title-33•N.D. Admin. Code Title 33 — State Department of Health
N.D. Admin. Code Title 33 — State Department of Health
title-33N.D. Admin. Code tit. 33Regulation
Article 33-01 General Administration
Chapter 33-01-01 Organization of Department
N.D. Admin. Code 33-01-01-01 Organization and functions of state department of health
1.Organization of department.
a.History. The territorial board of health for Dakota Territory came into being in 1885 with the responsibilities to make and enforce "all needful rules and regulations for the prevention and cure, and to prevent the spread of any contagious, infectious, or malarial disease among persons and domestic animals". In 1889, when Dakota Territory was divided, a board of health was established. In 1923, the state department of health was created, consisting of a public health advisory council, a state health officer, directors of divisions, and other employees. The public health laboratory, connected with the University of North Dakota since its inception in 1907, was placed under the state health department in 1933. In 1947, the legislative assembly reorganized the department, making necessary changes to provide for hospital registration and licensure. The reorganization changed the name of the advisory council to the state health council, giving it policymaking responsibility and increasing its membership.
In 1987, the state laboratories department was consolidated with the state health department forming the state department of health and consolidated laboratories. In 1995, the agency name was changed to state department of health.
b.Sections and divisions. The department consists of the following sections and divisions:
Administrative Support Accounting Education Technology Human Resources Vital Records Community Health Section Cancer Prevention and Control Division Chronic Disease Division Family Health Division Injury Prevention and Control Division Nutrition and Physical Activity Division Emergency Preparedness and Response Section Emergency Medical Services and Trauma Division Hospital Preparedness Public Health Preparedness Environmental Health Section Air Quality Division Laboratory Services Municipal Facilities Division Waste Management Division Water Quality Division Health Resources Section Food and Lodging Division Health Facilities Division Life Safety and Construction Division Medical Services Section Disease Control Division Forensic Examiner
c.Health officer. The health officer is appointed by the governor to hold office for four years.
The health officer must have had postgraduate training or experience in public health administration. If the governor does not appoint as state health officer a physician licensed in this state, the governor shall appoint at least three licensed physicians recommended by the state medical association to serve as an advisory committee to the state health officer. The health officer is responsible for the exercise of powers and duties prescribed to the health officer under the law.
d.Legal counsel. The attorney general of North Dakota is the ex officio attorney for the department. However, by statute, the attorney general may, and has chosen to, appoint legal counsel to act as chief legal adviser for the department.
2.Functions of department sections.
a.Administrative support section. This section provides support services to the divisions of the department and assists in coordinating department activities. More specifically, the divisions in this section provide services in the areas of personnel administration, fiscal management, health statistics, and certification of vital events.
b.Community health section. The community health section is responsible for coordination of public health education and intervention activities, including such areas as wellness promotion and health risk reduction, promotion of optimal nutrition, reduction in tobacco use, injury prevention, and improvements in dental health. Many of the services provided by this section are delivered through district, county, or city health units.
c.Emergency preparedness and response section. The emergency preparedness and response section is responsible for enhancing the preparedness and response capabilities of the state's public health and private medical providers. It works to create and promote a state of readiness and response to protect the health of North Dakotans during catastrophic events, large-scale disasters and emergencies.
The administration of the emergency medical services system, licensing of ambulance services, and certifying of emergency medical technicians are also responsibilities of this
section.
d.Environmental health section. The goal of this section is to assure that the quality of life in the state will not be diminished below acceptable standards as a result of degradation of the air, water, and physical environment.
Primary functions and responsibilities include coordinating communications with the environmental protection agency regarding state programs and related environmental issues, monitoring and enforcing compliance with state and federal environmental laws, and carrying out environmental chemistry analyses.
Priorities for the section are to continue to implement strategies for addressing environmental impacts and problems associated with new developments; administering a state hazardous waste management program; administering a water quality management program for cleaning up targeted lakes and rivers, and protecting ground water and drinking water aquifers; and controlling air, radiation, noise, and solid waste pollution.
e.Health resources section. This section is responsible for licensing inpatient health care facilities, home health agencies, electrologists, and electronic hair removal technicians.
The section conducts certification surveys of all facilities and programs providing service to persons eligible under the Medicare and Medicaid programs.
f.Medical services section. The section is responsible for disease prevention, surveillance, testing and identification, as well as epidemiologic investigation and forensic examinations.
3.Inquiries. General inquiries regarding the state department of health should be addressed to:
(Section or Division Name)
North Dakota State Department of Health - Department 301 600 East Boulevard Avenue Bismarck, ND 58505-0200
February 1, 1993; April 1, 1994; October 1, 1995; August 1, 1998; April 1, 2002; May 1, 2004;
October 1, 2013.
History
- History: Amended effective April 1, 1984; December 1, 1985; October 1, 1989; October 1, 1991;
- General Authority: NDCC 28-32-02.1
- Law Implemented: NDCC 28-32-02.1
Article 33-03 Public Health Division
Chapter 33-03-01 Free Standing Outpatient Facility - Including Surgical Facilities - Excluding Physicians Clinic [Repealed]
N.D. Admin. Code 33-03-01 Free Standing Outpatient Facility - Including Surgical Facilities - Excluding Physicians Clinic [Repealed]
ARTICLE 33-03
PUBLIC HEALTH DIVISION
Chapter 33-03-01Free Standing Outpatient Facility - Including Surgical Facilities - Excluding Physicians Clinic [Repealed] 33-03-02Abortion 33-03-03Maintenance and Operation of Public Waterworks Systems, Swimming Pools, and Sewerage Systems [Repealed] 33-03-04Quality of Water [Repealed] 33-03-05School Water and Sewerage Systems [Repealed] 33-03-06Sale of Bulk and Bottled Water Supplies Intended for Domestic Purposes [Repealed] 33-03-07Care and Disposal of Refuse and Garbage [Repealed] 33-03-08Approval of Plans and Specifications Prior to Construction of Water Works and Sewerage Systems [Repealed] 33-03-09Health Maintenance Organizations [Repealed] 33-03-10Home Health Agencies [Repealed] 33-03-10.1Home Health Agencies 33-03-11Electronic Hair Removal Technician 33-03-11.1Electrolysis 33-03-12Hemophilia 33-03-13Construction Standards for Residential Facilities for the Physically Disabled 33-03-14Construction Standards for Small Intermediate Care Facilities for the Mentally Retarded 33-03-15Hospice Programs 33-03-16Construction and Location of Toilets [Repealed] 33-03-17Temporary Work Camps [Repealed] 33-03-18Milk Sanitation [Repealed] 33-03-19Food and Drink Sanitation [Repealed] 33-03-20Minimum Requirements for Sanitation in Places of Employment [Repealed] 33-03-21Minimum Requirements for Sanitation in Camps [Repealed] 33-03-22Migrant Labor Housing [Repealed] 33-03-23Health Care Claims Data 33-03-24Basic Care Facilities [Repealed] 33-03-24.1Basic Care Facilities 33-03-24.2General Standard for Construction and Equipment for Basic Care Facilities 33-03-25Alternative Health Care Services Projects 33-03-26Organ Transplant Support Fund 33-03-27State Community Matching Physician Loan Repayment Program [Repealed] 33-03-28District Health Units 33-03-29Residential Care Facilities for Children With Autism 33-03-30Construction Standards for Residential Care Facilities for Children With Autism 33-03-31Certificate of Public Advantage [Repealed] 33-03-32State Community Matching Loan Repayment Program For Nurse Practitioners, Physicians Assistants, and Certified Nurse Midwives [Repealed] 33-03-33Long-Term Care Nursing Scholarship and Loan Repayment Grant Program 33-03-34Autism Spectrum Disorder Database 33-03-35Residential End-of-Life Facility Regulation 33-03-36Extended Stay Center Registration 33-03-37Health Care Professional Student Loan Repayment Program 33-03-38Community Health Workers
CHAPTER 33-03-01
FREE STANDING OUTPATIENT FACILITY - INCLUDING SURGICAL FACILITIES -
EXCLUDING PHYSICIANS CLINIC [Repealed effective August 1, 1999]
Chapter 33-03-02 Abortion
N.D. Admin. Code 33-03-02-01 Full disclosure and informed consent form
In accordance with requirements under North Dakota Century Code section 14-02.1-02, the state department of health has developed an Induced Abortion Disclosure and Consent Form (Appendix A) to be executed in duplicate. The form shall be used by the physician, patient, parent or parents, or legal guardian as prescribed in North Dakota Century Code chapter 14-02.1.
History
- Law Implemented: NDCC 14-02.1-02
N.D. Admin. Code 33-03-02-02 Life-supporting equipment
Life-supporting equipment for the preservation of a viable fetus shall, as a minimum, include all of the following:
1.Oxygen source.
2.Heat source (overhead warmer, incubator, warmed blankets).
History
- Law Implemented: NDCC 14-02.1-05
N.D. Admin. Code 33-03-02-03 Reporting of practice of abortion
In accordance with requirements of North Dakota Century Code section 14-02.1-07, the state department of health has a Report of Induced Abortion Form (Appendix B) to be executed in duplicate.
The form shall be used by the hospital or facility in which an induced abortion is performed.
History
- Law Implemented: NDCC 14-02.1-07
N.D. Admin. Code 33-03-02-04 Humane disposal of nonviable fetus
Superseded by section 33-03-02-05.
N.D. Admin. Code 33-03-02-05 Humane disposal of nonviable fetus
Disposal of a nonviable fetus in a humane fashion shall consist of incineration, burial, or cremation.
The licensed physician performing the abortion or the licensed hospital in which an abortion is performed may contract for out-of-state incineration, burial, or cremation of nonviable fetuses.
Incinerators within the state of North Dakota used for the disposal of nonviable fetuses must meet the requirement of chapter 33-15-14.
APPENDIX A
INDUCED ABORTION DISCLOSURE AND CONSENT FORM
PHYSICIAN'S DISCLOSURE AND STATEMENT CONCERNING ABORTION
-
Concerning the state of development of the fetus: _________
-
Concerning the method of abortion to be utilized and the effects of this method upon the fetus: ____________________
-
Concerning possible physical and psychological complications of abortion: ______________________________________________
-
Concerning available alternatives to abortion (e.g., childbirth, adoption): _________________________________________ I hereby certify that I have fully disclosed the above information to the undersigned individual regarding the abortion to which she has voluntarily consented.
Physician's Signature: ______________________ Date: ________ PATIENT CERTIFICATION AND CONSENT I hereby certify that the above disclosures have been fully stated to me and that I consent to the performance of this abortion of my own volition and without duress.
Patient's Signature: _________________________ Date: ________ ADDITIONAL CERTIFICATION AND CONSENT FOR ABORTION IN WHICH THE FETUS HAS REACHED A GESTATIONAL AGE OF 12 WEEKS OR MORE I hereby certify that I am the legal husband of the above mentioned patient and that I voluntarily consent to this abortion of my own volition and without duress.
Husband's Signature: _________________________ Date: ________ OR I hereby certify that I am the (parent, legal guardian) of the above mentioned patient and that I voluntarily consent to this abortion of my own volition without duress.
Signature of Parent or Legal Guardian: ___________________________ Date: ________
History
- History: Effective March 1, 1988.
- General Authority: NDCC 14-02.1-09, 23-01-03
- Law Implemented: NDCC 14-02.1-09
Chapter 33-03-03 Maintenance and Operation of Public Waterworks Systems, Swimming Pools, and Sewerage Systems [Repealed]
N.D. Admin. Code 33-03-03 Maintenance and Operation of Public Waterworks Systems, Swimming Pools, and Sewerage Systems [Repealed]
CHAPTER 33-03-03
MAINTENANCE AND OPERATION OF PUBLIC WATERWORKS SYSTEMS, SWIMMING
POOLS, AND SEWERAGE SYSTEMS [Repealed effective August 1, 1999]
Chapter 33-03-04 Quality of Water [Repealed]
N.D. Admin. Code 33-03-04 Quality of Water [Repealed]
CHAPTER 33-03-04
QUALITY OF WATER [Repealed effective August 1, 1999]
Chapter 33-03-05 School Water and Sewerage Systems [Repealed]
N.D. Admin. Code 33-03-05 School Water and Sewerage Systems [Repealed]
CHAPTER 33-03-05
SCHOOL WATER AND SEWERAGE SYSTEMS [Repealed effective August 1, 1999]
Chapter 33-03-06 Sale of Bulk and Bottled Water Supplies Intended for Domestic Purposes [Repealed]
N.D. Admin. Code 33-03-06 Sale of Bulk and Bottled Water Supplies Intended for Domestic Purposes [Repealed]
CHAPTER 33-03-06
SALE OF BULK AND BOTTLED WATER SUPPLIES
INTENDED FOR DOMESTIC PURPOSES [Repealed effective August 1, 1999]
Chapter 33-03-07 Care and Disposal of Refuse and Garbage [Repealed]
N.D. Admin. Code 33-03-07 Care and Disposal of Refuse and Garbage [Repealed]
CHAPTER 33-03-07
CARE AND DISPOSAL OF REFUSE AND GARBAGE [Repealed effective August 1, 1999]
Chapter 33-03-08 Approval of Plans and Specifications Prior to Construction of Water Works and Sewerage Systems [Repealed]
N.D. Admin. Code 33-03-08 Approval of Plans and Specifications Prior to Construction of Water Works and Sewerage Systems [Repealed]
CHAPTER 33-03-08
APPROVAL OF PLANS AND SPECIFICATIONS PRIOR TO CONSTRUCTION OF WATER
WORKS AND SEWERAGE SYSTEMS [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-03-09 Health Maintenance Organizations [Repealed]
N.D. Admin. Code 33-03-09 Health Maintenance Organizations [Repealed]
CHAPTER 33-03-09
HEALTH MAINTENANCE ORGANIZATIONS [Repealed effective November 1, 1991]
Determined repealed by the office of the Legislative Council pursuant to North Dakota Century Code
section 28-32-03 because the authority for adoption of the rules is transferred to another agency.
Chapter 33-03-10 Home Health Agencies [Repealed]
N.D. Admin. Code 33-03-10 Home Health Agencies [Repealed]
CHAPTER 33-03-10
HOME HEALTH AGENCIES [Repealed Effective January 1, 1998]
Chapter 33-03-10.1 Home Health Agencies
N.D. Admin. Code 33-03-10.1 Home Health Agencies
CHAPTER 33-03-10.1
HOME HEALTH AGENCIES
Section 33-03-10.1-01Definitions 33-03-10.1-02Conflict with Federal Requirements 33-03-10.1-03Application, Issuance, and Renewal of License 33-03-10.1-04Inspection by The Department 33-03-10.1-05Plan of Correction 33-03-10.1-06Enforcement 33-03-10.1-07Order and Notice of Order 33-03-10.1-08Request For Reconsideration 33-03-10.1-09Appeals 33-03-10.1-10Governing Body 33-03-10.1-11Quality Assessment and Performance Improvement 33-03-10.1-12Education Programs 33-03-10.1-13Medical Services 33-03-10.1-14Nursing Services 33-03-10.1-15Patient Plan of Care 33-03-10.1-16Clinical Record Services 33-03-10.1-17Therapeutic Services 33-03-10.1-18Home Health Aide Training and Competency Evaluation 33-03-10.1-01. Definitions.
The following definitions, in addition to the definitions in North Dakota Century Code section 23-17.3-01, apply to this chapter:
1."Agency" means home health agency.
2."Branch" means a location or site from which a home health agency provides services within a portion of the total geographic area served by the parent agency. The branch office is part of the home health agency and is located close enough to share administration, supervision, and services.
3."Clinical note" means a notation of a contact with a patient that is written and dated by a member of the health care team and that describes signs and symptoms, treatment and drugs administered and the patient's reaction, and any changes in physical or emotional condition.
4."Companion services" includes staying or traveling with a patient and may include provision of guided maneuvering or nonweight bearing assistance.
5."Department" means the department of health and human services.
6."Governing body" means the individual or group in whom the ultimate authority and legal responsibility is vested for the conduct of the agency.
7."Homemaker services" include preparing meals, shopping, assistance with bill paying, housework, laundry, transportation, communication, and mobility outside the patient's residence.
8."Parent" means the agency office that develops and maintains administrative control of the branch offices.
9."Progress notes" means a written notation, dated and signed by a member of the health care team, which summarizes facts about care furnished and the patient's response during a given period of time.
10."Supervised practical training" means training in a laboratory or other setting in which the home health aide trainee demonstrates tasks on an individual under the direct supervision of a registered or licensed practical nurse.
Law Implemented: NDCC 23-17.3-01, 23-17.3-08 33-03-10.1-02. Conflict with federal requirements.
If any part of this chapter is found to conflict with federal requirements, the more stringent shall apply. Such a finding or determination shall be made by the department and shall not affect the remainder of this chapter.
Law Implemented: NDCC 23-17.3-08 33-03-10.1-03. Application, issuance, and renewal of license.
An entity meeting the definition of home health agency in North Dakota Century Code section 23-17.3-01 must obtain a license from the department to operate in North Dakota. A person or entity may not establish or operate an agency or use the terms home health agency or home health services without first having obtained a license.
1.Any person or entity who desires to maintain and operate an agency shall apply to the department for a license in the form prescribed and shall obtain an initial license before accepting patients for care or treatment.
a.The department shall not approve an application for initial license unless:
(1)The application and all required attachments and statements submitted by the applicant meet the requirements of this chapter. A description of all services provided and the geographic areas to be served by agency staff must be included.
(2)The department has conducted an inspection or investigation of the agency to determine compliance with this chapter.
(3)The department has completed an investigation into the fitness of the applicant and determined the applicant to be fit based on the following:
(a)Evidence provided by the applicant which identifies that financial resources and sources of revenue for the applicant's agency appear adequate to provide the staff and services sufficient to comply with North Dakota Century Code
chapter 23-17.3 and this chapter;
(b)The applicant has furnished the department with a signed and notarized statement describing and dating every proceeding, within five years of the date of application, in which the applicant was involved which resulted in a limitation, suspension, revocation, or refusal to grant or renew an agency license or a Medicare or Medicaid decertification action; and (c)The applicant shall furnish a signed and notarized statement to the department describing every criminal proceeding within five years of the date of the application in which the licensee or any of its shareholders owning interest of five percent or more officers, directors, partners, or other controlling or managing persons, has been convicted or nolo contendere plea accepted, of a criminal offense related to the operation or ownership of an agency.
b.The initial license is valid for a period not to exceed one year and expires on December thirty-first of the year issued.
2.The department shall issue a renewal license when an agency is in compliance with the provisions of these licensing requirements, as determined by periodic unannounced onsite surveys conducted by the department and other information submitted by the agency upon the request of the department. Renewal licenses shall expire on December thirty-first of each year. The application for renewal must be received by the department with sufficient time to process prior to the beginning of the licensure period.
3.In the case of an agency or operators of a preexisting agency which has had its license suspended or revoked or denied, the applicant shall submit with the request for relicensure sufficient justification to indicate the reasons for the suspension, revocation, or denial no longer exist, reasonable assurance that they will not recur, and evidence that all licensure requirements are met.
4.The department shall require an applicant or licensee to disclose the name, address, and official position of all persons who have a five percent or more ownership interest in the agency.
5.The department may issue a provisional license, valid for a specific period of time not to exceed ninety days. A provisional license may be issued when the department has determined there are one or more serious deficiencies or a pattern of repeat deficiencies related to compliance with these licensing requirements.
a.A provisional license may be renewed at the discretion of the department, provided the licensee demonstrates to the department that it has made progress towards compliance and can effect compliance within the next ninety days. A provisional license may be renewed one time.
b.When an agency operating under a provisional license notifies the department that it has corrected its deficiencies, the department will ascertain correction. Upon finding compliance, the department shall issue a renewal license.
6.When a subdivision of an agency, for example, the home care department of a hospital, applies for a license, the subdivision rather than the parent organization must be licensed as an agency and maintain records in such a way that subdivision activities and expenditures attributable to services provided are identifiable. The parent organization may determine who signs the agreement and other documents and receive and disburse funds.
7.If one or more branch offices are operated under the same management, the branch offices will be licensed under the parent agency's license.
8.Each license is valid only in the hands of the entity to whom it is issued and is not subject to sale, assignment, or other transfer, voluntary or involuntary, nor is a license valid for any agency other than those for which originally issued. The license must be displayed in a conspicuous place within the agency.
9.The agency shall notify the department in writing at least thirty days in advance of any of the following changes:
a.Transfer or change of ownership.
b.Transfer of operating rights, including a lease of the agency where the lessor retains no control of the operation or management of the agency.
c.Change in the name of the agency.
d.A service is added or deleted.
e.A change in the geographic area served.
10.The agency shall notify the department in writing within thirty days of a change in administrative staff as identified on the annual licensure application or the nurse executive.
11.Upon discontinuance of the operation or transfer of ownership of an agency, the license must be returned to the department.
12.Existing agencies subject to this chapter which are already in operation on January 1, 1998, will be given a reasonable time, not to exceed May 1, 1998, within which to comply with the rules, regulations, and standards provided for herein.
General Authority: NDCC 23-01-04, 23-17.3-02, 23-17.3-08
Law Implemented: NDCC 23-17.3-02, 23-17.3-04, 23-17.3-05, 23-17.3-08 33-03-10.1-04. Inspection by the department.
The department may evaluate an agency's compliance with this chapter at any time through:
1.An announced or unannounced onsite review, including inspection and examination of all agency records and documents required by this chapter, interview with agency staff, and home visits with the patient's permission; or
2.A request for submission of written documentation verifying compliance.
Law Implemented: NDCC 23-17.3-04, 23-17.3-08, 23-17.3-09 33-03-10.1-05. Plan of correction.
1.An agency shall submit to the department a plan of correction addressing the areas of noncompliance with the licensure requirements of this chapter.
2.A plan of correction must include:
a.How the corrective action will be accomplished for those patients found to have been affected by the deficient practice;
b.How the agency will identify other patients or services in the agency having the potential to be affected by the same deficient practice;
c.What measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; and
d.How the agency will monitor its corrective actions to ensure that the deficient practice is being corrected and will not recur.
3.A plan of correction is required within ten calendar days of the receipt of the deficiency statement and is subject to acceptance, acceptance with revisions, or rejection by the department. Failure to submit an acceptable plan of correction may result in a directed plan of correction.
4.Corrections must be completed within sixty days of the survey completion date, unless an alternative schedule of correction has been specified by the department.
Law Implemented: NDCC 23-17.3-04, 23-17.3-08 33-03-10.1-06. Enforcement.
1.Agencies are subject to one or more enforcement actions, which may include suspension or revocation of a license or a denial to license for the following reasons:
a.Noncompliance with the licensure requirements in this chapter has been identified which:
(1)Presents imminent danger to patients;
(2)Has a direct or immediate relationship to the health, safety, or security of the agency's patients;
(3)If left uncorrected, has a potential for jeopardizing patient health or safety; or (4)Is a recurrence of the same or substantially same violation in a twenty-four-month period.
b.Failure to correct any deficiency pursuant to a plan of correction or directed plan of correction, unless the department approves in writing an extension or modification of the plan of correction.
c.Gross incompetence, negligence, or misconduct in operating the agency as determined through department investigation or through a court of law.
d.Fraud, deceit, misrepresentation, or bribery in obtaining or attempting to obtain a license.
e.Lending, borrowing, or using the license of another agency.
f.Knowingly aiding or abetting in any way the improper granting of a license.
2.Conditions or practices that the department has determined to present imminent danger to patients receiving services from the agency must be abated or eliminated immediately or within a fixed period of time as specified by the department.
Law Implemented: NDCC 23-17.3-07 33-03-10.1-07. Order and notice of order.
1.Upon a determination that the circumstances make imposition of a sanction appropriate, the department shall issue a written order identifying the violations and the sanction imposed. A copy of the order must be sent by registered mail, return receipt requested, to the agency's owner, the agency's administrator, or head of the agency's governing body. The order must specify the terms or conditions under which the sanction will be terminated. The order must also advise the agency of the right to seek reconsideration.
2.When an agency has been subjected to a sanction, the department may notify, as appropriate, applicable professional licensing agencies, boards of registration or licensure, and federal, state, or county agencies of the circumstances and sanctions imposed.
3.When an agency has been subjected to a sanction, the department shall notify the county social service board of each county where the agency provides services. Each county social service board so notified shall post, in a prominent place within the office, the name and address of the agency and the sanction. The posting must remain in place for the entire period of any sanction other than closure or termination from the program and for the first ninety days of closure or termination.
4.When an agency has been subjected to a sanction, the agency shall place notices of the sanction, supplied by the department at all agency entrances and exits. The department may also require the agency to purchase space in the print media to achieve public dissemination of information concerning any sanction. 33-03-10.1-08. Request for reconsideration.
1.Within ten days after receipt of the order, the agency may request reconsideration by the department. Within fifteen days after receipt of a request for reconsideration, the department shall grant or deny the request for reconsideration and may suspend the imposition of any sanction pending the decision on the reconsideration.
2.A request for reconsideration, in any event, must be denied unless it identifies, with specificity, each disputed violation and states the factual basis for its contention that the violation was erroneously determined. The correction of the factors that led to the determination of a violation may not be asserted as a basis for reconsideration.
3.If the department denies the request for reconsideration, the department shall notify the agency in writing of that decision. If the denial was for any reason other than a failure of the request to conform to the requirements of subsection 2, the notice must advise the agency of the right to appeal.
4.If the department determines to undertake the reconsideration, the decision on reconsideration must be rendered within forty days after the issuance of the order. The notice of the decision on reconsideration must advise the agency of the right to appeal.
5.If the agency fails to file a timely request for reconsideration which conforms to the requirements of subsection 2, the order is final in all respects, and no further administrative or judicial review is applicable. 33-03-10.1-09. Appeals.
1.An agency dissatisfied with a decision on a timely request for reconsideration, which conforms to the requirements of subsection 2 of section 33-03-10.1-08, may appeal. An appeal may be perfected by mailing or delivering the information described in subdivisions a through d, to the department, state capitol, Bismarck, North Dakota, so that the mailed or delivered material arrives at the office of the division of health facilities on or before 5:00 p.m. on the thirty-first day after the date of the determination the department made with respect to a request for reconsideration. An appeal under this section is perfected only if accompanied by written documents, including all of the following information:
a.A copy of the notice received from the department advising of the department's decision on the request for reconsideration;
b.A statement of each disputed violation and the reason or basis in fact for the dispute;
c.The authority in statute or rule upon which the appealing party relies for each disputed item; and
d.The name, address, and telephone number of the person upon whom all notices will be served regarding the appeal.
2.Except as otherwise provided in this section, the appeal must be considered as provided in
article 98-02.
3.The dispositive issue on appeal must be whether the violation occurred, not whether the violation has been corrected.
4.The hearing officer must make written findings of fact and conclusions of law, and must recommend a decision to the department. The recommended decision must set forth the reasons for the decision and the evidence upon which the decision is based.
5.The department may accept, modify, or reject the recommended decision. If the department rejects the recommended decision, it may remand the matter to the office of administrative hearings with directions. The department, through its directions, may require the receipt of additional evidence, and the submission of amended findings of fact, conclusions of law, and recommended decision which reflect consideration of additional evidence. The department, through its directions, may require that the matter be referred to the same or a different hearing officer and the office of administrative hearings shall comply with that direction unless compliance is impossible.
6.An appeal may not suspend or delay the imposition of a remedy under this chapter. 33-03-10.1-10. Governing body.
The governing body is legally responsible for the quality of patient care services; for patient safety and security; for the conduct, operation, and obligations of the agency; and for ensuring compliance with all federal, state, and local laws. Contracts, arrangements, or other agreements may not limit the responsibility of the governing body in any way. The governing body shall:
1.Have bylaws or the equivalent, which shall be reviewed annually and be revised as needed.
They must be made available to all members of the governing body. The bylaws or equivalent must specify the duties and responsibilities of the governing body.
2.Approve an overall plan and budget for the agency which includes an annual operating budget and capital expenditure plan.
3.Provide and maintain an office facility adequately equipped for efficient work and which provides a safe working environment in compliance with local ordinances and fire regulations.
4.Employ a qualified administrator who is designated in writing as administratively responsible and available for all aspects of agency operation including the employment of qualified staff, accuracy of public information, and implementation of the budget.
a.A qualified administrator is:
(1)A licensed physician, registered nurse, or college graduate with a bachelor's degree who has a minimum of three years of health care management; or (2)A person without a college degree may qualify by obtaining the equivalent of six years of supervisory experience in health care management.
b.The administrator and nurse executive may be the same individual if the individual is dually qualified.
c.The administrator must identify in writing an individual who is qualified and authorized to act in place of the administrator when the administrator is not available.
5.Organize agency services to ensure quality of patient care. An organizational chart, from the governing body to the patients, with a written description of the organization, authorities, responsibilities, accountabilities, and relationships must be maintained which must include:
a.A description of each service offered;
b.Policies and procedures pertaining to each service;
c.Job descriptions for each discipline; and
d.A description of the system for maintenance of patient records.
6.Ensure the development, implementation, review and revision of policies and procedures as changes in standards of practice occur. Policies and procedures must include the following:
a.Operation and administration of the agency, including:
(1)Provision of therapeutic and supportive services under the direction of a physician or registered nurse.
(2)Acceptance of only patients for whom they can provide the needed services.
Acceptance is based on medical, nursing, and social information provided by the patient's physician, the facility the patient is being discharged from, and the staff of the agency, as applicable.
(3)Provision of services to patients consistent with the treatment plan established, signed, and regularly reviewed by the physician responsible for the patient's care.
Supportive services may be provided, without a physician's order, consistent with the care plan established, signed, and regularly reviewed by the registered nurse when therapeutic services are not needed by the patient.
(4)If therapeutic services are ordered, review of the total plan of care by the patient's physician at such intervals as the patient's condition requires, but no less than once every two months. Verbal authorization to change the plan of treatment shall be reviewed and signed by the physician consistent with agency policy.
(5)Availability of services to patients regardless of age, sex, religion, or ethnic background.
(6)Clinical records that are accurate, concise, and consistent with current medical records standards of practice must be maintained for each patient which cover the services the agency provides directly or through arrangement, and contain pertinent past and current medical, nursing, and social information including the plan of treatment and care.
(7)A means to ensure all records must be maintained in a confidential manner.
(8)A means to report, investigate, and document action taken on grievances, including follow-through with the patient or the patient's family.
b.Personnel records that include the following documentation:
(1)Checking of state registries and licensure boards prior to employment for findings of inappropriate conduct, employment, disciplinary actions, and termination;
(2)Job descriptions;
(3)Orientation records;
(4)Training and education records;
(5)Disciplinary action records;
(6)Verification of current licensure or registration status, if applicable;
(7)Documentation of annual performance reviews; and (8)Documentation of competency evaluation of home health aides.
c.Notification of each patient in writing of the patient's rights during the initial evaluation visit prior to the initiation of treatment. Patient rights, at a minimum, include the right to:
(1)Be given care without discrimination as to race, color, creed, sex, age, or national origin.
(2)Exercise the person's right as a patient of the agency. If the patient has been judged incompetent, the patient's family or guardian may exercise the patient's rights.
(3)Choose care providers and the right to communicate with those providers.
(4)Be fully informed of the patient's medical condition and to have access to the patient's medical record.
(5)Be informed, in advance, about the care to be furnished and any changes in the care to be furnished, the disciplines that will furnish the care, the frequency of visits proposed, any changes in the plan of care before the change is made, and of the patient's right to participate in planning the care and planning any changes in the care.
(6)Refuse care and to be informed of possible health consequences of this action.
(7)Be provided information regarding advanced directives prior to the initiation of treatment.
(8)Be informed of the need for transfer, referral, or discharge from the agency.
(9)Be treated with dignity, privacy, respect, and consideration as well as freedom from abuse, neglect, or misappropriation of the patient's property.
(10)Voice grievances regarding treatment or care that is, or fails to be, furnished or regarding lack of respect for property by anyone who is furnishing services on behalf of the agency and to not be subjected to discrimination or reprisal for doing so.
(11)Confidentiality regarding the patient's medical condition and medical records.
(12)Advice, before care is initiated, of the extent to which payment for agency services may be expected from Medicare, Medicaid, or other sources and the extent to which payment may be required from the patient. The patient must also be informed orally and in writing of any changes in payment sources no later than thirty calendar days after the agency becomes aware of the changes.
(13)Use of the toll-free hotline established by the department to receive complaints or questions about local agencies and the hours of operation of the hotline.
7.Ensure there is a written agreement or contract in place and signed by both parties if arranging for services from individuals not employed directly by the agency or from other agencies.
a.The written agreement or contract must at a minimum state the following:
(1)Patients may be accepted for care only by the agency;
(2)The specific service to be provided;
(3)The period of time the contract is in effect;
(4)The availability of the service;
(5)Financial arrangements;
(6)Verification that any individual providing service is appropriately licensed or registered as required by state statute or regulation;
(7)Provisions for supervision of contract personnel where applicable;
(8)Assurance that individuals providing services under contractual arrangements meet the same requirements as those specified for agency personnel;
(9)Provision for the documentation of services rendered in the patient's record;
(10)Provision for the sharing of assessment and plan of care data;
(11)The geographic area the contractor agrees to serve;
(12)Specify that only the contracting agency shall bill for services provided under the written agreements and collect the applicable payments pertaining to the contracted services; and (13)Evaluation of the acceptability of the contracted services.
b.Contract services must be provided in accordance with the patient's plan of care.
c.The agency shall assure that all contract services are provided in accordance with the agreement. Agreements must be reviewed on an annual basis and updated as necessary.
d.The agency that is subcontracting its work must maintain or produce a complete home care record for each patient.
8.Ensure the agency obtains and maintains compliance with the applicable parts of the clinical laboratory improvement amendments of 1988, 42 CFR part 493, if the agency provides any laboratory testing service, regardless of the frequency or the complexity of the testing.
9.Meet with agency administrative staff to review the operation of the agency at a frequency sufficient to ensure safe and effective patient care.
10.Keep minutes of all meetings including actions taken. 33-03-10.1-11. Quality assessment and performance improvement.
1.The agency shall develop, implement, and document an ongoing agencywide quality assessment program to monitor, evaluate, and improve the quality of patient care, administrative, and support services, including all contracted services, and to ensure services are provided in compliance with professional standards of practice.
a.The quality assessment program must include a written plan that identifies a mechanism to identify problems, recommend appropriate action, implement recommendations, and monitor results.
b.The administrator shall maintain a record of the activities of the quality assessment program and ensure findings, conclusions, and recommendations are reported to the governing body.
2.The agency shall complete a performance improvement project annually and documentation of the reviews must be maintained as a part of the administrative records. 33-03-10.1-12. Education programs.
The agency shall design, implement, and document educational programs to orient new employees and keep all staff current on new and expanding programs, therapeutic services, techniques, equipment, and concepts of quality care.
1.The following topics must be covered with all staff annually:
a.Prevention and control of infections, including universal precautions;
b.Patient rights; and
c.Safety and emergency procedures.
2.In addition to meeting the training and competency evaluation or competency evaluation requirements in section 33-03-10.1-18, individuals providing home health aide services must receive twelve hours of inservice education within a twelve-month period.
a.This inservice education may occur while the aide is furnishing care to the patient.
b.Inservice training must be supervised by a registered nurse with a minimum of two years' experience, one of which is in the provision of home health services. 33-03-10.1-13. Medical services.
1.All therapeutic services delivered to the patient by the agency must be approved by the patient's physician, including frequency and duration of services.
2.All therapeutic services must be provided consistent with a written treatment plan established and periodically reviewed by the patient's physician and must include at least the following:
a.Orders for home health services, including orders for:
(1)Skilled nursing, home health aide services, or other therapeutic services;
(2)Medical supplies and equipment;
(3)Medications and treatments when applicable;
(4)Special dietary or nutritional needs when applicable; and (5)Medical tests including laboratory tests and x-rays when applicable.
b.Diagnosis and prognosis.
c.Functional limitations. 33-03-10.1-14. Nursing services.
1.Skilled nursing services must be provided under the direction of a nurse executive or director of nursing who is a registered nurse licensed to practice in North Dakota, with at least one year's full-time experience in providing direct patient care in a home health setting and three years' experience as a registered nurse. The nurse executive shall have written administrative
authority, responsibility, and accountability for the integration and coordination of nursing services consistent with the overall agency organization and plan for patient care. The nurse executive shall:
a.Be a full-time, salaried employee of the agency;
b.Supervise all patient care activities to assure compliance with current standards of accepted nursing and medical practice;
c.Develop, maintain, periodically review, and cause to implement philosophy, objectives, standards of practice, policies and procedures, and job descriptions for each level of nursing service personnel;
d.Ensure there are sufficient qualified nursing personnel to meet the nursing care needs of the patients in accordance with the plan of care;
e.Ensure there is a registered nurse available by telephone during operating hours and when home health services are being provided to receive referrals, orders, patient phone calls, and any other concerns that may arise; and
f.Identify an alternate registered nurse in writing to function as the nurse executive when the nurse executive is not available.
2.A registered nurse shall:
a.Make the initial evaluation visit, initiate the plan of care, regularly reevaluate the patients' nursing needs, and make necessary revisions to the plan of care.
(1)If the patient receives skilled nursing services and home health aide services, the registered nurse shall make supervisory visits no less frequently than every two weeks.
(2)If the patient is not receiving skilled nursing services, but is receiving home health aide, homemaker, or companion services, the registered nurse shall make contact at least every sixty days to determine the appropriateness of the plan of care and the acceptability of the care provided.
b.Initiate preventive and rehabilitative nursing procedures, prepare clinical notes, coordinate therapeutic and supportive services, inform the physician and other personnel of changes in the patient's condition and needs, and counsel the patient and family regarding patient care needs.
c.Assign home health aides to specific patients dependent upon the needs of the patient and the skill of the home health aide.
d.Participate in inservice programs, supervise and teach other nursing personnel.
3.Licensed practical nurses shall furnish patient care services in accordance with agency policies, prepare clinical and progress notes, and assist the physician and registered nurse in performing specialized procedures and patient teaching.
4.If home health aide services are provided, either directly or by contract, the services must be provided by individuals who meet the training and competency or competency requirements specified in section 33-03-10.1-18 and meet registry requirements as specified by state statute. Individuals providing home health aide services shall:
a.Be supervised by a registered nurse; and
b.Provide patient care and services that home health aides are permitted to provide by state statute and rules, which are consistent with the physician's orders; assigned by the registered nurse for a specific patient; and contained in the patient's plan of care, written instructions from the registered nurse or other appropriate professionals, and agency policies and procedures. 33-03-10.1-15. Patient plan of care.
A written plan of care must be developed for each patient which must include reference to at least the following:
1.All pertinent diagnoses;
2.Prognosis, including short-term and long-term objectives of care;
3.Types and frequency of services to be provided, including medication, diet, treatment procedures, equipment, and devices;
4.Functional limitations of the patient;
5.Activities permitted;
6.Safety measures required to protect the patient from injury; and
7.Sociopsychological needs of the patient. 33-03-10.1-16. Clinical record services.
An agency shall maintain clinical records for each patient and provide relevant information from these clinical records to the personnel providing services in the patient's home.
1.The clinical record must contain sufficient information to identify the patient clearly, to justify the diagnosis and treatment, and to document the results of treatment accurately. All clinical records must contain at least the following general categories of data:
a.Identification data and consent forms;
b.The name, address, and phone number of the patient's physician;
c.The physician's signed order for therapeutic services and the approved plan of care, which must include, when appropriate to the services being provided:
(1)Medical diagnosis;
(2)Medication orders;
(3)Dietary orders;
(4)Treatment orders;
(5)Activity orders; and (6)Safety orders.
d.Initial and periodic assessments and care plans by professionals providing services;
e.Signed and dated admission, observation, progress, clinical and supervisory notes, and other information necessary to document services are provided and not just offered;
f.Copies of summary reports sent to the physician;
g.Diagnostic and therapeutic orders signed by the physician;
h.Reports of treatment and clinical findings;
i.Transfer form, if applicable; and
j.Discharge summary.
2.All clinical information pertaining to the patient's care must be maintained in a centralized location by the parent or branch office.
3.Clinical records of services provided must be kept in ink, typed, or electronic data systems.
4.Entries into the clinical record for services rendered must be written within twenty-four hours and incorporated into the clinical record in a time frame specified by agency policy.
5.Entries must be made by the person providing services, must contain a statement of facts personally observed, and must be signed and dated. Initials may be used in the clinical record if the full name has been identified in another location in the record.
6.Verbal orders from a physician must be signed and incorporated into the clinical record in a time frame consistent with agency policy.
7.Clinical records must be safeguarded against loss or unauthorized use. Written policies and procedures must be in place regarding the use and removal of records and the conditions for release of information. The patient's or legal representative's written consent must be required for release of information not authorized by statute.
8.Clinical records must be maintained consistent with acceptable professional guidelines.
9.Retention of patient records must be as follows:
a.Patient records of discharged patients must be preserved for a period of ten years from the date of discharge. Records of deceased patients must be preserved seven years.
b.In the case of minors, records must be retained for the period of minority and ten years from the date of live discharge. Records of deceased patients who are minors must be preserved for the period of minority and seven years. 33-03-10.1-17. Therapeutic services.
Any therapeutic service provided by the agency, either directly or by contract, must be provided by individuals qualified consistent with state law to provide the therapeutic service. Individuals providing therapeutic services shall:
1.Provide treatments in accordance with the scope of practice for their profession.
2.Assess the needs of the patient, prepare a plan of care based on the assessment, and provide services to the patient as specified in the plan of care, reassessing the patient's response to services provided and revising a plan of care as needed.
3.Prepare clinical and progress notes to be included in the clinical record.
4.Participate in and document all care planning, care conferences, and quality improvement activities.
5.Act as a consultant to other agency personnel.
6.Work with the family.
7.Teach and supervise other health personnel when appropriate.
Law Implemented: NDCC 23-17.3-01, 23-17.3-05, 23-17.3-08 33-03-10.1-18. Home health aide training and competency evaluation.
Any individual employed by an agency to provide home health aide services directly or by contract must complete a nurse aide training and competency evaluation program or a competency evaluation program which meets the following:
1.The training program must total at least seventy-five clock hours, with at least sixteen of the seventy-five hours being devoted to classroom training prior to initiating the supervised practical training. At least sixteen hours of the total program hours must be devoted to supervised practical training.
a.The training, including supervised practical training, of home health aides must be performed under the general supervision of a registered nurse who possesses a minimum of two years of nursing experience, at least one year of which must be in the provision of home health care services. Other professionals may be used to provide instruction under the supervision of the qualified registered nurse.
b.The training program must, at a minimum, include the following topics:
(1)Communication skills;
(2)Observation, reporting, and documentation of patient status and care or services furnished;
(3)Reading and recording of temperature, pulse, and respiration;
(4)Basic infection control procedures;
(5)Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor;
(6)Maintenance of a clean, safe, and healthy environment;
(7)Recognizing emergencies and knowledge of emergency procedures;
(8)The physical, emotional, and developmental needs of and ways to work with the patients served;
(9)Patient rights;
(10)Appropriate and safe techniques in personal hygiene and grooming which include:
(a)Bed bath;
(b)Sponge, tub, or shower bath;
(c)Shampoo, sink, tub, or bed;
(d)Oral hygiene; and (e)Nail or skin care.
(11)Safe transfer techniques and ambulation;
(12)Normal range of motion and positioning;
(13)Adequate nutrition and fluid intake; and (14)Any other tasks the agency may choose to have the home health aide perform.
c.The agency must maintain sufficient documentation to demonstrate that the requirements for the training of home health aides of this section are met.
d.Agencies that have had state or federal enforcement action, other than the citation of deficiencies, filed against them in the past two years are not eligible to operate a home health aide training program.
2.An individual may provide home health aide services on behalf of the agency only after that individual has successfully completed a competency evaluation that consists of the following:
a.The competency evaluation must be conducted by a registered nurse.
b.The competency evaluation must address each of the items listed in subdivision b of subsection 1.
(1)The items listed in paragraphs 3, 10, 11, and 12 of subdivision b of subsection 1 must be completed by observation of the aide's performance of the tasks with a patient or other live individual.
(2)All other items listed in subdivision b of subsection 1 can be evaluated through written or oral examination or observation of the aide with a patient.
c.A home health aide is not considered to have successfully passed a competency evaluation program if the aide has an unsatisfactory rating in more than one of the required areas.
(1)A home health aide cannot perform any task for which the aide is evaluated to perform unsatisfactorily unless under the direct supervision of a licensed nurse.
(2)The home health aide must receive training in the areas determined unsatisfactory and pass a subsequent evaluation satisfactorily prior to performing the task without supervision.
d.The agency must maintain documentation that the competency evaluation requirements of this section have been met by each home health aide.
Chapter 33-03-11 Electronic Hair Removal Technician
N.D. Admin. Code 33-03-11-01 Definitions
Words defined in North Dakota Century Code chapter 43-38 have the same meaning in this
chapter, and in addition:
1."Aseptic technique" means practices that render and keep the skin site and instruments free from all micro-organisms or contamination.
2."Department" means the state department of health and consolidated laboratories.
3."Initial license" means the first license.
4."Person" means an individual human being.
5."Relicensure" means any license issued after the initial license.
History
- History: Effective September 25, 1979; amended effective February 1,1992; May 1, 1994.
- Law Implemented: NDCC 43-38-01
N.D. Admin. Code 33-03-11-02 License required - Fees
1.A person may not hold oneself out to the public as an electronic hair removal technician without a license issued by the department.
2.A license may not be sold, assigned, or transferred.
3.The license shall expire midnight on December thirty-first of the year issued. License renewal shall be on a calendar year basis renewable on January first of each year.
4.The license shall be displayed in a conspicuous place easily viewable by the persons treated.
5.The license fee shall be thirty dollars each for an initial license for the first year or part of a year.
6.The relicensure fee shall be twenty-five dollars each per year or part of a year.
7.Licenses shall be issued and license fees will be collected on a calendar year basis. License fees will not be prorated for a partial year.
History
- History: Effective September 25, 1979; amended effective February 1,1992; May 1, 1994.
N.D. Admin. Code 33-03-11-03 Application for license
Application for a license shall be made to the department on forms prescribed by the department.
N.D. Admin. Code 33-03-11-04 Issuance and renewal of licenses
1.The state health council shall delegate to the department the authority to manage and implement the electronic hair removal technician licensure program.
2.Upon receipt of an initial or relicensure application, the department shall evaluate the applicant's qualifications.
3.If minimum standards described in section 33-03-11-05 are met, the department shall issue a license.
History
- Law Implemented: NDCC 43-38-02
N.D. Admin. Code 33-03-11-05 Minimum standards for licensure
1.An applicant for licensure must meet the minimum standards prescribed by this subsection.
a.The applicant must be at least eighteen years of age.
b.The applicant must have a general education equivalent to the completion of four years of high school or certificate of general educational development.
c.An electronic hair removal technician must have successfully completed a course in an electrolysis school which meets the minimum standards as set forth in section 33-03-11-08 in electronic hair removal in the technique of removing hair other than through the use of the electric needle. The applicant must provide one letter of recommendation for the issuance of a technician license from one instructor knowledgeable in the electronic hair removal process without the use of an electric needle.
d.Written procedures for aseptic techniques acceptable to the department must be developed and implemented by the licensee.
2.Electronic hair removal technicians practicing or holding a license to practice from the North Dakota board of hairdressers and cosmetologists on June 30, 1979, will be deemed qualified and will be issued their licenses upon certification from the board as to the existence of such licenses. All other applicants for a license must document their qualifications for licensure in accordance with this section.
3.A licensed electronic hair removal technician is not permitted to remove hair with the use of the electric needle, but is permitted to practice any other method of hair removal.
History
- History: Effective September 25, 1979; amended effective February 1,1992; May 1, 1994.
N.D. Admin. Code 33-03-11-06 Denial, suspension, or revocation of license
The department may deny, suspend, or revoke a license for noncompliance with this chapter.
N.D. Admin. Code 33-03-11-07 Department - Administration of program
The department shall administer the licensing program in North Dakota pursuant to subsection 5 of North Dakota Century Code section 43-38-03.
History
- History: Effective September 25, 1979; amended effective February 1,1992; May 1, 1994.
- Law Implemented: NDCC 23-01-05, 43-38-03
N.D. Admin. Code 33-03-11-08 Recognition of curriculum
1.The department will recognize an applicant for a license as eligible for a license when the applicant has graduated from a school which has provided at a minimum two hundred hours of training in the following curriculum areas taught by instructors:
a.Practical training in the following branches of electrolysis:
Sanitation and sterilization as applied to electrology Patron protection Universal precautions Use of the electrical currents Use of equipment and instruments Precautionary measures to observe before and after treatment Immediate aftercare Home care (patron instruction in home care)
Destruction of the papilla Observation (demonstration and result of work)
Note: At least two-thirds of the hours in this subject shall be in actual performance of services on another person.
b.Theoretical and practical training in the following:
Ethics, professional conduct Optional and unassigned hours
c.Theory covering the following subjects:
Sanitation and sterilization as applied to electrology Universal precautions Electricity Dermatology Trichology Bacteriology Study of the peripheral vascular system (capillaries)
Study of the sensory nervous system (nerve endings)
Hygiene Provisions of the electrolysis law and regulations pertinent to the practice of electrology.
2.Students enrolled in North Dakota are prohibited to do practical work on patrons outside of school premises. Practical work may be done by students within the school premises and under the direct supervision of an instructor.
3.Cosmetology schools in North Dakota teaching the theory of electrolysis to their cosmetology students as part of the cosmetology curriculum are exempt from the provisions of this chapter.
However, such instructions on electrolysis in a cosmetology school will not be credited toward the number of hours required in an electrolysis school for licensure purposes.
History
- History: Effective September 25, 1979; amended effective February 1,1992; May 1, 1994.
N.D. Admin. Code 33-03-11-09 Curriculum substitution
In lieu of the course requirements listed in section 33-03-11-08, operators of depilatron and removatron-type hair removal machines shall be required to complete forty hours of coursework in an acceptable program designed specifically for the machines which they will be operating. Such coursework shall be submitted to the department and approved on a case-by-case basis prior to operator licensure. In addition to these requirements, an operator of a depilatron or removatron-type hair removal machine shall be a licensed cosmetologist in accordance with North Dakota Century Code
chapter 43-11.
History
- History: Effective February 1, 1983; amended effective May 1, 1994.
Chapter 33-03-11.1 Electrolysis
N.D. Admin. Code 33-03-11.1 Electrolysis
CHAPTER 33-03-11.1
ELECTROLYSIS
Section 33-03-11.1-01Definitions 33-03-11.1-02Licensure Requirements 33-03-11.1-03Application for Initial Licensure 33-03-11.1-04Applications for Licensure and Grandfathering Provision [Repealed] 33-03-11.1-05Electrologist Licensure Examination [Repealed] 33-03-11.1-06Notification of Examination Date, and Results [Repealed] 33-03-11.1-07Retake of Examination Sections [Repealed] 33-03-11.1-08Issuance, Renewal, and Reactivation of a License 33-03-11.1-09Continuing Education 33-03-11.1-10Infection Control and Safety 33-03-11.1-11Location of Business [Repealed] 33-03-11.1-12Equipment 33-03-11.1-13Restrictions to Practice 33-03-11.1-14Client Records 33-03-11.1-15Complaints 33-03-11.1-16Penalties for Infraction of This Chapter 33-03-11.1-17Approved Training Program 33-03-11.1-01. Definitions.
1."Approved" means determined acceptable in writing, by the department.
2."Aseptic technique" means practices that render and keep the skin site and instruments free from all micro-organisms or contamination.
3."Department" means the state department of health.
4."Electrologist" means a person proficient in the permanent removal of hair by electrology and who is currently licensed by the department to practice in North Dakota.
5."Electrology" means the permanent removal of hair by the conduction of an electrical current through a probe inserted into the hair follicle to destroy the papilla.
6."Electrology continuing education hour" means a sixty-minute session or home study course approved by a national electrology association or organization, or an infection control or electrology-related session provided by a hospital or another health care related setting.
7."Facility" means all areas used by the electrologist and client.
8."Initial license" means the first license.
9."Instruments" means probes, forceps, hemostats, tweezers, or other equipment required for the actual hair removal process.
10."National association or organization" means the American electrology association, the international guild of professional electrologists, or the society of clinical and medical electrologists.
11."Official transcript" means a school's certified document that lists the courses, course hours, and grades of an electrolysis program.
12."Probe" means the needle or filament used to administer the electric current to the hair-papilla.
13."Provisional" means license granted based on conditions as established specifically by the department in response to noncompliance with the licensure requirements in this chapter.
14."Relicensure" means the issuance of any license after the initial license.
15."Renew" means to extend a current license for one year if compliance with licensure rules has been maintained.
16."Violation of licensure requirement" means noncompliance with requirements of this chapter.
Law Implemented: NDCC 43-38-01 33-03-11.1-02. Licensure requirements.
1.The state health council shall delegate to the department the authority to manage and implement the electrology licensure program.
2.A person may not hold themselves out to the public as an electrologist or practice electrology without a current license issued by the department.
3.A license may not be sold, assigned, or transferred.
4.The license expires at midnight on December thirty-first of the year issued. Licensure renewal must be on a calendar year basis renewable on January first of each year.
5.The license must be displayed in a place easily viewable by clients and the public.
6.The initial license fee is fifty dollars for the first year and will not be prorated for a partial year.
7.The license renewal fee is twenty-five dollars per year. Licenses will be issued and license fees will be collected on a calendar year basis and will not be prorated for a partial year.
8.A licensed electrologist must practice permanent hair removal through the use of an electronic probe.
Law Implemented: NDCC 43-38-02, 43-38-03 33-03-11.1-03. Application for initial licensure.
Application for an initial license must be made to the department on forms prescribed by the department and must be accompanied by:
1.The initial license fee;
2.Proof of age of at least eighteen and identity such as driver's license or birth certificate, and a copy of a high school diploma, or certificate of general educational development, or degree from an accredited institution of higher education; and
3.An official transcript from an electrology school meeting the program requirements for training as defined in section 33-03-11.1-17.
Law Implemented: NDCC 43-38-02, 43-38-03 33-03-11.1-04. Applications for licensure and grandfathering provision. 33-03-11.1-05. Electrologist licensure examination. 33-03-11.1-06. Notification of examination date, and results. 33-03-11.1-07. Retake of examination sections. 33-03-11.1-08. Issuance, renewal, and reactivation of a license.
1.Upon receipt of an initial licensure application or a relicensure application, the department shall evaluate the qualifications of the applicant for compliance with the requirements of this
chapter.
2.Falsification of information on the application shall constitute license revocation.
3.The department may evaluate an electrologist's compliance with these licensure requirements at any time through:
a.An announced or unannounced onsite inspection scheduled at the discretion of the department; or
b.A request for submission of written documentation verifying compliance.
4.If the licensure applicant meets the requirements as found in this chapter, including the application fee and continuing education hours, the department shall issue a license.
5.Licenses not renewed by December thirty-first of each year will be deemed suspended and an additional fee not to exceed ten dollars must be assessed from the applicant. Licenses not renewed by March of each year will be terminated and reapplication for licensure will be needed to reinstate the license. 33-03-11.1-09. Continuing education.
1.To maintain licensure, electrologists must obtain a minimum of five electrology continuing education hours per year.
2.Certificates of completion to verify number of continuing education hours must be submitted to the department along with annual renewal applications and fees in order to obtain a renewal license. 33-03-11.1-10. Infection control and safety.
Written policies and procedures must be established and implemented by the licensed electrologist for infection control and safety and shall include at a minimum the following:
1.Handwashing and glove use.
a.Hands must be washed before treatment of each client, before donning gloves, and immediately after gloves are removed.
b.Handwashing must include the use of antibacterial soaps:
(1)Bar soaps must be kept on a rack to allow water to drain.
(2)Liquid soap containers must be disposable; or (3)Reusable liquid soap containers must be cleaned and refilled with fresh soap at least once a month.
c.The handwashing technique used must include:
(1)Use of antibacterial soap and water;
(2)A vigorous rubbing together of all surfaces of lathered hands, especially between fingers and fingernail areas, for at least fifteen to twenty seconds;
(3)A thorough rinsing under a stream of water; and (4)Hands dried thoroughly with a clean disposable paper towel, then faucets turned off with the paper towel.
d.A new pair of nonsterile disposable examination gloves must be worn during the treatment of each client.
e.When a treatment session is interrupted, gloves must be removed and discarded. When gloves are removed during a treatment session, hands must be washed as provided in subdivision c and a fresh pair of gloves used prior to continuing the treatment session.
f.Gloves must be worn during the procedures of mechanical precleaning, cleaning, rinsing, and drying of needles or probes and forceps or tweezers.
g.Torn or perforated gloves must be removed immediately, and hands must be washed as provided in subdivision c after the gloves are removed.
2.Cleaning and sterilizing instruments or items and other safety precautions.
a.Needles or probes and forceps or tweezers must either be presterilized disposable or thoroughly cleaned and sterilized between clients.
b.Reusable instruments and containers must be cleaned and then sterilized consistent with the following:
(1)New reusable instruments must be cleaned and then sterilized before initial use.
(2)All containers including the container lids used to hold contaminated needles or probes and forceps or tweezers must be cleaned and sterilized at least daily or whenever overtly contaminated on days the electrologist is practicing electrology.
(3)Pickup hemostats, forceps, or tweezers and holding cylinder must be cleaned and sterilized at least daily or whenever overtly contaminated on the days the electrologist is practicing electrology.
(4)Unused instruments in containers that have been opened must be resterilized after a twenty-four-hour period.
(5)Instruments contaminated before use, for example, dropping or touching a soiled surface, must be resterilized before use.
(6)Needles or probes that have been used to treat a client must be:
(a)Mechanically precleaned using a clean cottonball or swab moistened with a solution of low-residue detergent or a protein dissolving enzyme detergent and cool water;
(b)Accumulated in a holding container by submersion in a solution of low-residue detergent or a protein dissolving enzyme detergent and cool water;
(c)Thoroughly rinsed with warm water and drained;
(d)Cleaned by soaking in a protein dissolving enzyme detergent used according to manufacturer's instructions cleaned in an ultrasonic cleaning unit or used according to manufacturer's instructions; and (e)Rinsed and dried.
(7)Needles or probes and forceps or tweezers must be packaged individually or in small multiples, or unpackaged and placed in cleaned and dried stainless steel or heat-tempered glass containers. All containers must have well-fitting lids that are clean and dry.
(8)Cleaned instruments or items must be sterilized by one of the following methods:
(a)Dry heat. The following temperatures relate to the time of exposure after attainment of the specific temperature and do not include a heat-up lag time. [1]Three hundred forty degrees Fahrenheit [170 degrees Celsius] for one hour; or [2]Three hundred twenty degrees Fahrenheit [160 degrees Celsius] for two hours.
(b)Moist heat - autoclave. The following exposure times relate only to the time the material is at temperature and does not include a penetration or heat-up lag time. [1]Fifteen minutes at two hundred fifty degrees Fahrenheit [121 degrees Celsius]; fifteen pounds per square inch [103.5 kilopascals] for unpackaged instruments or items; or [2]Thirty minutes at two hundred fifty degrees Fahrenheit [121 degrees Celsius]; fifteen pounds per square inch [103.5 kilopascals] for packaged instruments or items.
(c)Other time-temperature relationships recommended by the manufacturer for a specific instrument.
(9)Dry heat ovens and autoclaves (steam under pressure) must be approved by the United States food and drug administration and must be cleaned, used, and maintained according to the manufacturer's instructions.
(10)Sterilizers must have visible physical indicators, for example, thermometers, timers.
(11)Chemical (i.e., color change) indicators must be used on or in each package or container to indicate items have been exposed to a sterilization process.
(12)Biological indicators must be used no less than once a month per sterilizer according to manufacturer's instructions to assure mechanical function and operator's technique and to determine sterilization efficiency and recorded in permanent sterility assurancefile.
c.Aseptic technique must be followed when handling sterilized instruments or items.
d.To prevent accidental needle-stick injuries, disposable or damaged needles or probes must not be recapped, bent, or otherwise manipulated by hand prior to disposal.
