§ 70.25(a)(2), (b), (e) and (g).
7.6.5Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas
For the purpose of this Part, requirements for expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas are defined by 10 C.F.R. §§ 30.36, 40.42 and 70.38.
7.6.6Renewal of Specific Licenses
A.Applications for renewal of specific licenses shall be filed in accordance with § 7.6.1 of this Part.
B.In any case in which a licensee, not less than thirty (30) days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by the Agency.
7.6.7Amendment of Licenses
A.For the purpose of this Part, requirements for amendment of licenses are defined by 10 C.F.R. §§ 30.38, 40.44 and 70.34.
B.A licensee shall notify the Agency by letter no later than thirty (30) days after:
1.An Authorized User or Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change; or
2.The licensee's mailing address changes; or
3.The licensee’s name changes, but the name change does not constitute a transfer of control of the license as described in § 7.6.3 of this Part; or
4.The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used.
7.6.8Agency Action on Applications to Renew or Amend
In considering an application to renew or amend a license, the Agency will apply the criteria set forth in §§ 7.5 or 7.6 of this Part as applicable.
7.6.9Transfer of Radioactive Material
For the purpose of this Part, requirements for transfer of radioactive material are defined by 10 C.F.R. §§ 30.41 [excluding § 30.41(b)(6)], 40.51 [excluding § 40.51(b)(6)] and 70.42 [excluding § 70.42(b)(6)].
7.6.10Requirements for a Specific License of Broad Scope
A.A person may file an application for specific license of broad scope in accordance with the provisions of § 7.6.1 of this Part.
B.For the purpose of this Part, requirements for the issuance of a Type A specific license of broad scope are defined by 10 C.F.R. § 32.13.
C.For the purpose of this Part, requirements for the issuance of a Type B specific license of broad scope are defined by 10 C.F.R. § 32.14.
D.For the purpose of this Part, requirements for the issuance of a Type C specific license of broad scope are defined by 10 C.F.R. § 32.15.
E.An application filed pursuant to this Part for a specific license other than one of broad scope will be considered by the Agency as an application for a specific license of broad scope under this Part if the requirements of the applicable sections of this Part are satisfied.
7.6.11Requirements for License to Manufacture or Initially Transfer Devices to Persons Generally Licensed Under § 7.7.1
A.For the purpose of this Part, requirements for a license to manufacture or initially transfer devices to persons generally licensed under § 7.7.1 of this Part are defined by 10 C.F.R. § 32.51.
B.For the purpose of this Part, license conditions for a person licensed under § 7.6.11(A) of this Part are defined by 10 C.F.R. § 32.51(a).
C.For the purpose of this Part, requirements for material transfer reports and records for a person licensed under § 7.6.11(A) of this Part are defined by 10 C.F.R. § 32.52.
7.6.12Requirements for License to Manufacture, Assemble, Repair or Initially Transfer Luminous Safety Devices for Use in Aircraft
A.For the purpose of this Part, requirements for a license to manufacture, assemble, repair or initially transfer luminous safety devices for use in aircraft are defined by 10 C.F.R. § 32.53.
B.For the purpose of this Part, requirements for labeling of devices licensed under § 7.6.12(A) of this Part are defined by 10 C.F.R. § 32.54.
C.For the purpose of this Part, requirements for quality assurance and prohibition of transfer of devices licensed under § 7.6.12(A) of this Part are defined by 10 C.F.R. § 32.55.
D.For the purpose of this Part, requirements for material transfer reports for persons licensed under § 7.6.12(A) of this Part are defined by 10 C.F.R. § 32.56.
7.6.13Requirements for License to Manufacture or Initially Transfer Calibration or Reference Sources Containing Americium-241, Plutonium or Radium-226
A.For the purpose of this Part, requirements for a license to manufacture or initially transfer calibration or reference sources containing Americium-241 or Radium-226 are defined by 10 C.F.R. § 32.57.
B.For the purpose of this Part, requirements for labeling of devices licensed under § 7.6.13(A) of this Part are defined by 10 C.F.R. § 32.58.
C.For the purpose of this Part, requirements for leak testing of each source licensed under § 7.6.13(A) of this Part are defined by 10 C.F.R. § 32.59.
D.For the purpose of this Part, requirements for a license to manufacture or initially transfer calibration or reference sources containing plutonium are defined by 10 C.F.R. § 70.39.
7.6.14Requirements for License to Manufacture or Initially Transfer Ice Detection Devices Containing Strontium-90
A.For the purpose of this Part, requirements for a license to manufacture or initially transfer ice detection devices containing Strontium-90 are defined by 10 C.F.R. § 32.61.
B.For the purpose of this Part, requirements for quality assurance and prohibition of transfer of devices licensed under § 7.6.14(A) of this Part are defined by 10 C.F.R. § 32.62.
7.6.15Requirements for License to Manufacture and Distribute Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License
For the purpose of this Part, requirements for a license to manufacture and distribute radioactive material for certain in vitro clinical or laboratory testing under general license are defined by 10 C.F.R. § 32.71.
7.6.16Requirements for License to Manufacture, Prepare, or Transfer for Commercial Distribution of Radioactive Drugs Containing Radioactive Material for Medical Use Under Part 9
A.For the purpose of this Part, requirements for a license to manufacture, prepare, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use under Part 9 of this Subchapter are defined by 10 C.F.R. § 32.72.
B.In addition to the requirements in § 7.6.16(A) of this Part, the applicant shall submit evidence that the applicant is at least one (1) of the following:
1.Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. § 207.20(a);
2.Licensed as a drug manufacturer and/or pharmacy in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors; or
3.Licensed as a positron emission tomography (PET) drug production facility pursuant to this Part.
C.In addition to the provisions of 10 C.F.R. § 32.72(b)(4), an individual may function as an authorized nuclear pharmacist only if they are licensed as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.
7.6.17Requirements for License to Manufacture and Distribute Sources or Devices Containing Radioactive Material for Medical Use
For the purpose of this Part, requirements for a license to manufacture and distribute sources or devices containing radioactive material for medical use are defined by 10 C.F.R. § 32.74.
7.6.18Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications
A.For the purpose of this Part, requirements for a license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications are defined by 10 C.F.R. § 40.34.
B.For the purpose of this Part, conditions of specific licenses issued pursuant to § 7.6.18(A) of this Part are defined by 10 C.F.R. § 40.35.
7.6.19Requirements for License to Initially Transfer Source Material for Use Under The 'Small Quantities of Source Material' General License
A.For the purpose of this Part, requirements for a license to initially transfer source material for use under the “small quantities of source material” general license are defined by 10 C.F.R. § 40.54.
B.For the purpose of this Part, requirements for quality control, labeling, safety instructions, and records and reports for licenses issued pursuant to § 7.6.19(A) of this Part are defined by 10 C.F.R. § 40.55.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.7** General Licenses {#sec-216-ricr-40-20-7-7.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.7}
7.7.1General License for Certain Detecting, Measuring, Gauging, or Controlling Devices and Certain Devices for Producing Light or an Ionized Atmosphere
For the purpose of this Part, requirements for a general license for certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere are defined by 10 C.F.R. § 31.5.
7.7.2General License to Install Devices Generally Licensed in § 7.7.1
For the purpose of this Part, requirements for a general license to install devices generally licensed in § 7.7.1 of this Part are defined by 10 C.F.R. § 31.6.
7.7.3General License for Luminous Safety Devices for Use in Aircraft
For the purpose of this Part, requirements for a general license for luminous safety devices for use in aircraft are defined by 10 C.F.R. § 31.7.
7.7.4General License for Calibration or Reference Sources
A.For the purpose of this Part, requirements for a general license for Americium-241 and Radium-226 in the form of calibration or reference sources are defined by 10 C.F.R. § 31.8.
B.For the purpose of this Part, requirements for a general license for plutonium in the form of calibration or reference sources are defined by 10 C.F.R. § 70.19.
7.7.5General License to Own Radioactive Material
A.A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Part, a general licensee not authorized to manufacture, produce, transfer, receive, possess, use, import, or export radioactive material except as authorized by a specific license.
B.A general license is hereby issued to own special nuclear material in quantities not sufficient to form a critical mass. Notwithstanding any other provisions of this Part, a general licensee under this section is not authorized to acquire, deliver, receive, possess, use or transfer special nuclear material in quantities not sufficient to form a critical mass, except as authorized in a specific license.
7.7.6General License for Strontium 90 in Ice Detection Devices
For the purpose of this Part, requirements for a general license for Strontium 90 in ice detection devices are defined by 10 C.F.R. § 31.10.
7.7.7General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing
For the purpose of this Part, requirements for a general license for use of radioactive material for certain in vitro clinical or laboratory testing are defined by 10 C.F.R. § 31.11.
7.7.8General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing
For the purpose of this Part, requirements for a general license for certain items and self-luminous products containing Radium-226 are defined by 10 C.F.R. § 31.12.
7.7.9General License for Small Quantities of Source Material
For the purpose of this Part, requirements for a general license for small quantities of source material are defined by 10 C.F.R. § 40.22.
7.7.10General License for Use of Certain Industrial Products or Devices
For the purpose of this Part, requirements for a general license for use of certain industrial products or devices are defined by 10 C.F.R. § 40.25.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.8** Serialization of Nationally Tracked Sources, Sealed Source & Device Registry, Records and Reports {#sec-216-ricr-40-20-7-7.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.8}
7.8.1Records
A.For the purpose of this Part, recordkeeping requirements are defined by 10 C.F.R. §§ 30.51, 40.61 and 70.51 [excluding 10 C.F.R. §§ 70.51(c), (d) and (e)].
B.Each record required by this Part must be legible throughout the retention period specified by each Agency Regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
7.8.2Right to Cause the Withholding or Recall of Radioactive Material
For the purpose of this Part, the right to cause the withholding or recall of radioactive material defined by 10 C.F.R. § 30.62.
7.8.3Serialization of Nationally Tracked Sources
Each licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.
7.8.4Sealed Source and Device Registry
A.Registration of Product Information. The Agency does not currently administer a sealed source and device registration program. Any manufacturer or initial distributor of a sealed source or device containing a sealed source who is subject to this Part shall submit a request for evaluation of radiation safety information about its product and for its registration to the Nuclear Regulatory Commission pursuant to 10 C.F.R. § 32.210.
B.Inactivation of Certificates of Registration of Sealed Sources and Devices
1.A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Agency shall request inactivation of the registration certificate. Such a request must be made to the Agency and must normally be made no later than two (2) years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two (2) years after that transfer, the certificate holder shall request inactivation of the certificate within ninety (90) days of this determination and briefly describe the circumstances of the delay.
2.If a distribution license is to be terminated in accordance with this Part, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Agency will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.
3.A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.
7.8.5Modification, Revocation, and Termination of Licenses
A.The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the Act, or by reason of Rules, Regulations, and orders issued by the Agency.
B.Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Agency to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the Act, or of the license, or of any Rule, Regulation, or order of the Agency.
C.Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.
D.The Agency may terminate a specific license upon request submitted by the licensee to the Agency in writing.
E.Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than one hundred twenty (120) days, in an unsealed form, shall forward the following records to the Agency:
1.Records of disposal of licensed material made under §§ 1.15.2, 1.15.3, 1.15.4 and 1.15.5 of this Subchapter; and
2.Records required by § 1.16.3 of this Subchapter.
F.If licensed activities are transferred or assigned in accordance with § 7.6.3 of this Part, each licensee authorized to possess radioactive material, with a half-life greater than one hundred twenty (120) days, in an unsealed form, shall forward the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:
1.Records of disposal of licensed material made under §§ 1.15.2, 1.15.3, 1.15.4 and 1.15.5 of this Subchapter; and
2.Records required by § 1.16.3 of this Subchapter.
G.Prior to license termination, each licensee shall forward the records required by § 7.6.4 of this Part to the Agency.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.9** Schedules {#sec-216-ricr-40-20-7-7.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.9}
7.9.1Exempt Concentrations
For the purpose of this Part, the schedule of exempt concentrations is defined by 10 C.F.R. § 30.70, Schedule A.
7.9.2Exempt Quantities
For the purpose of this Part, the schedule of exempt quantities is defined by 10 C.F.R. § 30.71, Schedule B.
7.9.3Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release
For the purpose of this Part, quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release are defined by 10 C.F.R. § 30.72.
7.9.4Schedule C: Quantities of Licensed Material Requiring Labeling
For the purpose of this Part, quantities of licensed material requiring labeling are defined by Appendix B to 10 C.F.R. Part 30.
7.9.5Decommissioning Funding Criteria
A.For the purpose of this Part, criteria relating to use of financial tests and parent company guarantees for providing reasonable assurance of funds for decommissioning are defined by Appendix A to 10 C.F.R. Part 30.
B.For the purpose of this Part, criteria relating to use of financial tests and self guarantees for providing reasonable assurance of funds for decommissioning are defined by Appendix C to 10 C.F.R. Part 30.
C.For the purpose of this Part, criteria relating to use of financial tests and self-guarantee for providing reasonable assurance of funds for decommissioning by commercial companies that have no outstanding rated bonds are defined by Appendix D to 10 C.F.R. Part 30.
D.For the purpose of this Part, criteria relating to use of financial tests and self-guarantee for providing reasonable assurance of funds for decommissioning by nonprofit colleges, universities, and hospitals are defined by Appendix E to 10 C.F.R. Part 30.
7.9.6Limits for a Specific License of Broad Scope
A.For the purpose of this Part, limits for a specific license of broad scope are defined by 10 C.F.R. § 33.100, Schedule C.
B.In addition to the values referenced in § 7.9.6(A) of this Part, the following table of limits for a specific license of broad scope is also applicable to this Part:
Radioactive Material
Col. I curies
Col. II curies
Beryllium-7
10
0.1
Cobalt-57
10
0.1
Radium-226
0.01
0.0001
Scandium-46
1
0.01
Sodium-22
0.1
0.001
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-7 § 7.10** Reciprocal Recognition of Licenses {#sec-216-ricr-40-20-7-7.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-7#7.10}
7.10.1Specific Radioactive Material Licenses
A.Subject to this Subchapter, and the limitations contained in § 7.10.1(D) of this Part, any person who holds a specific license from the U.S. Nuclear Regulatory Commission or any Agreement State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within Rhode Island, except for areas under exclusive federal jurisdiction, for a period not in excess of one hundred eighty (180) days in any calendar year provided that:
1.The licensing document does not limit the activity authorized by such document to specified installations or locations;
2.The out-of-State licensee submits Agency Form MAT-9i, a copy of the pertinent licensing document, and the appropriate fee as prescribed in § 15.5.4 of this Subchapter to the Agency at least three (3) days prior to engaging in such activity for the first time in a calendar year. If a submittal cannot be filed three (3) days before engaging in activities under reciprocity, because of an emergency or other reason, the Agency may waive the three (3) day time requirement provided the licensee:
a.Informs the Agency by telephone, facsimile, an Agency Form MAT-9N, or a letter of initial activities or revisions to the information submitted on the initial Agency Form MAT-9i;
b.Receives oral or written authorization for the activity from the Agency; and
c.Within three (3) days after the notification, files an Agency Form MAT-9N, a copy of the pertinent licensing document, and the appropriate fee as prescribed in § of this Subchapter.
3.The out-of-State licensee complies with all applicable Regulations of the Agency and with all the terms and conditions of his licensing document, except any such terms and conditions which may be inconsistent with applicable Regulations of the Agency;
4.The out-of-State licensee supplies such other information as the Agency may request; and
5.The out-of-State licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in § 7.10.1(A) of this Part except by transfer to a person specifically licensed by the Agency, another Agreement State or by the U.S. Nuclear Regulatory Commission to receive such material.
6.The out-of-State licensee files an amended Agency Form MAT-9N with the Agency to request approval for changes in work locations, radioactive material, or work activities different from the information contained on the initial MAT-9N.
B.Notwithstanding the provisions of § 7.10.1(A) of this Part, any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in § 7.7.1 of this Part within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in Rhode Island, except for areas under exclusive federal jurisdiction, provided that:
1.Such person shall file a report with the Agency within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in Rhode Island. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;
2.The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission or an Agreement State;
3.Such person shall assure that any labels required to be affixed to the device under Regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited;" and
4.The holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in § 7.7.1 of this Part.
C.The Agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.
D.The Agency will not accept any applications for reciprocity under this Part with respect to activities authorized pursuant to regulations that are equivalent to Part 9 of this Subchapter entitled “Medical Use of Radioactive Material.” These activities will only be authorized under the provision of a specific license issued by the Agency.
7.10.2Generally Licensed Devices
A.Reciprocity requests involving generally licensed devices registered pursuant to § 7.7.1 of this Part or the equivalent Regulations of the U.S. Nuclear Regulatory Commission or another Agreement State shall be handled in accordance with the procedures contained in § 7.10.1 of this Part. Applicants for reciprocity shall submit evidence of current registration pursuant to § 7.7.1 of this Part (or the equivalent regulations of the U.S. Nuclear Regulatory Commission or another Agreement State) in lieu of a specific radioactive materials license.
B.Reciprocity requests involving other generally licensed devices shall also be handled in accordance with the procedures contained in § 7.10.1 of this Part. In lieu of a specific radioactive materials license, applicants for reciprocity shall submit a copy of the general license authorization for the device and documentation that they are authorized to possess the device under a general license pursuant to the regulations of the U.S. Nuclear Regulatory Commission or another Agreement State that are applicable to the jurisdiction where the reciprocity request originated.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-8** Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material
##### **216-RICR-40-20-8 § 8.1** Authority {#sec-216-ricr-40-20-8-8.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part has been established to provide the requirements for the physical protection program for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material listed in § 8.8 of this Part. These requirements provide reasonable assurance of the security of category 1 or category 2 quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included. No provision of this Part authorizes possession of licensed material.
C.§§ 8.4 and 8.5 of this Part apply to any person who, under the regulations in this Part, possesses or uses at any site, an aggregated category 1 or category 2 quantity of radioactive material.
D.§ 8.6 of this Part applies to any person who, under the regulations of this Part:
1.Transports or delivers to a carrier for transport in a single shipment, a category 1 or category 2 quantity of radioactive material; or
2.Imports or exports a category 1 or category 2 quantity of radioactive material; the provisions only apply to the domestic portion of the transport.
E.Specific exemptions to the provisions of this Part are defined by 10 C.F.R. § 37.11(c).
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.2** Incorporated Material {#sec-216-ricr-40-20-8-8.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 37 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 8.2(A) of this Part, 10 C.F.R. §§ 37.1, 37.3, 37.7, 37.9, 37.11(a) & (b), 37.13, 37.101, 37.105, 37.107 and 37.109 are not incorporated by reference.
C.Effect of incorporation of 10 C.F.R. Part 37. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 37, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 37 as follows:
1.Any reference to NRC or the Commission shall be deemed to be a reference to the Agency, except:
a.§ 37.5 Definitions: Agreement State, Byproduct material, Commission, Person;
b.§ 37.27(a) and (c);
c.§ 37.29(a);
d.§ 37.71 referring to NRC's license verification system.
e.§ 37.71 licensee of the Commission or an Agreement State shall be deemed to be a reference to licensee of the Agency, NRC or an Agreement State.
2.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
3.Except as specifically directed in § 8.2(C)(1) of this Part, or as specifically noted in this Part, any notifications, reports or correspondence referenced in the incorporated parts of 10 C.F.R. Part 37 shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.3** Definitions {#sec-216-ricr-40-20-8-8.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.3}
A.In addition to the definitions contained in 10 C.F.R. § 37.5, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.4** Background Investigations and Access Control Program {#sec-216-ricr-40-20-8-8.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.4}
8.4.1Personnel Access Authorization Requirements for Category 1 or Category 2 Quantities of Radioactive Material
For the purpose of this Part, personnel access authorization requirements for category 1 or category 2 quantities of radioactive material are defined by 10 C.F.R. § 37.21.
8.4.2Access Authorization Program Requirements
For the purpose of this Part, access authorization program requirements are defined by 10 C.F.R. § 37.23.
8.4.3Background Investigations
For the purpose of this Part, background investigations requirements are defined by 10 C.F.R. § 37.25.
8.4.4Requirements for Criminal History Records Checks of Individuals Granted Unescorted Access to Category 1 Or Category 2 Quantities of Radioactive Material
A.For the purpose of this Part, requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material are defined by 10 C.F.R. § 37.27.
B.In lieu of the address given in 10 C.F.R. § 37.27(c), licensees shall submit fingerprint cards or records to U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, ATTN: Criminal History Program/Mailstop T-07D04M, 11545 Rockville Pike, Rockville, MD 20852.
8.4.5Relief from Fingerprinting, Identification, and Criminal History Records Checks and Other Elements of Background Investigations for Designated Categories of Individuals Permitted Unescorted Access to Certain Radioactive Materials
For the purpose of this Part, requirements for relief from fingerprinting, identification, and criminal history records checks and other elements of background investigations for designated categories of individuals permitted unescorted access to certain radioactive materials are defined by 10 C.F.R. § 37.29.
8.4.6Protection of Information
For the purpose of this Part, requirements for protection of information are defined by 10 C.F.R. § 37.31.
8.4.7Access Authorization Program Review
For the purpose of this Part, requirements for access authorization program review are defined by 10 C.F.R. § 37.33.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.5** Physical Protection Requirements During Use {#sec-216-ricr-40-20-8-8.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.5}
8.5.1Security Program
For the purpose of this Part, requirements for a security program are defined by 10 C.F.R. § 37.41.
8.5.2General Security Program Requirements
For the purpose of this Part, General security program requirements are defined by 10 C.F.R. § 37.43.
8.5.3LLEA Coordination
For the purpose of this Part, requirements for LLEA coordination are defined by 10 C.F.R. § 37.45.
8.5.4Security Zones
For the purpose of this Part, security zone requirements are defined by 10 C.F.R. § 37.47.
8.5.5Monitoring, Detection, and Assessment
For the purpose of this Part, requirements for monitoring, detection, and assessment are defined by 10 C.F.R. § 37.49.
8.5.6Maintenance and Testing
For the purpose of this Part, security program requirements for maintenance and testing are defined by 10 C.F.R. § 37.51.
8.5.7Requirements for Mobile Devices
For the purpose of this Part, requirements for mobile devices are defined by 10 C.F.R. § 37.53.
8.5.8Security Program Review
For the purpose of this Part, security program review requirements are defined by 10 C.F.R. § 37.55.
8.5.9Security Reporting of Events
For the purpose of this Part, requirements for reporting of events are defined by 10 C.F.R. § 37.57.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.6** Physical Protection in Transit {#sec-216-ricr-40-20-8-8.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.6}
8.6.1Additional Requirements for Transfer of Category 1 and Category 2 Quantities of Radioactive Material
For the purpose of this Part, additional requirements for transfer of category 1 and category 2 quantities of radioactive material are defined by 10 C.F.R. § 37.71.
8.6.2Applicability of Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material During Transit
For the purpose of this Part, applicability of physical protection of category 1 and category 2 quantities of radioactive material during transit is defined by 10 C.F.R. § 37.73.
8.6.3Preplanning and Coordination of Shipment of Category 1 or Category 2 Quantities of Radioactive Material
For the purpose of this Part, requirements for preplanning and coordination of shipment of category 1 or category 2 quantities of radioactive material are defined by 10 C.F.R. § 37.75.
8.6.4Advance Notification of Shipment of Category 1 Quantities of Radioactive Material
For the purpose of this Part, requirements for advance notification of shipment of category 1 quantities of radioactive material are defined by 10 C.F.R. § 37.77.
8.6.5Requirements for Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material During Shipment
For the purpose of this Part, requirements for physical protection of category 1 and category 2 quantities of radioactive material during shipment are defined by 10 C.F.R. § 37.79.
8.6.6Reporting of Events
For the purpose of this Part, requirements for reporting of events are defined by 10 C.F.R. § 37.81.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.7** Records Retention {#sec-216-ricr-40-20-8-8.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.7}
For the purpose of this Part, record retention requirements are defined by 10 C.F.R. § 37.103.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-8 § 8.8** Threshold Values for Category 1 and Category 2 Radioactive Materials {#sec-216-ricr-40-20-8-8.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-8#8.8}
For the purpose of this Part, threshold values for Category 1 and Category 2 radioactive materials are established by Appendix A to 10 C.F.R. Part 37.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-9** Medical Use of Radioactive Material
##### **216-RICR-40-20-9 § 9.1** Authority {#sec-216-ricr-40-20-9-9.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part contains the requirements and provisions for the medical use of radioactive material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects.
C.The requirements and provisions of this Part are in addition to, and not in substitution for, other requirements in this Subchapter. The requirements and provisions of this Part apply to applicants and licensees subject to this Subchapter unless specifically exempted.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.2** Incorporated Material {#sec-216-ricr-40-20-9-9.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 35 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 9.2(A) of this Part, 10 C.F.R. §§ 35.1, 35.5, 35.6, 35.7, 35.8, 35.10, 35.11, 35.12, 35.13, 35.14, 35.18, 35.19, 35.24, 35.26, 35.27, 35.40, 35.70, 35.75, 35.80, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 35.206, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35,2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642,35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045, and 35.3204 are not incorporated by reference.
C.Effect of incorporation of 10 C.F.R. Part 35. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 35, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 35 as follows:
1.Any reference to NRC or Commission shall be deemed to be a reference to the Agency.
2.Any reference to NRC or Agreement State shall be deemed to be a reference to the Agency, NRC or Agreement State.
3.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
4.Any notifications, reports or correspondence referenced in the incorporated parts of 10 C.F.R. 35 shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
5.Any reference to the Advisory Committee on the Medical Uses of Isotopes (ACMUI) shall be deemed to be a reference to the Agency’s Radiation Advisory Commission.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.3** Definitions {#sec-216-ricr-40-20-9-9.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.3}
A.In addition to the definitions contained in 10 C.F.R. § 35.2, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Medical Event” means an event that meets the criteria in § 9.5.9(A) of this Part.
4.“NARM” means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.
5.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
6.“Therapeutic medical unit” means any remote afterloader unit, teletherapy unit, gamma stereotactic radiosurgery unit or similar beam therapy device authorized pursuant to § 9.11.1 of this Part.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.4** General Requirements {#sec-216-ricr-40-20-9-9.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.4}
9.4.1Provisions for Research Involving Human Subjects
A.A licensee may conduct research involving human subjects using radioactive material provided:
1.That the research is conducted, funded, supported, or regulated by a Federal agency which has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its Agency license before conducting such research. Both types of licensees shall, at a minimum, obtain prior informed consent from the human subjects and obtain prior review and approval of the research activities by an "Institutional Review Board" in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects;
2.The research involving human subjects authorized in § 9.4.1(A)(1) shall be conducted using radioactive material authorized for medical use in the license; and
3.Nothing in this section relieves licensees from having to comply with the other requirements in this Part.
9.4.2FDA, Other Federal and State Requirements
Nothing in this Part relieves the licensee from having to comply with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices.
9.4.3License Required
A.A person shall manufacture, produce, acquire, receive, possess, use or transfer radioactive material for medical use only in accordance with a specific license issued by the Agency, the U.S. Nuclear Regulatory Commission or another Agreement State, or as allowed by §§ 9.5.3(A) and (B) of this Part. A specific license is not needed for an individual who:
1.Receives, possesses, uses, or transfers radioactive material in accordance with this Subchapter under the supervision of an Authorized User as provided in § 9.5.3 of this Part, unless prohibited by license condition; or
2.Prepares unsealed radioactive material for medical use in accordance with this Part under the supervision of an Authorized Nuclear Pharmacist or Authorized User as provided in § 9.5.3 of this Part, unless prohibited by license condition.
B.Human Use of Radioactive Material. In addition to the requirements set forth in § 7.6.2(A) of this Subchapter and other sections of this Part, a specific license for human use of radioactive material will be issued under the following conditions:
1.If the application is for human use sited in a medical institution, only the institution's management may apply. If the application is for human use not sited in a medical institution, the applicant or a person duly authorized to act for and on their behalf may apply.
2.The application includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), Authorized User(s), Authorized Medical Physicist(s), Ophthalmic Physicist(s), and Authorized Nuclear Pharmacist(s).
3.The application includes procedures required by §§ 9.11.2, 9.11.4, 9.11.10, 9.11.11, and 9.11.12 of this Part, as applicable.
4.An application for human use of radioactive material as described in § 9.12 of this Part must also include information regarding any radiation safety aspects of the human use of the material that is not addressed in this Part. The applicant shall also provide specific information on:
a.Radiation safety precautions and instructions;
b.Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and
c.Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.
9.4.4Maintenance of Records
Each record required by this Part shall be legible throughout the specified retention period specified by each Agency Regulation. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
9.4.5License Amendments
A.A licensee shall apply for and receive a license amendment:
1.Before it receives or uses radioactive material for a type of use that is permitted under this Part, but that is not authorized on the licensee's current license issued pursuant to this Part;
2.Before permitting anyone, except a Visiting Authorized User, Visiting Authorized Medical Physicist, Visiting Authorized Nuclear Pharmacist or Visiting Ophthalmic Physicist as described § 9.5.6 of this Part, to work as an Authorized User, Authorized Medical Physicist, Authorized Nuclear Pharmacist or Visiting Ophthalmic Physicist under the license;
3.Before changing a Radiation Safety Officer, except as provided in § 9.5.1(C) of this Part, or Authorized Medical Physicist;
4.Before ordering radioactive material in excess of the amount, or radionuclide or form different than authorized on the license;
5.Before adding to or changing the areas of use or address or addresses of use identified in the application or on the license;
6.Before changing statements, representations, and procedures which are incorporated into the license, except as provided for in § 9.5.15 of this Part;
7.Before it releases licensed facilities for unrestricted use.
8.In addition to the requirements specified above, a therapeutic medical unit licensee shall apply for and receive a license amendment before:
a.Making any change in the treatment room shielding;
b.Making any change in the location of the therapeutic medical unit within the treatment room;
c.Using the therapeutic medical unit in a manner that could result in increased radiation levels in areas outside the treatment room;
d.Relocating the therapeutic medical unit; or
e.Allowing an individual not listed on the licensee's license to perform the duties of the Authorized Medical Physicist, except as provided in § 9.5.6(B) of this Part.
9.Before a licensee receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.
10.Before a licensee permits anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license.
9.4.6Notifications
A.A licensee shall notify the Agency by letter no later than thirty (30) days after:
1.An Authorized User, an Authorized Nuclear Pharmacist, Radiation Safety Officer, Associate Radiation Safety Officer, Ophthalmic Physicist, or Authorized Medical Physicist permanently discontinues performance of duties under the license or has a name change; or
2.The licensee's mailing address changes; or
3.The licensee’s name changes, but the name change does not constitute a transfer of control of the license as described in § 7.6.3 of this Subchapter; or
4.The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used in accordance with either §§ 9.7.1 or 9.7.3 of this Part if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area.
5.The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in § 9.4.5 of this Part. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.
6.The licensee permits an individual qualified to be a Radiation Safety Officer under §§ 9.5.10 and 9.5.14 of this Part to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with § 9.5.1(C) of this Part;
9.4.7Exemptions Regarding Type A Specific Licenses of Broad Scope
For the purpose of this Part, exemptions regarding Type A specific licenses of broad scope are defined by 10 C.F.R. § 35.15.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.5** General Administrative Requirements {#sec-216-ricr-40-20-9-9.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.5}
9.5.1Authority and Responsibilities for the Radiation Protection Program
A.In addition to the radiation protection program requirements of § 1.6 of this Subchapter, a licensee's management shall approve in writing:
1.Requests for a license application, renewal, or amendments before submittal to the Agency;
2.Any individual before allowing that individual to work as a Visiting Authorized User, Visiting Authorized Medical Physicist, Visiting Authorized Nuclear Pharmacist, or Visiting Ophthalmic Physicist; and
3.Radiation protection program changes that do not require a license amendment and are permitted under § 9.5.15 of this Part;
B.A licensee's management shall appoint a Radiation Safety Officer, who agrees in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee’s management may appoint, in writing, one (1) or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensee’s management, must assign the specific duties and tasks to each Associate Radiation Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.
C.For up to sixty (60) days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer under §§ 9.5.10 and 9.5.14 of this Part, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in § 9.5.1(E) of this Part, if the licensee takes the actions required in §§ 9.5.1(B), (D), (E) and (H) of this Part, and notifies the Agency in accordance with § 9.4.6 of this Part.
D.A licensee may simultaneously appoint more than one (1) temporary Radiation Safety Officer, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of use of radioactive material permitted by the license.
E.A licensee shall establish in writing the authority, duties and responsibilities of the Radiation Safety Officer.
F.A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:
1.Identify radiation safety problems;
2.Initiate, recommend, or provide corrective actions;
3.Stop unsafe operations; and,
4.Verify implementation of corrective actions.
G.Licensees that are authorized for two (2) or more different types of uses of radioactive material under §§ 9.8.1, 9.9.1 or 9.11.1 of this Part, or two (2) or more types of units under § 9.11.1 of this Part, shall establish a Radiation Safety Committee to oversee all uses of radioactive material permitted by the license. The Committee shall include an Authorized User of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an Authorized User nor a Radiation Safety Officer, and may include other members as the licensee deems appropriate.
H.A licensee shall retain a record of actions taken by the licensee's management in accordance with § 9.5.1(A) of this Part for five (5) years. The record shall include a summary of the actions taken and a signature of licensee management.
I.The licensee shall retain a copy of both authority, duties and responsibilities of the Radiation Safety Officer as required by § 9.5.1(E) of this Part, and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by § 9.5.1(B) of this Part, for the duration of the license. The records shall include the signature of the Radiation Safety Officer and licensee management.
J.A licensee's Radiation Safety Committee shall meet as necessary, but at a minimum shall meet at intervals not to exceed six (6) months. The licensee shall maintain minutes of each Radiation Safety Committee meeting which shall include the date of the meeting, members present, members absent and a summary of deliberations and discussions.
K.For each Associate Radiation Safety Officer appointed under § 9.5.1(B) of this Part, the licensee shall retain, for five (5) years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee’s management.
9.5.2Duties of Authorized User and Authorized Medical Physicist
A.A licensee shall ensure that only Authorized Users for the type of radioactive material used:
1.Prescribe the radiopharmaceutical dosage and/or dose to be administered through the issuance of a written directive or reference to the diagnostic clinical procedures manual; and
2.Direct, as specified in §§ 9.5.3 and 9.5.4 of this Part, or in license conditions, the administration of radioactive material for medical use to patients or human research subjects;
3.Prepare and administer, or supervise the preparation and administration of radioactive material for medical use, in accordance with §§ 9.4.3(A)(1), (2) and 9.5.3 of this Part.
B.A licensee shall ensure that only Authorized Medical Physicists perform, as applicable:
1.Full calibration measurements as described in §§ 9.11.7, 9.11.8 and 9.11.9 of this Part;
2.Periodic spot-checks as described in §§ 9.11.10, 9.11.11 and 9.11.12 of this Part; and
3.Radiation surveys as described in § 9.11.14 of this Part.
9.5.3Supervision
A.A licensee that permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an Authorized User, as allowed by § 9.4.3(A) of this Part, shall:
1.In addition to the requirements in § 2.5 of this Subchapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, Regulations of this Part and license conditions with respect to the use of radioactive material;
2.Require the supervised individual to follow the instructions of the supervising Authorized User for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, this Subchapter, and license conditions with respect to the medical use of radioactive material; and;
3.If the individual is involved in administration of radiation/radioactive materials to humans, ensure that the individual possesses a current license in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, Radiation Therapists and Radiologist Assistants, unless the individual is specifically exempted from licensure by said Regulations;
B.A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an Authorized Nuclear Pharmacist or physician who is an Authorized User, as allowed by § 9.4.3(A)(2) of this Part, shall:
1.In addition to the requirements in § 2.5 of this Subchapter, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and
2.Require the supervised individual to follow the instructions of the supervising Authorized User or Authorized Nuclear Pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, this Subchapter, and license conditions.
C.A licensee that permits supervised activities under §§ 9.5.3(A) and (B) of this Part is responsible for the acts and omissions of the supervised individual.
9.5.4Written Directives
A.A written directive shall be dated and signed by an Authorized User prior to administration of I-131 sodium iodide greater than one and eleven one hundredths (1.11) MBq (thirty (30) Ci), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
1.If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible in writing in the patient's record. A written directive shall be prepared within forty-eight (48) hours of the oral directive.
B.The written directive shall contain the patient or human research subject's name and the following information:
1.For an administration of a dosage of radioactive drug containing radioactive material: the radioactive drug containing radioactive material, dosage, and route of administration;
2.For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;
3.For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;
4.For high dose rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;
5.For permanent implant brachytherapy:
a.Before implantation: the treatment site, the radionuclide, and the total source strength; and
b.After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date; and
6.For all other brachytherapy including low, medium and pulsed dose rate remote afterloaders:
a.Prior to implantation: treatment site, the radionuclide and dose; and
b.After implantation but before completion of the procedure: the radioisotope, treatment site, number of sources, total source strength and exposure time (or, the total dose); and date.
C.A written revision to an existing written directive may be made provided that the revision is dated and signed by an Authorized User prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next fractional dose.
1.If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the Authorized User within forty-eight (48) hours of the oral revision.
D.The licensee shall retain a copy of each written directive for three (3) years.
9.5.5Procedures for Administrations Requiring a Written Directive
A.For the purpose of this Part, procedures for administrations requiring a written directive are defined by 10 C.F.R. § 35.41.
B.A licensee shall retain a copy of the procedures required under § 9.5.5(A) of this Part for the duration of the license.
9.5.6Visiting Authorized User, Visiting Authorized Medical Physicist, Visiting Authorized Nuclear Pharmacist and Visiting Ophthalmic Physicist
A.A licensee may permit any Visiting Authorized User to use licensed material for medical use under the terms of the licensee's license for sixty (60) days each year if:
1.The Visiting Authorized User has the prior written permission of the licensee's management and Radiation Safety Committee if one is required;
2.The licensee has a copy of an Agency, Agreement State or U.S. Nuclear Regulatory Commission license that identifies the Visiting Authorized User by name as an Authorized User for medical use; and
3.Only those procedures for which the Visiting Authorized User is specifically authorized by an Agency, Agreement State or U.S. Nuclear Regulatory Commission license are performed by that individual.
B.A licensee may permit a medical physicist to act as a Visiting Authorized Medical Physicist, and perform the duties of a medical physicist under the terms of the licensee's license for sixty (60) days each calendar year if:
1.The medical physicist is registered with the Agency, under the provisions of § 3.6 of this Subchapter, as a provider of Radiation Physics Services in the area of calibration and compliance surveys of therapeutic medical units; and
2.The Visiting Authorized Medical Physicist has the prior written permission of the licensee's management and Radiation Safety Committee, if one is required; and
3.The licensee has a copy of:
a.An Agency, NRC or Agreement State license that identifies the individual as an Authorized Medical Physicist; or
b.A permit issued by an Agency, NRC or Agreement State specific license of broad scope that identifies the medical physicist by name as an Authorized Medical Physicist.
C.A licensee may permit a nuclear pharmacist to act as a Visiting Authorized Nuclear Pharmacist, and to perform the duties of a nuclear pharmacist under the terms of the licensee's license for sixty (60) days each calendar year if:
1.The nuclear pharmacist possesses a current license as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors; and
2.The visiting Authorized Nuclear Pharmacist has the prior written permission of the licensee's management and Radiation Safety Committee, if one is required; and
3.The licensee has a copy of:
a.An Agency, NRC or Agreement State license that identifies the individual as an Authorized Nuclear Pharmacist; or
b.A permit issued by an Agency, NRC or Agreement State specific license of broad scope that identifies the nuclear pharmacist by name as an Authorized Nuclear Pharmacist.
D.A licensee may permit an ophthalmic physicist to act as a Visiting Ophthalmic Physicist, and to perform the duties of an ophthalmic physicist under the terms of the licensee's license for sixty (60) days each calendar year if:
1.The visiting Ophthalmic Physicist has the prior written permission of the licensee's management and Radiation Safety Committee, if one is required; and
2.The licensee has a copy of:
a.An Agency, NRC or Agreement State license that identifies the individual as an Ophthalmic Physicist; or
b.A permit issued by an Agency, NRC or Agreement State specific license of broad scope that identifies the ophthalmic physicist by name as an Ophthalmic Physicist.
E.A licensee need not apply for a license amendment in order to permit:
1.A Visiting Authorized User to use licensed material as described in § 9.5.6(A) of this Part;
2.A Visiting Authorized Medical Physicist to perform licensed duties as described in § 9.5.6(B) of this Part;
3.A Visiting Authorized Nuclear Pharmacist to perform licensed duties as described in § 9.5.6(C) of this Part.
4.A Visiting Ophthalmic Physicist to perform licensed duties as described in § 9.5.6(D) of this Part.
F.A licensee shall retain copies of the records specified in §§ 9.5.6(A), (B), (C), and (D) of this Part for three (3) years from the date of the last visit.
9.5.7Requirements for Suppliers of Sealed Sources or Devices for Medical Use
For the purpose of this Part, requirements for suppliers of sealed sources or devices for medical use are defined by 10 C.F.R. § 35.49.
9.5.8Quality Control of Diagnostic Equipment
Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. The licensee shall conduct quality control procedures in accordance with written procedures.
9.5.9Report and Notification of a Medical Event
A.Other than events that result from intervention by a patient or human research subject, a licensee shall report any event in which:
1.The administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:
a.A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than five one hundredths (0.05) Sv (five (5) rem) effective dose equivalent, one half (0.5) Sv (fifty (50) rem) to an organ or tissue, or one half (0.5) Sv (fifty (50) rem) shallow dose equivalent to the skin; and
(1)The total dose delivered differs from the prescribed dose by twenty percent (20%) or more;
(2)The total dosage delivered differs from the prescribed dosage by twenty percent (20%) or more or falls outside the prescribed dosage range; or
(3)The fractionated dose delivered differs from the prescribed dose, for a single fraction, by fifty percent (50%) or more.
b.A dose that exceeds five one hundredths (0.05) Sv (five (5) rem) effective dose equivalent, one half (0.5) Sv (fifty (50) rem) to an organ or tissue, or one half (0.5) Sv (fifty (50) rem) shallow dose equivalent to the skin from any of the following:
(1)An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure;
(2)An administration of a radioactive drug containing radioactive material by the wrong route of administration;
(3)An administration of a dose or dosage to the wrong individual or human research subject;
(4)An administration of a dose or dosage delivered by the wrong mode of treatment; or
(5)A leaking sealed source.
c.A dose to the skin or an organ or tissue other than the treatment site that exceeds by:
(1)One half (0.5) Sv (fifty (50) rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration of the dose expected from the administration; and
(2)Fifty percent (50%) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.
(2)For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:
a.The total source strength administered differing by twenty percent (20%) or more from the total source strength documented in the post-implantation portion of the written directive;
b.The total source strength administered outside of the treatment site exceeding twenty percent (20%) of the total source strength documented in the post-implantation portion of the written directive; or
c.An administration that includes any of the following:
(1)The wrong radionuclide;
(2)The wrong individual or human research subject;
(3)Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or
(4)A leaking sealed source resulting in a dose that exceeds one half (0.5) Sv (fifty (50) rem) to an organ or tissue.
B.A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results, or will result in, unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
C.A licensee shall notify the Agency by telephone no later than the next calendar day after discovery of the medical event.
1.All required notifications shall use Agency contact information specified in § 1.4 of this Subchapter.
D.The licensee shall submit a written report to the Agency within fifteen (15) days after discovery of the medical event.
1.The written report shall include:
a.The licensee's name;
b.The prescribing physician's name;
c.A brief description of the event;
d.Why the event occurred;
e.The effect, if any, on the individual(s) who received the administration;
f.What actions, if any, have been taken, or are planned, to prevent recurrence;
g.Verification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.
2.The report shall not contain the individual's name or other information that could lead to identification of the individual.
E.The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than twenty-four (24) hours after its discovery, unless the referring physician personally informs the licensee either that he/she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or affected individual cannot be reached within twenty-four (24) hours, the licensee shall notify the individual as soon as possible thereafter. The licensee shall not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If an oral notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.
F.Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, individuals affected by the medical event, or that individual's responsible relatives or guardians.
G.A licensee shall retain a record of medical events reported in accordance with this section for three (3) years. The record shall contain:
1.The licensee's name;
2.Names of the individuals involved;
3.Identification number or if no other identification number is available, the social security number of the individual who is the subject of the medical event;
4.A brief description of the event; why it occurred; the effect, if any, on the individual;
5.The actions, if any, taken, or planned, to prevent recurrence; and
6.Whether the licensee notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.
H.The licensee shall provide a copy of the record required by § 9.5.9(G) of this Part to the referring physician, if other than the licensee, no later than fifteen (15) days after the discovery of the medical event.
9.5.10Training for a Radiation Safety Officer
For the purpose of this Part, training requirements for a radiation safety officer and associate radiation safety officer are defined by 10 C.F.R. § 35.50.
9.5.11Training for an Authorized Medical Physicist
A.For the purpose of this Part, training requirements for an Authorized Medical Physicist are defined by 10 C.F.R. § 35.51.
B.In addition to the requirements in § 9.5.11(A) of this Part, an Authorized Medical Physicist must be registered with the Agency, under the provisions of § 3.6 of this Subchapter, as a provider of Radiation Physics Services for the therapeutic modality(s) in which the individual is seeking approval as an Authorized Medical Physicist.
9.5.12Training for an Authorized Nuclear Pharmacist
A.For the purpose of this Part, training requirements for an Authorized Nuclear Pharmacist are defined by 10 C.F.R. § 35.55.
B.In addition to the requirements in § 9.5.12(A) of this Part, an Authorized Nuclear Pharmacist must possess a current license as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors .
9.5.13Training for Experienced Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist
A.For the purpose of this Part, training requirements for an experienced Radiation Safety Officer, teletherapy or medical physicist, Authorized Medical Physicist, Authorized User, nuclear pharmacist, and Authorized Nuclear Pharmacist are defined by 10 C.F.R. § 35.57.
B.An individual who does not qualify as an experienced medical physicist pursuant to § 9.5.13(A) of this Part, but has, prior to October 24, 2004, registered with the Agency, under the provisions of § 3.6 of this Subchapter, as a provider of Radiation Physics Services for the therapeutic modality(s) in which the individual is seeking approval as an Authorized Medical Physicist need not comply with the training requirements of § 9.5.11 of this Part. Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on Agency licenses for the same uses for which these individuals are authorized.
9.5.14Recentness of Training
For the purpose of this Part, training requirements regarding recentness of training are defined by 10 C.F.R. § 35.59.
9.5.15Radiation Protection Program Changes
A.A licensee may revise its radiation protection program without prior Agency approval if:
1.The revision does not require an amendment under § 9.4.5 of this Part;
2.The revision is in compliance with this Subchapter and the license;
3.The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and licensee's Radiation Safety Committee (as applicable); and
4.The affected individuals are instructed on the revised program before the changes are implemented.
B.A licensee shall retain a record of each change for five (5) years. The record shall include the effective date of the change, a copy of the old and new procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change and the signature of the licensee management representative that reviewed and approved the change.
C.A copy of the record required by § 9.5.15(B) of this Part shall be submitted to the Agency within thirty (30) days of adopting said change(s).
9.5.16Release of Individuals Containing Unsealed Radioactive Material or Implants Containing Radioactive Material
A.A licensee may authorize the release from its control of any individual who has been administered radioactive drugs or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed five (5) mSv (one half (0.5) rem).
1.NRC NUREG 1556-Vol. 9 "Consolidated Guidance About Materials Licenses: Program Specific Guidance About Medical Licenses" describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding five (5) mSv (one half (0.5) rem).
B.For patients administered radioactive material for which a written directive is required, a licensee shall provide the released individual, or the individual's parent or guardian, with oral and written instructions on actions recommended to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed one (1) mSv (one tenth (0.1) rem). If the total effective dose equivalent to a breast-feeding infant or child could exceed one (1) mSv (one tenth (0.1) rem) assuming there were no interruption of breast-feeding, the instructions shall also include:
1.Guidance on the interruption or discontinuation of breast-feeding; and
2.Information on the consequences, if any, of failure to follow the guidance.
C.For patients administered radioactive material for which a written directive is required, the licensee shall maintain a record, for three (3) years after the date of release, of the basis for authorizing the release of an individual.
D.The licensee shall maintain a record, for three (3) years after the date of release, that instructions required by § 9.5.16(B) of this Part were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding one (1) mSv (one tenth (0.1) rem).
E.The licensee shall immediately notify the Agency in accordance with § 9.5.17 of this Part if a patient departs prior to an authorized release.
F.The licensee shall notify the Agency in accordance with § 9.5.19 of this Part:
1.When they are aware that a patient containing radioactive material and who has been released in accordance with § 9.5.16 of this Part dies; and
2.If it is possible that any individual could receive an effective dose equivalent in excess of five (5) mSv (one half (0.5) rem) as a result of the deceased's body.
9.5.17Reports of Patient Departure Prior to Authorized Release
A.The licensee shall notify the Agency by telephone immediately upon discovery that a patient or human research subject has departed from the licensee's facility without authorization under § 9.5.16(A) of this Part.
B.The licensee shall submit a written report to the Agency within thirty (30) days after discovery of the unauthorized departure. The written report must include:
1.The licensee's name;
2.The date and time of the unauthorized departure;
3.The projected date and time when release would have occurred;
4.The address of the patient's or human research subject's home or anticipated destination following departure;
5.The radionuclide, chemical and physical form and calculated activity at time of release;
6.The apparent reason(s) for the departure prior to authorized release; and
7.A description of any changes in the licensee's patient release criteria or patient instructions that are designed to avoid a recurrence of such an event.
9.5.18Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child
For the purpose of this Part, training requirements for report and notification of a dose to an embryo/fetus or a nursing child are defined by 10 C.F.R. § 35.3047.
9.5.19Notification of Deceased Patients or Human Research Subjects Containing Radioactive Material
A.The licensee shall notify the Agency by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive an effective dose equivalent in excess of the dose limits set forth in § 1.8.1 of this Subchapter as a result of the deceased's body.
B.The licensee shall submit a written report to the Agency within thirty (30) days after discovery that the patient or human research subject referenced in § 9.5.19(A) of this Part has died. The written report shall include:
1.The licensee's name;
2.The date of death;
3.The radionuclide, chemical and physical form and calculated activity at time of death; and,
4.The names (or titles) and address(es) of known individuals who might have received a TEDE exceeding five (5) mSv (one half (0.5) rem).
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.6** General Technical Requirements {#sec-216-ricr-40-20-9-9.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.6}
9.6.1Possession, Use, and Calibration of Instruments Used to Measure the Activity of Unsealed Radioactive Material
For the purpose of this Part, requirements for possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material are defined by 10 C.F.R. § 35.60.
9.6.2Calibration of Survey Instruments
A.For the purpose of this Part, requirements for calibration of survey instruments are defined by 10 C.F.R. § 35.61.
B.The licensee shall retain a record of each calibration required in § 9.6.2(A) of this Part for three (3) years. The record shall include:
1.The model and serial number of the instrument;
2.The results of the calibration;
3.The name of the individual who performed the calibration; and
4.The date of calibration.
9.6.3Determination of Dosages of Unsealed Radioactive Materials for Medical Use
A.For the purpose of this Part, requirements for determination of dosages of unsealed radioactive materials for medical use are defined by 10 C.F.R. § 35.63.
B.The licensee shall retain a record of the dosage determinations required by § 9.6.3(A) of this Part for three (3) years. To satisfy this requirement, the record shall contain:
1.The radiopharmaceutical;
2.Patient's or human research subject's name, and identification number if one has been assigned;
3.Prescribed dosage and determined dosage, or a notation that the total activity is less than one tenth (1.1) MBq (thirty (30) Ci);
4.Date and time of the dosage determination; and
5.Name of the individual who determined the dosage.
9.6.4Authorization for Calibration, Transmission and Reference Sources
For the purpose of this Part, authorization for calibration, transmission and reference sources is defined by 10 C.F.R. § 35.65.
9.6.5Requirements for Possession of Sealed Sources and Brachytherapy Sources
A.For the purpose of this Part, requirements for possession of sealed sources and brachytherapy sources are defined by 10 C.F.R. § 35.67.
B.A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a physical inventory of all such sources at intervals not to exceed six (6) months.
1.The licensee shall retain each inventory record for three (3) years.
2.The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, date of the inventory, and the signature of the Radiation Safety Officer or the individual who performed the inventory.
9.6.6Vial Shields
A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
9.6.7Labeling of Vials and Syringes
For the purpose of this Part, requirements for labeling of vials and syringes are defined by 10 C.F.R. § 35.69.
9.6.8Surveys for Contamination and Ambient Radiation Dose Rate
A.A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radioactive drugs containing radioactive material were prepared for use or administered.
B.A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radioactive drugs containing radioactive material or radioactive wastes are stored.
C.A licensee shall conduct the surveys required by §§ 9.6.8(A) and (B) of this Part so as to able to measure dose rates as low as one (1) microsievert (one tenth (0.1) mrem) per hour.
D.A licensee shall establish dose rate action levels for the surveys required by §§ 9.6.8(A) and (B) of this Part and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level.
E.A licensee shall survey for removable contamination at least once each week all areas where generators and radioactive drugs containing radioactive material are prepared for use or administered or radioactive materials are stored.
F.A licensee shall conduct the surveys required by § 9.6.8(E) of this Part so as to be able to detect contamination on each wipe sample of two thousand (2,000) dpm.
G.A licensee shall establish removable contamination action levels for the surveys required by § 9.6.8(E) of this Part and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels.
H.A licensee does not need to perform the surveys required by § 9.6.8(A) of this Part in an area(s) where patients or human research subjects are confined when they cannot be released pursuant to § 9.5.116 of this Part.
I.A licensee shall retain a record of each survey for three (3) years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.
9.6.9Mobile Nuclear Medicine Service Requirements
A.The Agency shall license mobile nuclear medicine services or clients of such services. The mobile nuclear medicine service shall be licensed if the service receives, uses or possesses radioactive material. The client of the mobile nuclear medicine service shall be licensed if the client receives or possesses radioactive material to be used by a mobile nuclear medicine service.
B.A licensee providing mobile nuclear medicine service shall:
1.Obtain a letter signed by the management of each client for which services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the mobile nuclear medicine service and the client. If the client is licensed, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's address for use by the mobile nuclear medicine service;
2.Inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered.
3.Maintain all records required by this Part and Parts 1 and 2 of this Subchapter at a location within the Agency's jurisdiction that is:
a.A single address of use:
(1)Identified as the records retention location; and
(2)Staffed at all reasonable hours by individual(s) authorized to provide the Agency with access for purposes of inspection; or
b.When no address of use is identified on the license for records retention, the mobile unit:
(1)Identified in the license; and
(2)Whose current client's address schedule and location schedule are reported to the Agency.
4.Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, this check for proper function shall include a constancy check;
5.Transport to each client's address only syringes or vials containing prepared drugs or radioactive materials that are intended for reconstitution of radioactive drug kits;
6.Bring into each client's address all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste;
7.Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at a client's address;
8.Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function shall include a constancy check;
9.Check survey instruments for consistent response with a dedicated check source before use at each client's address;
10.Prior to leaving a client's address, perform area surveys and survey for removable contamination in all areas of use, to ensure compliance with the requirements in Parts 1 and 2 of this Subchapter;
11.Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the Agency pursuant to § 9.7.6 of this Part; and,
C.A mobile nuclear medical service shall not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.
D.A licensee providing mobile nuclear medical services shall retain a copy of each letter required by § 9.6.9(B)(1) of this Part. Each letter shall clearly delineate the authority and responsibility of the licensee and the client and shall be retained for three (3) years after the last provision of service.
E.A licensee providing mobile nuclear medical services shall retain the record of each survey required by § 9.6.9(B)(10) of this Part for three (3) years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.
F.A licensee providing mobile nuclear medical services shall, at a minimum, maintain the following documents on each mobile unit:
1.The current operating and emergency procedures;
2.A copy of the license;
3.Copies of the letter(s) required by § 9.6.9(B)(1) of this Part;
4.Current calibration records for each survey instrument and diagnostic equipment or dose delivery device in use; and
5.Survey records covering uses associated with the mobile unit during, at a minimum, the preceding thirty (30) calendar days.
9.6.10Decay in Storage
A.For the purpose of this Part, requirements for decay in storage are defined by 10 C.F.R. § 35.92(a).
B.For radioactive material disposed in accordance with § 9.6.10(A) of this Part, the licensee shall retain a record of each disposal for three (3) years. The record shall include the date of the disposal, the model and serial number of the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.
9.6.11Survey Instruments
A.Licensees authorized for radioactive material use under §§ 9.7.1, 9.7.3, 9.8.1, 9.9.1 and/or 9.11.1 of this Part shall possess an operable survey instrument that has been calibrated in accordance with § 9.6.2 of this Part and meets the following criteria:
AUTHORIZED USE
SURVEY INSTRUMENT
9.7.1 – Uptake, dilution, and excretion studies
Portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 Sv (0.1 mrem) per hour to 500 Sv (50 mrems) per hour
9.7.3 – Imaging & localization studies; or
9.8.1 – Unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required; or
9.9.1 – Manual brachytherapy
Portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 Sv (0.1 mrem) per hour to 500 Sv (50 mrems) per hour; and
Portable radiation measurement survey instrument capable of measuring dose rates over the range 10 Sv (1 mrem) per hour to 10 mSv (1000 mrems) per hour.
9.11.1 – Remote afterloader unit, teletherapy unit and/or gamma stereotactic radiosurgery unit
Portable radiation measurement survey instrument capable of measuring dose rates over the range 10 Sv (1 mrem) per hour to 10 mSv (1000 mrems) per hour.
B.A licensee authorized to use radioactive material as a sealed source for diagnostic purposes pursuant to § 9.10.1 of this Part shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one (1.0) Sv (one tenth (0.1) mrem) per hour to five hundred (500) Sv (fifty (50) mrems) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) Sv (one (1) mrem) per hour to ten (10) mSv (one thousand (1,000) mrems) per hour. The instrument shall be operable and calibrated in accordance with § 9.6.2 of this Part.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.7** Unsealed Radioactive Material – Written Directive Not Required {#sec-216-ricr-40-20-9-9.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.7}
9.7.1Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for Which a Written Directive is Not Required
For the purpose of this Part, requirements for use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required are defined by 10 C.F.R. § 35.100.
9.7.2Training for Uptake, Dilution, and Excretion Studies
For the purpose of this Part, training requirements for uptake, dilution, and excretion studies are defined by 10 C.F.R. § 35.190.
9.7.3Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is Not Required
A.For the purpose of this Part, requirements for use of unsealed radioactive material for imaging and localization studies for which a written directive is not required are defined by 10 C.F.R. § 35.200.
B.Provided the conditions of § 9.7.6 of this Part are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Agency.
C.Technetium-99m pertechnetate as an aerosol for lung function studies is not subject to the restrictions in § 9.7.3(B) of this Part.
9.7.4Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations
A.For the purpose of this Part, permissible Molybdenum-99, Strontium-82, and Strontium-85 concentrations are defined by 10 C.F.R. §§ 35.204(a) through (c).
B.A licensee shall maintain a record of the Molybdenum-99 concentration or Strontium-82 and Strontium-85 concentration tests required by § 9.7.4(A) of this Part for three (3) years. The record must include:
1.For each measured elution of Technetium-99m, the ratio of the measures expressed as kilobecquerel of Molybdenum-99 per megabecquerel of Technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or
2.For each measured elution of Rubidium-82, the ratio of the measures expressed as kilobecquerel of Strontium-82 per megabecquerel of Rubidium-82 (or microcuries of Strontium-82 per millicurie of rubidium), kilobecquerel of Strontium-85 per megabecquerel of Rubidium-82 (or microcuries of Strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.
C.A licensee shall report immediately to the Agency, and to the distributor of the generator within seven (7) calendar days after discovery, that an eluate exceeded the permissible concentration specified in § 9.7.4(A) of this Part. The report to the Agency must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.
D.The licensee shall submit a written report to the Agency within thirty (30) calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the report required by § 9.7.4(C) of this Part.
9.7.5Training for Imaging and Localization Studies
For the purpose of this Part, training requirements for imaging and localization studies are defined by 10 C.F.R. § 35.290.
9.7.6Control and Storage of Volatiles, Aerosols and Gases
A.A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed by §§ 1.7.1 and 1.8.1 of this Subchapter.
B.The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.
C.A licensee shall only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.
D.Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in § 1.18 of this Subchapter. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
E.A licensee shall post the time calculated in § 9.7.6(D) of this Part at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.
F.A licensee shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six (6) months. Records of these checks and measurements shall be maintained for three (3) years.
G.A copy of the calculations required in § 9.7.6(D) of this Part shall be recorded and retained for the duration of the license.
H.A licensee shall store volatile radioactive materials and radioactive gases in a radiation shield and container.
I.A licensee shall store and use a multidose container in a properly functioning fume hood.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.8** Unsealed Radioactive Material - Written Directive Required {#sec-216-ricr-40-20-9-9.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.8}
9.8.1Use of Unsealed Radioactive Material for Which a Written Directive is Required
For the purpose of this Part, requirements for use of unsealed radioactive material for which a written directive is required are defined by 10 C.F.R. § 35.300.
9.8.2Safety Instruction
A.For the purpose of this Part, requirements for safety instruction are defined by 10 C.F.R. § 35.310(a).
B.A licensee shall keep a record of individuals receiving instruction required by in § 9.8.2(A) of this Part for three (3) years. The record shall include a list of the topic(s) covered, the date of instruction or training the name(s) of the attendees, and the name(s) of the individual(s) who provided the instruction.
9.8.3Safety Precautions
For the purpose of this Part, requirements for safety precautions are defined by 10 C.F.R. § 35.315.
9.8.4Training for Use of Unsealed Radioactive Material for Which a Written Directive Is Required
For the purpose of this Part, training requirements for use of unsealed radioactive material for which a written directive is required are defined by 10 C.F.R. § 35.390.
9.8.5Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 gigabecquerels (33 millicuries)
For the purpose of this Part, training requirements for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to one and twenty-two one hundredths (1.22) gigabecquerels (thirty-three (33) millicuries) are defined by 10 C.F.R. § 35.392.
9.8.6Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater Than 1.22 gigabecquerels (33 millicuries)
For the purpose of this Part, training requirements for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than one and twenty-two one hundredths (1.22) gigabecquerels (thirty-three (33) millicuries) are defined by 10 C.F.R. § 35.394.
9.8.7Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive
For the purpose of this Part, training requirements for the parenteral administration of unsealed radioactive material requiring a written directive are defined by 10 C.F.R. § 35.396.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.9** Manual Brachytherapy {#sec-216-ricr-40-20-9-9.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.9}
9.9.1Use of Sources for Manual Brachytherapy
For the purpose of this Part, requirements for use of sources for manual brachytherapy are defined by 10 C.F.R. § 35.400.
9.9.2Surveys after Source Implant and Removal
A.For the purpose of this Part, requirements for surveys after source implant and removal are defined by 10 C.F.R. §§ 35.404(a) and (b).
B.A licensee shall retain a record of the surveys required by § 9.9.2(A) of this Part for three (3) years. Each record shall include the date and results of the survey, the serial number and the model number of the survey instrument used, and the name of the individual who made the survey.
9.9.3Brachytherapy Sources Accountability
A.For the purpose of this Part, requirements for brachytherapy sources accountability are defined by 10 C.F.R. §§ 35.406(a) and (b).
B.A licensee shall maintain a record of the brachytherapy source accountability as follows:
1.For temporary implants, the record shall include:
a.The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use;
b.The number and activity of sources not implanted, the time and date they were returned to storage, and the name of the individual who returned them to storage; and
c.The number and activity of sources temporarily implanted in the patient or human research subject.
2.For permanent implants, the record shall include:
a.The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;
b.The number and activity of sources returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage; and
c.The number and activity of sources permanently implanted in the patient or human research subject.
C.A licensee shall maintain the records required in § 9.9.3(B) of this Part for three (3) years.
9.9.4Safety Instruction
A.For the purpose of this Part, requirements for safety instruction are defined by 10 C.F.R. § 35.410(a).
B.A licensee shall keep a record of individuals receiving instruction required by § 9.9.4(A) of this Part for three (3) years. The record shall include a list of the topic(s) covered, the date of instruction or training the name(s) of the attendees, and the name(s) of the individual(s) who provided the instruction.
9.9.5Safety Precautions
For the purpose of this Part, requirements for safety precautions are defined by 10 C.F.R. § 35.415.
9.9.6Calibration Measurements of Brachytherapy Sources
A.For the purpose of this Part, requirements for calibration measurements of brachytherapy sources are defined by 10 C.F.R. § 35.432.
B.A licensee shall retain a record of each calibration of brachytherapy sources required by § 9.9.6(A) of this Part for three (3) years after the last use of the source. The record shall include:
1.The date of the calibration;
2.The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;
3.The source output or activity;
4.Source positioning accuracy within applicators;
5.The signature of the Authorized Medical Physicist; and
6.For surface applicators where the calibration was performed by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists, a complete copy of all calibration measurements provided for that source.
9.9.7Decay of Strontium-90 Sources for Ophthalmic Treatments
A.For the purpose of this Part, requirements for decay of Strontium-90 sources for ophthalmic treatments are defined by 10 C.F.R. § 35.433.
B.A licensee shall retain a record of decay calculations required by § 9.9.7(A) of this Part for three (3) years after the last use of the source. The record shall include:
1.The date and initial source output or activity as determined under § 9.9.6(A) of this Part;
2.For each decay calculation, the date and the source output or activity as determined under § 9.9.7(A) of this Part; and
3.The signature of the Authorized Medical Physicist.
9.9.8Therapy-related Computer Systems
A.For the purpose of this Part, requirements for acceptance testing on the treatment planning system of therapy-related computer systems are defined by 10 C.F.R. § 35.457.
B.In addition to the requirements of § 9.9.8(A) of this Part, acceptance testing shall include verification of the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.
9.9.9Training for Use of Manual Brachytherapy Sources
For the purpose of this Part, training requirements for use of manual brachytherapy sources are defined by 10 C.F.R. § 35.490.
9.9.10Training for Ophthalmic Use of Strontium-90
For the purpose of this Part, training requirements for ophthalmic use of Strontium-90 are defined by 10 C.F.R. § 35.491.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.10** Sealed Sources for Diagnosis {#sec-216-ricr-40-20-9-9.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.10}
9.10.1Use of Sealed Sources for Diagnosis
For the purpose of this Part, requirements for use of sealed sources for diagnosis are defined by 10 C.F.R. § 35.500.
9.10.2Training for Use of Sealed Sources for Diagnosis
For the purpose of this Part, training requirements for use of sealed sources for diagnosis are defined by 10 C.F.R. § 35.590.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.11** Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units {#sec-216-ricr-40-20-9-9.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.11}
9.11.1Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit
For the purpose of this Part, requirements for use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit are defined by 10 C.F.R. § 35.600.
9.11.2Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader Unit
A.For the purpose of this Part, requirements for surveys of patients and human research subjects treated with a remote afterloader unit are defined by 10 C.F.R. § 35.604.
B.A licensee shall retain a record of the surveys required by § 9.11.2(A) of this Part for three (3) years. Each record shall include the date and results of the survey, the serial number and the model number of the survey instrument used, and the name of the individual who made the survey.
9.11.3Installation, Maintenance, Adjustment, and Repair
A.For the purpose of this Part, requirements for installation, maintenance, adjustment, and repair are defined by 10 C.F.R. § 35.605.
B.A licensee shall retain a record of the installation, maintenance, adjustment and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for three (3) years. For each installation, maintenance, adjustment and repair, the record shall include the date, description of the service, and name(s) of the individual(s) who performed the work.
9.11.4Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
A.For the purpose of this Part, requirements for safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.610.
B.A licensee shall retain a copy of the procedures required by § 9.11.4(A) of this Part until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.
C.A licensee shall retain a record of the surveys required by § 9.11.4(A) of this Part for three (3) years. Each record shall include the date and results of the survey, the serial number and the model number of the survey instrument used, and the name of the individual who made the survey.
9.11.5Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
For the purpose of this Part, requirements for safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.615.
9.11.6Dosimetry Equipment
A.For the purpose of this Part, requirements for dosimetry equipment are defined by 10 C.F.R. § 35.630.
B.The licensee shall maintain a record of each calibration, intercomparison, and comparison of its dosimetry equipment required by § 9.11.6(A) of this Part for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include:
1.The date;
2.The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared or compared as required by §§ 9.11.6(A) and (B) of this Part;
3.The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and
4.The names of the individuals who performed the calibration, inter-comparison, or comparison, and evidence that the intercomparison was performed by or under the direct supervision of an Authorized Medical Physicist.
9.11.7Full Calibration Measurements on Teletherapy Units
A.For the purpose of this Part, requirements for full calibration measurements on teletherapy units are defined by 10 C.F.R. § 35.632.
B.A licensee shall maintain a record of each calibration required by § 9.11.7(A) of this Part for three (3) years. The record shall include:
1.The date of the calibration;
2.The manufacturer's name, model number and serial number for both the teletherapy unit and the source, and the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit;
3.The results and assessments of the full calibrations; and
4.The signature of the Authorized Medical Physicist who reviewed or performed the full calibration.
9.11.8Full Calibration Measurements on Remote Afterloader Units
A.For the purpose of this Part, requirements for full calibration measurements on remote afterloader units are defined by 10 C.F.R. § 35.633.
B.A licensee shall retain a record of each calibration required by § 9.11.8(A) of this Part for three (3) years. The record shall include:
1.The date of the calibration;
2.The manufacturer's name, model number, and serial number for both the remote afterloader unit and the source(s), and the model number and serial number of the instrument used to calibrate the unit;
3.The results and assessments of the full calibrations;
4.The results of the autoradiograph required for low dose-rate remote afterloader units; and
5.The signature of the Authorized Medical Physicist who reviewed or performed the full calibration.
9.11.9Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units
A.For the purpose of this Part, requirements for full calibration measurements on gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.635.
B.A licensee shall retain a record of each calibration required by § 9.11.9(A) of this Part for three (3) years. The record shall include:
1.The date of the calibration;
2.The manufacturer's name, model number, and serial number for both the gamma stereotactic radiosurgery unit and the sources, and the model number and serial number of the instrument used to calibrate the unit;
3.The results and assessments of the full calibrations; and
4.The signature of the Authorized Medical Physicist who reviewed or performed the full calibration.
9.11.10Periodic Spot-checks on Teletherapy Units
A.For the purpose of this Part, requirements for periodic spot-checks on teletherapy units are defined by 10 C.F.R. § 35.642.
B.A licensee shall maintain a record of each spot-check and a copy of the procedures required by § 9.11.10(A) of this Part for three (3) years. The record shall include:
1.The date of the spot-check;
2.The manufacturer's name, model number, and serial number for the teletherapy unit, source and the instrument used to measure the output of the teletherapy unit;
3.An assessment of timer constancy and linearity;
4.The calculated "on-off" error;
5.A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;
6.The determined accuracy of each distance measuring or localization device
7.The difference between the anticipated output and the measured output;
8.Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and
9.The signature of the individual who performed the periodic spot-check, and the signature of the Authorized Medical Physicist who reviewed the record of the spot-check.
9.11.11Periodic Spot-checks on Remote Afterloader Units
A.For the purpose of this Part, requirements for periodic spot-checks on remote afterloader units are defined by 10 C.F.R. § 35.643.
B.A licensee shall retain a record of each check and a copy of the procedures required by § 9.11.11(A) of this Part for three (3) years. The record shall include, as applicable:
1.The date of the spot-check;
2.The manufacturer's name, model number, and serial number for the remote afterloader unit and source;
3.An assessment of timer accuracy;
4.Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and
5.The signature of the individual who performed the periodic spot-check, and the signature of the Authorized Medical Physicist who reviewed the record of the spot-check.
9.11.12Periodic Spot-checks on Gamma Stereotactic Radiosurgery Units
A.For the purpose of this Part, requirements for periodic spot-checks on gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.645.
B.A licensee shall retain a record of each check and a copy of the procedures required by § 9.11.12(A) of this Part for three (3) years. The record shall include:
1.The date of the spot-check;
2.The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;
3.An assessment of timer linearity and accuracy;
4.The calculated “on-off” error;
5.A determination of trunnion centricity;
6.The difference between the anticipated output and the measured output;
7.An assessment of source output against computer calculations;
8.Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and
9.The signature of the individual who performed the periodic spot-check, and the signature of the Authorized Medical Physicist who reviewed the record of the spot-check.
9.11.13Additional Technical Requirements for Mobile Remote Afterloader Units
A.For the purpose of this Part, additional technical requirements for mobile remote afterloader units are defined by 10 C.F.R. § 35.647.
B.A licensee shall retain a record of each check required by § 9.11.13(A) of this Part for three (3) years. The record shall include:
1.The date of the check;
2.The manufacturer's name, model number, and serial number of the remote afterloader unit;
3.Notations accounting for all sources before the licensee departs from a facility;
4.Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators and source transfer tubes, and source positioning accuracy; and
5.The signature of the individual who performed the check.
9.11.14Radiation Surveys
A.For the purpose of this Part, requirements for radiation surveys are defined by 10 C.F.R. § 35.652.
B.A licensee shall maintain a record of the surveys required by § 9.11.14(A) of this Part for the duration of the license. The record shall include:
1.The date of the measurements;
2.The manufacturer's name, model number and serial number of the treatment unit, the source, and the instrument used to measure radiation levels;
3.Each dose rate measured around the source while in the "off" position and the average of all measurements, and
4.The signature of the Authorized Medical Physicist who reviewed or performed the survey.
9.11.15Full-Inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units
A.For the purpose of this Part, requirements for full inspection and servicing for teletherapy and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.655.
B.A licensee shall maintain a record of the inspection and servicing required by § 9.11.15(A) of this Part for the duration of use of the unit. The record shall contain:
1.The inspector's name;
2.The inspector's radioactive materials license number;
3.The date of inspection;
4.The manufacturer's name and model number and serial number for both the treatment unit and source;
5.A list of components inspected and serviced, and the type of service; and
6.The signature of the inspector.
9.11.16Therapy-related Computer Systems
For the purpose of this Part, requirements for acceptance testing on the treatment planning system of therapy-related computer systems are defined by 10 C.F.R. § 35.657.
9.11.17Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
For the purpose of this Part, training requirements for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units are defined by 10 C.F.R. § 35.690.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-9 § 9.12** Other Medical Uses of Radioactive Material or Radiation from Radioactive Material {#sec-216-ricr-40-20-9-9.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-9#9.12}
A.A licensee may use radioactive material or a radiation source approved for medical use which is not specifically addressed elsewhere in this Part if:
1.The applicant or licensee has submitted:
a.Information regarding any radiation safety aspects of the medical use of the material that is not addressed elsewhere in this Part; and
b.Specific information on:
(1)Radiation safety precautions and instructions;
(2)Training and experience of proposed users;
(3)Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and
(4)Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and
c.Any other information requested by the Agency in its review of the application; and
2.The applicant or licensee has received written approval from the Agency in a license or license amendment and uses the material in accordance with this Subchapter and specific conditions the Agency considers necessary for the medical use of the material.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-10** Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations
##### **216-RICR-40-20-10 § 10.1** Authority {#sec-216-ricr-40-20-10-10.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part provides establishes radiation safety requirements for persons utilizing sources of radiation for industrial radiography operations.
C.Except for industrial radiation machines regulated pursuant to Part 6 of this Subchapter, the Regulations in this Part apply to all licensees or registrants who use sources of radiation for industrial radiography; provided, however, that nothing in this Part shall apply to the use of sources of radiation in the healing arts.
D.The provisions and requirements of this Part are in addition to, and not in substitution for, other requirements of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-10 § 10.2** Incorporated Material {#sec-216-ricr-40-20-10-10.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 34 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 10.2(A) of this Part, 10 C.F.R. §§ 34.5, 34.8, 34.11, 34.13, 34.41, 34.43, 34.63, 34.65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.81, 34.89, 34.101, 34.111, 34.121 and 34.123 are not incorporated by reference.
C.Effect of incorporation of 10 C.F.R. Part 34. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 34, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 34 as follows:
1.Any reference to NRC or Commission shall be deemed to be a reference to the Agency.
2.Any reference to NRC or Agreement State shall be deemed to be a reference to the Agency, NRC or Agreement State.
3.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
4.Any notifications, reports or correspondence referenced in the incorporated sections of 10 C.F.R. Part 34 shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
5.Any reference to licensee shall be deemed to include registrant.
6.Any reference to license shall be deemed to include registration.
7.Any reference to licensed shall be deemed to include registered.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-10 § 10.3** Definitions {#sec-216-ricr-40-20-10-10.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.3}
A.In addition to the definitions contained in 10 C.F.R. § 34.3, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
4.“Registrant” means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to this Subchapter and the Act.
5.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-10 § 10.4** Specific Licensing Provisions {#sec-216-ricr-40-20-10-10.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.4}
A.In addition to the requirements set forth in § 7.6.2 of this Subchapter, a specific license for use of sealed sources in industrial radiography will be issued if:
1.The applicant submits an adequate program for training radiographers and radiographer's assistants that meets the requirements of § 10.6.3 of this Part.
2.The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.
3.The applicant submits written operating and emergency procedures as described in § 10.6.4 of this Part.
4.The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed six (6) months as described in § 10.6.3(E) of this Part.
5.The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegations of authority and responsibility.
6.The applicant identifies and lists the qualifications of the individual(s) designated as the RSO pursuant to § 10.6.2 of this Part, and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures.
7.If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing the test and the qualifications of the person(s) authorized to do the leak testing. If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include the:
a.Instruments to be used;
b.Method(s) of performing the analysis; and
c.Pertinent experience of the person who will analyze the wipe samples.
8.If the applicant intends to perform "in-house" calibrations of survey instruments the applicant must describe methods to be used and the relevant experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in § 10.5.4(A) of this Part.
9.The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations.
10.The applicant identifies the location(s) where all records required by this Part and other Parts of this Subchapter will be maintained.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-10 § 10.5** Equipment {#sec-216-ricr-40-20-10-10.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.5}
10.5.1Performance Requirements for Industrial Radiography Equipment
For the purpose of this Part, performance requirements for industrial radiography equipment are defined by 10 C.F.R. § 34.20.
10.5.2Limits on External Radiation Levels from Storage Containers and Source Changers
For the purpose of this Part, limits on external radiation levels from storage containers and source changers are defined by 10 C.F.R. § 34.21.
10.5.3Locking of Radiographic Exposure Devices, Storage Containers, and Source Changers
For the purpose of this Part, requirements for locking of radiographic exposure devices, storage containers, and source changers are defined by 10 C.F.R. § 34.23.
10.5.4Radiation Survey Instruments
For the purpose of this Part, requirements for radiation survey instruments are defined by 10 C.F.R. § 34.25.
10.5.5Leak Testing and Replacement of Sealed Sources
For the purpose of this Part, requirements for leak testing and replacement of sealed sources are defined by 10 C.F.R. § 34.27.
10.5.6Quarterly Inventory
For the purpose of this Part, requirements for quarterly inventory are defined by 10 C.F.R. § 34.29.
10.5.7Inspection and Maintenance of Radiographic Exposure Devices, Transport And Storage Containers, Associated Equipment, Source Changers, and Survey Instruments
For the purpose of this Part, requirements for inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments are defined by 10 C.F.R. § 34.31.
10.5.8Permanent Radiographic Installations
For the purpose of this Part, requirements for permanent radiographic installations are defined by 10 C.F.R. § 34.33.
10.5.9Labeling, Storage, and Transportation
For the purpose of this Part, requirements for labeling, storage, and transportation are defined by 10 C.F.R. § 34.35.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-10 § 10.6** Radiation Safety Requirements {#sec-216-ricr-40-20-10-10.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.6}
10.6.1Conducting Industrial Radiographic Operations
A.Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one (1) other qualified radiographer or an individual who has at a minimum met the requirements of § 10.6.3(C) of this Part. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one (1) qualified individual is present.
B.All radiographic operations shall be conducted in a permanent radiographic installation, unless otherwise specifically authorized by the Agency.
C.Except when physically impossible, collimators shall be used in industrial radiographic operations that use radiographic exposure devices that allow the source to be moved out of the device.
D.A licensee or registrant may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the Agency, the U.S. Nuclear Regulatory Commission or another Agreement State.
E.At a job site, the following shall be supplied by the licensee or registrant:
1.At least one (1) operable, calibrated survey instrument for each exposure device or radiation machine in use;
2.A current whole body personnel monitor (TLD or film badge) for each person performing radiographic operations;
3.An operable, calibrated pocket dosimeter with a range of zero (0) to two (2) millisieverts (two hundred (200) mrem) for each person performing radiographic operations;
4.An operable, calibrated, alarming ratemeter for each person performing radiographic operations using a radiographic exposure device; and
5.The appropriate barrier ropes and signs.
F.Each radiographer at a job site shall have on their person a valid certification ID card issued by a certifying entity.
G.Industrial radiographic operations shall not be performed if any of the items in §§ 10.6.1(E) and (F) of this Part are not available at the job site or are inoperable.
H.During an inspection, the Agency may terminate an operation if any of the items in §§ 10.6.1(E) and (F) of this Part are not available or operable, or if the required number of radiographic personnel are not present. Operations shall not be resumed until all required conditions are met.
10.6.2Radiation Safety Officer for Industrial Radiography
For the purpose of this Part, requirements for Radiation Safety Officer for industrial radiography are defined by 10 C.F.R. § 34.42.
10.6.3Training and Testing
A.The licensee or registrant shall not permit any individual to act as a radiographer until the individual:
1.Has received at least forty (40) hours of training in the subjects outlined in § 10.6.3(G) of this Part, in addition to on-the-job training consisting of hands-on experience under the supervision of a radiographer and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in § 10.6.11 of this Part. The on-the-job training shall include a minimum of two (2) months (three hundred twenty (320) hours) of active participation in the performance of industrial radiography utilizing radioactive material and/or one (1) month (one hundred sixty (160) hours) of active participation in the performance of industrial radiography utilizing radiation machines. Individuals performing industrial radiography utilizing radioactive materials and radiation machines must complete both segments of the on the job training (three (3) months or four hundred eighty (480) hours).
B.In addition, the licensee or registrant shall not permit any individual to act as a radiographer until the individual:
1.Has received copies of and instruction in RCA regulations as contained in this Part and applicable sections of Parts 1, 2, 7 and 12 of this Subchapter, in applicable DOT regulations as referenced in 10 C.F.R. Part 71, in the license(s) and/or certificate(s) of registration under which the radiographer will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures.
2.Has demonstrated understanding of the items in § 10.6.3(B)(1) of this Part by successful completion of a written or oral examination.
3.Has received training in the use of the registrant's radiation machines or the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and
4.Has demonstrated understanding of the use of the equipment described in § 10.6.3(B)(3) of this Part by successful completion of a practical examination.
C.The licensee or registrant shall not permit any individual to act as a radiographer's assistant until the individual:
1.Has received copies of and instruction in RCA regulations as contained in this Part and applicable sections of Parts 1, 2, 7 and 12 of this Subchapter, in applicable DOT regulations as referenced in 10 C.F.R. Part 71, license(s) and/or certificate(s) of registration under which the radiographer's assistant will perform industrial radiography, and the licensee's or registrant's operating and emergency procedures;
2.Has demonstrated an understanding of items in § 10.6.3(C)(1) of this Part by successful completion of a written or oral examination;
3.Has received training in the use of the registrant's radiation machines, or the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments;
4.Has demonstrated understanding of the use of the equipment described in § 10.6.3(C)(3) of this Part by successful completion of a practical examination.
D.The licensee or registrant shall provide annual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed twelve (12) months.
E.Except as provided in § 10.6.3(E)(4) of this Part, the RSO or designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the Agency's regulations, license and/or certificate of registration requirements, and the applicant's operating and emergency procedures are followed. The inspection program shall:
1.Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed six (6) months; and
2.Provide that, if a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than six (6) months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of § 10.6.3(B)(3) of this Part and the radiographer's assistant must re-demonstrate knowledge of the training requirements of § 10.6.3(C)(2) of this Part by a practical examination before these individuals can next participate in a radiographic operation.
3.The Agency may consider alternatives in those situations where the individual serves as both radiographer and RSO.
4.In those operations where a single individual serves as both radiographer and RSO, and performs all radiography operations, an inspection program is not required.
F.The licensee or registrant shall maintain records of the above training to include certification documents, written and practical examinations, refresher safety training and inspections of job performance in accordance with § 10.7.5 of this Part.
G.The licensee or registrant shall include the following subjects required in § 10.6.3(A) of this Part:
1.Fundamentals of radiation safety including:
a.Characteristics of gamma and X-radiation;
b.Units of radiation dose and quantity of radioactivity;
c.Hazards of exposure to radiation;
d.Levels of radiation from sources of radiation; and
e.Methods of controlling radiation dose (time, distance, and shielding);
2.Radiation detection instruments including:
a.Use, operation, calibration, and limitations of radiation survey instruments;
b.Survey techniques; and
c.Use of personnel monitoring equipment.
3.Equipment to be used including:
a.Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails);
b.Operation and control of radiation machines;
c.Storage, control, and disposal of sources of radiation; and
d.Inspection and maintenance of equipment.
4.The requirements of pertinent Agency and Federal Regulations; and
5.Case histories of accidents in radiography.
H.Records of radiographer certification maintained in accordance with § 10.7.5 of this Part provide appropriate affirmation of certification requirements specified in § 10.6.3(A) of this Part.
10.6.4Operating and Emergency Procedures
For the purpose of this Part, requirements for operating and emergency procedures are defined by 10 C.F.R. § 34.45.
10.6.5Supervision of Radiographers' Assistants
For the purpose of this Part, requirements for supervision of radiographers' assistants are defined by 10 C.F.R. § 34.46.
10.6.6Personnel Monitoring
For the purpose of this Part, requirements for personnel monitoring are defined by 10 C.F.R. § 34.47.
10.6.7Radiation Surveys
For the purpose of this Part, requirements for radiation surveys are defined by 10 C.F.R. § 34.49.
10.6.8Surveillance
For the purpose of this Part, surveillance requirements are defined by 10 C.F.R. § 34.51.
10.6.9Posting
For the purpose of this Part, posting requirements are defined by 10 C.F.R. § 34.53.
10.6.10Reporting Requirements
A.In addition to the reporting requirements specified under other sections of this Subchapter, each licensee shall provide a written report to the Agency within thirty (30) days of the occurrence of any of the following incidents involving radiographic equipment:
1.Unintentional disconnection of the source assembly from the control cable;
2.Inability to retract the source assembly to its fully shielded position and secure it in this position;
3.Failure of any component (critical to safe operation of the device) to properly perform its intended function; or
4.An indicator on a radiation machine fails to show that radiation is being produced, an exposure switch fails to terminate production of radiation when turned to the off position, or a safety interlock fails to terminate X-ray production.
B.The licensee or registrant shall include the following information in each report submitted under § 10.6.10(A) of this Part:
1.A description of the equipment problem;
2.Cause of each incident, if known;
3.Name of the manufacturer and model number of equipment involved in the incident;
4.Place, time and date of the incident;
5.Actions taken to establish normal operations;
6.Corrective actions taken or planned to prevent recurrence; and
7.Names and qualifications of personnel involved in the incident.
C.Reports of overexposure submitted under § 1.17.3 of this Subchapter which involve failure of safety components of radiography equipment must also include the information specified in § 10.6.10(B) of this Part.
D.Any licensee or registrant conducting radiographic operations or storing sources of radiation material at any location not listed on the license and/or certificate of registration for a period in excess of one hundred eighty (180) days in a calendar year, shall notify the Agency prior to exceeding the one hundred eighty (180) days.
10.6.11Radiographer Certification
For the purpose of this Part, requirements for radiographer certification are defined by Appendix A to 10 C.F.R. Part 34.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-10 § 10.7** Recordkeeping Requirements {#sec-216-ricr-40-20-10-10.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-10#10.7}
10.7.1Records Required at Temporary Jobsites
A.Each licensee or registrant shall maintain current copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite:
1.Appropriate license, certificate of registration or equivalent document authorizing the use of sources of radiation.
2.Operating and emergency procedures required by § 10.7.6 of this Part.
3.A copy of this Subchapter.
4.Survey records as required by § 10.7.8 of this Part, for the period of operation at the site.
5.Records of dosimeter readings as required by § 10.7.7 of this Part.
6.Utilization log for each source of radiation dispatched from that location as required by § 10.7.4 of this Part.
7.Records of equipment problems identified in daily checks of equipment as required by § 10.5.7 of this Part;
8.Records of alarm system and entrance control checks required by § 10.5.8 of this Part, if applicable;
9.Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by § 10.5.4 of this Part;
10.Evidence of the latest calibrations of alarm ratemeters and operability checks of dosimeters as required by § 10.7.7 of this Part;
11.The shipping papers for the transportation of radioactive materials required by 10 C.F.R. § 71.5; and
12.When operating under reciprocity pursuant to § 7.10 of this Subchapter, a copy of the applicable State license or certificate of registration, or U.S. Nuclear Regulatory Commission license authorizing the use of sources of radiation.
10.7.2Records of the Specific License for Industrial Radiography
For the purpose of this Part, requirements for records of the specific license for industrial radiography are defined by 10 C.F.R. § 34.61.
10.7.3Records of the Receipt and Transfer of Sealed Sources
For the purpose of this Part, requirements for records of the receipt and transfer of sealed sources are defined by 10 C.F.R. § 34.63.
10.7.4Utilization Logs
A.Each licensee or registrant shall maintain utilization logs showing for each source of radiation the following information:
1.A description, including the make, model and serial number of the radiation machine or the radiographic exposure device, transport or storage container in which the sealed source is located;
2.The identity and signature of the radiographer to whom assigned;
3.Locations where used and dates of use, including the dates removed and returned to storage; and
4.For permanent radiographic installations, the dates each radiation machine is energized.
B.The licensee or registrant shall retain the logs required by § 10.7.4(A) of this Part for three (3) years after the log is made.
10.7.5Records of Training and Certification
For the purpose of this Part, requirements for records of training and certification are defined by 10 C.F.R. § 34.79.
10.7.6Copies of Operating and Emergency Procedures
Each licensee or registrant shall maintain a copy of current operating and emergency procedures until the Agency terminates the license and/or certificate of registration. Superseded material must be retained for three (3) years after the change is made.
10.7.7Records of Personnel Monitoring Procedures
For the purpose of this Part, requirements for records of personnel monitoring procedures are defined by 10 C.F.R. § 34.83.
10.7.8Records of Radiation Surveys
For the purpose of this Part, requirements for records of radiation surveys are defined by 10 C.F.R. § 34.85.
10.7.9Form of Records
For the purpose of this Part, requirements for form of records are defined by 10 C.F.R. § 34.87.
10.7.10Location of Documents and Records
A.Each licensee or registrant shall maintain copies of records required by this Part and other applicable parts of this Subchapter at the location specified in § 10.4(A)(10) of this Part.
B.Records shall also be maintained at each applicable field station and each temporary jobsite, as specified by § 10.7.1 of this Part.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-11** Licenses for Well Logging and Radiation Safety Requirements for Well Logging Operations
##### **216-RICR-40-20-11 § 11.1** Authority {#sec-216-ricr-40-20-11-11.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part prescribes requirements for the issuance of a license or registration authorizing the use of sources of radiation in well logging in a single well. This Part also prescribes radiation safety requirements for persons using sources of radiation in these operations.
C.This Part applies to all licensees or registrants who use sources of radiation for well logging operations including mineral logging, radioactive markers, or subsurface tracer studies.
D.The requirements set out in this Part do not apply to the issuance of a license or registration authorizing the use of sources of radiation in tracer studies involving multiple wells, such as field flooding studies, or to the use of sources of radiation auxiliary to well logging but not lowered into wells.
E.The provisions and requirements of this Part are in addition to, and not in substitution for, other requirements of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-11 § 11.2** Incorporated Material {#sec-216-ricr-40-20-11-11.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 39 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Notwithstanding the provisions of § 11.2(A) of this Part, 10 C.F.R. §§ 39.5, 39.8, 39.11, 39.13, 39.17, 39.51, 39.53, 39.55, 39.73, 39.75, 39.77, 39.91, 39.101 and 39.103 are not incorporated by reference.
C.Effect of incorporation of 10 C.F.R. Part 39. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 39, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 39 as follows:
1.Any reference to NRC or Commission shall be deemed to be a reference to the Agency.
2.Any reference to NRC or Agreement State shall be deemed to be a reference to the Agency, NRC or Agreement State.
3.Any reference to byproduct material shall be deemed to be a reference to radioactive material.
4.Any notifications, reports or correspondence referenced in the incorporated sections of 10 C.F.R. Part 39 shall be directed to the Agency using contact information specified in § 1.4 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-11 § 11.3** Definitions {#sec-216-ricr-40-20-11-11.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.3}
A.In addition to the definitions contained in 10 C.F.R. § 39.2, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Annual” means an interval not to exceed twelve (12) months.
4.“Radioactive material” means any material (solid, liquid, or gas) which emits radiation spontaneously.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-11 § 11.4** Specific Licensing Requirements {#sec-216-ricr-40-20-11-11.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.4}
11.4.1Specific License for Well Logging
A.In addition to the requirements set forth in § 7.6.2 of this Subchapter, a specific license for use of sources of radiation in well logging will be issued if the applicant submits to the Agency:
1.A description of its program for training logging supervisors and logging assistants and which specifies:
a.Initial training;
b.On-the-job training;
c.Annual safety reviews provided by the licensee;
d.Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the Agency's Regulations and licensing requirements and the applicant's operating and emergency procedures; and
e.Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.
2.Written operating and emergency procedures as described in § 11.6.2 of this Part or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures.
3.A program for annual inspections of the job performance of each logging supervisor to ensure that the Agency's Regulations, license requirements, and the applicant's operating and emergency procedures are followed.
a.Inspection records must be retained for three (3) years after each annual internal inspection.
4.A description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.
5.If an applicant wants to perform leak testing of sealed sources, identify the manufacturers and the model numbers of the leak test kits to be used.
6.If the applicant wants to analyze its own wipe samples, a description of the procedures to be followed. The description must include:
a.Instruments to be used;
b.Methods of performing the analysis; and
c.Pertinent experience of the person who will analyze the wipe samples.
11.4.2Agreement with Well Owner or Operator
For the purpose of this Part, requirements for an agreement with well owner or operator are defined by 10 C.F.R. § 39.15.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-11 § 11.5** Equipment {#sec-216-ricr-40-20-11-11.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.5}
11.5.1Labels, Security, and Transportation Precautions
For the purpose of this Part, requirements for labels, security, and transportation precautions are defined by 10 C.F.R. § 39.31.
11.5.2Radiation Survey Instruments
For the purpose of this Part, requirements for radiation survey instruments are defined by 10 C.F.R. § 39.33.
11.5.3Leak Testing of Sealed Sources
For the purpose of this Part, requirements for leak testing of sealed sources are defined by 10 C.F.R. § 39.35.
11.5.4Physical Inventory
For the purpose of this Part, requirements for physical inventory are defined by 10 C.F.R. § 39.37.
11.5.5Utilization Records
For the purpose of this Part, requirements for utilization records are defined by 10 C.F.R. § 39.39.
11.5.6Design and Performance Criteria for Sealed Sources Used in Downhole Operations
For the purpose of this Part, requirements for design and performance criteria for sealed sources used in downhole operations are defined by 10 C.F.R. § 39.41.
11.5.7Inspection, Maintenance, and Opening of a Source or Source Holder
For the purpose of this Part, requirements for inspection, maintenance, and opening of a source or source holder are defined by 10 C.F.R. § 39.43.
11.5.8Subsurface Tracer Studies
For the purpose of this Part, requirements for subsurface tracer studies are defined by 10 C.F.R. § 39.45.
11.5.9Radioactive Markers
For the purpose of this Part, requirements for radioactive markers are defined by 10 C.F.R. § 39.47.
11.5.10Uranium Sinker Bars
For the purpose of this Part, requirements for uranium sinker bars are defined by 10 C.F.R. § 39.49.
11.5.11Use of a Sealed Source in a Well Without Surface Casing
A licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the source becoming lodged in the well. The procedure shall be approved by the Agency.
11.5.12Energy Compensation Source
A.A licensee may use an energy compensation source (ECS) which is contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed material not exceeding three and seven tenths (3.7) MBq (one hundred (100) microcuries).
1.For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of §§ 11.5.3, 11.5.4 and 11.5.5 of this Part.
2.For well logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of §§ 11.5.1, 11.5.3, 11.5.4, 11.5.5, 11.5.11 and 11.7.4 of this Part.
11.5.13Tritium Neutron Generator Target Source
A.Use of a tritium neutron generator target source, containing quantities not exceeding one thousand one hundred ten (1,110) MBq (thirty (30) curies) and in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this Part except §§ 11.5.1, 11.5.6, and 11.7.4 of this Part.
B.Use of a tritium neutron generator target source, containing quantities exceeding one thousand one hundred ten (1,110) MBq (thirty (30) curies) or in a well without a surface casing to protect fresh water aquifers, is subject to the requirements of this Part except § 11.5.6 of this Part.
11.5.14Handling Tools
The licensee shall provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.
11.5.15Particle Accelerators
No licensee or registrant shall permit above-ground testing of particle accelerators, designed for use in well-logging, which results in the production of radiation, except in areas or facilities controlled or shielded so that the requirements of §§ 1.7.1 and 1.8.1 of this Subchapter, as applicable, are met.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-11 § 11.6** Radiation Safety Requirements {#sec-216-ricr-40-20-11-11.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.6}
11.6.1Training
For the purpose of this Part, training requirements are defined by 10 C.F.R. § 39.61.
11.6.2Operating and Emergency Procedures
For the purpose of this Part, requirements for operating and emergency procedures are defined by 10 C.F.R. § 39.63.
11.6.3Personnel Monitoring
For the purpose of this Part, requirements for personnel monitoring are defined by 10 C.F.R. § 39.65.
11.6.4Radiation Surveys
For the purpose of this Part, requirements for radiation surveys are defined by 10 C.F.R. § 39.67.
11.6.5Radioactive Contamination Control
For the purpose of this Part, requirements for radioactive contamination control are defined by 10 C.F.R. § 39.69.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-11 § 11.7** Security, Records and Notifications {#sec-216-ricr-40-20-11-11.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-11#11.7}
11.7.1Security
For the purpose of this Part, security requirements are defined by 10 C.F.R. § 39.71.
11.7.2Documents and Records Required at Field Stations
A.Each licensee or registrant shall maintain, for inspection by the Agency, the following documents and records for the specific devices and sources used at the field station:
1.Appropriate license, certificate of registration, or equivalent document;
2.Operating and emergency procedures;
3.Applicable Regulations;
4.Records of the latest survey instrument calibrations pursuant to § 11.5.2 of this Part;
5.Records of the latest leak test results pursuant to § 11.5.3 of this Part;
6.Records of quarterly inventories required pursuant to § 11.5.4 of this Part;
7.Utilization records required pursuant to § 11.5.5 of this Part;
8.Records of inspection and maintenance required pursuant to § 11.5.7 of this Part;
9.Survey records required pursuant to § 11.6.4 of this Part; and
10.Training records required pursuant to § 11.6.1 of this Part.
11.7.3Documents and Records Required at Temporary Jobsites
A.Each licensee or registrant conducting operations at a temporary jobsite shall have the following documents and records available at that site for inspection by the Agency:
1.Operating and emergency procedures;
2.Survey records required pursuant to § 11.6.4 of this Part; for the period of operation at the site;
3.Evidence of current calibration for the radiation survey instruments in use at the site;
4.When operating in Rhode Island under reciprocity, a copy of the appropriate license, certificate of registration, or equivalent document(s); and
5.Shipping papers for the transportation of radioactive material.
11.7.4Notification of Incidents, Abandonment, and Lost Sources
A.Notification of incidents and sources lost in other than downhole logging operations shall be made in accordance with appropriate provisions of § 1.17.2 of this Subchapter.
B.Whenever a sealed source or device containing radioactive material is lodged downhole, the licensee shall:
1.Monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or logging tool during logging tool recovery operations; and
2.Notify the Agency immediately by telephone and subsequently, within thirty (30) days, by confirmatory letter if the licensee knows or has reason to believe that a sealed source has been ruptured. This letter shall identify the well or other location, describe the magnitude and extent of the escape of radioactive material, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.
C.When it becomes apparent that efforts to recover the radioactive source will not be successful, the licensee shall:
1.Advise the well-operator of the regulations of the Agency regarding abandonment and an appropriate method of abandonment, which shall include:
a.The immobilization and sealing in place of the radioactive source with a cement plug,
b.A means to prevent inadvertent intrusion on the source (e.g., the setting of a whipstock or other deflection device), unless the source is not accessible to any subsequent drilling operations, and
c.The mounting of a permanent identification plaque, at the surface of the well, containing the appropriate information required by § 11.7.4 of this Part;
2.Notify the Agency, by telephone, of the circumstances that resulted in the inability to retrieve the source, and:
a.Obtain Agency approval to implement abandonment procedures; or
b.That the licensee implemented abandonment before receiving Agency approval because the licensee believed there was an immediate threat to public health and safety; and
3.File a written report with the Agency within thirty (30) days of the abandonment. The licensee shall send a copy of the report to the State agency(s) that issued permits or otherwise approved of the drilling operation. The report shall contain the following information:
a.Date of occurrence and a brief description of attempts to recover the source,
b.A description of the irretrievable radioactive source involved, including radionuclide, quantity, and chemical and physical form,
c.Surface location and identification of well,
d.Results of efforts to immobilize and set the source in place,
e.Depth of the radioactive source,
f.Depth of the top of the cement plug,
g.Depth of the well,
h.The immediate threat to public health and safety justification for implementing abandonment if prior Agency approval was not obtained in accordance with § 11.7.4 of this Part.
i.Any other information, such as a warning statement, contained on the permanent identification plaque; and
j.The names of State and Federal agencies receiving a copy of this report.
D.Whenever a sealed source containing radioactive material is abandoned downhole, the licensee shall provide a permanent identification plaque for mounting at the surface of the well, unless the mounting of the plaque is not practical. This plaque shall:
1.Be at least seventeen (17) cm (seven inches (7”)) square and three (3) mm (one eighth of one inch (1/8”)) thick and be constructed of long-lasting material, such as stainless steel, brass, bronze, or monel; and
2.Contain the following engraved on its face:
a.The word "CAUTION;"
b.The radiation symbol without the conventional color requirement;
c.The date of abandonment;
d.The name of the well operator or well owner;
e.The well name and well identification number(s) or other designation;
f.The sealed source(s) by radionuclide and quantity of activity;
g.The source depth and the depth to the top of the plug; and
h.An appropriate warning, depending on the specific circumstances of each abandonment. Appropriate warnings may include:
(1)"Do not drill below plug back depth;"
(2)"Do not enlarge casing;" or
(3)"Do not re-enter the hole," followed by the words, "before contacting the Rhode Island Radiation Control Agency."
E.The licensee shall immediately notify the Agency by telephone and subsequently by confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable aquifer. Such notice shall designate the well location and shall describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss, and explain efforts planned or being taken to mitigate these consequences.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-12** Packaging and Transportation of Radioactive Material
##### **216-RICR-40-20-12 § 12.1** Authority {#sec-216-ricr-40-20-12-12.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes requirements for packaging, preparation for shipment, and transportation of licensed material.
C.The packaging and transportation of licensed material are also subject to the requirements of other agencies (e.g., the U.S. Department of Transportation, the U.S. Nuclear Regulatory Commission and the U.S. Postal Service) having jurisdiction over means of transport. The requirements of this Part are in addition to, and not in substitution for, other requirements.
D.This Part applies to any licensee authorized by specific or general license issued by the Agency to receive, possess, use or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the Agency license, or transports that material on public highways. No provision of this Part authorizes possession of licensed material.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.2** Incorporated Material {#sec-216-ricr-40-20-12-12.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.2}
A.Except as provided in this Part, the requirements of 10 C.F.R. Part 71 (2021) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.Postal Service Manual (Domestic Mail Manual), § 124, is incorporated by reference at 39 C.F.R. § 111.1 (2021).
C.Notwithstanding the provisions of § 12.2(A) of this Part, 10 C.F.R. §§ 71.0, 71.1, 71.2, 71.3, 71.8, 71.9, 71.10, 71.11, 71.12, 71.14(b), 71.16, 71.18, 71.19, 71.24, 71.25, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.53, 71.55, 71.57, 71.59, 71.61, 71.63, 71.64, 71.65, 71.70, 71.71, 71.73, 71.74, 71.75, 71.77, 71.85(a) (b) and (c), 71.91(b), 71.93, 71.95, 71.101(c)(1), (c)(2), (d) and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125 are not incorporated by reference.
D.Effect of incorporation of 10 C.F.R. Part 71. To reconcile differences between this Part and the incorporated sections of 10 C.F.R. Part 71, the following words and phrases shall be substituted for the language in 10 C.F.R. Part 71 as follows:
1.Where the words “NRC,” “Commission,” “Nuclear Regulatory Commission,” “United States Nuclear Regulatory Commission” or “Administrator of the appropriate Regional Office” appear in 10 C.F.R. Part 71, substitute the words Agency except when used in 10 C.F.R. §§ 71.5(b), 71.10, 71.17(c)(3) and (e), 71.85(c), 71.88(a)(4), 71.93(c), 71.95, 71.97(c), (c)(3)(iii), and (f).
2.The terms “certificate of compliance, compliance holder or applicant” apply to the NRC as they are the sole authority for issuing a package Certificate of Compliance.
3.Form RCA-1, “Notice to Employees”, must be posted instead of NRC Form 3 that is specified in 10 C.F.R. Part 71.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.3** Definitions {#sec-216-ricr-40-20-12-12.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.3}
A.In addition to the definitions contained in 10 C.F.R. § 71.4, whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.4** General Provisions {#sec-216-ricr-40-20-12-12.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.4}
12.4.1Requirement for License
No person shall transport radioactive material or deliver radioactive material to a carrier for transport except as authorized in a general or specific license issued by the Agency or as exempted in § 12.5 of this Part.
12.4.2Transportation of Licensed Material
For the purpose of this Part, requirements for transportation of licensed material are defined by 10 C.F.R. § 71.5.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.5** Exemptions {#sec-216-ricr-40-20-12-12.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.5}
12.5.1Exemption of Physicians
For the purpose of this Part, requirements for exemption of physicians are defined by 10 C.F.R. § 71.13.
12.5.2Exemption for Low-Level Materials
For the purpose of this Part, requirements for exemption for low-level materials are defined by 10 C.F.R. § 71.14(a).
12.5.3Exemption from Classification as Fissile Material
For the purpose of this Part, requirements for exemption from classification as fissile material are defined by 10 C.F.R. § 71.15.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.6** General Licenses {#sec-216-ricr-40-20-12-12.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.6}
12.6.1NRC-Approved Package
For the purpose of this Part, requirements for a general license for an NRC-approved package are defined by 10 C.F.R. § 71.17.
12.6.2General license: Use of foreign approved package
For the purpose of this Part, requirements for a general license for use of a foreign approved package are defined by 10 C.F.R. § 71.21.
12.6.3Fissile Material
For the purpose of this Part, requirements for a general license for fissile material are defined by 10 C.F.R. § 71.22.
12.6.4Plutonium-Beryllium Special Form Material
For the purpose of this Part, requirements for a general license for plutonium-beryllium special form material are defined by 10 C.F.R. § 71.23.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.7** External Radiation Standards for All Packages {#sec-216-ricr-40-20-12-12.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.7}
For the purpose of this Part, requirements for external radiation standards for all packages are defined by 10 C.F.R. § 71.47.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.8** Operating Controls and Procedures {#sec-216-ricr-40-20-12-12.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.8}
12.8.1Applicability of Operating Controls and Procedures
For the purpose of this Part, requirements for applicability of operating controls and procedures are defined by 10 C.F.R. § 71.81.
12.8.2Assumptions as to Unknown Properties
For the purpose of this Part, requirements for assumptions as to unknown properties are defined by 10 C.F.R. § 71.83.
12.8.3Preliminary Determinations
For the purpose of this Part, requirements for preliminary determinations are defined by 10 C.F.R. § 71.85(d).
12.8.4Routine Determinations
For the purpose of this Part, requirements for routine determinations are defined by 10 C.F.R. § 71.87.
12.8.5Air Transport of Plutonium
For the purpose of this Part, requirements for air transport of plutonium are defined by 10 C.F.R. § 71.88.
12.8.6Opening Instructions
For the purpose of this Part, requirements for opening instructions are defined by 10 C.F.R. § 71.89.
12.8.7Shipment Records
For the purpose of this Part, requirements for shipment records are defined by 10 C.F.R. §§ 71.91(a), (c) and (d).
12.8.8Shipment Reports
A.The licensee, after requesting the certificate holder's input, shall submit a written report to the Agency of:
1.Instances in which there is significant reduction in the effectiveness of any NRC-approved Type B or Type AF packaging during use;
2.Details of any defects with safety significance in any NRC-approved Type B or fissile material packaging after first use;
3.Instances in which the conditions of approval in the certificate of compliance were not observed in making a shipment.
B.The licensee shall submit a written report to the Agency of instances in which the conditions in the certificate of compliance were not followed during a shipment.
C.Each licensee shall submit a written report required by §§ 12.8.8(A) or (B) of this Part within sixty (60) days of the event or discovery of the event. The licensee shall also provide a copy of each report submitted to the Agency to the applicable certificate holder. Written reports prepared under other Regulations may be submitted to fulfill this requirement if the reports contain all the necessary information, and the appropriate distribution is made. These written reports must include the following:
1.A brief abstract describing the major occurrences during the event, including all component or system failures that contributed to the event and significant corrective action taken or planned to prevent recurrence.
2.A clear, specific, narrative description of the event that occurred so that knowledgeable readers conversant with the requirements of 10 C.F.R. Part 71, but not familiar with the design of the packaging, can understand the complete event. The narrative description must include the following specific information as appropriate for the particular event:
a.Status of components or systems that were inoperable at the start of the event and that contributed to the event;
b.Dates and approximate times of occurrences;
c.The cause of each component or system failure or personnel error, if known;
d.The failure mode, mechanism, and effect of each failed component, if known;
e.A list of systems or secondary functions that were also affected for failures of components with multiple functions;
f.The method of discovery of each component or system failure or procedural error;
g.For each human performance-related root cause, a discussion of the cause(s) and circumstances;
h.The manufacturer and model number (or other identification) of each component that failed during the event; and
i.For events occurring during use of a packaging, the quantities and chemical and physical form(s) of the package contents.
3.An assessment of the safety consequences and implications of the event. This assessment must include the availability of other systems or components that could have performed the same function as the components and systems that failed during the event.
4.A description of any corrective actions planned as a result of the event, including the means employed to repair any defects, and actions taken to reduce the probability of similar events occurring in the future.
5.Reference to any previous similar events involving the same packaging that are known to the licensee or certificate holder.
6.The name and telephone number of a person within the licensee's organization who is knowledgeable about the event and can provide additional information.
7.The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.
D.The reports submitted by licensees and/or certificate holders under § 12.8.8 of this Part must be of sufficient quality to permit reproduction and micrographic processing.
12.8.9Advance Notification of Shipment of Irradiated Reactor Fuel and Nuclear Waste
For the purpose of this Part, requirements for advance notification of shipment of irradiated reactor fuel and nuclear waste are defined by 10 C.F.R. § 71.97.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.9** Quality Assurance {#sec-216-ricr-40-20-12-12.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.9}
12.9.1Quality Assurance Requirements
A.Before the use of any package for the shipment of licensed material subject to this Subchapter, each licensee shall obtain Agency approval of its quality assurance program. Each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, by submitting the description to the Agency.
B.Before the fabrication, testing, or modification of any package for the shipment of licensed material subject to this Subchapter, each certificate holder, or applicant for a Certificate of Compliance (CoC) shall obtain Agency approval of its quality assurance program. Each certificate holder or applicant for a CoC shall file a description of its quality assurance program, including a discussion of which requirements of this Subchapter are applicable and how they will be satisfied.
C.For the purpose of this Part, quality assurance requirements are defined by 10 C.F.R. §§ 71.101(a), (b), (f) and (g).
12.9.2Quality Assurance Organization
For the purpose of this Part, quality assurance organization requirements are defined by 10 C.F.R. § 71.103.
12.9.3Quality Assurance Program
For the purpose of this Part, quality assurance program requirements are defined by 10 C.F.R. § 71.105.
12.9.4Changes to Quality Assurance Program
For the purpose of this Part, requirements for changes to a quality assurance program are defined by 10 C.F.R. § 71.106.
12.9.5Handling, Storage, and Shipping Control
For the purpose of this Part, requirements for handling, storage, and shipping control are defined by 10 C.F.R. § 71.127.
12.9.6Inspection, Test, and Operating Status
For the purpose of this Part, requirements for inspection, test, and operating status are defined by 10 C.F.R. § 71.129.
12.9.7Nonconforming Materials, Parts, or Components
For the purpose of this Part, requirements for nonconforming materials, parts, or components are defined by 10 C.F.R. § 71.131.
12.9.8Corrective Action
For the purpose of this Part, corrective action requirements are defined by 10 C.F.R. § 71.133.
12.9.9Quality Assurance Records
For the purpose of this Part, requirements for quality assurance records are defined by 10 C.F.R. § 71.135.
12.9.10Audits
For the purpose of this Part, requirements for audits are defined by 10 C.F.R. § 71.137.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-12 § 12.10** Determination of A 1 and A 2 {#sec-216-ricr-40-20-12-12.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-12#12.10}
For the purpose of this Part, requirements for determination of A1 and A2 are defined by Appendix A to 10 C.F.R. Part 71.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-13** Radiation Safety Requirements for Particle Accelerators
##### **216-RICR-40-20-13 § 13.1** Authority {#sec-216-ricr-40-20-13-13.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-13#13.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes procedures for the registration (or licensing) and the use of particle accelerators intended for other than healing arts use. Requirements for registration and use of particle accelerators for healing arts use are contained in Part 5 of this Subchapter.
C.In addition to the requirements of this Part, all registrants are subject to the requirements of Parts 1, 2 and 3 of this Subchapter. Registrants engaged in industrial radiographic operations are subject to the requirements of Part 10 of this Subchapter. Registrants (or licensees) whose operations result in the production of radioactive material are also subject to the requirements of Part 7 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-13 § 13.2** Definitions {#sec-216-ricr-40-20-13-13.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-13#13.2}
A.Whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3."Facility" means the location, building, vehicle, or complex under one (1) administrative control, at which one (1) or more radiation machines are installed, located and/or used.
4.“Registration” means registration with the Agency pursuant to this Subchapter and the Act.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-13 § 13.3** Registration Procedure {#sec-216-ricr-40-20-13-13.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-13#13.3}
13.3.1Registration (or Licensing) Requirement
No person shall receive, possess, use, transfer, own, or acquire a particle accelerator except as authorized in a registration (or license) issued pursuant to this Subchapter or as otherwise provided for in this Subchapter. The general procedures for registration (or licensing) of particle accelerator facilities are included in Parts 3 and 7 of this Subchapter.
13.3.2General Requirements for the Issuance of a Registration (or License) for Particle Accelerators
A.In addition to the requirement of Parts 3 and 7 of this Subchapter, a registration (or licensing) application for use of a particle accelerator will be approved only if the Agency determines that:
1.The applicant is qualified by reason of training and experience to use the accelerator in question for the purpose requested in accordance with this Part and Parts 1 and 2 of this Subchapter in such a manner as to minimize danger to public health and safety or property;
2.The applicant's proposed equipment, facilities, operating and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;
3.The issuance of the registration (or license) will not be inimical to the health and safety of the public;
4.The applicant has appointed a radiation safety officer;
5.The applicant and/or his staff has substantial experience in the use of particle accelerators for the intended uses;
6.The applicant has established a radiation safety committee to approve, in advance, proposals for uses of particle accelerators, whenever deemed necessary by the Agency; and
7.The applicant has an adequate training program for particle accelerator operators.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-13 § 13.4** Radiation Safety Requirements for the Use of Particle Accelerators {#sec-216-ricr-40-20-13-13.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-13#13.4}
13.4.1Limitations
A.No registrant (or licensee) shall permit any person to act as a particle accelerator operator until such person:
1.Has been instructed in radiation safety and shall have demonstrated an understanding thereof;
2.Has received copies of and instructions in this Part and the applicable requirements of Parts 1 and 2 of this Subchapter, pertinent registration (or license) conditions and the registrant's (or licensee's) operating and emergency procedures, and shall have demonstrated understanding thereof; and
3.Has demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be employed in his assignment.
B.Either the radiation safety committee or the radiation safety officer shall have the authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to minimize danger to public health and safety or property.
13.4.2Shielding and Safety Design Requirements
A.A qualified expert, registered with the Agency, shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.
B.Each particle accelerator installation shall be provided with such primary and/or secondary barriers as are necessary to assure compliance with §§ 1.7.1 and 1.8.1 of this Subchapter.
13.4.3Particle Accelerator Controls and Interlock System
A.Instrumentation, readouts and controls on the particle accelerator control console shall be clearly identified and easily discernible.
B.Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the machine under conditions of barrier penetration.
C.When a safety interlock system has been tripped, it shall only be possible to resume operation of the accelerator by manually resetting controls at the position where the safety interlock has been tripped, and lastly at the main control console.
D.Each safety interlock shall be on a circuit which shall allow its operation independently of all other safety interlocks.
E.All safety interlocks shall be fail safe (i.e., designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator).
F.A scram button or other emergency power cutoff switch shall be located and easily identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.
13.4.4Warning Devices
A.All locations designated as high radiation areas, and entrances to such locations shall be equipped with easily observable warning lights that operate when, and only when, radiation is being produced.
B.Except in facilities designed for human exposure, each high radiation area shall have an audible warning device which shall be activated for fifteen (15) seconds prior to the possible creation of such high radiation area. Such warning device shall be clearly discernible in all high radiation areas.
C.Barriers, temporary or otherwise, and pathways leading to high radiation areas shall be identified in accordance with § 1.14.1 of this Subchapter.
13.4.5Operating Procedures
A.Particle accelerators, when not in operation, shall be secured to prevent unauthorized use.
B.Only a switch on the accelerator control console shall be routinely used to run the accelerator beam on and off. The safety interlock system shall not be used to turn off the accelerator beam except in an emergency.
C.All safety and warning devices, including interlocks, shall be checked for proper operability at intervals not to exceed three (3) months. Results of such tests shall be maintained for inspection at the accelerator facility.
D.Electrical circuit diagrams of the accelerator, and the associated interlock systems, shall be kept current and maintained for inspection by the Agency and available to the operator at each accelerator facility.
E.If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:
1.Authorized by the radiation safety committee and/or radiation safety officer;
2.Recorded in a permanent log and a notice posted at the accelerator control console; and
3.Terminated as soon as possible.
F.A copy of the current operating and the emergency procedures shall be maintained at the accelerator control panel.
13.4.6Radiation Monitoring Requirements
A.There shall be available at each particle accelerator facility, appropriate portable monitoring equipment which is operable and has been calibrated for the appropriate radiations being produced at the facility. Such equipment shall be tested regularly and prior to use, and calibrated at intervals not to exceed twelve (12) months, and after each servicing and repair which could affect the calibration.
B.A radiation protection survey shall be performed and documented by an individual registered with the Agency to provide Radiation Physics Services pursuant to Part 3 of this Subchapter when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.