Disposable or damaged needles or probes must be placed in a sturdy puncture-resistant container. Disposal of the container must be as follows:
(1)The contents must be disinfected with a freshly prepared dilution of household bleach and water consisting of one part bleach and nine parts water; allowed to sit for thirty minutes; solution poured off; and the container securely sealed and disposed into the regular trash disposal, unless otherwise specified by department and local health regulations; or (2)Needles or probes may be decontaminated for handling by cleaning and sterilizing consistent with the requirements in this section and placed in a puncture-resistant container. The container must be securely sealed and disposed into the regular trash disposal.
e.Removable tip of epilator needle or probe holder must be removed after each treatment and cleaned with soap or detergent and water, rinsed, dried, and disinfected by submersion in seventy percent isopropyl alcohol for a minimum of ten minutes. The covered container used to hold the alcohol should be emptied at least daily or whenever visibly contaminated, then cleaned, dried, and refilled with fresh alcohol. Nonremovable tip of epilator needle or probe holders must be wiped with a detergent-germicide or disinfectant after each treatment.
3.Environmental control and housekeeping.
a.Offices and treatment rooms must be clean, well-lighted, and well-ventilated.
b.A sink with hot and cold running water must be accessible to each treatment room.
c.Toilet facilities must be available.
d.A hospital-grade disinfectant-detergent registered by the environmental protection agency must be used for all cleaning unless otherwise specifically stated in this chapter.
e.Fresh disposable paper drapes must be used on the treatment table or chair for each client, or the treatment table or chair must be wiped down with detergent-germicide or disinfectant or a bleach solution after each client.
f.Soiled disposable items must be discarded into a container lined with a plastic bag, securely fastened, and disposed daily into the regular trash disposal.
g.Epilator needle or probe holder and the portion of the cord in direct contact with the client or electrologist must be wiped with a detergent-germicide or disinfectant after each treatment.
h.Magnifier or treatment lamps must be wiped with a detergent-germicide or disinfectant after each treatment.
i.After each use, client eyeshields must be cleaned using a brush and soap or detergent and water, then rinsed and dried.
j.Blood spills on environmental surfaces must be cleaned as follows:
(1)Disposable gloves must be worn;
(2)Paper towels used to blot up the visible material;
(3)Paper towels then discarded into a plastic bag, securely fastened and disposed into the regular trash disposal;
(4)Area wiped down with paper towels and an environmental protection agency-registered disinfectant-detergent or a freshly prepared one to one hundred parts dilution of household bleach and water (one-fourth cup bleach and one gallon [3.79 liters] water);
(5)Area allowed to air dry; and (6)Paper towels and gloves discarded into a plastic bag, securely fastened and disposed into the regular trash disposal.
4.Client infection control considerations.
a.Blood and body fluid precautions must be consistently used for all clients.
b.The skin site must be evaluated prior to each treatment.
c.Before treatment, the skin site must be cleansed of visible soil using soap and water or a germicidal skin preparation, then wiped with an antiseptic product. Skin sites not visibly soiled must be wiped with an acceptable antiseptic product.
d.After treatment, the skin site must be wiped with an acceptable antiseptic product.
e.Application of ice in a fresh disposable paper towel in a fresh plastic bag or healing cream, lotion, or ointment, or a combination of these things, may be applied to the treated skin site at the discretion of the electrologist. Creams, lotions, and ointments must be kept in clean, covered containers and handled in a sanitary manner.
f.Client must be instructed on the appropriate posttreatment care to promote healing of the treated skin site.
5.Exposures to hepatitis B virus (HBV), HIV, and other bloodborne pathogens.
a.Electrologists should be immunized against hepatitis B virus.
b.Universal precautions must be implemented with all clients.
c.The following steps should be taken when a needle or probe stick, puncture injury, or mucous membrane exposure has occurred:
(1)Remove and discard gloves.
(2)Wash exposed surface with running water, soap or germicidal handwashing solution. If wound is bleeding, allow to bleed. After thoroughly cleaning the wound, apply alcohol, betadine, or hydrogen peroxide. If there is mucous membrane exposure, flush exposed area thoroughly with water.
(3)Immediate contact should be made with electrologist's personal physician forappropriate consultation, for example, for necessary postexposure strategies.
(4)Documentation of the exposure should be made, including: date, route of exposure, circumstance under which exposure occurred, name of source client, followup testing, and any necessary postexposure prophylaxis. 33-03-11.1-11. Location of business. 33-03-11.1-12. Equipment.
Practicing electrologists shall maintain the following equipment:
1.A probe-type epilator approved by the federal communications commission.
2.A sufficient supply of sterile disposable or nondisposable needles or probes, probe tips, and forceps or tweezers for each patient.
3.A treatment light to enable adequate visualization of the treatment area.
4.A hemostat, forceps, or tweezer forcep to transfer sterile instruments utilizing aseptic techniques. 33-03-11.1-13. Restrictions to practice.
Electrologists may not perform electrology treatment if any of the following are present:
1.Licensee is diagnosed as having a communicable disease or parasitic infection.
2.The hair to be removed is in an area of high bacterial colonization such as nostrils or ear canals.
3.The hair to be removed is from a wart, mole, birthmark, eyelashes, a diabetic client, or a client with a pacemaker unless written permission for the treatment has been obtained from the client's physician prior to treatment. 33-03-11.1-14. Client records.
Licensed electrologists shall compile and maintain a record of health history assessment information on each client. Each record must include at least:
1.Name and address of client.
2.Type of treatment required or requested and physician permission if necessary.
3.Description of hair and skin.
4.Date, duration, and area of each treatment.
5.Special instructions or notations relating to treatment precautions or needs, such as allergies or a pacemaker.
6.Name and telephone number of referring physician if applicable.
7.Outcome of treatment. 33-03-11.1-15. Complaints.
After receipt of a complaint regarding violation of electrology licensure rules, the department shall request that the complainant submit the complaint in writing. Confidentiality regarding the identity of the complainant will be maintained if requested by the complainant.
1.The department shall send a written summary of the complaint by certified mail to the electrologist requesting a written reply to the allegation.
2.A reply from an electrologist will be considered by the department if received within fourteen days of the date on which the electrologist received the complaint summary.
3.The department will determine if further action is required in investigating the complaint.
4.A summary of the results of the investigation will be sent to the complainant and the licensed electrologist within fourteen days of the completion of the investigation. 33-03-11.1-16. Penalties for infraction of this chapter.
The department may invoke penalties for violations of this chapter.
1.The department, based on a determination that a licensee has violated or continues to violate this chapter, may suspend, revoke, or impose a provisional license.
2.The department may levy a civil money penalty against an electrologist in an amount not to exceed twenty-five dollars per day for noncompliance with this chapter.
History: Effective February 1, 1992. 33-03-11.1-17. Approved training program.
Only programs that the department determines to meet the curriculum criteria in section 33-03-11.1-17 will be considered to be an approved training program.
1.A department-approved electrology training program must have a curriculum that contains, at a minimum, six hundred hours, three hundred seventy of which are practical training.
2.Curriculum content for an approved electrology training program must include the following:
Law and rules Bacteriology Sanitation and sterilization Anatomy and physiology Endocrinology Structure, dynamics, and diseases of skin and hair Circulatory and nervous system Electricity Electrolysis Galvanic Thermolysis Blend Draping and positioning Professional ethics and business practices
Chapter 33-03-12 Hemophilia
N.D. Admin. Code 33-03-12-01 Purpose
The state health officer hereby establishes a hemophilia program for the purpose of providing financial assistance to persons suffering from hemophilia and other related congenital bleeding disorders. The program shall assist those persons to purchase the blood derivatives and supplies necessary for home care.
History
- General Authority: NDCC 23-07.2-02
- Law Implemented: NDCC 23-07.2-02
N.D. Admin. Code 33-03-12-02 Definitions
The terms used throughout this chapter have the same meaning as in the North Dakota Century Code chapter 23-07.2, except:
1."Home care" means the self-infusion of a plasmatic clotting factor on an outpatient basis by the patient, or the infusion of a plasmatic clotting factor to a patient on an outpatient basis by a person trained in such procedures.
2."Income" means adjusted gross income as defined in the laws of the United States relating to federal income taxes, unless a different meaning is clearly required or contemplated.
3."Individual liability" means the individual's own liability for treatment under this program less that amount paid for through this program.
4."Net worth" means the sum of the value of liquid assets and real property, after excluding the full value of the home derived by dividing the assessed value by the assessment ratio of the taxation district.
5."Patient's eligibility for assistance" means any individual eligible for financial assistance under
section 33-03-12-03 who would suffer financial hardship, to be determined by the state health officer, if assistance were not forthcoming from this program.
6."Permanent resident" means any person who becomes a resident in North Dakota with a permanent North Dakota mailing address.
7."Person" means an individual human being.
History
- General Authority: NDCC 23-07.2-01
- Law Implemented: NDCC 23-07.2-01
N.D. Admin. Code 33-03-12-03 Eligibility
Any permanent resident of this state who suffers from hemophilia or other related congenital bleeding disorder may participate in the program if that person meets the requirements and standards of this chapter. The person may enter into an agreement with the state health officer for a maintenance program to be followed by that person as a condition for eligibility, and who produces evidence that this condition has been diagnosed by a licensed physician. The state health officer shall at least once in each six-month period, review the maintenance program and verify that the person is complying with the program.
N.D. Admin. Code 33-03-12-04 Reasonable cost for blood products
1.The reasonable cost, as determined by the state health officer, for blood products and supplies used in home care for which reimbursement is not prohibited under section 33-03-12-05 may be reimbursed under this program after deduction of the patient's liability.
Reasonable cost reimbursement shall be subject to availability of moneys for this program.
2.Moneys available for this program, will be used to assist individuals on a first-come, first-served basis. Moneys will only be used for current financial assistance to eligible persons.
Moneys will not be used to assist someone retroactively.
N.D. Admin. Code 33-03-12-05 When reimbursement not made
1.Reimbursement shall not be made under this chapter for any blood products or supplies which are not purchased pursuant to the state health officer's agreement.
2.Reimbursement shall not be made under this chapter for any portion of the costs of blood products or supplies which are payable under any other state or federal program or under any grant, contract, or any other contractual arrangement.
History
- General Authority: NDCC 23-07.2-03, 23-07.2-04
- Law Implemented: NDCC 23-07.2-03, 23-07.2-04
N.D. Admin. Code 33-03-12-06 Recovery from other sources
The state health officer may enter into agreements with third parties, including any insurer, for payments for blood products and for supplies used in home care by persons participating in the program.
N.D. Admin. Code 33-03-12-07 Patients' eligibility
In determining eligibility for reimbursement under this program, the severity of the hemophilia and the magnitude of medical expenses being encountered by the family may be considered as the sole criteria for eligibility for reimbursement regardless of income, family size, or net worth.
N.D. Admin. Code 33-03-12-08 Supplies and services covered in home care for reimbursement
The following supplies and services used in home care are covered under this program:
1.Coagulation factor.
2.Diluent, if needed.
3.Syringes and intravenous needles.
Chapter 33-03-13 Construction Standards for Residential Facilities for the Physically Disabled
N.D. Admin. Code 33-03-13-01 Definitions
In this chapter, unless the context or subject matter requires otherwise:
1."Ambulatory" means able to walk without assistance.
2."Department" means the state department of health.
3."Mobile nonambulatory" means unable to walk without assistance, but able to move from place to place with the use of a device such as a walker, crutches, a wheelchair, or a wheeled platform.
4."Nonambulatory" means unable to walk without assistance.
5."Nonmobile" means unable to move from place to place.
6."Physically disabled" means a mobile nonambulatory, nonambulatory, or nonmobile person.
7."Residential facility for physically disabled" means a facility of residential character having sleeping space for no more than fifteen physically disabled residents.
N.D. Admin. Code 33-03-13-02 Fire safety
Residential facilities for the physically disabled shall:
1.Be located in areas served by a fire extinguishing organization approved by the state fire marshal.
2.Comply with chapter 12 of the 1981 edition of the Life Safety Code. The fire safety evaluation system may be used in the design of a facility and in the evaluation of an existing building.
N.D. Admin. Code 33-03-13-03 Water supply
1.Residential facilities for the physically disabled shall be located in areas where public or private water supplies approved by the department are available. Approved public water supplies shall be used where available.
2.When a private water supply is utilized, water samples shall be submitted to the department and analyzed to determine bacteriological acceptability.
N.D. Admin. Code 33-03-13-04 Sewage disposal
1.Residential facilities for the physically disabled shall be located in areas where public or private sewage disposal systems approved by the department are available. Approved public sewage disposal systems shall be used where available.
2.Plans and specifications for proposed private sewage disposal systems or alteration to such systems must be approved by the department prior to their construction.
N.D. Admin. Code 33-03-13-05 Physical plant
Buildings housing a residential facility for the physically disabled shall:
1.Comply with North Dakota Century Code section 48-02-19.
2.Be constructed to accommodate no more than fifteen eligible residents.
3.Be limited in size to three hundred fifty square feet [32.52 square meters] per resident, inclusive of space for two employees of the applicant. Facilities of more than eight resident beds shall be limited to one hundred seventy-five square feet [16.26 square meters] per additional resident bed.
4.Be of modest design minimizing the length of hallways, the number of exterior corners, and complexity of construction.
5.Include provisions for its conversion to an alternate use at a reasonable cost.
6.Provide space for dining, kitchen, family living and recreation, utility, and bedrooms as an integral part of a single structure.
7.Provide these sleeping area standards:
a.Require no more than two residents to share a bedroom other than on a temporary basis.
b.Provide no less than one hundred square feet [9.29 square meters] of floor area exclusive of bathroom and closet space for single occupancy bedrooms.
c.Provide no less than eighty square feet [7.43 square meters] per bed of floor space exclusive of closet and bathroom space in double occupancy bedrooms.
d.Locate bedrooms on the outside wall and separate them from other rooms and spaces by walls extending from floor to ceiling.
e.Locate bedrooms at or above grade level.
8.Provide at least one full bathroom for every four residents.
9.Be designed to accommodate the resident's privacy with bedrooms and bathrooms arranged to provide separation of male and female residents.
10.Provide sufficient space in the kitchen to permit the participation of residents as well as staff in food preparation. Provide appropriate space and equipment, including a two-compartment sink, to adequately serve the food preparation and storage requirements of the facility.
11.Provide sufficient laundry space to include, in addition to a washer and a dryer, storage for laundry supplies, accommodation for ironing, and counterspace for folding clothing and linens.
12.Provide these staff accommodations:
a.Space to accommodate employees, limited to a living room, efficiency kitchen, one full bathroom, and a double occupancy bedroom, when, as a condition of employment, they must live onsite; or
b.A multipurpose space usable for sleeping for employees serving in shifts.
13.Provide sufficient storage, in addition to closet space, to accommodate the storage of out-of-season clothing, outdoor furniture, garden tools, lawnmower, and other equipment.
14.Provide a tempering valve, located to preclude resident access, to control the temperature of hot water supplied to lavatories and bathing facilities. The tempering valve shall permit control of temperature in the range of one hundred ten degrees Fahrenheit [47.22 degrees Celsius] to one hundred thirty-five to one hundred forty degrees Fahrenheit [57.22 to 60 degrees Celsius].
Hot water supplied to clotheswashers and dishwashers shall be one hundred thirty-five to one hundred forty degrees Fahrenheit [57.22 to 60 degrees Celsius].
15.Be equipped with emergency lighting capable of sustained battery operation, or onsite emergency electrical generation.
History
- History: Effective September 1, 1983; amended effective January 1, 1985.
N.D. Admin. Code 33-03-13-06 Variance
Upon written application, the department may grant a variance from specific provisions of this
chapter, except no variance may permit or authorize a danger to the health or safety of residents or impede their normalization process.
Chapter 33-03-14 Construction Standards for Small Intermediate Care Facilities for the Mentally Retarded
N.D. Admin. Code 33-03-14-01 Definitions
In this chapter, unless the context or subject matter requires otherwise:
1."Ambulatory" means able to walk without assistance.
2."Day service facility" means a nonresidential building in which a variety of activities are provided to maximize the developmental potential of persons served.
3."Department" means the state department of health.
4."Developmental disability" has the same meaning as in North Dakota Century Code chapter 25-01.2.
5."Mobile nonambulatory" means unable to walk without assistance, but able to move from place to place with the use of a device such as a walker, crutches, a wheelchair, or a wheeled platform.
6."Nonambulatory" means unable to walk without assistance.
7."Nonmobile" means unable to move from place to place.
8."Small intermediate care facility for the ambulatory developmentally disabled" means a facility of residential character having sleeping space for no more than fifteen ambulatory residents capable of taking action for self-preservation.
9."Small intermediate care facility for the mobile nonambulatory, nonambulatory, and nonmobile developmentally disabled" means a facility of residential character having sleeping space for no more than fifteen mobile nonambulatory, nonambulatory, or nonmobile residents incapable of taking action for self-preservation.
N.D. Admin. Code 33-03-14-02 Location of intermediate care facility for the developmentally disabled - Hazardous areas
1.Intermediate care facilities for the developmentally disabled shall be located at least three hundred feet [91.44 meters] from hazardous areas such as bulk fuel or chemical storage areas, anhydrous ammonia facilities, or other fire hazards or sources of noxious or odoriferous emissions.
2.Intermediate care facilities for the developmentally disabled may not be located in areas subject to adverse environmental conditions such as mud slides, harmful air pollution, smoke or dust, sewage hazards, rodent or vermin infestations, excessive noise, vibration, or vehicular traffic.
3.Intermediate care facilities for the developmentally disabled may not be located in an area within the one hundred year base flood elevations unless:
a.The facility is covered by flood insurance as required by 42 U.S.C. 4101; or
b.The finished lowest floor elevation is above the one hundred year base flood elevation and the facility is free from significant adverse effects of the velocity of moving water or by wave impact during the one hundred year flood.
N.D. Admin. Code 33-03-14-03 Fire safety
1.Small intermediate care facilities for the developmentally disabled shall be located in areas served by a fire extinguishing organization approved by the state fire marshal.
2.Small intermediate care facilities for the ambulatory developmentally disabled shall comply with chapter 20 of the 1981 edition of the Life Safety Code. The use of chapter 20 rather than
chapter 12 is permitted by 42 CFR 442.508 when a physician or psychologist, who meets the definition of a qualified mental retardation professional under paragraph 42 CFR 442.401, certifies that each resident served will:
a.Be ambulatory;
b.Receive active treatment; and
c.Be capable of following directions and taking appropriate action for self-preservation under emergency conditions.
3.A small intermediate care facility for the mobile nonambulatory, nonambulatory, and nonmobile shall comply with chapter 12 of the 1981 edition of the Life Safety Code. The fire safety evaluation system may be utilized in the design of the facility and in the evaluation of an existing building.
History
- History: Effective September 1, 1983; amended effective January 1, 1985.
N.D. Admin. Code 33-03-14-04 Water supply
1.Intermediate care facilities for the developmentally disabled shall be located in areas where public or private water supplies approved by the department are available. Approved public water supplies shall be used where available.
2.When a private water supply is utilized, water samples shall be submitted to the department and analyzed to determine bacteriological acceptability.
N.D. Admin. Code 33-03-14-05 Sewage disposal
1.Intermediate care facilities for the developmentally disabled shall be located in areas where public or private sewage disposal systems approved by the department are available.
Approved public sewage disposal systems shall be used where available.
2.Plans and specifications for proposed private sewage disposal systems or alteration to such systems must be approved by the department prior to their construction.
N.D. Admin. Code 33-03-14-06 Physical plant
Buildings housing a small intermediate care facility for the developmentally disabled shall:
1.Provide a design making:
a.The small intermediate care facility for the ambulatory developmentally disabled accessible to nonambulatory visitors and employees, with at least one bathroom accessible to and usable by such visitors and employees. When the facility is accessible and the bathroom provided, the balance of the handicapped standards may be waived by the department as provided for in 42 CFR 442.511. The waiver will be granted when only ambulatory developmentally disabled persons are served as listed under subsection 2 of
section 33-03-14-03.
b.The small intermediate care facility for the mobile nonambulatory, nonambulatory, and nonmobile developmentally disabled comply with North Dakota Century Code section 48-02-19.
2.Be constructed to accommodate no more than fifteen eligible residents.
3.Be limited in size to a maximum of three hundred fifty square feet [32.52 square meters] per resident, inclusive of space for two employees. Facilities of more than eight resident beds shall be limited to one hundred seventy-five square feet [16.26 square meters] per additional resident bed.
4.Be of modest design minimizing the length of hallways, the number of exterior corners, and complexity of construction.
5.Provisions for its conversion to an alternate use at a reasonable cost.
6.Provide space for dining, kitchen, family living and recreation, utility, and bedrooms as an integral part of a single structure.
7.Provide these sleeping area standards:
a.Require no more than two residents to share a bedroom other than on a temporary basis.
b.Provide no less than one hundred square feet [9.29 square meters] of floor area exclusive of bathroom and closet space for single occupancy bedrooms.
c.Provide no less than eighty square feet [7.43 square meters] per bed of floor space exclusive of closet and bathroom space in double occupancy bedrooms.
d.Locate bedrooms on an outside wall and separate them from other rooms and spaces by walls extending from floor to ceiling.
e.Locate bedrooms at or above grade level.
8.Provide at least one full bathroom for every four residents.
9.Be designed to accommodate the resident's privacy, with bedrooms and bathrooms arranged to provide separation of male and female residents.
10.Provide sufficient space in the kitchen to permit the participation of residents as well as staff in food preparation. Provide appropriate space and equipment, including a two-compartment sink, to adequately serve the food preparation and storage requirements of the facility.
11.Provide sufficient laundry space to include, in addition to a washer and dryer, storage for laundry supplies, accommodation for ironing, and counterspace for folding clothing and linens.
12.Provide staff accommodations:
a.Space to accommodate employees, limited to a living room, efficiency kitchen, one full bathroom, and a double occupancy bedroom, when, as a condition of employment, they must live onsite; or
b.A multipurpose space usable for sleeping for employees serving in shifts.
13.Provide sufficient storage, in addition to closet space, to accommodate the storage of out-of-season clothing, outdoor furniture, garden tools, lawnmower, and other equipment.
14.Provide a tempering valve, located to preclude resident access, to control the temperature of hot water supplied to lavatories and bathing facilities. The tempering valve shall permit control of temperature in the range of one hundred ten degrees Fahrenheit [47.22 degrees Celsius] to one hundred thirty-five to one hundred forty degrees Fahrenheit [57.22 to 60 degrees Celsius].
Hot water supplied to clotheswashers and dishwashers shall be one hundred thirty-five to one hundred forty degrees Fahrenheit [57.22 to 60 degrees Celsius].
15.Be equipped with emergency lighting capable of sustained battery operation.
History
- History: Effective September 1, 1983; amended effective January 1, 1985.
N.D. Admin. Code 33-03-14-07 Day service facility
Day service facilities providing services to eligible developmentally disabled residents shall comply with the requirements of chapter 10 of the 1981 edition of the Life Safety Code, whether the facilities are constructed, reconstructed, or acquired.
N.D. Admin. Code 33-03-14-08 Variance
Upon written application, the department may grant a variance from specific provisions of this
chapter, except no variance may permit or authorize a danger to the health or safety of residents or impede their normalization process.
Chapter 33-03-15 Hospice Programs
N.D. Admin. Code 33-03-15-01 General provisions
1.A new hospice program is subject to certificate of need review pursuant to North Dakota Century Code chapter 23-17.2.
2.The department must be notified in writing when a change of ownership, operation, location, or when discontinued or addition of a new service in a hospice program is contemplated.
3.The hospice program shall provide physician services, nursing services, medical social services, counseling services, bereavement services, volunteer services, home health aide and homemaker services, and short-term inpatient care. Two of these service must be provided directly. Direct services are those services provided by hospice program employees or volunteers. All other services may be provided through written contract or written agreement.
4.Nursing services and physician services shall be routinely available twenty-four hours a day seven days a week, as may be required in accordance with the hospice program service plan.
5.The home care component must be the primary form of care, and must be available on a
part-time, intermittent, regularly scheduled basis, and on an on-call, around-the-clock basis according to patient and family needs.
6.Short-term general inpatient care must be provided only in licensed hospitals or licensed skilled nursing facilities. If feasible, inpatient care must closely approximate a homelike environment and provide overnight family visitation within the facility.
N.D. Admin. Code 33-03-15-02 Governing body and management
1.A hospice program must have a clearly defined, organized governing body that must assume full legal responsibility for the overall conduct and operation of the hospice program including quality of care and services.
2.The governing body shall adopt bylaws which include at least the following:
a.The purpose of the hospice program.
b.The powers and duties of the officers and committees of the governing body.
c.The qualifications, methods of selection, and terms of office of members and chairman of committees.
d.A mechanism for approval of the appointment to the medical staff, if applicable.
e.Specifications of the frequency of governing body meetings and attendance requirements.
f.A provision for the taking of sufficient minutes of its meetings to record the business conducted and for making them available to all members.
3.There must be an organizational chart, description of services offered, and channels of
authority for responsibility for care provided to patients and their families.
4.There must be policies and procedures for each department or service offered, which must be reviewed annually by the governing body, or appropriate administrative representative.
a.Policies and procedures must be dated and signed to indicate the time of the most recent review.
b.All pen and pencil changes of policies and procedures must be dated with the date the change or revision was made and initialed by the department head.
5.When the hospice has services, including inpatient care, provided for under arrangement, there must be a current written agreement which must be signed and dated by the administrator of the hospice program, and the duly authorized official of the agency providing the service or resource. The agreement must clearly delineate the responsibilities of the parties involved and must include no less than the following:
a.Identification of services to be provided.
b.A stipulation that services provided are consistent with the hospice service plan of care.
c.The manner in which the contracted services are coordinated, supervised, and evaluated.
d.A statement that the hospice program retains the responsibility for planning and coordinating services and care on behalf of the patient and family.
e.Procedures for submitting clinical and progress notes when applicable.
f.Assurance that personnel and services contracted for meet the requirements specified herein pertaining to personnel and services, including licensure, personnel qualifications, and attendance at care conferences.
g.Reimbursement mechanism, charges, and terms for the renewal or termination of the agreement.
6.The governing body shall approve an annual operating budget and capital expenditure plan.
7.The governing body or its appropriate administrative representative shall appoint a member of the hospice program team who is responsible for providing for coordination and administration of hospice program service plan for patients and families. The person appointed shall:
a.Develop, implement, and annually evaluate the policies and procedures for the total hospice program operation.
b.Provide a formal budget that reflects the organization of the hospice program.
c.Provide a designation, in writing, of a qualified individual to act in the administrator's absence.
d.Act as a liaison between the governing body, medical staff, and other hospice program staff.
e.Implement personnel policies and practice with orientation of all new employees, maintenance of complete personnel records for each employee, verification of applicable current licensure or registration of personnel, performance evaluation based on a job description, and current health requirements.
f.Provide an ongoing program of training including orientation and continuing education for all employees. Records of inservice training must be maintained which list the content of and attendance at staff development programs.
N.D. Admin. Code 33-03-15-03 Physician services
1.Physician services must be provided by a physician licensed pursuant to North Dakota Century Code chapter 43-17 to meet the general needs of patients for management of the terminal illness and related conditions through palliative and supportive care and in accordance with hospice program policies.
2.The hospice program must have a medical director who is a physician licensed pursuant to North Dakota Century Code chapter 43-17.
3.The medical director has overall responsibility for medical policy in relation to the care and treatment of hospice program patients and their families provided by the hospice program care team.
4.Duties of the medical director include, but are not limited to:
a.Consulting and cooperating with the hospice program patient's attending physician.
b.Participating in the development of the hospice program service plan.
c.Serving as a liaison between the attending physician and the interdisciplinary team.
N.D. Admin. Code 33-03-15-04 Nursing services
1.The hospice program must provide the services of a registered nurse, licensed pursuant to North Dakota Century Code chapter 43-12.1, to organize, supervise, and coordinate the palliative and supportive care for patients and families provided by the hospice program care team.
2.The nurse supervisor is responsible for the development, maintenance, and revision of nursing care policy and procedure manuals, written job descriptions for each level of personnel, methods of coordination of nursing service with other services, and shall recommend the number and levels of nursing personnel to be employed.
3.The nursing services supervisor shall designate a qualified registered nurse to act in the supervisor's absence.
4.Nursing services must be directed and staffed to assure the nursing needs of patients are met.
5.There must be staff development programs and educational opportunities for nursing personnel which include orientation and inservice education.
a.There must be documentation maintained of the staff development program which includes content of program, name of instructor, name of those in attendance, length of program, and date of presentation.
b.Records must validate that initial orientation, including appropriate training to the tasks which personnel are expected to perform, and continual training is evident.
6.The hospice program must develop and maintain written policies and procedures for the administration and provision of pharmaceutical services consistent with the drug therapy needs of the patient. Policies and procedures must include, but not be limited to: the administration of treatment modalities, including intravenous procedures, chemotherapy, parenteral feedings, and injections; prescribing, preparing, administering, and recording of all drugs and biologicals; recording and reporting medication errors and adverse drug reactions.
a.The hospice program must have a policy for the disposal of controlled drugs maintained in the patient's home when these drugs are no longer needed by the patient.
b.Medications administered to patients must be ordered in writing, and the orders shall be authenticated by the person legally authorized to prescribe the medication.
c.A verbal medication order may be given to a licensed nurse, physician, or registered pharmacist. The hospice program shall initiate action to obtain the physician's signature for verbal orders within forty-eight hours.
d.Drugs and biologicals must be administered by the following:
(1)A licensed nurse or physician.
(2)The patient, a family member, or other caregiver, as specified in the patient's hospice program service plan.
N.D. Admin. Code 33-03-15-05 Medical social services
1.Medical social services must be provided by a qualified social worker licensed under North Dakota Century Code chapter 43-41.
2.Policies and procedures pertaining to social services must be provided, approved, and reviewed annually.
3.Records of pertinent social data about personal and family problems medically related to the patient's illness and care and action taken to meet the patient and family needs must be maintained in the patient's medical record.
4.Social services must be provided in accordance with the plan of care. The social worker shall assist and work with the hospice program care team in identifying significant social and emotional factors related to care. The scope of social work services must include, as a minimum:
a.Assisting in preadmission and discharge planning.
b.Conducting an assessment to determine the emotional and social needs of the patient and family.
c.Counseling the patient and family on an individual and group basis.
d.Identifying, utilizing, and working to develop appropriate community resources.
e.Maintaining adequate records relating to social work services which must be included in the patient's medical record.
N.D. Admin. Code 33-03-15-06 Counseling services
1.Spiritual counseling services must be available, upon request, to the patient and family. The hospice program may not impose the dictates of any value or belief system on hospice program patients or their families.
2.Dietary counseling services must be available to the patient and family, and must be provided by a dietitian licensed under North Dakota Century Code chapter 43-44.
3.Spiritual, dietary, and other counseling services provided must be documented in the patient and family record.
4.All counseling services must be provided in accordance with written policies and procedures governing the delivery and documenting of such services.
N.D. Admin. Code 33-03-15-07 Bereavement services
1.The hospice program must provide bereavement counseling and services to the patient's immediate family or primary caregiver. Bereavement services must be available for at least one year following the death of the patient.
2.Such services must be supervised by an individual qualified by training and experience for the development, implementation, and assessment of a hospice program service plan to meet the needs of the bereaved.
3.The individual supervising bereavement counseling may be a registered nurse, counselor, social worker, or other persons with documented evidence of training and experience in dealing with bereavement.
4.The hospice program must adopt written policies and procedures relating to this service.
N.D. Admin. Code 33-03-15-08 Volunteer services
1.The hospice program must provide for appropriate orientation and training that is consistent with acceptable standards of hospice program practice. There must be a written orientation checklist that identifies the tasks the individual is expected to perform. The training and orientation program must include, as a minimum:
a.Hospice program goals, services, and philosophy.
b.Confidentiality and protection of patient and family rights.
c.Family dynamics, coping mechanism, and psychological issues surrounding terminal illness, death, and bereavement.
d.Procedures to be followed in an emergency and following the death of a patient.
e.Guidance related specifically to individual responsibilities.
2.The hospice program must establish a mechanism to assure volunteers are effectively performing the duties and responsibilities assigned.
3.A hospice volunteer may provide direct patient care only when the following provisions are met:
a.Tasks and responsibilities are specified in writing and do not exceed the individual's capability.
b.Care is consistent with the hospice service plan.
c.The professional volunteer must be appropriately licensed or registered, if required.
d.Services rendered must be recorded in the patient's record.
e.The volunteer must have a clear understanding of the volunteer's duties and responsibilities.
f.Volunteers must be informed to whom they report and whom to contact if assistance is needed in carrying out their responsibilities.
N.D. Admin. Code 33-03-15-09 Home health aide services
1.The hospice program must provide homemaker and home health aide services as prescribed by the patient and family plan of care and consistent with policies of the hospice program.
2.The homemaker and home health aide may be assigned responsibilities and duties only after satisfactorily completing an organized education and training program consistent with and applicable to the hospice program.
3.The homemaker and home health aide shall provide care and other related services upon written instruction for patient care prepared by a registered nurse or therapist as appropriate.
Duties of the home health aide include:
a.The performance of simple procedures as an extension of therapy services.
b.Personal care.
c.Ambulation and exercise.
d.Household services essential to health care at home.
e.Reporting changes in the patient's condition and needs.
f.Completing appropriate records.
4.A registered nurse must visit the homesite at least every two weeks when aide services are provided. Documentation in the patient's medical record must include an assessment of the aide service.
N.D. Admin. Code 33-03-15-10 Interdisciplinary team services
1.The hospice program must designate interdisciplinary groups composed of individuals who provide or supervise the care and services offered by the hospice program.
2.The following individuals must be members of the interdisciplinary group or hospice program care team:
a.Patient and family.
b.Physician including the medical director and attending physician.
c.Registered nurse.
d.Medical social worker.
e.Trained volunteers.
f.Providers of special services including a spiritual counselor, a registered pharmacist, a registered dietitian, or professional in the field of mental health may be included in the hospice care team as determined appropriate by the hospice program.
3.Members of the hospice care team must have access to emotional support, as necessary, concerning job-related issues.
4.The interdisciplinary group is responsible to:
a.Participate in the establishment of the hospice service plan.
b.Provide for supervision of hospice care and services.
c.Review and update of the hospice service plan for each individual receiving hospice care.
d.Establish policies and procedures governing the day-to-day provision of hospice care and services.
e.Coordinate home and inpatient service.
5.The hospice program must identify a qualified member of the hospice care team who will be responsible for coordination and administration of the hospice service plan for patient and family. This person shall assure that adequate exchange of information, communication, and interaction occurs between all disciplines providing care.
N.D. Admin. Code 33-03-15-11 Admission criteria
1.Admission criteria must be clearly defined in the hospice program policies. Decisions regarding admission must be made by the hospice care team.
2.Admission to the hospice program must be by request of the patient. If the attending physician certifies that the patient is unable to request admission, a family member may request admission on the patient's behalf.
3.Any request to the hospice program must include written evidence of an informed consent signed by the person making the request. The informed consent must specify the type of care and services provided as part of hospice care and must be understandable to the person signing the consent.
4.If the hospice program requires a primary caregiver for each admission, this must be specified in the admission criteria and discussed with the patient and family during the patient's initial assessment.
5.A hospice program may not deny acceptance to any patient and family for services of the hospice on grounds of race, color, national origin, age, sex, religion, or ethnic affiliation.
6.At the time of admission to the hospice program, the hospice program must obtain documentation from the attending physician that the patient is terminally ill with an anticipated life expectancy of six months or less.
N.D. Admin. Code 33-03-15-12 Hospice service plan of care
1.After an initial assessment of patient and family needs, a written plan of care must be established by the hospice care team for each patient and family admitted to the hospice program.
a.At least a registered nurse or physician shall conduct an initial assessment of each patient and shall meet with one hospice care team member to develop the initial plan of care prior to admission.
b.Within seven days following admission of each patient and family, the hospice care team members shall meet to develop a comprehensive hospice service plan of care.
c.The hospice service plan of care must be developed with the participation of the patient and family and may include only those services which are acceptable to the patient and family. The family must be involved whenever possible in the implementation and continuous assessment of the hospice service plan of care.
2.The hospice service plan of care must include at least the following:
a.Patient diagnosis.
b.Complete assessment of patient and family needs.
c.Appraisal of, and need for, symptom control.
d.Identification of problems and goals and the types of services required to meet the patient and family goals.
e.Frequency of the services, medication, treatments needed to meet patient and family needs and the discipline involved in the delivery of care.
3.There must be written policies and procedures relating to the development, review, and revision of the hospice service plan in the home care and inpatient services. The plan of care must be reviewed, updated, and documented as needed, but at least biweekly, by the hospice care team.
N.D. Admin. Code 33-03-15-13 Medical records
1.The hospice program must keep accurate, current, and confidential records of all hospice patients and their families. The hospice program must safeguard the medical record against loss, destruction, and unauthorized use. Overall responsibility for medical records must be assigned to an employee of the hospice program.
2.The medical record must be complete, and documented promptly, accurately, and legibly.
3.Each medical record must contain sufficient information on all services provided, whether furnished directly or under arrangement by the hospice program, and entries must be signed with the legally acceptable signature by the person making the entry. Each patient and family medical record must contain, but is not limited to, the following:
a.Complete identification of each patient, including information on the patient's next of kin and responsible person or agency.
b.The initial and subsequent assessments by each discipline involved with the patient and family.
c.A medical history obtained prior to the development of a hospice care plan.
d.A current hospice care team plan.
e.Complete documentation of all home visits and services rendered if the service is provided directly.
f.If home care is not provided directly, provision must be made for the hospice program to obtain, as a minimum, a summary of services provided that reflect pertinent information relevant to the patient's and family's care.
g.Consent and authorization forms.
h.Patient diagnosis and prognosis certified by the attending physician.
i.Legible therapeutic orders authenticated by the attending physician. Action must be initiated by the hospice program to obtain the physician's signature for verbal orders within forty-eight hours.
j.At the time of discharge or transfer, the hospice must provide those responsible for the patient's care with an appropriate summary of information, including the hospice service plan, about the patient to ensure the optimal continuity of care.
k.Bereavement care plan and progress notes including bereavement assessment and followup.
4.Pertinent information regarding patient needs must accompany the patient upon discharge from the inpatient setting, and must be included as part of the hospice medical record.
5.The medical record of a discharged patient must be completed within thirty days after discharge.
6.Records must be maintained by the agency for a period of not less than ten years following the date of discharge or death. In the case of a minor, the records must be maintained for a period of twelve years following the date of discharge or death.
N.D. Admin. Code 33-03-15-14 Patient and family rights
1.Each hospice program must develop, adopt, implement, and make available for public review a statement of the rights and responsibilities of hospice patients and members of the hospice patient's family. This statement must be provided to the patient or family member designated by the patient, as evidenced by written acknowledgment, prior to or at the time of admission to the hospice program. The statement must include, but is not limited to, provisions assuring each patient and family the following minimum rights:
a.The right to be clearly informed of the responsibilities of the hospice program for care of the patient and family, including services to be provided.
b.The right to be fully informed, at the time of admission, of the materials and equipment available to the patient and family, any existing prepayment, refund and sliding scale fee policies, estimated cost, and of patient and family financial responsibility.
c.The right to participate in the development of the hospice service plan.
d.The right to be informed by a physician of the patient's medical condition.
e.The right to privacy in treatment and in caring for personal needs, and confidentiality in the treatment of personal and medical records.
f.The right to be treated courteously, fairly, and with the fullest measure of dignity.
2.Each program must prepare a written plan to implement this subsection.
N.D. Admin. Code 33-03-15-15 Quality assurance
Each hospice program must conduct a comprehensive self-assessment of the quality and appropriateness of care provided to the patient and family in the home and inpatient services.
1.The governing body shall delegate in writing responsibilities for implementation and maintenance of a planned process for reviewing and evaluating the appropriateness of patient and family care, as well as resolving identified problems.
2.The goals, objectives, methods for implementation, and responsibilities for monitoring and evaluating for effectiveness and efficiency of patient and family care must be specified in a written quality assurance plan which is reevaluated at least annually.
3.The hospice program, through the quality assurance program, must implement and report on activities and mechanisms for monitoring the quality of patient care, identify and resolve problems, and suggest improvements in patient care.
4.There must be documentation relating to the findings from and conclusions of the monitoring, evaluating, and problem solving activities, and the actions taken to resolve problems and improve patient and family services as defined in the quality assurance plan.
N.D. Admin. Code 33-03-15-16 Utilization review
1.The hospice program must appoint a utilization review committee whose responsibilities are to provide an ongoing evaluation and review of the hospice program and to make recommendations to the administrator who shall report findings and recommendations to the governing body on a timely basis. The committee shall meet at least semiannually and provide the administrator with dated, signed minutes of the meetings.
2.There must be a written utilization review plan describing the process used to monitor the utilization of the hospice program service and to resolve identified problems.
3.There must be evidence that the plan is reviewed at least annually and revised as necessary.
4.The utilization review committee shall conduct regular, ongoing utilization review to include, but not be limited to, a random sample and defined number of hospice medical records to determine at least the following:
a.The appropriateness of admission to the hospice program.
b.Continued stay longer than six months.
c.If the hospice program service plan was directly related to the identified physical and social needs of the patient and family.
d.If the service, medication, and treatment prescribed were in accordance with the current hospice service plan.
e.If the hospice program of care appropriately utilized inpatient hospice care on a short-term basis only, and maintained itself primarily as a home care program.
5.In addition to the medical record review, the following sources of information may be obtained and reviewed:
a.Billing information.
b.Quality assurance findings.
c.Reimbursement.
6.When problems in the utilization of hospice program services are identified, there must be evidence that action is taken to correct the problems.
Chapter 33-03-16 Construction and Location of Toilets [Repealed]
N.D. Admin. Code 33-03-16 Construction and Location of Toilets [Repealed]
CHAPTER 33-03-16
CONSTRUCTION AND LOCATION OF TOILETS [Repealed effective August 1, 1999]
Chapter 33-03-17 Temporary Work Camps [Repealed]
N.D. Admin. Code 33-03-17 Temporary Work Camps [Repealed]
CHAPTER 33-03-17
TEMPORARY WORK CAMPS [Repealed effective August 1, 1999]
Chapter 33-03-18 Milk Sanitation [Repealed]
N.D. Admin. Code 33-03-18 Milk Sanitation [Repealed]
CHAPTER 33-03-18
MILK SANITATION [Repealed effective August 1, 1999]
Chapter 33-03-19 Food and Drink Sanitation [Repealed]
N.D. Admin. Code 33-03-19 Food and Drink Sanitation [Repealed]
CHAPTER 33-03-19
FOOD AND DRINK SANITATION [Repealed effective August 1, 1999]
Chapter 33-03-20 Minimum Requirements for Sanitation in Places of Employment [Repealed]
N.D. Admin. Code 33-03-20 Minimum Requirements for Sanitation in Places of Employment [Repealed]
CHAPTER 33-03-20
MINIMUM REQUIREMENTS FOR SANITATION IN PLACES OF EMPLOYMENT [Repealed effective August 1, 1999]
Chapter 33-03-21 Minimum Requirements for Sanitation in Camps [Repealed]
N.D. Admin. Code 33-03-21 Minimum Requirements for Sanitation in Camps [Repealed]
CHAPTER 33-03-21
MINIMUM REQUIREMENTS FOR SANITATION IN CAMPS [Repealed effective August 1, 1999]
Chapter 33-03-22 Migrant Labor Housing [Repealed]
N.D. Admin. Code 33-03-22 Migrant Labor Housing [Repealed]
CHAPTER 33-03-22
MIGRANT LABOR HOUSING [Repealed effective August 1, 1999]
Chapter 33-03-23 Health Care Claims Data
N.D. Admin. Code 33-03-23-01 Definitions
As used in this article, except as otherwise specifically provided or where the context indicates otherwise:
1."Committee" means the health care data committee established in accordance with North Dakota Century Code chapter 23-01.1.
2."Comprehensive health association of North Dakota members" means those insurance companies who are participating members in the North Dakota comprehensive health association as determined by the insurance commissioner under North Dakota Century Code
section 26.1-08-03.
3."Council" means the state health council as established under North Dakota Century Code
section 23-01-02.
4."Data supplier" means any insurer, nonprofit health service corporation, health maintenance organization, insured or self-funded group health plan, or state agency which pays for health benefits or provider services, health data clearinghouse, community health information network, or health care provider cooperative.
5."Department" means the North Dakota state department of health.
6."Diagnosis-related group" (DRG) means the categorizations established by the health care financing administration for the purposes of hospital payment and any subsequent similar set of categorizations so established.
7."Group health plan" means an employee welfare benefit plan providing medical care as defined in 26 U.S.C. § 213(d), to participants or beneficiaries directly or through insurance, reimbursement, or otherwise.
8."HCFA-1500" means the health care financing administration form 1500 or successor forms.
9."Health maintenance organization" means any health maintenance organization certified by the North Dakota insurance department.
10."Health professional data" means any claims for inpatient, outpatient, or ambulatory medical or surgical services or other services normally submitted to the third party payer on HCFA-1500 or successor forms or other forms specified by the committee.
11."Hospital data" means any claims for inpatient, outpatient, or ambulatory surgical services or other services normally submitted to the third-party payer on form UB-92 or successor forms.
12."Insurers" means any insurance company licensed to do business in North Dakota by the insurance department.
13."Provider" means a person, agency, or organization which is engaged in the provision of health care to the public.
14."UB-92" means the health care financing administration form UB-92 or successor forms.
History
- History: Effective April 1, 1988; amended effective October 1, 1992; November 1, 1995.
- Law Implemented: NDCC 23-01.1-04
N.D. Admin. Code 33-03-23-02 Requests for data
The committee may require data suppliers and agencies of state government to provide certain data and information.
1.The committee shall establish uniform formats for the different types of data for use by data suppliers in providing hospitalization data, health professional data, nursing home data, health maintenance organization data, and other types of data as the committee finds necessary.
2.Data required to be submitted must be provided to the committee in the format established or, if the data supplier requests in writing, in a format which is technically equivalent and which supplies all of the necessary information. Third-party payers who cannot meet these reporting specifications and third-party payers who demonstrate that it is not economically feasible to report in accordance with these specifications shall request in writing approval to report the data in a specific, alternative form. These requests must be submitted to and approved inwriting by the department.
3.Data requests must be specific regarding the time period covered, data elements to be provided, and the form and format in which the data is to be provided.
4.Hospital data required to be provided must be limited to those data elements provided for on the health care financing administration form UB-92 (or replacement form) using the current definitions developed by the North Dakota uniform billing committee, and, as specified by the health care data committee, other data commonly collected in the course of billing and obtaining reimbursement of claims.
5.Health professional data required to be provided must be limited to those data elements provided for on the health care financing administration form 1500 or successor form or other forms specified by the health care data committee, and, as specified by that committee other data commonly collected in the course of billing and obtaining reimbursement of claims.
6.Data must be provided within sixty days of the committee's request for data. A fifteen-day extension of time for providing data may be granted if the data supplier adequately justifies the delay.
7.Prior to collecting hospital data or health professional data from any data supplier, the data supplier must be provided an exact format for reporting data and an explicit description of each data item to be reported. Descriptions of data elements shall include specifications in terms of form location, definitions and alternate specifications, and definitions for those data suppliers that do not maintain the exact UB-92 data as described in the North Dakota uniform billing procedures manual, or for data elements not provided for in the HCFA-1500 Medicare carriers manual (as revised). Those data suppliers that maintain similar elements shall report the comparable data elements that they maintain and a detailed code structure for each element to the department.
8.Data must be collected at least annually but not more often than quarterly from the following data suppliers:
a.Those comprehensive health association of North Dakota members, including health maintenance organizations, found by the North Dakota commissioner of insurance to be subject to an assessment of one percent or more as a participating member of the comprehensive health association of North Dakota, and any data supplier whose annual written premium is 0.5 percent or more of the total annual written premiums for individual or for group medical and major medical policies, as determined by the latest survey or census of insurance carriers conducted by the North Dakota commissioner of insurance, and any data supplier whose annual written premium for hospital-surgical expense coverage is one million dollars or more as determined by the latest survey or census of the North Dakota commissioner of insurance.
b.The committee may request, but may not require, that self-funded group health plans submit claims data.
c.State agencies that have paid any claims for hospital or health professional services during the calendar year, including Medicare and Medicare data in the possession of the agency.
9.The committee shall require that the data suppliers include a contract identifier number for contracts or plans paid for or subsidized by the North Dakota public employees retirement system or the comprehensive health insurance association of North Dakota and for those employer groups who have requested in writing that the department retain a contract identifier number.
10.The committee shall require that the data suppliers include identification codes for hospitals, health professionals, clinics, and patients.
11.Data must be collected at least annually, but not more often than quarterly, from the department of human services regarding basic care, intermediate care, and skilled nursing care provided in long-term care facilities located in this state. The data must include Medicare and Medicare claims for these facilities as collected by the department of human services.
12.Data must be supplied in the mode of transmission specified by the committee.
History
- History: Effective April 1, 1988; amended effective October 1, 1992; November 1, 1995.
- Law Implemented: NDCC 23-01.1-02, 23-01.1-04
N.D. Admin. Code 33-03-23-03 Prepublication review
Prior to publication of any reports required by statute, the committee shall allow data suppliers and providers an opportunity to review the data to be published and comment.
Data reports and analyses which are to be made available to the general public and which identify specific providers or which are solely derived from the records of a specific data supplier are subject to the following prepublication review procedures:
1.Prior to the publication of any reports required by statute, data, information, analyses, or reports relating to individual providers must be submitted to or available to the provider for verification of the accuracy of the information contained in the report. In the event that the provider finds a discrepancy between the data available to the provider and the information contained in the draft report, the provider may submit information substantiating or refuting the draft report. Hospital data and nursing home data will be submitted to each hospital or nursing home identified. Health professional data will be available onsite at the department, and onsite at the licensing or certifying authority of the health professional or available at locations determined by the committee.
2.If the committee has not received the provider's response in writing within thirty days of the mailing date of the draft report, the committee shall assume that the data contained in the report has been verified and shall proceed with publication.
3.If the provider responds within thirty days of the mailing date of the draft report that the information is incorrect and provides documentation that an error has occurred, the committee may accept the documentation and revise the draft report correspondingly or it may reject the documentation as inadequate and proceed with publication.
The committee shall notify the provider of its decision.
4.The provider may appeal the decision of the committee pursuant to North Dakota Century Code chapter 28-32.
5.Providers may have their data-specific comments published as an appendix to final reports.
History
- History: Effective April 1, 1988; amended effective October 1, 1992; November 1, 1995.
N.D. Admin. Code 33-03-23-04 Mutual responsibilities of the department and the board with regard to a physician directory
Repealed effective October 1, 1992.
N.D. Admin. Code 33-03-23-05 Confidentiality
Individual patient confidentiality shall be protected.
1.The committee shall adopt such procedures as it finds necessary for the protection of patient confidentiality provided that in no case shall data that specifically identify a patient by name or that could be used to identify a patient by name be released to the public, data researchers, or employers. Any provider that is identified in the claims data submitted to the committee may be identified by name and code number in the tabulations released by the committee.
2.The committee may enter into agreements with data users, researchers, and employers for the release of data in other than final published form. The committee shall establish within these agreements appropriate safeguards regarding the release of such data so that individual patients will not be identified.
History
- History: Effective April 1, 1988; amended effective October 1, 1992; November 1, 1995.
- Law Implemented: NDCC 23-01.1-05
N.D. Admin. Code 33-03-23-06 Accessibility and cost of reports
The committee shall make certain information available to the public, providers, data suppliers, researchers, and state agencies.
1.The committee shall direct and the department shall produce an annual report comparing the cost of hospitalization by hospital and for those diagnosis-related groups selected by the committee by diagnosis-related group.
2.The committee shall direct and the department shall produce an annual report comparing the fees of health professionals providing services identified by the committee.
3.Any person, organization, governmental agency, or other entity may request special tabulations of the UB-92 data or HCFA-1500 data or data from other forms as specified by the committee that are reported to the department, or direct access to a machine-readable, final data set prepared and maintained by the department. The final data set must include the exact list of data elements specified by the committee. All requests must be made in writing to the department. The written request must include the name, address, telephone number, employer, or organizational affiliation, and a detailed description of the data or tabulations being requested.
4.With the exception of those analyses, reports, and projects undertaken pursuant to section 33-03-23-08, no special tabulations may be produced by the department until all editing and updating of the data for the year to be included in the tabulations have been completed, and the data set is determined to be the final corrected data set.
5.When a request for special tabulations or computer tapes is received by the department that would include identification of a specific provider or facility in the special tabulations or on the requested computer tapes, the provider or facility must be notified by the department thatdata including the provider identification are being released. The notification must consist of a copy of the completed request form filed with the department and a cover letter indicating the anticipated date that the data shall be provided. If a request for special tabulations is received requesting statewide information or information on multiple providers or facilities, then notice as specified in this subsection must be provided to the organization representing that type of provider or facility. As used in this subsection, "facility" means a clinic, hospital, freestanding surgical center, or any other type of health care facility.
6.All direct and indirect costs associated with the fulfillment of special requests including staff time, computer time, copying costs, and supplies must be borne by the requester.
History
- History: Effective April 1, 1988; amended effective October 1, 1992; November 1, 1995.
- Law Implemented: NDCC 23-01.1-02, 23-01.1-06
N.D. Admin. Code 33-03-23-07 Maintenance of data
All data reported to the committee in response to the committee's requests for necessary data must be maintained for five years. A diagnosis-specific subset of the hospitalization claims data set (UB-92) andhealth professional claims data set (HCFA-1500 or data set from other forms specified by the committee) must be maintained for a period of not less than ten years.
History
- History: Effective April 1, 1988; amended effective October 1, 1992; November 1, 1995.
N.D. Admin. Code 33-03-23-08 Interagency agreements
1.The committee shall maintain memoranda of understanding with the department of human services, the workers compensation bureau, the public employees retirement system, the office of the commissioner of insurance, and any other state agency which the committee deems to have access to or authority over, or both, significant health care and nursing home data resources, for the sharing of information, data, data processing resources, and expertise.
2.These memoranda of understanding must contain provisions regarding the security and storage of data and data processing media, patient confidentiality, release restrictions, and the routine uses of the data reports to be produced, but shall not exempt any state agency that is a data supplier from full compliance with all the requirements imposed on data suppliers under this chapter.
None of the data files may be copied and resold in the form they were received by the requester for any amount greater than the reasonable cost of making a copy of the data file. However, a requester may sell reports derived or created from a data file, if the requester has made significant changes in the selection, coordination, or arrangement of the information in the data file, indicating sufficient originality to permit the requester to obtain a copyright for its reconfiguration of the information in the data file.
History
- History: Effective April 1, 1988; amended effective November 1, 1995. 33-03-23-08.1. Resale of data.
- History: Effective November 1, 1995.
N.D. Admin. Code 33-03-23-09 Civil penalty
Failure of a data supplier to respond to a request for data as set forth in this chapter shall constitute a violation subject to a civil penalty not to exceed five hundred dollars per day of violation. Procedures for the determination of a violation, assessment, and appeal of a penalty are governed by North Dakota Century Code chapter 28-32.
History
- History: Effective April 1, 1988; amended effective November 1, 1995.
- Law Implemented: NDCC 23-01.1-07
Chapter 33-03-24 Basic Care Facilities [Repealed]
N.D. Admin. Code 33-03-24 Basic Care Facilities [Repealed]
CHAPTER 33-03-24
BASIC CARE FACILITIES [Repealed effective January 1, 1995]
Chapter 33-03-24.1 Basic Care Facilities
N.D. Admin. Code 33-03-24.1 Basic Care Facilities
CHAPTER 33-03-24.1
BASIC CARE FACILITIES
Section 33-03-24.1-01Definitions 33-03-24.1-02Certificate of Need [Repealed] 33-03-24.1-03Issuance of License 33-03-24.1-04Waiver Provision 33-03-24.1-05Plans of Correction 33-03-24.1-06Enforcement Actions 33-03-24.1-07Reconsideration of Enforcement Actions 33-03-24.1-08Appeals 33-03-24.1-09Governing Body 33-03-24.1-10Fire Safety 33-03-24.1-11Education Programs 33-03-24.1-12Resident Assessments and Care Plans 33-03-24.1-13Resident Records 33-03-24.1-14Personal Care Services 33-03-24.1-15Pharmacy and Medication Administration Services 33-03-24.1-16Social Services 33-03-24.1-17Nursing Services 33-03-24.1-18Dietary Services 33-03-24.1-19Activity Services 33-03-24.1-20Housekeeping and Laundry Services 33-03-24.1-21Adult Day Care Services 33-03-24.1-22General Building Requirements [Repealed] 33-03-24.1-23End-of-Life Services 33-03-24.1-24Optional Alzheimer's, Dementia, Special Memory Care, or Traumatic Brain Injury Facility or Unit Services 33-03-24.1-01. Definitions.
1."Abuse" includes the willful infliction of mental, physical, sexual, and verbal abuse which could result in temporary or permanent mental, physical, emotional, or psychological injury or harm.
Mental abuse includes humiliation, harassment, intimidation, threats of punishment, or deprivation. Physical abuse includes hitting, slapping, pinching, kicking, unreasonable confinement, and deprivation, by an individual, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. It also includes controlling behavior through corporal punishment. Sexual abuse includes sexual harassment, sexual coercion, sexual contact, or sexual assault. Verbal abuse includes any use of oral, written, or gestured language that includes disparaging and derogatory terms to residents or their families, used within their hearing distance to describe the residents, regardless of their age, ability to comprehend, or disability.
2."Activities of daily living" means those personal, functional activities required by an individual for continued well-being, including eating, nutrition, dressing, personal hygiene, mobility, toileting, and behavior management.
a."Assistance" means the resident is able to help with most of an activity, but cannot do it entirely alone. The resident may need prompting, encouragement, or the minimal hands-on assistance of the personal care attendant.
b."Independent" means the resident can perform the activities of daily living without help.
3."Activity staff" means an employee who is responsible for providing an activity program.
4."Adult day care services" means the provision of basic care facility services to meet the needs of individuals who do not remain in the facility overnight.
5."Basic care facility" means a facility licensed by the department under North Dakota Century Code chapter 23-09.3 whose focus is to provide room and board and health, social, and personal care to assist the residents to attain or maintain their highest level of functioning, consistent with the resident assessment and care plan, to five or more residents not related by blood or marriage to the owner or manager. These services shall be provided on a twenty-four-hour basis within the facility, either directly or through contract, and shall include assistance with activities of daily living and instrumental activities of daily living; provision of leisure, recreational, and therapeutic activities; and supervision of nutritional needs and medication administration.
6."Capable of self-preservation" means a resident's ability, with or without assistance, to evacuate the facility or relocate from the point of occupancy to a point of safety in case of fire in compliance with the requirements of this chapter.
7."Department" means the North Dakota state department of health.
8."End-of-life care" means a program of palliative and supportive care for a resident with a licensed health care practitioner's order identifying a terminal illness or condition with a limited prognosis of six or fewer months to live.
9."Facility" means a basic care facility.
10."Governing body" means the entity legally responsible for the operation of a basic care facility.
11."Instrumental activities of daily living" includes preparing meals, shopping, managing money, housework, laundry, transportation, use of telephone, and mobility outside the basic care facility.
12."Licensed health care practitioner" means an individual who is licensed or certified to provide medical, medically related, or advanced registered nursing care to individuals in North Dakota.
13."Medication administration" means an act in which a drug or biological is given to a resident by an individual who is authorized in accordance with state laws and regulations governing such acts, and may include a licensed health care practitioner, licensed nurse, or medication assistant.
14."Misappropriation of resident property" means the deliberate misplacement, exploitation, or wrongful temporary or permanent taking or use of a resident's belongings or money, or both.
15."Neglect" includes failure to carry out resident services as directed or ordered by the licensed health care practitioner or other authorized personnel, or failure to give proper attention to residents.
16."Personal care" means assistance with activities of daily living and instrumental activities of daily living and general supervision of physical or mental well-being.
17."Resident" means an individual admitted and retained in a facility in order to receive room and board and health, social, and personal care who is capable of self-preservation, and whose condition does not require continuous, twenty-four-hour a day onsite availability of nursing or medical care.
18."Restricting device" means any device which limits a resident from freely exiting the facility or unit, including pressure devices which delay the time frame in which a door will open.
19."Secured facility" means a facility that is kept, used, maintained, advertised, or held out to the public as an Alzheimer's, dementia, or special memory care facility that has restricting devices to restrict residents from freely exiting the building.
20."Secured unit" means a specific area of the facility that is kept, used, maintained, advertised, or held out to the public as an Alzheimer's, dementia, or special memory care unit that has a restricting device separating the residents in the unit from the residents in the remainder of the facility.
21."Significant medication error" means a medication error which causes the resident discomfort or jeopardizes his or her health and safety, or a pattern of more than three medication errors that has the potential for causing a negative impact or harm to residents.
22."Unsecured facility" means a facility that is kept, used, maintained, advertised, or held out to the public as an Alzheimer's, dementia, or special memory care facility without restricting devices to restrict residents from freely exiting the building.