C.Radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.
D.All area monitors shall be calibrated at intervals not to exceed three (3) months.
E.Whenever applicable, periodic surveys shall be made to determine the amount of airborne particulate radioactivity present in areas of airborne hazards.
F.Whenever applicable, periodic smear surveys shall be made to determine the degree of contamination in target and other pertinent areas.
G.All area surveys shall be made in accordance with the written procedures established by a qualified expert, or the radiation safety officer of the particle accelerator facility.
H.Records of all radiation protection surveys, calibration results, instrumentation tests, and smear results shall be kept current and on file at each accelerator facility.
13.4.7Ventilation Systems
A.Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in § 1.19 of this Subchapter.
B.A registrant (or licensee), as required by § 1.8.1 of this Subchapter, shall not vent, release or otherwise discharge airborne radioactive material to an uncontrolled area which exceed the limits specified in § 1.19 of this Subchapter, except as authorized pursuant to §§ 1.15.2 or 1.8.1(A) of this Subchapter. For purposes of §§ 13.4.7(A) and (B) of this Part, concentrations may be averaged over a period not greater than twelve (12) months. Every reasonable effort should be made to maintain releases of radioactive material to uncontrolled areas, as far below these limits as practicable.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-14** Radiation Safety Requirements for Microwave Ovens
##### **216-RICR-40-20-14 § 14.1** Authority {#sec-216-ricr-40-20-14-14.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-14#14.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.This Part establishes radiation safety requirements (performance standards) for microwave ovens manufactured after October 6, 1971.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-14 § 14.2** Incorporated Material {#sec-216-ricr-40-20-14-14.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-14#14.2}
Except as provided in this Part, the requirements of 21 C.F.R. § 1030.10 (2018) are incorporated by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-14 § 14.3** Definitions {#sec-216-ricr-40-20-14-14.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-14#14.3}
A.Whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control".
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation - Radiation Control Program, Rhode Island Department of Health.
3.“External surface” means the outside surface of the cabinet or enclosure provided by the manufacturer as part of the microwave oven, including doors, door handles, latches, and control knobs.
4.“Equivalent plane-wave power density” means the square of the root-mean-square (rms) electric field strength divided by the impedance of free space (377 ohms).
5.“Microwave oven” means a device designed to heat, cook, or dry food through the application of electromagnetic energy at frequencies assigned by the Federal Communications Commission in the normal ISM heating bands ranging from 890 megahertz to 6,000 megahertz. As defined in this Part, “microwave ovens” are limited to those manufactured for use in homes, restaurants, food vending, or service establishments, on interstate carriers, and in similar facilities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-14 § 14.4** Performance Standards {#sec-216-ricr-40-20-14-14.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-14#14.4}
Microwave ovens manufactured after October 6, 1971 shall be maintained in compliance with 21 C.F.R. § 1030.10.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-14 § 14.5** Power Density Limits {#sec-216-ricr-40-20-14-14.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-14#14.5}
The equivalent plane-wave power density existing in the proximity of the external oven surface shall not exceed one (1) milliwatt per square centimeter (cm2) at any point five centimeters (5 cm) or more from the external surface of the oven, measured prior to acquisition by a purchaser, and, thereafter, five (5) milliwatts per cm2 at any such point.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-14 § 14.6** Noncompliance {#sec-216-ricr-40-20-14-14.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-14#14.6}
Any microwave oven manufactured after October 6, 1971 which fails to meet the requirements of this Part or 21 C.F.R. § 1030.10 shall be removed from service until the repairs or modifications necessary to meet the applicable requirements have been made.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
#### **216-RICR-40-20-15** X-Ray and Radioactive Materials Fees
##### **216-RICR-40-20-15 § 15.1** Authority {#sec-216-ricr-40-20-15-15.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-15#15.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3-5.
B.Persons and individuals who are subject to licensure and/or registration with the Agency pursuant to the Act and this Subchapter shall be assessed fees, established in the Department fee schedule, and in accordance with § 15.4 of this Part for X-ray registrants and/or § 15.5 of this Part for radioactive materials licensees.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-15 § 15.2** Definitions {#sec-216-ricr-40-20-15-15.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-15#15.2}
A.Whenever used in this Part, the following terms shall be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-1.3 entitled "Radiation Control."
2.“Agency” means Rhode Island Radiation Control Agency (RCA), Center for Health Facilities Regulation – Radiation Control Program, Rhode Island Department of Health.
3.“Department fee schedule” means Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-15 § 15.3** General Provisions {#sec-216-ricr-40-20-15-15.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-15#15.3}
A.Fee Exempt: Notwithstanding the requirement of § 15.1(B) of this Part, no fees shall be required for radioactive materials licenses authorizing the use of source material as shielding only in devices and containers, provided, however, that all other licensed radioactive material in the device or container will be subject to the fees required by § 15.5 of this Part.
B.Payment of Fees: All fees specified in the Department fee schedule shall be submitted to the Agency.
C.Inquiries: Any inquiry regarding Agency fees should be addressed to the Agency as specified in § 1.4 of this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-15 § 15.4** X-Ray Fees {#sec-216-ricr-40-20-15-15.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-15#15.4}
15.4.1Submission of Initial Fee
A.Each initial application for a Registration Certificate in a category for which a fee has been established in the Department fee schedule shall be accompanied by a fee in the amount of the Annual Fee specified for that registration category. A registration application shall not be considered prior to payment of the full amount specified. Registration applications for which no remittance is received shall be returned to the applicant.
B.Initial applications, accompanied by the appropriate registration fee and which are received by the Agency during the period July 1 through August 31 of a calendar year shall also constitute a renewal application for the period ending August 31 of the following calendar year, without payment of an additional annual registration fee.
15.4.2Nonstandard Facilities and Services Fee
Facilities and services which are approved by the Agency for registration, but which do not fit the descriptions of the categories in § 15.4.6 of this Part shall be assessed at a rate which coincides with an appropriate category, as determined by the Agency.
15.4.3Fee Rebates Not Authorized
Rebates shall not be made for existing registrants who terminate operations prior to the expiration of their Registration Certificates.
15.4.4Late Fees
Failure of any registered facility or service to submit the indicated annual registration fee for renewal of registration prior to the expiration date of current Registration Certificate shall be assessed a late fee established in the Department fee schedule in addition to the required registration fee.
15.4.5Annual Fees
The Agency shall issue an annual fee invoice to each registrant, based on the applicable annual fee established in the Department fee schedule. Fees shall be payable prior to the expiration date of the registrant's current Registration Certificate.
15.4.6X-Ray Registration Categories
A.Healing Arts Registration Categories
1.Dental X-ray Facility [DEF]. Facilities performing diagnostic radiography limited to intra-oral dental procedures and/or extra-oral dental procedures, including panoramic procedures and cephalometric procedures.
2.Hospital Radiology Facility [HRF]. Facilities performing general purpose diagnostic radiographic procedures (including fluoroscopy) in an institution licensed by the State of Rhode Island as a hospital.
3.Radiology Facility [RAD]. Facilities performing general purpose diagnostic radiographic procedures (including fluoroscopy) outside of an institution licensed by the State of Rhode Island as a hospital.
4.Radiation Therapy Facility [RTF]. Facilities utilizing one (1) or more therapeutic radiation machines, including dedicated therapy simulator(s).
5.Specific Radiology Facility (Single Category) [SRF]
a.Facilities performing diagnostic radiography (excluding fluoroscopy) limited to a single category of specific radiographic procedures, as specified on the facility’s application. The category shall also include facilities performing only chiropractic or podiatric procedures.
b.Facilities utilizing X-ray system(s) solely for human subjects research in accordance with Institutional Review Board (IRB) approval.
6.Specific Radiology Facility (Multiple Categories) [SRM]. Facilities performing two (2) or more categories of specific diagnostic radiography procedures (excluding fluoroscopy), as specified on the facility’s application.
7.Veterinary X-ray Facility [VEF]. Facilities performing diagnostic radiography limited to veterinary procedures.
B.Non-Healing Arts Registration Categories
1.Industrial Radiography Facility [IRF]. Facilities utilizing X-ray equipment to perform industrial radiographic procedures.
2.Industrial Radiation Machine (Type A) Facility [IRA]. Facilities utilizing a Category A industrial radiation machines as defined in Part 6 of this Subchapter.
3.Industrial Radiation Machine (Type B) Facility [IRB]. Facilities utilizing a Category B industrial radiation machines as defined in Part 6 of this Subchapter.
4.Other Non-Healing Arts Facility [OTH]. Facilities utilizing X-ray equipment for non-healing arts applications not otherwise defined in this Subchapter.
5.Particle Accelerator Facility [PAF]. Facilities utilizing particle accelerators not authorized for human use.
C.Services Registration Categories.
1.Provider of X-ray Services [PXS].
a.Individuals or facilities providing installation and/or servicing of X-ray equipment and associated components for Agency registrants.
b.Individuals or facilities providing NVLAP certified personnel dosimetry services for Agency registrants and/or radioactive materials licensees.
2.Radiation Physics Services [RPS]
a.Calibration of health physics instrumentation for Agency registrants and/or radioactive materials licensees
b.General radiation physics services for Agency registrants and/or radioactive materials licensees
c.Diagnostic X-ray Physics services for Agency registrants [Calibration and surveys of diagnostic X-ray equipment]
d.Diagnostic X-ray Physics services for Agency registrants [Calibration and surveys of computed tomography (CT) X-ray systems]
e.Radiotherapy Physics services for Agency registrants [Calibration and surveys of therapeutic radiation machines]
f.Radiotherapy Physics services for Agency materials licensees [Calibration and surveys of remote afterloader units, teletherapy units, and/or gamma stereotactic radiosurgery units]
3.Storage X-ray Facility [STO]. Facilities limited to storage of X-ray equipment, excluding X-ray equipment exempt from registration under this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
##### **216-RICR-40-20-15 § 15.5** Radioactive Materials Fees {#sec-216-ricr-40-20-15-15.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-40-20-15#15.5}
15.5.1Application Fee
Each initial application for a license in a category for which a fee has been established in the Department fee schedule shall be accompanied by a non-refundable fee in the amount of the Annual Fee specified for that license category. A license application shall not be considered prior to payment of the full amount specified. License applications for which no fee is received shall be returned to the applicant.
15.5.2Annual Fees
A.Assessment of Fees: The Agency shall issue an annual fee invoice to each licensee, based on the applicable annual fee established in the Department fee schedule. Fees shall be payable within thirty (30) days after receipt of a fee invoice.
B.Eligibility for Waiver of Annual Fee: Any broad-scope (academic or medical) licensee, or any licensee which is a governmental agency of the State of Rhode Island, that provides in-kind services to the Agency and/or performs services pursuant to an accepted written agreement with the Agency, and which are valued at an amount equal to or greater than their annual license fee, may submit a written request for a waiver from payment of the annual license fee. Upon approval by the Agency, this waiver shall only remain in effect for that annual licensing period. A new waiver request must be submitted for each subsequent annual licensing period.
1.For the purposes of this Part, “governmental agency” shall be construed to include any department, office, commission or similar public entity established by Executive Order or pursuant to the Rhode Island General Laws.
C.Revocation of Annual Fee Waiver: Upon written notice of noncompliance to the licensee, the Agency may revoke any waiver, approved pursuant to § 15.5.2(B) of this Part, for failure to provide or perform all services pursuant to the accepted written agreement. The Agency may also invoice the licensee for any difference between the originally waived annual fee and the value of services already performed during that annual licensing period.
15.5.3Amendment Fees
A.Assessment of Fees: A licensee shall notify the Agency prior to submitting an amendment so that the appropriate amendment fee can be determined. Amendment fees are established in the Department fee schedule and shall be assessed in accordance with written criteria established by the Agency. The written criteria shall be based on the Agency's estimate of the typical time and effort required to complete action on that general category of amendment request.
B.Nonstandard Amendment Fees: A nonstandard amendment request which is not addressed by the Agency's written criteria shall be assessed an amendment fee which most closely approximates the time and effort necessary to complete action on the amendment request, as determined by the Agency.
C.Submission of Amendment Fees: The appropriate amendment fee shall accompany the amendment request when it is submitted to the Agency. If the time and effort required to complete Agency action on the amendment request is significantly different than the basis for assessing the amendment fee, the Agency shall refund any overcharges or bill the licensee for an additional amendment fee up to a total maximum fee established in the Department fee schedule.
15.5.4Reciprocity Fees
A.Each annual application to operate in Rhode Island under reciprocity shall be accompanied by a non-refundable fee equal to the amount established in the Department fee schedule for the specified category of activity. There will be no pro-rating of reciprocity fees.
1.Category 1: Activities equivalent to those authorized by Categories 3D, 3K (broad-scope only) or 4B in § 15.5.7 of this Part.
2.Category 2: Activities equivalent to those authorized by Categories 1B, 2C, 3I, 3K (other than broad-scope), 4C or 5A in § 15.5.7 of this Part.
3.Category 3: Activities equivalent to those authorized by Categories 1A, 3L or 8A in § 15.5.7 of this Part.
4.Any activity which is not specifically identified in §§ 15.5.4(A)(1), (2) or (3) of this Part shall be assessed a fee which coincides with the appropriate Category, as determined by the Agency.
B.Notwithstanding the provisions of § 15.5.4(A) of this Part, a reciprocity application based on a radioactive materials license which authorizes activities comparable to § 15.5.7 of this Part – Category 3I, but which only requests authorization to perform “electronic checks” or other activities which do not involve disassembly of shielding or actual manipulation of sealed sources, shall be accompanied by a non-refundable fee established in the Department fee schedule.
C.A reciprocity application shall not be considered prior to payment of the full amount specified. Reciprocity applications for which no remittance is received shall be returned to the applicant.
D.No additional reciprocity fees shall be required for the same category of activity during the remainder of that calendar year. All reciprocity authorizations shall expire on December 31 of the year in which the application was submitted. Any additional reciprocity activity beyond December 31 of that year shall require a renewal application.
15.5.5Registration of General Licenses Pursuant to § 7.7.1 [GEN-4]
A.Each initial application for registration of a generally licensed device pursuant to § 7.7.1 of this Subchapter [GEN-4] shall be accompanied by a fee established in the Department fee schedule for each address or location of use and/or storage, as defined in § 7.7.1 of this Subchapter. There will be no pro-rating of registration fees.
B.No additional fees shall be required for:
1.Registration of additional generally licensed devices at the same address or location of use and/or storage.
2.Annual renewal of registrations pursuant to § 7.7.1 of this Subchapter.
C.All registrations issued pursuant to § 7.7.1 of this Subchapter [GEN-4] shall expire on December 31 of the year for which the registration information was submitted.
15.5.6Non-Routine Inspection Fees
A non-routine inspection is only conducted in response to a significant regulatory event including, but not limited to, a reportable incident or overexposure, loss of radioactive material or unresolved non-compliance with license conditions or regulatory requirements. The Agency shall issue a non-routine inspection fee invoice to each licensee whenever the Agency conducts an inspection of the licensee’s activities at an interval more frequent than currently established for that category of licensee. The fee shall be based on fifty percent (50%) of the applicable annual fee established in the Department fee schedule. Fees shall be payable within thirty (30) days after receipt of a fee invoice.
15.5.7Radioactive Materials License Categories
A.Category 1 – Special Nuclear Material
1.Category 1A: Licenses for possession and use of special nuclear material of less than a critical mass, as defined in 10 C.F.R. § 70.4, in sealed sources contained in devices used in industrial measuring systems including X-ray fluorescence analyzers. Licenses that cover both radioactive and special nuclear material in sealed sources for use in gauging devices will only be subject to the fee for Category 3l.
2.Category 1B – All other licenses for possession and use of special nuclear material in unsealed form and in quantities not sufficient to form a critical mass.
B.Category 2 – Source Material
1.Category 2A – Licenses for possession and use of source material in recovery operations such as milling, in-situ leaching, heap leaching, refining uranium mill concentrates to uranium hexafluoride, ore buying stations, ion exchange facilities, and in processing of ores containing source material for extraction of metals other than uranium or thorium, including licenses authorizing the possession of radioactive waste material (tailings) from source material recovery operations, as well as licenses authorizing the possession and maintenance of a facility in a standby mode.
2.Category 2B – Licenses for possession and use of source material for shielding. Licensees paying fees under Category 3B or 7B are not subject to fees under Category 2B for possession and shielding authorized on the same license.
3.Category 2C – All other source material licenses.
C.Category 3 – Radioactive Material Other Than Source Material and Special Nuclear Material
1.Category 3A
a.Licenses of broad scope for possession and use of radioactive material for processing or manufacturing of items containing radioactive material for commercial distribution.
b.Other (limited) licenses for possession and use of radioactive material for processing or manufacturing of items containing radioactive material for commercial distribution.
2.Category 3B
a.Licenses authorizing the processing or manufacturing and distribution or redistribution of radiopharmaceuticals, generators, reagent kits and/or sources and devices containing radioactive material.
b.Licenses and approvals authorizing the distribution or redistribution of radiopharmaceuticals, generators, reagent kits and/or sources and devices not involving processing of radioactive material.
3.Category 3C – This license category is not currently utilized in Rhode Island.
4.Category 3D – Licenses for possession and use of radioactive material for industrial radiography operations.
5.Category 3E – Licenses for possession and use of radioactive material in sealed sources for irradiation of materials in which the source is not removed from its shield (self-shielded units).
6.Category 3F
a.Licenses for possession and use of less than ten thousand (10,000) curies of radioactive material in sealed sources for irradiation of materials where the source is exposed for irradiation purposes.
b.Licenses for possession and use of ten thousand (10,000) curies or more of radioactive material in sealed sources for irradiation of materials where the source is exposed for irradiation purposes.
7.Category 3G
a.Licenses to distribute items containing radioactive material that require sealed source and/or device review to persons generally licensed, except specific licenses authorizing redistribution of items that have been authorized for distribution to generally licensed persons.
b.Licenses to distribute items containing radioactive material that do not require sealed source and/or device review to persons generally licensed, except specific licenses authorizing redistribution of items that have been authorized for distribution to generally licensed persons.
8.Category 3H – This license category is not currently utilized in Rhode Island.
9.Category 3I – Licenses that authorize service for other licensees, except:
a.Licenses that authorize leak testing and/or calibration services only are subject to the fees specified in Category 3L; and
b.Licenses that authorize waste disposal services are subject to fees specified in Categories 4A, 4B and 4C.
10.Category 3J – This license category is not currently utilized in Rhode Island.
11.Category 3K
a.Licenses of broad scope for possession and use of radioactive material for research and development that do not authorize commercial distribution.
b.Other (limited) licenses for possession and use of radioactive material for research and development that do not authorize commercial distribution.
c.Any other use of unsealed radioactive material that does not authorize commercial distribution.
12.Category 3L – All other specific radioactive materials, except those in Categories 4A through 8A. Licenses that cover both radioactive and special nuclear material in sealed sources for use in gauging devices will only be subject to the fee for Category 3L.
D.Category 4 – Waste Disposal
1.Category 4A – Licenses specifically authorizing the receipt of waste radioactive material from other persons for the purpose of commercial disposal by land burial by the licensee; or licenses for treatment or disposal by incineration, packaging of residues resulting from incineration and transfer of packages to another person authorized to dispose of waste material.
2.Category 4B – Licenses specifically authorizing the receipt of waste radioactive material from other persons for the purpose of packaging or repackaging the material. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material.
3.Category 4C – Licenses specifically authorizing the receipt of prepackaged waste radioactive material from other persons. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material.
E.Category 5 – Well Logging
1.Category 5A – Licenses specifically authorizing use of radioactive material for well logging, well surveys and tracer studies other than field flooding tracer studies.
2.Category 5B – Licenses for possession and use of radioactive material for field flooding tracer studies.
F.Category 6 – Nuclear Laundries
Category 6A – Licenses for commercial collection and laundry of items contaminated with radioactive material.
G.Category 7 – Human Use of Radioactive Material
1.Category 7A – Licenses for human use of radioactive material in sealed sources contained in gamma stereotactic radiosurgery units, teletherapy devices, or similar beam therapy devices.
2.Category 7B – Licenses issued for human use of radioactive material, except radioactive material in sealed sources contained in gamma stereotactic radiosurgery units, teletherapy devices, or similar beam therapy devices.
3.Category 7C – This license category is not currently utilized in Rhode Island.
4.Category 7D – Licenses of broad scope issued to medical institutions or two (2) or more physicians authorizing research and development, including human use of radioactive material, except radioactive material in sealed sources contained in gamma stereotactic radiosurgery units, teletherapy devices, or similar beam therapy devices.
H.Category 8 – Civil Defense
Category 8A – Licenses for possession and use of radioactive material for civil defense activities.
I.Category 9 – Device, Product or Sealed Source Safety Evaluation
1.Category 9A – This license category is not currently utilized in Rhode Island.
2.Category 9B – This license category is not currently utilized in Rhode Island.
3.Category 9C – This license category is not currently utilized in Rhode Island.
4.Category 9D – This license category is not currently utilized in Rhode Island.
J.Category 10 – Other Licenses and Authorizations
Category 10A – Radioactive materials licenses and other approvals authorizing decommissioning, decontamination, reclamation or site restoration activities in accordance with this Subchapter.
**History**
- *Amendment — effective from 2022-05-25 to current*
- *Periodic Refile — effective from 2022-01-04 to 05/25/2022*
- *Adoption — effective from 2019-01-01 to 01/04/2022*
## **Chapter 50** Environmental Health
### **Subchapter 05** Water Quality
#### **216-RICR-50-05-2** Private Drinking Water Systems
##### **216-RICR-50-05-2 § 2.1** Authority and Purpose {#sec-216-ricr-50-05-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.1}
A.These regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws §§ 23-1-5.3(5) and 23-1-5.3(6), in order to protect public health by ensuring the drinking water quality of private water supply systems.
B.The Office of Private Well Water Contamination (OPWWC) has established these rules and regulations to apply to all private-drinking-water systems, as defined in this Part, that do not meet the definition of a “public water supplier”, or those not covered by more stringent local community definitions. Additionally, these rules and regulations provide direction for local officials regarding local enforcement regarding data reporting requirements. Additional guidance, both electronic and hard copy will be published regarding the topics addressed within these rules and regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.2** Definitions {#sec-216-ricr-50-05-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.2}
A.Wherever used in these rules and regulations the following terms shall be defined as follows:
1.“Act” means R.I. Gen. Laws §§ 23-1-5.2 and 23-1-5.3.
2.“Action level” means detection of a constituent in drinking water which concentration equals or exceeds fifty percent (50%) of the HA, MCL, or SMCL (as defined below) and indicates need for further action such as increased monitoring.
3.“Certified laboratory” means an analytical laboratory licensed by the Department under R.I. Gen. Laws Chapter 23-16.2, to perform biological, microbiological, chemical or radiochemical examination of potable water; or laboratory exempt from this law as provided for in R.I. Gen. Laws § 23-16.2-3 but which shall be certified by the State Certification official in accordance with 40 C.F.R. § 142.10b.
4.“Commercial/mixed use private water supply system” means a private supply system that serves a structure(s) consisting of one or more commercial spaces and/or more than four (4) family dwelling units that has been occupied as a dwelling and is under control of a single entity(s).
5.“Constituent” means a chemical or elemental component found in private well water.
6.“Department” means the Rhode Island Department of Health.
7.“Director” means the Director of the Rhode Island Department of Health.
8.“End-user” means that person or persons using the water for consumption or other purposes requiring potable water.
9.“Exceedance” means a concentration of a constituent that is greater than a standard or recommended upper limit (e.g., MCL) for that constituent.
10.“First draw” means a one-liter sample of tap water, collected from a cold-water source. Water for each sample shall have stood motionless in the plumbing system for at least six (6) hours and shall be collected without flushing the tap.
11.“Global positioning system location” or “GPS location” means specific geographic locations as determined by satellite signals. GPS locations shall be reported in the appropriate coordinate system (RI State Plane Feet) or in Latitude/Longitude in decimal degrees.
12.“Health advisory level” or “HA” means that level recognized by the state for which corrective action should be performed.
13.“Individual private water supply system” means a system that supplies a single or duplex residential unit.
14."Interpreter” means an individual who has the education/experience necessary to interpret results of water quality analyses and is licensed to do so by the State of Rhode Island.
15.“Maximum contaminant level” or “MCL” means the maximum level allowable for a specific drinking water constituent.
16.“Multi-family residential systems” means systems that supply three (3) or more units.
17.“Non-potable” means a determination made through analysis that constituents that pose a health risk are present in levels exceeding existing standards.
18.“Notification” means the formal communication between the Department and the local public water supply agency and chief executive officer of the community if a private well shows contamination that threatens the local public water supply.
19.“Parameter”, as used herein, includes, but is not limited to, a constituent, contaminant, substance, organic chemical, metal, analyte, attribute, or other measurable physical property that can be analyzed for in drinking water.
20.“Person” means an individual, partnership, association, corporation, or any other legal entity or group of individuals who has/have decision-making responsibilities for one (1) or more end-users.
21.“pH” means a measurement of the acidity (hydrogen ion concentration) in water. Measurement ranges from 0 (acidic) – 14 (basic) with 7 being neutral.
22.“Point-of-entry treatment” means water treatment that serves the entire house by treating water and reducing contaminants as it enters the structure.
23.“Point-of-use treatment” means water treatment that serves only a single tap and reduces contaminants at the discharge point only.
24.“Potable” means fit or suitable to drink.
25.“Potability” means the determination that water is potable and is safe for consumption.
26.“Private-drinking-water system” means a system that extracts groundwater from a well or well field (wells on one (1) or more properties), provides potable water for human consumption, and does not meet the requirements to be classified as a public water system. These systems also include commercial – mixed use, multi-family residential, single/duplex residential, and individual private systems.
27.“Private well” means a water well that can serve as a private drinking water system.
28.“Private well field” means a collection of private wells that serve a private drinking water system.
29.“Private well water testing report form” means a standardized form for the reporting of certified laboratory results to be disseminated to the well owner or client to determine if the water is potable.
30.“Public notification” means a general notice relayed by the appropriate agency reporting well test detections of constituents (that could increase health risks to adjoining neighboring real estate owners) and recommending cautionary testing for parameters of concern.
31.“Public water system” means a system for the provision to the public of water for human consumption through pipes or constructed conveyances; if such a system has at least fifteen (15) service connections or regularly serves at least twenty-five (25) individuals daily at least sixty (60) days out of the year.
32.“Recommended limit” means the optimal range of upper and/or lower limits for various constituents, such as pH, Iron, or Manganese.
33.“Residence” means the location where a person is a domestic end-user of the water prior to entering the wastewater flow system.
34.“Residential building” means a structure consisting of one (1) or more residences that has an existing certificate of occupancy, but shall not include any structure newly constructed that is awaiting a certificate of occupancy.
35.“Sampler” means an individual who has education/experience necessary to acquire drinking water samples for laboratory analysis by following appropriate methods that may be found in New England States’ Common Sample Collection & Preservation Manual for Drinking Water.
36.“Secondary maximum contamination level” or “SMCL” means the acceptable level allowable for aesthetic purposes.
37.“Service connection” means the point in a water distribution system where water is diverted from a communal flow line to a specific end user or residential unit. Service connections may or may not be metered.
38.“Shared well” means a common well or well field that provides drinking water to more than one (1) residential unit, commercial enterprise, or any combination thereof.
39.“Single/duplex residential rental system” means a private system that serves a single or duplex residential rental property.
40.“Standard” means a water quality standard as defined herein.
41.“Transfer” means a change in property title resulting in a change in the end consumers of the water. It does not include foreclosures or modification of property titles as a result of divorce or other situation where the same parties will continue to have use of the water for consumption.
42.“Water quality standard or drinking water standard” means a standard that applies to a constituent required for testing pursuant to these rules and regulations.
43.“Wastewater flow system” means the system of collection, treatment, and discharge of water post end-user.
44.“Water well” means any hole or excavation that is constructed for the purpose of removal of water using standards set forth in R.I. Gen. Laws Chapter 46-13.2.
45.“Water-well permit” means written approval given by the local building official to permit the construction of a drinking water well at a given location for testing as a potable source of water, to replace an existing source, or prior to issuing a building permit for new construction.
46.“Well record” means the required submission of detailed information on the construction and hydro-geologic settings and properties of a new or improved well to the Rhode Island Department of Environmental Management (RIDEM), in accordance with R.I. Gen. Laws Chapter 46-13.2.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.3** Coverage {#sec-216-ricr-50-05-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.3}
These regulations apply to any and all water-well systems that do not meet the definition of public water supply as defined by the "Rules and Regulations Pertaining to Public Drinking Water" and that supply water for human consumption.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.4** Private Water System Classifications {#sec-216-ricr-50-05-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.4}
A.Commercial/Mixed Use Private Water Systems. Commercial/mixed use private water systems include, but are not limited to, small multi-unit commercial spaces or mixed-use (commercial/residential) buildings. This type of system provides potable water to tenants as part of some form of rental or lease agreement entered into by the owner of the system as part of a commercial enterprise.
B.Multi-Family Residential /Shared Well Private Water System. Multi-family residential/shared well private water system designed to supply multiple residential units with potable water. These systems may include but are not limited to; small apartment buildings or multiple houses/condos on a shared well or private well field.
C.Single/Duplex Residential Rental Private Water System. This type of system is designed to supply one or two tenants of record with potable water for consumption and use. The residential units (up to 2) associated with this type of system are not owner occupied.
D.Individual Private Water Systems. This type of system is designed to supply an owner(s) and/or one tenant of record with potable water for consumption and use.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.5** Classifications and Qualifications for Private Water System Professionals {#sec-216-ricr-50-05-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.5}
A.General Information
1.These regulations recognize three classifications of private-drinking water system professionals. They are:
a.Water Samplers;
b.Analytical Laboratories; and
c.Interpreters.
2.Each classification of professional shall possess the training, education, and experience as needed to either properly collect representative samples, analyze samples using accepted and appropriate methodologies, or to interpret results, form opinions, and to report conclusions using professional judgment based on existing standards. Specific qualifications and requirements are as follows.
B.Water Samplers
1.Individuals responsible for acquiring samples for analysis need to properly prepare sampling ports, determine appropriate containers and preservatives, and draw and assure proper sample handling based on analyses requested.
2.Samplers shall at a minimum, have or obtained the following qualifications:
a.Be eighteen (18) years of age or older;
b.Be of good moral character; and
(1)A high school diploma/GED, successful completion of a technical sampling course and six (6) months’ work experience performing water quality fieldwork; or
(2)An associate’s (or higher) degree in physical science or technical field, successful completion of a technical sampling course; or
(3)State certification as a Public Water Supply Treatment or Transmission and Distribution Operator under the "Rules and Regulations for Certification of Public Drinking Water Supply Treatment and Public Water Supply Transmission and Distribution Operators"; or
(4)Be employed, trained, and experienced in potable water sampling by an analytical lab certified by the Department to perform potability analysis in accordance with the "Rules and Regulations for Certifying Analytical Laboratories"; or
(5)Federal or State regulatory agencies will self-certify employees who perform sampling as a requirement of their job.
C.Analytical Laboratories
1.Only laboratories certified by the Department, in accordance with the "Rules and Regulations for Certifying Analytical Laboratories" shall be qualified to test private well samples for potability.
a.Laboratories shall possess analyte and method specific certificates for each category for which the laboratory is certified, as stated in R.I. Gen. Laws § 23-16.2-4.1.
b.In accordance with R.I. Gen. Laws § 23-16.2-13, it shall be unlawful for any analytical laboratory to perform testing or analyses of samples originating in this state, for which the Department requires certification, without having a certificate issued by the Department.
D.Interpreters
1.Interpreters shall possess sufficient training, education and experience needed to form opinions and draw conclusions using professional judgment. These opinions and conclusions shall be used to assist the property owner/buyer or building official to ensure that there is a feasible source of potable water available. In addition, the working knowledge of the interpreter will provide guidance on what actions, if any, are needed to treat or modify the water’s chemical composition through the installation of either a Point-of-Entry or Point-of-Use treatment system. An interpreter shall have a combination of education and related experience as indicated below:
a.Be a Registered professional engineer licensed to practice in the State of Rhode Island; or
b.Be an environmental scientist/hydrogeologist holding a “Professional” category membership in the American Institute of Hydrology and/or the American Institute of Professional Geologists; or
c.Have a Bachelor’s degree (or higher) in physical/earth science, or related field, with three (3) years’ experience performing interpretation of water quality data as they apply to set standards or similar activities; or
d.Associate’s degree in physical/earth science or engineering field and five (5) years related experience.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.6** General Licensing Requirements {#sec-216-ricr-50-05-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.6}
A.The Department currently certifies analytical laboratories in accordance with the "Rules and Regulations for Certifying Analytical Laboratories". Therefore, the following licensing requirements shall only apply to the water sampler and interpreter classifications. Government regulatory agencies can elect to self-certify government employees in the water-sampler classification for the purpose of performing work related duties. The Department retains the right to review, approve, or reject these certifications at any time.
B.No person shall act as a sampler or interpreter unless he or she is the holder of an appropriate and current license issued in accordance with the statutory provisions of the Act and the rules and regulations herein or is employed by a Department recognized self-certifying agency.
C.If disqualifying information, as presented in § 2.8 of this Part, is found with respect to any person applying for licensure as a sampler or interpreter, then the Department shall make a judgment regarding licensure of that person.
D.Application for licensure as a sampler or interpreter in this state shall be made on the forms provided by the Department. Such applications shall be accompanied by the following documents:
1.Proof of Right to Work:
a.for U.S. born applicants, a certified or notarized copy of birth certificate;
b.for foreign-born applicants, proof of lawful entry into the country and eligibility for employment in the United States.
2.Good moral character: indicated by signing the application affidavit statement.
3.Non-conflict of Interest: Signed statement on application.
4.Supporting evidence of education and training requirements in accordance with the classification sought as per § 2.5 of this Part: such documentation must be sent directly from the school or training program to the Department, in addition;
a.One (1) unmounted recent photograph of the applicant (head and shoulder frontal view) approximately 2x3 inches in size, with a legal signature in blue ink on the reverse side;
b.Such other information as the Department may deem necessary.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.7** General Licensing Information {#sec-216-ricr-50-05-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.7}
A.The Director shall issue to applicants who have satisfactorily met the licensing requirements herein, a license to act as a sampler or interpreter in this state.
B.Sampler or interpreter licenses, unless sooner suspended or revoked, shall be valid for a period of five (5) years and shall expire on of the fifth year from the date of issuance thereafter.
C.Every person licensed who wishes to renew his or her license shall file a completed renewal application with the Department.
D.Any person who allows his or her certification to lapse by failing to renew it within thirty (30) days of the anniversary date may be reinstated by the Director upon submission of an application, unless the license has been suspended or revoked.
E.Any person using the titles of “licensed sampler” or “licensed interpreter” or functioning as either during the time that his or her license has lapsed or been suspended or revoked shall be subject to the penalties for violation of the statutory and regulatory provisions of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.8** Grounds for Denial, Revocation or Suspension of Licenses {#sec-216-ricr-50-05-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.8}
A.The Department may suspend, revoke, or refuse to renew the license of a Sampler or Interpreter for cause, including but not limited to:
1.Failure to maintain compliance with the above qualifications;
2.Repeated or intentional violations (such as falsification of samples or data) of the Act or this Part; or
3.Conviction (including but not limited to a plea of nolo contendere) of a felony.
B.The Department may deny issuance of a license, suspend, revoke, or refuse to renew any license issued under the provisions of the Act and this Part, or may reprimand, censure or otherwise discipline, or place an interpreter/sampler on probation, upon decision and after hearing and upon proof that the licensee engaged in unprofessional conduct which includes but is not limited to:
1.Has become unfit or incompetent by reason of negligence, habits, or other causes such as physical and mental impairment that would interfere with proper performance of duties;
2.Has engaged in fraud or deceit in the practice of sampling private well water or interpretation of private well water analytical results or in his or her admission to such practice;
3.Has been convicted in a court of competent jurisdiction, either within or without this state, of a felony;
4.Misconduct in professional practice;
C.If a sampler/interpreter is placed on probation, the Department may require the licensee to:
1.Report regularly to the Department on matters that are the basis of the probation;
2.Limit practice to the areas prescribed by the Department; or
3.Complete a prescribed program of continuing professional education until the licensee attains a degree of skill satisfactory to the Department in those areas that are the basis of the probation.
D.All hearings and reviews as may be required herein shall be conducted in accordance with the provisions of § 2.10 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.9** Violations and Penalties {#sec-216-ricr-50-05-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.9}
Any violations as set forth in § 2.8 of this Part shall be cause for the Department to impose such sanctions, denial, revocation or suspension of licensure or imposing a reprimand or censure or such other disciplinary action.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.10** Rules Governing Practices and Procedures {#sec-216-ricr-50-05-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.10}
All hearings and reviews required under the provisions of R.I. Gen. Laws § 23-1-5.3 shall be held in accordance with the provisions of the Act and the "Rules and Regulations Pertaining to Practices and Procedures Before the Rhode Island Department of Health" and "Rules and Regulations Pertaining to Access to Public Records of the Rhode Island Department of Health".
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.11** Adoption of Drinking Water Quality Standards for Private Wells {#sec-216-ricr-50-05-2-2.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.11}
A.To be consistent in protecting public health, analytical methodologies and water quality standards from the "Rules and Regulations Pertaining to Public Drinking Water" shall be adopted for use among private-drinking water systems to determine potability or non-potability of water.
B.The constituents and corresponding limits presented in the "Rules and Regulations Pertaining to Public Drinking Water" will serve as the levels for determining exceedances of MCLs, SMCLs, and HAs for specific constituents listed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.12** Mandatory Testing Requirements for Private Water Supplies {#sec-216-ricr-50-05-2-2.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.12}
2.12.1Applicability
A.All wells that will be used for potable water supply shall be tested:
1.Before a certificate of occupancy may be granted for the building(s) it is intended to serve, whether new or previously occupied; and
2.Prior to the sale or transfer (as defined herein) of ownership of real property.
3.Whenever a new well or well field is installed that would serve as a new source to an existing building(s).
B.All wells subject to submission of a well record or local well permit shall be required to be tested as described in this section.
2.12.2Minimum Testing Requirements
At a minimum, all private wells subject to these regulations shall be required to test for those constituents presented in Table 1 of § 2.12.2 of this Part. Local building officials may add additional constituents based on their knowledge of local conditions or issues.
TABLE 1 – Minimum Constituents and Testing Requirements
Constituents. The minimal list of constituents needed for testing.
Testing Requirements (see guidance for testing frequency recommendations)
Alkalinity (as CaCO3)
For certificate of occupancy (new well for new or existing building) or transfer of real property
Total Coliform & Fecal or Escherichia Coliform
Hardness (as CaCO3)
Chloride
Fluoride
Iron
Lead
Manganese
Nitrate/Nitrite
pH
Specific Conductance
Sulfate
Total Dissolved Solids
Turbidity
Volatile Organic Compounds (VOCs). At a minimum, VOC testing must include the regulated VOCs listed in the "Rules and Regulations Pertaining to Public Drinking Water."
MTBE. No MCL available, Rhode Island State Health Advisory level at 40 ppb.
2.12.3New Private Water Systems
A.Prior to being placed into service, the local building official shall classify all new private water systems or existing systems with new sources as commercial/mixed use, multi-family residential, single/duplex residential rental, or individual, as described in § 2.4 of this Part. This classification shall be used to determine recommended guidance on testing and reporting for systems by type.
B.All required testing shall be performed on the well water in preparation for issuance of Certificate of Occupancy. However, Communities (building officials) or well drilling regulations may require preliminary screening tests to be completed prior to issuance of a building permit or initiation of construction.
C.All required testing shall be performed after all plumbing and water-using appliances are in place and the system has been properly disinfected. The sampling point for this sample shall be an interior faucet that yields untreated (raw) well water. Any and all drinking water quality treatment systems in-place shall be identified and noted.
D.All water samples for lead analyses shall be acquired as “first draw” samples from the cold-water tap. Bubblers or drinking fountains shall not be satisfactory sampling points. Any and all treatment systems in-place shall be identified and noted.
2.12.4Transfer of Existing Private Water Systems
A.In conjunction with R.I. Gen. Laws § 5-20.8-12, during the transfer or sale of any real property, served by a well(s) or which has a well(s) capable of being placed into service as a drinking water source, the well water shall be tested for, at a minimum, those constituents contained in Table 1 of § 2.12.2 of this Part and any other constituents detected during previous testing.
B.All water samples for lead analyses shall be acquired as “first draw” samples from the cold-water tap. Bubblers or drinking fountains shall not be satisfactory sampling points. Any and all treatment systems in-place shall be identified and noted.
C.Licensed interpreters shall interpret analytical results for compliance with adopted standards as stated within. Licensed interpreters shall submit letter reports containing their findings to their clients and the existing owners/designees.
D.The existing owner/designee shall make available for review to potential buyers/transferees, any and all letter reports and supporting data in owner/designee’s possession that relate to the water quality of the property in question, for the prior ten (10) years.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.13** Data Reporting {#sec-216-ricr-50-05-2-2.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.13}
A.Interpreters licensed to review and report on private well water results shall be required to submit to the Department, reports of all detections (directly or via a certified laboratory) on all mandatory testing (as defined in § 2.11 of this Part). These reports are required for inclusion of data into the private well module of the Department’s database. (Initial submissions will be copies of reports sent to private well customers while the electronic data transmission interface is being developed).
B.All reports shall be submitted within fifteen (15) days of completion of analysis and will include:
1.An accurate and complete street address;
2.Plat, Block, and Lot for the property on which the well is located, and GPS coordinates for the well itself;
3.As well as complete analytical results for constituents in Table 1 of § 2.12.2 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.14** Reporting Terms, Responses, and Notification Requirements {#sec-216-ricr-50-05-2-2.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.14}
A.The reporting terms presented in Table 2 of § 2.14(A) of this Part are intended to provide clear, effective, and consistent communication between water quality professionals and system owners. Analytical laboratories may consider the use of these reporting terms as an additional option (beyond reporting numerical values). The reporting terms reflect a comparison of the detected levels to the existing limits for a given constituent. The constituent detected, level of detection, and corresponding reporting terms shall be used to determine the appropriate response. Reporting terms and recommended responses for all constituents shall be as follows:
TABLE 2 – REPORTING TERMS AND RESPONSES
Level of Detection (with respect to MCL or HA)
Reporting Terms
Response. Any obvious change in water quality shall dictate consultation and retesting.
Detect up to 50% MCL or HA
Present
Note presence – monitor on regular schedule
>50% up to MCL or HA
Action Level
Monitor with more frequent testing (perhaps ½ suggested testing interval) – consider remediation or treatment options
> MCL or HA but < 10x
Elevated
Minimize ingestion and use bottled water. Water may still be used for other household purposes. Continued use may be dependent on the nature of the constituent. Retest immediately and seek remediation or treatment.
> Or = 10 x MCL or HA
Extremely Elevated
Discontinue use for all purposes
For SMCLs
Exceedance
Treatment is recommended not required
B.When the analytical result for a constituent is reported as “Present” with respect to MCLs and HAs as described in this section, the licensed interpreter shall:
1.Notify Department via a copy of the analytical report or by electronic data submission within fifteen (15) days of completion of analysis.
2.Notify the system owner of the constituent(s) present and what, if any appropriate response is needed.
C.When the analytical result for a constituent is reported as an “Action Level” or as “Elevated” with respect to MCLs and HAs as described in this section, the licensed interpreter shall:
1.Notify the Department,
2.Notify the system owner of the constituent(s) present and the appropriate response suggested or needed.
D.When the analytical result for a primary constituent is reported as “Extremely Elevated” with respect to MCLs and HAs as described in this section, the interpreter shall:
1.Immediately notify the Department,
2.Immediately notify the system owner of the constituent(s) and level(s) present and appropriate responses needed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
##### **216-RICR-50-05-2 § 2.15** Corrective Actions {#sec-216-ricr-50-05-2-2.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-2#2.15}
A.Licensed interpreters, and/or Local Building Officials shall determine appropriate corrective actions based on the reported level(s) of the constituents in the untreated water from a private water system. Additional testing may be required to evaluate whether a proposed treatment system is the most effective means to remove a constituent that is potentially hazardous to health.
B.Corrective actions are categorized as follows:
1.Immediate corrective actions shall be used upon the discovery of well water that is at the elevated or extremely elevated levels. These levels shall require minimizing or eliminating consumptive use and ingestion of the water. Immediate corrective actions shall include, but are not limited to: the use of bottled water or water from a different potable source for consumptive purposes and may require the discontinued use of the contaminated well water for other household purposes.
2.Short-term corrective actions shall be instituted in conjunction with immediate corrective actions associated with the highly elevated or hazardous levels, in order to provide a potable supply of water. Short-term corrective actions shall be an interim step while long-term corrective actions are considered. Short-term corrective actions may include, but are not limited to use of bottled water, installation of a point-of use or point-of entry treatment system.
3.Long-term corrective actions shall be instituted after a study of the source and nature of the constituent(s) present has been completed. Long-term corrective action options include: acquiring a new source, installation of a point-of use or point-of entry treatment system, or connection to public water supply.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-19 to 01/04/2022*
- *Adoption — effective from 2008-07-22 to 04/19/2018*
#### **216-RICR-50-05-4** Licensing Aquatic Venues
##### **216-RICR-50-05-4 § 4.1** Authority and Purpose {#sec-216-ricr-50-05-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.1}
4.1.1Authority
These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-22-2, for the purpose of adopting minimum safety standards for Aquatic Venues.
4.1.2Scope
These Regulations apply as defined in R.I. Gen. Laws § 23-22-1.
4.1.3Incorporation by Reference
A.These Regulations hereby adopt and incorporate the U.S. Department of Health and Human Services Centers for Disease Control and Prevention’s “2018 Model Aquatic Health Code” (July 2018) § 4.0, Facility Design and Construction Standards, by reference, and those sections of the Model Aquatic Health Code cross-referenced therein, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the American Public Health Association/American Water Association/Water Environmental Federation’s “Standard Methods for the Examination of Water and Wastewater, 23rd Edition” (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the NSF International Standard/American National Standard’s “NSF/ANSI 50 – 2016a, Equipment for Swimming Pools, Spas, Hot Tubs and Other Recreational Water Facilities” (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
##### **216-RICR-50-05-4 § 4.2** Definitions {#sec-216-ricr-50-05-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.2}
A.The following definitions shall apply in the interpretation and application of this Part:
1.“Americans with Disabilities Act” or “ADA” means the Americans with Disabilities Act of 1990 and subsequent amendments thereto.
2.“Authority having jurisdiction” or “AHJ” is synonymous with “Licensing Agency.”
3.“Applicant” means an individual or business entity with the legal authority to apply for licensure of an Aquatic Venue.
4.“Aquatic facility” is comprised of one (1) or more Aquatic Venues.
5.“Aquatic venue” means a traditional swimming pool, non-traditional pool, wading pool, therapeutic pool, hot tub or spa.
6.“Barrier” means an obstacle intended to prevent direct access from one (1) point to another.
7.“Cleansing shower” means a shower, located within a hygiene facility, using warm water and soap. The purpose of a cleansing shower is to remove contaminants including perianal fecal material, sweat, skin cells, personal care products, and dirt before bathers enter the Aquatic Venue.
8."Director" means the Director of the Rhode Island Department of Health or his or her designee.
9.“Enclosure” means an uninterrupted constructed feature or obstacle used to surround and secure an area that is intended to deter or effectively prevent unpermitted, uncontrolled, and unfettered access.
10.“Hygiene facility” means a structure or part of a structure that contains toilet, shower, diaper-changing unit, hand wash station, and dressing capabilities serving bathers and patrons at an aquatic facility.
11.“Hygiene fixtures” means all components necessary for hygiene facilities including plumbing fixtures, diaper-changing stations, hand wash stations, trashcans, soap dispensers, paper towel dispensers or hand dryers, and toilet paper dispensers.
12.“Imminent health hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries and the nature, severity, and duration of the anticipated injury or illness.
13.“Increased risk aquatic venue” means an aquatic venue which due to its intrinsic characteristics and intended users has a greater likelihood of affecting the health of the bathers of that venue by being at increased risk for microbial contamination (e.g., by children less than five (5) years old) or being used by people that may be more susceptible to infection (e.g., therapy patients with open wounds).
14.“Infinity edge” means a pool wall structure and adjacent perimeter deck that is designed in such a way where the top of the pool wall and adjacent deck are not visible from certain vantage points in the pool or from the opposite side of the pool. Water from the pool flows over the edge and is captured and treated for reuse through the normal pool filtration system. They are also referred to as “vanishing edges,” “negative edges,” or “zero edges.”
15.“In-kind replacement” means replacement equipment identical to that which was originally approved by the Licensing Agency when the Aquatic Facility or Aquatic Venue was constructed or during a subsequent alteration.
16.“Licensee” means any person who holds a license issued by the Licensing Agency pursuant to these Regulations and applicable statutes.
17."Licensing agency" means the Rhode Island Department of Health.
18.“Like-kind replacement” is synonymous with “in-kind replacement.”
19.“Model Aquatic Health Code” or “MAHC” means the 2016 Model Aquatic Health Code, 2nd Edition (July 2016), U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
20.“Non-substantial alteration” means the alteration, modification, or renovation of an Aquatic Venue where the total cost of the work is ten percent (10%) or less than the replacement cost of the Aquatic Venue and does not result in a change in water treatment or hydraulics.
21.“Operator” means Licensee or the Licensee’s designee responsible for the operation and maintenance of the water and air quality systems and the associated infrastructure of the Aquatic Facility or Aquatic Venue.
22.“Oocyst” means the thick-walled, environmentally resistant structure released in the feces of infected animals that serves to transfer the infectious stages of sporozoan parasites (e.g., Cryptosporidium) to new hosts.
23."Person" includes any partnership, association, corporation, city or town.
24.“Potable water source” means a Public Water System licensed by the Rhode Island Department of Health.
25.“ppm” means parts per million.
26.“Professional engineer” means an individual who is licensed as a professional engineer by the Rhode Island Board of Registration for Professional Engineers.
27.“Public water system” means water systems including licensed community water systems, non-transient/non-community water systems, or transient non-community water systems, as licensed by the Rhode Island Department of Health.
28.“Recirculation system” means the combination of the main drains, gutter or skimmer system, inlets, piping, pumps, controls, surge tank, balance tank and components that provide water recirculation to and from the Aquatic Venue and the treatment system.
29.“Rinse shower” means a shower typically located in the pool deck area with ambient temperature water.
30.“Secondary disinfection systems” means those disinfection processes or systems that are required for Increased Risk Aquatic Venues and are used in addition to disinfection systems that impart either a chlorine or bromine disinfectant residual.
31.“Substantial alteration” means the alteration, modification, or renovation of an Aquatic Venue where the total cost of the work exceeds ten percent (10%) of the replacement cost of the Aquatic Venue or results in a change in water treatment or hydraulics.
32.“Supplemental treatment systems” means those disinfection processes or systems that are not required for an Aquatic Venue for health and safety reasons. If approved by the Licensing Agency, they may be used to enhance overall system performance and improve water quality.
33."Swimming pool" as broadly defined in R.I. Gen. Laws § 23-22-1, includes the following sub-classifications:
a.“Traditional swimming pool" means a watertight structure of concrete, masonry, or other approved materials located either indoors or outdoors, used for bathing or swimming and filled with a filtered and disinfected water supply, together with buildings, appurtenances and equipment used in connection therewith, excluding "water slides" and/or "recreational water parks."
b.“Non-traditional pool” means a watertight structure of concrete, masonry, or other approved materials located either indoors or outdoors, filled with a filtered and disinfected water supply and allowing for total or partial bather immersion, together with buildings, appurtenances and equipment used in connection therewith. Non-traditional pools include lazy rivers, landing pools, wave pools, surf pools, and other special purpose pools holding a filtered and disinfected water supply for total or partial bather immersion.
c.“Hot tub” is synonymous with “Spa.”
d."Spa" means any watertight structure having a maximum depth of forty-eight inches (48”) (1.2 meters), filled with a filtered and disinfected water supply, either mineral or nonmineral in nature, utilizing hot, cold or ambient temperature water that is not emptied after each individual use, used in conjunction with high velocity water recirculation systems, together with buildings, appurtenances and equipment used in connection therewith.
e."Therapeutic pool" is synonymous with "Spa."
f."Wading pool" means a watertight structure of concrete, masonry, or other approved materials located either indoors or outdoors, used for bathing or swimming, filled with a filtered and disinfected water supply, which includes a range in water depth from two feet (2’) down to zero (0) for wading, together with buildings, appurtenances and equipment used in connection therewith.
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
##### **216-RICR-50-05-4 § 4.3** Licensure, Lifeguards and Inspections {#sec-216-ricr-50-05-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.3}
4.3.1Requirement to Obtain Licensure
No person acting severally or jointly with any other shall operate or maintain an Aquatic Venue without a license unless exempt under R.I. Gen. Laws Chapter 23-22.
4.3.2Period of Licensure
Periods of licensure for Aquatic Venues shall be determined in accordance with R.I. Gen. Laws § 23-22-6(a).
4.3.3Posting Requirements
A.A license issued in accordance with this Part shall be posted in a conspicuous place on the premises where it is visible by individuals who use the Aquatic Venue.
B.If an active license becomes defaced or is physically destroyed while still in effect, the Licensee shall apply for a duplicate license in accordance with the requirements of R.I. Gen. Laws § 23-22-10 and for the fee assessed in the Rules and Regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The Licensee shall display the duplicate license in accordance with § 4.3.3(A) of this Part.
C.Suspended and revoked licenses must be removed from display in accordance with R.I. Gen. Laws § 23-22-10.
4.3.4Application for New License
A.An application for a license to operate or maintain a newly constructed Aquatic Venue, or an application for a new license to operate or maintain an existing Aquatic Venue following a change of ownership, shall be submitted to the Licensing Agency on forms obtained from the Licensing Agency. The application form shall contain such information as the Licensing Agency reasonably requires and shall be accompanied by the licensure fee set forth in the Rules and Regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.The Licensing Agency’s granting of such license shall be in accordance with R.I. Gen. Laws § 23-22-7.
4.3.5License Renewal
A license may be renewed from year to year with approval by the Licensing Agency upon receipt of the license renewal fee set forth in the Rules and Regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
4.3.6Licenses for Existing Unlicensed Aquatic Venues
A.A license for an existing unlicensed Aquatic Venue subject to licensure under R.I. Gen. Laws Chapter 23-22 shall be granted if the Applicant demonstrates to the Licensing Agency’s satisfaction that the Aquatic Venue meets the requirements set forth in R.I. Gen. Laws Chapter 23-22 and this Part, or if the Applicant demonstrates to the Licensing Agency’s satisfaction that a variance to a regulatory requirement does not create a violation of Federal or State law and does not create a condition that presents an imminent health hazard.
B.Applicants for licensure shall follow the procedure set forth in § 4.3.4 of this Part.
4.3.7Denial of License
License applications are subject to denial in accordance with R.I. Gen. Laws § 23-22-7.
4.3.8Suspension and Revocation of License
Licenses are subject to suspension and revocation in accordance with R.I. Gen. Laws § 23-22-8.
4.3.9Procedure for Denial, Suspension or Revocation of License
A.Whenever an action shall be proposed to deny, suspend or revoke the license of an Applicant and/or Licensee, the Licensing Agency shall notify the Applicant or Licensee, by certified mail or by hand delivery, setting forth the reasons for the proposed action. The Applicant or Licensee shall be provided opportunity for hearing in accordance with R.I. Gen. Laws Chapter 42-35 and § 4.7.4 of this Part.
B.If the Licensing Agency determines that conditions at an Aquatic Venue present an imminent health hazard that requires emergency action and incorporates a finding to that effect in its order, the Licensing Agency may order summary suspension of a license pending proceedings for revocation or other action.
C.Any of the following violations are imminent health hazards which shall require immediate correction or immediate pool closure:
1.Failure to provide adequate supervision and staffing of the Aquatic Facility as prescribed in this Part;
2.Failure to provide the minimum disinfectant residual levels or exceeding the maximum disinfectant residual levels listed in this Part;
3.Failure to maintain pH level within the appropriate range stated in this Part;
4.Failure to continuously operate the Aquatic Venue filtration and disinfection equipment;
5.Use of an unapproved or contaminated water supply source;
6.Unprotected overhead electrical wires within twenty feet (20’) horizontally of the Aquatic Venue;
7.Non GFCI protected electrical receptacles within twenty feet (20’) of the inside wall of the Aquatic Venue;
8.Failure to maintain an emergency lighting source;
9.Absence of all required lifesaving equipment on deck;
10.Aquatic Venue bottom not visible;
11.Total absence of or improper depth markings at an Aquatic Venue;
12.Plumbing cross-connections between the drinking water supply and Aquatic Venue water or between sewage system and the Aquatic Venue including filter backwash facilities;
13.Failure to provide and maintain an enclosure or barrier as described in this Part to inhibit unauthorized access to the Aquatic Facility or Aquatic Venue when required;
14.Use of unapproved chemicals or the application of chemicals by unapproved methods to the Aquatic Venue water;
15.Broken, unsecured, or missing main drain grate or any submerged suction outlet grate in the Aquatic Venue;
16.Number of bathers/patrons exceeds the theoretical peak occupancy;
17.Broken glass, sharp objects, vomit, fecal matter, or any other item determined to be a public health hazard by the AHJ in the Aquatic Venue or on the deck area; and
18.Failure to maintain the water quality standards for cyanuric acid.
4.3.10Virginia Graeme Baker Pool and Spa Safety Act
A.Licenses shall not be issued for new Aquatic Venues that fail to demonstrate compliance with the requirements of the Virginia Graeme Baker Pool and Spa Safety Act, 15 U.S.C. §§ 8001-8003.
B.Licenses shall be suspended per § 4.3.9(B) of this Part for licensed Aquatic Venues that fail to demonstrate compliance with the requirements of 15 U.S.C. §§ 8001-8003 until such time that the Licensee demonstrates to the Licensing Agency’s satisfaction that compliance has been achieved.
4.3.11Unapproved Substantial Alterations to Existing Licensed Aquatic Venues
Licenses for any Aquatic Venue with substantial alterations that have not received prior approval from the Licensing Agency may be suspended per § 4.3.9 of this Part until such time the Licensee demonstrates to the Licensing Agency’s satisfaction that such alterations comply with §§ 4.4, 4.5 and 4.6 of this Part.
4.3.12Lifeguards
A.Requirements for lifeguard oversight of Aquatic Venues are pursuant to R.I. Gen. Laws § 23-22-6(b).
B.Aquatic Venues that operate without lifeguards shall comply with the requirements of §§ 4.5.14(H), 4.5.14(I)(3), 4.5.14(J), 4.6.6(D) and 4.6.8(C) of this Part.
4.3.13Inspections and Water Quality Testing
A.The Licensing Agency shall be granted access in accordance with R.I. Gen. Laws 23-22-11.
B.Upon request of the Licensing Agency, Licensees shall complete an Aquatic Venue self-assessment inspection checklist provided by the Licensing Agency. Licensees shall return the checklist to the Licensing Agency within thirty (30) days of the date of the request. Failure to return the checklist shall result in a violation as set forth in § 4.7 of this Part.
4.3.14Incident Reporting
Licensees are required to report to the Licensing Agency, within twenty-four (24) hours or on the next business day, any drowning, near drowning, or any entrapment or potentially life-threatening injury that occurs at the Aquatic Facility. Failure to report an incident will be deemed a violation resulting in action under § 4.7 of this Part.
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
##### **216-RICR-50-05-4 § 4.4** Design Standards and Construction Requirements for New Aquatic Facilities and Aquatic Venues; for Substantial Alterations to Existing Aquatic Facilities and Aquatic Venues; for Non-Substantial Alterations to Existing Aquatic Facilities and Aquatic Venues; and for In-Kind Replacements {#sec-216-ricr-50-05-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.4}
A.All Aquatic Venues that require licensure under R.I. Gen. Laws Chapter 23-22 shall comply with the requirements set forth in §§ 4.1.3(A), (B) and (C) of this Part.
B.An applicant/licensee shall not construct or alter an aquatic venue or facility without first obtaining preliminary approval for construction or alteration of an aquatic venue or facility from the Licensing Agency.
C.The applicant/licensee must submit an application, on forms provided by the Licensing Agency, in order to obtain a preliminary approval for construction or alteration of an aquatic venue or facility.
D.Designs for construction of new aquatic facilities and venues, substantial alterations to existing aquatic facilities and aquatic venues, non-substantial alterations to existing aquatic facilities and aquatic venues, and for in-kind replacements shall be reviewed and approved by either:
1.The Licensing Agency; or
2.A Professional Engineer hired by the applicant/licensee at the applicant’s or licensee’s expense.
E.The Professional Engineer must provide the Licensing Agency with his or her answers to the itemized Aquatic Venue Design Compliance Form that demonstrates conformity with all applicable State and Federal laws and Regulations.
1.Applicants seeking to build a new aquatic venue must use the new aquatic venue design compliance form found on the Department’s website here: https://health.ri.gov/applications/AquaticVenueForm4.docx
2.Licensees seeking to modify the recirculation or treatment system of an existing aquatic venue or are seeking to modify an existing aquatic venue where the costs will exceed ten percent (10%) of the cost to construct a new venue must use the Substantial Alteration to Existing Aquatic Venue Design Compliance Form found on the Department’s website here: https://health.ri.gov/applications/SubstantialAlterationExistingAquaticVenueForm4.docx
3.Licensees seeking to modify an existing aquatic venue (excluding recirculation or treatment system modifications) where the costs represent ten percent (10%) or less than the cost to build a new venue, must use the Non-Substantial Alteration to Existing Aquatic Venue Compliance Form found on the Department’s website here: https://health.ri.gov/applications/NonSubstantialAlterationExistingAquaticVenueForm2.docx
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
##### **216-RICR-50-05-4 § 4.5** Supplemental Regulations for Facility Design and Construction Requirements for All Aquatic Facilities and Aquatic Venues {#sec-216-ricr-50-05-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.5}
4.5.1General
A.Model Aquatic Health Code references to “design professional who is registered or licensed to practice their respective design profession” shall mean a Professional Engineer with an active Rhode Island registration. (Restriction on MAHC § 4.0)
B.Recirculation of unfiltered and/or untreated water is prohibited. (Restriction on MAHC § 4.7.1.10.2.1)
C.Aquatic Venues with infinity edges shall satisfy the enclosure requirements of § 4.5.14 of this Part and shall provide for a permanent, fixed safety barrier not less than five feet (5’) in height at the infinity edge to protect against falls from the infinity edge. (Restriction on MAHC § 4.5.15)
D.Food and/or beverage concessions shall be permitted in designated area(s) within the Aquatic Facility provided that the concession structures, service area, seating, patron circulation and related activities are separated from the Aquatic Venue by a permanent, fixed barrier that does not encroach on the Aquatic Venue’s perimeter walkway. (Restriction on MAHC § 4.6.9.1)
E.The Applicant shall coordinate review with all other agencies from which the Applicant is required to obtain approval. The Applicant shall provide copies to the Licensing Agency of permits issued by other agencies if the Licensing Agency so requests. (Restriction on § MAHC 4.1.3.1.2)
F.The Applicant shall communicate Licensing Agency approvals to other agencies involved in the construction of an Aquatic Facility or Aquatic Venue. (Restriction on MAHC § 4.1.3.1.3)
G.In cases where the Aquatic Facility or Aquatic Venue is exempt from Americans with Disabilities Act standards, the owner shall provide written documentation to the Licensing Agency attesting to such exemption at the time of application for construction or substantial alteration to an Aquatic Facility or Aquatic Venue. (Restriction on MAHC § 4.5.10)
H.The Licensing Agency or a Professional Engineer hired by the Applicant or Licensee at the Applicant’s or Licensee’s expense, shall conduct a conformance inspection of newly constructed Aquatic Facilities and Aquatic Venues, and substantially altered Aquatic Facilities and Aquatic Venues, upon completion of construction or renovation.
1.If the Applicant or Licensee uses the Licensing Agency to conduct the conformance inspection, the Licensing Agency shall not issue a license to operate until the Applicant or Licensee has corrected, to the satisfaction of the Licensing Agency, all deficiencies identified during the inspection. (Restriction on MAHC § 4.1.5.3)
2.If the applicant or licensee uses a Professional Engineer for a conformance inspection, then the Professional Engineer conducting the conformance inspection must sign an attestation that the Aquatic Venue owner has constructed the Aquatic Venue in accordance with the Aquatic Venue Design Compliance Form, including all applicable State and Federal laws and Regulations. The Applicant or Licensee must correct, to the satisfaction of the Professional Engineer, all deficiencies identified during the inspection.
3.The Applicant or Licensee must submit an application, including the Professional Engineer’s attestation, on forms provided by the Licensing Agency, in order to obtain a license or approval of modification of a license.
4.5.2Skimmer Systems
A.Skimmer systems shall include a minimum of two (2) skimmers.
B.The piping and other pertinent components of a skimmer system shall be sized based on one hundred percent (100%) of recirculation flow being directed through the skimmer system at the maximum possible recirculation flow rate as determined by pump capacity and minimum total dynamic head of the recirculation system. (Restriction on MAHC § 4.7.1.5.1.4)
C.Each skimming device shall be equipped with an equalizer pipe located at least one foot (1’) below the lowest skimmer overflow level, or some other device to prevent air lock in the skimmer suction line. (Restriction on MAHC § 4.7.1.5)
4.5.3Overflow Gutters
A.Overflow gutters extending completely around a pool shall be provided on all pools having a water surface area of four thousand (4,000) square feet or more. (Restriction on MAHC § 4.7.1.5.1.5)
B.The gutter system shall be designed to allow continuous removal of water from the pool’s upper surface based on one hundred twenty-five percent (125%) of recirculation flow being directed through the gutter system at the maximum possible recirculation flow rate as determined by pump capacity and minimum total dynamic head of the recirculation system. (Restriction on MAHC § 4.7.1.4.2.1)
C.A gutter system shall provide an acceptable handhold for bathers and present no accident hazard to bathers. (Restriction on MAHC § 4.5.14.1)
4.5.4Access and Egress
There shall be at least one (1) means of access and egress located at the shallow end of a swimming pool and at least one (1) means of access and egress located at the deep end of a swimming pool. (Restriction on MAHC § 4.5.3.1)
4.5.5Lane Markings
The Applicant shall state the basis of design for lane markings and end wall targets, such as FINA, NCAA, USA Swimming, NFSHSA, or another recognized standard. (Restriction on MAHC § 4.2.1.4)
4.5.6Diving Area
Platforms and diving stands that are over three feet (3’) high shall be equipped with guard rails. (Restriction on MAHC § 4.8.2.2.3)
4.5.7Theoretical Peak Occupancy
Three hundred (300) square feet of pool water surface area shall be reserved around each diving board or platform. This area shall not be included in determining the bather load capacity. (Restriction on MAHC § 4.1.2.3.5.3)
4.5.8Electrical Requirements
All electrical wiring for Aquatic Venues shall comply with R.I. Gen. Laws Chapter 23-27.3.
4.5.9Heater Requirements
A.Water heaters shall have a seal of approval from a standards testing agency such as the American National Standards Institute (ANSI-Z-21.56) or the Underwriters Laboratory (UL 1261). (Restriction on MAHC § 4.6.4)
B.Electrically operated water heaters shall comply with § 4.5.8 of this Part. (Restriction on MAHC § 4.6.4)
C.Water heaters shall be equipped with a thermostatic control for the water temperature and shall be set at a temperature not to exceed one hundred four degrees Fahrenheit (104° F). (Restriction on MAHC § 4.6.4)
D.A fixed thermometer shall be installed on the discharge side of the heater. (Restriction on MAHC § 4.6.4)
4.5.10Pre-Coat Filters
A.Pressure pre-coat filters shall be equipped with a pre-coat pot for the purpose of introducing filter aid to form a pre-coat evenly over the filter elements when a filter is put into initial operation and after each cleaning. (Restriction on MAHC § 4.7.2.3)
B.The filter plant shall be provided with such pressure, vacuum, or compound gauges as are required to indicate the condition of the filter. An air relief valve shall be provided at the high point of a pressure pre-coat filter. (Restriction on MAHC § 4.7.2.3)
C.Vacuum pre-coat filter installations shall be equipped with an adjustable high vacuum automatic shutoff to prevent damage to the pump by cavitation. (Restriction on MAHC § 4.7.2.3)
4.5.11Vacuum Cleaning
An existing aquatic venue that has an integral vacuum system as described by MAHC § 4.8.7.3 of the Model Aquatic Health Code shall be required to make, upon determination by the Department in its sole discretion that such configuration is present, all alterations necessary to comply with MAHC § 4.8.7. (Restriction on MAHC § 4.8.7.3)
4.5.12Hygiene Facilities and Hygiene Features
A.The minimum number of lavatories and water closets provided for each sex shall be equal to no less than one (1) per sixty (60) bathers based on maximum bather load. (Restriction on MAHC § 4.10.1.4)
B.The minimum number of cleansing showers provided for each sex shall be equal to no less than one (1) per forty (40) bathers based on maximum bather load. (Restriction on MAHC § 4.10.1.4)
C.Urinals for male bathers may be substituted for up to one third (1/3) the number of water closets required where more than one (1) water closet is required. (Restriction on MAHC § 4.10.1.4)
D.The Licensing Agency may increase the number of required fixtures for Aquatic Facilities at schools or other locations where scheduling of facility use warrants special consideration. (Restriction on MAHC § 4.10.1.4)
4.5.13Depth Markers and Diving Restrictions
A minimum of one (1) water depth marker and one (1) no-diving marker is required for all wading pools. (Restriction on MAHC § 4.5.19.8)
4.5.14Enclosures and Barriers
A.The maximum vertical clearance between grade and the bottom of an outdoor Aquatic Venue enclosure shall be no greater than two inches (2”), measured on the exterior side of the enclosure. (Restriction on § MAHC 4.8.6.2)
B.Openings in the enclosure structure shall not allow passage of a four inch (4”) diameter sphere. (Restriction on MAHC § 4.8.6.2)
C.Solid enclosures that do not have openings, such as a masonry or stone walls, shall not contain indentations or protrusions except for normal construction tolerances and tooled masonry joints. (Restriction on MAHC § 4.8.6.2)
D.Where the enclosure is composed of horizontal and vertical members and the distance between the tops of the horizontal members is less than forty-five inches (45”), the horizontal members shall be located on the interior side of the enclosure. Spacing between vertical members shall not exceed one and three fourths inches (1 ¾”) in width. Where the enclosure is composed of horizontal and vertical members and the distance between the tops of the horizontal members is forty-five inches (45”) or more, the distance between the vertical members shall not exceed four inches (4”). Where there are decorative cutouts within vertical members, spacing within the cutouts shall not exceed one and three fourths inches (1 ¾”) in width. (Restriction on MAHC § 4.8.6.2)
E.Where the enclosure is composed of diagonal members, such as a lattice fence, the maximum opening formed by the diagonal members shall be no more than one and three fourths inches (1 ¾”). (Restriction on MAHC § 4.8.6.2)
F.Enclosures constructed with chain-link fencing shall have a maximum mesh opening of two and one fourth (2 ¼) square inches unless the enclosure is provided with slats fastened at the top or the bottom which reduce the openings to no more than one and three fourths (1 ¾) square inches. (Restriction on MAHC § 4.8.6.2.1.2)
G.The fence or screen enclosure shall be equipped with self-closing and self-latching gates. Release mechanisms for self-latching devices must be located no less than fifty-four inches (54”) from the bottom of the gate. (Restriction on MAHC § 4.8.6.3.7)
H.Enclosures for outdoor Aquatic Venues operating without lifeguards shall comply with R.I. Gen. Laws §§ 23-22-6(b)(1) and (4).
I.Where a wall of a building serves as part of an outdoor Aquatic Venue enclosure, direct access to the pool through the wall shall be limited to doors and windows that meet the following conditions.
1.Windows leading to the Aquatic Venue area shall have a latching device at least fifty-four inches (54”) above the floor. (Restriction on MAHC § 4.8.6.2.3)
2.Hinged Doors, sliding doors or sliding screen doors leading to the Aquatic Venue area shall be self-closing and shall have a self-latching device that meets the requirements of § 4.5.13(G) of this Part. (Restriction on MAHC § 4.8.6.3)
3.Doors leading to outdoor Aquatic Venues that operate without lifeguards shall meet the requirements of R.I. Gen. Laws § 23-22-6(b)(1). (Restriction on MAHC § 4.8.6.3)
J.Access to Indoor Aquatic Facilities operating without lifeguards shall comply with the requirements of R.I. Gen. Laws § 23-22-6(b).
K.Where a wading pool is adjacent to the deep-water area of another Aquatic Venue, a minimum four foot (4’) vertical barrier with a self-closing and self-latching gate shall be installed to separate the two (2) Aquatic Venues. (Restriction on MAHC § 4.12.9.2)
4.5.15Water Supply and Wastewater Design
A.The discharge end of a pipe delivering potable water to an Aquatic Venue shall provide an air gap equivalent to at least two (2) pipe diameters above the maximum elevation of the water in the Aquatic Venue. Piping from a potable water system shall not be physically connected to the recirculation system of an Aquatic Venue. (Restriction on MAHC § 4.11)
B.There shall be no direct physical connection between any part of an Aquatic Venue or its recirculation system and a sanitary sewer or subsurface sewage disposal system unless equipped with a backflow device approved by the Licensing Agency. (Restriction on MAHC § 4.11)
4.5.16Consumables
All consumable materials, including but not limited to filter cartridges, filter media and water treatment chemicals, shall be listed and labeled to the standards of NSF/ANSI 50 by an ANSI-accredited certification organization.
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
##### **216-RICR-50-05-4 § 4.6** Requirements for the Operation of Aquatic Facilities and Aquatic Venues {#sec-216-ricr-50-05-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.6}
4.6.1General Sanitation Requirements
A.Aquatic Facilities shall be maintained in good repair and working order, and in a clean and sanitary condition.
B.Aquatic Facilities shall be kept clear of debris and organic materials. Aquatic Venue water and surfaces shall be kept clear of slime and biofilm.
C.The floors of dressing, toilet, shower rooms and passageways shall be well drained and shall be treated daily with an EPA-approved fungicide.
D.Hot tubs, spas and therapeutic pools shall be drained, cleaned, scrubbed, and water replaced using a water replacement interval (in days) calculated by dividing the spa volume (in gallons) by three (3) and then dividing by the average number of users per day. The interval between cleanings shall not exceed thirty (30) days.
1.The AHJ shall have discretion in determining the viability of cleaning intervals calculated pursuant to § 4.6.1(D) of this Part.
E.Aquatic Venues constructed or substantially altered shall operate at the approved design flow rate twenty-four (24) hours per day, except as provided for in § 4.6.1(E)(2) of this Part.
1.All components of the filtration and recirculation systems shall be kept in continuous operation twenty-four (24) hours per day.
2.The system flowrate shall not be reduced more than twenty-five percent (25%) lower than the minimum design requirements and only reduced when the Aquatic Venue is unoccupied.
4.6.2Daily Water Quality Monitoring
A.Operators shall, on each operating day prior to opening an Aquatic Venue to bathers, and every two (2) or four (4) hours thereafter, based on the type of feed in accordance with §§ 4.6.2(A)(4) and (5) of this Part, while the Aquatic Venue is open to bathers, visually observe water clarity and collect and analyze water samples to verify that water quality is not detrimental to the health and safety of bathers. If any water quality parameter is not within the range listed in the appropriate table in §§ 4.6.2(B)(8), (9), (10) (11) or (12) of this Part, or water clarity does not meet the standards of § 4.6.2(C) of this Part, the Aquatic Venue shall close and remain closed until such time that the Licensing Agency determines the water quality meets all standards.
1.Aquatic venues who use chlorine-based disinfectant must test free available chlorine (FAC), combined available chlorine (CAC) and pH.
2.Aquatic venues who use bromine-based disinfectant must test total bromine (TB) and pH.
3.Aquatic venues who use both a chlorine-based and bromine-based disinfectant (e.g., bromochlorodimethylhydatoin (BCDMH)) must test CAC, FAC, TB and pH.
4.For all aquatic venues using a manual disinfectant feed system that delivers disinfectant via a flow through erosion feeder or metering pump without an automated controller, pH and either TB or FAC and CAC, as applicable, shall be tested prior to opening to bathers and every two (2) hours thereafter while open to bathers.
5.For all aquatic venues using an automated disinfectant feed system, pH and either TB or FAC and CAC, as applicable, shall be tested prior to opening and every four (4) hours thereafter while open to bathers.
B.Chemical Standards of the Aquatic Venue water:
1.An Aquatic Venue shall be continuously disinfected by a chlorinated or brominated agent which imparts a measurable residual.
2.Only chlorine or bromine products that are EPA-registered for use as sanitizers or disinfectants in Aquatic Venues in the United States are permitted.
3.Bromine-based disinfectants may be applied to Aquatic Venues through the addition of an organic bromine compound (1,3-Dibromo-5,5-dimethylhydantoin (DBDMH) or 1-bromo-3-chloro-5,5-dimethylhydantoin (BCDMH)).
4.Use of cyanuric acid or stabilized chlorine is prohibited for use in all indoor Aquatic Venues and in outdoor hot tubs, spas and therapeutic pools.
5.Testing equipment shall be capable of measuring the maximum and minimum chemical standards based on Aquatic Venue type and disinfectant. FAS-DPD titration test kits are considered acceptable in determining maximum and minimum disinfectant residuals. Reagents shall be replaced prior to their expiration date.
6.Chemicals other than those used for the proper maintenance of the Aquatic Venue water shall not be added to an Aquatic Venue without the written approval of the Licensing Agency. The Licensing Agency shall determine, in its sole discretion, if such chemicals will require more frequent water quality monitoring and/or monitoring for additional water quality parameters.
7.Acceptable water quality parameters for traditional swimming pools, non-traditional pools, and wading pools using a chlorine disinfectant are as follows:
Parameter
Minimum
Ideal
Maximum
Free chlorine residual (ppm) for indoor traditional swimming pools, indoor non-traditional pools, and indoor wading pools
1.0
2.0 – 4.0
10.0
Free chlorine residual (ppm) for outdoor traditional swimming pools, outdoor non-traditional pools, and outdoor wading pools not using cyanuric acid or stabilized chlorine
1.0
2.0 – 4.0
10.0
Free chlorine residual (ppm) for outdoor traditional swimming pools, outdoor non-traditional swimming pools, and outdoor wading pools using cyanuric acid or stabilized chlorine
2.0
2.0 – 8.0
10.0
Combined Chlorine (ppm)
0.0
0.0
0.2
pH
7.2
7.4 – 7.6
7.8
8.Acceptable water quality parameters for all hot tubs, spas and therapeutic pools using a chlorine disinfectant are as follows:
Minimum
Ideal
Maximum
Temperature (degrees Fahrenheit)
Personal preference
104
Free chlorine residual (ppm) for all hot tubs, spas and therapeutic pools
2.0
3.0 – 5.0
10.0
Combined chlorine (ppm)
0.0
0.0
0.2
pH
7.2
7.4 – 7.6
7.8
9.Water quality parameters for traditional swimming pools, non-traditional pools, and wading pools using a bromine disinfectant are as follows:
Minimum
Ideal
Maximum
Total Bromine Residual (ppm)
3.0
4.0 – 6.0
8.0
pH
7.2
7.4 – 7.6
7.8
10.Water quality parameters for all hot tubs and spas using bromine disinfectant are as follows:
Minimum
Ideal
Maximum
Temperature (degrees Fahrenheit)
Personal preference
104
Total bromine residual (ppm)
4.0
4.0 – 6.0
8.0
pH
7.2
7.4 – 7.6
7.8
11.Cyanuric acid levels shall not exceed twenty-five (25) ppm.
12.Secondary and supplemental disinfectants shall at no time exceed the following concentrations, and delivery systems shall satisfy the following requirements:
Maximum
Requirements
Residual ozone
0.1 ppm
Ozone systems shall be operated and maintained according to the manufacturer’s instructions to maintain the required design performance to achieve 3-log (99.9%) reduction in the number of infective cryptosporidium parvum oocysts per pass through the system.
All employees shall be properly trained in the operation and maintenance of the equipment.
Copper/Silver ions
1.3 ppm (copper)
0.10 ppm (silver)
Only those systems that are EPA-registered for use as sanitizers or disinfectants in aquatic venues in the United States are permitted.
Ultraviolet light
Not applicable
UV systems shall only operate while the recirculation system is operating.
UV sensors shall be calibrated at a frequency in accordance with manufacturer recommendations.
Secondary UV systems shall be operated and maintained not to exceed the maximum validated flow rate and meet or exceed the minimum validated output intensity needed to achieve the required dose for a 3-log (99.9%) reduction in the number of infective cryptosporidium parvum oocysts per pass through the secondary disinfection system.
C.At all times an Aquatic Venue is open to bathers the water shall be sufficiently clear such that a marker tile or floor suction outlets are visible while the water is static. In the absence of a marker tile or floor suction outlet, the Operator shall obtain approval from the Licensing Agency for an alternate method of determining water clarity.
D.Operators shall record the results of all daily water quality analyses, water clarity observations, routine maintenance, corrective actions and closures on forms provided by the Licensing Agency. These records shall be available to the Licensing Agency at the time of an inspection authorized under § 4.3.13 of this Part, and shall be submitted to the Licensing Agency electronically within twenty-four (24) hours of any written or telephone request from the Licensing Agency.
1.Operators shall maintain copies of all records required under § 4.6.2(D) of this Part for no less than one (1) year.
4.6.3Bacteriological Analysis of Water
A.Operators shall collect one (1) water sample every ninety (90) days from each year-round Aquatic Venue for heterotrophic plate count analysis by a laboratory certified for Method 9215B. Free chlorine residual, combined chlorine, and pH must be measured and recorded concurrent with sample collection.
B.Operators shall collect one (1) water sample from each seasonal Aquatic Venue in June and one (1) water sample from each seasonal Aquatic Venue in August for heterotrophic plate count analysis by a laboratory certified for Method 9215B. Free chlorine residual, combined chlorine, and pH must be measured and recorded concurrent with sample collection.
C.No water sample shall have a heterotrophic plate count density greater than two hundred colony forming units per milliliter (200 CFU/ml) as determined by the standard thirty-five degree Celsius (35° C) agar plate count.
D.The Licensing Agency may require, when water quality or laboratory analytical results so warrant, Licensees with hot tubs, spas and therapeutic pools to collect water samples for analysis for the Pseudomonas group by a laboratory certified for Method 9213E or IDEXX Pseudalert.
E.No water sample shall contain Pseudomonas aeruginosa at a density greater than less than one (< 1) organisms per one hundred (100) ml.
F.Samples collected for microbiological examination testing shall be collected in accordance with procedures set forth in § 4.1.3(B) of this Part.
G.The Operator shall close the effected Aquatic Venue immediately upon notification that the heterotrophic plate count for a water sample exceeds two hundred (200) CFU or when Pseudomonas aeruginosa are present in a water sample at a density greater than five (5) organisms per one hundred (100) ml. Operators shall notify the Licensing Agency of the analytical results and the closure, by telephone, within twenty-four (24) hours or on the next business day. The Aquatic Venue shall remain closed until such time the Operator has restored water quality and has provided evidence of such to the Licensing Agency.
H.Year-round Aquatic Venues shall submit laboratory analytical results that do not require reporting under § 4.6.3(G) of this Part to the Licensing Agency electronically by the tenth (10th) day of the month following the month in which the sample was collected (e.g. results for a sample collected in February must be received by the Licensing Agency by March 10).
I.Seasonal Aquatic Venues shall submit laboratory analytical results that do not require reporting under § 4.6.3(G) of this Part to the Licensing Agency electronically by the tenth (10th) day of the month following the month in which the samples were collected (e.g. results for a sample collected in June must be received by the Licensing Agency by August 10).
J.The Licensing Agency shall require that an Aquatic Venue conduct bacteriological sampling at an increased frequency in accordance with § 4.7.3 of this Part if the Aquatic Venue fails to maintain water quality in accordance with §§ 4.6.2(B), (C), or 4.6.3 of this Part.
K.Water quality sample results – including HPC, free chlorine, combined chlorine, and pH – shall be submitted electronically by the analyzing laboratory to the Licensing Agency in a manner compatible with the Licensing Agency’s computer system. The results shall be submitted on or before deadlines set forth in §§ 4.6.3(H) or (I) of this Part.
4.6.4General Safety Requirements
All entrances to an Aquatic Venue shall be secured with a locking device at all times during which the Aquatic Venue is closed to bathers.
4.6.5Chemical Storage
A.Chemical storage shall comply with local building and fire codes.
B.Chemical handling shall be conducted in a safe and appropriate manner.
C.Storage, handling and use of all chemicals shall comply with the applicable manufacturers’ safety data sheets and labels.
D.Chemical manufacturer’s safety data sheets shall be consulted for storage incompatibilities with other chemicals. Aquatic Venue chemicals shall be stored so that no mixing of incompatible materials would occur if the packages were to leak.
E.Aquatic Venue chemicals shall be stored to prevent access by unauthorized individuals.
F.Aquatic Venue chemicals shall be stored so that they are protected from getting wet.
G.Possible ignition sources, including but not limited to gasoline, diesel, natural gas, or gas-powered equipment such as lawn mowers, motors, grills, pool heaters, or portable stoves shall not be stored or installed in the chemical storage space.
H.Smoking shall be prohibited in the chemical storage space.
I.Lighting in the chemical storage space shall be sufficient to allow operators to read labels on containers throughout the chemical storage space.
J.Chemicals shall be stored away from direct sunlight, temperature extremes, and high humidity.
K.A single container of a chemical that has been opened and is currently in use in the equipment room may be kept in a staging area of the equipment room if the chemical(s) is protected from exposure to heat and moisture.
L.The chemical storage space shall be separate from the equipment room.
M.Warning signs shall be posted on chemical storage space doors.
N.Personal protective equipment shall be available as required on the chemical safety data sheets.
O.Containers of chemicals shall be labeled, tagged, or marked with the identity of the material and a statement of the hazardous effects of the chemical.
P.All Aquatic Venue chemical containers (e.g. day tanks) shall be labeled as to their contents.
4.6.6Aquatic Facility Policies and Signage
A.All licensees shall establish written policies governing no less than the following:
1.Prohibiting any person with an infectious and/or communicable disease, open lesion, blister, rash, or cut from using the Aquatic Venue;
2.Prohibiting any person who currently has, or has had diarrhea within the prior two (2) weeks, from using the Aquatic Venue;
3.Prohibiting spitting, spouting water, and blowing of the nose in the Aquatic Venue;
4.Prohibiting hyperventilation or extended breath holding activities;
5.Prohibiting running, boisterous, or rough play in the Aquatic Venue and in surrounding areas;
6.Prohibiting animals in the Aquatic Facility, except for service animals as defined by the ADA.
7.Establishing safety provisions pertaining to the use of slides and diving boards;
8.Requiring bathers to take cleansing showers prior to entering the Aquatic Venue;
9.Prohibiting food and drink within the Aquatic Facility except in designated areas;
10.Stating maximum bather occupancy for each Aquatic Venue;
11.Stating the hours of operation and a prohibition of unauthorized use outside of hours of operation; and
12.Other provisions the Licensee may deem necessary for the protection and safety of bathers.
B.Licensees with therapeutic pools, hot tubs and spas shall establish additional written policies:
1.Advising the following to contact their physician regarding the appropriateness of their use of hot tubs and spas:
a.Pregnant women;
b.Individuals suffering from heart disease, diabetes and high or low blood pressure; and
c.Persons using alcohol, anticoagulants, antihistamines, vasoconstrictors, vasodilators, stimulants, narcotics or tranquilizers.
2.Permitting the use of the therapeutic pool, hot tub, or spa only for a reasonable length of time, not to exceed fifteen (15) minutes; and
3.Suggesting that bathers shower and cool down prior to returning for another brief stay to prevent nausea, dizziness and fainting.
C.The policies required in §§ 4.6.6(A) and (B) of this Part shall be posted on signs in lettering sufficiently large and at a sufficient number of locations to be visible by bathers throughout the Aquatic Facility.
D.Licensees with Aquatic Venues operating without lifeguards must post the signage required for compliance with R.I. Gen. Laws § 23-22-6(b)(3).
4.6.7Communications Equipment
A.Aquatic Facilities shall have a functional telephone or other communications system or device that is hard wired and capable of directly dialing 911 or functions as the emergency notification system.
B.The telephone or communications system or device required under § 4.6.7(A) of this Part shall be conspicuously provided and accessible to Aquatic Facility users such that it can be reached immediately.
C.Signage shall clearly identify the emergency telephone or communications system or device.
D.A permanent sign shall be posted by the emergency telephone or communications system or device providing the following:
1.Aquatic Facility address;
2.Emergency dialing instructions for police, fire and emergency responders; and
3.Contact information for Aquatic Facility management.
4.6.8First Aid
A.Aquatic Facilities shall have a designated location for first-aid equipment.
B.First aid supplies shall be continuously stocked and shall include at a minimum:
1.A first-aid guide;
2.Absorbent compress;
3.Adhesive bandages;
4.Adhesive tape;
5.Sterile pads;
6.Disposable gloves;
7.Scissors;
8.Elastic wrap;
9.Emergency blanket;
10.Resuscitation mask with one-way valve; and,
11.Blood-borne pathogen spill kit.
C.Aquatic Facilities operating without lifeguards shall comply with R.I. Gen. Laws § 23-22-6(b)(2).
4.6.9Rescue Devices
A.Aquatic Venues with depths greater than two feet (2’) of standing water shall provide and maintain a U.S. Coast Guard-approved aquatic rescue throwing device with at least one quarter inch (1/4”) thick rope that is fifty feet (50’) or one and one half (1 ½) times the width of the pool in length, whichever is less.
B.Aquatic Venues with depths greater than two feet (2’) of standing water shall provide and maintain a non-telescopic reaching pole of non-conductive material, twelve feet (12’) to sixteen feet (16’) in length, with a securely attached Shepherd’s Crook that has an aperture of at least eighteen inches (18”).
C.Rescue devices shall be located in the immediate vicinity of the Aquatic Venue and shall be accessible to bathers.
D.Aquatic Facilities operating with lifeguards shall provide at least one (1) spinal injury board constructed of easily sanitized/disinfected material shall be provided. The board shall be equipped with a head immobilizer and sufficient straps to immobilize a person to the spinal injury board.
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
##### **216-RICR-50-05-4 § 4.7** Compliance and Enforcement {#sec-216-ricr-50-05-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-4#4.7}
4.7.1Variances
A.The Licensing Agency may grant a variance to a requirement set forth in this Part, either upon its own motion or upon request of the applicant from the provisions of this Part in a specific case, if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant, provided that such variance will not be contrary to the public interest and/or the health and safety of the public.
B.An applicant requesting a variance shall file such request in writing setting forth in detail the basis upon which the request is made and providing sufficient evidence to demonstrate to the Licensing Agency’s satisfaction that a variance to a regulatory provision of this Part does not create a violation of Federal or State law and does not create a condition that presents an imminent health hazard.
C.Upon the filing of each request for variance with the Licensing Agency and within sixty (60) days thereafter, the Licensing Agency shall notify the applicant by certified mail of its approval. In the case of a denial, a hearing date, time and place may be scheduled if the applicant chooses to appeal the denial.
4.7.2Violations
Persons who violate the provisions of this Part shall be fined in accordance with R.I. Gen. Laws § 23-22-12.
4.7.3Return to Compliance
A.Upon the Licensing Agency’s determination in its sole discretion that an Aquatic Venue was operating in a manner detrimental to the health or safety of users, the Licensee shall post public notice where visible to users of the Aquatic Venue within twenty-four (24) hours of receiving Notice of Violation from the Licensing Agency, using the Public Notice document provided by the Licensing Agency. Within ten (10) days of completing the public notification requirements, the Licensee shall submit to the Licensing Agency a certification of compliance documenting the completion of public notification requirements. The Licensee must include with this certification a copy of the notice posted by the facility. Failure to comply with these provisions shall result in an additional violation as per § 4.7 of this Part.
B.The Licensee, at Licensee’s expense, shall collect water samples for laboratory analysis at an increased frequency determined by the Licensing Agency until such time that the Licensing Agency is satisfied that the detrimental condition has been corrected, after which time the Licensee shall revert to the routine sampling schedule required under § 4.6.3 of this Part.
C.The Licensing Agency may direct the Licensee to make an inspection at the Licensee’s expense to determine the cause of the detrimental condition and to develop a Corrective Action Plan.
D.A Corrective Action Plan shall be signed by a pool care professional with certification demonstrating competency in this field, including but not limited to certification obtained through the National Swimming Pool Foundation, the Association of Pool and Spa Professionals, or another agency that the Licensing Agency in its sole discretion considers to be equivalent. Corrective Action Plans that include engineering modifications to the Aquatic Venue shall also be signed by a Rhode Island-registered Professional Engineer.
E.The Corrective Action Plan shall be submitted to the Licensing Agency no later than thirty (30) days of the Licensing Agency’s notification to the Licensee that action is required under § 4.7.3(C) of this Part.
F.Upon the Licensing Agency’s determination that the Corrective Action Plan is acceptable, the Licensee shall implement and complete the Corrective Action Plan within the timeframe established by the Licensing Agency.
G.Aquatic Venues that receive water quality violations on three (3) separate occasions within a twelve (12) month period, on a rolling basis, shall be required to retain a Certified Pool Operator credentialed either by the National Swimming Pool Foundation or a similarly trained operator credentialed by an entity determined to be equivalent by the Licensing Agency in its sole discretion. The Certified Pool Operator shall be retained by the licensee until such time that the licensee demonstrates proficiency as determined by the Licensing Agency in its sole discretion.
4.7.4Hearings and Reviews
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 42-35 and this Part shall be held in accordance with the provisions of the Rules and Regulations for Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Amendment — effective from 2022-08-07 to current*
- *EMERGENCY RULE Amendment — effective from 2022-06-06 to 08/07/2022*
- *Periodic Refile — effective from 2022-01-04 to 06/06/2022*
- *Amendment — effective from 2021-08-24 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2021-06-18 to 07/24/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-21 to 06/18/2021*
- *EMERGENCY RULE Amendment — effective from 2021-05-10 to 05/21/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-26 to 05/10/2021*
- *EMERGENCY RULE Amendment — effective from 2021-03-16 to 03/26/2021*
- *EMERGENCY RULE Amendment — effective from 2021-02-15 to 03/16/2021*
- *EMERGENCY RULE Amendment — effective from 2021-01-14 to 02/15/2021*
- *EMERGENCY RULE Amendment — effective from 2020-07-03 to 01/14/2021*
- *EMERGENCY RULE Amendment — effective from 2020-06-15 to 07/03/2020*
- *EMERGENCY RULE Amendment — effective from 2020-05-30 to 06/15/2020*
- *Amendment — effective from 2020-04-28 to 08/24/2021*
- *Adoption — effective from 2019-01-01 to 04/28/2020*
#### **216-RICR-50-05-5** Certification of Public Drinking Water Supply Treatment and Public Water Supply Transmission and Distribution Operators
##### **216-RICR-50-05-5 § 5.1** Authority {#sec-216-ricr-50-05-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.1}
These Regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws § 23-65-4(1) and are established for the purpose of adopting minimum standards pertaining to operators of drinking water supply facilities and systems.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.2** Definitions {#sec-216-ricr-50-05-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.2}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Assistant superintendent” means the individual who is an operator who is responsible for the management, operation and maintenance of a water supply treatment facility or water transmission and distribution system in the absence of the superintendent and who shall have a full certificate appropriate to the type and grade of the water treatment facility or water transmission and distribution system.
2.“Association of Boards of Certification” or “ABC” means an international organization of environmental certification boards which is a not for profit corporation incorporated in the State of Iowa.
3.“Board” means the Board of Certification established by R.I. Gen. Laws § 23-65-2.
4.“Certificate” means a certificate of competency issued by the Director to an individual to operate one (1) or more specified classes of public water supply facilities.
5.“Community water supply” means any public water supply, which serves at least fifteen (15) service connections used by year-round residents or regularly serves at least twenty-five (25) year-round residents.
6.“Contact hour” means the one (1) hour actually spent in an instruction/training session. In calculating the number of contact hours for a session, the time used for refreshment breaks, lunches and other activities not directly part of the instructional experience shall be subtracted from the total number of hours in the session. One (1) continuing education unit (CEU) equals ten (10) contact hours of training or instruction.
7.“Director” means the Director of the Department of Health or a subordinate to whom the Director has assigned his or her functions.
8.“Full certification” means certification obtained pursuant to any one (1) of §§ 5.9(A) through (D) of this Part.
9.“Groundwater under the direct influence of surface water” means any water beneath the surface of the ground with:
a.Significant occurrence of insects or other microorganisms, algae, or large diameter pathogens such as Giardia lamblia; or
b.Significant and relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or pH which closely correlate to climatological or surface water conditions.
10.“In charge of a shift” means on-site responsibility of an operating shift.
11.“In responsible charge of any field operations” means the supervision of any field operations of any operating shift on a day-to-day basis. Operators in responsible charge are not required to be on-site.
12.“Lowest grade of certification” means a Class 1 certification for Class 1 through 4 systems and a Class VSS certification for Class VSS water systems.
13.“Non-community water system” means a public water system that is not a community water system.
14."Non-community non-transient water system” means a non-community water system that regularly serves at least twenty-five (25) of the same persons over six (6) months per year.
15.“Operational activities” are those involving the maintenance, repair, replacement or installation of components of operational public water supply treatment and distribution systems that may directly impact the quality or quantity of drinking water.
16.“Operational”, as it relates to public water supply treatment and distribution facilities, means the part or parts that are performing or able to perform (ready for or in a condition to undertake) a destined function.
17."Operator" means an individual employed at a water treatment facility or transmission and distribution system whose routine job duties involve performing operational activities or making decisions regarding the daily operational activities of a public water treatment facility and/or transmission and distribution system that may directly impact the quality and/or quantity of drinking water. "Operator" does not apply to an official exercising only general administrative supervision or engineering design duties, such as the City Engineer or an elected Water Commissioner, or clerical or administrative workers involved only in activities such as customer relations, billing, payroll, time keeping, etc. The term "operator", as used in this Part, does not apply to individuals whose only responsibility is to install and/or read meters.
18.“Operator-in-training” means an applicant who has passed a certification examination, but who does not meet the experience requirements specified in § 5.8 of this Part for the grade of examination passed. Individuals holding this type of certification may not make decisions regarding the daily operational activities of a public water treatment facility and/or transmission and distribution system, that may directly impact the quality and/or quantity of drinking water unless said decision is made in consultation with an operator holding a full certificate of the appropriate type and grade who must be on-site or able to be contacted as needed.
19."Owner" means any individual, corporation, partnership, public utility, nonprofit organization, trust, unincorporated association, federal, state, county, or local government, or any agency or subdivision thereof, or any combination of the foregoing, owning any public water system, distribution system, and/or water treatment plant. In addition, the owner of the land on which the well is located, where said well is the source for a public water system, is the owner of a public water system. A person or entity who leases the land on which a well is located is not the owner of the public water system.
20.“Person” means any individual, partnership, firm, association, joint venture, public or private corporation, trust estate, commission, board, public or private institution, utility, cooperative, municipality or any other political subdivision of this State, any interstate body, or any other legal entity.
21.“Public water supply” or "public water system" or "PWS" means a system for the provisions to the public of piped water for human consumption, if such system has at least fifteen (15) service connections or regularly serves at least twenty-five (25) individuals at least sixty (60) days out of the year.
22.“Superintendent” means the individual who is an operator who is directly responsible for the management, operation and maintenance of a water supply treatment facility or water transmission and distribution system during all working shifts and who shall hold a full certificate appropriate to the type and grade of the water treatment facility or water transmission and distribution system.
23.“Transmission and distribution system” means a network of pipes that transports, distributes and delivers water from a water treatment facility or well(s) to water system customers.
24.“Water supply treatment facility” means an arrangement of devices, equipment and structures constructed and/or installed for the purpose of the treatment of a water supply.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.3** Board of Certification {#sec-216-ricr-50-05-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.3}
A.The Board shall have all the powers and duties specified in R.I. Gen. Laws § 23-65-3.
B.All meetings of the Board shall be open to the public in accordance with R.I. Gen. Laws Chapter 42-46.
C.The Board shall meet at least quarterly. The chairperson of the Board may call special meetings if, in his/her judgment, circumstances require it. Special meetings may also be called on petition of three (3) members of the Board.
D.A quorum for the conduct of business at any meeting of the Board shall consist of four (4) members. Three (3) members of the Board at a regular or special meeting may receive and review reports, applications and other correspondence.
E.Majority Vote of the Board means the majority of the membership. The Board shall elect annually, by majority vote, one (1) chairperson, one (1) vice chairperson, and one (1) secretary.
F.The term of office of the Board Members shall be as provided in R.I. Gen. Laws § 23-65-2(b).
G.The chairperson shall preside at all meetings of the Board, shall sign all official documents of the Board, and shall act as the spokesperson for the Board. In the absence of the chairperson, the vice chairperson shall preside at meetings and perform all duties usually performed by the chairperson.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.4** Powers and Duties of the Director {#sec-216-ricr-50-05-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.4}
The Director shall have all the powers and duties specified in R.I. Gen. Laws § 23-65-4.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.5** Mandatory Certification of Public Water Supply Treatment Operators {#sec-216-ricr-50-05-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.5}
A.It shall be unlawful for any public water supply system using surface water or groundwater under the direct influence of surface water as determined by the Director, or any community or noncommunity non-transient water supply to supply water for human consumption unless the treatment of such water is under the supervision of a superintendent or assistant superintendent who is assigned direct responsibility for the management, operation, and maintenance of the water supply treatment facility during all working shifts and who shall hold a full certificate equal to the grade or classification of the water supply treatment facility, as established by this Part.
B.Each operator in charge of a shift at a public water supply system using surface water or groundwater under the direct influence of surface water, as determined by the Director, or any community or non-community non-transient water supply must hold a certificate no less than one (1) grade below the classification of the treatment facility.
C.In addition to §§ 5.5(A) and (B) of this Part, all persons employed to work as operators at a public water supply system using surface water or groundwater under the direct influence of surface water, as determined by the Director, or any community or non-community non-transient water supply must be certified to at least the lowest grade of treatment plant operation certification within a year of hire into such position.
D.Individuals holding Operator-In-Training certifications may not make decisions regarding the daily operational activities of public water treatment and/or transmission and distribution facilities, that may directly impact the quality and/or quantity of drinking water unless said decision is made in consultation with an operator holding a full certificate of the appropriate type and grade who must be on-site or able to be contacted as needed.
E.Individuals employed by private entities to repair, replace or install components of operational water supply treatment facilities must be under the supervision of a fully certified operator employed at that water supply treatment facility.
F.Violation of this section shall be considered a violation of the public drinking water supply under R.I. Gen. Laws Chapter 46-13 and water systems shall be subject to the enforcement and penalty provisions of R.I. Gen. Laws § 46-13-16.
G.During a State of Emergency declared by the governor pursuant to R.I. Gen. Laws § 30-15-9, an operator of a lower classification than that required in §§ 5.5(A) and (B) of this Part may take over the responsibilities of the superintendent, assistant superintendent, or an operator in charge of a shift.
1.The decision as to who would take over any of these roles shall be made by the superintendent unless the superintendent is unable to fulfill his or her superintendent duties due to circumstances that arise from the State of Emergency. In the event the superintendent is unable to fulfill his or her duties, the most senior person with the highest-level operator classification shall make the decision.
2.Public water systems operated by licensed contract operators who are unable to fulfill their duties due to circumstances that arise from the State of Emergency, must make every attempt to find another contract operator of an appropriate level of certification. If another contract operator is not available to provide its services, the owner may engage other professionals, including but not limited to town officials, professional engineers, licensed plumbers, and licensed water filtration/treatment system installers, to serve as an operator. Notwithstanding the foregoing, the owner maintains responsibility for the system.
3.In the event any of the provisions set forth in § 5.5(G) of this Part are implemented, the PWS must notify the Board and the Director in writing within twenty-four (24) hours.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.6** Mandatory Certification of Public Water Supply Transmission and Distribution System Operators {#sec-216-ricr-50-05-5-5.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.6}
A.It shall be unlawful for any community or non-community non-transient public water supply transmission and distribution system to distribute water for human consumption unless the operation of the system is under the supervision of a superintendent or assistant superintendent who is assigned direct responsibility for the management, operation, and maintenance of the transmission and distribution water system during all working shifts and who shall hold a full certificate equal to the grade or classification of the transmission and distribution facility, as established by this Part.
B.Each person in responsible charge of any field operations of a community or non-community non-transient public water supply transmission and distribution facility must hold a certificate no less than one (1) grade lower than the grade of the transmission and distribution facility, as established by this Part.
C.In addition to §§ 5.6(A) and (B) of this Part, all persons employed to work as operators at a community or non-community non-transient public water supply transmission and distribution facility must be certified to at least the lowest grade of distribution certification within a year of hire into such position.
D.Individuals holding Operator-In-Training certifications may not make decisions regarding the daily operational activities of public water treatment and/or transmission and distribution facilities, that may directly impact the quality and/or quantity of drinking water unless said decision is made in consultation with an operator holding a full certificate of the appropriate type and grade who must be on-site or able to be contacted as needed.
E.Individuals employed by private entities to repair, replace or install components of operational water supply transmission and distribution facilities must be under the supervision of a fully certified operator employed at that water supply transmission and distribution system.
F.Violation of this section shall be considered a violation of the public drinking water supply under R.I. Gen. Laws Chapter 46-13 and water systems shall be subject to the enforcement and penalty provisions of R.I. Gen. Laws § 46-13-16.
G.During a state of emergency declared by the governor pursuant to R.I. Gen. Laws § 30-15-9, an operator of a lower classification than that required in §§ 5.5(A) and (B) of this Part may take over the responsibilities of the superintendent, assistant superintendent, or an operator in charge of a shift.
1.The decision as to who would take over any of these roles shall be made by the superintendent unless the superintendent is unable to fulfill their duties due to circumstances that arise from the State of Emergency. In the event the superintendent is unable to fulfill his or her duties, the most senior person with the highest-level operator classification shall make the decisions.
2.Public water systems operated by licensed contract operators who are unable to fulfill their duties due to circumstances that arise from the State of Emergency, must make every attempt to find another contract operator of an appropriate level of certification. If another contract operator is not available to provide its services, the owner may engage other professionals, including but not limited to town officials, professional engineers, licensed plumbers, and licensed water filtration/treatment system installers, to serve as an operator. Notwithstanding the foregoing, the owner maintains responsibility for the system.
3.In the event any of the provisions set forth in § 5.6(G) of this Part are implemented, the PWS must notify the Board and the Director in writing within twenty-four (24) hours.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.7** Classification of Water Supply Treatment Facilities and Water Supply Transmission and Distribution Facilities {#sec-216-ricr-50-05-5-5.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.7}
A.Public water supply treatment and public water supply transmission and distribution facilities classified in any class may be classified in a higher class at the discretion of the Board, by reason of the existence of unusual operating conditions.
B.Classification of any water supply treatment or water supply distribution facility may be changed due to changes in any condition or circumstances under which the original classification was given. Due notice of any such change shall be given to the owner of the facility. Sufficient time shall be given to such system to obtain the required certifications.
C.Water supply treatment facilities and water supply transmission and distribution facilities shall be classified as very small water system, Class 1, Class 2, Class 3, or Class 4, with 4 being the largest and most complex, in accordance with the following classification system.
1.Water supply treatment facilities shall be classified according to the following point system:
a.Class VSST: less than ten (10) points
b.Class 1T: ten (10) to thirty (30) points
c.Class 2T: thirty-one (31) to fifty-five (55) points
d.Class 3T: fifty-six (56) to seventy-five (75) points
e.Class 4T: seventy-six (76) points and greater
2.Points shall be assigned to each plant according to the schedule in § 5.7(D) of this Part.
a.For purposes of certification, sources without treatment, such as pumping only, shall be considered to be a distribution system and not a treatment facility.
3.Water supply distribution and transmission facilities shall be classified according to the population served. The classifications are as follows:
a.Class VSSD: fewer than five hundred (500) persons served
b.Class 1D: five hundred (500) to one thousand five hundred (1,500) persons served
c.Class 2D: one thousand five hundred and one (1,501) to fifteen thousand (15,000) persons served
d.Class 3D: fifteen thousand and one (15,001) to forty thousand (40,000) persons served
e.Class 4D: forty thousand and one (40,001) or more persons served
D.Water Treatment Plant Classification
1.Notes on classifying treatment plants: Each unit process should have points assigned only once. (i.e., for a plant using oxidation, precipitation and filtration for iron removal, add ten (10) points for the iron removal only and nothing for filtration).
2.The points rating scale for water treatment plants is:
Item
Points
Size (two (2) to twenty (20) points total)
Maximum population served, peak day (one (1) to ten (10)) (Maximum of ten (10) points)
One (1) point per ten thousand (10,000) or part
Design flow, average day or peak month’s average day, whichever is larger (one (1) to ten (10)) (Maximum of ten (10) points)
One (1) point per MGD or part
Water Supply Source (three (3) to eighteen (18) points)
Groundwater
Three (3)
Surface water
Five (5)
Average raw water quality (zero (0) to ten (10) points) (the key concept is the variation or change in the quality of the raw water source with point values ranging from zero (0) to ten (10))
Little or no variation
Zero (0)
Raw water quality (other than turbidity) varies enough to require treatment changes approximately ten percent (10%) of the time
Two (2)
Raw water quality (turbidity) varies severely enough to require pronounced and/or very frequent treatment changes
Five (5)
Raw water quality subject to periodic serious industrial waste pollution
Ten (10)
Aeration
Two (2)
Packed tower aeration
Six (6)
pH adjustment
Four (4)
Stability or corrosion control
Four (4)
Taste and odor control
Eight (8)
Color control
Four (4)
Iron or iron/manganese removal
Ten (10)
Ion exchange softening
Ten (10)
Chemical precipitation softening
Twenty (20)
Coagulant addition
Four (4)
Flocculation
Six (6)
Sedimentation
Five (5)
Upflow clarification
Fourteen (14)
Filtration
Ten (10)
Fluoridation
Five (5)
Disinfection (zero (0) to ten (10) points) (For disinfectants, such as ozone, chlorine dioxide or chloramines, assign five (5) points for chlorination or comparable and five (5) points for on-site generation of disinfectant)
No disinfection
Zero (0)
Chlorination or comparable
Five (5)
On-site generation of disinfectant
Five (5)
Gaseous chlorine
Five (5)
Special process (including reverse osmosis, electrodialysis)
Fifteen (15)
Sludge/backwash water disposal (zero (0) to five (5) points)
No disposal to raw water source to sewer or off watershed
Zero (0)
Any disposal to raw water source supernatant discharge to reservoir
Two (2)
Any disposal to plant raw water
Five (5)
Laboratory control (zero (0) to twenty (20) points) (The key concept is to credit laboratory analyses done on-site by plant personnel with point values ranging from zero (0) to twenty (20) points)
Bacteriological/biological (zero (0) to ten (10) points)
Lab work done outside of plant
Zero (0)
Membrane filter procedures
Three (3)
Use of fermentation tubes or any dilution method; fecal coliform determination
Five (5)
Biological identification
Seven (7)
Viral studies of similarly complex work done on site
Ten (10)
Chemical/physical (zero (0) to ten (10) points)
Lab work done outside the plant
Zero (0)
Push button or colorimetric methods for simple tests such as chlorine residual, pH
Three (3)
Additional procedures such as titration jar tests, alkalinity, hardness
Five (5)
More advanced determinations such as numerous inorganics
Seven (7)
Highly sophisticated instrumentation such as atomic absorption and gas chromatography
Ten (10)
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.8** Classification and Qualifications of Water Supply Treatment and Water Supply Transmission and Distribution Operators {#sec-216-ricr-50-05-5-5.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.8}
A.All applicants for Full Certification shall meet the following educational and experience requirements for the grade of certification applied for as shown below. The experience requirements shall be in the same field (treatment or transmission and distribution) as the type of certificate for which the applicant is applying. Applicants for Operator-in-Training certification shall meet the following minimal educational requirements for the grade of certification applied for as shown below.
B.Grade VSS Treatment (VSST): High school diploma or equivalent and three (3) calendar months of acceptable operating experience at a Class VSST or higher drinking water supply treatment facility. Experience or relevant training may be used to satisfy the educational requirement (i.e. six (6) calendar months of acceptable operating experience or six (6) contact hours of on the job, in the field training or 0.6 Continuing Education Units of education in the operation of a very small water system that shall satisfy the educational requirement). Experience and training used to satisfy the educational requirement may not be used to satisfy the operating experience requirement.
C.Grade VSS Distribution (VSSD): High school diploma or equivalent and three (3) calendar months of acceptable operating experience at a Class VSSD or higher drinking water supply distribution facility. Experience or relevant training may be used to satisfy the educational requirement (i.e. six (6) calendar months of acceptable operating experience or six (6) contact hours of on the job, in the field training or 0.6 Continuing Education Units of education in the operation of a very small water system shall satisfy the educational requirement). Experience and training used to satisfy the educational requirement may not be used to satisfy the operating experience requirement.
D.Grade 1 Treatment (1T): High school diploma (or equivalent) and six (6) months full-time experience as an operator at a Class 1T (or higher) drinking water supply treatment facility.
E.Grade 1 Distribution (1D): High school diploma (or equivalent) and six (6) months full-time experience as an operator at a Class 1D (or higher) drinking water supply distribution facility.
F.Grade 2 Treatment (2T)
1.Possession of a Grade 1T Full Certification with full-time experience as an operator at a Class 1T (or higher) drinking water supply treatment facility for one (1) additional year after certification; or
2.High school diploma (or equivalent) and two (2) years full-time experience as an operator at a Class 1T (or higher) drinking water supply treatment facility.
G.Grade 2 Distribution (2D)
1.Possession of a Grade 1D Full Certification with full-time experience as an operator at a Class 1D (or higher) drinking water supply distribution facility for one (1) additional year after certification; or
2.High school diploma (or equivalent) and two (2) years full-time experience as an operator at a Class 1D (or higher) drinking water distribution facility.
H.Grade 3 Treatment (3T)
1.Possession of a Grade 2T Full Certification with full-time experience as an operator at a Class 2T (or higher) drinking water treatment facility for an additional two (2) years after certification; or
2.High school diploma (or equivalent) and four (4) years full-time experience as an operator at a Class 2T (or higher) drinking water treatment facility; or
3.An Associate’s Degree in the physical and/or biological sciences and two (2) years full-time experience as an operator at a Class 2T (or higher) drinking water treatment facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board); or
4.A Bachelor's degree in the physical and/or biological sciences and one (1) year full-time experience as an operator at a Class 2T (or higher) drinking water treatment facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board).
I.Grade 3 Distribution (3D)
1.Possession of a Grade 2D Full Certification with full-time experience as an operator at a Class 2D (or higher) drinking water distribution facility for an additional two (2) years after certification; or
2.High school diploma (or equivalent) and four (4) years full-time experience as an operator at a Class 2D (or higher) drinking water distribution facility; or
3.An Associate’s degree in the physical and/or biological sciences and two (2) years full-time experience as an operator at a Class 2D (or higher) drinking water distribution facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board); or
4.A Bachelor's degree in the physical and/or biological sciences and one (1) year full-time experience as an operator at a Class 2D (or higher) drinking water distribution facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board).
J.Grade 4 Treatment (4T)
1.An Associate’s Degree in the physical and/or biological sciences and four (4) years full time experience as an operator at a Class 3T (or higher) drinking water supply treatment facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board); or
2.A Bachelor's degree in the physical and/or biological sciences and two (2) years full-time experience as an operator at a Class 3T (or higher) drinking water supply treatment facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board); or
3.Have been employed at a Rhode Island public water supply treatment facility of Class 3T (or higher) and possess a grade 3T Full Certification with five (5) years continuous full-time experience as an operator at a Class 3T (or higher) drinking water supply treatment facility and have completed a minimum of fourteen (14) semester credits of post high school education in the physical and/or biological sciences including chemistry, math, biology or other related disciplines acceptable to the Board.
K.Grade 4 Distribution (4D)
1.An Associate’s Degree in the physical and/or biological sciences and four (4) years full time experience as an operator at a Class 3D (or higher) drinking water supply distribution facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board); or
2.A Bachelor's degree in the physical and/or biological sciences and two (2) years full-time experience as an operator at a Class 3D (or higher) drinking water supply distribution facility. (Degree shall be in the areas of sanitary, civil, chemical, or environmental engineering, public health, biology, chemistry, or other discipline acceptable to the Board); or
3.Have been employed at a Rhode Island public water supply distribution facility of Class 3D (or higher) and possess a grade 3D Full Certification with five (5) years continuous full-time experience as an operator at a Class 3D (or higher) drinking water supply distribution facility.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.9** Certification {#sec-216-ricr-50-05-5-5.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.9}
A.Full Certification for Grades VSS – 4 by Examination
An applicant seeking Full Certification for Grades VSS through 4 by examination must meet all the minimum qualifications outlined in § 5.7 of this Part for the certification type and grade for which he/she is seeking before he/she will be allowed to take the examination. If the applicant passes the examination to the satisfaction of the Board, the Board shall grant the applicant Full Certification which will be in effect for three (3) years from issuance and may be renewed in accordance with § 5.12 of this Part.
B.Full Certification by Reciprocity
1.Full certificates may be issued, upon application, without examination, in a comparable classification to any individual who holds a certificate issued by any state, territory or possession of the United States, any country, if in the judgment of the Board, the requirements for certification of operators under which such certification was issued are equivalent to the requirements of this Part.
a.Notwithstanding the foregoing, in the event of a State of Emergency declared by the governor pursuant to R.I. Gen. Laws § 30-15-9, the Board shall delegate to the Director the duty to determine whether the requirements of another state, territory, or possession of the United States for certification of operators is equivalent to the requirements of this Part.
2.At the time of application, applicants must be in good standing with the state in which the original certificate was issued, including having completed the continuing educational requirements on a pro-rated basis.
3.A certificate issued under the provisions of § 5.9(B) of this Part is valid at any water system of that grade or classification as specified by the Board.
4.Certificates issued under § 5.9(B) of this Part shall remain in effect for a period of three (3) years at which time they may be renewed in accordance with § 5.12 of this Part.
C.Full Certification by Grandfathering
1.Grandfathered certificates shall become null and void upon the classification of the water system changing or the termination of the operator’s employment.
2.Certificates granted under § 5.8(C) of this Part will be in effect for three (3) years from issuance and may be renewed in accordance with § 5.12 of this Part.
3.Certificates granted under § 5.8(C) of this Part shall be issued to a particular individual for a particular water system.
D.Prior Certification
Operator certification for operators of drinking water treatment facilities acquired by examination in the State of Rhode Island prior to January 1, 1996 shall remain in effect. Such certificates shall remain in effect for two (2) years from the date that these Rules and Regulations are adopted and may be renewed in accordance with § 5.12 of this Part. Upon renewal, certificates will remain in effect for a period of three (3) years and may be renewed in accordance with § 5.12 of this Part.
E.Provisional Certification
1.If a water system does not have a certified operator as specified in §§ 5.5 and 5.6 of this Part and if the Board determines that this is due to reasons beyond the water systems’ control, the Board may grant a provisional operator status to an operator. The water system must submit a request in writing, which indicates the reasons for not having a qualified operator together with an application and supporting education/experience credentials of the proposed applicant.
2.Provisional certification shall be issued to a particular individual for a particular water system.
3.Provisional certification issued pursuant to § 5.9(E)(1) of this Part shall be in effect for a period of no longer than one (1) year during which time the water system must be actively looking for a certified operator.
4.In the event of a State of Emergency declared by the governor pursuant to R.I. Gen. Laws § 30-15-9, the Board may grant a six (6) month provisional certification to those operators who have retired within the previous five (5) years. The six (6) month provisional certification shall be at the same grade that the operator held at the time of retirement.
F.Operator-in-Training Certification
1.An applicant seeking certification as an Operator-in-Training must meet all of the minimum qualifications outlined in § 5.8 of this Part except for the full-time employment and/or full time experience requirements for the certification type and grade for which he/she is seeking before he/she will be allowed to take the examination. If the applicant passes the examination to the satisfaction of the Board, the Board shall issue the applicant a certification as an Operator-in-Training. Upon satisfactory completion of the required full-time employment and/or full-time experience for the certification type and grade for which the operator in training is certified, and upon application to the Board, Full Certification shall be granted.
2.Operator-in-training certificates will only be issued for Grades VSS through 3 treatment and transmission/distribution.
3.Certificates issued under § 5.9(F) of this Part will be in effect for two (2) years from issuance and may be renewed in accordance with § 5.12 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.10** Application {#sec-216-ricr-50-05-5-5.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.10}
A.Applications for certification by grandfathering under § 5.9(C) of this Part must include official detailed job descriptions for all operators seeking certification. Job descriptions should be specific with respect to duties relating to water system treatment and/or transmission and distribution.
B.An operator desiring to be certified shall file an application, on a form provided by the Board, which must be received by the Board or postmarked at least forty-five (45) calendar days preceding the date of the examination.
C.The Board shall review applications and supporting documents, determine the eligibility of the applicant for examination and promptly notify the applicant, in writing, of the same.
D.The action of the Board shall be recorded both in the minutes of the meeting and upon the face of the application. A fee will be charged to each applicant submitting an application to the Board, and shall be of an amount determined by the Board to cover the cost of the examination and as set forth in the Rules and Regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) and shall be submitted with the application form. This fee shall be refundable if the applicant is deemed not qualified to take the examination by the Board. Otherwise, the fee shall be non-refundable.
E.No member of the Board during his/her tenure shall permit his/her name to be used as a reference in connection with the filing of an application for certification as an operator of a drinking water supply facility.
F.Applications for certification as operators shall be mailed or delivered to: Board of Certification of Operators for Water Supply Facilities, Cannon Building, Room 209, Three Capitol Hill, Providence, Rhode Island 02908-5097.
G.No application will be considered complete unless accompanied by required fee(s) and until all required supporting documents have been received by the board.
H.Each applicant shall be required to demonstrate his/her eligibility by submitting in support of his/her formal application authentic proof of the statements made therein by attaching documentary evidence, affidavits, registrar's statements, diploma's, published data, photographs, or other sworn or proven evidence. The Board reserves the right to retain, as a permanent part of the application, any or all documents submitted which shall be properly marked for identification and ownership. Original documents may be replaced by photocopies of such documents, however, at the request and expense of the applicant.
I.Personal appearances before the Board, if required, shall be at the time and place designated by the Board. Failure to provide additional evidence or information within the time specified, or to appear before the Board when such appearance is deemed necessary by the Board, may be considered just and sufficient cause for disapproval of the application.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.11** Examinations {#sec-216-ricr-50-05-5-5.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.11}
A.The Board shall administer the examination prepared by the Association of Boards of Certification (ABC). The Board shall determine the passing score.
B.Examinations shall be held at least twice per year at a time and place designated by the Board.
C.Examinees will be allowed as many attempts as necessary to pass a certification exam during the twelve (12) months following entry into a position which requires a particular level of certification; thereafter, they will be allowed to sit for a particular exam once annually.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.12** Renewal {#sec-216-ricr-50-05-5-5.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.12}
A.Operators shall be sent renewal notices approximately sixty (60) days prior to the expiration of their current certification. If an operator fails to renew by the expiration date of their current certificate, he/she may still submit a renewal application up to six (6) months after the expiration date. Any operator allowing this grace period to expire must meet all minimum experience, training and examination requirements to become re-certified.
B.To renew any grade or classification of certificate, the applicant shall have been actively working in the area of his/her certification for at least twenty percent (20%) of the time.
C.As a prerequisite to certificate renewal, an applicant must complete the number of continuing training/education contact hours related to drinking supply treatment and/or transmission and distribution specified below and which are acceptable to the Board. Courses approved for training contact hour credit may be used for renewal a maximum of one (1) time during any renewal period.
D.Contact Hours required (one (1) continuing education unit (CEU) equals ten (10) contact hours):
Class
Two (2) Year Renewal Period
Three (3) Year Renewal Period
VSS
Two (2) Hours
Three (3) Hours
Class 1
Ten (10) Hours
Fifteen (15) Hours
Class 2
Ten (10) Hours
Fifteen (15) Hours
Class 3
Twenty (20) Hours
Thirty (30) Hours
Class 4
Twenty (20) Hours
Thirty (30) Hours
E.Applicants must complete fifty percent (50%) or more of their required training contact hours in technical areas directly related to the operations of the water system employing them and may complete no more than twenty-five percent (25%) each, in the areas of health/safety and supervisory skills.
F.Failure to meet these requirements or to furnish the required information shall constitute grounds for refusal to renew.
G.In the event of a State of Emergency declared by the governor pursuant to R.I. Gen. Laws § 30-15-9, the Board may grant an extension beyond the six (6) month grace period for a license that expired during the State of Emergency.
H.During the pendency of a State of Emergency declared by the governor pursuant to R.I. Gen. Laws § 30-15-9, the superintendent (designated operator) may continue with his or her duties as operator in-direct-responsible charge of a public water system past the expiration date of his or her license.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.13** Approval of Operator Training Courses {#sec-216-ricr-50-05-5-5.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.13}
A.This section outlines the requirements and procedures for obtaining Board approval to award training contact hours for drinking water operator certification courses to be used towards meeting the certification renewal requirements. All applications for approval should be submitted to the Board a minimum of ninety (90) days prior to the date the training is to occur. There are four (4) methods in which a training program may be approved by the Board to issue training credits to be used towards certification renewal:
1.The individual or organization conducting training has been approved by the Board to issue training contact hours for a specific training course.
2.The organization conducting the training has had their training program approved by the Board for issuing training contact hours.
3.The training program or specific training is co-sponsored or sanctioned by an organization which has had their training program approved by the Board for conducting training and issuing training contact hours towards certification renewal.
4.The organization conducting the training is an accredited college or university and the course is in a drinking water supply related field.
B.Criteria for the Approval of a Specific Training Course. Any individual or organization wishing approval to conduct a renewal training course for water supply operators shall submit the following to the Board for review:
1.The date, location of the training and description of the training facility
2.The name, address and telephone number of person(s) to contact regarding the training
3.The course outline showing the topic(s) to be presented and time allotted for each (including beginning and ending times)
4.The criteria for determining the successful completion of the course
5.A copy of the instruction materials, including a copy of handouts, overheads, videotapes, etc. if appropriate
6.The name, address, and background information or resume of instructor(s) which shows the instructor’s competence in the subject matter and ability to communicate the program content at an appropriate level
7.Instructor's affiliation with the drinking water field
C.A copy of the certificate of completion being issued to the attendees containing the following information:
1.Attendee’s name
2.Name of course
3.Renewal credits issued
4.Date the course was held
5.Name of the course instructor and affiliation
D.A copy of the attendance roster to be used containing the following information:
1.Name of the course
2.Training contact hours to be issued
3.Date the course was held
4.Location of the course
5.Name of course instructor(s)
6.Names of the attendees and certificate numbers
E.Number of contact hours to be issued
1.Contact hours are based upon actual contact time in the training. All breaks and meal times must be noted on the agenda and will not count toward contact hours.
2.No credit will be given prior to the completion of any training course.
3.Participants must attend and stay for the entire session to complete the program satisfactorily. The completion date of a multi-day course is the last day of the course.
4.Contact hours will be issued in increments of one half (0.5) hours. Any approved training issuing continuing education units (CEUs) will be given credit at the rate of ten (10) contact hours per one (1) CEU.
F.Once a course has been approved, the course information does not have to be resubmitted for subsequent sessions of that course provided that there are no major changes in the course content, time allotted, instructor or material used. Any revisions must be submitted to the Board ninety (90) days in advance of any subsequent sessions of an approved course.
G.Approved courses may be used for training contact hour credit a maximum of one (1) time during any renewal period.
H.The Board will grant credit for a particular course retroactively if the course is approved within six (6) months of the date it is taken.
I.Criteria for the Approval of Training Programs:
1.Organizations involved in a drinking water supply related field conducting training may apply to the Board for approval of their training program. If granted, this approval will allow the organization to issue training contact hours for training courses without individual course pre-approval.
2.To obtain training program approval, the organization must submit to the Board for review their training criteria which should include the following information:
a.A mission statement that outlines the functions, structure, processes, and philosophy which guides the operations of the continuing education of training program
b.A policy to ensure the competence of the instructor(s) in the subject matter and ability to communicate the program content at an appropriate level
c.A written policy for determining the successful completion of a training course
d.A written policy on maintaining records, preparing attendance rosters and issuing certificates of completion. Reference §§ 5.13(C) through (D) of this Part
3.Any organization obtaining approval for its entire program must provide an annual training curriculum including a brief description of each course proposed to be offered during the upcoming year to the Board by the end of the preceding calendar year. The descriptions must include the number of training contact hours to be issued for each training course.
4.Any changes or modifications to the information submitted to the Board for training program approval shall be submitted to the Board for review and approval ninety (90) days before the date of the training.
J.Sanctioned or Co-Sponsored Training
1.Training, seminars, or workshops conducted by individuals may issue credits towards certification renewal if their training courses are co-sponsored or sanctioned by an organization that has had their training program approved by the Board. The credits shall be jointly issued with the sanctioning or co-sponsoring organization. The co-sponsoring or sanctioned organization must ensure that both the administrative and program criteria are followed for issuing training contact hours to be used towards certificate renewal. Permanent records for each participant who successfully completes the training must be established and maintained by the organization co-sponsoring or sanctioning the training.
2.If not specified by the association, the number of training contact hours issued for approved conferences and symposiums held by the American Water Works Association, New England Water Works Association, and Rhode Island Water Works Association shall be equal to the number of hours attended with a maximum of five (5) contact hours per day.
K.University and College Courses
1.Courses taken in a drinking water related field at an accredited college or university can be approved for credit towards the renewal training requirements. Courses should be in the areas of sanitary, civil, chemical or environmental engineering, environmental science, public health, biology, chemistry, mathematics or other drinking water related fields. Course credits will be approved at the rate of one (1) semester credit hour is equivalent to fifteen (15) training contact hours.
2.To ensure that a course will be approved by the Board for credit towards the renewal training requirements, the operator should request approval, in writing, ninety (90) days prior to the start of the course. The request should include the following:
a.Name of college or university offering course
b.Title of the course
c.Copy of the course material to be covered
d.Date the course is to be taken
e.Number of semester credit hours to be issued
3.Credit will only be given for the successful completion of the course with a passing grade as determined by the college or university.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.14** Disciplinary Actions {#sec-216-ricr-50-05-5-5.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.14}
The Board may revoke, suspend or otherwise discipline the holder of a certificate issued under this Part when it is found that the individual performed his/her duties in a negligent manner that produced a supply below standards normal for the particular facility operated; or that he/she has practiced fraud or deception; or that reasonable care, judgment or the application of this knowledge or ability was not used in the performance of his/her duties or that an individual is incompetent or unable to perform his/her duties in violation of R.I. Gen. Laws Chapter 46-13 or Regulations promulgated pursuant to R.I. Gen. Laws Chapter 46-13.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.15** Administrative Procedures {#sec-216-ricr-50-05-5-5.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.15}
All hearings and appeals shall be conducted in accordance with the Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
##### **216-RICR-50-05-5 § 5.16** Severability {#sec-216-ricr-50-05-5-5.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-5#5.16}
If any provisions of this Part or the application thereof to any person or circumstance is held invalid by a court of competent jurisdiction, the remainder of this Part shall not be affected thereby. The invalidity of any section or sections or parts of any section or sections shall not affect the validity of the remainder of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-10-07 to 01/04/2022*
- *EMERGENCY RULE Amendment — effective from 2020-04-07 to 10/07/2020*
- *Technical Revision — effective from 2012-12-10 to 04/07/2020*
- *Amendment — effective from 2012-12-10 to 12/10/2012*
- *Amendment — effective from 2005-07-28 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 07/28/2005*
#### **216-RICR-50-05-6** Drinking Water State Revolving Fund
##### **216-RICR-50-05-6 § 6.1** Authority {#sec-216-ricr-50-05-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.1}
These regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws § 46-12.8-4(a)(4) for the purpose of implementing a perpetual revolving loan fund as a source of low-cost financial assistance to any public water system for eligible infrastructure improvement.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.2** Definitions {#sec-216-ricr-50-05-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.2}
A.Wherever used in these rules and regulations, the following terms shall be construed as follows:
1."Approved project" means any project or portion thereof of a governmental unit or privately organized water supplier that has been issued a certificate of approval by the Department for assistance through the Bank.
2.“AWWA” means the American Water Works Association.
3.“Bank” means the Rhode Island Infrastructure Bank.
4.“Certificate of approval” means the approval issued by the Department which enables the Bank to execute a loan agreement with the qualifying public water system for drinking water system improvements that effectuate the Safe Drinking Water Act (SDWA). Financial assistance may not be extended by the Bank without the issuance of the Certificate of Approval.
5.“Chief Executive Officer” means the mayor in any city, the president of the town council in any town, the executive director of any authority or commission, the president of any association, cooperative, corporation or company, or some other officer or body designated to perform the functions of a chief executive officer under the provisions of a local charter or other law.
6.“Community comprehensive plan” means a plan prepared pursuant to the Rhode Island Comprehensive Planning and Land Use Regulation Act, R.I. Gen. Laws Chapter 45-22.2.
7.“Community water system” means a public water system which serves at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents.
8.“Cumulative impact” means the impact on the environment which results from the incremental impact of project(s) when added to other past, present, and reasonably foreseeable future actions or projects, regardless of which agency or person undertakes such other actions or projects.
9."Department" means the Rhode Island Department of Health.
10.“Director” means the Director of the Department of Health or her/his designee.
11.“DWSRF” means the Drinking Water State Revolving Fund.
12.“Effects” and “impacts,” as used in this Part, are synonymous. Effects include ecological (such as the effects on natural resources and on the components, structures, and functioning of affected ecosystems), aesthetic, historic, cultural, economic, social, and health, whether direct, indirect, or cumulative. The distinctions are:
a.Direct effects are caused by project(s) and occur at the same time and place.
b.Indirect effects are also caused by project(s) and may be later in time or farther removed in distance, but are still reasonably foreseeable. Indirect effects may include growth-inducing effects and other effects related to induced changes in the pattern of land use, population density or growth rate, and related effects on air, water and other natural systems, including ecosystems.
c.Cumulative effects are caused by both the direct and indirect effects of the project, plus the effects of other projects which are planned in the planning area.
13.“Environment” shall be interpreted comprehensively to include the natural and physical environment and the relationship of people with that environment (see the definition of “effects”).
14.“Environmental assessment” means a document that:
a.serves to:
(1)Briefly provide sufficient evidence and analysis of effects of proposed project(s) as a basis for the Department to determine whether to issue a Finding of No Significant Impact or require an Environmental Impact Statement to be prepared.
(2)Document compliance with state and federal environmental review requirements when no Environmental Impact Statement is required.
(3)Facilitate preparation of an Environmental Impact Statement when one is necessary.
b.shall include:
(1)Brief discussions of the need for the proposed project(s).
(2)Brief discussions of alternatives to recommended project(s) which involve unresolved conflicts concerning alternative uses of available resources.
(3)Brief discussions of the environmental impacts of the proposed project(s) and alternatives, and outline means to mitigate environmental impacts.
(4)Agencies and persons consulted during the environmental assessment, and responses to substantive comments.
15.“Environmental impact statement” means a detailed written statement that identifies significant impacts associated with the preferred alternative project(s). The Environmental Impact Statement will address:
a.The environmental impact(s) of the proposed project(s).
b.Any detrimental effects on the environment which cannot be avoided should the proposed project(s) be implemented.
c.Alternatives to the proposed project(s) and the environmental impacts of those alternatives.
d.The relationship between local short-term uses of the environment and the maintenance and enhancement of long-term productivity.
e.Any irreversible and irretrievable commitments of resources which would be involved in the project(s) if implemented.
16.“EPA” means the United States Environmental Protection Agency.
17.“Finding of no significant impact” means a document prepared by the Department briefly presenting the reasons for determining why project(s) will not have a significant effect on the environment. It shall include the Environmental Assessment and shall note any other environmental documents related to it. The Finding of No Significant Impact need not repeat any of the discussion in the Environmental Assessment, but may incorporate it by reference.
18.“Local governmental unit” means any town, city district, commission, agency, authority, board or other political subdivision or instrumentality of the state or of any political subdivision thereof responsible for the ownership or operation of a community water system or a nonprofit noncommunity water system within the state.
19.“Mitigation” means:
a.Avoiding an impact altogether by not implementing a certain project or parts of a project.
b.Minimizing an impact by limiting the degree or magnitude of a project and its implementation.
c.Rectifying an impact by repairing, rehabilitating, or restoring the effected environment.
d.Reducing or eliminating an impact over time by preservation and maintenance operations during the life of the project.
e.Compensating for an impact by replacing or providing substitute resources or environments.
20.“National Environmental Policy Act” means the federal National Environmental Policy Act of 1969, 42 U.S.C. § 4321 et. seq.
21.“Noncommunity water system” means a public water system that is not a community water system.
22.“Public water system” means a system for the provisions to the public for piped water for human consumption, provided such system has at least 15 service connections or regularly serves an average of at least 25 individuals daily at least 60 days out of the year. The term “public water system” shall include all sources, and facilities involved in collecting, treating, storing, and distributing the water.
23.“Privately organized water supplier” means any community water system or noncommunity nonprofit water system not owned or operated by a local governmental unit.
24.“Record of decision” means a document prepared by the Department that briefly reviews the significant effects that a project(s) will have on the environment. It shall include the Environmental Impact Statement and shall note any other environmental documents related to it. Since the Environmental Impact Statement is included, the Record of Decision need not repeat any of the discussion in the Environmental Impact Statement, but may incorporate it by reference. The Record of Decision will specify mitigation measures necessary to allow a project to proceed.
25.“SDWA or Safe Drinking Water Act” means the federal Safe Drinking Water Act of 1974, 42 U.S.C. § 300f et. seq.
26.“Significantly”, as used in the Department’s environmental review process, means considering both the context and intensity of impacts, whether beneficial or detrimental.
a.Context means that the significance of the impacts of a project must be analyzed in several contexts such as: the community as a whole (social, economic); the effected region; the effected interests; and the locality. Significance varies with the setting of the proposed project(s). In the case of a site-specific action, such as siting of a drinking water treatment facility, significance would usually depend upon the effects in the locale rather than in the whole planning area. Conversely, extending distribution lines to a previously undeveloped portion of the planning area would result in effects on many elements of the environment.
b.Intensity refers to the severity of the impact. The parties responsible for facility planning must bear in mind that more than one agency may make decisions about partial aspects of a major action. The following should be considered in evaluating intensity.
c.Impacts may be both beneficial and detrimental. A significant effect may exist even if it is believed on balance that the effect will be beneficial.
d.The degree to which the proposed project(s) affect public health and safety.
e.Unique characteristics of the geographic area impacted by the project(s) such as proximity to historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas.
f.The degree to which the effects of the proposed project(s) on the quality of the environment are likely to be controversial.
g.The degree to which the possible effects on the environment are uncertain or involve unique or unknown risks.
h.The degree to which a project may establish a precedent for future projects with similar effects or represents a decision in principle about future consideration.
i.Whether the project(s) is related to other projects with individually minor but cumulatively major impacts. Significance exists if it is reasonable to anticipate a cumulative major impact on the environment. Significance cannot be avoided by terming a project temporary or by breaking it down into small component parts.
j.The degree to which the project may detrimentally affect districts, sites, highways, structures or objects listed in or eligible for listing in the National Register of Historic Places, or may cause loss or destruction of significant scientific, cultural, or historic resources.
k.The degree to which the project may detrimentally affect an endangered or threatened species or its habitat that has been determined to be critical under the federal Endangered Species Act of 1973, 16 U.S.C. § 1531 et.seq.
l.Whether a project threatens a violation of federal, state or local laws or requirements imposed for the protection of the environment.
27.“State guide plan” means goals, policies, or plan elements for the physical, economic, and social development of the state, adopted by the State Planning Council in accordance with R.I. Gen. Laws § 42-11-10.
28.“This Part” mean all parts of Rhode Island rules and regulations pertaining to the Drinking Water State Revolving Fund (216-RICR-50-05-6).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.3** System Eligibility {#sec-216-ricr-50-05-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.3}
A.Community public water systems and nonprofit noncommunity public water systems, both privately organized water suppliers and local governmental units, are eligible to receive assistance from the DWSRF.
B.Lack of technical, managerial and financial capability
1.Public water systems that lack the technical, managerial or financial capability to maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter, are not eligible to receive funding from the DWSRF unless the owner or operator of the system agrees to undertake feasible and appropriate changes in operation, or if the use of the financial assistance from the DWSRF will ensure compliance. See § 6.9 of this Part for further discussion on capacity development.
C.Significant noncompliance
1.Public water systems that are in significant noncompliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter, as determined by the Director, are not eligible to receive funding from the DWSRF unless the Director determines that the project will enable the system to return to compliance and the system will maintain an adequate level of technical, managerial and financial capability to maintain compliance.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.4** Project Eligibility {#sec-216-ricr-50-05-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.4}
A.Compliance with Drinking Water Regulations and Health Standards
1.The DWSRF may provide assistance only for expenditures (not including monitoring, operation, and maintenance expenditures) of a type or category which will facilitate compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
2.Projects to address state and/or federal drinking water health standards that have been exceeded or to prevent future violations of these standards are eligible for assistance. This includes projects to extend the water lines of an existing public water system to an area served by contaminated private drinking water wells.
3.Projects to replace aging infrastructure are also eligible if they are needed to maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
B.Land Acquisition
1.Land acquisition is eligible only if it is integral to a project that is needed to meet or maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter. In this instance, land that is integral to a project is only the land needed to locate eligible treatment or distribution projects. In addition, the acquisition has to be from a willing seller. The purchase of land for source water protection is not eligible.
C.Restructuring
1.Projects to restructure a public water system that is in noncompliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter, or a public water system that lacks the technical, managerial or financial capability to maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter, may be eligible for assistance from the DWSRF under the following conditions:
a.Funding may be provided to assist an eligible public water system to consolidate with other public water systems only if the assistance will ensure that the system returns to and maintains compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
b.If the system does not have the technical, managerial, and/or financial capability to ensure compliance, or is in significant noncompliance, the system may receive assistance only if:
(1)The assistance will ensure compliance; or
(2)The owner or operator of the system agrees to undertake appropriate changes in operations to ensure compliance. These changes include consolidation or management changes that will ensure that the system has the technical, managerial, and financial capability to ensure and maintain compliance with the SDWA and the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
D.Planning and Design
1.Planning, design and other related activities for eligible projects, as determined by the Director in accordance with §§ 6.4(A), (B), and (C) of this Part, are eligible for funding. Planning, design, and other related activities may be handled as a separate project.
E.Refinancing of Existing Facilities
1.DWSRF funds may buy or refinance debt obligations of municipal, intermunicipal or interstate agencies, for eligible projects where the initial debt was incurred and construction started after July 1, 1993. Projects which are being refinanced must meet all the requirements of this Part, including eligibility criteria, compliance with all applicable state and federal laws and regulations, and environmental reviews.
F.Guarantee or Purchase Insurance for Local Debt Obligations
1.DWSRF funds may be used to guarantee or purchase insurance for local debt obligations undertaken to finance projects eligible for assistance. Projects for which DWSRF funds are being used to guarantee or purchase insurance for local debt obligations must meet all the requirements of this Part, including eligibility criteria, compliance with all applicable state and federal laws and regulations, and environmental reviews.
G.Projects not eligible for funding:
1.The DWSRF cannot provide funding assistance for the following projects and activities:
a.Dams, or rehabilitation of dams;
b.Water rights, except if the water rights are owned by a system that is being purchased through consolidation as part of a capacity development strategy;
c.Reservoirs, except for finished water reservoirs and those reservoirs that are part of the treatment process and are located on the property where the treatment facility is located;
d.Laboratory fees for monitoring;
e.Operation and maintenance expenses;
f.Projects needed mainly for fire protection;
g.Projects for systems that lack adequate technical, managerial and financial capability, as determined by the Director, unless assistance will ensure compliance;
h.Projects for systems in significant noncompliance, unless funding will enable the system to return to compliance;
i.Projects primarily intended to serve future growth. However, assistance may be provided to address population growth expected to occur over the useful life of the project to be funded.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.5** Project Priority List {#sec-216-ricr-50-05-6-6.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.5}
A.A project cannot receive funding from the DWSRF program unless it is on the approved Project Priority List. The chief executive officer of the eligible public water system must submit to the Department an application requesting that the proposed project be placed on the Project Priority List. The application must include:
1.A description of the project.
2.The reason for the project. The explanation of the reason for the project should be of sufficient detail for the Director to determine the project’s eligibility under § 6.4 of this Part and to rank the project pursuant to § 6.6 of this Part.
3.Average annual residential water bill. The average annual residential water bill is to be based on 70,000 gallons of water per year. Supporting documentation must be provided with the application.
4.The Median Household Income of the community in which the water service area is located. The Median Household Income is to be determined from income data in the most recent United States census. If there is reason to believe that the census data is not an accurate representation of the MHI within the area being served, the reason will be documented and the applicant will furnish additional information regarding the MHI. Information will consist of reliable data from local, regional, state or from an income survey conducted by a reliable impartial source. Median Household Incomes for service areas which cross municipal boundaries is the weighted average based on the number of service connections in each community. Supporting documentation must be provided with the application.
5.The anticipated total cost of the project based on accepted engineering design and construction cost estimates.
6.Anticipated start and finish dates.
7.Public health benefits of the project. The public benefits of the project shall be of sufficient detail to clearly demonstrate the public health benefit of the project.
8.System type.
9.System ownership.
10.System ownership type.
11.Age of the system.
12.Population served (current) by the project. Report the population that the project will serve directly at project completion (not the potential number of people that the project can serve in twenty (20) years).
13.Population served by the system. Report the number of people connected to the water system.
14.The number of service connections served by the project.
15.The number of service connections served by the system.
16.Project location. Provide the physical location of the primary place of performance of the funded activity. If the project spans a large geographic area such as distribution project, provide a street address that best represents the location of the center of the project.
a.Address line 1. Provide the primary street address of the project.
b.Address line 2. Provide any secondary street address information for the primary street address of the project (e.g. P.O. Box 123, pole #).
c.Provide the primary city/or other political jurisdiction of the project location.
d.Provide the primary zip code (zip + 4) of the project (e.g., 12345-6789).
e.Congressional District. Provide the primary congressional district of the project location.
B.The information provided pursuant to § 6.5(A) of this Part will be reviewed for accuracy and eligibility and then given a priority ranking score based on the ranking system in § 6.6 of this Part. The eligible projects and their respective information will then be listed in order of priority, highest to lowest, in a Project Priority List. The Project Priority List will show the following information: name of system, project description, population served, priority point score, and dollars to be funded. The Project Priority List will then be placed in the Intended Use Plan which will go out for public review and comment.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.6** Project Ranking {#sec-216-ricr-50-05-6-6.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.6}
A.The Director shall rank each project according to the project ranking criteria developed by the Department. The Director shall assign points to each project ranking criterion based upon the most current information available to him/her, including information received prior to and during the public review process. The Director shall annually evaluate the ranking of each project and make changes as deemed necessary.
B.Tie Breaking Procedure
1.When two or more projects score equally under the Project Ranking System, the project with the greatest score in Section A (Health Risk and Compliance) of the priority ranking system will receive the higher ranking. If this still results in a tie score, the system with the higher score in Section B (Economic Factors) will be given a higher ranking.
C.Non-construction projects
1.Projects to refinance existing debt, guarantee or purchase insurance for local debt obligations, or for other non-construction activities such as planning and designing will be ranked in the same manner as construction projects. The ranking will be based on the original purpose of the project for which funding is being requested.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.7** Project Priority List Revisions {#sec-216-ricr-50-05-6-6.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.7}
A.As necessary, but not less than annually, the Director shall review the Project Priority List for changes in estimated schedules, project costs and/or scope. The Director may propose modifications of the Project Priority List at any time according to these procedures:
1.Addition to the list: projects can only be added to the list after the solicitation of public comments.
2.By-pass provisions: a project on the Project Priority List may be by-passed, without soliciting public comments, if it is apparent that the project will not be ready to proceed (i.e. system will not be able to sign a loan agreement) by the end of the federal fiscal year in which funding is designated. The highest ranked unfunded project or projects on the priority list which is(are) ready to proceed will be selected for funding utilizing the money freed-up by the by-passed project. By-passed projects will not lose their priority ranking and will be eligible for future DWSRF moneys when the water system is ready to proceed with the project.
3.By-pass provisions for small water systems: to the extent that projects exist, a minimum of 15% of the money available for funding projects each year must go to public water systems that serve a population of less than 10,000 people (small systems). The lowest priority project or projects for water systems that serve 10,000 or more people may be by-passed, without soliciting public comments, in order to achieve this 15% assistance to small systems. As necessary, the highest priority small system projects will be selected to satisfy the minimum 15% level.
4.Emergency projects: without soliciting public comments, projects necessary to address an imminent risk to public health, as determined by the Director, will be moved to the top of the priority list, even if the project was not previously on the priority list. A water system would be considered as having an imminent risk if there is either a known waterborne disease outbreak or a threat of disease outbreak by the presence of an acute contaminant in the system; or the total loss of water supply or loss of a major component due to a natural or unforeseen disaster which could not have been prevented by the applicant.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.8** Eligible Costs {#sec-216-ricr-50-05-6-6.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.8}
Eligible costs, as applied to any eligible project, means any or all costs, including, but not limited to, amounts for the following: planning, design, acquisition, construction, improvement and rehabilitation of facilities; demolitions and relocations; labor, materials, machinery and equipment; services of architects, engineers, and environmental and financial experts and other consultants; feasibility studies, plans, specifications, surveys; and environmental reviews; interest prior to and during the carrying out of any project and for a reasonable period thereafter; reserves for debt service or other capital expenses; cost of issuance of local governmental obligations or obligations of privately organized water suppliers issued to finance the obligations including, without limitation, fees, charges, and expenses and costs relating to the loan evidence.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.9** Capacity Development {#sec-216-ricr-50-05-6-6.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.9}
A.In order to be eligible for financial assistance under the DWSRF program, eligible public water systems must demonstrate that they have the technical, financial and managerial capability to maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter, unless the owner or operator of the system agrees to undertake feasible and appropriate changes in operation or if the use of the financial assistance from the DWSRF will ensure compliance.
B.Technical and Managerial Capacity
1.The Department’s determination of technical and managerial capacity will be based on the water system’s ability to maintain substantial compliance with all of the requirements specified in the Department’s Technical and Managerial Capacity Analysis worksheet. Assurance of technical and managerial capacity will be based on:
a.Compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
b.Compliance with the Rules and Regulations Pertaining to the Certification of Public Drinking Water Supply Treatment and Public Water Supply Transmission and Distribution Operators, Part 5 of this Subchapter.
c.Compliance with the Rules and Regulations for Clean Water Infrastructure Plans, Part 7 of this Subchapter.
d.Compliance with the Public Drinking Water Protection Act (R.I. Gen. Laws. Chapter 46-15.3).
e.Compliance with the Water Supply Management Act (R.I. Gen. Laws Chapter 46-15.4).
f.Correction of all critical deficiencies on the applicant’s last sanitary survey.
g.For water systems serving less than 50 million gallons per year, an analysis of necessary and/or planned operational and capital improvements over the next five (5) years.
C.Financial Capacity
1.In order to be eligible for financial assistance from the DWSRF program, eligible public water systems must demonstrate that they have the financial ability to maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.10** Certificate of Approval {#sec-216-ricr-50-05-6-6.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.10}
A.A Certificate of Approval for a project shall be issued by the Director to a local governmental unit or privately organized water supplier prior to receiving financial assistance from the Bank. The Certificate of Approval shall specify the project or portion thereof eligible for financial assistance, the cost of the project or portion thereof, and other terms, conditions, and limitations with respect to the planning, engineering, construction and operation of the project as the Director shall determine.
B.All applications for a Certificate of Approval must be submitted to the Department and must include:
1.A summary sheet listing a breakdown of project costs and portions for which financial assistance is being sought.
2.Sufficient evidence to show that the water system has the technical and managerial capabilities to maintain compliance with the Rules and Regulations Pertaining to Public Drinking Water, Part 1 of this Subchapter.
3.A Categorical Exclusion (CE), Finding of No Significant Impact, or a Record of Decision indicating that the project has successfully undergone an environmental review in accordance with § 6.11 of this Part.
4.Certification that the project is consistent with the State Guide Plan. Projects that qualify for categorical exclusions are exempt.
5.Certification of intent to comply with all applicable provisions of federal and/or state laws.
C.Applications for a Certificate of Approval for new water sources and/or the construction or alteration of a public drinking water supply facility, including but not limited to, pumping, treatment, storage and distribution, which have an impact on drinking water quality, as determined by the Director, shall be required to include all applicable Architectural and Engineering reports and plans for review and approval.
D.Exceptions to the requirements in §§ 6.10(B), and (C) of this Part can be made by the Director when the eligible system requires funding to move its project forward. A Certificate of Approval can be issued, in these circumstances, provided the Certificate of Approval contains conditions that require the submission of all the required elements including planning, land acquisition, engineering design, State Guide Plan consistency, and the environmental review, as required in § 6.11 of this Part. In such circumstances, an application for the Certificate of Approval must be made and at a minimum the requirements in §§ 6.10(B)(1), (2), and (5) of this Part must be included.
E.Drinking water projects shall be designed, installed and constructed in accordance with applicable American Water Works Association (AWWA) standards with reference to materials to be used and construction procedures to be followed. In the absence of AWWA standards, Departmental review shall be based upon the Recommended Standards for Water Works by Great Lakes Upper Mississippi River Board of State Public Health & Environmental Managers (i.e., the 10 State Standards), National Sanitation Foundation (NSF) Standards, and other recognized standards utilized by design engineers.
F.The issuance of a Certificate of Approval shall not be in lieu of, and every approved project shall remain subject to, each and all environmental, technical and regulatory approval requirements as provided in applicable state and federal laws and regulations, including those requirements which are administered by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.11** Environmental Review Process {#sec-216-ricr-50-05-6-6.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.11}
A.General Process and Background
1.This State Environmental Review Process (SERP) addresses compliance with the National Environmental Policy Act, a requirement of the SDWA for all projects funded with the federal portion of the Rhode Island DWSRF program. Further, environmental review for natural resources inventories and consistency with the State Guide Plan (SGP) is required for all projects funded by the state portion of the DWSRF program, except for those that qualify for a categorical exclusion. The Rhode Island Comprehensive Planning and Land Use Act [R.I. Gen. Laws Chapter 45-22.2] requires not only the coordination and consistency between state and local planning programs in the development of the Community Comprehensive Plan, but also consideration of environmental conditions during planning similar in many respects to National Environmental Policy Act.
B.Public Water System Responsibility
1.The public water system shall prepare and submit an environmental review as part of the application for a Certificate of Approval. Exceptions to the requirement to submit the environmental review with the application for a Certificate of Approval can be made in accordance with § 6.10(D) of this Part.
2.Except where exempted in § 6.11(C) of this Part, the public water system shall prepare an Environmental Assessment for all projects utilizing DWSRF funds. Comments by all agencies with statutory and/or regulatory authority within the planning area (e.g. RI Statewide Planning, RI Coastal Resources Management Council, RI Department of Environmental Management, RI Historical Preservation and Heritage Commission, RI Department of Transportation, U.S. Fish & Wildlife, etc.) shall be requested by the public water system as part of the Environmental Assessment process. If the Environmental Assessment does not identify significant impacts from the proposed project(s), the Department will issue a Finding of no Significant Impacts. If, as a result of the Environmental Assessment, significant impacts are identified, the public water system must prepare an Environmental Impact Statement.
3.The public water system must hold at least one (1) public meeting/workshop during the preparation of the Environmental Assessment, preferably once the alternatives have been developed and the environmental impacts analyzed. This meeting will explain the plan of study and solicit public opinions and concerns. If the impacts identified with the preferred alternative in the Environmental Assessment are significant, the public water system must issue a public notice stating that an Environmental Impact Statement is being initiated and that a scoping meeting will be held. In addition to the public meeting/workshop, when the preferred alternative is identified, the public water system must hold a public hearing on the draft Environmental Assessment/Environmental Impact Statement. The final Environmental Assessment/Environmental Impact Statement submitted to the Department for review and approval must include responses to all substantive public comments. Documentation of the meeting/ workshop and public hearing announcements including media announcement public postings etc., attendance sheet, project presentation, public comment and notes of the meeting/workshop shall be included in the Appendix of the Environmental Assessment/Environmental Impact Statement. Stenographic or a video of the public hearing must also be included in the Appendix of the Environmental Assessment/Environmental Impact Statement.
4.Mitigation measures and comments by other agencies shall be incorporated in the Environmental Assessment/Environmental Impact Statement and will be reflected in any final determination rendered by the Department.
C.Categorical Exclusion
1.Categories of projects which do not individually or cumulatively have significant effects on the quality of the environment may be exempted from the substantive environmental review requirements of this section. Projects that solely involve the acquisition, construction, reconstruction, renovation, or installation of facilities or structures, for replacement or restoration purposes, with minimal change in use, size, capacity, purpose or location from the original facility, may be eligible for a categorical exclusion. Environmental assessments and/or Environmental Impact Statements will not be required for excluded actions. It must be emphasized that even though a project is excluded from further environmental reviews under this section, it is not excluded from other applicable local, state, and federal environmental laws.
2.General Categories of Actions Eligible for Exclusions. Projects consistent with any of the following categories may be eligible for a categorical exclusion:
a.Repairing or replacing existing water mains.
b.Replacing an existing water storage tank with a new tank of similar size and stature at the same location.
c.The installation, replacement or repair of equipment (i.e., treatment, pumps, controls, etc.) within existing buildings.
d.Minor rehabilitation of existing facilities.
e.Other projects which, as determined by the Director, do not individually, cumulatively over time, or in conjunction with other state, federal, local, or private actions have a significant effect on the quality of the environment.
3.General Categories of Actions Not Eligible for Exclusions. The full environmental review procedures of this section shall be followed if the undertaking of a project consistent with allowable categories in § 6.11(C)(2) of this Part involves a serious local or environmental issue, or meets any of the following criteria:
a.The project is known or expected to have a significant effect on the environment, either individually, cumulatively over time, or in conjunction with other state, federal, local or private actions;
b.The project is known or expected to directly affect:
(1)Cultural resource areas such as archaeological and historic sites;
(2)Endangered or threatened species and their critical habitats;
(3)Environmentally important natural resource areas such as floodplains, wetlands, important farmlands, and aquifer recharge zones;
4.Public water systems wishing to obtain a categorical exclusion for a project should submit a written request to the Director. The written request should include a brief description of the proposed project and a brief statement of how the project meets the criteria for a categorical exclusion. The Director shall review the request and determine whether to issue or deny a categorical exclusion for the proposed project. The Director shall notify the public water system of the decision to issue or deny a categorical exclusion as soon as practicable.
5.The Director shall revoke a categorical exclusion and shall require a full environmental review if, subsequent to the granting of an exclusion, the Director determines that the proposed project no longer meets the requirements for a categorical exclusion due to changes in the proposed project or determines from new evidence that serious local or environmental issues exist or that federal, state, or local laws are being or may be violated.
D.Consistency Requirements
1.To ensure compliance with state law, the Department will not issue a Certificate of Approval for a DWSRF project unless it is consistent with the local Community Comprehensive Plan. Projects that qualify for a categorical exclusion will be exempt from the State Guide Plan consistency requirement. Applications for a Certificate of Approval must contain a certification by the Department of Administration’s Division of Planning that the project is consistent with the SGP or excerpts from a Community Comprehensive Plan approved by the State Planning Council. However, a Certificate of Approval may be issued prior to the Environmental Assessment in accordance with § 6.10(D) of this Part.
E.Department’s Public Review Process
1.The Department will independently review and evaluate the environmental information provided. If it is determined that there will be no substantive environmental impacts the Department shall decide to issue a CE, Finding of No Significant Impact or Record of Decision.
2.Following the Department’s decision to issue a CE, Finding of No Significant Impact, Record of Decision, or reaffirmation of a previous decision, the Department will invite public comments for thirty (30) days, or as required by R.I. Gen. Laws Chapter 42-35, by publishing a notice of the determination made in a paper of statewide circulation, on the Department’s website and/or any other acceptable means in accordance with R.I. Gen. Laws Chapter 42-35. In addition, notification of such determination will be sent to all persons and associations who have advised the Department that they wish to be notified. During the public comment period, any interested party may submit written comments. Requests for a public hearing shall be made in accordance with R.I. Gen. Laws § 42-35-2.8. Following public notice or public hearing, the final determination will be made by the Director.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.12** Green Project Reserve (GPR) {#sec-216-ricr-50-05-6-6.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.12}
6.12.1Introduction
A.GPR may be used for planning, design and/or building activities. Under the GPR in the DWSRF both entire projects may be considered for inclusion or appropriate identifiable components of larger projects may be considered for inclusion. All projects or project components counted toward the GPR requirement must clearly advance one or more of the objectives articulated in the following four (4) categories of GPR:
1.Green Infrastructure;
2.Water Efficiency;
3.Energy Efficiency; and
4.Environmentally Innovative. Source water protection projects are not eligible for RI DWSRF funding.
6.12.2DWSRF Green Project Reserve Eligibility Principles
A.All GPR projects and activities must otherwise be eligible for DWSRF funding. The GPR requirement does not create new funding authority beyond that described in the SDWA § 1452.
B.GPR project and activities must meet the definition of one of four GPR categories. The individual GPR categories do not create new eligibility for the DWSRF. The projects that count toward the GPR must otherwise be eligible for DWSRF funding.
C.GPR projects and activities must further the goals stated in the SDWA § 1452.
6.12.3Business Case Requirement
A.Projects and activities that fit within the four (4) specific categories as detailed in §§ 6.12.4(B), 6.12.5(B), 6.12.6(B), and 6.12.7(B) of this Part, define each category of GPR projects that do not require a business case. These sections list projects that are clearly eligible for GPR, heretofore known as categorically eligible projects.
B.Projects that do not appear on the list of categorically eligible projects must be evaluated for their eligibility within one of the four (4) targeted types of GPR eligible projects based upon a business case that provides clear documentation.
C.The Department, in consultation with the EPA, as necessary, is responsible for the business case review and will either accept or reject the business case. The Certificate of Approval process will not commence without an approved Business Case. Approved business cases will be posted on the Department website.
6.12.4Green Infrastructure
A.Green stormwater infrastructure includes a wide array of practices at multiple scales that manage wet weather and that retains and restores natural hydrology by infiltrating, evapotranspiring and harvesting and using stormwater. On a regional scale green infrastructure is the preservation and restoration of natural landscape features, such as forest, floodplains and wetlands coupled with policies such as infill and redevelopment that reduce overall imperviousness in a watershed. On the local scale, green infrastructure consists of site and neighborhood-specific practices, such as bioretention, trees, green roofs, permeable pavements and cisterns.
B.Categorical Projects
1.The following types of projects, proposed at a utility-owned facility or as part of a water infrastructure project, can be counted toward the GPR if they are part of an eligible DWSRF project:
a.Pervious or porous pavement;
b.Bioretention;
c.Green roofs;
d.Rainwater harvesting/cisterns;
e.Grey water use;
f.Xeriscape;
g.Landscape conversion programs;
h.Moisture and rain sensing irrigation equipment.
C.Projects That Do Not Meet the Definition of Green Infrastructure
1.Stormwater controls that have impervious or semi-impervious liners and provide no compensatory evapotranspirative or harvesting function for stormwater retention.
2.Stormwater ponds that serve an extended detention function and/or extended filtration. This includes dirt lined detention basins.
3.In-line or end-of-pipe treatment systems that only filter or detain stormwater.
4.Underground stormwater control and treatment devices such as swirl concentrators hydrodynamic separators, baffle systems for grit, trash removal/floatables oil and grease, inflatable booms and dams for in-line underground storage and diversion of flows.
5.Stormwater conveyance systems that are not soil/vegetation based (swales) such as pipes and concrete channels, Green infrastructure projects that include pipes to collect stormwater may be justified as innovative environmental projects pursuant to § 6.12.7 of this Part.
D.Decision Criteria for Business Cases
1.Green infrastructure projects are designed to mimic the natural hydrologic conditions of the site or watershed.
2.Projects capture, treat, infiltrate or evapotranspire storm water on the parcels where it falls and does not include inter basin transfer of water.
3.GPR project is in lieu of or to supplement municipal hard/grey infra-structure.
4.Projects considering both landscape and site scale will be most successful at protecting water quality.
5.Design criteria is available on EPA’s website
6.12.5Water Efficiency
A.EPA’s WaterSense program defines water efficiency as the use of improved technologies and practices to deliver equal or better services with less water. Water efficiency encompasses conservation and reuse efforts, as well as water loss reduction and prevention, to protect water resources for the future.
B.Categorical Projects
1.Installing or retrofitting water efficient devices such as plumbing fixtures and appliances.
a.For example, showerheads, toilets, urinals, and other plumbing devices.
b.Implementation of incentive programs to conserve water such as rebates.
c.WaterSense labeled products
2.Installing any type of water meter in previously unmetered areas
a.If rate structures are based on metered use,
b.Can include backflow prevention devices if installed in conjunction with water meter.
3.Replacing existing broken/malfunctioning water meters with:
a.Automatic meter reading systems (AMR) for example:
(1)Advanced metering infrastructure (AMI)
(2)Smart meters.
b.Meters with built in leak detection.
c.Can include backflow prevention devices if installed in conjunction with water meter replacement.
4.Retrofitting/adding AMR capabilities or leak equipment to existing meters (not replacing the meter itself).
5.Conducting water utility audits, leak detection studies, and water use efficiency baseline studies, which are reasonably expected to result in a capital project or in a reduction of demand to alleviate the need for additional capital investment. For standard practices, refer to AWWA M36 Water Audits and Loss Control Programs. Free Water Audit Software is available through AWWA.
6.Developing conservation plans/programs reasonably expected to result in water conserving capital projects or in reduction in water demands to alleviate the need for additional capital investment. For standard practices see AWWA M52 Water Conservation Programs – A Planning Manual.
7.Recycling and water reuse projects that replace potable sources with non-potable sources,
a.Gray water, condensate, and wastewater reuse systems (where local codes allow the practice).
b.Extra treatment equipment costs and distribution pipes associated with water reuse.
8.Retrofit or replacement of existing landscape irrigation systems to more efficient landscape irrigation systems, including moisture and rain sensing controllers.
9.Projects that result from water efficiency related assessments (such as water audits, leak detection studies, conservation plan, etc.) as long as the assessments adhered to the standard industry practices referenced above.
10.Distribution system leak detection equipment, portable or permanent.
11.Automatic flushing systems (portable or permanent).
12.Pressure reducing valves (PRVs)
13.Internal plant water reuse as allowed by the rules and regulations pertaining to Public Drinking Water (Part 1 of this Subchapter).
C.Projects That Do Not Meet the Definition of Water Efficiency
1.Covering open finished water reservoirs – Federally mandated, so not considered “above and beyond.”
D.Decision Criteria for Business Cases
1.Water efficiency can be accomplished through water saving elements or reducing water consumption. This will reduce the amount of water taken out of rivers, lakes, streams, groundwater or other sources.
2.Water efficiency projects should deliver equal or better services with less net water use as compared to traditional or standard technologies and practices.
3.Efficient water use often has the added benefit of reducing the amount of energy required by a drinking water system, since less water would need to be treated and transported; therefore there are energy and financial savings.
4.Proper water infrastructure management should address where water losses could be occurring in the system and fix or avert them. This could be achieved for example, by making operational changes or replacing aging infrastructure.
E.Example Projects Requiring a Business Case
1.Water meter replacement with traditional water meters (see AWWA M6 Water Meter –Selection, Installation Testing and Maintenance).
2.Distribution pipe replacement or rehabilitation to reduce water loss and prevent water main breaks (see AWWA M28 Rehabilitation of Water Mains).
3.Storage tank replacement/rehabilitation to reduce water loss.
4.New water efficient landscape irrigation system.
6.12.6Energy Efficiency
A.Energy efficiency is the improved technologies and practices to reduce the energy consumption of water projects, use energy in a more efficient way, and/or produce/utilize renewable energy. Refer to EPA’s website for further information on energy efficiency.
B.Categorical Projects. EPA has concluded that existing literature does not support a twenty percent (20%) energy efficiency improvement threshold for drinking water system. Therefore. there is no categorical twenty percent (20%) threshold for pumping/ treatment systems for the DWSRF. A business case is required.
1.Renewable energy projects, which are part of a larger public health project, such as wind, solar, geothermal, and micro-hydroelectric that provide power to a utility (. Micro-hydroelectric projects involve capturing energy from pipe flow.
a.Utility-owned renewable energy projects can be located on-site or off-site.
b.Includes a portion of a publicly owned renewable energy project that serves the utility energy needs.
c.Must feed into the grid that the utility draws from and/or there is a direct connection.
2.Utility energy management planning, including energy assessments, energy audits, optimization studies, and sub-metering of individual processes to determine high energy use areas, which are reasonably expected in energy efficiency capital projects or in a reduction in demand to alleviate the need for additional capital investment.
3.National Electric Manufacturers Association (NEMA) Premium energy efficiency motors
C.Projects That Do Not Meet the Definition of Energy Efficiency
1.Simply replacing a pump, or other piece of equipment, because it is at the end of its useful service life, with something of average efficiency. (Note: replacing it with a higher efficiency equipment requires a business case)
2.Hydroelectric facilities, except micro-hydroelectric projects. Micro- hydroelectric projects involve capturing the energy from pipe flow.
D.Decision Criteria for Business Cases
1.Projects should include products and practices which will decrease environmental impact, such as reducing greenhouse gas emissions, and provide financial savings.
2.Projects should include approaches to integrate energy efficient practices into daily management and long-term planning.
3.Operator training in conjunction with any energy saving project is strongly encouraged in order to maximize the energy saving potential.
4.Using existing tools such as Energy Star’s Portfolio Manager to document the current energy usage and track anticipated savings.
E.Example Projects Requiring a Business Case
1.Energy efficient retrofits, upgrades, or new pumping systems and treatment processes (includes variable frequency drives (VFDs)).
2.Pump refurbishment to optimize pump efficiency (such as replacing or trimming impellers if pumps have too much capacity, replacing damaged or worn wearing rings/seals/bearings, etc.).
3.Projects that result from an energy efficiency related assessments (such as energy audits, energy assessment studies, etc.), that are not otherwise designated as categorical.
4.Projects that cost effectively eliminate pumps or pumping stations.
5.Project that achieve the remaining increments of energy efficiency in a system that is already very efficient.
6.Upgrade of lighting to energy efficient sources (such as metal halide pulse start technologies, compact fluorescent, light emitting diode, etc.).
7.Automated and remote control systems (SCADA) that achieve substantial energy savings (see AWWA M2 Instrumentation and Control).
6.12.7Environmentally Innovative
A.Environmentally innovative projects include those that demonstrate new and/or innovative approaches to delivering services or managing water resources in a more sustainable way.
B.Categorical Projects
1.Total/integrated water resources management planning, or other planning framework where project life cycle costs (including infrastructure, energy consumption, and other operational costs) are minimized, resulting in communities adopting more efficient and cost-effective infrastructure solutions.
a.Plans to improve water quantity and quality associated with water system technical, financial and managerial capacity.
b.Planning activities by a utility to prepare for adaption to the long-term effects of climate change and/or extreme weather.
2.Utility Sustainability plan consistent with EPA’s SRF Sustainability policy.
3.Greenhouse gas (GHG) inventory or mitigation plan and submission of a GHG inventory to a registry (such as Climate Leaders or Climate Change Registry), if for a facility which is eligible for DWSRF assistance.
a.EPA Climate Leaders
b.Climate Change Registry
4.Construction of United States Building Council LEED certified buildings, or renovation of an existing building, owned by the utility, which is part of an eligible DWSRF project.
a.Any level of certification (Platinum, Gold, Silver Certified)
b.All building costs are eligible, not just stormwater, water efficiency and energy efficiency related costs. Costs are not limited to incremental additional costs associated with LEED certified buildings.
C.Projects That Do Not Meet the Definition of Environmentally Innovative
1.Higher sea walls to protect water infrastructure facilities from sea level rise.
2.Reflective roofs at water infrastructure facilities to combat heat island effect.
D.Decision Criteria for Business Cases
1.The State program is allowed flexibility in determining what projects qualify as innovative in their state based on unique geographical and climatological conditions.
a.Technology or approach whose performance is expected to address quality but the actual performance has not been demonstrated in the state; or
b.Technology or approach that is not widely used in the state, but does perform as well or better than conventional technology/approaches at lower costs; or
c.Conventional technology or approaches that are used in a new application in the state.
E.Example Projects Requiring a Business Case
1.Projects or components of projects that result from total/integrated water recourses management planning (including climate change) consistent with the Decision Criteria for environmentally innovative projects and that are DWSRF eligible.
2.Application of innovative treatment technologies or systems that improve environmental conditions and are constant with the Decision Criteria for environmentally innovative projects.
a.Projects that significantly reduce or eliminate the use of chemicals in water treatment.
b.Treatment technologies or approaches that significantly reduce the volume of residuals, minimize the generation of residuals, or lower the amount of chemicals in the residuals.
c.Trenchless or low impact construction technology
d.Using recycled materials or reusing materials on site.
3.Educational activities and demonstration projects for water or energy efficiency such as rain gardens.
4.Projects that achieve the goals/objectives of utility asset management plans.
6.12.8Business Case Development
A.A business case is a due diligence document for those projects or portions of a projects, which are not included in the categorical projects listed in §§ 6.12.4(B), 6.12.5(B), 6.12.6(B), and 6.12.7(B) of this Part. A business case will be required to demonstrate that an assistance recipient has thoroughly researched anticipated ‘green’ benefits of a project. Business cases must be approved by the State in conjunction with the EPA prior to receiving a Certificate of Approval for the project or portion of the project which the assistance recipient seeks an additional Green Project Reserve (GPR) financial assistance subsidy. A GPR financial assistance subsidy shall be subject to availability of funds. The approved business case must be included in the assistance recipient project files and contain clear documentation that the project achieves identifiable and substantial benefits.
B.Length of a Business Case
1.Business cases should be adequate but not exhaustive.
a.There are many formats and approaches. State and EPA does not require any specific one.
b.Some projects will require detailed analysis and calculations, while others may not require more than one page.
c.Limit the information contained in the business case to only the pertinent ‘green’ information needed to justify the project.
2.A business case can simply summarize results from and then cite, existing documentation – such as engineering reports, water or energy audits, results of water system tests, etc.
C.Content of a Business Case
1.Business cases must address the decision criteria for the category project.
2.Quantifiable water and/or energy savings or water loss reduction for water and energy efficiency projects shall be included.
3.The costs and financial benefit of the project shall be included, along with the payback time period, where applicable.
D.Items Which Strengthen Business Case, but Are Not Required
1.Showing that the project was designed to enable equipment to operate most efficiently.
2.Demonstrating that equipment will meet or exceed standards set by professional associations.
3.Including operator training or committing to utilizing existing tools such as Energy Star’s Portfolio Manager or CUPSS for energy efficiency projects
4.Example Business Cases are available at http://www.srfbusinesscases.net/
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.13** Loan Program {#sec-216-ricr-50-05-6-6.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.13}
All loan requirements are contained in the Bank’s loan policies and procedures
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.14** Project Administration and Audit {#sec-216-ricr-50-05-6-6.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.14}
The Department shall have the authority to inspect the construction and operation of approved projects for compliance with this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
##### **216-RICR-50-05-6 § 6.15** Rules Governing Practices and Procedures {#sec-216-ricr-50-05-6-6.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-6#6.15}
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 46-12.8, shall be held in accordance with the provisions of Practices and Procedures Before the Rhode Island Department of Health, Part 10-05-4 of this Title, and Access to Public Records, Part 10-05-1 of this Title.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2018-04-19 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/19/2018*
- *Amendment — effective from 2011-06-20 to 04/19/2018*
- *Amendment — effective from 2006-05-21 to 06/20/2011*
- *Periodic Refile — effective from 2002-01-02 to 05/21/2006*
#### **216-RICR-50-05-7** Clean Water Infrastructure Plans
##### **216-RICR-50-05-7 § 7.1** AUTHORITY {#sec-216-ricr-50-05-7-7.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.1}
A.These rules and regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws § 46-15.6-7.
B.The terms and provisions of the rules and regulations shall be liberally construed to allow the Department of Health to effectuate the purposes of the state law, goals, and policies consistent with the R.I. Gen. Laws Chapter 46-15.6.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.2** PURPOSE {#sec-216-ricr-50-05-7-7.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.2}
A.The waters of this state are a critical renewable resource which must be protected to insure the continued availability of safe and potable drinking water for present and future needs. It is a paramount policy of the state to protect the purity of present and future drinking water supplies by protecting the infrastructure of potable water, including sources, treatment plants and distribution systems. The decay of water supply infrastructure due to deterioration or functional obsolescence can threaten the quality of water supplies and therefore can endanger public health. Therefore, it is necessary to take timely and continuing steps to repair and replace the infrastructure used to treat and deliver drinking water from public water suppliers.
B.By planning and funding for future infrastructure replacement, unexpected large capital expenditures causing sudden increases in water rates can hopefully be avoided. The intent of this Infrastructure Replacement Plan is to provide a planning and funding mechanism to ensure that infrastructure replacement programs are carried out by each municipality, district, agency, authority, or other entity engaged in the supply, treatment, transmission, and/or distribution of drinking water.
C.Goals of the plan include the justification of a facility replacement program, the provision of a dedicated and sufficient funding mechanism, the prioritization of infrastructure replacement, and the prevention of the erosion of drinking water infrastructure.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.3** DEFINITIONS {#sec-216-ricr-50-05-7-7.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.3}
A.Wherever used in this Part, the following terms shall be construed as follows:
1.“Audit” means the annual formal examination of the water supplier's financial statements including all investments, interest, expenditures, and operating costs.
2.“Commission” means the Public Utilities Commission (PUC) of the State of Rhode Island.
3.“Comprehensive plan” means the Comprehensive Plan adopted and approved in accordance with R.I. Gen. Laws Chapter 45-22.2, the RI Comprehensive Planning and Land Use Regulation Act. A document prepared by each local municipality which contains the planning and implementation program for land use, housing, economic development, natural and cultural resources, services and facilities, open space and recreation, and circulation.
4.“Department” means the Department of Health (DOH), Division of Drinking Water Quality.
5.“Distribution facilities” means the pipes and appurtenant facilities employed specifically to deliver, to dispense, to render or to circulate potable water directly to the consumer.
6.“Drinking water” means potable water served to the public.
7.“Economic life” means the expected financial lifespan of a component of a public water system which is used to depreciate the capital expense of the component.
8.“Eligible expenditures” means those costs and expenses necessary to fund, manage, and implement the infrastructure replacement plan, only. This may include associated accounting fees, consulting fees, replacement construction, etc.
9.“Infrastructure” means the permanent underlying framework of the public water system, including but not limited to, supplies, transmission, storage, distribution, pumping, and treatment facilities.
10.“Life expectancy” means the expected physical lifespan of a component of a public water system.
11.“Maintenance” means a planned program of inspection, adjustment, exercise, lubrication, etc. which allows the maximum continuous service of the equipment in the system at the lowest possible cost to the utility as required in the Water Resources Board "Rules and Procedures for Water Supply Systems Management Planning" § 8.07(c). Routine maintenance expenditures are not eligible for funding from the Infrastructure Replacement Plan.
12.“Rate fee” means the charge per unit for public water based upon a ratio, scale, or standard relative to the cost of supplying potable drinking water.
13.“Rehabilitation” means rehabilitation which restores existing facilities or components to a condition which extends the physical and economic life of the component. Rehabilitation is an eligible expenditure under the Infrastructure Replacement Plan.
14.“Repair” means expenditures to return into service a component of the infrastructure that has failed is not an eligible expenditure under the Infrastructure Replacement Plan.
15.“Replacement” means new construction to substitute for existing facilities or components which cannot be rehabilitated or repaired cost effectively is an eligible expenditure under the Infrastructure Replacement Plan.
16.“Special account” means an account established by physically opening an account designated as the "Infrastructure Replacement Fund" that is acceptable under this Part. This account shall be self-contained in that deposits and withdrawals are recorded by the financial institution through a fiduciary relationship with the utility. This special account shall be a restricted receipt account dedicated solely for funding of eligible expenditures from the infrastructure replacement program and be administered by the general manager of the water supplier or his designee. All receipts, income, and interest earned on these funds shall be accrued within this special account.
17.“Surcharge” means a fee charged in addition to normal system rate fees which is used to fund extraordinary or special conditions of the water system.
18.“Transmission facilities” means the pipes, pumping stations, and storage facilities required to carry raw and/or potable water from a water source to or throughout an area served or to be served by a water supply system for the specific purpose of supplying water to support a general population.
19.“Water supplier” means any municipality, municipal department, agency, district, authority, or other entity engaged in or authorized to engage in the supply, treatment, transmission, or distribution of drinking water on a wholesale or retail sales basis.
20.“Water supply sources” means Department of Health approved sources of supply connected to a water supply system and available for distribution. These sources may be surface waters or groundwater wells.
21.“Water supply management plan” means a plan prepared by applicable public water suppliers which plans and implements effective and efficient conservation, development, utilization, and protection of water supply resources consistent with the present and future needs of the State and its people as defined in R.I. Gen. Laws § 46-15.4.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.4** APPLICABILITY - PREPARATION OF PLANS {#sec-216-ricr-50-05-7-7.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.4}
All water suppliers which supply, obtain, transport, distribute, purchase, and/or sell on a wholesale or retail basis, more than fifty million (50,000,000) gallons of water per year shall be required to prepare, maintain, and carry out a clean water infrastructure replacement plan as described in this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.5** CONFORMITY WITH OTHER LEGISLATION {#sec-216-ricr-50-05-7-7.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.5}
The clean water infrastructure replacement plans shall be in conformity with all applicable provisions of state and federal laws including the federal Safe Drinking Water Act (42 U.S.C. § 300f et seq.); and R.I. Gen. Laws Chapter 46-13, Public Drinking Water Supply. Infrastructure replacement plans must be consistent with the Comprehensive 3 Plan for the community or communities associated with the water system. Infrastructure replacement plans shall also be consistent with the water supply management plans required under R.I. Gen. Laws § 46-15.3-5.1.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.6** CONTENTS OF PLANS {#sec-216-ricr-50-05-7-7.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.6}
A.Clean water infrastructure replacement plans shall be prepared in the format, and shall address each of the topics listed in this section, to the extent that each is relevant to the water supplier, the water source, the water system, and the transmission/distribution/storage system. Systems which currently have an infrastructure replacement plan may review the existing plan and utilize existing information to the extent that it is consistent with the intent of the infrastructure replacement plan outlined below. The initial plan may include a schedule for the completion of the evaluation of major components or items which require detailed investigation. The schedule must demonstrate an expeditious, responsible, and reasonable time period for compliance.
B.All principal components of the water system such as sources, reservoirs, dams, spillways, intakes, treatment plants, pump stations, storage facilities, pumping and well equipment, shall be listed and evaluated. Relatively small and numerous components of the system such as water mains, distribution piping, valves, hydrants, and interconnections may be evaluated as a group. This evaluation shall consider the following:
1.A brief description of the system with a schematic of the process flow will be included in the plan. This description of the system may be taken directly from the Water Supply Management Plan where relevant and is not intended as a duplicate effort but to facilitate the evaluation of individual components. Age and condition of the existing component and the necessity for replacement of the component within a twenty (20) year time frame shall be evaluated. Specific components may be in need of immediate replacement while others may extend well beyond the twenty (20) year time frame. Replacement should be evaluated and prioritized over a minimum of five (5) year intervals. The level of detail in the analysis of the component should reflect the priority of the component to the proper operation of the system as well as the age and known condition of the component. A detailed schedule for the initial five (5) year interval must be included. No infrastructure replacement construction is required to take place within any time interval if demonstrated to not be necessary.
2.Life expectancy of the component shall be determined. Life expectancy shall be determined by design criteria, specific site conditions, maintenance records, manufacturer's documentation, engineering evaluation, physical inspection, invasive and/or non-destructive integrity testing, or a combination of all of the above. Records of inspection and maintenance may be reviewed when determining the life expectancy of the component. The attached Component Life Expectancy and Actual Life Expectancy Guideline (“Guideline”), in § 7.9 of this Part, is intended to serve as a general rule of thumb for component life expectancy and actual life expectancy within an individual system may be demonstrated to be significantly more or less than the Guideline value.
3. Consideration shall be given to the public water system's ability to meet current and future requirements of the Safe Drinking Water Act. Treatment requirements should be analyzed to the extent possible to ensure that infrastructure replacement and/or rehabilitation will comply with mandated requirements consistent with the Safe Drinking Water Act.
4.A financial forecast shall be based on the analysis of the condition and life expectancy of the existing facilities, prioritized needed repairs and replacements and amortize proportionally such improvement requirements on an annual basis over the next twenty years consistent with their respective life expectancy. The forecast shall include contingency costs, range of construction costs, and/or confidence limits of the financial forecast.
5.Infrastructure replacement shall meet the needs of the water suppliers, however priority of anticipated replacement and grouping of replacement projects by time of replacement, similarity of projects, and importance of the component to the system shall be considered when establishing the schedule. Priority should be given to components which have a known need for replacement and less detailed analysis given to relatively new infrastructure items.
C.When planning infrastructure replacement, the water supplier shall consider sizing facilities to meet the approved local comprehensive plans for existing or proposed service areas. The existing or proposed service area shall be defined consistent with that described in the supplier's most recent Water Supply Management Plan. Funding for proposed expansion shall come from the capital improvement program utilizing new capital rather than from replacement funding. It is intended that the infrastructure replacement plan evolve from the Water Supply Management Plan and expand the concepts of capital improvement planning initiated in the Water Supply Management Plan. The infrastructure replacement plan shall be consistent with sound waterworks practice.
D.The infrastructure replacement plan must recognize and maintain existing fiscal controls and accounting standards in accordance with Generally Accepted Government Accounting Principles sufficient to ensure fiscal responsibility for the evaluation and implementation of the infrastructure replacement. These fiscal controls and accounting standards must be established where none currently exist. The financial requirements of the plan shall conform to those outlined in § 7.8 of this Part.
E.Funds from the watershed protection fund may be used for the preparation of clean water infrastructure replacement plans up to fifty percent (50%) of the cost of the plan. Disbursements from the fund shall be in accordance with R.I. Gen. Laws Chapter 46-15.3-11 of the Public Drinking Water Resources Board Operating Fund. The remaining costs are eligible for funding through the Safe Drinking Water Revolving Loan Fund. The plan shall incorporate the proposed rate structure impacts, schedule of proposed rate changes, and schedule for full funding consistent with the funding requirements for scheduled infrastructure replacement.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.7** REVIEW OF PLANS {#sec-216-ricr-50-05-7-7.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.7}
A.Water suppliers subject to the requirements of this Part shall file six copies of the clean water infrastructure plan with the Center for Drinking Water Quality of the Department. Plans must be submitted no later than one year subsequent to the date the system's water supply management plan is due.
B. The Department shall coordinate review of the plan with the Department of Environmental Management's Division of Water Supply Management, the Department of Administration's Division of Planning, the Water Resources Board, and the Public Utilities Commission. The PUC shall only review Plans for those systems which are regulated by the PUC. Each Department shall have one hundred twenty (120) days to review the plan and submit comments to the Department of Health. Upon consideration of the comments, the Department shall determine if the plan complies with the requirements of this Part within two hundred forty days (240) of the initial submission. A thirty (30) day public comment period is inclusive in this two hundred forty day (240) review period.
C.Water suppliers shall review and update their infrastructure replacement plans at a minimum frequency of every five years. Major modifications or revisions to the infrastructure replacement plan shall be submitted for review more frequently as necessary.
D.Water suppliers shall implement the infrastructure replacement plan according to the approved plan. On-site review of facility components may be conducted by the Department when appropriate and/or applicable. The responsible official of the water supply system shall be required to verify that construction expenditures are consistent with the plan.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.8** FINANCING INFRASTRUCTURE IMPROVEMENTS {#sec-216-ricr-50-05-7-7.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.8}
A. Each water supplier subject to the requirements of this Part shall establish a separate special account designated as the Infrastructure Replacement Fund to be held as a restricted receipt account and to be administered by the water supplier solely to implement and carry out the replacement or rehabilitation of infrastructure in accordance with the approved plan. The dedicated account should be invested in accordance with the standards established for the agency, municipality, or water supplier.
B. The costs of programs to implement infrastructure replacement shall be paid by the users of the water system at a rate directly proportional to the users' consumption of water. Charges shall be limited to those necessary and reasonable for implementation of the plan. These charges shall be based upon the annual funding requirements of the facility improvements necessitated over each successive twenty (20) year period.
C.Interest earned on this account shall be credited to this account only. Accumulated funds in excess of that estimated to be necessary to implement the plan shall revert to the rate payers of the system on a biannual basis. Funds will be allowed to accumulate with the intent to build sufficient capital to finance the estimated costs of major projects. It is understood that annual investments may be necessary over many years to fund major projects. Funds accumulated that are in excess of that estimated to implement the plan will cause the water supplier to reduce the future charges for infrastructure replacement.
D. Water suppliers may alternatively fund the infrastructure replacement program through partial or complete external funding at the option of the water supply system. Debt service and debt service issuance costs for any and all funding shall be an eligible expense as part of the program's funding requirements.
E. The Public Utilities Commission, as to water suppliers within its jurisdiction, shall permit an increase for just and reasonable infrastructure replacement in the portion of the water suppliers' rate structure to comply with this Part and shall allow the water supplier to add this required funding to its rate base in accordance with this Part. Proposed increases in rates by regulated water utilities to finance infrastructure improvements shall be filed and reviewed in conformance with R.I. Gen. Laws Title 39.
F. The applicable section of the water supplier's annual audit shall be submitted to the Department to verify compliance with the funding intentions of the infrastructure replacement plan. The dedicated fund for infrastructure replacement will be a separate line item in the audit. Financial and summary status reports shall be submitted for each on-going project which outlines funds spent on the project, funds remaining, percentage of completion, and a brief description of work completed and work remaining. Project expenditures must be consistent with the plan and be eligible expenditures under the plan. Audits shall be submitted within 180 days from the end of the water supplier's fiscal year. Extensions will be allowed for reasonable cause.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
##### **216-RICR-50-05-7 § 7.9** Component Life Expectancy and Actual Life Expectancy Guideline {#sec-216-ricr-50-05-7-7.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-05-7#7.9}
7.9.1Typical Life Expectancy
A.Source of Supply Plant
1.Structures and improvements: 35-40 years
2.Collecting/Impounding reservoirs: 50-75 years
3.Intake structures: 35-45 years
4.Wells and springs: 25-35 years
5.Galleries and tunnels: 25-50 years
6.Supply mains: 50-75 years
B.Pumping Plant
1.Structures: 35-40 years
2.Pumping equipment: 10-15 years
3.Other pumping plant: 20 years
C.Water Treatment Plant
1.Structures: 35-40 years
2.Water treatment equipment: 15-20 years
D.Transmission/Distribution
1.Structures: 35-40 years
2.Reservoirs and tanks: 30-60 years
3.Mains: 50-75 years
4.Services: 30-50 years
5.Meters: 15 years
6.Hydrants: 40-60 years
E.General Plant
1.Structures: 35-40 years
2.Furniture/equipment: 15-20 years
3.Transportation equipment: 7 years
4.Stores equipment: 10 years
5.Tools, shop equipment: 7-10 years
6.Laboratory equipment: 10-15 years
7.Power operated equipment: 10 years
8.Communication equipment: 10 years
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 08/21/2018*
### **Subchapter 10** Food Protection
#### **216-RICR-50-10-1** Rhode Island Food Code
##### **216-RICR-50-10-1 § 1.1** Authority and Scope {#sec-216-ricr-50-10-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.1}
1.1.1Authority
A.These Regulations are amended pursuant to the authority of R.I. Gen. Laws Chapters 21-27 and 23-1 and are developed for establishing minimum standards for food safety and sanitation in food businesses and food establishments.
1.1.2Scope
A.These Regulations establish definitions; sets standards for management and personnel, food operations and equipment and facilities; and provides food establishment plan review, plan issuance, inspection, employee restriction and permit suspension. It applies to retail food operations within food establishments licensed by the Rhode Island Department of Health (RIDOH) but does not apply to activities regulated by Part 4 and Part 6 of this Subchapter.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.2** Incorporation by Reference {#sec-216-ricr-50-10-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.2}
A.These Regulations hereby adopt and incorporate the 2022 FDA Food Code by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.3** Definitions {#sec-216-ricr-50-10-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.3}
A.Wherever used in this Part, the terms listed below shall be construed in the following manner:
1."Approved" means approved by the Director or his or her duly appointed agents.
2."Approved source" means that the food is purchased from commercial supplies, including cottage food manufacturers, under regulatory control that has been deemed acceptable by RIDOH based on a determination of conformity with principles, practice and generally recognized standards that protect public health.
3."Bed and breakfast" means an owner-occupied residence providing accommodations for a charge to the public in operation for more than ten (10) nights in a twelve (12) month period. Breakfast may be only provided to guests. The total number of visitors shall not exceed twelve (12), including the owner and any other individuals living or eating on the premises. Bed and breakfast establishments shall not include motels, hotels or boarding houses.
4."Center" means the Center for Food Protection, RIDOH.
5."Code" means the FDA Food Code (2022).
6."Commissary" means an operating base location to which a mobile food establishment or transportation vehicle returns regularly for such things as food preparation, food storage, vehicle, and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins.
7.“Cottage food manufacture” means the production in accordance with the requirements of R.I. Gen. Laws § 21-27-6.2 of allowable foods for retail sale directly to the consumer in a residential kitchen or a rented commercial kitchen licensed by RIDOH.
8."Director" refers to the Director of RIDOH or the Director's duly appointed agents.
9."Employee" means any person who works with or without pay in a food establishment.
10."Farm home food manufacture" means the production in accordance with the requirements of R.I. Gen. Laws § 21-27-6.1 of food for retail sale in a residential kitchen on a farm which produces agricultural products for human consumption and the operator of which is eligible for exemptions from the sales and use tax in accordance with R.I. Gen. Laws § 44-18-30(32).
11."Farmer's market" means a market where two (2) or more farmers are selling produce exclusively grown on their own farms on a retail basis to consumers. Excluded from this term is any market where farmers or others are selling produce at wholesale and/or any market in which any individual is selling produce not grown on his or her own farm.
12."Food" means:
a.Articles used for food or drink for people or animals;
b.Chewing gum; and/or
c.Articles used for components of any food or drink article.
13."Food business" means and includes any establishment or place, whether fixed or mobile, where food or ice is held, processed, manufactured, packaged, prepared, displayed, served, transported or sold.
14."Food service establishment" means any fixed or mobile restaurant, coffee shop, cafeteria, short-order café, luncheonette, grill, tearoom, sandwich shop, soda fountain, tavern, bar, cocktail lounge, nightclub, roadside stand, industrial feeding establishment, cultural heritage education facility, private, public or non-profit organization or institution routinely serving food, catering kitchen, commissary or similar place in which food or drink is prepared for sale or for service on the premise or elsewhere, and any other eating or drinking establishment or operation where food is served or provided for the public with or without charge.
15."Full-time equivalent" means forty (40) hours a week.
16."Good hygiene practices" means proper handwashing and personal cleanliness as specified under §§ 2-3 and 2-4 of the Code.
17."Hazard analysis critical control point" or "HACCP" means a written document that delineates the formal procedures for following HACCP principles developed by the National Advisory Committee on microbiological criteria for foods.
18."Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are:
a.Immunocompromised, preschool age children, or older adults; and
b.Obtaining food at a facility that provides services such as custodial care health care or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center.
19."Itinerant vendor" means a food vending business serving food or drink from any establishment or conveyance without food locations and without connection to water supply and sewage disposal systems.
20."Manager certified in food safety" means a person certified in this State in accordance with the requirements in R.I. Gen. Laws Chapter 21-27.
21."Mobile food establishment" or "MFE" means a food service operation that is operated from a movable motor driven or propelled vehicle, portable structure, or watercraft that can change location.
22."Mobile food service unit" means a unit that prepares and/or sells food products for direct consumption.
23."Operator" in relation to food vending machines means any person who by contract, agreement, lease, rental or ownership sells food from vending machines.
24."Person" means any individual, firm, co-partnership, association, or private or municipal corporation.
25."Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection.
26."Permanent food establishment" or "PFE" means a licensed food establishment operating in a permanently constructed structure. This does not include a temporary food establishment or mobile food establishment.
27."Processor" means one who combines, handles, manufactures or prepares, packages and stores food products.
28."Retail peddler" means a food business which sells meat, seafood, and dairy products directly to the consumer, house to house or in a neighborhood.
29."RIDOH" means the Rhode Island Department of Health.
30."R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.
31."Roadside farm stand" means a stand or location adjacent to a farm where produce grown only on that farm is sold at the time of harvest.
32."Special event" means a temporary event, or transitory public gathering that takes place at a given location for a specific purpose, including, but not limited to, a fair, festival, exposition, show, concert or other similar activity that does not recur on a regularly scheduled basis within a year and is conducted wholly on public property or partly on public property. The event has a defined start and stop date, with the given event not exceeding fourteen (14) consecutive days.
33."Special event sponsor" means the person, group, association, organization, corporation or governmental agency sponsoring or promoting and coordinating a special event.
34."Temporary food establishment" means a food establishment that operates for a period of no more than fourteen (14) consecutive days in conjunction with a single event or celebration.
35."Time temperature control for safety food” or “TCS" means any food or food ingredient, natural or synthetic, in a form capable of supporting pathogenic microorganism growth or toxin formation.
36."Vending machine site or location" means the room, enclosure, space or area where one (1) or more vending machines are installed and/or operated.
37."Warehouse" means a place for the storage of dried, fresh or frozen food or food products, not including those areas associated within or directly part of a food establishment or retail market.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.4** Management and Personnel {#sec-216-ricr-50-10-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.4}
1.4.1Supervision
A.The food establishment shall have a manager certified in food safety, as specified in Part 2 of this Subchapter.
B.Food employees and conditional employees are informed in writing of their responsibility to report in accordance with the law, to the person in charge, information about their health and activities as they relate to diseases that are transmissible through food.
1.4.2Employee Health – Exclusions and Restrictions
The Person in Charge shall adhere to the exclusion or restrictions requirements within the 2022 FDA Food Code based on the food employee’s symptoms and/or diagnosis. The following exceptions apply:
A.General Exclusions for Symptoms of Vomiting and Diarrhea
1.Conditions of Exclusion
a.The person in charge must exclude a food employee from the premises if the food employee is symptomatic with vomiting, diarrhea.
2.Removing Exclusion
a.If the food employee who was excluded is not associated with a confirmed disease outbreak, unless otherwise prohibited by RIDOH, the person in charge may reinstate the food employee, after discussing good hygiene practices with the employee, once more than forty-eight (48) hours have passed since symptoms of vomiting and diarrhea resolved.
B.General Exclusions for Salmonella
1.Conditions of Exclusion
a.The person in charge must exclude a food employee from the premises if the food employee is symptomatic with vomiting or diarrhea and diagnosed with an infection from nontyphoidal Salmonella.
b.If a food employee is diagnosed with an infection from nontyphoidal Salmonella and is asymptomatic, the person in charge must discuss good hygiene practices with the employee, and he/she may return to work.
2.Removing Exclusion
a.If the food employee who was excluded is not associated with a confirmed disease outbreak, unless otherwise prohibited by RIDOH, the person in charge may reinstate the food employee, after discussing good hygiene practices with the employee, once more than twenty-four (24) hours have passed since symptoms of vomiting and diarrhea resolved.
b.If the food employee who was excluded is associated with a confirmed disease outbreak, the food employee may be reinstated after the person in charge discusses good hygiene practices with the employee if one (1) of the following conditions is met:
(1)The excluded food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of nontyphoidal salmonella infection based on test results showing two (2) consecutive negative stool specimen cultures taken:
i.Not earlier than forty-eight (48) hours after discontinuance of antibiotics; and
ii.At least twenty-four (24) hours apart.
(2)The person in charge obtains approval from RIDOH to reinstate the food employee.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.5** Food {#sec-216-ricr-50-10-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.5}
1.5.1Preventing Contamination from Hands
A.Food employees may not contact exposed, ready-to-eat food with their bare hands and shall use suitable utensils such as deli tissue, spatula, tongs, single-use gloves or dispensing equipment. This does not apply to the following:
1.Contains a raw animal food and is to be cooked in the food establishment to heat all parts of the food to minimum temperatures as specified in the Code.
2.Does not contain a raw animal food but it is to be cooked in the food establishment to heat all parts of the food to a temperature of at least sixty-three degrees Celsius (63° C) (one hundred forty-five degrees Fahrenheit (145° F)).
1.5.2Raw Animal Foods
A.A raw animal food such as raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak tartare; or a partially cooked food such as lightly cooked fish, soft cooked eggs, or rare meat other than whole-muscle, intact beef steaks as specified in the Code, may be served or offered for sale upon consumer request or selection in a ready-to-eat form if:
1.The food service establishment serves a population that is not a highly susceptible population;
2.The food, if served or offered for service by consumer selection from a children's menu, does not contain comminuted meat;
3.The consumer is over twelve (12) years of age and is informed as specified under the Consumer Advisory in the Code that to ensure its safety, the food should be cooked as specified therein.
1.5.3Time as a Public Health Control
A.If time without temperature control is used as the public health control for a working supply of time temperature control for safety food before cooking, or for ready-to-eat time temperature control for safety food that is displayed or held and sold for immediate consumption:
1.Written procedures shall be approved in advance, maintained in the food service establishment and made available to RIDOH upon request that specifies:
a.Methods of compliance with time-maximum up to four (4) hours and up to six (6) hours if the food starts at less than or equal to forty-one degrees Fahrenheit (= 41° F) and never exceeds seventy degrees Fahrenheit (70° F); and
b.Methods of compliance with cooling for food that is prepared, cooked, and refrigerated before time is used as a public health control.
1.5.4Pasteurized Foods, Prohibited Reservice and Prohibited Food
A.In addition to a food service establishment that serves a highly susceptible population, undercooked comminuted meat may not be offered for sale or service for children twelve (12) years of age and under.
1.5.5Drinking Water
A.Any food business or food service establishment that utilizes drinking water to wash, prepare or cook food or drink that is sold on the premises or uses drinking water to clean food contact surfaces of equipment and utensils, must obtain its drinking water from a public water system pursuant to R.I. Gen. Laws Chapter 46-13, Public Drinking Water Supply.
B.Any food business or food service establishment that does not utilize drinking water to wash, prepare or cook food or drink that is sold on the premises and does not use drinking water for food contact surfaces of equipment and utensils, may obtain its drinking water from a nonpublic water system that is constructed, maintained and operated pursuant to law regarding nonpublic water systems.
C.Any variance of exception to the public water system requirement that was granted to a food business or food service establishment prior to the effective date of this Part remains in full force and effect and the food business or food service establishment may continue to operate pursuant to the variance or exception.
D.Any food business or food service establishment that does not use drinking water to wash, prepare or cook food sold on the premises and does not use drinking water to clean food contact surfaces of equipment and utensils that seeks to use drinking water to wash prepare or cook food or drink sold on the premises or wash food contact surfaces of equipment and utensils, must comply with the requirements of R.I. Gen. Laws Chapter 46-13, Public Drinking Water Supply, and Subchapter 05 Part 1 of this Chapter, Public Drinking Water.
1.5.6Food Donation
A.All food donations must be made pursuant to R.I. Gen. Laws Chapter 21-34.1, Rhode Island Food Donation Act.
1.5.7Approved Source, Romaine Lettuce
A.Romaine lettuce shall be obtained from an approved source marked with the harvest location and date.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.6** Physical Facilities {#sec-216-ricr-50-10-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.6}
1.6.1Prohibiting Animals
A.Live animals may not be allowed on the premises of a food establishment, except as follows:
1.Live animals may be allowed in the following situations if the contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles will not result:
a.Edible fish or decorative fish in aquariums, shellfish or crustacea on ice or under refrigeration, and shellfish and crustacea in display tank systems;
b.Patrol dogs accompanying police or security officers in offices and dining, sales, and storage areas, and sentry dogs running loose in outside fenced areas;
c.Service animals controlled by a disabled employee or person are permitted in areas that are not used for food preparation and that are usually open to customers, such as indoor and outdoor dining and sales areas, but only if a health or safety hazard will not result from the presence or activities of the service animal.
d.Pets in the common dining areas of institutional care facilities such as nursing homes, assisted living facilities, group homes, or residential care facilities at times other than during meals if:
(1)Effective partitioning and self-closing doors separate the common dining areas from food storage or food preparation areas,
(2)Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining areas when pets are present, and
(3)Dining areas including tables, countertops, and similar surfaces are effectively cleaned before the next meal service; and
e.In areas that are not used for food preparation, storage, sales, display, or dining, in which there are caged animals or animals that are similarly confined, such as in a variety store that sells pets or a tourist park that displays animals.
2.Live or dead fish bait may be stored if contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles will not result.
3.A food establishment with an outdoor dining area may allow a patron's dog to accompany the patron in the outdoor dining area during the hours designated by the owner of the restaurant.
a.All persons must comply with R.I. Gen. Laws § 21-27-12 and this Part.
b.This Section shall not affect the right of an individual to use a service animal as provided by R.I. Gen. Laws.
1.6.2Three-Compartment Sinks
A.For new establishments and an establishment that has undergone a renovation where the cost is fifty (50%) percent of the establishment value, a three-compartment sink is required at a bar that serves food or beverages.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.7** Compliance {#sec-216-ricr-50-10-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.7}
1.7.1Contents of the Plans and Specifications
A.The plans and specifications for a food establishment, including a food establishment specified under HACCP Plan requirements under the Code, shall include, as required by RIDOH based on the type of operation, type of food preparation, and foods prepared, the following information to demonstrate conformance with Code provisions:
1.Intended menu;
2.Anticipated volume of food to be stored, prepared, and sold or served;
3.Proposed layout, mechanical schematics, construction materials, and finish schedules;
4.Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities, and installation specifications;
5.Evidence that standard operating procedures that ensure compliance with the requirements of the Code are developed or being developed; and
6.Other information that may be required by RIDOH for the proper review of the proposed construction, conversion or modification, and procedures for operating a food establishment.
1.7.2When a Hazard Analysis Critical Control Point (HACCP) Plan is Required
A.Before engaging in an activity that requires a HACCP plan, a permit applicant or permit holder shall submit to RIDOH for approval a properly prepared HACCP plan as specified in the relevant provisions of the Code if:
1.Submission of a HACCP plan is required according to law;
2.A variance is required as specified under §§ 3-401.11(D)(4), 3-502.11, and 4-204.110(B) of the Code;
3.RIDOH determines that a food preparation or processing method requires a variance based on a plan submittal specified in § 1.7.1 of this Part, an inspectional finding, or a variance request.
B.Before engaging in reduced oxygen packaging without a variance as specified under § 3-502.12 of the Code, a permit applicant or permit holder shall submit a properly prepared HACCP plan to RIDOH.
1.7.3Contents of a HACCP Plan
A.For a food service establishment that is required under § 8-201.13 of the Code to have a HACCP plan, the plan and specifications shall indicate:
1.General information such as the name of the permit applicant or permit holder, the food establishment address, and contact information;
2.A categorization of the types of time temperature control for safety foods that are to be controlled under the HACCP Plan; and
3.A flow diagram or chart for each specific food or category type that identifies:
a.Each step in the process;
b.The hazards and controls for each step in the flow diagram or chart;
c.The steps that are critical control points;
d.The ingredients, materials, and equipment used in the preparation of that food; and
e.Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved.
4.A critical control points summary for each specific food or category type that clearly identifies:
a.Each critical control point;
b.The critical limits for each critical control point;
c.The method and frequency for monitoring and controlling each critical control point by the designated food employee or the person in charge;
d.The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points;
e.Action to be taken by designated food employee or person in charge if the critical limits for each critical control point are not met; and
f.Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed.
5.Supporting documents such as:
a.Food employee and supervisory training plan that addresses the food safety issues of concern;
b.Copies of blank records forms that are necessary to implement the HACCP Plan;
c.Additional scientific data or other information, as required by RIDOH, supporting the determination that food safety is not compromised by the proposal.
6.Any other information required by RIDOH.
1.7.4Performance and Risk-Based Inspections
A.RIDOH shall prioritize, and conduct inspections based upon its assessment of a food establishment's history of compliance with the Code and this Part and the establishment's potential as a vector of foodborne illness by evaluating:
1.Past performance, for nonconformance with the Code and this Part or HACCP plan requirements that are critical;
2.Past performance, for numerous or repeat violations of the Code and this Part or HACCP plan requirements that are noncritical;
3.Past performance, for complaints investigated and found to be valid;
4.The hazards associated with the particular foods that are prepared, stored, or served;
5.The type of operation including the methods and extent of food storage, preparation, and service;
6.The number of people served; and
7.Whether the population served is a highly susceptible population.
1.7.5Responsibilities of the Permit Holder
A.In addition to § 8.304.11 of the Code, permit holders must provide immediate access to shopper card and customer food product purchase information when needed during an investigation for a foodborne illness or other imminent threat to public health.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.8** Supplemental Regulations for Mobile Food Establishments {#sec-216-ricr-50-10-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.8}
A.In addition to the specific requirements of this Part, the following apply to mobile food establishments:
1.8.1Classifications of Mobile Food Establishments
A.MFE Type 1
1.Commercially processed pre-packaged food that is Non-Time Temperature Control for Safety food (e.g., cookies, crackers, potato chips, pretzels)
2.Commercially processed pre-packaged Time Temperature Control for Safety food that is ready to eat (e.g., cold sandwiches, ice cream)
3.Dispensed bulk Non-Time Temperature Control for Safety food (e.g., popcorn, roasted nuts, frozen lemonade)
4.Pre-cooked, low-risk Time Temperature Control for Safety food (e.g., hot dogs, precooked sandwiches)
5.Requirements:
a.Adequate cold holding if Time Temperature Control for Safety food
b.No commissary needed
c.No hand sink required
B.MFE Type 2
1.Time Temperature Control for Safety food for same day service (e.g., hamburgers, grilled sandwiches)
2.Reheating commercially-processed Time Temperature Control for Safety food (e.g., reheating canned soups)
3.Shellfish shucking
4.Requirements:
a.Adequate cold holding
b.Adequate cooking and hot holding equipment
c.Hand sink
d.Three (3) bay sink
e.Manager certified in food safety as required under Part 2 of this Subchapter
f.Purchase food daily or need commissary for food storage
g.Tags for shellfish
C.MFE Type 3
1.Complex Time Temperature Control for Safety food that includes advanced preparation and/or cooling (e.g., chowders, meatballs)
2.Requirements:
a.Adequate cold holding
b.Adequate cooking and hot holding equipment
c.Hand sink
d.Three (3) bay sink
e.Manager certified in food safety as required under Part 2 of this Subchapter
f.Commissary for food preparation and/or storage
1.8.2Food Operation Limitation
A.RIDOH may limit and/or modify the nature of the food service operation and/or the type of food served by a mobile food establishment to protect the health and safety of the public. Mobile food establishment operations may be limited regarding types of food and methods of preparation.
1.8.3Mobile Food Establishment Vendor Requirements
A.Plan Review
1.Any person desiring to operate any Mobile Food Establishment shall submit structural and operating plans.
a.The structural plan should include the materials and layout of the mobile food establishment, dimensions, mechanical schematics, plumbing, equipment and the finish schedule.
b.Standard operating procedures shall include menu, methods of preparation and temperature control, food and water sources, employee health and hygiene and staff training.
1.8.4Application Requirements
A.An applicant shall submit an application for a permit at least thirty (30) days in advance.
B.An applicant shall pay the required fee for mobile food establishment license.
C.An applicant shall provide:
1.Vehicle Identification Number (VIN) of the vehicle used for the mobile food establishment;
2.The license plate number and State of issuance of the vehicle used for the mobile unit;
3.The menu and methods of preparation;
4.A signed agreement with a licensed commissary when applicable
D.Unapproved license applications may be returned to the applicant with information regarding the reason(s) for not approving the license.
E.The following mobile food establishments may be exempt from obtaining a permit:
1.Food which is sold, offered, displayed for sale, or served at the establishment does not constitute a potential or actual hazard to the public health. Exemptions include, but are not limited to:
a.Commercially bottled or canned beverages, including water, that do not require refrigeration and are served from the sealed, original, properly-labeled container without addition of ice or other regulated product.
b.Sealed, commercially packaged food not requiring time temperature control from an approved source with proper labeling including, but not limited to, candy bars and other similar food.
1.8.5Approval Procedure
A.RIDOH shall conduct an inspection of the mobile food establishment and approve or reject the pending license based on adherence to the operational plan that was previously submitted.
B.RIDOH shall record the findings on an inspection report and furnish the original to the mobile food establishment.
C.The mobile food establishment shall ensure that all documented violations are corrected as specified on the health inspection report.
D.Any changes in the operation including the commissary, menu and mobile food establishment must be approved by the RIDOH.
1.8.6General Requirements
A.Supervision
1.Each mobile food establishment shall have a designated person in charge responsible for knowledge of, and compliance with, this Part. Such person shall be on-site and accessible during all hours of operation of the mobile food establishment. Facilities without such person in charge shall not be approved to open or operate.
2.Except for § 1.8.6(A)(3) of this Part, the mobile food establishment shall have a manager certified in food safety as specified in Part 2 of this Subchapter.
3.As specified in this Part, mobile food establishments that serve only commercially pre-packaged foods, beverages and commercially pre-cooked potentially hazardous foods requiring no manual handling and/or when only cold foods are prepared and there is no modified atmospheric packaging, a manager certified in food safety may not be required.
B.Food Preparation
1.All food handling and preparation shall take place within the licensed mobile food establishment unless prepared at an approved commissary.
2.Food employees shall eliminate bare hand contact with ready-to-eat food by suitable means including but not limited to deli paper, spatulas, tongs, single-use nonlatex gloves, or dispensing equipment.
3.Food employees shall minimize hand and arm contact with exposed food that is not in ready to eat form.
4.Hands shall be washed before donning gloves for working with food and after removing gloves when handling raw animal products.
5.Food employees of a mobile food establishment shall not use a pair of gloves intended for a single use for more than one (1) purpose and shall discard the gloves after they are damaged or soiled, or after the process of preparing food has been interrupted.
C.Physical Structure
1.The interior walls and ceiling of the mobile food establishment shall be durable, smooth, and easily cleanable. Floors shall be constructed of nonabsorbent, durable material. A floor covering such as carpeting or similar material may not be installed in food preparation areas.
2.The exterior structure of the mobile food establishment shall effectively protect the interior from the weather and the entry of insects, rodents and other animals.
3.A mobile food establishment shall not be used for living or sleeping quarters.
4.The mobile food establishment shall be maintained in good repair.
5.The mobile food establishment shall be kept clean and free of food debris, grease and other dirt.
6.The light intensity shall be sufficient for food preparation.
7.Adequate ventilation shall be provided to keep the vehicle free of food debris, grease and other dirt.
8.The water tank of the mobile food establishment shall meet the requirements specified within this Part.
9.Sewage and liquid waste shall be removed from a mobile food establishment at an approved commissary or by a sewage transport vehicle.
D.Restroom Facilities
1.A toilet facility on a mobile food establishment shall be fully enclosed with a tight-fitting self-closing door.
2.The toilet facility shall be clean and in good repair.
3.The toilet facility shall have toilet paper and a hand sink with water, soap and paper towels.
4.A mobile food establishment that does not have toilet facilities and that does business at a location for more than sixty (60) minutes shall have access to a toilet room located within two hundred feet (200’) of the vehicle.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.9** Supplemental Regulations for Temporary Food Establishment {#sec-216-ricr-50-10-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.9}
A.RIDOH may limit and/or modify the nature of the food service operation and/or the type of food served at the temporary food establishment to protect the health and safety of the public. Temporary food establishment operations may be limited in terms of the number of individuals served, methods of preparation and storage, the kinds of utensils used, or the type of food served.
1.9.1Sponsor Requirements
A.The event sponsor shall complete the sponsor form thirty (30) days prior to the event.
B.The event sponsor shall inform RIDOH of any changes or additions made after the original application was reviewed.
C.The event sponsor shall notify temporary food establishments that will be associated with the special event that they are required to make advance application for a permit to operate.
D.The event sponsor shall ensure that unapproved temporary food establishments do not operate at or during the special event.
1.9.2Site Requirements
A.Temporary food establishments shall be constructed and located to minimize the risk of food contamination from external sources including, but not limited to, sewage, flooding, dust, insects and vermin.
B.Outdoor open food operations shall have overhead protection unless otherwise specified by the local fire authority.
C.Temporary food establishments may not be closer than fifty feet (50’) from any non-sewered toilets and/or animal pens. The fifty foot (50’) setback requirement may be waived by RIDOH if public health concerns are not compromised.
1.9.3Responsibilities of the Sponsor
A.The event sponsor shall be responsible for all items as specified on the event sponsor application which may include, but are not limited to the following:
1.The event coordinator shall ensure that there is an adequate potable water supply for cooking purposes, handwashing, and cleaning and sanitization of equipment, utensils and food contact surfaces.
2.A public water supply shall be protected with the appropriate backflow prevention device. Non-food grade or garden hoses shall not be used for delivery of water for human consumption or food preparation.
3.Handwashing sinks shall be located at all toileting areas utilized by food handlers, including all non-sewered toilet areas.
a.The operator of a special event shall provide at least one (1) facility for hand washing for each group of toilet facilities.
b.Handwashing sinks shall be adequately serviced, stocked and maintained during the event with soap in a pump dispense and single-use paper towels dispensed in a sanitary manner.
4.Adequate power shall be supplied by the event sponsor to those temporary food establishments that require electrical or mechanical means to hold food products at required temperatures. When mechanical refrigeration is used, power shall be provided in advance to bring units down to adequate temperatures.
5.When central refrigeration services for food vendors are provided, the event sponsor shall ensure that equipment is capable of maintaining food at required temperatures. When equipment is not maintaining food at required temperatures, it shall be taken out of service and any temperature abused food shall be discarded.
6.A minimum of twenty-foot (20’) candles of artificial light shall be provided after dusk in all common areas.
7.Common warewashing facilities, if provided, shall be maintained as specified in these Regulations, and drain into an approved sewage disposal system.
8.The event sponsor shall ensure that an adequate number of toilet facilities are provided for patron and participant use so as not to create a nuisance or public health hazard.
a.When the number of sewered toilets is insufficient, non-sewered toilets shall be provided.
b.All toilets shall be adequately serviced, stocked with dispenser-held toilet tissue, and maintained during the event.
9.Hoses connected to potable water sources shall meet the requirements as specified in this Part and § 5-3 of the Code.
10.The event coordinator shall ensure that all wastewater generated at an event is discharged as specified in this Part.
11.The event coordinator shall ensure proper disposal of garbage.
a.The event coordinator shall provide for the removal of any solid waste scattered on the event premises as a result of event activities, including the removal of such waste during and at the conclusion of the event. Trash receptacles shall be emptied as often as necessary to prevent excessive accumulation of solid waste so as not to create a public health nuisance.
12.Animal attractions shall not create nuisance, odors, or fly problems that impact food service operations. RIDOH may impose additional restrictions and requirements to ensure the health of the public.
1.9.4Application Requirements
A.A person desiring to operate any temporary food establishment shall submit a written application for a permit in accordance with this Part.
1.An applicant shall submit an application for a permit at least thirty (30) days in advance.
2.An applicant shall pay the required fee for the temporary event license.
3.An applicant should complete the temporary event form and submit it with the written application for a temporary event license.
4.If approved by RIDOH, the temporary food establishment will receive a license.
5.Unapproved license applications will be returned to the applicant with information regarding the reason(s) for not approving the license.
6.The following food establishments may be exempt from obtaining a permit:
a.A religious, charitable or other non-profit organization that sells food occasionally to raise money, provided the sale occurs on the premises of the organization. If the sale is to occur off the premises of the organization, a permit shall be required.
b.Food which is sold, offered, displayed for sale or served at the establishment does not constitute a potential or actual hazard to the public health. Exemptions include but are not limited to:
(1)Commercially bottled or canned beverages, including water, that do not require refrigeration, and are served from the sealed, original, properly-labeled container without addition of ice or other regulated product.
(2)Sealed, commercially packaged food not requiring time temperature control from an approved source with proper labeling including, but not limited to, candy bars and other similar food.
1.9.5Approval Procedure
A.RIDOH shall conduct an inspection of the temporary food establishment at the special event and approve or reject the license.
B.RIDOH shall record the findings on an inspection report and furnish the original to the temporary food establishment.
C.The temporary food establishment shall ensure that all documented violations are corrected as specified on the health inspection report.
1.9.6General Requirements
A.Each temporary food establishment shall have a designated person in charge responsible for knowledge of, and compliance with, this Part. Such person shall be on-site and accessible during all hours of operation of the temporary food establishment. Facilities without such person in charge shall not be approved to open or operate.
B.When indicated by menu and/or food preparation, the temporary food establishment may need a manager certified in food safety as specified in Part 2 of this Subchapter.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.10** Farm Home Food Manufacturers {#sec-216-ricr-50-10-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.10}
A.All farm home food manufacturers must comply with R.I. Gen. Laws § 21-27-6.1, Farm Home Food Manufacture.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.11** Cottage Food Manufacturers {#sec-216-ricr-50-10-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.11}
A.All cottage food manufacturers must comply with R.I. Gen. Laws § 21-27-6.2, Cottage Food Manufacture.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
##### **216-RICR-50-10-1 § 1.12** Enforcement {#sec-216-ricr-50-10-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-1#1.12}
1.12.1Denial, Suspension, Revocation of Registration
A.RIDOH is authorized to deny, suspend or revoke the registration of a food establishment for just cause which includes, but is not limited to:
1.Failure to comply with this Part; and
2.Failure to comply with any Federal, State, or local laws and Regulations relating to food and/or food establishments.
B.Whenever an action shall be proposed to deny, suspend, or revoke the registration of a food business, RIDOH shall notify the food business by certified mail, setting forth the reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9.
1.If RIDOH finds that public health, safety or welfare imperatively requires emergency action and incorporates a finding to that effect in its order, RIDOH may order summary suspension of registration or curtailment of activities pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
1.12.2Other Enforcement Actions
A.RIDOH is empowered to institute such measures authorized by law which it deems appropriate to secure compliance with the provisions of this Part. Any such action shall include notice and opportunity for a hearing, provided; however, if an imminent health hazard exists the Director may issue an immediate compliance order requiring immediate action pursuant to the authority contained in R.I. Gen. Laws § 23-1-21.
1.12.3Hearings and Reviews
A.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 21-31 and/or R.I. Gen. Laws Chapter 23-1 and this Part shall be held in accordance with the provisions of Part 10-05-4 of this Title.
**History**
- *Amendment — effective from 2025-01-08 to current*
- *Amendment — effective from 2022-12-12 to 01/08/2025*
- *Periodic Refile — effective from 2022-01-04 to 12/12/2022*
- *Amendment — effective from 2021-02-01 to 01/04/2022*
- *Technical Revision — effective from 2018-02-26 to 02/01/2021*
- *Adoption — effective from 2018-02-26 to 02/26/2018*
#### **216-RICR-50-10-2** Certification of Managers in Food Safety
##### **216-RICR-50-10-2 § 2.1** AUTHORITY AND PURPOSE {#sec-216-ricr-50-10-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-2#2.1}
2.1.1authority
These amended Rules and Regulations for Certification of Managers in Food Safety are promulgated pursuant to the authority conferred in R.I. Gen. Laws Chapters 21-27 and 23-1, as amended, and are established for the purpose of protecting Rhode Island consumers from foodborne illness.
2.1.2Purpose
The purpose of these rules and regulations is to provide the requirements for the certification and recertification of food safety managers.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-10-15 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 10/15/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-10-2 § 2.2** DEFINITIONS {#sec-216-ricr-50-10-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-2#2.2}
A."Bed and breakfast establishment" means an owner/occupied residence providing accommodations for a charge to the public in operation for more than ten (10) nights in a twelve (12) month period. Breakfast may be provided to guests only. The total number of individuals served shall not exceed twelve (12), including the owner and any other individuals living or eating on the premises. Bed and breakfast establishments shall not include motels, hotels, or boarding houses.
B."Center" means the Center for Food Protection, Rhode Island Department of Health.
C."Director" means the Director of the Rhode Island Department of Health.
D."Employee" means any person who works with or without pay in a food establishment.
E."Examination" means an examination in food safety approved by the Center in accordance with the provisions of these regulations.
F."Food establishment" means any place where food is prepared and intended for individual portion service, and includes the site at which individual portions are provided. The term includes any such place regardless of whether consumption is on or off the premises and regardless of whether there is a charge for the food. The term includes but is not limited to restaurants, caterers, nursing and retirement homes, hospitals, private clubs, industrial cafeterias, public and private educational institutions, and delicatessens in retail food stores that cook and offer prepared food in individual service portions.
G."Food Safety Course" means a course approved by the Center in accordance with the provisions of these regulations.
H."Full-time equivalent" means forty (40) hours a week.
I."Itinerant vendor" means a food vending business serving food or drink from any establishment or conveyance without fixed locations and without connection to water supply and sewage disposal systems.
J."Manager certified in food safety" means a person certified in this state in accordance with the requirements herein.
K."Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection.
L."Time Temperature Control for Safety Food (TCS)" means any food or food ingredient, natural or synthetic in a form capable of supporting a) the rapid and progressive growth of infectious or toxigenic microorganisms or b) the slower growth of Clostridium botulinum.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-10-15 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 10/15/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-10-2 § 2.3** CERTIFICATION REQUIREMENTS {#sec-216-ricr-50-10-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-2#2.3}
2.3.1General Requirements
A. Each food establishment where Time Temperature Control for Safety Food (TCS) is prepared shall employ at least one (1) full-time, on-site manager certified in food safety who is at least eighteen (18) years of age.
B.Each food establishment where TCS is prepared must have a person in charge on-site during food preparation and serving times. The person in charge must demonstrate knowledge by successfully completing a Center approved food safety certification course.
C. Establishments which employ ten (10) or more full-time equivalent employees directly involved in food preparation shall employ at least two (2) full time, on-site managers certified in food safety.
D. Once a manager certified in food safety terminates employment, establishments shall have sixty (60) days to employ a new manager certified in food safety, or have an individual enrolled in a Center approved food safety course. However, said time period may be extended by the Center.
E. Department of Health certificates for managers certified in food safety shall be prominently posted in the establishment next to the license to operate. The certificate shall be removed when the individual is no longer employed by the establishment.
F. No person shall use the title "Manager Certified in Food Safety", or in any way represent themselves as a manager certified in food safety unless they shall hold a current certificate pursuant to these regulations.
2.3.2 Qualifications for Certification
A. In order to obtain certification as a manager in food safety an individual must meet the following requirements:
1. be of good moral character;
2. have successfully completed a food safety certification course approved by the Center within three years of application; and
3.have successfully passed a Center approved Food Safety Certification Examination administered under secure conditions.
a. If a person does not pass the certification examination after three (3) attempts, he/she must again successfully complete an approved food safety certification course prior to being admitted to any subsequent examination. All attempts at retaking the examination must be completed within six (6) months of successful completion of the course.
B. Reciprocity
1. The Center will recognize similar course work and/or certificates and develop reciprocity agreements or similar approval agreements with educational institutions, industry, and state or local health departments, provided that:
a. the course work or certificate was completed within three (3) years of applying for Rhode Island certification in food safety, and
b. the standards for certification are essentially equivalent to the requirements of this regulations, and
c. the reciprocal course and/or certificate is approved by the Center in writing.
2. Reciprocity agreements shall be reviewed on an annual basis.
2.3.3 APPLICATION AND FEE
A. Application for certification shall be made on forms provided by the Center. Said forms shall be completed and submitted to the Center for Food Protection. Such application shall be accompanied by the following documents:
1. A recent identification photograph of the applicant, head and shoulder, front view, approximately 2x3 inches in size;
2. An application fee of fifty ($50.00) dollars;
3. Certificate of successful completion of the Food Safety course;
4. Examination results, mailed directly from the Center approved testing company.
2.3.4RESPONSIBILITIES OF CERTIFIED MANAGERS IN FOOD SAFETY
A. The manager shall have supervisory, training, and management responsibilities and shall be responsible for food preparation and service with authority and responsibility to direct and control such activities.
B.The manager certified in food safety shall notify the Center in writing within ten (10) days of a change of name, employment or address.
C.The certified food safety manager is responsible for operating the establishment in compliance with all relevant federal and state rules and regulations pertaining to food.
D.The certified food safety manager shall assure that all employees engaged in food preparation do so in a manner consistent with food safety.
E.The certified food safety manager shall develop and implement a written plan for assessing, monitoring, and controlling foodborne disease hazards in the food establishment.
F.The certified manager shall report any illness which appears to be foodborne in nature to the Center within twenty-four (24) hours.
2.3.5 RENEWAL OF CERTIFICATION
A.Renewal of certification shall occur every three (3) years. Within thirty (30) days prior to expiration of certification, the Center for Food Protection shall mail an application for renewal of certification to each person to whom a certificate has been issued during the current certification period. Every person who intends to continue their certification shall submit a renewal application duly executed together with a renewal fee of fifty dollars ($50.00), made payable to the General Treasurer, State of Rhode Island, and evidence of successful completion of the requirements as set forth in § 2.3.5(B) of this Part. Managers of municipal or state food establishments shall be exempt from payment of the renewal fee.
B.In order to renew certification, applicants must present evidence of compliance with renewal requirements, including:
1.Passing a Center approved Food Safety Certification Examination administered under secured conditions within one (1) year prior to the expiration of certification.
C.An individual with a certificate which has been expired for more than six (6) months must complete an approved eight-hour food safety certification course including the examination.
2.3.6SUSPENSION OR REVOCATION OF CERTIFICATION
A.Certification of managers in food safety may be suspended or revoked for repeated violations of the rules and regulations of the state of Rhode Island pertaining to Food Establishments or for preventing health department personnel from performing their duty.
B.The individual shall surrender the certificate to the Center when certification has been suspended or revoked.
C.Mandatory retraining may be required for certified managers employed in establishments where there is displayed an inability to maintain safe and sanitary food handling practices as demonstrated by foodborne illnesses, serious repeat violations or other factors increasing the risk to consumers.
D.The certificate holders at that establishment may be required to attend a Center approved training program and repeat all requirements for certification. Under the aforementioned conditions, the Center may also require all employees to attend a Center approved training program.
E.The Director may also take other appropriate action pursuant to the provisions of R.I. Gen. Laws Chapter 23-1.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-10-15 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 10/15/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-10-2 § 2.4** REQUIREMENTS FOR CERTIFICATION OF TRAINING PROGRAM {#sec-216-ricr-50-10-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-2#2.4}
2.4.1aPPROVAL OF MANAGER CERTIFICATION IN FOOD SAFETY TRAINING PROGRAM
A.All manager certification training programs must be approved by the Center. The Center shall approve only those programs offered by an approved institution/agency.
B.Approved institutions/agencies may include: departments of state government, colleges, universities, food/hospitality industry associations, industry chains, health care facilities, regional vocational/technical career centers, public high schools, institutional training programs or nutrition consultation agencies. Further, said course must be taught by an instructor who meets the qualifications in section 2.4.1(C) of this Part. Course content must meet requirements found in section 2.4.1(D) of this Part.
C.Any institution wishing to offer a training program for the certification of food managers shall apply to the Center for approval by submitting a completed application on forms provided by the Center, accompanied by documented evidence pertaining to no less than the following:
1.Sources and locations of potential students, faculty, classrooms, and other resources;
2. Names and qualifications of instructors;
3.Copy of curriculum, including any provision for practical experience;
4. A copy of the course syllabus, which shall include:
a.Textbook and other teaching materials used
b.Methods and locations used for instructions
c.Course content
d.Topics and length of class meeting
e.Method used to determine students participation and presence during the course sessions, examples, sign-up sheets, roster, provisions for make-up work, etc.
D.Approval shall be granted on a triennial basis, if the program is found to meet the prescribed requirements herein. Such approval shall be based on data accompanying the application for program approval and from on-site visits which may be conducted by the Center.
E. Criteria for Instructors:
To be eligible for approval as a training program, only instructors who meet the qualifications in this section can teach the course. The minimum qualifications for a Center approved instructor are:
1. A minimum of two years’ experience teaching or consulting on food related issues, or two year's employment in the food industry, or two year's employment with a food regulatory agency.
2.Currently certified in food safety through completion a nationally accredited food safety certification program approved by the Center and completion of an approved examination from a nationally recognized testing company with a final score of 90% or higher. If a final score of 90% or higher is not obtained after the second attempt, the individual must take an approved food safety management certification course prior to retaking the examination.
3.Successful completion of an eight (8) hour Center approved food safety instructor training course. The requirements for successful completion of the eight (8) hour Center approved Food Safety Instructor Certification course may be waived by the Center upon presentation of equivalent educational credentials.
4.Commencing January 1993 and every three years thereafter, instructors must earn eight (8) professional development units. The eight (8) professional development units must equal eight (8) hours of Center approved training in food safety and sanitation topics. The following are examples of proof of such attendance:
a. A college transcript with course description
b.A certificate of completion of the course with the course description
F.Criterial for Course Content for the Certification of Managers in Food Safety:
1.Each course shall meet the standards for content and length of training, and must be based on:
a.the Standards developed by the Ad Hoc Committee on Training, Testing and Certification of Food Managers as approved by the Conference for Food Protection.
b.Rhode Island Rules and Regulations pertaining to food establishments, and
c.current FDA model Food Sanitation Codes.
2. The course shall be a minimum of eight (8) hours in length. The instructor should consider expanding the number of contact hours when a review of the participants reveals learning disabilities, language barriers or other factors which may inhibit learning. The course shall provide the candidates for certification with the skills necessary to implement the "Demonstrable Elements of Competency" identified in the Conference for Food Protection standards for certification of food managers.
G.Records
Each approved institution maintains records, for a minimum of three years, establishing its compliance with all requirements herein and such other records as the Center deems appropriate.
H.Denial, Suspension, or Revocation of Program Approval
1. The Center shall monitor the performance of all programs, and shall consider the following in granting and revoking approval of programs:
a.Compliance with these regulations;
b.Ability to effectively train applicants in food safety principles; and
c.Instructor performance.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-10-15 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 10/15/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-10-2 § 2.5** ADMINISTRATION AND ENFORCEMENT {#sec-216-ricr-50-10-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-2#2.5}
2.5.1exemptions
A.Employees of municipal and state food establishments shall be exempt from payment of the renewal fee.
B.The provision of R.I. Gen. Law §§ 21-27-11 through 21-27-11.13 of the general laws, and these regulations concerning certification of managers in food safety, shall not apply to:
1.Special events sponsored by town or nonprofit civic organizations such as, but not limited to, school sporting events, firemen's picnics, little league food booths, grange and church suppers, and fairs;
2.Temporary food services which have a frequency of less than six (6) events a year such as bazaars, bake sales and suppers. Individuals responsible for temporary food operations preparing TCS shall be required to register with the Center, obtain food safety informational brochures and distribute these materials to the individuals engaged in food preparation for the event;
3.Itinerant vendors and other food establishments that serve only commercially pre-packaged foods, beverages and commercially precooked TCS requiring no manual handling of the food product such as frankfurters;
4. Retail food stores and delicatessens where only cold foods are prepared provided, however, that no vacuum packaging or other processes are performed which will support the growth of Clostridium botulinum.
5.Private homes, and bed and breakfast establishments.
2.5.2ADMINISTRATIVE FINES
A.The Center after due notice and opportunity for hearing shall have the right to levy administrative fines of up to five hundred ($500.00) dollars against any manager certified in food safety or food establishment who violates the provisions of the rules and regulations governing food establishments.
2.5.3SEVERABILITY
A.If any provision of these rules and regulations or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end the provisions of the rules and regulations are declared to be severable.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2017-10-15 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 10/15/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-50-10-4** Good Manufacturing Practices for Food
##### **216-RICR-50-10-4 § 4.1** Authority and Purpose {#sec-216-ricr-50-10-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.1}
4.1.1Authority
These Regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws Chapters 21-27, 21-31, and 23-1, and are established for the purpose of adopting minimum safety standards for manufacturing, packing, holding or distributing human food for sale in Rhode Island.
4.1.2Scope
A.This Part applies to every person who grows, manufactures, packs, repacks, cans, bottles, keeps, exposes, stores, handles, sells, transports or distributes food in Rhode Island, whether or not for profit. It applies to wholesale food processing operations within food establishments licensed by RIDOH but does not apply to food prepared in the home for family consumption, or activities regulated by the Rhode Island Food Code (Part 1 of this Subchapter), and Processing and Distribution of Shellfish (Part 6 of this Subchapter).
B.The requirements of this Part include but are not limited to every person who:
1.Operates as a wholesale seafood dealer or a wholesale seafood truck;
2.Cooks, smokes or otherwise processes seafood or combines seafood with non-seafood ingredient(s), for sale at wholesale;
3. Engages in the business of slaughtering livestock or poultry or processing meat or poultry for sale at wholesale;
4.Operates a milk pasteurization plant;
5.Manufactures butter or cheese for sale at wholesale;
6.Manufactures frozen desserts or frozen dessert mix;
7.Manufactures or bottles non-alcoholic beverages, whether carbonated or non-carbonated, for human consumption;
8.Manufactures juice or apple cider for sale at wholesale;
9.Operates a cold storage or refrigerating warehouse, or a food warehouse;
10.Manufactures, processes or distributes any food not specifically named in this section, including dietary supplements, for sale at wholesale.