23."Unsecured unit" means a specific area of the facility that is kept, used, maintained, advertised, or held out to the public as an Alzheimer's, dementia, or special memory care unit that is separate from the residents in the remainder of the facility without a restricting device.
History: Effective January 1, 1995; amended effective January 1, 2008; July 1, 2015; January 1, 2018;
July 1, 2020.
Law Implemented: NDCC 23-09.3 33-03-24.1-02. Certificate of need.
Repealed effective October 1, 1998. 33-03-24.1-03. Issuance of license.
A facility meeting the definition of a basic care facility as outlined in North Dakota Century Code
chapter 23-09.3, North Dakota Administrative Code chapter 33-03-24.2, and this chapter must obtain a license from the department in order to operate in North Dakota.
1.Application to operate a facility must be made to the department prior to opening a facility, prior to change in ownership, annually, and upon determination by the department that a facility meets the definition of a basic care facility.
2.Floor plans must be submitted to the department for review and approval prior to opening a facility and prior to making structural alterations, including those which increase or decrease resident bed capacity.
3.Upon receipt of an application for an initial license, the department may schedule an inspection. Upon completion of the inspection and consideration of the findings, the department may issue an initial or provisional license, or deny the application.
4.An initial license is valid for a period not to exceed one year and shall expire on December thirty-first of the year issued.
5.Licenses must be issued on a calendar year basis and expire on December thirty-first of each year. An application for licensure renewal must be received by the department with sufficient time prior to the beginning of the licensure period to process.
6.A provisional license may be issued to a facility that does not comply with this chapter if practices in the facility do not pose a danger to the health and safety of the residents, as determined by the department.
a.A provisional license must be accompanied by a written statement of the specific rules or statutes violated and the expiration date of the license, which is not to exceed three months from the date of issuance.
b.If compliance with the requirements has been determined by the department prior to the expiration of the provisional license, an annual license may be issued. If an acceptable plan of correction has been approved by the department but compliance has not yet been achieved, the provisional license may be renewed no more than one time for an additional period up to three months at the discretion of the department.
7.Once issued, the facility shall display the license in a conspicuous place. A license is not subject to sale, assignment, or other transfer, voluntary or involuntary. A license is not valid for any premises other than those for which originally issued.
8.The department may, at any time, inspect a facility that the department determines meets the definition of a basic care facility as described in North Dakota Century Code chapter 23-09.3 and this chapter.
9.The facility must provide the department access to any material and information necessary, as determined by the department, for determining compliance with these requirements.
10.Information regarding facilities is public information and is available upon request through the department.
History: Effective January 1, 1995; amended effective January 1, 2008; July 1, 2015.
Law Implemented: NDCC 23-09.3-04, 23-09.3-05 33-03-24.1-04. Waiver provision.
The department may waive licensure requirements for specified periods of time in specific instances, provided compliance with the requirement would result in an unreasonable hardship upon the facility and lack of compliance does not adversely affect the health or safety of the residents. 33-03-24.1-05. Plans of correction.
1.A basic care facility must submit a plan of correction within ten days of receipt of the notification of deficiencies pursuant to this chapter.
2.The plan of correction must address how each deficiency will be corrected, what the facility will put in place to assure continued compliance, and the date upon which the corrective action will be completed.
3.The department may accept, reject, negotiate modifications to, or direct the plan of correction.
A directed plan of correction is a plan of correction which has been developed in coordination with the department.
4.Correction of deficiencies must be completed within sixty days of the survey completion date, unless an alternative schedule of correction has been approved by the department.
5.The department shall determine, based on the review of the facility's plan of correction, what followup is necessary to verify the correction of deficiencies has been completed. Followup may occur by telephone, mail, or onsite revisit.
6.The department shall make available to the public, on the department's website, the deficiency statement and accepted plan of correction, following verification of correction.
Law Implemented: NDCC 23-09.3-05 33-03-24.1-06. Enforcement actions.
1.Facilities are subject to one or more enforcement actions, which include a ban or limitation on admissions, suspension or revocation of a license, or a denial to license, for the following reasons:
a.Noncompliance with the requirements of this chapter or chapter 33-03-24.2 have been identified which:
(1)Present imminent danger to residents. These conditions or practices must be abated or eliminated immediately or within a fixed period of time as specified by the department;
(2)Have a direct or immediate negative relationship to the health, safety, or security of the residents; or (3)Have a potential for jeopardizing resident health, safety, or security if left uncorrected.
b.Recurrence of the same or substantially same deficient practice in a thirty-six-month period.
c.Failure to provide an acceptable plan of correction or to correct any deficiency pursuant to an approved plan of correction.
d.Refusal to allow a survey of the facility by representatives of the department.
e.Gross incompetence, negligence, or misconduct in operating the facility as determined through department investigation or by a court of law.
f.Fraud, deceit, misrepresentation, or bribery in obtaining or attempting to obtain a license.
g.Knowingly aiding and abetting in any way the improper granting of a license.
2.The effective date of the enforcement action must be ninety days from the date the department notifies the facility in writing of the department's decision to initiate an enforcement action, unless the department determines there is imminent danger to the residents.
3.The notice to the facility must include the basis of the department's decision and the effective date of the enforcement action and must also advise the facility of their right to:
a.Request a review by the department.
(1)A request for a review by the department to verify correction of the deficient practices must be submitted by the facility to the department within forty-five days from the date the department notifies the facility in writing of its decision to initiate an enforcement action.
(2)The facility must submit written documentation to the department with the request for a review to verify correction of the deficient practices that were cited. The department shall determine, based on review of the documentation submitted, if an onsite revisit is warranted. The department review and onsite revisit, if conducted, must take place within sixty days of the date the department notified the facility in writing of its decision to initiate an enforcement action.
(3)If the department determines, based on the review of the facility documentation and the onsite revisit, if conducted, that the deficient practices have been corrected, the enforcement action may be halted. The department shall notify the facility in writing of the decision within ten days of this determination.
(4)If the department determines, based on the review of the facility documentation and the onsite revisit, if conducted, that the deficient practices were not corrected, the enforcement action will be imposed. If imposed, the enforcement action will, at a minimum, remain in effect until the department determines that the conditions leading to the enforcement action have been corrected.
b.Request a reconsideration of an enforcement action consistent with section 33-03-24.1-07.
4.If the department sustains the decision, the department shall publish a public notice in the local newspaper not less than fifteen days prior to the imposition of the enforcement action stating the name of the facility, the enforcement action to be imposed, the reason for the action, the date on which the enforcement action will be effective, and the length of time for which it will be imposed.
5.The department of human services and the county social service office in the county in which the facility is located will be notified in writing by the department regarding the enforcement action.
Law Implemented: NDCC 23-09.3 33-03-24.1-07. Reconsideration of enforcement actions.
The facility has the right to request a reconsideration of decisions resulting in enforcement actions.
1.A written request for a reconsideration must be filed with the department within ten days of the date the department notified the facility in writing of the decision to initiate an enforcement action.
2.The facility requests for reconsideration must be accompanied by written documents, including:
a.A copy of the notice received from the department.
b.The reason or basis in fact for the dispute and request for reconsideration.
c.The statutes or rules relied upon with respect to each disputed issue and the factual
basis for the facility's contention that the violation was erroneously determined.
d.The name, address, and telephone number of the person to whom all notices will be mailed or delivered regarding the request for reconsideration.
3.Within ten days after the receipt of the request for reconsideration, the department shall grant or deny the request.
4.A request for reconsideration will be denied unless it specifically identifies each disputed deficient practice and states the factual basis for the facility's contention that the deficient practice was erroneously determined. The correction of the factors that led to the determination of a deficient practice may not be asserted as a basis for a request for reconsideration.
5.If the department denies the request for reconsideration, the department shall notify the facility in writing of that decision. If denial was for any reason other than a failure of the request to conform to the requirements of subsection 4, the notice must advise the facility of the right to appeal.
6.If the department determines to undertake reconsideration, the decision on reconsideration must be rendered within twenty days of receipt of the request for the reconsideration and the department must notify the facility in writing of the decision. The notice of the decision on the reconsideration must advise the facility of the right to appeal.
7.The reconsideration of an enforcement action does not delay the implementation of the enforcement action. The date of implementation of the enforcement action is effective unless otherwise determined. 33-03-24.1-08. Appeals.
1.A facility dissatisfied with the decision on a request for reconsideration, which conforms to the requirements of subsection 4 of section 33-03-24.1-07, may appeal. An appeal may be initiated by mailing or delivering the information described in subdivisions a through d to the department, division on health facilities, state capitol, Bismarck, North Dakota, on or before 5:00 p.m. on the fortieth day from the date the department notified the facility in writing of the department's decision to initiate an enforcement action. Written documents including all of the following must accompany the appeal:
a.A copy of the notice received from the department regarding the department's decision on the request for reconsideration.
b.A statement of each disputed deficient practice and the reason or basis in fact for the dispute.
c.The authority in statute or rule upon which the facility relies for each disputed item.
d.The name, address, and telephone number of the person to whom all notices will be mailed or delivered regarding the appeal.
2.Except as otherwise provided in this section, the appeal must be considered as provided in
article 98-02.
3.The appeal must be decided based on whether the deficient practice occurred, not whether the deficient practice has been corrected.
4.The hearing officer must make written findings of fact and conclusions of law and must recommend a decision to the department. The recommended decision must set forth the reasons for the decision and the evidence upon which the decision is based.
5.The department may accept, modify, or reject the recommended decision. If the department rejects the recommended decision, it may remand the matter to the office of administrative hearings with directions. The department may require, through its directions, the receipt of additional evidence and the submission of amended findings of fact and conclusions of law and recommend a decision that reflects consideration of the additional evidence. The department may require, through its direction, that the matter be referred to the same or a different hearing officer, and the office of administrative hearings shall comply with that direction unless compliance is impossible. 33-03-24.1-09. Governing body.
1.The governing body is legally responsible for the quality of resident services; for resident health, safety, and security; and to ensure the overall operation of the facility is in compliance with all applicable federal, state, and local laws.
2.The governing body is responsible for approval and implementation of effective resident care and administrative policies and procedures for the operation of the facility. These policies and procedures must be in writing, signed, dated, reviewed annually, and revised as necessary, and shall address:
a.All services provided by the facility to meet the needs of the residents, including admission, transfer, discharge, discharge planning, and referral services.
b.Protocols developed by appropriately licensed professionals for use in the event of serious health-threatening conditions, emergencies, or temporary illnesses. These protocols must include provisions for:
(1)Designation of a licensed health care practitioner for each resident and arrangements to secure the services of another licensed health care practitioner if the resident's designated licensed health care practitioner is not available.
(2)Notification of an appropriately licensed professional in the event of an illness or injury of a resident.
c.Provisions for pharmacy and medication services developed in consultation with a registered pharmacist, including:
(1)Assisting residents in obtaining individually prescribed medications from a pharmacist of the resident's choice.
(2)Disposing of medications that are no longer used or are outdated, consistent with applicable federal and state laws.
(3)Allowing the resident to be totally responsible for the resident's own medication upon resident request and based on the assessment of the resident's capabilities with respect to this function by an appropriately licensed professional.
d.Infection control practices, including provision of a sanitary environment and an active program for the prevention, investigation, management, and control of infections and communicable diseases in residents and staff members.
e.Prohibition of resident abuse, neglect, and misappropriation of resident property, including investigation, reporting to the department, and followup action.
f.Reporting a significant medication error to officials in accordance with state law. A significant medication error by a medication assistant I or II shall be reported to the department of health.
g.A process for handling complaints made by residents or on behalf of residents.
h.Resident rights which comply with North Dakota Century Code chapter 50-10.2.
i.Personnel policies to include checking state registries and licensure boards prior to employment for findings of inappropriate conduct, employment, disciplinary actions, and termination.
j.Personnel records to include job descriptions, verification of credentials where applicable, and records of training and education.
3.If the facility provides any clinical laboratory testing services to an individual, regardless of the frequency or the complexity of the testing the governing body is responsible to obtain and maintain compliance with the applicable parts of the clinical laboratory improvement amendments of 1988, 42 CFR part 493.
4.The governing body shall appoint an administrator to be in charge of the general administration of the facility. Provisions must be made for a staff member to be identified in writing to be responsible for the onsite operation of the facility in the absence of the administrator.
5.The governing body shall ensure sufficient trained and competent staff are employed to meet the residents' needs. Staff must be in the facility, awake and prepared to assist residents twenty-four hours a day. 33-03-24.1-10. Fire safety.
The fire safety provisions located in section 33-03-24.2-08 apply to this chapter.
History: Effective January 1, 1995; amended effective July 1, 1996; October 1, 1998; July 1, 2015.
Law Implemented: NDCC 18-01-03.2, 23-09.3-09 33-03-24.1-11. Education programs.
1.The facility shall design, implement, and document educational programs to orient new employees and develop and improve employees' skills to carry out their job responsibilities.
2.On an annual basis, all employees shall receive inservice training in at least the following:
a.Fire and accident prevention and safety.
b.Mental and physical health needs of the residents, including behavior problems.
c.Prevention and control of infections, including universal precautions.
d.Resident rights.
3.The administrator shall attend at least twelve continuing education hours per year relating to care and services for residents.
4.The staff responsible for food preparation shall attend a minimum of two dietary educational programs per year.
5.The staff responsible for activities shall attend a minimum of two activity-related educational programs per year. 33-03-24.1-12. Resident assessments and care plans.
1.An assessment is required for each resident within fourteen days of admission and as determined by an appropriately licensed professional thereafter, but no less frequently than quarterly.
2.The assessment must be completed in writing by an appropriately licensed professional. The assessment must include:
a.A review of health, psychosocial, functional, nutritional, and activity status.
b.Personal care and other needs.
c.Health needs.
d.The capability of self-preservation.
e.Specific social and activity interests.
3.A care plan, based on the assessment and input from the resident or person with legal status to act on behalf of the resident, must be developed within twenty-one days of the admission date and consistently implemented in response to individual resident needs and strengths.
4.The care plan must be updated as needed, but no less than quarterly. 33-03-24.1-13. Resident records.
1.The facility shall provide for secure maintenance and storage of all resident records.
2.Resident records must include:
a.The resident's name, social security number, marital status, age, sex, previous address, religion, personal licensed health care practitioner, dentist, and designated representative or other responsible person.
b.The licensed health care practitioner's orders and report of an examination of the resident's current health status.
c.An admission note.
d.A copy of an initial and current assessment and care plan.
e.Documentation of resident observations by authorized staff.
f.Documentation of death, including cause and disposition of the resident's personal effects, money, or valuables deposited with the facility.
g.A quarterly progress note documenting the resident's current health condition, level of functioning, activity involvement, nutritional status, psychosocial interactions, and needs.
h.Documentation of review of prescribed diets.
i.Transfer forms that are completed, signed, and sent with the resident when transferred to another facility.
j.A medication administration record documenting medication administration consistent with applicable state laws, rules, and practice acts.
k.Documentation of an annual medication regimen review.
l.A written report of any funds kept at a resident's request. Such record shall show deposits to and withdrawals from the fund.
m.Documentation of a fire drill walk-through within five days of admission.
n.All agreements or contracts entered into between the facility and the resident or legal representative.
o.A discharge note.
3.The facility shall maintain resident records for a period of not less than five years from the date of discharge or death.
Law Implemented: NDCC 23-09.3-03, 23-09.3-04 33-03-24.1-14. Personal care services.
The facility shall provide personal care services to assist the resident to attain and maintain their highest level of functioning consistent with the resident assessments and care plans. These services must include assistance with:
1.Activities of daily living and instrumental activities of daily living and observation and documentation of changes in physical, mental, and emotional functioning, as needed.
2.Arrangements to seek health care when the resident shows signs or describes symptoms of an illness or abnormality for which treatment may be indicated.
3.Arrangements for appropriate transfer and transport as needed.
4.Functional aids or equipment, such as glasses, hearing aids, canes, crutches, walkers, or wheelchairs.
5.Clothing and other personal effects as well as maintenance of personal living quarters.
Law Implemented: NDCC 23-09.3-03, 23-09.3-04 33-03-24.1-15. Pharmacy and medication administration services.
1.The facility shall provide assistance to the resident in obtaining necessary medications and medical supplies.
2.The facility shall provide a secure area for medication storage consistent with chapter 61-03-02.
a.A specific system must be identified for the accountability of keys issued for locked drug storage areas.
b.Residents who are responsible for their own medication administration must be provided a secure storage place for their medications.
3.Medication administration services must be available for residents.
4.All medications used by residents which are administered or supervised by staff must be:
a.Properly recorded by staff at the time of administration.
b.Kept and stored in original containers labeled consistently with state laws.
c.Properly administered.
5.The resident's licensed health care practitioner, another licensed health care professional consistent with applicable state practice acts, or a consulting pharmacist shall review the medication regimen of each resident as needed, but at least annually.
6.A medication record need not be kept for those residents for whom authorization has been given by the licensed health care professional to keep their medication in their rooms and to be fully responsible for taking the medication in the correct dosage and at the proper times. 33-03-24.1-16. Social services.
Social services must be available to meet the needs of the residents either by the facility directly or arranged by the facility through an appropriate agency offering social services. 33-03-24.1-17. Nursing services.
Nursing services must be available to meet the needs of the residents either by the facility directly or arranged by the facility through an appropriate individual or agency providing nursing services. 33-03-24.1-18. Dietary services.
The facility must meet the dietary needs of the residents and provide dietary services in conformance with the North Dakota sanitary requirements for food establishments. Dietary services must include:
1.A minimum of three meals each day. Meals must be nutritious and well-balanced in accordance with the recommended dietary allowances of the food and nutrition board of the national research council, national academy of sciences.
2.No more than a fourteen-hour span may exist between an evening meal and breakfast.
3.Snacks between meals and in the evening. These snacks must be listed on the daily menu.
Vending machines may not be the only source of snacks.
4.Provisions for prescribed diets, if the facility accepts or retains individuals in need of such diets.
a.The facility shall provide for preparation and serving of prescribed diets.
b.Menus for prescribed diets must be planned and reviewed as needed by a professional consistent with North Dakota Century Code chapter 43-44.
5.Menus of food served, which must be kept for at least three months.
6.Preparation of food by methods that will conserve nutritive value and enhance flavor and appearance, and be served at the proper temperatures and in a form to meet individual needs.
7.Meals must be served to all residents in a dining room, except for residents with a temporary illness. 33-03-24.1-19. Activity services.
There must be a planned and meaningful activity program to meet the needs and interests of the residents and encourage self-care and continuity of normal activities. This program must:
1.Be developed based on the activity needs and interests of each resident identified through the initial and ongoing assessments.
2.Develop and post a monthly group activity calendar, based on the individual interests identified, which lists social, recreational, and other events available to residents.
3.Activities must be available and provided to meet the needs of all residents during the day, in the evening, and on the weekend.
4.Assist residents with arrangements to participate in social, recreational, religious, or other activities within the facility and the community in accordance with individual interests and capabilities. 33-03-24.1-20. Housekeeping and laundry services.
The facility shall maintain the interior and exterior of the facility in a safe, clean, and orderly manner and provide sanitary laundry services, including personal laundry services, for residents. 33-03-24.1-21. Adult day care services.
1.A facility must obtain approval from the department to provide adult day care services.
2.Use of existing space and equipment to deliver adult day care services is acceptable if this does not diminish the services provided to the residents of the facility and their needs being met.
3.Medications and treatments must be administered only by order of a licensed health care practitioner.
4.Records must be maintained of services provided to individuals participating in adult day care services.
5.An area allowing privacy for adult day care individuals must be developed to allow for rest periods. 33-03-24.1-22. General building requirements.
Repealed effective July 1, 2015. 33-03-24.1-23. End-of-life services.
A facility that retains residents who require end-of-life care continues to be responsible for the care and services of all residents, must comply with the requirements of this section, and apply on basic care application form and indicate a change in services provided.
1.A facility may retain residents who require more than intermittent nursing care if the resident requires end-of-life care and chooses to remain in the facility.
2.A facility providing end-of-life care must employ or contract with a registered nurse to supervise resident care to meet the needs of the residents at all times, either directly or indirectly. The facility must employ a licensed nurse to identify and respond to resident needs, care plan accordingly, provide oversight related to care, and review and document the resident's individual needs and care provided.
3.The facility, the resident in need of end-of-life care, or the resident's designee may contract with a person or hospice agency to meet the needs of the resident.
4.Individuals in need of end-of-life care who require skilled nursing care or are not capable of self-preservation may not be admitted.
5.The facility, in consultation with the resident or resident's designee, shall develop and implement an interdisciplinary care plan that identifies how the resident's needs are met and includes delineation of the roles of facility staff and others in the provision of care and services for the resident in need of end-of-life care and a list of medications the resident receives related to end-of-life care and who is authorized to administer the medications.
6.Facility evacuation or E scores must be completed when there is a significant change in the resident's capability for self evacuation when a resident is receiving end-of-life care. A significant change for the resident is defined as any change in the resident’s status or capabilities which results in a change in the E score for that resident. Facility staffing must be adjusted consistent with the E scores to maintain a slow evacuation capability. The fire evacuation needs of the resident receiving end-of-life care may be met by facility staff that wraps around hospice staff, family members, the resident's designee, or volunteers.
7.If a facility provides end-of-life care to residents, the facility shall ensure training and competency evaluation is completed for all nursing and personal care staff members specific to the care and services necessary to meet the needs of the terminally ill resident. The training and competency evaluation must be completed prior to caring for a resident in need of end-oflife care. The facility staff must be trained by a nurse. Training of the other individuals may be completed by any of the following:
a.Facility personnel;
b.Other experts;
c.Nurse or nurse consultant; or
d.Hospice agency nurse.
If the facility utilizes family, volunteers, or the resident's designee to provide end-of life care, the facility shall ensure appropriate training for these individuals specific to the care and services provided by this person. The facility shall assure the competency of the individual for this task and address changes if the needs of the resident are not being met.
8.If the facility is unable, or becomes unable, to meet the needs of the resident requiring end-of-life care or the facility is unable to comply with these requirements, the facility shall promptly make arrangements to discharge or transfer the resident to a safe and appropriate location consistent with the level of care required to meet the resident's needs.
History: Effective July 1, 2015; amended effective July 1, 2020.
General Authority: NDCC 23-09.3-09, 28-32-02
Law Implemented: NDCC 23-09.3-04, 23-09.3-08.1, 23-09.3-09 33-03-24.1-24. Optional Alzheimer's, dementia, special memory care, or traumatic brain injury facility or unit services.
A basic care facility or unit that admits or retains only residents with Alzheimer's, dementia, or special memory care needs in a secured or unsecured facility or unit, or a facility that admits and retains only residents with traumatic brain injury must comply with the additional requirements of this
section, apply on an application as specified by the department, and receive written approval from the department before providing the services. A basic care facility may not advertise or hold itself out to the public to provide specialized care to residents with Alzheimer's, dementia, memory loss, or care for residents with traumatic brain injury unless licensed consistent with this section. The facility must meet the following requirements:
1.A basic care facility licensed to provide specialized services to residents in this section may admit and retain residents who require twenty-four-hour per day dedicated personal care staff; however, do not need more than intermittent nursing or medical care.
2.Residents with Alzheimer's, dementia or special memory care needs, or traumatic brain injury admitted and retained must meet the basic care functional level of care and be capable of self-preservation.
3.The facility or unit licensed to provide specialized care and services to residents under this
section shall provide:
a.Care of residents with chronic moderate to severe memory loss or an individual who has significant emotional, behavioral, or cognitive impairments and needs services that may include independent living skills, support and training to promote and develop relationships, participate in the social life of the community, and develop behavioral skills as determined necessary based on assessment and care plan;
b.Protective oversight and supervision in a structured environment that is staffed with sufficient personal care and intermittent licensed nursing staff to monitor, evaluate, and accommodate an individual's changing needs;
c.Service in which assistance with activities of daily living and independent activities of daily living, therapeutic, social, and recreational programming is provided; and
d.Care furnished in a way that fosters the maintenance or improvement, as appropriate, to promote independence of the resident.
4.The facility shall develop a written policy related to resident rights and provide the policy to the resident or designee, verbally and in writing. The facility shall ensure each resident's right to privacy, dignity and respect, and freedom from coercion and restraint by promoting individual initiative, autonomy, and independence in making life choices related to daily activities, physical environment, and with whom to interact. The facility or unit must comply with residents' rights in North Dakota Century Code chapter 50-10.2, and:
a.Residents must be provided privacy in their sleeping or living area, including entrance doors lockable by the individual, with only appropriate staff having keys to the doors;
b.Residents sharing a room with another resident must have a choice of roommate in that setting;
c.Residents must be granted the freedom to furnish and decorate their sleeping unit or living area to the extent allowable based on facility policy and fire code requirements;
d.Residents must have the freedom and support to control their schedules and activities and have access to food any time and eat where they choose;
e.Residents are allowed to have visitors of their choosing at any time;
f.Must have access to the community; and
g.Residents must have access to outdoor space. Residents in a secured facility or unit must have access to a secured outdoor space.
5.The facility shall develop a person-centered care plan for each resident. The care plan must be completed following the functional assessment and be based on input from the resident or designee.
6.The person-centered care plans must be reviewed quarterly and anytime there is a change in need by the resident based on the assessment, and modified as needed.
7.A basic care facility licensed to provide specialized services to residents in this section shall ensure training and competency evaluation is completed for all nursing and personal care staff members specific to the care and services necessary to meet the needs of the residents. A minimum of eight educational hours on the following topics must be completed within three months from the date of hire. Nursing and personal care staff may not be assigned to work independently until they have successfully completed a competency evaluation. The areas to be covered include:
a.Dementia education, including progression of the disease, memory loss, and psychiatric and behavioral symptoms;
b.Techniques for understanding and approaching behavioral symptoms, such as aggravating behaviors, sexual behaviors, and wandering, including alternatives to chemical and physical restraints;
c.Positive therapeutic interventions;
d.Strategies for addressing social needs and providing options for meaningful activities;
e.Information on how to address aspects of care and safety, such as pain, food, fluid, and wandering;
f.Communication issues;
g.Resident rights, including dignity, respect, choice, independence, and privacy; and
h.Strategies for providing person-centered care.
8.Each nursing or personal care staff member shall receive annually a minimum of four hours of educational training in two or more of the topics identified in subsection 7.
9.Nursing or personal care staff members must successfully complete a competency evaluation in the areas identified in subsection 7 annually.
10.For other staff members hired to work in a facility or unit licensed under this section, training upon hire and annual training shall include at a minimum an overview of dementia and communication issues, and may include other topics identified in subsection 7 as needed.
11.Before providing services to residents, a basic care facility licensed to provide specialized services to residents in this section shall comply with the additional requirements in this
section and receive approval on a printed new license from the department.
12.The department may issue existing facilities a provisional license not to exceed one year to complete construction or remodel to come into compliance with environmental requirements if it does not pose a danger to the health and safety of the residents. An additional provisional license for no more than six months may be granted at the discretion of the department to complete the project.
13.If the facility or unit is unable to meet the needs of the resident, or the resident no longer meets the criteria for retention, the facility promptly shall make arrangements to discharge or transfer the resident to a safe and appropriate placement consistent with the level of care required to meet the resident's needs.
History: Effective January 1, 2018.
General Authority: NDCC 23-09.3-09, 28-32-02
Law Implemented: NDCC 23-09.3-04, 23-09.3-09
Chapter 33-03-24.2 General Standard for Construction and Equipment for Basic Care Facilities
N.D. Admin. Code 33-03-24.2 General Standard for Construction and Equipment for Basic Care Facilities
CHAPTER 33-03-24.2
GENERAL STANDARD FOR CONSTRUCTION AND EQUIPMENT FOR BASIC CARE
FACILITIES
Section 33-03-24.2-01Definitions 33-03-24.2-02Waiver Provision 33-03-24.2-03Access and Surveillance by the Department 33-03-24.2-04Plans of Correction 33-03-24.2-05Emanating Services 33-03-24.2-06Plans and Specifications 33-03-24.2-07Codes and Standards 33-03-24.2-08Fire Safety 33-03-24.2-09General Building Requirements 33-03-24.2-01. Definitions.
The definitions located in section 33-03-24.1-01 apply to this chapter. 33-03-24.2-02. Waiver provision.
The waiver provision located in section 33-03-24.1-04 applies to this chapter. 33-03-24.2-03. Access and surveillance by the department.
The provisions located in section 33-03-24.1-03 apply to this chapter.
Law Implemented: NDCC 23-09.3-04, 23-09.3-05 33-03-24.2-04. Plans of correction.
The provisions located in section 33-03-24.1-03 apply to this chapter. 33-03-24.2-05. Emanating services.
1.Sufficient information on the design of other types of facilities physically attached to the basic care facility must be submitted to the department so as to determine that safety from fire and the adequacy of the spaces and services of the facility are not compromised.
2.Occupants of other types of facilities may use service spaces, such as dining and activities in the facility only when the size of such spaces exceeds the standards of this chapter by providing a minimum of fifteen square feet per additional occupant using the space. 33-03-24.2-06. Plans and specifications.
1.A facility shall contact the department prior to any substantial changes in or alterations to any portion of the structure to determine to what extent it is subject to review. A substantial change includes alterations affecting the fire safety or structural integrity of the building, changes in service areas or services provided within a service area, changes in bed capacity, or any other change governed by the standards of this chapter. The department may request plans, specifications, or other information as may be required and shall make the final determination on those areas subject to review.
2.A facility shall submit plans and specifications to the department for all construction, remodeling, and installations subject to review. The plans and specifications must be prepared by an architect or engineer licensed in North Dakota, unless otherwise determined by the department.
3.Start of construction prior to approval by the department of the final plans and specifications is not permitted.
4.All construction, remodeling, and installations must be in accordance with the final plans and specifications approved by the department. Modifications or deviations from the approved plans and specifications must be submitted to and approved by the department.
5.The department may make inspections of construction, remodeling, or installations and arrange conferences with the facility to ensure conformance with approved plans and specifications.
6.The construction specifications must require the contractor to perform tests to ensure all systems conform to the approved plans and specifications.
7.Routine maintenance does not require the submission of plans and specifications. For the
purpose of this subsection, routine maintenance means repair or replacement of existing equipment, room finishes and furnishings, and similar activities. 33-03-24.2-07. Codes and standards.
1.A basic care facility must be designed, constructed, equipped, maintained, and operated in compliance with:
a.This chapter;
b.The Guidelines for Residential Health, Care and Support Facilities, 2014 edition, compiled by the facility guidelines institute;
c.The national fire protection association 101 Life Safety Code, 2012 edition;
d.North Dakota Century Code section 54-21.3-04.1, relating to accessibility for disabled persons;
e.The requirements for food and beverage establishments issued by the department;
f.North Dakota Administrative Code article 62-03.1 relating to plumbing standards;
g.North Dakota Administrative Code article 24-02 relating to electrical wiring standards;
h.North Dakota Administrative Code article 45-12 relating to boiler rules and regulations;
i.North Dakota Administrative Code article 33-15 governing air pollution control, relating to incinerators; and
j.North Dakota Administrative Code article 33-10 relating to radiological health.
2.A basic care facility must comply with all applicable building codes, ordinances, and rules of city, county, or state jurisdictions.
3.These standards are established to bring about a desired performance result. If specific limits are prescribed, equivalent solutions may be acceptable if approved in writing by the department as meeting the intent of these standards. 33-03-24.2-08. Fire safety.
1.The basic care facility shall comply with the national fire protection association Life Safety Code, 2012 edition, chapters 32 and 33, residential board and care occupancy, slow evacuation capability, or a greater level of fire safety.
2.Fire drills must be held monthly with a minimum of twelve per year, alternating with all workshifts. Residents and staff, as a group, shall either evacuate the building or relocate to an assembly point identified in the fire evacuation plan. At least once a year, a fire drill must be conducted during which all staff and residents evacuate the building.
3.Fire evacuation plans must be posted in a conspicuous place in the facility.
4.Written records of fire drills must be maintained. These records must include dates, times, duration, names of staff and residents participating and those absent and why, and a brief description of the drill, including the escape path used and evidence of simulation of a call to the fire department.
5.Each resident shall receive an individual fire drill walk-through within five days of admission.
6.Any variation to compliance with the fire safety requirements must be approved in writing by the department.
7.Residents of facilities meeting a greater level of fire safety must meet the fire drill requirements of that occupancy classification.
Law Implemented: NDCC 18-01-03.2, 23-09.3-09 33-03-24.2-09. General building requirements.
The basic care facility must be operated in conformance with all state and local laws, rules, and ordinances concerning fire safety and sanitation.
1.Lounge and activity space must be provided at a minimum of fifteen square feet [1.39 square meters] per licensed bed for recreation, visiting, and an activity program. The lounge and activity area may be used to accommodate religious services and activities. Each lounge area for resident use must be provided with an adequate number of reading lamps, tables, and chairs or couches. These furnishings must be well-constructed and accommodate the needs of the residents.
2.Kitchen. Dietary areas and equipment must be designed to accommodate the requirements for sanitary storage, processing, and handling.
3.Dining area.
a.A minimum of fifteen square feet [1.39 square meters] per licensed bed must be provided for dining. Activity and dining areas must be separate.
b.Dining room furnishings must be well-constructed, comfortable, in good repair, and must accommodate the needs of the residents. There must be a sufficient number of tables of suitable design to accommodate the needs of all residents using wheelchairs.
4.Resident bedrooms.
a.All bedrooms used for residents must be dry, well-ventilated, and otherwise suitable for occupancy. Each room must have direct access to a corridor and have an outside wall with natural light provided by a window. Resident bedrooms licensed after the effective date of these rules must be at or above grade level.
b.The glazed areas of the window may not be less than one-tenth of the floor area of the room. Windows must be easily opened and must be provided with screens. Windows may have stops to prevent full opening that could result in accidental falls or unintended exiting from window openings.
c.Room size will vary depending on the number of beds, but minimum floor dimensions may not be less than ten feet [3.05 meters]. In computing floor area, only usable floor space may be included. Single rooms must provide at least one hundred square feet [9.29 square meters]. Double rooms must provide at least eighty square feet [7.43 square meters] per bed.
d.Each resident must be provided with a bed and mattress. Cots, rollaways, or folding beds may not be used. Double beds may be used if requested by the resident and there is adequate space. Each bed must be provided with springs in good repair and a clean, firm, comfortable mattress of appropriate size for the bed, as well as a minimum of one clean, comfortable pillow.
e.Each bedroom window must have window shades, or an equivalent, in good repair.
f.Light levels to meet the needs of residents and to allow for reading and safety must be provided.
g.Each bedroom must be provided with a mirror unless there is a mirror in a toilet room opening into the bedroom. Each resident lavatory must be provided with a mirror.
Bedrooms or bathrooms in a secured unit or secured facility may or may not have mirrors based on the assessment of the resident.
h.For each bed there must be furnished a minimum of two adequately sized dresser drawers, a chair, a bedside table or stand, an individual towel rack, and closet, locker, or wardrobe space for hanging clothing within the room.
5.Toilet rooms and bathing facilities.
a.Separate toilets for public use must be provided.
b.Each bath and toilet room must be well-lighted.
6.The facility shall provide for adequate ventilation throughout to assure an odor-free, comfortable environment.
7.Office spaces and other areas must be furnished with desks, chairs, lamps, cabinets, benches, worktables, or other furnishings essential to the proper use of the area.
Law Implemented: NDCC 23-09.3-04
Chapter 33-03-25 Alternative Health Care Services Projects
N.D. Admin. Code 33-03-25-01 Definitions
1."Alternative health care services pilot project" means any health care service subject to licensure or certification by the department in which the state health council must waive any existing North Dakota law or rule in order for the project to be developed or operated. This may include, but not be limited to, state laws or rules governing the standards of practice regulating health professionals such as physicians, nurses, pharmacists, or other health professionals; changes in state tax laws, health care reimbursement through state programs, health facility and health program standards, and other changes judged appropriate by the council. The intent of the alternative health care services pilot project is to provide a means for testing new and experimental ways of providing health care services.
2."Council" means the state health council.
3."Department" means the state department of health.
4."Waiver" means that applicable state laws or rules relative to the creation or operation of a pilot project providing alternative health care services do not need to be met for a period of time as specified by the council, but not exceeding the duration of the approved pilot project.
N.D. Admin. Code 33-03-25-02 Term of pilot project
The term of the project must begin on the date of the council's initial approval. Any project approved by the council must be for a term of up to one year with renewals for a maximum term of five years.
N.D. Admin. Code 33-03-25-03 Process
1.Forms for applying as a pilot project must be available from the department. Completed applications must be submitted to the department.
2.The department shall review the application within sixty days of its receipt. The review must evaluate the project for compliance with section 33-03-25-05 and with federal and state laws and rules. Following its review, the department shall send the application and review to the council. Upon submission of the application to the council, the department shall issue notices of a public hearing on the application.
a.The notice must be at least thirty days prior to the public hearing and must appear in the official newspaper of each county served by the pilot project.
b.At the same time the department issues the notice of a public hearing, the notice and a copy of the application must be sent to public or private agencies or boards that have been identified by the department as having a responsibility for licensure, certification, or
regulation of people or programs directly affected by the proposed project and to any other person requesting a copy of the application or notice.
c.The public hearing must occur at the next regularly scheduled council meeting.
3.The council shall make a decision on the application within one hundred eighty days after the public hearing.
N.D. Admin. Code 33-03-25-04 Criteria
Criteria to be considered must include:
1.The number of people who will be served.
2.The size of the geographical area, its location, and its designation as a health professional shortage area.
3.Evidence that the project will contain the cost of health care and provide a high quality of care.
4.Evidence that the project provides financial and geographical access to needed health care services.
5.Evidence that the project is primary care focused with referral and emergency provisions.
6.Evidence of unmet health care needs which require the waivers requested.
N.D. Admin. Code 33-03-25-05 Standards
1.Unless waived by the council, a pilot project must be in compliance with all state laws and rules.
2.Each pilot project must maintain safety and quality associated with the provision of health care services.
3.Personnel operating or providing health services must be competent and knowledgeable in terms of the services provided.
4.Backup personnel must be available to provide emergency medical assistance.
5.The physical plant must be appropriate for the services provided.
N.D. Admin. Code 33-03-25-06 Report from pilot project
As a condition of approval, the applicant must agree to report at least quarterly to the department and provide information specified by the council and department.
N.D. Admin. Code 33-03-25-07 Onsite review and continued approval
The department shall conduct an onsite review following initiation of the pilot project and at least one annual unannounced onsite review to evaluate the pilot project. Based on the onsite reviews and other information, the department shall provide an annual report to the council on each pilot project.
Based on its review and other information, the council shall renew its approval of the pilot project, require modification of the pilot project, or deny continued operation of the pilot project.
N.D. Admin. Code 33-03-25-08 Council report
The council shall provide a written report of its findings concerning each pilot project and will make recommendations to the next legislative assembly concerning any necessary changes in North Dakota statutes.
N.D. Admin. Code 33-03-25-09 Termination
Any project may be terminated at any time by the council or at the request of the legal agent of the project. The council may base its decision upon evidence that people have been or will be harmed by further operation or use of the pilot project, upon evidence that the project is excessively costly to operate or use, upon evidence that the project is not meeting its expressed purpose or meeting the needs of the people served, or upon other evidence considered by the council sufficient to justify termination. Discontinuance of a pilot project must be accomplished in an orderly fashion in a time frame and manner approved by the department.
Chapter 33-03-26 Organ Transplant Support Fund
N.D. Admin. Code 33-03-26-01 Selection process
Prior to the end of each biennium, the state health officer shall use the following procedure to select the private nonprofit patient-oriented organization incorporated in North Dakota which will administer grant moneys distributed from the organ transplant support fund provided for by the fifty-second legislative assembly in house bill no. 1499. Selection of the initial grant administrator must be made prior to January 1, 1992.
1.At least thirty days before the deadline for receipt of proposals, an advertisement must be placed in each daily newspaper in North Dakota. The advertisement must run at least once per week for two weeks. Facilities within North Dakota which perform transplants and individuals who have contacted the department in writing requesting a copy of the advertisement must also be mailed a copy of the advertisement at least thirty days prior to the deadline for receipt of proposals.
2.The advertisement must include the date for submission of proposals, a general description of the requirements necessary to meet the qualifications set forth in section 33-03-26-02 and the statutory requirements, where a copy of the specific requirements can be obtained, and a summary of the procedure to be used in making the selection.
3.Prior to submitting an advertisement, the state health officer shall establish a selection committee of five people consisting of the state health officer, two North Dakota transplant recipients, a representative selected by the North Dakota insurance commissioner, and a member of the staff of the department of human services who is familiar with the Medicaid program.
4.Upon receipt, the selection committee shall review and award from one to ten points for each qualification identified in section 33-03-26-02. The three applicants with the highest total score must be invited for a personal interview with the selection committee.
5.At the personal interview, the selection committee shall again score each applicant on each qualification on a scale from one to ten. The applicant with the highest total score, based only on the personal interview, must be offered the contract to administer grant moneys from the organ transplant support fund. If the offer is refused, the applicant with the second highest score must be offered the contract. If the second highest scoring applicant refuses to enter the contract, it must be offered to the third highest scoring applicant. If all three of the highest scoring applicants refuse to accept, the selection process will be reconducted beginning with a readvertisement. The requirement that the grant administrator be selected prior to the beginning of the biennium does not apply if the selection process must be redone. If the selection process is not completed prior to the end of the biennium and completion of the contract with the existing grant administrator, the existing grant administrator shall continue to administer the grant program in accordance with the existing contract.
History
- History: Effective December 1, 1991.
- General Authority: NDCC 23-01-05.1
- Law Implemented: NDCC 23-01-05.1
N.D. Admin. Code 33-03-26-02 Qualifications
The entity selected as the private nonprofit patient-oriented organization incorporated in North Dakota for administration of grants from the organ transplant support fund must be selected based upon the following:
1.Whether the organization meets the requirements of section 1 of 1991 house bill no. 1499. If the requirements of this subsection are not met, the organization may not be selected.
2.Whether the organization has a volunteer board of directors which has members representing transplant centers, medical social workers, transplant recipients, medical personnel, accountants, and attorneys.
3.Whether the organization is structured to allow for expeditious decisions.
4.Whether the organization is structured to avoid or minimize administrative costs so they do not exceed ten percent of available grant moneys.
5.Whether the organization's bylaws or structure provide that no part of the fund may be used for the benefit of the directors; and provide a mechanism to assure board members who may have a conflict are not able to vote or influence the board's decision on the matter on which a conflict exists.
6.Whether the organization has a demonstrated ability to raise funds from other sources.
7.Whether the organization has corporate goals which focus on patient needs associated with transplants.
8.The length of time the organization has been in existence.
History
- History: Effective December 1, 1991.
- General Authority: NDCC 23-01-05.1
- Law Implemented: NDCC 23-01-05.1
Chapter 33-03-27 State Community Matching Physician Loan Repayment Program [Repealed]
N.D. Admin. Code 33-03-27 State Community Matching Physician Loan Repayment Program [Repealed]
CHAPTER 33-03-27
STATE COMMUNITY MATCHING PHYSICIAN LOAN REPAYMENT PROGRAM [Repealed effective July 1, 2016]
Chapter 33-03-28 District Health Units
N.D. Admin. Code 33-03-28-01 Definitions
1."Approved health department" means a city health department which:
a.Is in compliance with all minimum standards for core services/programs as established by the department;
b.Has at a minimum, a city health officer and at least a one-half time registered nurse;
c.Submits records and reports as requested by the department; and
d.Is funded by the city at a level of at least two dollars and fifty cents per capita.
2."Department" means the state department of health.
3."District health unit" means one or more contiguous counties which have adopted a district health plan pursuant to North Dakota Century Code chapter 23-14. It includes all cities within the counties except those cities of greater than fifteen thousand population which have specifically rejected the plan.
History
- Law Implemented: NDCC 23-14-01.1
N.D. Admin. Code 33-03-28-02 District board of health - Name
Each newly formed district board of health shall select a name for its district health unit. The name may be changed at any time upon a majority vote by the district board of health.
History
- Law Implemented: NDCC 23-14-04, 23-14-09
N.D. Admin. Code 33-03-28-03 City-county health districts - Contracts
1.A contract entered into between an approved health department and a board of county commissioners pursuant to North Dakota Century Code sections 23-14-01.1 and 54-40-08 must specify the public health services and programs to be provided, the manner in which they will be provided, and the cost to the county for their provision.
2.The contract must be reviewed annually by the board of county commissioners and by the city health department to determine whether the services provided are adequate, whether additional needs exist, and whether any changes to the contract need to be negotiated.
History
- Law Implemented: NDCC 23-14-01.1
N.D. Admin. Code 33-03-28-04 Equality of services provided
1.The district board of health is responsible for determining which public health services and programs the district health unit will provide.
2.Any services provided by the district health unit must be made available to all areas within the health district.
3.If it is not practical for the district health unit to provide the services directly through its own staff, it may contract with another entity to deliver the services.
4.To maintain equality of service throughout the district, it is recommended that the district health unit employ, at a minimum, the services of at least a one-half time registered nurse for each county within the district, and that each county within the district have the services of a public health officer.
History
- Law Implemented: NDCC 23-14-01.6
N.D. Admin. Code 33-03-28-05 Distribution of grants
1.To be eligible for any grant of state moneys through the department, a district health unit must meet all of the following criteria:
a.Be funded at a level of two dollars and fifty cents or greater for each person residing within the health district exclusive of any state grant money;
b.Have an active district board of health that meets quarterly, maintains minutes of its meetings, and provides a copy of the minutes to the department;
c.Have the services of at least a one-half time registered nurse for each county within the district;
d.Have a health officer available for each county within the district;
e.Submit records and reports as requested by the department; and
f.Be in compliance with all minimum standards for core services and programs as established by the department.
2.Notwithstanding the provisions of subsection 1, any district health unit may, at the department's discretion, be granted a waiver of the requirements in subdivisions a, c, and f of subsection 1 for the first three years of the district's existence.
History
- Law Implemented: NDCC 23-14-01.6
Chapter 33-03-29 Residential Care Facilities for Children with Autism
N.D. Admin. Code 33-03-29-01 Definitions
1."Abuse" includes mental, physical, sexual, and verbal abuse. Mental abuse includes humiliation, harassment, threats of punishment, or deprivation. Physical abuse includes hitting, slapping, pinching, and kicking. It also includes controlling behavior through corporal punishment. Sexual abuse includes sexual harassment, sexual coercion, sexual contact, or sexual assault. Verbal abuse includes any use of oral, written, or gestured language that includes disparaging and derogatory terms to residents or their families, or within their hearing distance, to describe residents, regardless of their age, ability to comprehend, or disability.
2."Administrator" means the individual person who is in general administrative charge of the facility.
3."Autism" has the same meaning as in North Dakota Century Code chapter 23-09.4.
4."Children with autism" means individuals up to the age of twenty-two who have a medical diagnosis of autism or autistic-like characteristics.
5."Direct supervision" means the provision of guidance by a superior who is on the premises, for the accomplishment of an assigned task.
6."Mental health professional" means:
a.A psychologist with at least a master's degree who has been either licensed or approved for exemption by the North Dakota board of psychology examiners.
b.A social worker with a master's degree in social work from an accredited program.
c.A registered nurse with a master's degree in psychiatric nursing from an accredited program.
d.A registered nurse with a minimum of two years of psychiatric clinical experience under the supervision of a registered nurse as identified in subsection 3.
7."Neglect" includes failure to carry out resident services as directed or ordered by the physician or other authorized personnel in the facility, failure to give proper attention to facility residents, or failure to carry out services for residents of the facility as through careless oversight.
8."Resident" means an individual up to the age of twenty-two who lives and receives services in a residential care facility for children with autism.
History
- Law Implemented: NDCC 23-09.4-01, 23-09.4-02
N.D. Admin. Code 33-03-29-02 General licensing provision
1.No person or entity may establish, maintain, or operate a residential care facility for children with autism without first having obtained a license from the department. Any person or entity who owns or leases a residential care facility for children with autism and desires to maintain or operate it shall apply to the department for a license on the form prescribed and shall obtain a license before accepting children for care or treatment.
2.Each residential care facility for children with autism applying for licensure must be designated by a distinctive name consistent with the services offered to avoid public confusion or misrepresentation. The name may not be changed without department approval.
3.Upon receipt of a completed license application, the department shall review the residential care facility for children with autism, including architectural plans submitted by the facility, to determine compliance with this chapter, including onsite inspections, as appropriate.
4.Once received, the license must be displayed in a conspicuous place. Each license is valid only in the hands of the person or entity to whom it is issued and is not subject to sale, assignment, or other transfer, voluntary or involuntary.
5.The department may require submission of periodic reports including, but not limited to, staffing reports, census data, statistical information, and such business records as the department may reasonably require for the performance of its licensure functions.
6.The department and any duly authorized representative thereof has the right to enter upon and into the premises of any residential care facility for children with autism or facility providing services consistent with this chapter or the North Dakota statutory definition for residential care facility for children with autism.
7.An initial or renewal license is valid for one year from the date of issuance.
8.If a facility holds a current license from the department or another appropriate state agency and appropriately responds to the population served, then additional licensure under this
chapter is not required.
N.D. Admin. Code 33-03-29-03 Unrestricted license
An unrestricted license is valid for a period not to exceed one year from the date of issuance and must state the maximum number of persons who may reside in the residential care facility for children with autism.
N.D. Admin. Code 33-03-29-04 Provisional license
1.A provisional license may be issued to a residential care facility for children with autism which does not comply with this chapter if practices in the facility do not pose a danger to the health or safety of the residents as determined by the department.
2.A provisional license must be prominently stamped and state that the residential care facility for children with autism has failed to comply with applicable rules of the department and must be accompanied by a written statement of the specific rule or statute violated and the factual
basis of the violation. The provisional license must expire at a set date, not to exceed ninety days from the date of issuance.
3.A provisional license will be revoked by the department on the ninetieth day from the date of issuance, or sooner if applicable, if compliance is not achieved or a department-approved, acceptable plan of correction is not received. If compliance is achieved, the provisional license will be exchanged for an unrestricted license which will bear the same date as the date on which the facility was found by the department to be in compliance with the licensure rules.
N.D. Admin. Code 33-03-29-05 Denial or revocation of license
1.Application for renewal of a license for a residential care facility for children with autism must be denied and the license will be terminated or allowed to expire when the department finds that a condition, occurrence, or situation in the facility is a threat to the health or safety of the residents.
2.When the department decides that an application for renewal is to be denied, or that a license is to be revoked, the department shall notify the residential care facility for children with autism. The notice to the facility must include:
a.A clear and concise statement of the denial or revocation. The statement must include a citation to the provisions of this chapter on which the application for renewal is being denied, or the process for licensure revocation is being implemented.
b.A statement of the date on which the current license of the residential care facility for children with autism will expire must be included.
c.A description of the right of the applicant to appeal the denial or revocation of the application for the renewal of the license and the right to a hearing must be mailed to the licensee.
3.The current license of the residential care facility for children with autism may be extended by the department when it finds that such extension is necessary to assist relocation of residents.
History
- Law Implemented: NDCC 23-09.4-03, 23-09.4-08
N.D. Admin. Code 33-03-29-06 Denial of initial license
1.A suitability review by the department must be completed prior to approval of a licensure application.
2.A determination by the department through a suitability review to deny the issuance of a license must be based on a finding that one or more of the following criteria are met:
a.The applicant, any member of the firm, partnership, or association which is the applicant, any officer or stockholder of the corporation which is the applicant, or the person designated to manage or supervise the residential care facility for children with autism has been convicted of, or had probation for, a crime within the past five years that would impact the suitability of the applicant specific to operation of the facility. Probation or a conviction must be verified by a certified copy of the court record.
b.The applicant has had a prior license revocation in the past five years and both of the following conditions are met:
(1)The residential care facility for children with autism in question was owned or operated by the applicant, by a controlling owner of the applicant, by a combination of owners of the applicant, or by an affiliate who is a controlling owner of the applicant. Operated for purposes of this section means exercising overall management, direction, or supervision of the residential care facility for children with autism; and (2)The basis of the prior revocation renders the applicant unqualified or incapable of operating a residential care facility for children with autism in accordance with the standards set forth in this chapter. This determination will be based on the applicant's qualifications and ability to meet the criteria outlined in this section as evidenced by the application and the applicant's prior history.
N.D. Admin. Code 33-03-29-07 Criteria for adverse licensure actions
1.Adverse licensure actions include determinations to deny the issuance of an initial license, or to deny the issuance of a renewal of a license of a residential care facility for children with autism.
2.A determination by the department to take adverse licensure action against a residential care facility for children with autism may be based on a finding that one or more of the following criteria are met:
a.The residential care facility for children with autism has failed to meet the standards specified in this chapter.
b.The existing residential care facility for children with autism is operating, or the applicant intends to operate, with personnel which are insufficient in number or unqualified by training or experience to properly care for the number and type of residents in the facility.
c.The residential care facility for children with autism is not under direct supervision of an administrator or an individual assigned to carry out the administrative responsibilities.
d.The residential care facility for children with autism has committed either of the following actions:
(1)The residential care facility for children with autism has inappropriately converted for its own use the property of a resident.
(2)The residential care facility for children with autism has secured property, or a bequest of property, from a resident or family by undue influence.
e.The residential care facility for children with autism submitted false information either on the licensure or renewal application forms or during the course of an inspection or survey of the residential care facility for children with autism.
f.The residential care facility for children with autism has refused to allow an inspection or survey of the facility by agents of the department.
g.The facility employs personnel, has practices or procedures, or construction hazards which would be detrimental to the health, safety, or well-being of residents.
3.The department shall consider all available evidence at the time of the determination, including the history of the residential care facility for children with autism and the applicant in complying with this chapter, notices of violations which have been issued to the residential care facility for children with autism and the applicant, findings of surveys and inspections, and evidence provided by the residential care facility for children with autism, residents, law enforcement officials, and other interested individuals.
History
- Law Implemented: NDCC 23-09.4-02, 28-32-05.1
N.D. Admin. Code 33-03-29-08 Restriction or limitation of admissions
1.The department reserves the right to restrict or limit admissions to a residential care facility for children with autism under the following conditions:
a.One or more complaints of resident abuse in the residential care facility for children with autism have been reported, investigated, and substantiated by the department. The restriction will be in effect for six months or until the conditions leading to the abuse have been corrected as substantiated by the department.
b.The department has surveyed the facility and found rules related to health or safety are not being met or the facility is in the process of correction and placing additional residents in the facility would adversely affect the health or safety of a resident. The restriction will be in effect for six months or until the facility demonstrates to the department's satisfaction that the corrections have been made and the facility is in compliance with the licensure rules.
2.The department shall notify the facility in writing when a decision is made to restrict or limit admissions. The restriction or limitation takes effect ninety days from the date on which the onsite survey or complaint investigation visit was completed.
a.The notice must include the basis of the department's decision and must advise the facility of the right to request review through an onsite revisit by the department. The request must be made in writing within forty-five days of the survey or complaint investigation completion date.
b.If a request for review is made, the department will review all material relating to the allegation and to the limitation and restriction on admissions. The department shall determine, based on review of the material and an onsite revisit, if requested, whether or not to sustain the decision to limit or restrict placement of residents and shall notify the facility in writing of the decision within ten days of the completion of the onsite revisit.
c.If the department determined not to sustain the decision, the limitation or restriction may not be implemented. The restriction or limitation on admissions, if the department sustains the decision, will remain in effect until the department determines that the conditions leading to the restriction or limitation have been corrected.
d.When the department sustains the decision, a public notice must be published by the department in the local newspaper fifteen days prior to the imposition of the restriction or limitation stating the name of the facility, the restriction or limitation to be imposed, the date on which the limitation or restriction will be effective, and the length of time for which it will be imposed. Upon rescinding a restriction, the department will publish a notice in the local newspaper stating the date upon which the restriction was rescinded.
(1)The department of human services, developmental disabilities division, as well as the department of public instruction, special education division, must be notified in writing by the department regarding the restriction or limitation of admissions.
(2)Information regarding residential care facilities for children with autism is public information and is available upon request through this department.
e.A department decision may be appealed to the district court under North Dakota Century Code chapter 28-32.
History
- Law Implemented: NDCC 23-09.4-02, 23-09.4-03, 28-32-05.1
N.D. Admin. Code 33-03-29-09 Enforcement - Penalties
The purpose of enforcement actions is to protect residents. Enforcement actions by the department against a residential care facility for children with autism may include monetary penalties against a residential care facility for children with autism for failure to correct a violation or failure to comply with a department-approved plan of correction for such violation as follows:
1.Not less than five dollars per resident per day for each day the violation remains uncorrected if the area of noncompliance relates primarily to administrative tasks within the facility.
2.Not less than eight dollars per resident per day for each day the violation remains uncorrected if the noncompliance relates primarily to provisions dealing with the rights of residents as described in North Dakota Century Code chapter 50-10.2.
3.Not less than ten dollars per resident per day for each day the violation remains uncorrected for noncompliance relating primarily to provisions adopted to protect the health or safety of residents.
4.For purposes of department-imposed penalties under this section, a noncompliance issue or violation must be deemed to have first occurred as of the date of the department determination of noncompliance or the date of the onsite investigation completion, whichever is later.
History
- Law Implemented: NDCC 23-09.4-06, 23-09.4-08
N.D. Admin. Code 33-03-29-10 Accreditation
1.The residential care facility for children with autism shall provide services to assist children with a medical diagnosis of autism or autistic-like characteristics gain or regain their highest practicable level of mental, physical, and emotional functioning including the capacity to function adaptively in their environment, to care for themselves, and be accepted by society. In achieving this goal, residential care facilities for children with autism shall attain and maintain accreditation by the commission on accreditation of rehabilitation facilities standards for organizations serving people with disabilities in the categories of integrated living programs and infant and early childhood developmental programs or accreditation by the accreditation council on services for people with developmental disabilities.
2.The residential care facility for children with autism shall provide, through an interdisciplinary assessment and approach, at a minimum, services including:
a.Twenty-four-hour assistance with activities of daily living in a homelike environment which includes dietary, laundry, housekeeping, and janitorial services.
b.Provision of or arrangement for diagnostic and treatment services specific to the individual needs of children with autism including, but not limited to, medical, dental, nursing or physician services, audiology and speech services, physical and occupational therapy and orthotics services, and psychiatric services.
c.Behavioral management services provided by or under the direction of a qualified mental health professional.
d.Educational and special education services provided by certified personnel in accordance with North Dakota Century Code chapters 15-47 and 15-59.
3.As a result of interdisciplinary assessments, an individualized program plan for the resident must be established which describes specific needs, services, and time frames for implementation and evaluation.
4.The residential care facility for children with autism shall comply with all applicable federal, state, and local laws, rules, regulations, and requirements.
History
- Law Implemented: NDCC 23-09.4-02, 23-09.4-04, 23-09.4-05
N.D. Admin. Code 33-03-29-11 Submission and availability of accreditation documents
1.The residential care facility for children with autism, upon receipt, shall submit all accreditation survey results, recommendations, and plans of correction to the department.
2.The department may, based on the accreditation survey results, require changes or additions, or both, to recommendations or plans of corrections, or both, in instances where endangerment to the health, well-being, or safety of residents is involved.
3.In addition to department involvement with plans of correction, the department may impose enforcement sanctions including restriction or limitation of admissions, or monetary penalties.
4.Onsite review must be conducted by the department to assess compliance with licensure requirements not included in the accreditation process.
N.D. Admin. Code 33-03-29-12 Provision for becoming accredited
1.Residential care facilities for children with autism not having attained accreditation by the commission on accreditation of rehabilitation facilities in the categories of integrated living facility and infant and early childhood development programs or the accreditation council on services for people with developmental disabilities shall attain accreditation within twelve months of February 1, 1992.
2.Residential care facilities for children with autism requesting licensure after January 1, 1992, will be required to be accredited prior to licensure as a facility for children with autism.
N.D. Admin. Code 33-03-29-13 Complaints
1.No residential care facilities for children with autism or persons therein may violate resident rights as defined in North Dakota Century Code chapter 50-10.2.
2.Any person may register a complaint with the department alleging violation of applicable laws, rules, requirements, or allegations of abuse, neglect, or theft of resident funds by a facility or other persons in the residential care facility for children with autism. Individuals alleging abuse shall report to other entities as required by North Dakota Century Code section 50-25.1-03.
3.If a complaint becomes the subject of a formal administrative or judicial proceeding, nothing in this subsection may be construed to prohibit the disclosure of information which would otherwise be disclosed in a judicial or administrative proceeding.
4.The department shall have the authority to conduct unannounced inspections of the residential care facility for children with autism involved in a complaint and any other investigations necessary to determine the validity of the complaint.
5.The department or the department's representative shall notify the facility's administrator or person in charge of the facility involved in the complaint of the substance of the complaint for the first time at the time of the investigation.
6.No later than ten days after the completion of the investigation, the department shall prepare a written report of the results of the investigation and shall notify the complainant and the facility in writing of the results of the investigation.
7.Residential care facilities for children with autism are prohibited from discharging or discriminating in any way against a resident by whom or on whose behalf a complaint has been submitted to the department or who has participated in a complaint investigation process. Facilities are prohibited from discharging or discriminating against any employee who has submitted a complaint or who has assisted the department or any other legal authority in a complaint-related investigation for reason of such submission or assistance. Violation of prohibitions in this item is grounds for suspending or revoking a facility license.
History
- Law Implemented: NDCC 23-09.4-02, 23-09.4-06, 28-32-05.1
Chapter 33-03-30 Construction Standards for Residential Care Facilities for Children with Autism
N.D. Admin. Code 33-03-30-01 Definitions
In this chapter, unless the context or subject matter requires otherwise:
1."Ambulatory" means able to walk without assistance.
2."Department" means the state department of health.
3."Developmental disability" includes children with autism.
4."Mobile nonambulatory" means unable to walk without assistance, but able to move from place to place with the use of a walker, crutches, a wheelchair, or a wheeled platform.
5."Nonambulatory" means unable to walk without staff assistance.
6."Nonmobile" means unable to move from place to place without staff assistance.
7."Residential care facility for children with autism" means a residential facility providing a homelike atmosphere designed and arranged to meet the needs of ambulatory autistic children capable of taking action for self-preservation consistent with the fire code requirements.
History
- Law Implemented: NDCC 23-09.4-01, 23-09.4-02
N.D. Admin. Code 33-03-30-02 Location of residential care facilities for children with autism - Hazardous areas
1.Residential care facilities for children with autism must be located at least three hundred feet [91.44 meters] from hazardous areas such as bulk fuel or chemical storage areas, anhydrous ammonia facilities, or other fire hazards or sources of noxious or odoriferous emissions.
2.Residential care facilities for children with autism may not be located in areas subject to adverse environmental conditions such as mud slides, harmful air pollution, smoke or dust, sewage hazards, rodent or vermin infestations, excessive noise, vibration, or vehicular traffic.
3.Residential care facilities for children with autism may not be located in an area within the one hundred year flood base elevations unless the lowest floor elevation is above the one hundred year base flood elevation and the facility is free from significant adverse effects of the velocity of moving water or by wave impact during the one hundred year flood.
N.D. Admin. Code 33-03-30-03 Fire safety
1.Residential care facilities for children with autism must be located in areas served by an organized fire department.
2.Residential care facilities for children with autism must comply with chapter twenty-one of the 1988 edition of the Life Safety Code and its appendices. Residents of the facility must be ambulatory and capable of following directions and taking appropriate action forself-preservation under emergency conditions.
3.A residential care facility for children with autism for the mobile nonambulatory, nonambulatory, and nonmobile shall comply with chapters twelve or thirteen of the 1988 edition of the Life Safety Code as applicable. The fire safety evaluation system may be utilized in the evaluation of existing buildings.
N.D. Admin. Code 33-03-30-04 Water supply
1.Residential care facilities for children with autism must be located in areas where public or private water supplies approved by the department are available. Approved public water supplies must be used where available.
2.When a private water supply is utilized, annual water samples must be submitted to the department and analyzed to determine bacteriological and nitrate content.
N.D. Admin. Code 33-03-30-05 Sewage disposal
1.Residential care facilities for children with autism must be located in areas where public or private sewage systems approved by the department are available. Approved public sewage disposal systems must be used where available.
2.Plan and specifications for proposed private sewage disposal systems or alteration to such systems must be approved by the department prior to their construction.
N.D. Admin. Code 33-03-30-06 Physical plant
Buildings housing facilities for children with autism shall:
1.Provide a design making:
a.The residential care facility for children with autism for the ambulatory developmentally disabled accessible to nonambulatory visitors and employees, with at least one bathroom accessible to and usable by such visitors and employees. When the facility houses only ambulatory persons, the department may waive this requirement and the balance of the handicapped standards in North Dakota Century Code section 48-02-19. The waiver may be granted when only ambulatory developmentally disabled persons are served.
b.The residential care facility for children with autism for the mobile nonambulatory, nonambulatory, and nonmobile developmentally disabled comply with North Dakota Century Code section 48-02-19.
2.Be constructed to accommodate no more than fifteen eligible residents.
3.Be limited in size to a maximum of three hundred fifty square feet [32.52 square meters] per resident for the first eight residents, inclusive of space for employees. Facilities of more than eight resident beds must be limited to one hundred seventy-five square feet [16.26 square meters] per additional resident bed.
4.Provide space for dining, kitchen, family living, and recreation including outdoor play area, utility, and bedrooms as an integral part of a single structure.
5.Meet these sleeping area standards:
a.Require no more than two residents to share a bedroom other than on a temporary basis not to exceed ten days.
b.Provide no less than one hundred square feet [9.29 square meters] of floor area exclusive of bathroom and closet space for single occupancy bedrooms.
c.Provide no less than eighty square feet [7.43 square meters] per bed of floor space exclusive of closet and bathroom space in double occupancy bedrooms.
d.Locate bedrooms on an outside wall and separate them from other rooms and spaces by walls extending from floor to ceiling.
e.Locate bedrooms at or above grade level to provide sufficient window space to accommodate adequate lighting.
6.Provide at least one full bathroom for every four residents.
7.Be designed to accommodate the resident's privacy, with bedrooms and bathrooms arranged to provide separation of male and female residents.
8.Provide sufficient space in the kitchen to permit the participation of residents as well as staff in food preparation. Provide appropriate space and equipment, including two-compartment sink, to adequately serve the food preparation and storage requirements of the facility.
9.Provide sufficient laundry space to include, in addition to a washer and dryer, storage for laundry supplies, accommodation for ironing, and counterspace for folding clothing and linens.
10.Provide sufficient areas appropriate for group and individual classroom activities, recreational and leisure activities, special therapy, and family visiting activities.
11.Provide staff accommodations including space to accommodate employees, limited to living room, efficiency kitchen, one full bathroom, and a double occupancy bedroom, when as a condition of employment they must live onsite or a multipurpose space usable for sleeping for employees serving in shifts. Staff accommodations other than bedroom space, for employees required to live onsite may be utilized jointly by staff and residents.
12.Provide sufficient storage, in addition to closet space, to accommodate the storage of out-of-season clothing, outdoor furniture, garden tools, lawnmower, and other equipment as needed.
13.Provide a tempering valve, located to preclude resident access, to control the temperature of hot water supplied to lavatories and bathing facilities. The tempering valve must permit control of temperature in the range of one hundred ten degrees Fahrenheit [47.22 degrees Celsius] to one hundred forty degrees Fahrenheit [60 degrees Celsius]. Hot water supplied to clothes washers and dishwashers must be one hundred thirty-five to one hundred forty degrees Fahrenheit [57.22 to 60 degrees Celsius].
14.Be equipped with emergency lighting capable of sustained battery operation.
15.Provide for maintenance of building and equipment including:
a.The interior and exterior of the building must be clean, orderly, and in good repair.
b.All essential mechanical and electrical equipment must be maintained in a safe operating condition.
c.Resident care equipment must be clean and maintained in a safe operating condition.
d.There must be limitation of sound at comfort levels.
e.Provision must be made for adequate and comfortable lighting levels in all areas.
f.All resident areas must be clean, sanitary, and free from odors.
g.A comfortable room temperature must be maintained.
N.D. Admin. Code 33-03-30-07 Waiver process
Upon written application, the department may grant a waiver from specific provisions of this
chapter, except no waiver may be granted which may permit or authorize a danger to the health or safety of residents or impede their normalization process. Waivers specific to Life Safety Code requirements must be approved in writing by the state fire marshal prior to department approval.
Chapter 33-03-31 Certificate of Public Advantage [Repealed]
N.D. Admin. Code 33-03-31 Certificate of Public Advantage [Repealed]
CHAPTER 33-03-31
CERTIFICATE OF PUBLIC ADVANTAGE [Repealed effective October 1, 2013]
Determined repealed by the Legislative Council pursuant to North Dakota Century Code section 28-32-06 because the authority for adoption of the rules was repealed by S.L. 2013, ch. 35, § 10.
Chapter 33-03-32 State Community Matching Loan Repayment Program for Nurse Practitioners, Physicians Assistants, and Certified Nurse Midwives [Repealed]
N.D. Admin. Code 33-03-32 State Community Matching Loan Repayment Program for Nurse Practitioners, Physicians Assistants, and Certified Nurse Midwives [Repealed]
CHAPTER 33-03-32
STATE COMMUNITY MATCHING LOAN REPAYMENT PROGRAM FOR NURSE
PRACTITIONERS, PHYSICIANS ASSISTANTS, AND CERTIFIED NURSE MIDWIVES [Repealed effective July 1, 2016]
Chapter 33-03-33 Long-Term Care Nursing Scholarship and Loan Repayment Grant Program
N.D. Admin. Code 33-03-33-01 Definitions
1."Acceptable loan" means an educational loan to a nurse or an individual training to become a nurse under the long-term care nursing scholarship and loan repayment grant program which is made by a bank, credit union, savings and loan association, insurance company, accredited school, government, or other fiscal or credit institution in its capacity as lender and in which the lender is subject to examination and supervision by an agency of the United States or the state in which the lender has its principal place of business.
2."Applicant" means a licensed nursing facility seeking a grant for nursing education scholarships or loan repayments to nurses and other nursing facility staff employed or recruited by and employed or under contract with the applicant.
3."Council" means the state health council.
4."Department" means the state department of health.
5."Eligible nurse loan repayment applicant" means a nurse who is licensed or registered to practice by the North Dakota board of nursing and is employed or recruited by and under contract with a nursing facility.
6."Eligible scholarship applicant" means an individual enrolled in an accredited school of nursing approved by the North Dakota board of nursing, pursuing a nursing degree, and who is employed or recruited by and under contract with a nursing facility.
7."Nurse" has the meaning set forth in North Dakota Century Code section 43-12.1-02.
8."Nursing facility" has the meaning set forth in North Dakota Century Code section 50-30-01.
N.D. Admin. Code 33-03-33-02 Responsibilities and process
1.A nursing facility wishing to be designated as eligible for participation in the program shall complete an application form developed by the department. This application form will be available upon request from the department. Completed forms must be submitted to the department. In addition to the criteria stated in North Dakota Century Code section 23-01-03.3, the application must include assurances the nursing facility:
a.Is licensed by the department;
b.Has matching funds equal to the amount of the grant request;
c.Will use grant and matching dollars under this program for loan repayment or scholarship purposes; and
d.Will not use any money received under section 24 of chapter 431 of the 2001 Session Laws for the purpose of providing the facility's matching share of a long-term care nursing scholarship and loan repayment grant.
2.If a nursing facility files an application for a grant after June 30, 2002, the application must include a statement of nursing personnel needs and a plan to retain nurses that is acceptable to the council.
3.A nurse may apply to a nursing facility for a grant to repay an acceptable loan and an individual may apply to the nursing facility for a nursing education scholarship on an application form provided by the nursing facility.
4.Prior to July first each year, each nursing facility that receives a long-term care nursing scholarship and loan repayment grant shall submit an annual report to the department on a form supplied by the department.
5.The department will review each application for compliance with the law and rule. The council, at its next regularly scheduled meeting, will consider the applications recommended by the department and will approve or deny the applications.
N.D. Admin. Code 33-03-33-03 Eligibility and priority
If the council determines, with respect to grants awarded after June 30, 2002, that there are insufficient funds to give awards in the amount requested to all qualified nursing facilities, then the council in awarding grants may consider any factors that the council considers important to retain current nursing staff or recruit additional nurses at nursing facilities in this state.
Chapter 33-03-34 Autism Spectrum Disorder Database
N.D. Admin. Code 33-03-34-01 Purpose
The purpose of these rules is to establish and administer a state autism spectrum disorder database of all reported cases of autism spectrum disorder to improve current knowledge and understanding of autism spectrum disorder in North Dakota.
N.D. Admin. Code 33-03-34-02 Definitions
As used in this chapter:
1."Autism spectrum disorder" is a neurodevelopmental disorder that refers to a wide range of symptoms and severity levels which is typically manifested in impaired social interaction; problems with verbal and nonverbal communications; and restricted, repetitive patterns of behavior, interests, or activities.
2."Autism spectrum disorder database" is the system established by the department for reporting and recording of all reported cases of autism spectrum disorder in the state.
3."Complete physical evaluation" is the evaluation of an individual which is performed as part of the diagnostic process for autism spectrum disorder. The purpose is to rule out other conditions with similar symptoms to autism spectrum disorder.
4."Department" means the state department of health.
5."Reporter" is any physician, psychologist, or other licensed or certified health care professional who is qualified by training and by licensure or certification to make the diagnosis of autism spectrum disorder. Qualified reporters include physicians, psychologists, nurse practitioners, clinical nurse specialists, licensed independent clinical social workers, and licensed professional clinical counselors.
6."Licensed independent practitioner" is any practitioner permitted by law to provide care and services, without direction or supervision, within the scope of the practitioner license and consistent with individually assigned clinical responsibilities.
7."Reporter's designee" is a person who has been designated by a reporter to report an individual to the autism spectrum disorder database.
N.D. Admin. Code 33-03-34-03 Reporting requirements
1.A reporter or the reporter's designee shall report to the department any individual diagnosed with autism spectrum disorder who is the reporter's patient or client, provided the individual or at least one of the individual's parents or guardians is a resident of North Dakota.
2.A reporter or the reporter's designee shall report in the form and manner directed by the department, including the reported individual's diagnosis under the most recent edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders and whether a complete physical evaluation was performed by a licensed independent practitioner as part of the diagnostic process for autism spectrum disorder.
3.A reporter or the reporter's designee shall report newly diagnosed individuals to the department within thirty days of the diagnosis. A reporter or the reporter's designee shall report a previously diagnosed individual to the department within thirty days of the individual's first patient or client encounter with the reporter or thirty days of the effective date of these regulations, whichever is later.
Chapter 33-03-35 Residential End-of-Life Facility Regulation
N.D. Admin. Code 33-03-35-01 Definitions
1."Facility" means a residential end-of-life facility.
2."Residential services" means intermittent, nonpersonal care tasks, such as housekeeping, laundry, shopping, and arranging for transportation.
3."Support services" includes responsibility for patient health and safety, assistance with activities of daily living and instrumental activities of daily living, provision of leisure, recreational, and therapeutic activities, supervision of nutritional needs, and medication administration.
4."Volunteer services" means the services provided by individuals, voluntarily and without remuneration, who have successfully completed a training program implemented by the facility.
N.D. Admin. Code 33-03-35-02 Issuance of license and fees
A facility shall obtain a license from the department in order to operate in this state.
1.Application to operate a facility must be made to the department before opening a facility upon determination by the department that the facility meets the definition of a facility.
2.A facility shall apply to the department for a license in the form and manner prescribed by the department.
3.Upon receipt of an application for an initial license, the department may schedule an inspection. Upon completion of the inspection and consideration of the findings, the department may issue an initial or provisional license, or deny the application.
4.An initial license is valid for a period not to exceed one year and shall expire on December thirty-first of the year issued.
5.Licenses must be issued on a calendar year basis and expire on December thirty-first of each year. An application for licensure renewal must be received by the department thirty days before the beginning of the licensure period to process.
6.A provisional license may be issued to a facility that does not comply with this chapter if practices in the facility do not pose a danger to the health and safety of the patients, as determined by the department.
a.A provisional license must be accompanied by a written statement of the specific rules or statutes the facility is in noncompliance of and the expiration date of the license, which is not to exceed three months from the date of issuance.
b.If compliance with the requirements has been determined by the department before the expiration of the provisional license, an annual license may be issued. If an acceptable plan of correction has been approved by the department but compliance has not yet been achieved, the provisional license may be renewed no more than one time for an additional period up to three months at the discretion of the department.
7.The facility shall display the current license in a conspicuous place.
8.A facility shall notify the department and reapply for licensure upon any change in ownership of the facility.
9.A license is not subject to sale, assignment, or other transfer, voluntary or involuntary. A license is not valid for any premises other than those for which originally issued.
10.The department may, at any time, inspect a facility that the department determines meets the definition of a residential end-of-life facility as described in North Dakota Century Code
chapter 23-17.7 and this chapter, to determine compliance with licensure requirements and standards.
11.The department may deny, suspend, or revoke the license of a facility for noncompliance with North Dakota Century Code chapter 23-17.7 or this chapter.
12.The facility shall provide the department access to any materials and information necessary, as determined by the department, for determining compliance with licensure requirements and standards.
13.The facility shall submit floor plans directly or through an architect or engineer for new construction or a renovation project to be reviewed by the department. The estimated cost of the project is to accompany the submission of the project. Based on the estimated cost of the project, a letter is sent from the department to the facility administrator or designee indicating the plan review fee that needs to be submitted. The plan review fee schedule based on size and project costs is:
a.Small project. A fee of five hundred dollars for a project cost between zero and fifty thousand dollars.
b.Medium project. A fee of one percent of the project costs for a project cost between fifty thousand and one dollar and four million dollars.
c.Large project. A fee of forty thousand dollars plus twenty-five hundredths of one percent of the project cost after four million is subtracted for a project with project cost greater than four million dollars.
14.An application for a license for facilities not owned by the state or its political subdivisions must be accompanied by the following fees:
a.Ten thousand dollars for each initial application.
b.Two thousand five hundred dollars for each renewal application.
N.D. Admin. Code 33-03-35-03 Waiver provision
The department may waive licensure requirements for specified periods of time provided compliance with the requirement would result in an unreasonable hardship upon the facility and lack of compliance does not adversely affect the health or safety of the patients.
N.D. Admin. Code 33-03-35-04 Governing body
1.The facility shall have a clearly defined, organized governing body that assumes full legal responsibility for the overall conduct and operation of the facility.
2.The governing body is responsible for approval and implementation of effective patient care and administrative policies and procedures for the operation of the facility. These policies and procedures must be in writing, signed, dated, reviewed annually, and revised as necessary.
3.The governing body shall appoint an administrator to be in charge of the general administration of the facility. Provisions must be made in writing for an identified staff member to be responsible for the onsite operation of the facility in the absence of the administrator.
4.The governing body shall ensure sufficient trained and competent staff are available to provide twenty-four-hour residential and support services.
5.The governing body shall ensure training and competency evaluation is completed for all staff and volunteers specific to the care and services provided and necessary to meet the needs of the terminally ill patient.
6.The governing body shall ensure a homelike environment is provided and provide overnight family visitation within the facility.
7.The governing body shall ensure the facility has an agreement with one or more hospice programs licensed under North Dakota Century Code chapter 23-17.4 to provide hospice services. The agreement must clearly detail the responsibility of the parties involved and must include:
a.A detail of the licensed hospice program and the facility's responsibilities for all services delivered to the hospice patient or the hospice patient's family, including:
(1)Providing medical direction and management of the hospice patient;
(2)Nursing services;
(3)Spiritual, dietary, bereavement, or other counseling services;
(4)Social work;
(5)Provisions of medical supplies and equipment;
(6)Provisions of drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions; and (7)Any other hospice services that are necessary for the care of the patient.
b.A detail of the responsibilities of the hospice provider and the facility to provide bereavement services to facility staff.
c.The manner in which the facility and hospice program are to communicate and document communications to ensure patient needs are met twenty-four hours a day.
d.A provision allowing the hospice program to use the facility staff and volunteers to assist in the administration of the hospice plan of care only to the extent that the hospice program would routinely use the services of a volunteer or hospice patient's family in implementing the hospice plan of care.
e.A provision stating the licensed hospice program assumes responsibility for determining the appropriate course of hospice care, including the determination to change the level of services provided.
f.A requirement that the hospice program and facility coordinate regarding the hospice patient's plan of care and the facility patient's plan of care.
g.A statement that the facility agrees to abide by the hospice patient's plan of care established by the hospice program.
h.A requirement that the facility records must include documentation of all support services provided to the hospice patient and that a copy must be provided to the hospice program.
i.A provision that requires the facility to immediately notify the hospice program if:
(1)The patient has a significant change in physical, mental, social, or emotional status;
(2)Clinical complications appear that suggest a need to alter the hospice plan of care;
(3)A need to transfer a patient from the facility occurs; or (4)A patient dies.
N.D. Admin. Code 33-03-35-05 Codes and standards
1.A facility must be designed, constructed, equipped, maintained, and operated in compliance with:
a.North Dakota Century Code section 54-21.3-04.1, relating to accessibility standards;
b.The requirements for food and beverage establishments issued by the department;
c.Article 62-03.1 relating to plumbing standards;
d.Title 24.1 relating to electrical wiring standards; and
e.Article 45-12 relating to boiler rules and regulations.
2.A facility shall comply with all applicable building codes, ordinances, and rules of city, county, or state jurisdictions. The most stringent requirement must be applied.
N.D. Admin. Code 33-03-35-06 Plans and specifications
1.A facility shall submit plans and specifications to the department for approval for all construction, remodeling, and installations subject to review. The plans and specifications must be prepared by an architect or engineer licensed in North Dakota, unless otherwise determined by the department.
2.A facility shall contact the department prior to any substantial changes in or alterations to any portion of the structure to determine to what extent it is subject to review. A substantial change includes alterations affecting the fire safety or structural integrity of the building, changes in service areas or services provided within a service area, changes in bed capacity, or any other change governed by the standards of this chapter. The department may request plans, specifications, or other information as may be required and shall make the final determination on those areas subject to review.
3.Start of construction prior to approval by the department of the final plans and specifications is not permitted.
4.All construction, remodeling, and installations must be in accordance with the final plans and specifications approved by the department. Modifications or deviations from the approved plans and specifications must be submitted to and approved by the department.
5.The department may make inspections of construction, remodeling, or installations and arrange conferences with the facility to ensure conformance with approved plans and specifications.
6.The construction specifications must require the contractor to perform tests to ensure all systems conform to the approved plans and specifications.
N.D. Admin. Code 33-03-35-07 Fire safety
1.Each facility must be constructed as a single-story facility with a minimum construction Type V (111), that is arranged, equipped, maintained, and operated to ensure the safety of its occupants from fire, smoke, fumes, or resulting panic during the period of time necessary for escape from the structure in case of fire or other emergency. Walls and ceilings separating each dwelling unit must have a one-hour fire rating. Dwelling unit doors must be substantial doors, such as those of one and three-fourths inch thick, solid bonded wood-core construction or of other construction of equal or greater stability and fire integrity. These doors must be selfclosing or automatic closing and must be provided with latches or other mechanisms suitable for keeping the doors closed.
2.Every dwelling unit must have access to a primary and secondary means of escape located to provide a safe path of travel to the outside at grade level. Designated means of escape must be continuously maintained free of all obstructions.
3.No doors in any means of escape may be locked against egress when the building is occupied.
4.The facility shall provide an automatic fire alarm system with a means for manual activation.
Occupant notification must be provided automatically and without delay. Private operating mode must be permitted to be used. This allows staff and other personnel required to evacuate patients to be notified. The notification must include means to readily identify the area or building in need of evacuation. Each sleeping room must be provided with an approved smoke alarm that is interconnected to the fire alarm system. The fire alarm system must be installed and tested in accordance with National Fire Protection Association 72, National Fire Alarm and Signaling Code, 2010 edition.
5.The facility must be protected throughout by an approved automatic sprinkler system using quick-response, residential sprinklers or domestic sprinklers and must initiate the fire alarm system. All habitable areas, closets, roofed porches, roofed decks, and roofed balconies must be protected by the sprinkler system. An automatic sprinkler system with a minimum of a thirty-minute water supply must be permitted. The sprinkler system supervision must be in accordance with the type of sprinkler system that is installed and the testing for the system must be in accordance with National Fire Protection Association 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 2011 edition.
Attics used for storage or fuel-fired equipment must be protected with automatic sprinklers.
Attics not used for storage or fuel-fired equipment must be provided with one of the following:
a.Protected throughout by a heat detection system arranged to activate the building fire alarm system;
b.Protected with automatic sprinkler system;
c.Must be noncombustible construction; or
d.Constructed of fire-retardant-treated wood.
6.Any space where there is a storage or activity having fuel conditions exceeding those of a one- or two-family dwelling and that possesses the potential for a fully involved fire must have a one-hour fire resistance rating. These spaces must also be provided with an automatic fire detection system connected to the fire alarm system and the area must have automatic sprinkler protection.
7.Interior wall and ceiling finish materials must be class A, class B, or class C.
8.The facility shall maintain a written plan that specifies action and procedures for responding to emergency situations, such as fire; severe weather; loss of utility services, such as heat, water, sewer, or electricity; communicable disease outbreaks; or a missing individual. The plan must be developed with the assistance and advice of the local fire or rescue authority or any other appropriate resource. An accident or incident report must be maintained for at least one year. A copy of the plan must be readily available at all times.
9.The emergency plan must be clearly communicated to all staff during orientation. Each staff must be knowledgeable of and must implement the emergency plan. The duties and responsibilities under the emergency plan must be reviewed by the staff not less than every twelve months. The emergency plan must include:
a.Assignment of staff to specific tasks and responsibilities in case of an emergency situation;
b.Instructions relating to the use of alarm systems and signals;
c.Systems for notification of appropriate entities outside of the facility;
d.Information on the location of emergency equipment in the facility;
e.Specification of evacuation routes and procedures; and
f.A requirement that emergency egress drills must be conducted not less than six times per year on a bimonthly basis, with not less than two drills conducted during the night when patients and families may be sleeping. These records must include dates, times, duration, names of staff participating, and a brief description of the drill, including the escape path used and evidence of simulation of a call to the fire department. The emergency drills must be permitted to be announced to the patients and families in advance. These emergency drills must be conducted without disturbing patients and families by choosing the location of the simulated emergency in advance and by closing the doors in the vicinity prior to initiation of the drill. The purpose of an emergency drill is to test the efficiency, knowledge, and response of staff in implementing the emergency plan. Its purpose is not to disturb or excite patients and their families. Patients and families are not required to actively participate in the drill.
10.Portable fire extinguishers must be maintained in a fully charged and operable condition and must be kept in their designated locations at all times when they are not being used. Fire extinguishers must be installed so the maximum travel distance to an extinguisher is seventyfive feet and must be located along normal paths of travel, including exits from areas.
11.A facility may be directed to remove or correct other hazardous conditions not covered in this
chapter if the department considers the conditions to have the potential to cause injury or illness to the patients or staff.
N.D. Admin. Code 33-03-35-08 General building requirements
1.The facility shall design and equip areas for the comfort and privacy of each patient and patient's family. Each dwelling unit must have:
a.A bed, a mattress, appropriate bedding, a bedside stand, and a chair appropriate to the needs and comfort of the patient. All furniture and furnishings must be well-constructed, comfortable, in good repair, kept clean, and maintained in a serviceable condition.
b.Physical space for private patient and family visiting.
c.Physical space to ensure visual privacy for personal care.
d.Accommodations for the patient's family to remain with the patient. When sleeping accommodations, including a recliner, sleep chair, or sleep sofa, are in the patient room, adequate space for circulation when the furnishing is fully open must be provided so staff can access the patient in case of an emergency. Storage space must be provided to accommodate and secure overnight guests' belongings.
e.If a hardwired communication system is used in patient dwelling units, each patient must be provided with a call device. Calls must be initiated by a patient activating a device that sends a call signal to the staff call station or a hand-held mobile device carried by a staff member.
f.Bedroom windows must have window shades and provision shall be made for patient and family to completely darken the patient's room.
2.A facility shall allow patients to bring items from home to place in the bedroom to the extent the facility and space allows.
3.The facility shall provide space for storage of clean linen, clean supplies, patient care equipment, housekeeping, and cleaning supplies.
4.Grab bars must comply with all local, state, and federal requirements. Grab bars must be installed in all patient toilet rooms, showers, and bathing facilities. Toilets used by patients must allow sufficient clearance on both sides to enable physical access and maneuvering by caregivers who may have to assist patients in wheelchair-to-toilet transfers and returns.
5.Ground fault circuit interrupters must be provided for outlets within six feet of the outside edge of a sink.
6.A convenience portable space heater, portable halogen lamp, household-type electric blanket, or household-type heating pad may not be used in a facility.
7.The storage and transfilling of oxygen cylinders or containers must meet the requirements of the National Fire Protection Association 99, Standard for Health Care Occupancies, 2012 edition.
8.Electrically powered exhaust ventilation must be provided in all soiled areas, wet areas, toilet rooms, and storage rooms. Clean storage rooms may also be ventilated by supplying and returning air from the building's air-handling system. The facility shall provide for adequate ventilation to assure an odor-free, comfortable environment.
9.Office space and other areas must be furnished with desks, chairs, lamps, cabinets, benches, worktables, or other furnishings essential to the proper use of the area.
10.Families shall have showering capabilities in a dedicated toilet room.
11.Staff shall have showering capabilities in a dedicated staff toilet room.
12.An essential electrical source must provide lighting for at least a ninety-minute duration during an interruption of the normal electrical supply. Illumination must be automatic and is permitted to be met by means, such as:
a.Two separate electric lighting systems with independent wiring. One system is permitted to be supplied from an outside source, such as a public utility service, and the other from an electric generator on the premises driven by an independent source of power; or
b.An electric circuit, or circuits, used only for means of egress illumination, with two independent electric sources arranged so that, on the failure of one, the other will automatically and immediately operate. One such source is permitted to be a connection from a public utility, or similar outside power source, and the other an approved storage battery with suitable provisions to keep it automatically charged.
13.Emergency lighting for safe egress and access shall be evaluated for all facilities. Each patient bedroom must have general lighting and night lighting.
14.Functional testing shall be conducted monthly for not less than thirty minutes for generators and not less than thirty seconds for battery-powered lighting. Functional testing shall also be conducted annually for a minimum of ninety minutes.
N.D. Admin. Code 33-03-35-09 Patient records
1.The facility shall keep accurate, current, and confidential records of all patients.
2.The facility shall provide for secure maintenance and storage of all patient records.
3.Patient records must include:
a.Complete identification of each patient, including information on the patient's next of kin and responsible person.
b.Initial and subsequent assessments of each patient.
c.The current person-centered care plan.
d.The current hospice care plan.
e.Complete documentation of all services rendered.
f.An admission note.
g.A medication administration record documenting medication administration consistent with applicable state laws, rules, and practice acts.
h.Consent and authorization forms.
i.A discharge note, including disposition of the patient's personal effects, money, or valuables deposited with the facility.
4.The facility shall maintain patient records for a period of not less than five years from the date of discharge or death.
N.D. Admin. Code 33-03-35-10 Pharmacy and medication administration services
1.The facility shall coordinate with the licensed hospice provider for the administration and provision of pharmaceutical services consistent with the drug therapy needs of the patient.
2.The facility shall provide assistance to the patient in obtaining necessary medications and medical supplies.
3.Drugs and biologicals must be administered by an individual certified or licensed to administer medications or the patient, family member, or other caregiver as specified in the patient's plan of care.
4.The facility shall provide a secure area for medication storage and shall have policies and procedures for the control, storage, handling, administration, recordkeeping, and disposal of medication, including medications the patient brought from home.
5.All medications used by patients which are administered or supervised by staff must be:
a.Properly recorded by staff at the time of administration.
b.Kept and stored in original containers labeled consistently with state laws.
c.Properly administered.
N.D. Admin. Code 33-03-35-11 Dietary services
The facility shall meet the dietary needs of the patients, provide dietary services, and the sanitary requirements for food establishments in compliance with chapter 33-33-04.1.
N.D. Admin. Code 33-03-35-12 Housekeeping and laundry services
The facility shall provide housekeeping and maintenance services necessary to maintain the interior and exterior of the facility in a safe, clean, orderly, and comfortable manner and provide sanitary laundry services, including personal laundry services for patients.
N.D. Admin. Code 33-03-35-13 Admission criteria
Admission and discharge planning for hospice patients must be coordinated with a licensed hospice program.
N.D. Admin. Code 33-03-35-14 Staffing
1.The facility shall maintain a sufficient number of qualified staff and volunteers who are trained and competent to provide the care and services necessary to meet the needs of the terminally ill patient.
2.The facility shall employ or contract with a registered nurse to supervise patient care to meet the needs of the patients at all times, either directly or indirectly. The facility shall employ, contract, or utilize volunteer services of a licensed nurse to respond to patient needs.
3.When utilizing volunteer services:
a.The facility shall provide for appropriate orientation and training that is consistent with acceptable standards of end-of-life care. There must be an orientation that identifies the tasks the volunteer is expected to perform. The orientation program must include, at a minimum:
(1)The facility goals, services, and philosophy;
(2)Confidentiality and protection of patient and family rights;
(3)Procedures to be followed in an emergency and following the death of a patient; and (4)Guidance related specifically to individual responsibilities.
b.The facility shall establish a process to assure volunteers are effectively performing the duties and responsibilities assigned.
c.A facility shall ensure a volunteer only provides direct patient care when the following provisions are met:
(1)Tasks and responsibilities are specified in writing and do not exceed the volunteer's capability;
(2)Care is consistent with the hospice service plan;
(3)The volunteer shall be appropriately licensed, registered, or certified, if required;
(4)Services rendered must be recorded in the patient's record;
(5)The volunteer shall have a clear understanding of the volunteer's duties and responsibilities; and (6)Volunteers shall be informed to whom they report and whom to contact if assistance is needed in carrying out their responsibilities.
N.D. Admin. Code 33-03-35-15 Patient and family rights
The facility shall develop, adopt, and implement a statement of the rights and responsibilities of hospice patients and members of the hospice patient's family. This statement must be provided to the patient or family member designated by the patient prior to or at the time of admission to the facility.
The statement must include provisions assuring each patient and family the following minimum rights:
1.The right to be clearly informed of the responsibilities of the facility for care of the patient and family, including services to be provided.
2.The right to be fully informed, at the time of admission, of the materials and equipment available to the patient and family, any financial policies, and estimated cost.
3.The right to privacy in treatment and in caring for personal needs, and confidentiality in the treatment of personal and service records.
4.The right to be informed of any change in patient status.
5.The right to be treated courteously, fairly, and with the fullest measure of dignity.
Chapter 33-03-36 Extended Stay Center Registration
N.D. Admin. Code 33-03-36-01 Definitions
1."Ambulatory surgical center" means a facility that is certified as an ambulatory surgical center by the centers for Medicare and Medicaid services.
2."Facility" means an extended stay center.
3."License" means a certificate of registration.
N.D. Admin. Code 33-03-36-02 Issuance of license and fees
A facility shall obtain a license from the department in order to operate in this state.
1.Application to operate a facility must be made to the department prior to opening a facility upon determination by the department that the facility meets the definition of a facility.
2.A facility shall apply to the department for a license in the form and manner prescribed by the department.
3.Upon receipt of an application for an initial license, the department may schedule an inspection. Upon completion of the inspection and consideration of the findings, the department may issue an initial or provisional license, or deny the application.
4.An initial license is valid for a period not to exceed one year and shall expire on December thirty-first of the year issued.
5.Licenses must be issued on a calendar year basis and expire on December thirty-first of each year. An application for licensure renewal must be received by the department thirty days prior to the beginning of the licensure period to process.
6.A provisional license may be issued to a facility that does not comply with this chapter if practices in the facility do not pose a danger to the health and safety of the patients, as determined by the department.
a.A provisional license must be accompanied by a written statement of the specific rules or statutes the facility is in noncompliance of and the expiration date of the license, which is not to exceed three months from the date of issuance.
b.If compliance with the requirements has been determined by the department prior to the expiration of the provisional license, an annual license may be issued. If an acceptable plan of correction has been approved by the department but compliance has not yet been achieved, the provisional license may be renewed no more than one time for an additional period up to three months at the discretion of the department.
7.The facility shall display the current license in a conspicuous place.
8.A facility shall notify the department and reapply for licensure upon any change in ownership of the facility.
9.A license is not subject to sale, assignment, or other transfer, voluntary or involuntary. A license is not valid for any premises other than those for which originally issued.
10.The department may, at any time, inspect a facility that the department determines meets the definition of an extended stay center as described in North Dakota Century Code chapter 23-17.6 and this chapter, to determine compliance with licensure requirements and standards.
11.The department may deny, suspend, or revoke the license of a facility for noncompliance with North Dakota Century Code chapter 23-17.6 or this chapter.
12.The facility shall provide the department access to any materials and information necessary, as determined by the department, for determining compliance with licensure requirements and standards.
13.The facility shall submit floor plans directly or through an architect or engineer for new construction or a renovation project to be reviewed by the department. The estimated cost of the project is to accompany the submission of the project. Based on the estimated cost of the project, a letter is sent from the department to the facility administrator or designee indicating the plan review fee that needs to be submitted. The plan review fee schedule based on size and project costs is:
a.Small project: A fee of five hundred dollars for a project cost between zero and fifty thousand dollars.
b.Medium project: A fee of one percent of the project costs for a project cost between fifty thousand and one dollar and four million dollars.
c.Large project: A fee of forty thousand dollars plus twenty-five hundredths of one percent of the project cost after four million dollars is subtracted for a project with project cost greater than four million dollars.
14.An application for a license for facilities not owned by the state or its political subdivisions must be accompanied by the following fees:
a.Ten thousand dollars for each initial application.
b.Two thousand five hundred dollars for each renewal application.
N.D. Admin. Code 33-03-36-03 Waiver provision
The department may waive licensure requirements for specified periods of time provided compliance with the requirement would result in an unreasonable hardship upon the facility and lack of compliance does not adversely affect the health or safety of the patients.
N.D. Admin. Code 33-03-36-04 Governing body
1.The facility shall have a clearly defined, organized governing body that assumes full legal responsibility for the overall conduct and operation of the facility.
2.The governing body is responsible for approval and implementation of effective patient care and administrative policies and procedures for the operation of the facility. These policies and procedures must be in writing, signed, dated, reviewed annually, and revised as necessary.
3.The governing body shall appoint an administrator to be in charge of the general administration of the facility. Provisions must be made in writing for an identified staff member to be responsible for the onsite operation of the facility in the absence of the administrator.
4.The governing body shall ensure sufficient trained and competent staff are available to provide twenty-four hour extended stay services whenever there are patients admitted.
5.The governing body shall ensure training and competency evaluation is completed for all staff and volunteers specific to the care and services provided and necessary to meet the needs of the patients.
6.The governing body shall ensure the facility has a written agreement with one or more affiliated ambulatory surgery centers who have been certified for more than twenty-four consecutive months. The agreement must clearly detail the responsibility of the parties involved.
N.D. Admin. Code 33-03-36-05 Codes and standards
1.A facility must be designed, constructed, equipped, maintained, and operated in compliance with:
a.North Dakota Century Code section 54-21.3-04.1, relating to accessibility standards;
b.The requirements for food and beverage establishments issued by the department;
c.Article 62-03.1 relating to plumbing standards;
d.Article 24.1-06 relating to electrical wiring standards; and
e.Article 45-12 relating to boiler rules and regulations.
2.A facility shall comply with all applicable building codes, ordinances, and rules of city, county, or state jurisdictions. The most stringent requirement must be applied.
N.D. Admin. Code 33-03-36-06 Plans and specifications
1.A facility shall submit plans and specifications to the department for approval for all construction, remodeling, and installations subject to review. The plans and specifications must be prepared by an architect or engineer licensed in North Dakota, unless otherwise determined by the department.
2.A facility shall contact the department prior to any substantial changes in or alterations to any portion of the structure to determine to what extent it is subject to review. A substantial change includes alterations affecting the fire safety or structural integrity of the building, changes in service areas or services provided within a service area, changes in bed capacity, or any other change governed by the standards of this chapter. The department may request plans, specifications, or other information as may be required and shall make the final determination on those areas subject to review.
3.Start of construction prior to approval by the department of the final plans and specifications is not permitted.
4.All construction, remodeling, and installations must be in accordance with the final plans and specifications approved by the department. Modifications or deviations from the approved plans and specifications must be submitted to and approved by the department.
5.The department may make inspections of construction, remodeling, or installations and arrange conferences with the facility to ensure conformance with approved plans and specifications.
6.The construction specifications must require the contractor to perform tests to ensure all systems conform to the approved plans and specifications.
N.D. Admin. Code 33-03-36-07 General building requirements
1.The facility shall design and equip areas for the comfort and privacy of each patient. Each patient room must have:
a.A bed, a mattress, appropriate bedding, a bedside stand, and a chair appropriate to the needs and comfort of the patient. All furniture and furnishings must be well-constructed, comfortable, in good repair, kept clean and maintained in a serviceable condition.
b.Physical space for private visiting.
c.Physical space to ensure visual privacy for personal care.
d.If a hardwired communication system is used in patient rooms, each patient must be provided with a call device. Calls must be initiated by a patient activating a device that sends a call signal to the staff call station or a hand-held mobile device carried by a staff member.
e.A window with a shade.
f.Patient toilet room with a handwashing station. Each patient shall have access to a toilet room without having to enter a corridor. Toilets used by patients must allow sufficient clearance on both sides to enable physical access and maneuvering by caregivers who may have to assist patients in wheelchair-to-toilet transfers and returns.
2.The facility shall provide space for storage of clean linen, clean supplies, patient care equipment, housekeeping, and cleaning supplies.
3.Grab bars must be installed in all patient toilet rooms, showers, and bathing facilities. Grab bars must comply with all local, state, and federal requirements.
4.Ground fault circuit interrupters must be provided for outlets within six feet [1.83 meters] of the outside edge of a sink.
5.A convenience portable space heater, portable halogen lamp, household-type electric blanket, or household-type heating pad may not be used in a facility.
6.The storage and transfilling of oxygen cylinders or containers must meet the requirements of the National Fire Protection Association 99, Standard for Health Care Occupancies, 2012 edition.
7.Electrically powered exhaust ventilation must be provided in all soiled areas, wet areas, toilet rooms, and storage rooms. Clean storage rooms may also be ventilated by supplying and returning air from the building's air-handling system. The facility shall provide for adequate ventilation to assure an odor-free, comfortable environment.
8.Office space and other areas must be furnished with desks, chairs, lamps, cabinets, benches, worktables, or other furnishings essential to the proper use of the area.
9.The facility shall provide a dedicated staff toilet room.
10.An essential electrical source must provide lighting for at least a ninety-minute duration during an interruption of the normal electrical supply. Illumination must be automatic and is permitted to be met by means such as:
a.Two separate electric lighting systems with independent wiring. One system is permitted to be supplied from an outside source, such as a public utility service, and the other from an electric generator on the premises driven by an independent source of power, or
b.An electric circuit, or circuits, used only for means of egress illumination, with two independent electric sources arranged so that, on the failure of one, the other will automatically and immediately operate. One such source is permitted to be a connection from a public utility, or similar outside power source, and the other an approved storage battery with suitable provisions to keep it automatically charged.
11.Emergency lighting for safe egress and access shall be evaluated for all facilities. Each patient room must have general lighting and night lighting.
12.Functional testing shall be conducted monthly for not less than thirty minutes for generators and not less than thirty seconds for battery-powered lighting. Functional testing shall also be conducted annually for a minimum of ninety minutes.
N.D. Admin. Code 33-03-36-08 Fire safety
1.Each facility must be a maximum of two stories in height with a minimum construction type rating of one hour, that is arranged, equipped, maintained, and operated to ensure the safety of its occupants from fire, smoke, fumes, or resulting panic during the period of time necessary for escape from the structure in case of fire or other emergency. Walls and ceilings separating each patient room must have a one-hour fire rating. Patient room doors must be substantial doors, such as those of one and three-fourths inch [4.45 centimeters] thick, solid bonded wood-core construction or of other construction of equal or greater stability and fire integrity. These doors must be self-closing or automatic closing and must be provided with latches or other mechanisms suitable for keeping the doors closed.
2.Every patient room must have access to a primary and secondary means of escape located to provide a safe path of travel to the outside. Designated means of escape must be continuously maintained free of all obstructions.
3.No doors in any means of escape may be locked against egress when the building is occupied.
4.The facility shall provide an automatic fire alarm system with a means for manual activation.
Occupant notification must be provided automatically and without delay. Private operating mode must be permitted to be used. This allows staff and other personnel required to evacuate patients to be notified. The notification must include means to readily identify the area or building in need of evacuation. Each sleeping room must be provided with an approved smoke alarm that is interconnected to the fire alarm system. The fire alarm system must be installed and tested in accordance with National Fire Protection Association 72, National Fire Alarm and Signaling Code, 2010 edition.
5.The facility must be protected throughout by an approved automatic sprinkler system using quick-response, residential sprinklers or domestic sprinklers and must initiate the fire alarm system. All habitable areas, closets, roofed porches, roofed decks, and roofed balconies must be protected by the sprinkler system. An automatic sprinkler system with a minimum of a thirty-minute water supply must be permitted. The sprinkler system supervision must be in accordance with the type of sprinkler system that is installed and the testing for the system must be in accordance with National Fire Protection Association 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 2011 edition.
Attics used for storage or fuel-fired equipment must be protected with automatic sprinklers.
Attics not used for storage or fuel-fired equipment must be provided with one of the following:
a.Protected throughout by a heat detection system arranged to activate the building fire alarm system;
b.Protected with automatic sprinkler system;
c.Must be noncombustible construction; or
d.Constructed of fire-retardant-treated wood.
6.Any space where there is a storage or activity having fuel conditions exceeding those of a one or two-family dwelling and that possesses the potential for a fully involved fire must have a one-hour fire resistance rating. These spaces must also be provided with an automatic fire detection system connected to the fire alarm system and the area must have automatic sprinkler protection.
7.Interior wall and ceiling finish materials must be class A, class B, or class C.
8.The facility shall maintain a written plan that specifies action and procedures for responding to emergency situations such as fire, severe weather, loss of utility services such as heat, water, sewer, or electricity, communicable disease outbreaks, or a missing individual. The plan must be developed with the assistance and advice of the local fire or rescue authority or any other appropriate resource. An accident or incident report must be maintained for at least one year.
A copy of the plan must be readily available at all times.
9.The emergency plan must be clearly communicated to all staff during orientation. Each staff must be knowledgeable of and must implement the emergency plan. The duties and responsibilities under the emergency plan must be reviewed by the staff not less than every twelve months. The emergency plan must include:
a.Assignment of staff to specific tasks and responsibilities in case of an emergency situation;
b.Instructions relating to the use of alarm systems and signals;
c.Systems for notification of appropriate entities outside of the facility;
d.Information on the location of emergency equipment in the facility;
e.Specification of evacuation routes and procedures; and
f.A requirement that emergency egress drills must be conducted not less than six times per year on a bimonthly basis, with not less than two drills conducted during the night when patients may be sleeping. These records must include dates, times, duration, names of staff participating, and a brief description of the drill, including the escape path used and evidence of simulation of a call to the fire department. The emergency drills must be permitted to be announced to the patients in advance. These emergency drills must be conducted without disturbing patients by choosing the location of the simulated emergency in advance and by closing the doors in the vicinity prior to initiation of the drill.
The purpose of an emergency drill is to test the efficiency, knowledge, and response of staff in implementing the emergency plan. Its purpose is not to disturb or excite patients.
Patients and families are not required to actively participate in the drill.
10.Portable fire extinguishers must be maintained in a fully charged and operable condition and must be kept in their designated locations at all times when they are not being used. Fire extinguishers must be installed so the maximum travel distance to an extinguisher is seventyfive feet [22.86 meters] and must be located along normal paths of travel, including exits from areas.
11.A facility may be directed to remove or correct other hazardous conditions not covered in this
chapter if the department considers the conditions to have the potential to cause injury or illness to the patients or staff.
N.D. Admin. Code 33-03-36-09 Patient records
1.The facility shall keep accurate, current, and confidential records of all patients.
2.The facility shall provide for secure maintenance and storage of all patient records.
3.Patient records must include:
a.Complete identification of each patient, including information on the patient's next of kin and responsible person.
b.Initial and subsequent assessments of each patient.
c.The current person-centered care plan.
d.Complete documentation of all services rendered.
e.An admission note.
f.A medication administration record documenting medication administration consistent with applicable state laws, rules, and practice acts.
g.Consent and authorization forms.
h.A discharge note, including disposition of the patient's personal effects, money, or valuables deposited with the facility.
4.The facility shall maintain patient records for a period of not less than five years from the date of discharge.
N.D. Admin. Code 33-03-36-10 Pharmacy and medication administration services
1.The facility shall provide assistance to the patient in obtaining necessary medications and medical supplies.
2.Drugs and biologicals must be administered by an individual certified or licensed to administer medications or the patient.
3.The facility shall provide a secure area for medication storage and shall have policies and procedures for the control, storage, handling, administration, recordkeeping, and disposal of medication, including medications the patient brought from home.
4.All medications used by patients which are administered or supervised by staff must be:
a.Properly recorded by staff at the time of administration.
b.Kept and stored in original containers labeled consistently with state laws.
c.Properly administered.
N.D. Admin. Code 33-03-36-11 Dietary services
The facility shall meet the dietary needs of the patients, provide dietary services, and the sanitary requirements for food establishments in compliance with chapter 33-33-04.1.
N.D. Admin. Code 33-03-36-12 Housekeeping and laundry services
The facility shall provide housekeeping and maintenance services necessary to maintain the interior and exterior of the facility in a safe, clean, orderly, and comfortable manner and provide sanitary laundry services.
N.D. Admin. Code 33-03-36-13 Admission and discharge criteria
Admission and discharge criteria must be specified in writing.
N.D. Admin. Code 33-03-36-14 Staffing
1.The facility shall employ or contract with a registered nurse to supervise patient care to meet the needs of the patients at all times.
2.The facility shall maintain a sufficient number of qualified staff who are trained and competent to provide the care and services necessary to meet the needs.
N.D. Admin. Code 33-03-36-15 Patient rights
The facility shall develop, adopt, and implement a statement of the rights and responsibilities of patients. This statement must be provided to the patient or the patient representative prior to or at the time of admission to the facility. The statement must include provisions assuring each patient the following minimum rights:
1.The right to be clearly informed of the responsibilities of the facility for care of the patient, including services to be provided.
2.The right to be fully informed, at the time of admission, of the materials and equipment available to the patient, any financial policies, and estimated cost.
3.The right to privacy in treatment and in caring for personal needs, and confidentiality in the treatment of personal and service records.
4.The right to be informed of any change in patient status.
5.The right to be treated courteously, fairly, and with the fullest measure of dignity.
N.D. Admin. Code 33-03-36-16 Data and metrics reporting
The facility shall provide data and metrics to the department as determined by the department.
Chapter 33-03-37 Health Care Professional Student Loan Repayment Program
N.D. Admin. Code 33-03-37-01 Definitions
1."Defined area of need" means a service area or site selected considering the availability of health care services available to individuals who are underserved, experiencing health care professional shortage, or in a rural area.
2."Department" means the department of health and human services.
3."Direct health care services" means case consultation, case management, management of an individual's medications, charting, care coordination activities, diagnostic and treatment services followup, telehealth, and patient correspondence.
4."Employer" means a public or private entity seeking to fill health care needs and includes a clinic, hospital, tribal health organization, an institution or facility that provides services to an individual with developmental disabilities, substance use disorder treatment programs, behavioral health clinic, long-term care facility, assisted living home, correctional facility, a site, or other health care organization that employs health care professionals.
5."Full-time" means a permanent and program-eligible health care professional position in which the health care professional:
a.Is physically present and works in a defined area of need at least thirty hours each week at the location identified in the contract; and
b.Works thirty hours in no less than three days each week.
6."Half-time" means a permanent and program-eligible health care professional position in which the health care professional:
a.Is physically present and works in a defined area of need at least fifteen hours each week at the location identified in the contract;
b.Works fifteen hours at the location identified in the contract no less than two days each week; and
c.Provides telehealth services at least fifteen hours each week in a defined area of need to a second location identified in the contract.
7."Health care professional" means a qualifying individual practicing as a physician, clinical psychologist, advanced practice registered nurse, registered nurse, physician assistant, or behavioral health professional who provides direct health care services.
8."Loan repayment" means money specified in a health care professional's authorized service contract to be paid directly to the loan servicer.
9."Program" means the health care professional student loan repayment program.
10."Site" means a university, technical college, or teaching hospital that provides education or training to health care professionals; a federally qualified health center; or other facilities.
History
- Law Implemented: NDCC 43-12.3-01
N.D. Admin. Code 33-03-37-02 Designation as a defined area of need
The department shall designate a service area or site as being or as being located in a defined area of need, if at least one of the following criteria is met:
1.There is evidence that at least thirty percent of the population consists of individuals who are underserved;
2.The service area is a rural area;
3.The level of support from the service area;
4.The United States department of health and human services' health resources and services administration has:
a.Designated the service area as a health professional shortage area under 42 U.S.C. 254e; or
b.Designated the service area as a medically underserved area or one with a medically underserved population; or
5.There is evidence that the site provides education or training to health care professionals seeking to fill health care needs and to increase access to health care services.
History
- Law Implemented: NDCC 43-12.3-03, 43-12.3-04
N.D. Admin. Code 33-03-37-03 Health care professional eligibility
A health care professional shall meet the following requirements to be eligible to participate in this program:
1.The health care professional meets the criteria established by this chapter and North Dakota Century Code sections 43-12.3-05 and 43-12.3-06.
2.The health care professional works full time or half time. If a health care professional works more than twelve hours in any twenty-four-hour period, only twelve hours will count toward the health care professional's full-time or half-time status.
3.The health care professional may not have a simultaneous contract or service obligation with another person for loan repayment. For purposes of this subsection, a simultaneous contract or service obligation does not include:
a.An employer's signon bonus, retention bonus, or productivity bonus;
b.A service obligation in the:
(1)Reserves of the armed forces of the United States;
(2)North Dakota national guard; or (3)Commissioned corps of the United States department of health and human services, office of the surgeon general, public health service; or
c.Public service loan forgiveness.
4.The health care professional is qualified to work in the United States.
5.The employer contractually commits to provide matching funds equal to the amount required by North Dakota Century Code section 43-12.3-06.
6.The health care professional agrees to provide services to patients covered by Medicare and Medicaid, if applicable.
History
- Law Implemented: NDCC 43-12.3-05, 43-12.3-06
N.D. Admin. Code 33-03-37-04 Employer eligibility
To participate in the program an employer shall:
1.Provide services in a service area or site that is or is located in a defined area of need established under section 33-03-37-02;
2.Submit an employer application in the form and manner approved by the department;
3.Maintain clinical and employment documentation for auditing and provide required documents within thirty days upon the department's request;
4.Maintain a designated representative authorized by the employer to:
a.Review and sign contract and program participation documents; and
b.Submit progress reports in the form and manner approved by the department for participating health care professionals;
5.Ensure that each eligible health care professional charges for provided services at the usual and customary rates in the employer's area, unless a service recipient is unable to pay a fee set at those rates. An individual unable to pay may be charged at a reduced rate or not charged any fee;
6.Provide services to patients covered by Medicare and Medicaid, and submit a twelve-month billing summary with its application;
7.Verify each eligible health care professional's credentials using a process that includes reference review, licensure verification, and a query of the national practitioner data bank;
8.Employ a health care professional that qualifies under section 33-03-37-03; and
9.Contractually commit to provide matching funds equal to the amount required by North Dakota Century Code section 43-12.3-06.
History
- Law Implemented: NDCC 43-12.3-03, 43-12.3-04
N.D. Admin. Code 33-03-37-05 Health care professional and employer prioritization
Annually the department shall issue a list or criteria of priorities for the application process for eligible health care professional and employers. This list or criteria must include occupation types, locations, practice settings, distribution of program applicants and recipients, and available funding. The department may consider other relevant factors in considering applicants, including:
1.The level of social, behavioral, and medical needs in the defined area of need;
2.The number of current vacancies within the defined area of need;
3.The extent to which the defined area of need is rural;
4.The percentage of individuals who are underserved being served;
5.The health care professional's specialty within an area;
6.The employer and practice setting;
7.Whether the health care professional is a new recruit or a retention candidate;
8.The health care professional's date of availability and anticipated term of availability;
9.The health care professional's education and experience; and
10.The health care professional's willingness to accept Medicare and Medicaid.
History
- Law Implemented: NDCC 43-12.3-03, 43-12.3-04, 43-12.3-05
N.D. Admin. Code 33-03-37-06 Health care professional application process
1.A current full permanent unencumbered unrestricted licensed health care professional wishing to participate in the program shall complete and submit an online application in the form and manner approved by the department. The application must include:
a.A current resume or curriculum vitae;
b.A current copy of all educational loan statements from each loan servicer;
c.The licensure status of the health care professional;
d.A history of all medical licenses held by the health care professional;
e.A description of any litigation to which the health care professional is a party;
f.A signed copy of the health care professional's employment contract with all addendums;
g.A signed statement of endorsement and financial commitment to participate in this program from the health care professional's employer; and
h.Three letters of recommendation, two of which must include:
(1)A direct supervisor; and (2)Other organization official.
2.The department shall consider the criteria specified in North Dakota Century Code section 43-12.3-05 and this chapter, as well as all information contained in the application and accompanying documents.
3.The department shall review and score the health care professional's application and approve or deny within ninety days of the application closing based on established criteria set forth by the department.
History
- Law Implemented: NDCC 43-12.3-02
N.D. Admin. Code 33-03-37-07 Employer application process
1.An employer wishing to be eligible for participation in the program shall complete and submit an online application in the form and manner approved by the department. The application must include:
a.A statement of need;
b.A statement of the type of services required to meet the needs of the patients served; and
c.A statement that the eligible health care professional shall accept Medicare and Medicaid, if applicable.
2.The department shall review and score the employer's application and approve or deny the application within ninety days of the application closing based on established criteria set forth by the department.
History
- Law Implemented: NDCC 43-12.3-02
N.D. Admin. Code 33-03-37-08 Loan repayment contract
1.Before receiving loan repayment under this chapter, each health care professional and employer selected shall enter into a loan repayment contract with the department, in the form and manner approved by the department, agreeing to the terms and conditions upon which the loan repayment is granted, the penalties for a breach of the loan repayment contract, and the conditions under which the health care professional may be released from any obligations under the contract without penalty.
2.A designated representative that is authorized by the employer shall sign the loan repayment contract on behalf of the employer.
3.The loan repayment contract must include:
a.The amounts to be paid to the lending institution by the department and by the employer;
b.The specific term in which the health care professional is obligated to provide medical services within the community; and
c.A provision that any financial obligation of the department arising out of a loan repayment contract entered into under this chapter is contingent on funds being appropriated by the legislative assembly and available for loan repayments under North Dakota Century Code chapter 43-12.3 and matching funds paid by the health care professional's employer as required by North Dakota Century Code section 43-12.3-07.
N.D. Admin. Code 33-03-37-09 Department and employer payments
1.The health care professional shall submit an annual payment verification form to the department, in the form and manner approved by the department, for yearly payment. The form must include:
a.The loan lender name;
b.Remittance address; and
c.Account number.
2.Fees associated with international loans requiring a wire transfer are the responsibility of the health care professional or employer.
3.The department shall calculate the annual payment that the employer is required to pay under North Dakota Century Code section 43-12.3-06 based on:
a.The health care professional's discipline; and
b.The qualifying student loan debt level for the health care professional.
4.The department shall use a progress report to monitor the health care professional's contractual compliance with the service obligation. The progress report must be:
a.Submitted by the employer and approved by the health professional to document the service provided at the location specified in the contract for the specified population and the duration of the health care professional's service; and
b.Submitted on a form and manner approved by the department.
N.D. Admin. Code 33-03-37-10 Amendment - Termination
The department shall amend or terminate a loan repayment contract only through a fully executed amendment or termination document.
Chapter 33-03-38 Community Health Workers
N.D. Admin. Code 33-03-38-01 Definitions
1."Abuse" means mental, physical, sexual, or verbal abuse.
2."Chronic condition" means a condition that lasts twelve months or longer and requires ongoing medical attention or limits a member's activities of daily living.
3."Competence" means the application and integration of knowledge, skills, ability, and judgment necessary to meet standards.
4."Deny" means the department's refusal to issue a certification or recertification.
5."Mental abuse" includes humiliation, harassment, threats of punishment, or deprivation.
6."Physical abuse" includes hitting, slapping, pinching, kicking, or controlling behavior through corporal punishment.
7."Revoke" means the withdrawal by the department of the community health worker certification for a specified period of time of no less than one year. If no specified period of time is identified by the department, revocation is permanent.