4.1.3Incorporation by Reference
A.These Regulations hereby adopt and incorporate the FDA Food Safety Modernization Act (FSMA) Final Rule on Preventive Controls for Human Food 21 C.F.R. Part 117 (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
B.These Regulations hereby adopt and incorporate the FDA FSMA Final Rule on Sanitary Transportation of Human and Animal Food 21 C.F.R. Part 1 (2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
C.These Regulations hereby adopt and incorporate the FDA FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration Rule 21 C.F.R. Part 121 (2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
D.These Regulations hereby adopt and incorporate the Grade “A” Pasteurized Milk Ordinance (2019) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these Regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.2** Definitions {#sec-216-ricr-50-10-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.2}
A. Wherever used in this Part, the terms listed below shall be construed in the following manner:
1."Administrative penalty" means a civil monetary fine that RIDOH may assess pursuant to statutory authority.
2."Adulterated food" means the definition in R.I. Gen. Laws § 21-31-10 and as described below.
3."Air temperature" means that steady temperature determined by allowing the probe of an accurate thermometer or other appropriate means of temperature measurement to equilibrate to the temperature of a representative area of the air environment in question.
4."Approved laboratory" means a laboratory approved by the Director or certified by the EPA or certified by the primary enforcement authority in any State which has been granted primacy by EPA or certified (accredited) by a third (3rd) party organization acceptable to a primacy State.
5."Approved source," when used in reference to a bottled water plant's product water or water used in the plant's operation, means the source of the water whether it be from a spring, artesian well, drilled well, public or community water system or any other source that has been inspected and the water sampled, analyzed and found to be of a safe and sanitary quality, per standards approved by the Director.
6."Bottled water" means bottled water as defined in 21 C.F.R. § 129.3(b).
7."Bottled water plant" means any place or establishment in which bottled water is prepared for sale.
8."Bulk water" means water intended for potable uses, which is transported via tanker truck or an equivalent means from one (1) area to another for the purposes of treatment, processing, packaging and/or human consumption, including bottling purposes.
9."Carbonated non-alcoholic beverage" means a carbonated beverage of any flavor containing no alcohol and includes but is not limited to soda water, sparkling water made with added carbon dioxide, seltzer water, carbonated water and tonic water.
10."Carbonated water" or "Sparkling water" means bottled water containing carbon dioxide.
11."Center" means the Center for Food Protection of the Rhode Island Department of Health.
12."C.F.R." means the Code of Federal Regulations.
13."Critical violation" means any violation by a facility or any other occurrence or condition in a facility that has the potential to pose a threat to public health.
14."Dedicated" means equipment used exclusively for the bottling and manufacturing for water and food.
15."Denature" means to use a material to render an article unfit for human consumption.
16."DEM" means the Rhode Island Department of Environmental Management.
17."Director" means the Director of RIDOH.
18."Embargo" means action taken pursuant to R.I. Gen. Laws § 21-31-6.
19."EPA" means the U.S. Environmental Protection Agency.
20."Equipment" means items used in the storage, preparation, display, or transportation of food such as stoves, ovens, hoods, slicers, grinders, mixers, scales, cutting blocks, tables, food shelving, reach-in refrigerators and freezers, sinks, ice makers, dishwashers, steam tables, utensils and similar items used in the operation of a food processing operation.
21."Facility" means the premises or parts thereof, and delivery or other vehicles used for or in connection with the slaughtering, preparing, processing, manufacturing, packaging, repackaging, canning, bottling, keeping, exposing, storing, handling, distributing, transporting or holding of food. It does not include a food establishment as defined in the Rhode Island Food Code (Part 1 of this Subchapter).
22."Farm warehouse (meat products)" means a frozen storage area on a farm used to hold meat that has been slaughtered and packaged in a USDA facility.
23."Fluoridated water" means bottled water containing fluoride. The label shall specify whether the fluoride is naturally occurring or added. Any water which meetings the definition of this subsection shall contain not less than 0.8 milligrams per liter fluoride ion and otherwise comply with the FDA quality standards in 21 C.F.R. § 165.110(b)(4)(ii).
24."FDA" means the U.S. Food and Drug Administration.
25."Food" means articles used for food or drink for man or other animals; chewing gum; articles used for components of any such article; includes raw materials and ingredients; as defined in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(f). Food includes dietary supplements as defined in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(ff).
26."Food-contact surfaces" means those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food-contact surfaces includes utensils and food-contact surfaces of equipment.
27."Freezing" means the removal of latent heat from the product, so that it enters a solid state.
28."Frozen" means the temperature of the product (except frozen desserts) has reached zero degrees Fahrenheit (0° F) (negative eighteen degrees Celsius (-18° C)) or lower at the thermal center, after thermal stabilization.
29."Frozen dessert mix" means any unfrozen mixture to be used in the manufacture of frozen desserts or milk shakes.
30."Frozen food" means articles in package form used for food or drink for man or other animals, which have been preserved by freezing.
31."FSIS" means the Food Safety and Inspection Service of the U.S. Department of Agriculture.
32."Grade A" means the standard of quality which may be attached to all those products which meet the requirements of and have been processed in accordance with the requirements of the RIDOH's administrative Regulations based on the Grade "A" Pasteurized Milk Ordinance (PMO).
33."Hermetically sealed container" means a container designed and intended to be secure against the entry of microorganisms and to maintain the commercial sterility of its contents after processing.
34."Imminent danger to the public health" means any occurrence or condition which has the potential to pose a serious threat to public health and shall include, but not be limited to:
a.A loss of water supply that may result in adulteration of food;
b.The use of an unapproved source of water within the facility;
c.A failed sewer system or a sewage backup into the facility;
d.A power outage that may result in adulteration of food;
e.Information that indicates that food may have been intentionally adulterated;
f. The facility has been subject to one (1) or more of the following: flood, fire, chemical exposure, natural disaster and/or catastrophic event;
g.An employee is found to be infected with a communicable disease;
h.A food-borne illness outbreak that appears to be associated with the facility;
i.Severe unsanitary conditions that threaten to contaminate the facility, a part of the facility, or a particular product;
j.Failure to comply with an order to correct a critical deficiency immediately;
k.Failure to submit an approved correction plan for a critical deficiency in timely manner;
l.Failure to comply with an approved correction plan for a critical deficiency in a timely manner; or
m.Failure to carry out a product recall.
n.The failure to include other violations, occurrence or conditions in Imminent Danger to the Public Health shall not be construed as a determination that such other violations, occurrences or conditions are not or may not be considered an imminent danger to the public health.
35."Inedible" means adulterated or not intended for use as human food.
36."Inspector" means an agent of the Rhode Island Department of Health, as defined in R.I. Gen. Laws § 21-31-21.
37."Juice" means the aqueous liquid expressed or extracted from one (1) or more fruits or vegetables, purees of the edible portions of one (1) or more fruits or vegetables, or any concentrates of such liquid or puree.
38."Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Part that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper, as defined in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(k).
39."Labeling" means all labels and other written, printed, or graphic matter:
a.Upon any article or any of its containers or wrappers, or
b.Accompanying such article, as defined in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(m).
40."Landing" means that point in time when seafood has been brought on-shore after harvesting.
41."Law" means any applicable Federal, State or local statute, ordinances and Regulations.
42."License" means any license or permit issued by RIDOH pursuant to this Part and applicable statutes.
43."Licensee" means any person who holds a license or permit issued by RIDOH pursuant to this Part and applicable statutes.
44."Livestock" means any animal raised commercially or privately, excluding poultry, which can or may be used in and for the preparation of meat or meat food products. In this Part, livestock includes so-called non-amenable animals raised for sale as food, including but not limited to buffalo, rabbits, frogs and turtles.
45."Major food allergen" means a major food allergen as defined by 21 U.S.C. § 321(qq).
46."Meat" except as used in § 4.6 of this Part, means the edible portion of livestock or wild-caught animals after slaughter.
47."Meat food product" means any article used as human food which is made wholly or in part from any meat or other portion of the carcass of any livestock, except those exempted from definition as a meat food product pursuant to 9 C.F.R. Part 317.
48."Misbranded food" means the definition of R.I. Gen. Laws § 21-31-11.
49."Noncompliance," "Failure to comply," and "Violation" each mean any act or failure to act that constitutes or results in one (1) or more of the following:
a.Engaging in any operation subject to this Part or applicable statute, without a license, permit, or approval whenever engaging in such an operation requires a license, permit or approval;
b.Engaging in any activity prohibited by, or not in compliance with this Part or other applicable statute or Regulation, or prohibited by or not in compliance with any order, license, permit, approval, certification, guideline, policy or protocol issued by RIDOH pursuant to this Part or applicable statute.
c.Failing to do, or failing to do in a timely manner, anything required by this Part or other applicable statute or Regulation, or required by any order, license, permit, approval, certification, guideline, policy or protocol issued by RIDOH pursuant to this Part or applicable statute.
50."Pasteurization plant" means a facility for the pasteurization of milk.
51."Person" means any individual, partnership, corporation, association or other legal entity.
52."Person in charge" means the individual present in the facility who has actual or apparent authority to supervise the activities of the facility and the employees at the time of the inspection.
53."Pest" refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies and larvae.
54."Potentially hazardous food" or "PHF", has the same meaning as "Time Temperature Control for Safety Food" or "TCS."
55."Poultry" means any bird, whether live or dead, intended for use as food.
56.''Poultry food product" means any product capable of use as human food which is made wholly or in part from any poultry carcass or part thereof, except those exempted from definition as a poultry product pursuant to 9 C.F.R. § 381.15.
57."Public water system" means a system for the provision to the public of water for human consumption, as defined by 42 U.S.C. § 300(f), the Safe Drinking Water Act, in compliance with R.I. Gen. Laws or comparable standards of the State or foreign country where the public water system is located.
58."Reduced oxygen packaging" or "ROP" means the removal or partial removal of oxygen from a package with or without replacing it with a gas mixture, to control food spoilage. ROP includes Controlled Atmospheric Packaging (CAP), Modified Atmospheric Packaging (MAP), straight Vacuum Packaging (VP), sous vide and cook-chill.
59."Refrigeration" means mechanical lowering of the temperature of food to, at a maximum, forty-one degrees Fahrenheit (41° F) (five degrees Celsius (5° C)), or to a temperature required by other applicable law, regulation or ordinance.
60."Regulatory agency" means the Rhode Island Department of Health, Center for Food Protection.
61."Remodel" means to make a material change to the facility.
62."Retail" means sale to the ultimate consumer.
63."Retail seafood dealer" means a person who sells raw, fresh or frozen seafood directly to the consumer.
64."RIDOH" means the Rhode Island Department of Health.
65."Safe and suitable" means that the ingredient performs an appropriate function in the food in which it is used and is used at a level no higher than necessary to achieve its intended purpose in that food.
66."Seafood" means all fish and/or fishery products.
67."Sell" means to sell, offer or expose for sale, barter, trade, deliver, give away, possess with intent to sell, or dispose of in any other commercial manner.
68."Shelf life" means a period after the date of packaging during which a food product has no significant risk of spoilage, loss of nutritional value, or loss of palpability, given compliance with recommended conditions of storage and handling as disclosed on the label of such product.
69."Time temperature control for safety food" or "TCS" means any food or food ingredient, natural or synthetic, in a form capable of supporting:
a.the rapid and progressive growth of infectious or toxigenic microorganisms; or
b.the slower growth of Clostridium botulinum.
70."USDA" means the United States Department of Agriculture.
71."Water source" means any ground or surface water body and the site from which water is withdrawn.
72."Wholesale" means sale to other than the ultimate consumer.
73."Wholesale seafood dealer" means a person who in a facility does any or all of the following: handling, storing, preparing, heading, eviscerating, shucking, freezing, manufacturing, preserving, packing, labeling or shipping raw fish and/or shellfish, whether frozen or unfrozen, for sale at wholesale.
74."Wild game" means an animal that is used for food, that is not domesticated and that is harvested in the wild, including but not limited to wild deer, elk, moose, rabbits, squirrels and raccoons, and wild birds such as ducks, pheasants, quail and turkeys.
4.2.1Adulterated Food
A.The criteria and definitions in this Part shall apply in determining whether a food is adulterated:
1.Within the meaning of R.I. Gen. Laws § 21-31-10(1)(iii) in that the food has been manufactured under such conditions that it is unfit for food; or
2.Within the meaning of R.I. Gen. Laws § 21-31-10(1)(iv) in that the food has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
B.The criteria and definitions in this Part also apply in determining whether a food is in violation of § 361 of the Public Health Service Act, 42 U.S.C. § 264.
C.Food covered by specific current good manufacturing practice Regulations is also subject to the requirements of this Part.
D.For the purposes of this Part, a food shall be deemed to be adulterated:
1.Poisonous, Insanitary or Deleterious Ingredients
a.If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but if the substance is not an added substance such food shall not be considered adulterated under § 4.2.1(D)(1)(a) of this Part if the quantity of such substance in such food does not ordinarily render it injurious to health; or
b.If it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive or a color additive) that is unsafe within the meaning of § 408(a) of the Federal Food, Drug and Cosmetic Act; or
c.If it bears or contains a pesticide chemical residue that is unsafe within the meaning of § 408(a) of the Federal Food, Drug and Cosmetic Act; or
d.If it is or if it bears or contains:
(1)Any food additive that is unsafe within the meaning of § 409 of the Federal Food, Drug and Cosmetic Act; or
(2)A new animal drug (or conversion product thereof) that is unsafe within the meaning of § 512 of the Federal Food, Drug and Cosmetic Act; or
e.If it consists in whole or in part of any filthy, putrid or decomposed substance, or it is otherwise unfit for food; or
f.If it has been prepared, packaged or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health; or
g.If it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or
h.If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
i.If it has been intentionally subjected to radiation, unless the use of radiation was in conformity with a Regulation or exemption in effect pursuant to § 409 of the Federal Food, Drug and Cosmetic Act.
2.Absence, Substitution or Addition of Constituents
a.If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or
b.If any substance has been substituted wholly or in part therefore; or
c.If damage or inferiority has been concealed in any manner; or
d.If any substance has been added thereto or mixed or packed therewith to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is.
3.Color Additives
If it is, or it bears or contains, a color additive which is unsafe within the meaning of § 721(a) of the Federal Food, Drug and Cosmetic Act.
4.Confectionary Containing Alcohol or Nonnutritive Substance. If it is confectionary, and:
a.Has partially or completely imbedded therein any nonnutritive object except that this requirement shall not apply in the case of any nonnutritive object where the FDA has determined that such object is of practical functional value to the confectionary product and would not render the product injurious or hazardous to health;
b.Bears or contains any alcohol other than alcohol not more than one half of one per centum (0.5%) by volume derived solely from the use of flavoring extracts, except that this is requirement shall not apply to confectionary which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionary is permitted under the laws of the State in which such confectionary is intended to be offered for sale; or
c.Bears or contains any nonnutritive substance, except that this requirement shall not apply to a safe nonnutritive substance which is in or on confectionery due to its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this Part.
5.Oleomargarine Containing Filthy, Putrid, etc., Matter.
If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid or decomposed substance or such oleomargarine or margarine or butter is otherwise unfit for food.
6.Dietary Supplement or Ingredient: Safety. If it is a dietary supplement or contains a dietary ingredient that:
a.Presents a significant or unreasonable risk of illness or injury under:
(1)Conditions or use recommended or suggested in labeling, or
(2)If no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use; or
b.Is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; or
c.The FDA declares that it poses an imminent hazard to public health or safety; or
d.Is or contains a dietary ingredient that renders it adulterated under § 4.2.1(D) of this Part under the conditions of use recommended or suggested in the labeling of such dietary supplement.
7.Dietary Supplement: Manufacturing Practices
If it is a dietary supplement and it has been prepared, packed or held under conditions that do not meet current good manufacturing practices standards established by this Part or Regulations promulgated by the FDA, including, when necessary, expiration date labeling.
8.Unsanitary Transport
If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver or any other person engaged in the transportation of food under conditions that are not in compliance with Regulations promulgated under § 416 of the Federal, Food, Drug and Cosmetic Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.3** Adoption of Federal Regulations {#sec-216-ricr-50-10-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.3}
A.All licensees and permit holders shall comply with all Federal Regulations that are applicable to the type of food processing that they conduct. Such Regulations include but are not necessarily limited to the following:
1.Food Processing
a.21 C.F.R. Part 106 (except § 106.120): Infant Formula Quality Control Procedures;
b.21 C.F.R. Part 109: Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Materials;
c.21 C.F.R. Part 110: Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food;
d.21 C.F.R. Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements;
e.21 C.F.R. Part 113: Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers;
f.21 C.F.R. § 108.35: Emergency Permit Control – Thermal Processing of Low-Acid Foods Packaged in Hermetically Sealed Containers;
g.21 C.F.R. Part 114: Acidified Foods;
h.21 C.F.R. § 108.25: Emergency Permit Control – Acidified Foods;
i.21 C.F.R. Part 115: Shell Eggs;
j.21 C.F.R. Part 117: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food;
k.21 C.F.R. Part 118: Production, Storage and Transportation of Shell Eggs;
l.21 C.F.R. Part 120: Hazard Analysis and Critical Control Point (HACCP) Systems;
m.21 C.F.R. Part 123: Fish and Fishery Products;
n.21 C.F.R. Part 129: Processing and Bottling of Bottled Drinking Water.
2.Food Labeling
a.21 C.F.R. Part 1: General Enforcement Regulations:
(1)Subpart B: General Labelling Requirements;
b.21 C.F.R. Part 100: General:
(1)Subpart G: Specific Administrative Rulings and Decisions;
c.21 C.F.R. Part 101: Food Labeling (except §§ 101.69 and 101.108);
d.21 C.F.R. Part 102 (except § 102.19): Common or Usual Name for Non-standardized Foods;
e.21 C.F.R. Part 104: Nutritional Quality Guidelines for Foods;
f.21 C.F.R. Part 105: Foods for Special Dietary Use;
g.21 C.F.R. Part 107 (except §§ 107.200-107.280): Infant Formula;
h.21 C.F.R. Part 190: Dietary Supplements;
i.9 C.F.R. Part 317: Labeling, Marking Devices and Containers.
3.Standards of Identity
a.21 C.F.R. Part 130: Food Standards: General (except §§ 130.5-6 and 130.17);
b.21 C.F.R. Part 131: Milk and Cream;
c.21 C.F.R. Part 133: Cheeses and Related Cheese Products;
d.21 C.F.R. Part 135: Frozen Desserts;
e.21 C.F.R. Part 136: Bakery Products;
f.21 C.F.R. Part 137: Cereal Flours and Related Products;
g.21 C.F.R. Part 139: Macaroni and Noodle Products;
h.21 C.F.R. Part 145: Canned Fruits;
i.21 C.F.R. Part 146: Canned Fruit Juices;
j.21 C.F.R. Part 150: Fruit Butters, Jellies, Preserves and Related Products;
k.21 C.F.R. Part 152: Fruit Pies;
l.21 C.F.R. Part 155: Canned Vegetables;
m.21 C.F.R. Part 156: Vegetable Juice;
n.21 C.F.R. Part 158: Frozen Vegetables;
o.21 C.F.R. Part 160: Eggs and Egg Products;
p.21 C.F.R. Part 161: Fish and Shellfish;
q.21 C.F.R. Part 163: Cacao Products;
r.21 C.F.R. Part 164: Tree Nut and Peanut Products;
s.21 C.F.R. Part 165: Beverages;
t.21 C.F.R. Part 166: Margarine;
u.21 C.F.R. Part 168: Sweeteners and Table Syrups;
v.21 C.F.R. Part 169: Food Dressings and Flavorings;
w.9 C.F.R. Part 319: Definitions and Standards of Identity or Composition.
4.Food Additives
a.21 C.F.R. Part 170: Food Additives (except §§ 170.6, 170.15, and 170.17);
b.21 C.F.R. Part 172: Food Additives Permitted for Direct Addition to Food for Human Consumption;
c.21 C.F.R. Part 173: Secondary Direct Food Additives Permitted in Food for Human Consumption;
d.21 C.F.R. Part 174: Indirect Food Additives: General;
e.21 C.F.R. Part 175: Indirect Food Additives: Adhesives and Components of Coatings;
f.21 C.F.R. Part 176: Indirect Food Additives: Paper and Paperboard Components;
g.21 C.F.R. Part 177: Indirect Food Additives: Polymers;
h.21 C.F.R. Part 178: Indirect Food Additives: Adjuvants, Production Aids and Sanitizers;
i.21 C.F.R. Part 180: Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study;
j.21 C.F.R. Part 181: Prior-Sanctioned Food Ingredients;
k.21 C.F.R. Part 182: Substances Generally Recognized as Safe;
l.21 C.F.R. Part 184: Direct Food Substances Affirmed as Generally Recognized as Safe;
m.21 C.F.R. Part 186: Indirect Food Substances Affirmed as Generally Recognized as Safe;
n.21 C.F.R. Part 189: Substances Prohibited from Use in Human Food.
5.Color Additives
a.21 C.F.R. Part 70: Color Additives (only §§ 70.20-70.25);
b.21 C.F.R. Part 73: Listing of Colors Exempt from Certification (only §§ 73.1-73.615);
c.21 C.F.R. Part 74: Listing of Color Additives Subject to Certification (only §§ 74.101-74.706);
d.21 C.F.R. Part 81: General Restrictions for Provisional Color Additives for Use in Foods, Drugs and Cosmetics;
e.21 C.F.R. Part 82: Listing of Certified Provisionally Listed Colors and Specifications (only §§ 82.3-82.706).
6.Sanitary Transportation
a.21 C.F.R. Part 1: Subpart O: Sanitary Transportation of Human and Animal Food;
b.21 C.F.R. Part 11: Electronic Records; Electronic Signatures.
7.Intentional Adulteration
a.21 C.F.R. Part 121: Mitigation Strategies to Protect Food Against Intentional Adulteration
8.Federal Food, Drug and Cosmetic Act
a.Definitions: 21 U.S.C. §§ 321(f), (k), (m) and (ff);
b.Prohibited Acts: 21 U.S.C. §§ 331(a), (b), (c), (d), (e), (f), (k) and (v);
c.Penalties: 21 U.S.C. § 333;
d.Seizure: 21 U.S.C. § 334;
e.Definitions and Standards for Food: 21 U.S.C. § 341;
f.Adulterated Food: 21 U.S.C. § 342;
g.Misbranded Food: 21 U.S.C. § 343;
h.New Dietary Ingredients: 21 U.S.C. § 350(b);
i.Regulations and Hearings: 21 U.S.C. § 371;
j.Records of Interstate Shipments: 21 U.S.C. § 373;
k.Factory Inspection: 21 U.S.C. § 374.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.4** Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard—Defect Action Levels {#sec-216-ricr-50-10-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.4}
A.Compliance with defect action levels does not excuse violation of the requirement of R.I. Gen. Laws Chapter 21-31 that food not be prepared, packed, or held under unsanitary conditions or the requirements of this Part that food manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of this Part, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall always utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.
B.The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of this Part, regardless of the defect level of the final food.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.5** Supplemental Regulations for Fish and Fishery Products {#sec-216-ricr-50-10-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.5}
No person shall operate as a wholesale seafood dealer, retail seafood dealer or wholesale seafood truck without a valid permit issued by RIDOH. No person shall operate as such a dealer in violation of applicable laws or in violation of any of the requirements specified in this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.6** Supplemental Regulations for Meat and Poultry Slaughter and Processing {#sec-216-ricr-50-10-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.6}
A.All persons operating within Rhode Island for the purpose of slaughtering any animal for human consumption, or for canning, curing, smoking, salting, packing, rendering, or handling the carcass of any animal or part of the carcass, or for the manufacturing of any meat product or meat food product, must obtain a permit from RIDOH.
B.All persons who operate a meat or poultry slaughter and/or processing facility shall comply with R.I. Gen. Laws Chapter 21-11 and this Part.
4.6.1Special Requirements Pertaining to a Farm Warehouse (Meat Products)
A.A farm warehouse shall not further process any meat items. This includes, but is not limited to, opening packages and handling exposed product, relabeling product, applying net weights or repackaging product.
B.A farm warehouse shall:
1.Register with the Food Safety and Inspection Service (FSIS) of the USDA as a meat handler pursuant to 9 C.F.R. § 320.5 and comply with all applicable USDA requirements;
2.Register with RIDOH as a food business;
3.Utilize only slaughtering and processing facilities approved by the USDA and operated in compliance with 21 U.S.C. §§ 601 through 695;
4.Ensure that all meat products are handled and stored under acceptable conditions/practices which will prevent unsanitary conditions and the misbranding and/or adulteration of the meat products;
5.Ensure that storage units, such as coolers or freezers, are:
a.Dedicated for the meat products that will be offered for sale; and
b.Indoors, clean, in good repair and can keep meat products frozen or below forty-one degrees Fahrenheit (41° F) (five degrees Celsius (5° C));
6.Ensure that vehicles, refrigerators and/or chest type freezers used for transport of fresh or frozen meat products are in good working condition, able to keep meat products frozen or below forty-one degrees Fahrenheit (41° F) (five degrees Celsius (5° C)), designed to prevent unsanitary conditions and capable of maintaining all meat products in a safe, wholesome condition.
C.Notwithstanding the requirements of this Part, a farm warehouse shall only be required to ensure that any water that contacts food-contact surfaces is safe and of adequate sanitary quality.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.7** Supplemental Regulations for Grade A Milk and Milk Products {#sec-216-ricr-50-10-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.7}
A.All pasteurization plants in Rhode Island, as well as all facilities in Rhode Island that produce or transport milk products must comply with the Grade "A" Pasteurized Milk Ordinance incorporated by reference in § 4.1.3(D) of this Part.
B.No person shall operate a pasteurization plant without a valid license granted by RIDOH or in violation of any of the requirements specified in this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.8** Supplemental Regulations for Non-Alcoholic Beverages, Drinks and Juices {#sec-216-ricr-50-10-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.8}
A.All persons manufacturing or bottling for sale or to sell or offer for sale any carbonated or non-alcoholic beverage, soda water, fruit juice, syrup, bottled drinking water either plain or carbonated, or any other so-called soft drink, must obtain a permit from RIDOH.
B.No carbonated or non-alcoholic beverage, soda water, fruit juice, syrup, bottled drinking water either plain or carbonated, or any other so-called soft drink, which has been manufactured outside of this State shall be sold or offered for sale within this State unless the person, firm, or corporation manufacturing or bottling it for sale holds a permit to do so from RIDOH.
C.Any person applying for a permit to bottle or manufacture apple cider shall certify that he or she does not manufacture or bottle any carbonated or non-alcoholic beverage, soda water, fruit juice, syrup, bottled drinking water, either plain or carbonated, or any other so-called soft drink, other than apple cider. Permits shall not apply to any person who manufactures and bottles during any one (1) calendar year not exceeding five hundred (500) gallons of cider.
D.All persons who operate with non-alcoholic beverages, drinks and juices and/or processing facility shall comply with R.I. Gen. Laws Chapter 21-23 and this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.9** Supplemental Regulations for Bottled Water {#sec-216-ricr-50-10-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.9}
A.The sources of all bulk or bottled drinking water located in Rhode Island must be approved by the Director. Sources of all bottled drinking water located outside of Rhode Island must be approved by the agency having jurisdiction.
B.New sources of all bottled drinking water located in Rhode Island shall comply with those requirements found in the Rhode Island Department of Health Rules and Regulations for the Public Drinking Water, Subchapter 05 Part 1 of this Chapter.
C.Licensed sources of all bottled drinking water located in Rhode Island, following termination for any reason of their license to manufacture bottled drinking water, shall meet the requirements for new sources of bottled drinking water prior to reactivation of their bottled water license.
4.9.1Equipment
A.All tanks, pipelines and equipment used to store, handle and transport water for bottled water purposes shall be inspected, maintained, cleaned and sanitized per the following requirements.
1.Storage Tanks
a.Inspected for cleanliness monthly and shall be kept free of scale, evidence of oxidation and residue;
b.Cleaned monthly by sanitizing and flushing with product water.
2.Product Water Pipelines
a.Must be kept free of scale, evidence of oxidation and residue;
b.Cleaned daily by sanitizing with chlorine water of two hundred (200) ppm for five (5) minutes, followed by product water flushing, or continuous recirculation of at least one tenth (0.1) ppm ozonated water.
3.Product Equipment
a.Cappers shall be sanitized daily;
b.Hoppers shall be kept covered, free of residue and contact surfaces shall be sanitized daily;
c.Ozone mixing tanks and equipment; soft water tanks and other associated equipment shall be inspected monthly, disassembled, if necessary cleaned and sanitized as needed;
d.Bottle washing equipment shall be checked daily to assure proper timing and adequate washing of bottles;
e.Fillers shall be kept free from residue and shall be sanitized daily. Filling and capping operations shall be conducted as to prevent contamination of water being bottled. The filler reservoir shall be kept covered at all times.
4.9.2Contents of Label
A.Each label shall indicate:
1.Type of Source Water
a.Water coming from springs may be labeled "Spring Water" or "Natural Spring Water;"
b.Artesian or pumped water taken from the ground, from drilled wells may be labeled, "Well Water," "Artesian Water," or "Natural Water;"
c.For water containing carbon dioxide that emerges from the source and is bottled directly with its entrapped gas or from which the gas is mechanically separated and later reintroduced at a level not higher than naturally occurring in the water may be labeled "Naturally Carbonated" or "Naturally Sparkling." Bottled water which contains carbon dioxide other than that naturally occurring in the source of the product shall be labeled "Carbonated," "Carbonation Added" or "Sparkling;"
d.Mineral water may be labeled "Mineral Water" or "Natural Mineral Water." Bottled water to which minerals are added shall be labeled to disclose that minerals are added and may not be labeled "Natural Mineral Water;"
e.For a municipal water supply source, the name of the municipal water supply must be stated.
2.Supplemental printed information and graphics concerning recognized uses of the water may appear on the label but shall not imply properties of the product or preparation methods which are not factual.
3.Location of water source must be stated.
4.Sodium Labeling
Certain descriptive terms about the quantitative sodium content of bottled water may be used on the label, provided such statements indicate the number of milligrams of sodium per measured volume of bottled water.
5.Additional Label Statements
Whenever any term such as "no fluorides," "no chlorides," "no bromides," etc., is used in labeling, quantitative information shall be provided, which includes milligrams per liter or milligrams per measured serving. All label statements are subject to review and approval by the Director.
4.9.3Sampling Requirements, Methods and Analysis
A.When determined to be necessary by the director, more frequent sampling or additional monitoring may be required by the Director.
B.All required source water quality analysis must be performed by a laboratory meeting either domestic approval or foreign approval by the appropriate government agency for source water analysis.
4.9.4Bulk Water
A.Tank trucks, loading and unloading facilities and other equipment used to transport bulk water for bottled water purposes shall be maintained in clean and sanitary conditions at all times.
B.Tanks previously used to transport milk or juice products, toxic materials, petroleum products or other deleterious substances shall not be used to haul drinking water.
C.All sources of water for bulk water shipment must be approved by the Director.
D.All source water storage facilities must be maintained in a clean and sanitary condition at all times.
E.Bulk Transport and Transfer Procedure
1.Sanitation
a.Prior to filling, tank interior shall be cleaned, flushed with potable water, sanitized with no less than one hundred (100) ppm chlorine water solution for a contact period of not less than twenty (20) minutes and rinsed with potable water.
b.All hoses, connections and fittings shall be sanitized with a concentrated solution of chlorine, three (3) ounces of five and one quarter percent (5.25%) household bleach to two (2) gallons of water by brushing solution on all exposed parts.
c.The cover shall not be opened after sanitizing.
2.Fluid Transfer
a.Tank trucks or tank trailers may be filled through the fitting on the inner dome cover when the rear pipe cannot be used.
b.Water quality in the tank, after twenty to thirty (20 – 30) gallons have been delivered into the tank, shall be checked as follows:
(1)Stop filling;
(2)Have discharge valve opened;
(3)Inspect water as it discharges. If water has unpleasant odor and/or looks dirty, it shall be rejected for use and the tank shall be re-sanitized.
c.When these checks indicate satisfactory water quality proceed to fill the tank.
d.The dome cover shall be closed and sealed after filing to volume desired.
e.The tank discharge valve cover shall be closed and sealed after filling.
f.If used a fill connectional shall be constructed in a manner to prevent contamination and shall be capped at all times when not in use.
F.Sampling
1.Analysis of the samples must be performed for the plant by an approved laboratory.
2.When deemed necessary by the Director, sampling of water from bulk water system (i.e. tank truck, water buffalo, storage tank, transfer line, etc.) shall be conducted and analyzed.
G.Records
1.Shall be maintained and include the number of gallons delivered daily, cleansing and sanitizing methods used for tank truck and tank trailer interiors, risers, connections, hoses, etc.
2.Such records shall include date, time and location of delivery, concentration of sanitizing solution, time of contact when applicable, and water quality analysis results as legal evidence of compliance with public health practices and standards.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
##### **216-RICR-50-10-4 § 4.10** Compliance and Enforcement {#sec-216-ricr-50-10-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-4#4.10}
4.10.1Variances
RIDOH may grant a variance by modifying or waiving the requirements of this Part if, in the opinion of RIDOH, a health hazard or nuisance will not result from the variance. If a variance is granted, RIDOH shall retain the information in its records.
4.10.2Enforcement Options
A.The Director may pursue any combination of the following administrative and judicial enforcement actions, depending upon the circumstances and gravity of each case:
1.Confiscation of food pursuant to R.I. Gen. Laws § 21-27-4;
2.Notice to cease business pursuant to R.I. Gen. Laws § 21-27-5;
3.Penalties for violations pursuant to R.I. Gen. Laws §§ 21-27-9 and/or 21-31-5;
4.Administrative fines pursuant to R.I. Gen. Laws § 21-27-11.11;
5.Embargo, condemnation and destruction of adulterated food pursuant to R.I. Gen. Laws § 21-31-6;
6.Penalties for obstruction of inspections or examinations pursuant to R.I. Gen. Laws § 23-1-19;
7.Compliance orders pursuant to R.I. Gen. Laws § 23-1-20;
8.Immediate compliance orders pursuant to R.I. Gen. Laws § 23-1-21;
9.Enforcement of compliance orders pursuant to R.I. Gen. Laws § 23-1-23;
10.Criminal penalties pursuant to R.I. Gen. Laws § 23-1-25; and
11.Revocation, suspension, or other disciplinary action pursuant to R.I. Gen. Laws § 21-27-10(c) regarding a registration issued in accordance with R.I. Gen. Laws § 21-27-10.
B.The imposition of one (1) of more remedies and/or penalties provided in § 4.10 of this Part shall not prevent the Director from jointly exercising any other remedy or penalty available to him or her by statute or Regulation.
C.Consent Agreement/Order. Nothing in this Part shall preclude the Director from resolving outstanding violations or penalties through a Consent Agreement or Consent Order at any time he or she deems appropriate.
4.10.3Hearing and Reviews
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 21-31 and/or R.I. Gen. Laws Chapter 23-1 and this Part shall be held in accordance with the provisions of the Rules and Regulations pertaining to Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2020-12-14 to 01/04/2022*
- *Technical Revision — effective from 2017-12-20 to 12/14/2020*
- *Technical Revision — effective from 2017-12-20 to 12/20/2017*
- *Adoption — effective from 2017-12-20 to 12/20/2017*
#### **216-RICR-50-10-6** Processing and Distribution of Shellfish
##### **216-RICR-50-10-6 § 6.1** Authority and Purpose {#sec-216-ricr-50-10-6-6.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-6#6.1}
6.1.1Authority
A.This Part is adopted pursuant to R.I. Gen. Laws§ 21-14-3 and are established for the purpose of updating minimum standards and requirements related to the processing and distribution of shellfish, to adopt requirements of National Shellfish Sanitation Program (NSSP) 2023 Model Ordinance, to assure the safety of shellfish brought into the State of Rhode Island for sale, and to protect the health, safety, and welfare of the public.
6.1.2Purpose
A.This Part establishes minimum sanitary requirements for the conduct of molluscan shellfish business and the sanitary quality of shellfish sold and distributed to the public.
6.1.3Applicability
A.The terms and provisions of this Part shall be liberally construed to permit the Rhode Island Department of Health to effectuate the purposes of State law, goals, and policies.
6.1.4Incorporation by Reference
A.This Part hereby adopts and incorporates 21 C.F.R. § 123.6 (1997) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.This Part hereby adopts and incorporates 21 C.F.R. § 123 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
C.This Part hereby adopts and incorporates National Shellfish Sanitation Program’s Guide for Control of Molluscan Shellfish (2023) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
D.This Part hereby adopts and incorporates 21 C.F.R. § 161.130 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
E.This Part hereby adopts and incorporates the Federal Fair Packaging and Labeling Act, 15 U.S.C. §§ 1451-1461 (1967) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
F.This Part hereby adopts and incorporates Jenkins, David, Joseph J. Connors, and Arnold E. Greenberg, Standard Methods for the Examination of Water and Wastewater. Washington, D.C: American Public Health Association (1981), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Amendment — effective from 2026-03-18 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/18/2026*
- *Amendment — effective from 2021-03-01 to 01/04/2022*
- *Amendment — effective from 2017-12-04 to 03/01/2021*
- *Technical Revision — effective from 2017-05-16 to 12/04/2017*
- *Amendment — effective from 2017-05-16 to 05/16/2017*
- *Amendment — effective from 2012-12-10 to 05/16/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Adoption — effective from 2002-10-07 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 10/07/2002*
##### **216-RICR-50-10-6 § 6.2** Definitions {#sec-216-ricr-50-10-6-6.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-6#6.2}
A.For the purpose of this Part, these terms shall have the following meaning:
1."Approved" means approved by the Director.
2."Buy boat" means a boat that is considered to be an extension of the shellfish business facility. Boats can only operate in open harvest areas.
3."Certification” or “certify" means the issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:
a.Permission from the Director to conduct the activity; and
b.Compliance with the requirements of this Part.
4."Certification number" means the unique identification number issued by the Director to each dealer for each location. Each certification number shall consist of a one (1) to five (5) digit Arabic number preceded by the two (2) letter State abbreviation and followed by a two (2) letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with this Part using the following terms: shellstock shipper (SS), shucker-packer (SP), repacker (RP), and reshipper (RS).
5."Commingle or commingling" means the act of combining different lots of shellfish or shucked shellfish.
6."Compliance schedule" means a written schedule that provides a correction time period to eliminate key and other deficiencies.
7."Critical control point" means a point, step, or procedure in a food process at which control can be applied to prevent, eliminate, or reduce a food safety hazard to acceptable levels.
8."Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter shall be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.
9."Dealer" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), or limited liability company engaged in shellfish business as defined in § 6.2 of this Part.
10."Department" means the Rhode Island Department of Health.
11."Director" means the Director of the Rhode Island Department of Health or their designee.
12."Dry storage" means the storage of shellstock out of water.
13."Food contact surface" means an equipment surface or utensil which normally comes into direct or indirect contact with shucked shellfish.
14."Food safety hazard" means any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
15.“Hazard Analysis Critical Control Point ("HACCP")” is, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven (7) principles identified by the National Advisory Committee on Microbiological Criteria for Foods (1992).
16."HACCP plan" means a written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in 21 C.F.R. § 123.6, incorporated by reference in § 6.1.4(A) of this Part, as adopted by the Interstate Shellfish Sanitation Conference.
17."Harvest area" means an area that contains commercial quantities of shellstock and may include aquaculture sites and facilities.
18.“Harvest time” means the time when the first shellstock in a lot is taken from the water or, in the case of intertidal harvest, the time of first exposure.
19."License" means the document issued by the Director to a person to harvest or transport shellstock for commercial sale.
20."Operational plan" means a written description of the design and activities of the facility specific to, but not limited to, the species of shellfish to be processed, the source of the shellfish to be processed, how the shellfish will be processed, and how the required records will be maintained.
21."Person" means any individual, firm, co-partnership, association, or private or municipal corporation.
22."Preventive measure" means physical, chemical, or other factors that can be used to control an identified food safety hazard.
23."Primary dealer" means a dealer who purchases shellfish directly from the harvester.
24."Processing” means as defined in R.I. Gen. Laws § 21-14-1(6).
25."Raw" means shellfish that have not been thermally processed:
a.To an internal temperature of one hundred forty-five degrees Fahrenheit (145° F) (sixty-two and eight tenths degrees Centigrade (62.8° C)) or greater for fifteen (15) seconds (or equivalent); or
b.Altering the organoleptic characteristics.
26."Repacker" or “RP” means:
a.Any person who repacks shucked shellfish; and
b.Any person who repacks shellstock.
27."Repacking " means the practice of removing shellfish from containers and placing it into other containers.
28."Reshipper" or “RS” means any person who purchases shellfish or shucked shellfish from dealers and sells the product without repacking or relabeling to other dealers, wholesalers or retailers.
29."Sanitize" means to adequately treat food contact surfaces by a process that is effective in:
a.Destroying vegetative cells of microorganisms of public health significance;
b.Substantially reducing the numbers of other undesirable microorganisms; and
c.Not adversely affecting the product or its safety for the consumer.
30."Shellfish" means and include oysters, mussels, and all varieties of clams and scallops except where the final product will be the adductor muscle only whether:
a.Shucked or in the shell;
b.Raw, including post-harvest processed;
c.Frozen or unfrozen; or
d.Whole or in part.
31."Shellfish business" means as defined in R.I. Gen. Laws § 21-14-1(8).
32."Shellstock" means raw, in-shell molluscan shellfish.
33."Shellstock shipper" or “SS” means any person who buys, repacks, sells, ships or receives shellstock.
34."Shucked shellfish" means molluscan shellfish that have one (1) or both shells removed.
35."Shucker-packer" or “SP” means any person who shucks shellfish. A shucker-packer may act as a shellstock shipper or reshipper or may repack shellfish originating from other certified dealers.
36."Tag" means a record of harvesting information attached to a container of shellstock by the harvester, processor or dealer.
37."Transaction record" means the form or forms used to document each purchase or sale of shellfish at the wholesale level, and includes shellfish harvest and sales records, ledgers, purchase records, invoices and bills of lading.
38."Wet storage" means the storage, by a dealer, of shellstock from growing areas in the Approved classification or in the open status of the Conditionally Approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater at any permitted land-based activity or facility.
**History**
- *Amendment — effective from 2026-03-18 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/18/2026*
- *Amendment — effective from 2021-03-01 to 01/04/2022*
- *Amendment — effective from 2017-12-04 to 03/01/2021*
- *Technical Revision — effective from 2017-05-16 to 12/04/2017*
- *Amendment — effective from 2017-05-16 to 05/16/2017*
- *Amendment — effective from 2012-12-10 to 05/16/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Adoption — effective from 2002-10-07 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 10/07/2002*
##### **216-RICR-50-10-6 § 6.3** Licensure Requirements {#sec-216-ricr-50-10-6-6.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-6#6.3}
6.3.1License for a Shellfish Business
A.The provisions of R.I. Gen. Laws Chapter 21-14 and this Part shall not apply to retail operators offering for sale to the consumer only shellfish which have been obtained from persons licensed to operate a shellfish business.
B.No person shall conduct within the State of Rhode Island any shellfish business without a valid license issued by the Department and any and all necessary permits or licenses from such agencies as the Department of Environmental Management (DEM), and the Coastal Resources Management Council (CRMC).
C.As a condition of initial and continued licensure, shellfish businesses licensed in the State of Rhode Island shall meet the requirements of 21 C.F.R. Part 123 (2017) entitled “Fish and Fishery Products” (not to include later amendments thereof), incorporated by reference in § 6.1.4(B) of this Part, where applicable.
D.The Director shall, upon receipt of application for a license to conduct a shellfish business, cause the applicant's shellfish business facilities to be investigated and, if they are found to comply with the provisions of this Part herein, shall issue a license upon receipt of a fee as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, for a shipper/reshipper or a fee as set forth for a shucker-packer/repacker.
E.Any person who is seeking licensure as a dealer shall have and implement a HACCP plan, and have a program of sanitation monitoring and record keeping in compliance with 21 C.F.R. Part 123 (2017) (not to include later amendments thereof), incorporated by reference in § 6.1.4(B) of this Part, except for the requirement for harvester identification on a dealer’s tag.
F.Any license so issued shall apply only to those phases of the shellfish business as approved by the Department and as defined in this Part.
G.The license period shall be for twelve (12) months, unless sooner suspended or revoked for cause, commencing on the first (1st) day of January, and the license fee shall be at the full annual rate regardless of the date of application or the date of issuance of license. The fee for renewal of a license to conduct a shellfish business shall be as set forth in Part 10-05-2 of this Title, Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health, for a shipper/reshipper or as set forth for a shucker-packer/repacker.
H.Licenses issued pursuant to this Part may be suspended or revoked for violation of the provisions of R.I. Gen Laws Chapter 21-14 and this Part.
I.The Director may, after a hearing, refuse to issue any such license to any person who has been convicted of any violation of R.I. Gen Laws Chapter 21-14 or this Part.
J.Each dealer shall have a business facility address or aquaculture lease at which inspections of facilities, activities, equipment, or records can be conducted.
K.Facility Plan
1.A licensee shall submit to the Department properly prepared plans and specifications for review and approval a minimum of thirty (30) days before:
a.The construction of a structure for use as a shellfish business;
b.The conversion of an existing structure for use as a shellfish business; or
c.The remodeling of a shellfish business or a change of type of shellfish business if the Department determines that plans and specifications are necessary to assure compliance with this Part.
L.Operational Plan
1.An operational plan shall be submitted with a licensure application or when there is a change in operations of a shellfish business.
6.3.2Sale of Non-Complying Shellfish Prohibited
A.No person shall sell or possess with intent to sell within the State of Rhode Island for human consumption any shellfish which have not been processed, labeled, transported, or sold in compliance with the provisions of R.I. Gen. Laws Chapter 21-14 and this Part.
B.Any shellfish which the Director shall have reasonable cause to believe have been taken from unapproved areas or which have not been processed, labeled, transported, or sold in compliance with the provisions of this Part shall be confiscated. Search warrants may be issued by any district court upon complaint of the Director or the Director's duly authorized agents relating to violations of R.I. Gen. Laws Chapter 21-14 and this Part.
6.3.3Inspection of Business Premises
A.The Director shall make regular inspections of the business premises of licensees and no person shall interfere with or obstruct the entrance of the Director to any dealer or structural appurtenance thereto, vessel, or vehicle, for the purpose of making inspection related to compliance with R.I. Gen. Laws Chapter 21-14 and this Part during reasonable business hours and no person shall obstruct the conduct of this inspection; provided, however, that inspections as to sanitary conditions shall be made only by the Director or employees of the Department.
B.In accordance with R.I. Gen Laws § 21-14-14, all such agents, so appointed by the Director, by virtue of their appointment and until these appointments shall be cancelled and revoked, may seize all shellfish in possession of any person violating the provisions of R.I. Gen. Laws Chapter 21-14, and may make complaints for all such violations, and in any such complaint they shall not be required at the time of complaint or thereafter to enter into recognizance or in any way to become liable for the costs that may accrue thereon.
6.3.4Certification Program
A.Any shellfish business which requests to be included on the Interstate Certified Shellfish Shippers List (ICSSL) issued by the Department shall meet all requirements of the National Shellfish Sanitation Program’s Guide for Control of Molluscan Shellfish: 2023 Revision (not to include later amendments or editions thereof)
B.No dealer shall ship shellfish out of the State of Rhode Island prior to obtaining certification from the Department.
**History**
- *Amendment — effective from 2026-03-18 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/18/2026*
- *Amendment — effective from 2021-03-01 to 01/04/2022*
- *Amendment — effective from 2017-12-04 to 03/01/2021*
- *Technical Revision — effective from 2017-05-16 to 12/04/2017*
- *Amendment — effective from 2017-05-16 to 05/16/2017*
- *Amendment — effective from 2012-12-10 to 05/16/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Adoption — effective from 2002-10-07 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 10/07/2002*
##### **216-RICR-50-10-6 § 6.4** General Requirements {#sec-216-ricr-50-10-6-6.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-6#6.4}
6.4.1General Requirements
A.Licensure Requirements
1.Types of Licensure Activities
a.Shucker-packer (SP). Any person who shucks shellfish shall be licensed as a shucker-packer.
b.Repacker (RP)
(1)Any person who repacks shucked shellfish shall be licensed as a shucker-packer or repacker;
(2)Any person who repacks shellstock shall be licensed as a shellstock shipper, shucker-packer, or repacker;
(3)A repacker shall not shuck shellfish.
c.Shellstock Shipper (SS). Any person who ships and receives shellstock in interstate commerce shall be licensed as a shellstock shipper, repacker, or shucker-packer.
d.Reshipper (RS). Any person who purchases shellstock or shucked shellfish from dealers and sells the product without repacking or relabeling to other dealers, wholesalers or retailers shall be licensed as a reshipper. Reshippers are not required to have a business facility address as required in § 6.3.1(J) of this Part.
2.General Licensure Requirements
a.No person shall act as a dealer prior to obtaining a license.
b.Any person who wants to be a dealer shall:
(1)Make application to the Director for a license; and
(2)Have and implement a HACCP Plan.
B.Shellstock Identification
1.General
a.The dealer shall keep the harvester's tag affixed to each container of shellstock until the container is:
(1)Shipped; or
(2)Emptied to wash, grade or pack the shellstock.
b.When the dealer is also the harvester and they elect not to use a harvest tag, the dealer shall affix their dealer tag to each container of shellstock.
2.Tags
a.The dealers’ tags shall be:
(1)Durable, waterproof and sanctioned by the Department prior to use; and
(2)At least 13.8 square inches [89.03 square cm] in size.
b.The dealer's tag shall contain the following indelible, legible information in the order specified below:
(1)The dealer’s name and address;
(2)The dealer’s license number or certification number as assigned by the Department and the original shellstock shipper’s license number, if applicable;
(3)The date of harvest;
(4)The time of harvest (when appropriate);
(5)The harvest location, as designated in the Rhode Island Shellfish Harvest Area Tagging Map including the initials for the State of Rhode Island (RI), or the harvest area it appears on the original dealer's tag, including the initials of the State of origin; and
(6)When the shellstock has been taken across State lines and has been placed in wet storage in a dealer’s operation, the statement: “THIS PRODUCT IS A PRODUCT OF (NAME OF STATE) AND WAS WET STORED AT (FACILITY LICENSE NUMBER) FROM (DATE) TO (DATE);”
(7)The type and quantity of shellfish; and
(8)The following statement in bold capitalized type on each tag: “THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE, IN CHRONOLOGICAL ORDER, FOR 90 DAYS.” "RETAILERS: DATE WHEN LAST SHELLFISH FROM THIS CONTAINER SOLD OR SERVED (INSERT DATE)"
(9)All shellstock intended for raw consumption shall include a consumer advisory. The following statement, from § 3-603.11 of the 2022 FDA Food Code, or an equivalent statement, shall be included on all shellstock: “Consuming raw or undercooked meats, poultry, seafood, shellfish or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions."
(10)The statement “Keep Refrigerated” or an equivalent statement shall be included on the tag.
(11)If the shellstock is removed from the original container, the tag on the new container shall meet the requirements in §§ 6.4.1(B) through (D) in this Part.
C.Tagging Shellstock during Intermediate Processing
1.When the shellstock is removed from the original container, the dealer shall:
a.Keep the harvester tag for ninety (90) days;
b.Keep track of the growing area and date of harvest for shellstock; and
c.Maintain identity of all shellstock during any intermediate stage of processing.
2.A dealer receiving bulk tagged lots of shellstock shall have an intermediate processing plan approved by the Department to ensure that each lot of shellstock is kept separate and identified in a way which prevents commingling or misidentification.
3.In order for a dealer to tag a lot container (e.g. a pallet) of shellfish in lieu of meeting the requirement in §§ 6.4.1(B) through (D) of this Part for a harvester or dealer tag on each individual container, the dealer shall have an intermediate processing plan approved by the Department which establishes the procedures the dealer shall use to tag the lot during the washing, packing or staging of shellfish.
4.Unless the dealer is included in the Department’s commingling plan, the dealer’s intermediate processing plan for tagging a lot of shellfish during the intermediate stage of processing shall ensure that each lot of shellfish is separated and identified in a way which prevents commingling or misidentification. The identification shall be provided by:
a.A harvester's or dealer's tag which meets the requirements of §§ 6.4.1(B) through (D) of this Part; or
b.A tag for each lot of shellstock which contains the following information:
(1)A statement that "All shellstock containers in this lot have the same harvest date and area of harvest;"
(2)Harvest date;
(3)Harvest time (when appropriate);
(4)Growing area;
(5)Original dealer license or certification number (if applicable); and
(6)Number of individual containers in each lot of shellstock container (e.g. a pallet) after washing, packing or staging has been completed.
5.When a dealer has an approved intermediate processing plan, the dealer shall tag each lot of shellstock in accordance with the intermediate processing plan while the lot of shellstock is being processed in the plant.
D.Transaction Record. If shellstock are sold in bulk, the dealer shall provide a transaction record prior to shipment. This transaction record shall contain all the information required in § 6.4.1(E) of this Part with the addition of the name of the consignee.
E.Shucked Shellfish Labeling
1.All shellfish intended for raw consumption shall include a consumer advisory. The following statement, from § 3-603.11 of the 2022 FDA Food Code, or an equivalent statement, shall be included on all shellfish:
a.“RETAILERS, INFORM YOUR CUSTOMERS” “Consuming raw or undercooked meats, poultry, seafood, shellfish or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions.”
2.If the shucker-packer uses returnable containers to transport shucked shellfish between dealers for the purpose of further processing or packing, the returnable containers are exempt from the labeling requirements in § 6.4.1(E) of this Part. When returnable containers are used, the shipment shall be accompanied by a transaction record containing:
a.The original shucker-packer's name and license or certification number (if applicable);
b.The shucking date; and
c.The quantity of shellfish per container and the total number of containers.
3.If the dealer uses master shipping cartons, the master cartons are exempt from these labeling requirements when the individual containers within the carton are properly labeled.
4.At a minimum the dealer shall label each individual package containing fresh or frozen shucked shellfish meat in a legible and indelible form in accordance with 21 C.F.R. § 161.130 (2017) (not to include later amendments thereof), incorporated by reference in § 6.1.4(D) of this Part and the Federal Fair Packaging and Labeling Act, 15 U.S.C. §§ 1451-1461, incorporated by reference in § 6.1.4(E) of this Part.
5.The dealer shall assure that each package containing less than sixty-four (64) fluid ounces of fresh or frozen shellfish shall have:
a.The shucker-packer's or repacker's license or certification number (if applicable) on the label; and
b.A "SELL BY DATE" which provides a reasonable subsequent shelf-life or the words "BEST IF USED BY" followed by a date when the product would be expected to reach the end of its shelf-life. The date shall consist of the abbreviation for the month and number of the day of the month. For frozen shellfish, the year shall be added to the date.
6.The dealer shall assure that each package containing more than sixty-four (64) fluid ounces of fresh or frozen shellfish shall have:
a.The shucker-packer's or repacker's license or certification number (if applicable) on the label; and
b.A "DATE SHUCKED" which shall:
(1)For fresh shellfish, consist of Julian format or the month and the number of the day of the month;
(2)For frozen shellfish, the year should be added to the month and day of the month if using the non-Julian format; and
(3)Appear on the lid and sidewall or bottom of single-use containers.
7.If the dealer thaws and repacks frozen shellfish, the dealer shall label the shellfish container as previously frozen.
8.The dealer shall provide all label information in a legible and indelible form.
9.The dealer shall maintain lot integrity when shucked shellfish are stored using in-plant reusable containers.
F.Shucked Shellfish
1.If the SP or RP elects to repack shellfish, the dealer shall pack and label all shellfish in accordance with §§ 6.4.1(E), (F), and (G) of this Part, except that the original date of shucking shall be used in establishing the SELL BY DATE.
G.Buy Boats
1.Boats used to purchase shellfish shall be operated in compliance with all applicable requirements of R.I. Gen. Laws Chapter 21-14 and this Part, including but not limited to:
a.Hand washing equipment, such as sanitizing baby wipes or potable water and soap, shall be provided on the vessel and used any time the hands have become contaminated.
b.Boats shall provide overhead protection of shellstock from exposure to sun, birds, and other adverse conditions.
c.Boats may be cleaned with water from open harvest areas or a potable water supply.
d.Shellstock shall be placed under temperature control of forty-five degrees Fahrenheit (45º F) (seven and two tenths degrees Centigrade (7.2º C)) ambient air temperature (or below) as soon as possible not to exceed two (2) hours from the time the boat leaves the harvest area in which it was operating; and
e.§ 6.4.1(G)(2) of this Part, outlined below.
2.Disposal of Human Sewage from Vessels
a.Human sewage shall not be discharged overboard from a vessel used in the harvesting of shellstock, or from vessels which buy shellstock while the vessels are in growing areas.
b.As required by the Department, in consultation with the Food and Drug Administration (FDA), an approved marine sanitation device (MSD), portable toilet or other sewage disposal receptacle shall be provided on the vessel to contain human sewage and vomitus.
c.Portable toilets shall:
(1)Be used only for the purpose intended;
(2)Be secured while on board and located to prevent contamination of shellshock by spillage or leakage;
(3)Be emptied only into a sewage disposal system;
(4)Be cleaned before being returned to the boat; and,
(5)Not be cleaned in equipment used for washing or processing food.
d.Use of other receptacles for sewage disposal may be approved by the Department if the receptacles are:
(1)Constructed of impervious, cleanable materials and have a tight-fitting lid;
(2)Indelibly labeled “Human Waste” in contrasting letters at least three inches (3”) in height; and
(3)Meet the requirements of § 6.4.1(G)(2)(c) of this Part.
6.4.2General HACCP Requirements
A.Hazard Analysis. Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of shellfish product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of shellfish product being processed in the absence of those controls. In the hazard analysis, the dealer shall consider the critical control points listed in this Part.
B.HACCP Plan. Every dealer shall have and implement a written HACCP plan. A HACCP plan shall be specific to:
1.Each location where shellfish products are processed by that dealer; and
2.Each kind of shellfish product processed by the dealer. The plan may group kinds of shellfish products together, or group kinds of production methods together, if the food safety hazard, critical control points, critical limits, and procedures required to be identified and performed in § 6.4.2 (C) of this Part are identical for all shellfish products so grouped or for all production methods so grouped.
C.Contents of the HACCP Plan. The HACCP plan shall, at a minimum:
1.List the food safety hazards that are reasonably likely to occur, as identified in accordance with § 6.4.2(A) of this Part and that thus shall be controlled for each shellfish product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:
a.Natural toxins;
b.Microbiological contamination;
c.Chemical contamination;
d.Pesticides;
e.Drug residues;
f.Unapproved use of direct or indirect food or color additives; and
g.Physical hazards.
2.List the critical control points for each of the identified food safety hazards, including as appropriate:
a.Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. At a minimum, the critical control points shall include those identified in § 6.4 of this Part, as applicable. As an alternative, the dealer may establish other critical control points which the dealer can demonstrate to the Department provide equivalent public health protection. If the dealer can demonstrate to the Department through a hazard analysis that the food safety hazard is not reasonably likely to occur, the critical control point is not required with the exception of receiving which shall always be considered as a critical control point.
b.Critical control points designed to control food safety hazards that could be introduced in the processing plant environment. As an alternative, the dealer may establish other critical control points which the dealer can demonstrate to the Department provide equivalent public health protection. If the dealer can demonstrate to the Department through a hazard analysis that the food safety hazard is not reasonably likely to occur, the critical control point is not required. At a minimum, the critical control points shall include those identified in § 6.4 of this Part, as applicable.
3.List the critical limits that shall be met at each of the critical control points. At a minimum, the critical limits shall include those listed in § 6.4 of this Part, as applicable. As an alternative, the dealer may establish other critical limits which the dealer has demonstrated provide equivalent public health protection, with the exception of receiving, which shall always be considered as a critical control point. In any case, the critical limits identified in § 6.4 of this Part, shall be met as components of good manufacturing practices.
4.List the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits.
5.Include any corrective action plans that have been developed in accordance with § 6.4.2 of this Part to be followed in response to deviations from critical limits at critical control points.
6.Provide for a record keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.
7.List the verification procedures, and frequency thereof, that the dealer will use in accordance with § 6.4.2 of this Part.
D.Signing and Dating the HACCP Plan
1.The HACCP plan shall be signed and dated, either by the most responsible individual on site at the processing facility or by a higher level official of the dealer. This signature shall signify that the HACCP plan has been accepted for implementation by the dealer.
2.The HACCP plan shall be signed and dated:
a.Upon initial acceptance;
b.Upon any modification; and
c.Upon verification of the plan.
E.Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with this Part, they do not need to be included in the HACCP plan, and vice versa.
F.Corrective Actions
1.Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:
a.Following a corrective action plan that is appropriate for the particular deviation, or
b.Following the procedures in § 6.4.2 of this Part.
2.Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with § 6.4.2 of this Part, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:
a.No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and
b.The cause of the deviation is corrected.
3.When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:
a.Segregate and hold the affected product, at least until the requirements of § 6.4.2 of this Part are met;
b.Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review. Adequate training may or may not include training in accordance with § 6.4.2 of this Part;
c.Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;
d.Take corrective action, when necessary, to correct the cause of the deviation; and,
e.Perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with § 6.4.2 of this Part, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.
4.All corrective actions taken in accordance with this Section shall be fully documented in records that are subject to verification in accordance with § 6.4.2 of this Part and the record keeping requirements of § 6.4.2 of this Part.
G.Verification
1.Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:
a.A reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. These changes may include: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an individual or individuals who have been trained in accordance with § 6.4.2 of this Part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of § 6.4.2 of this Part.
b.Ongoing verification activities including:
(1)A review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;
(2)The calibration of process-monitoring instruments; and
(3)At the option of the dealer, the performing of periodic end-product or in-process testing.
c.A review, including signing and dating, by an individual who has been trained in accordance with § 6.4.2 of this Part, of the records that document:
(1)The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one (1) week of the day that the records are made;
(2)The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with § 6.4.2 of this Part. This review shall occur within one (1) week of the day that the records are made; and
(3)The calibrating of any process monitoring instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the dealer’s verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the processor’s written procedures. These reviews shall occur within a reasonable time after the records are made.
d.Dealers shall immediately follow the procedures in § 6.4.2 of this Part whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.
e.The calibration of process-monitoring instruments, and the performing of any periodic end-product and in-process testing, in accordance with § 6.4.2 of this Part shall be documented in records that are subject to the record keeping requirements of § 6.4.2 of this Part.
H.Records
1.All records required by § 6.4.2 of this Part shall include:
a.The name and location of the dealer;
b.The date and time of the activity that the record reflects;
c.The signature or initials of the person performing the operation; and
d.Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.
2.All records required by § 6.4.2 of this Part shall be retained at the processing facility for at least one (1) year after the date they were prepared in the case of refrigerated products and for at least two (2) years after the date they were prepared in the case of frozen products.
3.Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two (2) years after their applicability to the product being produced at the facility.
4.If the processing facility is closed for a prolonged period between seasonal operations, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations but shall be immediately returned for official review upon request.
5.All records and HACCP plans required by § 6.4.2 of this Part shall be available for official review and copying at reasonable times.
6.Tags on containers of shellstock are not subject to the requirements of this Section unless they are used to fulfill the requirements of § 6.4.1 of this Part.
7.The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.
I.Training
1.All dealers shall obtain Department-approved training every five (5) years. The training shall include required processing, handling, and transportation practices as determined by the Department.
a.A dealer shall receive proof of completion of the required training. Proof of training obtained by the dealer within the past two (2) years shall be presented to the Department prior to certification, recertification, or licensing.
b.At a minimum, one (1) individual involved in the shellfish operations shall obtain the required training.
c.The dealer shall maintain the record of the completed training.
2.At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to shellfish processing at least equivalent to that received under standardized curriculum recognized as adequate by the Department or who is otherwise qualified through job experience to perform these functions:
a.Developing a HACCP plan, which could include adapting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements § 6.4.2 of this Part.
b.Reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in § 6.4.2 of this Part and the HACCP plan in accordance with the verification activities specified in § 6.4.2 of this Part; and.
c.Performing the record review required by § 6.4.2 of this Part.
3.Job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum as determined by the Department.
4.The trained individual need not be an employee of the dealer.
J.Sanitation Monitoring. Each dealer shall monitor conditions and practices that are both appropriate to the plant and the food being processed with sufficient frequency to ensure, at a minimum, conformance with the requirements specified in § 6.4.3 of this Part. The requirements specified in these Sections shall relate to the following sanitation items:
1.Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice, hereinafter referred to as: Safety of water for processing and ice production;
2.Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, hereinafter referred to as: Condition and cleanliness of food contact surfaces;
3.Prevention of cross contamination from unsanitary objects to food, food packaging materials, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, hereinafter referred to as: Prevention of cross contamination;
4.Maintenance of hand washing, hand sanitizing, and toilet facilities, hereinafter referred to as: Maintenance of hand washing, hand sanitizing and toilet facilities;
5.Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants, hereinafter referred to as: Protection from adulterants;
6.Proper labeling, storage, and use of toxic compounds, hereinafter referred to as: Proper labeling, storage, use of toxic compounds;
7.Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces, hereinafter referred to as: Control of employees with adverse health conditions; and
8.Exclusion of pests from the food plant, hereinafter referred to as: Exclusion of pests.
9.While monitoring of those specified conditions and practices (listed in §§ 6.4.2(J)(1) through (9) of this Part) that are not appropriate to the plant and the food being processed is not required, compliance with such conditions and practices remains mandatory.
K.Sanitation Monitoring Records. Each dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by § 6.4.2 of this Part.
L.Relationship to HACCP Plan. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with § 6.4.2 of this Part, they need not be included in the HACCP plan, and vice versa.
6.4.3Sanitation Requirements (HACCP Key Points of Sanitation)
A.Each dealer shall comply with the requirements specified in this Section that are appropriate to the plant and the food being processed. Monitoring and record keeping for these conditions and practices is required.
B.Safety of Water for Processing and Ice Production
1.Water Supply
a.The dealer shall provide a potable water supply in accordance with applicable Federal, State and local Regulations.
b.If the water supply is from a private source, the dealer shall make arrangements to have the water supply sampled by persons recognized by the Department and tested at laboratories sanctioned or certified by the Department:
(1)Prior to use of the water supply;
(2)Every six (6) months while the water supply is in use; and
(3)After the water supply has been repaired and disinfected.
c.The dealer shall assure that any steam used in food processing or that comes in contact with food contact surfaces is free from any additives, or deleterious substances consistent with Federal and State laws and Regulations.
2.Ice Production. Any ice used in the processing, storage, or transport of shellstock or shucked shellfish shall:
a.Be made on-site from potable water in a commercial ice machine; or
b.Come from a facility sanctioned by the Department or the appropriate regulatory agency.
3.Shellstock Washing. Water from either a potable water supply or a growing area in the Approved classification shall be used to wash shellstock.
4.Plumbing and Related Facilities. The dealer shall design, install, modify, repair, and maintain all plumbing and plumbing fixtures to:
a.Prevent contamination of water supplies;
b.Prevent any cross-connection between the pressurized potable water supply and water from an unacceptable source. The dealer shall install and maintain in good working order devices to protect against backflow and back siphonage.
5.Shellstock washing storage tanks and related plumbing shall be fabricated from safe materials and tank construction shall be such that it:
a.Is easily accessible for cleaning and inspection;
b.Is self-draining; and
c.Meets the requirements for food contact surfaces.
C.Condition and Cleanliness of Food Contact Surfaces. Equipment and utensil construction for food contact surfaces
1.The dealer shall use only equipment and utensils, including approved plastic ware and finished product containers which are:
a.Constructed in a manner and with materials that can be cleaned, sanitized, maintained or replaced in a manner to prevent contamination of shellfish products;
b.Free from any exposed screws, bolts, or rivet heads on food contact surfaces; and
c.Fabricated from food grade materials.
2.The dealer shall assure that all joints on food contact surfaces:
a.Have smooth easily cleanable surfaces; and
b.Are welded.
3.Shucking blocks shall be provided which are:
a.Easily cleanable;
b.Fabricated from safe material;
c.Solid, one (1) piece construction; and
d.Easily removed from the shucking bench unless the block is an integral part of the bench.
e.The dealer shall provide a temperature measuring device accurate to +/- two degrees Fahrenheit (2 F) for use in monitoring product temperatures.
4.All equipment used in heat shock processing shall meet the requirements of § 6.4.3 of this Part.
5.All equipment used to handle ice shall be kept clean and stored in a sanitary manner, and shall meet the construction requirements in § 6.4.3 of this Part.
6.Wet storage tanks and all containers used in wet storage tanks shall be kept clean and stored in a sanitary manner, and shall meet the construction requirements in § 6.4.3 of this Part.
D.Cleaning and Sanitizing of Food Contact Surfaces
1.Food contact surfaces of equipment, utensils (including ice shovels), and containers shall be cleaned and sanitized to prevent contamination of shellfish and other food contact surfaces. The dealer shall:
a.Provide adequate cleaning supplies and equipment, including three (3) compartment sinks, brushes, detergents, and sanitizers, hot water and pressure hoses shall be available within the plant;
b.Sanitize equipment and utensils prior to the start-up of each day's activities and following any interruption during which food contact surfaces may have been contaminated;
c.Wash and rinse equipment and utensils at the end of each day; and,
d.Provide a test kit or other device that accurately measures the parts per million concentration of sanitizing solutions.
2.All conveyances and equipment which come into contact with stored shellstock shall be cleaned and maintained in a manner and frequency as necessary to prevent shellstock contamination.
3.Shellfish shall be protected from contamination by washing and rinsing shucking containers and sanitizing before each filling.
4.Containers which may have become contaminated during storage shall be washed, rinsed, and sanitized prior to use or shall be discarded.
5.Shucked shellfish shall be packed in clean containers and stored in a manner which assures their protection from contamination.
6.If used, the finger cots or gloves shall be:
a.Made of impermeable materials except where the use of such material is inappropriate or incompatible with the work being done;
b.Sanitized at least twice daily;
c.Cleaned more often, if necessary;
d.Properly stored until used; and
e.Maintained in a clean, intact, and sanitary condition.
E.Prevention of Cross Contamination
1.Protection of Shellfish
a.Shellstock shall be stored in a manner to protect shellstock from contamination in dry storage and at points of transfer.
b.Shucked shellfish shall be protected from contamination.
c.Shellstock shall not be placed in containers with standing water for the purposes of washing shellstock or loosening sediment.
d.Equipment and utensils shall be stored in a manner to prevent splash, dust, and contamination.
2.Employee Practices
a.Where the same employee works in both the shucking and packing activities, the employee shall wash their hands thoroughly after entering.
b.The dealer shall require all employees to wash their hands thoroughly with soap and water and sanitize their hands in an adequate handwashing facility:
(1)Before starting work;
(2)After each absence from the work station;
(3)After each work interruption; and
(4)Any time when their hands may have become soiled or contaminated.
c.Any employee handling shucked shellfish shall be required to:
(1)Wear effective hair restraints;
(2)Remove any hand jewelry that cannot be sanitized or secured;
(3)Wear finger cots or gloves if jewelry cannot be removed;
(4)Wear clean outer garments, which are rinsed or changed as necessary to be kept clean.
(5)In any area where shellfish are shucked or packed and in any area which is used for the cleaning or storage of utensils, the dealer shall not allow employees to: store clothing or other personal belongings; eat or drink; spit; and use tobacco in any form.
d.Separation of Operations
(1)Facilities for shucking and packing activities shall be separated by use of: separate rooms; partitions; or sufficient spacing.
(2)Manufacturing activities which could result in the contamination of the shellfish shall be separated by adequate barriers.
(3)The dealer shall provide toilet room doors which are tight fitting, self-closing, and do not open directly into a processing area.
F.Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities
1.Handwashing facilities with warm water at a minimum temperature of one hundred ten degrees Fahrenheit (110° F) (forty-three degrees Centigrade (43° C)), dispensed from a hot and cold mixing or combination faucet, shall be provided.
2.Handwashing facilities shall be provided which are:
a.Convenient to work areas;
b.Separate from the three (3) compartment sinks used for cleaning equipment and utensils;
c.Directly plumbed to an approved sewage disposal system; and,
d.Adequate in number and size for the number of employees.
3.The dealer shall provide at least one (1) hand sink in the packing room.
4.The dealer shall provide at each handwashing facility:
a.A supply of hand cleansing soap or detergent;
b.A conveniently located supply of single service towels in a suitable dispenser or a hand drying device that provides heated air;
c.An easily cleanable waste receptacle; and
d.Handwashing signs in a language understood by the employees.
5.Sewage and liquid disposable wastes shall be properly removed from the facility.
6.An adequate number of conveniently located toilets shall be provided.
7.The dealer shall provide each toilet facility with an adequate supply of toilet paper in a suitable holder.
G.Protection from Adulterants
1.Shellfish shall be protected from contamination while being transferred from one (1) point to another during handling and processing.
2.Any lighting fixtures, light bulbs, skylights, or other glass suspended over food storage or processing activities in areas where shellfish are exposed shall be of the safety type or protected to prevent food contamination in case of breakage.
3.Food contact surfaces shall be protected from contamination by adulterants by using cleaning compounds and sanitizing agents only in accordance with applicable Federal and State laws and Regulations.
4.The dealer shall assure that any steam used in food processing or that comes in contact with food contact surfaces is free from any additives, or deleterious substances consistent with Federal and State laws and Regulations.
5.Air pump intakes shall be located in a protected place. Air filters shall be installed on all blower air pump intakes. Oil bath type filters are not allowed.
H.Protection of Ice Used in Shellfish Processing
1.Any ice which is not made on site in the shellfish processing facility shall be inspected upon receipt and rejected if the ice is not delivered in a way so as to be protected from contamination.
2.Ice shall be stored in a safe and sanitary manner to prevent contamination of the ice.
3.Adequate ventilation shall be provided to minimize condensation in areas where food is stored, processed or packed.
I.Proper Labeling of Storage of Toxic Compounds
1.The dealer shall assure that only toxic substances necessary for plant activities are present in the facility.
2.Each of the following categories of toxic substances shall be stored separately:
a.Insecticides and rodenticides;
b.Detergents, sanitizers, and related cleaning agents; and
c.Caustic acids, polishes, and other chemicals.
3.The dealer shall not store toxic substances above shellfish or food contact surfaces.
J.Use and Labeling of Toxic Compounds
1.When pesticides are used, the dealer shall apply pesticides in accordance with applicable Federal and State Regulations to control insects and rodents in such a manner to prevent the contamination of any shellfish or packaging materials with residues.
2.Cleaning compounds and sanitizing agents shall be labeled and used only in accordance with applicable Federal and State laws and Regulations.
3.Toxic substances shall be labeled and used in accordance with the manufacturer's label directions.
K.Control of Employees with Adverse Health Conditions
1.The dealer shall take all reasonable precautions to assure that any employee with a disease in the communicable stage which might be transmissible through food shall be excluded from working in any capacity in which the employee may come in contact with the shellfish or with food contact surfaces. The diseases which are transmissible from food workers through food are those determined by the US Centers for Disease Control and Prevention, in compliance with 42 U.S.C. § 1201 et seq. the Americans with Disabilities Act, and published in the Federal Register. These include:
a.Norovirus
b.Hepatitis A virus
c.Shigella spp.
d.Enterohemorrhagic or Shiga Toxin-producing Escherichia coli, or
e.Salmonella typhi
2.All employees shall immediately report to the dealer and/or the supervisor information about their health and activities as they relate to diseases that are transmissible through food. All employees shall report the information in a manner that allows the dealer and/or supervisor to reduce the risk of shellfish-borne disease transmission, including providing necessary additional information, such as the date of onset of symptoms of an illness, or of a diagnosis without symptoms, or if the employee:
a.Has any of the following symptoms:
(1)Vomiting,
(2)Diarrhea,
(3)Jaundice,
(4)Sore throat with fever, or
(5)A lesion containing pus such as a boil or infected wound that is open or draining on any part of the body, or
b.Has an illness diagnosed by a health practitioner due to:
(1)Norovirus
(2)Hepatitis A virus,
(3)Shigella spp.,
(4)Enterohemorrhagic or Shiga Toxin-producing Escherichia coli, or
(5)Salmonella typhi
c.Had a previous illness, diagnosed by a health practitioner, within the past three (3) months due to Salmonella typhi, without having received antibiotic therapy, as determined by a health practitioner;
d.Has been exposed to, or is the suspected source of, a confirmed disease outbreak, because the employee consumed or prepared food implicated in the outbreak, or consumed food at an event prepared by a person who is infected or ill with:
(1)Norovirus within the past twenty-four (24) hours of the last exposure:
(2)Enterohemorrhagic or Shiga toxin-producing Escherichia coli or Shigella spp. Within the past three (3) days of the last exposure;
(3)Salmonella typhi within the past fourteen (14) days of the last exposure;
(4)Hepatitis A virus within the past thirty (30) days of the last exposure; or
e.Has been exposed by attending or working in a setting where there is a confirmed disease outbreak, or living in the same household as, and has knowledge about, an individual that works or attends a setting where there is a confirmed disease outbreak or living in the same household as, and has knowledge about, an individual diagnosed with an illness caused by:
(1)Norovirus within the past twenty-four (24) hours of the last exposure;
(2)Enterohemorrhagic or Shiga toxin-producing Escherichia coli, or Shigella spp. Within the past three (3) days of the last exposure;
(3)Salmonella typhi within the past fourteen (14) days of the last exposure; or
(4)Hepatitis A virus within the past thirty (30) days of the last exposure.
3.If an employee with an infected wound keeps it covered with a proper bandage, an impermeable barrier, and a single-use glove for a hand lesion, the dealer may allow the employee to work in the shellfish processing facility without additional restrictions.
4.The dealer shall notify the State Shellfish Control Authority and the Department when notified by an employee of a diagnosis or exhibits symptoms of hepatitis, and shall ensure that the employee is excluded from working in any capacity in which the employee may come in contact with the shellfish or with food contact surfaces or that may transmit the illness to other employees.
L.Exclusion of Pests. The dealer shall operate their facility to assure that insects, rodents, and other pests are excluded from the facility and processing activities. Dogs, cats, birds, and other animals shall also be excluded.
6.4.4Other Requirements
A.Each dealer shall comply with the requirements specified in § 6.4.4 of this Part that are appropriate to the plant and the food being processed. However, monitoring and record keeping for these conditions and practices is not required, unless specifically stated.
B.Recalls
1.Dealers shall adopt written procedures for conducting recalls of adulterated or misbranded shellfish products. These written procedures for conducting recalls shall be based on, and complementary to, the FDA Enforcement Policy on Recalls.
2.Dealers shall follow their written recall procedures to include timely notification to the Department of a situation requiring recall, timely notification of consignee who received the affected product, and effective removal or correction of the affected product.
C.Plants and Grounds
1.General
a.The physical facilities shall be maintained in good repair.
b.Animals or unauthorized persons shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored.
D.Flooding
1.Facilities in which shellfish are stored, shucked, packed, repacked or reshipped shall be located so that these facilities are not subject to flooding during ordinary high tides.
2.If facilities are flooded:
a.Shellfish processing, shucking or repacking activities shall be discontinued until the flood waters have receded from the building; and the building is cleaned and sanitized.
b.Any shellfish coming in contact with the flood waters while in storage shall be destroyed; or discarded in non-food use.
3.The dealer shall operate their facility to provide adequate protection from contamination and adulteration by assuring that dirt and other filth are excluded.
E.Plant Interior
1.Sanitary conditions shall be maintained throughout the facility.
a.All dry area floors shall be hard, smooth, easily cleanable; and
b.All wet area floors used in areas to store shellstock, process food, and clean equipment and utensils shall be constructed of easily cleanable, impervious, and corrosion resistant materials which:
(1)Are graded to provide adequate drainage;
(2)Have even surfaces, and are free from cracks that create sanitary problems and interfere with drainage;
(3)Have sealed junctions between floors and walls to render them impervious to water; and
2.Walls and Ceilings. Interior surfaces of rooms where shellfish are stored, handled, processed, or packaged shall be constructed of easily cleanable, corrosion resistant, impervious materials.
3.Grounds. Grounds around the facility shall be maintained to be free from conditions which may result in shellfish contamination. These conditions include, but may not be limited to:
a.Excessively dirty or dusty parking lots, grounds or roads;
(1)Rodent, insect, or bird attraction and harborage; and
(2)Inadequate drainage.
4.Plumbing and Related Facilities
a.All plumbing and plumbing fixtures shall be designed, installed, modified, repaired, and maintained to provide a water system that is adequate in quantity and under pressure, and includes:
(1)Cold and warm water at all sinks; and
(2)Handwashing facilities adequate in number and size for the number of employees, and located where supervisors can observe employee use;
b.Adequate floor drainage, including backflow preventers such as air gaps, shall be provided where floors are:
(1)Used in shellstock storage;
(2)Used for food holding units (e.g. refrigeration units); and
(3)Cleaned by hosing, flooding, or similar methods.
c.A safe, effective means of sewage disposal for the facility shall be provided in accordance with applicable Federal and State laws and Regulations;
d.Installation of drainage or waste pipes over food processing or food storage areas, or over areas in which containers and utensils are washed or stored shall not be permitted.
5.Utilities
a.Ventilation, heating, or cooling systems shall not create conditions that may cause the shellfish products to become contaminated.
b.The dealer shall provide lighting throughout the facility that is sufficient to promote good manufacturing practices.
F.Insect and Vermin Control
1.The dealer shall employ necessary internal and external insect and vermin control measures to ensure that insects and vermin are not present in their facility including:
a.Tight fitting, self-closing doors;
b.Screening of not less than fifteen (15) mesh per inch; and
c.Controlled air current.
G.Disposal of Other Wastes
1.Disposal of waste materials shall be conducted in accordance with appropriate Federal and State laws and Regulations.
2.Shell and other non-edible materials shall be promptly and effectively removed from the shucking bench or table.
3.All areas and receptacles used for the storage or conveyance of waste shall be operated and maintained to prevent attraction, harborage, or breeding places for insects and vermin.
H.Equipment Construction and Design for Non-Food Contact Surfaces
1.The dealer shall use only equipment, including approved plastic ware, which is constructed in a manner and with materials that can be cleaned, sanitized, maintained, or replaced.
2.The dealer shall use easily cleanable, corrosion-resistant, durable, impervious materials, free from cracks to construct:
a.Shucking benches and contiguous walls;
b.Stands or stalls and stools for shucker; and,
c.Any non-food contact surfaces in shellfish storage or handling areas.
3.Shucking benches shall drain completely and rapidly, and shall drain away from any shellfish on the benches.
4.Dealers shall have sufficient refrigeration, capable of cooling and holding shellfish, as required by this Part.
I.Cleaning Non-Food Contact Surfaces
1.Cleaning activities for equipment shall be conducted in a manner and at a frequency appropriate to prevent contamination of shellfish and food contact surfaces.
2.All conveyances and equipment which come into contact with stored shellstock shall be cleaned and maintained in a manner and frequency as necessary to prevent shellstock contamination.
J.Shellfish Storage and Handling
1.The dealer shall:
a.Assure that shellstock is:
(1)Reasonably free of sediment; and
(2)Culled.
b.Completely empty shucking buckets at the packing room so that no overage is returned to the shucker;
c.Inspect incoming shipments and shall reject dead or inadequately protected shellstock;
d.Not allow the use of dip buckets for hand or knife rinsing;
e.Not have on the premises any usable containers or container covers bearing a certification number different from the one issued for those premises unless documentation exists to verify the legitimate source of the containers and the containers contain shellfish from that source;
f.Wash, blow, and rinse all shellfish meats in accordance with 21 C.F.R. § 161.130, incorporated by reference in § 6.1.4(D) of this Part.
g.Thoroughly drain, clean as necessary, and pack shucked shellfish meats promptly after delivery to the packing room;
h.Conduct packing activities so as to conform to applicable food additive Regulations;
i.Store packaged shellfish, if they are to be frozen, at an ambient temperature of zero degrees Fahrenheit (0° F) (negative seventeen and eight tenths degrees Centigrade (-17.8° C)) or less; and frozen solid within twelve (12) hours following the initiation of freezing.
j.Not commingle shellstock during shucking unless the dealer is included in the Department’s commingling plan.
k.Shellstock shall not remain outside of temperature control for two (2) or more hours during processing.
l.Cool oysters and/or hard clams to an internal temperature of fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) or below within ten (10) hours after placement into refrigeration during periods when the risk of Vibrio illness is reasonably likely to occur. When deemed appropriate by the Department an exception may be permitted for hard clams to allow for tempering.
K.Heat Shock
1.A dealer may elect to use heat shock to prepare shellstock for shucking. The dealer shall:
a.Post the schedule for the heat shock process in a conspicuous location;
b.Make sure all responsible persons are familiar with the requirements; and,
c.Cool all hot dipped shellstock immediately after the heat shock process. This cooling shall be accomplished by:
(1)Dipping in an ice bath; or
(2)Use of flowing potable water.
2.If a heat shock water tank is used and the water temperature is maintained at or above one hundred forty degrees Fahrenheit (140° F) (sixty degrees Centigrade (60° C)), the dealer shall completely drain and flush the tank at the end of each day's operation so that all mud and debris which have accumulated in the dip tank are eliminated.
a.If the tank is maintained at or below one hundred forty degrees Fahrenheit (140° F) (sixty degrees Centigrade (60° C)), the tank shall be drained and flushed at three (3) hour intervals.
L.Supervision
1.Supervisors shall not allow unauthorized persons in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored. A reliable, competent individual shall be designated to supervise general plant management and activities;
2.Cleaning procedures shall be developed and supervised to assure cleaning activities do not result in contamination of shellfish or food contact surfaces.
3.All supervisors shall be:
a.Trained in proper food handling techniques and food protection principles; and
b.Knowledgeable of personal hygiene and sanitary practices.
4.The dealer shall require:
a.Supervisors to monitor employee hygiene practices, including handwashing, eating, and smoking at work stations, and storing personal items or clothing.
b.Supervisors to assure that proper sanitary practices are implemented, including:
(1)Plant and equipment clean-up;
(2)Rapid product handling; and
(3)Shellfish protection from contamination.
c.Employees:
(1)To be trained in proper food handling and personal hygiene practices, and
(2)To report any symptoms of illness to their supervisor.
6.4.5Shipping Documents, Records and Written Recall Procedure/Transportation and Receiving
A.Trucks or Other Vehicles Used to Transport Shellfish
1.The dealer who transports shellstock shall assure that all trucks and other conveyances used to transport shellstock are properly constructed, operated, and maintained to prevent contamination, adulteration, cross contamination, deterioration, and decomposition.
a.Shellfish shall be transported in refrigerated trucks.
2.Prechilling trucks or other vehicles shall be required when ambient air temperatures are such that unacceptable bacterial growth or deterioration may occur.
3.Refrigeration trucks or other conveyances shall be:
a.Equipped with automatic controls; and
b.Capable of maintaining the ambient air temperature in the storage area at temperatures of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less.
4.Any ice used to cool shellstock during transport shall meet the requirements of § 6.4.3(B)(2).
5.Cats, dogs, and other animals shall not be allowed in any part of the vessel, buy boat, truck or other vehicle where shellstock is stored.
B.Transportation Containers
1.All containers used to transport shellstock shall be:
a.Constructed to allow for easy cleaning; and
b.Operated and maintained to prevent product contamination.
C.All containers shall be cleaned with:
1.Potable water; and
2.Detergents, sanitizers, and other supplies acceptable for food contact surfaces.
D.Shipping Documents
1.Each shellfish shipment shall be accompanied by a shipping document.
2.The shipping document shall contain:
a.The name, address, and certification number of the shipping dealer;
b.The name and address of the major consignee; and
c.The kind and quantity of the shellfish product.
3.The receiving dealer shall:
a.Maintain in their files a copy of the completed shipping document; and
b.Make the shipping document available to the Department upon request.
4.If the shipment is subdivided to different dealers, each receiving dealer shall maintain records sufficient to trace their portion back to the original shipment.
E.Shipment Acceptability
1.Shellfish shipments shall be considered acceptable when:
a.Shipments are properly identified with tags and shipping documents;
b.Shellstock is alive and in a conveyance with an ambient air temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less;
c.Shucked shellfish is cooled to a temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less, or packed in ice; and
d.The time-temperature indicating device shows that the ambient air temperature has exceeded forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) but the shellstock internal body temperature is fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) or less; and
e.All other conditions of shipment in this Part are met.
F.Receiving Shellfish
1.The dealer shall reject or discard any shellfish shipments which:
a.Do not originate from a licensed harvester or certified dealer; and/or
b.Contains shellfish that are not properly identified with tags and shipping documents;
c.The internal shellstock body temperature exceeds fifty degrees Fahrenheit (50° F) (fifteen and six tenths Centigrade (15.6° C)) unless the harvest initiation time is documented and is in compliance with Rhode Island Department of Environmental Management Regulations, 250-RICR-40-00-1 Aquaculture of Marine Species in Rhode Island Waters, and 250-RICR-90-00-4, Shellfish.
d.Contains shucked shellfish that exceed forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)); or
e.Are unwholesome, inadequately protected, or whose source cannot be identified.
2.Transportation agents or common carriers used by a dealer are not required to be certified.
3.The dealer shall:
a.Inspect incoming shellfish shipments to assure that the shipments are received under the conditions required in this Part;
b.Ensure that shellstock are not permitted to remain without ice, mechanical refrigeration, or other approved methods of storage, as required [wet storage, iced, at or below forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C))] for more than two (2) hours at points of processing or transfer such as loading docks;
c.Ensure that shucked shellfish are not permitted to remain without ice, mechanical refrigeration, or other approved means of maintaining shellfish temperature at forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less; and,
d.Ensure that frozen shellfish remain frozen.
G.Shipping Times
1.Shipping Time is No More Than Four (4) Hours
a.When the shipping time is four (4) hours or less, the dealer shall ship under temperature control.
b.When mechanical refrigeration units are used, the units shall be equipped with automatic controls and shall be capable of maintaining the ambient air in the storage area at temperatures of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less.
c.The dealer shall not be required to provide thermal recorders during shipment.
2.Shipping Time is Greater Than Four (4) Hours
a.When the shipping time is greater than four (4) hours, the dealer shall ship all shellfish in mechanically refrigerated conveyances which are equipped with automatic controls and capable of maintaining the ambient air in the storage area at temperatures of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less; or
b.Unless the dealer has an approved HACCP plan with an alternate means of monitoring time-temperature, the initial dealer shall assure that a suitable time-temperature recording device accompanies each shipment of shellfish.
c.The initial dealer shall note the date and time on the temperature indicating device, if appropriate.
d.Each receiving dealer shall write the date and time on the temperature indicating device, if appropriate, when the shipment is received and the doors of the conveyance or the containers are opened.
e.The final receiving dealer shall keep the time-temperature recording chart or other record of time and temperature in his files and shall make it available to the Department upon request.
f.An inoperative temperature indicating device shall be considered as no recording device.
3.Transaction and Shipping Records
a.Each dealer shall have a business address at which transaction records are maintained.
b.Each dealer shall maintain complete, accurate and legible records of the Department's required information in a form authorized by the Department.
c.Transaction records shall be sufficient to:
(1)Document that the shellfish are from a source authorized under these requirements;
(2)Permit a container of shellfish to be traced back to the specific incoming lot of shucked shellfish from which it was taken;
(3)Permit a lot (or commingled lots) of shucked shellfish or a lot of shellstock to be traced back to the growing area(s), date(s) of harvest, harvest time (when directed by the Department) and the harvester or group of harvesters; and,
(4)Trace the wet storage history of the shellfish including, original harvest site, original harvest date, original harvest time (when directed by the Department) wet storage site(s) and dates.
d.Purchase and sales shall be recorded:
(1)In a permanently bound ledger book; or
(2)Using shipping/sales documents as required in § 6.4.5(D) of this Part and to include the harvest area, harvest date and harvest time (when directed by the Department); or
(3)Using other recording methods acceptable to and authorized by the Department within seventy-two (72) hours of any purchase or sales.
e.The transaction records shall be retained:
(1)In the case of fresh shellfish, for a minimum of one (1) year; and
(2)In the case of frozen shellfish, for at least two (2) years or the shelf-life of the product, whichever is longer.
f.If computer records are maintained, the Department shall approve the format and its use.
6.4.6Post-Harvest Processing
A.A dealer may elect to use a process to reduce Vibrio vulnificus levels in shellfish. The dealer shall have a HACCP plan approved by the Department for the process which includes:
1.An end point criteria for the process as non-detectable (less than three (< 3) MPN/gram) to be determined by use of the Vibrio vulnificus FDA approved EIA procedure of Tamplin, et al, as described in Chapter 9 of the “Bacteriological Analytical Manual,” 8th Edition, Revision A (2004) as required by the 2023 Model Ordinance, incorporated by reference in § 6.1.4(C) of this Part; and
2.A sampling program to demonstrate that the end point criteria is met.
B.Package and label all shellfish in accordance with all requirements contained in this Part. This includes the labeling all shellfish which has been subjected to the process but which is not frozen in accordance with applicable shellfish tagging and labeling requirements in §§ 6.4.1(B) through (F) of this Part.
C.Keep records in accordance with §§ 6.4.1(E) and (F) of this Part.
D.A dealer who meets the requirements of § 6.4.6 of this Part may label product which has been subjected to the reduction process as “Processed to reduce Vibrio vulnificus to non-detectable levels."
E.Processed Products with Labeling Claims for Safety. All certified dealers processing products with labeling claims for safety shall:
1.Consult with and adhere to advice from the U.S. Food and Drug Administration for all special labeling claims.
2.Meet all applicable requirements of R.I. Gen. Laws § 21-14-3. For the purposes of refrigeration, if the end product is dead, treat the product as shucked product. If the end product is live it shall be treated as shellstock for the purposes of refrigeration; and,
3.Ensure through controls in their HACCP Plan that claims are met.
6.4.7Shucking and Packing
A.Heat Shock
1.The dealer shall submit for approval the scheduled process for heat shock. The schedule may be developed by the Department or qualified persons with adequate facilities for conducting the appropriate studies.
2.The dealer shall assure that the critical factors which may affect the heat shock process have been adequately studied and provided for in establishing the process. The critical factors shall include:
a.Type and size of shellfish;
b.Time and temperature of exposure;
c.Type of process;
d.Size of tank, tunnel or retort;
e.Water to shellfish ratios in tanks; and
f.Temperature and pressure monitoring devices;
3.The dealer shall assure that heat shock process does not:
a.Change the physical and organoleptic properties of the species;
b.Kill the shellfish prior to shucking; and
c.Increase microbial deterioration of the shucked shellfish.
4.The dealer shall retain records covering all aspects of the establishment of the heat shock process.
B.Critical Control Points
1.Receiving Critical Control Point – Critical Limits. The dealer shall shuck and pack only shellstock which is:
a.Obtained from a licensed harvester who has:
(1)Harvested the shellstock from an Approved or Conditionally Approved area in the open status as indicated by the tag; and
(2)Identified the shellstock with a tag on each container or transaction record on each bulk shipment; or
b.Obtained from a dealer other than the original harvester who has identified the shellstock with a tag on each container or transaction record with each bulk shipment that has:
(1)Shipped the shellstock in a conveyance at or below forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) ambient air temperature; or fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) internal temperature or less;
(2)Identified the shellstock with a tag on each container or transaction record with each bulk shipment.
(3)All shipments of shellstock shall be accompanied with documentation indicating the time of shipment and that all shipping conveyances comply with the requirements of § 6.4.7 of this Part.
c.Shucked shellfish is received in a conveyance with an ambient temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or adequately iced.
d.Harvested in compliance with the time-temperature requirements as described in Rhode Island Department of Environmental Management Regulations, 250-RICR-40-00-1 Aquaculture of Marine Species in Rhode Island Waters, and 250-RICR-90-00-4, Shellfish.
2.Shellstock Storage Critical Control Point – Critical Limits. The dealer shall ensure that:
a.If wet storage is practiced, water quality meets the requirements outlined in § 6.4.11 of this Part; and
b.Once placed under temperature control and until sale to the processor or final consumer, shellstock shall be:
(1)Iced; or
(2)Placed and stored in a storage area or conveyance maintained at forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less; and
(3)Not permitted to remain without ice, mechanical refrigeration or other approved methods of refrigeration, as required in §§ 6.4.9(B)(1) and (2) of this Part, for more than two (2) hours at points of transfer such as loading docks.
3.Processing Critical Control Point – Critical Limits. The dealer shall ensure that:
a.For shellstock which has not been refrigerated prior to shucking, shucked meats are chilled to an internal temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less within three (3) hours of shucking.
b.For shellstock refrigerated prior to shucking, shucked meats are chilled to an internal temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less within four (4) hours of removal from refrigeration.
c.If heat shock is used, once heat shocked shellstock is shucked, the shucked shellfish meats shall be cooled to forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less within two (2) hours after the heat shock process.
d.When heat shock shellstock are cooled and held under refrigeration for later shucking, the heat shocked shellstock shall be cooled to an internal temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) within two (2) hours from time of heat shock.
4.Shucked Meat Storage Critical Control Point – Critical Limit. The dealer shall store shucked and packed shellfish in covered containers at an ambient air temperature in the storage area of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or covered with ice.
6.4.8Repacking of Shucked Shellfish
A.Receiving Critical Control Point – Critical Limits. The dealer shall repack only shellfish which:
1.Originated from a dealer; and
2.Were shipped in a conveyance at or below forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) ambient air temperature or covered in ice; and
3.Are identified with a label as outlined in §§ 6.4.1(E) and (F) of this Part.
4.Was harvested in compliance with the time-temperature requirements as described in Rhode Island Department of Environmental Management Regulations, 250-RICR-40-00-1 Aquaculture of Marine Species in Rhode Island Waters, and 250-RICR-90-00-4, Shellfish.
5.Are accompanied with documentation indicating the time of shipment, that shellfish has been shipped adequately iced or in a conveyance pre-chilled at or below forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) ambient air temperature.
B.Processing Critical Control Point – Critical Limits. The dealer shall ensure that repacked shellfish do not exceed an internal temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) for more than two (2) hours.
C.Shucked Meat Storage Critical Control Point – Critical Limit. The dealer shall store repacked shellfish in covered containers at an ambient air temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or covered with ice.
6.4.9Shellstock Shipping
A.Receiving Critical Control Point – Critical Limits
1.The dealer shall ship or repack only shellstock which is obtained from a licensed harvester who has:
a.Harvested the shellstock from an Approved or Conditionally Approved area in the open status as identified by the tag; and
b.Identified the shellstock with a tag on each container or transaction record on each bulk shipment; or
c.Obtained from a dealer who has identified the shellstock with a tag on each container.
d.Harvested the shellstock in compliance with the time-temperature requirements as described In Rhode Island Department of Environmental Management Regulations, 250-RICR-40-00-1 Aquaculture of Marine Species in Rhode Island Waters, and 250-RICR-90-00-4, Shellfish.
2.Obtained from a dealer other than the original harvester who has:
a.Identified the shellstock with a tag on each container or transaction record with each bulk shipment.
b.Shipped the shellstock in a conveyance at or below forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) ambient air temperature; or fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) internal temperature or less;
c.All shipments of shellstock shall be accompanied with documentation indicating the time of shipment and that all shipping conveyances comply with the requirements of § 6.4.7 of this Part.
B.Shellstock Storage Critical Control Point – Critical Limits. The dealer shall ensure that:
1.If wet storage in artificial bodies of water is practiced, water quality meets the requirements outlined in § 6.4.11 (D)(1) of this Part; and
2.Once placed under temperature control and until sale to the processor or final consumer, shellstock shall be:
a.Iced; or
b.Placed in a storage area or conveyance maintained at forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less; and
c.Not permitted to remain without ice, mechanical refrigeration or other approved methods of refrigeration, as required in § 6.4.9(A) of this Part for more than two (2) hours at points of transfer such as loading docks.
3.The dealer shall store shucked and packed shellfish in covered containers at an ambient temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or covered with ice.
4.A dealer may receive shellstock from a dealer who has elected to ship shellstock without the shellstock meeting the receiving requirements of § 6.4.8 of this Part if the product is accompanied with documentation indicating:
a.Shellstock has been cooled to an internal temperature of fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) or less; or
b.All shipments of shellstock have been accompanied with documentation indicating the time of shipment and that all shipping conveyances comply with the requirements of § 6.4.8 of this Part. This documentation shall include a notice of all shellstock harvested under the requirements of § 6.4.9(A)(4) of this Part.
5.A dealer may receive shellstock from a dealer who has elected to ship shellstock without the shellstock meeting the receiving requirements of § 6.4.9 of this Part if the product is accompanied with a time-temperature recording device indicating and documenting that continuing cooling has occurred. Shipments of four (4) hours or less will not be required to have a time-temperature device.
6.Shellstock that is received bearing a restricted use tag shall only be shipped to a certified dealer and shall include specific language detailing the intended use of the shellstock. The transaction record shall indicate the quantity of restricted use shellstock containers.
7.All oysters harvested under State Vibrio Control Plans other than those labeled for a restricted use shall meet the following temperature requirements:
a.Oysters and/or hard clams shall be cooled to an internal temperature of fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) or below within ten (10) hours or less after placement into refrigeration during periods when the risk of Vibrio illness is reasonably likely to occur.
b.The dealer’s HACCP Plan shall include controls necessary to ensure, document and verify that the internal temperature of oysters and/or hard clams has reached fifty degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) or below within ten (10) hours or less after placement into refrigeration.
c.When deemed appropriate by the Department an exception may be permitted for hard clams to allow for tempering. Oysters and/or hard clams without proper HACCP records demonstrating compliance with this cooling requirement shall be diverted to PHP or labeled “for shucking only,” or other means to allow the hazard to be addressed by further processing.
8.The effectiveness of the Plan should be evaluated yearly. The Vibrio Control Plan may be modified when the evaluation shows the Plan is ineffective, or when new information is available or new technology makes this prudent as determined by the Department.
9.Product intended for relay, wet storage or depuration, or either geoduck clams (Panopea generose), or Mercenaria sp which are being cooled utilizing a Department-approved tempering plan are exempt from the Vibrio Control Plan requirement.
6.4.10Reshipping
A.Receiving Critical Control Point – Critical Limits. The dealer shall reship only shellfish which:
1.Originated from a dealer;
2.Are identified with a tag as outlined in § 6.4.1 of this Part or a label as outlined in § 6.4.1 of this Part.
3.Has been shipped in compliance with § 6.4.9 of this Part.
B.Shellstock Storage Critical Control Point – Critical Limits. The dealer shall ensure that once placed under temperature control and until sale to the processor or final consumer, shellstock shall be:
1.Iced; or
2.Placed in a storage area or conveyance maintained at forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less; and
3.Not permitted to remain without ice, mechanical refrigeration, or other approved means of refrigeration for more than two (2) hours at points of transfer such as loading docks.
C.Shucked Meat Storage Critical Control Point – Critical Limit. The dealer shall store shucked shellfish at a temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or covered with ice.
6.4.11Wet Storage
A.Requirements for the Dealer: Source of Shellstock
1.The dealer shall wet store shellstock harvested only from areas classified as Approved, or Conditionally Approved, when in the open status.
2.Shellstock shall be harvested, identified and shipped to the wet storage operation in accordance with the requirements of § 6.4.5 of this Part.
B.General Requirements
1.Wet storage may be used to store, condition, remove sand or to add salt to shellstock. Wet storage shall be deemed a processing activity, however licensees are not subject to any additional license fees and therefore not required to obtain a separate Department food processor license.
2.Wet storage of depurated product shall occur only within the facility in which it was depurated. The shellstock shall be packed and labeled according to the requirements of this Part.
3.Wet storage shall be practiced only by a dealer in strict compliance with the provisions in the written approval for the wet storage activity given by the Department.
4.While awaiting placement in a wet storage operation, shellstock shall be protected from physical, chemical or thermal conditions which may compromise the shellstock's survival, quality or activity during wet storage.
5.Conditions and water quality during wet storage shall be sufficient to minimize the potential for compromising the sanitary quality of the shellstock during storage.
6.For the purpose of certification, each wet storage site or operation shall be evaluated annually. The evaluation shall include an inspection of the near shore storage site and floats, or the wet storage operation.
7.Shellstock from a wet storage operation shall be harvested, identified and shipped according to the requirements of §§ 6.4.2 and 6.4.5 of this Part. Any dealer who wet stores shellstock from another State and ships the shellstock as a product of the State where the shellstock was wet stored shall be required to:
a.Have an operational plan approved by the Department which describes how this labeling change will be employed in assuring that shellstock can be traced to its source; and
b.Meet the requirements of § 6.4.5 of this Part.
8.The wet storage operator shall keep complete and accurate records to enable a lot of shellstock to be traced back to the original harvest location and wet storage location, and include the dates the shellstock were held in wet storage. The records shall be maintained for at least one (1) year.
a.Different lots of shellfish shall not be commingled during wet storage. If more than one (1) lot of shellfish is being held in wet storage at the same time, the identity of each lot of shellfish shall be maintained.
C.Wet Storage in Artificial Bodies of Water (Land-Based)
1.General
a.If the dealer chooses to practice wet storage in artificial bodies of water, the dealer shall also meet the requirements of §§ 6.4.11(A) and (B) of this Part
b.For the purpose of permitting, each wet storage site or operation shall be evaluated at intervals not to exceed six (6) months. The evaluation shall include the operation's plan and operating procedures for an onshore activity as submitted by the dealer.
c.Prior to commencing construction, all plans for construction or remodeling of onshore wet storage facilities or operations shall be reviewed and authorized by the Department.
d.The wet storage facility or operation evaluation shall include a review of:
(1)The purpose of the wet storage activity, such as holding, conditioning or increasing the salt content of shellstock;
(2)Any species specific physiological factors that may affect design criteria; and
(3)The plan giving the design of the land-based wet storage facility, source and quantity of process water to be used for wet storage, and details of any process water treatment system.
2.Operation Specifications
a.Each land-based wet storage activity shall meet the following design, construction, and operating requirements:
(1)Effective barriers shall be provided to prevent entry of birds, animals, and vermin into the area.
(2)Storage tanks and related plumbing shall be fabricated of safe material and shall be easily cleanable. This requirement shall include:
(A)Tanks constructed so as to be easily accessible for cleaning and inspection, self-draining and fabricated from non-toxic, corrosion resistant materials; and
(B)Plumbing designed and installed so that it can be cleaned and sanitized on a regular schedule, as specified in the operating procedures.
(3)Storage tank design, dimensions, and construction are such that adequate clearance between shellstock and the tank bottom shall be maintained.
(4)Shellstock containers, if used, shall be designed and constructed so that the containers allow the free flow of water to all shellstock within a container.
(5)When a building is used for the wet storage activity:
(A)Floors, walls, and ceilings shall be constructed in compliance with the applicable provisions of § 6.4.4 of this Part; and
(B)Lighting, plumbing, water and sewage disposal systems shall be installed in compliance with applicable provisions of § 6.4.4 of this Part.
(6)When the wet storage activity is outdoors or in a structure other than a building, tank covers shall be used. Tank covers shall:
(A)Prevent entry of birds, animals or vermin; and
(B)Remain closed while the system is in operation except for periods of tank loading and unloading, or cleaning.
3.Wet Storage Source Water
a.General
(1)Except for wells, the quality of the surface source water prior to treatment shall meet, at a minimum, the bacteriological standards for the restricted classification and water classified as Prohibited or Conditionally Restricted when in the Closed Status shall not be used as source water.
(2)Any well used as source water for wet storage shall meet the requirements (with the exception of the salt content in saltwater wells).
(3)Except when the source of the water is a growing area in the Approved classification, a water supply sampling schedule shall be included in the dealer's operating procedures and water shall be tested according to the schedule.
(4)Results of water samples and other tests to determine the suitability of the source water supply shall be maintained for at least two (2) years.
(5)Disinfection or other water treatment such as the addition of salt cannot leave residues unless they are Generally Recognized as Safe (GRAS) and do not interfere with the shellstock's survival, quality or activity during wet storage.
(6)Disinfected process water entering the wet storage tanks shall have no detectable levels of the coliform group as measured by a recognized multi-tube MPN test per one hundred (100) ml for potable water and acceptable for use with marine water and follow the protocol of the Decision Tree (Section IV. Guidance Documents Chapter VII. 01. of the 2023 NSSP Model Ordinance, incorporated by reference in § 6.1.4(C) of this Part).
(7)When the laboratory analysis of a single sample of disinfected process water entering the wet storage tanks shows any positive result for the coliform group daily sampling shall be immediately instituted until the problem is identified and eliminated.
(8)When the problem that is causing disinfected process water to show positive results for the coliform group is eliminated, the effectiveness of the correction shall be verified on the first operating day following correction through the collection, over a twenty-four (24) hour period, of a set of three (3) samples of disinfected process water.
(9)For water that is disinfected by ultra-violet treatment, turbidity shall not exceed twenty (20) nephelometric turbidity units (NTUs) measured in accordance with Standard Methods for the Examination of Water and Wastewater (Jenkins, David, Joseph J. Connors, and Arnold E. Greenberg. Standard Methods for the Examination of Water and Wastewater. Washington, D.C: American Public Health Association, 1981) (not to include later amendments thereof)), incorporated by reference in § 6.1.4(F) of this Part.
(10)The disinfection unit(s) for the process water supply shall be cleaned and serviced as frequently as necessary to assure effective water treatment.
4.Continuous Flow-through System
a.If the system is of continuous flow-through design, water from a growing area classified as:
(1)Approved may be used, without disinfection, in wet storage tanks provided that the near shore water source used for supplying the system meets the Approved classification bacteriological criteria at all times that shellstock are being held in wet storage; or
(2)Conditionally Approved in the Closed Status, Restricted or Conditionally Restricted in the Open Status may be used if the source water is continuously subjected to disinfection and it is sampled and analyzed daily following disinfection.
b.When a source classified as other than Approved is used, a study shall be required to demonstrate that the disinfection system will consistently produce water that tests negative for the coliform group under normal operating conditions. The study shall:
(1)Include five (5) sets of three (3) samples from each disinfection unit collected for five (5) consecutive days at the outlet from the disinfection unit or at the inlet to at least one (1) of the wet storage tanks served by the disinfection system;
(2)Include one (1) sample daily for five (5) consecutive days from the source water prior to disinfection;
(3)Use NSSP recognized methods to analyze the samples to determine coliform levels;
(4)Require all samples of disinfected water to be negative for the coliform group; and
(5)Be repeated if any sample of disinfected water during the study is positive for the coliform group.
c.Once sanctioned for use, the water system shall be sampled daily to demonstrate that the disinfected water is negative for the coliform group.
d.When other than Approved water is located between the intake of a flow-through wet storage system and the land-based facility then the Department may require periodic verification of the system's integrity to ensure that the other than approved water does not infiltrate into the intake pipe.
5.Recirculating Water System
a.A study shall be required to demonstrate that the disinfection system for the recirculating system will consistently produce water that tests negative for the coliform group under normal operating conditions. The study shall meet the requirements in § 6.4.11(C)(4)(b) of this Part.
b.Once sanctioned for use, the recirculating water system shall be sampled weekly to demonstrate that the disinfected water is negative for the coliform group.
c.When make-up water of more than ten percent (10%) of the water volume in the recirculating system is added from a growing area source classified as other than Approved, a set of three (3) samples of disinfected water and one (1) sample of the source water prior to disinfection shall be collected within a twenty-four (24) hour period to reaffirm the ability of the system to produce water free from the coliform group or viable bacteria.
d.When ultra-violet treatment is used as the water disinfectant, each time a bulb change is required either to replace a burned out bulb or for servicing, new ultraviolet bulbs shall be installed and old bulbs discarded, and the weekly disinfected process water sample shall be collected and analyzed.
e.Failure to meet the weekly water sampling requirements of § 6.4.11(C)(5)(b) of this Part may result in termination of the system, pending approval of the Department.
6.Shellstock Handling
a.Shellstock shall be thoroughly washed with water from an approved source and culled prior to wet storage in tanks. Due to the adverse effects of culling on mussel physiology, culling of mussels may be done after wet storage, subject to permission from the Department.
b.Unless the dealer is in the Department’s commingling plan, different lots of shellstock shall not be commingled during wet storage in tanks. If more than one (1) lot of shellstock is being held in wet storage at the same time, the identity of each lot of shellstock shall be maintained.
c.Bivalve mollusks shall not be mixed with other species in the same tank. Where multiple tank systems use a common water supply system for bivalve mollusks and other species, wet storage water shall be effectively disinfected prior to entering tanks containing the bivalve mollusks.
**History**
- *Amendment — effective from 2026-03-18 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/18/2026*
- *Amendment — effective from 2021-03-01 to 01/04/2022*
- *Amendment — effective from 2017-12-04 to 03/01/2021*
- *Technical Revision — effective from 2017-05-16 to 12/04/2017*
- *Amendment — effective from 2017-05-16 to 05/16/2017*
- *Amendment — effective from 2012-12-10 to 05/16/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Adoption — effective from 2002-10-07 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 10/07/2002*
##### **216-RICR-50-10-6 § 6.5** Enforcement, Variances, and Practices/Procedures {#sec-216-ricr-50-10-6-6.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-10-6#6.5}
A.Enforcement, Inspections, Penalties
1.Documenting Information and Observations. The Department shall document, on an inspection report form, specific factual observations of conditions that violate R.I. Gen. Laws Chapter 21-14 and the requirements of this Part that require correction by the permit holder.
2.Specifying Time Frame for Corrections. The Department shall specify on the inspection report form the time frame for correction of the violations.
3.Issuing Report and Obtaining Acknowledgment of Receipt. At the conclusion of the inspection and according to law, the Department shall provide a copy of the completed inspection report and the notice to correct violations to the person in charge, and request a signed acknowledgment of receipt.
B.Refusal to Sign Acknowledgment
1.The Department shall:
a.Inform a person who declines to sign an acknowledgment of receipt of inspectional findings as specified in § 6.5(A)(3) of this Part that:
(1)An acknowledgment of receipt is not an agreement with findings,
(2)Refusal to sign an acknowledgment of receipt will not affect the permit holder's obligation to correct the violations noted in the inspection report within the time frames specified, and
(3)A refusal to sign an acknowledgment of receipt is noted in the inspection report and conveyed to the Department’s historical record for the dealer; and
b.Make a final request that the person in charge signs an acknowledgment of receipt of inspectional findings.
2.Ceasing Operations and Reporting: Imminent Health Hazard
a.Except as specified in § 6.5(B)(2)(b) of this Part, a permit holder shall immediately discontinue operations and notify the Department if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross unsanitary occurrence or condition, or other circumstance that may endanger public health;
b.A permit holder need not discontinue operations in an area of an establishment that is unaffected by the imminent health hazard.
C.Resumption of Operations
1.If operations are discontinued as specified under § 6.5(B)(2) of this Part or otherwise according to law, the permit holder shall obtain approval from the Department before resuming operations.
2.Timely Correction
a.Except as specified in § 6.5(C)(2)(b) of this Part, a permit holder shall, at the time of inspection, correct a critical violation of R.I. Gen. Laws Chapter 21-14 and this Part and implement corrective actions for a HACCP plan provision that is not in compliance with its critical limit.
b.Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the Department may agree to or specify a longer time frame, not to exceed ten (10) calendar days after the inspection, for the permit holder to correct critical violations of R.I. Gen. Laws Chapter 21-14 or this Part or HACCP plan deviations.
D.Verification and Documentation of Correction
1.After observing at the time of inspection a correction of a critical violation or deviation, the Department shall enter the violation and information about the corrective action on the inspection report.
2.As specified under § 6.5(D) of this Part, after receiving notification that the permit holder has corrected a critical violation or HACCP plan deviation, or at the end of the specified period of time, the Department may verify correction of the violation, document the information on an inspection report, and enter the report in the Department's records.
E.Time Frame for Correction
1.Except as specified in § 6.5(E)(2) of this Part, the permit holder shall correct noncritical violations by a date and time agreed to or specified by the Department but no later than ninety (90) calendar days after the inspection.
2.The Department may approve a compliance schedule that extends beyond the time limits specified under § 6.5(E)(1) of this Part if a written schedule of compliance is submitted by the permit holder and no health hazard exists or will result from allowing an extended schedule for compliance.
F.Grounds for Discipline without Hearing
1.The Director may, temporarily, suspend the license of a shellfish business without a hearing if the Director finds that evidence in their possession substantiates that continuation in practice would constitute an immediate danger to the health, safety, and welfare of the public. In the event that the Director temporarily suspends the license of a shellfish business without a hearing, a hearing by the Department shall be held within ten (10) days after the suspension has occurred.
G.Variances Procedure
1.The Department may grant a variance upon request of the applicant from the provisions of this Part, if it finds in specific cases, that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest.
a.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made, citing the relevant regulation and the alternative(s).
H.Commingling
1.Shellfish from different harvest areas or different harvest days can only be comingled by a primary dealer under the following conditions:
a.Only partial containers that are left over at the end of the day's production;
b.Shellfish from no more than two (2) different harvest areas; or
c.No more than two (2) different harvest days;
d.The tag shall identify the two (2) harvest areas or the two (2) dates of harvest.
2.Aquacultured shellstock cannot be comingled under any circumstances.
I.Rules Governing Practices and Procedures
1.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 21-14 shall be held in accordance with the provisions of Part 10-05-4 of this Title entitled Practices and Procedures Before the Rhode Island Department of Health.
**History**
- *Amendment — effective from 2026-03-18 to current*
- *Periodic Refile — effective from 2022-01-04 to 03/18/2026*
- *Amendment — effective from 2021-03-01 to 01/04/2022*
- *Amendment — effective from 2017-12-04 to 03/01/2021*
- *Technical Revision — effective from 2017-05-16 to 12/04/2017*
- *Amendment — effective from 2017-05-16 to 05/16/2017*
- *Amendment — effective from 2012-12-10 to 05/16/2017*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Adoption — effective from 2002-10-07 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 10/07/2002*
### **Subchapter 15** Healthy Environment
#### **216-RICR-50-15-1** Asbestos Control
##### **216-RICR-50-15-1 § 1.1** Authority and Purpose {#sec-216-ricr-50-15-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-24.5-5(c) and are established for the purpose of adopting minimum standards for asbestos control, and provide for the licensing of Asbestos Contractors, Asbestos Supervisors, and Asbestos Workers, the submission of asbestos abatement plans, certification of training courses, Competent Persons, Analytical Services, and Consultants, and other requirements related to the safe abatement of asbestos hazards.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.2** Incorporation by Reference {#sec-216-ricr-50-15-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.2}
A.These regulations hereby adopt and incorporate 29 C.F.R. § 1926.1101 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
B.These regulations hereby adopt and incorporate 40 C.F.R. § 763 Subpart A, Appendix A and Subpart E, Appendix C (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
C.These regulations hereby adopt and incorporate 29 C.F.R. § 1910.134 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
D.These regulations hereby adopt and incorporate USDOT 49 C.F.R. § 172, Subpart E (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
E.These regulations hereby adopt and incorporate Appendix D to 40 C.F.R. § 763, Subpart E (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
F.These regulations hereby adopt and incorporate USDOT 49 C.F.R. § 173.1300 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
G.These regulations hereby adopt and incorporate 40 C.F.R. § 763.95 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
H.These regulations hereby adopt and incorporate 40 C.F.R. § 763.90 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
I.These regulations hereby adopt and incorporate 40 C.F.R. § 763.94 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
J.These regulations hereby adopt and incorporate 40 C.F.R. § 763.92 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
K.These regulations hereby adopt and incorporate 40 C.F.R. § 763.85 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
L.These regulations hereby adopt and incorporate 40 C.F.R. § 763.86 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
M.These regulations hereby adopt and incorporate 40 C.F.R. § 763.88 (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
N.These regulations hereby adopt and incorporate EPA's NESHAP requirements, 40 C.F.R. § 61, Subpart M (2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.3** Definitions {#sec-216-ricr-50-15-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.3}
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-24.5, entitled Asbestos Abatement.