8."Sexual abuse" includes sexual harassment, sexual coercion, sexual contact, or sexual assault.
9."Supervision" means maintaining accountability to determine whether services provided by a community health worker are adequate and delivered appropriately.
10."Suspend" means the temporary withholding by the department of the ability to practice as a community health worker for a specified or indefinite period of time not to exceed one year.
11."Verbal abuse" includes any use of oral, written, or gestured language that includes disparaging and derogatory terms to or within hearing distance of a client or the client's family to describe a client's ability to comprehend or disability, regardless of the client's age.
History
- General Authority: NDCC 43-66-01, 43-66-03
- Law Implemented: NDCC 43-66-01, 43-66-03
N.D. Admin. Code 33-03-38-02 Scope of practice
1.A community health worker is a frontline public health worker who is certified by the department to provide preventative services.
2.A community health worker may not perform services that require licensure or training outside what is required for community health worker certification.
N.D. Admin. Code 33-03-38-03 Competencies
An applicant for community health worker certification, community health worker, or community health representative shall have competencies in the following areas:
1.Roles, advocacy, and outreach;
2.Organization and resources;
3.Teaching and capacity building;
4.Legal and ethical responsibilities and conduct;
5.Coordination and documentation;
6.Communication and cultural competency; and
7.Health promotion.
N.D. Admin. Code 33-03-38-04 Community health worker certification requirements
An applicant for community health worker certification shall file an application on forms provided by the department showing to the department's satisfaction that the applicant has satisfied all the requirements of North Dakota Century Code chapter 43-66 and under this chapter, including:
1.The applicant shall successfully complete one of the following:
a.Community health worker training program approved by the department and internship.
An applicant's training program must include the following components and the associated competencies identified in section 33-03-38-03:
(1)Understanding the scope;
(2)How to find local health systems and resources;
(3)Coaching and reinforcing health education;
(4)Confidentiality, mandatory reporting, conflict of interest, and ethical practice;
(5)Working with a care team under a care plan and service documentation;
(6)Motivational interviewing, active listening, trauma informed care, and knowledge of cultural practices in the community;
(7)Health promotion and disease prevention; and (8)An internship of two hundred hours or more. The internship may include supervised work or be exclusively supervised work.
b.Community health representative training by the Indian health service to provide community-based and medically guided health care, which may include traditional native concepts.
c.Functioning within the scope of practice of a community health worker under supervision.
(1)The supervised work experience must:
(a)Equal or exceed one thousand hours; and (b)Have occurred within three years prior to the date of application.
(2)The applicant's supervisor shall provide a letter of recommendation attesting to the applicant's knowledge and abilities while functioning within the scope of practice of a community health worker.
2.The applicant shall be eighteen years of age or older.
3.The applicant shall submit the required initial certification fee of thirty dollars.
4.The application must be accompanied by the documents, affidavits, and certificates necessary to establish that the applicant has satisfied the requirements of this chapter.
N.D. Admin. Code 33-03-38-05 Student and intern supervision
1.A student and an intern each may function within a community health worker scope of practice while directly supervised by a qualified supervisor or community health worker.
2.A qualified supervisor must be one of the following:
a.A community health worker certified in good standing with the department;
b.A community health worker training program instructor;
c.A physician;
d.A registered nurse; or
e.A licensed social worker.
N.D. Admin. Code 33-03-38-06 Community health worker certification of reciprocity
An application for community health worker certification by reciprocity must be considered by the department if the applicant has filed an application on forms provided by the department and the following requirements are met:
1.The applicant holds a current valid license or certification in good standing to practice as a community health worker or community health representative in another state or jurisdiction.
Official written verification of licensure or certification status must be received by the department from the other state or jurisdiction;
2.The licensure or certification requirements of the other state or jurisdiction are substantially similar as in North Dakota at the time the application for reciprocal certification is submitted; and
3.The applicant has submitted the required initial certification fee.
N.D. Admin. Code 33-03-38-07 Recertification
1.A community health worker certification expires on December thirty-first of even-numbered years.
2.A certification may be renewed by December thirty-first of even-numbered years by filing a recertification application on forms provided by the department and a recertification fee of thirty dollars if the community health worker's certification is current and in good standing with the department and grounds for denial under section 33-03-38-08 do not exist.
3.For an applicant who receives initial certification after July first of an even-numbered year, the certification is automatically recertified on December thirty-first for one additional certification period without payment of an additional recertification fee or submission of a recertification application.
4.The applicant shall complete twelve hours of department-approved virtual or in-person continuing education in topics related to the scope of practice of a community health worker, including two hours of legal and ethical responsibilities.
5.If the recertification application and recertification fee are not received by December thirty-first, the certification expires, and the community health worker may not practice as a community health worker.
6.If an individual with an expired community health worker certification is identified as continuing to practice, the department shall notify the individual and the individual's employer, if known, that the individual immediately shall cease practicing as a community health worker until the recertification process is completed and the individual's certification status becomes current.
7.For thirty days after expiration, an expired license may be renewed by complying with subsections 2 and 4, notwithstanding the deadline under subsection 2.
8.If an expired certification is not renewed within thirty days after expiration, an expired certification may not be renewed, and an applicant shall apply for initial certification.
N.D. Admin. Code 33-03-38-08 Denial of certification or recertification
1.The department may deny an application for the issuance of a certification or recertification made by an applicant who:
a.Failed to comply with North Dakota Century Code chapter 43-66 or this chapter;
b.Has been convicted of a crime determined by the department to be substantially related to the qualifications, functions, or duties of a community health worker;
c.Has knowingly provided false information to the department to obtain or attempt to obtain certification or recertification;
d.Is currently under certification or license suspension or discipline in any jurisdiction for any type of professional licensure related to health care;
e.Has previously had a community health worker or community health representative certification or license revoked in any jurisdiction;
f.Has otherwise violated the laws or rules regarding community health workers; or
g.Has operated as a community health worker without a current certification from the department.
2.If a certification or recertification application is denied by the department, an applicant may request a hearing pursuant to North Dakota Century Code chapter 28-32, in writing, within thirty days of notification of the denial.
N.D. Admin. Code 33-03-38-09 Disciplinary actions
1.The department may suspend, revoke, or take other action provided in this section regarding the certification of a community health worker who:
a.Has obtained or attempted to obtain certification or recertification as a community health worker by fraud, deceit, or intentional misrepresentation;
b.Has been convicted of a crime determined by the department to be substantially related to the qualifications, functions, or duties of a community health worker;
c.Has impersonated a licensed health care provider;
d.Has operated as a community health worker without a certification from the department;
e.Has intentionally or negligently engaged in conduct that has been determined by the department to have resulted in a significant risk to the health or safety of a client or in injury to a client;
f.Used alcohol or drugs to such a degree as to interfere with the community health worker's ability to safely operate;
g.Has a physical or mental disability materially affecting the ability of the community health worker to perform the duties of the profession in a competent manner;
h.Has violated this chapter or North Dakota Century Code chapter 43-66;
i.Has failed to cooperate with an investigation or disciplinary action by the department;
j.Is incapable of working with reasonable skill, competence, or safety for the public; or
k.Has misappropriated the property of, abused, or neglected a client.
2.A person may file a complaint against a community health worker with the department. The complaint must be signed and state the claims on a form provided by the department. The complaint may include supporting documentation.
3.Upon receiving the complaint, the department shall provide a copy of the complaint and any supporting documentation to the community health worker.
4.The community health worker has twenty days from the date the individual receives the complaint within which to file a response with the department. The response may include supporting documentation.
5.If the community health worker files a timely response, the department shall consider the complaint, response, and any documentation submitted by the parties, and based on this information, the department may:
a.Dismiss the complaint as unfounded; or
b.Determine there is a reasonable basis to believe the claims are true and subject to disciplinary action by the department.
6.If the department determines formal disciplinary action against the community health worker is proper, the department shall prepare a complaint and serve the complaint, along with a notice of hearing, on the community health worker and then proceed with the matter under North Dakota Century Code chapter 28-32. If the matter is unable to be informally resolved and a hearing is held under North Dakota Century Code chapter 28-32, all hearings must be held in Bismarck unless the department and the community health worker agree otherwise.
7.If the community health worker's employer continues to use the individual during the disciplinary action process, the employer shall take reasonable steps to prevent further harm to clients.
Article 33-04 Health Statistics
Chapter 33-04-01 Duties of the State Registrar
N.D. Admin. Code 33-04-01-01 Forms
All paper certificates, forms, and reports used in the system of vital records registration and health statistics tabulation and analysis are the property of the state department of health and shall be surrendered to the state registrar upon demand. The forms prescribed and distributed by the state registrar for reporting vital events shall be used only for official purposes. No forms shall be used in the reporting of vital events or making copies thereof except those furnished or approved by the state registrar.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-04
N.D. Admin. Code 33-04-01-02 Requirements for preparation of paper certificates and worksheets
All paper certificates and records for all vital events must be printed on security paper directly from an authorized computer or copier. All signatures required shall be entered in black nonfading ink or be an acceptable e-signature. Unless otherwise specified by the state registrar, no certificates or record shall be complete, correct, and acceptable for registration that:
1.Does not include the certifier's name.
2.Does not supply all items of information called for thereon or satisfactorily account for their omission.
3.Contains significant alterations or erasures.
4.Does not contain handwritten signatures where required.
5.Is marked "copy" or "duplicate".
6.Is a carbon, photographic, or xerographic copy.
7.Is prepared on an improper form.
8.Contains inconsistent or improper data.
9.Contains an indefinite cause of death which denotes only symptoms of disease or conditions resulting from disease.
10.Is not prepared in conformity with rules or instructions issued by the state registrar.
History
- History: Amended effective January 1, 2008; July 1, 2022.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-04
Chapter 33-04-02 Duties of the Local Registrars [Repealed]
N.D. Admin. Code 33-04-02 Duties of the Local Registrars [Repealed]
CHAPTER 33-04-02
DUTIES OF THE LOCAL REGISTRARS [Repealed effective January 1, 2008]
Chapter 33-04-03 Duties of Subregistrars [Repealed]
N.D. Admin. Code 33-04-03 Duties of Subregistrars [Repealed]
CHAPTER 33-04-03
DUTIES OF SUBREGISTRARS [Repealed effective January 1, 2008]
Chapter 33-04-04 Birth Registration
N.D. Admin. Code 33-04-04-01 General provisions
If the mother of the child was not married at the time of conception or birth, the child's surname shall be shown on the record as the legal surname of the mother at the time of the birth unless otherwise determined in a court paternity action, or unless an acknowledgment of paternity signed by both parents is received stating the surname of the child to be the legal surname of the mother or father.
If the father is not named on the certificate of birth, no other information about the father shall be entered on the certificate.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-13
N.D. Admin. Code 33-04-04-02 Home births
If a birth occurs outside an institution and is not attended by a physician or midwife, or is not witnessed by a physician or midwife immediately after the birth, the parents are required to provide additional documents approved by the state registrar to prove the mother was pregnant, the child was born alive, and the child was born in North Dakota, before the birth will be registered.
If the parents are unable or unwilling to provide all the additional documents, the birth may only be registered by an order received from a court of competent jurisdiction. The parents shall complete the informational worksheets containing all the birth facts, regardless of the terms of the order.
History
- History: Effective July 1, 2022.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-13
Chapter 33-04-05 Infants of Unknown Parentage: Foundling Registration
N.D. Admin. Code 33-04-05-01 General provisions
1.Registration procedures. The report for an infant of unknown parentage shall be registered using the electronic birth registration system and shall:
a.Show the required facts as determined by the approximation and have parentage data left blank.
b.Amend the certification of the attendant to show the signature of the custodian and indicate title, if any.
2.Inspection of records. When a report has been sealed as provided by subsection 4 of North Dakota Century Code section 23-02.1-14, the state registrar may inspect such information for purposes of properly administering the vital records registration program.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-14
Chapter 33-04-06 Delayed Registration of Births
N.D. Admin. Code 33-04-06-01 Registration - Seven days to one year
Records of birth filed after seven days, but within one year from the date of birth, shall be registered using the electronic birth registration system in the manner prescribed in North Dakota Century Code
section 23-02.1-13. Such records shall not be marked "delayed".
If the record is signed by someone other than the attendant, a notarized statement setting forth the reason therefore must accompany the record. The state registrar may require additional evidence in support of the facts of birth or an explanation for the delay in filing.
N.D. Admin. Code 33-04-06-02 Delayed record of birth form
All records registered one year or more after the date of the birth are to be registered on a form prescribed by the state registrar.
N.D. Admin. Code 33-04-06-03 Who may request the registration of and sign a delayed record of birth
Any person born in this state whose birth is not recorded in this state, or the person's parent, guardian, next of kin, or an authorized representative may request the registration of a delayed record of birth, subject to these rules and instructions issued by the state registrar.
Each delayed record of birth shall be signed and sworn to before an official authorized to administer oaths by the person whose birth is to be registered if such person is of legal age and is competent to sign and swear to the accuracy of the facts stated therein; otherwise the record shall be signed and sworn to by one of the following in the indicated order of priority:
1.One of the parents of the registrant.
2.The guardian of the registrant.
3.The next of kin of the registrant.
4.An authorized representative.
N.D. Admin. Code 33-04-06-04 Facts to be established for a delayed registration of birth
The minimum facts which must be established by documentary evidence shall be all of the following:
1.The full name of the person at the time of birth.
2.The date of birth and the place of the birth.
3.The full maiden name of the mother.
4.The full name of the father; except that if the mother was not married to the father of the child either at the time of conception or birth, the name of the father shall not be entered on the delayed record unless otherwise determined in a court paternity action, or unless an acknowledgment of paternity signed by both parents is received stating the surname of the child to be the legal surname of the mother or father.
N.D. Admin. Code 33-04-06-05 Delayed registration following a legal change of status
When evidence is presented reflecting a legal change of status by adoption, legitimation, paternity determination, or acknowledgment of paternity, a new delayed record may be established to reflect such changes.
The existing record and evidence upon which the new record was based shall be placed in a special file. Such files shall not be open to inspection except upon order of a court of competent jurisdiction or by the state registrar for purposes of properly administering the vital records registration program.
N.D. Admin. Code 33-04-06-06 Documentary evidence - Requirements
To be acceptable for filing, the name of the registrant and date and place of birth entered on the delayed record of birth shall be supported by at least:
1.Two pieces of documentary evidence, only one of which may be an affidavit of personal knowledge, if the record is filed within seven years after the date of birth.
2.Three pieces of documentary evidence, only one of which may be an affidavit of personal knowledge, if the record is filed seven years or more after the date of birth.
Facts of parentage need be supported by only one document which may be one of the documents above other than the affidavit of personal knowledge.
N.D. Admin. Code 33-04-06-07 Documentary evidence - Acceptability
The state registrar may establish a priority of best evidence.
All documents submitted in evidence, other than an affidavit of personal knowledge, must have been established at least ten years prior to the date of application and at least one of those documents must have been established prior to the applicant's tenth birthday.
An affidavit of personal knowledge, to be acceptable, must be prepared by one of the parents, the next of kin, or any older person and must be signed before an official authorized to administer oaths.
The affiant must be at least ten years older than the applicant, except that if the affiant is a member of the applicant's immediate family, the affiant need only be at least four years older than the applicant, and have personal knowledge of the facts of birth.
N.D. Admin. Code 33-04-06-08 Abstraction of documentary evidence
The state registrar, or the state registrar's designated representative, shall abstract on the delayed record of birth a description of each document submitted to support the facts shown on the delayed birth record. The description shall include:
1.The title or description of the document.
2.The name and address of the affiant, if the document is an affidavit of personal knowledge, or of the custodian, if the document is an original or certified copy of a record or signed statement.
3.The date of the original filing of the document being abstracted.
4.The information regarding the birth facts contained within the document.
All documents submitted in support of the delayed birth registration shall be returned to the applicant after review and abstraction.
N.D. Admin. Code 33-04-06-09 Certification by the state registrar
The state registrar, or the state registrar's designated representative, shall, by the state registrar's signature, certify:
1.That no prior birth record is on file for the person whose birth is to be recorded.
2.That the state registrar has reviewed the evidence submitted to establish the facts of birth.
3.That the abstract of the evidence appearing on the delayed record of birth accurately reflects the nature and the content of the document.
History
- Law Implemented: NDCC 23-02.1-04
N.D. Admin. Code 33-04-06-10 Dismissal after two years
Applications for delayed records of birth which have not been completed within two years from the date of application may be dismissed at the discretion of the state registrar.
History
- Law Implemented: NDCC 23-02.1-04
Chapter 33-04-07 Delayed Registration of Death
N.D. Admin. Code 33-04-07-01 General provisions
The registration of a death after the time prescribed by statute and regulations shall be registered on the standard record of death form in the manner prescribed below:
1.If the attending physician or coroner at the time of death and the attending funeral director or person who acted as such are available to complete and sign the record of death, it may be completed without additional evidence and filed with the state registrar. However, for those records filed one year or more after the date of death, the physician or coroner and the funeral director or person who acted as such must state in accompanying affidavits that the information on the record is based on records kept in their files.
2.In the absence of the attending physician or coroner and the funeral director or the person who acted as such, the record may be filed by the next of kin of the deceased and shall be accompanied by:
a.An affidavit of the person filing the record swearing to the accuracy of the information on the record.
b.Two documents which identify the deceased and the deceased's date and place of death.
3.In the case of presumptive death, a certified copy of a court decree finding that such death has occurred and the date of such death must be received by the state registrar before a death record can be filed.
In all cases the state registrar may require additional documentary evidence to prove the facts of death.
A summary statement of the evidence submitted in support of the delayed registration shall be endorsed on the record.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-19
Chapter 33-04-08 New Records of Birth Following Adoption, Legitimation, and Paternity Determination
N.D. Admin. Code 33-04-08-01 Adoption in other states or a foreign nation
A new record of birth may be prepared by the state registrar for a child born in this state upon receipt of an adoption report or certified copy of an adoption decree made by a court of competent jurisdiction.
N.D. Admin. Code 33-04-08-02 Legitimation
If the natural parents marry after the birth of a child, a new record of birth shall be prepared by the state registrar for a child born in this state upon receipt of an acknowledgment of paternity signed by the natural parents of the child or a certified copy of a court determination of paternity made by a court of competent jurisdiction, together with a certified copy of the parents' marriage record. However, if another man is shown as the father of the child on the original record, a new record may be prepared only when a court determination of paternity has been made by a court of competent jurisdiction.
N.D. Admin. Code 33-04-08-03 Determination of paternity
A new record of birth may be prepared by the state registrar for a child born in this state upon receipt of a certified copy of a court determination of paternity, together with a request from the natural mother or person having legal custody of the child that such new record be prepared. The surname of the child shall remain unchanged unless the decree provides otherwise.
N.D. Admin. Code 33-04-08-04 New record
The new certificate of birth shall be on the form in use at the time of its preparation and shall include the following items of information and such other information necessary to complete the certificate:
1.The name of the child.
2.The date and place of birth as transcribed from the original certificate.
3.The names and personal particulars of the adoptive parents or of the natural parents.
4.The name of the attendant, printed or typed.
5.The same birth number as was assigned to the original certificate.
6.The original filing date.
The necessary data to locate the existing certificate and the data necessary to complete the new certificate shall be submitted to the state registrar on forms prescribed and approved by the state registrar.
N.D. Admin. Code 33-04-08-05 Existing record to be placed in special file
After preparation of a new certificate of birth, the existing certificate and the evidence upon which the new certificate was based are to be placed in a special file. The state registrar may inspect such information for purposes of properly administering the vital records registration program. No other inspection shall be permitted except as provided by order of a court of competent jurisdiction.
Chapter 33-04-09 Death Registration
N.D. Admin. Code 33-04-09-01 Acceptance of incomplete death record - Delayed record of cause of death
If the attending physician or coroner is unable to complete the medical certification of cause of death or if the funeral director is unable to obtain the personal information about the deceased within the prescribed period, the funeral director shall file a death record with all available information completed. Such records shall be the authority for the subregistrar to issue a burial transit permit.
A supplemental report providing the information missing from the original record shall be filed with the state registrar as soon as is possible, but in all cases within thirty days.
The supplemental report shall be made a part of the existing death record. Such reports shall not be considered an amendment, and the death record shall not be marked "amended".
History
- History: Amended effective January 1, 2008.
- Law Implemented: NDCC 23-02.1-19
N.D. Admin. Code 33-04-09-02 Attending physician not available
An associate physician who relieves the attending physician while the attending physician is on vacation or otherwise unavailable may certify to the cause of death in any case where the associate physician has access to the medical history of the case, provided that the associate physician views the deceased at or after death and that the death is from natural causes. In all other cases in which a physician is unavailable, the coroner shall prepare and file the medical certification of cause of death.
History
- Law Implemented: NDCC 23-02.1-19(3)
N.D. Admin. Code 33-04-09-03 Hospital or institution may assist in preparation of record
When a death occurs in a hospital or other institution and the death is not under the jurisdiction of the coroner, the person in charge of such institution, or the person's designated representative, may, when the cause of death is known, initiate the preparation of the death record by all of the following:
1.Place the full name of the deceased and the date and the place of death on the death record and obtain from the attending physician the medical certification of the cause of death and the physician's signature.
2.Present the partially completed death record to the funeral director or person acting as such.
History
- History: Amended effective January 1, 2008.
- Law Implemented: NDCC 23-02.1-19
Chapter 33-04-10 Permits
N.D. Admin. Code 33-04-10-01 Hospital disposition of fetus
A hospital, by written authorization of the parents, may dispose of a dead fetus of any period of gestation. A burial-transit permit must also be obtained from the state registrar for the disposition of a fetus if the fetus has reached gestation period of twenty completed weeks. The hospital must file the completed burial-transit permit with the county recorder in the registration district where the final disposition takes place.
N.D. Admin. Code 33-04-10-02 Removal of body
1.Requirements for removal of body. Before removing a dead body or fetus from the place of death, the funeral director or person acting as such shall:
a.Obtain assurances from the attending physician that death is from natural causes and that the physician will assume responsibility for certifying to the cause of death or fetal death; or
b.Contact the coroner if the case comes within the coroner's jurisdiction and receive authorization from the coroner to remove the body.
2.Burial-transit permits. The original burial-transit permit shall be filed with the county recorder in that registration district in which final disposition takes place.
All subregistrars shall return all completed stub sections of such burial-transit permits to the county recorder upon demand, but at no time to exceed a period of thirty days.
N.D. Admin. Code 33-04-10-03 Disposal of permits
Burial-transit permits must be retained permanently by the county recorder.
N.D. Admin. Code 33-04-10-04 Disinterment permits
A disinterment permit shall be issued by the state registrar upon receipt of a written application signed by the next of kin and licensed embalmer who is in charge of the disinterment or upon receipt of an order of a court of competent jurisdiction directing such disinterment. Upon receipt of a court order or signed permission of the next of kin, the state registrar may issue one permit to authorize the disinterment and reinterment of all remains in a mass disinterment provided that insofar as possible the remains of each body be identified and place of disinterment and reinterment be specified. The disinterment permit shall be the authorization for disinterment, transportation, and reinterment.
A dead body properly prepared by an embalmer and deposited in a receiving vault shall not be considered a disinterment when removed from the vault for final burial.
Chapter 33-04-11 Extension of Time
N.D. Admin. Code 33-04-11-01 General provisions
1.When for reasons satisfactory to the state registrar a death or fetal death record cannot be completed within the time period specified by North Dakota Century Code sections 23-02.1-19 and 23-02.1-20, the state registrar may grant an extension.
2.The subregistrar may issue a burial-transit permit once the facts of death are filed with the state registrar.
3.In all cases, a completed death record must be filed with the state registrar after a period of no more than thirty days after an extension has been granted.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-22
Chapter 33-04-12 Correction and Amendment of Vital Records
N.D. Admin. Code 33-04-12-01 Amendment of minor errors on birth records during the first year
Amendment of obvious errors, transposition of letters in words of common knowledge, or omissions on birth records may be made by the state registrar within the first year after the date of birth either by the state registrar's own observation or query or upon request of an individual with a direct and tangible interest in the record as defined in section 33-04-13-01. When such additions or minor amendments are made by the state registrar, a notation as to the source of the information together with the date the change was made and the initials of the authorized agent making the change shall be made on the record in such a way as not to become a part of any record issued. The record is not to be marked as "amended".
History
- History: Amended effective January 1, 2008; January 1, 2024.
- Law Implemented: NDCC 23-02.1-25(2)
N.D. Admin. Code 33-04-12-02 Amendments as a result of gender identity change
1.Evidence and documents required. The birth record of a person born in this state who has undergone a sex conversion operation may be amended as follows:
a.Upon written request of the person who has undergone the operation;
b.An affidavit by a physician that the physician has performed an operation on the person, and that by reason of the operation, the sex designation of such person's birth record should be changed; and
c.An order of a court of competent jurisdiction decreeing a legal change in name.
2.New record. Pursuant to such amendment, a new record of birth will be created by the state registrar showing original data as transcribed from the original record excepting those items that have been amended. The new record will be clearly marked in the upper margin with the word "amended" and a description of the amended items may be added to the certified copy for clarification.
3.Sealing of original record. The original record shall be then placed in a special file and shall not be open to inspection except by order of a court of competent jurisdiction or by the state registrar for purpose of carrying out the provisions of North Dakota Century Code chapter 23-02.1 and properly administering the vital records registration program.
N.D. Admin. Code 33-04-12-03 All other amendments
1.Provisions for other amendments. Unless otherwise provided in this chapter or in the statute, all other amendments to vital records shall be supported by:
a.A request setting forth:
(1)Information to identify the record.
(2)The incorrect data as it is listed on the record.
(3)The correct data as it should appear.
b.One or more items of documentary evidence which support the alleged facts and which were established at least five years prior to the date of the application for amendment and are prior to the applicant's eighteenth birthday.
c.If the item to be corrected or amended is the date of birth, the state registrar will require additional documentary evidence established as follows:
(1)If the correction is being made to the month or day of birth, the applicant must provide one item of documentary evidence which was established prior to the applicant's eighteenth birthday.
(2)If the correction is being made to the year of birth, the applicant must provide two items of documentary evidence which were established prior to the eighth birthday.
d.If the item to be corrected or amended is the applicant's legal name, the state registrar will require additional documentary evidence established as follows:
(1)If the correction is a minor spelling change to the legal name, the applicant must provide one item of documentary evidence which was established prior to the applicant's eighteenth birthday.
(2)If the correction is a legal name change, the applicant must provide two items of documentary evidence, one of which was established prior to the applicant's eighth birthday and a second item that was established prior to the eighteenth birthday.
2.Validity of evidence. The state registrar shall evaluate the evidence submitted in support of any amendment, and when the state registrar finds reason to doubt its validity or adequacy the state registrar may reject the amendment and shall advise the applicant of the reasons for this action.
History
- Law Implemented: NDCC 23-02.1-25
N.D. Admin. Code 33-04-12-04 Who may apply
1.To amend a birth record, application may be made by one of the parents, the guardian, or the registrant if at least eighteen years of age.
2.To amend a death or fetal death record, application may be made by the next of kin or the funeral director or an individual acting as such. Applications to amend the medical certification of cause of death shall be made by the attending physician or coroner.
History
- History: Amended effective January 1, 2008; January 1, 2024.
- Law Implemented: NDCC 23-02.1-25(3)
N.D. Admin. Code 33-04-12-05 Amendment of registrant's given names on birth record within the first year
Until the registrant's first birthday, given names may be amended upon written request of any of the following:
1.Both parents.
2.The mother, in the case of a child born out of wedlock.
3.The father, in the case of the death or incapacity of the mother.
4.The mother, in the case of the death or incapacity of the father.
5.The guardian or agency having legal custody of the registrant.
A record amended in this manner prior to the first birthday is not to be marked "amended".
History
- Law Implemented: NDCC 23-02.1-25(3)
N.D. Admin. Code 33-04-12-06 Addition of given names
1.After the first birthday. After the registrant's first birthday, given names, for a child whose birth was recorded without given names, may be added to the record upon written request of any of the following:
a.Both parents.
b.The mother, in the case of a child born out of wedlock.
c.The father, in the case of the death or incapacity of the mother.
d.The mother, in the case of the death or incapacity of the father.
e.The guardian or agency having legal custody of the registrant.
A record amended in this manner after the first birthday shall be marked "amended".
2.Documentary evidence. After the first birthday, the applicant must provide two items of documentary evidence, one of which was established prior to the applicant's eighth birthday and a second item that was established prior to the eighteenth birthday.
History
- Law Implemented: NDCC 23-02.1-25
N.D. Admin. Code 33-04-12-07 Medical items
All items in the medical certification or of a medical nature may be amended only upon receipt of a signed statement from those individuals responsible for the completion of such items. The state registrar may require documentary evidence to substantiate the requested amendment.
History
- History: Amended effective January 1, 2024.
N.D. Admin. Code 33-04-12-08 Amendment of the same item more than once
Once an amendment of an item is made on a vital record, that item shall not be amended again unless a court order is received from a court of competent jurisdiction.
N.D. Admin. Code 33-04-12-09 Methods of amending records
1.Procedures utilized in amending records. Records of birth, death, and fetal death may be amended by the state registrar in the following manner:
a.Preparing a new record showing the correct information when the state registrar deems that the nature of the amendment so requires.
In the case of birth, such new records shall be prepared in a manner prescribed by the state registrar. The new record shall contain a space for inclusion of the amended item as it appeared on the existing record. It shall also include a summary of the evidence presented in support of the amendment and a certification statement by the state registrar that the state registrar has evaluated the evidence submitted.
For all other vital events, the new record shall be prepared in a manner used for registering current events at the time of the amendment. The item number or the entry that was amended shall be identified on the new record.
In all cases the new record shall show the date the amendment was made and be given the same state file number as the existing record. Signatures appearing on the existing record shall be typed or digitally recorded on the new record.
b.Completing the item in any case where the item was left blank on the existing record.
c.In the case of an actual paper certificate, drawing a single line through the item to be amended and inserting the correct data immediately above or to the side thereof. The line drawn through the original entry must not obliterate such entry.
2.Notations of amendments to be made. In all cases, there shall be inserted on the record a statement identifying the affidavit and documentary evidence used as proof of the correct facts, the date the amendment was made, and the initials or user id of the person making the change. As required by statute or regulation, the record shall be marked as "amended".
Chapter 33-04-13 Disclosure of Records [Repealed]
N.D. Admin. Code 33-04-13 Disclosure of Records [Repealed]
CHAPTER 33-04-13
DISCLOSURE OF RECORDS [Repealed effective April 1, 1994]
Chapter 33-04-13.1 Disclosure of Records
N.D. Admin. Code 33-04-13.1 Disclosure of Records
CHAPTER 33-04-13.1
DISCLOSURE OF RECORDS
Section 33-04-13.1-01Definitions 33-04-13.1-02General Provisions 33-04-13.1-03Proof of Identity 33-04-13.1-01. Definitions.
1."Guardian" means a person who has been appointed as legal guardian through some judicial process.
2."Relative" means a person's current or surviving spouse, a parent or legal guardian, a child, a grandparent, or a grandchild. The state registrar may require proof of the relationship. 33-04-13.1-02. General provisions.
1.In order to protect vital records from loss, mutilation, or destruction and to prevent improper disclosure of confidential information, a person may not be allowed direct physical access to the original vital records in the custody and care of the state registrars. Every person wishing to review records or desiring information contained in such records must make a request for a certified copy to the state registrar.
2.Nothing in this section may be construed to permit disclosure of information contained in the "confidential information for medical and health use only" section of vital records unless specifically authorized by the state registrar for statistical research or if authorized by a court of competent jurisdiction.
3.The state registrar may furnish data from vital records for statistical research purposes, subject to such conditions as the state registrar may impose. Data may not be furnished from records under this subsection until the state registrar has prepared in writing the conditions under which the data will be used and received a data use agreement signed by a responsible agent of the research organization agreeing to meet with and conform to such conditions. 33-04-13.1-03. Proof of identity.
Whenever it is deemed necessary to establish an applicant's right to confidential information from vital records, the state registrar may require written application, identification of the applicant, or a sworn notarized statement. The state registrar may furnish information, at the written request of the applicant entitled to such information, to any person or agency designated by the applicant.
Chapter 33-04-14 Copies of Data from Vital Records
N.D. Admin. Code 33-04-14-01 General provisions
1.Full or short form certified copies of vital records may be made by mechanical, electronic, or other reproductive processes, except that information contained in the "confidential information for medical and health use only" section of vital records on birth and fetal death records shall not be included.
2.When a certified copy is issued, each certification shall be signed and certified as a true copy by the state registrar and shall include the date issued, the name of the issuing office, the state registrar's signature or an authorized facsimile thereof (or the same for the deputy state registrar), and the seal of the issuing office shall be affixed thereon.
3.When the state registrar finds evidence that a record was registered through misrepresentation or fraud, the state registrar shall have authority to withhold the issuance of a certified copy of such record until a court determination of the facts has been made.
History
- History: Amended effective April 1, 1994; amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-28
Chapter 33-04-15 Fees for Copies and Searches
N.D. Admin. Code 33-04-15-01 Fee required before issuance or search
No certified copies shall be issued or a search for a record can be started until the fee for such copy (and filing fee for delayed records of birth) or search has been received unless specific approval has been obtained from the state registrar or otherwise provided by statute or regulation.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-29
N.D. Admin. Code 33-04-15-02 Amount of fee
1.For the issuance of the first full certified copy, short form, or certification of a birth record, the initial fee per request is fifteen dollars. The filing fee for a delayed record of birth is fifteen dollars. The fee for amendments to vital records is fifteen dollars per request. The fee for creation of a new record of birth following adoption, legitimation, or paternity determination is fifteen dollars. For each search of the files when no birth record is found or no copy is made, a fee of fifteen dollars shall be charged.
2.For the issuance of the first certified copy of a death, fetal death, or marriage record, the initial fee per request is fifteen dollars. For subsequent copies issued at the time of the request, the fee is ten dollars per copy. For each search of the files when no death or marriage record is found or no copy is made, a fee of fifteen dollars shall be charged.
3.For statistical research purposes, the state registrar shall determine the fee for such services and shall determine the manner in which the costs are to be paid.
4.For each verification of a vital record, the fee is the same as the first certified copy for that record unless specific approval has been obtained from the state registrar or otherwise provided by statute or regulation.
History
- History: Amended effective February 1, 1984; January 1, 1986; January 1, 2008; July 1, 2022.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-29
Chapter 33-04-16 Persons Required to Keep Records
N.D. Admin. Code 33-04-16-01 Subregistrars required to keep information
Each subregistrar shall keep a record containing as a minimum, the following information about each dead body or fetus the subregistrar handles:
1.The date, place, and time of receipt.
2.The date, place, and manner of disposition.
3.If the dead body or fetus is delivered to another subregistrar, the date of such delivery and the name and the address of the subregistrar to whom delivered.
4.Items required by the record of death or fetal death in use when the event occurs for those events for which the subregistrar is required to file the record.
History
- History: Amended effective January 1, 2008.
- General Authority: NDCC 23-02.1-04, 28-32-02
- Law Implemented: NDCC 23-02.1-30
Article 33-05 Care and Custody of the Dead
Chapter 33-05-01 Care and Custody of Dead
N.D. Admin. Code 33-05-01-01 Burial-transit permits
1.A burial-transit permit, issued by the proper death registration authority, shall be required for each body transported by common carrier, and in all cases when transported by automobile, airplane, or any other conveyance, in lieu of a common carrier, and in every case when removed out of the state.
2.The burial-transit permit shall contain the information required on the blank furnished by the state department of health for the shipment of the dead and be properly signed by the local registrar.
3.The burial-transit permit shall be given to the person in charge of the corpse, or if shipped by express, attached to the shipping case in a strong envelope and in either case delivered with the body at the destination to the sexton or other person in charge of the cemetery.
4.When it is desired to reship a body after it has reached its original destination, and providing the body has not been interred, the burial-transit permit shall be filed with the local registrar at the original destination and a new burial-transit permit shall be obtained at this original destination for reshipment to the final destination.
History
- Law Implemented: NDCC 23-06-08, 23-06-09, 23-06-10, 23-06-11
N.D. Admin. Code 33-05-01-02 Disinterment
No person, except a licensed funeral practitioner, after having obtained a permit from the state registrar of vital statistics, shall disinter the body of a deceased person, providing the authorities in charge of a cemetery may transfer bodies buried therein from one part of such cemetery to another part thereof with the approval of the local health officer. All disinterred remains must be encased in a tight container or strong box. The disinterment permit shall be on the regular burial-transit permit and shall be issued only by the state registrar to funeral practioners duly licensed in North Dakota.
History
- History: Amended effective August 1, 2003.
N.D. Admin. Code 33-05-01-03 Opening of hermetically sealed caskets
The opening of hermetically sealed caskets containing disinterred remains of persons dead from any cause and shipped for burial in North Dakota is hereby forbidden except when so ordered by a court of competent jurisdiction.
N.D. Admin. Code 33-05-01-04 Depth of grave and requirements for above surface interments
1.No dead human body shall be interred in a public burial ground unless the distance from the top of the box containing the casket shall be at least three and one-half feet [106.68 centimeters] from the natural surface of the ground.
2.If the casket is placed in an approved metal, concrete, or similar vault, the distance from the top of the vault shall be at least eighteen inches [45.72 centimeters] from the natural surface of the ground.
3.If the casket is placed in a surface vault, the cover of the vault may be placed flush with the natural surface of the ground.
4.No person or persons, organizations, or associations shall place, establish, or construct wholly or partially above the natural surface of the ground any vault, crypt, columbarium, mausoleum, or other structure or device by whatever name for the interment of any dead human body without first meeting the cemetery registration requirements and submitting the plans and specifications for the proposed installation to the state department of health for preliminary inspection and recommendation. The plans and specifications shall be submitted to the state department of health in triplicate and shall be developed to assure conformance to the following basic requirements:
a.Designation of the sections, halls, rooms, corridors, elevators, or other subdivisions and including descriptive names and numbers of the areas.
b.Arrangement of the structure so that the cell, niche, or crypt may be readily examined by those legally authorized.
c.Provision for hermetically and permanently sealing in a suitable manner each crypt or cell so that no fluid may escape therefrom after the placing of any dead human body therein.
d.Provision of construction materials of the best quality and of a character best suited for the purposes intended.
e.Construction to ensure durability, permanence and the protection of the safety, convenience, comfort, and health of the community in which it is located consistent with modern mausoleum construction and engineering science at the time.
N.D. Admin. Code 33-05-01-05 Cemeteries
1.All cemeteries must be registered with the state department of health on forms provided by the department.
2.All cemeteries must be surveyed by a registered land surveyor prior to filing a plat of the cemetery with the recorder in the county in which the cemetery is located, as outlined in North Dakota Century Code section 43-19.1-30.
3.No body can be accepted for burial without a burial permit issued by the registrar where the death occurred.
4.The sexton or other person making burial must endorse on the burial permit the time and place of burial, and file the permit with the registrar having jurisdiction over the territory where the burial was made.
5.Sextons must keep permanent records of every burial or disinterment. The following items of record are required:
a.Full name of deceased.
b.Age at death and sex.
c.Date and place of death.
d.Date of burial.
e.Place of burial, block, lot, and grave.
f.Number of burial permit.
g.Name and address of funeral practitioner.
6.All cemetery authorities must make such reports at such time as the state department of health may from time to time direct.
7.The state department of health has recommended a standard uniform record book for cemetery records. It may be obtained from the larger printing concerns in the state.
History
- History: Amended effective February 1, 1984; August 1, 2003.
- General Authority: NDCC 23-01-03, 23-06-23
- Law Implemented: NDCC 23-01-03, 23-06-21, 23-06-23
N.D. Admin. Code 33-05-01-06 Cremation
The cremation of a dead human body shall be considered the final disposition of that body.
Chapter 33-05-02 Notification of Blood and Body Fluid Precaution
N.D. Admin. Code 33-05-02-01 Definitions
For purposes of this chapter, the term "post-mortem communicable disease" shall include the following:
1.Viral hepatitis (any etiology).
2.Tuberculosis.
3.Acquired immune deficiency syndrome (AIDS).
4.Plague.
5.Creutzfeldt-Jakob.
6.Rabies.
7.Meningococcal meningitis.
N.D. Admin. Code 33-05-02-02 Notification required of death from post-mortem communicable diseases
When any person dies who has been diagnosed or suspected as having a post-mortem communicable disease, a written notice stating "BLOOD AND BODY FLUIDS PRECAUTIONS SHOULD BE OBSERVED" must be securely attached to the body in a prominent location thereon so it can be easily seen when the body is removed for disposition as follows:
1.If the person dies in a hospital or other health care facility, the notice must be prepared and placed by the attending physician or other health care professional or representative on behalf of the hospital or health care facility.
2.If the person dies outside of a hospital or health care facility, the notice must be prepared and placed by the attending physician, or in the absence of an attending physician, by the examining coroner.
Any person who removes a dead human body for disposition which has a notice attached pursuant to this chapter shall ensure that such notice remains attached to the dead body until the body is presented to any funeral practitioner, funeral director, or other person taking possession of the dead body.
History
- History: Effective May 1, 1987; amended effective August 1, 2003.
N.D. Admin. Code 33-05-02-03 Disclosure limited
Any notifications required to be made pursuant to section 33-05-02-02 are privileged and confidential and may be disclosed only if one of the following applies:
1.Disclosure is required by any state or federal law.
2.Disclosure is made by a physician pursuant to a state or federal law permitting disclosure.
3.Disclosure is for research purposes and does not reveal either the identity of the deceased or information by which the identity of the deceased could be determined.
4.Disclosure involves information regarding a deceased minor and the disclosure is made to the parent or guardian of that minor.
5.Disclosure is made to the person who removes the dead human body or is made in the ordinary course of business to any employee or agent of any person or entity authorized or required under this chapter to receive or report that information.
N.D. Admin. Code 33-05-02-04 Violations reported to appropriate licensing board
Any person practicing an occupation, trade, or profession for which the license, permit, certificate, or registration is required from any state agency, board, commission, or department who willfully violates any provision of this chapter must be reported to such agency, board, commission, or department for such action as it may determine appropriate.
Article 33-06 Reportable Conditions
Chapter 33-06-01 Conditions Designated as Reportable
N.D. Admin. Code 33-06-01-01 Reportable conditions
All reports and information concerning reportable conditions are confidential and not open to inspection. The following designated reportable conditions must be reported to the department of health and human services by the persons designated in chapter 33-06-02. If any reportable condition is designated by an asterisk, an appropriate sample or isolate must be submitted to the public health laboratory in addition to the required report.
1.Acute flaccid myelitis.
2.Alpha-gal syndrome.
3.Anthrax*.
4.Arboviral infection.
5.Botulism*.
6.Brucellosis*.
7.Campylobacteriosis.
8.Cancer, all malignant and in situ carcinomas; in addition, all benign cancers of the central nervous system, pituitary gland, pineal gland, and craniopharyngeal duct. Carcinoma in situ of the cervix is not collected. Basal or squamous cell carcinoma is not collected unless diagnosed in the labia, clitoris, vulva, prepuce, penis, or scrotum.
9.Candida auris*.
10.CD4 test results (all).
11.Chickenpox (varicella).
12.Chlamydial infections.
13.Cholera*.
14.Cluster of severe or unexplained illness or deaths.
15.Coccidioidomycosis.
16.Creutzfeldt-Jakob disease.
17.Critical congenital heart disease (CCHD).
18.Cryptosporidiosis.
19.Cyclosporiasis.
20.Diphtheria*.
21.E. coli, shiga toxin-producing*.
22.Fetal alcohol syndrome (FAS).
23.Foodborne or waterborne outbreaks.
24.Giardiasis.
25.Glanders*.
26.Gonorrhea.
27.Haemophilus influenzae infection (invasive infection with haemophilus influenzae isolated from blood, cerebral spinal fluid, or other normal sterile site)*.
28.Hantavirus*.
29.Hemolytic uremic syndrome.
30.Hepatitis (A*, B, C, D, and E), including hepatitis B and C nucleic acid test result (detectable or nondetectable) and hepatitis C genotype results.
31.Human immunodeficiency virus (HIV) infection, including acquired immunodeficiency syndrome (AIDS). (Any positive HIV test result, including gene sequencing and drug resistance patterns.) Human immunodeficiency virus (HIV) nucleic acid test result (including nondetectable).
32.Influenza (electronic laboratory reporting, novel cases, and pediatric deaths)*.
33.Laboratory incidences involving the possible release of category A bioterrorism agents or novel influenza viruses into the laboratory environment.
34.Lead blood level results (all).
35.Legionellosis.
36.Leptospirosis.
37.Listeriosis*.
38.Malaria*.
39.Measles (rubeola)*.
40.Melioidosis*.
41.Meningococcal disease (invasive infection with Neisseria meningitidis isolated from blood, cerebral spinal fluid, or other normal sterile site)*.
42.Mumps*.
43.Neonatal abstinence syndrome (NAS).
44.Nipah viral infections*.
45.Nosocomial outbreaks.
46.Novel severe acute illness*.
47.Organisms resistant to carbapenem or with emerging antimicrobial resistance*.
48.Orthopoxvirus*.
49.Overdose.
50.Pertussis.
51.Plague*.
52.Poliomyelitis*.
53.Pregnancy in a person infected with hepatitis B or C, HIV, or syphilis.
54.Q fever*.
55.Rabies (animal or human*), all results.
56.Respiratory panel test result (electronic laboratory reporting).
57.Respiratory syncytial virus (electronic laboratory reporting and pediatric deaths).
58.Rubella*.
59.Salmonellosis*.
60.Scabies outbreaks in institutions.
61.Severe acute respiratory syndrome-associated coronavirus disease (electronic laboratory reporting and pediatric deaths)*.
62.Shigellosis*.
63.Staphylococcus aureus, vancomycin resistant and intermediate resistant (VRSA and VISA)*.
64.Staphylococcus enterotoxin B intoxication*.
65.Streptococcus pneumoniae infections (invasive infection isolated from blood, cerebral spinal fluid, or other normal sterile site)*.
66.Suicide and suicide attempts.
67.Syphilis.
68.Tetanus.
69.Tickborne diseases*.
70.Trichinosis.
71.Tuberculosis (tuberculosis infection caused by Mycobacterium tuberculosis or Mycobacterium bovis)*. Laboratories that receive specimens for tuberculosis testing shall report all results obtained by an appropriate procedure. This includes all smear results for acid-fast bacilli, results of cultures to look for M. tuberculosis complex, and results of rapid methodologies, including nucleic acid amplifications which are performed when M. tuberculosis complex is suspected (only via electronic laboratory reporting). Positive results of tests performed by purified protein derivative antigen and all results by any other test approved for the purpose of identifying tuberculosis infection, (i.e. interferon gamma release assay) with corresponding values as available.
72.Tularemia*.
73.Tumors of the central nervous system.
74.Typhoid fever*.
75.Unexplained or emerging critical illness or death.
76.Vibriosis*.
77.Violent death.
78.Viral hemorrhagic fevers.
79.Weapons of mass destruction suspected event.
80.Yellow fever*.
October 1, 1990; January 1, 1991; February 1, 1992; May 1, 1994; January 1, 1995; July 1, 1996;
February 1, 2000; August 1, 2002; March 1, 2003; July 1, 2004; April 1, 2007; January 1, 2011;
January 1, 2018; October 1, 2019; January 1, 2024.
History
- History: Amended effective May 1, 1984; December 1, 1986; January 1, 1988; January 1, 1989;
- General Authority: NDCC 23-07-01
- Law Implemented: NDCC 23-07-01
Chapter 33-06-02 Reporting
N.D. Admin. Code 33-06-02-01 Reporting
1.Morbidity reports. Reporting may be conducted by completion of reporting forms, telephonic, electronic, or through other means designated by the state department of health. All morbidity reports must be made as soon as a laboratory test result is positive or a clinical diagnosis is made.
2.Printed forms. Reporting forms will be provided by the state department of health. For those conditions which may require investigation to prevent spread of the condition, forms are available which specify the patient's name and address, age, sex, occupation, probable source of infection, date of exposure, date of onset, and name and address of the person making the report. For those conditions which donot require investigations, forms are available for reporting the conditions by number only.
3.Telephonic reports. Physicians shall notify the state health officer by telephone of any unusual outbreak of food infections and poisonings, and of any case of bubonic plague, rabies, anthrax, botulism, Rocky Mountain spotted fever, and such other conditions as the state department of health may from time-to-time designate.
4.Teacher must report suspected cases. Whenever any school principal or teacher in any private, public, or parochial school has reason to suspect that any pupil is suffering from or has been exposed to any communicable condition, such principal or teacher shall send the child home with instructions to see the child's family physician. Any pupil so excluded shall not be permitted to attend school again until the pupil shall present a certificate from a physician licensed to practice medicine in North Dakota or from the local health department stating that the child is not suffering from a communicable condition and that it is safe for the child to return to school. Such principal or teacher shall also report any such suspected case to the local health officer, who, upon receipt of such report, shall use the officer's best judgment as to the necessity for further investigating the case.
5.All medical diagnostic laboratories are required to report any laboratory test result (serological, culture, etc.) which may be interpreted as indicative of any of the reportable conditions to the state department of health. Test results from specimens sent by in-state laboratories to out-of-state laboratories are also required to be reported.
6.In addition to reporting requirements specified under subsection 5, mandatory reporters include:
a.All physicians and other health care providers administering screening, diagnostic, or therapeutic services.
b.Hospitals, including those providing inpatient or outpatient services, or both.
c.Health care facilities, including basic care facilities and mobile units, providing screening, diagnostic, or therapeutic services.
History
- History: Amended effective July 1,1996.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
Chapter 33-06-03 Health Officer Investigation
N.D. Admin. Code 33-06-03-01 Infectious or communicable disease
When any infectious or communicable disease is reported to a health officer or when the health officer has reason to suspect that such disease exists within the officer's jurisdiction, the officer shall make a thorough investigation, if necessary, and if such disease is found to exist, the officer shall take such steps as are required by the laws of the state and by this chapter. If upon investigation the health officer shall find that a disease for which isolation is required has recently existed on any premises within the officer's jurisdiction, the officer shall place such premises under surveillance until the expiration of the incubation period.
History
- Law Implemented: NDCC 23-01-03
N.D. Admin. Code 33-06-03-02 Insanitary condition
Each health officer shall investigate whenever and wherever the officer has reason to suspect that any insanitary condition dangerous to public health exists within the officer's jurisdiction, and if such insanitary condition is found to exist, the officer shall order its removal within a specified time by a written notice served on the owner or agent of the property whereon such insanitary condition exists. If the owner or agent shall fail to remove or remedy such insanitary condition within the time specified in such written notice, the health officer shall bring the matter to the attention of the county attorney and, if necessary, file a complaint against such owner or agent for maintaining an insanitary condition dangerous to public health and in violation of the laws of the state and regulations of the state department of health.
History
- History: Amended effective February 1, 1996.
- Law Implemented: NDCC 23-07-06
N.D. Admin. Code 33-06-03-03 School may be closed
Whenever, in the judgment of the state department of health or of any county or city health officer, it is advisable to close the schools because of the prevalence of any contagious or infectious disease or diseases, the health officer shall serve written notice upon the board of school directors or the responsible officials of any private, parochial, public, or Sunday school in the same district in which such disease or diseases prevail, directing them to close all schools immediately nor shall any such schools be reopened until ordered by the proper health official.
History
- History: Amended effective February 1, 1996.
- Law Implemented: NDCC 23-01-03
N.D. Admin. Code 33-06-03-04 Disclosure of records
Information contained in disease control records and held by the state department of health is strictly confidential information. Information contained in disease control records includes all information, records of interviews, written reports, statements, notes, memoranda, or other data procured by the department in connection with disease control, or carried on by the department jointly with other persons, agencies, or organizations, or procured by such other persons, agencies, or organizations, for the purpose of disease control or for such purposes of reducing the morbidity or mortality from any cause or condition of health.
No officer or employee of the state department of health may be examined in any judicial, executive, legislative, or other proceeding regarding the existence or content of any individual's report retained by the department for disease control. The information may not be released, shared with any agency or institution, or made public, upon subpoena, search warrant, discovery proceedings, or otherwise, except that:
1.Medical or epidemiologic information may be released for statistical purposes in a manner such that no individual person can be identified.
2.Medical or epidemiologic information may be released to medical personnel to the extent necessary to protect the health or life of any individual.
3.Medical or epidemiologic information may be released to the person to whom the record pertains, that person's attending physician, or their legal or designated agent or guardian, provided no other person is identified. The department may require a signed consent from the patient prior to such release.
4.Disease control records other than those relating to human immunodeficiency virus infection may be released to a person engaged in a bona fide research project concerning medical, psychological, or sociological issues provided all of the following conditions are met:
a.The research project must be sponsored by a public or private college or university; a governmental entity; a nonprofit medical, sociological, or psychological association; or the pharmaceutical industry.
b.Identifying information may not appear in any report, summation, thesis, or other document arising out of the research project.
c.Identifying information may not be provided to a person engaged in a bona fide research project until that person has submitted a written proposal explaining and justifying the need to examine such information which is satisfactory to the state health officer.
d.All documents received by the researcher and all documents containing identifying information made by or on behalf of the researcher, by whatever means, including hard copies, typewritten or handwritten copies, photocopies, facsimiles, and electronic or electromagnetic recording or imaging, must be returned to the department on or before a date which shall be set by the state health officer.
e.The researcher shall submit a written plan explaining how all identifying information in the researcher's possession will be kept secure, to the satisfaction of the state health officer, who shall obtain written assurance that the plan will be implemented.
f.The researcher shall agree to provide the state health officer a copy of any report, summation, thesis, or other document arising out of the research project for departmental review of compliance with this section before providing it to the publisher.
g.The researcher shall consent in writing to the use and reproduction of the document by the department.
h.The researcher shall agree in writing to pay all costs of the state health officer or the department incurred in providing copy or search services to the researcher.
5.Release may be made as otherwise provided by statute.
6.For purposes of this section:
a."Disease" includes physical, genetic, or environmental conditions, psychological or mental conditions, and addictions.
b."Identifying information" includes any information which, alone or in conjunction with information available to the public, could identify a particular person as having or potentially having been exposed to a disease, having or potentially having a disease, or having or potentially having a predisposition for disease.
History
- History: Effective April 1, 1990; amended effective February 1, 1996.
- General Authority: NDCC 23-01-03, 23-07-01.2
- Law Implemented: NDCC 23-01-15, 23-07-02.2, 23-07-20.1
Chapter 33-06-04 Control of Specific Diseases
N.D. Admin. Code 33-06-04-01 Scientific guidance
In the control of infectious diseases, the department, local public health units, local law enforcement agencies, and veterinarians shall apply applicable guidelines set forth by the centers for disease control and prevention, advisory committee on immunization practices, American academy of pediatrics, American public health association, and other applicable experts.
History
- History: Amended effective January 1, 2018.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
N.D. Admin. Code 33-06-04-02 Measles
N.D. Admin. Code 33-06-04-03 Mumps
N.D. Admin. Code 33-06-04-04 Pertussis
N.D. Admin. Code 33-06-04-05 Poliomyelitis
N.D. Admin. Code 33-06-04-06 Rabies
1.How reported. If any physician or veterinarian has knowledge that any person has been bitten or scratched by, or otherwise exposed to a dog, other domestic animal, or a wild mammal, infected or suspected of being infected with rabies, the physician or veterinarian shall report these facts within forty-eight hours to the state department of health. The requirements of this subsection do not apply to dog or cat bites, scratches, or saliva exposure if there is a standing order or agreement with health care providers to report animal bites or possible exposure to rabies to a local law enforcement agency.
2.Vaccine replacement. The state health officer, or the health officer's designee, in that person's discretion may provide for the replacement of rabies vaccine and rabies immune globulin used to treat possible exposure to rabies. Any request for rabies vaccine and rabies immune globulin must be in writing, must be signed by the person who received postexposure vaccine or the person's parent or guardian, and must indicate that the person was possibly exposed to rabies, not through the person's own fault or that of the person's parent or guardian, and is financially unable to pay for the vaccine and immune globulin. A person will not be considered financially unable to pay if:
a.An insurer or a governmental agency other than the state department of health includes as a covered benefit, or another person is liable for, rabies vaccine or rabies immune globulin;
b.The person is eligible for complimentary vaccine or immune globulin from a vaccine manufacturer; or
c.The person, or the person's family, has an adjusted gross income of more than one hundred thirty-three percent of the poverty line determined in accordance with 42 U.S.C. 9902(2) applicable to a family of the size involved or assets in excess of those permitted under section 75-02-02.1-26, including the exceptions allowed under section 75-02-02.1-27.
Notwithstanding the limitations of this subsection, the state health officer, or the state health officer's designee, in that person's discretion also may supply rabies vaccine and immune globulin to a person if more than one person in a family requires postexposure treatment or some other hardship would prevent a person from receiving medically necessary treatment.
History
- History: Amended effective July 1, 1987; October 1, 1988; May 1, 1989; January 1, 1990; February 1, 2000; January 1, 2018.
- General Authority: NDCC 23-36
- Law Implemented: NDCC 23-36
N.D. Admin. Code 33-06-04-07 Rubella
N.D. Admin. Code 33-06-04-08 Tuberculosis
N.D. Admin. Code 33-06-04-09 Typhoid fever, paratyphoid fever
N.D. Admin. Code 33-06-04-10 Sexually transmitted diseases
1.Contact tracing is appropriate for the following sexually transmitted diseases:
a.Human immunodeficiency virus (HIV) infection;
b.Acquired immunodeficiency syndrome (AIDS);
c.Chlamydia;
d.Gonorrhea;
e.Hepatitis B virus (HBV); and
f.Syphilis.
2.Individuals infected with a sexually transmitted disease for which contact tracing is appropriate shall disclose information concerning the source of the infection to their attending physician or public health officer.
3.Information obtained pursuant to this section will be used solely for epidemiological purposes.
History
- History: Amended effective January 1, 1990.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-07-07(3), 23-07-07(4)
N.D. Admin. Code 33-06-04-11 Vaccines
Administrative charges by physicians, private or public clinics, and hospitals for the administration of any vaccine obtained from the state department of health through the federal vaccines for children program are limited to no more than the charges established by the federal regional fee caps as set forth in 59 Federal Register 50235 (October 3, 1994).
History
- History: Effective January 1, 1990; amended effective December 1, 1993; January 1, 2008; April 1, 2012.
- General Authority: NDCC 23-01-04.2, 28-32-02
- Law Implemented: NDCC 23-01-04.2
Chapter 33-06-05 School Immunization Requirements
N.D. Admin. Code 33-06-05-01 Requirements
1.Definitions. As used in this section:
a."Advisory committee on immunization practices" refers to a panel of experts in fields associated with immunization who have been selected by the secretary of the United States department of health and human services to provide advice and guidance to the secretary, the assistant secretary for health, and the centers for disease control and prevention on the most effective means to prevent vaccine-preventable diseases.
b."Age-appropriate immunizations" refers to the vaccines a child should receive based on age and previous immunization history as recommended by the advisory committee on immunization practices of the United States department of health and human services and outlined by the North Dakota immunization schedule.
c."Beliefs" as used in subsection 3 of North Dakota Century Code section 23-07-17.1 means sincerely held religious, philosophical, or moral beliefs which are not a pretense for avoiding legal requirements.
d."Institution" includes all early childhood facilities, head start programs, preschool educational facilities, public and private kindergartens, and elementary, middle, and high schools operating in North Dakota.
e."Institutional authority" means anyone designated by the governing body of an institution.
f."Medical exemption" means an exemption from an immunization requirement based on a form signed by a licensed physician stating that the physical condition of the child seeking the exemption is such that the vaccine administered would endanger the life or health of the child.
2.Minimum requirements.
a.Minimum requirements for children attending early childhood facilities, head start programs, and preschool educational facilities shall be age-appropriate immunizations against diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, rubella, haemophilus influenzae type B disease, varicella (chickenpox), pneumococcal disease, rotavirus, hepatitis A, and hepatitis B.
b.Minimum requirements for children attending kindergarten through grade twelve shall be age-appropriate immunizations against diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, rubella, varicella (chickenpox), meningococcal disease, and hepatitis B.