2."Adequately wet" means sufficiently mixed or penetrated with liquid to prevent the release of particulates. If visible emissions are observed coming from ACM, then that material has not been adequately wetted. However, the absence of visible emissions is not sufficient evidence of being adequately wet.
3."Agent" means any individual performing work on an asbestos abatement project for the Asbestos Contractor, that is not an employee of the Contractor (e.g. industrial hygiene subcontractor).
4."Amended water" means water to which a surfactant has been added.
5."Asbestiform materials" means those naturally occurring fibers of similar shape, size, strength, surface and characteristics of asbestos fibers as are otherwise described in the publication entitled "Non Occupational Health Risks of Asbestiform Fibers" published by the Committee on Non Occupational Health Risks of Asbestiform Fibers, Board on Toxicology and Health Hazards of the Commission on Life Sciences of the National Research Council; U.S. Environmental Protection Agency and National Academy of Sciences, National Academy Press, Washington, DC, 1984, E.P.A. 68-01-4655.
6."Asbestos" means a unique group of naturally occurring minerals that separate into fibers of high tensile strength, resistant to heat, wear and chemicals, described as the following types: chrysotile, amosite, crocidolite, tremolite, anthophyllite, and actinolite, and every product containing any of these materials that have been chemically treated and/or altered which, after manufacture, are used for such products and end uses as insulation, textiles, paper, cement sheets, floor tile, wall covering, decorations, coating, sealants, cement pipe and reinforced plastics and other compounds.
7."Asbestos abatement" means any activity involving the removal, encapsulation, enclosure, renovation, repair, demolition or other disturbance of friable asbestos containing materials. Asbestos Abatement shall be synonymous with Asbestos Management for the purposes of this Part.
8."Asbestos consultant" means an Asbestos Inspector, Asbestos Management Planner, or Asbestos Project Designer licensed by the Department.
9."Asbestos abatement project" means all activities, including site preparation and clean-up, associated with asbestos abatement, from the time of initial arrival of the contractor on-site through obtaining an acceptable final clearance air sample in the abatement area(s) and/or removal of all abated ACM from the project site, whichever is later.
10."Asbestos supervisor" means an employee of a licensed Asbestos Contractors who supervises asbestos abatement projects.
11."Asbestos worker" means any employee of a licensed Asbestos Contractor who engages in Asbestos Abatement.
12."Asbestos containing material” or “ACM" means any material or product which contains more than one percent (1%) asbestos, as determined using the method specified in Appendix A, Subpart F, 40 C.F.R. Part 763, Section 1, Polarized Light Microscopy (PLM). If the asbestos content of friable material is less than 10 percent as determined by a method other than point counting by PLM, the asbestos content must be verified by point counting using PLM.
13."Asbestos containing waste materials" means RACM waste and materials contaminated with asbestos including disposable equipment and clothing.
14."Asbestos contractor" means any person or entity engaged in asbestos abatement as a business and whose employees perform the asbestos abatement work. (see also: Asbestos Abatement)
15."Asbestos hazard emergency response act regulations” or “AHERA regulations" refers to specific amendments to Title II of the Toxic Substances Control Act enacted by 15 U.S.C. §§ 2641-2654 and the regulations of the U.S. Environmental Protection Agency contained in 40 C.F.R. §§ 763.80 through 763.99 (Subpart E).
16."Asbestos inspector" means an individual who:
a.conducts inspections and reinspections to identify locations of friable and nonfriable ACM;
b.collects bulk samples of homogeneous areas of friable surfacing materials;
c.conducts surveillance of thermal systems insulation; and/or
d.discharges other such related activities.
17."Asbestos management planner" means an individual who, for any school or school building subject to the AHERA regulations:
a.develops an asbestos abatement/management plan for abatement action(s) no larger than small-scale short-duration maintenance activities, as defined by 40 C.F.R. § 763 Subpart E, Appendix C incorporated by reference at § 1.2(B) of this Part, that disturb friable ACM and/or for minor fiber release episode(s);
b.maintains records and reports of asbestos activities relating to the implementation of abatement/management plans;
c.is responsible for the implementation and administration of the abatement/management plan; and/or
d.discharges other such related activities.
18."Asbestos project designer" means an individual who:
a.designs all types of abatement actions including other than small-scale, short-duration maintenance activities, as defined by 40 C.F.R. § 763 Subpart E, Appendix C, and major fiber release episodes; and/or
b.discharges other such related activities.
19."Authorized asbestos disposal facility" means a location approved for handling asbestos waste by the Rhode Island Department of Environmental Management or by an equivalent regulatory agency if the material is disposed of outside the state of Rhode Island.
20."Auxiliary work" means work activity which does not directly involve the performance of an asbestos abatement project but may, in the process of assisting in the performance of that project, disturb or cause exposure to asbestos or asbestos-containing materials.
21."Category I nonfriable asbestos containing material" means any ACM in the form of packings, gaskets, resilient floor covering, and asphalt roofing products.
22."Category II nonfriable asbestos containing material" means any ACM, excluding Category I nonfriable ACM, that, when dry, cannot be crumbled, pulverized, or reduced to powder by hand pressure.
23."Clean room" means an uncontaminated area or room which is a part of the worker decontamination enclosure system with provisions for storage of worker's street clothes and clean protective equipment.
24."Competent person" means a designated public employee, designated public maintenance person, maintenance worker in the private sector, teacher and/or parent representative certified under the provision of § 1.19 of this Part.
25. "Cutting" means penetrating with a sharp-edged instrument. This term also includes sawing, but does not include shearing, slicing, or punching.
26."Demolition" means the wrecking or taking out of any load-supporting structural member of a facility together with any related handling operations or the intentional burning of any facility (see also: Structural Member).
27."Department" means the Rhode Island Department of Health.
28."Emergency asbestos abatement project" means any Asbestos Abatement Project which was not planned but results from a sudden, unexpected event. This includes operations required by non-routine failures of equipment.
29."Emergency renovation operation" means a renovation operation that was not planned but:
a.results from a sudden, unexpected event that, if not immediately attended to, presents a safety or public health hazard;
b.is necessary to protect equipment from damage; or
c.is necessary to avoid imposing an unreasonable financial burden.
d.This term also includes operations necessitated by nonroutine failures of equipment.
30."Encapsulation" means the application of an encapsulant to asbestos containing materials to control the release of asbestos fibers into the air. The encapsulant creates a membrane over the surface (bridging encapsulant) or penetrates the material and binds its components together (penetrating encapsulant). [c.f. also: Removal Encapsulant]
31."EPA" means the U.S. Environmental Protection Agency.
32."Equipment room" means a contaminated area or room which is part of the worker decontamination enclosure system with provisions for storage of contaminated clothing and equipment.
33."Facility" means any institutional, commercial, public or industrial structure, installation or building. For compliance with § 1.24 of this Part, this definition also includes any ship and any structure, installation, or building containing condominiums or individual units operated as a residential cooperative, but excluding residential buildings having four or fewer dwelling units. For the purposes of this definition, any building, structure, or installation that contains a loft used as a dwelling is not considered a residential structure, installation, or building. Any structure, installation, or building that was previously subject to either the NESHAP regulations 40 C.F.R. § 61, Subpart M incorporated by reference at § 1.2(N) of this Part, or this Part is not excluded, regardless of its current use or function. This term does not include a private residence as defined in the Act.
34."Facility component" means any part of a facility including equipment.
35."Friable asbestos material" means any ACM that, when dry, can be crumbled, pulverized or reduced to powder by hand pressure.
36."Glove bag" means a sealed compartment with attached inner gloves used for the handling of asbestos containing materials. Properly installed and used, glove bags provide a small work area enclosure typically used for small-scale asbestos stripping operations.
37."Grinding" means reducing to powder or small fragments. This term also includes mechanical chipping or drilling.
38."HVAC" means heating, ventilation and air conditioning system.
39."HEPA filtration" means high efficiency particulate air filtration found in respirators and vacuum systems capable of filtering 0.3-micron particles with 99.97% efficiency, for use in asbestos contaminated environments.
40."High priority areas" means those areas of a building which are used or occupied by a high percentage of the building population on a regular basis. Such areas include classrooms, cafeterias, gymnasiums, offices, places of assembly, work stations, corridors, lobbies, restrooms, and others that may be determined by the Director of Health.
41."High priority building" means a child inhabited or child frequented structure either privately or publicly owned. This category shall include, but not be limited to, public and parochial schools (Grades Pre-K to 12), day care centers, nurseries, acute or chronic children's hospitals (or wardrooms thereof) as otherwise defined by the National Building Code Use Groups E, B and I. Private residences used for the above purposes and housing or occupied by ten (10) children or less are excluded from this group.
42."Homogeneous material" means asbestos containing material having a similar distribution of mineralogical types of asbestos and approximately the same percentages of each type throughout.
43."Individual" means any human being.
44."Industrial hygiene consultant" means an individual who provides industrial hygiene services in one or more of the following categories: Collection of Air Samples; Compliance Monitoring of Asbestos Abatement/ Management Plans; and/or Respiratory Protection Programs.
45."In poor condition" means the binding of the material is losing its integrity as indicated by peeling, cracking, or crumbling of the material.
46. "Installation" means any building or structure or any groups of buildings or structures at a single demolition or renovation site that are under the control of the same owner or operator (or owner or operator under common control).
47."Intermediate priority building" means public buildings, other than those in the high and low priority groups, which are designated within the National Building Code Use Groups as follows: Places of public assembly (Group A); structures occupied by adult inmates and/or patients, and state employees (Group I); colleges, hospitals, and auditoriums (Group I); and occupied places of employment (Group F). Also included are private buildings which are: private colleges, hospitals, banks, and other business, industrial, educational and mercantile institutions (Groups M, H, I, R1 and R2) including, but not limited to, hotels, motels, multi-family dwellings and places of employment with more than ten (10) employees.
48."Leak-tight" means solids or liquids cannot escape or spill out. This term also means dust-tight.
49."License" means the permit issued by the Department to allow an Asbestos Contractor to engage in asbestos abatement projects.
50."Low priority areas" means those areas of a building which are used or occupied by a small fraction of the building population or very infrequently used. Such areas include general access storage rooms and manned boiler rooms unless these areas supply ventilation air to other parts of the building, in which case they would be classed according to the areas served by the ventilation air. These are areas where exposure to asbestos would be limited to a small number of people and where a reasonable course of action would be educating occupants or users of these areas in proper prevention and safety techniques.
51."Low priority building" means public or private buildings which are not in the other groups and which are infrequently used or closed, or abandoned or scheduled for same in the immediate future and those structures which are private residences (Groups S, R3 and 4).
52."Major fiber release episode" means the falling or dislodging of greater than three (3) square or linear feet of friable ACM.
53."Minor fiber release episode" means the falling or dislodging of three (3) square or linear feet or less of friable ACM.
54."NESHAP" means the National Emission Standards for Hazardous Air Pollutants.
55."NIOSH" means the National Institute for Occupational Safety and Health.
56."Nonfriable asbestos containing material" means any ACM that, when dry, cannot be crumbled, pulverized, or reduced to powder by hand pressure.
57."Nonscheduled renovation operation" means a renovation operation necessitated by the routine failure of equipment, which is expected to occur within a given period based on past operating experience, but for which an exact date cannot be predicted.
58."Outside air" means the air outside buildings and structures including, but not limited to, the air under a bridge or in an open-air ferry dock.
59."Owner" means the person or entity having legal title to property and/or buildings. For purposes of publicly owned property only, the owner shall be defined to be the chief executive officer of the state or municipal agency which owns, leases or controls the use of the property.
60."Owner or operator of a demolition or renovation activity" means any person who owns, leases, operates, controls, or supervises the facility being demolished or renovated or any person who owns, leases, operates, controls, or supervises the demolition or renovation operation, or both.
61."OSHA" means the Occupational Health and Safety Administration of the U.S. Department of Labor.
62. "Particulate asbestos material" means finely divided particles of asbestos or material containing asbestos.
63."Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, and other State or political subdivision or agency thereof, and the legal successor, representative, agent or agency of the foregoing.
64."Planned asbestos abatement project" means an asbestos abatement project or many such projects in which the amount of asbestos containing material to be removed, stripped or otherwise disturbed within a given period can be predicted. Individual, non-scheduled abatements are included if many such operations can be predicted to occur during a given period based on operating experiences.
65."Planned renovation operations" means a renovation operation, or many such operations, in which some RACM will be removed or stripped within a given period and that can be predicted. Individual nonscheduled operations are included if many such operations can be predicted to occur during a given period based on operating experience.
66."Private residence" means any structure which is designated within National Building Code Use Groups R3 or R4.
67."Regulated asbestos containing material” or “RACM" means:
a.Friable asbestos material;
b.Category I nonfriable ACM that has become friable;
c.Category I nonfriable ACM that will be or has been subjected to sanding, grinding, cutting, or abrading; or
d.Category II nonfriable ACM that has a high probability of becoming or has become crumbled, pulverized, or reduced to powder by the forces expected to act on the material during the demolition or renovation operations regulated by this Part.
68."Removal" means the taking out of RACM or facility components that contain, or are covered with, RACM from any facility.
69."Removal encapsulant" means a penetrating encapsulant specifically designed for use in removal of asbestos containing material rather than for permanent encapsulation.
70."Renovation" means altering a facility or one or more facility components in any way, including the stripping or removal of RACM from a facility component. Operations in which load-supporting structural members are wrecked or taken out are demolitions.
71."Repair" means the restoration of asbestos containing insulation that has been damaged, usually located on pipes, boilers, tanks, turbines, ducts or other facility components. Repair usually consists of the application of duct tape, rewettable glass cloth, canvas, cement or other suitable material to seal exposed areas where asbestos fibers may be released. Repair of previously encapsulated asbestos containing materials may involve filling damaged areas with non-asbestos substitutes and re-encapsulating. Repair of enclosures around asbestos containing materials is also included in this category of abatement.
72."Restricted use areas" means those areas of a building which have infrequent occupancy such as unmanned boiler rooms, mechanical rooms, electrical rooms and secured storage rooms unless those areas supply ventilation air to the other parts of the building, in which case they would be classed according to the areas served by the ventilation air.
73."Resilient floor covering" means Asbestos containing floor tile, including asphalt and vinyl floor tile, and sheet vinyl floor covering containing more than one (1%) percent asbestos as determined using the methods specified in Appendix A, Subpart F, 40 C.F.R. Part 763, Section 1, Polarized Light Microscopy or any other method approved by the EPA for this type of analysis.
74."Shower room" means a room between the clean room and the equipment room in the worker decontamination enclosure with hot and cold or warm running water controllable at the tap and suitably arranged for complete showering during decontamination.
75."Spot repair" means any removal, repair, encapsulation, enclosure or other disturbance which encompasses:
a.up to ten (10) linear feet of asbestos from piping and/or
b.up to twenty-five (25) square feet of asbestos from any surfaces other than pipes. Large project divided into smaller segments are not Spot Repairs.
76."Strip" means to take off RACM from any part of a facility or facility components.
77."Structural component " means any pipe, duct, boiler, tank, reactor, turbine or furnace at or in a facility or any structural member of a facility. (see also: Structural Member)
78."Structural member" means any load-supporting member of a facility, such as beams and load-supporting walls or any non-load-supporting member, such as ceilings and non-load-supporting walls.
79."Structure" means a whole facility, building or a major portion thereof, such as a building wing.
80."Visible emissions" means any emissions, which are visually detectable without the aid of instruments, coming from RACM or Asbestos Containing Waste Material.
81."Waste generator" means any owner or operator of a facility covered by this Part whose act or process produces Asbestos Containing Waste Material.
82."Waste shipment record" means the shipping document, required to be originated and signed by the waste generator, used to track and substantiate the disposition of Asbestos Containing Waste Material.
83."Wet cleaning" means the process of eliminating asbestos contamination from building surfaces and objects by using cloths, mops or other cleaning utensils which have been dampened with amended water or diluted removal encapsulant and afterwards thoroughly decontaminated or disposed of as asbestos contaminated waste.
84."Wet methods, wetted or wetting agents" means the use of amended water or removal encapsulants to control fiber release from asbestos containing materials.
85."Working day" means Monday through Friday and includes holidays that fall on any of the days Monday through Friday.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.4** General Provisions {#sec-216-ricr-50-15-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.4}
1.4.1Exemptions, Variance and Practices and Procedures
A.The requirements for licensing and the submission of an asbestos abatement plan shall not apply to the performance of spot repairs.
B.The requirements for licensing and the submission of an asbestos abatement plan shall not apply to private residences as defined in this Part.
C.Variance Procedures
1.The Department may grant a variance, either upon its own motion or upon request of the applicant, from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such a variance will not be contrary to the public interest, public health and/or health and safety of the public.
2.A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis upon which the request is made. Upon filing of each request for a variance with the Department, and within thirty (30) days thereafter, the Department shall notify the applicant by certified mail of its approval, or in the case of a denial, a hearing date, time and place may be scheduled if the applicant appeals the denial and in accordance with the provisions of § 1.4.1(D) of this Part.
D.Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-24.5 shall be held in accordance with the provisions of the rules and regulations governing the Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
1.4.2Prohibitions
A.No asbestos abatement project shall be undertaken unless the Asbestos Contractor is licensed with the Department and an asbestos abatement plan has been approved by the Department.
B.No on-site work for an approved asbestos abatement project may be conducted unless at least one of the Asbestos Contractor's licensed Asbestos Supervisors and an individual certified by the American Red Cross (or equivalent) in Cardio-Pulmonary Resuscitation and basic first-aid are physically present on the job site.
C.No owner shall allow any person to be exposed to friable asbestos materials when such exposure is a violation of the provisions of the Act, this Part or the indoor non-occupational air exposure standard defined in § 1.5 of this Part.
D.No building or demolition permit involving asbestos abatement shall be issued by any municipal or state official unless the application for the permit includes a certified copy of an approved abatement plan and a certified copy of the license of the Asbestos Contractor who shall undertake the work.
E.Individuals certified only for spot repairs in accordance with § 1.19 of this Part shall not undertake any asbestos abatement project which is:
1.Larger than the size limits for a Spot Repair as defined by this Part; or
2.In buildings other than those specifically authorized on their Certification.
1.4.3Closing of Buildings
A.The Director of Health may prohibit and/or limit access to any building or portion of a building in which the Director, after notice and hearing, has found to contain friable asbestos in such condition or amount that there exists a public health danger. Access to such areas shall be limited to individuals designated as competent persons for said area or certified as consultants in accordance with § 1.21 of this Part.
B.No building or portion thereof to which access has been prohibited and/or limited in accordance with the provisions of § 1.4.3(A) of this Part above shall be reopened to unlimited access until the Director of Health issues a reoccupancy permit.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.5** Indoor Non-Occupational Air Exposure Standard {#sec-216-ricr-50-15-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.5}
For the purposes of this Part, the Indoor Non-Occupational Air Exposure Standard for asbestos exposure shall be 0.01 fibers per cubic centimeter (f/cc) for fibers greater than five (5) microns in length as measured by OSHA-NIOSH phase contrast optical microscopic methods and calculated as an eight (8) hour time weighted average (or 300 nanograms per cubic meter).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.6** Submission of Asbestos Abatement Plans {#sec-216-ricr-50-15-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.6}
1.6.1General Requirements
A.Any building owner who intends to conduct an asbestos abatement project, except for spot repairs as defined in this Part, must submit an asbestos abatement plan in compliance with the requirements of § 1.17 of this Part and must not proceed with said project until written approval of said plan has been received from the Department.
B.Any building owner who is notified that the results of a Department evaluation conducted in accordance with § 1.22 of this Part indicate that an asbestos abatement plan is required shall submit said plan to the Department within one hundred twenty (120) days of receipt of said notice.
C.In addition to the requirements of § 1.22 of this Part, any building owner who is notified that areas have received an Asbestos Hazard Rating greater than ninety (90) shall, within ten (10) days of receipt of said notice, submit to the Department the immediate corrective action(s) to be taken, as well as an Interim Operations and Maintenance Plan in accordance with §§ 1.17.2(B) and (C) of this Part.
1.6.2Emergency Asbestos Abatement Projects
A.The work procedures contained in § 1.14 of this Part will apply to all Emergency Asbestos Abatement Projects unless specific alternative procedures have been approved by the Department.
B.A building owner shall contact the Department in advance for permission to conduct an Emergency Asbestos Abatement Project in the absence of an approved asbestos abatement plan. Ordinarily permission will be granted only to prevent personnel injury or property damage. However, if the emergency is of such a nature that immediate action is deemed essential, the building owner may proceed to resolve the emergency in the most expeditious manner possible. Nevertheless, all asbestos abatement that is beyond the scope of Spot Repairs, as defined by this Part, must be performed by a licensed asbestos contractor. The building owner shall notify the Department no later than one (1) working day following the beginning of an emergency asbestos abatement project and confirm the name and license number of the Asbestos Contractor, the amount of asbestos containing material involved and the expected length of the abatement project. Within ten (10) working days of completing the project, the building owner shall submit a written report to the Department which includes as a minimum: a narrative description of the area(s) abated, including the type and quantity of asbestos containing material; annotated blueprint(s), floorplan(s) or other engineering drawing(s) which show the location(s) of abated and remaining asbestos containing material; specific work procedures followed during the abatement process; copies of the results of clearance air testing; copies of disposal receipts for all asbestos that was removed; and any other information specifically requested by the Department.
C.Removal of asbestos containing material from a building ordered demolished by a municipal building official in accordance with R.I. Gen. Laws § 23-27.3-125.5 may be handled as an Emergency Asbestos Abatement Project under the following conditions:
1.All asbestos abatement work is performed by a licensed Asbestos Contractor under the provisions of an Asbestos Abatement Plan previously approved for the demolition of unsafe structures in the jurisdiction of the municipal building official ordering the demolition;
2.The licensed Asbestos Contractor complies with the provisions of §§ 1.6.2(A) and (B) of this Part;
3.The Asbestos Contractor provides the Department with all project specific information required by the approval letter for the previously approved Asbestos Abatement Plan; and
4.All asbestos containing material is removed from the building prior to its demolition.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.7** Licensing of Asbestos Contractors, Asbestos Supervisors, and Asbestos Workers {#sec-216-ricr-50-15-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.7}
1.7.1General Licensing Requirement
No person shall engage in any asbestos abatement project at a facility unless he or she is licensed to do so by the Department under the provisions of this § 1.7 of this Part.
1.7.2Applicability
A.The licensing requirements of § 1.7 of this Part apply to all Asbestos Contractors, as defined in this Part, and each of their Asbestos Supervisors and Asbestos Workers.
B.Persons who perform only spot repairs are exempted from the licensing requirement contained in § 1.7.2(A) of this Part. However, persons performing spot repairs must be certified in accordance with § 1.19 of this Part.
1.7.3License Application
A.To apply for a license, an Asbestos Contractor, Asbestos Supervisor, or Asbestos Worker shall submit a completed application to the Department on forms provided by the Department. The application shall include all information required by the Act, as well as by the form and accompanying instructions.
B.The Department may at any time after the filing of the original application require further information to enable the Department to determine whether the application should be approved or denied.
C.Each application for an Asbestos Contractor License shall be signed by the applicant or a person duly authorized to act on behalf of the applicant. Each application for an Asbestos Supervisor or Asbestos Worker License shall be signed by the applicant. All applications shall include a certification by the applicant that his or her License or other authorization to perform asbestos abatement work has not been suspended or revoked by any other state and that no enforcement actions by any state or federal agency are pending against the applicant.
1.7.4License Fees and Issuance/Renewal of Licenses
A.Asbestos Contractors
1.Pursuant to the provisions of R.I. Gen. Laws § 23-24.5-12(h), the Department shall grant a license to an Asbestos Contractor who meets the licensure requirements set forth in this Part, and upon submission of the licensure fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Said license shall expire two (2) years from the date of issuance, unless sooner suspended or revoked. Said license may be renewed every two (2) years in accordance with the provisions of § 1.7.8 of this Part and upon payment of the licensure renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Asbestos Supervisors
1.Pursuant to the provisions of R.I. Gen. Laws § 23-24.5-12(h), the Department shall grant a license for an Asbestos Supervisor, provided said Asbestos Supervisor meets the licensure requirements set forth in this Part, and upon submission of the licensure fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Said license shall expire one (1) year from the date of issuance, unless sooner suspended or revoked. Said license may be renewed annually in accordance with the provisions of § 1.7.8 of this Part, upon documentation of compliance with the requirements of § 1.9.1 of this Part, and upon payment of the licensure renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Asbestos Workers
1.Pursuant to the provisions of R.I. Gen. Laws § 23-24.5-12(e), the Department shall grant a license for an Asbestos Worker provided said Asbestos Worker meets the licensure requirements set forth in this Part, and upon submission of the licensure fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Said license shall expire one (1) year from the date of issuance, unless sooner suspended or revoked. Said license may be renewed annually in accordance with the provisions of § 1.7.8 of this Part, upon documentation of compliance with the requirements of § 1.9.1 of this Part, and upon payment of the licensure renewal fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
D.No license shall be issued or renewed until the correct application fee has been remitted. Fees will not be prorated for a period less than the full term of a license.
1.7.5Denial of Applications
A.The Department may deny an application if it determines that the applicant has not demonstrated the ability to comply fully with applicable requirements established by the Act and/or by this Part.
B.An applicant whose application is denied may request a hearing in accordance with the rules and regulations pertaining to Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title).
1.7.6Suspension or Revocation of a License and/or Imposition of Civil Penalties
The Department may, for cause or for violation of this Part, suspend or revoke any license issued under § 1.7 of this Part and/or impose administrative fines in accordance with the Act.
1.7.7Replacement of Lost or Damaged License
Application for replacement of a lost or damaged Abatement Supervisor or Abatement Worker License must be made by the licensed individual and must be accompanied by the fee required in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
1.7.8Renewal of a License
Requests for renewal of licenses issued under § 1.7 of this Part must contain all the information requested by § 1.7.3 of this Part without reference to any previously submitted material.
1.7.9Additional Requirements
The Department may, by rule, regulations, or order, impose upon any licensee such requirements in addition to those established in this Part as it deems appropriate or necessary to minimize danger to public health and safety or property.
1.7.10Communications
All communications and reports concerning this Part, and applications filed thereunder, should be addressed to the Department at its office located at:
Rhode Island Department of Health
Center for Healthy Homes and Environment
206 Cannon Building Three Capitol Hill
Providence, RI 02908-5097
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.8** Licensee Recordkeeping and Notification {#sec-216-ricr-50-15-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.8}
1.8.1Notification of Asbestos Abatement Projects
A.A licensed Asbestos Contractor shall utilize the most current revision of the Department's Form ASB-22 to notify the Department in writing at least ten (10) working days before beginning any on-site work at a planned asbestos abatement project. A licensed Asbestos Contractor may not submit this notification until the building owner has received notification of Department approval for the planned asbestos abatement project. Delivery of the notice by email, facsimile, U.S. Postal Service, commercial delivery service, or hand delivery is acceptable.
B.A licensed Asbestos Contractor or Asbestos Supervisor shall also notify the Department by telephone when they begin on-site preparation for an approved asbestos abatement project.
C.In accordance with the provisions of R.I. Gen. Laws § 23-28.4-6.1, a licensed Asbestos Contractor shall also notify the local firefighting authorities, in writing, prior to initiating any activity in conjunction with an approved asbestos abatement project.
D.The written notice required by § 1.8.1(A) of this Part above shall be updated as necessary, including when the amount of asbestos changes by at least twenty (20) percent.
E.If an Asbestos Abatement Project will begin on a date other than the one contained in the original notice, notice of the new start date must be provided to the Department as follows:
1.When the Asbestos Abatement Project will begin after the date contained in the notice:
a.Notify the Department of the new start date by telephone as soon as possible before the original start date; and
b.Provide the Department with a written notice of the new start date as soon as possible before, and no later than, the original start date.
2.When the Asbestos Abatement Project will begin on a date earlier than the original start date, provide the Department with a written notice of the new start date at least ten (10) working days before the Asbestos Abatement Project begins.
3.In no event shall an Asbestos Abatement Project begin on a date other than the date contained in the written notice of the new start date.
1.8.2Retention of Records
Each licensed Asbestos Contractor shall maintain records of all asbestos abatement projects which it performs and shall make these records available to the Department upon request. The Asbestos Contractor shall retain the records until the Department authorizes their disposition.
1.8.3Required Records
A.The Asbestos Contractor shall maintain the following information for each asbestos abatement project at the project site for the duration of the project:
1.The name, address and license number of each Asbestos Supervisor and Asbestos Worker utilized on the project.
2.A complete copy of the approved asbestos abatement plan for the project, including all amendments.
3.Starting and completion dates If completion date differs from that originally scheduled, a statement of reasons for the change must be included.
4.Documentation of compliance with all applicable regulatory requirements. (e.g., Copies of workers' medical monitoring and results of respirator fit testing.)
5.Copies of any correspondence with regulatory agencies concerning the project (e.g. building or demolition permits, notices of violation, etc.).
6.Receipts and/or manifests indicating the date(s) and amount(s) of ACM removed from the abatement project site for disposal, as well as the location(s) to which the ACM has been removed and/or the agent(s) to whom the ACM was transferred.
7.The methodology and results of all air sampling conducted by the Asbestos Contractor during the abatement process. The results of all air sampling required by OSHA 29 C.F.R. § 1926.1101(f) incorporated by reference at § 1.2(A) of this Part shall be maintained in accordance with OSHA 29 C.F.R. § 1926.1101(n) incorporated by reference at § 1.2(A) of this Part.
8.Documentation of current required annual review training for all Asbestos Supervisor(s) and Asbestos Worker(s) utilized on the Asbestos Abatement Project, as well as a list of any other agents working for the Asbestos Contractor.
9.A log of control of access to the work areas.
10.A current copy of this Part.
11.Documentation of adequacy of compressed air systems/respiratory protection systems. This documentation must include a list of compatible components. The maximum number of respirators that may be used with the system and the types of respirators that may be used shall be specified.
12.Copies of the procedures for the utilization of the decontamination enclosure system and/or any other procedures which have been established to prevent contamination of areas outside the work area.
13.Copies of procedures to be followed during medical emergencies, including phone numbers of the nearest hospital and/or rescue squad that will accept individuals with potential asbestos contamination. A 24-hour Emergency Contact Number for the Asbestos Contractor must be posted on site at all times.
14.Asbestos Supervisor and Asbestos Worker licenses must be worn or prominently posted at the project site whenever the licensed individual is being utilized in conjunction with an Asbestos Abatement Project.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.9** Licensee Training Requirements {#sec-216-ricr-50-15-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.9}
1.9.1General Training Requirement
A.Licensed Asbestos Contractors shall not allow any Asbestos Worker or Asbestos Supervisor to participate in asbestos abatement projects until the initial training requirement contained in § 1.9.2 of this Part has been satisfied. The criteria for successful completion of a required training course must include obtaining a passing score on the final course examination, unless the certified training course has been specifically authorized in writing by the Department to use an alternative method of determining successful completion.
B.Asbestos Workers and Asbestos Supervisors may not continue to work beyond the anniversary of their initial training or last annual review course until a current annual review course has been completed.
C.Asbestos Contractors shall satisfy the training requirement either by utilizing certified courses offered by outside agents or by establishing an in-house training program and submitting it for certification in accordance with the procedures contained in § 1.18 of this Part.
D.The Asbestos Contractor shall ensure that personnel designated as Asbestos Supervisor also successfully complete a certified initial training course of at least eight (8) hours duration (exclusive of lunch and break times) as outlined in § 1.9.3 of this Part.
E.The Asbestos Contractor shall ensure that Asbestos Workers and Asbestos Supervisors successfully complete a certified annual review course of at least eight (8) hours duration (exclusive of lunch and break times) as outlined in § 1.9.4 of this Part.
1.9.2Certification of Training
Requirements for certification of training courses shall be those contained in § 1.18 of this Part.
1.9.3Content of Initial Training Courses
A.The initial training course shall provide, at a minimum, information on the following topics:
1.The physical characteristics of asbestos including fiber size, aerodynamic characteristics and physical appearance;
2.The health hazards of asbestos including, the nature of asbestos related diseases, routes of exposure, dose response relationships, synergism between cigarette smoking and asbestos exposure, latency period for disease and health basis for standards;
3.Asbestos Worker personal protective equipment including: the classes and characteristics of respirator types; limitations of respirators; proper selection, inspection, donning, use, maintenance and storage procedures; methods for field testing of the facepiece-to-face seal (positive and negative pressure fitting tests); qualitative and quantitative fit testing procedures; variability between field and laboratory protection factors; factors that alter respirator fit (e.g. facial hair); the components of a proper respiratory protection program; selection and use of personal protective clothing; use, storage and handling of launderable clothing, non- slip footwear, gloves, eye protection and hard hats;
4.Medical monitoring procedures and requirements included under OSHA 29 C.F.R. § 1926.1101 incorporated by reference at § 1.2(A) of this Part and 29 C.F.R. § 1910.134 incorporated by reference at § 1.2(C) of this Part, additional recommended procedures and tests, benefits of medical monitoring and employee access to records;
5.Air monitoring procedures and requirements included under OSHA 29 C.F.R. § 1926.1101 incorporated by reference at § 1.2(A) of this Part including a description of equipment and methods, reasons for air monitoring, types of samples and current standards with proposed changes;
6.Additional safety hazards that may be encountered during asbestos abatement activities and how to deal with them including electrical hazards, heat stress, air contaminants other than asbestos, fire and explosion hazards, scaffold and ladder hazards, slips, trips and falls, confined spaces and noise;
7.Personal hygiene including entry and exit procedures for the work area, use of showers and prohibition of eating, drinking, smoking and chewing (gum or tobacco) in the work area;
8.State-of-the-art work practices for asbestos abatement activities including purpose, proper construction and maintenance of barriers and decontamination enclosure systems, posting of warning signs, electrical and ventilation system lock-out, proper working techniques for minimizing fiber release, use of wet methods and surfactants, use of negative pressure ventilation equipment, use of HEPA vacuums and proper clean-up and disposal procedures. Work practice requirements as they apply to removal, repair, enclosure and encapsulation shall be discussed individually; and
9.The requirements, procedures and standards established by OSHA, EPA and the provisions of the Act and this Part.
B.In addition to the training specified in § 1.9.3(A) of this Part, individuals designated as Asbestos Supervisors shall also receive at least six (6) hours of additional training (exclusive of lunch and break times) which shall provide, at a minimum, information on the following topics:
1.Legal responsibilities and potential liabilities of various parties including, but not limited to, contractors, licensees, employers, employees, building owners and suppliers;
2.Insurance and bonding;
3.Establishing a medical surveillance program in accordance with OSHA 29 C.F.R. § 1926.1101 incorporated by reference at § 1.2(A) of this Part;
4.Rhode Island Department of Health, EPA, and OSHA recordkeeping requirements;
5.How to supervise effectively;
6.Additional emphasis on work practices, including purpose, proper construction and maintenance of barriers and decontamination systems, posting of warning signs, electrical and ventilation system lock-out, proper working techniques for minimizing fiber release, use of wet methods and surfactants, use of negative pressure ventilation equipment, use and maintenance of HEPA vacuums, proper clean-up and disposal procedures; and
7.Key elements of contract specifications.
1.9.4 Content of Annual Training Courses
The yearly review course shall consist of at least eight (8) hours of instruction and shall provide, at a minimum, an adequate review of the topics outlined in § 1.9.3 of this Part, updated information on state-of-the-art procedures and equipment and reviews of regulatory changes and interpretations. Specific topic coverage may be requested by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.10** Licensee Respiratory Protection {#sec-216-ricr-50-15-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.10}
1.10.1General Requirement
All license applications from Asbestos Contractors shall include a written respiratory protection program in accordance with the requirements of OSHA 29 C.F.R. § 1910.134(c) incorporated by reference at § 1.2(C) of this Part and 29 C.F.R. § 1926.1101(h) incorporated by reference at § 1.2(A) of this Part. This program shall be posted at all projects requiring asbestos abatement activities over more than a single day.
1.10.2Selection Requirements
Respirators shall be selected that meet the level of protection requirements contained in OSHA 29 C.F.R. § 1926.1101(h) incorporated by reference at § 1.2(A) of this Part and shall be utilized in accordance with OSHA 29 C.F.R. § 1910.134 incorporated by reference at § 1.2(C) of this Part.
1.10.3Fitting of Respirators
A.Each Asbestos Supervisor and Asbestos Worker shall be given an opportunity to try on a variety of respirator styles and sizes and to select a respirator for comfortable fit.
B.Each Asbestos Supervisor and Asbestos Worker shall be instructed in the performance of positive and negative pressure fit checks and be able to successfully perform them.
C.Each Asbestos Supervisor and Asbestos Worker shall be fit tested using generally acceptable quantitative fit testing methods or by qualitative fit testing procedures as detailed in the OSHA Construction Industry Standard, 29 C.F.R. § 1910.134 Appendix A incorporated by reference at § 1.2(C) of this Part, and adequately pass the selected fit test procedure.
D.Asbestos Supervisors and Asbestos Workers shall be provided with the brand name and model number of respirators that they have been fitted for and are trained to use.
1.10.4Prohibited Activity
A.No Asbestos Supervisor, Asbestos Worker, or agent shall be permitted in the work area without the respiratory protection required for the level of exposure in the workplace. This requirement shall be strictly enforced by the Asbestos Contractor.
B.No personnel with beards, long sideburns or other physical characteristics which interfere with negative pressure respirator faceplate-to-face seal shall be permitted in the work area when respiratory protection is required by the level of exposure.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.11** Protective Clothing {#sec-216-ricr-50-15-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.11}
Each Asbestos Supervisor and Asbestos Worker shall be provided with personal protective equipment and clothing in accordance with OSHA 29 C.F.R. § 1926.1101(i) incorporated by reference at § 1.2(A) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.12** Medical Monitoring {#sec-216-ricr-50-15-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.12}
A.General Requirement
Asbestos Contractors must ensure that any Asbestos Supervisor, Asbestos Worker or agent who may be exposed to airborne asbestos is medically monitored in accordance with the requirements of OSHA 29 C.F.R. § 1926.1101(m) incorporated by reference at § 1.2(A) of this Part, prior to engaging in any asbestos abatement activity. Monitoring shall include, at a minimum, those elements required by OSHA 29 C.F.R. § 1926.1101(m)(2)(ii) incorporated by reference at § 1.2(A) of this Part.
B.Asbestos Supervisors and Asbestos Workers must also be given an opportunity to be evaluated by a physician to determine their capability to safely work while breathing through the added resistance of a respirator. Examining physicians should be made aware of the nature of respiratory protective hazards and knowledgeable about the specific types of respirators the Asbestos Supervisor or Asbestos Worker shall be required to wear and the work he will be required to perform. They should also be advised as to special hazards that may exist in the work place (e.g. high temperatures, toxic contaminants).
C.Chest X-rays shall be taken by a Registered Radiological Technologist and interpreted in accordance with OSHA 29 C.F.R. § 1926.1101 Appendix E incorporated by reference at § 1.2(A) of this Part.
D.Pulmonary function testing shall be conducted by a NIOSH Certified Pulmonary Technician or other health professional with training in pulmonary function testing.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.13** Worker Air Monitoring {#sec-216-ricr-50-15-1-1.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.13}
The Asbestos Contractor must provide representative air monitoring, in accordance with OSHA 29 C.F.R. § 1926.1101(f) incorporated by reference at § 1.2(A) of this Part, for Asbestos Supervisors and Asbestos Workers during asbestos abatement activities. Affected Asbestos Supervisors, Asbestos Workers, and agents of the Asbestos Contractor must be notified of the results of air monitoring in accordance with OSHA 29 C.F.R. § 1926.1101(f)(5) incorporated by reference at § 1.2(A) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.14** Work Practice Requirements {#sec-216-ricr-50-15-1-1.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.14}
1.14.1Applicability
Any Asbestos Contractor that engages in any Asbestos Abatement Project that involves greater than ten (10) linear feet (three (3) meters) of pipe covered or coated with asbestos containing material or twenty five (25) square feet (three (3) square meters) of asbestos containing material used to cover or coat any surface other than pipe shall comply with the work practices contained in § 1.14 of this Part and any additional work practice requirements contained in the asbestos abatement plan approved for that project by the Director of Health. Specific requirements for Category I and Category II Nonfriable ACM that is not Regulated Asbestos Containing Material (RACM) are contained in §§ 1.14.8 and 1.15 of this Part.
1.14.2General Requirements for Removal, Encapsulation and/or Enclosure of Regulated Asbestos Containing Material (RACM)
A.Barriers to isolate contaminated from uncontaminated areas shall be constructed of polyethylene sheeting attached securely in place.
B.All surfaces shall be wet cleaned of dust or debris. Wet cleaning of contaminated items shall be performed if necessary. All movable objects shall be removed from the work area. All nonmovable objects in the work area shall be covered with 6-mil polyethylene sheeting secured in place. All openings or penetrations between the work area and uncontaminated areas shall be sealed, including windows, doorways, elevator openings, corridor entrances, drains, ducts, grills, grates, diffusers and skylights.
C.Floor sheeting shall consist of two (2) layers of 6-mil polyethylene sheeting. Floor sheeting shall extend up sidewalls at least twelve (12) inches and be sized to minimize seams. No seams shall be located at wall/floor joints. Floors being abated of resilient floor coverings and associated mastics/adhesives shall be exempt from this requirement.
D.Wall sheeting shall consist of two (2) layers of 4-mil polyethylene sheeting. It shall be installed to minimize joints and shall extend beyond wall/floor joint at least twelve (12) inches. No seams shall be located at wall/wall joints.
E.A worker decontamination enclosure system, consisting of a clean room, shower room and equipment room, each separated from each other and from the work area by airlocks and accessible through doorways protected with two (2) overlapping polyethylene sheets, shall be provided in accordance with OSHA 29 C.F.R. § 1926.1101(j) incorporated by reference at § 1.2(A) of this Part. Procedures for the utilization of this system shall be established which prevent contamination of areas outside the work area.
F.All HVAC equipment in or passing through the work area shall be shut down and locked out. All intake and exhaust openings, as well as any seams in system components shall be sealed with 6-mil polyethylene sheeting and/or tape. All system filters shall be replaced after the abatement and disposed of as asbestos waste. The ventilation system ductwork interiors shall be decontaminated whenever necessary.
G.Posting
1.Warning signs in accordance with OSHA 29 C.F.R. § 1926.1101(k)(7) incorporated by reference at § 1.2(A) of this Part shall be displayed at all approaches to any location where airborne fiber levels can be expected to exceed the Indoor Non-Occupational Air Exposure Standard established by § 1.5 of this Part.
2.Warning signs to advise the public of the location(s) within the building where any asbestos abatement activity is in progress shall be posted at all building entrances and at least one other conspicuous place per floor. These signs shall be of the same dimensions as the Warning/Danger signs required in § 1.14.2(G)(1) of this Part.
3.Warning signs shall be posted on vehicles used to transport Asbestos Containing Waste Materials during loading and unloading of the waste.
H.Clean-up procedures using HEPA vacuuming and wet cleaning techniques shall be performed following abatement. Wet cleaning shall be followed by HEPA vacuuming after surfaces have been allowed to dry. The sequence of wet cleaning and vacuuming shall be repeated at twenty-four (24) hour intervals until no visible residue is observed in the work area.
I.Negative pressure ventilation units with HEPA filtration, in sufficient number to provide one (1) workplace air change every fifteen (15) minutes, shall be operated continuously from the time of barrier construction through the time acceptable final clearance air-monitoring results are obtained. These units shall exhaust filtered air to the outside of the building. Filtered air shall not be exhausted to uncontaminated interior spaces.
J.All Asbestos Containing Waste Materials shall be adequately wetted before being placed into containers for disposal.
K.Asbestos Containing Waste Materials shall be placed in impermeable containers for disposal. Metal or fiber drums with locking-ring tops shall be used when asbestos waste contains sharp edged components. Double polyethylene bags of at least 6-mil thickness and which can be securely sealed may be used for waste. Large components or structural members may be removed intact and contained in leak-tight wrapping, equivalent to at least two (2) layers of 6-mil polyethylene sheeting, secured with tape for disposal.
L.All containers, bags, drums and wrapped components shall be labeled so that labels have the appearance of or are constructed in accordance with USDOT 49 C.F.R. 172, Subpart E incorporated by reference at § 1.2(D) of this Part and OSHA 29 C.F.R. § 1926.1101(k)(8) incorporated by reference at § 1.2(A) of this Part. Each container, bag, drum or wrapped component shall also be labeled or tagged with the name and license number of the asbestos contractor generating the waste, as well as the asbestos abatement project number and location at which the waste was generated.
M.Storage of asbestos waste containers awaiting transport to an authorized disposal facility shall be in a secured location to prevent access by unauthorized personnel.
N.Transport and disposal of asbestos waste shall be in accordance with the provisions of Appendix D to 40 C.F.R. 763, Subpart E incorporated by reference at § 1.2(E) of this Part and USDOT 49 C.F.R. § 173.1300 incorporated by reference at § 1.2(F) of this Part.
O.Disposal of Asbestos Containing Waste Materials. All Asbestos Containing Waste Materials shall be deposited as soon as is practical by the waste generator at:
1.A waste disposal site operated in accordance with the provisions of 40 C.F.R. § 61.154, or equivalent regulations promulgated by a state or local NESHAP designee; or
2.An EPA-approved site that converts RACM and Asbestos Containing Waste Materials into nonasbestos (asbestos-free) material according to the provisions of 40 C.F.R. § 61.155.
P.Access to work areas shall be controlled and posting requirements shall remain in effect until compliance with the air exposure standard has been verified by procedures outlined below:
1.Samples shall be collected and analyzed in accordance with the procedures specified by NIOSH Method 7400 (most current Revision) for asbestos fibers in air or equivalent method;
2.Air volumes shall be sufficient to accurately determine fiber concentrations to 0.01 fibers/ cubic centimeter of air (f/cc) for fibers greater than five (5) microns in length or 300 nanograms per cubic meter. A minimum air volume of 1000 liters shall be sampled;
3.Air sampling shall be conducted in representative locations with portable fans circulating air to simulate actual use conditions;
4.An acceptable airborne fiber concentration, as established by clearance air monitoring shall not exceed 0.01 f/cc for fibers greater than five (5) microns in length or 300 nanograms per cubic meter; and
5.Air sampling shall be conducted by a representative of the building owner who is not subject to the control or supervision of the Asbestos Contractor for the asbestos abatement plan.
6.Notwithstanding the requirements contained in § 1.14.2(P) of this Part above, control of access and posting requirements for buildings subject to the AHERA regulations shall remain in effect until compliance with §§ 1.17.3(A)(5) through (8) of this Part has been demonstrated.
1.14.3Specific Requirements for Removal of Regulated Asbestos Containing Material (RACM)
A.All RACM shall be adequately wetted prior to removal. In addition, all RACM exposed during cutting and disjoining operations shall be adequately wet and all RACM shall be kept adequately wet during stripping operations.
B.Components shall be removed intact or in large sections whenever possible and carefully lowered to the floor.
C.RACM shall be removed in small sections and containerized when adequately wet. At no time shall material be allowed to accumulate or become dry. Structural components shall be adequately wetted prior to being contained in leak-tight wrapping for disposal.
D.Material shall not be dropped or thrown to the floor level. For materials located at heights greater than fifty (50) feet above the floor, a dust-tight, enclosed chute shall be constructed to transport removed material to containers on the floor. RACM may be dropped to a raised scaffold or containerized at elevated levels for disposal. Materials greater than fifteen (15) feet above the floor shall be dropped onto inclined chutes or scaffolding or containerized at elevated levels for eventual disposal.
E.A coating of encapsulating agent shall be applied to any porous surfaces that have been stripped of RACM to securely seal any residual fibers that may be present. The encapsulating agent should be chosen to be compatible with subsequent coverings.
F.RACM is not required to be stripped from large facility components such as reactor vessels, large tanks, and steam generators if the following requirements are met:
1.The component is removed, transported, stored, disposed of, or reused without disturbing or damaging the RACM.
2.The component is encased in a leak-tight wrapping.
3.The leak-tight wrapping is labeled during all loading and unloading operations and during storage.
G.When the temperature at the point of wetting is below 0°C (32°F):
1.The Asbestos Contractor need not comply with the wetting provisions of §§ 1.14.3(A) and (C) of this Part.
2.The Asbestos Contractor shall remove facility components containing, coated with, or covered with RACM as units or in sections to the maximum extent possible.
3.During periods when wetting operations are suspended due to freezing temperatures, the Asbestos Contractor must record the temperature in the area containing the facility components at the beginning, middle, and end of each workday and keep daily temperature records available for inspection by the Department during normal business hours at the asbestos abatement project site. The Asbestos Contractor shall retain temperature records for at least two years.
1.14.4Specific Requirements for Encapsulation of Regulated Asbestos Containing Material (RACM)
A.All loose and hanging RACM shall be removed in accordance with § 1.14.3 of this Part.
B.Filler material applied to gaps in existing material shall contain no asbestos, adhere well to the substrate and provide an adequate base for the encapsulating agent.
C.Encapsulants shall be applied using only airless spray equipment with nozzle pressure adjustable between four hundred (400) and fifteen hundred (1500) PSI and in accordance with the manufacturer's recommendations for a particular encapsulant.
D.Encapsulated materials shall be specially designated by signs, labels, color coding or some mechanism to warn individuals who may be required to disturb the material.
E.Encapsulants shall not be solvent-based or utilize a vehicle consisting of hydrocarbons.
1.14.5Specific Requirements for Enclosure of Regulated Asbestos Containing Material (RACM)
A.All areas of RACM shall be adequately wetted with wetting agents if they are to be disturbed during the installation of hangers, brackets or other portions of the enclosure.
B.All loose and hanging RACM shall be removed in accordance with § 1.14.3 of this Part.
C.Non-asbestos containing substitutes shall be used to patch thermal insulation and fireproofing materials when required and where appropriate.
D.Enclosures for RACM shall be specially designated by signs, labels, color coding or some mechanism to warn individuals who may be required to disturb or enter the enclosure.
1.14.6Specific Requirements for Demolition of Structures Containing Asbestos
A.Any demolition of a structure or portion of a structure which contains structural members, building materials or structural components composed of or covered by RACM shall be preceded by a removal of all such materials in accordance with §§ 1.14.2 and 1.14.3 of this Part. Said removal must be completed before any activity begins that would break up, dislodge, or similarly disturb the material or preclude access to the material for subsequent removal. Notwithstanding the foregoing, RACM need not be removed before demolition if:
1.It is Category I nonfriable ACM that is not in poor condition and is not friable; or
2.It is on a facility component that is encased in concrete or other similarly hard material and is adequately wet whenever exposed during demolition; or
3.It was not accessible for testing and was, therefore, not discovered until after demolition began and, because of the demolition, the material cannot be safely removed. If not removed for safety reasons, the exposed RACM and any asbestos contaminated debris must be treated as Asbestos Containing Waste Material and adequately wet at all times until disposed of; or
4.It is Category II nonfriable ACM and the probability is low that the materials will become crumbled, pulverized, or reduced to powder during demolition.
B.For Emergency Asbestos Abatement Projects described in § 1.6.2(C) of this Part, adequately wet the portion of the facility that contains RACM during the wrecking operation.
C.If a facility is demolished by intentional burning, all RACM, including Category I and Category II nonfriable ACM, must be removed in accordance with this Part before burning.
D.In lieu of the requirements specified in §§ 1.14.2(B), (C), (D), (F) and 1.14.3(E) of this Part, Asbestos Contractors engaging in demolition activities shall comply with the following:
1.Prior to beginning a demolition project, all doors, windows, floor drains, vents and other openings to the outside of the building and to areas within the building that do not contain asbestos materials shall be sealed off with 6-mil polyethylene sheeting and waterproof tape or equivalent acceptable to the Department.
2.If a structure is to be partially demolished, HVAC equipment in the demolition area or passing through it but servicing areas of the building which will remain, shall be shut down and locked out and thoroughly sealed with 6-mil polyethylene sheeting and waterproof tape.
3.If the building owner proposes not to conduct clearance air sampling following asbestos abatement activities conducted for demolition purposes, the building owner must submit written justification to the Department which describes how personnel who must occupy the building prior to demolition will be protected.
4.All other requirements of §§ 1.14.2 and 1.14.3 of this Part, unless specified in § 1.14.6(D) of this Part, shall apply to demolition abatement activities.
1.14.7General Requirements for Use of Glove Bags During Removal and/or Encapsulation of Regulated Asbestos Containing Material (RACM)
A.In lieu of the requirements specified in §§ 1.14.2(A) through (F), (H), and (I) of this Part, Asbestos Contractors using glove bags during removal and/or encapsulation of RACM shall comply with the following:
1.All glove bags must remain stationary during asbestos abatement activities. The use of moving and/or sliding glove bag techniques are prohibited.
2.Abatement projects which do not exceed the scope of Spot Repairs, as defined by this Part, and which can be contained within one stationary glove bag may be performed in accordance with the glove bag procedures contained in 29 C.F.R. § 1926.1101(g)(5) incorporated by reference at § 1.2(A) of this Part without the use of additional containment or negative pressure ventilation. The clearance air monitoring provisions of § 1.14.2(P) of this Part are waived unless there has been a breach of the glove bag containment.
3.All other abatement projects that involve less than two hundred and sixty (260) linear feet [eighty (80) meters] of pipe covered or coated with RACM or one hundred and sixty (160) square feet [fifteen (15) square meters] of RACM used to cover or coat any surface other than pipe shall comply with the following requirements:
a.All doors, windows, floor drains, vents and other openings to the outside of the building and to areas within the building that do not contain asbestos materials shall be sealed off with 6-mil polyethylene sheeting and waterproof tape or equivalent acceptable to the Department.
b.Floor sheeting shall consist of at least one (1) layer of 6-mil polyethylene sheeting. Floor sheeting shall be placed directly beneath the glove bag and shall extend at least ten (10) feet in all horizontal directions. If any wall is less than ten (10) feet from the glove bag, the floor sheeting shall be extended up that wall to at least the height of the glove bag.
c.HVAC equipment in the abatement area or passing through it but servicing other areas of the building shall be shut down and locked out and thoroughly sealed with 6-mil polyethylene sheeting and waterproof tape.
d.Negative pressure ventilation units with HEPA filtration shall be operated continuously from the time of barrier construction through the time acceptable final clearance air-monitoring results are obtained. These units shall exhaust filtered air to the outside of the building. Filtered air shall not be exhausted to uncontaminated interior spaces.
e.Manufacturer's instructions concerning preparation, sealing, utilization and removal of glove bags must be followed unless the abatement plan and/or this Part specify more restrictive requirements.
f.A worker decontamination enclosure system must be available immediately adjacent to the abatement area. A two-chamber decontamination system may be used if shower facilities are otherwise available on the project site.
4.All abatement projects that involve more than two hundred and sixty (260) linear feet [eighty (80) meters] of pipe covered or coated with RACM or one hundred and sixty (160) square feet [fifteen (15) square meters] of RACM used to cover or coat any surface other than pipe shall comply with the following requirements:
a.All doors, windows, floor drains, vents and other openings to the outside of the building and to areas within the building that do not contain asbestos materials shall be sealed off with 6-mil polyethylene sheeting and waterproof tape or equivalent acceptable to the Department.
b.Floor sheeting shall consist of at least one (1) layer of 6-mil polyethylene sheeting. Floor sheeting shall extend up sidewalls at least twelve (12) inches and be sized to minimize seams. No seams shall be located at wall/floor joints.
c.Wall sheeting shall consist of at least one (1) layer of 4-mil polyethylene sheeting. It shall be installed to minimize joints and shall extend from the wall/ ceiling joint to at least twelve (12) inches beyond the wall/floor joint. No seams shall be located at wall/wall joints.
d.HVAC equipment in the abatement area or passing through it but servicing other areas of the building shall be shut down and locked out and thoroughly sealed with 6-mil polyethylene sheeting and waterproof tape.
e.Negative pressure ventilation units with HEPA filtration shall be operated continuously from the time of barrier construction through the time acceptable final clearance air monitoring results are obtained. These units shall exhaust filtered air to the outside of the building. Filtered air shall not be exhausted to uncontaminated interior spaces.
f.Manufacturer's instructions concerning preparation, sealing, utilization and removal of glove bags must be followed unless the abatement plan and/or this Part specify more restrictive requirements.
g.A three-chamber worker decontamination enclosure system, in accordance with 29 C.F.R. § 1926.1101(j) incorporated by reference at § 1.2(A) of this Part, must be available immediately adjacent to the abatement area.
5.All other requirements of §§ 1.14.2 and 1.14.3 of this Part, unless specifically deleted in § 1.14.7(A) of this Part, shall apply to use of glove bags during removal and/or encapsulation of asbestos.
B.Any requests for additional waivers and/or alternative procedures must be submitted for Department review and approval in accordance with § 1.16 of this Part.
1.14.8Specific Requirements for Removal of Category I Nonfriable ACM - Asphalt Roofing Products
A.All surfaces shall be wet cleaned of dust or debris. All movable objects shall be removed from the roof area. All openings or penetrations on the roof area and at least one level below the roof area shall be sealed, including windows, doorways, drains, ducts, grills, grates, diffusers and skylights.
B.Floor/ground sheeting shall consist of at least two (2) layers of 6-mil polyethylene sheeting and shall be utilized as follows:
1.If the roof is pitched, sheeting shall be applied to the first horizontal surface below the work area and shall extend from the edge of the building to at least ten (10) feet away from the building. All material being abated shall be confined to the roof area.
2.If the roof is flat, sheeting shall extend at least ten (10) feet away from the perimeter of the work area. When the edge of the roof is less than ten (10) feet from the perimeter of the work area, sheeting shall be applied such that the outer edge of the sheeting is at least ten (10) feet from the perimeter of the work area.
C.All HVAC intake or exhaust vents on the roof area and at least one level below the roof area shall be shut down and locked out. All intake and exhaust openings, as well as any seams in system components shall be sealed with 6-mil polyethylene sheeting and/or tape.
D.A minimum of a two-chambered worker decontamination enclosure system shall be provided on site. Procedures for the utilization of this system shall be established which prevent contamination of areas outside the roof area.
E.Warning signs shall be posted in accordance with § 1.14.2(G) of this Part.
F.Category I Nonfriable ACM shall be removed in small sections and containerized when wet. At no time shall material be allowed to accumulate or become dry.
G.Category I Nonfriable ACM shall not be dropped or thrown to the floor/ground level. For roofs at heights greater than fifty (50) feet above the floor/ground, a dust-tight, enclosed chute shall be constructed to transport removed Category I Nonfriable ACM to containers on the floor/ground. Category I Nonfriable ACM may be dropped to a raised scaffold or containerized at elevated levels for disposal.
H.All Category I Nonfriable ACM shall be adequately wetted before being placed into containers for disposal. Disposal shall be in accordance with §§ 1.14.2(K) through (O) of this Part.
I.A coating of encapsulating agent shall be applied to any porous surfaces that have been stripped of Category I Nonfriable ACM to securely seal any residual fibers that may be present. The encapsulating agent should be chosen to be compatible with subsequent coverings.
J.Clean-up procedures using HEPA vacuuming and wet cleaning techniques shall be performed following abatement.
K.Personnel air monitoring of Asbestos Supervisors and Asbestos Workers, which demonstrates compliance with the provisions of OSHA 29 C.F.R. § 1926.1101(f) incorporated by reference at § 1.2(A) of this Part, may be used in lieu of the clearance air sampling requirements contained in § 1.14.2(P) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.15** Work Practice Requirements – Spot Removals {#sec-216-ricr-50-15-1-1.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.15}
1.15.1Applicability
A.Individuals performing spot repairs must be certified as a competent person in accordance with § 1.19 of this Part and shall take reasonable precautions to prevent the release of asbestos fibers to the environment. The reasonable precautions required by § 1.15.1 of this Part shall include, but are not limited to the following:
1.Barriers constructed shall be adequate to contain asbestos fibers released within the work area.
2.Procedures shall be established to prevent asbestos contamination in all areas outside the work area(s).
3.All asbestos containing material shall be wetted prior to removal and kept wet until containerized.
4.HEPA vacuum equipment and wet cleaning techniques shall be used to clean up the work area following abatement until there is no visible residue.
5.Asbestos waste shall be packaged in impermeable containers such as polyethylene sheeting, bags and/or fiber or metal drums and shall be labeled so that labels have the appearance of or are constructed in accordance with USDOT 49 C.F.R. § 172, Subpart E incorporated by reference at § 1.2(D) of this Part and OSHA 29 C.F.R. § 1926.1101 incorporated by reference at § 1.2(A) of this Part. Each container, bag, drum or wrapped component shall also be labeled or tagged with the name and license number of the asbestos contractor generating the waste, as well as the asbestos abatement project number and location at which the waste was generated.
6.Transport and disposal of asbestos waste shall be in accordance with the provisions of Appendix D to 40 C.F.R. § 763, Subpart E incorporated by reference at § 1.2(E) of this Part and USDOT 49 C.F.R. § 173.1300 incorporated by reference at § 1.2(F) of this Part.
1.15.2Documentation
A.Documentation of all spot repairs must be maintained with the permanent building records. This documentation shall include, at a minimum, the identity of the competent person performing the spot repair, the date the spot repair was performed, the specific location that was repaired, the methods used to perform the spot repair, the quantity of asbestos that was involved in the spot repair and receipts for the disposal of any asbestos waste.
B.Exposure monitoring shall be in accordance with the provisions of OSHA 29 C.F.R. § 1926.1101(f) incorporated by reference at § 1.2(A) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.16** Alternative Procedures {#sec-216-ricr-50-15-1-1.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.16}
The Department may, on a case-by-case basis, approve an alternative procedure for control of emissions from an asbestos abatement project provided that the building owner submits the alternative procedure to the Department in writing and demonstrates to the satisfaction of the Department that compliance with the prescribed procedures is not practical or not feasible or that the proposed alternative procedures provide equivalent control of asbestos. The Department, following its review, may approve an alternative procedure if it determines that it will minimize the emission of asbestos.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.17** Abatement (Management) Plans and Owner Responsibilities {#sec-216-ricr-50-15-1-1.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.17}
1.17.1 General Requirements
A.This section applies to Asbestos Abatement (Management) Plans submitted pursuant to § 1.6 of this Part. All asbestos abatement projects conducted at any facility, except for spot repairs as defined in this Part, must be conducted in accordance with an Asbestos Abatement (Management) Plan which has been submitted by the building owner and approved by the Department.
B.Asbestos Abatement (Management) Plans shall be submitted on forms provided by the Department. Said forms shall be signed by the building owner or legally authorized agent. Consultants retained to prepare Asbestos Abatement (Management) Plans are not authorized to sign these forms.
C.An Asbestos Abatement (Management) Plan for any school or school building subject to the AHERA regulations must be prepared by a consultant certified for the proposed scope of abatement work in accordance with §§ 1.21.2(B)(2) and/or 1.21.2(B)(3) of this Part.
D.An Asbestos Abatement (Management) Plan for any public or private building, other than schools or school buildings subject to the AHERA regulations, must be prepared by the building owner, a full-time employee of the building owner or an Asbestos Project Designer certified in accordance with § 1.21.2(B)(2) of this Part.
1.17.2Contents of an Abatement (Management) Plan
A.An Asbestos Abatement (Management) Plan submitted in accordance with § 1.6 of this Part must include all the information required by the forms provided by the Department.
B.An Asbestos Abatement (Management) Plan must include an interim Operations and Maintenance Program that will be implemented until the asbestos containing material can be abated. Furthermore, any Asbestos Abatement (Management) Plan which does not include complete removal of all asbestos containing material in the area(s) being abated must also include a long-term Operations and Maintenance Program for the remaining asbestos containing material.
C.An Operations and Maintenance Program must address, as a minimum, the following items:
1.Action(s) to be taken when the monitoring program discovers asbestos containing material in need of abatement;
2.Monitoring the physical conditions of the asbestos containing materials in accordance with § 1.22 of this Part, including a schedule for monitoring and methods for documentation of findings;
3.Educating the building staff and occupants regarding the presence and location of asbestos containing material;
4.Procedures for alerting outside service personnel and others to the presence and location of asbestos containing material, including the Warning Label provisions of 40 C.F.R. § 763.95 incorporated by reference at § 1.2(G) of this Part;
5.Steps to be taken which will minimize the likelihood of asbestos fiber release. (e.g., Modification of maintenance activities, spot repairs, etc.); and
6.Steps to be taken which will minimize the potential of human exposure to asbestos (e.g., Limit access to areas known to contain friable asbestos material in deteriorating condition.)
1.17.3Post Abatement Requirements
A.Clearance Air Sampling. Clearance air sampling for all buildings subject to the AHERA regulations shall be conducted in accordance with §§ 1.17.3(A)(5) through (8) of this Part. Clearance air sampling for all other buildings shall be conducted in accordance with §§ 1.17.3(A)(1) through (4) of this Part.
1.Clearance air sampling shall be conducted and reviewed for compliance with the Indoor Non-Occupational Air Exposure Standard established by § 1.5 of this Part prior to dismantling the containment barriers and prior to reoccupancy of the abated area.
2.Clearance air samples shall be collected by a representative of the building owner in accordance with the requirements of § 1.14.2(P) of this Part. This representative shall be an independent agent who is not subject to the Asbestos Contractor's control or supervision. All such clearance air samples shall only be analyzed by an Asbestos Analytical Service certified for this activity in accordance with § 1.20 of this Part.
3.The building owner shall review the results of clearance air sampling prior to dismantling the containment barriers and prior to reoccupancy of the abated area. If sampling results exceed the Indoor Non-Occupational Air Exposure Standard established by § 1.5 of this Part, the area shall be recleaned in accordance with §§ 1.7 through 1.16 of this Part and the clearance air sampling shall be repeated. Cleaning and resampling shall be repeated at no less than twenty-four (24) hour intervals until the abated area follows the Indoor Non-Occupational Air Exposure Standard established by § 1.5 of this Part.
4.Within three (3) working days of receipt of clearance air sampling results for an abated area, the building owner shall notify the Department either by telephone or in writing of the completion of the asbestos abatement project and the results of the clearance air sampling. The building owner shall also submit to the Department a certified copy of results of all clearance air sampling conducted in the abatement area and each area adjacent to the abatement area indicating each area follows the Indoor Non-Occupational Air Exposure Standard established by § 1.5 of this Part.
5.Clearance air sampling shall be conducted in accordance with 40 C.F.R. §§ 763.90(i)(2) through (i)(8) incorporated by reference at § 1.2(H) of this Part and reviewed for compliance with the average asbestos concentration established by 40 C.F.R. §§ 763.90(i)(3) through (i)(7) incorporated by reference at § 1.2(H) of this Part prior to dismantling the containment barriers described in the approved asbestos abatement plan and prior to reoccupancy of the abated area.
6.Clearance air samples shall be collected by a representative of the building owner in accordance with the requirements of 40 C.F.R. § 763.90(i)(2) incorporated by reference at § 1.2(H) of this Part. This representative shall be an independent agent who is not subject to the Asbestos Contractor's control or supervision. All such clearance air samples shall only be analyzed by an Asbestos Analytical Service certified for this activity in accordance with § 1.20 of this Part. Notwithstanding the preceding, the requirement to use only Department certified laboratories for samples analyzed via Transmission Electron Microscopy (TEM) is waived until the Department has established requirements for the certification of such facilities.
7.The building owner shall review the results of clearance air sampling prior to dismantling the containment barriers and prior to reoccupancy of the abated area. If sampling results exceed the average asbestos concentration established by 40 C.F.R. § 763.90(i)(3) through (i)(7) incorporated by reference at § 1.2(H) of this Part, the area shall be recleaned in accordance with §§ 1.7 through 1.16 of this Part and the clearance air sampling shall be repeated. Cleaning and resampling shall be repeated at no less than twenty-four (24) hour intervals until the abated area follows the average asbestos concentration established by 40 C.F.R. §§ 763.90(i)(3) through (i)(7).
8.Within three (3) working days of receipt of clearance air sampling results for an abated area, the building owner shall notify the Department either by telephone or in writing of the completion of the asbestos abatement project and the results of the clearance air sampling. The building owner shall also submit to the Department a certified copy of results of all clearance air sampling conducted in the abatement area and each area adjacent to the abatement area indicating each area follows the Indoor Non-Occupational Air Exposure Standard established by § 1.5 of this Part and/or the average asbestos concentration established by 40 C.F.R. §§ 763.90(i)(3) through (i)(7) incorporated by reference at § 1.2(H) of this Part, as appropriate.
B.Confirmation of Disposal of Asbestos. For all Asbestos Containing Waste Material transported off the Asbestos Abatement Project Site, the Asbestos Contractor shall:
1.Maintain waste shipment records, using the most current revision of Agency Form ASB-23 to provide the following information:
a.The name, address, and telephone number of the Asbestos Contractor.
b.The approximate quantity in cubic yards (cubic meters).
c.The name and telephone number of the disposal site operator.
d.The name and physical site location of the disposal site.
e.The date transported.
f.The name, address, and telephone number of the transporter(s).
g.A certification that the contents of this consignment are fully and adequately described by proper shipping name and are classified, packed, marked, and labeled, and are in all respects in proper condition for transport by highway according to applicable international and government regulations.
2.Provide a properly completed copy of Agency Form ASB-23 to the disposal site owners or operators at the same time as the Asbestos Containing Waste Material is delivered to the waste disposal site.
3.Provide the building owner with the original (white) copy of Agency Form ASB-23 signed by the owner or operator of the designated disposal site. Said original copy shall be transmitted to the Department by the building owner within five (5) working days of receipt.
4.For waste shipments where a copy of the waste shipment record, signed by the owner or operator of the designated disposal site, is not received by the Asbestos Contractor within thirty-five (35) days of the date the waste was accepted by the initial transporter [i.e. the date the waste left the abatement project site], contact the transporter and/or the owner or operator of the designated disposal site to determine the status of the waste shipment.
5.Report in writing to the Department if a copy of the waste shipment record, signed by the owner or operator of the designated waste disposal site, is not received by the Asbestos Contractor within forty-five (45) days of the day the waste was accepted by the initial transporter. Include in the report the following information:
a.A copy of the waste shipment record for which a confirmation of delivery was not received; and
b.A cover letter signed by the Asbestos Contractor explaining the efforts taken to locate the asbestos waste shipment and the results of those efforts.
6.Retain a copy of all waste shipment records, including a copy of the waste shipment record signed by the owner or operator of the designated waste disposal site, for at least two (2) years.
1.17.4Revocation of Department Approval for an Asbestos Abatement (Management) Plan
A.The Department may revoke any Asbestos Abatement (Management) Plan approval issued pursuant to this Part if the granting of said approval was based upon statements which prove to be false or based on misrepresentation of fact.
B.Any aggrieved party shall have the right to a hearing on any such revocation. Said request for a hearing shall be in writing and shall be made within ten (10) days of notification of said revocation.
1.17.5Expiration of Department Approval for an Asbestos Abatement (Management) Plan
A.An Asbestos Abatement (Management) Plan approval issued by the Department pursuant to this Part shall become invalid unless the work authorized by said approval shall have been commenced within six (6) months after its issuance and been completed within twelve (12) months after its issuance.
B.The six (6) month limit provided for by § 1.17.5(A) of this Part above may be extended, for cause, up to an additional ninety (90) days. Written justification for such an extension must be submitted for Department review prior to the approval expiration date. All Department approvals for such an extension must be in writing.
C.The six (6) month limit provided for by § 1.17.5(A) of this Part above shall not apply to any suspension or abandonment of an Department approved abatement project when the suspension or abandonment is due to a court order prohibiting such work as authorized by said approval.
1.17.6Asbestos Abatement (Management) Plan Fees
A.The application fee must accompany the Asbestos Abatement (Management) Plan and shall be in the form of a check made payable to General Treasurer, State of Rhode Island. This fee is nonrefundable and will not be returned if the Asbestos Abatement (Management) Plan is denied or otherwise not approved by the Department. The application fee also includes the inspection fee, authorized by R.I. Gen. Laws § 23-24.5-7(d), for any inspections of said Asbestos Abatement Project which are deemed necessary by the Department.
B.The application fee is based on the number of NESHAP units of ACM involved in the abatement project. One (1) NESHAP unit equals two hundred and sixty (260) linear feet [eighty (80) meters] of ACM or one hundred and sixty (160) square feet [fifteen (15) square meters] of ACM or thirty-five (35) cubic feet [one (1) cubic meter] of ACM off facility components where the length or area could not be measured previously. If any combination of linear, square or cubic feet is involved, the sum of the fractions must be used to determine the actual number of NESHAP units involved in the asbestos abatement project. The application fees are as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Any amendments to the Asbestos Abatement (Management) Plan which increase the scope of work into a higher fee category will be reassessed. The difference in the two fees shall be submitted to the Department in the form of a check made payable to General Treasurer, State of Rhode Island.
D.Any amendments to the Asbestos Abatement (Management) Plan which request additional waivers and/or variances under the provisions of § 1.16 of this Part will be assessed a flat fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Said fee shall be submitted to the Department in the form of a check made payable to General Treasurer, State of Rhode Island. However, said fee will be waived if the amendment(s) to the Asbestos Abatement (Management) Plan also include a request for an increase in the scope of work which would result in the fee difference in accordance with § 1.17.6(C) of this Part being assessed.
E.All other amendments to the Asbestos Abatement (Management) Plan, including those involving only minor changes that can receive Department approval over the telephone, will not be charged a fee.
F.Waiver and/or exemption of Asbestos Abatement (Management) Plan Fees: The application fee shall be waived for any Asbestos Abatement (Management) Plan which is eligible for loans or grants in accordance with the provisions of R.I. Gen. Laws § 23-24.5-19 and/or any rules or regulations promulgated by the Rhode Island Department of Administration pursuant to the authority conferred by R.I. Gen. Laws § 23-24.5-19. State agencies shall be exempt from application fees associated with the submittal of Asbestos Abatement (Management) Plans.
1.17.7Recordkeeping Requirements for AHERA Management Plans
All records required by 40 C.F.R. § 763.94 incorporated by reference at § 1.2(I) of this Part for school buildings subject to the AHERA regulations shall be maintained in a centralized location in the administrative office of both the school building and the Local Education Agency (LEA) and shall be considered a part of the AHERA management plan(s) for all such buildings. These records shall be maintained until their disposal is specifically authorized in writing by the Department unless a shorter retention period is specifically authorized by 40 C.F.R. § 763.94 incorporated by reference at § 1.2(I) of this Part for that type of record.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.18** Certification of Asbestos Abatement Training Courses {#sec-216-ricr-50-15-1-1.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.18}
1.18.1General Requirement
A.Training courses offered and conducted for the purpose of meeting the training requirements of this Part must be certified in accordance with § 1.18 of this Part. Applicants, in order to obtain certification for a training course, must submit an application which demonstrates compliance with the requirements of § 1.18 of this Part.
B.Notwithstanding the requirements of § 1.17.1(A) of this Part, initial or review training courses for Asbestos Inspectors, Asbestos Project Designers or Asbestos Management Planners that are currently certified by other jurisdictions in accordance with the EPA Model Accreditation Program (MAP) will be considered as having been certified in accordance with § 1.18 of this Part.
C.The criteria for successful completion of a required training course must include obtaining a passing score on the final course examination, unless the certified training course has been specifically authorized in writing by the Department to use an alternative method of determining successful completion.
D.The training provider shall notify the Department of all scheduled, canceled, and completed asbestos training courses within seven (7) days of scheduling and completion. When implemented, the use of the Department's electronic training reporting system constitutes compliance with these notification requirements.
1.18.2Application for Certification of Training Courses
A.An applicant for certification of any asbestos abatement training course shall submit the following information for Department review at least forty-five (45) days prior to the first scheduled course date:
1.The name and address of the person(s), consulting firm, union, trade association, governmental agency, educational institution or other entity which proposes to conduct the training course, background information about the course sponsors, the name of the responsible individual and his/her telephone number.
2.The type of course(s) for which certification is being requested.
3.A detailed outline of the course curriculum including the amount of time allotted to each topic, the name and training/qualifications of the individual(s) responsible for developing the instruction program for each topic and the name of the instructor(s) for each topic.
4.A description of the teaching methods to be used to present each topic including, where appropriate, lectures, discussions, demonstrations and audio-visual materials. When applicable, include the name, producer and date of production of audio-visual materials to be used.
5.Copies of written materials to be distributed. All materials submitted in conjunction with the application shall be typewritten or machine printed.
6.Evidence demonstrating that the applicant has employed or contracted as instructors, either on a full time or temporary basis, enough persons (a minimum of two) who meet the training and experience criteria contained in § 1.18.3 of this Part. Resumes describing special training and education and/or prior experience may be submitted for providing this evidence.
7.A list of the types, brand names and quantities of respirators to be used to demonstrate and fit test or flow test respirators.
8.A description of the type and quantity of protective clothing to be used during practice exercises and demonstrations.
9.A description of the materials to be used for hands-on practice exercises and demonstrations, including hand tools, ladders, plastic sheeting and other barrier construction supplies, negative air filtration units, water spray devices and decontamination facilities.
10.A detailed description of the site of the training course including address where demonstrations and hands-on practice exercises will be conducted.
11.Any restrictions on attendance (language, degree of literacy required, union or group association, etc.).
a.Oral final examinations are not permitted unless specifically requested by the applicant and authorized in writing by the Department. The applicant must specifically identify the circumstances under which an oral final examination will be used. If oral final examinations are to be given in a language other than English, the applicant must outline the procedure used to ensure the integrity of the examination process.
b.Only Initial and Annual Review courses for Asbestos Workers and Competent Persons may be presented in a foreign language. Where such foreign language courses are offered, the applicant must translate all the course materials into the foreign language and submit them to the Department. The applicant must certify to the Department that the translations have been adequately checked for accuracy and provide the qualifications of the person(s) making the translation.
c.Written final examinations must be administered in the same language in which the other course materials were presented.
d.Department approval of an English language Asbestos Worker Initial or Annual Review course does not constitute approval to offer that course in any other language. Each foreign language version of an Asbestos Worker Initial or Annual Review course must receive specific Department approval. Department approval to present Asbestos Worker Initial or Annual Review courses in a foreign language must be issued prior to its initial offering and will not be retroactive.
12.Instructor to student ratio for the hands-on practice exercises and demonstrations. Written justification must be submitted for student to instructor ratios greater than ten to one (10:1).
13.Copies of typical final examination questions/answers, including the typical number and distribution of questions among the various subject areas, as well as the minimum grade which must be obtained for a trainee to successfully complete the course. Final examinations for Asbestos Inspector, Asbestos Management Planner and Asbestos Worker training courses must consist of at least fifty (50) multiple choice questions. Final examinations for Asbestos Project Designer and Asbestos Contractor/Supervisor training courses must consist of at least one-hundred (100) multiple choice questions. Final examinations for all Annual Review and Competent Person training courses, as well as any other Department approved training course containing up to fourteen (14) instructional hours, must consist of at least fifteen to twenty-five (15-25) multiple choice questions, depending on the length of the training course. The minimum passing grade must be at least seventy percent (70%).
14.The Department shall be immediately notified in writing of any significant changes in any information submitted by the applicant. These changes may not be implemented until they have been approved by the Department.
15.Appropriate course content and duration, as defined by § 1.18.8 of this Part.
16.The mechanism(s) that the applicant will use to ensure that all prospective students have successfully completed the appropriate initial training course(s) before being allowed to enroll in the respective annual review course(s), and that all prospective students have successfully completed any prerequisites for an initial training course (e.g., Inspector initial training is required for Management Planner).
1.18.3Criteria for Instructors
A.To be eligible for certification of any training course, two (2) or more course instructors shall be employed. Enough instructors shall be hired to ensure that all the education and experience criteria for instructors set forth below are met:
1.An instructor shall have experience in both the design, field performance and evaluation of air monitoring programs and the design and implementation of respiratory protection programs.
2.To qualify to teach the sections of the course concerning the health effects of asbestos, a qualified health professional shall be employed.
3.To qualify to teach the sections of the course covering the hands-on practice sessions, an instructor shall be employed with experience as an asbestos contractor or experience as an on-site foreman or supervisor of asbestos workers. This person shall have had direct experience in all phases of asbestos abatement work including work area preparation, construction of barriers, the use of personal protective equipment, engineering controls, work practices, clean-up, disposal and decontamination.
4.An instructor shall have experience in designing, implementing and evaluating either employee educational programs in occupational health and safety or vocational educational programs.
1.18.4Recordkeeping Requirements
The training entity shall maintain documentation of each certified course offered which shall include as a minimum: type of course, date(s) and location(s) of course, class roster and results of any final examination/evaluation, as well as the unique certificate number, for each student enrolled. The training entity shall retain all required records for a period of at least ten (10) years and shall make this information available to the Department upon request.
1.18.5Suspension or Revocation of Certification
A.The Department may suspend or revoke any certification issued under § 1.18 of this Part for:
1.Submitting false information on an application;
2.Failure to comply with this Part;
3.Incompetence and/or negligence; or
4.Any good cause within the meaning and purpose of this Part or the Act.
1.18.6Asbestos Training Course Fees and Issuance/Renewal of Certificates
A.An application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) must accompany the application and shall be in the form of a check made payable to General Treasurer, State of Rhode Island. This fee is non-refundable and will not be returned if the application is denied or otherwise not approved by the Department.
B.Pursuant to the provisions of R.I. Gen. Laws § 23-24.5-14(c), the Department shall grant a certificate to an Asbestos Training Course which meets the certification requirements set forth in this Part, and upon submission of the certification fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Said certificate shall expire two (2) years from the date of issuance unless sooner suspended or revoked. Said certificate may be renewed every two (2) years in accordance with the provisions of § 1.18.7 of this Part and upon payment of the renewal application fee and the appropriate certification fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Amendments to Asbestos Training Courses will not be charged a fee.
D.Waiver of Asbestos Training Course Fees. The application and certification fees shall be waived for any Asbestos Training Course which is conducted by a Rhode Island state college or university and/or any agency of the State of Rhode Island or its political subdivisions.
1.18.7Renewal of Certification
A.Requests for renewal of certifications issued under § 1.18 of this Part must contain all the information requested by § 1.18.2 of this Part without reference to any previously submitted material.
B.In any case in which the responsible individual of a training course with complete certification, not less than 30 days prior to expiration of its existing complete certification, has filed an application in proper form for renewal, such existing complete certification shall not expire until final action on the application has been taken by the Department.
1.18.8Certified Training Courses - Types, Content and Duration
A.The initial training course for all Asbestos Workers and Asbestos Supervisors shall conform to the content specified by § 1.9.3(A) of this Part, shall consist of at least thirty-two (32) hours over a period of at least four (4) days. The course shall include a minimum of eight (8) hours conducting practice exercises which demonstrate that the participant can:
1.Properly perform all aspects of asbestos abatement work; and
2.Prevent unnecessary asbestos exposure to the general public and co-workers by properly constructing and maintaining temporary plastic barriers, by properly using respiratory protection, protective clothing and other protective equipment, and by using proper work area clean-up, decontamination and waste disposal techniques.
B.The additional training for all Asbestos Supervisors shall conform to the content specified by § 1.9.3(B) of this Part and shall consist of at least eight (8) hours of instruction.
C.The annual review course for all Asbestos Workers and Asbestos Supervisors shall consist of the one (1) day (at least eight (8) hours of instruction) training course specified by § 1.9.4 of this Part.
D.The initial training course for Competent Persons required by § 1.19.1 of this Part shall consist of at least sixteen (16) hours of instruction and must contain the material required by § 1.19.2(A) of this Part.
E.The initial training for all individuals providing Asbestos Inspection Services shall consist of a three (3) day (twenty-four (24) hours in duration) training course. Lectures, demonstrations and field exercise(s) shall provide, at a minimum, all of the information required for initial training of Inspectors by the EPA Model Accreditation Plan (40 C.F.R. Part 763, Subpart E, Appendix C, incorporated by reference at § 1.2(B) of this Part). The initial training course must also include specific training in the asbestos assessment protocol contained in § 1.22 of this Part.
F.The annual review course for all individuals providing Asbestos Inspection Services shall consist of the one-half (1/2) day (at least four (4) hours of instruction) training course which shall provide, at a minimum, an adequate review of the topics specified by § 1.18.8(E) of this Part, updated information on state-of-the-art procedures and equipment, and reviews of regulatory changes and interpretations. Specific topic coverage may be requested by the Department.
G.The initial training for all individuals providing Asbestos Project Designer Services shall consist of a three (3) day (twenty-four (24) hours in duration) training course. Lectures, demonstrations and field trip(s) shall provide, at a minimum, all of the material required for initial training of Abatement Project Designers by the EPA Model Accreditation Plan (40 C.F.R. 763, Subpart E, Appendix C, incorporated by reference at § 1.2(B) of this Part).
H.The annual review course for all individuals providing Asbestos Project Designer Services shall consist of the one (1) day (at least eight (8) hours of instruction) training course which shall provide, at a minimum, an adequate review of the topics specified by § 1.18.8(G) of this Part, updated information on state-of-the-art procedures and equipment, and reviews of regulatory changes and interpretations. Specific topic coverage may be requested by the Department.
I.The initial training for all individuals providing Asbestos Management Planner Services shall consist of both the three (3) day (twenty-four (24) hours in duration) training course for Asbestos Inspectors specified by § 1.18.8(E) of this Part and an additional two (2) day (sixteen (16) hours in duration) training course specifically for Asbestos Management Planners. This additional training course shall consist of lectures, demonstrations and field trip(s) and shall provide, at a minimum, all of the material required for initial training of Asbestos Management Planners by the EPA Model Accreditation Plan (40 C.F.R. Part 763, Subpart E, Appendix C, incorporated by reference at § 1.2(B) of this Part).
J.The annual review for all individuals providing Asbestos Management Planner Services shall consist of one half (1/2) day (at least four (4) hours of instruction) training course specifically for Asbestos Management Planners which shall provide, at a minimum, an adequate review of the topics specified by § 1.18.8(I) of this Part, updated information on state-of-the-art procedures and equipment, and reviews of regulatory changes and interpretations. Specific topic coverage may be requested by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.19** Certification of Competent Persons {#sec-216-ricr-50-15-1-1.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.19}
1.19.1General Requirement
A.Any designated public employee, designated public maintenance person, maintenance worker in the private sector, teacher and/or parent representative who desires to be certified as competent in the basic aspects of asbestos inspections and abatement process evaluations, as defined by the Act, or to perform spot repairs within the jurisdiction of the applicant's agency, municipality or building(s) must file an application with the Department which includes evidence of successful completion of a certified training course of at least sixteen (16) hours duration (exclusive of lunch and break times) as outlined in § 1.19.2 of this Part.
B.Maintenance personnel in the private sector, including but not limited to plumbers, electricians and oil burner repairmen, who perform asbestos abatement activities that are subject to this Part in conjunction with their primary profession must be certified as a Competent Person for Spot Repair in accordance with § 1.19.1(A) of this Part.
1.19.2Content of Competent Person Training Courses
A.The initial training course for Competent Person shall consists of at least sixteen (16) hours of instruction and shall provide, at a minimum, information on the following topics:
1.The training for maintenance and custodial employees required by 40 C.F.R. § 763.92(a)(1) and (a)(2) incorporated by reference at § 1.2(J) of this Part;
2.The requirements, procedures and standards established by this Part, particularly those sections dealing with spot repairs (§ 1.15 of this Part) and the inspection and evaluation criteria for asbestos in public buildings (§ 1.22 of this Part); and
3.At least four (4) hours of hands-on instruction in state-of-the-art spot repair techniques.
B.The yearly review course shall consist of at least eight (8) hours of instruction and shall provide, at a minimum, information on the following topics:
1.An adequate review of the topics outlined in § 1.19.2(A) of this Part;
2.Updated information on state-of-the-art procedures and equipment;
3.Reviews of regulatory changes and interpretations;
4.Specific topic coverage as requested by the Department; and
5.At least four (4) hours of hands-on instruction in state-of-the-art spot repair techniques.
C.Notwithstanding the requirements of § 1.19.2(B)(5) of this Part above, certified annual review courses may include a mechanism for trainees to demonstrate proficiency in the hands-on portion of said course, in lieu of repeating the four (4) hours of hands-on instruction.
D.Any annual review course that proposes to include the proficiency test provided for by § 1.19.2(C) of this Part must also submit a detailed description of how said proficiency test will be administered. This description shall include, as a minimum, the skills that will be evaluated, the types of evaluations that will be conducted, the name(s) and qualifications of the instructor(s) that will conduct the evaluation, the degree of proficiency that will be necessary to pass this evaluation, and additional training that will be required before a trainee can be retested after failing any portion of the evaluation.
1.19.3Suspension or Revocation of Competent Person Certification and/or Imposition of Civil Penalties
A.The Department may suspend or revoke any Competent Person certification issued under § 1.19 of this Part for:
1.Failure to maintain appropriate proficiency in the required areas.
2.Incompetence and/or negligence.
3.Submitting false information on an application.
4.Failure to comply with this Part; or
5.Any good cause within the meaning and purpose of this Part or the Act.
B.Civil Penalties
Any person certified only for spot repairs who undertakes any asbestos abatement project larger than the size limits for a Spot Repair as defined by this Part or who does not follow the work practices for Spot Repairs contained in § 1.15.2 of this Part shall be subject to a fine of no more than five hundred dollars ($500) per violation. This provision shall also be applicable to the employers of said persons.
1.19.4Expiration of Certification
A.Unless sooner revoked or suspended by the Department in accordance with the provisions of § 1.19.3 of this Part, certification as a Competent Person shall expire one (1) year from the date of the issuance of the certification.
B.Notwithstanding the requirements of § 1.19.4(A) of this Part, Competent Person certifications issued prior to 1 August 1990 shall expire on the date indicated on said certification. However, individuals holding said Competent Person certifications are subject to the annual review requirements contained in § 1.19.2(B) of this Part.
1.19.5 Renewal of Certification
Requests for renewal of certifications issued under § 1.19 of this Part must contain evidence that the applicant has successfully completed a certified annual review course, as described in § 1.19.2(B) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.20** Certification of Asbestos Analytical Services {#sec-216-ricr-50-15-1-1.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.20}
1.20.1General Requirement
Asbestos analytical services offered for meeting the requirements of this Part must be certified in accordance with § 1.20 of this Part. Applicants, to obtain certification for asbestos analytical services, must submit an application which demonstrates compliance with the requirements of § 1.20 of this Part.
1.20.2Application for Certification of Asbestos Analytical Services
A.An applicant for certification of any asbestos analytical service shall submit the following information for Department review:
1.The name, address and phone number of the facility and person in charge;
2.The names, duties and dates of employment of the personnel who will be performing and/ or certifying the asbestos analysis;
3.The type(s) of asbestos analysis for which the person is requesting certification;
4.For analysis of air samples: Evidence that the National Institute for Occupational Safety and Health (NIOSH) has rated the applicant's laboratory facility as "Proficient (P)" in the Proficiency Analytical Testing (PAT) program's most recent round for asbestos evaluation.
5.For analysis of bulk asbestos samples: Evidence that the applicant's laboratory facility is currently accredited for Polarized Light Microscopy (PLM) in the Asbestos Fiber Analysis Program administered by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology (NIST).
6.Evidence that any analyst who is proposed to certify results of asbestos analysis conducted by Phase Contrast Microscopy (PCM) and/or Polarized Light Microscopy (PLM) has successfully completed:
a.A formal course in PCM and/or PLM analysis of asbestos which is acceptable to the Department and conducted by a center recognized for training personnel to perform PCM and/or PLM analysis of asbestos; or
b.An in-house training program, acceptable to the Department, under the supervision of an individual who meets the requirements of § 1.20.2(A)(6)(a) of this Part.
7.A copy of the quality control procedures for asbestos analysis established by the applicant's laboratory. If the document is lengthy, a summary of the essential elements may be submitted.
8.For analysis of asbestos samples by Transmission Electron Microscopy (TEM): Evidence that the applicant's laboratory facility is currently accredited for TEM in the Asbestos Fiber Analysis Program administered by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology (NIST).
9.Evidence that any analyst who is proposed to certify results of asbestos analysis conducted by Transmission Electron Microscopy (TEM) has successfully completed:
a.A formal course in TEM analysis of asbestos which is acceptable to the Department and conducted by a center recognized for training personnel to perform TEM analysis of asbestos; or
b.An in-house training program, acceptable to the Department, under the supervision of an individual who meets the requirements of § 1.20.2(A)(9)(a) of this Part.
B.In addition to the requirements contained in § 1.20.2(A) of this Part, the person shall also submit:
1.Evidence of licensure as an analytical laboratory by the Rhode Island Department of Health, Division of Laboratories or, for facilities located outside of Rhode Island, evidence of licensure/certification by an equivalent state, county or municipal agency if said jurisdiction requires licensure/certification; and
2.Evidence that the facility has previous experience in successful asbestos analysis utilizing NIOSH Method 7400 (most current Revision), the EPA Interim Method for the Determination of Asbestos in Bulk Insulation Samples or alternative methods acceptable to the Department.
3.Evidence that the facility has previous experience in successful asbestos analysis utilizing the method contained in 40 C.F.R. Part 763, Subpart A, Appendix A incorporated by reference at § 1.2(B) of this Part or alternative methods acceptable to the Department. [Applicable only to facilities requesting certification for Transmission Electron Microscopy (TEM).]
1.20.3Suspension or Revocation of Laboratory Certification
A.The Department may suspend or revoke any laboratory certification issued under § 1.19 of this Part for:
1.Failure to maintain proficiency and/or accreditation in the required proficiency testing programs outlined in §§ 1.20.2(A)(4), (5), and/or (8) of this Part.
2.Submitting false information on an application.
3.Failure to comply with this Part.
4.Any good cause within the meaning and purpose of this Part or the Act; or
5.Failure to perform asbestos analysis in accordance with prevailing methods of practice.
1.20.4Asbestos Analytical Services Fees and Issuance/Renewal of Certificates
A.An application fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) must accompany the application and shall be in the form of a check made payable to General Treasurer, State of Rhode Island. This fee is non-refundable and will not be returned if the application is denied or otherwise not approved by the Department.
B.Pursuant to the provisions of R.I. Gen. Laws § 23-24.5-14(c), the Department shall grant a certificate to an Asbestos Analytical Service which meets the certification requirements set forth in this Part, and upon submission of the certification fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). All prospective analysts that meet Department training requirements will be included on this certification. Said certificate shall expire one (1) year from the date of issuance unless sooner suspended or revoked. Said certificate may be renewed each year in accordance with the provisions of § 1.20.5 of this Part and upon payment of the renewal application and certification fees as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
C.Amendments to Asbestos Analytical Service certificates will not be charged a fee.
1.20.5Renewal of Certification
Requests for renewal of certifications issued under § 1.20 of this Part must contain all the information requested by § 1.20.2 of this Part without reference to any previously submitted material.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.21** Certification of Consultants {#sec-216-ricr-50-15-1-1.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.21}
1.21.1General Requirement
Asbestos consultant services offered for meeting the requirements of this Part must be certified in accordance with § 1.21 of this Part. Applicants, to obtain certification for asbestos consultant services, must submit an application which demonstrates compliance with the requirements of § 1.21 of this Part.
1.21.2Certification of Consultants
A.Any individual requesting certification as an asbestos consultant must submit a completed application to the Department on forms provided by the Department. The application shall include all information required by the Act, this Part, as well as by the form and accompanying instructions. The appropriate fee(s) required in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) must also be submitted with the application.
B.In addition to the requirements contained in § 1.21.2(A) of this Part, the individual shall also submit evidence of competence in the activity being requested. The following are minimum criteria for establishing competence in the various activities:
1.Asbestos Inspection Services. Successful completion of a Department certified training course covering state-of-the-art techniques in Asbestos Inspection specified by § 1.18.8(E) of this Part.
2.Asbestos Project Designer Services. Successful completion of a Department certified training course covering state-of-the-art techniques in Asbestos Project Design specified by § 1.18.8(G) of this Part.
3.Asbestos Management Planner Services. Successful completion of a Department certified training course covering state-of-the-art techniques in Asbestos Management Planning specified by § 1.18.8(I) of this Part.
1.21.3Suspension or Revocation of Consultant Certification
A.The Department may suspend or revoke any consultant certification issued under § 1.21 of this Part for:
1.Failure to maintain appropriate proficiency in the required areas, including failure to successfully complete the annual training requirement specified by § 1.21.7 of this Part.
2.Incompetence and/or negligence.
3.Submitting false information on an application.
4.Failure to discharge activities in accordance with statutory and regulatory provisions contained in this Part.
5.Failure to discharge activities in a manner consistent with prevailing standards of practice; or
6. Any good cause within the meaning and purpose of this Part or the Act.
1.21.4Asbestos Consultant Fees and Issuance/Renewal of Certificates
A.Pursuant to the provisions of R.I. Gen. Laws § 23-24.5-14(c), the Department shall grant a certificate to an Asbestos Consultant who meets the certification requirements set forth in this Part, and upon submission of the certification fee(s) as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), made payable by check to the General Treasurer, State of Rhode Island. Said certificate shall expire one (1) year from the date of issuance unless sooner suspended or revoked. Said certificate may be renewed each year in accordance with the provisions of § 1.21.5 of this Part, upon documentation of compliance with the requirements of § 1.21.7 of this Part, and upon payment of the renewal certification fees as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title), made payable by check to the General Treasurer, State of Rhode Island.
B.Waiver of Asbestos Consultant Fees. Full time employees of a Local Education Agency (LEA) that maintain Asbestos Inspector or Asbestos Management Planner certificates solely because of requirements contained in the AHERA regulations may receive a waiver of application and certification fees under the following conditions:
1.Each LEA will be limited to three (3) fee waivers for Asbestos Consultant certificates during any twelve (12) consecutive month period. An application for certification as an Asbestos Inspector, Asbestos Management Planner, or Asbestos Project Designer shall be considered as separate fee waivers.
2.The applicant's initial or renewal application must be accompanied by a written statement from the LEA Superintendent (or equivalent official) that said applicant's assigned duties require possession of the specified certificate(s).
3.The certificate(s) will limit authorized activities to those buildings owned by, or under the direct control of, the LEA, and will terminate before the stated expiration date if the certificate holder is no longer a full-time employee of the LEA.
C.Amendments to Asbestos Consultant certificates will not be charged a fee.
1.21.5Renewal of Certification
Requests for renewal of certifications issued under § 1.21 of this Part must contain all the information requested by § 1.21.2 of this Part without reference to any previously submitted material. All applications for renewal of certification must also include documentation of compliance with the provisions of § 1.21.7 of this Part regarding successful completion of required annual review training.
1.21.6Assessment Criteria
Inspection Services certified under § 1.21 of this part shall use the assessment criteria established by § 1.22 of this Part unless the Service is authorized by the Department, in writing, to utilize other assessment criteria.
1.21.7Annual Training Requirement
A.Consultants certified in accordance with § 1.21 of this Part must successfully complete the annual training requirements specified below:
1.An individual certified for Asbestos Inspection Services must successfully complete the certified annual review course specified by § 1.18.8(F) of this Part.
2.An individual certified for Asbestos Project Designer Services must successfully complete the certified annual review course required by § 1.18.8(H) of this Part.
3.An individual certified for Asbestos Management Planner Services must successfully complete the certified annual review course required by § 1.18.8(J) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.22** Hazard Assessment Criteria {#sec-216-ricr-50-15-1-1.22 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.22}
1.22.1Inspection of Buildings
A.General Requirement. Inspections of buildings for making the following determinations shall be conducted in accordance with the requirements contained in § 1.22 of this Part: the asbestos content of materials; conducting information surveys for asbestos containing materials.
B.Establishing the Asbestos. Content of Materials Bulk sampling of materials suspected of containing asbestos shall be conducted in accordance with the procedures contained in § 1.23 of this Part. Analysis of bulk samples shall be performed by a laboratory certified in accordance with § 1.20 of this Part.
C.Conducting Information. Surveys for Asbestos Containing Materials Asbestos inspections for schools subject to the AHERA regulations shall be in accordance with 40 C.F.R. § 763.85 incorporated by reference at § 1.2(K) of this Part and 763.86 incorporated by reference at § 1.2(L) of this Part. In all other cases, information to be collected for the evaluation of asbestos hazards in buildings shall be conducted on forms required by the Department.
D.Determining the Degree of Hazard Posed by Asbestos Containing Materials. The degree of hazard posed by asbestos containing materials in school buildings subject to the AHERA regulations shall be evaluated in accordance with 40 C.F.R. § 763.88 incorporated by reference at § 1.2(M) of this Part. In all other cases, the degree of hazard posed by asbestos containing materials in buildings shall be evaluated using the following algorithm:
1.Range or Extent of Material Condition Deterioration/Damage.
a.None: Score 0
b.Moderate/Small Area: Score 2
c.Moderate/Large Area: Score 3
d.Severe/Small Area: Score 4
e.Severe/Large Area: Score 5
f.For the purposes of §§ 1.22.1(D)(1)(b) through (e) of this Part:
(1)Moderate means any uncovered pipe and/or delamination, crack, etc. in a surface that is basically intact.
(2)Severe means obvious deterioration or physical separation that is not easily repaired.
(3)Small Area means any area less than or equal to ten (10) liner feet for pipes or twenty-five (25) square feet for surfaces other than pipes.
(4)Large Area means any area greater than ten (10) liner feet for pipes or twenty-five (25) square feet for surfaces other than pipes.
2.Material Condition Rating.
a.Water Damage:
(1)None: Score 0
(2)Damage over Small Area or No Damage but with flat roof immediately overhead: Score 1
(3)Damage over Small Area with flat roof immediately overhead or Damage to Large area regardless of roof type: Score 2
b.Exposed Surface Area
(1)Not exposed (i.e. located above suspended ceiling and/or not visible without removing panels or ceiling sections: Score 0
(2)10% or less of the material is exposed: Score 1
(3)10%-100% of the material is exposed: Score 4
3.Accessibility.
a.Not accessible: Score 0
b.Low (access requires removal of temporary barrier such as drop-ceiling: Score 1
c.Low-Moderate (accessible only with devices or equipment not common to the area: Score 2
d.Moderate (accessible only with devices or equipment common to the area: Score 3
e.High (accessible with no additional devices or equipment: Score 4
4.Activity and Movement.
a.None or Low (sedentary activities only): Score 0
b.Moderate (ordinary movement, more walking than sitting): Score 1
c.High (elevated levels of physical activity such as running, jumping, or manual labor): Score 2
5.Air Plenum or Direct Air Stream.
a.None: Score 0
b.Present: Score 1
6.Friability.
a.Not Friable: Score .1
b.Potentially Friable (difficult but possible to damage by hand and/or material that has been properly encapsulated or enclosed): Score 1
c.Moderately Friable (easy to dislodge and crush): Score 2
d.Highly Friable (fluffy, spongy, or flaking and/or pieces hanging and/or falls apart when touched): Score 3
7.Asbestos Content.
a.Trace to <1%: Score 0
b.1% to 50%: Score 2
c.50% to 100%: Score 3
8.Occupancy and Use.
a.Low Priority Buildings: Score 0
b.Low Priority Areas: Score 0
c.Restricted Use Areas: Score 0
d.High Priority Areas of Intermediate Priority Buildings: Score 8
e.High Priority Areas of High Priority Buildings: Score 12
9.Total Degree of Hazard shall equal the sum of the scores for §§ 1.22.1(D)(1) through (5) of this Part, multiplied by the score for § 1.22.1(D)(6) of this Part, multiplied by the score for § 1.22.1(D)(7) of this Part, plus the score for § 1.22.1(D)(8) of this Part.
10.Notwithstanding the requirements of §§ 1.22.1(C) and 1.22.1(D) of this Part, assessments of schools shall also be conducted in accordance with § 1.22.1(D) of this Part for determining eligibility for funding in accordance with R.I. Gen. Laws § 23-24.5-19 and regulations adopted thereunder.
1.22.2Development of Asbestos Abatement Remedies
A.General Requirement
1.Areas of buildings receiving a score greater than zero from the hazard assessment conducted in accordance with § 1.22.1(D) of this Part will require some type of asbestos abatement (management) plan. This asbestos abatement plan must be developed by the building owner in accordance with § 1.17 of this Part and submitted for Department review.
2.Decisions regarding the abatement remedies that may be proposed to the Department as part of an asbestos abatement plan are the responsibility of the building owner. These strategies may range from simple operations and maintenance plans to complete removal. The remedies proposed in the asbestos abatement plan will be governed by the nature and extent of the hazards that have been identified, as reflected by the numerical score determined in accordance with § 1.22.1(D) of this Part. The acceptability of proposed abatement remedies will be reviewed by the Department during the plan approval process in accordance with § 1.17 of this Part.
1.22.3Reinspection of Schools and School Buildings
General Requirement. All schools and school buildings, as defined by the AHERA regulations, must have all friable and nonfriable known or assumed ACM reinspected at least once every three (3) years in accordance with 40 C.F.R. § 763.85(b) incorporated by reference at § 1.2(K) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.23** Sampling Protocol for Hazard Assessment {#sec-216-ricr-50-15-1-1.23 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.23}
A.Number of Samples. Samples of suspect asbestos containing materials must be taken for laboratory analysis. The number of samples to be taken is dependent upon the type of material to be sampled.
1.Friable or Potentially Friable Surfacing Material A consultant certified for Asbestos Inspection Services in accordance with § 1.21.2(B)(2) of this Part or a Competent Person certified in accordance with § 1.19 of this Part shall collect bulk samples, in a statistically random manner that is representative of each homogeneous area, as follows:
a.At least three (3) bulk samples from each homogeneous area that is one thousand (1000) square feet or less, except as provided in §§ 1.23(A)(1)(d) and (e) of this Part.
b.At least five (5) bulk samples from each homogeneous area that is greater than one thousand (1000) square feet but less than five thousand (5000) square feet, except as provided in §§ 1.23(A)(1)(d) and (e) of this Part.
c.At least seven (7) bulk samples from each homogeneous area that is greater than five thousand (5000) square feet, except as provided in §§ 1.23(A)(1)(d) and (e) of this Part.
d.A homogeneous area shall be determined to contain ACM based on a finding that the results of at least one (1) sample collected from that area shows that asbestos is present in an amount greater than one percent (1%).
e.A homogeneous area is considered not to contain ACM only if the results of all samples required to be collected from that area show asbestos in amounts of one percent (1%) or less.
2.Thermal System Insulation. A consultant certified for Asbestos Inspection Services in accordance with § 1.21.2(B)(2) of this Part or a Competent Person certified in accordance with § 1.19 of this Part shall collect bulk samples, in a statistically random manner that is representative of each homogeneous area, as follows:
a.At least three (3) bulk samples from each homogeneous area that is damaged, except as provided in §§ 1.23(A)(1)(d) and (e) of this Part.
b.At least one (1) bulk sample from each homogeneous area of patched thermal system insulation if the patched section is less than six (6) linear or square feet, except as provided in in §§ 1.23(A)(1)(d) and (e) of this Part.
c.In a manner sufficient to determine whether the material is ACM or not ACM, collect bulk samples from each insulated mechanical system where cement is used on tees, elbows or valves, except as provided in §§ 1.23(A)(1)(d) and (e) of this Part.
3.Miscellaneous and Non-Friable Material
A consultant certified for Asbestos Inspection Services in accordance with § 1.21(B)(2) of this Part or a Competent Person certified in accordance with § 1.19 of this Part shall collect bulk samples from each homogeneous area in a manner sufficient to determine whether the material is ACM or not ACM, except as provided in in §§ 1.23(A)(1)(d) and (e) of this Part.
4.Homogeneous Areas Assumed to Contain ACM
Notwithstanding the requirements of §§ 1.23(A)(1), (2), and (3) of this Part above, any homogeneous area that is assumed to be ACM in accordance with 40 C.F.R. §§ 763.85(a)(4)(iii) and (iv) incorporated by reference at § 1.2(K) of this Part does not have to be sampled if the remaining elements of the assessment required by 40 C.F.R. § 763.85(a)(4)(v) incorporated by reference at § 1.2(K) of this Part and/or § 1.22 of this Part are completed.
B.Sampling Procedures
1.Materials
a.Clean, dry small jar (35 mm film canister or small, wide-mouthed glass jar) with screw-on lid
b.Knife (optional)
c.Core borer (optional)
d.Half-face cartridge respirator with two screw-in canisters; NIOSH approval number TC-23C-153 (Mine Safety Appliance chemical cartridge: approved for organic volatiles, chlorine, sulfur dioxide and hydrogen chloride; with dust, fume, mist (high efficiency) filter.
2.Sampling Methods
a.The material should be sampled when the area is not in use.
b.Only those persons needed for sampling should be present.
c.The sampler should wear an approved respirator.
d.The material to be sampled should be lightly misted with water to minimize fiber release.
e.Gently twist the open end of the container into the material, penetrating the depth of the material until material falls into the container. Use a knife or core borer to take the sample of cementitious materials and then empty the material into the container.
f.Close the container tightly and wipe off the exterior with a damp cloth. Tape the lid to prevent accidental opening during shipment or handling.
g.Label the sample container with a unique identification number, the name of the building, initials of the person who sampled, and the date of sample collection.
h.Make a record of each sample by noting the date the sample was taken, location of material sampled (including room or area), and the sample ID number.
i.Wet mop or wipe-up with a wet cloth any material which may have fallen on the floor.
j.Spray the area sampled with a clear shellac, varnish or similar material to minimize the potential for fiber release.
k.Clean the knife or core borer, if used, with water.
l.Submit samples to a laboratory certified by the Department to analyze asbestos.
m.Request that results be reported as type and percent asbestos by a method capable of determining asbestos content with a minimum detection level of 1% by weight.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-50-15-1 § 1.24** NESHAP Requirements {#sec-216-ricr-50-15-1-1.24 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-1#1.24}
Federal facilities and such other persons who are not otherwise subject to these regulations shall comply with EPA's NESHAP requirements, 40 C.F.R. § 61, Subpart M incorporated by reference at § 1.2(N) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Technical Revision — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2019-01-01 to 01/01/2019*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-50-15-2** Radon Control
##### **216-RICR-50-15-2 § 2.1** Authority {#sec-216-ricr-50-15-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-61-4(8) and 23-61-7(b), and are established for the purpose of protection of human health and prevention of exposure to elevated concentrations of radon.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.2** Applicability {#sec-216-ricr-50-15-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.2}
These regulations provide for the detection of radon and radon progeny hazards in buildings, for the safe mitigation of those hazards, and for the licensing and/or certification of the persons who engage in radon activities.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.3** Definitions, General Provisions, and Radon Standards {#sec-216-ricr-50-15-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.3}
2.3.1 Definitions
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-61, entitled Radon Control.
2."Alpha track detector" means a passive radon testing device which performs time-integrated measurement.
3."Back-drafting" means a condition where normal upward movement of combustion products is reversed.
4."Charcoal adsorption device" means one of several variously configured containers filled with a measured amount of activated charcoal and used to measure radon.
5.“Child care facility” means a facility which accommodates five (5) or more children of any age who are not related and is licensed by the Department of Children, Youth, & Families or the Department of Education.
6.“Continuous radon monitor” means an active radon detection device which uses an electronic detector to accumulate and store information related to the periodic measurement of average radon concentration.
7.“Department” means the Rhode Island Department of Health (RIDOH).
8.“Diagnostic tests” means tests performed or procedures used to determine appropriate radon mitigation methods.
9.“Director” means the director of the Rhode Island Department of Health.
10.“Electret Ion Chamber” means a passive measurement device consisting of a canister containing a charged electret.
11.“EPA” means the United States Environmental Protection Agency.
12.“Follow-up testing” means a test in which the radon testing device is exposed for a minimum of ten (10) days but not longer than one year.
13.“High priority building” means any public building or public, private, and/or parochial school (Grades pre-K to 12), and/or child care facility.
14.“HVAC” means heating, ventilation and air conditioning system.
15.“OSHA” means the Occupational Safety and Health Administration of the United States Department of Labor.
16.“Owner” means the person having legal title to property and/or buildings. For purposes of publicly owned property only, the owner shall be defined as the chief executive officer of the state or municipal agency which owns, leases or controls the use of the property.
17.“Person” means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, and other state or political subdivision or agency thereof, and any legal successor, representative, agent or agency of the foregoing.
18.“Picocurie per liter (pCi/L)” means a unit of measurement of the concentration of radioactivity in a gas which equals 2.22 disintegrations per minute of radioactive material per liter. One picocurie is equivalent to 10 to the minus 12 (10-12) of a curie.
19.“Public building” means any building owned, managed, leased, furnished, or occupied by a state or municipal agency or commission, or public school.
20.“Radon” means the radioactive noble gas radon 222.
21.“Radon analytical service” means any person engaged in the reading or analysis of radon testing devices.
22.“Radon testing business” means any person engaged in radon testing for a fee, whose employees test for radon or radon progeny.
23.“Radon inspector” means an individual who performs radon or radon progeny testing, provides professional advice on such testing, health risks, radon related exposure, radon entry routes, and other radon related consulting activities.
24.“Radon contractor” means a person who engages in radon mitigation as a business, whose employees install systems to mitigate radon or radon progeny contamination.
25.“Radon supervisor” means an individual who evaluates diagnostic tests to determine appropriate radon or radon progeny mitigation strategies, designs and supervises the installation of mitigation systems. This individual will be named on the radon contractor's license.
26.“Radon worker” means an individual who helps install radon or radon progeny mitigation systems.
27.“Radon progeny” means the short lived radionuclides formed as a result of the decay of radon 222, including polonium 218, bismuth 214, lead 214, and polonium 214.
28.“Radon/radon progeny mitigation” means any actions or measures taken and any materials or equipment installed to reduce levels of radon gas and/or radon progeny in the air or water supply of a building, or to prevent entry of radon or radon progeny into the indoor atmosphere.
29.“Radon training course” means a course that provides instruction in radon testing or mitigation techniques.
30.“RCP” means the EPA National Radon Contractor Proficiency Program.
31.“RMP” means the EPA National Radon Measurement Proficiency Program.
32.“Short-term testing” means a test in which a radon testing device is exposed for a minimum of forty-eight (48) hours in closed conditions up to a maximum of ninety (90) days.
33.“Working Level (WL)” means the concentration of short lived radon progeny in the air that will result in 130,000 million electron volts (1.3 x 105 MeV) of potential alpha particle energy per liter of air.
2.3.2General Provisions
A.Variance Procedures.
1.The Department may grant a variance either upon its own motion or upon the request of the applicant from the provisions of any rule or regulation herein, if it finds, in specific cases, that a literal enforcement of such provisions will result in unnecessary hardship to the applicant. A variance shall not be granted if it is contrary to the public interest and/or health and safety of the public. The provisions of this section shall not be applicable to the requirements of §§ 2.7 through 2.14 of this Part pertaining to licensing and certification.
2.A request for a variance shall be filed by the applicant in writing, setting forth in detail the basis upon which the request is made. Within sixty (60) days after filing, the Department shall notify the applicant as to whether the request has been approved or denied. In the case of a denial, a hearing date, time and place may be scheduled if the applicant appeals the denial.
B.Rules Governing Practices and Procedures.
1.All hearings and reviews required under the provisions of R.I. Gen. Laws Chapter 23-61, shall be held in accordance with the provisions of the rules and regulations governing Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
2.3.3Radon Standards
Air Standard. The indoor air standard for naturally occurring radon gas or radon progeny in buildings covered by this Part shall be less than 4 pCi/L (0.02 WL) as an annual average.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.4** Testing of Radon in Air in High Priority Buildings {#sec-216-ricr-50-15-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.4}
2.4.1Purpose and Scope.
A.Testing protocols for radon in air are designed:
1.To identify structures in which the potential exists for elevated radon concentrations;
2.When elevated concentrations are found, to specify follow-up testing procedures to determine the level of occupant exposure; and
3.When elevated concentrations are verified using follow-up testing procedures, to initiate appropriate remediation activities.
2.4.2Buildings Requiring Radon Testing.
All public and high priority buildings, as defined in § 2.3.1 of this Part, must be tested for radon or radon progeny by a certified radon inspector according to the procedures, schedules and protocols contained in this section.
2.4.3Initial Testing of Public and High Priority Buildings.
A.It is the responsibility of the owner of a public or high priority building or buildings to:
1.Submit a radon testing schedule to the Department, identifying each building and the dates of initial short-term radon testing scheduled for each building. Testing schedules shall be designed to ensure that child occupied buildings are completed first.
2.Complete all initial short-term testing within three (3) years after the effective date of this Part.
3.Report all short-term test results to the Department within thirty (30) days of receipt of results.
4.Retest any area which has initial short-term test results of 4 pCi/L (0.02 WL) or greater, using follow-up testing requirements as described in § 2.4.9 of this Part.
2.4.4Periodic Retesting of Public and High Priority Buildings.
Ten (10) percent of the first floor and below ground areas of the building must be retested three (3) years after the initial testing and every three (3) years thereafter. A different ten (10) percent of the first floor and below ground areas of the building must be tested every three (3) years. However, whenever a short-term test result in a room or other area of a building is 4 pCi/L (0.02 WL) or higher, that area must be included in subsequent periodic retesting.
2.4.5Acceptable Radon Testing Methods.
Only those testing methods (devices) which have been determined to be acceptable by the EPA under the National Radon Measurement Proficiency Program and by the Department shall be acceptable for determining compliance with these regulations.
2.4.6Placement of Testing Devices.
A.Testing device locations are to be determined after an analysis of the building.
B.The location of all short-term and follow-up testing shall be noted on a floor plan of the building.
C.Each habitable room on ground level and below, with the exception of rest rooms, closets, or shower areas, shall be tested in the initial test.
D.In rooms greater than two thousand (2,000) square feet, at least one (1) test shall be taken for each two thousand (2,000) square feet, or portion thereof, of habitable floor space.
E.Duplicate tests shall be taken in ten percent (10%) of the testing device locations.
F.For each twenty (20) devices, one (1) additional testing device shall be opened, immediately resealed for the remainder of the exposure period, and processed with the other exposed testing devices to be utilized as a field blank.
G.Testing devices must remain undisturbed during the test period or the reading shall be declared invalid and a new test shall be taken.
H.Testing devices must be placed as follows:
1.Between two and six (2 and 6) feet above the floor;
2.A minimum of one and one-half (1.5) feet from any wall;
3. Away from room corners, windows, drafts, direct sunlight, and any device that emits heat or moisture;
4.In areas of normal air supply;
5.Where the device shall not be blocked or covered during the testing period.
2.4.7Ventilation Requirements.
A.The HVAC system shall be operated, for the entire testing period, in the normal heating, cooling, or ventilation cycle required for the building and the time of year.
B.The operation of the HVAC system during the testing period shall be documented.
2.4.8Short-term Testing Requirements.
A. For short-term testing:
1.The building to be tested shall be left closed at least twelve (12) hours prior to and during the entire testing period. Routine entrances and exits are allowed.
2.The testing devices shall be left in place for a minimum of forty-eight (48) hours.
B.Short-term tests shall not be conducted when severe storms, high winds, heavy rainfalls, or rapid barometric changes are predicted.
C.Short-term tests in any public and high priority buildings, as defined in § 2.3.1 of this Part, shall be conducted during the months of October through March excluding weekends and holidays.
2.4.9Follow-up Testing Requirements.
A.Short-term test results greater than or equal to 4 pCi/L (0.02 WL) but less than 20 pCi/L (0.1 WL) require the following steps to be taken:
1.Begin follow-up testing within three (3) months after receiving the short-term results.
2.Expose the testing device for a minimum of one hundred and twenty (120) days and no more than one (1) year.
B.Short-term test results greater than or equal to 20 pCi/L (0.1 WL) but less than 100pCi/L (0.5 WL) require the following steps to be taken:
1.Begin follow-up testing within twenty (20) calendar days after receiving the short-term results.
2.Expose the testing device for a minimum of thirty (30) days but no longer than ninety (90) days.
C.Short-term test results greater than 100 pCi/L (0.5 WL) require the following steps to be taken:
1.Begin follow-up testing within ten (10) calendar days after receiving the short-term results.
2.Expose the testing device for a minimum of ten (10) days but no longer than forty-five (45) days.
3.After the testing period is complete, increase the amount of ventilation to the room until test results are available. If levels are found to be above normal, continue the increased ventilation until permanent steps are taken to reduce the level.
D.During follow-up testing, windows and doors shall be operated as usual for the building and the time of year.
E.Follow-up testing in school buildings must be conducted during the occupied portion of the school year, but may include both weekends and holidays, other than summer vacation.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.5** Mitigation Requirements and Protocols for Public and High Priority Buildings {#sec-216-ricr-50-15-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.5}
2.5.1Mitigation Requirements and Schedule.
A.Any area of a public or high priority building having an annual average level of radon in excess of or equal to 4 pCi/L (0.02 WL), measured according to the follow-up testing specifications in § 2.4.9 of this Part, must be mitigated to a level below 4 pCi/L (0.02 WL).
B.Mitigation systems installations shall be completed according to the following schedule:
1.Within one (1) year for results greater than or equal to 4 pCi/L (0.02 WL) but less than 20 pCi/L (0.1 WL).
2.Within six (6) months for results greater than or equal to 20 pCi/L (0.1 WL) but less than 100 pCi/L (0. WL).
3.Within sixty (60) days for results greater than or equal to 100 pCi/L (0.5 WL).
C.Mitigation systems shall be installed by a licensed radon contractor.
2.5.2Mitigation System Requirements.
A.Licensed radon contractors shall follow standardized mitigation procedures contained in the applicable American National Standards Institute (ANSI) documents, referenced as follows:
1.“Radon Mitigation Standards for Schools and Large Buildings” (RMS-LB 2014).
2.“Protocols for Measuring Radon and Radon Decay Products in School and Large Buildings” (MALB 2014).
3.“Protocol for Conducting Radon and Radon Decay Product Measurements in Multifamily Buildings” (RMS-MF 2014).
4.“Radon Mitigation Standards for Multifamily Buildings” (RMS-MF 2014).
5.“Protocols for Measuring Radon and Radon Decay Products in Homes” (MAH 2014)
6.“Standard Practice for Mitigation Systems in Existing Low-Rise Residential Buildings” (ASTM E2121-12)
7.“Standard: Reducing Radon in New Construction of 1 & 2 Family Dwellings and Townhouses” (CCAH-2013)
B.Radon reduction systems shall be clearly labeled with the following information:
1.Identification as a radon mitigation system.
2.Name, address, telephone number, and license number of the contractor.
3.Date of installation.
C.All active radon reduction systems shall be designed to run continuously.
D.Licensed radon contractors shall test for back-drafting to ensure that all combustion systems have sufficient air supply.
2.5.3Post Mitigation Requirements.
A.After installation of a mitigation system, testing shall be repeated in all mitigated rooms or areas, using the guidelines for initial short-term testing as identified in §§ 2.4.3 through 2.4.8 of this Part.
B.Post mitigation tests shall be taken by a certified radon testing business that is not subject to the radon contractor's control or supervision.
C.The building owner shall ensure that all post mitigation test results are submitted to the Department within thirty (30) days of any mitigation system installation.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.6** Recordkeeping and Reporting Requirements for Public and High Priority Buildings {#sec-216-ricr-50-15-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.6}
2.6.1Recordkeeping Requirements
A.The building owner shall maintain the following records until disposal is authorized in writing by the Department.
1.Schedule for initial short-term testing.
2.Annotated floor plan of each building tested showing short and follow-up testing locations.
3.Documentation of all radon tests taken.
4.A list of any and all mitigation systems installed.
2.6.2Reporting Requirements
A.The building owner shall provide the following records to the Department:
1.Results of all radon tests shall be submitted in writing within 30 days of receipt.
2.Results equal to or greater than 100 pCi/L (0.5 WL) shall be reported to the Department and by phone within two (2) business days and by certified mail within five (5) business days.
3.Plans for follow-up testing of any area with a short-term test result greater than or equal to 4 pCi/L (0.02 WL), including:
a.Areas that will be tested
b.Date that testing will be initiated
c.Duration of the test
4.Plans for response to follow-up test results that are greater or equal to 4 pCi/L (0.02 WL), as specified in § 2.5 of this Part.
5.Documentation of installation of mitigation systems
B.Public, private, and parochial schools (Grades Pre-K to 12), and child care facilities shall notify the families of all students attending that facility of a radon test result greater than or equal to 4 pCi/L (0.02 WL) within 30 days of receipt of that result using language supplied by the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.7** General Licensing and Certification Requirements {#sec-216-ricr-50-15-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.7}
2.7.1Application Requirements.
A.No person may measure or analyze for radon or conduct associated radon mitigation activities in Rhode Island unless such person has been licensed and/or certified as provided by this Part. This Part in no way exempts any person from other state and local occupational licensure and/or certification requirements.
B.An applicant seeking licensing and/or certification for radon testing or mitigation services within the state of Rhode Island shall:
1.Complete the appropriate application form, available from the Department.
2.Submit the application, supporting credentials, and the appropriate licensing and/or certification fee, as identified in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) to the Department of Health, Radon Control Program, 3 Capitol Hill, Room 206, Providence, RI 02908-5097. Analytical services and training courses include an additional assessment based on the amount of services or courses offered.
2.7.2Application Exemptions.
A.The license and/or certification requirements of this Part shall not apply to:
1.Those individuals testing or mitigating a private residence owned or leased by the individual who is performing the testing or mitigation.
2.Any individual testing their own living area.
3.Those persons who sell or offer radon testing devices, such as charcoal canisters, for sale at a retail outlet and do not manage the testing process or perform radon mitigation services.
2.7.3Approval of Application.
A.The requested license and/or certification shall be approved after the applicant:
1.Submits a complete and accurate application;
2.Submits the required application fee, as identified in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title);
3.Provides evidence of qualifications for the licensure and/or certification being sought; and
4.If licensed and/or certified in another state, produces evidence that his/her status is in good standing.
B.The Department may at any time after filing of the original application require further information to aid in making a determination.
C.A license and/or certification shall be valid for up to one year following the date of issuance. No radon testing or mitigation activity shall be conducted after the expiration date of the license and/or certification.
D.A replacement certificate, license, and/or picture identification (ID) may be obtained by submitting a written request and a fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) to the Department.
2.7.4Denial of Application.
The Department may deny an application if requirements established by the Act and/or by this Part have not been met. The applicant may request a hearing in accordance with the provisions of R.I. Gen. Laws Chapter 42-35.
2.7.5Renewal of License and/or Certification.
A.The renewal application must be completed on the appropriate form and submitted with the appropriate fee, as identified in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
B.Renewal will be approved or denied in accordance with the provisions of §§ 2.7.3 and 2.7.4 of this Part, respectively.
C.The current license or certification will remain valid for the period of time necessary for a final determination on a renewal application that has been filed thirty (30) days or more before the expiration of the current license.
2.7.6Suspension or Revocation of License or Certification.
A.Pursuant to the provisions of R.I. Gen. Laws Chapter 23-61, the Department may suspend or revoke any license and/or certification for good cause. Good cause shall be deemed to include but not limited to:
1. Performance of radon related activities for which s/he is not licensed and/or certified.
2. Failure to carry on person a current picture ID, issued by the Department, at all times while performing any radon-related function.
3. Failure to report any changes in the information provided in the original or renewal application to the Department, including changes in licensed and/or certified personnel, in writing and within ten (10) business days of the change.
4. Failure to allow authorized representatives of the Department to have access during normal business hours to facilities, offices, and files for inspection and examination of radon-related records and test procedures.
5. Failure to allow authorized representatives of the Department to observe and inspect on-site radon related testing or mitigation activities, with approval of the property owner, occupant, or other authorized person.
6. Failure to conduct all radon-related activities in accordance with provisions of this Part and other applicable municipal, county, state and federal regulations.
7.Failure to comply with the reporting requirements in § 2.7.7 of this Part.
8. Failure to comply in any way with the Act or this Part.
2.7.7Reporting Requirements
A.The certified radon testing business shall submit all radon and radon progeny test results for public and high priority buildings to the Department. The results from the previous quarter shall be submitted within thirty (30) days of the last day of each quarter on the appropriate reporting form, which is available from the Department.
B.The certified radon testing business shall submit all radon and radon progeny test results for testing other than public and high priority buildings to the Department. The results from the previous quarter shall be submitted within thirty (30) days of the last day of each quarter on the appropriate reporting form, which is available from the Department. The information and results on this form will only be used for the tracking of testing.
C.The certified radon testing business or the licensed radon contractor shall report radon and radon progeny test results to the client within thirty (30) days of receiving said results.
D.Any client who is informed of the results of radon testing must also be informed of the name and the certification number of the person who took the measurements and the certified radon analytical service that performed the analysis.
E.Radon test results shall be reported in picocuries per liter; radon progeny test results shall be reported in working levels.
F.The report provided to the client shall include the following statement:
1.This notice is provided to you by an organization or individual licensed and/or certified by the Department to perform radon or radon progeny testing or radon mitigation services. Any questions, comments, or complaints regarding the person performing these testing or mitigation services may be directed to the Rhode Island Department of Health, Radon Control Program, 3 Capitol Hill, Room 206, Providence, RI 02908-5097.
G.Results equal to or greater than 100 pCi/L (0.5 WL) shall be reported to the Department and the client by phone within two (2) business days and by certified mail within five (5) business days. The client should also be advised to contact the Department’s Radon Control Program.
H.A licensed radon contractor shall submit a report to the Department on all mitigation work completed during the previous quarter. Reports shall be submitted within thirty (30) days of the last day of each quarter on the appropriate reporting form, which is available from the Department.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.8** Requirements for Radon Contractors {#sec-216-ricr-50-15-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.8}
2.8.1Licensing Requirements.
In addition to the general licensing requirements in § 2.7 of this Part, all applicants for a radon mitigation license must identify the licensed radon supervisor(s) to be utilized.
2.8.2Performance Requirements.
A.In addition to the general requirements for all applicants listed in § 2.7 of this Part, the radon contractor must:
1.Maintain a licensed radon supervisor on staff. In the event of the resignation or termination of said specialist, notify the Department in writing within five (5) business days and refrain from engaging in any radon mitigation activities until another specialist is hired.
2.Ensure that radon mitigation system installations are performed by a licensed radon supervisor or licensed radon worker(s) under the direct supervision of the specialist.
3.Subcontract only those portions of the mitigation project which involve the pouring of concrete slabs, plumbing, and electrical work.
4.Provide to the client, in writing:
a.All warranties regarding radon level reductions and proper functioning of mitigation equipment. The precise coverage shall be explicitly stated in the contract offered to the client, and all warranties offered must be honored.
b.All instructions regarding the operation and maintenance of each component of the mitigation system.
c. An estimate of approximate added energy costs.
5.Ensure that all mitigation work complies with these regulations, R.I. Gen. Laws Chapter 23-27.3, and local building codes.
2.8.3Recordkeeping.
A.The following records shall be maintained by the radon mitigation contractor until the Department authorizes disposition and shall be made available to the Department upon request:
1. Records of all mitigation work performed, which shall include:
a.Address of mitigation.
b.Initial short-term test results.
c.Any follow-up test results.
d.Diagnostic test results if taken.
e.A description of each mitigation system.
f.Post-mitigation test results, if known, that include testing method.
g.All pertinent dates.
2.All instrument calibrations and warranted equipment installations.
3.Copies of the licenses for all radon supervisor(s) and radon worker(s) employed.
2.8.4Notification.
A. The radon contractor shall ensure that the Department receives notification of the initiation of mitigation work on the appropriate form at least three (3) business days in advance of beginning any mitigation project. The radon contractor shall also notify the Department by telephone on the date that the project begins.
B. The radon contractor shall ensure that the Department receives notification in writing at least one (1) business day in advance of any changes in the project.
2.8.5Employee Health and Safety.
A.To ensure the continued health and safety of all radon mitigation employees, the radon contractor shall:
1.Develop and adhere to a health and safety program which:
a.Complies with all OSHA standards pertinent to health and safety.
b.Complies with the OSHA Ionizing Radiation standard (29 C.F.R. § 1910.1096).
2. Make this program available to all employees and to any federal, state, or local regulatory agencies.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.9** Requirements for Radon Testing Businesses {#sec-216-ricr-50-15-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.9}
2.9.1Certification Requirements.
In addition to the general licensing requirements in § 2.7 of this Part, all applicants for a radon testing business certification must identify the certified radon inspector(s) to be utilized.
2.9.2Performance Requirements.
A.In addition to the general requirements for all applicants, as listed in § 2.7 of this Part, the owners of a radon testing business must:
1.Maintain the services of a certified radon inspector. In the event of the resignation or termination of said consultant, the business must notify the Department in writing within seven (7) days and refrain from engaging in any radon testing activities until obtaining the services of another certified radon inspector.
2.Ensure that all radon and radon progeny testing, including the placement and retrieval of all testing devices, is performed by certified radon inspectors.
3.Develop and adhere to a quality assurance and quality control plan for each service and technique provided.
4.Use only radon testing methods and protocols that have been determined acceptable by the EPA's National Radon Measurement Proficiency Program and the RIDOH. The Department must be notified in five (5) business days of any change in the type of device being used.
5.Identify all analytical services to be used. These services must be listed by this agency as a radon analytical service for the testing device(s) analyzed.
2.9.3Recordkeeping.
A.The following records shall be maintained until the Department authorizes disposition and shall be made available to the Department upon request:
1.All tests taken, which shall include:
a.Address of test(s).
b.Initial short-term test and retest results.
c.Follow-up test results.
d.Diagnostic test results.
e.Post-mitigation test results that include the testing method.
f.Name and certification number of person making the test(s).
g.Name of the certified radon analytical service used.
h.All pertinent dates.
2.All instrument calibrations.
3.Copies of the certifications for all radon inspectors employed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.10** Requirements for Radon Supervisors {#sec-216-ricr-50-15-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.10}
2.10.1Licensing and Training Requirements.
A.In addition to the general requirements for all applicants, as listed in § 2.7 of this Part, the applicant for the position of radon supervisor must:
1.Successfully complete a course that is approved by the EPA and the Department.
2.License renewal applications must also include documentation regarding successful completion of a required biennial review course that is approved by the Department.
3. Provide documentation of passing the EPA radon mitigation proficiency (RCP) examination.
2.10.2Performance Requirements.
A.A person who performs radon mitigation activities for which licensing is required shall either be licensed as a radon contractor or be employed by a licensed radon contractor prior to performing any radon mitigation services.
B.Radon supervisor services must be performed under the auspices of a licensed radon contractor. A specialist may be listed on more than one radon contractor's license and may also qualify as a licensed radon worker for other contractors.
C.All radon supervisors shall maintain a listing in the EPA Radon Contractor Proficiency Program (RCP).
D.A radon supervisor shall notify the Department of termination of services from a contractor within five (5) business days.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.11** Requirements for Radon Inspectors {#sec-216-ricr-50-15-2-2.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.11}
2.11.1Certification and Training Requirements.
A.In addition to the general requirements for all applicants, as listed in § 2.7 of this Part, the applicant for the position of radon inspector must:
1.Successfully complete a course that is approved by the Department.
2.Certification renewal applications must also include documentation regarding successful completion of a required biennial review course that is approved by the Department.
3.Provide documentation of passing the EPA radon measurement proficiency (RMP) examination.
2.11.2Performance Requirements.
A.A person who performs radon testing activities for which certification is required shall either own a certified radon testing business or be employed by a certified radon testing business prior to performing radon testing services.
B.Radon inspector services must be performed under the auspices of a certified radon testing business. A consultant may be listed with more than one radon testing business.
C.All radon inspectors shall maintain a listing in the EPA Radon Measurement Proficiency Program (RMP).
D.The consultant for a radon testing business shall:
1.Perform test(s).
2.Provide signed quarterly reports to the Department.
3.Notify clients of radon levels, in accordance with the provisions of these regulations.
4.Assess quality assurance and quality control measures.
5.Evaluate operating procedures and ensure compliance with state and federal regulations.
E.A radon inspector shall notify the Department of termination of services from a testing business within seven (7) days.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.12** Requirements for Radon Workers {#sec-216-ricr-50-15-2-2.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.12}
2.12.1Licensing and Training Requirements.
In addition to the general requirements for all applicants, as listed in § 2.7 of this Part, the applicant for the position of radon worker must successfully complete a Department-approved course for radon workers or other equivalent training (4 hours) given by a licensed supervisor which must include instruction on radon testing, mitigation installation techniques, worker safety, and radon health effects.
2.12.2Performance Requirements.
A.Radon worker services must be performed under the on-site supervision of a licensed supervisor.
B.The applicant must also receive a biennial review of radon mitigation techniques and instruction on new technology and industry practices given by the licensed supervisor.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.13** Requirements for Radon Analytical Services {#sec-216-ricr-50-15-2-2.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.13}
2.13.1Certification Requirements.
A.In addition to the general requirements for all applicants, as listed in § 2.7 of this Part, the applicant for a radon analytical service must:
1.Provide documentation of successful completion of the EPA Radon Measurement Proficiency Program (RMP) for each primary testing device for which certification is desired.
2. Identify all personnel performing analysis or readings.
3.Provide the Department with a copy of the quality assurance and quality control procedures for each radon testing method established by the applicant.
4.Provide evidence of licensure as an analytical laboratory by the RIDOH in accordance with R.I. Gen. Laws Chapter 23-16.2 entitled "Laboratories" for the following methods:
a.Alpha Track Detectors
b.Charcoal Adsorption Devices
c.Charcoal Liquid Scintillation Devices
d.Continuous Radon Monitors
e.Electret Ion Chambers
2.13.2Performance Requirements.
A.Radon analytical services must maintain a listing in the EPA Radon Measurement Proficiency Program (RMP) for each primary testing device for which certification is requested.
B.Analytical services certified in accordance with this Part must comply with any other applicable state and local licensing and/or certification requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
##### **216-RICR-50-15-2 § 2.14** Requirements for Radon Training Courses {#sec-216-ricr-50-15-2-2.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-2#2.14}
2.14.1Certification Requirements.
A.In addition to the general requirements for all applicants, as listed in § 2.7 of this Part, the applicant for certification of a radon training course must:
1.Submit the application for a radon training course to the Department for review at least forty-five (45) days before the course is scheduled to begin.
2.Submit copies of the course curriculum, training materials, and qualifications of the proposed instructors to the Department.
3.Obtain certification for each of the following courses that the applicant plans to offer:
a.Initial Radon Supervisor - 32 hours
b.Initial Radon Inspector - 16 hours
c.Initial Radon Worker - 4 hours
d.Radon Supervisor Biennial Review - 8 hours
e.Radon Inspector Biennial Review - 8 hours
B.Radon contractor courses must be approved by the EPA and the Department. All other courses must be approved by the Department and meet the requirements of this Part.
C.The Department shall utilize EPA guidelines to evaluate the training course.
D.Certification will be valid for one (1) year following the date of issuance. Approval for course material shall be granted for a period of two (2) years unless the requirements for course approval are not met.
2.14.2 Performance Requirements.
A.The course provider shall:
1.Update the subject matter as necessary to conform to all currently accepted techniques and protocols.
2.Any proposed changes in course materials or instructors shall be reported in writing to the Department at least fifteen (15) business days and must be approved prior to implementation of the change(s).
3.Allow authorized representatives of the Department to observe and evaluate training sessions, instructors, and course materials.
4.Provide the course participants with an opportunity to evaluate, in writing, all aspects of the course including:
a.Instructor;
b.Teaching methods;
c.Course content; and
d.Facilities.
5.Results of this evaluation shall be available for Department inspection for five (5) years after course completion.
6.Provide each participant with a written verification of successful course completion which shall include:
a.Name of participant.
b.Title and date of course.
c.Name, address, and phone number of course provider.
d.Name and signature(s) of course instructor(s)
2.14.3Recordkeeping.
A.The course provider shall:
1.Maintain attendance records.
2.Maintain documentation of each certified course given and shall include as a minimum:
a.The type of course;
b.The date(s) and location(s) of course;
c.The class roster.
3.Retain all records for a minimum of five (5) years.
2.14.4Notifications.
A.The course provider shall:
1.Submit the date(s) and locations of all training courses to be received by the Department in writing at least seven (7) days prior to start of course.
2.Submit a roster of course participants to the Department on the appropriate form within thirty (30) days after course completion.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-01-01 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 01/01/2019*
- *Amendment — effective from 2007-06-19 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 06/19/2007*
#### **216-RICR-50-15-3** Lead Poisoning Prevention
##### **216-RICR-50-15-3 § 3.1** Authority and Purpose {#sec-216-ricr-50-15-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.1}
3.1.1Authority
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapter 23-1, 23-24.6, and 42-128.1, and 40 C.F.R Part 745 for the purpose of establishing a comprehensive program to protect public health by reducing exposure to environmental lead and preventing childhood lead poisoning.
B.In 1999, the United States Environmental Protection Agency (EPA) delegated authority to the Department to enforce the provisions of the Federal Lead-Based Paint Program (40 C.F.R. Part 745). In 2010, EPA delegated authority to the Department to enforce the provisions of the Federal Lead Renovation, Repair, and Painting Program (40 C.F.R. Part 745 Subpart E).
C.The following Regulations also provide procedures related to this Part:
1.Rules and Regulations Pertaining to the Fee Structure for Licensing Laboratory and Administrative Services provided by the Department of Health (Part 10-05-2 of this Title);
2.Rules and Regulations Pertaining to Reporting of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title);
3.Rules and Regulations for Certifying Analytical Laboratories (Part 60-05-5 of this Title);
4.Rules and Regulations for Clinical Laboratories and Stations (Part 60-05-4 of this Title);
5.Rules and Regulations Pertaining to Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title); and
6.Rules and Regulations Relating to Equal Access to Justice (Part 10-05-3 of this Title).
7.Lead Training, Certification, and Licensing (Part 11 of this Subchapter)
8.Lead Inspections, Testing Methods and Standards (Part 5 of this Subchapter)
9.Lead Safe Work Practices (Part 12 of this Subchapter)
10.Rules and Regulations Governing Lead Hazard Mitigation (860-RICR-00-00-2).
3.1.2Purpose
A.The purpose of this Part is to:
1.Implement and enforce requirements of the Act and R.I. Gen. Laws Chapters 42-128.1, Lead Poisoning Prevention Act of 1991 and Rhode Island Housing Resources Act of 1998.
2.Implement and enforce federally delegated provisions, responsibilities, and requirements of the US Environmental Protection Agency (EPA) in § 3.1.1(B) of this Part;
3.Protect the public health and public interest by establishing Rules and Regulations to minimize public, occupant, and worker exposure to environmental lead and prevent childhood lead poisoning; and
4.Establish programs for screening children under the age of six (6) who are at risk for lead poisoning;
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.2** Applicability {#sec-216-ricr-50-15-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.2}
3.2.1Regulated Persons
A.The following persons are subject to this Part:
1.Medical Providers
a.Primary care physicians, pediatricians, or other health care providers licensed in Rhode Island;
b.Primary care physicians, pediatricians, or other health care providers of children residing in Rhode Island;
c.Rhode Island health care facilities, including but not limited to, hospitals, clinics and health maintenance organizations;
d.Health care programs funded in whole or in part with State funds or administered by any State agency and having child health components, including, but not limited to: Special Supplemental Food Program for Women, Infants & Children (WIC); Preventive Pediatric Services Program; Medicaid; General Public Assistance; and RIte Care.
2.Administrators of Schools and Child Care Facilities
a.Public and private kindergartens, preschools, early childhood education programs, child day care centers, or other child care programs shall require written verification of compliance with the blood lead screening requirements in this Section as a condition for initial enrollment.
b.The written verification must be completed by the child's health care provider, or other individual who conducted the screening, on forms approved by the Department.
c.The blood lead screening requirements in § 3.4 of this Part do not apply if a child’s parent signs a sworn statement indicating that blood lead screening is contrary to his or her religious tenets and practices.
3.Sellers and Lessors
a.The following persons are subject to the real estate notification and disclosure requirements in § 3.8 of this Part:
(1)All persons who sell or lease target housing;
(2)All persons who act as an agent for a seller or lessor of target housing; and
(3)Mortgagees selling target housing through a foreclosure process.
4.Exemptions to Real Estate Notification and Disclosure
a.Sellers, lessors, and their agents are exempt from the real estate notification and disclosure requirements in § 3.5 of this Part for the following transactions:
(1)Sales and leases of any residential dwelling constructed after January 1, 1978;
(2)Sales and leases of any residential premises which meet the lead-safe standards in § 5.8 of this Subchapter, provided that a Certification of Lead-Free Status or Full Lead-Safe Certificate (Form PBLC-21) is provided to the purchaser(s) or lessee(s), as applicable;
(3)Renewals of existing leases in which the lessor has previously complied with all requirements of this Section, if proof of disclosure is retained for at least three (3) years or the term of tenancy, whichever period is longer;
(4)Sales and leases of zero (0) bedroom dwelling units or housing for the elderly or persons with disabilities in which no child resides; and
(5)Short-term leases of one hundred (100) days or less where no lease renewal or extension can occur.
5.Property Owners and Managers
a.The following persons are subject to the owner responsibilities in § 3.2.4 of this Part:
(1)Owners of target housing;
(2)Owners of regulated facilities; and
(3)Owners in receipt of any notice or order from the Department.
6.Persons who offer or conduct any activity in Rhode Island that will disturb lead-based paint for any reason at a regulated facility or for compensation at target housing require a license and/or certification, as applicable, in accordance with §§ 11.4 and 11.5 or 11.6 of this Subchapter, as applicable.
7.Persons who offer or conduct blood lead analysis and/or environmental lead analysis require a certification, license, and/or approval from the Department in accordance with § 11.9 of this Subchapter, as applicable.
8.Persons who advertise to provide any regulated activities in Rhode Island shall include their applicable Department license number in all advertisements for that work.
3.2.2Regulated Facilities
A.The following facilities are subject to the requirements of this Part:
1.Residential Facilities
a.Non-exempt pre-1978 residential rental units, including single-family dwellings, multi-family dwelling units and common areas, whether occupied or vacant;
b.Pre-1978 owner-occupied dwelling units, including single-family dwellings, multi-family dwelling units and common areas, in which a child resides or is expected to reside;
c.Any pre-1978 foster home where a foster child resides or is expected to reside;
d.Any other pre-1978 property in which a child resides or is expected to reside; or
e.Any pre-1978 building or part of a building being converted into target housing.
2.Child Care Facilities
a.Family child care homes;
b.Group family child care homes;
c.Child day care centers;
d.Nursery schools, preschools, and kindergarten classrooms; and
e.Any pre-1978 building or part of a building being converted into child care facilities.
3.Exemptions
a.Housing for the elderly or persons with disabilities provided that no child resides in such dwellings; and
b.Zero (0) bedroom dwelling units in which no child resides.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.3** Definitions {#sec-216-ricr-50-15-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.3}
A.Whenever used in this Part, the following terms must be construed as follows:
1.“Act” means R.I. Gen. Laws Chapter 23-24.6 entitled "Lead Poisoning Prevention.”
2.“Agent” means any person authorized, in writing or otherwise, by an owner to act on behalf of or represent the interests of the owner. For purposes of § 3.5 of this Part, an agent is any designated client representative, transaction facilitator, transaction coordinator, or dual facilitator as defined by R.I. Gen. Laws § 5-20.6-2 who enters into a contract with a seller or lessor with the objective of selling or leasing real estate, but does not include designated client representative for the buyer.
3.“Approved” means approved by the Department, State, or local authority having legal and administrative authority for such.
4.“Cease work order” means an order issued by a State Inspector to immediately stop regulated activities, being conducted in violation of this Part, until the violator can demonstrate their ability to comply with the Department.
5.“Child” or “children” means, for the purposes of this Part, any individual younger than six (6) years of age.
6.“Child care facility” means any building and/or area whose primary purpose is or will be to educate or care for children younger than six (6) years of age, including, but not limited to, child day care centers, nursery schools, preschools, kindergarten classrooms, public and private elementary schools. Child care facilities located in public or commercial buildings encompass only those common areas that are routinely used by children, such as restrooms and cafeterias. Common areas that children only pass through, such as hallways, staircases, and garages are not included. The child care center also encompasses the exterior sides of the building that are immediately adjacent to the child care center and the exterior common areas or play areas routinely used by children.
7.“Child day care” means daily care and/or supervision offered commercially to the public for any part of a twenty-four (24) hour day to children away from their homes.
8.“Child day care center” means any person, firm, corporation, association, or agency who, on a regular or irregular basis, receives any child under the age of sixteen (16) years, for the purpose of care and/or supervision, not in a home or residence, apart from the child’s parent for any part of a twenty-four (24) hour day irrespective of compensation or reward. It shall include childcare programs that are offered to employees at the worksite. It does not include nursery schools or other programs of educational services subject to approval by the commissioner of elementary and secondary education.
9.“Childhood lead poisoning” means, for the purposes of this Part, a confirmed blood lead level equal to or greater than five micrograms per deciliter (5 µg/dL).
10.“Common area(s)” means a portion of a residential property that is available for shared use by occupants of more than one (1) dwelling unit, such as hallways, stairways, lobbies, community rooms, recreational rooms, laundry rooms, garages, playgrounds, and boundary fences; in general, any area not kept locked.
11.“Department” means the Rhode Island Department of Health.
12.“Director” means the Director of the Rhode Island Department of Health or his/her designee.
13.“Dwelling” means an enclosed space which is wholly or partly used or intended to be used for living or sleeping by human occupants as defined in R.I. Gen. Laws § 23-24.6-4 (5).
14.“Dwelling unit” means any room or group of rooms located within a dwelling and forming a single habitable unit with facilities which are used or intended to be used for living, sleeping, cooking, and eating as defined in R.I. Gen. Laws § 23-24.6-4 (6). For the purposes of this Part, a dwelling unit includes all relative interior and exterior common areas including soil.
15.“Environmental lead” means, for the purposes of this Part, inorganic lead contained in paint, dust, soil, and/or water.
16.“EPA” means the United States Environmental Protection Agency.
17.“Expected to reside” means actual knowledge that a child will occupy a single-family house or dwelling unit within the next twelve (12) months for fourteen (14) or more consecutive or nonconsecutive days per year. If a resident woman is known to be pregnant, there is actual knowledge that a child will reside in her dwelling unit.
18.“Foster home” means placement of a child in temporary custody or custody of DCYF in a foster family home or in a private or public child care facility which is licensed by the State. (See R.I. Gen. Laws § 40-11-12.1(h))
19."Family child care home" means a licensed residence where the resident can provide child care for up to six (6) children, or up to eight (8) children with an assistant approved by the Department of Human Services.
20.“Group family child care home” means a residence where the resident can provide child care for eight (8) to twelve (12) children with one (1) or two (2) approved assistants (dependent on enrollment details).
21.“Housing for the elderly or persons with disabilities” means retirement communities and other housing reserved for households composed of one (1) or more persons sixty-two (62) years of age or older, or other age if recognized as elderly by a specific federal housing assistance program, or persons with disabilities, and is owned, managed by, or for which the rent is subsidized or paid by a Federal, State or local government housing agency.
22.“HUD” means the United States Department of Housing and Urban Development.
23.“Immediate Compliance Order” means an order issued by the Director to immediately stop specified activities which pose a threat to the health or safety of children, occupants, workers, or the public.
24.“Interim controls” means a set of measures designed to temporarily reduce human exposure to lead hazards, including specialized cleaning, repairs, maintenance, painting, non-permanent encapsulation or enclosure, and ongoing monitoring of lead-based paint or potential lead hazards, and the establishment and operation of management and resident education programs.
25.“Lead assessor” means a person, either authorized to act as an enforcing officer under the housing code or a designated employee of a Federal, State or municipal agency with jurisdiction over housing, occupational health, child welfare and/or environmental standards who successfully completed a Lead Assessor training course and obtained a license, pursuant to Part 11 of this Subchapter, to conduct lead inspections.
26.“Lead-based paint” means any paint or other surface coating that contains lead in excess of the Lead-Safe thresholds specified in § 5.8 of this Subchapter.
27.“Lead contractor” means, as defined by R.I. Gen. Laws § 23-24.6-4, any person or entity engage in lead hazard reduction as a business that includes consultants who design, perform, oversee, or evaluate lead hazard reduction projects undertaken pursuant to the requirements of this chapter.
28.“Lead hazard control” or “LHC” means any window replacement and/or interim controls intended to correct lead hazards identified in a lead inspection report or standard treatments to remove lead-based paint and/or minimize lead exposure, which may include measures to reduce the concentration of lead in paint, dust, soil, and/or water using approved treatment methods specified in this Part.
29.“Lead hazard mitigation” or “LHM” means spot removal or minor repair and maintenance activities by a property owner or designated person in a residential rental unit intended to correct lead hazards, which may include measures to reduce friction or stabilize paint using approved treatments and work methods specified in this Part.
30.“Lead hazard reduction” or “LHR” means, as defined by R.I. Gen. Laws § 23-24.6-4, any action or actions designed to reduce exposure to toxic levels of lead which impose an unacceptable risk of exposure in any dwelling or dwelling unit where a child under the age of six (6) years with environmental intervention blood lead levels or greater resides, or on any premises and may include, but is not limited to: repair, enclosure, encapsulation, or removal of lead based paint and/or lead contaminated dust, soil or drinking water relocation of occupants; and cleanup measure or ongoing maintenance measures which may include, activities and/or measures that do not present an undue risk to children under age six (6). See “Lead Contractor.”
31.“Lead inspector” means an individual, who successfully completed a certified Lead Inspector training course, passed the Lead Inspector State examination, completed a supervised field apprenticeship, and obtained a license, pursuant to Part 11 of this Subchapter, to conduct lead inspections.
32.“Lead professional” means an occupational grouping of individuals and organizations licensed or certified pursuant to Part 11 of this Subchapter.
33.“Lead renovation firm” means any person or organization engaged in renovation, repair, and painting (RRP) or lead hazard control (LHC) as a business and licensed pursuant to Part 11 of this Subchapter.
34.“Lead renovator” means an individual who successfully completed a certified Lead Renovator training course and obtained a valid training certificate, pursuant to Part 11 of this Subchapter, to perform renovation, repair, and painting (RRP) and lead hazard control (LHC) work.
35.“Lead safe” means, as defined by R.I. Gen. Laws § 23-24.6-4, that a dwelling, dwelling unit, or premises has undergone sufficient lead hazard reduction to ensure that no significant environmental lead hazard is present and includes but is not limited to covering and encapsulation.
36.“Lead-safe standard” means lead in paint, dust, soil and water below the Lead-Safe thresholds in § 5.8 of this Subchapter or intact paint and covered soil above the lead safe thresholds in § 5.8 of this Subchapter.
37.“Lead screening” means a method for identifying an asymptomatic child at high risk of having childhood lead poisoning from a population of children not previously diagnosed as having lead poisoning or in a child not exhibiting signs or symptoms believed to be related to lead poisoning, including the obtaining of the necessary specimen(s) for a blood lead screening test, and specimen handling and preparation.
38.“Lease” means any agreement, written or oral, between a lessor and lessee concerning the rent, use and occupancy of a residential dwelling, dwelling unit, or premises subject to the provisions of the Residential Landlord and Tenant Act (R.I. Gen. Laws Chapter 34-18).
39.“Lessee” means a person named as the renter in a rental agreement or occupancy agreement for a single-family house, dwelling unit, or premises. See “Occupant” and “Tenant.”
40.“Lessor” means any person who offers to rent, lease, or sublease a single-family house, dwelling unit, or premises.
41.“License” means an authorization granted by the Department to engage in a business or occupation that is subject to regulation by the Department. For the purposes of this Part, a registration, certification, permit or similar authorization issued by the Department is also considered to be a license.
42.“Lis pendens” means "suit pending” in Latin. Lis pendens is taken as constructive notice of a pending lawsuit or an existing unsettled Department enforcement action and it serves to place a cloud on the title of the property in question until the enforcement action or suit is resolved and/or the lis pendens is released.
43.“Mechanical paint removal” means the use of any mechanical force to remove paint from a surface, including, but not limited to, electrical or other power equipment or abrasive blasting.
44.“Minor repair and maintenance” means work activities, including minor heating, ventilation, and air conditioning (HVAC) work, electrical work, or plumbing work that disturbs less than six square feet (6 ft2) of lead-based paint per room for interior activities or less than twenty square feet (20 ft2) of lead based-paint for exterior activities where none of the work practices prohibited or restricted by this Part are used and where the work does not involve window replacement or demolition of painted surfaces. For the purposes of this Part, the term minor repair and maintenance shall be synonymous with spot removal. See “Spot removal.”
45.“Mortgagee” means a person or entity, usually a bank or financial institution, who is the party to a mortgage who makes a loan and holds mortgaged property as security for repayment of the loan. A mortgagee is not considered an owner unless such person has taken full legal title through foreclosure, deed in lieu of foreclosure, or otherwise.
46.“Noncompliance” or “nonconformance” or “failure to comply” or “violation” means any act or failure to act which constitutes or results in or from:
a.Engaging in any activity prohibited by, or not in compliance with, any law administered by the Director or any Rule, Regulation, notice, license, certification, consent agreement or order adopted pursuant to the Director's authority;
b.Engaging in any business or other activity without a necessary permit, license, certification, or approval that is required by law or Regulation; and/or
c.The failure to perform, or the failure to perform in a timely fashion, anything required by a law administered by the Director or by a Rule, Regulation, notice, license, certification, consent agreement or order adopted and/or issued pursuant to the Director's authority.
47.“Notice of violation” means a legal notice issued by the Department to an owner of a property where a Department-initiated lead inspection identified lead hazards. A Notice of Violation requires corrective action, pursuant to Part 8 of this Subchapter.
48.“Occupant” means, as defined by R.I. Gen. Laws § 23-24.6-4, any person who legally resides in, or regularly uses, a dwelling, dwelling unit, or structure; provided, however, that a guest of any age shall not be considered an occupant for the purposes of this Part. See “Lessee” and “Tenant.”
49.“Order” means the whole or a part of an action, finding, declaration or disposition by the Department, whether affirmative, negative, injunctive or declaratory in form, other than rulemaking but including notices of violation, orders to correct, compliance orders, permits, certifications, licenses, and approvals issued pursuant to the Director's authority.
50.“OSHA” means the United States Occupational Safety and Health Administration.
51.“Owner” means as defined by R.I. Gen. Laws § 23-24.6-4, any person who, alone or jointly or severally with others:
a.Shall have legal title to any dwelling or dwelling unit with or without accompanying actual possession of it; or
b.Shall have charge, care, or control of any dwelling or dwelling unit as owner or agent of the owner or an executor, administrator, trustee, or guardian of the estate of the owner. Any person representing the actual owner shall be bound to comply with the provisions of this Chapter and with Rules and Regulations adopted pursuant to this Chapter to the same extent as if that person were the owner. An agent of the owner excludes real estate and property management functions where the agent is only responsible for the property management and does not have authority to fund capital and/or major property rehabilitation on behalf of the owner.
c.For purposes of publicly owned property only, the owner shall be defined to be the Chief Executive Officer of the municipal or State agency which owns, leases or controls the use of the property.
52.“Paint” means any substance applied to a surface as a surface coating, including, but not limited to, household paints, varnishes and stains.
53.“Painted surface” means a component surface covered in whole or in part with paint or other surface coatings.
54.“Painted surface to be disturbed” means a painted surface that is to be stripped, scraped, sanded, cut, penetrated or otherwise affected by renovation or rehabilitation work in a manner that could potentially create a lead hazard by generating dust, fumes, or paint chips.
55.“Person” means any individual, partnership, firm, corporation, association, or organization, including municipal and State agencies.
56.“Premises” means, as defined by R.I. Gen. Laws § 23-24.6-4, a platted lot or part thereof or unplatted lot or parcel of land, occupied by a dwelling or structure and includes any building, accessory structure or other structure thereon which is or will be frequently used by children under the age of six (6) years.
57.“Purchaser” means any person who purchases or enters into a contractual agreement to gain legal title to a dwelling, condominium, or residential premises.
58.“Real estate” means any property consisting of land and the buildings on it.
59.“Renovation, repair, and painting” or “RRP” means activities being done by a Lead Renovation Firm typically performed at the option of the property owner for aesthetic or other reasons, or as an interim control to minimize lead hazards. RRP is not designed to permanently eliminate lead-based paint. Since RRP projects can disturb lead-based paint in homes and buildings built before 1978, thus creating new lead hazards, individual renovators must be trained and certified, use lead-safe work practices, and firms must be licensed. Any additional work which disturbs lead-based paint, other than emergency renovation operations, performed in the same room or area within the same thirty (30) day period must be considered the same RRP project for the purpose of determining whether the work is spot removal or renovation, repair, and painting (RRP).
60.“Residential dwelling” means a building containing one (1) or more residential dwelling units.
61.“Second notice of violation” or “2nd NOV” means a legal notice issued by the Department to an owner who did not meet the requirements of the (first) Notice of Violation. The Department shall post the Second Notice of Violation at the property and record it as a lis pendens with the Recorder of Deeds in the city/town where the property is located. See “Notice of Violation.”
62.“Seller” means any person who has the authority to transfer legal title to real estate.
63.“Spot removal or de minimis” means minor repair and maintenance activities, which do not involve window replacement, interior mechanical paint removal, or demolition of painted surface areas, and disturb less than six square feet (6 ft2) of interior lead-based paint per room or less than twenty square feet (20 ft2) of exterior lead-based paint, and provided that no prohibited work practices are used. When removing painted components, or portions of painted components the entire surface area removed is the amount of lead-based paint being disturbed. Any additional work which disturbs lead-based paint, performed in the same room or area within the same thirty (30) day period of an RRP project must be considered the same RRP project and not spot removal.
64.“State inspector” means the Director, his or her designee, or any inspector employed by the Department who is authorized by the director to conduct comprehensive environmental lead inspections and/or other inspections for the Department.
65.“Target housing” means any pre-1978 residential dwelling, except housing for the elderly or persons with disabilities or zero (0) bedroom units in which no child resides.
66.“Temporary lead hazard control measures” means a set of measures designed to temporarily reduce human exposure or likely exposure to lead hazards, including but not limited to, specialized cleaning, temporary containment (e.g. plastic sheeting and/or duct tape), ongoing monitoring, and the establishment and operation of lead management and resident education programs.
67.“Tenant” means any person, other than the owner, who enters into an agreement to rent, lease, or sublease a single-family house, dwelling unit, or premises. See “Lessee or Occupant.”
68.“Zero-bedroom dwelling unit” means any residential dwelling unit in which the living area is not separated from the sleeping area, including, but not limited to, efficiencies, studio apartments, dormitory or single room occupancy housing, and military barracks.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.4** Childhood Lead Poisoning Screening {#sec-216-ricr-50-15-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.4}
3.4.1General Requirements
A.Health care providers shall ensure that childhood lead poisoning screening is conducted either by venipuncture or by capillary blood lead sampling in accordance with the following requirements:
1.Screening Schedule
Rhode Island children shall be screened for lead poisoning at least twice, at least twelve (12) months apart, and before the age of thirty-six (36) months. For additional information on screening for lead poisoning see the Screening and Referral Guidelines on the Department’s website.
2.Screening Samples
a.All blood lead screening and blood lead confirmatory samples submitted to the Department’s laboratory for analysis must be accompanied by a completed laboratory requisition form, including all data necessary for reimbursement by health insurers, and must be packaged in accordance with procedures established by the Department’s laboratory.
b.All blood lead screening samples must be submitted to the Department’s laboratory for analysis, unless the Department has approved the use of another laboratory.
c.All results of blood lead screening performed by any other laboratory must be reported to the Department in an electronic format specified by the Department.
3.Confirmatory Samples
a.All blood lead confirmatory samples must be sent to a clinical laboratory licensed by the Department to perform routine chemistry analysis of blood.
b.All results of confirmatory blood lead testing must be reported to the Department in an electronic format specified by the Department.
4.Samples Submitted to Department Laboratory
All blood lead screening and blood lead confirmatory samples submitted to the Department’s laboratory for analysis must be accompanied by a completed laboratory requisition form, including all data necessary for reimbursement by health insurers, and must be packaged in accordance with procedures established by the Department’s laboratory.
3.4.2Fees for Childhood Lead Poisoning Screening
Fees for blood lead screening are included in the Department’s Rules and Regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services provided by the Department of Health (Part 10-05-2 of this Title).
3.4.3Reporting of Cases of Childhood Lead Poisoning
A.Any person employed as or by a health care provider who makes the diagnosis of childhood lead poisoning shall report such diagnosis to the Department within ten (10) days of the diagnosis using a reporting method approved by the Department.
B.Use of the Department’s laboratory, or other Department-approved laboratory, shall constitute compliance with these reporting requirements.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.5** Lead Disclosure {#sec-216-ricr-50-15-3-3.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.5}
3.5.1EPA/HUD Lead Disclosure Rule
The requirements in § 3.5 of this Part are in addition to, not in lieu of, Federal requirements for disclosure of lead-based paint and/or environmental lead hazards in housing (24 C.F.R. Part 35, Subpart A and 40 C.F.R. Part 745, Subpart F).
3.5.2Records and Reports
A.Property owners shall maintain information concerning the presence of lead-based paint and/or environmental lead hazards including, but not limited to, lead certificates and inspection reports for as long as they own that property.
B.The owner shall notify each agent about the existence of any such available lead certificates and reports, including any certificates or reports which are in the possession of the seller or lessor or which are reasonably obtainable.
3.5.3Disclosure Requirements for Sellers and Lessors
A.Non-exempt sellers and lessors shall meet all of the following requirements before a purchaser or lessee is obligated under any contract to purchase or lease target housing:
1.Educational Pamphlet
The seller or lessor shall provide the purchaser or lessee with the EPA pamphlet Protect Your Family from Lead in Your Home containing the insert What You Should Know about the Rhode Island Lead Law, available on the Department’s website.
2.Lead Warning Statement
The seller or lessor shall include in each contract for the sale or lease of any residential dwelling, including oral leases, a lead warning statement and a written disclosure acknowledgment that is in accordance with 24 C.F.R. § 35.92 and 40 C.F.R. § 745.113.
3.Lead Disclosure
a.The seller or lessor shall disclose to the purchaser or lessee, as well as to each agent, any known information about the presence of lead-based paint and/or environmental lead hazards at the property being sold or leased.
b.Any agreement to transfer real estate must contain an acknowledgment that a completed lead disclosure form has been provided to the buyer by the seller in accordance with the provisions of § 3.5 of this Part.
c.For all properties, the lead disclosure must include the following:
(1)The property address and dwelling unit number, if applicable;
(2)A copy of any current lead certificate(s) for the dwelling or dwelling unit and common areas;
(3)A chronological listing of all available lead inspection reports and certificates for the property being sold or leased; and
(4)Instructions on how to obtain copies of those reports and certificates. Delivery to the requesting purchaser or lessee must be made within seven (7) days of the request and at no charge.
d.For residential rental properties, the lead disclosure must also include:
(1)Basic information about this Part and its applicability to the subject property;
(2)The name and contact information of the owner, registered agent, and/or designated person who is responsible for maintaining the property.
e.The disclosure acknowledgment must be a stand-alone document, which includes the property address, or its own separate page when included in a written lease.
f.The seller or lessor shall retain a copy of the signed and dated disclosure acknowledgment for a minimum of three (3) years or the term of the tenancy, whichever period is longer, as proof of compliance with § 3.5 of this Part.
3.5.4Additional Requirements for Sellers
A.Lead Inspection Period
1.Sellers of any one (1) to four (4) unit residential dwelling built prior to 1978 shall allow the purchaser a ten (10) day period in which to have an inspection for the presence of lead-based paint and/or environmental lead hazards prior to the purchaser becoming obligated under any Contract for the Purchase and Sale of Residential Real Property.
a.A mortgagee selling a property at a foreclosure auction is exempt from allowing the inspection.
b.A seller and purchaser may agree to change the terms of the lead inspection period, provided that the agreement is in writing and the seller has fully complied with all other disclosure requirements.
3.5.5Responsibilities of Real Estate Agents
A.Each agent shall ensure compliance with all requirements of § 3.5 of this Part by informing the seller or lessor of his/her responsibilities and ensuring that the seller or lessor has performed all required activities or personally ensuring compliance with the disclosure requirements.
B.If the agent has complied with § 3.5.5(A) of this Part, the agent shall not be liable for the failure to disclose to a purchaser or lessee the presence of lead-based paint, existing environmental lead exposure hazards, or potential environmental lead exposure hazards known by a seller or lessor but not disclosed to the agent.
C.If the agent has not complied with § 3.5.5(A) of this Part, the Department shall report the agent to the Department of Business Regulation, Division of Commercial Licensing and Regulation, Real Estate Section, for enforcement action pursuant to R.I. Gen. Laws Chapter 5-20.5.
3.5.6Responsibilities of Property Owners
A.Owners of regulated facilities shall maintain their properties in a lead-safe condition, free from lead hazards.
B.Owners of pre-1978 residential rental units shall obtain a valid lead certificate for all non-exempt rental units by hiring a licensed Lead Inspector to perform a lead inspection.
C.Owners of regulated facilities performing lead hazard mitigation, spot removal or minor repair and maintenance activities shall not use any work practices prohibited in § 12.5 of this Subchapter.
D.Owners of regulated facilities and target housing shall employ a licensed Lead Renovation Firm or Lead Contractor for:
1.Any window removal/replacement (no de minimis);
2.Interior mechanical paint removal (no de minimis);
3.Interior or partial demolition activities (no de minimis);
4.Activities that disturb six square feet (6 ft2) or more of lead-based paint per interior room; and/or
5.Activities that disturb twenty square feet (20 ft2) or more of exterior lead-based paint.
E.Owners in receipt of any notice or order from the Department shall comply with all terms and conditions as directed in that notice or order to avoid potential enforcement actions, pursuant to § 5.7 of this Subchapter.
F.Owners in receipt of a notice or order from a Lead Assessor or other government enforcement authority, as applicable, shall:
1.Contact that enforcement authority to arrange a follow-up inspection for the property, as directed in the notice or order; or
2.Hire a licensed Lead Inspector to perform the applicable follow-up inspection, as directed in the notice or order.
G.Owners of any dwelling or dwelling unit that was the subject of any lead inspection shall notify the occupants of the results within seven (7) days of receiving those results and provide a complete copy of the lead inspection report upon request.
H.Owners shall notify and disclose information about lead-based paint and/or environmental lead hazards to prospective tenants or buyers, as well as to each designated client representative, transaction facilitator, transaction coordinator, or dual facilitator, pursuant to § 3.5 of this Part.
I.Owners and their agents who fail to comply with the requirements of this Part and any related State law or Regulation shall be subject to the compliance and enforcement procedures, pursuant to § 3.6 of this Subchapter.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.6** Compliance and Enforcement {#sec-216-ricr-50-15-3-3.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.6}
3.6.1Licenses and Certifications
A.Denial of Applications
1.Any person who neglects or refuses to pay an administrative fine or penalty cannot obtain or renew any Department-issued license or certification until all outstanding administrative fines or penalties have been paid.
2.The Department may deny an application for licensure or certification pursuant to this Part if the Department determines that the applicant has not complied with or has not demonstrated the ability to comply fully with all applicable requirements established by the Act and/or this Part.
3.If the applicant appeals the denial, a hearing will be scheduled in accordance with the provisions of § 3.6.11 of this Part.
B.Action against a License or Certification
1.The Department may restrict, limit, suspend, revoke, or take other disciplinary action against any license or certification issued pursuant to Part 11 of this Subchapter in accordance with R.I. Gen. Laws § 23-24.6-20(e) for noncompliance with this Part, including, but not limited to:
a.False representation of credentials as an appropriately licensed or certified lead professional;
b.Obtaining licensure or certification based on misrepresentation or fraud;
c.Using a license or certification for fraudulent, deceptive, or unethical purposes;
d.Failure to discharge activities in accordance with the Act or this Part, including employers who fail to comply with applicable OSHA requirements;
e.Failure to meet requirements of this Part and/or within the allotted time frame, including, but not limited to:
(1)Failure of a Lead Contractor or Lead Renovation Firm to distribute appropriate pre-renovation education information to owners and occupants required by EPA/HUD and this Part;
(2)Failure of a licensed lead professional to notify the Department of any changes to information submitted in an application for licensure or certification from the Department;
(3)Failure to successfully complete the training required by this Part; and/or
(4)Failure of a Lead Inspector, Lead Assessor, or Lead Renovator to distribute lead test results, lead inspection reports, and/or lead certificates in accordance with the requirements of Part 5 of this Subchapter.
f.Issuing fictitious results, reports, or certificates;
g.Failure to meet the terms or conditions of any notice, order, or consent agreement with the Department; and
h.Any good cause within the meaning and purpose of the Act or this Part.
2.A person whose license or certification was issued by reciprocity shall immediately notify the Department in writing of any final administrative action taken against the licensee by EPA or another jurisdiction during the term of said license. The Department may subject the license by reciprocity to such action taken by EPA or the other jurisdiction.
3.A person whose license or certification is restricted, limited, suspended, or revoked may request a hearing in accordance with the administrative procedures contained in § 3.6.11 of this Part.
4.Any person who is subject to a Cease Work Order has the right to request an administrative hearing, in writing, within thirty (30) days of the order.
5.No request for a hearing on an Immediate Compliance Order can be made.
3.6.2Failure to Comply
A.The following violations are acts of noncompliance for which the Department may initiate an enforcement response against an owner, their agent, or another regulated person:
1.Failure to maintain the premises of a regulated facility in a lead-safe condition;
2.Failure of a non-exempt residential rental unit or child care facility to have an appropriate lead certificate;
3.Failure to comply with the lead disclosure requirements in § 3.5 of this Part;
4.Failure to grant access to a premise for inspection by State Inspectors or the Department’s duly authorized designees, upon presenting identification and appropriate credentials;
5.Failure to hire appropriately licensed or certified lead professionals to conduct regulated activities;
6.Failure of a person conducting regulated activities to be appropriately licensed or certified, pursuant to this Part 11 of this Subchapter;
7.Failure to comply with the requirements of any Department-issued or approved lead professional license or certification;
8.Failure to comply with the terms of any Department notice, order, or consent agreement and/or by the deadline specified in the notice, order, or consent agreement;
9.Failure to establish, maintain, and/or provide the Department access to the records required by this Part; and
10.Failure to adhere to any other applicable conditions or requirements of this Part.
3.6.3Enforcement Response
A.Whenever the Department determines that any person fails to comply with any requirements of the Act, this Part, or any Department-issued notice, order, consent agreement, license or certification, the Department may pursue enforcement action pursuant to this Part, to correct the noncompliance and/or impose a fine or penalty.
B.All fines and/or penalties will be assessed in accordance with the provisions of the Department’s Penalty Matrix in § 3.6.5(C) of this Part below.
C.The Department can also refer the noncompliance to OSHA, EPA, HUD, the Rhode Island Department of Attorney General, other State agencies, district courts, and/or local municipalities for additional enforcement actions.
D.Nothing contained in this Section shall limit the Department from requiring immediate compliance with any and all terms of an order, when, in the Department’s discretion, circumstances present an immediate risk to the health or safety of a child, workers in or occupants of a building toward which the order is directed, and/or the general public.
3.6.4Enforcement Options
A.Pursuant to the authorities defined in R.I. Gen. Laws Chapters 23-1 and 23-24.6, the Department may pursue any combination of administrative and/or judicial enforcement actions, depending upon the circumstances and gravity of each case, including, but not limited to:
1.Enforcement of compliance with this Part and the Act;
2.Determination and prioritization of properties with “clear and significant health risks” where there have been instances of childhood lead poisoning;
3.Issuance of compliance notices or orders, including but not limited to:
a.Notice of Violation;
b.Second Notice of Violation;
c.Notice of Noncompliance;
d.Cease Work Order; and/or
e.Immediate Compliance Order.
4.Assessment of administrative fines and penalties;
5.Recording a notice, order, or consent agreement as a Notice of Lis Pendens against the title of the property, and/or recording any outstanding fees or administrative penalties as a lien against the property with the Registry of Deeds in the municipality where the property is located;
6.Coordination of enforcement actions including, but not limited to the following State, Federal and local agencies:
a.Municipal building officials;
b.Municipal housing code enforcement;
c.Rhode Island Department of Environmental Management (DEM);
d.Rhode Island Contractor’s Registration and Licensing Board (CRLB);
e.Rhode Island Department of Business Regulation (DBR);
f.US Environmental Protection Agency (EPA);
g.US Department of Housing and Urban Development (HUD); and/or
h.US Occupational Safety and Health Administration (OSHA).
7.Pursuit of criminal or civil remedies through the Department of Attorney General, district courts, or municipal courts;
8.Revocation, suspension, limitation, restriction, or other disciplinary action regarding a license or certification issued pursuant to Part 11 of this Subchapter; and/or
9.Invalidation of a lead certificate or inspection exemption issued pursuant to this Part 5 of this Subchapter; and/or
10.Suspension or revocation of database access for Lead Inspectors or Lead Assessors to issue lead certificates.
B.Nothing herein shall preclude the Department from resolving outstanding violations or penalties through a consent agreement at any time the Department deems appropriate.
C.The imposition of one (1) or more remedies and/or penalties provided shall not prevent the Department from jointly exercising any other remedy available, except:
1.Fines or penalties levied pursuant to R.I. Gen. Laws § 23-24.6-27 shall be in lieu of any administrative fines or penalties issued pursuant to R.I. Gen. Laws § 45-24.3-18(a), and
2.No municipality shall issue any fine or penalty for the same violation.
3.6.5Penalties
A.Applicability and Scope
1.Pursuant to the provisions of R.I. Gen. Laws § 23-24.6-27, the Department may impose an administrative fine or penalty of up to five thousand dollars ($5,000.00) per violation per day for each current or past violation of:
a.The Act or any Regulations promulgated pursuant to the Act; and/or
b.Any notices, orders, or consent agreements issued pursuant to the Act or this Part.
2.The Department, in its discretion, may adjust the fine or penalty upward or downward based on the criteria listed in this Section, provided that no fine or penalty exceeds five thousand dollars ($5,000.00) per violation per day.
B.Assessment of Fines and Penalties
1.The total amount of any administrative fine or penalty to be levied shall be calculated according to the guidelines in this Section and provided in the Department’s Penalty Matrix in § 3.6.5(C) of this Part below.
2.The penalty may be based on the gravity of the violation. That portion will be calculated according to the applicable "Penalty Matrix" in § 3.6.5(C) of this Part. The applicable penalty range is reached by first determining the "Type of Violation" and the "Deviation from the Standard" of the alleged violation.
3.“Type of Violation" – refers to the nature of the legal requirement allegedly violated.
a.Type I violations include violations of legal requirements identified by the Department as directly related to the protection of the public health, safety, welfare or environment. Such violations include, but are not necessarily limited to:
(1)Acts which pose an actual or potential for harm to the public health, safety, welfare or the environment;
(2)Acts or failures to act which are of major importance to the regulatory program;
(3)Any failure to obtain a required license or approval from the Department;
(4)Any failure to report an unauthorized activity which actually or potentially threatens the public health, safety, welfare or the environment;
(5)Any failure to take remedial action to mitigate a known or suspected harm; and/or
(6)Any failure to comply with an order of the Department which is presently enforceable.
b.Type II violations include violations of legal requirements identified by the Department as important but indirectly related to the protection of the public health, safety, welfare or environment. Such violations include, but are not necessarily limited to:
(1)Acts which pose an indirect actual or potential for harm to the public health, safety, welfare or the environment;
(2)Acts or failures to act which are of moderate importance to the regulatory program; and/or
(3)Failure to comply with any procedure required by any law administered by the Department, or by a Rule or Regulation adopted pursuant to the Department’s authority for the prevention of harm to the public health, safety, welfare or the environment.
c.Type III violations include violations of legal requirements identified by the Department as important but incidental to the protection of public health, safety, welfare or the environment. Such violations include, but are not necessarily limited to:
(1)Acts of noncompliance with inspection standards, reporting requirements or methods which are incidental to the Department's ability and obligation to enforce the laws administered by the Department.
4."Deviation of the standard" – refers to the degree to which the violation is out of compliance with the legal requirement allegedly violated. The Deviation from the Standard may be determined without consideration of factor (I) enunciated below in cases of strict liability. In all other cases, the Department's assessment of whether a violation is a minor, moderate or major deviation from the standard is based upon an evaluation of one (1) or more of the following factors except to the extent already considered:
a.The extent to which the act or failure to act was out of compliance;
b.Environmental conditions;
c.The amount of the pollutant;
d.The toxicity or nature of the pollutant;
e.The duration of the violation;
f.The areal extent of the violation;
g.Whether the person took reasonable and appropriate steps to prevent and/or mitigate the non-compliance;
h.Whether the person has previously failed to comply with any Regulations, order, statute, license, permit or approval issued or adopted by the Department, or any law which the Department has the authority or responsibility to enforce;
i.The degree of willfulness or negligence, including but not limited to, how much control the violator had over the occurrence of the violation and whether the violation was foreseeable;
j.Any other factor(s) that may be relevant in determining the amount of a penalty, provided that said other factor(s) shall be set forth in the Notice of Violation or other written notice of the assessment of a penalty.
C.Penalty Matrix
TYPE OF VIOLATION
I
II
III
MAJOR
Up to $5,000.00
Up to $2,500.00
Up to $1,000.00
DEVIATION
$2,500.00
$1,000.00
$500.00
FROM THE
MODERATE
To
To
To
STANDARD
$1,000.00
$500.00
$100.00
MINOR
Up to $1,000.00
Up to $500.00
Up to $100.00
1.Multiple Violations. For the purposes of determining the total administrative fine or penalty to be assessed:
a.Each violation at any premises may, within the Department’s discretion, be considered as a separate violation.
b.When multiple violations of this Part or of any notice, order, or consent agreement issued by the Department are to be counted as separate violations, each act is counted as separate and distinct from any other act:
(1)By its nature;
(2)Time or place; or
(3)Risk of harm to the public health.
c.When applicable, the period for calculating the fine or penalty for a violation begins on the day following the:
(1)Receipt or posting of a notice or order issued by the Department;
(2)Expiration of a compliance period;
(3)Expiration of a consent agreement; or
(4)Expiration of an extension of a compliance period or consent agreement.
d.Each day of a continued violation may be considered a separate violation and compounded for each day during which the violation is repeated, continued, or remains in place.
D.Criteria for Assessment of Fines and Penalties
1.In deciding whether to assess an administrative fine or penalty the Department, in its discretion, may weigh the relevance of each factor in any case, as well as the amount of any such administrative fine or penalty. The Department shall consider, but not be limited to, the following:
a.The ability of the violator to comply;
b.The willfulness of the violation(s);
c.The total number of violations;
d.The cumulative number of days of noncompliance;
e.Any prior record of noncompliance with any Regulation, notice, order, consent agreement, license or certification issued or adopted by the Department;
f.The economic benefit derived by the violator from noncompliance;
g.Any costs incurred by the State related to the investigation and enforcement of the noncompliance;
h.The ability of the violator to pay potential fines and penalties;
i.Actual or potential injury to public health and safety; and/or
j.Any other factors that the Department considers relevant.
E.Payment of Fines and Penalties
1.Unless another time period is specified in the Department’s order, any administrative fine or penalty assessed pursuant to this Section shall be due and payable within thirty (30) days of service of the notice of the order.
2.If the person named in the order requests a hearing, pursuant to R.I. Gen. Laws Chapter 23-24.6, within thirty (30) days of receipt of the notice of the order the thirty (30) day payment period shall be stayed pending a hearing on the matter.
3.All payments must be made in the form of a cashier's check, certified check, money order, or any other method approved by the Department, payable to: General Treasurer, State of Rhode Island.
F.Failure to Pay
1.If, after demand, any person assessed an administrative fine or penalty pursuant to this Section neglects or refuses to pay, the assessed amount together with interest and any other costs that may accrue will be a lien filed in favor of the State upon:
a.The violator’s current and future Rhode Island income tax refunds; and/or
b.The violator’s real property subject to the order, recorded with the Registry of Deeds in the municipality where the property is located.
3.6.6Extension of Compliance Period
A.Requests for extensions to the compliance period specified in a Department-issued notice, order, or consent agreement, shall be made in writing to the Department.
B.Extensions may be granted, at the discretion of the Department, based on the circumstances of a case and if an extension is not considered to pose a threat to the health or safety of children, other occupants of the building, and/or the general public.
C.Owners who request an extension to the compliance period specified in a Department-issued notice or order, shall enter into a consent agreement with the Department and complete temporary lead hazard control measures within a time frame approved by the Department.
D.In deciding whether to grant an extension, as well as any condition(s) attached to such an extension, the Department shall consider, but not be limited to, the following factors:
1.The current threat to public health posed by the violation(s);
2.The severity of the violation(s);
3.The progress made toward correcting the violation(s); and
4.Any prior or concurrent instances of noncompliance by the person named in the notice, order, or agreement.
E.Persons, who fail to comply with the terms of this Part, or a Department-issued notice, order, or consent agreement, may be subject to additional escalated enforcement action by the Department, DEM, CRLB, OSHA, Department of the Attorney General, and/or the municipality where the violation occurred.
F.Unless an extension is granted by the Department in writing, the Department may assess a fine or penalty for failure to comply with this Part, or a Department- issued notice, order, or consent agreement, by the compliance period or deadline specified in a Department-issued notice, order, or consent agreement.
G.The Department may declare any extension granted pursuant to this Section immediately null and void if the Department determines that the terms of the notice, order, or consent agreement have been violated.
3.6.7Injunctive Relief
A.If an owner fails to comply with the lead-safe standards of Part 5 of this Subchapter, as applicable:
1.Households of an “at risk occupant” may seek injunctive relief from a court with jurisdiction against the owner in the form of a court order to compel compliance with the requirements for lead hazard mitigation, lead hazard control or lead hazard reduction, as applicable.
2.Such cases brought before the court shall be granted an accelerated hearing.
3.6.8Equal Access to Justice
The Department’s Rules and Regulations Relating to Equal Access to Justice (Part 10-05-3 of this Title) define the process and procedures to carry out the provisions of R.I. Gen. Laws Chapter 42-92 and provide for equal access to justice for small businesses and individuals.
3.6.9Declaratory Rulings
A.In accordance with R.I. Gen. Laws § 42-35-8, any person affected by any statutory provision administered by the Department or affected by any Rule or order of the Department and this Part, may petition the Department for a declaratory ruling as to the applicability of such statute, Rule or order. The petition shall clearly and concisely identify:
1.The precise statute, Rule, or order under which a declaratory ruling is sought;
2.How the petitioner is affected by the statute, Rule, or order; and
3.The petitioner's position on how the applicable statute, Rule, or order should be interpreted, including citations to any applicable documents or law that support the petitioner's position.
3.6.10Variance from this Part
A.A variance from compliance with one (1) or more provisions of this Part may be granted by the Department in a specific case, either upon its own motion or upon the request of an applicant, if the Department determines that a literal enforcement of the provision(s) would result in unnecessary hardship to a regulated person and that such a variance will not be contrary to the public health or public interest.
B.A request for a variance must be filed by an applicant in writing, setting forth in detail the basis upon which the request is made. The applicant must further certify that the measures taken pursuant to the variance will be as protective of public health as this Part.
C.After filing of a request for a variance with the Department, and within thirty (30) days thereafter, the Department shall notify the applicant of its approval or denial, unless the Department has indicated that additional time is needed.
D.If the applicant appeals the denial, a hearing will be scheduled in accordance with the provisions of § 3.6.11 of this Part.
E.The Department may declare any variance granted pursuant to this Section immediately null and void if the Department determines that the terms of the variance have been violated.
3.6.11Administrative Hearing and Judicial Review
A.Any person who is subject to enforcement action by the Department or who is otherwise aggrieved by a final decision of the Department has the right to request an administrative hearing to contest the action or decision, provided that no request for a hearing on an immediate compliance order issued pursuant to R.I. Gen. Laws § 23-1-21 may be made.
B.Any request for a hearing must be made in writing and must be received by the Department within thirty (30) days of service of the Department’s notice or order. Failure to make a timely request for a hearing or electing to waive such a hearing shall result in a final order of the Department.
C.If a timely request for a hearing is made, the hearing shall be conducted in accordance with the provisions of R.I. Gen. Laws Chapter 42-35 and Rules and Regulations Governing the Practices and Procedures before the Department of Health (Part 10-05-4 of this Title).
D.Judicial review of any final decision of the Administrative Hearing Officer shall be available in accordance with R.I. Gen. Laws § 42-35-15.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.7** Communications and Correspondence {#sec-216-ricr-50-15-3-3.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.7}
A.All inquiries and correspondence should be directed to:
Rhode Island Department of Health Division of Environmental Health
Center for Healthy Homes and Environment
Three Capitol Hill, Room 206 Providence, RI 02908-5097
Website: https://health.ri.gov/
E-mail: [email protected]
Information Line: (401) 222-5960, Phone (401) 222-7796
Fax: (401) 222-2456, 222-7759
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
##### **216-RICR-50-15-3 § 3.8** Interpretation and Severability {#sec-216-ricr-50-15-3-3.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-3#3.8}
The provisions of this Part shall be liberally construed and shall be held to be in addition to, and not in substitution for or a limitation of, the provisions of any other Regulation or law. If any provision or part thereof of this Part or application thereof to any person or circumstance is held unconstitutional or otherwise invalid, the remainder of this Part and the application of such provisions to any other persons or circumstances other than those to which it is held invalid shall not be affected thereby.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2022-01-02 to 01/04/2022*
- *Technical Revision — effective from 2018-01-01 to 01/02/2022*
- *Technical Revision — effective from 2018-01-01 to 01/01/2018*
- *Adoption — effective from 2018-01-01 to 01/01/2018*
#### **216-RICR-50-15-4** Air Quality in Ice Arenas
##### **216-RICR-50-15-4 § 4.1** Authority {#sec-216-ricr-50-15-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-1-17(a) and 23-1-18(6), for the purpose of regulating the air quality in ice arenas to protect public health.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.2** Applicability {#sec-216-ricr-50-15-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.2}
The requirements of this Part apply to all owners and operators of ice arenas in which internal combustion engine-powered ice resurfacing machines, internal combustion engine-powered (e.g. gas-fired) heaters and/or other devices which emit carbon monoxide and/or nitrogen dioxide are used.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.3** Definitions {#sec-216-ricr-50-15-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.3}
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1.“Department” means the Rhode Island Department of Health.
2.“Director” means the Director of the Rhode Island Department of Health or his/her designee.
3.“Edger” means internal combustion engine-powered equipment used to modify the perimeter of an ice surface.
4.“Ice arena” means any building with a roof and partially or fully enclosed sides which contains an ice rink.
5.“Ice maintenance machine” means an edger or a resurfacing machine.
6.“Operator” means the person designated by the owner as responsible for the day to day operation of the ice arena.
7.“Owner” means the person having legal title to property and/or buildings. For purposes of publicly owned property only, the owner shall be defined to be the chief executive officer of the state or municipal agency which owns, leases or controls the use of the property.
8.“Person” means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, and other State or political subdivision or agency thereof, and the legal successor, representative, agent or agency of the foregoing.
9.“Resurfacing machine” means any internal combustion engine-powered machine used for modifying the entire ice rink surface.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.4** Acceptable Indoor Air Quality {#sec-216-ricr-50-15-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.4}
The owner/operator of an ice arena must maintain acceptable air quality conditions in the ice rink and in all other areas of the ice arena that are accessible to the public at all times that the ice arena is open to the public. Such conditions are defined as a one-hour average air concentration of not more than thirty (30) parts per million (ppm) of carbon monoxide and a one-hour average air concentration of not more than 0.5 ppm of nitrogen dioxide.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.5** Maintenance of Air Quality Conditions {#sec-216-ricr-50-15-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.5}
A.The owner/operator of an ice arena shall use the following methods to maintain acceptable air quality conditions:
1.Mechanical adjustment (tuning) and maintenance of the internal combustion engines of all ice maintenance machines, internal combustion heaters and other devices which emit carbon monoxide and/or nitrogen dioxide, according to the manufacturers’ recommendations; and
2.Proper ventilation of the ice arena; and/or
3.Another method approved in writing by the Director.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.6** Measurement of Air Quality Conditions {#sec-216-ricr-50-15-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.6}
A.The owner/operator of an ice arena shall measure air quality conditions in the ice rink according to the specifications in this section.
B.Air quality conditions shall be measured as the concentration of carbon monoxide and, on and after July 1, 2018, as the concentration of nitrogen dioxide.
C.Air quality conditions shall be measured at least three times during each week that the arena is open to the public, including at least two weekdays and at least one weekend day.
D.Measurements shall be taken at a time of maximum frequency of use of the resurfacing machine, twenty (20) minutes after resurfacing is completed.
E.If an edger is operated in the ice arena, additional air quality measurements shall be taken at least once per week:
1.Twenty (20) minutes after edging is completed, if the arena building is open to the public when edging occurs; or
2.Before the public reoccupies the building, if the arena building is not open to the public when edging occurs.
F.Measurements shall be taken at board height, inside the boards, and at the centerline of the ice.
G.Carbon monoxide shall be measured using a device that accurately and reliably measures carbon monoxide levels in a range of zero (0) to one hundred (100) ppm in increments of 1 ppm.
H.On and after July 1, 2018, nitrogen dioxide shall be measured using a device that accurately and reliably measures nitrogen dioxide in a range of zero (0) to five (5) ppm in increments of 0.1 ppm.
I.Measuring devices shall be operated, stored, maintained and calibrated according the manufacturer’s specifications.
J.Measurements and information on measuring devices shall be documented and reported as specified in § 4.8 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.7** Failure to Maintain Air Quality {#sec-216-ricr-50-15-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.7}
4.7.1Evacuation and Immediate Notification
Whenever any reading greater than or equal to 85 ppm of carbon monoxide and/or any reading greater than or equal to two (2) ppm of nitrogen dioxide is measured in the ice arena, all persons shall be immediately evacuated from the ice rink surface and adjacent areas. The Director shall be immediately notified by telephone of any such action and the ice arena may not reopen until authorized by the Director.
4.7.2Corrective Action
A.Whenever any reading in excess of thirty (30) ppm of carbon monoxide and/or any reading in excess of 0.5 ppm of nitrogen dioxide is measured in the ice arena, the owner or operator shall implement immediate and long-term corrective actions, as specified in this section.
B.The owner or operator shall immediately increase the ventilation rate in the skating rink area and suspend operation of ice maintenance machines and other internal combustion engine-powered equipment. These actions shall remain in place until follow-up air quality measurements, taken as specified in § 4.7.3 of this Part, demonstrate that acceptable indoor air conditions have been restored.
C.As soon as reasonably practical, the owner or operator shall identify the cause of the air quality measurement that exceeded the levels specified in § 4.7.2(A) of this Part, and shall take corrective actions to prevent future exceedances. Such long-term corrective actions may include, but are not limited to:
1.Increasing general ventilation rates and/or installing local ventilation in problem areas which vent to the outside;
2.Increasing the interval between resurfacing operations;
3.Decreasing the length of time that ice maintenance machines, including edgers, are operated;
4.Warming up the resurfacing machine outside the ice arena;
5.Adjusting (tuning up) or repairing ice maintenance machines and other internal combustion engine-powered equipment and, subsequently, adjusting, maintaining and operating that equipment according to the manufacturer’s instructions;
6.Replacing ice maintenance machines with equipment having no or lower emissions;
7.Installing a vertical exhaust pipe that vents above the highest point of the resurfacing machine; and
8.Installing a catalytic convertor, oxygen sensor, or another device designed to reduce emissions from ice maintenance machines.
4.7.3Follow-up Action Required
A.Whenever the conditions described in § 4.7.2(A) of this Part occur, the owner/operator of an ice arena must immediately begin measuring air quality conditions according to the following schedule:
1.Measurements must be taken at intervals of not more than twenty (20) minutes until carbon monoxide measurements are lower than thirty (30) ppm and nitrogen dioxide measurements are lower than 0.5 ppm;
2.Measurements must be taken twenty (20) minutes after the next five (5) uses of ice maintenance equipment; and
3.Measurements must be taken at least once per day for the subsequent three (3) days of arena operation.
B.The Director shall be immediately notified by telephone of:
1.Any measurement in the ice arena that is greater than or equal to eighty-five (85) ppm of carbon monoxide and/or two (2) ppm of nitrogen dioxide; and
2.Any time that carbon monoxide levels exceed thirty (30) ppm and/or nitrogen dioxide levels exceed 0.5 ppm for more than one hour.
C.Whenever the conditions described in § 4.7.2(A) of this Part occur, the owner/operator must submit a written report to the Director within five (5) working days that includes the information specified in § 4.8.3 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.8** Recordkeeping and Reporting {#sec-216-ricr-50-15-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.8}
4.8.1Equipment Records
A.The owner/operator of an ice arena shall maintain the following records at the arena and shall make those records available to the Department upon request:
1.The following information for each ice maintenance machine and any other equipment powered by an internal combustion engine that is used in the ice arena:
a.Name of equipment manufacturer;
b.Model identifier and age of equipment;
c.Fuel used to operate equipment;
d.The date that each equipment readjustment (tuning) and other service occurs and the nature of that service:
e.The manufacturer, type and date of installation of any catalytic convertor, oxygen sensor, or other device designed to reduce emissions;
f.The date that a vertical exhaust pipe or other modification of the resurfacing machine occurs: and
g.The name, company and signature of the person who performs the functions listed in §§ 4.8.1(A)(1)(d) through (f) of this Part and documentation that the person performing that function has received formal and/or on-the-job training relevant to the repair and maintenance of the equipment serviced.
2.The following information for each device used to measure air quality conditions in the ice arena:
a.Name of equipment manufacturer;
b.Model identifier and documentation that shows that the device meets the specifications in § 4.6(G) of this Part for carbon monoxide measurement devices or § 4.6(H) of this Part for nitrogen dioxide measuring devices;
c.Calibration records, which shall include, at a minimum, the following data:
(1)Name of person performing the calibration;
(2)Date of calibration;
(3)Actual reading observed;
(4)Concentration of calibration gas used; and
(5)Any problems that could invalidate the calibration.
d.Records of any additional service to measuring devices, including the date and nature of service.
4.8.2Air Quality Measurement Records and Reports
A.The owner/operator of an ice arena shall record measurements of air quality conditions, as required in §§ 4.6 and 4.7.5 of this Part, on Form ICE-1, which is available on the Department’s website, or its equivalent. The owner/operator shall maintain those records at the ice arena for a minimum of three years and shall submit a copy of the Form ICE-1 data for each month to the Director not later than the fifth day of the following month.
B.All information contained on Form ICE-1 (or equivalent) shall be made available, on reasonable request, to any person with an interest in the operation of the ice arena including, but not limited to, headmasters/school superintendents, league/association officials, referees and coaches. The owner/operator of an ice arena must post copies of Form ICE-1 (or equivalent) in the ice arena foyer or other location that is readily accessible to both ice arena employees and the general public. Alternatively, the owner/operator of an ice arena may post a notice indicating where such information is available for review.
4.8.3Failure to Maintain Air Quality Condition Reports
A.Whenever the conditions described in § 4.7.2(A) of this Part occur, a written report must be submitted to the Director within five (5) working days that includes:
1.An explanation of why the air quality control methods in place at the arena failed to maintain acceptable air quality conditions;
2.Documentation of evacuation, notification, corrective and follow-up actions that were taken; and
3.A plan that identifies actions that have been or will be implemented to prevent a recurrence of unacceptable air quality conditions, including a timetable for implementing those actions.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.9** Communication and Notification {#sec-216-ricr-50-15-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.9}
4.9.1Telephone Notifications
All telephone notifications to the Director that are required in § 4.7 of this Part should be made by calling 401-222-5960, 24 hours a day.
4.9.2Written Reports
All written reports to the Director that are required in this Part should be sent to:
Rhode Island Department of Health
Healthy Homes and Environment
Three Capitol Hill, Room 206
Providence, RI 02908-5097
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.10** Inspection and Enforcement {#sec-216-ricr-50-15-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.10}
4.10.1Inspections
The Director, or his or her designee, may inspect an ice arena at a reasonable time, without prior notice, to review the implementation of this Part or to respond to a complaint of the existence of air quality conditions that are not in compliance with this Part.
4.10.2Compliance and Enforcement
Violations of this Part will be handled by the Director in accordance with procedures contained in R.I. Gen. Laws §§ 23-1-20 through 23-1-25.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
##### **216-RICR-50-15-4 § 4.11** Practices and Procedures {#sec-216-ricr-50-15-4-4.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-4#4.11}
4.11.1Rules Governing Practices and Procedures
All hearings and reviews required under these regulations shall be held in accordance with the provisions of the rules and regulations regarding Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-07-02 to 01/04/2022*
- *Periodic Refile — effective from 2002-01-02 to 07/02/2018*
#### **216-RICR-50-15-5** Lead Inspections
##### **216-RICR-50-15-5 § 5.1** Authority and Purpose {#sec-216-ricr-50-15-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.1}
5.1.1Authority
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapters 23-1, 23-24.6, and 42-128.1, and 40 C.F.R. Part 745 for the purpose of establishing the requirements for evaluating lead in drinking water, household dust, painted surfaces, soil and/or other appropriate fixed surfaces that may contain lead.
5.1.2Purpose
A.Purpose of a Lead Inspection
1.A lead inspection may be initiated for a variety of reasons, including, but not limited to, the following:
a.To determine the applicability of the Renovation, Repair, and Painting (RRP) Rule.
b.To determine compliance with one (1) or more lead standards in § 5.8 of this Part;
c.To identify lead hazards and recommend treatment options to correct those hazards;
d.To satisfy a notice or order from the Department; and/or
e.To obtain one (1) of the following lead certificates, as applicable:
(1)Partial Lead-Safe Certificate (Form PBLC-27);
(2)Certificate of Lead Conformance (Form PBLC-30)
(3)Conditional Lead-Safe Certificate (Form PBLC-15); or
(4)Full Lead-Safe Certificate (Form PBLC-21).
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.2** Definitions {#sec-216-ricr-50-15-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.2}
A.Wherever used in this Part, the terms listed below shall be construed in the following manner:
1.“Accessory structure” means a detached or ancillary structure (e.g., garage, shed, or gazebo) which is not used or intended to be used for living or sleeping by human occupants, and which is located on the same premises with a dwelling.
2."Act" means R.I. Gen. Laws Chapter 23-24.6, Lead Poisoning Prevention.
3.“Approved” means approved by the Department, State, or local authority having legal and administrative authority for such.
4.“Certificate of Lead Conformance” or “LHM-2-1” means a certificate issued by a Lead Inspector or Lead Assessor which documents that a single-family house, dwelling unit and common areas, or premises meets the lead mitigation standards for paint and dust in § 5.8 of this Part. This certificate is valid for two (2) years from the inspection date.
5.“Child or children” means, for the purposes of this Part, any individual younger than six (6) years of age.
6.“Child care facility” means any building and/or area whose primary purpose is or will be to educate or care for children younger than six (6) years of age, including, but not limited to, child care homes, child care centers, nursery schools, preschools, kindergarten classrooms, public and private elementary schools. Child care facilities located in public or commercial buildings encompass only those common areas that are routinely used by children, such as restrooms and cafeterias. Common areas that children only pass through, such as hallways, staircases, and garages are not included. The child care facility also encompasses the exterior sides of the building that are immediately adjacent to the child care facility and the exterior common areas or play areas routinely used by children.
7.“Clearance inspection” means a visual assessment and lead testing, as applicable, done at the conclusion of a renovation, repair, and painting (RRP), lead hazard control (LHC), or lead hazard reduction (LHR) project to determine compliance with this Part.
8.“Common area(s)” means a portion of a residential property that is available for shared use by occupants of more than one (1) dwelling unit, such as hallways, stairways, lobbies, community rooms, recreational rooms, laundry rooms, garages, playgrounds, and boundary fences; in general, any area not kept locked.
9.“Component or building component” means specific design or structural elements or fixtures of a building or residential dwelling that are distinguished from each other by form, function, and location. These include, but are not limited to, interior components such as: ceilings, crown molding, walls, chair rails, doors, door trim, floors, fireplaces, radiators and other heating units, shelves, shelf supports, stair treads, stair risers, stair stringers, newel posts, railing caps, balustrades, windows and trim (including sashes, window heads, jambs, sills or stools and wells or troughs), built in cabinets, columns, beams, bathroom vanities, counter tops, and air conditioners; and exterior components such as: painted roofing, chimneys, flashing, gutters and downspouts, ceilings, soffits, fascias, rake boards, corner boards, bulkheads, doors and door trim, fences, floors, joists, lattice work, railings, and railing caps, siding, handrails, stair risers and treads, stair stringers, columns, balustrades, window sills or stools and wells or troughs, casings, sashes, and air conditioners.
10.“Comprehensive environmental lead inspection” or “CELI” means a surface-by-surface investigation of a child care facility, single-family house, dwelling unit and common areas, or premises to determine the presence of lead in paint, dust, soil, and water in order to identify lead hazards or determine compliance with the lead-safe standards in § 5.8 of this Part.
11.“Conditional Lead-Safe Certificate” or “Form PBLC-15” means a certificate issued by a Lead Inspector, typically at the conclusion of a lead hazard control (LHC) or lead hazard reduction (LHR) project, which certifies that a child care center, single-family house, dwelling unit and common areas, or premises had a Comprehensive Environmental Lead Inspection and meets the conditional lead-safe standards § 5.8 of this Part for paint, dust, soil, and water. Routine maintenance and renewal inspections are required to re-certify conditional compliance.
12."Department" or “RIDOH” means the Rhode Island Department of Health.
13."Director" means the Director of the Rhode Island Department of Health or his or her agents, subordinates to whom the Director has delegated the powers and duties vested in the Director by these Regulations.
14.“Dwelling” or “dwelling unit” means an enclosed space used for living and sleeping by human occupants as a place of residence, including, but not limited to a house, an apartment, or condominium, but for the purpose of this Chapter, shall not include hotels or “temporary housing.”
15.“Environmental lead” means, for the purposes of this Part, inorganic lead contained in paint, dust, soil, and/or water.
16.“EPA” means the United States Environmental Protection Agency.
17.“Family child care home" means a licensed residence where the resident can provide child care for up to six (6) children, or up to eight (8) children with an assistant approved by the Department of Human Services. Family child care homes located in residential buildings encompass the entire single-family house, dwelling unit and common areas, or premises, as applicable.
18.“Field blank” means a new, unused dust wipe that has been exposed to the on-site sampling conditions and analyzed to determine whether the sampling media is below the minimum reporting level of the analyzing laboratory.
19.“First-draw water sample” means a sample of tap water collected after the household water has been unused for at least six (6) hours.
20.“Flushed water sample” means a sample of tap water collected after the tap has been allowed to run at its maximum flow rate until cold, or at least one (1) minute, before the sample collection.
21.“Full Certificate of Lead Conformance” or “LHM-2-3” means a certificate issued by a Lead Inspector or Lead Assessor which documents that a single-family house, dwelling unit and common areas or premises meets the lead mitigation standards for interior and exterior paint and interior dust in § 5.8 of this Part. This certificate expires two (2) years from the interior dust wipe clearance specified in the Interior Certificate of Lead Conformance (Form LHM-2-2).
22.“Group family child care home” means a residence where the resident can provide child care for eight (8) to twelve (12) children with one (1) or two (2) approved assistants (dependent on enrollment details).
23.“HUD” means the United States Department of Housing and Urban Development.
24.“Interior Certificate of Lead Conformance” or “LHM-2-2” means a certificate issued by a Lead Inspector or Lead Assessor which documents that a single-family house, dwelling unit and common areas, or premises meets the lead mitigation standard for interior paint and interior dust in § 5.8 of this Part. This certificate is based on a weather variance issued between November 1st and March 31st and is valid until the following June 30th.
25.“Lead assessor” means a person, either authorized to act as an enforcing officer under the housing code or a designated employee of a Federal, State or municipal agency with jurisdiction over housing, occupational health, child welfare and/or environmental standards who successfully completed a Lead Assessor training course and obtained a license, pursuant to Part 11 of this Subchapter, to conduct lead inspections.
26.“Lead contractor” means any person or entity engage in lead hazard reduction as a business and licensed pursuant to this Part 11 of this Subchapter.
27.“Lead hazard” means a condition that presents a clear and significant health risk to occupants of a child care center, single-family house, dwelling unit and common areas, or premises, particularly where children reside. Lead concentrations in damaged paint, interior dust, bare soil, and/or drinking water which exceed the lead-safe thresholds in § 5.8 of this Part are an immediate lead exposure hazard requiring corrective action at a regulated facility.
28.“Lead hazard control” or “LHC” means any window replacement and/or interim controls intended to correct lead hazards identified in a lead inspection report or standard treatments to remove lead-based paint and/or minimize lead exposure, which may include measures to reduce the concentration of lead in paint, dust, soil, and/or water using approved treatment methods specified in this Part.
29.“Lead hazard control project” or “LHC project” means a project being done by a Lead Renovation Firm for the purpose of controlling lead hazards. An LHC Clearance Inspection or LHM Clearance Inspection is required at the conclusion of an LHC project.
30.“Lead hazard mitigation inspection” or “LHM inspection” means an inspection of a single-family house, dwelling unit and common areas, or premises by a Lead Inspector or Lead Assessor to determine compliance with the lead mitigation standards in § 5.8 of this Part, required at unit turnover or once in a twenty-four month (24) period, whichever period is the longer.
31.“Lead hazard mitigation project” or “LHM Project” means a project being done by an owner or designated person for the purpose of mitigating lead hazards. An LHM Inspection is required at the conclusion of an LHM project to obtain a Certificate of Lead Conformance (Form LHM-2-1), required for non-exempt residential rental units.
32.“Lead hazard reduction” means any action or actions designed to reduce exposure to toxic levels of lead which impose an unacceptable risk of exposure in any dwelling or dwelling unit where a child under the age of six (6) years with environmental intervention blood lead levels or greater resides, or on any premises and may include, but is not limited to: repair, enclosure, encapsulation, or removal of lead based paint and/or lead contaminated dust, soil or drinking water relocation of occupants; and cleanup measure or ongoing maintenance measures which may include, activities and/or measures that do not present an undue risk to children under age six (6).
33.“Lead hazard reduction project” or “LHR project” means a project being done by a Lead Contractor for the purpose of reducing lead hazards. An LHR Clearance Inspection is required at the conclusion of an LHR project.
34.“Lead inspection” means any type of physical investigation of a child care center, single-family house, dwelling unit, or premises to identify the presence of environmental lead, lead hazards, or compliance with the cleaning requirements and lead standards in § 5.8 of this Part for paint, dust, soil, and/or water.
35.“Lead inspection report” means a written report, on forms provided or approved by the Department, which documents the results of a lead inspection, conducted pursuant to this Part, and includes the visual assessment, field testing, sample analysis results, summary of findings, and, for regulated facilities and target housing, lead hazard reduction or lead hazard control requirements and site-specific recommendations, as applicable.
36.“Lead inspector” means an individual, who successfully completed a certified Lead Inspector training course, passed the Lead Inspector Department examination, completed a supervised field apprenticeship, and obtained a license, pursuant to Part 11 of this Subchapter, to conduct lead inspections.
37.“Lead inspector-in-training” means an individual who successfully completed a certified Lead Inspector training course, passed the Lead Inspector Department examination, and obtained a license, pursuant to Part 11 of this Subchapter, to conduct a supervised apprenticeship to meet the requirements for a Lead Inspector license.
38.“Lead renovation firm” means any person or organization engaged in renovation, repair, and painting (RRP) or lead hazard control (LHC) as a business and licensed pursuant to Part 11 of this Subchapter.
39.“Lead renovator” means an individual who successfully completed a certified Lead Renovator training course and obtained a valid training certificate, pursuant to Part 11 of this Subchapter, to perform renovation, repair, and painting (RRP) and lead hazard control (LHC) work under the authority of a Lead Renovation Firm license.
40.“Lead Safe" means that a dwelling, dwelling unit, or premises has undergone sufficient, lead-hazard reduction to ensure that no significant, environment lead hazard is present and includes, but is not limited to, covering and encapsulation and is evidenced by a lead-safe certificate issued by the Department of Health.
41.“Lead supervisor” means an individual who successfully completed a certified Lead Supervisor training course, passed the Lead Supervisor Department examination, and obtained a license, pursuant to Part 11 of this Subchapter, to perform and/or supervise lead hazard reduction (LHR) work.
42.“Lead worker” means an individual who successfully completed a certified Lead Worker training course and obtained a license, pursuant to Part 11 of this Subchapter, to perform lead hazard reduction work.
43.“Mitigation report” means the final lead hazard mitigation inspection report and laboratory report.
44.“Owner” means any person who, alone or jointly or severally with others:
a.Shall have legal title to any dwelling or dwelling unit with or without accompanying actual possession of it; or
b.Shall have charge, care, or control of any dwelling or dwelling unit as owner or agent of the owner or an executor, administrator, trustee, or guardian of the estate of the owner. Any person representing the actual owner shall be bound to comply with the provisions of this Chapter and with Rules and Regulations adopted pursuant to this Chapter to the same extent as if that person were the owner. An agent of the owner excludes real estate and property management functions where the agent is only responsible for the property management and does not have authority to fund capital and/or major property rehabilitation on behalf of the owner.
c.For purposes of publicly owned property only, the owner shall be defined to be the Chief Executive Officer of the municipal or State agency which owns, leases or controls the use of the property.
45.“Partial Lead-Safe Certificate” or “Form PBLC-27” is a temporary certificate to document that certain rooms/areas or media met the lead-safe standards in § 5.8 of this Part at the time of the inspection.
46.“Regulated facility” means any child care facility, single-family house, dwelling unit and common areas, or premises as specified in § 3.2.2 of this Subchapter.
47.“Renewal inspection” means the combination of a visual assessment of painted surfaces and environmental lead sampling, when applicable, at premises where lead-based paint or lead-contaminated soil is still present, to determine if the dwelling, dwelling unit, or premises, including soil, has been maintained in a lead-safe condition for renewing the Conditional Lead-Safe Certificate (Form PBLC-15).
48.“Renovation” means the modification of any existing structure, or portion thereof that results in the disturbance of lead-painted surfaces, unless that activity is performed as part of a lead hazard control (LHC) or lead hazard reduction (LHR) project. The term renovation includes, but is not limited to: the removal, modification or repair of painted surfaces or painted components (e.g. modification of painted doors, surface restoration, window repair); surface preparation activities such as sanding, scraping, or other such activities which may generate paint dust; the removal of building components (e.g. walls, ceilings, plumbing, windows); weatherization projects (e.g. cutting holes in painted surfaces to install blown-in insulation or to gain access to attics, planning thresholds to install weather-stripping); and interim controls that disturb lead-painted surfaces. A renovation performed for converting a building, or part of a building, into target housing or child care facilities is a renovation under this Part. The term renovation does not include minor repair and maintenance activities.
49.“Renovation, repair, and painting project” or “RRP project” means a project which is being done by a Lead Renovation Firm for purposes other than removing lead-based paint or correcting lead hazards (although it may result in this). The purpose of an RRP project is to ensure that renovations performed at a regulated facility or for compensation at target housing are done safely and prevent lead exposure to owners, occupants and neighbors of the property where the work is performed. Any additional work which disturbs lead-based paint, other than emergency renovation operations, performed in the same room or area within the same thirty (30) day period must be considered the same RRP project for the purpose of determining whether the work is spot removal or renovation, repair, and painting (RRP).
50.“Supervised lead inspector-in-training” means a Lead Inspector-in-Training who is performing a field apprenticeship under the direct on-site supervision of a Department-approved Lead Inspector for the purpose of meeting the Lead Inspector licensing requirements of Part 11 of this Subchapter.
51.“Visual assessment” means the visual examination of a residential dwelling or a child care facility following a lead hazard control (LHC) project or lead hazard reduction (LHR) project to determine whether the project has been successfully completed; or, the visual examination of a residential dwelling or a child care facility to determine the existence of deteriorated paint or other potential sources of environmental lead exposure as part of a Risk Assessment.
52.“Visual inspection” means a visual inspection by an owner or designated person to determine that the lead mitigation standards in § 5.8 of this Part were maintained when the term of tenancy is two (2) years or more. A notarized Affidavit of Completion of Visual Inspection must be submitted to the Department every two (2) years until tenant turnover.
53.“X-ray fluorescence analyzer” or “XRF analyzer” means a portable instrument that measures lead concentration using the principle of x-ray fluorescence.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.3** Inspection Types {#sec-216-ricr-50-15-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.3}
A.Lead Hazard Mitigation Inspection
1.A Lead Hazard Mitigation (LHM) Inspection by a Lead Inspector or Lead Assessor is required to determine compliance with the lead hazard mitigation standards in 860-RICR-00-00-2.4(I) and 860-RICR-00-00-2.4.3(E), Rules and Regulations Governing Lead Hazard Mitigation, and obtain a Certificate of Lead Conformance (Form LHM-2-1), required by 860-RICR-00-00-2.5.6 for all non-exempt residential rental units.
2.For LHM Inspections conducted between November 1st and March 31st, an Interior Certificate of Lead Conformance (Form LHM-2-3) may be issued for a dwelling unit and interior common areas with a weather variance to complete the exterior work by the following June 30th.
B.Comprehensive Environmental Lead Inspection (CELI)
1.A Comprehensive Environmental Lead Inspection by a Lead Inspector is required to determine compliance with the lead-safe standards in § 3.5.8 of this Subchapter and obtain a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21).
2.For Comprehensive Environmental Lead Inspections conducted between November 1st and March 31st, an Interior Lead-Safe Certificate (Form PBLC-15I) may be issued for a dwelling unit and interior common areas with a weather variance to complete the exterior work by the following June 30th.
C.Clearance Inspection
1.A Clearance Inspection by a Lead Inspector is required at the conclusion of a lead project to determine that the scope of work including cleanup was completed and the dwelling unit, common areas, child care facility, or work area(s), as applicable, are safe for re-occupancy.
2.A Clearance Inspection may be a “whole unit” or “worksite only” inspection.
D.Renewal Inspection
1.A Renewal Inspection by a Lead Inspector is required every two (2) years to renew a Conditional Lead-Safe Certificate (Form PBLC-15).
E.Partial Lead Inspection
1.A Partial Lead Inspection is any lead inspection other than a Lead Hazard Mitigation Inspection, Comprehensive Environmental Lead Inspection, Clearance Inspection, or Renewal Inspection.
2.A Partial Lead Inspection may be limited to certain rooms/areas or media (paint, dust, soil, or water).
5.3.1General Requirements for Inspections
A.Environmental Lead Samples
1.A Lead Inspector, Lead Assessor, or Lead Renovator shall submit all environmental lead samples to a Department-certified laboratory for analysis within seven (7) days of collecting the samples or completing the inspection, as applicable.
2.The lead inspection report must be completed within seven (7) days of receiving the sample results.
3.The lead inspection report must include copies of all applicable laboratory reports.
B.Reporting Requirements
1.A Lead Inspector or Lead Assessor who performed a lead inspection at a regulated facility or target housing shall complete and sign a lead inspection report and any applicable lead certificates, using the most current inspection report and certificate forms provided or approved by the Department.
2.Lead inspection reports must contain all applicable information required on the forms and be submitted in the Department’s electronic reporting system:
a.Within seven (7) days of receiving the environmental lead sample results from the laboratory; or
b.Within seven (7) days of completing the lead inspection if no environmental lead samples were collected.
3.Lead certificates must have a unique certificate number, generated by the Department’s electronic reporting system, to be valid.
4.In addition to submission in the Department’s electronic reporting system, all lead inspection reports, and related lead certificates must be submitted, with delivery confirmation, within seven (7) days to:
a.The property owner(s);
b.The tenants or occupants, if not the owner; and
c.The party who initiated the inspection, if not the owner or occupants.
5.In addition, a notification must be provided to the owner of the lead disclosure requirements in § 3.5 of this Subchapter.
6.Alternatively, a Lead Assessor may report lead testing results in accordance with the reporting requirements of his or her employer if no lead certificate was issued.
7.All environmental lead test results, inspection reports, laboratory reports, and/or lead certificates must be retained by the Lead Inspector or Lead Assessor’s employer for a minimum of three (3) years.
8.If requested, the Lead Inspector or Lead Assessor’s employer shall provide copies of any test results, lead inspection reports, laboratory reports, and/or lead certificates to the Department within seven (7) days of the request.
C.Conflict of Interest
1.A conflict of interest includes, but is not limited to the following:
a.Lead Inspectors, Lead Inspectors-in-Training, and their respective employer and/or employees shall not perform lead inspections or issue lead certificates at any property that is or will be owned or managed by the Lead Inspector, Lead Inspector-in-Training, their respective employer, employees, and/or family members.
(1)A Lead Assessor may perform lead inspections and issue lead certificates at properties owned or managed by their employer.
b.Lead Inspectors and Lead Inspectors-in-Training, their respective employer and/or employees shall not perform lead inspections or issue lead certificates at any property where the Lead Inspector, Lead Inspector-in-Training, Lead Assessor, their respective employer, employees, and/or family members performed or will perform any renovation, repair, and painting (RRP), lead hazard control (LHC), or lead hazard reduction (LHR) activities.
(1)A Lead Assessor shall not perform lead inspections or issue lead certificates at any property where the Lead Assessor performed any RRP, LHC, or LHR activities.
c.A clearance inspection must be performed by a Lead Inspector and/or supervised Lead Inspector-in-Training who is independent of the Lead Contractor or Lead Renovation Firm performing the work.
d.A Lead Inspector, Lead Inspector-in-Training, or their respective employer must disclose any current or potential financial interest in the analyzing laboratory to the person initiating the inspection as well as in the Lead Inspection Report.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.4** Lead Hazard Mitigation (LHM) Inspections {#sec-216-ricr-50-15-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.4}
A.Only a Lead Inspector or Lead Assessor shall conduct an LHM Inspection.
1.Exceptions
a.When an owner is in receipt of a notice or order from the Department which requires a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21), all dwelling units at the subject property are disqualified and prohibited from obtaining a Certificate of Lead Conformance (Form LHM-2-1) from a private Lead Inspector for as long as the notice or order remains in effect, regardless of occupancy or blood lead levels.
b.The owner shall contact the Department to arrange for lead inspection(s) of any other dwelling units at the subject premises by a State Inspector during the period the notice or order remains in effect.
c.For condominium units, the inspection requirements are limited to the interior of the dwelling unit. The interior and exterior common areas are exempt from the LHM inspection requirements.
B.Paint
1.The Lead Inspector or Lead Assessor shall follow the comprehensive environmental lead inspection protocol for evaluating paint in § 5.5(B) of this Part, except that paint testing is not required. All pre-1978 painted surfaces not tested must be assumed to be lead-based paint.
a.Intact lead-based paint is conditionally lead safe.
b.Damaged paint may be tested pursuant to § 5.7.2 of this Part. Paint below the lead-safe thresholds in § 5.8 of this Part is lead-safe regardless of its condition.
C.Dust
1.The Lead Inspector or Lead Assessor shall collect dust wipe samples pursuant to § 5.7.3 of this Part.
a.For a single-family dwelling or dwelling unit, a minimum of three (3) dust wipe samples from floors and window sills or window wells and one (1) field blank must be collected.
b.For a multi-unit dwelling, at least one (1) additional dust wipe sample must be collected in each relative common area.
2.Dust wipe sampling may be postponed until the follow up inspection if the LHM Inspection identified any paint hazards.
D.Soil
1.Optional soil sampling may be conducted pursuant to § 5.7.4 of this Part. The Lead Inspector or Lead Assessor shall follow the comprehensive environmental lead inspection protocol for soil sampling in § 5.5(D) of this Part.
a.Covered soil is conditionally lead safe.
2.The Mitigation Report must indicate whether the soil was tested and lead safe or lead hazard, or not tested.
E.Water
1.Optional water sampling may be conducted pursuant to § 5.7.5 of this Part. The Lead Inspector or Lead Assessor shall follow the comprehensive environmental lead inspection protocol for water sampling in § 5.5(E) of this Part.
2.The Mitigation Report must indicate whether the water was tested and lead safe or lead hazard, or not tested.
F.Certificate of Lead Conformance
1.The Lead Inspector or Lead Assessor who conducted the LHM Inspection shall issue a Certificate of Lead Conformance (Form LHM-2-1) when the dwelling or dwelling unit and common areas, as applicable, including the building exterior and accessory structures, meet the lead mitigation standards in § 5.8 of this Part.
a.The expiration date of the Certificate of Lead Conformance (FormLHM-2-1) will be two (2) years from the inspection date.
2.Between November 1st and March 31st, the Lead Inspector or Lead Assessor who conducted the LHM Inspection shall issue an Interior Certificate of Lead Conformance (Form LHM-2-3) when only the interior of the dwelling or dwelling unit and common areas, as applicable, meet the lead mitigation standards in § 5.8 of this Part.
a.The expiration date of the Interior Certificate of Lead Conformance (Form LHM-2-3), will be the following June 30th; and
b.The exterior paint hazards must be corrected by the following June 30th and an exterior re-inspection is required on or before June 30th to obtain a Certificate of Lead Conformance (Form LHM-2-2); and
c.Before June 30th, the Lead Inspector or Lead Assessor who passes the exterior re-inspection shall issue a Certificate of Lead Conformance (Form LHM-2-2) and the expiration date of the certificate which includes the exterior, will be two (2) years from the date of achieving interior dust wipe clearance in the dwelling or dwelling unit and interior common areas, as applicable; or
d.After June 30th, a full LHM Inspection, including interior dust wipe sampling, is required to obtain a valid Certificate of Lead Conformance (Form LHM-2-1).
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.5** Comprehensive Environmental Lead Inspections {#sec-216-ricr-50-15-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.5}
A.General Requirements
1.Only a Lead Inspector shall conduct a Comprehensive Environmental Lead Inspection.
2.A Comprehensive Environmental Lead Inspection is a surface-by-surface investigation which includes a thorough evaluation of all interior and exterior paint, interior dust, drinking water, and soil within the entire lot using the approved lead testing methods in § 5.7 of this Part.
3.For the purposes of this Part, a Comprehensive Environmental Lead Inspection includes an entire single-family house, dwelling unit and common areas, or premises, as applicable.
4.Family child care homes or group family child care homes located in residential buildings encompass the entire single-family house, dwelling unit and common areas, or premises, as applicable.
5.Child care centers, nursery schools, preschools, kindergarten classrooms, or other child care programs located in public or commercial buildings encompass only those common areas that are routinely used by children, such as restrooms and cafeterias. Common areas that children only pass through, such as hallways, staircases, and garages are not included. The child care center also encompasses the exterior sides of the building that are immediately adjacent to the child care center and the exterior common areas or play areas routinely used by children.
B.Paint
1.A Lead Inspector shall evaluate pre-1978 painted surfaces using one (1) or more approved testing methods in § 5.7.2 of this Part, and such evaluation must include evaluation of:
a.All building components with a separate, distinct painting history; and
b.Representative painted surfaces for each room or common area, including the building exterior and the exterior of any accessory structure within the lot.
C.Dust
1.A Lead Inspector shall collect interior single-surface dust wipe samples, pursuant to § 5.7.3 of this Part, which represent a "worst case" situation from areas nearest entries, in high traffic areas, under windows, and in areas frequently used by children.
2.Residential Dwelling Units
a.For each single-family house or dwelling unit, a minimum of five (5) dust wipe samples must be collected, with at least one (1) sample from each of the following surfaces, as available:
(1)Floors;
(2)Window sills;
(3)Window wells;
(4)A sample in a child’s bedroom, if present, or the smallest bedroom, if not present; and
(5)A sample in a child’s playroom, if present, or the living room, if not present.
3.Residential Common Areas
a.In addition to the dust wipe sampling required in § 5.5(C)(2) of this Part, a minimum of one (1) dust wipe sample must be collected from each of the following surfaces in each common area:
(1)Floors; and
(2)Window sills or window wells, if present.
4.Residential Family Child Care Homes
a.For each residential family child care home or group family child care home, dust wipe samples must be collected pursuant to the requirements in §§ 5.5(C)(2) and (3) of this Part, as applicable.
5.Non-residential Child Care Centers
a.For each child care center, nursery school, preschool, kindergarten classroom, or other non-residential child care program, a minimum of one (1) dust wipe sample must be collected from each of the following surfaces:
(1)Floors, within one foot (1’) of each exterior door; and
(2)Floors, on each distinctive flooring type; and
(3)Representative window sills and/or window wells.
6.Additional Sampling
a.In addition to the minimum dust wipe sampling requirements in § 5.5(C), additional dust sampling may be collected:
(1)Wherever a Lead Inspector deems necessary to ensure that the premises comply with the lead-safe standards in § 5.8 of this Part; and/or
(2)Pursuant to the current HUD Guidelines for the Evaluation and Control of Lead Based Paint Hazards in Housing.
7.Exemption
a.A Lead Inspector may, in his or her discretion, choose to postpone dust sampling until the clearance inspection if any interior lead-based paint hazards were identified in:
(1)A single-family house or dwelling unit where no child resides or is expected to reside; or
(2)A multi-unit common area where no child resides or is expected to reside in any associated dwelling unit.
D.Soil
1.A Lead Inspector shall collect the following soil samples pursuant to § 5.7.4 of this Part:
2.Primary Structure
a.A minimum of one (1) sample of bare soil must be collected between the foundation and the drip line on each side of the primary structure, or from any other area that contains bare soil on a side of the primary structure where the soil in the drip zone is covered, pursuant to § 12.5.13 of this Subchapter.
(1)A composite soil sample may only include representative subsamples collected on the same side of a primary structure.
3.Accessory Structure(s)
a.A minimum of one (1) sample of bare soil must be collected within the drip zone of each painted accessory structure, including, but not limited to, garages, sheds, play equipment, and fencing known or suspected to have been painted with lead-based paint.
(1)A composite soil sample may only include representative subsamples taken from the same accessory structure.
4.Play Area
a.A minimum of one (1) sample of bare soil must be collected in each play area, or mid-yard if there is no play area. It should be noted in the lead inspection report if there is no area designated or suitable for play.
(1)A composite soil sample may only contain representative subsamples from the same play area.
(2)A separate sample must be collected from each sandbox, if present.
5.Additional Sampling
a.In addition to the minimum soil evaluation requirements of this Section, additional soil sampling may be conducted:
(1)In any areas where paint chips or sanding residue are visible, including areas where the soil is otherwise covered;
(2)Wherever a Lead Inspector deems necessary to ensure that the premises comply with the lead-safe standards in § 5.8 of this Part;
(3)Pursuant to the current HUD Guidelines for the Evaluation and Control of Lead Based Paint Hazards in Housing.
6.Exemption
a.A Lead Inspector may delay soil sampling to a future date when the ground is frozen or covered with ice or snow.
(1)The reason for the delay must be noted in the lead inspection report.
(2)The samples must be collected as soon as weather permits, and no later than the following March 31st.
E.Water
1.A Lead Inspector shall collect water samples pursuant to § 5.7.5 of this Part.
2.First Draw Sample
a.If feasible, a first draw sample of cold water should be collected from the tap(s) when the water has gone unused for six (6) hours or more.
b.Residential Facility
(1)The tap that serves as the main source of drinking water in a residential dwelling unit must be identified as the water sampling location. Secondary drinking water sources (e.g. bathroom sinks) are not required to be sampled.
c.Non-Residential Facility
(1)All taps that are used for food preparation, cooking, and/or drinking purposes at a non-residential facility must be identified as the sampling location(s). This includes all drinking fountains used by children.
3.Flushed Sample
a.As a minimum, one (1) flushed sample of cold water must be collected by running the tap(s) for approximately one (1) minute, or until the water turns cold. A period of longer than one (1) minute may be required for the water to turn cold in a dwelling unit above the first (1st) floor of a multi-unit building or a child-occupied facility located within a large building. The exact flushing time should be recorded in the lead inspection report.
b.Residential Facility
(1)The tap that serves as the main source of drinking water in a residential dwelling unit must be identified as the water sampling location. Secondary drinking water sources (e.g., bathroom sinks) are not required to be sampled.
c.Non-Residential Facility
(1)All taps that are used for food preparation, cooking, and/or drinking purposes at a non-residential facility must be identified as the sampling location(s). This includes all drinking fountains used by children. A minimum of one (1) tap must be sampled at a child care center even if no tap is reportedly used for food preparation, cooking, or drinking purposes.
F.Lead-Safe Certificate
1.The Lead Inspector who conducted the Comprehensive Environmental Lead Inspection shall issue the following lead certificate, as applicable:
a.A Full Lead-Safe Certificate (Form PBLC-21) when all paint, dust, soil, and water results are below the lead-safe thresholds in § 5.8 of this Part; or
b.A Conditional Lead-Safe Certificate (Form PBLC-15) when all paint, dust, soil, and water results at least meet the conditional lead-safe standards in § 5.8 of this Part (e.g., intact lead-based paint, covered soil); or
c.Between November 1st and March 31st, an Interior Conditional Lead-Safe Certificate (Form PBLC-15-I) when at least the interior paint, dust, and water meet the conditional lead-safe standards in § 5.8 of this Part.
(1)The expiration date of the Interior Conditional Lead-Safe Certificate (Form PBLC-15I), will be the following June 30th; and
(2)The exterior paint hazards must be corrected by the following June 30th and an exterior re-inspection is required on or before June 30th to obtain a Conditional Lead-Safe Certificate (Form PBLC-15); and
(3)Before June 30th, the Lead Inspector who passes the exterior re-inspection shall issue a Conditional Lead-Safe Certificate (Form PBLC-15) and the expiration date of the new Conditional Lead-Safe Certificate (Form PBLC-15), which includes the exterior and soil, will be two (2) years from the date of achieving interior dust wipe clearance.
(4)After June 30th, an LHR Clearance Inspection, including interior dust wipe sampling, is required to obtain a valid Conditional Lead-Safe Certificate (Form PBLC-15).
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.6** Clearance Inspections {#sec-216-ricr-50-15-5-5.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.6}
5.6.1General Requirements
A.The purpose of a clearance inspection is to ensure that lead hazard reduction (LHR), lead hazard control (LHC), or renovation, repair, and painting (RRP) activities:
1.Were performed using lead-safe work practices;
2.Appropriate cleanup was completed;
3.Paint, dust, soil, and/or water testing, as applicable, are performed pursuant to § 5.7 of this Part;
a.The Lead Inspector or Lead Assessor, as applicable, shall wait at least one (1) hour after final cleanup is completed before collecting any dust samples.
4.Paint, dust, soil, and/or water test results, as applicable, meet the lead-safe standards in § 5.8 of this Part; and
5.The child care center, single-family house, dwelling unit and common areas, or work area(s), as applicable, are safe for re-occupancy.
B.A lead Inspector, who performed a clearance inspection where the visual assessment or environmental lead sample results failed to meet the requirements of §§ 5.6 and 5.8 of this Part, shall inform the owner and Lead Supervisor or Lead Renovator, as applicable, of the failure(s) and additional work required prior to repeating the clearance inspection.
5.6.2Lead Hazard Reduction (LHR) Projects
A.General Requirements
1.A Lead Inspector shall conduct an LHR Clearance Inspection pursuant to § 5.6(B) of this Part and § 12.4 of this Subchapter.
2.Surfaces containing lead-based paint which were made intact, covered, removed or replaced as well as lead in dust, soil, or water treatments must all be documented in a lead inspection report.
B.The Lead Hazard Reduction Clearance Inspection must include:
1.A visual assessment to verify that all lead-based paint is intact with no friction or impact surfaces and no visible dust or paint chips remain in the clearance area;
2.Interior dust wipe samples, collected pursuant to §§ 5.5(C) and 5.7.3 of this Part;
3.Soil samples, collected, pursuant to §§ 5.5(D) and 5.7.4 of this Part, in any areas of bare soil not previously determined to meet the lead-safe standards in § 5.8.5 of this Part; and
4.Water sample(s), collected, pursuant to §§ 5.4(E) and 5.7.5 of this Part, in all instances in which lead hazard reduction included repairs or modifications to the plumbing system.
C.If the LHR project is done in phases, a temporary Partial Lead-Safe Certificate (Form PBLC-27) may be issued at the conclusion of each phase of the project to certify that the work area(s) specified on Form PBLC-27 are safe for re-occupancy.
D.For an LHR project done in phases where temporary Partial Lead-Safe Certificates (Form PBLC-27) were issued at the conclusion of each phase of the project, a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21), as applicable, must be issued by the Lead Inspector who conducts the final LHR clearance inspection.
1.The expiration date of the Conditional Lead-Safe Certificate (Form PBLC-15) is two (2) years from the date the dust wipes passed in the dwelling unit. A Renewal Inspection is required every two (2) years.
E.For a Conditional Lead-Safe Certificate (PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21), the LHR clearance area must include the entire single-family house, or dwelling unit and common areas, as applicable.
F.If an initial CELI was not performed prior to the LHR project, a CELI must be performed at the conclusion of the project, in lieu of an LHR Clearance Inspection, to obtain a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21), as applicable.
G.A Lead Inspector who performed an LHR Clearance Inspection must also provide a signed copy of any related lead certificates to the Lead Contractor who performed the work.
5.6.3Lead Hazard Control (LHC) Projects
A.General Requirements
1.A Lead Inspector shall conduct an LHC Clearance Inspection pursuant to and § 5.6 of this Part.
2.Surfaces containing lead-based paint which were made intact, covered, removed or replaced as well as lead in dust, soil, or water treatments must all be documented in a lead inspection report.
B.An LHC Clearance Inspection must include:
1.A visual assessment to verify that all lead-based paint is intact with no friction or impact surfaces and no visible dust or paint chips remain in the clearance area;
2.Interior dust wipe samples, collected pursuant to §§ 5.5(C) and 5.7.3 of this Part;
3.Soil samples, collected pursuant to §§ 5.5(D) and 5.7.4 of this Part, in any areas of bare soil not previously determined to meet the lead-safe standards in § 5.8 of this Part; and
4.Water sample(s) collected pursuant to §§ 5.5(E) and 5.7.5 of this Part, in all instances in which lead hazard control included repairs or modifications to the plumbing system.
C.If the LHC scope of work is limited to certain rooms/areas, components, or media, a temporary Partial Lead-Safe Certificate (Form PBLC-27) may be issued at the conclusion of the work to certify that the work area(s) specified on Form PBLC-27 are safe for re-occupancy.
D.If the LHC project is done in phases, a temporary Partial Lead-Safe Certificate (Form PBLC-27) may be issued at the conclusion of each phase of the project to certify that the work area(s) specified on Form PBLC-27 are safe for re-occupancy.