3.Effective dates.
a.Effective with the 2008-09 school year, a student must receive a second dose of varicella (chickenpox) vaccine before being admitted into kindergarten or first grade if the student's school does not have a kindergarten. Each subsequent school year, the next higher grade will be included in the second dose varicella (chickenpox) immunization requirement so those students transferring into North Dakota schools are added to the second dose varicella (chickenpox) immunization cohort.
b.Effective with the 2014-15 school year, a student must receive meningococcal conjugate and tetanus, diphtheria, and pertussis (tdap) vaccine before being admitted into any seventh grade.
c.Effective with the 2018-19 school year, a student must be adequately immunized according to the advisory committee on immunization practices with tetanus, diphtheria, and pertussis (tdap) vaccine before being admitted into eighth through twelfth grade.
d.Effective with the 2018-19 school year, a student must be adequately immunized according to the advisory committee on immunization practices with meningococcal conjugate vaccine before being admitted into eighth through twelfth grade.
4.Exemptions. A child with a medical or a beliefs exemption is exempt from any one or all of the immunization requirements. A physician must sign an exemption form indicating the vaccines that are included in the medical exemption. A parent or guardian must sign an exemption form stating that the child has a beliefs exemption and indicate which vaccines are exempt because of beliefs. A child with a reliable history of chickenpox, hepatitis A, hepatitis B, measles, mumps, or rubella is exempt from applicable immunization requirements. A physician must sign an exemption form stating that the child has had disease. Exemption forms must be kept on file with the immunization records at the child's school, early childhood facility, head start program, or preschool educational facility.
5.Recordkeeping and reporting. Records and reports requested by the state department of health shall be completed and submitted to the state department of health.
a.Certificates of immunization, a North Dakota immunization information system (NDIIS) record, or other official proof of immunization must be presented to the designated institutional authority before any child is admitted to an institution.
b.Upon request by the institutional authority and approval by the department, the department shall provide access to the NDIIS. The department of health shall disclose immunization records maintained by the NDIIS to an institutional authority or designee to fulfill the required proof of immunization.
c.The parent or guardian of a child claiming a medical, history of disease, or beliefs exemption shall present an appropriately signed statement of exemption to the designated institutional authority. Proof of immunization or the statement of exemption must be maintained by the child's school or early childhood facility.
d.The school or early childhood facility immunization summary report must be submitted to the state department of health by November first of each year or such other annual date as the department may designate.
6.Appointment of an institutional authority. An institutional authority shall be appointed for each institution by its governing board or authorized personnel. The authority must be an employee of such institution.
7.Provisional admission - Exclusion. Any child admitted to school or early childhood facility under the provision that such child is in the process of receiving the required immunizations shall be required to receive the immunizations according to the recommended schedule set forth by the state department of health. Any child admitted to school and not adhering to the recommended schedule shall provide proof of immunization or a certificate of immunization by October first or within thirty calendar days of enrollment if enrolling after October first or be excluded from school. Any child admitted to an early childhood facility and not adhering to the recommended schedule shall provide proof of immunization or a certificate of immunization within thirty calendar days of enrollment or be excluded from the early childhood facility.
History
- History: Amended effective November 1, 1979; September 1, 1991; January 1, 1998; February 1, 2000; January 1, 2004; January 1, 2008; January 1, 2014; January 1, 2018.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-07-17.1
Chapter 33-06-05.1 General Provisions
N.D. Admin. Code 33-06-05.1 General Provisions
CHAPTER 33-06-05.1
GENERAL PROVISIONS
Section 33-06-05.1-01Purpose 33-06-05.1-02Definitions 33-06-05.1-03Adoption of Policy by Governing Body 33-06-05.1-01. Purpose.
Chapters 33-06-05.1 through 33-06-05.6 establish guidelines for adoption of policies and procedures for the governing body of an institution to follow in the event the institution obtains knowledge that an employee, independent contractor, or student contracts a significant contagious disease. The rules should be interpreted to assure consideration of the rights of all involved under 29 United States Code section 794, section 504 Rehabilitation Act of 1973 and North Dakota Century Code chapter 14-02.4. It is recognized that each institution may have individual situations to address; therefore, each institution may adopt policies to fit their individual requirements which are not inconsistent with chapters 33-06-05.1 through 33-06-05.6. In adopting policies to implement chapters 33-06-05.1 through 33-06-05.6, an institution may be guided by "Recommended Policies for School Boards and Boards of Health Regarding School-age Children and School Employees" if the policies contained therein are not inconsistent with chapters 33-06-05.1 through 33-06-05.6.
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1 33-06-05.1-02. Definitions.
When used in chapters 33-06-05.1 through 33-06-05.6, unless the context or subject matter otherwise requires:
1."Affected person", "affected individual", or "affected student" means an individual who has been diagnosed by a physician as having contracted a significant contagious disease.
2."Decisionmaker" is the affected person's personal physician. However, whenever an affected student is also disabled as defined under the Education For All Handicapped Children Act, 20 U.S.C. 1401(a)(1) or North Dakota Century Code chapter 15-59, the decisionmaker is the multidisciplinary team provided for under subsection 4 of North Dakota Century Code section 15-34.1-03.
3."Employee" means all persons employed by the institution including faculty, maintenance, and administrative personnel.
4."Governing body" means a board of directors, a school board, or other entity vested with
authority to make binding decisions on behalf of an institution.
5."Independent contractor" means any person or entity who is free of control or direction over performance of the service provided both under the contract and in fact, who renders service outside the ordinary course of business or outside of the place of business of the contractor and who is engaged in an independently established trade, organization, profession, or business.
6."Individualized education program" denotes a specialized education plan created in compliance with 20 U.S.C. 1401(a)(19).
7."Institution" includes all public kindergartens, elementary, junior high, and high schools operating within all school districts in North Dakota.
8."Reasonable accommodations" is as defined by subsection 16 of North Dakota Century Code
section 14-02.4-02 or U.S.C. 794.
9."Significant contagious disease" includes cytomegalovirus (CMV), hepatitis B (HBV) and human immunodeficiency (HIV) infection. The local board of health or the state health officer may determine that other diseases are significant contagious diseases.
10."Special provisions" are individually tailored education decisions designed to meet the needs of students requiring unique accommodations to ensure an educational opportunity. Special provisions are directed to students not covered by an individualized education program.
11."Universal precautions" means protecting one's self from exposure to blood or body fluids, through the use of latex gloves, masks, or eye goggles, cleaning blood and body fluid spills with soap and water and then disinfecting and incineration or decontaminating infective waste before disposing in a sanitary landfill.
Law Implemented: NDCC 14-02.4, 23-01-03, 23-07-16, 23-07-16.1 33-06-05.1-03. Adoption of policy by governing body.
In accordance with the guidelines set out in chapters 33-06-05.1 through 33-06-05.6, the governing body of each institution shall adopt policies:
1.For education of student, employees, and independent contractors concerning significant contagious disease;
2.To protect the identity of affected individuals;
3.To protect the health of students, employees, independent contractors, and the public;
4.To provide to the public only that information which is essential for protection of public health;
5.To provide for attendance, employment, or contracts regarding affected individuals and to establish procedures for the development of special provisions and reasonable accommodations;
6.To protect affected individuals from harassment and discrimination within the institutional setting; and
7.To receive information concerning the status of students, employees, and independent contractors from their physicians.
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1
Chapter 33-06-05.2 Students with Significant Contagious Diseases
N.D. Admin. Code 33-06-05.2 Students with Significant Contagious Diseases
CHAPTER 33-06-05.2
STUDENTS WITH SIGNIFICANT CONTAGIOUS DISEASES
Section 33-06-05.2-01Student Attendance 33-06-05.2-02Confidentiality 33-06-05.2-03Individual Student Needs 33-06-05.2-01. Student attendance.
No student may be prohibited from attending the institution solely because they have, or they are perceived to have, a significant contagious disease. If the student is well enough to attend the institution, and does not constitute a public health threat, as determined by the decisionmaker, the student must be permitted to attend the institution. If the student is unable to attend regular class instruction or requires special consideration, then special provisions or individualized education programs must be provided for the student.
Law Implemented: NDCC 15-34.1-03, 23-01-03, 23-07-16, 23-07-16.1 33-06-05.2-02. Confidentiality.
Unless disclosed by the affected person, their parent or guardian, or their personal physician, no individual may be informed of an affected individual's infection. In order to eliminate discrimination, the local governing body should develop policies concerning the comprehensive application of universal precautions throughout the institution.
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1 33-06-05.2-03. Individual student needs.
If an affected student is unable to participate in regular classroom instruction, either reasonable accommodations, special provisions, or an individualized education program will be provided.
Law Implemented: NDCC 15-47-38, 23-01-03, 23-07-16, 23-07-16.1
Chapter 33-06-05.3 Employees with Significant Contagious Diseases
N.D. Admin. Code 33-06-05.3 Employees with Significant Contagious Diseases
CHAPTER 33-06-05.3
EMPLOYEES WITH SIGNIFICANT CONTAGIOUS DISEASES
Section 33-06-05.3-01Standards for Employment 33-06-05.3-02Confidentiality 33-06-05.3-03Reasonable Accommodations 33-06-05.3-01. Standards for employment.
No employee or potential employee may be terminated or prevented from becoming employed at the institution solely because they have or they are perceived to have a significant contagious disease.
If the employee is well enough to perform their job and does not constitute a public health threat to others, as determined by a personal physician, the employee must be permitted to perform the duties.
Law Implemented: NDCC 14-02.4, 23-01-03, 23-07-16, 23-07-16.1 33-06-05.3-02. Confidentiality.
Unless disclosed by the affected person, or their personal physician, no disclosure of an affected individual's condition may be made. In order to eliminate discrimination, the local governing body should develop policies concerning the comprehensive application of universal precautions throughout the institution.
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1 33-06-05.3-03. Reasonable accommodations.
The institution shall consider and implement reasonable accommodations to allow the affected individual to become an employee or continue as an employee.
Law Implemented: NDCC 14-02.4; 29 USC 794
Chapter 33-06-05.4 Treatment of Independent Contractors with Significant Contagious Diseases
N.D. Admin. Code 33-06-05.4 Treatment of Independent Contractors with Significant Contagious Diseases
CHAPTER 33-06-05.4
TREATMENT OF INDEPENDENT CONTRACTORS WITH
SIGNIFICANT CONTAGIOUS DISEASES
Section 33-06-05.4-01Standards of Contracting for Independent Contractors 33-06-05.4-02Confidentiality 33-06-05.4-03Reasonable Accommodations 33-06-05.4-01. Standards of contracting for independent contractors.
No independent contractor may be terminated or prohibited from contracting with the institution solely because they have or they are perceived to have a significant contagious disease. If the independent contractor is capable of performing the work, or reasonable accommodations can be made to allow the independent contractor to perform the work, and the independent contractor does not constitute a public health threat to others, as determined by a personal physician, the independent contractor must be permitted to contract with the institution. 33-06-05.4-02. Confidentiality.
Unless disclosed by the affected person, or their personal physician, no individual may be informed of an affected individual's infection. In order to eliminate discrimination, the local governing body should develop policies concerning the comprehensive application of universal precautions throughout the institution. 33-06-05.4-03. Reasonable accommodations.
The institution shall consider and implement reasonable accommodations to allow the affected individual to contract as an independent contractor or to continue an existing contract as an independent contractor.
Chapter 33-06-05.5 Relations with the Public
N.D. Admin. Code 33-06-05.5 Relations with the Public
CHAPTER 33-06-05.5
RELATIONS WITH THE PUBLIC
Section 33-06-05.5-01Dissemination of Information 33-06-05.5-02Procedure for Addressing Public Knowledge of Affected Individuals at an Institution 33-06-05.5-01. Dissemination of information.
Except as required by law, information concerning the identity and status of an affected individual may not be released to the public. No release may be made of any information either confirming or denying the presence within the institution setting of a person who has contracted a significant contagious disease.
History: Effective January 1, 1991.
General Authority: NDCC 23-07-16.1
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1 33-06-05.5-02. Procedure for addressing public knowledge of affected individuals at an institution.
The institution shall develop a procedure for addressing situations when information concerning an affected individual becomes public. The procedure adopted under this section must include the identification of a single spokesperson for the institution, a means of protecting against possible breeches of confidentiality, and a plan for conflict resolution which may include a request for assistance from an appropriate consultant.
History: Effective January 1, 1991.
General Authority: NDCC 23-07-16.1
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1
Chapter 33-06-05.6 Education
N.D. Admin. Code 33-06-05.6 Education
CHAPTER 33-06-05.6
EDUCATION
Section 33-06-05.6-01Education Concerning Significant Contagious Diseases Required 33-06-05.6-01. Education concerning significant contagious diseases required.
Each institution shall adopt and implement a policy requiring the education of all students, employees, and independent contractors. The policy adopted must include information concerning the means of transmission of significant contagious diseases in an institutional setting, the means of protecting against contracting the disease in an institutional setting, and the use of universal precautions.
History: Effective January 1, 1991.
General Authority: NDCC 23-07-16.1
Law Implemented: NDCC 23-01-03, 23-07-16, 23-07-16.1
Chapter 33-06-06 Food Handlers [Repealed]
N.D. Admin. Code 33-06-06 Food Handlers [Repealed]
CHAPTER 33-06-06
FOOD HANDLERS [Repealed effective August 1, 1999]
Chapter 33-06-07 Laboratory Specimens for Carriers of Disease
N.D. Admin. Code 33-06-07-01 Specimens to be submitted
Any person suspected of being a carrier of disease that may be spread through the person's bodily excretions or discharges or in any other way shall on request of any health officer of North Dakota submit to the state department of health specimens of such bodily excretions or discharges in the manner and amount, at such intervals, and under such supervision as prescribed by the state health officer.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
Chapter 33-06-08 Isolation Requirements
N.D. Admin. Code 33-06-08-01 Use of isolation requirements
1.Exposure in an infectious state. The health officer or an attending physician of a person with communicable disease may, in the officer's or physician's judgment, forbid the person with the case in an infectious state from exposing other noninfected individuals to the person's infection.
2.Measures on the control. The health officer or an attending physician of a person with a communicable disease may require restrictive or corrective measures which apply to the control of a specific disease.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-07-06
Chapter 33-06-09 Common Carriers Federal Regulation Adopted and Shipment of Birds of the Psittacine Family
N.D. Admin. Code 33-06-09-01 Common carriers federal regulation adopted
All common carriers operating in North Dakota, whether engaged in the interstate business or intrastate business or both, shall comply with the regulations of the United States public health service made and promulgated for the control of common carriers engaged in interstate business, and the regulations made by the United States public health service are hereby declared to be a part of this
chapter of the state department of health of North Dakota.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
N.D. Admin. Code 33-06-09-02 Importation of parrots, parakeets, and other birds of the psittacine family
Shipment of parrots, parakeets, and other birds of the psittacine family shall comply with all federal interstate regulations.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
Chapter 33-06-10 Disinfection
N.D. Admin. Code 33-06-10-01 Disinfection, fumigation, and renovation
1.Definition. "Disinfection" means killing of infectious agents outside the body by chemical germicides, or boiling water.
2.Disinfection. Disinfection should be applied immediately after the discharge of infectious material from the body of an infected person or after the soiling of articles with such infectious discharges; all personal contacts with such discharges or articles should be prevented prior to disinfection to the extent possible.
3.Disinfection of school buildings. Whenever any pupil, janitor, or teacher in any public, private or parochial school is afflicted with any infectious or contagious disease for which disinfection is required, the local health officer shall have the authority to require disinfection of the school or school rooms, if in the local health officer's medical opinion this would prevent the further spread of the disease.
4.Fumigation. Fumigation is not an effective means of disinfection and is not recommended except where the destruction of insects, mosquitoes, body lice, and rodents, such as rats, is accomplished by the employment of gaseous agents.
5.Renovation. When in the judgment of the health officer the circumstances and conditions of the premises or the nature of the disease seem to warrant it, a thorough renovation shall be required in addition to disinfection.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-07-06
Chapter 33-06-11 [Reserved]
N.D. Admin. Code 33-06-11 [Reserved]
CHAPTER 33-06-11 [Reserved]
Chapter 33-06-12 [Reserved]
N.D. Admin. Code 33-06-12 [Reserved]
CHAPTER 33-06-12 [Reserved]
Chapter 33-06-13 [Reserved]
N.D. Admin. Code 33-06-13 [Reserved]
CHAPTER 33-06-13 [Reserved]
Chapter 33-06-14 [Reserved]
N.D. Admin. Code 33-06-14 [Reserved]
CHAPTER 33-06-14 [Reserved]
Chapter 33-06-15 Preparation of Bodies and Transportation
N.D. Admin. Code 33-06-15-01 Preparation of bodies with certain communicable diseases and transportation of the dead
1.Communicable diseases. The following requirements shall be met by funeral directors for bodies dead from these contagious or infectious diseases - anthrax, cholera, meningococcus meningitis, plague, smallpox, and tuberculosis:
a.Only a licensed funeral practitioner or an intern embalmer who is closely supervised by a licensed funeral practitioner shall accept and prepare the body.
b.In the preparation of the body, appropriate outer garments and rubber gloves shall be worn.
c.The body shall be thoroughly embalmed with an approved disinfecting fluid by arterial and cavity injection, all orifices and any discharging sinuses closed with absorbent cotton, and the body washed with an appropriate disinfecting fluid.
No embalming fluid containing compounds of arsenic, mercury, zinc, or other highly poisonous metals shall be sold or used in North Dakota for the embalming of dead human bodies for burial.
d.Following the preparation, the instruments shall be sterilized by boiling or placing in an antiseptic solution, and the hands shall be washed with soap and water.
e.Without delay, the body shall receive the finishing preparation, placed in a casket, and the casket permanently closed. The casket may be provided with transparent material of sufficient dimensions to disclose the face.
f.Bodies prepared as herein stated may be accepted for transportation.
2.Embalming and transportation.
a.A burial-transit permit may be issued for the bodies of those dead from causes listed under subsection 1 only if the body has been embalmed.
b.A burial-transit permit may be issued for the bodies of those dead from causes other than those listed under subsection 1 without embalming or refrigeration, provided they reach their destination within forty-eight hours from the time of death. If the body cannot reach its destination within the prescribed forty-eight hours, it must be embalmed.
c.A burial-transit permit may be issued for the bodies of those dead from causes other than those listed under subsection 1 without embalming if they are refrigerated to a temperature of between thirty-eight and forty degrees Fahrenheit, provided they reach their destination within seventy-two hours from the time of death. If the body cannot reach its destination within the prescribed seventy-two hours with constant refrigeration, it must be embalmed.
d.Destination shall be considered the burial, cremation, or final disposition of the body.
Storage of a body during the winter months when burial is difficult shall not be considered final disposition.
History
- History: Amended effective February 1, 2000; August 1, 2003.
- General Authority: NDCC 23-01-03, 23-06-07
- Law Implemented: NDCC 23-01-03, 23-06, 23-07, 23-21
Chapter 33-06-16 Newborn Screening Program
N.D. Admin. Code 33-06-16-01 Definitions
As used in this chapter:
1."Care coordination" means services that promote the effective and efficient organization and utilization of resources to assure access to necessary comprehensive services for children with special health care needs and their families.
2."Licensed clinician" means a currently licensed physician, physician assistant, or advanced practice registered nurse.
3."Metabolic disease" and "genetic disease" mean a disease as designated by the state health officer for which early identification and timely intervention will lead to a significant reduction in mortality, morbidity, and associated disabilities.
4."Metabolic disorders clinic team" means medical providers and other professionals that provide comprehensive pediatric evaluations and coordinated care recommendations using a team approach to help effectively manage care for individuals with metabolic disorders.
5."Newborn screening program" means the North Dakota screening program in the department of health and human services facilitating access to appropriate testing, followup, diagnosis, intervention, management, evaluation, and education regarding metabolic diseases and genetic diseases identified in newborns.
6."Protected health information" means any information, including genetic information, demographic information, and fluid or tissue samples collected from an individual, diagnostic and test results, whether oral or recorded in any form or medium, which:
a.Is created or received by a health care provider, health researcher, health plan, health oversight authority, public health authority, employer, health or life insurer, school or university; and b.(1)Relates to the past, present, or future, physical or health or condition of an individual, including individual cells and their components; the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual; and (2)(a)Identifies an individual; or (b)With respect to which there is a reasonable basis to believe that the information can be used to identify an individual.
7."Responsible clinician" means the licensed clinician, midwife, naturopath, doula, or birth attendant attending a newborn.
8."Screening" means initial testing of a newborn for the possible presence of metabolic disease or genetic disease.
9."Screening laboratory" means the laboratory the department of health and human services selects to perform screening.
History
- History: Effective December 1, 1996; amended effective March 1, 2003; January 1, 2006; April 1, 2016; January 1, 2025.
- General Authority: NDCC 23-01-03.1, 23-01-04, 23-01-15, 25-17-01, 25-17-02
N.D. Admin. Code 33-06-16-02 Testing of newborns
Repealed effective April 1, 2016.
N.D. Admin. Code 33-06-16-03 Physician responsibility
Repealed effective April 1, 2016.
N.D. Admin. Code 33-06-16-04 Refusal of testing
1.If the parents or guardians refuse to have their infant receive newborn screening testing after being provided written information, that refusal shall be documented by a written statement signed by the parents or guardians.
2.The original refusal statement shall become a part of the infant's medical record and a copy of the statement must be submitted to the newborn screening program within six days after testing was refused.
History
- History: Effective March 1, 2003; amended effective January 1, 2006; April 1, 2016.
- General Authority: NDCC 23-01-03(3), 23-01-03.1, 23-01-04, 23-01-15, 25-17-01, 25-17-02
N.D. Admin. Code 33-06-16-05 Research and testing materials
1.Access to information or testing materials may be obtained only as follows:
a.Information may be disclosed for statistical purposes in a manner such that no individual person can be identified.
b.Protected health information may be disclosed to the individual tested, that person's parent or guardian, or that person's licensed clinician, responsible clinician, dietitian, metabolic disorders clinic team, screening laboratory, other employees and contractors of the department of health and human services with need for the information, or to special health services within the department of health and human services for purposes of care coordination and provision of medical and low-protein modified foods.
2.Information and testing materials must be stored in such a way as to protect the integrity of the materials and the privacy of patients.
3.Dried blood spots must be destroyed thirty days after completion of testing. Residual specimens may be retained for laboratory quality assurance purposes and must be destroyed after completion of quality assurance activities.
4.Information and testing materials may be destroyed by any available means that preserves individual confidentiality and, for the testing materials, complies with any applicable standards for destruction of human blood samples.
History
- History: Effective March 1, 2003; amended effective April 1, 2016; January 1, 2025.
- General Authority: NDCC 23-01-03.1, 23-01-04, 23-01-15, 25-17-01, 25-17-02
Article 33-07 Licensing Medical Hospitals
Chapter 33-07-01 Hospitals
N.D. Admin. Code 33-07-01 Hospitals
ARTICLE 33-07
LICENSING MEDICAL HOSPITALS
Chapter 33-07-01Hospitals [Superseded] 33-07-01.1Hospitals 33-07-02General Standards of Construction and Equipment for Hospitals [Superseded] 33-07-02.1General Standards of Construction and Equipment for Hospitals 33-07-03Long-Term Care Facilities [Superseded] 33-07-03.1Long-Term Care Facilities [Repealed] 33-07-03.2Nursing Facilities 33-07-04General Standards of Construction and Equipment for Long-Term Care Facilities [Superseded] 33-07-04.1General Standards of Construction and Equipment for Long-Term Care Facilities [Repealed] 33-07-04.2General Standards of Construction and Equipment for Nursing Facilities 33-07-05Nursing Facility Sanctions 33-07-06Nurse Aide Training, Competency Evaluation, and Registry [Repealed]
CHAPTER 33-07-01
HOSPITALS [Superseded by Chapter 33-07-01.1]
Chapter 33-07-01.1 Hospitals
N.D. Admin. Code 61-07-01 The hospital, upon receipt, shall submit to the department a copy of the annual board of pharmacy hospital inspection report under subsection 2 of section 61-07-01-13 and plans of correction to the department
2.Primary care hospitals are subject to the pharmaceutical services requirements for general
3.Specialized hospitals are subject to the pharmaceutical services requirements for general 33-07-01.1-22. Laboratory services.
1.General acute hospitals shall have a well-organized, adequately supervised, clinical laboratory service available with the necessary space, facilities, and equipment and qualified, licensed staffing to perform these services commensurate with the hospital's needs for its patients. At a minimum, the hospital must adhere to the following:
a.Laboratory services must be provided in accordance with the clinical laboratory improvement amendments at 42 Code of Federal Regulations part 493.
b.Provisions must be made to assure twenty-four-hour availability of emergency laboratory services either directly or through contract.
c.All clinically relevant surgically removed tissues must be examined by a pathologist consistent with hospital policy and signed reports must be included in the patient's medical record. Anatomical pathology services may be provided either by the hospital directly or per contractual arrangement with a certified laboratory. Written policies and procedures must be established through the medical staff and pathologist governing prompt transportation of specimens and submission of reports.
d.An autopsy service must be provided either directly by the hospital or by contractual arrangement with another institution having an approved laboratory. Hospitals providing the service directly must have adequate space, equipment, and personnel for services provided.
e.Each hospital shall provide appropriate facilities and equipment for the procurement, storage, safekeeping, and administration of whole blood and blood products either directly or through contractual arrangement. Written policies and procedures for all phases of operation of blood banks and transfusion services must be established and revised as needed.
2.Primary care hospitals are subject to the laboratory services requirements for general acute
3.Specialized hospitals shall provide laboratory services to meet the needs of patients served consistent with the laboratory services requirements for general acute hospitals in this section.
If onsite laboratory services are not necessary to meet the needs of patients served, the laboratory services may be provided through a contractual agreement with a certified laboratory.
1.The general acute hospital shall provide and maintain radiology services sufficient to perform and interpret the radiological examinations necessary for the diagnosis and treatment of patients, to the extent that the complexity of services are commensurate with the size, scope, and nature of the hospital. Additional required services must be provided by shared services or referral of patients.
a.The physician responsible for the direction and supervision of radiology services must be board certified or eligible for certification by the American board of radiology or equivalent. The physician responsible for radiology services must be a member of the medical staff. This individual's responsibilities must be identified in the policy and procedure manual or other document.
b.Technicians and technologists employed in the radiology services must have had sufficient training and experience to carry out the procedures safely and efficiently commensurate with the size, scope, and nature of the service. A means for evaluating qualifications must be established and used. The physician responsible for radiology services shall document as to the acceptability of the qualifications specific to each radiology technician or technologist.
c.The hospital shall provide for emergency radiology services at all times.
d.Complete signed reports of the radiological examinations must be made part of the patient's record and duplicate copies, as well as the images, must be kept in the hospital for a period of five years.
e.Written reports of each radiological interpretation, consultation, and treatment must be signed by the physician responsible for conducting the radiological examination and must be a part of the patient's medical record.
f.Radiation workers must be checked by film dosimeter to determine the amount of radiation to which they are routinely exposed. Records must be maintained to reflect each individual's exposure level. These checks must be conducted on a monthly basis until the radiation exposure history for the radiation worker indicates levels below maximum permissible dose for a period of one year. When radiation dose levels have remained below the maximum permissible dose for a year, radiation doses may be monitored on a quarterly basis as long as the exposure remains below the maximum permissible dose.
2.Primary care hospitals are subject to the radiology services requirements for general acute
3.Specialized hospitals shall provide radiology services to meet the needs of patients served consistent with the radiology services requirements for general acute hospitals in this section.
If onsite radiology services are not necessary, such as in hospitals serving only psychiatric or substance abuse patients, the radiology services may be provided through a contractual agreement with an institution providing radiology services. 33-07-01.1-24. Nuclear medicine services.
1.If the acute hospital provides nuclear medicine services, the services must be provided to meet the needs of the patients and in a safe and effective manner.
a.The hospital shall have available written verification of compliance with article 33-10.
b.The hospital shall have evidence of licensure to handle radioactive materials.
c.The physician responsible for the direction of the nuclear medicine services must be a physician who is qualified to provide nuclear medicine services and who is a member of the medical staff.
d.Nuclear medicine services may be ordered only by a licensed health care practitioner whose qualifications and medical staff privileges allow such referrals.
e.Personnel employed in nuclear medicine services must meet the qualification and training requirements, perform the functions, and carry out the responsibilities specified by the director and approved by the medical staff.
f.The diagnostic procedures must be interpreted by a licensed health care practitioner who has been approved by the medical staff to do so. The licensed health care practitioner shall document, sign, and date reports of procedures, interpretations of procedures, and consultations.
g.The hospital shall retain copies of nuclear medicine reports consistent with current standards of practice.
h.The nuclear medicine services shall develop and implement policies in accordance with standards of practice specific for the services provided, and consistent with chapter 61-05-01, including:
(1)Handling, maintenance, and inspection of equipment.
(2)Protection of patients and personnel from radiation hazards.
(3)Testing of equipment for radiation hazards.
(4)Maintenance of personnel radiation monitoring devices.
(5)Preparation and administration of radio-pharmaceutical.
(6)Documentation of receipt, storage, use, and disposal of radioactive materials.
2.If the primary care hospital provides nuclear medicine services, the hospital shall comply with nuclear medicine services requirements for general acute hospitals in this section.
3.Specialized hospitals providing nuclear medicine services are subject to the nuclear medicine 33-07-01.1-25. Emergency services.
1.Each general acute hospital shall provide emergency services to its inpatients. If the hospital does not provide emergency services to the public, it shall be prepared to provide immediate lifesaving measures to individuals who may appear for emergency care and arrange for their transfer to another hospital that does provide a public emergency service.
a.Each hospital shall have a well-defined plan for emergency care service based on the capability of the hospital and its specialized supportive services.
(1)The hospital plan for emergency care services must be developed to coordinate with representatives of community emergency medical services agencies or groups.
(2)Hospitals without emergency service for the public shall have written policies and procedures governing the handling of emergencies.
b.Every hospital with an emergency service shall provide treatment to every individual in an emergency without discrimination on account of economic status or source of payment.
c.Every emergency service shall have a qualified licensed health care practitioner designated in charge of the emergency medical services to ensure that emergency patient care services meet the standards herein and for the coordination of professional coverage according to a plan established by the medical staff and approved by the governing body.
d.A hospital must have one or more licensed health care practitioners qualified by training and experience in care of emergency patients on duty or call at all times and available to respond to emergencies within thirty minutes. The licensed health care practitioner shall determine the nature, level, and urgency of care required of all individuals seeking treatment and categorize them accordingly, assuring that serious cases are accorded priority treatment.
e.The staffing pattern of nursing or allied health personnel must be consistent with the scope and complexity of the emergency services provided. At least one licensed individual who is qualified by training and experience in emergency care must be assigned to the emergency services at all times.
f.A current roster of licensed health care practitioners, medical specialists, or consultants on emergency call, including alternates, must be kept posted at all times in the emergency service area.
g.There must be current written policies governing emergency services. The policies and procedures must pertain to at least the following:
(1)Medical staff and obligation for emergency patient care.
(2)Circumstances under which definitive care will not be provided and procedures to be followed in referrals.
(3)Procedures that may or may not be performed in the emergency service area.
(4)Handling of individuals who are emotionally ill, under the influence of drugs or alcohol, dead on arrival, or other categories of special cases as determined necessary.
(5)Procedures for early transfer of severely ill or injured to special in-house treatment areas or to other facilities.
(6)Written instructions to be given for followup care and disposition of all cases.
(7)Notification of patient's personal licensed health care practitioner and transmission of relevant reports.
(8)Disclosure of patient information in accordance with federal and state law.
(9)Communication with police, health authorities, and emergency vehicle operators.
(10)Appropriate utilization of observation beds.
(11)Procurement of equipment and drugs.
(12)Location and storage of medications, supplies, and special equipment.
(13)Operation of the emergency service in times of disaster.
h.A list of poison antidotes and the telephone number of the poison control center must be posted in a prominent place in the emergency service area.
i.The emergency service shall have necessary supportive services available on a twenty-four-hour basis. These services must include onsite clinical laboratory service plasma expanders, provision for blood or blood products; pharmaceutical service; onsite radiology service including protocol to govern the interpretation by a radiologist of diagnostic images produced by x-ray, or other modalities if provided, including a procedure for the prompt communication of the radiologist's interpretation; and surgical and anesthesia service or referral process for surgical and anesthesia service.
j.At a minimum, the following special supplies and equipment must be available in a complete set of adult and pediatric sizes for the provision of emergency services:
(1)Oxygen.
(2)Pulse oximeter.
(3)Complete set of bag/valve/mask ventilation devices.
(4)Complete set of oral and nasal airways.
(5)Suction equipment.
(6)Endotracheal intubation, pericardiocentesis, thoracotomy, and cricotracheotomy trays.
(7)Electrocardiograph.
(8)Cardiac monitor and defibrillator with battery pack.
(9)Moveable equipment cart for use as a crash cart.
(10)American heart association advanced cardiac life support recommended drug inventory.
(11)Intravenous fluids including lactated ringers solution and dextrose five percent in water.
(12)Infusion pump.
(13)Pressure infuser.
(14)Gastric lavage equipment.
(15)Urinary catheter kits.
(16)Emergency obstetrical pack.
(17)Spine board.
(18)Rigid cervical collars.
(19)Fracture splints.
(20)Sterile dressings and bandages.
(21)Gurney or exam table.
k.Facilities must be provided to assure prompt diagnosis and emergency treatment.
(1)Facilities must be separate from, and independent of, the operating rooms.
(2)The location of the emergency services must be easily accessible from an exterior entrance of the hospital.
l.Adequate emergency room medical records on every patient must be kept and must include:
(1)Patient identification and history of disease or injury.
(2)Physical findings and laboratory and x-ray reports, if any.
(3)Time of arrival, time of treatment, major diagnosis, treatment provided, and disposition including discharge instructions.
2.Primary care hospitals are subject to the emergency services requirements for general acute hospitals in this section. Primary care hospitals providing emergency services to the public may provide low intensity outpatient services consistent with those services commonly provided in a physician's office and consistent with the privileges granted to the licensed health care practitioner rendering the service.
3.Specialized hospitals are subject to the emergency services requirements for general acute hospitals in this section, with the exception of rural emergency hospitals, which are subject to the emergency services requirements for primary care hospitals in this section. 33-07-01.1-26. Social services.
1.Social services must be provided in all general acute hospitals by a qualified social worker or a social services designee to meet the needs of the patients. Hospitals utilizing social services designees must have quarterly consultation by a qualified social worker.
a.Records of social service activity related to individual patient's needs must be kept, and must be available to the professional personnel concerned. Functions and activities recorded must include, as appropriate:
(1)Assessment, planning, implementation, and evaluation of psychosocial and rehabilitation needs of patients.
(2)Evaluation of financial status of patients.
(3)Referrals to community agencies.
b.The hospital shall provide facilities that will serve the personnel of the service. The services must be easily accessible to patients and to the medical staff, and must assure privacy for interviews.
2.Primary care hospitals are subject to the social services requirements for general acute
3.Specialized hospitals are subject to the social services requirements for general acute 33-07-01.1-27. Basic rehabilitation services.
1.General acute hospitals shall provide basic rehabilitation services, including physical, occupational, and speech pathology and audiology to meet the needs of the patients served.
a.Basic rehabilitation services must be provided by qualified staff licensed or certified consistent with state law either directly or through contract or referral to an appropriate facility.
b.Basic rehabilitation services must be provided consistent with a written plan of treatment and based on the orders of the licensed health care practitioner who is authorized by the medical staff to order such services. The licensed health care practitioner's orders must be incorporated into the patient's medical record.
c.Sufficient qualified staff must be available to ensure the following services are provided:
(1)Evaluate the patient.
(2)Initiate the plan of treatment.
(3)Instruct and supervise supportive personnel when they are used to provide services.
(4)Provide education as needed to the patient and significant others.
d.Documentation of basic rehabilitation services provided must be placed in the patient's medical record, including the nature, duration, frequency, and complexity of the treatment and the results.
e.If basic rehabilitation services are offered on an outpatient basis, the quality of the service must be consistent with the inpatient basic rehabilitation services in accordance with the complexity of the services provided.
f.Specialized rehabilitation services must be provided in a distinct, clearly defined, special unit of a general acute hospital, or in a rehabilitation hospital. Hospitals holding themselves out to the public as providing specialized rehabilitation services are subject to licensure as a specialized rehabilitation hospital as described in section 33-07-01-35.
2.Primary care hospitals are subject to the basic rehabilitative services requirements for general
3.Specialized hospitals are subject to the basic rehabilitative services requirements for general 33-07-01.1-28. Housekeeping and related services including laundry.
1.The general acute hospital shall provide the housekeeping and related services necessary to maintain a sanitary and comfortable environment.
a.The hospital shall provide personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner. The hospital shall establish, implement, and update consistent with current standards of practice procedures whereby:
(1)Housekeeping personnel use accepted practices and procedures to keep the facility free from offensive odors; accumulations of dirt, rubbish, and dust; and safety hazards.
(2)Floors are cleaned regularly. Polishes on floors provide a nonslip finish. Throw or scatter rugs are not used, except for nonslip entrance mats.
(3)Walls and ceilings are maintained free from cracks and are cleaned and painted as needed.
(4)Grounds are kept free from refuse and litter.
b.The hospital must be maintained free from insects and rodents.
(1)A pest control program must be operated in the hospital. Pest control services must be provided by maintenance personnel of the hospital or by contract with a pest control company. Care must be taken to use the least toxic and least flammable effective insecticides and rodenticides. These compounds must be stored in nonpatient areas and in nonfood preparation and storage areas. Poisons must be locked in cabinets provided for this purpose.
(2)Windows and doors, if appropriate, must be screened during the insect breeding season.
(3)Harborages and entrances for insects and rodents must be eliminated.
(4)Garbage and trash must be stored in appropriately covered containers in areas separate from those used for the preparation and storage of food and must be removed from the premises in a timely manner to avoid infection control problems.
c.The hospital shall establish and implement procedures whereby the hospital has available at all times a quantity of linen essential for the proper care and comfort of patients and that linens are handled, stored, and processed so as to control the spread of infection.
(1)Clean linen and clothing must be stored in clean, dry, and dust-free areas easily accessible to the patient rooms.
(2)Soiled linen must be sorted and stored in well-ventilated areas, separate from other laundry spaces, and may not be permitted to accumulate. Soiled linen and clothing must be stored separately in suitable bags or covered containers. Contaminated and potentially infectious soiled linen must be handled with particular attention to avoid contamination of clean linen.
(3)Soiled linen may not be sorted, laundered, rinsed, or stored in bathrooms, patient rooms, kitchens, or food storage areas.
(4)When linen is sent to an outside laundry, it must be the responsibility of the hospital to determine that work is done in accordance with approved standards.
2.Primary care hospitals are subject to the housekeeping and related services including laundry
3.Specialized hospitals are subject to the housekeeping and related services including laundry 33-07-01.1-29. Surgical services.
1.The general acute hospital that provides surgical services shall have effective policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation of the surgical patient.
a.Surgical services must be provided in a manner sufficient to meet the surgical needs of the patients. The surgical service must have a defined organization, must be integrated with other departments and services of the hospital, and must be governed by current written policies and procedures.
b.Surgical services must be directed by a physician who is qualified by training and experience and approved by the medical staff and governing body.
c.A roster of physicians, specifying the surgical privileges of each, must be maintained and available to staff in the surgical services area and in the files of the hospital administration.
d.The operating rooms must be supervised by a qualified registered nurse.
(1)A licensed practical nurse or a surgical technician may be used as "scrub nurse" under the supervision of the registered nurse.
(2)A registered nurse may perform circulating duties in the operating room in accordance with applicable state law. Licensed practical nurses and surgical technicians may assist in circulating duties under the supervision of a registered nurse who is immediately available to respond to emergencies.
e.The following equipment must be available for use in the surgical services area: call-in system, cardiac monitor, resuscitator, defibrillator, aspirator, tracheotomy tray, and such other instruments or equipment available for lifesaving measures.
f.The surgical services area must be located so that traffic in and out can be and is controlled and there is no through traffic.
g.All infections of clean surgical cases must be recorded and reported to administration and medical staff. A written procedure must be established for the investigation of such cases.
h.The operating room register must be maintained as identified by hospital policy and procedure.
i.There must be a complete history and physical examination, including any indicated laboratory and x-ray examination reports, in the medical record of every patient prior to surgery, except in life-threatening emergencies. If this has been transcribed, but not yet recorded in the patient's record, there must be a statement to that effect, an admission note identifying any abnormal findings, and the preoperative diagnosis in writing by the physician in the patient's medical record.
j.An operative report describing techniques, findings, and tissue removed or altered must be dictated or written immediately after the surgery and signed by the surgeon.
k.There must be a properly executed informed consent form consistent with hospital policies for operation in the patient's medical record prior to surgery, except in life-threatening emergencies.
l.If outpatient surgical services are offered by a hospital, the quality of the services must be consistent with the inpatient surgical services in accordance with the complexity of the services.
2.If the primary care hospital provides surgical services, the hospital shall comply with surgical
3.If a specialized hospital provides surgical services, the specialized hospital is subject to the surgical services requirements for general acute hospitals in this section. 33-07-01.1-30. Recovery services.
1.Postoperative recovery services must be provided by all general acute hospitals in which surgery is performed.
a.Recovery services must be provided in a room where patients who have undergone surgical procedures can be immediately observed, receive specialized care by selected and trained personnel, and when necessary, prompt emergency care can be initiated.
b.The services of the postoperative recovery room may be utilized for postpartum if the delivery room or place of delivery is in close proximity to the postoperative recovery room. Postpartum patients, after appropriate observation, must be returned to the obstetrical service area.
c.A physician shall be responsible for the conduct of the recovery services and for the establishment of admission and discharge policies and procedures.
d.A registered nurse who has education and experience in postoperative recovery services shall supervise all personnel performing nursing service functions.
(1)A licensed nurse shall be in attendance at all times when patients are in the recovery room.
(2)There must be sufficient nursing personnel to provide the specialized care required for the postsurgical patient.
e.Known contaminated cases must be returned to the isolation room or a private room.
f.A member of the medical staff shall provide initial orders for the care of each patient upon admission to the recovery services.
(1)A member of the medical staff shall be responsible for the patient's discharge from the recovery services.
(2)Patients under or recovering from anesthesia, and those who have received sedatives or analgesics, must remain under continuous, direct nursing supervision until vital signs have stabilized. Any nurse performing this duty must have been instructed in the management of postanesthetic patients, must have no other clinical duties while supervising such patients, and must have immediate recourse to the attending surgeon or anesthesiologist, or certified registered nurse anesthetist, present in the hospital.
(3)Side rails must be attached to movable carts and beds and raised above mattress level when occupied by anesthetized patients. Cribs must be provided for the anesthetized or postsurgical child.
g.Personnel with communicable diseases must be excluded from the recovery services.
h.Drugs, supplies, and equipment must be immediately and continually accessible in the unit during postoperative care, including emergencies. These include cardiac-respiratory resuscitation materials.
2.If the primary care hospital provides recovery services, the hospital shall comply with recovery
3.If a specialized hospital provides surgical services, the hospital is required to provide recovery services consistent with the recovery services requirements for general acute hospitals in this
section. 33-07-01.1-31. Central services.
1.General acute hospitals shall provide central services consistent with at least the following:
a.The central services must be provided with adequate direction, staffing, and facilities to provide service to all services in the hospital.
b.Policies and procedures must be developed, implemented, and updated as needed for all decontamination and sterilization services provided and at a minimum must include:
(1)Sterilization of equipment and supplies.
(2)Shelf life of stored sterile items.
(3)Reuse of disposable items.
(4)Reprocessing of disposable items to be reused.
(5)Proper handling of linen.
2.Primary care hospitals are subject to the central service requirements for general acute
3.Specialized hospitals are subject to the central services requirements for general acute 33-07-01.1-32. Anesthesia services.
1.General acute hospitals providing surgical services shall provide anesthesia services to meet the needs of the patients served and shall ensure the following:
a.The anesthesia service must be under the direction of a qualified physician who is a member of the medical staff.
b.The anesthesia service must be organized under current written policies and procedures regarding staff qualifications, the administration of anesthetics, the maintenance of safety controls, and required electronic monitoring of patient vital signs and oxygen levels during the anesthetic procedures consistent with current standards of practice. The anesthesia service is responsible for all anesthetics administered in the hospital.
c.The patient must receive a preoperative visit from the anesthesiologist or the certified registered nurse anesthetist involved in the case.
d.The anesthesia service shall establish policies, procedures, rules, and regulations for the control, storage, and safe use of combustible anesthetics, oxygen, and other medicinal gases in accordance with national fire protection association standards; types of anesthesia to be administered and procedures for each; personnel permitted to administer anesthesia; infection control; safety regulations to be followed; and responsibility for regular inspection, maintenance, and repair of anesthesia equipment and supplies.
e.Anesthesia services may be initiated only when ordered by a member of the medical staff and must be administered only by individuals qualified and licensed in the management of such materials.
f.An intraoperative anesthetic record must be made a part of the patient's medical record.
Drugs used, vital signs, and other relevant information must be recorded at regular intervals during anesthesia.
(1)There must be a preanesthesia evaluation by an individual qualified and licensed to administer anesthesia, performed within forty-eight hours prior to the surgery, with findings recorded in the patient's medical record.
(2)Except in emergency, anesthetic may not be administered until the patient has had a history and physical examination, and a record made of the findings.
g.Postanesthetic followup visits must be made within forty-eight hours after the procedure by the anesthesiologist, certified registered nurse anesthetist, or responsible physician who shall note and record any postoperative abnormalities or complications from anesthesia.
2.If the primary care hospital provides anesthesia services, the hospital shall comply with anesthesia services requirements for general acute hospitals in this section.
3.Specialized hospitals providing surgical services shall comply with the anesthesia services
1.If the general acute hospital provides respiratory care services, the services must be under the supervision of a licensed health care practitioner, organized and integrated with other services of the hospital.
a.Respiratory care policies and procedures must be developed, implemented, and updated as needed for at least the following:
(1)Responsibility of the service to the medical staff.
(2)Clear protocol as to who can perform specific procedures.
(3)Written procedures for each type of therapeutic or diagnostic procedure.
(4)Written procedures for the cleaning, disinfection, or sterilization of all equipment that is not disposable.
(5)Written procedures for infection control.
(6)Written procedures for the control of all water used for respiratory therapy, if applicable.
(7)Protocol that establishes calibration and operation of equipment consistent with manufacturer's specifications and ensures that all equipment is maintained according to an established schedule.
b.All treatments involving respiratory care must be recorded in the patient's medical record by the individual rendering the service, and must include type of therapy, date and time of treatments, any adverse reactions to treatments, and records of periodic evaluations by the licensed health care practitioner.
c.All treatments must be administered by respiratory therapists or other qualified staff in compliance with state law.
2.If the primary care hospital provides respiratory care services, the hospital shall comply with the respiratory care services requirements for general acute hospitals in this section.
3.If the specialized hospital provides respiratory care services, the hospital shall comply with the respiratory care services requirements for general acute hospitals in this section. 33-07-01.1-34. Obstetrical services.
1.All general acute hospitals providing obstetrical services shall provide for the admission, medical care, transfer, or discharge of obstetric and neonatal patients. Obstetrical services must include the following:
a.The obstetrical services must have an organized obstetric staff with a chief of obstetrical services who is either certified or qualified in obstetrics or a physician who regularly practices obstetrics as head of the obstetrical service. The level of qualification and expertise of the chief of the obstetrical services must be appropriate to the level of care rendered in the hospital. Responsibilities of the chief of the obstetrical service include:
(1)The general supervision of the care of obstetrical patients.
(2)The arrangement of conferences held at regular intervals to review surgical procedures and operations, complications, and mortality.
(3)The provision for exchange of information between medical, administrative, and nursing staffs.
b.Only members of the medical staff with appropriate privileges may admit and care for patients in the obstetrical services areas. A roster of licensed health care practitioners, specifying the obstetrical privileges of each, must be maintained and available to staff in the obstetrical services area and in the files of the hospital administration.
c.Obstetrical patients under the effect of an analgesic or an anesthetic, in active labor or delivery, must be monitored and attended in accordance with the current standards of practice for obstetric-gynecologic services as identified by the association of women's health, obstetric and neonatal nursing and defined by hospital policies and procedures.
d.Fetal maturity must be established and documented prior to elective inductions and Caesarean sections.
e.There must be a written policy and procedure established in accordance with the current standards of practice as identified by the association of women's health, obstetric, and neonatal nursing concerning the administration and documentation of oxytocic drugs and their effects. Oxytocin may be used for medical induction or stimulation of labor only when qualified personnel, determined by the medical staff, can attend the patient closely.
If electronic fetal monitoring is not available, the patient must be monitored on a one-to-one basis during the administration of the oxytocic drugs. The following areas must be included in the written policy and procedure for administration and documentation of oxytocic medications:
(1)The licensed health care practitioner shall evaluate the patient for induction or stimulation, especially with regard to indications for use of oxytocic medications.
(2)The licensed health care practitioner or other individuals starting the oxytocin shall be familiar with its effects and complications and be qualified to identify both maternal and fetal complications.
(3)A qualified licensed health care practitioner shall be immediately available as necessary to manage complications effectively.
f.Birthing and delivery rooms must be equipped and staffed to provide emergency resuscitation for infants in accordance with the current association of women's health, obstetric, and neonatal nursing standards of practice. Only personnel qualified and trained to do so may use infant emergency resuscitation equipment.
g.Equipment and personnel trained to use the equipment to maintain a neutral thermal environment for the neonate must be available and utilized as needed.
h.Nursing staff for obstetrical services must include:
(1)Nursing supervision by a registered nurse must be provided for the entire twenty-four-hour period the obstetrical services is occupied.
(2)At least one nurse trained in obstetrical and nursery care must be assigned to the care of mothers and infants at all times. Infants must be visually or electronically monitored at all times.
(3)A registered nurse must be in attendance at all deliveries, and must be available to monitor the mother's general condition and that of the fetus during labor.
i.A clean nursery must be provided near the mothers' rooms with adequate lighting and ventilation and must include the following:
(1)Bassinets equipped to provide for the medical examination of the newborn and for the storage of necessary supplies and equipment.
(2)A glass observation window through which infants may be viewed.
(3)Each nursery must have immediately on hand equipment necessary to stabilize the sick infant in accordance with current standards of practice established by the association of women's health, obstetric, and neonatal nursing and defined in hospital policies.
j.The hospital shall identify specific rooms and beds to be used exclusively for obstetrical patients, obstetrical and gynecological patients, and nursery patients as provided in a plan specifically approved by the department.
(1)Obstetrical services must be located and arranged to provide maximum protection for obstetrical and neonatal patients from infection and cross-infection from patients in other services of the hospital.
(2)Obstetrical services must be located in the hospital so as to prevent through traffic to any other part of the hospital.
2.If the primary care hospital provides obstetrical services, the hospital shall comply with obstetrical services requirements for general acute hospitals in this section.
3.If a specialized hospital provides obstetrical services, the specialized hospital is subject to the obstetrical services requirements for general acute hospitals.
1.General acute hospitals providing outpatient birth services in hospitals are subject to the outpatient birth services requirements for specialized hospitals in this section.
2.Primary care hospitals may not provide outpatient birth services.
3.Any facility that provides outpatient birth services shall comply with this section. A facility may not hold itself out to the public as providing outpatient birth services unless such outpatient birth service has been licensed by the department and meets the requirements for outpatient birth services in this section.
a.The facility provides peripartum care of low-risk women for whom prenatal and intrapartum history, physical examination, and laboratory screening procedures have demonstrated normal, uncomplicated singleton term (thirty-seven to forty-one and sixsevenths weeks), multipara pregnancies with a spontaneous labor, and vertex presentation that are expected to have an uncomplicated birth. The policy and procedures must specify medical and social criterion to determine risk status at admission and during labor.
b.Patients who are not considered low risk, patients who experience no cervical dilation in over three hours who are considered in active labor according to the American college of obstetricians and gynecologists standards, and patients who develop a high-risk condition based on standards of practice shall be transferred as described in subsection 6.
c.Patients shall be fully informed on and provide written consent to the benefits and risks of the services available and alternatives if more advanced services are required.
d.Surgical procedures must be limited to those procedures normally encountered during uncomplicated childbirth, such as episiotomy and repair, and must not include operative obstetrics or cesarean section. Circumcisions of newborns are allowed.
e.Labor may not be inhibited, stimulated, or augmented with chemical agents during the first or second stage of labor nor may labor be induced by artificial rupture of membranes.
f.Vacuum extractors, forceps, and recorded electronic fetal monitors are not appropriate for use after admittance in active labor in outpatient birth services. Patients requiring these interventions shall be transferred as described in subsection 6.
g.General and conduction anesthesia may not be administered. Local anesthesia and pudendal block may be administered if procedures are established and approved by medical staff.
h.Emergency medications, equipment, and supplies must be available, including tocolytics and uterotonic medications. Nothing in the foregoing should be construed to prohibit exercise of medical skills or the use of emergency medications to benefit the mother or the baby in case of emergency. Patients requiring these interventions shall be transferred as described in subsection 6.
i.Mothers and infants must be discharged within twenty-six hours after birth in accordance with standards set by the medical staff and specified in the policies and procedures. A program for prompt followup care and postpartum evaluation after discharge must be ensured and outlined in the policies and procedures. This program must include assessment of infant health, including physical examination, laboratory and screening tests required by state law at the appropriate times, maternal postpartum status, instruction in child care including immunization, referral to sources of pediatric care, provision of family planning services, and assessment of mother-child relationship including breastfeeding.
4.The outpatient birth services shall ensure care is provided by licensed health care practitioners and nursing staff with access to and availability of consulting clinical specialists as follows:
a.Every birth must be attended by at least two health care professionals, licensed or certified consistent with state laws, with relevant experience, training, and demonstrated competence and who have maintained competence in basic life support, including fluid resuscitation and a neonatal resuscitation program to respond to patient needs.
b.The primary maternity care licensed health care practitioner who attends each birth shall be educated, licensed, and have approved clinical privileges to provide birthing services.
c.A licensed health care practitioner with relevant experience, training, and demonstrated competence shall be on call and readily available within a reasonable time of birth for resuscitation if needed.
d.A licensed health care practitioner with relevant experience, training, and demonstrated competence shall assess the neonate within twenty-four hours of delivery.
e.There must be adequate numbers of nursing staff who have completed orientation and demonstrated competence in the care of uncomplicated pregnancies with the ability to detect, stabilize, and initiate management of unanticipated maternal-fetal or neonatal problems which occur during the antepartum, intrapartum, or postpartum period until the patient can be discharged or transferred to a facility at which specialty maternal care is available.
5.An appropriately staffed level I nursery must be available on the premises.
6.There must be criteria and a written agreement for transfer of patients to an acute care hospital capable of providing inpatient obstetrical and neonatal services with a level II or level Ill nursery. The outpatient birth services must be located within thirty minutes of this
7.There must be provisions in place either directly or by agreement for transport services, obstetric consultation services, pediatric consultation services, and childbirth and parent education support services.
8.The outpatient birth service shall develop and implement policies and procedures to ensure physical security of mothers and newborns.
1.Specialized rehabilitation services in a general acute hospital must be provided in a distinct, clearly defined, special unit and are subject to the specialized rehabilitation services in hospitals requirements for specialized hospitals in this section. If in the course of the inspection of a general acute hospital, the department finds from a review of the rehabilitation services rendered and the adequacy of the consultation and referral resources that the hospital practice and staffing warrants the establishment of a specialized rehabilitation service, the department shall recommend the establishment of such service.
2.Primary care hospitals may not provide specialized rehabilitation services.
3.The specialized rehabilitation hospital shall provide preventive, diagnostic, therapeutic, and rehabilitative services to patients in accordance with the licensure requirements in this
chapter.
a.The rehabilitation hospital shall provide for services to inpatients and outpatients by a core group of professionals, who are licensed or certified consistent with state laws, which must include, dependent on the patient's needs, the following:
(1)Occupational therapist.
(2)Physical therapist.
(3)Physician.
(4)Psychologist.
(5)Rehabilitation nurse.
(6)Social worker.
(7)Speech and language pathologist.
(8)Therapeutic recreation specialist.
b.Additional services that must be provided to inpatients and outpatients, either directly by the rehabilitation hospital or by arrangement, dependent upon the identified needs and program goals, include:
(1)Audiology.
(2)Chaplaincy.
(3)Chemical dependency counseling.
(4)Dental services.
(5)Dietary services and nutritional counseling.
(6)Driver evaluation and education.
(7)Environmental modification.
(8)Laboratory services.
(9)Licensed health care practitioner services.
(10)Orthotics and prosthetics.
(11)Pharmaceutical services.
(12)Physiatry.
(13)Radiology services.
(14)Rehabilitation engineering.
(15)Respiratory care services.
(16)Sexual counseling.
(17)Vocational testing and rehabilitation.
c.For inpatients, unless contraindicated in writing by the qualified physiatrist, the rehabilitation hospital shall provide at a minimum three hours of services per patient per day, which must include one or a combination of the following: physical therapy, occupational therapy, speech-language pathology, prosthetics and orthotics services, or therapeutic recreational therapy.
d.Rehabilitation hospitals must be accredited by the commission on accreditation of rehabilitation facilities in the category of comprehensive inpatient rehabilitation prior to licensure as a rehabilitation hospital by the department.
e.If a hospital licensed by the department provides specialized rehabilitation services in addition to other hospital services, the hospital shall adhere to the rules of this section in addition to the rules for other hospital services.
f.Submission of documents and onsite review must be as follows:
(1)The rehabilitation hospital, upon receipt, shall submit all commission on accreditation of rehabilitation facilities survey results, recommendations, and plans of correction to the department.
(2)Based on the commission on accreditation of rehabilitation facilities survey results, the department may require changes or additions to the recommendations or plans of corrections if endangerment to the health, well-being, or safety of patients is involved.
(3)Onsite review must be conducted by the department to assess compliance with licensure requirements not included in the commission on accreditation of rehabilitation facilities standards. 33-07-01.1-36. Psychiatric services in hospitals.
1.General acute hospitals providing psychiatric services are subject to the psychiatric services in hospitals requirements for specialized hospitals in this section. If, in the course of the inspection of a general acute hospital, the department finds from a review of the psychiatric treatment rendered and the adequacy of the consultation and referral resources that the hospital practice and staffing warrants the establishment of a psychiatric service, the department shall notify the hospital of the need to establish the service in a manner that complies with this section.
2.Primary care hospitals may not provide psychiatric services.
3.Any facility that provides or purports to provide psychiatric inpatient or inpatient and outpatient diagnosis or treatment on other than an emergency basis shall comply with this section. A hospital may not hold itself out to the public as providing psychiatric services unless such psychiatric service has been licensed by the department and meets the requirements for a psychiatric hospital in this section.
a.Hospitals accredited by a national accrediting entity in the category of psychiatric services shall submit, upon receipt, all accreditation survey results, recommendations, and plans of correction to the department.
b.In hospitals without an approved psychiatric service, psychiatric care to patients with a primary diagnosis of a psychiatric disorder may be rendered on an emergency basis by appropriate members of the medical staff as determined by the hospital. Psychiatric consultation must be available and utilized appropriately as determined by the hospital.
c.The organization and responsibilities of the medical staff for psychiatric services must be in accordance with licensure requirements, except as amended and modified:
(1)The physician in charge of the psychiatric services must be a psychiatrist who is licensed to practice medicine in North Dakota.
(2)The psychiatrists on the staff of the psychiatric hospital or psychiatric services of a general acute hospital must have as minimum qualifications at least three years' approved residency training in psychiatry or equivalent training and experience. If physicians other than psychiatrists are authorized to treat patients in a psychiatric hospital or in a psychiatric service there must be timely evidence of psychiatric consultation after the patient is admitted, and ongoing consultation with a psychiatrist who is a member of the psychiatric staff, as needed.
(3)There must be other medical staff in appropriate specialties, available at all times to the psychiatric staff.
d.The organization and staffing of the nursing service must be in accordance with the licensure requirements, except as amended and modified:
(1)The registered nurse supervising the nursing services of the psychiatric services must have experience and demonstrated competency in psychiatric nursing.
(2)The nursing personnel of the psychiatric services in a general acute hospital must be a separate staff who are assigned to the psychiatric services.
(3)There must be at least one registered nurse with experience in psychiatric nursing on duty at all times on each psychiatric nursing unit. The number of registered nurses and other nursing personnel must be adequate to provide the individual patient care required to carry out the patient care plan for each patient.
e.The following services or consultative resources are required: clinical psychological services, social work services, and occupation and recreational therapy services. These services must be under the direction of a psychiatrist in charge of the psychiatric services in a general acute hospital or the psychiatric diagnosis or treatment units in a psychiatric hospital. The staff used to support these services must be adequate in number and be qualified by professional education, experience, and demonstrated ability. If registration or licensing of personnel is required by statute or regulation, the registration number must be on file and available upon request.
f.Personnel development and training for psychiatric services staff must include the following:
(1)There must be written evidence of orientation training for all staff and ongoing, planned, and scheduled inservice training for all staff.