E.For an LHC project done in phases where temporary Partial Lead-Safe Certificates (Form PBLC-27) were issued at the conclusion of each phase of the project, a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21), as applicable, must be issued by the Lead Inspector who conducts the final LHC clearance inspection.
1.The expiration date of the Conditional Lead-Safe Certificate (Form PBLC-15) is two (2) years from the date the dust wipes passed in the dwelling unit. A Renewal Inspection is required every two (2) years.
F.For a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21):
1.The LHC clearance area must include the entire child care center, single-family house, or dwelling unit and common areas, as applicable.
2.If an initial Comprehensive Environmental Lead Inspection was not performed prior to the LHC project, a CELI must be performed at the conclusion of the LHC project, in lieu of an LHC Clearance Inspection, to obtain a Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21), as applicable.
G.Alternatively, an LHM Inspection may be performed by a Lead Inspector or Lead Assessor, in lieu of an LHC Clearance Inspection, to obtain a Certificate of Lead Conformance (LHM-2-1).
5.6.4Renovation, Repair, and Painting (RRP) Projects
A.A Lead Inspector or Lead Assessor shall conduct an optional RRP Clearance Inspection pursuant to § 5.6 of this Part. Additional information on RRP clearance inspections can be found in the Department guidance document Lead-Safe Work Practices.
B.For a Partial Lead-Safe Certificate (Form PBLC-27), the RRP clearance area(s) must include the contained work area(s), which should be at least six feet (6’) beyond where any lead-based paint was disturbed, plus two feet (2’) beyond the containment area(s), as well as pathways used to access the work area(s), and pathways used to remove waste.
C.The RRP Clearance Inspection must include a visual assessment and enough dust wipe sampling to verify that the work area(s) were adequately cleaned. As a minimum, three (3) dust wipes and one (1) field blank must be collected, pursuant to § 5.7.3 of this Part. Additional information on dust wipes can be found in the Department Guidance document, Lead-Safe Work Practices.
D.The clearance area(s) and scope of work must be clearly specified on the Partial Lead-Safe Certificate (Form PBLC-27).
E.Spot Removal
1.A clearance inspection is not required for spot removal or minor repairs and maintenance activities provided that the work did not include any:
a.Prohibited work practices;
b.Window removal or replacement;
c.Interior mechanical paint removal; or
d.Demolition activities.
5.6.5Renewal Inspections
A.General Requirements
1.A Lead Inspector shall perform a Renewal Inspection pursuant to § 5.6.5 of this Part.
2.The purpose of a Renewal Inspection is to determine that a child care center, single-family house, or dwelling unit and common areas, as applicable, are maintained in a lead-safe condition, free of lead hazards, in order to renew a Conditional Lead-Safe Certificate (Form PBLC-15).
a.A Conditional Lead-Safe Certificate (Form PBLC-15) expires two (2) years from the date of achieving interior dust wipe clearance, as specified on Form PBLC-15.
b.Renewal Inspections are required at regulated facilities every two (2) years, regardless of occupancy.
B.The Renewal Inspection must include:
1.A visual assessment to verify that all lead-based paint is intact with no friction or impact surfaces;
2.Interior dust wipe sampling, collected pursuant to §§ 5.5(C) and 5.7.3 of this Part;
3.Soil sampling, pursuant to §§ 5.5(D) and 5.7.4 of this Part, in any areas of bare soil not previously determined to meet the lead-safe standards in § 5.8 of this Part; and
4.Additional water sampling, pursuant to §§ 5.5(E) and 5.7.5 of this Part, in all instances in where repairs or modifications to the plumbing system were made since the previous lead inspection.
5.6.6Partial Lead Inspections
A.General Requirements
1.A Partial Lead Inspection does not provide the complete evaluations of a Comprehensive Environmental Lead Inspection and cannot serve to determine lead-safe compliance with this Part for a child care center, single-family house, or dwelling unit and common areas.
a.Only a Lead Inspector or Lead Assessor shall conduct a Partial Lead Inspection to identify lead hazards or determine compliance with one (1) or more lead standards in § 5.8 of this Part.
b.A Partial Lead Inspection may be an initial or follow-up inspection.
c.A Partial Lead Inspection may be limited to certain rooms/areas or media.
B.Testing Methods
1.A Lead Inspector or Lead Assessor shall use the approved testing methods for paint, dust, soil, and/or water in § 5.7 of this Part.
C.Lead Certificate
2.A Lead Inspector or Lead Assessor may issue a temporary Partial Lead-Safe Certificate (Form PBLC-27) for any rooms/areas or media that meet the lead-safe standards in § 5.8 of this Part but is not required to do so.
5.6.7Special Requirements for Renovation Repair and Painting (RRP) Testing
A.General Requirements
1.Only a Lead Inspector or Lead Assessor may perform representative testing of painted surfaces to determine the applicability of the RRP Rule.
a.A Lead Inspector or Lead Assessor who performs a Partial Lead Inspection for the purpose of determining the applicability of the RRP Rule, shall complete and sign a Partial Lead Inspection Report, pursuant to all applicable requirements of § 5.6.6 of this Part.
2.A Lead Renovator, who uses EPA-recognized lead test kits or collects paint chip samples to determine the applicability of the RRP Rule, shall test or paint chip sample every affected component.
a.For the purposes of this Part, paint testing by a Lead Renovator to determine the applicability of the RRP Rule is not considered a Partial Lead Inspection.
B.Reporting Requirement
1.The Lead Renovator shall document all information required on an EPA Test Kit Documentation Form or Paint Chip Sample Collection Form, as applicable.
2.The Lead Renovator shall provide a copy of the EPA Test Kit Documentation Form and/or Paint Chip Sample Collection Form to the owner within seven (7) days of the test date or seven (7) days of receipt of the paint chip sample results provided that the samples were received for laboratory analysis within seven (7) days of being collected.
3.If requested, the Lead Renovator shall provide a copy of the EPA Test Kit Documentation Form and/or Paint Chip Sample Collection Form to the Department within seven (7) days of the request.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.7** Environmental Lead Testing Methods {#sec-216-ricr-50-15-5-5.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.7}
5.7.1Approved Testing Methods
A.A Lead Inspector, Lead Assessor, or Lead Renovator is trained and licensed or certified to use one (1) or more of the following testing methods for lead in paint, dust, soil, and/or water:
1.EPA-recognized lead test kit for positive or inconclusive results by a Lead Inspector or Lead Assessor;
2.EPA-recognized lead test kit for applicability of the RRP Rule used by a Lead Renovator;
3.X-Ray Fluorescence (XRF) Analyzer for on-site paint testing by a Lead Inspector or supervised Lead Inspector-in-Training;
4.XRF analysis of dust wipe or soil samples by a person who is ELPAT-accredited as being proficient for lead analysis during the period the dust wipe or soil sample analysis, as applicable, is performed;
5.Paint chip, dust wipe, soil, or drinking water sampling for analysis by a laboratory certified pursuant to § 11.9 of this Subchapter; and/or
6.Any other method approved in writing by the Department.
Approved Lead Testing Methods
Paint
Dust
Soil
Water
EPA recognized Lead Test Kit
Lead Assessor
Lead Inspector
Supervised Lead Inspector-in-Training
Certified Lead Renovator
Not Applicable
Not Applicable
Not Applicable
XRF Analyzer
Lead Inspector
Supervised Lead Inspector-in-Training
ELPAT-accredited person
ELPAT-accredited person
Not Applicable
Lead Sampling for Laboratory Analysis
Lead Assessor
Lead Inspector
Supervised Lead Inspector-in-Training
Certified Lead Renovator
Lead Assessor
Lead Inspector
Supervised Lead Inspector-in-Training
Lead Assessor
Lead Inspector
Supervised Lead Inspector-in-Training
Lead Assessor
Lead Inspector
Supervised Lead Inspector-in-Training
5.7.2Paint
A.General Requirements
1.The construction date of the subject building, dwelling, and/or accessory structure(s) must be determined:
a.For the purposes of this Part, all painted surfaces constructed after January 1, 1978 (post-1978) are assumed to be below the lead-safe thresholds in § 5.8 of this Part, unless proven otherwise; testing is not required.
b.For the purposes of this Part, all painted surfaces constructed before January 1, 1978 (pre-1978) must be assumed to exceed the lead-safe threshold in § 5.8 of this Part, unless proven otherwise; testing is required to determine if the lead concentration is below the lead-safe thresholds in § 5.8 of this Part.
2.Only a Lead Inspector or Lead Assessor may group together building components which have the same painting histories into a single representative test in one (1) building, dwelling, dwelling unit, common area, or accessory structure, as applicable.
a.Painted fixtures which are physically attached to the premises must be included.
3.A Lead Renovator shall test each component that will be disturbed by renovation, repair, and painting (RRP) activities, either by using a lead test kit or by collecting a paint chip sample for laboratory analysis.
(1)Painted fixtures which are physically attached to the premises must be included.
4.For the purposes of this Part, a surface coating is lead-based paint if a single testing method is positive for lead when multiple testing methods are used (i.e. lead test kit, XRF Analyzer, or laboratory analysis of a paint chip sample).
B.Lead Test Kits
1.EPA-recognized lead test kits may be used by a certified Lead Renovator in accordance with the manufacturer’s instructions to confirm the presence of lead-based paint, either to show that damaged paint is a lead hazard or to show whether the Renovation, Repair, and Painting (RRP) Rule applies to the tested surface.
a.EPA-recognized lead test kits may be used by a Lead Inspector or Lead Assessor to confirm the presence of lead-based paint to show that damaged paint is a lead hazard. A Lead Inspector or Lead Assessor shall not damage intact paint to use a lead test kit.
2.Test kits may not be used to determine lead-safe status, to determine eligibility for exemption from the Lead Disclosure Rule or the Lead Safe Housing Rule, or to serve as the basis for a Full Lead-Safe Certificate (Form PBLC-21).
C.Paint Chip Sampling
1.A Lead Inspector or Lead Assessor shall collect paint chip samples for laboratory analysis by collecting a minimum of one (1) sample from each testing combination that is the minimum weight or area required by the analyzing laboratory.
2.A Lead Renovator shall collect paint chip samples by collecting a sample that is the minimum weight or area required by the analyzing laboratory from each building component that will be affected by renovation, repair, and painting (RRP) activities.
3.Paint samples must be removed in a manner that minimizes the possibility of creating lead-contaminated dust or debris and immediately cleaning any dust or debris, if generated, and repairing the surface from which the paint sample was collected, if necessary.
4.Alternatively, paint chip samples may be collected pursuant to the EPA RRP Program Paint Chip Sample Collection Guide and reported as milligrams per square centimeter (mg/cm2).
D.XRF Testing
1.A Lead Inspector or supervised Lead Inspector-in-Training shall successfully complete radiation safety training approved by the Department before operating or transporting an XRF Analyzer in Rhode Island.
2.A Lead Inspector or supervised Lead Inspector-in-Training shall use an XRF Analyzer for on-site measurements of painted surfaces in accordance with the most current EPA/HUD XRF Performance Characteristic Sheet (PCS) for that instrument.
3.A Lead Inspector or supervised Lead Inspector-in-Training shall operate an XRF under a currently valid specific or general radioactive materials license for the XRF instrument used, in accordance with the Department’s Rules and Regulations for the Licensing of Radioactive Material (Part 40-20-7 of this Title).
4.A Lead Inspector or supervised Lead Inspector-in-Training, using an XRF instrument in Rhode Island with a radioactive materials license issued by another jurisdiction, shall follow the reciprocity provisions of the Department’s Rules and Regulations for the Licensing of Radioactive Material (Part 40-20-7 of this Title).
5.The manufacturer, model number, and serial number of the XRF Analyzer and results of all calibration verification checks for a lead inspection must be recorded in the lead inspection report.
5.7.3Dust
A.General Requirements
1.Dust wipe samples must represent a "worst case" situation and, for floors, the samples must be collected from areas nearest entries, in high traffic areas, under windows, and in areas frequently used by children.
2.For clearance inspections, dust wipe samples must be collected in work areas, adjacent to work areas, as well as pathways used to access work areas and pathways used to remove waste.
3.Additional sampling may be conducted pursuant to the current HUD Guidelines for the Evaluation and Control of Lead Based Paint Hazards in Housing.
B.Dust Wipe Sampling
1.A Lead Inspector or Lead Assessor shall collect single surface dust wipe samples in accordance with:
a.The current HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing Appendix 13.1 Wipe Sampling of Settled Dust for Lead Determination and the sampling material requirements of the analyzing laboratory; or
b.Active Standards ASTM E1728/E1728M Standard Practice for Collection of Settled Dust Samples Using Wipe Sampling Methods for Subsequent Lead Determination and ASTM E1792 Standard Specification for Wipe Sampling Materials for Lead in Surface Dust.
C.Field Blank
1.Every day for each building, the Lead Inspector or Lead Assessor shall prepare one (1) field blank prior to leaving the building where dust wipe samples are collected.
2.The purpose of the field blank is to identify errors or contamination in supplies, sample collection, or analysis. If the field blank result is not below the reporting limit of the analyzing laboratory, then all dust wipe sample results from the subject building are considered invalid, for the purposes of this Part, and must be repeated in their entirety.
5.7.4Soil
A.For each soil sample, the Lead Inspector or Lead Assessor shall collect the soil samples from the top half inch (0.5”) of soil using a clean spade, auger, centrifuge tube, or by hand while wearing a new, clean pair of powderless disposable gloves.
1.A soil sample may be an individual (“grab”) sample or a composite sample.
2.A composite sample must incorporate equal amounts of subsamples which are representative of the sampling area.
5.7.5Water
A.General Requirements
1.A Lead Inspector or Lead Assessor shall:
a.Ensure that no water has been used for at least six (6) hours for a first-draw sample; or
b.The exact flushing time must be recorded in the inspection report for a flushed sample; and
c.Indicate in the inspection report whether flushing is required to meet the lead-safe standard in § 5.8.5 of this Part.
B.Residential Water Sampling
1.A Lead Inspector or Lead Assessor shall:
a.Sample the tap which is most frequently used if there are multiple taps in the inspection area; and
b.Sample the water directly from the tap if a faucet- mounted water filter is present.
C.Non-Residential Water Sampling
1.Water sampling in schools should be conducted in accordance with the EPA 3Ts for Reducing Lead in Drinking Water in Schools or the most current EPA non-residential water sampling protocol.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.8** Environmental Lead Standards {#sec-216-ricr-50-15-5-5.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.8}
5.8.1Lead Mitigation Standards
A.All lead-based paint, including pre-1978 painted surfaces required to be assumed positive, must be intact with no paint or coating on a damaged or deteriorated component; no surface which has loose, delaminating, flaking, peeling, chipping, chalking, or blistering paint; no paint that is otherwise becoming separated from the substrate; no paint which is abraded by friction or impact, shows evidence of teeth marks, or is damaged by water;
B.All surfaces must be clean and free of lead dust, paint chips or debris; and
C.All horizontal surfaces except ceilings (e.g. floors, stairs, window sills, window wells) must be covered with a smooth, cleanable covering or coating.
5.8.2Lead-Safe Standards
A.All painted surfaces constructed after January 1, 1978 (post-1978) are assumed to be below the lead-safe threshold shown in § 5.8.5 of this Part, unless proven otherwise; paint testing is not required.
B.For post-1978 construction, dust, soil, and water testing are required to determine if these media are below the lead-safe thresholds shown in § 5.8.5 of this Part.
C.All painted surfaces constructed before January 1, 1978 (pre-1978), must be assumed to exceed the lead-safe threshold shown in § 5.8.5 of this Part, unless proven otherwise.
F.For pre-1978 construction, paint, dust, soil, and water must be tested to determine if these media are below the lead-safe thresholds shown in § 5.8.5 of this Part.
G.A Full Lead-Safe Certificate (Form PBLC-21) documents that the lead concentrations in all media (paint, dust, soil, and water) at a child care center, dwelling, or dwelling unit and common areas are below the lead-safe thresholds shown in § 5.8.5 of this Part and no action is required.
5.8.3Conditional Lead-Safe Standards
A.Intact paint, above the lead-safe thresholds shown in § 5.8.5 of this Part, is conditionally lead safe and constitutes a potential lead exposure hazard if the paint is disturbed, vulnerable to friction or impact, or the intact paint condition is not maintained.
B.Covered soil, above the lead-safe threshold shown in § 5.8.5 of this Part, is conditionally lead safe and constitutes a potential lead exposure hazard if the soil is disturbed, the ground covering is not maintained or is vulnerable to erosion.
C.Ongoing monitoring, routine repair and maintenance, and renewal inspections are required to maintain a Conditional Lead-Safe Certificate (Form PBLC-15) when the lead concentrations in paint and/or soil exceed the lead-safe thresholds shown in § 5.8.5 of this Part.
D.Intact paint and/or covered soil that were not tested may be considered conditionally lead safe for as long as the intact paint condition and/or soil coverings are maintained.
5.8.4Lead Hazard Standards
A.Lead hazard means that the lead concentrations in paint, dust, soil, and/or water are above the lead-safe thresholds shown in § 5.8.5 of this Part.
1.Damaged paint, interior dust, bare soil, and/or drinking water above the lead-safe thresholds shown in § 5.8.4 of this Part constitute immediate lead exposure hazards which require corrective action to a lead-safe concentration or condition at a regulated facility, pursuant Part 12 of this Subchapter.
B.Damaged paint and/or bare soil that were not tested must be assumed to constitute a lead hazard requiring corrective action to at least a lead-safe condition.
5.8.5Environmental Lead Standards
Media
Lead Safe
Conditionally Lead Safe
Lead Hazard
Paint
All Paint
Intact Paint
Damaged Paint
< 5,000 ppm
< 1.0 mg/cm2
= 5,000 ppm
= 1.0 mg/cm2
= 5,000 ppm
= 1.0 mg/cm2
Dust
Floors
< 5 µg/ft2
N/A
= 5 µg/ft2
Sills
< 40 µg/ft2
N/A
= 40 µg/ft2
Wells
< 100 µg/ft2
N/A
= 100 µg/ft2
Any Other Surface
< 10 µg/ft2
N/A
= 10 µg/ft2
Soil
All Soil
Covered Soil
Bare Soil
< 400 ppm
= 400 ppm
= 400 ppm
Water
< 15 ppb
N/A
= 15 ppb
A.Lead clearance standards are lead concentrations or conditions that meet the full lead-safe or conditional lead-safe standards and are less than the lead hazard concentrations and conditions shown in § 5.8.5 of this Part.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
##### **216-RICR-50-15-5 § 5.9** Severability {#sec-216-ricr-50-15-5-5.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-5#5.9}
A.The provisions of this Part shall be liberally construed and shall be held to be in addition to, and not in substitution for or a limitation of, the provisions of any other Regulation or law. If any provision or part thereof of this Part or application thereof to any person or circumstance is held unconstitutional or otherwise invalid, the remainder of this Part and the application of such provisions to any other persons or circumstances other than those to which it is held invalid shall not be affected thereby.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-03 to 05/24/2026*
#### **216-RICR-50-15-11** Lead Training, Certification and Licensing
##### **216-RICR-50-15-11 § 11.1** Authority {#sec-216-ricr-50-15-11-11.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.1}
A.These Regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws Chapters 23-1, 23-24.6, and 42-128.1 and 40 C.F.R Part 745 for the purpose of establishing the requirements for licensing or certification of lead training courses, lead inspectors, lead inspectors-in-training, lead assessors, lead contractors, lead supervisors, lead workers, and lead renovation firms.
B.The following Regulations also provide procedures related to this Part:
1.Rules and Regulations Pertaining to the Fee Structure for Licensing Laboratory and Administrative Services provided by the Department of Health (Part 10-05-2 of this Title);
2.Rules and Regulations Pertaining to Reporting of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title);
3.Rules and Regulations for Certifying Analytical Laboratories (Part 60-05-5 of this Title);
4.Rules and Regulations for Clinical Laboratories and Stations (Part 60-05-4 of this Title);
5.Rules and Regulations Pertaining to Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title);
6.Rules and Regulations Relating to Equal Access to Justice (Part 10-05-3 of this Title);
7.Rules and Regulations Governing Lead Hazard Mitigation (860-RICR-00-00-2);
8.Lead Poisoning Prevention Compliance and Enforcement (Part 3 of this Subchapter);
9.Lead Inspections (Part 5 of this Subchapter); and
10.Lead Safe Work Practices (Part 12 of this Subchapter);
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.2** Definitions {#sec-216-ricr-50-15-11-11.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.2}
A.Wherever used in this Part, the terms listed below shall be construed in the following manner:
1."Act" means R.I. Gen. Laws Chapter 23-24.6, Lead Poisoning Prevention.
2.“Approved” means approved by the Department, State, or local authority having legal and administrative authority for such.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Rhode Island Department of Health or his or her agents, subordinates to whom the Director has delegated the powers and duties vested in the Director by these Regulations.
5.“Employ” means to use or engage the services of someone.
6.“Environmental lead” means, for the purposes of this Part, inorganic lead contained in paint, dust, soil, and/or water.
7.“EPA” means the United States Environmental Protection Agency.
8.“Hands-on training or activities” means a training activity that involves active participation; applied, as opposed to theoretical, i.e. the hands-on portion of a lead training course which allows the student to practice specific techniques in a simulated or actual setting with equipment and supplies typically used in the profession. Hands-on training, by definition, must be completed in person.
9.“HUD” means the United States Department of Housing and Urban Development.
10.“Lead assessor” means a person, either authorized to act as an enforcing officer under the housing code or a designated employee of a federal, state or municipal agency with jurisdiction over housing, occupational health, child welfare and/or environmental standards who successfully completed a Lead Assessor training course and obtained a license, pursuant to this Part, to conduct lead inspections within the purview of their employment.
11.“Lead contractor” means any person or entity engage in lead hazard reduction as a business and licensed pursuant to this Part.
12.“Lead hazard” means a condition that presents a clear and significant health risk to occupants of a child care facility, single-family house, dwelling unit and common areas, or premises, particularly where children reside. Lead concentrations in damaged paint, interior dust, bare soil, and/or drinking water which exceed the lead-safe thresholds in § 5.8 of this Subchapter are an immediate lead exposure hazard requiring corrective action at a regulated facility.
13.“Lead hazard control” or “LHC” means any window replacement and/or interim controls intended to correct lead hazards identified in a lead inspection report or standard treatments to remove lead-based paint and/or minimize lead exposure, which may include measures to reduce the concentration of lead in paint, dust, soil, and/or water using approved treatment methods specified in Part 12 of this Subchapter.
14.“Lead hazard reduction” or “LHR” means, as defined by R.I. Gen. Laws § 23-24.6-4, any action or actions designated to reduce exposure to toxic levels of lead which impose an unacceptable risk or exposure in any dwelling or dwelling unit, where a child under the age of six (6) years, with environmental intervention blood lead level or greater resides, or on any premises and may include, but is not limited to: repair, enclosure, encapsulation, or removal of lead based paint and/or lead contaminated dust, soil, or drinking water; relocation of occupants; and cleanup measures or ongoing maintenance measures, which may include activities and/or measures that do not present an undue risk to children under age six (6).
15.“Lead inspection” means any type of physical investigation of a child care facility single-family house, dwelling unit, or premises to identify the presence of environmental lead, lead hazards, or compliance with the cleaning requirements and lead standards in § 5.8 of this Subchapter for paint, dust, soil, and/or water.
16.“Lead inspector” means an individual, who successfully completed a certified Lead Inspector training course, passed the Lead Inspector Department examination, completed a supervised field apprenticeship, and obtained a license, pursuant to this Part, to conduct lead inspections.
17.“Lead inspector-in-training” means an individual who successfully completed a certified Lead Inspector training course, passed the Lead Inspector Department examination, and obtained a license, pursuant to this Part, to conduct a supervised apprenticeship to meet the requirements for a Lead Inspector license.
18.“Lead professional” means an occupational grouping of individuals and organizations licensed or certified pursuant to this Part.
19.“Lead renovation firm” means any person or organization engaged in renovation, repair, and painting (RRP) or lead hazard control (LHC) as a business and licensed pursuant to this Part.
20.“Lead renovator” means an individual who successfully completed a certified Lead Renovator training course and obtained a valid training certificate, pursuant to this Part, to perform renovation, repair, and painting (RRP) and lead hazard control (LHC) work.
21.“Lead supervisor” means an individual who successfully completed a certified Lead Supervisor training course, passed the Lead Supervisor Department examination, and obtained a license, pursuant to this Part, to perform and/or supervise lead hazard reduction (LHR) work.
22.“Lead training course” or “LTC” means a lead training course certified by the Department to meet the training prerequisite of a specific lead professional license issued by the Department or the certification requirement of a Lead Renovator.
23.“Lead worker” means an individual who successfully completed a certified Lead Worker training course and obtained a license, pursuant to this Part, to perform lead hazard reduction work.
24.“License” means an authorization granted by the Department to engage in a business or occupation that is subject to regulation by the Department. For the purposes of this Part, a registration, certification, permit or similar authorization issued by the Department is also considered to be a license.
25.“Occupant” means, as defined by R.I. Gen. Laws § 23-24.6-4, any person who legally resides in, or regularly uses, a dwelling, dwelling unit, or structure; provided, however, that a guest of any age shall not be considered an occupant for the purposes of this Chapter.
26.“Owner” means, as defined by R.I. Gen. Laws § 23-24.6-4, any person who, alone or jointly or severally with others:
a.Shall have legal title to any dwelling or dwelling unit with or without accompanying actual possession of it; or
b.Shall have charge, care, or control of any dwelling or dwelling unit as owner or agent of the owner or an executor, administrator, trustee, or guardian of the estate of the owner. Any person representing the actual owner shall be bound to comply with the provisions of this Chapter and with Rules and Regulations adopted pursuant to this Chapter to the same extent as if that person were the owner. An agent of the owner excludes real estate and property management functions where the agent is only responsible for the property management and does not have authority to fund capital and/or major property rehabilitation on behalf of the owner.
c.For purposes of publicly owned property only, the owner shall be defined to be the Chief Executive Officer of the municipal or State agency which owns, leases or controls the use of the property.
27.“Person” means any individual, partnership, firm, corporation, association, or organization, including municipal and State agencies.
28.“Renovation” means the modification of any existing structure, or portion thereof that results in the disturbance of lead-painted surfaces, unless that activity is performed as part of a lead hazard control (LHC) or lead hazard reduction (LHR) project. The term renovation includes, but is not limited to: the removal, modification or repair of painted surfaces or painted components (e.g. modification of painted doors, surface restoration, window repair); surface preparation activities such as sanding, scraping, or other such activities which may generate paint dust; the removal of building components (e.g. walls, ceilings, plumbing, windows); weatherization projects (e.g. cutting holes in painted surfaces to install blown-in insulation or to gain access to attics, planning thresholds to install weather-stripping); and interim controls that disturb lead-painted surfaces. A renovation performed for converting a building, or part of a building, into target housing or child care facilities is a renovation under this Part. The term renovation does not include minor repair and maintenance activities.
29.“Renovation, repair, and painting project” or “RRP project” means a project which is being done by a Lead Renovation Firm for purposes other than removing lead-based paint or correcting lead hazards (although it may result in this). The purpose of an RRP project is to ensure that that renovations performed at a regulated facility or for compensation at target housing are done safely and prevent lead exposure to owners, occupants and neighbors of the property where the work is performed. Any additional work which disturbs lead-based paint, other than emergency renovation operations, performed in the same room or area within the same thirty (30) day period must be considered the same RRP project for the purpose of determining whether the work is spot removal or renovation, repair, and painting (RRP).
30.“Supervised lead inspector-in-training” means a Lead Inspector-in-Training who is performing a field apprenticeship under the direct on-site supervision of a Department-approved Lead Inspector for the purpose of meeting the Lead Inspector licensing requirements of this Part.
31.“Temporary training facility” or “temporary training location” means a non-permanent training location approved by the Department for a lead training course certified pursuant to this Part.
32.“Training hour” means at least fifty (50) minutes of actual learning, including, but not limited to, time devoted to lecture, learning activities, demonstrations, evaluations, and hands-on experience.
33.“Training provider” means a person offering or conducting a lead training course certified pursuant to this Part.
34.“Treatments” means any methods designed to control or reduce lead exposure hazards. Treatments include lead abatement, interim controls, or a combination of both.
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.3** Certification Requirements for Lead Training Courses {#sec-216-ricr-50-15-11-11.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.3}
11.3.1Training Providers
A.A training provider shall employ the following:
1.A training manager, qualified pursuant to § 11.3.2 of this Part;
2.One (1) or more individuals qualified as principal instructors pursuant to § 11.3.3 of this Part;
3.One (1) or more individuals with work experience as a Lead Supervisor, Lead Worker, or Lead Renovator to teach the hands-on portion of a Lead Renovator training course;
4.One (1) or more individuals with work experience as a Lead Supervisor to teach the hands-on portion of a Lead Supervisor or Lead Worker training course;
5.One (1) or more individuals with work experience as a Lead Inspector/Lead Assessor to teach the hands-on portion of a Lead Inspector or Lead Assessor training course.
6.Enough instructors to ensure that the student-to-instructor ratio for the hands-on training activities will not be greater than:
a.Eight to one (8:1) for a Lead Supervisor, Lead Worker, or Lead Renovator training course; or
b.Six to one (6:1) for a Lead Inspector or Lead Assessor training course.
B.A training provider shall provide training site(s) with adequate facilities and training equipment, pursuant to § 11.3.6 of this Part, for the delivery of the course curriculum, including, but not limited to, lectures, power point presentations, demonstrations, hands-on training, and the course test.
C.A training provider shall notify the Department of all scheduled, canceled, and completed Lead Training Courses, pursuant to § 11.3.8 of this Part.
D.A training provider shall issue a unique course completion certificate, pursuant to § 11.3.11 of this Part, to each individual who successfully completes a Lead Training Course.
E.A training provider shall permit the Department to audit any Lead Training Course, certified pursuant to this Section, and/or inspect all applicable records required in § 11.3.12 of this Part.
F.A training provider shall not combine refresher and initial training courses and must maintain separate course certifications.
11.3.2Training Managers
A.Training Manager Qualifications
1.The training manager shall meet the following education, training, and work experience requirements:
a.Successful completion of a “Train the Trainer” course approved by the Department; and
b.Experience, education, or training in lead inspections, lead hazard remediation, asbestos abatement, other related construction trades, industrial hygiene, occupational safety and health, or other related fields; and
c.A bachelor’s or graduate degree in education, public health, industrial hygiene, occupational safety and health, engineering, building construction, or a related field; or
d.A general education diploma (GED) or high school diploma and at least three (3) years of experience in managing a training program specializing in environmental hazards or occupational safety and health; or
e.A GED or high school diploma and at least three (3) years of experience, education, or training in designing, implementing and evaluating either employee educational programs or vocational educational programs for adults.
2.A training manager who meets the qualifications of § 11.3.2(A) of this Part may also be a principal instructor.
3.A training manager who meets the qualifications of §§ 11.3.2(A)(1)(c), (d) or (e) of this Part, as applicable, may also be a hands-on instructor.
B.Training Manager Responsibilities
1.Responsibilities of the training manager include the following:
a.All communications with the Department;
b.Ensuring that the certified Lead Training Course complies with all requirements of this Section;
c.Developing and implementing a quality control plan;
d.Development of the curriculum and organization of the course material, if using the training provider’s own curriculum;
e.Designation and oversight of a principal instructor for each class;
f.Ensuring the qualifications of all hands-on instructors;
g.Conducting and documenting an annual review of the competency of each instructor;
h.Maintaining the validity and integrity of the hands-on skills assessment to ensure that it accurately evaluates the student’s performance;
i.Maintaining the validity and integrity of the course test to ensure that it accurately evaluates the student’s knowledge and retention of the course topics;
j.Ensuring compliance with the Department’s Licensing of Radioactive Material (Part 40-20-7 of this Title), when applicable;
k.Providing the Department with a pre-certification inspection of the training facility, teaching methods and materials, and hands-on equipment and supplies; and
l.Maintaining timely course offering information and downloading all required completed course information into the Department’s electronic reporting system, or other manner approved by the Department, pursuant to § 11.3.11 of this Part; and reporting and recordkeeping requirements pursuant to § 11.3.12 of this Part.
11.3.3Principal Instructors
A.Principal Instructor Qualifications
1.Each principal instructor shall meet the following education, training, and work experience requirements:
a.A GED, high school diploma, or higher degree;
b.Experience, education or training in teaching adults;
c.Experience, education, or training in lead inspections, lead hazard remediation, asbestos abatement, other related construction trades, industrial hygiene, occupational safety and health, or other related fields;
d.Successful completion of a related initial lead professional training course approved by the Department;
e.Successful completion of a related lead professional review course, completed by the instructor within the three (3) year period prior to submission of the application; and
f.Successful completion of a “Train the Trainer” course approved by the Department; and
g.For non-English courses, the principal instructor must be fluent in both English and the language in which the course is offered.
2.A principal instructor who meets the qualifications of §§ 11.3.2(A)(1)(c), (d) or (e) of this Part, as applicable, may also be a hands-on instructor.
B.Principal Instructor Responsibilities
1.Responsibilities of the principal instructor for each course include the following:
a.Teaching the course content and/or being physically present during all course instruction, including guest instructors and hands-on training activities;
b.Oversight of all guest instructors;
c.Verifying each student’s identity;
d.Assessing the student’s proficiency of the hands-on activities;
e.Administering the final course test;
f.Certifying all student records for performance and attendance;
g.Ensuring that students complete the course evaluation; and
h.Reporting any course deficiencies or training issues and providing feedback to the Training Manager regarding potential improvements.
11.3.4Application Requirements
A.General Requirements
1.A separate lead training course application, provided by the Department, must be submitted for each lead training course which includes all information required on the application form and documentation of each applicable checklist item in paper and electronic format.
2.The application must demonstrate compliance with the requirements of § 11.3.4 of this Part to the satisfaction of the Department. If the Department determines that the application does not meet the requirements of this Section, the applicant will have thirty (30) days from the date of the Department’s request to adequately respond to deficiencies in the application.
3.The certification will expire on the last day of the month, four (4) years from the date of issuance or renewal, unless sooner surrendered, suspended, or revoked.
4.The application package, including but not limited to any supporting documentation, must be submitted to the Department, in the form and manner approved by the Department.
B.Initial Application
1.An initial application must be submitted for review and approval by the Department at least ninety (90) days prior to the first Lead Training Course offering.
2.A pre-certification inspection may be required prior to final approval of the initial application.
C.Renewal Application
A complete renewal application must be submitted for review and approval by the Department at least sixty (60) days prior to the expiration of the current course certification.
D.Application Amendments
1.Changes to the training provider’s contact information must be submitted in writing within thirty (30) days of the changes.
2.Training provider-initiated changes or additions to training personnel, training facilities, curriculums, or any other course materials or equipment require submission of an amended application, at least thirty (30) days in advance of the proposed change(s), for review and approval by the Department.
a.Each application must include a description of any changes to the training facility or course materials since the previous application was reviewed and approved.
b.Each application must include all items required in the lead training course checklist in electronic format. Paper copies of only those items that changed since the previous application submittal are required for review and approval by the Department.
3.The Department reserves the right to require changes to any lead training course curriculum and/or course test when significant changes in legislation, Regulations, research, policies, etc. warrant revisions. Notification of Department-initiated changes requires an implementation date not to exceed thirty (30) days from the date of the notification.
11.3.5General Requirements for Lead Training Course Curriculums
A.The Lead Worker, Lead Supervisor, Lead Assessor, Lead Renovator and Lead Inspector training courses must all include, as a minimum, instruction on the following topics as applicable to the specific license:
1.Basic background information on lead, including, but not limited to history of lead usage, sources of environmental lead contamination (e.g. paint, dust, water, soil), and other sources of lead exposure (e.g. ceramics, folk remedies, hobbies, occupational exposure);
2.Health effects of exposure to lead including, but not limited to, how lead enters the body, how lead affects the body, symptoms and diagnosis of lead toxicity, blood lead levels of concern, and treatments for lead poisoning;
3.Overview of applicable Department, HRC, DEM, EPA, HUD, and OSHA lead Regulations, including significant definitions;
4.Overview of all environmental lead professional licenses issued by the Department, including the authority and restrictions of each one;
5.Department-regulated facilities, persons, and activities;
6.Department-approved lead testing methods and lead standards;
7.Lead hazard identification, prioritization, and treatment options;
8.Community relations, occupant protection, and worksite containment;
9.Introduction to worker protection including medical monitoring, personal protective equipment, respirator fit tests, and air monitoring;
10.Prohibited work practices, approved work practices, waste storage and disposal requirements;
11.Cleaning procedures, clearance inspections, and lead certificates;
12.Available guidance, policies, and public educational materials; and
13.Other topics as required by EPA/HUD and/or the Department.
B.All initial lead training courses must have a hands-on skills assessment and all lead training courses must have a final course test.
C.Additional topics for specific lead professional licenses are delineated in the Department’s Lead Training, Certification, and Licensing Guidance document.
D.Additional details on applications for non-English lead training courses are delineated in the Department’s Lead Training, Certification, and Licensing Guidance document.
11.3.6Training Facilities
A.Facility Requirements
1.Training facilities must be conducive to learning, including, but not limited to, the following (when applicable):
a.Adequate seating, lighting, temperature control, and hygiene facilities;
b.Adequate electronic equipment and sound system for power point presentations and videos;
c.Adequate space and equipment for hands-on activities;
d.Availability of utilities and water required for hands-on activities, if applicable; and
e.Meeting all State and local safety and fire codes.
B.Adding or Deleting a Facility
1.A training provider shall notify the Department in writing at least thirty (30) days prior to either:
a.Adding a permanent or temporary training location; or
b.Vacating a previously approved permanent or temporary training location.
2.A training provider shall either add or delete the training facility in the Department’s electronic training reporting system.
a.New approved locations must be added in the reporting system within seven (7) days.
b.Vacated training locations must be deleted from the reporting system within thirty (30) days of vacating.
B.The Department reserves the right to inspect any facility and/or equipment prior to final approval of the application.
11.3.7Alternatives to Classroom Training
A.For any lead training course, a training provider may propose using novel training approaches, such as online training, as part of their curriculum for the classroom portion of the training.
1.In addition to complying with all course content requirements established by this Part, an electronic-learning (e-learning) format lead training course must follow the EPA Learning Management System requirements for providing the e-learning component content, as well as the Department’s technical guidance for e-learning.
2.Live, interactive virtual conferencing training sessions must have an in-person hands-on component in accordance with the EPA Learning Management System requirements for e-learning. The hands-on training activities, skills assessment, and course test must be completed in person.
3.The application submittal must include a copy of the e-learning component in the form of a CD and/or a link to the webpage with login and password.
4.A direct instructor-student contact of at least one (1) training hour must be provided for questions and review.
5.The hands-on training activities, skills assessment, and course test must be completed in person.
11.3.8Course Notification Requirements
A.A training provider shall notify the Department, in a manner approved by the Department, of all in-person and virtual conferencing lead training courses as soon as a course has been scheduled and not less than seven (7) days prior to the scheduled start date. The notification must include the information specified in § 11.3.11(B) of this Part for each course.
B.If it becomes necessary to cancel or reschedule a course for which a notification has been submitted to the Department pursuant to this Section, the training provider shall notify the Department not less than forty-eight (48) hours prior to the scheduled start date.
C.A training provider shall notify the Department of all completed in-person lead training courses within seven (7) days of completion. The notification must include the information specified in § 11.3.11 of this Part for each student who registered for or attended the course.
1.For pre-recorded online courses, pre-training notification is not required.
2.For pre-recorded online courses, post-training notification is required. A training provider may submit post-training notifications to the Department on a monthly basis, by the seventh (7th) day of the following month, which includes the information specified in § 11.3.11 of this Part for each student who completed the course in the previous month.
11.3.9Hands-on Skills Assessment
A.The principal instructor shall administer a hands-on skills assessment, if applicable, at the completion of each course.
B.Instructors shall allow each student to practice the required hands-on activity steps. The instructor shall watch each student, make corrections and suggestions as the steps proceed, and determine if additional practice is necessary.
C.The principal instructor shall evaluate the work of each student and once the student can complete a skill set correctly, the principal instructor shall indicate by name that the student is proficient for that skill set on a participant progress log.
D.The principal instructor shall document in writing each skill set for which a student has demonstrated proficiency. Once the student has demonstrated proficiency for all required hands-on activities, the principal instructor shall sign a verification that the student successfully completed the hands-on portion of the Lead Training Course.
E.Each student must successfully complete the hands-on skills assessment, if applicable, in order to receive a course completion certificate.
11.3.10Final Course Test
A.The principal instructor shall administer a written course test at the completion of each course.
B.A maximum of one (1) training hour is allowed for the course test.
C.The principal instructor shall document the student’s responses and the circumstances under which an oral course test is given to Lead Renovators or Lead Workers instead of a written test. The oral test must be reviewed and approved by the Department in advance.
D.Each student must receive a passing score of at least seventy percent (70%) on the course test in order to receive a course completion certificate.
11.3.11Training Reporting System
A.All providers of Department-certified lead training courses shall report the training information, including but not limited to, training course, student information, and training certificate information, in a manner that is authorized by the Department.
1.Training Certificate
a.A training provider shall issue a unique course completion certificate to everyone who completes a Lead Training Course and passes the hands-on skills assessment and course test.
b.The course completion certificate must include, as a minimum:
(1)A unique identification number;
(2)Full name and address of the student;
(3)Lead training course and Department certification (LTC#);
(4)Date(s) of the course and date that the individual passed the course test, if other than the last day of the course;
(5)Expiration date of the certificate;
(6)Name, address, and telephone number of the training provider; and
(7)Language in which the training course was given. If the course test was in a language other than written English, the language and method of evaluation must also be included.
(8)For Lead Renovator Training Courses, the completion certificates must contain a photograph of the student pursuant to 40 C.F.R. Part 745.
c.The course completion certificate must be provided to each student within seven (7) days of the course end date or the date that the student passed the course test, if other than the last day of the course.
11.3.12Recordkeeping
A.A training provider shall maintain, and make available to the Department upon request, a complete copy of the lead training course application submission(s) for each lead training course certification.
B.A training provider shall maintain, and make available to the Department, upon request, the following records for each lead training course offering:
1.Lead training course and Department certification (LTC#);
2.Date(s) and location(s) of course;
3.Principal instructor and guest instructors, if any;
4.Class roster (including daily class attendance records bearing the signature of the principal instructor);
5.Verification of student identity in the form of a current State driver’s license, valid State photo ID card, or passport;
6.Actual course tests, answer keys, and dates each test was given;
7.Results of hands-on skills assessments and course tests;
8.Information regarding how the hands-on assessment was conducted including, but not limited to:
a.The instructor who conducted the assessment;
b.Evaluation criteria; and
c.Facilities, equipment, and supplies utilized.
9.Lead training course evaluations.
C.A training provider shall maintain these records for at least five (5) years from each course end date or the date a student passed the course test, if other than the last day of the course.
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.4** Licensing Requirements for All Lead Professionals {#sec-216-ricr-50-15-11-11.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.4}
11.4.1Persons Required to be Licensed or Certified
A.Persons who offer or conduct any lead training course for the purpose of licensure or certification as a lead professional in Rhode Island require a certification from the Department, in accordance with § 11.3 of this Part, for each lead training course.
B.The lead professional license requirements of this Part are applicable to those organizations, including sole proprietorships and self-employed individuals, applying to be licensed as a:
1.Lead Renovation Firm; or
2.Lead Contractor.
C.The lead professional license requirements of this Part are applicable to those individuals applying to be licensed as a:
1.Lead Supervisor;
2.Lead Worker;
3.Lead Inspector;
4.Lead Inspector-in-Training; or
5.Lead Assessor.
11.4.2General Requirements
A.No person shall perform or offer to perform any lead professional services unless that person is specifically trained, certified, licensed, and/or approved by the Department to do so.
B.No person shall employ another person to perform any lead professional services unless that person is specifically trained, certified, licensed, and/or approved by the Department to do so.
C.Any person licensed by the Department to perform lead professional services shall include their applicable license number in all offers and/or advertisements to perform those services.
11.4.3Lead Professional Licenses
A.Pursuant to the provisions of the Act and the Department's delegation of authority from EPA, the Department shall issue a license or certification to an applicant who the Department determines meets the requirements of this Part.
B.The Department may, at any time after the filing of an application, require further information in order to determine whether the applicant meets the requirements of this Part.
C.The Department may deny an application for licensure pursuant to this Part if the Department determines that the applicant has not complied with or has not demonstrated the ability to comply fully with all applicable requirements established by the Act and/or this Part. If the applicant appeals the denial, a hearing will be scheduled in accordance with the provisions of § 3.6.11 of this Subchapter.
D.Upon request by the Department, applicants shall provide the Department with proof of identity prior to issuance of the initial license. Acceptable proof of identity includes a current State driver’s license, valid State photo identification card, or current passport.
E.An initial Lead Contractor, Lead Supervisor, Lead Worker, Lead Inspector, Lead Inspector-in-Training, or Lead Assessor license issued by the Department will expire on the last day of the month at the end of the two (2) year license term after the date of issuance, unless sooner surrendered, suspended, or revoked.
F.A Lead Contractor, Lead Supervisor, Lead Worker, Lead Inspector, Lead Inspector-in-Training, or Lead Assessor license renewed by the Department will expire on the anniversary date of the initial license expiration at the end of the two (2) year license term, unless sooner surrendered, suspended, or revoked.
G.An initial Lead Renovation Firm license issued by the Department will expire on the last day of the month at the end of the five (5) year license term after the date of issuance, unless sooner surrendered, suspended, or revoked.
H.A Lead Renovation Firm license renewed by the Department will expire on the anniversary date of the initial license expiration at the end of the five (5) year license term, unless sooner surrendered, suspended, or revoked.
I.A Lead Renovator certification from an in-person training course will expire five (5) years after the end date of the lead training course, unless sooner surrendered or decertified. A Lead Renovator certification from an online training course will expire three (3) years after the end date of the lead training course, unless sooner surrendered or decertified.
1.Lead Renovators who utilize online review training must alternate with in-person hands on training. Lead Renovators can only take the online certification training every other time they are trained.
J.The Department may restrict, limit, suspend, or revoke a Department-issued lead professional license or certification for failure to comply with the requirements of this Part. A person whose license or certification is restricted, limited, suspended, or revoked may request a hearing in accordance with the administrative procedures contained in § 3.6.11 of this Subchapter.
11.4.4Lead Training Courses
Applicants shall complete an appropriate lead training course prior to submission of an application for a lead professional license.
11.4.5Department License Examinations
A.Applicants for a Lead Contractor, Lead Supervisor, or Lead Inspector/Lead Inspector-in-Training license shall pass a license-specific Department examination prior to submission of an initial license application.
B.Applicants for a Department examination, including repeating a failed examination, shall register for the examination with the Department, or its third (3rd) party vendor, and provide the following on or before taking any examination:
1.Proof of identity in the form of a current State driver’s license, valid State photo identification card, or current passport; and
2.Documentation of any prerequisites, including successful completion of the required lead training course.
11.4.6Fees
All fees for applications and examinations are established in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services provided by the Department of Health (Part 10-05-2 of this Title). All fees are non-refundable.
11.4.7Penalties
Any person who owes an administrative fine or penalty imposed by a final order of the Department shall submit payment of the fine or penalty in full as a condition of licensure.
11.4.8Initial License for Lead Professional
Applicants for an initial lead professional license shall submit all information specified on the Department’s initial license application form and accompanying instructions.
11.4.9License Renewal
A.Applicants for a lead professional license renewal shall submit all information specified on the Department’s renewal application form and accompanying instructions.
B.The renewal application must be submitted for review and approval by the Department at least thirty (30) days prior to the expiration of the current license.
C.A renewal application received after the license expiration date but less than twelve (12) months beyond its expiration date requires an additional late fee.
D.A lead professional license more than twelve (12) months beyond the expiration date is not eligible for renewal but may be reinstated. Reinstatements must be done in a manner approved by the Department.
11.4.10License Replacement
A.Applicants for replacement of a lost or damaged lead professional license shall submit all requirements specified on the Department’s license profile change form, available on the Department’s website.
B.Replacement fees are established in the Rules and Regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services provided by the Department of Health (Part 10-05-2 of this Title). All fees are non-refundable.
11.4.11Notification of Changes
A.A lead professional licensee, whose name (e.g. maiden to married), address, or contact information changes during the license term, shall notify the Department in writing within thirty (30) days of the change(s).
B.A lead professional licensee shall submit an amended license application, for review and approval by the Department, before making any other change(s) that would render the information contained in a previous application no longer accurate.
C.There is no fee for notification of the changes or amendments required in §§ 11.4.11(A) or (B) of this Part.
D.Any lead professional licensee, whose ownership, business organization (e.g. sole proprietorship to corporation), social security number (SSN), or Federal employer identification number (FEIN) changes, is considered to be a new legal entity who shall surrender their current license and submit an appropriate initial license application to the Department with the application fee established in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.5** License Requirements for Lead Renovation Firms and Certification Requirements for Lead Renovators {#sec-216-ricr-50-15-11-11.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.5}
A.Organizations, including sole proprietorships and subcontractors, and self-employed individuals shall be licensed by the Department as a Lead Renovation Firm in order to offer or perform renovation, repair, and painting (RRP) or lead hazard control (LHC) work in Rhode Island.
B.A certified Lead Renovator shall only perform RRP or LHC work in Rhode Island under the authority of a Lead Renovation Firm licensed by the Department.
C.A Lead Renovation Firm shall assign a certified Lead Renovator to supervise each RRP or LHC project and designate that individual on the Start Work Notification (Form PBLC-9), pursuant to § 12.4.1 of this Subchapter.
D.A currently valid Lead Renovator training course completion certificate, pursuant to § 11.3.11(A)(1)(c) of this Part, constitutes certification as a Lead Renovator.
1.A Lead Renovator certification issued pursuant to a Department-certified lead training course is considered to be issued by the Department and may be restricted, limited, suspended, or revoked for failure to comply with the requirements of this Part.
2.A Lead Renovator whose certification is restricted, limited, suspended, or revoked by the Department may request a hearing in accordance with the administrative procedures contained in § 3.6.11 of this Subchapter.
3.A Lead Renovator whose certification is restricted, limited, suspended, or revoked by EPA or the EPA-authorized State, who issued the certification, is considered invalid for the purposes of this Part.
E.A worker, trained by a certified Lead Renovator pursuant to § 12.3.2(B)(1)(c) of this Subchapter, shall only perform RRP or LHC work activities in Rhode Island under the direct on-site supervision of a certified Lead Renovator.
F.No untrained workers shall perform any RRP or LHC work in Rhode Island.
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.6** License Requirements for Lead Contractors, Lead Supervisors, and Lead Workers {#sec-216-ricr-50-15-11-11.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.6}
11.6.1General Requirements
A.Organizations, including sole proprietorships and subcontractors, and self-employed individuals shall be licensed by the Department as a Lead Contractor in order to offer or perform lead hazard reduction (LHR) work in Rhode Island.
B.A Lead Supervisor or Lead Worker shall only perform LHR work under the authority of a Lead Contractor licensed by the Department.
C.All individuals working on an LHR project shall be appropriately licensed by the Department.
D.A Lead Contractor shall assign a Lead Supervisor to supervise each LHR project and designate that individual on the Start Work Notification (Form PBLC-9), pursuant to § 12.4.1 of this Subchapter.
E.A Lead Worker shall only perform LHR work under the direct on-site supervision of a Lead Supervisor licensed by the Department.
F.Any individual possessing a Lead Supervisor license issued by the Department is considered to also possess a Lead Worker license, for the purposes of this Part, and may assume the duties and responsibilities of a Lead Worker.
G.All individuals working on an LHR project shall have documentation of compliance with the medical monitoring requirements specified in § 12.5.1 of this Subchapter.
11.6.2License by Reciprocity for Lead Supervisors
A.An individual who has a valid, equivalent Lead Supervisor license from the EPA or another EPA-authorized State may apply for an initial Lead Supervisor license. Applicants for a license by reciprocity shall submit an initial application with documentation of the following:
1.A lead supervisor license issued by the EPA or another EPA-authorized State, which the Department shall determine, in its discretion, whether that license is equivalent to a Lead Supervisor license issued by the Department;
2.Proof of completion of an initial Lead Supervisor training course, accredited by the EPA or the EPA-authorized State who issued the Lead Supervisor license, which meets or exceeds the requirements of § 11.3 of this Part;
3.An eight (8) hour review Lead Supervisor training course certified pursuant to § 11.3 of this Part successfully completed by the applicant;
4.Proof of passing the Department’s Lead Supervisor examination.
5.Compliance with the medical monitoring requirements specified in § 12.5.1 of this Subchapter; and
6.All other information required on the application form and accompanying instructions
11.6.3License by Reciprocity for Lead Workers
A.An individual who has a valid, equivalent Lead Worker license from the EPA or another EPA-authorized State may apply for an initial Lead Worker license. Applicants for a license by reciprocity shall submit an initial application with documentation of the following:
1.A Lead Worker license issued by the EPA or another EPA-authorized State, which the Department shall determine, in its discretion, whether that license is equivalent to a Lead Worker license issued by the Department;
2.Proof of completion of an initial Lead Worker training course, accredited by the EPA or the EPA-authorized State who issued the Lead Worker license, which meets or exceeds the requirements of § 11.3 of this Part;
3.An eight (8) hour review Lead Worker training course certified pursuant to § 11.3 of this Part successfully completed by the applicant;
4.Compliance with the medical monitoring requirements specified in § 12.5.1 of this Subchapter; and
5.All other information required on the application form and accompanying instructions.
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.7** License Requirements for Lead Inspectors {#sec-216-ricr-50-15-11-11.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.7}
11.7.1General Requirements
A.A Lead Inspector-in-Training shall conduct lead inspections for the purpose of meeting the initial Lead Inspector licensing requirements in § 11.7.1(C)(4) of this Part under the direct on-site supervision of a Department-approved Lead Inspector.
B.Written approval from the Department must be obtained by a Lead Inspector prior to supervising a Lead Inspector-in-Training for the purpose of meeting the licensure requirements in § 11.7.1(C)(4) of this Part.
C.Applicants for a Lead Inspector license shall submit their application, in a manner and format acceptable to the Department with documentation of the following:
1.A current Lead Inspector-in-Training License;
2.An eight (8) hour review Lead Inspector training course;
3.Documentation of compliance with the Rules and Regulations for the Control of Radiation (Part 40-20-7 of this Title)
4.A minimum of fifteen (15) Comprehensive Environmental Lead Inspections, performed at fifteen (15) distinct properties, five (5) LHR or LHC Clearance Inspections, and five (5) LHM Inspection, supervised by a Department-approved Lead Inspector, and performed in accordance with all requirements of this Part within the twelve (12) month period prior to submission of the Lead Inspector license application; and
5.A satisfactory field audit and report review by the Department.
D.Action against any lead professional license issued by the Department constitutes grounds for denial or revocation of the Department’s approval to supervise a Lead Inspector-in-Training for the purpose of meeting the licensure requirements in § 11.7.1(C)(4) of this Part.
11.7.2License by Reciprocity for Lead Inspectors
A.An individual who has a Lead Inspector/Lead Assessor license from the EPA or another EPA-authorized State may apply for an initial Lead Inspector license. Applicants for a license by reciprocity shall submit an initial application with documentation of the following:
1.A Lead Inspector/Lead Assessor license issued by the EPA or another EPA-authorized State, which the Department shall determine, in its discretion, whether that license is equivalent to a Lead Inspector license issued by the Department;
2.Proof of completion of an initial Lead Inspector/Lead Assessor training course, accredited by the EPA or the EPA-authorized State who issued the Lead Inspector/Lead Assessor license, which meets or exceeds the requirements of § 11.3 of this Part;
3.Review and approval of the applicant’s field experience, which the Department shall determine, in its discretion, whether the experience meets or exceeds the requirements of § 11.7.1(C)(4) of this Part;
4.An eight (8) hour review Lead Inspector training course certified pursuant to § 11.3 of this Part successfully completed by the applicant;
5.Proof of passing the Department’s Lead Inspector license examination;
6.Documentation of compliance with the Department’s Licensing of Radioactive Material, Part 40-20-7 of this Title; and
7.Five (5) lead hazard mitigation (LHM) Inspections, supervised by a Department-approved Lead Inspector and performed in accordance with all requirements of this Part; and
8.A satisfactory field audit and report review by the Department; and
9.All other information required on the application form and accompanying instructions.
11.7.3Supervising Lead Inspector Approval
A.Written approval from the Department must be obtained by a Lead Inspector prior to supervising a Lead Inspector-in-Training for the purpose of meeting the licensure requirements in § 11.7.1(C)(4) of this Part. Criteria for the Department approval include, but are not limited to, the following:
1.A Lead Inspector license issued by the Department for the three (3) year period prior to the request for approval;
2.Review and approval of lead certificates and inspection reports issued by the Lead Inspector during the three (3) year period prior to the request for approval; and
3.A satisfactory field audit and report review by the Department.
B.Action against any lead professional license issued by the Department constitutes grounds for denial or revocation of the Department’s approval to supervise a Lead Inspector-in-Training for the purpose of meeting the licensure requirements in § 11.7.1(C)(4) of this Part.
11.7.4Lead Inspectors-in-Training
A.Applicants for a Lead Inspector-in-Training license shall submit their application, in a manner and format acceptable to the Department with documentation of the following:
1.A general education diploma (GED), high school diploma, or higher degree and a forty (40) hour initial Lead Inspector training course; or
2.A forty (40) hour initial Lead Inspector training course, certified pursuant to § 11.3 of this Part, completed by the applicant; and
3.The Department Lead Inspector examination passed by the applicant; and
4.All other information required by the application form and accompanying instructions.
11.7.5License Reciprocity for Lead Inspector-in-Training
A.An individual, who has a Lead Inspector license issued by EPA or another EPA-authorized State, may apply for an initial Lead Inspector-in-Training license pursuant to § 11.7.2 of this Part. Applicants for a license by reciprocity shall submit an initial application, available on the Department's website, with documentation of the following additional requirements:
1.A Lead Inspector license issued by EPA or another EPA-authorized State which the Department shall determine, in its discretion, whether that license is equivalent to a Lead Inspector-in-Training license issued by the Department;
2.An initial Lead Inspector training course, accredited by EPA or another EPA-authorized State who issued the license, which meets or exceeds the requirements of § 11.3 of this Part, completed by the applicant;
3.An eight (8) hour review Lead Inspector training course, certified pursuant to § 11.3 of this Part, successfully completed by the applicant; and
4.The Department Lead Inspector examination passed by the applicant;
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.8** License Requirements for Lead Assessors {#sec-216-ricr-50-15-11-11.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.8}
11.8.1General Requirements
A.A Lead Assessor shall be a designated employee of a Federal, State, or municipal agency with jurisdiction over housing, occupational health, child welfare, environmental standards and/or authorized to act as an enforcing officer under the State Property Maintenance Code (SB-6).
B.A Lead Assessor shall conduct lead inspections only within the jurisdiction of his/her employer.
C.Applicants for a Lead Assessor license shall submit their application, in a manner and format acceptable to the Department with documentation of the following:
1.Proof of employment from the list in § 11.8.1(A) of this Part; and, either
2.A current Lead Inspector license issued by the Department; or
3.A sixteen (16) hour initial Lead Assessor training course.
11.8.2Special Requirements for Issuing Lead Certificates
A Lead Assessor shall conduct five (5) Lead Hazard Mitigation (LHM) Inspections under the direct on-site supervision of a Department-approved Lead Inspector or Lead Assessor prior to obtaining access to the Department’s electronic reporting system to issue Certificates of Lead Conformance (Form LHM-2-1).
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.9** Certification and Licensing Requirements for Laboratories Performing Lead Analysis {#sec-216-ricr-50-15-11-11.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.9}
11.9.1Blood Lead Analysis
No person shall provide or offer to provide analysis of lead concentration in blood, for the purpose of meeting the requirements of this Part, unless that person is licensed pursuant to the provisions of Part 60-05-5 of this Title and/or approved by the Department.
11.9.2Environmental Lead Analysis
No person shall provide or offer to provide analysis of lead concentration in paint, dust, soil, water, or consumer products, for the purpose of meeting the requirements of this Part, unless that person is certified pursuant to the provisions of Part 60-05-5 of this Title and/or approved by the Department, and unless the certification specifically identifies lead as an authorized analyte.
**History**
- *Adoption — effective from 2022-01-02 to current*
##### **216-RICR-50-15-11 § 11.10** Severability {#sec-216-ricr-50-15-11-11.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-11#11.10}
If any provision of these Regulations, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or applications of the Regulations which can be given effect without the invalid provisions or applications and to this end the provisions are declared to be severable.
**History**
- *Adoption — effective from 2022-01-02 to current*
#### **216-RICR-50-15-12** Lead Safe Work Practices
##### **216-RICR-50-15-12 § 12.1** Authority {#sec-216-ricr-50-15-12-12.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.1}
A.This Part is promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-1, 23-24.6, and 42-128.1, and 40 C.F.R. Part 745 for the purpose of establishing the requirements for activities that disturb environmental lead including prohibited and approved treatment methods for correcting lead hazards in drinking water, household dust, painted surfaces, soil and/or other appropriate fixed surfaces that may contain lead.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.2** Definitions {#sec-216-ricr-50-15-12-12.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.2}
A.Wherever used in this Part, the terms listed below shall be construed in the following manner:
1.“Abrasive blasting” means the procedure of removing paint from a surface by using mechanical force to apply an abrasive material (e.g. sand, grit, or other similar material) to the painted surface.
2."Act" means R.I. Gen. Laws Chapter 23-24.6, Lead Poisoning Prevention.
3.“Certificate of Lead Conformance (Form LHM-2-1)” means a certificate issued by a Lead Inspector or Lead Assessor which certifies that a single-family house, dwelling unit and common areas, or premises has passed a Lead Hazard Mitigation (LHM) Inspection.
4.“Child care facility” means any building and/or area whose primary purpose is or will be to educate or care for children younger than six (6) years of age, including but not limited to, child day care centers, nursery schools, preschools, Kindergarten classrooms, public and private elementary schools. Child care facilities located in public or commercial buildings encompass only those common areas that are routinely used by children, such as restrooms and cafeterias. Common areas that children only pass through, such as hallways, staircases, and garages are not included. The child care facility also encompasses the exterior sides of the building that are immediately adjacent to the child care facility and the exterior common areas or play areas routinely used by children.
5.“Cleaning verification card” or “CV card” means a card developed and distributed, or otherwise approved, by EPA for the purpose of determining, through comparison of wet and dry disposable cleaning cloths with the card, whether post-renovation cleaning has been properly completed.
6.“Cleaning verification procedure” or “CV” means the EPA procedure for determining whether post-renovation cleaning has been properly completed through comparison of wet and dry disposable cleaning cloths with an EPA-approved cleaning verification card.
7.“Clearance inspection” means a visual assessment and lead testing, as applicable, done at the conclusion of a renovation, repair, and painting (RRP), lead hazard control (LHC), or lead hazard reduction (LHR) project to determine compliance with § 5.8.4 of this Subchapter.
8.“Common area(s)” means a portion of a residential property that is available for shared use by occupants of more than one (1) dwelling unit, such as hallways, stairways, lobbies, community rooms, recreational rooms, laundry rooms, garages, playgrounds, and boundary fences; in general, any area not kept locked.
9.“Component or building component” means specific design or structural elements or fixtures of a building or residential dwelling that are distinguished from each other by form, function, and location. These include, but are not limited to, interior components such as: ceilings, crown molding, walls, chair rails, doors, door trim, floors, fireplaces, radiators and other heating units, shelves, shelf supports, stair treads, stair risers, stair stringers, newel posts, railing caps, balustrades, windows and trim (including sashes, window heads, jambs, sills or stools and wells or troughs), built in cabinets, columns, beams, bathroom vanities, counter tops, and air conditioners; and exterior components such as: painted roofing, chimneys, flashing, gutters and downspouts, ceilings, soffits, fascias, rake boards, corner boards, bulkheads, doors and door trim, fences, floors, joists, lattice work, railings, and railing caps, siding, handrails, stair risers and treads, stair stringers, columns, balustrades, window sills or stools and wells or troughs, casings, sashes, and air conditioners.
10.“Conditional Lead-Safe Certificate (Form PBLC-15)” means a certificate issued by a Lead Inspector, typically at the conclusion of a lead hazard control (LHC)or lead hazard reduction (LHR) project, which certifies that a child care center, single-family house, dwelling unit and common areas, or premises had a Comprehensive Environmental Lead Inspection and meets the conditional lead safe standards for paint, dust, soil, and water in § 12.7 of this Part and § 5.8 of this Subchapter. Routine maintenance and renewal inspections every two (2) years are required to re-certify conditional compliance.
11.“Conditionally lead safe” means intact lead-based paint and/or covered soil for which the lead concentrations are above the lead-safe thresholds in § 12.7 of this Part and § 5.8 of this Subchapter. See “lead safe”.
12.“Containment or containment barriers” means physical measures taken to ensure that a process for protecting workers, residents, and the environment by controlling lead exposures with a system of temporary barriers, typically plastic sheeting or other impenetrable material, used to isolate a work area so that no dust, paint chips, or other debris escapes while work that will disturb known or assumed lead-based paint is being performed.
13.“DEM” means the Rhode Island Department of Environmental Management.
14.“Demolition” means, for the purposes of this Part, the removal of any structural member, architectural component, or fixture by destruction, as distinguished from removing the component whole or piece by piece.
15."Department" means the Rhode Island Department of Health.
16."Director" means the Director of the Rhode Island Department of Health or his/her agents, subordinates to whom the Director has delegated the powers and duties vested in the Director by these Regulations.
17.“DOT” means the Rhode Island Department of Transportation.
18.“Dry disposable cleaning cloth” means a commercially available dry, electrostatically charged, white disposable cloth designed to be used for cleaning hard surfaces such as uncarpeted floors or counter tops.
19.“Dust wipe sample” means a sample collected by wiping a representative surface of a measured area, as determined by ASTM E1728, Standard Practice for Field Collection of Settled Dust Samples Using Wipe Sampling Methods for Lead Determination by Atomic Spectrometry Techniques, or an equivalent method approved in writing by the Department.
20.“Dwelling” or “dwelling unit” means, as defined by R.I. Gen. Laws Chapter 42-128.1, an enclosed space used for living and sleeping by human occupants as a place of residence, including, but not limited to: a house, an apartment, or condominium, but for the purpose of this Chapter, shall not include hotels or temporary housing.
21.“Encapsulation” means any covering or coating that acts as a barrier between lead-based paint and the environment which relies for its durability on adhesion between the encapsulant and the existing painted surface, and on the integrity of the bonds between the paint layers with each other and with the substrate. Encapsulation may be used as an abatement method only if it is designed and guaranteed to be “permanent.”
22.“Enclosure” means the use of rigid, durable construction materials which are mechanically fastened to the substrate, and sealed or caulked, in order to act as a barrier between lead-based paint and the environment. Enclosure may be used as an abatement method only if it is designed to be “permanent.”
23.“EPA” means the United States Environmental Protection Agency.
24.“Feathering” means light sanding of interior surfaces, performed after damaged material has been removed by scraping, to soften abrupt transitions between bare substrate and remaining intact paint; or exposed layers of intact paint; or patching materials and the surrounding surface. Proper feathering will produce a surface which, after painting, has no edges that can be lifted with a fingernail.
25.“First-draw water sample” means a sample of tap water collected after the household water has been unused for at least six (6) hours.
26.“Flushed water sample” means a sample of tap water collected after the tap has been allowed to run at its maximum flow rate until cold, or at least one (1) minute, before the sample collection.
27.“Friction surface” means a surface that is subject to abrasion, such as certain door, window, floor, and stair surfaces, that may generate dust from abrasion during normal use.
28.“Full Lead-Safe Certificate (Form PBLC-21)” means a certificate issued by a Lead Inspector, typically at the conclusion of a lead hazard control (LHC) or lead hazard reduction (LHR) project, which certifies that a child care center, single-family house, dwelling unit and common areas, or premises had a Comprehensive Environmental Lead Inspection and meets the lead-safe standards for paint, dust, soil, and water in § 12.7 of this Part. A Full Lead-Safe Certificate does not expire.
29.“HEPA filter” means a high-efficiency particulate air filter, used in respirators and vacuum systems, capable of capturing particles of 0.3 microns with 99.97% efficiency.
30.“HEPA vacuum” means a vacuum cleaner which has been designed with a HEPA filter as the last filtration stage. The vacuum cleaner must be designed so that all the air drawn into the machine is expelled through the HEPA filter with none of the air leaking past it. HEPA vacuums must be operated and maintained in accordance with the manufacturer’s instructions.
31.“Impact surface” means a surface that either moves or meets with a moveable surface and is subject to damage by repeated sudden force, impact, or contact, such as doors and windows with certain parts of their frames.
32.“Interim controls” means a set of measures designed to temporarily reduce human exposure to lead hazards, including specialized cleaning, repairs, maintenance, painting, non-permanent encapsulation or enclosure, and ongoing monitoring of lead-based paint or potential lead hazards, and the establishment and operation of management and resident education programs.
33.“Lead assessor” means a person, either authorized to act as an enforcing officer under the housing code or a designated employee of a Federal, State or municipal agency with jurisdiction over housing, occupational health, child welfare and/or environmental standards who successfully completed a Lead Assessor training course and obtained a license, pursuant to Part 11 of this Subchapter, to conduct lead inspections within the purview of their employment.
34.“Lead-based paint” means any paint or other surface coating that contains lead in excess of the Lead-Safe thresholds specified in § 5.8 of this Subchapter.
35.“Lead contractor” means, any person or entity engage in lead hazard reduction as a business and licensed pursuant to Part 11 of this Subchapter.
36.“Lead free” means paint below the Consumer Product Safety Commission (CPSC) limit on lead in paint (16 C.F.R. § 1303.1) and plumbing materials which meet the lead-free definition under the EPA Safe Drinking Water Act (40 C.F.R. Part 141).
37.“Lead hazard” means a condition that presents a clear and significant health risk to occupants of a child care center, single-family house, dwelling unit and common areas, or premises, particularly where children reside. Lead concentrations in damaged paint, interior dust, bare soil, and/or drinking water which exceed the Lead-Safe thresholds in § 5.8 of this Subchapter are an immediate lead exposure hazard requiring corrective action at a regulated facility.
38.“Lead hazard control” or “LHC” means any window replacement and/or interim controls intended to correct lead hazards identified in a lead inspection report or standard treatments to remove lead-based paint and/or minimize lead exposure, which may include measures to reduce the concentration of lead in paint, dust, soil, and/or water using approved treatment methods specified in this Part.
39.“Lead hazard control project” or “LHC project” means a project being done by a Lead Renovation Firm for the purpose of controlling lead hazards. An LHC Clearance Inspection is required at the conclusion of an LHC project.
40.“Lead hazard mitigation” or “LHM” means spot removal or minor repair and maintenance activities by a property owner or designated person at a residential rental unit intended to correct lead hazards, which may include measures to reduce friction, stabilize paint, and cover bare soil for the purpose of obtaining a Certificate of Lead Conformance (FormLHM-2-1).
41.“Lead hazard mitigation project” or “LHM Project” means a project being done by an owner or designated person for the purpose of mitigating lead hazards. An LHM Clearance Inspection is required at the conclusion of an LHM project to obtain a Certificate of Lead Conformance (FormLHM-2-1), required for non-exempt residential rental units.
42.“Lead hazard reduction” means, as defined by R.I. Gen. Laws § 23-24.6-4, any action or actions designed to reduce exposure to toxic levels of lead which impose an unacceptable risk of exposure in any dwelling or dwelling unit where a child under the age of six (6) years with environmental intervention blood lead levels or greater resides, or on any premises and may include, but is not limited to: repair, enclosure, encapsulation, or removal of lead based paint and/or lead contaminated dust, soil or drinking water relocation of occupants; and cleanup measure or ongoing maintenance measures which may include, activities and/or measures that do not present an undue risk to children under age six (6).
43.“Lead hazard reduction project” or “LHR project” means a project being done by a Lead Contractor for the purpose of reducing lead hazards. An LHR Clearance Inspection is required at the conclusion of an LHR project.
44.“Lead inspection” means any type of physical investigation of a child care center, single-family house, dwelling unit, or premises to identify the presence of environmental lead, lead hazards, or compliance with the cleaning requirements and lead standards in § 5.8 of this Subchapter for paint, dust, soil, and/or water.
45.“Lead inspection report” means a written report, on forms provided or approved by the Department, which documents the results of a lead inspection, conducted pursuant to Part 5 of this Subchapter, and includes the visual assessment, field testing, sample analysis results, summary of findings, and, for regulated facilities and target housing, lead hazard reduction or lead hazard control requirements and site-specific recommendations, as applicable.
46.“Lead inspector” means an individual, who successfully completed a certified Lead Inspector training course, passed the Lead Inspector Department examination, completed a supervised field apprenticeship, and obtained a license, pursuant to Part 11 of this Subchapter, to conduct lead inspections.
47.“Lead professional” means an occupational grouping of individuals and organizations licensed or certified pursuant to Part 11 of this Subchapter.
48.“Lead renovation firm” means any person or organization engaged in renovation, repair, and painting (RRP) or lead hazard control (LHC) as a business and licensed pursuant to Part 11 of this Subchapter.
49.“Lead renovator” means an individual who successfully completed a certified Lead Renovator training course and obtained a valid training certificate, pursuant to Part 11 of this Subchapter, to perform renovation, repair, and painting (RRP) and lead hazard control (LHC) work.
50.“Lead safe” means paint, dust, soil, and/or water for which the lead concentrations are below the lead safe thresholds in § 12.7 of this Part. A lead safe concentration does not require corrective action and would be expected to persist indefinitely unless additional lead is added. See “conditionally lead safe.”
51.“Lead supervisor” means an individual who successfully completed a certified Lead Supervisor training course, passed the Lead Supervisor Department examination, and obtained a license, pursuant to Part 11 of this Subchapter, to perform and/or supervise lead hazard reduction (LHR) work.
52.“Lead worker” means an individual who successfully completed a certified Lead Worker training course and obtained a license, pursuant to Part 11 of this Subchapter, to perform lead hazard reduction work.
53.“Mechanical paint removal” means the use of any mechanical force to remove paint from a surface, including, but not limited to, electrical or other power equipment or abrasive blasting.
54.“Minor repair and maintenance” means work activities, including minor heating, ventilation, and air conditioning (HVAC) work, electrical work, or plumbing work that disturbs less than six square feet (6 ft2) of lead-based paint per room for interior activities or less than twenty square feet (20 ft2) of lead based-paint for exterior activities where none of the work practices prohibited or restricted by this Part are used and where the work does not involve window replacement or demolition of painted surfaces. For the purposes of this Part, the term minor repair and maintenance shall be synonymous with spot removal. See “Spot removal.”
55.“Occupant” means, as defined by R.I. Gen. Laws § 23-24.6-4, any person who legally resides in, or regularly uses, a dwelling, dwelling unit, or structure; provided, however, that a guest of any age shall not be considered an occupant for the purposes of this Chapter.
56.“OSHA” means the United States Occupational Safety and Health Administration.
57.“Owner” means any person who, alone or jointly or severally with others:
a.Shall have legal title to any dwelling or dwelling unit with or without accompanying actual possession of it; or
b.Shall have charge, care, or control of any dwelling or dwelling unit as owner or agent of the owner or an executor, administrator, trustee, or guardian of the estate of the owner. Any person representing the actual owner shall be bound to comply with the provisions of this Chapter and with Rules and Regulations adopted pursuant to this Chapter to the same extent as if that person were the owner. An agent of the owner excludes real estate and property management functions where the agent is only responsible for the property management and does not have authority to fund capital and/or major property rehabilitation on behalf of the owner.
c.For purposes of publicly owned property only, the owner shall be defined to be the Chief Executive Officer of the municipal or State agency which owns, leases or controls the use of the property.
58.“Paint” means any substance applied to a surface as a surface coating, including, but not limited to, household paints, varnishes and stains.
59.“Paint removal” means a method of abatement that permanently eliminates lead-based paint from surfaces; or surface preparation by stripping, scraping or sanding, as part of paint stabilization, or prior to encapsulation.
60.“Paint stabilization” means repairing any physical defects in the substrate of a painted surface that is causing paint deterioration, removing loose paint and other material from the surface to be treated, and applying a new protective coating or paint to achieve intact status.
61.“Paint stripper” means any chemical and/or caustic substance applied to a surface for the purpose of removing paint.
62.“Painted surface” means a component surface covered in whole or in part with paint or other surface coatings.
63.“Painted surface to be disturbed” means a painted surface that is to be stripped, scraped, sanded, cut, penetrated or otherwise affected by renovation or rehabilitation work in a manner that could potentially create a lead hazard by generating dust, fumes, or paint chips.
64.“Permanent” means an expected design life of at least twenty (20) years.
65.“Personal protective equipment” or “PPE” means any equipment such as disposable gloves, eye, face, foot or hair coverings, respirators, as well as outerwear which is either disposable or which must be laundered separately, worn to protect workers from lead exposure.
66.“Premises” means, as defined by R.I. Gen. Laws § 23-24.6-4, a platted lot or part thereof or unplatted lot or parcel of land, occupied by a dwelling or structure and includes any building, accessory structure or other structure thereon which is or will be frequently used by children under the age of six (6) years.
67.“Regulated facility” means any child care facility, single-family house, dwelling unit and common areas, or premises, as specified in § 3.2.2 of this Subchapter, which is subject to the requirements of this Part.
68.“Renovation” means the modification of any existing structure, or portion thereof that results in the disturbance of lead-painted surfaces, unless that activity is performed as part of a lead hazard control (LHC) or lead hazard reduction (LHR) project. The term renovation includes, but is not limited to: the removal, modification or repair of painted surfaces or painted components (e.g. modification of painted doors, surface restoration, window repair); surface preparation activities such as sanding, scraping, or other such activities which may generate paint dust; the removal of building components (e.g. walls, ceilings, plumbing, windows); weatherization projects (e.g. cutting holes in painted surfaces to install blown-in insulation or to gain access to attics, planning thresholds to install weather-stripping); and interim controls that disturb lead-painted surfaces. A renovation performed for converting a building, or part of a building, into target housing or child care facilities is a renovation under this Part. The term renovation does not include minor repair and maintenance activities.
69.“Renovation, repair, and painting project” or “RRP project” means a project which is being done by a Lead Renovation Firm for purposes other than removing lead-based paint or correcting lead hazards (although it may result in this). The purpose of an RRP project is to ensure that renovations performed at a regulated facility or for compensation at target housing are done safely and prevent lead exposure to owners, occupants and neighbors of the property where the work is performed. Any additional work which disturbs lead-based paint, other than emergency renovation operations, performed in the same room or area within the same thirty (30) day period must be considered the same RRP project for the purpose of determining whether the work is spot removal or renovation, repair, and painting (RRP).
70.“Sample” means an individual sample collected at one (1) time and in one (1) place, such as a “grab” sample of soil or a single-surface dust wipe.
71.“Spot removal or de minimis” means minor repair and maintenance activities, which do not involve window replacement or demolition of painted surface areas, and disturb less than six square feet (6 ft2) of interior lead-based paint per room or less than twenty square feet (20 ft2) of exterior lead-based paint, and provided that no prohibited work practices are used. When removing painted components, or portions of painted components the entire surface area removed is the amount of lead-based paint being disturbed. Any additional work which disturbs lead-based paint, performed in the same room or area within the same thirty (30) day period of an RRP project must be considered the same RRP project and not spot removal.
72.“Standard treatments” means a series of lead hazard control or lead hazard reduction measures designed to correct assumed lead hazards without the benefit of a lead inspection. See “treatments.”
73.“Substrate” means the material directly beneath the painted surface out of which the components are constructed. The underlying surface which remains after paint is removed. Examples of substrates include wood, plaster, sheetrock, concrete, and metal.
74.“Target housing” means any pre-1978 residential dwelling, except housing for the elderly or persons with disabilities or zero (0) bedroom units in which no child resides.
75.“Temporary lead hazard control measures” means a set of measures designed to temporarily reduce human exposure or likely exposure to lead hazards, including but not limited to, specialized cleaning, temporary containment (e.g. plastic sheeting and/or duct tape), ongoing monitoring, and the establishment and operation of lead management and resident education programs.
76.“Tenant” means any person, other than the owner, who enters into an agreement to rent, lease, or sublease a single-family house, dwelling unit, or premises.
77.“Treatments” means any methods designed to control or reduce lead exposure hazards. Treatments include lead abatement, interim controls, or a combination of both. See “standard treatments.”
78.“Vertical containment” means a vertical barrier consisting of plastic sheeting or other impenetrable material over scaffolding or a rigid frame, or an equivalent system of containing the work area. Vertical containment is required for some exterior renovations, but it may be used on any renovation.
79.“Wet cleaning” means a process of eliminating lead contamination from surfaces and objects by using water or detergent solutions and rinsing with clean water.
80.“Wet disposable cleaning cloth” means a commercially available, pre-moistened white disposable cloth designed to be used for cleaning hard surfaces such as uncarpeted floors or counter tops.
81.“Work area” means the area established by an appropriately licensed or certified lead professional to contain the dust and debris generated by activities that disturb painted surfaces.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.3** Regulated Activities {#sec-216-ricr-50-15-12-12.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.3}
A.Spot Removal or Minor Repair and Maintenance
1.A Lead Renovation Firm or Lead Contractor licensed by the Department is not required for spot removal or minor repair and maintenance activities.
2.Spot removal or minor repair and maintenance activities include activities that disturb less than six square feet (6 ft2) of interior lead-based paint per room or less than twenty square feet (20 ft2) of exterior lead-based paint, provided that the work does not include:
a.Any window removal/replacement (no de minimis);
b.Any interior mechanical paint removal (no de minimis);
c.Interior or partial demolition activities (no de minimis); or
d.Prohibited work practices specified in § 12.5.8 of this Part.
3.Disturbing lead-based paint in excess of the spot removal de minimis at a regulated facility or for compensation at target housing must be done by a Lead Renovation Firm or Lead Contractor licensed by the Department.
4.When removing painted components, or portions of painted components the entire surface area to be removed is the amount of lead-based paint being disturbed.
5.Any work that disturbs lead-based paint, other than emergency renovation operations, performed in the same room or area within the same thirty (30) day period must be considered the same project for the purpose of determining whether the work is spot removal or renovation, repair, and painting (RRP).
B.Lead Hazard Mitigation (LHM)
1.An owner or his/her designated person who completed a Department approved lead hazard awareness seminar may perform spot removal or minor repair and maintenance activities at their own rental properties.
2.The owner or designated person must be a certified Lead Renovator working under the authority of a Lead Renovation Firm license from the Department for any work that includes:
a.Disturbing painted surfaces in excess of the spot removal de minimis thresholds;
b.Any window removal/replacement (no de minimis);
c.Any interior mechanical paint removal (no de minimis); or
d.Interior or partial demolition activities (no de minimis).
C.Renovation, Repair, and Painting (RRP) and Lead Hazard Control (LHC)
1.RRP and LHC activities must be performed by a Lead Renovation Firm licensed by the Department.
2.The purpose of an RRP project is to perform renovations, repairs, painting and related construction work for reasons other than correcting environmental lead hazards.
3.The purpose of an LHC project is to perform lead hazard control to correct known or assumed environmental lead hazards at a residential dwelling or child care facility.
D.Lead Hazard Reduction (LHR).
1.Lead hazard reduction (LHR) activities must be performed by a Lead Contractor licensed by the Department.
2.The purpose of an LHR project is to perform lead hazard reduction to eliminate all environmental lead hazards at a residential dwelling.
12.3.1Exemptions
A.A Lead Renovation Firm or Lead Contractor is not required for the following activities which are not considered RRP, LHC, or LHR projects for the purposes of this Part:
1.Disturbing painted surfaces which do not contain lead-based paint, as determined by a Lead Inspector, Lead Assessor, or Lead Renovator, pursuant to § 5.7.2 of this Subchapter;
2.Temporary lead hazard control measures, provided that no lead-based paint is disturbed;
3.Spot removal or minor repair and maintenance activities that disturb less than six square feet (6 ft2) of lead-based paint per interior room, provided that no prohibited work practices, as specified in § 12.5.8 of this Part are used, and the work does not involve window removal/replacement, interior mechanical paint removal, or interior demolition activities;
4.Spot removal or minor repair and maintenance activities that disturb less than twenty square feet (20 ft2) of exterior lead-based paint, provided that no prohibited work practices specified in § 12.5.8 of this Subchapter or Removal of Lead Based Paint from Exterior Surfaces (250-RICR-120-05-24), are used and the work does not involve window removal/replacement or partial demolition activities;
5.Encapsulation or enclosure of painted surfaces, provided that the total amount of lead-based paint that is disturbed does not exceed the spot removal de minimis;
6.Remediation of lead-contaminated dust, which was not generated during RRP, LHC, or LHR activities;
7.Remediation of lead-contaminated soil;
8.Remediation of lead-contaminated drinking water; and/or
9.Complete razing of an entire free-standing building or structure, in accordance with all applicable DEM air pollution control requirements, when permitted for such by an appropriate municipal or State agency.
12.3.2 Responsibilities
A.Lead Renovation Firm
1.For each RRP or LHC project, the Lead Renovation Firm shall ensure that the following requirements are met (when applicable):
a.The firm is licensed by the Department pursuant to Part 11 of this Subchapter;
(1)Any subcontractors are licensed by the Department pursuant to Part 11 of this Subchapter;
b.Pre-renovation education (PRE) information is distributed pursuant to § 12.4 of this Part;
c.The property owner is informed of the cleaning verification procedure and/or clearance inspection requirements;
d.For exterior work, Notification of Removal of Exterior Lead Based Paint is made pursuant to Removal of Lead-Based Paint from Exterior Surfaces (250-RICR-120-05-24);
e.A certified Lead Renovator is assigned as the person responsible for oversight of each RRP or LHC project and discharges all the Lead Renovator responsibilities identified in § 12.3.2(B) of this Part;
f.For RRP projects that include any window replacement, interior mechanical paint removal, demolition activities, or any variance from this Part granted by the Department, a Start Work Notification (Form PBLC-9), pursuant to § 12.4.1 of this Part, is received by the Department at least seven (7) days before the work begins;
g.For all LHC projects, a Start Work Notification (Form PBLC-9), pursuant to § 12.4.1 of this Part, is received by the Department at least seven (7) days before the work begins;
h.All individuals working on behalf of the Lead Renovation Firm are either certified Lead Renovators or have been trained by a certified Lead Renovator, pursuant to § 12.3.2(B)(1)(c) of this Part, and the training is documented.
i.All RRP and LHC work is performed pursuant to §§ 12.5 and 12.6 of this Part, and/or Removal of Lead-Based Paint from Exterior Surfaces (250-120-05-24), as applicable;
j.The worker protection requirements of OSHA 29 C.F.R. § 1926.62 and 29 C.F.R. § 1910.125 are met;
k.The waste transportation and disposal requirements of DEM and DOT are met; and
l.The recordkeeping requirements of § 12.8 of this Part are met.
B.Lead Renovator
1.For each RRP or LHC project, the Lead Renovator shall ensure that the following requirements are met (when applicable):
a.A certified Lead Renovator is physically on-site to perform and/or supervise all RRP or LHC activities;
b.The work area(s) are contained so that no lead dust, paint chips, or other debris leave the containment area(s) while the RRP or LHC work is in progress;
c.Any non-certified workers are trained in the lead-safe work practice requirements which they must follow in performing their assigned tasks, and the training is documented;
d.All RRP or LHC tasks are performed following the lead-safe work practice requirements in §§ 12.5 and 12.6 of this Part, and/or Removal of Lead Based Paint from Exterior Surfaces (250-RICR-120-05-24), as applicable;
e.The documentation specified in § 12.8(A) of this Part is maintained on-site for the duration of the project;
f.The integrity of the containment is maintained for the duration of the project;
g.All warning signs remain in place and readable for the duration of the project;
h.The work area(s) are cleaned pursuant to § 12.6 of this Part;
i.A visual assessment of the work area(s) is conducted at the conclusion of the RRP or LHC work;
j.For RRP projects, the cleaning verification procedure is performed and documented on the RRP checklist;
k.For LHC projects, the owner and Lead Inspector are notified when the project is ready for the clearance inspection;
m.Warning signs and critical barriers are removed after the cleaning verification is successfully completed or dust wipe clearance is achieved;
n.For RRP projects, the RRP checklist is completed, signed, and provided to the owner; and
o.For LHC projects, a copy of the lead certificate, signed by the Lead Inspector who conducted the clearance inspection, is obtained.
C.Lead Contractor Responsibilities
1.For each LHR project, the Lead Contractor shall ensure that the following requirements are met (when applicable):
a.The organization is licensed by the Department pursuant to Part 11 of this Subchapter;
(1)Any subcontractors are licensed by the Department pursuant to Part 11 of this Subchapter;
b.Pre-renovation education (PRE) information is distributed pursuant to § 12.4 of this Part;
c.The property owner is informed of the clearance inspection and Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead-Safe Certificate (Form PBLC-21) requirements;
d.For exterior work, Notification of Removal of Exterior Lead Based Paint is made pursuant to DEM Regulation Removal of Lead-Based Paint from Exterior Surfaces (250-RICR-120-05-24);
e.A Start Work Notification (Form PBLC-9), pursuant to § 12.4.1 of this Part, is received by the Department at least seven (7) days before the work begins;
f.The Lead Supervisor assigned to each LHR project discharges all the Lead Supervisor responsibilities delineated in § 12.3.2(B) of this Part;
g.All individuals working on behalf of the Lead Contractor are licensed Lead Supervisors or Lead Workers;
h.An access logbook with consecutively numbered pages is maintained at each LHR project site;
i.All LHR work is performed pursuant to §§ 12.5 of this Part, and/or DEM Regulation Removal of Lead-Based Paint from Exterior Surfaces (250-RICR-120-05-24), as applicable;
j.The worker protection requirements of 294 C.F.R. §§ 1926.62 and 1910.1025 are met;
k.The waste transportation and disposal requirements of DEM and DOT are met; and
l.The recordkeeping requirements of § 12.8 of this Part, are met.
D.Lead Supervisor
1.For each LHR project, the Lead Supervisor shall ensure that the following requirements are met (when applicable):
a.A Lead Supervisor is physically on-site to perform and/or supervise all LHR activities;
b.The Department is notified by telephone, pursuant to § 12.4.1(H) of this Part, when on-site preparation for the LHR project begins;
c.The work area(s) are contained so that no lead dust, paint chips, or other debris leave the containment area(s) while the LHR work is in progress;
d.All Lead Supervisor and Lead Worker licenses are either worn or prominently posted at the LHR project site;
e.Each person gaining access to a containment area prints and signs their name in the access logbook, documenting the date and time entering and leaving the containment area, and includes their LHR license number or affiliation and reason for entering the containment area;
f.All LHR tasks are performed following the lead-safe work practice requirements pursuant to § 12.5 of this Part, and/or Removal of Lead-Based Paint from Exterior Surfaces (250-RICR-120-05-24), as applicable;
g.The documentation requirements of § 12.8(A) of this Part are maintained on-site for the duration of the project;
h.The integrity of the containment is maintained for the duration of the project;
i.Warning signs remain in place and readable for the duration of the project;
j.The work area(s) are cleaned pursuant to § 12.6 of this Part;
k.The owner and Lead Inspector are notified when the project is ready for the clearance inspection;
l.Warning signs and critical barriers remain in place until after dust wipe clearance is achieved; and
m.A copy of the lead certificate, issued by the Lead Inspector who conducted the clearance inspection, is obtained.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.4** Notification {#sec-216-ricr-50-15-12-12.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.4}
12.4.1Pre-Renovation Education (PRE)
A.Pamphlet
1.Not less than seven (7) days and no more than sixty (60) days before beginning an RRP, LHC, or LHR project, the Lead Renovation Firm or Lead Contractor, as applicable, shall provide a Department-approved pamphlet, available on the Department’s website, to the owner, occupants, and/or parents, as applicable.
B.Notification Form
1.The Pre-Renovation Notification (Form PBLC-29), Pre-Abatement Notification (Form PBLC-12), or the equivalent, must include the following information:
a.The name, license number, and contact information for the Lead Renovation Firm or Lead Contractor, as applicable;
b.The nature and location of the work; and
c.The start date and end date of the work.
C.Owner
1.The Lead Renovation Firm or Lead Contractor, as applicable, shall inform the owner of the cleaning verification procedure and/or clearance inspection requirements and obtain:
a.PRE-Form PBLC-29 or PBLC-12, or the equivalent, signed by the owner; or
b.Proof of mailing the pamphlet and the US Postal Service delivery confirmation.
D.Occupants
1.If the owner does not occupy the dwelling unit, the Lead Renovation Firm or Lead Contractor, as applicable, shall:
a.Obtain PRE-Form PBLC-29 or PBLC-12, or the equivalent, signed by the tenant;
b.Indicate on PRE-Form PBLC-29 or PBLC-12, or the equivalent, the date and time the pamphlet was delivered, and the tenant was unavailable to sign the form or declined to sign the form; or
c.Obtain proof of mailing the pamphlet and a US Postal Service delivery confirmation.
E.Common Areas
1.The Lead Renovation Firm or Lead Contractor, as applicable, shall provide notification to the occupants of any affected dwelling units by:
a.Posting signs, where they are most likely to be seen by the affected tenants, containing the information required in § 12.4(B) of this Part and how to get a free copy of the pamphlet; or
b.Providing the pamphlet to all affected tenants and completing a PRE-Form PBLC-29 or PBLC-12, or the equivalent, to document how each pamphlet was delivered.
F.Child care Facilities
1.For RRP or LHC projects, the Lead Renovation Firm shall provide notification to the parents of all children using the facility by:
a.Posting signs, where they are most likely to be seen by the affected families, containing the information required in § 12.4(B) of this Part and how to get a free copy of the pamphlet; or
b.Providing the pamphlet to all affected families and completing a PRE-Form PBLC-29, or the equivalent, to document how each pamphlet was delivered.
12.4.2Start Work Notification (SWN)
A.For any RRP project that includes window replacement, interior mechanical paint removal, interior or partial demolition, or for which a variance from this Part was granted by the Department, a complete and accurate Start Work Notification (Form PBLC-9) must be received by the Department at least seven (7) days before the work begins.
B.For all LHC projects, a complete and accurate Start Work Notification (Form PBLC-9) must be received by the Department at least seven (7) days before the work begins.
C.For all LHR projects, a complete and accurate Start Work Notification (Form PBLC-9) must be received by the Department at least seven (7) days before the work begins. In addition, the Lead Supervisor shall notify the Department by telephone when on-site preparation for the project or phase begins.
D.For any project for which a variance from this Part was granted by the Department, a copy of the variance request and approval letter must be submitted with the SWN Form PBLC- 9.
D.If the project will be done in phases, a separate SWN Form PBLC-9 must be submitted for each phase of the project indicating the start and end dates of the phase.
E.The work must not begin prior to the start date indicated on the SWN Form PBLC-9.
F.If the work does not begin within seven (7) days of the start date and/or end within seven (7) days of the end date indicated on SWN Form PBLC-9, a revised SWN Form PBLC-9 must be submitted to the Department.
G.If the project or phase is canceled, or postponed with no known start date, a canceled SWN Form PBLC-9 must be submitted to the Department.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.5** Lead Safe Work Practices {#sec-216-ricr-50-15-12-12.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.5}
12.5.1Worker Protection
A.The OSHA requirements specified in 29 C.F.R. §§ 1926.62 and 1910.125 apply to all RRP, LHC, and LHR projects.
B.The OSHA requirements also apply when the person disturbing lead or performing LHM, RRP, LHC, or LHR activities is an employee of the property owner.
12.5.2Occupant Protection
A.The owner shall make all reasonable efforts to ensure that occupants are not present during LHM, RRP, or LHC activities.
B.The owner shall ensure that occupants vacate the premises for the duration of an LHR project.
C.The Lead Renovator or Lead Supervisor, as applicable, shall ensure that occupants’ belongings are protected from contamination by lead dust, paint chips, or other debris during the work by:
1.Removing all movable objects from the work area or covering them with polyethylene sheeting secured in place with duct tape; and/or
2.Covering all non-movable objects in the work area with polyethylene sheeting secured in place with duct tape.
3.For LHR projects, HEPA vacuuming and/or wet cleaning all objects and surfaces in the contained work area of all visible dust, paint chips, or other debris before covering them. The thickness of the polyethylene sheeting must be six (6) mils.
D.Both the owner and Lead Renovator or Lead Supervisor, as applicable, shall make reasonable efforts to ensure that no unauthorized person or pet enters or remains in a containment area until passing cleaning verification or dust wipe clearance, as applicable.
E.Warning signs must be posted at all entrances to the work area(s).
F.The worksite must be secured against unauthorized entry.
12.5.3Control of Access
A.Warning Signs
1.Warning signs must be posted at all entrances to the work area(s) before beginning any RRP, LHC, or LHR project and must be illuminated and cleaned as necessary so that the text is readily visible.
2.The signs must contain at least the following text which is required by 29 C.F.R. § 1926.62(m):
Danger Lead Work Area
May Damage Fertility or the Unborn Child
Causes Damage to the Central Nervous System
Do Not Eat, Drink, or Smoke in this Area
3.The signs must contain a twenty-four (24) hour emergency contact telephone number.
4.To the extent practicable, these signs must be in the primary language of the occupants, be readily visible, and securely affixed in such a way that prevents their loss or unintentional removal.
5.The signs must remain in place and readable until cleaning verification or acceptable clearance, as applicable, is achieved.
B.For LHR projects, the worksite must be secured against unauthorized entry by changing locks and/or the addition of padlocks to all entrances to an interior containment area, when practicable, provided that the entrance(s) can be locked without violating building safety or fire codes regarding means of egress.
1.For the purposes of this Part, the following persons are permitted to enter an LHR containment area:
a.A licensed lead professional employed by the Lead Contractor;
b.An appropriately trained, licensed, and supervised subcontractor of the Lead Contractor;
c.A Federal, State or local inspector/enforcement official with jurisdiction over one (1) or more of the activities within the work area;
d.A tenant only to access a common hallway when no other means of access or egress is available; and
e.Specialized trades people (e.g. plumbers, electricians) only when responding to an emergency, provided that a detailed explanation is submitted in writing to the Department on the next business day.
2.The following persons may enter a containment area only when accompanied by a Lead Supervisor, as appropriate:
a.The property owner or agent; or
b.An agent of a lender with a security interest in the dwelling.
3.The Lead Supervisor, who accompanies a person authorized to enter a containment area pursuant to this Section, shall warn such person of the danger of entering a containment area without respiratory protection.
4.The Lead Supervisor shall ensure that all persons who enter an LHR containment area print and sign their names in the access logbook, to document the date and time entering and leaving the containment area and include their lead professional license number or affiliation and reason for entering the containment area.
12.5.4Containment
A.Interior Containment.
1.Before beginning any RRP, LHC, or LHR project, the Lead Renovator or Lead Supervisor, as applicable, shall ensure that any interior work area is contained so that no lead dust, paint chips, or other debris leave a work area while the work is in progress.
2.The Lead Renovator or Lead Supervisor, as applicable, shall ensure that containment is installed in such a manner that it does not interfere with occupant or worker egress in an emergency.
3.For LHR projects, the thickness of the polyethylene sheeting must be six (6) mils.
4.Critical barriers between work areas and non-work areas must be constructed. Barriers must consist of at least one (1) layer of polyethylene sheeting, sized to minimize seams, and be attached securely in place with duct tape.
5.All windows and doors in the work area must be closed.
6.Windows which open to an enclosed area must be securely locked or sealed with polyethylene sheeting and duct tape.
7.Doors used as an entrance to the work area must be covered with two (2) layers of polyethylene sheeting in a manner that allows workers to pass through while confining dust and debris to the work area.
8.A physical barrier, such as a cone or warning tape, must be placed outside the entry to the work area if the entry is not a door.
9.Installed carpeting may be removed and disposed, pursuant to § 12.5.12 of this Part, at the beginning of the project and the exposed subfloor must be covered with polyethylene sheeting secured with duct tape.
10.Floors, including any remaining installed carpeting in the work area, must be covered with polyethylene sheeting secured with duct tape.
11.If using chemical strippers, a second (2nd) smaller layer of floor sheeting must be placed immediately below the work area and duct taped to the top of the first (1st) layer.
12.When the RRP or LHC work area encompasses less than the entire dwelling unit, interior room, or common area, floor covering is required as follows:
a.All installed carpets in the room or area must be completely covered with at least one (1) layer of polyethylene sheeting secured with duct tape.
b.Uncarpeted floors must be covered a minimum of six feet (6’) in all directions around the paint being disturbed or a sufficient distance to contain the dust, whichever is greater.
c.Disposable tack pads may be duct taped to an outer corner of the polyethylene sheeting to remove dust from feet. If used, the tack pads must be replaced at least once each day.
13.Containment may stop at the edge of the vertical barrier when using a vertical containment system consisting of impenetrable barriers that extend from the floor to the ceiling and are tightly sealed at joints with the floor, ceiling and walls.
14.All HVAC equipment in or passing through the work area must be shut down and locked out. All intake and exhaust openings, as well as any seams in system components within the work area, must be sealed with polyethylene sheeting and/or duct tape.
15.All other openings between work areas and non-work areas, including but not limited to, doorways, drains, ducts, grills, grates, and diffusers must be sealed with polyethylene sheeting and duct tape.
16.The Lead Renovator or Lead Supervisor, as applicable, shall maintain the integrity of the containment by ensuring that the containment materials are not torn or displaced, and taking any other steps necessary to ensure that no lead dust, paint chips, or other debris leaves the work area during RRP, LHC, or LHR activities.
17.The interior work area(s) must be secured against unauthorized entry at the end of each workday.
18.At the conclusion of each workday and at the conclusion of the project, waste that has been collected from the work activities must be stored under containment, in an enclosure, or behind a barrier outside of the work area which prevents access by unauthorized persons prior to removal for disposal.
B.Exterior Containment
1.All toys and play equipment, including sandboxes, and outdoor furnishings within a minimum of fifty feet (50’) from the work area and/or any other distance which spent abrasive, paint, particulate, dust and/or other debris may travel must be removed or covered with an impenetrable material.
2.A twenty-foot (20') perimeter around the work area must be established, if space permits. Access can be limited with cones, sawhorses, and/or warning tape.
3.Doors used as entrances to the work area must be covered with two (2) layers of polyethylene sheeting in a manner that allows workers to pass through while confining dust and debris to the work area.
4.All windows and doors that are within twenty feet (20’) of the work area must be closed. On multi-story buildings, all windows and doors within twenty feet (20’) of the work area on the same floor and all windows and doors on all floors below, which are the same horizontal distance, must be closed.
5.If using abrasive blasting or mechanical paint removal equipment, all windows and doors on walls which will be disturbed must be closed and securely sealed from the outside. Air conditioning units on those walls must be turned off and covered with polyethylene sheeting secured with duct tape.
6.The ground below the work area must be covered with an impenetrable material to keep any and all spent abrasive, paint, particulate, dust, and/or other debris from being deposited on the ground. The ground sheeting must extend a minimum of ten feet (10’) from the work area, if space permits. The ground sheeting must be attached by staking, weighing down, or any other method to ensure that it remains in place during the work activities.
7.Vertical containment shrouds must be erected if space does not permit the ground sheeting to extend a minimum of ten feet (10’) from the work area and/or if there is visible movement of abrasive material, paint, dust, and/or other debris beyond the ground sheeting.
8.At the conclusion of each workday and at the conclusion of the project, waste that has been collected from the work activities must be stored under containment, in an enclosure, or behind a barrier outside of the work area which prevents access by unauthorized persons prior to disposal.
12.5.5Special Requirements in Common Area Hallways
A.General Requirements
1.Whenever an RRP, LHC, or LHR project is being conducted in a common area hallway of an occupied multi-unit dwelling, the Lead Renovator or Lead Supervisor, as applicable, shall ensure the following:
a.All building and fire code requirements for means of egress are maintained; and
b.All residents and pets use alternative entrances and exits which do not require passage through a containment area.
B.Two (2) Common Hallways
1.When two (2) separate common hallways are available for entrance and exit from occupied dwelling units, the Lead Renovator or Lead Supervisor, as applicable, shall:
a.Conduct the RRP, LHC, or LHR work in one (1) hallway at a time, and successfully pass the cleaning verification procedure or dust wipe clearance, as applicable, in the first (1st) hallway before beginning work in the second (2nd) hallway; and
b.Instruct all affected residents in writing to use only the hallway, which is not undergoing RRP, LHC, or LHR work.
C.One (1) Common Hallway
1.When only one (1) common hallway is available for entrance and exit from occupied dwelling units, the Lead Renovator or Lead Supervisor, as applicable, shall:
a.Ensure that the affected dwelling units are vacated until after successfully passing the cleaning verification procedure or dust wipe clearance; or
b.Ensure that all occupants of the units which have access to the common hallway:
(1)Received written notification specifying the dates and times of reduced hallway access and stating that children should not be allowed to linger or play in the hallway until after the area achieves cleaning verification or dust wipe clearance, as applicable; and
(2)Exit the building each day before the start of any RRP, LHC, or LHR work activities in the hallway and before setting up hallway containment; and
(3)Do not return until after completion of the day’s work and required cleaning.
2.Conduct a thorough cleaning at the end of each workday in the common hallway before any tenants can gain access to the hallway. The cleaning must include the packaging and removal of all lead-containing debris, followed by a HEPA vacuum/wet wash sequence, pursuant to § 12.6 of this Part, until no visible dust remains.
12.5.6Additional Requirements for Interior Mechanical Paint Removal
A.In addition to the interior containment requirements in § 12.5.4 of this Part, the following containment is also required for interior mechanical paint removal, to the maximum extent feasible:
1.Floor sheeting must consist of two (2) layers of six (6) mil polyethylene;
2.Wall sheeting must consist of one (1) layer of six (6) mil polyethylene sheeting;
3.All windows and doors in the containment area must be covered and sealed with two (2) layers of six (6) mil polyethylene sheeting and duct tape; and
4.If baseboards are present, the floor/baseboard and baseboard/wall joints must be:
a.HEPA vacuumed and then caulked; or
b.Sealed with an additional layer of six (6) mil polyethylene sheeting attached with duct tape above the top of the baseboard, extending down the wall and out onto the floor at least six inches (6”) from the wall, and secured with duct tape.
c.If an additional layer of polyethylene sheeting is used to cover the baseboard area, this sheeting must not be removed until all demolition and/or LHR work above the baseboard has been completed.
12.5.7Additional Requirements for Demolition Activities
A.Using hammers or other tools that impact the integrity of a building component is considered demolition for the purposes of this Part. Projects that include interior demolition, including, but not limited to, partial demolition of a structure, total interior strip-outs, selective interior demolition, interior structural deconstruction, and gut rehabilitation must be conducted in accordance with the lead-safe work practice requirements § 12.5 of this Part and the following additional requirements:
1.All RRP, LHC, or LHR projects which include demolition must also comply with the Department’s Rules and Regulations for Asbestos Control (Part 1 of this Subchapter).
2.RRP, LHC, or LHR projects which include exterior demolition must also comply with DEM Regulation Fugitive Dust (250-RICR-120-05-5).
B.In addition to the interior containment requirements in § 12.5.4 of this Part, the following containment is also required for interior demolition, to the maximum extent feasible:
1.Floor sheeting must consist of two (2) layers of six (6) mil polyethylene;
2.Wall sheeting must consist of one (1) layer of six (6) mil polyethylene sheeting;
3.All windows and doors in the containment area must be covered and sealed with two (2) layers of six (6) mil polyethylene sheeting and duct tape; and
4.If baseboards are present, the floor/baseboard and baseboard/wall joints must be:
a.HEPA vacuumed and then caulked; or
b.Sealed with an additional layer of six (6) mil polyethylene sheeting attached with duct tape above the top of the baseboard, extending down the wall and out onto the floor at least six inches (6”) from the wall, and secured with duct tape.
c.If an additional layer of polyethylene sheeting is used to cover the baseboard area, this sheeting must not be removed until all demolition and/or RRP, LHC, or LHR work above the baseboard has been completed.
12.5.8Paint Treatment Options
A.The following lead-based paint remedies are approved by the Department and may be used as standard treatments for painted surfaces assumed to contain lead-based paint. Treatments which temporarily reduce lead exposure are considered interim controls and require ongoing monitoring and maintenance. Treatments that can be expected to permanently eliminate or reduce lead exposure for at least twenty (20) years under normal conditions are considered lead abatement.
B.Paint Stabilization
1.Lead-based paint stabilization is an interim control which includes surface preparation, specified in Lead Safe Work Practices Guidance, and the application of new protective coatings or paint.
a.No known or assumed lead-based paint should be in a damaged condition. As a minimum, all lead-based paint must be stabilized to an intact condition.
C.Paint Removal
1.Lead-based paint removal includes stripping, scraping, or other methods to remove paint from a substrate. Because it is extremely difficult to completely remove all lead from a painted surface, stripped components may not meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter.
a.The following lead-based paint removal methods are prohibited at a regulated facility or for compensation at target housing under all conditions:
(1)Dry hand scraping, except for within one foot (1’) of electrical outlets;
(2)Dry hand sanding, except for “feathering” of previously treated interior painted surfaces;
(3)Using a heat gun or other heated device, which chars paint, or at surface temperatures at or above one thousand one hundred degrees Fahrenheit (1100º F);
(4)Open flame burning or torching;
(5)Using paint strippers which are flammable or contain methylene chloride or using volatile strippers in a poorly ventilated space;
(6)Using mechanical paint removal equipment without a shroud or containment system equipped with a HEPA vacuum, and/or with a sanding or scraping disk wider than the direct surface upon which it is being used;
(7)Using dry abrasive blasting equipment not controlled by a HEPA vacuum system on exterior surfaces;
(8)Using dry abrasive blasting equipment on interior surfaces;
(9)Uncontained hydro blasting, including but not limited to, using wet abrasive blasting equipment, and pressure or power washing;
(10)Any other interior methods not approved by the Department;
(11)Any other exterior methods not approved by DEM Office of Air Resources; and/or
(12)Any treatment in violation of local municipal building codes.
b.Approved Methods. The following paint removal methods are approved for use at a regulated facility or for compensation at target housing when lead based paint is disturbed for any reason.
(1)Wet hand scraping or sanding;
(2)“Feathering” of previously treated interior painted surfaces;
(3)Using heat guns that do not char paint or exceed one thousand one hundred degrees Fahrenheit (1100º F);
(4)Paint stripping in adequately ventilated areas using non-flammable chemical strippers that do not contain methylene chloride;
(5)Using shrouded mechanical paint removal equipment controlled by a HEPA vacuum system, provided that any and all spent abrasive, paint, particulate, dust, and/or other debris generated by the operations is immediately collected by the system, and provided that no sanding or scraping disk is wider than the direct surface upon which it is being used;
(6)Using exterior dry abrasive blasting equipment controlled by a HEPA vacuum system, provided that any and all spent abrasive, paint, particulate, dust, and/or other debris generated by the operations is immediately collected by the system, or a vacuum blast system used in accordance with the manufacturer’s guidelines;
(7)Using exterior wet abrasive blasting equipment provided that a vertical containment system that prevents any and all fallout generated by the operation from traveling beyond the ground containment is used. Additionally, any and all liquid waste generated by the operation must be adequately contained and handled in accordance with applicable waste disposal Regulations.
(8)Any other interior methods approved in writing by the Department; or
(9)Any other exterior methods approved in writing by DEM Office of Air Resources.
12.5.9Special Requirements for Friction and Impact Surfaces
A.Friction Surfaces
1.Remediation of friction surfaces must eliminate friction points or treat the friction surface so that lead-based paint is not subject to abrasion and/or dust generation caused by normal use such as opening a double-hung wooden window, closing a door that binds with its frame, or foot traffic on floors and stairs. Lead-based paint removal methods, which do not result in friction surfaces meeting the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter require additional interim controls.
B.Impact surfaces
1.Remediation of impact surfaces is required when lead-based paint on an impact surface is damaged, abraded, rubbed, impacted or otherwise deteriorated and/or the damaged lead-based paint is caused by impact from a related building component such as a doorknob that knocks into a wall, or a door that hits against its frame. Treatments for impact surfaces must protect the lead-based paint from impact.
12.5.10Covering Painted Surfaces
A.Encapsulation
1.Encapsulation is a process that makes lead-based paint inaccessible by providing a barrier between the lead-based paint and the environment. Depending on the circumstances and product, encapsulation may be used to achieve abatement that can be expected to eliminate exposure to lead-based paint for at least twenty (20) years under normal conditions.
2.For the purposes of this Part, liquid encapsulation products that are not applied to at least the minimum dry film thickness at which the coating met the applicable ASTM standard are considered an interim control.
3.For the purposes of this Part, the encapsulation product or system must be guaranteed by the manufacturer to perform for at least twenty (20) years in locations and conditions like those of the planned application and the installation process must be approved in advance by the Department to be considered a form of abatement.
4.The encapsulation process must meet all requirements for the manufacturer’s twenty (20) year warranty, including but not limited to, surface assessment testing, proper preparation, approved primers, application methods, number and thickness of coats, periodic monitoring and touch up as necessary. Warranties solely against manufacturer’s defects are insufficient.
B.Enclosure
1.Enclosure is the installation of a rigid, durable barrier that is mechanically fastened to building components, with all edges and seams sealed with caulk or another sealant. Enclosure may be used to achieve abatement that can be expected to eliminate exposure to lead-based paint for at least twenty (20) years under normal conditions.
12.5.11Removing/Replacing Painted Components
A.Removal of lead-painted building components and/or replacement with lead-free components is a permanent treatment.
1.Components may be removed intact and replaced, as specified in the Lead Safe Work Practices Guidance Document.
2.Using hammers or other tools that impact the integrity of a building component is considered demolition for the purposes of this Part. There is no de minimis for demolition.
B.Component removal and replacement must be done in compliance with all applicable building codes. For some preservation projects, component removal, replacement, or demolition may not be permitted.
12.5.12Dust Treatment Options
A.Cleaning of lead-contaminated dust that was not generated by RRP, LHC, or LHR activities does not require lead professional licensure by the Department but must follow the lead-safe work practices in this Section. This includes immediate cleanup after spot removal or minor repair and maintenance activities.
B.Disturbing painted surfaces in excess of the spot removal de minimis to remediate known or assumed sources of lead-contaminated dust requires lead professional licensure by the Department and is subject to all applicable lead-safe work practice requirements of this Part.
C.Prohibited Cleaning Methods
1.The following cleaning methods are prohibited in all areas that contain known or suspected lead-contaminated dust, paint chips, or debris.
a.Dry sweeping; and/or
b.Using a vacuum cleaner which is not a true HEPA vacuum.
D.Approved Cleaning Methods
1.The following cleaning methods are standard treatments for cleaning lead-contaminated dust:
2.Bare Surfaces
a.Uncarpeted floors and other hard surfaces must be cleaned by a process of:
(1)HEPA vacuuming;
(2)Wet washing with detergent;
(3)Rinsing with clean water, changing rinse water often;
(4)Followed by a final HEPA vacuuming; and
(5)Repeating the above sequence until no visible dust remains.
3.Covered Surfaces
a.Surfaces covered by a rug, carpeting, upholstery, or fabric must be cleaned as follows:
(1)Lead-contaminated upholstery or fabrics must be thoroughly vacuumed using a HEPA vacuum, followed by steam extraction cleaning or another appropriate professional cleaning, if necessary.
(2)Installed carpeting that will not be removed must be thoroughly vacuumed using a HEPA vacuum with a beater bar attachment, followed by steam extraction cleaning or another appropriate professional cleaning, if necessary.
b.Protective measures must be used to prevent the spread of dust during removal of a rug, carpeting, or padding by:
(1)HEPA vacuuming the rug, carpeting, and/or padding using a beater bar attachment;
(2)Misting the rug, carpeting and/or padding with water;
(3)Cutting the rug, carpeting, and/or padding into pieces of a manageable size and weight, if necessary;
(4)Bagging or wrapping and sealing the pieces of the rug, carpeting, and/or padding before removing them from the room or area; and
(5)HEPA vacuuming and wet washing the floor surface, underneath where the rug, carpeting, and/or padding was removed, using the process specified in § 12.5.12(D)(2) of this Part.
12.5.13Soil Treatment Options
A.There are no standard treatments for soil. Approved treatments for soil depend upon the actual concentration of lead in the soil. The appropriate treatment must be used in order to meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter.
1.General Requirements
a.Remediation of soil hazards does not require licensure by the Department but must follow the lead-safe work practices in this Section.
b.All work that disturbs lead-contaminated soil must be performed while the soil is wet or damp to minimize the creation of dust.
c.Excavated lead-contaminated soil must be handled and disposed pursuant to all DEM and DOT requirements.
2.Prohibited Methods
a.Dry raking or shoveling of known or reasonably suspected lead-contaminated soil is prohibited.
b.Dry sweeping of known or suspected lead-contaminated soil, dust, paint chips, and/or other debris is prohibited.
c.Relocating excavated lead-contaminated soil to any area of the premises that does not require soil remediation is prohibited.
d.Any treatment in violation of local municipal codes is prohibited.
3.Lead in Soil: less than four hundred (400) ppm.
a.No action is required for lead concentrations in soil below the lead-safe threshold in § 12.7 of this Part and § 5.8 of this Subchapter.
4.Treatment options for bare soil with lead concentrations of four hundred (400) ppm to less than one thousand two hundred (1,200) ppm include:
a.Interim control by complete covering of the existing soil with mulch to a depth of at least six inches (6”); stone or gravel to a depth of at least four inches (4”); lead-safe soil to a depth of at least three inches (3”); sod, new grass, or other live ground cover; if area to be controlled is heavily traveled this may not be appropriate.
b.Abatement by excavating and removing existing soil, pursuant to all applicable DEM Regulations, to a depth of at least three inches (3”) followed by replacement of at least three inches (3”) of lead-safe soil;
c.Abatement by permanent covering with pavement; or
d.A site-specific remediation plan approved in writing by the Department.
5.Treatment options for bare soil with lead concentrations of one thousand two hundred (1,200) ppm to less than five thousand (5,000) ppm include:
a.Interim control by leaving existing soil in place and installing landscaping fabric along with adequate containment to avoid erosion, followed by covering pursuant to § 12.5.13(A)(4)(a) of this Part;
b.Interim control by tilling existing soil with lead-safe soil to reduce the concentration of lead to less than one thousand two hundred (1,200) ppm, followed by covering pursuant to § 12.5.13(A)(4)(a) of this Part;
c.Abatement by excavating and removing existing soil, pursuant to all applicable DEM Regulations, to a depth of at least three inches (3”) followed by replacement of at least three inches (3”) of lead-safe soil;
d.Abatement by permanent covering with pavement; or
e.A site-specific remediation plan approved in writing by the Department.
6.Treatment options for soil with lead concentrations of five thousand (5,000) ppm or greater include:
a.Abatement by excavating and removing existing soil, pursuant to all applicable DEM Regulations, to a depth of at least six inches (6”) followed by replacement of at least six inches (6”) of lead-safe soil;
b.Abatement by permanent covering with pavement; or
c.A site-specific remediation plan approved in writing by the Department
12.5.14Water Treatment Options
A.There are no standard treatments for water. Approved treatment options for drinking water depend upon the type of sample collected and the resulting lead concentration in the sample. The appropriate treatment(s) must be used in order to meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter.