(2)Ongoing interdisciplinary staff conferences must be held to ensure communication, coordination, and participation of all professional staff and personnel involved in the care of patients.
g.Specialized procedures for psychiatric services must be provided for and implemented as follows:
(1)A patient may not be subject to the withholding of privileges or to any system of rewards, except as part of a treatment plan.
(2)Electroconvulsive therapy, experimental treatments involving any risk to the patient, or aversion therapy may not be prescribed, unless:
(a)The patient's treatment team has documented in the patient's record that all reasonable and less intensive treatment modalities have been considered, the treatment represents the most effective therapy for the patient at that time, the patient has been given a full explanation of the nature and duration of the proposed treatment and why the treatment team is recommending the treatment, and the patient has been informed of the right to accept or refuse the proposed treatment and, if the patient consents, has the right to revoke the consent for any reason at any time prior to or between treatments.
(b)The treatment was recommended by qualified staff members trained and experienced in the treatment procedure and has been approved by the psychiatrist.
(c)The patient has given written informed consent to the specific proposed treatment. In the alternative, oral informed consent is sufficient if that consent is witnessed by two individuals not part of the patient's treatment team. In either case, such consent must be limited to a specified number of maximum treatments over a period of time and must be revocable at any time before or between treatments. Such withdrawal of consent is immediately effective.
(d)If a patient's treatment team determines that the patient could benefit from one of those specified treatments but also believes that the patient does not have the capacity to give informed consent to the treatment, appropriate consent consistent with applicable state laws must be obtained before such treatment may be administered to the patient.
(3)A patient may not be subject to chemical, physical, or psychological restraints, including seclusion, other than in accordance with the policy and procedures for seclusion and restraint approved by the medical staff and governing body. A copy of the applicable regulations must be made available to patients upon request.
(4)A patient may not be the subject of any research, unless conducted in strict compliance with federal regulations on the protection of human subjects. Patients considered for research approved by the hospital must receive and understand a full explanation of the nature of the research, the expected benefit, and the potential risk involved. Copies of the federal regulations must be made available to patients or their advocates involved in, or considering becoming involved in, research.
h.If the treatment team determines that continued voluntary inpatient treatment is not indicated, the treatment team shall discharge the patient with an appropriate postdischarge plan. The postdischarge plan must address followup needs, future consultative needs, or in the event of patient regression or deterioration, treatment or admission needs.
i.Care of patients for psychiatric services must include the following:
(1)Each psychiatric unit shall have available recreational and occupational therapy and other appropriate facilities adequate in size in relation to patient population, number of beds, and program.
(2)Restraints and seclusion facilities must be available, and written policies must be established for their use. Mechanical restraints or seclusion may be used only on the written order of a physician. This written order must be valid for specific periods of time. In an emergency, the licensed professional in charge may order restraints.
Confirmation of the order by a physician must be secured. Policies and procedures regarding use of restraints and seclusion must be reviewed annually. The patient medical record must indicate justification for the restraint, time applied and released, and other pertinent information.
(3)A current policy and procedure manual must be maintained for the psychiatric service. The manual must include procedures for the care and treatment of patients including the care of suicidal and assaultive patients, and the elopement of patients.
The manual must identify the relationship with state agencies and community organizations providing psychiatric services. It must also describe plans for the evaluation and disposition of psychiatric emergencies.
(4)The design of facilities and the selection of equipment and furnishings must be conducive to the psychiatric program and must minimize hazards to psychiatric patients.
j.The psychiatric services shall develop an interdisciplinary team composed of mental health professionals, health professionals, and other individuals who may be relevant to the patient's treatment. At least one member of the team must be a psychiatrist. The team and patient or advocate shall formulate and evaluate an appropriate treatment plan for the patient.
(1)The director of the interdisciplinary team shall assure that staff trained and experienced in the use of modalities proposed in the treatment plan participate in its development, implementation, and review.
(2)The director of the interdisciplinary team is responsible for:
(a)Ensuring that the patient in treatment is encouraged to become increasingly involved in the treatment planning process.
(b)Implementing and reviewing the individualized treatment plan and participating in the coordination of service delivery with other service providers.
(c)Ensuring that the unique skills and knowledge of each team member are utilized and that specialty consultants are utilized when needed.
(3)Although an interdisciplinary team must be under the direction of a psychiatrist, specific treatment modalities may be under the direction of other mental health professionals when they are specifically trained to administer or direct such modalities.
k.A comprehensive individualized treatment plan must:
(1)Be formulated to the extent feasible with the consultation of the patient. When appropriate to the patient's age, or with the patient's consent, the patient's family, personal guardian, or appropriate other individuals should be consulted about the plan.
(2)Be based upon diagnostic evaluation that includes examination of medical, psychological, social, cultural, behavioral, familial, educational, vocational, and developmental aspects of the patient's situation.
(3)Set forth treatment objectives and prescribe an integrated program of therapies, activities, experiences, and appropriate education designed to meet these objectives.
(4)Result from the collaborative recommendation of the patient's interdisciplinary team.
(5)Be maintained and updated with progress notes, and be retained in the patient's medical record.
(6)State the basis for the restraints if the plan provides for restraints. The patient medical record must indicate what less restrictive alternatives were considered and why they were not utilized.
(7)Be written in terms easily explainable to the lay person. A copy of the current treatment plan must be available for review by the patient in treatment.
(8)Note when the most appropriate form of treatment for the individual is not available or is too expensive to be feasible.
l.At least once every seven days every patient in treatment must be plan reviewed. A report of the review and findings must be summarized in the patient's medical record and the treatment plan must be updated as necessary.
m.Subject to certain limitations authorized by a parent, legal guardian, legal custodian, or a court of law concerning a minor or guardian of an individual who is incapacitated or restrictions by the treating physician or psychiatrist, which in their professional judgment is in the best interest of the patient, each patient has the right to:
(1)Receive or refuse treatment for mental and physical ailments and for the prevention of illness or disability.
(2)The least restrictive conditions necessary to achieve the purposes of the treatment plan.
(3)Be treated with dignity and respect.
(4)Be free from unnecessary restraint and isolation.
(5)Visitation and telephone communications.
(6)Send and receive mail.
(7)Keep personal clothing and possessions.
(8)Regular opportunities for outdoor physical exercise.
(9)Participate in religious worship of choice.
(10)Be free from unnecessary medication.
(11)Exercise all civil rights, including the right to habeas corpus.
(12)Not be subjected to experimental research without the express written consent of the patient or of the patient's guardian.
(13)Not be subjected to psychosurgery, electroconvulsive treatment, or aversive reinforcement conditioning, without the express and informed written consent of the patient or the patient's guardian.
n.Each hospital must have a clearly defined appeal system through which any patient who wishes to voice objections concerning the patient's treatment must be heard and have objections determined.
(1)Each hospital shall monitor the appeal system to see that it works properly and records must be maintained for review by the department in order to investigate any complaint.
(2)All patients must be advised of such system and be encouraged to use it when they believe their treatment plan is not necessary or appropriate to their needs.
o.Medical record requirements for psychiatric hospitals and psychiatric services of general acute hospitals must include the following:
(1)Medical records must stress the psychiatric components of the patient's condition and care including history of findings and treatment rendered for the psychiatric condition for which the patient is hospitalized.
(2)A provisional or admitting diagnosis must be made on every patient at the time of admission and include the diagnoses of current diseases as well as the psychiatric diagnoses.
(3)Data from all pertinent sources must be included, in addition to data obtained from the patient.
(4)A psychiatric evaluation must be performed within forty-eight hours of admission, include a medical history, contain a record of mental status, and note the onset of illness, the circumstances leading to admission, attitudes, behavior, estimate of intellectual functions, memory functioning, orientation, and an inventory of the patient's assets in descriptive, not interpretive, fashion.
(5)A complete neurological examination must be recorded at the time of the admission physical examination, when indicated.
(6)Social service records, including reports of interviews with patients, family members, and others must provide an assessment of home plans, family attitudes, and community resource contacts, with appropriate recommendations for family or community resource involvement, as well as a social history.
(7)Reports of consultations, reports of electroencephalograms, and other pertinent reports of special studies.
(8)The patient's comprehensive treatment plan must be recorded, must be based on an inventory of the patient's strengths as well as disabilities, and must include a substantiated diagnosis in the terminology of the most current edition of the American psychiatric association's diagnostic and statistical manual, short-term and long-range goals, and the specific treatment modalities utilized as well as the responsibilities of each member of the treatment team in such a manner that it provides adequate justification and documentation for the diagnoses and for the treatment and rehabilitation activities carried out.
(9)The treatment received by the patient must be documented to assure that all active therapeutic efforts such as individual and group psychotherapy, drug therapy, milieu therapy, occupational therapy, recreational therapy, industrial or work therapy, nursing care, and other therapeutic interventions are included.
(10)The discharge summary must include a recapitulation of the patient's hospitalization and recommendations from appropriate services concerning followup or aftercare as well as a brief summary of the patient's condition on discharge.
(11)Confidentiality of the psychiatric record must be recognized and safeguarded in medical records services of the hospital.
History
- History: Effective April 1, 1994; amended effective July 1, 2020. 33-07-01.1-23. Radiology services.
- History: Effective April 1, 1994; amended effective August 1, 1999; January 1, 2024. 33-07-01.1-33. Respiratory care services.
- History: Effective April 1, 1994; amended effective May 1, 1998; August 1, 1999. 33-07-01.1-34.1. Outpatient birth services in hospitals.
- History: Effective July 1, 2017. 33-07-01.1-35. Specialized rehabilitation services in hospitals.
Chapter 33-07-02 General Standards of Construction and Equipment for Hospitals
N.D. Admin. Code 33-07-02 General Standards of Construction and Equipment for Hospitals
CHAPTER 33-07-02
GENERAL STANDARDS OF CONSTRUCTION AND EQUIPMENT FOR HOSPITALS [Superseded by Chapter 33-07-02.1]
Chapter 33-07-02.1 General Standards of Construction and Equipment for Hospitals
N.D. Admin. Code 33-07-02.1 General Standards of Construction and Equipment for Hospitals
CHAPTER 33-07-02.1
GENERAL STANDARDS OF CONSTRUCTION AND EQUIPMENT FOR HOSPITALS
Section 33-07-02.1-01Site 33-07-02.1-02Plans and Specifications 33-07-02.1-03Codes and Standards 33-07-02.1-04Special Considerations 33-07-02.1-05Patient Rooms 33-07-02.1-06Details 33-07-02.1-07Conflict With Federal Requirements 33-07-02.1-01. Site.
The site of the hospital must be away from nuisances that may be detrimental to the proposed services, such as commercial or industrial developments, or other types of facilities that produce noise or air pollution. A site plan must be submitted to the department. 33-07-02.1-02. Plans and specifications.
1.Hospitals shall contact the department prior to any substantial changes in or alterations to any portion of the structure to determine to what extent they are subject to review. A substantial change must include any alterations affecting the fire safety or structural integrity of the building, changes in service areas or services provided within a service area, changes in bed capacity, or any other changes that may be governed by the standards of this article. The department may request plans, specifications, or other information as may be required and shall make the final determination on those areas subject to review.
2.Hospitals shall submit plans and specifications to the department for all construction, remodeling, and installations subject to review. The plans and specifications must be prepared by an architect or engineer, as appropriate, licensed in North Dakota.
3.Start of construction prior to completion and approval by the department of the final plans and specifications is not permitted.
4.Routine maintenance does not require the submission of plans and specifications. For purposes of this subsection, "routine maintenance" includes repair or replacement of existing equipment, room finishes, and furnishings and similar activities.
5.All construction, remodeling, and installations must be in accordance with the final plans and specifications as approved by the department. Modifications or deviations from the approved plans and specifications must be submitted to and approved by the department.
6.The department may make inspections of construction, remodeling, or installations and arrange conferences with the hospital to assure conformance with the approved plans and specifications.
7.The construction specifications must require the contractor to perform tests to assure that all systems conform to the approved plans and specifications. 33-07-02.1-03. Codes and standards.
1.Hospitals must be designed, constructed, equipped, maintained, and operated in compliance with:
a.This chapter.
b.The Guidelines for Hospitals and Outpatient Facilities, 2014 edition, compiled by the facility guidelines institute.
c.The national fire protection association 101 Life Safety Code, 2012 Edition.
d.North Dakota Century Code section 54-21.3-04.1, relating to accessibility for disabled persons.
e.The requirements for food and beverage establishments issued by the department.
f.Article 62-03.1 relating to plumbing standards.
g.Article 24-02 relating to electrical wiring standards.
h.Article 45-12 relating to boiler rules and regulations.
i.Article 33-15 governing air pollution control, relating to incinerators.
j.Article 33-10 relating to radiological health.
2.Hospitals shall comply with all applicable building codes, ordinances, and rules of city, county, or state jurisdictions.
3.These minimum standards are established to bring about a desired performance result. If specific limits are prescribed, equivalent solutions will be acceptable if they are approved in writing by the department as meeting the intent of these standards.
History: Effective April 1, 1994; amended effective July 1, 2015. 33-07-02.1-04. Special considerations.
1.Hospitals with a capacity of fifty beds or less may qualify for special consideration of these standards. Some functions allotted separate spaces or rooms in these standards may be combined, provided the resulting arrangement does not compromise safety and medical and nursing practices. In all other respects, these standards apply, including the space requirements.
2.If services are to be shared or purchased, modifications or deletions in space requirements may be allowed by the department. However, the services to be shared or purchased must be approved in writing by the department. 33-07-02.1-05. Patient rooms.
Each patient room must meet the following requirements:
1.A patient room may not be located on a floor unless a portion of the floor is at or above grade level. A patient room may not have its floor more than thirty inches [.76 meter] below the adjacent grade.
2.Patient rooms must have adequate space to conveniently house necessary furniture and equipment, to provide for efficient patient care, to provide for convenient movement of stretchers, and for the transfer of patients to and from beds.
3.The smallest dimension of a rectangular single patient room may not be less than ten feet [3.05 meters] free of fixed obstructions and the floor area may not be less than one hundred twenty-five square feet [11.61 square meters].
4.The smallest dimension of a rectangular multiple patient room may not be less than eleven feet six inches [3.51 meters] free of fixed obstructions, except in specially arranged rectangular rooms such as toe-to-toe arrangements where the minimum clear width may not be less than ten feet [3.05 meters] free of fixed obstructions.
5.In other than rectangular-shaped rooms, the principles of space allocation specified by the minimum dimensions and floor area requirements in rectangular-shaped rooms must be adhered to.
6.Each patient room must have an outside wall with natural light provided by a window. The area of the glazing material in the window may not be less than one-tenth of the floor area of the patient room.
7.Multiple patient rooms must be designed to permit no more than two beds side by side parallel to the window wall.
8.A patient room may not be located more than one hundred twenty feet [36.58 meters] from the nurses station, the clean workroom, and the soiled workroom.
9.Patient toilet rooms must be functionally accessible and usable by the patients whom they serve. 33-07-02.1-06. Details.
1.At least one room must be provided for toilet training. It must be accessible from the corridor and may also serve the bathing area, and must provide three feet [.91 meter] clearance at the front and both sides of the water closet.
2.Ceilings must be acoustically treated in patient area corridors, nurses stations, labor rooms, dining areas, and dayrooms.
3.All lavatories and sinks required in patient care areas must have the water supply spout mounted so that its discharge point is a minimum distance of five inches [12.7 centimeters] above the rim of the fixture.
4.Flush valves installed on plumbing fixtures must be of quiet operating type equipped with silencers. 33-07-02.1-07. Conflict with federal regulations.
If any part of this chapter is found to conflict with federal requirements, the more stringent shall apply. Such a finding or determination shall be made by the department and shall not affect the remainder of this chapter.
History: Effective July 1, 2015.
General Authority: NDCC 23-01-03, 28-32-02
Chapter 33-07-03 Long-Term Care Facilities
N.D. Admin. Code 33-07-03 Long-Term Care Facilities
CHAPTER 33-07-03
LONG-TERM CARE FACILITIES [Superseded by Chapter 33-07-03.1]
Chapter 33-07-03.1 Long-Term Care Facilities [Repealed]
N.D. Admin. Code 33-07-03.1 Long-Term Care Facilities [Repealed]
CHAPTER 33-07-03.1
LONG-TERM CARE FACILITIES [Repealed effective July 1, 1996]
Chapter 33-07-03.2 Nursing Facilities
N.D. Admin. Code 33-07-03.2 Nursing Facilities
CHAPTER 33-07-03.2
NURSING FACILITIES
Section 33-07-03.2-01Definitions 33-07-03.2-02Conflict With Federal Requirements 33-07-03.2-03Application for and Issuance of License 33-07-03.2-04Waiver Provision 33-07-03.2-05Access and Surveillance by the Department 33-07-03.2-06Plan of Correction 33-07-03.2-07Governing Body 33-07-03.2-08Physical Environment 33-07-03.2-09Emergency Plan 33-07-03.2-10Quality Improvement Program 33-07-03.2-11Infection Control Program 33-07-03.2-12Education Programs 33-07-03.2-13Medical Services 33-07-03.2-14Nursing Services 33-07-03.2-15Resident Assessment and Care Plan 33-07-03.2-16Dietary Services 33-07-03.2-16.1Paid Feeding Assistants 33-07-03.2-17Resident Record Services 33-07-03.2-18Pharmaceutical Services 33-07-03.2-19Social Services 33-07-03.2-20Activity Services 33-07-03.2-21Approved Activity Training Program 33-07-03.2-22Specialized Rehabilitative Services 33-07-03.2-23Diagnostic Services 33-07-03.2-24Housekeeping, Maintenance, and Laundry Services 33-07-03.2-25Adult Day Care Services 33-07-03.2-26Secured Units 33-07-03.2-01. Definitions.
The following terms are defined for this chapter, chapter 33-07-04.2, and North Dakota Century Code chapter 23-16:
1."Abuse" for the purposes of this chapter is defined in section 33-07-06-01.
2."Adult day care" means the provision of facility services to meet the needs of individuals who do not remain in the facility overnight.
3."Authentication" means identification of the individual who made the resident record entry by that individual in writing, and verification that the contents are what the individual intended.
4."Bed capacity" means bed space designed for resident care.
5."Department" means the department of health and human services.
6."Discharge" means movement from a facility to a noninstitutional setting when the discharging facility ceases to be legally responsible for the care of the resident.
7."Emanating services" means services which are provided from a facility to nonresidents.
8."Facility" means a nursing facility.
9."Governing body" means the individual or group in whom legal responsibility is vested for conducting the affairs of a private or governmental facility. Governing body includes, where appropriate, a proprietor, the partners of any partnership including limited partnerships, the board of directors and the shareholders or members of any corporation including limited liability companies and nonprofit corporations, a city council or commission, a county commission or human service zone board, a governmental commission or administrative entity, and any other person or persons vested with management of the affairs of the facility irrespective of the name or names by which the person or group is designated.
10."Licensed health care practitioner" means an individual who is licensed or certified to provide medical, medically related, or advanced registered nursing care to individuals in North Dakota.
11."Licensee" means the legal entity responsible for the operation of a facility.
12."Medical staff" means a formal organization of licensed health care practitioners with the delegated authority and responsibility to maintain proper standards of medical care.
13."Misappropriation of resident property" means the willful misplacement, exploitation, or wrongful temporary or permanent use of a resident's belongings or money without the resident's consent. Willful for the purpose of this definition means to do so intentionally, knowingly, or recklessly.
a."Intentionally" means to do deliberately or purposely.
b."Knowingly" means to be aware or cognizant of what one is doing, whether or not it is one's purpose to do so.
c."Recklessly" means to consciously engage in an act without regard or thought to the consequences.
14."Neglect" for the purposes of this chapter is defined in section 33-07-06-01.
15."Nursing facility" means an institution or a distinct part of an institution established to provide health care under the supervision of a licensed health care practitioner and continuous nursing care for twenty-four or more consecutive hours to two or more residents who are not related to the licensee by marriage, blood, or adoption; and who do not require care in a hospital setting.
16."Paid feeding assistant" means an individual who has successfully completed a department-approved paid feeding assistant training course and is paid to feed or provide assistance with feeding residents of a nursing facility.
17."Secured unit" means a specific area of the facility that has a restricting device separating the residents in the unit from the residents in the remainder of the facility.
18."Signature" means the name of the individual written by the individual or an otherwise approved identification mechanism used by the individual that may include the approved use of a rubber stamp or an electronic signature.
19."Transfer" means movement from a facility to another institutional setting when the legal responsibility for the care of the resident changes from the transferring facility to the receiving institutional setting.
20."Writing" means the use of any tangible medium for entries into the medical record, including ink or electronic or computer coding, unless otherwise specifically required.
History: Effective July 1, 1996; amended effective May 1, 2001; July 1, 2004; January 1, 2024.
General Authority: NDCC 50-06-16 33-07-03.2-02. Conflict with federal requirements.
If any part of this chapter or chapter 33-07-04.2 is found to conflict with federal requirements, the more stringent shall apply. Such a finding or determination shall be made by the department and shall not affect the remainder of this chapter or chapter 33-07-04.2. 33-07-03.2-03. Application for and issuance of license.
An entity meeting the definition of nursing facility in this chapter must obtain a license from the department to operate in North Dakota. No person or entity shall establish or operate a facility without first having obtained a license.
1.Any person or entity who owns or leases a facility and desires to maintain or operate it shall apply to the department for a license in the form prescribed and shall obtain an initial license before accepting residents for care or treatment.
a.The department shall not approve an application for an initial license unless:
(1)The application and all required attachments and statements submitted by the applicant meet the requirements of this chapter and chapter 33-07-04.2.
(2)The department has conducted an inspection or investigation of the facility to determine compliance with this chapter and chapter 33-07-04.2.
(3)The department has completed an investigation into the fitness of the applicant and determined the applicant to be fit based on the following:
(a)Evidence provided by the applicant which identifies that financial resources and sources of revenue for the applicant's facility appear adequate to provide staff, services, and the physical environment sufficient to comply with North Dakota Century Code chapter 23-16, this chapter, and chapter 33-07-04.2;
(b)The applicant has furnished the department with a signed and notarized statement describing and dating every proceeding, within five years of the date of the application, in which the applicant was involved that resulted in a limitation, suspension, revocation, or refusal to grant or renew a nursing facility license or resulted in a ban on Medicare or Medicaid admissions or a Medicare or Medicaid decertification action; and (c)The applicant shall furnish a signed and notarized statement to the department describing every criminal proceeding within five years of the date of the application in which the licensee or any of its shareholders owning interest of five percent or more, officers, directors, partners, or other controlling or managing persons, has been convicted or nolo contendere plea accepted, of a criminal offense related to the operation, management, or ownership of a nursing facility.
b.The initial license shall be valid for a period not to exceed one year and shall expire on December thirty-first of the year issued.
2.The department shall issue a renewal license when a facility is in substantial compliance with the provisions of these licensing requirements, as determined by periodic unannounced onsite surveys conducted by the department and other information submitted by the facility upon the request of the department. Renewal licenses shall expire on December thirty-first of each year. The application for renewal must be received by the department with sufficient time prior to the beginning of the licensure period to process.
3.The department may issue a provisional license, valid for a specific period of time not to exceed ninety days, when there are one or more serious deficiencies or a pattern of deficiencies related to compliance with these licensing requirements.
a.A provisional license may be renewed at the discretion of the department, provided the licensee demonstrates to the department that it has made progress towards compliance and can effect compliance within the next ninety days. A provisional license may be renewed one time.
b.When a facility operating under a provisional license notifies the department that it has corrected its deficiencies, the department will ascertain correction. Upon finding compliance, the department shall issue a renewal license.
4.In the case where two or more buildings operated under the same management are used in the care of residents, a separate license is required for each building.
5.Each license is valid only in the hands of the entity to whom it is issued and is not subject to sale, assignment, or other transfer, voluntary or involuntary, nor is a license valid for any premises other than those for which originally issued. The license must be displayed in a conspicuous place within the facility.
6.The facility shall notify the department in writing thirty days in advance of any of the following changes:
a.Transfer or change of ownership.
b.Transfer of operating rights, including a lease of the facility where the lessor retains no control of the operation or management of the facility.
c.Change in bed capacity.
d.Change in the name of the facility.
7.The facility shall notify the department in writing within thirty days of a change in administrator or nurse executive.
8.The department will review all reported allegations of resident abuse, neglect, and misappropriation of resident property by an individual used in a nursing facility to provide resident services. If there is reason to believe, either through oral or written evidence, that an individual used by a nursing facility to provide services to residents could have abused or neglected or misappropriated a resident's property, the department will investigate the allegation or refer the allegation to the appropriate licensure authority for followup.
9.If the department makes a preliminary determination that an individual used by a nursing facility to provide services to residents abused or neglected or misappropriated resident property, the individual will be notified and provided the same appeal and review rights provided to nurse aides on the registry identified in sections 33-07-06-10 and 33-07-06-11.
10.The department will maintain a registry of individuals used by the nursing facility to provide services to residents that the department has investigated and validated findings of resident abuse, neglect, or misappropriation of resident property.
History: Effective July 1, 1996; amended effective July 1, 2004. 33-07-03.2-04. Waiver provision.
Any provisions of this chapter or chapter 33-07-04.2 may be waived by the department for a specified period in specific instances, provided such a waiver does not adversely affect the health and safety of the residents and would result in unreasonable hardship upon the facility. A waiver may be granted for a specific period of time not to exceed one year and shall expire on December thirty-first of the year issued. 33-07-03.2-05. Access and surveillance by the department.
The department may evaluate a facility's compliance with this chapter or chapter 33-07-04.2 at any time through:
1.An announced or unannounced onsite review; or
2.A request for submission of written documentation verifying compliance. 33-07-03.2-06. Plan of correction.
1.A facility shall submit to the department a plan of correction addressing areas of noncompliance with the licensure requirements of this chapter and chapter 33-07-04.2.
2.A plan of correction must include:
a.How the corrective action will be accomplished;
b.How the facility will identify other residents or portions of the facility having the potential to be affected by the same deficient practice;
c.What measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; and
d.How the facility will monitor its corrective actions to ensure that the deficient practice is being corrected and will not recur.
3.A plan of correction is required within ten calendar days of receipt of the deficiency statement and is subject to acceptance, acceptance with revisions, or rejection by the department.
4.Corrections must be completed within sixty days of the survey completion date, unless an alternative schedule of correction has been specified by the department. 33-07-03.2-07. Governing body.
The governing body is legally responsible for the quality of resident care services; for resident safety and security; for the conduct, operation, and obligations of the facility; and for ensuring compliance with all federal, state, and local laws.
1.The governing body shall establish, cause to implement, maintain, and as necessary, revise its practices, policies, procedures, and bylaws for the ongoing evaluation of the services operated or delivered by the facility and for the identification, assessment, and resolution of problems that may develop in the conduct of the facility. These policies, procedures, and bylaws must be in writing, dated, and made available to all members of the governing body and facility staff.
2.The governing body shall appoint a qualified administrator who is responsible for the management of the facility.
a.The administrator shall hold a valid North Dakota nursing home administrator's license.
b.In the absence of the administrator, an employee must be designated in writing to act on behalf of the administrator.
3.The governing body must ensure sufficient trained and competent staff is employed to meet the residents' needs. The governing body shall approve and ensure implementation of written personnel policies and procedures including:
a.Written job descriptions for personnel positions in all service areas. Job descriptions must include definition of title, qualifications, duties, responsibilities, and to whom the position reports.
b.Provisions for checking state registries and licensing boards for current licensure or registry status and history of disciplinary actions prior to employment.
c.Procedures to ensure all personnel for whom licensure, certification, or registration is required have a valid and current license, certificate, or registration.
d.Prohibitions on resident abuse, neglect, and misappropriation of resident property, and procedures for investigation, reporting, and followup action.
4.The governing body shall ensure the development and implementation of written policies and procedures for all services provided by the facility, including emanating services. These policies and procedures must be current and shall be revised when changes in standards of practice occur.
5.The governing body shall ensure the development and implementation of written resident care policies, procedures, and practices including:
a.Admission or retention policies which ensure:
(1)Only those persons whose needs can be met within the accommodations and services provided by the facility are admitted and retained by the facility.
(2)Residents are admitted to the facility only by the order of a licensed health care practitioner.
(3)Resident information, including current medical findings, diagnosis, and orders from the licensed health care practitioner for immediate care of the resident are available to the facility prior to or at the time of admission.
(4)Other pertinent information including family history and past medical history is received from the licensed health care practitioner within forty-eight hours of admission.
(5)A physical examination of the resident is performed by the licensed health care practitioner within five days prior to admission or within forty-eight hours after admission, unless the licensed health care practitioner documents the current examination remains accurate.
(6)Each resident in the facility is under the supervision of a licensed health care practitioner.
(a)Licensed health care practitioners shall visit residents as often as medically indicated, but no less frequently than annually.
(b)Orders must be signed by the licensed health care practitioner at the time of each visit.
(c)Progress notes must be written or dictated at the time of each visit and signed within a time frame as determined by the facility, not to exceed thirty days.
b.A procedure whereby an ongoing evaluation of resident status and need for facility care is conducted and made a part of the resident record.
c.Arrangements are made in the form of a written contract for specific resident care services to be provided by outside resources if the specific resident care services required are not available by facility staff. Outside resource shall apprise the appropriate facility staff of recommendations, plans for implementation, and continuing assessment through dated, and signed reports.
d.Provisions to ensure resident rights are met in compliance with North Dakota Century Code chapter 50-10.2.
e.Prohibition of resident abuse, neglect, or misappropriation of resident property.
f.Provisions to ensure residents are free from physical restraints imposed or psychoactive drugs administered for the purpose of discipline or convenience that are not required to treat the resident's medical symptoms.
6.The governing body is responsible for services furnished in the facility whether or not they are furnished directly by the facility or by outside resources. The governing body shall ensure that a contractor of services furnishes such services that permit the facility to comply with all applicable laws, codes, rules, and regulations. The governing body shall:
a.Ensure the services performed under contract are provided in a safe and effective manner.
b.Maintain a copy of current contracts for all contracted services. The contracts must identify the scope and nature of the services provided. 33-07-03.2-08. Physical environment.
The facility must be constructed, arranged, and maintained to ensure the safety and well-being of the residents.
1.The physical plant must comply with the construction standards of chapter 33-07-04.2; and
2.The facility must provide an environment that is maintained, clean, comfortable, and appropriately responds to the physical, functional, and psychosocial needs of the residents.
The facility must provide adequate space, lighting levels, ventilation, and safety measures consistent with the services being offered and the needs of the residents being served.
Law Implemented: NDCC 23-01-03, 23-16-01 33-07-03.2-09. Emergency plan.
The facility shall have a written procedure to be followed in case of emergencies. The emergency plan must specify persons to be notified, locations of alarm signals and fire extinguishers, evacuation routes, procedures for evacuating residents, and assignment of specific tasks, and responsibilities to the personnel of each shift. 33-07-03.2-10. Quality improvement program.
1.The facility shall develop and implement a quality improvement program, approved by the governing body, for assessing and improving the quality of services and care provided to residents. The written program must describe objectives, organization, scope, and mechanisms for overseeing and reporting the effectiveness of monitoring, evaluation, and improvement activities.
2.The quality improvement program must include a written plan for all services including indicators of care that are important to the health and safety of the residents.
3.The indicators of the written quality improvement plan must relate to quality of services and care provided to residents and must be objective, measurable, and based on current standards of practice.
4.Written documentation of quality improvement activities, including infection control, must be prepared and reported to the governing body.
Law Implemented: NDCC 23-16-06 33-07-03.2-11. Infection control program.
The facility shall develop and implement a facilitywide program, approved by the governing body, for surveillance, prevention, and control of infections. This program must be consistent with the centers for disease control and prevention standards specific to disease control. The responsibilities of the program include:
1.Establishment of an infection control plan that includes the use of techniques and precautions in accordance with the standards of practice for each department or service.
2.Establishment of policies and procedures for reporting, logging, surveillance, monitoring, and documentation of infections, and the development and implementation of systems to collect and analyze data and activities to prevent and control infections.
3.Development and implementation of policies and procedures including:
a.The criteria to determine admission eligibility of an individual with a contagious or infectious disease; and
b.The immediate isolation of all residents in whom the condition jeopardizes the safety of the resident or other residents.
4.Assignment of the responsibility for management of infection surveillance, prevention, and control to a qualified person or persons.
5.Maintenance of proper facilities and appropriate procedures used for disposal of all infectious and other wastes.
6.Development and implementation of a process for inspection and reporting of any employee with an infection who may be in contact with residents, their food, or laundry.
Law Implemented: NDCC 23-01-03, 23-16-01 33-07-03.2-12. Education programs.
The facility shall design, implement, and document educational programs to orient new employees and keep all staff current on new and expanding programs, techniques, equipment, and concepts of quality care. The following topics must be covered with all staff annually:
1.Safety and emergency procedures, including procedures for fire and other disasters.
2.Prevention and control of infections, including universal precautions.
3.Resident rights.
4.Advanced directives.
5.Care of the emotionally disturbed and confused resident. 33-07-03.2-13. Medical services.
1.The facility shall have a licensed physician who is specified as the medical director or a medical staff organized under bylaws and rules approved by and responsible to the governing body. The medical director or medical staff shall be responsible for the quality of all medical care provided to residents and for the ethical and professional practices of its members.
2.The duties and responsibilities of the medical director or medical staff must be delineated in a formal agreement with the governing body.
3.The medical director or medical staff shall be involved in the development of written medical staff policies which are approved by the governing body, which delineate the responsibilities of licensed health care practitioners.
4.The medical director or a member of the medical staff shall participate in the quality improvement and infection control program meetings. 33-07-03.2-14. Nursing services.
1.Nursing services must be under the direction of a nurse executive (director of nursing) who is employed by the facility and is a registered nurse licensed to practice in North Dakota.
2.The nurse executive must have written administrative authority, responsibility, and accountability for the integration of nursing services consistent with the overall facility plan and philosophy of resident care. The nurse executive shall retain administrative responsibility to:
a.Ensure development, maintenance, implementation, and revision of nursing service objectives, standards of practice, policy and procedure manuals, and written job descriptions for each level of nursing personnel, including unlicensed staff.
b.Ensure a resident assessment is completed and a comprehensive care plan is established in coordination with the resident or legal representative within the required time frames.
c.Ensure care plans are implemented so as to assist each resident to attain and maintain their highest level of functioning.
3.The facility shall have sufficient qualified nursing personnel on duty at all times to meet the nursing care needs of the residents including:
a.At least one registered nurse on duty eight consecutive hours per day, seven days a week; and
b.At least one licensed nurse on duty and designated to work charge twenty-four hours a day seven days a week.
General Authority: NDCC 28-32-02(1)
Law Implemented: NDCC 23-01-03 33-07-03.2-15. Resident assessment and care plan.
1.The facility shall complete and maintain an up-to-date comprehensive resident assessment for each resident by using the resident assessment instrument, the utilization guidelines, the minimum data set of core elements and common definitions, and the resident assessment protocol summary with triggers as specified by the department and approved by health care financing administration and published in the state operations manual.
2.In coordination with the resident or resident's legal representative and staff providing resident care services, a comprehensive written resident care plan for each resident must be developed and maintained consistent with each resident's individual needs and licensed health care practitioner's plan of medical care. An initial care plan must be implemented upon admission and revised within seven days after the completion of the resident assessment instrument.
3.A care plan must be individualized to meet the needs of the resident and must include problem and strength identification, measurable resident-centered goals, plans of action, and which professional service is responsible for each element of care. Goals must be measurable, behavior oriented, time-limited, and achievable.
4.Resident assessment and quarterly assessment information on each resident must be submitted electronically to a location specified by the department in a time frame specified by the department. 33-07-03.2-16. Dietary services.
The facility shall provide for the dietary needs of the residents and provide dietary services in conformance with the food service sanitation manual issued by the department. Dietary services must include:
1.A qualified director of dietary services must be designated to be responsible for the dietary service of the facility.
a.A director of dietary services is:
(1)A dietitian licensed to practice in North Dakota and registered by the academy of nutrition and dietetics or its predecessor or successor organization;
(2)A graduate of a dietetic technician or dietetic assistant training program approved by the academy of nutrition and dietetics or it predecessor or successor organization;
(3)A certified dietary manager, certified by the certifying board for dietary managers;
(4)A graduate of a state-approved course that provides ninety or more hours of instruction in dietary service supervision in a health care institution with consultation from a licensed and registered dietitian; or (5)An individual trained and experienced in food service supervision and management in a military service equivalent to the program described in paragraph 2 or 4.
b.If the director of dietary services is not a licensed and registered dietitian, regularly scheduled consultation from a consultant licensed and registered dietitian must be obtained at least monthly.
2.Dietary service personnel and all personnel who are actively engaged in assisting residents with eating must be in good health and practice hygienic food handling techniques.
3.Menus for all diets must be planned in accordance with the recommended dietary allowances of the food and nutrition board of the national research council, national academy of science.
Sufficient food must be prepared as planned for each meal to meet the nutritional needs of residents.
a.Menus must be written at least one week in advance. The current week's menus must be located in the dietary services area for easy use by dietary services staff.
b.When changes in the menu are necessary, substitutions must provide equal nutritive value. The change and the reason for the change must be noted in writing on the menu.
c.Menus of food served must be filed and maintained for thirty days.
d.Menus must be adjusted to address the requests of the residents when possible.
4.Therapeutic diets when prescribed by the licensed health care practitioner.
5.At least three meals or the equivalent must be served daily, at regular times.
a.There must be no more than a fourteen-hour span between a substantial evening meal and breakfast unless a nourishing snack is provided at bedtime. Up to sixteen hours may elapse between a substantial evening meal and breakfast the following day if the residents agree to this meal span and a nourishing evening snack is served.
b.A substantial evening meal is an offering of three or more menu items at one time, one of which includes a high quality protein item such as meat, fish, egg, or cheese.
c.Snacks must be offered at bedtime daily.
6.A current diet manual, approved by the medical staff or medical director, must be readily available.
7.Providing each resident with food prepared by methods that conserve nutritive value, flavor, and appearance. The food must be attractively served at the proper temperatures and in a form to meet individual needs. Equipment must be provided and procedures established to:
a.Maintain hot food above one hundred forty degrees Fahrenheit [60 degrees Celsius] during dishing.
b.Ensure that cold foods leave the kitchen at no more than forty-five degrees Fahrenheit [7.22 degrees Celsius].
8.Table service for all who can and will eat at a table. For those not eating at a table, the proper eating equipment must be available and used.
9.Facilities for the general dietary needs of the residents, and for the maintenance of sanitary conditions in the storage, preparation, service and distribution of food.
History: Effective July 1, 1996; amended effective April 1, 2013. 33-07-03.2-16.1. Paid feeding assistants.
Any individual employed by a facility, or under contract, to feed or assist with the feeding of nursing facility residents must either have successfully completed a department-approved paid feeding assistant training course or be a certified nurse aide.
1.Instructors of a department-approved paid feeding assistant course must meet the following requirements:
a.The primary instructor of the program must be a licensed health care professional with experience in the feeding of nursing facility residents.
b.Certified nurse aides and paid feeding assistants may not be used as instructors in a department-approved paid feeding assistant course.
2.A department-approved paid feeding assistant course must have a curriculum which contains, at a minimum, eight hours of training.
3.The course must, at a minimum, include the following:
a.Feeding techniques.
b.Assistance with feeding and hydration.
c.Communication and interpersonal skills.
d.Appropriate responses to resident behavior.
e.Safety and emergency procedures, including the Heimlich maneuver.
f.Infection control.
g.Resident rights.
h.Recognizing changes in residents that are inconsistent with their normal behavior and the importance of reporting those changes to the supervisory nurse.
4.The instructor must verify in writing the successful completion of the course, including a competency evaluation of feeding skills, by the individual. The process for evaluation of successful completion of the course must be included in the materials submitted to the department for review and approval.
5.The nursing facility must maintain a record of all individuals used by the nursing facility as paid feeding assistants who have successfully completed a department-approved paid feeding assistant training course.
6.The nursing facility must ensure that paid feeding assistants feed only residents who have no complicated feeding problems. Complicated feeding problems include difficulty swallowing, recurrent lung aspirations, and tube or parenteral intravenous feedings.
7.The charge nurse must assess the residents to determine which residents may be fed by a paid feeding assistant. This assessment must be documented and the use of the paid feeding assistant to feed the resident must be included in the residents' plan of care.
8.The nursing facility must ensure that paid feeding assistants work under the supervision of a registered nurse or a licensed practical nurse. In an emergency, a paid feeding assistant must call a supervisory nurse for help using the resident call system if the nurse is not present during the feeding of a resident.
9.The nursing facility must ensure that the ongoing competency of paid feeding assistants is evaluated and documented at least annually.
10.The initial department approval of a paid feeding assistant course shall be determined based on the review of the information submitted by the nursing facility for compliance with these requirements.
11.The nursing facility must notify the department and receive approval of any subsequent changes in the curriculum or primary instructor of the course.
12.The department shall determine continued compliance with these requirements during an onsite visit to the nursing facility.
13.Failure to comply with these requirements may result in loss of department approval for a paid feeding assistant course to be offered by the nursing facility.
History: Effective July 1, 2004.
General Authority: NDCC 28-32-02 33-07-03.2-17. Resident record services.
The governing body of the facility shall establish and implement policies and procedures to ensure the facility has a resident record service with administrative responsibility for resident records.
1.A resident record must be maintained and kept confidential for each resident admitted to the facility. The resident record shall be complete, accurately and legibly documented, and readily accessible.
a.The resident or the resident's legal representative have the right to view and authorize release of their medical information.
b.The facility shall develop policies which address access to resident records.
c.Resident records may be removed from the facility only upon subpoena, court order, or pursuant to facility policies when a copy of the original record is maintained at the facility.
2.All records of discharged residents must be preserved for a period of ten years from date of discharge. Records of deceased residents must be preserved to seven years.
a.In the case of minors, records must be retained for the period of minority and ten years from the date of live discharge. Records of deceased residents who are minors must be preserved for the period of minority and seven years.
b.It is the governing body's responsibility to determine which records have research, legal, or medical value and to preserve such records beyond the above-identified time frames until such time the governing body determines the records no longer have a research, legal, or medical value.
3.An employee of the facility must be assigned the responsibility for ensuring records are maintained, completed, and preserved.
4.Each resident record must include:
a.The name of the resident, personal licensed health care practitioner, dentist, and designated representative or other responsible person, admitting diagnosis, final diagnosis, condition on discharge, and disposition.
b.Initial medical evaluation including medical history, physical examination, and diagnosis.
c.A report from the licensed health care practitioner who attended the resident in the hospital or other health care setting, and a transfer form used under a transfer agreement.
d.Licensed health care practitioner's orders, including all medication, treatments, diet, restorative plan, activities, and special medical procedures.
e.Licensed health care practitioner's progress notes describing significant changes in the resident's condition, written at the time of each visit.
f.Current comprehensive resident assessment and plan of care.
g.Quarterly reviews of resident assessments and nurse's notes containing observations made by nursing personnel for the past year.
h.Medication and treatment records including all medications, treatments, and special procedures performed.
i.Laboratory and x-ray reports.
j.Consultation reports.
k.Dental reports.
l.Social service notes.
m.Activity service notes.
n.Resident care referral reports.
5.All entries into the resident record must be authenticated by the individual who made the written entry, as defined by facility policy and applicable state laws and regulations, and must at a minimum include the following:
a.All entries the licensed health care practitioner personally makes in writing must be signed and dated by the licensed health care practitioner.
b.Telephone and verbal orders may be used provided they are given only to qualified licensed personnel and reduced to writing and signed or initialed by a licensed health care practitioner responsible for the care of the patient.
c.Signature stamps may be used consistent with facility policies as long as the signature stamp is used only by the licensed health care practitioner whose signature the signature stamp represents. Written assurance must be on file from the licensed health care practitioner to indicate the practitioner is the sole user of the signature stamp.
d.Electronic signatures may be used if the facility's medical staff and governing body adopt a policy permitting authentication by electronic signature. The policy must include:
(1)The staff within the facility authorized to authenticate entries in resident records using an electronic signature.
(2)The safeguards to ensure confidentiality, including:
(a)Each user must be assigned a unique identifier generated through a confidential access code.
(b)The facility shall certify in writing each identifier is kept strictly confidential. This certification must include a commitment to terminate the user's use of that particular identifier if it is found the identifier has been misused. Misused means the user has allowed another individual to use the user's personally assigned identifier, or the identifier has otherwise been inappropriately used.
(c)The user must certify in writing the user is the only individual with user access to the identifier and the only individual authorized to use the signature code.
(d)The facility shall monitor the use of the identifiers periodically and take corrective action as needed. The process by which the facility will conduct the monitoring must be described in policy.
(3)A process to verify the accuracy of the content of the authenticated entries, including:
(a)A system that requires completion of certain designated fields for each type of document before the document may be authenticated, with no blanks, gaps, or obvious contradictory statements appearing within those designated fields. The system must require that correction or supplementation of previously authenticated entries must be made by additional entries, separately authenticated and made subsequent in time to the original entry.
(b)An opportunity for the user to verify the accuracy of the document and to ensure the signature has been properly recorded.
(c)As part of the quality improvement activities, the facility shall periodically sample records generated by the system to verify accuracy and integrity of the system.
(4)A user may terminate authorization for use of an electronic signature upon written notice to the staff member in charge of resident records.
(5)Each report generated by the user must be separately authenticated.
(6)A list of confidential access codes must be maintained under adequate safeguards by facility administration.
History: Effective July 1, 1996; amended effective January 1, 2024.
General Authority: NDCC 50-06-16
Law Implemented: NDCC 23-01-12, 23-16-01 33-07-03.2-18. Pharmaceutical services.
The facility shall provide pharmaceutical services to meet resident needs.
1.The facility shall obtain the services of a licensed pharmacist who shall develop policies and procedures for the provision of pharmaceutical services within the facility consistent with
chapter 61-03-02, state laws, and federal laws. These policies and procedures must be approved by medical staff or medical director and governing body and must include provisions for:
a.The procurement, storage, dispensing, labeling, administration, and disposal of drugs and biologicals.
b.Allowing the resident to be totally responsible for the resident's own medication based on request of the resident, assessment of the functional capability of the resident by facility nursing staff, documentation of the assessment and resultant recommendations, and specific approval and order of the licensed health care practitioner. The facility must provide a secure storage area for medications self-administered by the resident.
2.The pharmacist shall review each resident's medications monthly and report any discrepancies to the nurse executive or the resident's licensed health care practitioner.
3.All medications administered to a resident must be ordered in writing by a licensed health care practitioner. Telephone and verbal orders may be given to qualified licensed personnel and must be immediately reduced in writing, signed, and dated by the individual receiving the order, and countersigned or initialed by the licensed health care practitioner.
4.When ordered, medications not specifically limited as to time or number of doses must be automatically stopped in accordance with a written policy. The resident's attending licensed health care practitioner must be notified of stop order policies and contacted promptly for a decision concerning renewal of such orders so continuity of the resident's therapeutic regimen is not inadvertently interrupted.
5.Standing orders for drugs must specify the circumstances for drug dosage, route, duration, and frequency of administration. The order must be reviewed annually and, if necessary, renewed. When a standing order is implemented for a specific resident, it must be entered in the resident's record, dated, and signed by the licensed health care practitioner who prescribed the order.
6.All medications must be administered by individuals authorized to do so in accordance with state laws and regulations governing such acts. Each dose administered must be properly recorded in the resident record.
7.All medications administered by facility staff must be stored in a locked area or locked cart.
a.Medications requiring refrigeration must be kept in a separate refrigerator which is locked or in a separate refrigerator in a lockable medication room near the nurses' station.
b.Medications for "external use only" must be kept in a locked area and separate from other medications. 33-07-03.2-19. Social services.
The governing body shall ensure social services are provided to ensure each resident attains and maintains their highest level of physical, mental, and psychosocial functioning.
1.The facility shall have one or more designated staff members trained in the assessment of residents' psychosocial needs and in the provision of services to meet those needs. If a designee is not a qualified social worker as defined in North Dakota Century Code chapter 43-41, the designee shall receive onsite consultation from a qualified social worker on a quarterly basis.
2.If the facility does not provide social services directly, the facility must have a contract with an agency or individual qualified to provide such services.
3.The facility shall have policies and procedures for the delivery of social services. 33-07-03.2-20. Activity services.
The facility shall provide an ongoing program of activity services to meet the needs and interests of each resident which promotes or maintains each resident's physical, mental, and psychosocial well-being.
1.The facility shall employ a qualified activity coordinator who is responsible for the direction and supervision of the resident activity services. A qualified activity coordinator is:
a.An individual certified as a therapeutic recreation specialist by a recognized accrediting body;
b.An individual who is eligible for certification as a therapeutic recreation specialist by a recognized accrediting body for the first year the individual is eligible;
c.An individual who is activity director certified by a recognized accrediting body;
d.An individual who is activity consultant certified by a recognized accrediting body;
e.A qualified occupational therapist as defined in North Dakota Century Code chapter 43-40;
f.A certified occupational therapy assistant;
g.An individual who has the equivalent of two years of full-time experience in a social or recreational program within the last five years, one of which was in a resident activity program in a health care setting; or
h.An individual who has completed an activity training program approved by the department as meeting the requirements in section 33-07-03.2-21; and (1)Has one year of full-time experience in the past five years in an activity program in a health care setting; or (2)Receives monthly onsite consultation for a minimum of one year after the completion of the program from an individual meeting the qualifications described in subdivision a, d, e, f, or g.
2.The facility shall have sufficient activity staff to provide an ongoing program of meaningful, stimulating, therapeutic, and leisure time activities to meet the needs and suited to the interests of each resident.
3.The facility shall have policies and procedures for the delivery of activity services.
4.Each resident's activity plan must be developed in accordance with instructions of the licensed health care practitioner.
5.The activity plan must be coordinated with the resident's overall plan of care and altered as needed.
6.Activity notes, including observations of resident's participation in activity programs, must be recorded and retained in the resident's record.
7.Resident's request to see clergy must be honored and space must be provided for privacy during these visits.
8.The facility shall have adequate equipment and material to support independent and group activities.
History: Effective July 1, 1996; amended effective April 1, 2026. 33-07-03.2-21. Approved activity training program.
Only programs that the department determines meet the criteria in this section and approves in writing are considered to be an approved activity training program.
1.A department-approved activity training program must have a curriculum which contains, at a minimum, ninety hours of training.
2.The primary instructor of a program shall have:
a.A bachelor's degree or be activity consultant certified;
b.Current activity experience as a director or as a practicing consultant; and
c.Experience in teaching adults.
3.Supplemental instructors shall have a minimum of one year of experience in their field.
4.The theory portion of the program must include, at a minimum, the topics identified in the basic education course for activity professionals developed by the national association of activity professionals and the national certification council for activity professionals.
5.Training on nursing and nursing-related services, including transferring, positioning, toileting, and feeding, may not be included in the curriculum of an activity training program.
6.At the completion of the program, the instructor shall verify in writing to the department the successful completion of the program for each participant.
7.A listing of state-approved activity training programs and the date of approval must be maintained by the department.
8.An approved activity training program may include only those topics which were submitted to and approved by the department for inclusion. Changes which are made to the program must be approved by the department prior to implementation or the program is no longer considered to be approved.
History: Effective July 1, 1996; amended effective April 1, 2026. 33-07-03.2-22. Specialized rehabilitative services.
Specialized rehabilitative services shall, at a minimum, include physical therapy, speech and language pathology, occupational therapy, and health services for mental illness and mental retardation and shall:
1.Be provided upon a written order of a licensed health care practitioner, who shall be responsible for the general medical direction of such services as part of the total care of the resident.
2.Be provided directly by facility staff or obtained through contract with outside resources. 33-07-03.2-23. Diagnostic services.
The facility shall provide or have arrangements for obtaining diagnostic services consistent with the needs of the resident.
1.If the facility provides any clinical laboratory testing services to residents, regardless of the frequency or the complexity of the testing, the governing body is required to obtain and maintain compliance with the applicable parts of the clinical laboratory improvement amendments of 1988, 42 CFR part 493.
2.If the facility provides radiology or other diagnostic services to residents, these services must be provided in accordance with the current standards of practice and state and federal regulations. 33-07-03.2-24. Housekeeping, maintenance, and laundry services.
The facility shall provide housekeeping and maintenance services necessary to maintain a sanitary and comfortable environment and laundry services, including personal laundry services, to meet the needs of the residents.
1.The facility shall employ sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner. The facility shall establish, implement, and update policies and procedures consistent with current standards of practice including procedures to ensure:
a.The facility is kept free from offensive odors, accumulations of dirt, rubbish, dust, and safety hazards;
b.Floors are regularly cleaned, polishes on floors provide a nonslip finish, and throw or scatter rugs have a nonslip backing;
c.Walls and ceilings are maintained, cleaned, and painted as needed;
d.The grounds are kept free from refuse and litter; and
e.Poisons and chemical compounds must be stored away from resident and food preparation and storage areas.
2.The facility shall be maintained free from insects and rodents.
a.Pest control services must be provided by the facility or by contract with a pest control company.
b.Windows and doors must be appropriately screened to exclude insects.
c.Harborages and entrances for insects and rodents must be eliminated.
3.The facility shall have available at all times a sufficient supply of linen in good condition for the care and comfort of residents and ensure there is sufficient trained staff and facilities available to provide these services in a manner that controls the spread of infection.
a.Clean linen and clothing must be stored in clean, dry, dust-free, and easily accessible areas.
b.Soiled linen must be sorted and stored in well-ventilated areas, separate from clean laundry spaces, and must not be permitted to accumulate.
(1)Soiled linen and clothing must be stored separately in suitable bags or containers.
(2)Potentially infectious soiled linen must be handled with particular attention to avoid contamination of clean linen.
(3)Soiled linen may not be sorted, laundered, rinsed, or stored in bathrooms, resident rooms, kitchens, or food storage areas. 33-07-03.2-25. Adult day care services.
1.Any facility seeking to develop an adult day care service shall contact the department and receive advance approval as a condition of licensure.
2.A facility may use existing space and equipment to deliver adult day care services provided services to the residents of the facility are not diminished and their needs are being acceptably addressed with the following exceptions:
a.The facility shall provide dining space for congregate dining of adult day care participants in addition to space required under section 33-07-04.2-06.
b.The facility shall provide activity space in addition to space required under section 33-07-04.2-06.
c.The facility shall provide an area allowing privacy for adult day care participants to allow for rest periods.
3.A facility accepting persons for adult day care shall develop policies and procedures covering all aspects of adult day care including:
a.Medications and treatments shall be provided by facility staff only by order of a licensed health care practitioner, and records must be maintained of services provided to individual adult day care participants.
b.Individuals having a communicable disease shall not participate in the adult day care program. 33-07-03.2-26. Secured units.
Secured units, such as those designed for residents with Alzheimer's disease or other dementias, must comply with the following:
1.Prior to admission or within seven days of admission, a multidisciplinary team shall evaluate the appropriateness of a resident's placement in a secured unit. The multidisciplinary team shall, at a minimum, consist of a registered nurse and a licensed social worker who will be providing service to the resident in the secured unit, the resident's licensed health care practitioner, and the resident or the individual who has legal status to act on behalf of the resident;
2.Licensed health care practitioner orders for placement in a secured unit must be documented in the resident's record and must be reviewed during the licensed health care practitioner's regular visits;
3.Placement in a secured unit may not be used as a punishment or for the convenience of the staff; and
4.A resident in a secured unit shall have access to the same services as other residents in the facility including provisions for routine and ongoing access to the outdoors as appropriate based on the resident's past history, personal preferences, and current condition.
Chapter 33-07-04 General Standards of Construction and Equipment for Long-Term Care Facilities
N.D. Admin. Code 33-07-04 General Standards of Construction and Equipment for Long-Term Care Facilities
CHAPTER 33-07-04
GENERAL STANDARDS OF CONSTRUCTION AND
EQUIPMENT FOR LONG-TERM CARE FACILITIES [Superseded by Chapter 33-07-04.1]
Chapter 33-07-04.1 General Standards of Construction and Equipment for Long-Term Care Facilities [Repealed]
N.D. Admin. Code 33-07-04.1 General Standards of Construction and Equipment for Long-Term Care Facilities [Repealed]
CHAPTER 33-07-04.1
GENERAL STANDARDS OF CONSTRUCTION AND
EQUIPMENT FOR LONG-TERM CARE FACILITIES [Repealed effective July 1, 1996]
Chapter 33-07-04.2 General Standards of Construction and Equipment for Nursing Facilities
N.D. Admin. Code 33-07-04.2 General Standards of Construction and Equipment for Nursing Facilities
CHAPTER 33-07-04.2
GENERAL STANDARDS OF CONSTRUCTION AND
EQUIPMENT FOR NURSING FACILITIES
Section 33-07-04.2-01Definitions 33-07-04.2-02Conflict With Federal Requirements 33-07-04.2-03Waiver Provision 33-07-04.2-04Access and Surveillance by the Department 33-07-04.2-05Plans of Correction 33-07-04.2-06Site 33-07-04.2-07Emanating Services 33-07-04.2-08Plans and Specifications 33-07-04.2-09Codes and Standards 33-07-04.2-10Nursing Unit 33-07-04.2-11Dining and Activity Areas 33-07-04.2-12Rehabilitation Therapy 33-07-04.2-13Dietary Services 33-07-04.2-14General Storage 33-07-04.2-15Details 33-07-04.2-16Elevators 33-07-04.2-17Mechanical Requirements 33-07-04.2-18Electrical Requirements 33-07-04.2-01. Definitions.
The definitions located in section 33-07-03.2-01 apply to this chapter. 33-07-04.2-02. Conflict with federal requirements.
The provisions located in section 33-07-03.2-02 apply to this chapter. 33-07-04.2-03. Waiver provision.
The waiver provision located in section 33-07-03.2-04 applies to this chapter. 33-07-04.2-04. Access and surveillance by the department.
The provisions located in section 33-07-03.2-05 apply to this chapter. 33-07-04.2-05. Plans of correction.
The provisions located in section 33-07-03.2-06 apply to this chapter. 33-07-04.2-06. Site.
For new construction, the site of the facility must be away from nuisances detrimental to the proposed services, such as commercial or industrial developments, or other types of facilities that produce noise or air pollution. A site plan must be submitted to the department. 33-07-04.2-07. Emanating services.
1.Sufficient information on the design of other types of facilities physically attached to the nursing facility must be submitted to the department so as to determine that safety from fire and the adequacy of the spaces and services of the facility are not compromised.
2.Occupants of other types of facilities may use service spaces such as dining and activities in the facility only when the size of such spaces exceed the standards of this chapter.
Law Implemented: NDCC 23-01-03, 23-16-06 33-07-04.2-08. Plans and specifications.
1.A facility shall contact the department prior to any substantial changes in or alterations to any portion of the structure to determine to what extent it is subject to review. A substantial change includes alterations affecting the fire safety or structural integrity of the building, changes in service areas or services provided within a service area, changes in bed capacity, or any other change governed by the standards of this chapter. The department may request plans, specifications, or other information as may be required and shall make the final determination on those areas subject to review.
2.A facility shall submit plans and specifications to the department for all construction, remodeling, and installations subject to review. The plans and specifications must be prepared by an architect or engineer licensed in North Dakota, unless otherwise determined by the department.
3.Start of construction prior to approval by the department of the final plans and specifications is not permitted.
4.All construction, remodeling, and installations must be in accordance with the final plans and specifications approved by the department. Modifications or deviations from the approved plans and specifications must be submitted to and approved by the department.
5.The department may make inspections of construction, remodeling, or installations and arrange conferences with the facility to ensure conformance with approved plans and specifications.
6.The construction specifications must require the contractor to perform tests to ensure all systems conform to the approved plans and specifications.
7.Routine maintenance does not require the submission of plans and specifications. For the
purpose of this subsection, "routine maintenance" means repair or replacement of existing equipment, room finishes and furnishings, and similar activities. 33-07-04.2-09. Codes and standards.
1.A nursing facility must be designed, constructed, equipped, maintained, and operated in compliance with:
a.This chapter;
b.The Guidelines for Residential Health, Care, and Support Facilities, 2014 edition, compiled by the facility guidelines institute;
c.The national fire protection association 101 Life Safety Code, 2012 edition;
d.North Dakota Century Code section 54-21.3-04.1, relating to accessibility for disabled persons;
e.The requirements for food and beverage establishments issued by the department;
f.North Dakota Administrative Code article 62-03.1 relating to plumbing standards;
g.North Dakota Administrative Code article 24-02 relating to electrical wiring standards;
h.North Dakota Administrative Code article 45-12 relating to boiler rules and regulations;
i.North Dakota Administrative Code article 33-15 governing air pollution control, relating to incinerators; and
j.North Dakota Administrative Code article 33-10 relating to radiological health.