1.General Requirements
a.Remediation of lead in drinking water does not require licensure by the Department but must follow the lead-safe work practices of § 12.5.14 of this Part.
b.Replacing pipes, joints, couplings or plumbing fixtures may require licensure by the Department of Labor and Training (DLT) and/or a permit from the municipality where the property is located.
c.Any treatment in violation of local municipal code is prohibited.
2.First Draw Samples
a.Lead in Water: less than fifteen (15) ppb.
(1)No action is required for lead concentrations below the lead-safe threshold in § 12.7 of this Part and § 5.8 of this Subchapter.
b.Lead in Water: fifteen (15) ppb to less than five hundred (500) ppb.
(1)Analysis of a flushed water sample is required for a lead concentration above the lead-safe threshold in § 12.7 of this Part and § 5.8 of this Subchapter; the treatment will be determined by the result of the flushed sample.
c.Lead in Water: five hundred (500) ppb or greater.
(1)The owner shall provide bottled water for the occupants drinking and cooking until the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter are achieved;
(2)The sampled tap(s), and any other taps used for drinking or cooking, must be labeled with at least the following text: “Lead Warning: Do not use for drinking or cooking”. To the extent practicable, the lead warning must be in the primary language of the occupants; and
(3)All lead-containing pipes, soldered joints, couplings, and fixtures must be replaced with lead-free materials; or
(4)A site-specific remediation plan must be approved in writing by the Department for each dwelling unit.
3.Flushed Samples
a.Lead in Water: less than fifteen (15) ppb.
(1)The owner shall instruct the occupants to use only cold water for drinking and cooking; and
(2)Flush the tap(s) before using any water for drinking or cooking.
b.Lead in Water: fifteen (15) ppb to less than one hundred (100) ppb.
(1)The owner shall provide bottled water for drinking and cooking until the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter are achieved;
(2)The sampled tap(s), and any other taps used for drinking or cooking, must be labeled with at least the following text: “Lead Warning: Do not use for drinking or cooking”. To the extent practicable, the lead warning must be in the primary language of the occupants;
(3)All lead-containing pipes, soldered joints, couplings and fixtures must be replaced with lead-free materials; or
(4)The owner may request a temporary variance from the Department to install a State approved NSF-53 certified water filtration system capable of reducing lead concentrations in drinking water, and sign a consent agreement with the Department to maintain the filtration system in accordance with the manufacturer’s specifications; or
(5)A site-specific remediation plan must be approved in writing by the Department for each dwelling unit.
c.Lead in Water: greater than one hundred (100) ppb.
(1)The owner shall provide bottled water for drinking and cooking until the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter are achieved;
(2)The sampled tap(s), and any other taps used for drinking or cooking, must be labeled with at least the following text: “Lead Warning: Do not use for drinking or cooking”. To the extent practicable, the lead warning must be in the primary language of the occupants;
(3)All lead-containing pipes, soldered joints, couplings and fixtures must be replaced with lead-free materials; or
(4)A site-specific remediation plan must be approved in writing by the Department for each dwelling unit.
4.After plumbing work is completed, either:
a.Remove faucet aerators and flush the supply pipes by letting them run for several minutes to remove small pieces of loose solder. Any debris from the faucet aerators must be cleaned before reinstalling the faucet aerator. The water must then be retested; or
b.Install new faucet aerators and retest the water.
c.The water filtration system(s) must be maintained in accordance with the manufacturer’s specifications.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.6** Cleaning {#sec-216-ricr-50-15-12-12.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.6}
A.Interior Cleaning
1.The Lead Renovator or Lead Supervisor, as applicable, shall be responsible to ensure that all surfaces in the containment area(s) and any areas outside any containment area that were contaminated with visible dust, paint chips, or other debris from the RRP, LHC, or LHR work, are cleaned in accordance with the following procedures:
a.Preliminary cleanup must be performed by HEPA vacuuming the containment area, carefully removing all protective coverings except containment barriers, misting the polyethylene sheeting with water, then carefully folding the sheeting upon itself to trap all dust, and bagging or sealing the sheeting with duct tape.
b.For non-mechanical paint removal, final cleanup must begin no sooner than one (1) hour after preliminary cleanup was completed to ensure that airborne dust has time to settle.
c.For mechanical paint removal, final cleanup must begin no sooner than twenty-four (24) hours after preliminary cleanup was completed to ensure that airborne dust has time to settle.
d.Final cleanup must consist of HEPA vacuuming all surfaces in the containment area, followed by wet cleaning and changing rinse water as often as necessary, then a second HEPA vacuuming of those surfaces. This sequence of vacuuming, wet cleaning, rinsing, and vacuuming must be repeated until no visible residue is observed in the containment area or adjacent to the containment area. Particular attention must be made to floor, baseboard, and wall joints to ensure that no dust, paint chips, or other debris remains.
e.When the RRP or LHC work area encompasses less than the entire dwelling unit, interior room, or common area, floor cleaning is required as follows:
(1)Uncarpeted floors must be cleaned a minimum of two feet (2’) beyond the contained work area.
(2)Carpeted floors in the entire room or common area must be cleaned using a HEPA vacuum with a beater bar attachment.
f.HVAC system ductwork must be decontaminated, and system filters replaced if the ductwork was contaminated during the RRP, LHC, or LHR work.
g.In addition, any areas outside the work area that were contaminated with visible dust, paint chips, or other debris must be cleaned using the above sequence of vacuuming, wet washing, rinsing, and vacuuming until no visible residue is observed outside the containment area. Particular attention must be made to pathways used to access work area(s) and pathways used to remove waste from work area(s).
h.Precautions must be taken to ensure that all workers, tools, waste containers, and other items leaving a work area are free from dust, paint chips, and/or other debris. The removal of lead from PPE, tools, etc., by blowing, shaking, or any other means which disperses lead into the air is prohibited.
i.All lead-containing waste materials must be wrapped, bagged, or placed in an appropriate container for storage and disposal.
j.At the conclusion of the RRP, LHC, or LHR work activities, the Lead Renovator or Lead Supervisor, as applicable shall conduct a visual inspection to verify that no visible dust, paint chips, or other debris remain, and the project is ready for the cleaning verification procedure or a clearance inspection, as applicable.
k.Cleaning verification or dust wipe sampling must begin no sooner than one (1) hour after final cleanup was completed to ensure that airborne dust has time to settle.
l.Containment barriers and warning signs must not be removed until cleaning verification meets the EPA standards in 40 C.F.R. Part 745.85(b), or the Lead Renovator or Lead Supervisor, as applicable, is notified by the Lead Inspector who conducted the clearance inspection, that the work areas are safe for re-occupancy.
B.Exterior Cleaning
1.At the end of each workday:
a.If a dry removal procedure was used, any and all spent abrasive, paint, particulate, dust, and/or other debris present on the ground sheeting and/or other containment materials must be misted with water, collected, and placed in an appropriate container.
b.The Lead Renovator or Lead Supervisor, as applicable, shall visually inspect all areas, including areas that extend beyond the sheeted area, to determine whether any spent abrasive, paint, particulate, dust and/or other debris escaped containment. If any spent abrasive, paint, particulate, dust and/or other debris generated by the operations is observed, it must be collected and placed in an appropriate container.
c.Any and all liquid waste must be collected and stored in appropriate containers.
d.Precautions must be taken to ensure that all workers, tools, waste containers, and other items leaving a work area are free from dust, paint chips, and/or other debris. The removal of lead from PPE, tools, etc., by blowing, shaking, or any other means which disperses lead into the air is prohibited.
e.Ground sheeting, vertical shrouds, other containment materials, and waste containers should be stored in a secure area not easily accessible to the public prior to removal for disposal.
2.At project completion:
a.Any and all spent abrasive, paint, particulate, dust, and/or other debris present on the ground sheeting and/or other containment materials must be misted with water, collected, and placed in an appropriate container. The sheeting must then be carefully folded upon itself and sealed with duct tape or bagged and goose necked.
b.The Lead Renovator or Lead Supervisor, as applicable, shall visually inspect all areas, including areas that extend beyond the sheeted area, to determine whether any spent abrasive, paint, particulate, dust and/or other debris has escaped containment. If any spent abrasive, paint, particulate, dust and/or other debris generated by the project is observed, it must be collected and placed in an appropriate container.
c.All waste must be contained to prevent the release of dust and debris when transported from the work areas.
(1)All liquid waste must be collected in appropriate containers.
(2)Any and all bags and waste containers must be securely sealed.
d.Precautions must be taken to ensure that all workers, tools, waste containers, and other items leaving a work area are free from dust, paint chips, and/or other debris. The removal of lead from PPE, tools, etc., by blowing, shaking, or any other means which disperses lead into the air is prohibited.
12.6.1RRP Cleaning Verification
A.The Lead Renovator shall clean the work area(s) pursuant to the EPA standards for renovation activities in 40 C.F.R. § 745.85(a)(5).
B.Cleaning verification need not be performed if the contract between the Lead Renovation Firm and the owner requires dust clearance sampling at the conclusion of the RRP project.
C.If the cleaning verification procedure is performed, the work area(s) must meet the EPA standards for post-renovation cleaning verification in 40 C.F.R. § 745.85(b) and be documented on the RRP checklist.
D.Unless the cleaning verification procedure is performed, an RRP Clearance Inspection with dust wipe sampling is required. If dust wipe sampling is performed, cleaning verification is no longer an option.
E.The dust clearance samples must be collected by a Department-licensed Lead Inspector or Lead Assessor pursuant to Part 5 of this Subchapter and analyzed by a laboratory certified pursuant to Part 11 of this Subchapter.
F.The Lead Renovation Firm must re-clean the work area(s) until the dust clearance sample results are below the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter.
12.6.2Clearance Inspections
A.The purpose of a Clearance Inspection is to:
1.Determine that the scope of work is completed and documented in a lead inspection report;
2.The child care center, single-family house, dwelling unit and common areas, or work area(s) were adequately cleaned;
3.Any environmental lead testing results meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter; and
4.The child care center, single family house, dwelling unit and common areas, or work area(s), as applicable are safe for re-occupancy.
B.For RRP or LHC projects, the clearance inspection may be a “work area” or "whole unit" inspection which includes interior paint, exterior paint, interior dust, exterior soil, and/or drinking water, as applicable. For LHR projects, the clearance inspection must be a “whole unit” inspection.
C.Upon notification that the Clearance Inspection failed the visual assessment, the Lead Renovator or Lead Supervisor, as applicable, shall ensure that the remaining work and/or cleaning, specified by the Lead Inspector who conducted the inspection, is completed and all surfaces are free of visible dust, paint chips, or other debris.
D.Upon notification that one (1) or more dust samples failed to meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter, the Lead Renovator or Lead Supervisor, as applicable, shall ensure that the final cleanup procedures are repeated, pursuant to § 12.6 of this Part.
1.Subsequent dust sampling must include dust wipes from the entire child care center, single-family house, dwelling unit, common area, or work area, as applicable, not just the location(s) where the previous failed sample(s) were obtained.
E.Upon notification that one (1) or more soil samples failed the Clearance Inspection, the Lead Renovator or Lead Supervisor, as applicable, shall arrange for the additional work required to meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter.
F.Upon notification that one (1) or more water samples failed the Clearance Inspection, the Lead Renovator or Lead Supervisor, as applicable, shall arrange for any additional work required to meet the lead-safe standards in § 12.7 of this Part and § 5.8 of this Subchapter.
G.At the conclusion of an LHC project:
1.A work area or whole unit clearance inspection, as applicable, must be performed to document that the lead hazards were corrected and the child care center, single family house, dwelling unit and common areas, or work area(s) are safe for re-occupancy; or
2.An LHM Inspection may be performed to obtain a Certificate of Lead Conformance (LHM-2-1); or
3.A Comprehensive Environmental Lead Inspection may be performed to obtain a Conditional Lead-Safe Certificate (Form PBLC-15) or a Full Lead-Safe Certificate (Form PBLC-21), as applicable.
H.At the conclusion of an LHR project:
1.A Conditional Lead-Safe Certificate (Form PBLC-15) or Full Lead Safe Certificate (Form PBLC-21) is required.
2.A Comprehensive Environmental Lead Inspection must be performed pursuant to Part 5 of this Subchapter in lieu of a Clearance Inspection if an initial Comprehensive Environmental Lead Inspection was not performed.
12.6.3Waste Storage and Disposal
A.All lead-containing waste must either be disposed of daily or stored in a secure location to prevent access by unauthorized persons prior to disposal.
1.Solid Waste
a.All solid waste from an RRP, LHC, or LHR project must be contained to prevent the release of dust, paint chips and/or other debris before the waste is removed from the work area(s) and/or project site for storage and/or disposal by:
(1)Collecting paint chips and small debris in single six (6) mil or double four (4) mil polyethylene trash bags, or appropriate containers;
(2)Storing larger building components in containers or wrapping bulk debris such as doors, windows, and woodwork in six (6) mil polyethylene sheeting and sealing with duct tape;
(3)Using a covered chute to remove waste from the work area(s);
(4)Using a covered dumpster to store waste until the project is completed; and/or
(5)Using another method approved in writing by DEM Office of Waste Management.
2.Residential Waste
a.Solid waste materials generated at residential facilities are generally considered to be household waste and therefore exempt from the Rules and Regulations for Hazardous Waste Management (250-RICR-140-10-1).
b.Liquid or other waste, including chemical paint strippers, must be properly characterized by the generator in accordance with the Rules and Regulations for Hazardous Waste Management (250-RICR-140-10-1).
3.Non-Residential
a.Waste material generated at child care centers or other non- residential facilities must be properly characterized based on laboratory analysis for TCLP lead, or on knowledge of the material.
(1)Disposable Personal Protective Equipment (PPE) and supplies, such as polyethylene sheeting, may be characterized as non-hazardous solid waste based on knowledge of the material and properly disposed.
(2)Manually or mechanically removed lead-based paint and wooden components or debris containing lead-based paint may be characterized as non-hazardous solid waste based on knowledge of the material and properly disposed.
(3)Metal components containing lead-based paint may be characterized as non-hazardous solid waste based on knowledge of the material and properly disposed or recycled at a scrap metal facility.
(4)Liquid or other waste must be properly characterized based on laboratory analysis for TCLP lead and properly disposed.
(5)Chemical paint strippers must be properly characterized based on laboratory analysis for TCLP lead and other factors and properly disposed.
4.Wastewater
a.Water used for cleanup must never be dumped on the ground, down a storm drain, or down a sink or tub. This water must be filtered and dumped in a toilet or disposed pursuant to all applicable local water treatment authority, DEM, and DOT requirements.
5.Disposal.
a.All lead-containing waste material must be removed from the project site within seven (7) days of the project’s completion.
b.Homeowner-generated solid waste and non-hazardous solid waste may be disposed in any construction and demolition landfill or a municipal solid waste landfill. The waste must be contained in a manner that prevents the release of any dust or debris and be transported from the project site pursuant to all applicable DEM and DOT requirements.
c.Materials characterized as hazardous waste must be transported pursuant to all DOT requirements and disposed pursuant to the Rules and Regulations for Hazardous Waste Management (250-RICR-140-10-1).
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.7** Environmental Lead Standards {#sec-216-ricr-50-15-12-12.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.7}
Lead clearance standards are lead concentrations or conditions that meet the full lead-safe or conditional lead-safe standards and are less than the lead hazard concentrations and conditions shown in § 12.7 of this Part.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.8** Recordkeeping {#sec-216-ricr-50-15-12-12.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.8}
A.The Lead Renovator shall maintain the following information for each RRP or LHC project on-site for the duration of the project (when applicable):
1.Documentation of the Lead Renovation Firm’s license;
2.Documentation of the Lead Renovator(s)’ certification;
3.Documentation of training for all non-certified workers;
4.Documentation of distribution of the Pre-Renovation Education Form PBLC-29, or the equivalent;
5.A copy of the Start Work Notification (Form PBLC-9) and any revised SWN Form PBLC- 9 for the project;
6.Copies of any correspondence with regulatory agencies concerning the project (e.g. building permits, variances, notices or orders from the Department);
7.Lead Inspection Report, EPA Test Kit Documentation Form, EPA Paint Chip Sample Collection Form, or the equivalents by a Lead Inspector, Lead Assessor, or Lead Renovator, as applicable; and
8.For RRP projects, the RRP checklist to be completed by the Lead Renovator.
B.The Lead Renovation Firm shall retain and, if requested, make available to the Department all records necessary to demonstrate compliance with this Part for a period of at least three (3) years following completion of each RRP or LHC project including (when applicable):
1.All items specified in § 12.8(A) of this Part;
2.A copy of the DEM Notification of Removal of Lead Based Paint and a list of the parties to whom it was delivered;
3.For RRP projects, documentation of the cleaning verification procedure;
4.A complete and accurate RRP checklist, signed by the Lead Renovator assigned to the RRP project;
5.For LHC projects, a copy of an appropriate lead certificate issued by the Lead Inspector who conducted the clearance inspection;
6.Documentation of compliance with the worker protection requirements of OSHA 294 C.F.R. §§ 1926.62 and 1910.1025; and
7.Documentation of compliance with all applicable DEM and DOT Regulations for transportation and disposal of waste.
C.The Lead Supervisor shall maintain the following information for each LHR project on-site for the duration of the project (when applicable):
1.Documentation of the Lead Contractor license;
2.The access logbook, pursuant to § 12.5.3(B)(4) of this Part;
3.Documentation of compliance with all applicable OSHA medical monitoring requirements (e.g. blood lead test results, respirator fit test results);
4.The methodology and results of any air sampling conducted during the LHR project;
5.A copy of the Start Work Notification (Form PBLC-9) and any revised SWN Form-PBLC-9s;
6.Copies of any correspondence with regulatory agencies concerning the project (e.g. all municipal building or demolition permits, and any variances, notices or orders from the Department);
7.Interim Clearance Inspection results which document any previously completed and successfully cleared work area(s) as safe for re-occupancy; and
8.A current copy of this Part.
D.The Lead Contractor shall retain and, if requested, make available to the Department all records necessary to demonstrate compliance with this Part for each LHR project for a period of at least three (3) years following completion of that project including (when applicable):
1.All items specified in § 12.8(C) of this Part;
2.Documentation of compliance with all notifications pursuant to § 12.4 of this Part;
3.A copy of the DEM Notification of Removal of Lead Based Paint and a list of the parties to whom it was delivered;
4.Documentation of compliance with the licensing and supervision requirements, pursuant to § 12.8 of this Part and Part 11 of this Subchapter;
5.Documentation of compliance with OSHA 294 C.F.R. § 1926.62 and 294 C.F.R. § 1910.1025 for the project;
6.Documentation of compliance with all applicable DEM and DOT Regulations for transportation and disposal of waste for the project; and
7.A copy of the lead certificate(s) issued by the Lead Inspector who performed the clearance inspection.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
##### **216-RICR-50-15-12 § 12.9** Severability {#sec-216-ricr-50-15-12-12.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-50-15-12#12.9}
A.If any provision of these Regulations, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or applications of the Regulations which can be given effect without the invalid provisions or applications and to this end the provisions are declared to be severable.
**History**
- *Amendment — effective from 2026-05-24 to current*
- *Adoption — effective from 2022-01-02 to 05/24/2026*
## **Chapter 60** Laboratories and Medical Examiner
### **Subchapter 05** State Laboratory
#### **216-RICR-60-05-1** Determination of the Amount of Alcohol and/or Drugs in a Person’s Blood by Chemical Analysis of the Breath and/or Blood
##### **216-RICR-60-05-1 § 1.1** Authority {#sec-216-ricr-60-05-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-1#1.1}
These Regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws §§ 31-27-2(g) and 31-27-2.1(a) for the purpose of establishing procedures for administering tests of breath testing instruments, approving testing instruments, certifying and re-certifying operators, and describing the instrument monitoring program. These Regulations also establish blood testing collection and specimen handling requirements for alcohol and chemical analysis and describe the requirements for the competency of laboratory analysts, the methods of laboratory analysis, and reporting.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-02-26 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 02/26/2018*
- *Amendment — effective from 2006-06-12 to 12/23/2012*
- *Amendment — effective from 2003-09-03 to 06/12/2006*
- *EMERGENCY RULE Adoption — effective from 2003-05-23 to 09/03/2003*
- *Periodic Refile — effective from 2002-01-02 to 05/23/2003*
##### **216-RICR-60-05-1 § 1.2** Definitions {#sec-216-ricr-60-05-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-1#1.2}
A.Wherever used in this Part, the following terms shall be construed to mean:
1."Act" means R.I. Gen. Laws Chapter 31-27, entitled "Motor Vehicle Offenses."
2."Chemical test" means the analysis, or test(s) of a person's blood or breath for determining the chemical content of the blood or breath using methods of general scientific acceptance in the field of chemistry pursuant to the provisions of R.I. Gen. Laws § 31-27-2.1, and administered in accordance with the requirements of the Act and this Part.
3."Department" means the Rhode Island Department of Health.
4."Director" means the Director of the Rhode Island Department of Health or his/her duly authorized agent.
5.“Health care facility” means any institutional health service provider, facility, or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to: hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services); rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, and physician ambulatory surgery centers and podiatry ambulatory surgery centers providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, outpatient clinics, infirmaries and health centers, school based health centers and neighborhood health centers. The term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in R.I. Gen. Laws Chapter 7-51 (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association).
6."Medical technician" means a person employed by a hospital, a clinical laboratory, or other health care facility, who has been authorized by the director of that facility to draw blood. No civil liability shall be incurred by an authorized person drawing blood for this Act, or by the agency or institution employing that person, if the technique followed accepted medical practices.
7.“Preliminary breath tests" means a test for a chemical analysis of the breath administered in accordance with the Act and regulatory requirements of this Part for assisting law enforcement officers in conducting their investigation pursuant to R.I. Gen. Laws § 31-27-2.3.
8."R.I. Gen. Laws" means the Rhode Island General Laws.
9.“Target value” means the ethanol concentration that the standard solutions are designed to produce during simulation tests.
10.“This Part” mean all parts of the rules and regulations regarding Determination of the Amount of Alcohol and/or Drugs in a Person's Blood by Chemical Analysis of the Breath and/or Blood [216-RICR-60-05-1].
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-02-26 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 02/26/2018*
- *Amendment — effective from 2006-06-12 to 12/23/2012*
- *Amendment — effective from 2003-09-03 to 06/12/2006*
- *EMERGENCY RULE Adoption — effective from 2003-05-23 to 09/03/2003*
- *Periodic Refile — effective from 2002-01-02 to 05/23/2003*
##### **216-RICR-60-05-1 § 1.3** Breath Testing {#sec-216-ricr-60-05-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-1#1.3}
1.3.1Preliminary Breath Testing
A.Approval of Breath Testing Instruments
1.Only preliminary testing instruments designed for the quantitative determination of the alcohol content of the breath and that have been tested to the satisfaction of the Director and found reliable shall be given approval by the Director and included in the list of approved instruments. The Department shall maintain the list of approved instruments and shall be available upon request.
2.Any approved instrument currently being utilized for breath testing purposes may continue to be utilized until such time as it needs to be replaced (“grandfathered”). Any new testing instrument purchased for determining the alcohol content of the breath shall appear on the Department’s list of approved instruments that is in effect on the date of instrument purchase.
B.Certification of Breath Testing Operators
1.The Director shall consider applications for certification as a preliminary breath testing operator from persons who:
a.have satisfactorily completed a training course conducted by the Department determining their competency with one (1) or more types of preliminary breath testing instruments; and
b.hold a current certificate as evidentiary breath testing operators in accordance with the requirements of § 1.3.2(B) of this Part.
2.Operators shall be certified for three hundred sixty-five (365) days. If an operator’s certification lapses, said operator shall not function as an operator of a preliminary breath testing instrument.
3.Certificates may be revoked for just cause as determined by the Director.
C.Recertification
1.To obtain recertification, operators shall be qualified by the Director through a written examination and/or practical demonstration of competence within three hundred sixty-five (365) days of the test prescribed in R.I Gen. Laws § 31-27-2(5).
2.If re-certification as an operator has not taken place within seven hundred thirty (730) days from the last certification expiration date, the operator shall complete a course of training for preliminary breath analysis testing as approved by the Director for this purpose.
3.If an operator’s certification lapses, said operator shall not function as an operator of a preliminary breath testing instrument.
D.Instrument Monitoring Program
1.The Department shall check all approved preliminary breath testing instruments at intervals not exceeding one hundred eighty (180) days to determine the accuracy of the instruments.
2.All standard alcohol solutions used for equilibration or simulation tests shall be prepared by analysts within the Forensic Sciences Section of the Department’s Division of Laboratories, or purchased. If purchased, the vendor shall supply a certificate of analysis for every lot of solution supplied.
E.Administration of Breath Tests
1.Preliminary breath tests shall consist of obtaining, by using approved breath testing instruments (see § 1.3.1(A) of this Part), breath samples of deep lung (alveolar) air. Such tests shall be administered:
a.by individuals certified to carry out such procedure pursuant to § 1.3.1(B) of this Part;
b.in accordance with the procedures specified for each type of instrument, as prescribed by the manufacturer of each instrument and in accordance with statutory provisions; and
c.in a sanitary manner, by utilizing separate disposable mouth pieces for each test administered.
1.3.2Evidentiary Breath Testing
A.Approval of Breath Testing Instruments
1.Only evidentiary testing instruments designed for the quantitative determination of the alcohol content of the breath and that have been tested to the satisfaction of the Director and found reliable shall be given approval by the Director and included in the list of approved instruments. The list of approved instruments shall be maintained by the Department and shall be available upon request.
2.Any approved instrument currently being utilized for breath testing purposes may continue to be utilized until such time as it needs to be replaced (“grandfathered”). Any new testing instrument purchased for determining the alcohol content of the breath shall appear on the Department’s list of approved instruments that is in effect on the date of instrument purchase.
B.Certification of Breath Testing Operators
1.The Director shall consider applications for certification from those individuals who present evidence of satisfactory completion of a training course for breath analysis testing approved by the Director.
2.Applicants may be approved and certificates issued upon the satisfactory completion of an examination conducted by the Department. Such examination shall include written and practical demonstration of competence in one (1) or more approved methods.
3.Operators shall be certified for three hundred sixty-five (365) days. If an operator’s certification lapses, said operator shall not function as an operator of an evidentiary breath testing instrument.
4.Certificates may be revoked for just cause as determined by the Director.
C.Recertification
1.To obtain recertification, the Department shall qualify operators through a written examination and/or practical demonstration of competence within three hundred sixty-five (365) days of the test prescribed in R.I. Gen. Laws § 31-27-2(5).
2.If re-certification has not taken place within seven hundred thirty (730) days from the last certification expiration date, the operator shall complete a course of training for breath analysis testing as approved by the Director.
3.If an operator’s certification lapses, said operator shall not function as an operator of an evidentiary breath testing instrument.
D.Instrument Monitoring Program
1.An authorized agent of the Director shall check the accuracy of approved breath testing instruments as prescribed by R.I. Gen. Laws Chapter 31-27. The instrument shall read within +/- 0.005 or +/- 5% (whichever is greater) of the target value.
2.All standard alcohol solutions used for equilibration or simulation tests shall be prepared by analysts within the Forensic Sciences Section of the Department’s Division of Laboratories, or purchased. If purchased, the vendor shall supply a certificate of analysis for every lot of solution supplied.
E.Administration of Breath Tests
1.Evidentiary breath samples shall be obtained, by using approved breath testing instruments (see § 1.3.2(A) of this Part). Breath samples shall be collected from deep lung (alveolar) air. Collection shall be administered by individuals certified to carry out such procedure pursuant to § 1.3.2(B) of this Part.
2.The following procedures shall apply:
a.A complete breath test shall consist of two (2) valid breath samples.
b.The breath samples shall be taken after the suspect has been observed for a minimum of fifteen (15) minutes to ensure that the suspect has not ingested or inserted any substance into his/her mouth, or caused any residual mouth alcohol to occur. This observation period does not require the officer or person administering the test to stare continuously at the suspect.
c.The breath samples shall be collected within fifteen (15) minutes of each other and the results reported as the alcohol level based upon grams of alcohol per two hundred ten (210) liters of breath. To be acceptable as a valid breath test, the two (2) results shall be within +/- 0.020 g/210L and taken within fifteen (15) minutes of each other. If the results of the first and second sample are more than +/- 0.020 g/210L apart, a third sample shall be analyzed.
d.To be acceptable as a valid breath test, any two (2) of the three (3) results shall be within +/- 0.020 g/210L and taken within fifteen (15) minutes of each other. In the event the person tested fails to provide the required number of valid breath samples, then this event shall constitute a refusal in accordance with R.I Gen. Laws § 31-27-2.1. If this process exceeds the allocated time, a second series may be implemented to satisfy the requirements of obtaining a valid breath test.
e.Each breath test shall be administered in accordance with the procedures for the instrument used, as prescribed by the Director.
f.When a law enforcement agency uses any approved breath analysis instrument, the accuracy of the instrument shall be tested by the internal detectors of the instrument. The result of the internal test shall be printed on the record.
g.Care shall be taken to ensure that a new and uncontaminated mouth piece is used for each breath test administered.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-02-26 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 02/26/2018*
- *Amendment — effective from 2006-06-12 to 12/23/2012*
- *Amendment — effective from 2003-09-03 to 06/12/2006*
- *EMERGENCY RULE Adoption — effective from 2003-05-23 to 09/03/2003*
- *Periodic Refile — effective from 2002-01-02 to 05/23/2003*
##### **216-RICR-60-05-1 § 1.4** Blood Testing {#sec-216-ricr-60-05-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-1#1.4}
A.Collection
1.The blood specimen(s) for chemical analysis shall be collected by a licensed physician, a registered nurse, or other licensed health care practitioner acting within the scope of his/her practice, or a "medical technician" as defined in § 1.2(A)(6) of this Part.
2.Prior to insertion of the needle preparatory to drawing blood, clean the superficial skin over the vein with a sanitizing agent devoid of alcohol.
3.Collect the blood specimen(s) in a sterile laboratory tube. It is preferable that the tube contains chemical(s) designed to prevent bacterial growth. (Such chemicals are commonly found in tubes with grey stoppers).
4.Blood specimens collected voluntarily from an individual for determining blood alcohol content and/or drug screening shall be turned over to the requesting law enforcement authority at the time of blood drawing.
B.Integrity of Specimen(s)
1.Maintaining the chain-of-custody and minimizing deterioration of the specimen(s), until delivery to the laboratory, shall be the responsibility of the requesting law enforcement authority.
2.The law enforcement authority shall maintain records containing, but not limited to, the following:
a.name and address of person apprehended,
b.date of birth of person apprehended,
c.date and time of occurrence,
d.type of bodily substance(s) collected,
e.date and time of collection of specimen(s),
f.name and place of employment of person collecting the specimen(s),
g.name of arresting officer, and
h.name of attending officer (if different).
3.To minimize specimen deterioration, the law enforcement authority shall:
a.avoid prolonged exposure of the specimen(s) to temperatures above ninety degrees Fahrenheit (90 °F),
b.deliver the specimen(s) to the laboratory as soon as practical, and
c.refrigerate tubes without preservative(s) until transported to the laboratory.
C.Competency of Laboratory Analysts
1.Persons employed in the several classes of Forensic Scientist within the Forensic Toxicology Laboratory of the Department’s Division of Laboratories shall be deemed competent by the Director to perform analyses of blood for alcohol or drugs.
2.All persons employed in a licensed hospital laboratory in Rhode Island are deemed competent by the Director to perform analyses of blood for alcohol or drugs, if the director of the hospital laboratory determines that the qualifications of the person(s) meet at least the minimum requirements set for Forensic Scientist.
D.Methods of Analysis
1.The laboratory shall employ evidence handling procedures designed to protect the chain-of custody of the specimen(s) and to minimize deterioration of the specimen(s).
2.The analysis of blood for alcohol shall be performed by means of gas chromatography or other technique generally recognized in the scientific community as being at least as accurate. Alcohol detected and identified during analysis shall be reported in terms of weight of alcohol (ethanol) per volume of substance analyzed (w/v).
3.The analysis of blood for drugs shall include confirmation of presumptively positive results by mass spectrometry or other technique generally recognized in the scientific community as being at least as accurate. Specified drugs and/or their metabolites, that are detected and identified, shall be reported as “present”.
E.Reports of Analysis
1.Upon completion of analysis, the individual who performed the analysis or the laboratory by whom she/he is employed, shall prepare a report of the result of said analysis.
2.The report shall be submitted only to the law enforcement authority requesting the analysis.
3.A copy of all reports of analysis under the Act shall be retained in accordance with the Department’s record retention schedule established for this category of document.
4.The confidential nature of all results of analysis shall be maintained.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-02-26 to 01/04/2022*
- *Amendment — effective from 2012-12-23 to 02/26/2018*
- *Amendment — effective from 2006-06-12 to 12/23/2012*
- *Amendment — effective from 2003-09-03 to 06/12/2006*
- *EMERGENCY RULE Adoption — effective from 2003-05-23 to 09/03/2003*
- *Periodic Refile — effective from 2002-01-02 to 05/23/2003*
#### **216-RICR-60-05-2** Rhode Island DNA Database & Databank
##### **216-RICR-60-05-2 § 2.1** Authority {#sec-216-ricr-60-05-2-2.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.1}
These regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws § 12-1.5-3(2), and are established for the purpose of adopting minimum standards for the collection, submission, identification, analysis, storage, and disposition of DNA samples and typing results of DNA samples submitted under the requirements of R.I. Gen. Laws Chapter 12-1.5 and for the creation of a DNA database for use in criminal investigations and humanitarian identification purposes.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.2** Incorporated Materials {#sec-216-ricr-60-05-2-2.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.2}
A.These regulations hereby adopt and incorporate the Federal Bureau of Investigation publication, "Quality Assurance Standards for Forensic DNA Testing Laboratories", U.S. Department of Justice, Federal Bureau of Investigation, (September 1, 2011) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate the "NDIS Operational Procedures Manual", Version 6, U.S. Department of Justice, Federal Bureau of Investigation, (July 17, 2017) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.3** Definitions {#sec-216-ricr-60-05-2-2.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.3}
A.Wherever used in these Regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 12-1.5, entitled, "DNA Detection of Sexual and Violent Offenders."
2."CODIS", derived from combined DNA index system, means the Federal Bureau of Investigation's national DNA identification index system that allows the storage and exchange of DNA records submitted by state and local forensic DNA laboratories.
3.“Crimes of violence” means murder, manslaughter, first degree arson, kidnapping with intent to extort, robbery, larceny from the person, first degree sexual assault, second degree sexual assault, first and second degree child molestation, assault with intent to murder, assault with intent to rob, assault with intent to commit first degree sexual assault, burglary, and entering a dwelling house with intent to commit murder, robbery, sexual assault, or larceny.
4."Department" means the Rhode Island Department of Health.
5."Director" means the Director of the Rhode Island Department of Health.
6.“DNA" means deoxyribonucleic acid, which is located in the cells of the body and provides an individual's personal genetic blueprint. DNA encodes genetic information that is the basis of human heredity and forensic identification.
7."DNA record" means DNA identification information only, which is stored in the State of Rhode Island DNA database or the combined DNA index system for the purpose of generating investigative leads or supporting statistical interpretation of DNA test results. The DNA record is the result obtained from the DNA typing tests. The DNA record is comprised of the characteristics of a DNA sample which are of value only in establishing the identity of individuals. The DNA record, however, does not include the DNA sample, and the DNA record may never include the results of tests of any structural genes. The results of all DNA identification tests on an individual's DNA sample are also collectively referred to as the DNA profile of an individual.
8.“DNA sample" means a blood or tissue sample provided by any person with respect to offenses covered by the Act or submitted to the Department of Health Laboratory pursuant to the Act for DNA analysis or storage, or both.
9.“DNA sample collection kit” means materials designed for the collection, documentation, and security of DNA samples.
10.“FBI” means the Federal Bureau of Investigation.
11.“Laboratory” means the Rhode Island Department of Health Laboratory.
12.“Secured” means limited and controlled access only by authorized personnel including use of protection and safety devices to safeguard any and all functions of that equipment or facility.
13.“State of Rhode Island DNA databank" means the repository of DNA samples collected under the Act, which is administered by the Department.
14."State of Rhode Island DNA database" means the state-level DNA identification record system to support law enforcement which is administered by the Department and which provides DNA records to the FBI for storage and maintenance in CODIS. It is the collective capability to store and maintain DNA records related to forensic casework, the DNA records of those convicted offenders required to provide a DNA sample under state law, and anonymous DNA records used for research, quality control, and other DNA analysis support systems.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.4** Scope of the Act and Applicable Offenses {#sec-216-ricr-60-05-2-2.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.4}
A.For law enforcement purposes, the Act is applicable to adult persons arrested for crimes of violence as defined in R.I. Gen. Laws § 12-1.5-2(8) and/or convicted of any felony.
B.Except as otherwise provided in R.I. Gen. Laws § 12-1.5-11, use of DNA samples and DNA records collected under the Act are limited to those purposes stated in R.I. Gen. Laws § 12-1.5-10(4), and shall not be used for the purposes stated in R.I. Gen. Laws § 12-1.5-10(5).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.5** Procedures for Conduct, Disposition, and Use of DNA Analysis {#sec-216-ricr-60-05-2-2.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.5}
A.All DNA sample typing results, all DNA records and all DNA samples shall be securely stored in the State of Rhode Island DNA database and DNA databank pursuant to R.I. Gen. Laws § 12-1.5-10.
B.DNA records and samples are confidential and shall not be disclosed except as governed by Rhode Island statute. All files, computer, and sample storage systems maintained by the Department pursuant to the Act shall be secured. Access shall be limited to employees of the Department and technical or repair personnel as required to maintain the system as authorized by the Department. All database searches shall be performed via secured communications systems.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.6** State of Rhode Island DNA Databank {#sec-216-ricr-60-05-2-2.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.6}
A.In accordance with the requirements of the Act, a State of Rhode Island DNA databank is established pursuant to this Part. It shall serve as the repository of DNA samples collected under the Act and shall be administered by the Department. Requirements for DNA sampling are pursuant to R.I. Gen. Laws § 12-1.5-8.
B.DNA samples collected under the provisions of this Part shall be processed in accordance with Standard Operating Procedures, Rhode Island Department of Health, Division of Laboratories, January 2017 (and any subsequent amendments thereto), which is based on "Quality Assurance Standards for Forensic DNA Testing Laboratories" incorporated above at § 2.2(A) of this Part.
C.The Department shall be responsible for the collection of DNA samples from convicted offenders, and law enforcement personnel shall be responsible for the collection of DNA samples from arrested individuals.
D.DNA samples shall be obtained using a sample collection kit designed and/or recommended by the Department.
E.Thumbprint, signature and/or other personal identifiers shall document the identity of the offender.
F.If the sample is unsuitable for laboratory testing, the Department may authorize collection of a second specimen.
G.The collection kit shall be sealed and hand-delivered or sent by mail to the Laboratory.
H.Upon submission of the sample collection kit to the Department, designated personnel shall record the date and time of receipt. The kit shall receive a unique identifying number that does not include any personal identification information.
I.The sample shall be secured in the appropriate storage area until analysis is performed. The Laboratory shall maintain an internal chain of custody to track the sample throughout its storage and analysis.
J.The genetic markers comprising the DNA profile shall consist of those adopted by the DNA Advisory Board of the Federal Bureau of Investigation.
K.Protection from civil or criminal liability for withdrawal of DNA samples is pursuant to R.I. Gen. Laws § 12-1.5-9.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.7** State of Rhode Island DNA Database {#sec-216-ricr-60-05-2-2.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.7}
A.In accordance with the requirements of the Act, a State of Rhode Island DNA database is established pursuant to this Part. It shall be administered by the Department and provide DNA records for the FBI for storage and maintenance by CODIS. The State of Rhode Island DNA database’s capabilities and requirements are stated in R.I. Gen. Laws §§ 12-1.5-4 and 12-1.5-11.
B.Procedures for using the national DNA database shall be in accordance with "NDIS Operational Procedures Manual" incorporated above at § 2.2(B) of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.8** Confidentiality of Records {#sec-216-ricr-60-05-2-2.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.8}
Confidentiality of records is pursuant to R.I. Gen. Laws § 12-1.5-16.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.9** Prohibition and Disclosure {#sec-216-ricr-60-05-2-2.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.9}
Prohibition and disclosure is pursuant to R.I. Gen. Laws § 12-1.5-14.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.10** Expungement {#sec-216-ricr-60-05-2-2.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.10}
Expungement is pursuant to R.I. Gen. Laws § 12-1.5-13.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
##### **216-RICR-60-05-2 § 2.11** Violations and Penalties {#sec-216-ricr-60-05-2-2.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-2#2.11}
Violations and penalties are pursuant to R.I. Gen. Laws § 12-1.5-15.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2015-11-23 to 04/30/2018*
- *Periodic Refile — effective from 2002-01-02 to 11/23/2015*
#### **216-RICR-60-05-3** Collection of Bodily Substances for Criminal Identification Purposes
##### **216-RICR-60-05-3 § 3.1** Authority {#sec-216-ricr-60-05-3-3.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-3#3.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 12-5-2(5), and are established for the purpose of adopting prevailing standards for the collection and submission of blood, saliva, hair, bodily tissues, bodily fluids, or dental impressions from the body of a person that may yield evidence of the identity of the perpetrator of a crime when subjected to scientific or other forensic analysis.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2005-09-13 to 04/30/2018*
- *Amendment — effective from 2005-06-02 to 09/13/2005*
- *EMERGENCY RULE Adoption — effective from 2005-03-18 to 06/02/2005*
- *EMERGENCY RULE Adoption — effective from 2004-11-18 to 03/18/2005*
##### **216-RICR-60-05-3 § 3.2** Definitions {#sec-216-ricr-60-05-3-3.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-3#3.2}
A.Wherever used in these regulations, the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 12-5 entitled, "Search Warrants."
2.“Bodily fluids” means fluids that have human origin and commonly include blood, saliva, and urine.
3.“Bodily tissues” means a group or collection of similar cells and their intercellular substance that act together in the performance of a function in a human body.
4.“Buccal swab” means a sample of tissue cells taken from the inner lining of the cheek or mouth.
5.“Dentist” means an individual licensed to practice dentistry in this state under the provisions of R.I. Gen. Laws Chapter 5-31.1, or an individual licensed to practice dentistry under the laws of another state or territory of the United States, or another country.
6."Department" means the Rhode Island Department of Health.
7.“Interocclusal relationship” means the correlation between the occlusal surfaces or cusps of opposing teeth of the maxillary and mandibular arches.
8.“Qualified medical personnel” means a licensed physician, a physician assistant, a registered or practical nurse, or a phlebotomist, trained to properly collect blood samples in accordance with the prevailing standard of practice.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2005-09-13 to 04/30/2018*
- *Amendment — effective from 2005-06-02 to 09/13/2005*
- *EMERGENCY RULE Adoption — effective from 2005-03-18 to 06/02/2005*
- *EMERGENCY RULE Adoption — effective from 2004-11-18 to 03/18/2005*
##### **216-RICR-60-05-3 § 3.3** General Requirements {#sec-216-ricr-60-05-3-3.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-3#3.3}
3.3.1Scope of Application
A.These regulations apply to the seizure of any of the following: samples of blood, saliva, hair, bodily tissues, bodily fluids, or dental impressions from the body of a person that may yield evidence of the identity of the perpetrator of a crime when subjected to scientific or other forensic analysis. When any of the samples are seized, the seizure shall be conducted in accordance with this Part.
B.By adopting this Part, the Department does not intend to determine under what circumstances a search warrant is required, or should be issued, pursuant to R.I. Gen. Laws § 12-5-2.
3.3.2Integrity of Specimen
Specimens of bodily tissues and substances obtained for analysis shall be collected in a manner to ensure the integrity of the specimen(s).
3.3.3Exposure to Infectious Material
All specimens shall be collected in an appropriate manner to minimize the occupational exposure to blood or other potentially infectious materials, and to reduce the likelihood of exposure to disease.
3.3.4Packaging and Labeling of Specimen
A.All specimens of bodily tissues and substances collected pursuant to the Act shall be collected, properly packaged, and properly preserved as required by this Part.
B.To the extent possible, all specimens shall include appropriate identifying information, such as the name, date of birth, and gender of the person to whom the specimen belongs, the name or initials of the individual collecting the specimen, the case number, date(s)/ time(s) on which the specimens were collected or transferred, a brief description of the sample, and the name of the agency submitting the specimen.
C.Evidence shall be sealed in a manner to prevent deleterious changes and/or contamination. Seals shall be of a kind that readily show signs of tampering.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2005-09-13 to 04/30/2018*
- *Amendment — effective from 2005-06-02 to 09/13/2005*
- *EMERGENCY RULE Adoption — effective from 2005-03-18 to 06/02/2005*
- *EMERGENCY RULE Adoption — effective from 2004-11-18 to 03/18/2005*
##### **216-RICR-60-05-3 § 3.4** Procedures Related to the Collection and Packaging of Bodily Tissues and Substances {#sec-216-ricr-60-05-3-3.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-3#3.4}
3.4.1Blood
A.The blood specimen(s) taken for analysis shall be collected by qualified medical personnel.
B.The blood specimen(s) shall be collected in a sterile laboratory tube or such other container to avoid contamination, preferably with ethylenediaminetetraacetic acid (EDTA) as a preservative.
3.4.2Urine
Urine shall be collected in a previously-sealed sterile container.
3.4.3Hair
A.A representative hair sample of sufficient quantity for testing shall be collected from the head, pubic, or other body area(s).
B.Approximately twenty (20) hairs plucked from the pubic region, and a representative sample of approximately fifty (50) hairs plucked from the head, must be collected, if possible.
C.The hair samples from each body area must be packaged separately into paper envelopes.
3.4.4Buccal (Oral) Swabs
A.The buccal swab must be collected using one (1) of the following methods:
1.Sterile cotton swabs:
a.Use swabs that are individually packaged in singles or pairs. (Opening a large package of swabs will render them unsterile).
b.Remove two (2) sterile swabs from protective packaging.
c.Holding the handles of the pair of swabs, place the swabs in the mouth and rub the swabs using a twisting motion for at least ten (10) seconds on the inside of the cheek. Repeat using the same swabs on the inside of the other cheek.
d.Place swabs back into their original packaging, placing handles in first, taking care not to touch the swab end and allow to air dry.
e.Place dried swabs and packaging into an appropriate transport container, preferably an evidence collection envelope or other envelope with two sealed corners.
f.If swabs are going to be stored, freeze them.
2.A buccal swab may be collected using a commercially available collection device, in accordance with the manufacturer’s standards, such as an FTA card, designed for the collection and room-temperature storage of biological samples for subsequent DNA analysis.
3.4.5Fingernail scrapings
Collect fingernail scrapings in an appropriate, unused collection device.
3.4.6Dental Impressions
A dentist shall take a dental impression and shall include an impression of each arch using accepted dental impression techniques, such as those outlined by the American Dental Association. The interocclusal relationship shall be established.
3.4.7Collection of Foreign Debris
Foreign debris such as dried semen, blood, or saliva shall be collected from a body’s skin surface area by lightly moistening sterile cotton swabs with distilled water and then thoroughly swabbing the area with the swabs. Allow the swabs to air dry and then return them to their original paper sleeve with the handles placed in the paper sleeve first.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-30 to 01/04/2022*
- *Amendment — effective from 2005-09-13 to 04/30/2018*
- *Amendment — effective from 2005-06-02 to 09/13/2005*
- *EMERGENCY RULE Adoption — effective from 2005-03-18 to 06/02/2005*
- *EMERGENCY RULE Adoption — effective from 2004-11-18 to 03/18/2005*
#### **216-RICR-60-05-4** Clinical Laboratories and Stations
##### **216-RICR-60-05-4 § 4.1** Authority {#sec-216-ricr-60-05-4-4.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-16.2-5, and are established for the purpose of adopting minimum standards for licensure of clinical laboratories and for the protection of the health, safety and welfare of the public.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.2** Definitions {#sec-216-ricr-60-05-4-4.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.2}
A.Wherever used in this Part the following terms shall be construed to mean:
1."Act" means R.I. Gen. Laws Chapter 23-16.2, entitled, "Laboratories."
2."Authorized medical personnel" means licensed health professionals working under the auspices of a physician or other licensed health care professional acting within his/her scope of practice.
3."Clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, radiobioassay, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings, pursuant to R.I. Gen. Laws § 23-16.2-2(2) of the Act.
4."Director" means the Director of the Rhode Island Department of Health.
5."Licensing agency" means the Rhode Island Department of Health.
6.“Limited function test” means those tests listed in the Federal Register under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests.
7."Persons" means any individual, firm, partnership, corporation, company, association, or joint stock association.
8."Reference laboratory" means a Rhode Island-licensed laboratory to which another Rhode Island laboratory has referred patient samples for testing.
9."Specialty" means a group of laboratory tests recognized by the U.S. Department of Health and Human Services.
10."Station" means a facility for the collection, processing, and transmission of such materials for such purposes pursuant to R.I. Gen. Laws § 23-16.2-2(5) of the Act.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.3** General Requirements {#sec-216-ricr-60-05-4-4.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.3}
A.It shall be unlawful for any person, corporation or other form of business entity to perform clinical laboratory services on specimens collected in this state or to own, conduct or maintain a clinical laboratory or station in this state without a license pursuant to the requirements of the Act, and this Part, unless exempt in accordance with R.I. Gen. Laws § 23-16.2-3 as follows:
1.A laboratory maintained by a hospital licensed under R.I. Gen. Laws Chapter 23-17, or by food preparation or processing establishments performing analysis to determine the quality of their own products, or by a licensed physician or group of licensed physicians who make the tests referred to in R.I. Gen. Laws § 23-16.2-2 personally and solely in connection with the treatment of their own patients; however, an independent laboratory which makes the tests on its own responsibility for a single physician or group of physicians is subject to the Act; and
2.Any temporary or ad hoc health promotion screening program conducted for the general public which offers generally accepted mass screening procedures; provided the health promotion or screening program is conducted pursuant to a permit issued in accordance with rules and regulations pertaining to Permits for Screening Programs (Part 20-10-1 of this Title).
B.A clinical laboratory or station shall represent itself in its advertisements, publications, or other forms of communication, as providing only those services for which it is licensed and shall not advertise in a manner which tends to mislead the public.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.4** Application for License {#sec-216-ricr-60-05-4-4.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.4}
A.Application for a license to establish, conduct, maintain, or operate a clinical laboratory or a station shall be made to the licensing agency on forms provided by the licensing agency for initial licensure and for license renewal.
1.Each application for license and renewal thereof shall contain such information as the licensing agency reasonably requires that includes affirmative evidence of ability to comply with the provisions of the Act and this Part.
2.Each application for licensure or renewal thereof as a station, shall be accompanied by the fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
3.Each application for license or renewal thereof as a clinical laboratory shall be accompanied by the fee as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for each specialty in which the laboratory seeks licensure. The check shall be made payable to the General Treasurer, State of Rhode Island and submitted to the Department of Health.
4.Application for license renewal shall be submitted to the licensing agency one month prior to the expiration date of the license.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.5** Issuance and Renewal of License {#sec-216-ricr-60-05-4-4.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.5}
A.No less than thirty (30) days after receipt of an application for an initial license, the licensing agency shall issue a license, if the applicant meets the requirements of the Act and this Part. Said license, unless sooner suspended or revoked, shall expire on the 30th day of December of every other the year following the date of license.
B.A license shall be issued only for the premises and persons named in the application and shall not be transferable.
C.The license issued to a clinical laboratory shall clearly identify the specialty(ies) the laboratory is licensed to provide. Such specialties shall include, but not be limited to, the following:
1.Microbiology, including bacteriology, virology, mycology and parasitology;
2.Immunohematology, including blood group and Rh typing and crossmatching;
3.Diagnostic immunology, including syphilis serology and general immunology;
4.Pathology, including tissue, oral and cytology;
5.Hematology, including coagulation;
6.Clinical chemistry, including urinalysis, endocrinology, and toxicology;
7.Radiobioassay techniques; and
8.Other specialties and subspecialties as recognized by the U.S. Department of Health and Human Services.
D.Prior to issuing a license, the licensing agency shall review the following documents required to be provided by a laboratory prior to licensure:
1.Laboratory Director: provide documentation of the qualifications of the individual designated as laboratory director and a copy of that individual's resume;
2.Laboratory staff: provide a list of technical personnel that includes qualification designations (MT, MLT, etc); also designate the individuals' primary special area(s), if the application is for more than one specialty area;
3.Hours of operation: provide a statement about the laboratory hours of operation;
4.Laboratory facility: provide floor plans or a description of the facility that supports a statement that the facility is adequate for the scope of services for which licensure is requested;
5.Equipment: provide a current equipment list representing all of the testing equipment for the specialty area(s) for which licensure is requested;
6.Summary of tests performed: provide a list of all the tests for which licensure is requested;
7.Proficiency testing program: identify the proficiency testing program(s) for each specialty, subspecialty, or analyte for which licensure is requested;
8.Quality control program: provide information regarding how the daily quality control program is achieved and used to ensure accurate testing;
9.Quality assurance: provide a description of the laboratory's quality assurance program or a copy of the quality assurance plan;
10.Fees: see §§ 4.4(A)(1) and (2) of this Part and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
E.A license issued under this Part shall be the property of the state and loaned to the licensee and shall be kept posted in a conspicuous place on the licensed premises.
F.Out-of-State Laboratories
1.In addition to meeting the requirements stated in §§ 4.5(A) through (E) of this Part, an out-of-state laboratory shall be required to meet the additional requirements stated in § 4.5(F)(3) of this Part.
2.Notwithstanding the foregoing, upon payment of any applicable license fees, the Director may grant immediate licensure to any clinical laboratory licensed as such in another state and certified under the Clinical Laboratory Improvements Act of 1988, when such clinical laboratory has been asked to perform a clinical laboratory service which is not offered by any other clinical laboratory then licensed in this state.
3.Any out-of-state laboratory performing clinical laboratory tests on specimens collected in Rhode Island shall be licensed in accordance with the requirements stated in this Part.
a.Prior to issuing a license, the licensing agency shall review documentation of certification/licensure status supplied by the out-of-state laboratory to determine if the laboratory is:
(1)Certified by a federal agency in the specialties for which it is seeking licensure; and/or
(2)Licensed in good standing by the state agency in which the laboratory is located, and provided the laws, rules and regulations for licensure of said state are deemed equivalent to or exceed the laws, rules and regulations in this Part as determined by the Director of Health.
4.If an out-of-state laboratory meets the all of the requirements stated in this Part, the licensing agency shall issue a license.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.6** Inspections {#sec-216-ricr-60-05-4-4.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.6}
A.The licensing agency shall make, or cause to be made, such inspections and investigations as it deems necessary in accordance with R.I. Gen. Laws § 23-16.2-9.
B.Each clinical laboratory and station shall be given prompt notice by the licensing agency of all deficiencies recorded as a result of an inspection or investigation.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.7** Denial, Suspension or Revocation of License {#sec-216-ricr-60-05-4-4.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.7}
A.In addition to those grounds stated in R.I. Gen. Laws § 23-16.2-7(a), the licensing agency may deny, revoke, or suspend the license of any clinical laboratory or station for engaging in conduct that includes, but is not limited to, the following:
1.Failure to comply with the rules and regulations in this Part and any state or federal regulations or statutes;
2.Making false or deceptive representation of any testing results and reports thereof;
3.Not abiding by the statutory provisions of the Confidentiality of Health Care Communications and Information Act, R.I. Gen. Laws Chapter 5-37.3;
4.Engaging in false or deceptive advertising;
5.Making false or deceptive representation on any application for licensure or renewal thereof; and/or
6.Failure to maintain prevailing standards of laboratory practice that may be considered grounds for licensure suspension, revocation, or curtailment of activities or other disciplinary action at the discretion of the Director.
B.Lists of deficiencies noted in inspections and investigations conducted by the licensing agency, shall be maintained on file in the licensing agency, and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license of a clinical laboratory or station.
C.Whenever action shall be proposed to deny, suspend or revoke a license or take other disciplinary action, the licensing agency shall notify the facility by certified mail setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9, and the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title) pursuant to § 4.11.3 of this Part.
1.However, if the licensing agency finds that public health, safety and welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
D.The appropriate state and federal reimbursement agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license or other disciplinary action.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.8** Organization and Management {#sec-216-ricr-60-05-4-4.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.8}
4.8.1Governing Body and Management
A.Each clinical laboratory and/or station shall have a governing body or equivalent legal authority ultimately responsible for:
1.The management and control of the operation;
2. The assurance of the quality of services;
3.The compliance with all federal, state and local laws and regulations; and
4.Compliance with other relevant health and safety requirements, including the rules and regulations of this Part.
4.8.2Director of Laboratory
A.Each clinical laboratory shall have a laboratory director who shall be responsible for the day to day management and operation of the laboratory and to ensure the achievement and maintenance of quality standards of practice. The director shall meet the following minimum qualifications:
1.Be a person of good moral character;
2.Has earned from an accredited college or university a doctorate of philosophy, science, public health or medicine after successful completion of a curriculum that has been accredited by a national or regional certifying authority and has a minimum of one (1) year experience in supervising laboratory procedures, or has earned a master's degree in chemistry, bacteriology, biology or allied sciences and has at least two (2) years experience in laboratory procedures that includes one year of supervision; or has earned a bachelor's degree in bacteriology, biology, chemistry or allied sciences and has a minimum of at least four (4) years experience in laboratory procedures, including two (2) years of supervision.
B.The director of each clinical laboratory or his/her designee who meets the qualifications of § 4.8.2(A)(2) of this Part shall furthermore be responsible for no less than the following:
1.Be present on the premises of the laboratory during the hours of operation for a sufficient period of time to ensure adequate and appropriate supervision of laboratory activities;
2.The accurate performance of all tests in the laboratory including the submission of appropriate reports on all tests pursuant to § 4.8.4 of this Part;
3.The work of all personnel in the laboratory and for hiring adequately trained personnel commensurate with the workload;
4.Be available at all times during the hours of operation for personal or telephone consultation with personnel;
5.Notify the licensing agency within ten (10) days of any change in laboratory services or supervisory personnel;
6.Establish and maintain an effective quality assurance program; and
7.Other such activity(ies) as may be deemed appropriate.
C.In the event the director of the laboratory is absent for a continuous period of time longer than one (1) month duration, the laboratory shall not operate unless a person who meets the qualifications of § 4.8.2(A)(2) of this Part is in attendance.
4.8.3Personnel
A.Each clinical laboratory and station shall employ a sufficient number of qualified personnel who are licensed and/or certified pursuant to provisions of R.I. Gen. Laws § 23-16.2-6 commensurate with the workload to ensure that services are provided effectively and safely and in accordance with current laboratory standards of practice.
1.A job description for each position shall be established, clearly delineating qualifications, duties, and responsibilities for each position.
2.Personnel records shall be maintained for each employee that shall contain no less than:
a.Current background information pertaining to qualifications, to justify initial and continued employment;
b.Evidence of periodic evaluation of technical work performance;
c.Such other data as may be deemed appropriate.
B.Stations
1.Personnel in blood collection stations shall be proficient in venipuncture, specimen processing and shall have training in patient management and emergency situations.
4.8.4Records and Reports
A.Each clinical laboratory shall maintain appropriate records and reports, that shall be available for inspection by authorized representatives of the licensing agency. Such records and reports shall include:
1.Records of the operation and maintenance of all laboratory equipment;
2.Records of all specimen examinations in accordance with § 4.8.4(D) of this Part;
3.Records of control values, standard values, calibration curves and calculations of standard deviations; and
4.Reports of proficiency testing program results as well as copies of forms used by the laboratory to report results to the proficiency testing company;
5.Policies and procedures that describe a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality of the total testing process; and
6.Such other reports as may be deemed necessary.
B.Clinical laboratory reports shall be based upon and confined to the findings of the laboratory examinations. Test results shall be submitted promptly to the licensed physician or other authorized medical personnel who requested the test(s).
1.No reports shall be worded to convey or simulate a diagnosis or prognosis or to specify or suggest specific medication, surgical manipulation or other form of treatment unless signed by a physician or other authorized medical personnel.
2.Reports to physicians or other authorized medical personnel on specimens submitted by a licensed laboratory to a reference laboratory shall specify the name and address of the reference laboratory that shall be licensed in accordance with § 4.9.3(C) of this Part.
3.Each clinical laboratory shall report communicable diseases in accordance with the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title).
C.Each station shall maintain a record(s) in chronological sequence indicating the daily collection of specimens.
D.Each clinical laboratory and station shall maintain a record indicating the processing of specimens, each of which shall be uniquely identified. The records of specimens shall contain no less than:
1.The unique laboratory identifier;
2.The name and other identification of the person from whom the specimen was obtained;
3.The name of the licensed physician or other authorized person or clinical laboratory that submitted the specimen;
4.Date of the collection and source of the specimen;
5.Condition of specimen upon receipt (e.g., broken, turbid, etc.);
6.The date and time of specimen receipt;
7.The type of test requested and performed;
8.The results of laboratory tests or cross reference to results;
9.The date of reporting;
10.The identity of the testing personnel; and
11.The name and address of laboratory to which specimen(s) are referred if procedure(s) are not performed on the premises.
E.Reports and records shall be retained for no less than five (5) years, except for histopathology reports that shall be retained for ten (10) years from the date the reports were issued.
F.Laboratories shall retain all cytology slide preparations for five years from the date of examination and all histologic slide preparations for ten (10) years from the date of examination.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.9** Quality Assurance Program {#sec-216-ricr-60-05-4-4.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.9}
4.9.1General Requirements
Each clinical laboratory or station shall have clearly established internal and external quality control programs to ensure high standards of performance and reliability of test results. These programs shall consider such factors as preventive maintenance, periodic inspection, testing for proper operation of equipment and instruments as may be appropriate, validation of methods, evaluation of reagents and volumetric equipment, surveillance results, remedial action taken to correct deficiencies and such other relevant factors as required in these rules and regulations and as may be deemed necessary.
4.9.2Procedural Manual
A.Each clinical laboratory shall have available at all times in the immediate bench area of personnel engaged in conducting clinical laboratory testing, a procedure manual that includes a detailed compilation of all automated and manual methods and procedures for all clinical tests that are performed by the laboratory and for which it is licensed. Furthermore, such manual shall:
1.Contain information concerning preparation and storage of reagents, control and calibration procedures and pertinent literature references;
2.Describe the laboratory's technical procedures for the collection, processing and examination of specimens based on current standards of practice;
3.For those tests that are normally performed on automated test equipment, provide for alternate methods or for storage of the test specimens, in the event the automated equipment becomes inoperable; and
4.Procedures shall be approved, signed, and dated by the laboratory director. Procedures shall be re-approved, signed and dated if the directorship of the laboratory changes. Each change in a procedure shall be approved, signed, and dated by the current director of the laboratory.
B.Each station shall have available at all times a procedure manual that includes a detailed compilation of methods and procedures for the collection, processing, and transmission of specimens including preparation of patients, based on current practices.
4.9.3Collection, Identification and Examination of Specimens
A.No specimen shall be examined if unsuitable for testing as a result of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection and examination, or for such other reason(s) that would render findings of doubtful validity.
B.Specimens shall be examined only at the documented request of a licensed physician or other authorized medical personnel, pursuant to statutory provisions of this state.
C.Clinical laboratories in state and out of state may receive reference specimens for examination provided the reference laboratory is licensed in this state, pursuant to R.I. Gen. Laws Chapter 23-16.2 and this Part.
D.Whenever a clinical laboratory licensed by the state of Rhode Island isolates any one of the specified microorganisms identified in the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title), the original culture or a subculture shall be submitted to the Rhode Island Department of Health Laboratory for confirmation, typing, or banking in accordance with the aforementioned regulations.
1.All specimens shall be accompanied by identifying data such as name of the patient, physician or other authorized medical personnel, and laboratory.
E.A clinical laboratory collecting blood for lead analysis and/or performing blood lead analyses shall do so in accordance with the regulations of Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title) and Lead Poisoning Prevention (Part 50-15-3 of this Title).
4.9.4Radiobioassay, Pathological, and Cytological Examinations
A.A clinical laboratory licensed in the category of radiobioassay shall comply with the applicable rules and regulations for Radiation (Chapter 40 Subchapter 20 of this Title).
B.Pathological examination of specimens of excised tissue(s) shall be performed only by a physician licensed in this state who is either qualified for certification, or is certified in anatomic pathology by the American Board of Pathology.
C.Cytological examination of specimens shall be performed only under the supervision of a physician licensed in this state who is either qualified for certification, or is certified in anatomic pathology or cytopathology by the American Board of Pathology.
4.9.5Methodologies for Quality Control
A.Each clinical laboratory shall establish an internal program of quality control covering each type of analysis performed for the verification and assessment of accuracy, measurement of precision, and detection of error. The factors that constitute the quality control provisions shall be based on current acceptable standards of practice such as those promulgated in the most current version of the rules and regulations of the Department of Health and Human Services’ "Clinical Laboratory Improvement Amendments of 1988.”
B.Each clinical laboratory shall furthermore be required to participate in an external proficiency testing program to assess the accuracy and reliability of testing performance for each category and subcategory of clinical specialties for which the laboratory is licensed.
1.Appropriate proficiency testing programs shall be those approved by the U.S. Department of Health and Human Service or such as those the Director may deem appropriate based upon national standards.
2.A determination of satisfactory performance on proficiency testing shall be made by the licensing agency based on the passing score for each analyte as established by the proficiency testing program.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.10** Physical Plant and Equipment {#sec-216-ricr-60-05-4-4.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.10}
4.10.1Physical Facility, Equipment, and Supplies
A.General Requirements: Clinical Laboratories and stations shall be maintained in a manner that protects the health and safety of personnel and the public in accordance with all applicable state and local laws and codes. Where there is a difference between codes, the code having the more stringent standard shall apply.
B.Clinical Laboratories: Each clinical laboratory shall be housed in well-lighted, sanitary, properly ventilated quarters, equipped with hot and cold running water, toilet facilities and shall include adequate space to process and examine the specimens commensurate with the total workload. Furthermore, clinical laboratories shall:
1.Be in distinct and separate locations from living quarters unless provisions exist for separate entrances and plumbing fixtures;
2.Have ample workbench space, well-lighted and conveniently located to sink, water, gas and suction and electrical outlets as necessary;
3.Have adequate and proper storage space for volatile chemicals and inflammable solvents, located in non-hazardous areas in accordance with "Rhode Island State Fire Safety Code", R.I. Gen. Laws Chapter 23-28.1.
4.Have adequate temperature humidity controls as may be required for proper performance of tests and operation of instruments affected by variations in temperatures;
5.Have sufficient, consistent voltage levels at electrical sources to which automated equipment is connected;
6.Have adequate refrigerated storage facilities for reagents used in testing. Said facilities shall be conveniently located to the testing area(s);
7.Have on hand and readily available on the premises, all equipment, reagents and glassware necessary for the accurate performance of the clinical laboratory work;
8.Calibrate all precision equipment at regular intervals and maintain calibration logs that provide evidence of calibrations. Or, documentation of calibration by a qualified laboratory instrument service organization shall be acceptable; and
9.Have sharps containers assembled according to manufacturer's intended use(s) and shall ensure the use of biohazard containers at the point of generation of the medical waste.
C.Stations: each station shall be located in well-lighted, sanitary quarters with hot and cold running water, toilet facilities and shall have:
1.A blood drawing chair or cot;
2.A telephone; and
3.A procedure manual outlining steps to be taken in the event of an emergency;
4.A procedure manual, as required in § 4.9.2(B) of this Part; and
5.Have sharps containers assembled according to manufacturer's intended use(s) and shall ensure the use of biohazard containers at the point of generation of the medical waste.
4.10.2Fire and Safety
A.Adequate fire and safety precautions shall be established and maintained. Safety instructions shall be posted for the protection of personnel and patients against physical, chemical, and biological hazards.
1.Personnel shall be given an orientation to the safety policies and procedures that shall be compiled in a safety manual and available at all times to all personnel.
4.10.3Medical Waste Disposal
Medical waste as defined in the Medical Waste Regulations of the Rhode Island Department of Environmental Management, 250-RICR-140-15-1, shall be managed in accordance with the provisions of the aforementioned regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-05-4 § 4.11** Practices and Procedures, and Violations {#sec-216-ricr-60-05-4-4.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-4#4.11}
4.11.1Variance Procedure
A.The licensing agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such variance will not be contrary to the public interest, public health and/or health and safety of patients. The provisions of this section shall not be applicable to the requirements of §§ 4.8.2(A) and (B) of this Part pertaining to the director of the clinical laboratory.
B.A request for a variance shall be filed by an applicant in writing setting forth in detail the basis upon which the request is made.
1.Upon the filing of each request for variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval or in the case of a denial, a hearing date, time and place may be scheduled if the station or clinical laboratory appeals the denial.
4.11.2Violations
In addition to revocation or suspension of licenses granted, any person who violates the statutory or regulatory provisions herein shall be subject to the sanctions of R.I. Gen. Laws § 23-16.2-13.
4.11.3Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of this Part herein shall be held in accordance with the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *EMERGENCY RULE Amendment — effective from 2020-08-04 to 07/30/2021*
- *Amendment — effective from 2018-08-21 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 08/21/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
#### **216-RICR-60-05-5** Certifying Analytical Laboratories
##### **216-RICR-60-05-5 § 5.1** Authority {#sec-216-ricr-60-05-5-5.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.1}
These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws § 23-16.2-5(a), and are established for applying minimum standards for certification of analytical laboratories that analyze potable water, non-potable water, or other environmental matrices for the protection of the health, safety, and welfare of the public. The proper operation of analytical laboratories within the state is a matter of vital concern to the health and safety of the state. The determination and enforcement of proper standards is necessary to ensure the qualifications and competence of personnel and to ensure the adequacy of equipment, facilities, and quality assurance programs.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.2** Incorporated Materials {#sec-216-ricr-60-05-5-5.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.2}
A.These regulations hereby adopt and incorporate 40 C.F.R. Parts 122, 136, 141, 143, 430, 455, and 465 (July 1, 2003) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
B.These regulations hereby adopt and incorporate 40 C.F.R. Part 136, Docket Number EPA-HQ-OW-2010-0192 (March 6, 2013) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
C.These regulations hereby adopt and incorporate EPA Solutions to Analytical Chemistry Problems with Clean Water Act Methods, EPA 821-R-07-002 (March 2007) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
D.These regulations hereby adopt and incorporate EPA Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition, EPA 815-R-05-004 (January 2005) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
E.These regulations hereby adopt and incorporate EPA Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water. EPA 815-F-08-006 (June 2008) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
F.These regulations hereby adopt and incorporate APHA Standard Methods for the Examination of Water and Wastewater, American Public Health Association, 18th – 22nd editions (1992-2012) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
G.These regulations hereby adopt and incorporate Methods for the Chemical Analysis of Water and Wastes, U.S. Environmental Protection Agency, EPA-600/4-79-020 (March 1983) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
H.These regulations hereby adopt and incorporate Methods for the Organic Chemical Analysis of Municipal and Industrial Wastewater, USEPA, EPA 600/4-82-057 (July 1982) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.3** Definitions {#sec-216-ricr-60-05-5-5.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.3}
A.Wherever used in these rules and regulations the following terms shall be construed to mean:
1.“A2LA” means American Association for Laboratory Accreditation, a voluntary program for accrediting environmental lead laboratories and proficiency testing providers to the ISO/IEC 17025 standard.
2.“Accredited” means to be recognized as conforming to a standard by an accrediting organization (i.e., NELAP approved accrediting authorities, American Industrial Hygiene Association [AIHA], American Association for Laboratory Accreditation [A2LA]).
3."Act" means R.I. Gen. Laws Chapter 23-16.2, entitled "Laboratories."
4.“AIHA” or “American Industrial Hygiene Association” means a voluntary program for accrediting environmental lead laboratories for the testing of Environmental Lead per the ISO/IEC 17025 standard.
5."Analytical laboratory" means a facility for the biological, microbiological, chemical, physical, and radiochemical examination of potable water, non-potable water, or other environmental matrices.
6.“Analytical reagent grade”, “(AR) grade”, “ACS reagent grade”, and “reagent grade” means reagents that conform to the current specifications of the Committee on Analytical Reagents of the American Chemical Society (ACS).
7.“ASTM” means the American Society for Testing and Materials.
8.“Applicant” means a laboratory applying to the Department to become a certified analytical laboratory.
9.“Certification” means the determination by the Department of Health that an analytical laboratory can perform tests or analyses of environmental samples in accordance with the requirements of these rules and regulations.
10.“Certified thermometer” means a thermometer that has documentation from the manufacturer that it has been calibrated by NIST.
11.“Class ‘A’ glassware” means glassware satisfying the applicable requirements for Class A glassware established by NIST.
12.“Compliance analysis or testing” means the analysis of a sample that is required by law or regulation.
13.“Department” means the Rhode Island Department of Health.
14."Director" means the Director of the Rhode Island Department of Health.
15.“Environmental lead” means lead in paint, dust, wipe and soil and/or water samples collected for laboratory testing to support the migration of lead hazard or exposure.
16.“EPA” means the United States Environmental Protection Agency.
17.“ISO/IEC 17025” means the International Organization for Standardization Standard 17025 used by laboratories that produce testing and calibration results.
18.“NELAP” means National Environmental Laboratory Accreditation Program, which implements the TNI standards and evaluates the accrediting authority programs.
19.“NPDES” means National Pollutant Discharge Elimination System, a program of the EPA.
20.“NIST” means National Institute of Standards and Technology, an agency that sets accuracy standards for laboratory equipment and accredits proficiency test providers.
21."Persons" means any individual, firm, partnership, corporation, company, association, or joint stock ownership.
22.“Proficiency testing sample” or “PT sample” means a subsample of a matrix containing analytes of a concentration unknown to the laboratory that is used to evaluate the performance of its analytical systems. Proficiency testing samples shall be obtained from a provider that is accredited by the TNI Proficiency Testing Provider Accreditation Program.
23.“Quality assurance” or “QA” means the integrated system of operations and measurements performed to assure that data meets defined standards of quality within a stated level of confidence.
24.“Quality control” or “QC” means the practice of standardized operations or measurements that determine or predict aspects of data quality.
25.“TNI” or “NELAC Institute” means a voluntary non-profit organization whose mission is to foster performance standards for the operation of environmental laboratories for the generation of environmental data of known and documented quality through process that is endorsed by the EPA. TNI also maintains the Proficiency Testing Provider Accreditor program.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.4** Certification {#sec-216-ricr-60-05-5-5.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.4}
5.4.1General Requirements
A.It shall be unlawful for any analytical laboratory to perform testing or analyses of samples originating in this state, for which the Department requires certification, without obtaining certification pursuant to the Act and this Part.
B.Certification for specific analytes and methods shall be required for laboratory testing of potable water, non-potable water, and environmental samples for lead content. Certification for potable water is required whenever a laboratory performs analytical tests on drinking water supply samples. Certification for non-potable water is required whenever a laboratory performs analytical tests on water other than drinking water.
C.Certification is required for laboratories performing environmental lead analysis in accordance with the rules and regulations for Lead Poisoning Prevention (Part 50-15-3 of this Title). A certificate for environmental lead analysis shall be issued only to laboratories providing documentation of accreditation through a program recognized by the EPA’s National Environmental Lead Laboratory Accreditation Program (e.g., A2LA or AIHA).
D.An analytical laboratory shall represent itself in its advertisements, publications, or other forms of communication, as providing only those services for which it is certified and shall not advertise in a manner that tends to mislead the public.
5.4.2Application for Certification
A.Application for certification to conduct laboratory testing of potable water, non-potable water, and environmental lead shall be made to the Department on forms provided for initial certification and for certification renewal.
B.Applications for certification renewal shall be submitted to the Department on or before the date specified by the Department.
C.Each application for certification and renewal thereof shall contain such information as the Department reasonably requires which may include affirmative evidence of ability to comply with the provisions of the Act and the rules and regulations herein.
D.Each application for certification or renewal thereof must be accompanied by the non-refundable fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for each category for which the laboratory is requesting certification, and made payable to the General Treasurer of the State of Rhode Island and submitted to the Department of Health.
E.The annual fee schedule per category for both in-state and out-of-state laboratory certification is as set forth in in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).
5.4.3 Issuance of a Certificate & Renewal of Certification
A.No less than thirty (30) days after receipt of a satisfactorily completed application for initial certification, the Department shall issue a certificate if the applicant meets the requirements of the Act and this Part for certification. Said certification, unless sooner suspended or revoked, shall expire by limitation on the thirtieth (30th) day of December, of every year following the date of certification and shall be renewed annually.
B.Certificates shall not be issued to an analytical laboratory located in Rhode Island prior to an inspection and correction of any deficiencies in a manner acceptable to the Department as specified in § 5.4.4 of this Part. Further, said laboratory must comply with the proficiency testing requirements for initial certification as described in § 5.7.5 of this Part.
C.The Department may issue a certificate to an out-of-state laboratory provided the laboratory is:
1.Certified by the EPA in the analytes and methods it is to perform; or
2.Licensed, certified, or accredited by the state agency in the state where the laboratory is located, and provided the laws, rules and regulations for licensure, certification or accreditation of said state agency are deemed equivalent to or exceed the Act and this Part, as determined by the Director; or
3.Accredited by NELAP for analytes and methods not offered by the state where the laboratory is located, but allowable by these rules.
D.Analytical laboratories in this state and out-of-state may receive samples from another laboratory for examination provided the laboratory is certified in this state pursuant to the Act and this Part.
E.A certificate shall be issued only for the premises and persons named in the application and shall not be transferable or assignable.
F.The certificate issued to an analytical laboratory shall clearly identify the laboratory and those analytes and methods under each category for which the laboratory is certified. Such categories include:
1.Potable Water pertaining to the following subcategories:
a.microbiology,
b.organic chemistry, and
c.inorganic chemistry.
2.Non-Potable Water pertaining to the following subcategories:
a.microbiology,
b.organic chemistry, and
c.inorganic chemistry.
3.Radiochemistry
4.Environmental Lead
G.A certificate issued hereunder shall be the property of the state and loaned to the laboratory and shall be kept posted in a conspicuous place on the premises.
5.4.4Inspections
A.The Director or authorized agent(s) or employees shall at all reasonable times have authority to enter upon all parts of the premises on which any analytical laboratory is located and of the premises appurtenant thereto, to make any examination or investigation whatsoever for determining compliance with the provisions of the Act and this Part.
B.Each analytical laboratory shall be provided a written report by the Department of all deficiencies recorded as a result of an inspection or investigation within sixty (60) days of such inspection or investigation.
C.The analytical laboratory shall provide a plan of corrective action, including expected completion dates for all deficiencies listed on such report within thirty (30) days of receipt.
D.At the discretion of the Director, a follow-up inspection may be conducted to assure that all deficiencies have been corrected.
5.4.5Denial, Suspension, or Revocation of Certificate
A.In addition to the grounds for revocation and suspension stated in R.I. Gen. Laws § 23-16.2-7, the Department may deny, revoke, or suspend the certificate of any analytical laboratory for engaging in conduct that includes but is not limited to:
1.making false or deceptive representation on any application for certification or renewal thereof;
2.failure to maintain professional and competent standards of practice;
3.making false or deceptive representation of any testing results and reports thereof;
4.engaging in false or deceptive advertising;
5.failure to maintain a quality assurance system and follow a quality assurance plan;
6.failure to perform proper managerial review and approval prior to issuance of reports of any testing results; and
7.for certified out-of-state laboratories, failure to comply with § 5.4.5(D) of this Part.
B.Lists of deficiencies noted in inspections and investigations conducted by the Department shall be maintained on file in the Department and shall be considered by the Department in rendering determinations to deny, suspend, or revoke the certificate of an analytical laboratory.
C.Whenever action shall be proposed to deny, suspend, or revoke the certificate or take another disciplinary action, the Department shall notify the facility by certified mail setting forth reasons for the proposed action, and the applicant or certified laboratory shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9, Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title), and § 5.13 of this Part.
1.However, if the Department finds that public health, safety, and welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of certification pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).
D.Certified laboratories not located in Rhode Island shall notify the Department of changes in its accreditation, certification, or licensure status within fourteen (14) days of receiving a notification of such changes.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.5** Organization, Management, and Personnel {#sec-216-ricr-60-05-5-5.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.5}
5.5.1Governing Body
A.Each analytical laboratory shall have a governing body or equivalent legal authority ultimately responsible for:
1.the management and control of the operation;
2.the assurance of the quality of services;
3.the compliance with all federal, state and local laws and regulations; and
4.compliance with other relevant health and safety requirements, including this Part.
5.5.2Management
A.Each analytical laboratory shall have a laboratory director who shall be responsible for the day-to-day management and operation of the laboratory and to ensure the achievement and maintenance of quality standards of practice. The laboratory director shall meet the following minimum qualifications:
1.be a person of good moral character; and
2.has earned, from a college or university accredited by a national or regional certifying authority; a doctorate in the chemical or biological sciences and a minimum of two (2) years analytical laboratory experience, or has earned a master's degree in the chemical or biological sciences and has a minimum of four (4) years of analytical laboratory experience, or has earned a bachelor’s degree in the chemical or biological sciences and has a minimum of five (5) years of analytical laboratory experience.
B.Exempt from § 5.5.2(A)(2) of this Part are directors of analytical laboratories that were in operation on October 25, 1987 and who meet all other qualifications set forth in this Part.
C.Directors of laboratories in municipal waste treatment facilities testing non-potable water for only fecal coliforms, Biochemical Oxygen Demand and total suspended solids shall be deemed to be qualified if they have earned an associate’s degree in the biological or chemical sciences and have a minimum of two (2) years of laboratory experience; or they have earned a bachelor’s degree in the chemical or biological sciences and have a minimum of one (1) year of laboratory experience.
D.The director of each analytical laboratory or his/her designee, who meets the qualifications of § 5.5.2(A)(2) of this Part shall furthermore be responsible for no less than the following:
1.to be present on the premises of the laboratory during the hours of operation for a sufficient period of time to ensure adequate and appropriate supervision of laboratory activities;
2.to ensure the accurate performance of all tests in the laboratory including the submission of appropriate reports on all tests pursuant to § 5.6 of this Part.
3.to ensure the supervision of all personnel in the laboratory and for hiring adequately trained personnel commensurate with the workload;
4.to be available during the hours of operation for personal or telephone consultation with personnel;
5.to notify the Department within ten (10) days of any change in laboratory services or supervisory personnel;
6.to establish and adhere to written policies and procedures for a comprehensive quality assurance program; and
7.such other activity as may be deemed appropriate.
E.In the event the director of the laboratory is absent for a continuous period longer than one-month duration, the laboratory shall not operate unless a person who meets the qualifications of § 5.5.2(A)(2) of this Part is in attendance.
F.The laboratory director shall designate a quality assurance officer who has the responsibility for the laboratory’s quality assurance plan and its implementation. The laboratory director may be the self-designated Quality Assurance Officer or a consultant may be designated to serve as the Quality Assurance Officer.
1.The quality assurance officer shall have earned at least a bachelor’s degree in a chemical or biological science and two years of related laboratory experience. The quality assurance officer qualifications may be met if the person has previous laboratory quality assurance experience acceptable to the Department in a licensed, certified or accredited laboratory, or possesses other qualifications acceptable to the Department.
2.The quality assurance officer shall:
a.be responsible for the oversight of QC data, including establishing acceptance criteria and documenting/monitoring corrective action;
b.where staffing allows, be independent of the technical areas for which he/she has QA oversight;
c.have general knowledge of the methodologies for which data review is performed;
d.have oversight of the laboratory’s quality assurance system and conduct or arrange for annual internal audits of the technical operation and report findings to the laboratory director.
5.5.3Personnel
A.Each analytical laboratory shall employ a sufficient number of qualified personnel commensurate with the workload to ensure that services are provided effectively and safely and in accordance with prevailing laboratory standards and practices.
B.A job description for each classification of position shall be established, clearly delineating qualifications, duties and responsibilities inherent in each position.
C.Personnel records shall be maintained for each employee which contain no less than:
1.current background information pertaining to qualifications, to justify initial and continued employment;
2.orientation, including an initial demonstration of capability for each method and/or instrument the analyst will be performing and/or operating;
3.evidence of periodic evaluation of work performance; and
4.such other data as may be deemed appropriate.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.6** Records & Reports {#sec-216-ricr-60-05-5-5.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.6}
A.Each analytical laboratory shall maintain appropriate records and reports, which shall be available for inspection by authorized representatives of the Department.
B.The certified laboratory shall create, control, and maintain records of raw data, chain-of-custody records, calculations, quality control data, and other essential documentation. All records shall be complete with signatures, units of measurement, and documentation sufficient for verification of results. All records shall be retained in such a manner as to permit prompt retrieval. Such records shall include:
1.records of the operation and maintenance of all laboratory equipment;
2.records of all sample examinations in accordance with § 5.7.3 of this Part;
3.records of control values, standard values, calibration curves and calculations of standard deviations; and
4.reports of proficiency testing programs and of such other records as may be deemed necessary.
C.All records and reports shall clearly indicate which analytes have been analyzed by certified methods and which have not. If a report references a method for which the laboratory is certified, adherence to the method is required. All records and reports including correspondence related to reported results and compliance issues shall be retained a minimum of five (5) years and be available for review.
D.Laboratory reports shall clearly identify the name, address and Rhode Island analytical laboratory certification number of the laboratory (which may be a subcontracted laboratory) actually performing the test(s), and shall include the results and the date of the reporting.
E.Multipage reports shall be paginated.
F.All reports of laboratory analyses for compliance purposes shall be submitted to the Department by the certified laboratory contracted by the public water system to analyze the samples.
G.Any portion of the analysis sub-contracted to another certified laboratory shall be reported by the primary contracted laboratory. The primary contracted laboratory shall submit the final report to the Department.
H.Certified laboratories shall submit forms to the Department in a format approved by the Department, which includes hard copy or electronic forms.
I.Certified laboratories must report, to both their public water facility client and to the Department's Center for Drinking Water Quality, any priority test results no later than twenty-four (24) hours after the results are known, or the next business day if State offices are closed. Priority results include:
1.Positive total coliform results;
2.E. coli positive results;
3.Nitrate results exceeding the Maximum Contaminant Level as defined by Public Drinking Water (Part 50-05-1 of this Title);
4.Nitrite results exceeding the Maximum Contaminant Level as defined by Public Drinking Water (Part 50-05-1 of this Title); and
5.Lead results exceeding fifteen (15) parts per billion (ppb).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.7** Quality Assurance and Quality Control Programs {#sec-216-ricr-60-05-5-5.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.7}
5.7.1General Requirements
A.Each analytical laboratory shall have clearly established internal and external quality controls to ensure high standards of performance and reliability of test results. These quality controls shall consider such factors as preventative maintenance, periodic inspection, testing for proper validation of methods, evaluation of reagents and volumetric equipment, surveillance of results, remedial action taken to correct deficiencies and quality control failures and such other equivalent factors as required in this Part and as may be deemed necessary.
B.The laboratory shall perform all analyses which will be used for compliance with state or federal regulations, using the prescribed methods incorporated above at §§ 5.2(A) through (H) of this Part.
C.The laboratory’s quality assurance plan shall be accessible to all personnel in the laboratory. It shall include, but not be limited to:
1.sampling procedures (if performed by the laboratory);
2.laboratory sample handling procedures;
3.instrument calibration procedures;
4.a list of detailed analytical procedures or analytical references;
5.data reduction, validation, and reporting procedures including non-compliance action plan;
6.types and frequency of internal audit samples (quality control samples) and external audit samples (proficiency testing samples);
7.internal audit procedures and frequency;
8.preventative maintenance procedures and schedules;
9.procedures for determining accuracy and precision and method detection limits of all analytes and specified frequency;
10.control limits and corrective action policies;
11.laboratory organization, staff, and responsibilities; and
12.procedures for laboratory and managerial data review.
D.The method detection limit (MDL) shall be determined prior to placing a new method in service and annually thereafter for each analyte per 40 C.F.R. § 136 Appendix B incorporated above at § 5.2(A) of this Part, or other such MDL guidance as deemed appropriate by the Department.
1.Method Detection Limits determined by the laboratory for analytes in the potable water category must meet the detection limit criteria specified in 40 C.F.R. §§ 141.23 and 24 incorporated above at § 5.2(A) of this Part. If the laboratory cannot meet said criteria for an analyte, a request for a variance must be submitted pursuant to § 5.11 of this Part.
E.The laboratory shall follow the quality control requirements specified in “Standards Methods for the Examination of Water and Wastewater” incorporated above at § 5.2(F) of this Part.
F.The laboratory shall follow all applicable quality control activities described in the “EPA Manual for the Certification of Laboratories Analyzing Drinking Water” incorporated above at § 5.2(D) of this Part. This requirement applies to pertinent non-potable water testing as well.
5.7.2Procedure Manual
A.Each analytical laboratory shall have available, at all times, in the immediate bench area of personnel engaged in conducting analytical laboratory testing, a procedure manual which includes a detailed compilation of all automated and manual methods and procedures for all analytical tests which are performed by the laboratory and for which it is certified. Furthermore, such manuals shall:
1.Specify the approved method employed;
2.Describe the quality control activities pertinent to the method;
3.Contain information concerning preparation and storage of media, reagents, control and calibration procedures and pertinent literature references;
4.Describe the laboratory's technical procedures for the collection, processing and examination of samples;
5.For those tests which are normally performed on automated test equipment, provide for alternate methods or for storage of test samples, in the event the automated equipment becomes inoperable; and
6.Be approved, signed, and dated by the current laboratory supervisor/director and the QA Officer. Changes in procedures must be approved, signed, and dated by the current supervisor/director and QA Officer.
7.Required methodologies for testing can be found in EPA Manual for the Certification of Laboratories Analyzing Drinking Water, Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, Standard Methods for the Examination of Water and Wastewater, Methods for the Chemical Analysis of Water and Wastes and, Methods for the Organic Chemical Analysis of Municipal and Industrial Wastewater incorporated at §§ 5.2(D) through (H) of this Part.
5.7.3Collection, Identification & Examination of Samples
A.Information that accompanies samples shall be sufficiently detailed to permit identification and document chain of custody.
B.The laboratory shall not accept samples for examination unless there is sufficient documentation to verify proper collection, preservation, and other conditions as prescribed in the relevant methods, and to permit adherence to holding times.
C.The laboratory shall not accept samples for examination without sufficient sample volume to perform the requested analyses.
D.Each analytical laboratory shall maintain a record indicating the daily accession of samples, each of which shall be numbered or otherwise appropriately identified. The records of samples shall contain no less than:
1.the laboratory number or other identification,
2.the name of the person or analytical laboratory that submitted the sample,
3.date of sample collection,
4.date of sample receipt,
5.condition of sample upon receipt,
6.type of test requested and performed,
7.the results and date of laboratory tests and date of reporting, and
8.the name and address of laboratory to which the sample(s) is forwarded for procedures not performed on the premises.
5.7.4Other Applicable Regulations
An analytical laboratory certified in the category of radiochemistry shall comply with the Rules and Regulations for the Control of Radiation and shall obtain, as applicable, the appropriate radioactive materials license from the Department.
5.7.5Proficiency Testing
A.Each laboratory shall participate in a proficiency testing program approved by the Department for each analyte (or group of analytes) and method for which the laboratory is certified or is requesting certification. Proficiency testing samples shall be procured from a provider of proficiency test samples accredited by a Proficiency Testing Provider Accreditor (PTPA) that meets the TNI requirements.
B.The laboratory shall analyze a PT sample annually for each analyte and matrix by each method and receive an acceptable evaluation from the PT provider for that analyte/method/matrix, with the following exceptions:
1.laboratories certified for environmental lead must maintain a proficient status according to their respective accrediting agency;
2.laboratories must receive an acceptable evaluation for at least eighty percent (80%) of the Regulated Volatile Organic Compounds and eighty percent (80%) of Haloacetic Acids, in potable water, to maintain certification for these analyte groups, (as defined in the reference incorporated above at § 5.2(A) of this Part); and,
3.laboratories certified for potable and non-potable water-microbiology must correctly analyze ninety percent (90%) of the samples in a shipment with no false negatives for qualitative microbiology proficiency testing, and for quantitative microbiology proficiency testing no more than one (1) of the target organisms in a sample set containing three (3) or more samples may be incorrectly quantified.
C.Proficiency test results shall be submitted directly from the accredited provider to the certification office by October 31 of each year. The Department shall be designated as the recipient of the laboratory results before the results are available to the laboratory.
D.Whenever a laboratory receives an unacceptable evaluation for an analyte in a study, it shall determine the cause for the failure, take corrective action, and participate in another PT study for the failed analyte. Documentation of the investigation and corrective action shall be maintained and a copy provided to the Department before the next proficiency testing study.
E.Failure to complete PT studies or failure to obtain an acceptable result in a PT study as specified in § 5.7.5(D) of this Part shall result in loss of certification for the analyte until two (2) consecutive PT studies resulting in acceptable evaluations have been completed. There shall be an interval of at least thirty (30) days between the two (2) studies.
F.All proficiency test samples shall be analyzed in the same manner and frequency as a real environmental sample using the same staff, procedures and equipment.
G.Laboratories shall not send a PT sample, or a portion thereof, to another laboratory for any analysis for which it is certified or seeks certification.
H.A laboratory shall not knowingly receive any PT sample, or a portion thereof, from another laboratory for any analysis for which the sending laboratory is certified or seeks certification.
I.Laboratory management or staff shall not communicate with any individual at another laboratory concerning a PT sample or attempt to obtain the assigned value from their PT provider.
J.All raw data obtained in analyzing PT samples shall be retained and be available for review for a minimum of five (5) years.
K.The use of supplemental PT samples shall be allowed only if the PT provider certifies, in writing, that PT samples meet the criteria specified by the EPA.
L.A laboratory not located in Rhode Island shall follow the proficiency testing requirements of the state in which it is located.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.8** Physical Plant, Equipment, and Supplies {#sec-216-ricr-60-05-5-5.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.8}
A.Each analytical laboratory shall be housed in well lighted, sanitary, properly vented quarters equipped with hot and cold running water, and toilet facilities and shall contain ample space to process and examine the samples commensurate with the total workload. Furthermore, said analytical laboratories shall:
1.be in distinct and separate locations from living quarters unless provisions exist for separate entrances and plumbing fixtures;
2.have ample workbench space, be well lighted and have sufficient water, gas, suction, electrical outlets and sinks;
3.have adequate and proper storage space for all chemicals including explosive, flammable, corrosive and caustic materials;
4.have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;
5.have adequate temperature and humidity controls as may be required for proper performance of tests and operation of instruments affected by environmental conditions;
6.have adequate electrical supply; and
7.have adequate refrigeration for samples, standards, and reagents used in testing
a.food for consumption may not be stored in refrigerators containing laboratory materials.
B.The laboratory shall possess suitable equipment required for certified analyses that shall meet the requirements of the methods. All instruments shall be physically located on site.
C.The laboratory shall have sufficient glassware and plastic labware necessary for the analyses. Glassware shall be borosilicate glass or other corrosion-resistant glass. It shall be free of cracks and chips. Markings and etchings shall be legible. Volumetric flasks, pipettes, and other glassware used for volumetric analysis shall be class “A”.
D.All precision equipment and instruments shall be calibrated and checked for accuracy at regular intervals as required by the method and the laboratory’s quality assurance policies. Documentation of calibration and accuracy checks shall be maintained. Records of service by a qualified instrument service organization shall be maintained.
E.Balance range and sensitivity shall be appropriate for the application for which it is used. Balances shall be kept clean and free of corrosion and spillage and shall be checked daily with weights meeting ASTM Type I, Class 1 or 2 specifications with values that bracket the laboratory’s weighing needs. Records shall be maintained that include acceptance criteria for the checks. ASTM weights shall be recalibrated every five (5) years or immediately if nicked or corroded. Non-reference weights may be used but shall be calibrated every six (6) months against ASTM type 1, 2 or 3 weights.
1.All balances shall be calibrated annually by a professional balance service.
F.All incubators, refrigerators, ovens, and water baths shall contain calibrated thermometers.
G.Thermometer range and graduation increments should be appropriate for the application for which it is used. Glass thermometers shall be checked for accuracy annually, and other types of thermometers quarterly, by comparing with a NIST traceable thermometer at the temperatures of interest. Thermometers shall be tagged with the date of accuracy check and the correction factor (which may be zero). There shall be no separation in the liquid column of glass thermometers.
H.Analytical reagent grade chemicals are required for analyses unless otherwise allowed or specified by the analytical method.
I.Bottles of dehydrated microbiology media shall be dated when received and dated when opened. Media shall not be used beyond the manufacturer’s expiration date or within one (1) year from opening, whichever is sooner. It shall be discarded immediately if caked or otherwise deteriorated. Prepared, prepackaged media are permitted.
J.All plastic labware used for microbiology shall be clear and non-toxic.
K.For chemical analyses, reagent water for general use shall be distilled or deionized and have a resistivity value greater than 0.5 megohms/cm or a conductivity value of less than 2 microhmos/cm at 25C. Quality checks shall be made according to specified analytical method requirements, but at least monthly, with a conductivity meter. All such quality checks shall be recorded.
L.For microbiological analyses, reagent water shall meet all criteria listed in the following table:
PARAMETER
LIMITS
FREQUENCY
resistivity or
> 0.5 megohms/cm
monthly
conductivity
< 2 micromhos/cm
monthly
Pb, Cd, Cr, Cu, Ni, Zn
< 0.05 mg/L per contaminant and
< 0.1 mg/L total
annually
total chlorine residual
none detectable
monthly
Heterotrophic plate count
< 500/mL
monthly
bacteriological quality of reagent water
Ratio of growth rate: 0.8 to 3.0 (see Standard Methods, Section. 9020B. This test is not required if laboratories use water that meets the criteria for Types I and II water as defined in Standard Methods, Section 1080).
annually
M.All reagents and solutions shall be labeled to indicate identity, concentration, storage requirements, expiration dates, and any other pertinent information.
N.All reagents and solutions shall be dated when received and opened. No materials shall be used beyond their expiration dates.
O.All laboratory prepared reagents and solutions must be labeled with preparation and expiration dates. No laboratory prepared materials shall be used beyond their expiration dates.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.9** Safety & Security {#sec-216-ricr-60-05-5-5.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.9}
A.Adequate safety and security precautions shall be established and maintained. Safety instructions shall be present in a laboratory safety manual for the protection of personnel from exposure to physical, chemical and biological hazards in laboratories. The laboratory safety manual shall include applicable procedures for the protection of employees and visitors.
B.Personnel shall be given a safety orientation reviewing policies and procedures in the safety manual.
C.Samples, standards, reagents, solvents, acids, chemicals and data must be kept in restricted access areas.
D.The laboratory must supervise visitors, repairmen, and maintenance workers in restricted areas.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.10** Waste Disposal {#sec-216-ricr-60-05-5-5.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.10}
A.The laboratory must manage medical waste pursuant to the Medical Waste Regulations (250-RICR-140-15-1).
B.The laboratory must manage hazardous waste pursuant to the Rules and Regulations for Hazardous Waste Management (250-RICR-140-10-1).
C.Wastes, which are not classified as medical waste or hazardous waste or which are not otherwise regulated by law or rule, may be disposed in dumpsters or load packers provided the following precautions are maintained:
1.Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and placed on concrete slabs preferably graded to a drain. Water supply shall be available within easy accessibility for washing down of the area. In addition, the pickup schedule shall be maintained with more frequent pickups when required. The dumping site of waste materials must be in sanitary landfills approved by the Department of Environmental Management; and
2.Load packers must conform to the same restrictions required for dumpsters and shall be high enough off the ground to facilitate the cleaning of the underneath areas of the stationary equipment and the loading section shall be construed and maintained to prevent rubbish from blowing away.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.11** Variance Procedure {#sec-216-ricr-60-05-5-5.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.11}
A.The Department may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in specific instances where it is found that literal enforcement of such provisions will result in unnecessary hardship to the applicant and such variance will not be contrary to federal regulations, the public interest, public health, or health and safety of individuals.
B.A request for variance shall be made in writing, setting forth in detail the basis of the request.
C.Upon filing of such request with the Department and within a reasonable time thereafter, the Department shall notify the applicant by certified mail of its approval, or in case of a denial, a hearing date, time, and place may be scheduled if the applicant appeals the decision.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.12** Violations {#sec-216-ricr-60-05-5-5.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.12}
In addition to revocation or suspension of certificates granted, any person who violates the statutory or regulatory provisions of this Part shall be subject to the sanctions of R.I. Gen. Laws § 23-16.2-13.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
##### **216-RICR-60-05-5 § 5.13** Rules Governing Practices & Procedures {#sec-216-ricr-60-05-5-5.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-05-5#5.13}
All hearings and reviews required under the provision of this Part will be held in accordance with Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2019-04-30 to 01/04/2022*
- *Amendment — effective from 2018-04-19 to 04/30/2019*
- *Amendment — effective from 2012-12-10 to 04/19/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Amendment — effective from 2005-01-12 to 10/18/2007*
- *Periodic Refile — effective from 2002-01-02 to 01/12/2005*
### **Subchapter 10** Medical Examiner
#### **216-RICR-60-10-1** Medical Examiner System
##### **216-RICR-60-10-1 § 1.1** Authority {#sec-216-ricr-60-10-1-1.1 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.1}
These regulations are promulgated pursuant to the authority conferred by R.I. Gen. Laws § 23-4-2(a) and are established to provide minimum uniform standards governing the reporting, investigation, and disposition of reportable deaths to assist the Office of State Medical Examiners (OSME), the general public, law enforcement agencies, hospitals, and physicians to maintain an effective medical examiner system.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.2** Definitions {#sec-216-ricr-60-10-1-1.2 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.2}
A.Whenever used in these rules and regulations, the following terms shall be construed as follows:
1."Chief Medical Examiner" means the person responsible for the immediate supervision of the Office of State Medical Examiners.
2."Assistant Medical Examiners" means a duly licensed doctor of medicine or osteopathy appointed to assist the Office of State Medical Examiners on a part-time basis.
3."The Medical Examiner" means the Chief Medical Examiner, or his/her duly authorized agent or representative.
4."Law Enforcement Agencies" means (not limited to) state or municipal organized police forces, and federal, state or municipal officers concerned with law enforcement investigations.
5."OSME" means the Office of State Medical Examiners.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.3** Establishment of Office {#sec-216-ricr-60-10-1-1.3 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.3}
OSME is established in the Department of Health in accordance with R.I. Gen. Laws § 23-4-2.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.4** Functions {#sec-216-ricr-60-10-1-1.4 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.4}
The OSME shall function as prescribed in R.I. Gen. Laws § 23-4-3.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.5** Jurisdiction {#sec-216-ricr-60-10-1-1.5 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.5}
The OSME shall have jurisdiction as prescribed in R.I. Gen. Laws § 23-4-4.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.6** Procedures for Autopsies Against a Family's Religious Beliefs {#sec-216-ricr-60-10-1-1.6 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.6}
Procedures shall follow those prescribed in R.I. Gen. Laws § 23-4-4.1
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.7** Staffing {#sec-216-ricr-60-10-1-1.7 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.7}
OSME staffing qualifications, descriptions, and responsibilities shall follow those prescribed in R.I. Gen. Laws § 23-4-5.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.8** State Medical Examiners Commission {#sec-216-ricr-60-10-1-1.8 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.8}
A State Medical Examiners Commission shall be established and shall follow the organization, procedure, and duties prescribed in R.I. Gen. Laws § 23-4-6.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.9** Death Reporting Requirements {#sec-216-ricr-60-10-1-1.9 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.9}
A.Requirements for reporting deaths to the OSME shall follow those prescribed in R.I. Gen. Laws § 23-4-7.
B.In addition to those prescribed in R.I. Gen. Laws § 23-4-7, the following types of occurrences must be reported:
1.All maternal deaths in which there is reasonable evidence to suspect a criminal abortion, and those deaths during or following therapeutic abortion or delivery, and all maternal deaths up to six (6) weeks following normal or abnormal delivery, and those maternal deaths after six (6) weeks if thought to be due to or resulting from any procedure involving pregnancy, delivery, and postpartum treatment.
2.All cases where the immediate cause of death may be natural disease, but where a history of an injury exists which may have been responsible for initiating the sequence of events leading to death.
3.All deaths during or following anesthesia, diagnostic or therapeutic procedures regardless of the location, procedure, and circumstances, or regardless of survival time if death is thought to be directly related to the procedure or complications resulting from said procedure.
4.All fetal deaths occurring without medical attendance or after delivery of a live born fetus following therapeutic abortion, or when inquiry is required in accordance with R.I. Gen. Laws § 23-3-17(e).
5.All instances in which the environment of present or past employment may have caused or contributed to death by trauma or disease, including any consequence of any physical or toxic injury incurred while employed, and including all deaths during or related to employment.
6.All sudden, unexpected, traumatic or any unnatural death after long term confinement of patients suffering from mental and physical disorders in hospitals, or nursing or personal care homes in accordance with the rules and regulations for Licensing of Nursing Facilities (Part 40-10-1 of this Title).
7.All deaths in which there is reasonable evidence to suspect accident, suicide, homicide, or other unnatural process or unusual manner.
8.All deaths occurring unexpectedly where the decedent was not under continuous medical treatment for the disease or condition believed to be the cause of death including:
a.instantaneous death without obvious cause;
b.death during or after an acute, unexplained rapidly fatal illness, including "crib death" (SIDS) of young infants;
c.deaths occurring in public places, such as buildings, streets, parks or like areas;
d.sudden deaths occurring on flights of aircraft landing in the state; or
e.sudden deaths occurring on board ship docked at piers in the state or in state territorial waters.
9.All deaths in which the decedent was:
a.unattended by a physician in accordance with R.I. Gen. Laws § 23-3-16(d),
b.found dead without obvious cause,
c.not under treatment for the apparent cause of death, or
d.not seen by the attending physician within two weeks prior to death.
10.All deaths occurring, whether directly or indirectly related, from a narcotic drug, medicinal substance, drug treatment modality and including ethyl alcohol containing beverages, whether sudden, or whether short or long term survival has occurred.
11.All deaths (whether homicide, suicide, or accident) in which an external cause or agent contributes to the death irrespective of the period between injury and death. External agents may include mechanical, chemical, electrical, thermal or another trauma.
12.Deaths of newborns and stillbirths delivered or occurring outside of a hospital or when the mother was involved in a recent or past traumatic event (motor vehicle crash, suicide attempt, etc.) that may have precipitated the delivery and may have a causal relationship to the newborn death, and all infant deaths occurring within 24 hours of delivery without known reasonable cause of death, or if the cause is suspected to be traumatic before, during or after said delivery.
13.In-hospital deaths including:
a.all deaths suspected to be due to or contributed to by trauma or whatever type (physical, firearms, chemical abortion, etc.) including accidentally, suicidally, and homicidally inflicted trauma;
b.deaths occurring while under the influence of anesthesia, during the post anesthetic period without the patient regaining consciousness, or following long term survival if the original incident is thought to be related to the surgical procedure or the anesthetic agent;
c.all deaths occurring during or following therapeutic or diagnostic procedures, including blood transfusions, whether thought to be related to death or independent therefrom;
d.all deaths where the industrial environment is suspected as cause of the terminal disease or where illness began on the job or at place of employment; or
e.all deaths occurring within 24 hours of admission.
14.Hospital emergency room deaths including:
a.all cases "dead on arrival",
b.deaths due to or suspected from trauma in accordance with § 1.9(B)(11) of this Part, and
c.deaths occurring within 24 hours of entry into the emergency room.
15.In-hospital or emergency room deaths specified in §§ 1.9(B)(13) and (14) of this Part, where the attending physician has no adequate or reasonable explanation of the cause of death.
C.It shall be the duty and responsibility of any person, be he or she a physician, law enforcement officer, funeral director, hospital official, relative of the deceased person responsible for burial or cremation, or other individual having knowledge of any person, the circumstances of whose death may be categorized in accordance with § 1.9 of this Part, to immediately notify OSME.
D.Any person reporting a death to OSME shall submit the following data: the name, address, and age of the decedent, if known; the location of the body, a summary of the circumstances of death, and any pertinent medical information, such as names of doctor, hospital, prescription, etc.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.10** Investigations {#sec-216-ricr-60-10-1-1.10 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.10}
A.In those instances where a person has met death in any manner or circumstance as stated in § 1.9 of this Part, the Medical Examiner shall determine the medico-legal authority of the case, and if accepted, shall take charge at the scene, if appropriate, in accordance with R.I. Gen. Laws § 23-4-8, and shall be the first to examine the dead body.
B.The body shall not be disturbed without authorization of the Medical Examiner except in those cases in which a possibility of life remains, whereupon, the law enforcement officer or appropriate rescue team personnel on the scene shall initiate and facilitate such lifesaving procedures as may be appropriate.
C. The Medical Examiner shall initiate the necessary investigatory procedures, which may include but shall not be limited to:
1.investigating circumstances surrounding the death;
2.viewing the scene of death;
3.reviewing past medical and other history;
4.conducting toxicology and other laboratory tests;
5.examining physical evidence; and
6.performing postmortem examinations or autopsies.
D.Any information required by the Medical Examiner to conduct investigations shall be made available to OSME. Such information may include but shall not be limited to:
1.medical histories;
2.witnesses' statements; and
3.hospital records including X-rays, pertinent body fluid and other specimens, clothing, personal effects, medications and prescriptions, and any other items having a possible bearing on the cause and manner of death.
E.In all traffic death situations, the following evidence shall be made available to the Medical Examiner:
1.the brake and accelerator pedals in all motor vehicle driver deaths;
2.helmets and other protective gear in all cyclist deaths;
3.all clothing and personal effects of decedents from any vehicular death, especially those in which an offending vehicle has left the scene ("hit and run");
4.a copy of the incident report and subsequent investigation of any vehicular accident resulting in death;
5.any vehicle, such as auto, cycles, or other when pertinent; and
6.any weapon, instrument or other modality possibly related to the cause and manner of death.
F.In crime scene investigations, the body of the victim shall not be disturbed and any weapons, ligatures, drugs, and any other evidence possibly related to the death shall be preserved at the scene for examination by the Medical Examiner. Normal police procedures such as inquiries, dusting for fingerprints, (excluding fingerprinting the deceased) and scene photography may be carried out prior to the arrival of the Medical Examiner. The Medical Examiner shall take charge, examine the body of the victim, and cooperate with the law enforcement agency or agencies conducting the police investigation.
G.In narcotic or drug overdose death investigations, all related paraphernalia including needles, syringes, suspected drugs, tourniquet, etc., shall be removed by the Medical Examiner from the scene of occurrence. Such evidence as may be warranted shall subsequently be submitted by the Medical Examiner for toxicological examination, analysis, and report. In addition, the requirements of § 1.10(H) of this Part shall apply.
H.In all cases of hospital emergency room deaths, hospitals shall maintain the following practices:
1.All clothing, including shoes, from any case of trauma including those possibly due to a criminal act, shall be retained and not washed, cleaned or disturbed.
2.Any clothing, foreign materials or other debris lodged in wounds shall be preserved, when possible.
3.Needle marks incurred before arrival at the hospital shall be marked to separate "marks" from those received in emergency room.
4.All wounds of a serious nature shall be precisely documented by diagram and description in the hospital record.
5.X-rays, medical records, and other reports, or copies thereof, shall be made available to the Medical Examiner as requested.
6.One blood specimen (full 10cc, red-top tube) shall be retained where feasible and labeled "Medical Examiner" from any victim of mechanical, (e.g. auto accident) chemical, ("overdose") or other trauma who is a potential fatality referable to the Medical Examiner. This blood specimen shall be discarded by the hospital laboratory in those cases discharged alive. Other body fluid and tissue specimens, including gastric contents, shall likewise be retained at least in part, and made available to the Medical Examiner upon request in case of death and acceptance of authority.
I.In all cases of death within the authority of the Medical Examiner, any drug dispensing agency or drug rehabilitation program or like agency having contact with the decedent or his or her agent shall furnish, upon request, all pharmaceutical prescriptions and other relevant information.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.11** Removal of Body from Scene {#sec-216-ricr-60-10-1-1.11 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.11}
A.The Medical Examiner shall authorize the removal of the body of the decedent including pertinent evidence on or about the body, and including instrumentalities which may be pertinent to the cause and manner of death, to the state morgue, or to whatever place is deemed appropriate by the medical examiner.
B.In the event a person dies suddenly in a public place from apparent natural causes or from a highway accident, provisions described in R.I. Gen. Laws § 23-4-9 shall be followed.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.12** Autopsies {#sec-216-ricr-60-10-1-1.12 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.12}
A.The Medical Examiner shall perform autopsies in those cases where, in the judgment of the Medical Examiner, the cause of death cannot be established with a reasonable degree of certainty and in those cases where the actual pathological findings must be documented, and in those instances where indicated in support of the provisions of R.I. Gen Laws Chapter 23-4 or this Part. In such cases autopsies may be performed without requiring permission of next of kin or legal representative.
B.Hospitals may request permission to perform autopsies on reportable death cases only upon completion of the investigation by the Medical Examiner or upon release of jurisdiction of the case by the Medical Examiner.
1.In some circumstances, the Medical Examiner may permit the hospital to perform the autopsy prior to issuance of the death certificate, provided that hospital obtains the proper permission from the next of kin or legal representative.
2.Hospitals performing autopsies must meet the requirements of the rules and regulations for the Licensing of Hospitals (Part 40-10-4 of this Title).
3.Copies of any autopsy reports performed by hospitals on cases referred to or released by the Medical Examiner shall, upon request, be submitted to OSME.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.13** Effects and Property of Deceased {#sec-216-ricr-60-10-1-1.13 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.13}
All articles and property of a deceased shall be handled per the provisions of R.I. Gen. Laws § 23-4-11.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.14** Disposition of Deceased Bodies {#sec-216-ricr-60-10-1-1.14 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.14}
A.The disposition of deceased bodies shall follow the provisions of R.I. Gen. Laws § 23-4-10. The public notices described in this section shall be no less than fourteen (14) days.
B.In addition, any funeral director receiving permission to remove a decedent shall provide a written communication from the next of kin to OSME prior to removal of said decedent.
C.If a person dies suddenly on a public highway or elsewhere in the public view and the death appears to be from natural causes or the result of injuries received from a highway accident, the procedure shall follow those provisions described in R.I. Gen. Laws § 23-4-9.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.15** Pronouncement of Death {#sec-216-ricr-60-10-1-1.15 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.15}
Pronouncement of death shall be made, if appropriate, at the scene of death by the Medical Examiner only in those cases where OSME has assumed authority for investigation in accordance with § 1.10 of this Part. This pronouncement shall be in accordance with the uniform determination of death described in R.I. Gen. Laws § 23-4-16.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.16** Issuance of Death Certificate {#sec-216-ricr-60-10-1-1.16 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.16}
Following investigations, postmortem examinations, or autopsies, the Medical Examiner shall prepare the death certificate in medicolegal cases and including but not limited to cases referred to in § 1.15 of this Part.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.17** Notification of Death {#sec-216-ricr-60-10-1-1.17 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.17}
Notification of the death of any individual to the next of kin shall be the responsibility of the law enforcement agency in whose authority the death occurred.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.18** Transplantation of Organs from Decedent Bodies or Cadavers {#sec-216-ricr-60-10-1-1.18 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.18}
A.All cases of transplantation of organs from decedent bodies or cadavers shall follow the provisions detailed in the Revised Uniform Anatomical Gift Act, R.I. Gen. Laws Chapter 23-18.6.1.
B.OSME shall be notified of all cases in which the transplantation of organs from bodies of persons who have died within the State of Rhode Island is to be carried out. A copy of any "document of gift", in accordance with R.I. Gen. Laws Chapter 23-18.6.1, shall be made available for examination by the Medical Examiner.
C.The Medical Examiner reserves the right to approve or disapprove the execution of a donor transplantation procedure in cases which would create conflict with the discharge of responsibilities of OSME. When approval is given, a copy of approval, signed by the next of kin or legal representative shall be forwarded to the Medical Examiner. In homicide, suspected homicide cases, or those where a criminal act may have occurred, transplant of (donor) organs shall be prohibited unless specifically authorized by the Medical Examiner and the Attorney General.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.19** Cremation {#sec-216-ricr-60-10-1-1.19 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.19}
A.No body shall be cremated in, or removed from the state for purposes of cremation without a cremation certificate obtained from OSME in accordance with R.I. Gen. Laws § 23-3-18(e).
B.Whenever the death of a person whose body is to be cremated has occurred outside the state of Rhode Island, a cremation certificate shall be obtained from OSME, following investigation of the case from the state or county in which the death occurred. The physician, hospital, and any other or involved party shall, upon request of the Medical Examiner, supply appropriate information regarding the deceased. The funeral director shall provide, where feasible, a certified copy of the certificate of death to the OSME for their interpretation and records.
C.In those cases which appear suspicious or at variance from the available information, the Medical Examiner may request additional examinations including postmortem investigation and autopsy.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.20** Records and Reports {#sec-216-ricr-60-10-1-1.20 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.20}
A.Information and reports obtained from law enforcement agencies, local or state institutions, agencies such as hospitals, and employers in relation to deaths reported in accordance with § 1.9 of this Part, which are deemed by federal or state law to be confidential, shall be kept confidential by the OSME and be released only to person(s) who can demonstrate a legal right to said information and/or records and then only pursuant to a valid subpoena.
B.Autopsies and other reports and findings of OSME (except homicides and other criminal cases remaining under investigation and awaiting adjudication) shall be available to:
1.the next of kin or authorized legal representative responsible for the disposition of the body,
2.insurance carriers subject to the written consent of the next of kin or authorized legal representatives, and
3.physicians who were responsible for the care of the decedent.
C.Copies of autopsy reports shall not be provided for inclusion in hospital medical records.
D.All requests for reports must be submitted in writing.
E.Certified copies of death certificates are to be procured from the Division of Vital Statistics, Rhode Island Department of Health.
F.Certified copies of "Proof of Death" are available from the Medical Examiner in lieu of a death certificate which has not been completed.
G.For Rhode Island Deaths, cremation certificates shall be available from OSME.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.21** Fees for Reports and Services {#sec-216-ricr-60-10-1-1.21 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.21}
OSME shall collect fees for reports and services performed by OSME in accordance with the fee schedule set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Agencies of state government, cities and towns shall be exempt from payment of fees.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.22** Violations and Penalties {#sec-216-ricr-60-10-1-1.22 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.22}
Violations and penalties shall be as set forth in R.I. Gen. Laws § 23-4-7.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*
##### **216-RICR-60-10-1 § 1.23** Exception {#sec-216-ricr-60-10-1-1.23 omnilex-key=us-ri-regs-official--title-216--216-RICR-60-10-1#1.23}
Modification of any individual standard of this Part, for experimental or demonstration purposes, or as deemed appropriate by the State Medical Examiners Commission, if such modification will not be contrary to the public interest and the public health, shall require advance written approval by the State Medical Examiners Commission.
**History**
- *Periodic Refile — effective from 2022-01-04 to current*
- *Amendment — effective from 2018-04-17 to 01/04/2022*
- *Amendment — effective from 2012-12-10 to 04/17/2018*
- *Amendment — effective from 2007-10-18 to 12/10/2012*
- *Periodic Refile — effective from 2002-01-02 to 10/18/2007*Continue your research in ChatGPT or Claude
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