2.A nursing facility must comply with all applicable building codes, ordinances, and rules of city, county, or state jurisdictions.
3.These standards are established to bring about a desired performance result. If specific limits are prescribed, equivalent solutions may be acceptable if approved in writing by the department as meeting the intent of these standards.
History: Effective July 1, 1996; amended effective July 1, 2015. 33-07-04.2-10. Nursing unit.
1.A resident room must have adequate space to house necessary furniture and equipment, to provide for resident care, to provide for movement of beds, and for the transfer of residents to and from beds.
2.The smallest dimension of a rectangular single resident room may not be less than ten feet [3.05 meters] free of fixed obstructions and the floor area may not be less than one hundred twenty square feet [11.15 square meters].
3.The smallest dimension of a rectangular multiple resident room may not be less than eleven feet six inches [3.51 meters] free of fixed obstructions, except in specially arranged rectangular rooms such as toe-to-toe arrangements where the minimum clear width may not be less than ten feet [3.05 meters] free of fixed obstructions.
4.In other than a rectangular-shaped room, the principles of space allocation specified by the minimum dimensions and floor area requirements in a rectangular-shaped room must be adhered to.
5.Each resident room must have an outside wall with natural light provided by a window. The area of the glazing material in the window may not be less than one-tenth of the floor area of the resident room.
6.In existing construction, a multiple resident room may not permit more than two beds side by side parallel to the window wall.
7.In new construction, a multiple resident room must be designed to permit no more than two beds.
8.A janitor's closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided for each nursing unit.
9.A visiting room shall be provided where residents may visit privately.
10.Resident toilet rooms must be functionally accessible and usable by the residents which they serve. In new construction, a resident toilet room must provide space for two staff members to assist a resident as needed. 33-07-04.2-11. Dining and activity areas.
The dining areas and activities areas may not be the same space.
1.The total area set aside for dining must be a minimum of twenty square feet [1.86 square meters] per bed.
2.The total area set aside for activities must be a minimum of fifteen square feet [1.40 square meters] per bed. Adequate storage space must be provided for recreational equipment and supplies in addition to the space required.
3.A dayroom must be provided in each nursing unit in addition to the required activity space.
4.A functionally accessible toilet room must be provided convenient to activity and dining areas. 33-07-04.2-12. Rehabilitation therapy.
Exercise and treatment areas of at least three hundred square feet [27.87 square meters] must be provided for physical therapy, occupational therapy, or restorative nursing services. 33-07-04.2-13. Dietary services.
Dietary areas and equipment must be designed to accommodate the requirements for sanitary storage, processing, and handling consistent with the food service sanitation manual issued by the department.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 28-32-02 33-07-04.2-14. General storage.
1.Resident space may not be used for general facility storage.
2.Separate storage space with provisions for locking and security control must be provided for residents' personal effects. 33-07-04.2-15. Details.
All details must meet the following requirements:
1.Soap in a soap dispenser must be provided at all lavatories and sinks used by personnel for handwashing.
2.In new construction, boiler rooms must not be located under any portion of the facility.
3.Ceilings must be acoustically treated in corridors in resident areas, nurses stations, and dining and activity areas.
4.Noise reduction criteria shown in the following table apply to partition, floor, and ceiling assembly construction in resident areas:
Airborne Sound Transmission Class (STC)* Impact Insulation Class (IIC)** LocationPartitionsFloorsFloors Resident room to resident room454551 Public space to resident room ***505051+ Service areas to resident room ++555555+ Footnotes: *Sound transmission class (STC) must be determined by tests in accordance with methods set forth in ASTM Standard E 90 and ASTM Standard E 413. **Impact insulation class (IIC) must be determined in accordance with criteria set forth in HUD FT/TS 24. ***Public space includes lobbies, dining rooms, recreation rooms, treatment rooms, and similar spaces. +Impact noise limitation applicable only when corridor, public space, or service area is over resident's room. ++Service areas include kitchens, elevators, elevator machine rooms, laundries, garages, maintenance rooms, boiler and mechanical equipment rooms, and similar spaces of high noise or vibration or both. Mechanical equipment located on the same floor or above or below the residents' rooms, offices, nurses' stations, and similar occupied spaces must be effectively isolated from such spaces with respect to noise and vibration.
NOTE: The requirements set forth in this table assume installation methods which will not appreciably reduce the efficiency of the assembly as tested. Location of electrical receptacles, grilles, duct work, and other mechanical items, and blocking and sealing of partitions at floors and ceilings must not compromise the sound isolation required. 33-07-04.2-16. Elevators.
1.An appropriate number of elevators, at least one which complies with the provisions of ANSI A17.1, must be provided in all multistory buildings. All new hospital-type elevators must comply with this standard.
2.All elevators, except freight elevators, must be equipped with a two-way special service switch to permit the car to bypass all landing button calls and be dispatched directly to any floor. 33-07-04.2-17. Mechanical requirements.
1.Asbestos insulation may not be used. Insulation of soft-type, spray-on, etc., may not be used where it is subject to air or mechanical erosion or where loose particles may create a maintenance problem.
2.Air-conditioning, heating, and ventilation systems.
a.Air-conditioning is optional.
b.A temperature range of seventy-one to eighty-one degrees Fahrenheit [39.4 to 45.0 degrees Celsius] must be maintained for all occupied areas.
c.All air supply and air exhaust systems must be mechanically operated. Gravity exhaust may be used in nonresident areas and in areas not normally occupied by staff.
d.A ceiling exhaust fan may be used to ventilate a single isolated toilet room when a central exhaust system is not readily available.
e.Boiler rooms must be provided with sufficient air to maintain equipment combustion rates and to limit room temperatures.
f.Unit ventilators may be used to ventilate individual rooms in existing facilities, and in additions to existing facilities not to exceed six beds. Such ventilators may only be used when a central ventilation system is inaccessible.
g.Filters for a central ventilation system must be located upstream of air-conditioning equipment. If a prefilter is employed, the prefilter must be upstream of the equipment and the final filter may be located downstream.
h.A manometer must be installed across each filter serving a central ventilation system.
i.An exhaust hood in a dietary area must have an exhaust rate of not less than fifty cubic feet [1.41 cubic meters] per minute per square foot of face area. Face area is defined as the open area from the exposed perimeter of the hood to the average perimeter of the cooking surfaces.
3.Plumbing and other piping systems.
a.Systems must be designed to supply water to the fixtures and equipment located on upper floors at a minimum pressure of fifteen pounds per square inch [6.80 kilograms per 6.45 square centimeters] during maximum demand periods.
b.All handwashing facilities in resident care areas shall have the water supply spout mounted so its discharge point is a minimum distance of five inches [12.7 centimeters] above the rim of fixtures.
c.Flush valves installed on plumbing fixtures must be a quiet operating type, equipped with silencers.
d.Bedpan flushing devices must be provided in not less than half of the resident toilet rooms and in the soiled workroom. In new construction, rough-in plumbing for bedpan flushing devices in the remaining resident toilet rooms is required. 33-07-04.2-18. Electrical requirements.
1.All materials must be listed as complying with applicable standards of underwriters' laboratories incorporated, or other similarly established standards.
2.Circuit breakers or fusible switches that provide disconnecting means and overcurrent protection for conductors connected to switchboard and distribution panels must be enclosed or guarded to provide a dead-front type of assembly. The main switchboard must be located in a separate enclosure accessible only to authorized persons. The switchboard must be convenient for use, readily accessible for maintenance, clear of traffic lanes, and in a dry ventilated space devoid of corrosive fumes or gases. Overload protective devices must be suitable for operating properly in the ambient temperature conditions.
3.Lighting and appliance panels must be provided for the circuits on each floor. This requirement does not apply to emergency system circuits.
4.Two duplex receptacles are required between adjacent beds.
5.A nurse calling station must be installed at each resident bed, toilet, bath, and shower. The nurse calling station at the toilet, bath, or shower must be an emergency call.
a.All calls must register both visibly and audibly at the nurses' station and must actuate a visible signal in the corridor at the resident's door, in the clean workroom, and soiled workroom.
b.If installed, a nurse calling system providing two-way voice communication must be equipped with an indicating light at each calling station that lights and remains lighted as long as the voice circuit is operative.
6.Emergency electric service must be provided to circuits as follows:
a.Lighting at the switch-gear location and boiler room.
b.Nurse calling system.
c.Refrigerators for dietary and medication needs.
d.Fire pump, if installed.
e.All required duplex receptacles in resident corridors.
f.Equipment, such as burners and pumps necessary for operation of one or more boilers and their necessary auxiliaries and controls, required for heating and sterilization.
g.Equipment necessary for maintaining electrical service.
h.A minimum of one duplex receptacle convenient to the bed location for each resident requiring the use of life support systems.
Chapter 33-07-05 Nursing Facility Sanctions
N.D. Admin. Code 33-07-05-01 Purpose
This chapter is intended to conform North Dakota law to the requirements of 42 U.S.C. 1396r(h) by the creation of an enforcement process to be applied upon a finding, on the basis of a standard, extended, or partial extended survey of a nursing facility, or otherwise, that a nursing facility no longer meets the requirements of 42 U.S.C. 1396r(c) (requirements relating to residents' rights), or 42 U.S.C. 1396r(d) (requirements relating to administration and other matters), or of rules, regulations, or policies adopted to implement those requirements including rules and regulations relating to North Dakota Century Code section 23-16-01.
N.D. Admin. Code 33-07-05-02 Authority and objective
The state department of health is authorized by North Dakota Century Code section 23-01-11 to adopt such rules as necessary to enable the state to be in compliance with any federal laws in order to qualify for any federal funds related to medical facilities or agencies licensed by the department.
N.D. Admin. Code 33-07-05-03 Definitions
1."Class I violation" refers to a requirement found out of compliance that immediately jeopardizes the health or safety of one or more residents.
2."Class II violation" refers to requirement found out of compliance that has the potential for causing a direct and substantial threat to the health, safety, welfare, rights of one or more residents, or unauthorized removal of a posted notice of sanction.
3."Class III violation" refers to a requirement found to be or to have been out of compliance on consecutive surveys or visits, or failure to inform a caller inquiring about the availability of beds in the facility of the violations that are the subject of an order imposing sanctions.
4."Department" means the state department of health.
5."Director" means the director of the division of health facilities of the state department of health, or the director's designee.
6."Facility" or "nursing facility" means an institution or a distinct part of an institution which:
a.Is primarily engaged in providing to residents:
(1)Skilled nursing care and related services for residents who require medical or nursing care;
(2)Rehabilitation services for the rehabilitation of injured, disabled, or sick persons; or (3)On a regular basis, health-related care and services to individuals who because of their mental or physical condition require care and services (above the level of basic care) that can be made available to them only through institutional facilities;
b.Is required to have in effect a transfer agreement (meeting the requirements of 42 U.S.C. 1395x(1) with one or more hospitals having agreements in effect under 42 U.S.C. 1395cc; and
c.Is required to meet the requirements for a nursing facility described in 42 U.S.C. 1396r(b), (c), and (d) and North Dakota Century Code section 23-16-01.
7."Initial deficiency" means the first occurrence of a violation recorded by the survey agency, including violations found during a standard survey, during an extended survey, in response to a complaint investigation visit, or otherwise.
8."Repeat deficiency" means a violation which is substantially similar to a violation cited within the thirty-six preceding months.
9."Secretary" means the secretary of the United States department of health and human services.
10."Survey agency" means the state department of health.
N.D. Admin. Code 33-07-05-04 Provision of sanctions
The department may impose any sanction described in section 33-07-05-06 if it is found that a nursing facility no longer meets a requirement of 42 U.S.C. 1396r(b), (c), or (d), or North Dakota Century Code section 23-16-01, and it is further found that the facility's deficiencies are:
1.A class I violation which immediately jeopardizes the health or safety of its residents, in which case the director shall immediately recommend the appointment of a receiver, as provided for in North Dakota Century Code chapter 23-16.1, and as specified in subsection 8 of section 33-07-05-06, or recommend termination of the facility's participation in the medical assistance program, and may provide, in addition, for one or more of the other sanctions described in
section 33-07-05-06; or
2.A class II or class III violation which does not immediately jeopardize the health or safety of its residents, in which case the department may:
a.Recommend termination of the facility's participation under the state plan;
b.Provide for one or more of the remedies described in section 33-07-05-06; or
c.Do both.
N.D. Admin. Code 33-07-05-05 Imposition of sanctions
1.The department may implement sanctions based on a determination that a nursing facility no longer meets the requirements of 42 U.S.C. 1396r(b), (c), or (d), or of rules or regulations adopted to implement those requirements, including licensure requirements. The determination of appropriate sanctions must be at the discretion of the department. The appointment of a receiver must be as provided in North Dakota Century Code chapter 23-16.1. The department shall provide for the imposition of incrementally more severe sanctions for the violations that are repeated, uncorrected, pervasive, or present a threat to the health, safety, or welfare of the residents. When a determination is made that a civil money penalty will be imposed, the amount of the penalty will be based on recommendations made to the department by a committee composed of a representative from medical services, a representative from aging services, and a representative from health facilities.
2.The following factors must be considered in determining the sanctions to be imposed:
a.Seriousness of the violation;
b.Extent of the violation;
c.History of prior violations;
d.Prior imposition of sanctions;
e.Prior provision of provider information and training;
f.Willingness of facility management to adhere to program rules;
g.Agreement to make restitution to residents, the medical assistance program, or other third-party payors; and
h.Actions taken or recommended by licensing boards.
3.A sanction, once imposed, must continue until the facility has demonstrated to the department that the conditions or circumstances giving rise to the sanction have been corrected.
N.D. Admin. Code 33-07-05-06 Scope of sanctions
The following sanctions may be imposed upon a finding that a nursing facility no longer meets the requirements of 42 U.S.C. 1396r(b), (c), or (d) or the requirements of North Dakota Century Code
section 23-16-01:
1.Preparation, by the facility, of a directed plan of correction which is subject to approval of the department.
2.Mandatory attendance at provider information sessions.
3.Recommendation to the state Medicaid agency to implement one hundred percent review of the facility's claims prior to payment.
4.Recommendation for denial of payment with respect to any individual admitted to the nursing facility after receipt of the order. Denial of payment may not provide a basis for discharge or transfer of the individual.
5.A ban on the admission of residents, except those who were temporarily absent from the facility on hospital or therapeutic leave on the date of receipt of the order or thereafter.
6.Recommendation of denial of payment for any service furnished after receipt of the order.
Denial of payment may not provide a basis for discharge, transfer, or denial of service to a resident of the facility.
7.A civil money penalty, not exceeding one hundred fifty dollars per licensed facility bed, assessed, with interest at the legal rate, up to a maximum of ten thousand dollars, for each day the violation existed or continues to exist.
8.The appointment of a receiver to oversee the operation of the facility and to assure the health and safety of the facility's residents, where there is a need for temporary management while:
a.There is an orderly closure of the facility; or
b.Improvements are made in order to bring the facility into compliance with the requirements of the 42 U.S.C. 1396r(b), (c), and (d) and North Dakota Century Code
section 23-16-01
9.In the case of an emergency closure of the facility or transfer of facility residents to other facilities, or both.
N.D. Admin. Code 33-07-05-07 Determination of amount of civil money penalties
A facility which has been subjected to the imposition of a sanction under subsection 7 of section 33-07-05-06 is liable to the state for each day the violation existed or continues to exist. A violation must be presumed to continue to exist from the time it is found until the department finds it to have been corrected. The amount of the civil money penalty must be determined as follows:
1.For each class I violation, not more than fifty dollars per licensed facility bed;
2.For each class II violation, not more than twenty-five dollars per licensed facility bed;
3.For each class III violation, not more than ten dollars per licensed facility bed; and
4.For each repeat violation, not more than three times the amount otherwise provided for under subsection 1, 2, or 3.
N.D. Admin. Code 33-07-05-08 Recommendation of prohibition on submission of claims through other providers
The department shall recommend that any facility which is subject to a suspension or termination from participation or to any limitation or denial of payment shall be prohibited from submitting claims for payment, either directly or through any clinic, group, corporation, or other association, to the division of medical services or any fiscal agent or any services or supplies provided under the medical services program except for any services or supplies provided prior to the effective date of imposition of the remedy. The submission of any claim in violation of this section may subject the provider submitting the claim to sanctions under this chapter.
N.D. Admin. Code 33-07-05-09 Order and notice of order
1.Upon a determination that the circumstances make the imposition of a sanction appropriate, the department shall issue a written order identifying the violations and the sanction imposed.
If the violations are of a nature to require the imposition of an incrementally more severe sanction, the order must identify the reasons therefor. A copy of the order must be sent by registered or certified mail, return receipt requested, to the facility's owner, the facility's administrator, or head of the facility's governing board; or hand delivered to the facility's owner, the facility's administrator, or the head of the facility's governing board. The order must specify the terms or conditions under which the sanction will be terminated. The order must also advise the facility of the right to seek reconsideration.
2.When a facility has been subjected to a sanction, the department may notify, as appropriate, applicable professional licensing agencies, boards of registration or licensure, and federal, state, or county agencies of the circumstances and the sanctions imposed.
3.When a facility has been subjected to a sanction, the department shall notify the long-term care ombudsman and the county social service board of each county within seventy-five miles [120.7 kilometers] of the location of the facility. Each county social service board so notified shall post, in a prominent place within its office, the name and location of the facility and the sanction. The posting must remain in place for the entire period of any sanction other than closure or termination from the program and for the first ninety days of a closure or termination.
4.When a facility has been subjected to a sanction, the facility shall place notices of the sanction, supplied by the department, at all facility entrances and exits. In the event a sanction was imposed under subsection 5, 8, or 9 of section 33-07-05-06, the facility shall inform every person inquiring by telephone about the availability of beds in the facility of the violations and the sanctions imposed. Unauthorized removal of a posted notice, or failure to so inform a telephone caller, is a class II violation. The director may also require the facility to purchase space in the print media to achieve the public dissemination of information concerning any sanction.
N.D. Admin. Code 33-07-05-10 Request for reconsideration
1.Within ten days after receipt of the order, the facility may request reconsideration by the department. Within fifteen days after receipt of a request for reconsideration, the department shall grant or deny the request for reconsideration and may suspend the imposition of any sanction except one imposed under subsection 8 or 9 of section 33-07-05-06, pending a decision on reconsideration.
2.A request for reconsideration must, in any event, be denied unless it identifies, with specificity, each disputed violation and states the factual basis for its contention that the violation was erroneously determined. The correction of the factors which led to the determination of a violation may not be asserted as a basis for a request for reconsideration.
3.If the department denies the request for reconsideration the department shall notify the facility in writing of that decision. If the denial was for any reason other than a failure of the request to conform to the requirements of subsection 2, the notice must advise the facility of the right to appeal.
4.If the department determines to undertake reconsideration, the decision on reconsideration must be rendered within forty days after the issuance of the order. The notice of the decision on reconsideration must advise the facility of the right to appeal.
5.If the facility fails to file a timely request for reconsideration which conforms to the requirements of subsection 2, the order is final in all respects, and no further administrative or judicial review is applicable.
N.D. Admin. Code 33-07-05-11 Appeals
1.A facility dissatisfied with a decision on a timely request for reconsideration, which conforms to the requirements of subsection 2 of section 33-07-05-10, may appeal. An appeal may be perfected by mailing or delivering the information, described in subdivisions a through d, to the department, state capitol, Bismarck, North Dakota, so that the mailed or delivered material arrives at the office of the division of health facilities on or before 5:00 p.m. on the thirty-first day after the date of the determination of the department made with respect to a request for reconsideration. An appeal under this section is perfected only if accompanied by written documents including all of the following information:
a.A copy of the notice received from the department advising of the department's decision on the request for reconsideration;
b.A statement of each disputed violation and the reason or basis in fact for the dispute;
c.The authority in statute or rule upon which the appealing party relies for each disputed item; and
d.The name, address, and telephone number of the person upon whom all notices will be served regarding the appeal.
2.Except as otherwise provided in this section, the appeal must be considered as provided in
article 98-02.
3.The dispositive issue on appeal must be whether the violation occurred, not whether the violation has been corrected.
4.The hearing officer must make written findings of fact and conclusions of law, and must recommend a decision to the department. The recommended decision must set forth the reasons for the decision and the evidence upon which the decision is based.
5.The department may accept, modify, or reject the recommended decision. If the department rejects the recommended decision, it may remand the matter to the office of administrative hearings with directions. The department may, through its directions, require the receipt of additional evidence, and the submission of amended findings of fact, conclusions of law and recommended decision which reflects consideration of additional evidence. The department may, through its directions, require that the matter be referred to the same or a different hearing officer, and the office of administrative hearings shall comply with that direction unless compliance is impossible.
N.D. Admin. Code 33-07-05-12 Application
An appeal may not suspend or delay the imposition of a remedy under this chapter. All civil penalties received pursuant to this chapter must be paid into a special fund of the department for the cost of implementation of this chapter, to be applied to the protection of the health or property of residents or patients of facilities that the department or the secretary finds in violation, including payment for the costs for relocation of patients, maintenance of temporary management to operate a facility pending correction of a violation or closure of the facility, or for reimbursement to residents and patients for personal funds lost due to a cited violation.
Chapter 33-07-06 Nurse Aide Training, Competency Evaluation, and Registry [Repealed]
N.D. Admin. Code 33-07-06 Nurse Aide Training, Competency Evaluation, and Registry [Repealed]
CHAPTER 33-07-06
NURSE AIDE TRAINING, COMPETENCY EVALUATION, AND REGISTRY [Repealed effective March 12, 2026]
Article 33-09 Certificate of Need for Expansion of Hospital Facilities
Chapter 33-09-01 Certification of Need
N.D. Admin. Code 33-09-01 Certification of Need
ARTICLE 33-09
CERTIFICATE OF NEED FOR EXPANSION OF HOSPITAL FACILITIES
Chapter 33-09-01Certification of Need [Superseded] 33-09-02Certificate of Need Reviews [Superseded] 33-09-03Certificate of Need
CHAPTER 33-09-01
CERTIFICATION OF NEED [Superseded by Chapter 33-09-02]
Chapter 33-09-02 Certificate of Need Reviews
N.D. Admin. Code 33-09-02 Certificate of Need Reviews
CHAPTER 33-09-02
CERTIFICATE OF NEED REVIEWS [Superseded by Chapter 33-09-03]
Chapter 33-09-03 Certificate of Need
N.D. Admin. Code 33-09-03-01 Definitions
"Replacement equipment" means equipment which will be used instead of existing equipment which is documented to be obsolete, or not serviceable. Such equipment may be expected to possess expanded capabilities due to technical improvements but will not provide expansion into new health services.
History
- History: Effective November 1, 1987; amended effective May 1, 1992.
N.D. Admin. Code 33-09-03-02 Notification of intent - Filing fee
1.Each applicant shall submit a notification of intent on forms prescribed by the health council.
Each notification of intent must be accompanied by a filing fee of seventy-five dollars payable to the North Dakota state department of health.
2.The department, with concurrence of the health council, will determine purview.
3.The department will notify the applicant of the purview determination or seek additional information necessary to the determination of purview within fifteen working days of the receipt of a notification of intent. When appropriate, application forms prescribed by the health council will be sent to the applicant by the department.
4.Notifications of intent will expire one year following the mailing of the notice of the purview determination. In the case of any notification of intent deemed not subject to review, failure by the applicant to obligate funds for implementation of the proposal within the designated time will require the filing of a new notification of intent prior to implementation. In the case of any notification of intent deemed subject to review, failure by the applicant to complete the application form and to provide sufficient information to satisfy requirements to deem the application complete, as specified in subdivision b of subsection 1 of section 33-09-03-03, prior to the expiration of the notification of intent will cause both the notification of intent and the application to expire.
History
- History: Effective November 1, 1987; amended effective June 1, 1988.
- Law Implemented: NDCC 23-17.2-09
N.D. Admin. Code 33-09-03-03 Types of review - Procedures
1.Full review. A full review must be conducted of each proposal found subject under North Dakota Century Code section 23-17.2-03, unless the proposal is found eligible for a special review under provisions of subsection 2 of this section.
a.Completed applications must be submitted to the department. Each application must be accompanied by a fee payable to the North Dakota state department of health as prescribed by North Dakota Century Code section 23-17.2-09.
b.Applications received with appropriate fee will be reviewed for completeness by the department within fifteen working days of receipt. Each application must address the state health plan, each of the criteria for review and each of the policy issues stated in
section 33-09-03-04, and must include documentation of assertions found in the application. Submissions of requested additional information will be reviewed for completeness within fifteen working days of receipt. The department must deem the application complete or request necessary additional information from the applicant by the fifteenth working day. Such additional information must include documentation of assertions found in the application. No information may be required of an applicant which is not reasonably related to the state health plan, criteria for review, or policy issues specified in section 33-09-03-04 and necessary to perform review of the application.
c.Written notice that an application has been deemed complete will be provided to the applicant and must be published in one or more newspapers of general circulation within the affected service area. The notice must include:
(1)The name and address of the applicant, and a description of the proposal and its estimated costs.
(2)The proposed schedule for review.
(3)The time and manner by which affected persons may request an informal local hearing to provide additional information concerning the application.
(4)The date of notice shall be the date of earliest publication or fourteen days following the date on which the application is deemed complete, whichever comes first.
d.The department will have ninety days from the date of notice of completeness to conduct a review of the application based on criteria specified in section 33-09-03-04. The ninety-day-review period may be extended with concurrence of the applicant and the department. Recommendations of the department will be communicated to the applicant and to the health council.
e.The health council may, at its option for the purpose of simultaneous consideration of like applications, delay consideration of certain applications. In such circumstances, the health council shall specify to the applicant a date certain by which the application will be considered. In no case will the health council cause consideration of any application to be delayed more than one hundred eighty days without the consent of the applicant.
f.The health council will, except in cases described in subdivision e of subsection 1 of
section 33-09-03-03, make its determination at the next scheduled meeting following completion of the department's review. The department will cause the determination and the basis for the determination to be communicated to the applicant in writing. This communication will be made within five working days of the date of determination. Written notice of the determination must be published in one or more newspapers of general circulation within the affected service area. The notice must include:
(1)The name and address of the applicant and a description of the proposal and its proposed costs.
(2)The determination of the health council.
(3)The time and manner by which affected persons may request a hearing conducted under North Dakota Century Code chapters 28-32 and 23-17.2 for reconsideration of the health council's determination.
(4)The manner in which additional information concerning the application or the reconsideration process may be obtained.
(5)Affected persons will have a minimum of fifteen days to respond following earliest publication of the notice.
2.Special review. The department may issue, but not deny, certificates of need for proposals which qualify. Special reviews will be conducted based on information obtained through the notification of intent form and any supplemental information required by the department to verify qualification under the following circumstances:
a.Emergency or circumstances beyond the control of the applicant.
b.Elimination or prevention of imminent safety hazards as defined by federal, state, or local fire, building, or life safety codes, rules, or regulations.
c.Compliance with state licensure, accreditation, or federal certification standards or building requirements for handicapped accessibility required to continue reimbursement for existing services under title XVIII or title XIX of the Social Security Act, or under North Dakota Century Code chapters 50-01 or 50-06.
d.Cost overruns experienced in implementation of a proposal which exceed by ten percent or more the capital expenditure approved and specified in any certificate of need and which are not precipitated by a change in the scope of the project.
e.Projects mandated by state law, with need established through the legislative process as indicated by the appropriation of funds for implementation.
f.Acquisition and installation of replacement equipment if the equipment to be replaced meets applicable standards for minimum utilization adopted by the health council.
g.Refinancing of existing debt which does not create additional capital except debt service reserve held in restricted capital accounts or capitalized costs of bondissuance.
h.Proposals for the expansion of the physical plant of long-term care facilities which do not require a capital expenditure exceeding fifty thousand dollars and which do not facilitate the addition or expansion of services offered by the applicant.
History
- History: Effective November 1, 1987; amended effective May 1, 1992; April 1,1995.
N.D. Admin. Code 33-09-03-04 State health plan - Criteria for review - Policy issues
The health council will base its consideration of each application subject to full review on the department's review of the proposal and on the record of administrative proceedings held on the application. Complex applications may, at the discretion of the department, be divided into major components, each of which will be reviewed separately. Any such division will be communicated to the applicant as part of the notice of purview determination required by subsection 3 of section
N.D. Admin. Code 33-09-03-02 Proposal modification or redefinition following the notice of purview determination, but preceding the notice that an application has been deemed complete required by subdivision c of subsection 1 of section 33-09-03-03, may require change in the division of the application by the department. Any such change in division will be communicated to the applicant as part of the notice that the application has been deemed complete. If an application is subdivided for review by the department, the applicant may provide written notice to the department of preference that the application be considered in its entirety rather than its components. Such notice must include the applicant's rationale for preferring the consideration to be as a whole and must be received by the department within fifteen working days of the mailing date of the notice deeming the application complete. Pursuant to subsection 4 of North Dakota Century Code section 23-17.2-11, the health council may consider the application as a whole, by major components, or may condition the approval of an application in any other manner the council deems appropriate
1.Finding. For each application or major component of an application, the health council must make a finding of consistent or inconsistent with the state health plan or any applicable document adopted by the health council as an addendum or appendix to the state health plan.
2.Criteria for review. The health council must make a finding of consistent, inconsistent, or not applicable for each of the following criteria, in relation to each application or major component of an application. An application or major component of the application must be found consistent with all criteria which are found applicable to the application in order to be approved by the health council.
a.The population served or to be served has a need for the services proposed to be offered or expanded based upon the following:
(1)Changes in the health needs of population within the identified service area.
(2)Unavailability of alternative existing facilities or resources.
(3)Obsolescence of existing facilities or equipment.
(4)Absence of adequate space or facilities to conduct a needed new or existing service.
(5)Requirement for recruitment of qualified personnel to respond to the needs of persons residing in the service area.
(6)Regulatory or accreditation requirements.
(7)Evidence that the proposal will reduce or prevent harm to the population intended to be served by the proposal.
b.Any additional costs incurred to implement a proposal which result in increased charges to the public will:
(1)Provide improved access to needed services;
(2)Maintain access to needed services that would otherwise be lost; or (3)Improve the value of needed services sufficiently to warrant the increased charges.
c.The applicant has actively explored alternatives to the proposal including:
(1)Consideration of alternative uses of resources that may be more beneficial to the population intended to be served; and (2)Consideration of the availability of less costly or more effective alternative means for providing the services to be offered, expanded, reduced, or relocated.
3.Policy issues. The health council must consider the following policies or practices and where appropriate may require adoption of such policies and practices as a condition for an approved certificate of need.
a.The proposed service or facility will contribute to meeting the health-related needs of persons or groups which have traditionally experienced difficulty in obtaining equal access to health services.
b.The resources including plant, personnel, appropriate ancillary or support services, and funds for acquisition and operation are sufficient to reasonably ensure compliance with applicable state licensing and federal certification requirements upon implementation of the proposal.
c.The application proposes special innovations in the financing of health services that may favorably affect the price of services proposed.
d.The application proposes special innovations in the delivery of health services that may improve patient access or patient outcome.
e.The proposed service or facility will address special circumstances or needs of health professional training programs or schools and health research programs located in the affected service area.
History
- History: Effective November 1, 1987; amended effective May 1, 1992.
N.D. Admin. Code 33-09-03-05 Certificate of need expiration
Each certificate of need is valid for a period of one year from the date of determination. One extension of one hundred eighty days may be granted by the department upon request of the applicant.
Failure by the applicant to obligate funds for implementation of the proposal within the designated time will render the certificate of need null and void. However, time spent in a reconsideration action or a court appeal will not count toward the expiration of a certificate of need.
History
- History: Effective November 1, 1987.
Article 33-11 Licensing of Emergency Medical Services
Chapter 33-11-01 North Dakota Ground Ambulance Services [Repealed]
N.D. Admin. Code 33-11-01 North Dakota Ground Ambulance Services [Repealed]
ARTICLE 33-11
LICENSING OF EMERGENCY MEDICAL SERVICES
Chapter 33-11-01North Dakota Ground Ambulance Services [Repealed] 33-11-01.1North Dakota Quick Response Units 33-11-01.2North Dakota Ground Ambulance Services 33-11-02Basic Life Support Ground Ambulance License 33-11-03Advanced Life Support Ground Ambulance License 33-11-04North Dakota Air Ambulance Services 33-11-05Basic Life Support Air Ambulance License [Repealed] 33-11-06Advanced Life Support Air Ambulance License [Repealed] 33-11-07Critical Care Air Ambulance License 33-11-08Emergency Medical Services Grants
CHAPTER 33-11-01
NORTH DAKOTA GROUND AMBULANCE SERVICES [Repealed effective January 1, 2008]
Chapter 33-11-01.1 North Dakota Quick Response Units
N.D. Admin. Code 33-11-01.1 North Dakota Quick Response Units
CHAPTER 33-11-01.1
NORTH DAKOTA QUICK RESPONSE UNITS
Section 33-11-01.1-01Definitions 33-11-01.1-02License Required 33-11-01.1-03Application for License 33-11-01.1-04Issuance and Renewal of Licenses 33-11-01.1-05Availability of Quick Response Unit [Repealed] 33-11-01.1-06Driver's License Required 33-11-01.1-07Number of Personnel Required 33-11-01.1-08Minimum Equipment Requirements 33-11-01.1-09Other Requirements 33-11-01.1-10Quick Response Units Performing Advanced Life Support Interventions 33-11-01.1-11Transporting of Patients 33-11-01.1-12Communications 33-11-01.1-01. Definitions.
Words defined in North Dakota Century Code chapter 23-27 shall have the same meaning in this
chapter. For purposes of this chapter:
1."Department" means the department of health and human services.
2."Driver" means an individual who operates a quick response unit vehicle.
3."Driver's license" means the license as required under sections 39-06-01 and 39-06-02 of the North Dakota Century Code.
4."Emergency medical responder" means an individual who is certified as an emergency medical responder by the department.
5."Emergency medical technician" means an individual who is licensed as an emergency medical technician by the department.
6."Equivalent" means training of equal or greater value which accomplishes the same results as determined by the department.
7."Patient care provider" means a qualified individual on the quick response unit crew responsible for the care of the patient.
8."Personnel" means qualified patient care providers, or drivers, or both, within a quick response unit service.
9."Quick response unit run" means the response of a quick response unit vehicle and personnel to an emergency or nonemergency for the purpose of rendering medical care to someone sick or incapacitated, including canceled calls, no transports, and standby events where medical care may be rendered.
10."State radio" means the North Dakota department of emergency services division of state radio located at Fraine barracks in Bismarck, North Dakota.
History: Effective January 1, 2008; amended effective July 1, 2010; April 1, 2024. 33-11-01.1-02. License required.
1.The license shall expire midnight on June thirtieth of the odd year following issuance. License renewal shall be on a biennial basis.
2.A license is valid only for the service for which it is issued. A license may not be sold, assigned, or transferred.
General Authority: NDCC 23-27-02
Law Implemented: NDCC 23-27-02 33-11-01.1-03. Application for license.
Application for the license shall be made in the manner prescribed by the department. 33-11-01.1-04. Issuance and renewal of licenses.
1.The department or its authorized agent may inspect the service. If minimum standards are met, the department shall issue a license.
2.If minimum standards are not met, the department will allow the quick response unit thirty days to comply with the standards. The department will work with the quick response unit to obtain compliance. 33-11-01.1-05. Availability of quick response unit.
Repealed effective July 1, 2010. 33-11-01.1-06. Driver's license required.
All drivers of quick response unit vehicles shall have a current valid driver's license pursuant to requirements under sections 39-06-01 and 39-06-02 of the North Dakota Century Code. 33-11-01.1-07. Number of personnel required.
The minimum personnel required on each quick response unit run shall be one patient care provider who may function as the driver and is certified as an emergency medical responder or its equivalent. 33-11-01.1-08. Minimum equipment requirements.
The quick response unit shall have the following:
1.Automated external defibrillator.
2.Blood pressure manometer, cuff in child, adult, and large adult sizes; and stethoscope.
3.Disposable gloves - four pair of each size small, medium, and large.
4.One blunt shears.
5.One portable suction device with catheter.
6.One portable oxygen unit size "D" with variable flowmeter.
7.Two nasal cannulas and two nonrebreather masks with supply tubing.
8.Nasopharyngeal airways in adult and child sizes.
9.Oropharyngeal airways in adult, child, and infant sizes.
10.Two cold packs.
11.Four hot packs.
12.Two space blankets.
13.Twelve four-by-four sterile gauze pads.
14.Three sterile soft roller self-adhering bandages.
15.Four rolls of tape.
16.Two sterile occlusive dressings.
17.One sterile multitrauma dressing approximately ten inches [25.4 centimeters] by thirty-six inches [91.44 centimeters].
18.One sterile burn sheet or its equivalent.
19.Equipment case.
20.Equipment storage - readily accessible and safe from the elements. 33-11-01.1-09. Other requirements.
1.Personnel must be able to identify and locate all equipment items required to be carried in a quick response unit.
2.All licensed quick response unit agencies shall keep the quick response unit vehicle and other equipment clean and in proper working order.
3.All linens, airways, oxygen masks, nasal cannulas, and other equipment coming in direct contact with the patient must be either a single-use disposable type or cleaned, laundered, or disinfected after each use.
4.All licensed quick response units must either be affiliated with a licensed ambulance service, as defined in chapter 33-11-02.1, that provides medical oversight for the quick response unit, or upon approval by the department, have their own medical director not affiliated with an ambulance service. 33-11-01.1-10. Quick response units performing advanced life support interventions.
Quick response units may provide advanced life support interventions on an as-needed basis if the following requirements are met:
1.The primary care provider is licensed to provide the level of care required.
2.The service complies with the equipment list as set forth by its medical director.
3.A North Dakota licensed physician has authorized advanced life support interventions by verbal or written order.
4.The transporting ambulance's primary care provider is licensed to provide or maintain any advanced life support intervention provided by the quick response unit. 33-11-01.1-11. Transporting of patients.
1.Except as otherwise provided in subsection 2, quick response units may not transport patients.
2.Notwithstanding subsection 1, quick response units may transport patients during a major catastrophe or mass casualty incident if all of the following conditions are met:
a.An incident command system has been established and the incident commander has authorized the use of quick response units to transport patients.
b.The ambulance services that normally provide service or mutual aid in the area of the catastrophe or mass casualty incident are insufficient or unavailable to transport.
c.The primary care provider on the quick response unit must be an emergency medical technician or its equivalent.
d.The quick response unit must rendezvous with a licensed ambulance service if one becomes available during transport. 33-11-01.1-12. Communications.
To ensure responder safety and a seamless integration with the broader public safety response system, quick response units must have the following elements to their communications system:
1.They must have a radio call sign issued by state radio.
2.They must be dispatched directly from a public safety answering point by radio or pager.
3.They must have a radio capable of transmitting and receiving voice communications with the local public safety answering point, law enforcement responders, fire responders, and other public safety agencies on radio frequencies determined by state radio.
History: Effective July 1, 2010.
Chapter 33-11-01.2 North Dakota Ground Ambulance Services
N.D. Admin. Code 33-11-01.2 North Dakota Ground Ambulance Services
CHAPTER 33-11-01.2
NORTH DAKOTA GROUND AMBULANCE SERVICES
Section 33-11-01.2-01Definitions 33-11-01.2-02License Required - Fees 33-11-01.2-03Application for License 33-11-01.2-04Issuance and Renewal of Licenses 33-11-01.2-05Waivers 33-11-01.2-06Other Requirements for Substation Ambulance Operation [Repealed] 33-11-01.2-06.1Headquarter and Substation Ambulance Requirements 33-11-01.2-07Ground Ambulance Service Requirements 33-11-01.2-08Driver's License Required [Repealed] 33-11-01.2-09Number of Personnel Required [Repealed] 33-11-01.2-10Other Requirements [Repealed] 33-11-01.2-11Out-of-State Operators 33-11-01.2-12Specialty Care Transport 33-11-01.2-13Ground Ambulance Service Vehicle Requirements 33-11-01.2-14Transporting of Patients 33-11-01.2-15Required Advanced Life Support Care 33-11-01.2-16Communications 33-11-01.2-17Response Times 33-11-01.2-18Strike Team Designation [Repealed] 33-11-01.2-19Mutual Aid Agreements [Repealed] 33-11-01.2-19.1Service Areas 33-11-01.2-20Emergency Operations Plan 33-11-01.2-21Denial, Suspension, or Revocation of Licensure 33-11-01.2-22Industrial Site Ambulance Services 33-11-01.2-23Government Agency Ambulance Services 33-11-01.2-24General Operating Standards 33-11-01.2-25General Standards for Providing Emergency Medical Services 33-11-01.2-01. Definitions.
Words defined in chapter 23-27 of the North Dakota Century Code shall have the same meaning in this chapter. For purposes of this chapter:
1."Advanced life support ambulance service" means an emergency medical services operation licensed under and meeting all requirements of chapter 33-11-03.
2."Ambulance run" means the response of an ambulance vehicle and personnel to an emergency or nonemergency for the purpose of rendering medical care or transportation, or both, to someone ill or injured, including canceled calls, no transports, and standby events where medical care may be rendered.
3."Department" means the department of health and human services.
4."Designated trauma center" means a licensed hospital with a trauma designation as defined in
section 33-38-01-06.
5."Dispatch center" means a dispatching service that operates on a continual basis with dedicated personnel and receives ambulance run requests from a public safety answering point and radio dispatches ambulances.
6."Driver's license" means the license as required under sections 39-06-01 and 39-06-02 of the North Dakota Century Code.
7."Emergency medical service vehicle operator" means an individual who operates an ambulance or other emergency medical service vehicle and has had emergency vehicle operation training.
8."Emergency medical technician" means an individual certified by the national registry of emergency medical technicians as an emergency medical technician. An emergency medical technician is eligible for licensure as an emergency medical technician upon completion of a license application and approval by the department.
9."Equivalent" means qualifications reasonably comparable to those specifically listed as required for training, certification, licensure, credentialing, or recognition.
10."Headquarters ambulance service" means the base of operations for an ambulance service that operates subordinate substation ambulances.
11."Industrial site ambulance service" means an ambulance service that serves a private organization and not the general public.
12."Licensed health care facilities" means facilities licensed under chapter 23-16 of the North
13."Nonemergency health transportation" means health care transportation not provided by a licensed ambulance service that takes place on a scheduled basis by licensed health care facilities to their own patients or residents whose impaired health condition requires special transportation considerations, supervision, or handling but does not indicate a need for medical treatment during transit or emergency medical treatment upon arrival at the final destination.
14."Paramedic" means an individual certified by the national registry of emergency medical technicians as a paramedic. A paramedic is eligible for licensure as a paramedic upon completion of a license application and approval by the department.
15."Paramedic with additional training" means evidence of successful completion of additional training and appropriate periodic skills verification in such topics as management of patients on ventilators, twelve-lead electrocardiograms or other critical care monitoring devices, drug infusion pumps, and cardiac or other critical care medications, or any other specialized procedures or devices determined at the discretion of the paramedic's medical director.
16."Personnel" means an individual maintained on an emergency medical service agency roster.
17."Public safety answering point" means a government-operated call center that receives 911 calls from the public and dispatches public safety resources.
18."Revocation" means the official cancellation of a license.
19."Sanction" means to impose a penalty for disobeying a law or rule.
20."Service area" means the geographic area that a basic or advanced life support ground ambulance service is obligated to provide emergency medical transportation services. This includes emergency and nonemergency responses and medically appropriate patient transfers between hospitals or other medical facilities.
21."Specialty care transport" means interfacility transportation, including transfers from a hospital to an aeromedical intercept site, of a critically injured or ill patient by a ground ambulance vehicle, including medically necessary supplies and services, at a level of service beyond the scope of the paramedic.
22."State radio" means the North Dakota department of emergency services division of state radio.
23."Substation ambulance service" means a subordinate operation of a headquarters ambulance service.
24."Suspension" means the temporary withdrawal of a license during the period of the suspension.
25."Trauma patient" means any patient meeting the red or yellow criteria of the American college of surgeons national guideline for the field triage of injured patients.
History: Effective January 1, 2008; amended effective July 1, 2010; April 1, 2024. 33-11-01.2-02. License required - Fees.
1.A person, as an owner, agent or otherwise, may not operate, conduct, maintain, advertise, or otherwise engage in or profess to be engaged in operating a basic life support ambulance service or advanced life support ambulance service in this state unless that person holds a license as a basic life support ambulance service or advanced life support ambulance service or is exempt from these requirements.
2.The license shall expire midnight on October thirty-first of the even year following issuance.
The department shall relicense for a two-year period, expiring on October thirty-first, a basic life support or advanced life support ambulance service successfully meeting the requirements of the North Dakota ambulance service licensure program.
3.A license is valid only for the entity for which it is issued. A license may not be sold, assigned, or transferred.
4.The license decal shall be displayed in a conspicuous place inside the patient compartment of the ambulance vehicle.
5.The nonrefundable biennial license fee shall be fifty dollars for each ground ambulance service, including headquarters, substations, and industrial ambulance services.
6.Entities solely providing nonemergency health transportation services are not required to obtain a license under chapter 23-27 of the North Dakota Century Code as long as they do not advertise or offer emergency medical services to the general public or render acute medical care. 33-11-01.2-03. Application for license.
An application for a basic life support ambulance service or advanced life support ambulance service license shall be submitted on a form or through an electronic process, as prescribed by the department. The application must contain the following information as well as additional information and documents that may be solicited by the application form:
1.The name and mailing address of the applicant and a primary contact individual and telephone number and electronic mail address at which that individual can be reached.
2.The name under which the applicant shall hold itself out to the public in conducting its emergency medical service operations and the address of its primary location in this state out of which it shall conduct its emergency medical service operations. If the applicant seeks to conduct emergency medical service agency operations out of more than one location, the address of its primary operational headquarters and each other location out of which it intends to operate must be provided. If the applicant holds itself out to the public under different fictitious names for the emergency medical service operations it conducts at different locations, the fictitious name under which it intends to operate at each location must be provided.
3.The manner in which the applicant is organized.
4.The tax status of the applicant.
5.The geographic area for which the applicant intends to provide service. If the service is a type of service that is dispatched by a public safety answering point, the applicant shall detail the geographic area, if any, in which it plans to routinely respond to emergency dispatches.
6.A personnel roster.
7.The number and types of emergency medical service vehicles to be operated by the applicant and identifying information for each emergency medical service vehicle.
8.The communication access and capabilities of the applicant.
9.A full description of the emergency medical service agency services that the applicant intends to provide out of each location and how it intends to respond to emergency calls if it will not conduct operations out of a fixed location or locations.
10.The names, titles and summary of responsibilities of individuals who will be staffing the emergency medical service operation as officers, directors, or other emergency medical service agency officials.
11.A statement attesting to the veracity of the application, which shall be signed by the principal official of the applicant.
History: Effective January 1, 2008; amended effective July 1, 2010; April 1, 2024. 33-11-01.2-04. Issuance and renewal of licenses.
1.The department or its authorized agent may inspect the service. If minimum standards for either basic life support ground ambulance services or advanced life support ground ambulance services are met, the department may issue a license and designate its service area. The department may designate a new ambulance service to operate in a service area if the following conditions are present:
a.The existing ambulance service has not complied with the performance standards outlined in section 33-11-01.2-14 or 33-11-01.2-17 or chapter 33-11.2-15; or
b.The county commission or city commission having governing authority within an ambulance service area has petitioned the department requesting another ambulance service to operate in their area due to poor performance. Ambulance service performance issues must be documented, quantifiable, and persistent.
2.A service may request that the department consider it in compliance with this chapter if it is fully accredited by an ambulance accreditation agency recognized by the department.
3.Services requesting their compliance with this chapter to be verified through an accrediting agency shall submit to the department a copy of the entire accrediting agency survey report.
Subsequent accreditation or revisit documentation must be submitted prior to license renewal.
History: Effective January 1, 2008; amended effective July 1, 2010; April 1, 2024. 33-11-01.2-05. Waivers.
1.Based on each individual case, the department may waive any provisions of this chapter.
2.The waiver provision must only be used for a specific period in specific instances, provided such a waiver does not adversely affect the health and safety of the individual transported, and then only if a nonwaiver would result in unreasonable hardship upon the ambulance service. 33-11-01.2-06. Other requirements for substation ambulance operation. 33-11-01.2-06.1. Headquarter and substation ambulance requirements.
In addition to requirements as listed in the remainder of chapter 33-11-01.2, the following items apply to headquarter ambulance services and substations:
1.Application for licensure by a headquarter ambulance service shall be made as described in
section 33-11-01.2-03 and shall include all information regarding all substations under the control of the headquarters ambulance service.
2.A substation ambulance operation and all of its operational assets must be fully owned or leased and operated by a headquarters ambulance service. A substation ambulance may not establish a separate business structure independent of the headquarters service.
3.A substation ambulance service may not have its own governing board separate from a governing board of the headquarters ambulance service.
4.All logos, vehicle lettering, personnel uniforms, and signage on any substation building must reflect the name of the headquarters ambulance service. However, a logo, vehicle lettering, personnel uniforms, or signage on a substation building may include the name of the substation.
5.A licensed advanced life support ambulance service meeting the requirements of chapter 33-11-03 may operate a substation ambulance that meets the basic life support ambulance standards outlined in chapter 33-11-02.
6.A substation ambulance service may not be established in a city that has a licensed ambulance service based in that city.
7.A substation ambulance service may be available intermittently. The headquarters ambulance service is responsible for responding when the substation ambulance is unavailable. In lieu of responding, the headquarters ambulance service may request that the quickest available ambulance to respond be dispatched when the substation is unavailable. The headquarters ambulance service must inform its dispatching entity as to the time of availability of its substation ambulance service. 33-11-01.2-07. Ground ambulance service requirements.
1.A headquarters ambulance service shall be available twenty-four hours per day and seven days per week, except as exempted through waiver by the department.
2.A substation ambulance service may be available intermittently. When the substation ambulance is not available it is the responsibility of the headquarters service to respond to calls within that area if no closer ambulance can respond. The headquarters ambulance service must inform its dispatching entity as to the time of availability of its substation ambulance service.
3.All drivers of ambulance or emergency medical service vehicles shall have a current valid driver's license pursuant to requirements under sections 39-06-01 and 39-06-02 of the North
4.All licensed ambulance services shall keep the ambulance vehicle and other equipment clean and in proper working order.
5.All supplies and other equipment coming in direct contact with the patient must be either a single-use disposable type or cleaned, laundered, or disinfected after each use.
6.When a vehicle has been utilized to transport a patient known to have a communicable disease, the vehicle and all exposed equipment must be disinfected before the transport of another patient.
7.Each ambulance run must be reported to the department electronically via the North Dakota emergency medical services data repository.
8.All ambulance services shall give the receiving health care facility a detailed patient report at the time of patient transfer.
9.All ambulance services shall submit a trauma, stroke, cardiac, and other time-critical condition transport plan to the department upon request.
10.All licensed ambulance services shall keep either an electronic or paper copy of each patient care report on file for a minimum of seven years.
11.All licensed ambulance services shall have current written protocols developed and signed by their medical director. The current version of the protocols must be kept on file with ambulance service management. The ambulance service manager shall keep inactive protocols for a period of seven years after deactivating the protocol.
12.All ambulance services shall report any collision involving an ambulance that results in property damage of four thousand dollars or greater, or personal injury. The report must be made within thirty days of the event and on a form or in a manner provided by the department. 33-11-01.2-08. Driver's license required. 33-11-01.2-09. Number of personnel required. 33-11-01.2-10. Other requirements. 33-11-01.2-11. Out-of-state operators.
1.Operators licensed in another state may pick up patients within this state for transportation to locations within this state under the following circumstances:
a.When there is a natural disaster, such as a tornado, earthquake, or other disaster, which may require all available ambulances to transport the injured; or
b.When an out-of-state ambulance is traveling through the state for whatever purpose comes upon an accident or medical emergency where immediate emergency ambulance services are necessary.
2.Out-of-state fire units responding to this state for the purposes of forest fire or grassland fire suppression may bring their own emergency medical personnel to provide emergency medical treatment to their own staff. The emergency medical personnel must be certified by the national registry of emergency medical technicians and have physician oversight. 33-11-01.2-12. Specialty care transport.
1.Specialty care transport is necessary when a patient's condition requires ongoing care that must be provided by one or more health care professionals in an appropriate specialty area, for example, nursing, emergency medicine, respiratory care, cardiovascular care, or paramedic with additional training.
2.Qualifying interventions for specialty care transports are patients with:
a.One of the following:
(1)Intravenous infusions;
(2)Vasopressors;
(3)Vasoactive compounds;
(4)Antiarrhythmics;
(5)Fibrinolytics;
(6)Paralytics; or (7)Any other pharmaceutical unique to the patient's special health care needs; and
b.One or more of the following special monitors or procedures:
(1)Mechanical ventilation;
(2)Multiple monitors;
(3)Infusion pumps;
(4)Cardiac balloon pump;
(5)External cardiac support such as a ventricular assist device;
(6)Rapid sequence intubation;
(7)Surgical airways; or (8)Any other specialized devices or procedures unique to the patient's health care needs.
3.Minimum required staffing shall be one emergency medical technician or its equivalent and at least one of the following critical care providers: physician, physician assistant, nurse practitioner, registered nurse with special knowledge of the patient's needs, paramedic with additional training, respiratory therapist, or any licensed health care professional designated by the transferring physician.
History: Effective January 1, 2008; amended effective July 1, 2010. 33-11-01.2-13. Ground ambulance service vehicle requirements.
1.All ground ambulances must have a vehicle manufactured to be an ambulance.
2.A ground ambulance must have a patient care compartment that is designed to carry at least one patient on a stretcher that is securely mounted to the ambulance and that enables transportation in both the supine and seated upright positions.
3.A ground ambulance must have a patient care compartment that is designed to provide sufficient access to a patient's body to perform and maintain advanced life support skills, including adequate space for one caregiver to sit superior to the patient's head to perform required advanced life support airway skills, and other emergency medical services skills required by the emergency medical service agency's emergency medical services protocols.
4.A ground ambulance must have a design that does not compromise patient safety during loading, unloading, or patient transport. A ground ambulance must be equipped with a door that will allow loading and unloading of the patient without excessive maneuvering.
5.A ground ambulance must be equipped with permanently installed climate control equipment to provide an environment appropriate for the medical needs of a patient.
6.A ground ambulance must have interior lighting adequate to enable medical care to be provided and patient status monitored without interfering with the vehicle operator's vision.
7.A ground ambulance must be designed for patient safety so that the patient is isolated from the operator's compartment in a manner that minimizes distractions to the vehicle operator during patient transport and prevents interference with the operator's manipulation of vehicle controls.
8.A ground ambulance must be equipped with appropriate patient restraints and with restraints in every seating position within the patient compartment.
9.A ground ambulance must be equipped with two-way radios capable of communication with medical command facilities, receiving facility communications centers, public safety answering points, and ambulances for the purpose of communicating medical information and assuring the continuity of resources for patient care needs.
10.A ground ambulance must carry an oxygen supply that is cable of providing high flow oxygen at twenty-five or more liters per minute to a patient for the anticipated duration of patient transport.
11.All ground ambulance service vehicles must be equipped with a siren and flashing lights as described for class A emergency vehicles in subsection 2 of section 39-10-03 of the North 33-11-01.2-14. Transporting of patients.
Ambulance services shall transport patients to the nearest appropriate licensed health care facility according to their hospital transport plan except for:
1.Interfacility transports must be made in accordance with the referring physician's orders.
2.In the following specific instances transport must be made to a licensed health care facility with specific capabilities or designations. This may result in bypassing a closer licensed health care facility for another located farther away. An ambulance service may deviate from these rules contained in this section on a case-by-case basis if online medical control is consulted and concurs.
a.Trauma patients must be transported to a designated trauma center under article 33-38 or to an Indian health service facility that has entered into a memorandum of understanding with the department certifying the facility meets the requirements of a designated trauma center under article 33-38.
b.A patient suffering acute chest pain that is believed to be cardiac in nature or an acute myocardial infarction determined by a twelve-lead electrocardiograph must be transported to a licensed health care facility capable of performing primary percutaneous coronary intervention or fibrinolytic therapy pursuant to the North Dakota cardiac system ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and acute coronary syndrome guide.
c.A patient suffering a suspected stroke must be transported to a designated acute stroke ready hospital, primary stroke center, or a comprehensive stoke center pursuant to the North Dakota acute stroke treatment guidelines.
d.In cities with multiple hospitals an ambulance service may bypass one hospital to go to another hospital with equal or greater services if the additional transport time does not exceed ten minutes.
3.An officer, employee, or agent of any emergency medical services operation may refuse to transport an individual to a licensed health care facility for which transport is not medically necessary and may recommend an alternative course of action to that individual, including transportation to an alternative destination such as an urgent care center, clinic, physician's office, or other appropriate destination identified by the emergency medical services operation's medical director, if the emergency medical service operation has developed protocols to refuse transport of an individual and recommend an alternative course of action.
History: Effective January 1, 2008; amended effective July 1, 2010; April 1, 2024; August 22, 2024;
January 1, 2025. 33-11-01.2-15. Required advanced life support care.
When it would not delay transport time, basic life support ambulance services shall call for a rendezvous with an advanced life support capable agency, paramedic, or its equivalent if the basic life support ambulance is unable to provide the advanced life support interventions needed to fully treat a patient exhibiting:
1.Traumatic injuries that meet the trauma code activation criteria as defined in section 33-38-01-03.
2.Cardiac chest pain or acute myocardial infarction.
3.Cardiac arrest.
4.Severe respiratory distress or respiratory arrest.
5.Suspected stroke or stroke-like symptoms.
History: Effective January 1, 2008; amended effective July 1, 2010; April 1, 2024. 33-11-01.2-16. Communications.
To ensure responder safety and a seamless integration with the broader public safety response system, ground ambulance services shall have the following elements to their communications system:
1.They shall have a radio call sign issued by state radio.
2.They shall be dispatched directly from a public safety answering point.
3.They shall have a radio capable of transmitting and receiving voice communications with the local public safety answering point, law enforcement responders, fire responders, and other public safety agencies.
4.During the response and transport phases of an emergency ambulance run, an ambulance shall notify its dispatch center or public safety answering point when it:
a.Is en route to the scene.
b.Has arrived at the scene.
c.Has left the scene.
d.Has arrived at the transport destination.
e.Is available for the next ambulance run.
5.An ambulance may respond to the scene of an emergency with a fragmented crew if:
a.Any crewmember that is responding to the scene separately from the ambulance has a hand-held radio capable of transmitting and receiving radio traffic on frequencies designated for ambulances.
b.The crewmembers communicate with each other by radio to ensure that a full crew will ultimately arrive at the scene of an emergency and be able to treat and transport patients.
6.During the transport phase of an emergency ambulance run, the ambulance shall give a radio or telephone report on the patient's condition to the receiving hospital as soon as it is practical.
Early notification to the receiving hospital allows the hospital more time to prepare for the patient's arrival. 33-11-01.2-17. Response times.
Ground ambulances shall meet the following time standards ninety percent of the time when dispatched to an emergency request as determined by public safety answering point protocols or to an emergency interfacility transport as determined by the transferring health care provider. The time of dispatch to the time that the ambulance is en route must not exceed ten minutes to those incidents in which the public safety answering point or transferring health care provider, as appropriate, has determined that a potential life-threat exists.
History: Effective July 1, 2010; amended effective October 1, 2010; April 1, 2024. 33-11-01.2-18. Strike team designation. 33-11-01.2-19. Mutual aid agreements. 33-11-01.2-19.1. Service areas.
To ensure reasonably adequate ambulance service coverage and to prevent competition that would impair the long-term availability of services to the public, the department shall designate service areas when requested or at the department's discretion.
1.Upon request by a licensed ambulance service the department shall designate its service area. The requesting agency shall have a base of operations within that service area, currently be providing ambulance response within that service area, and be in good standing with the department.
2.The geographic area of the service area must be defined by the department based on the reasonableness of a licensed ambulance service to respond to all requests for service within the area.
3.Service area designation may not impede the ability of the designee or health care facility requesting interfacility transportation to utilize other licensed ground ambulance services for mutual aid when the designee is unable to provide services due to capacity, level of service required exceeds what the local ambulance service can provide, or for specialty care transport that the designee cannot provide. 33-11-01.2-20. Emergency operations plan.
Each licensed ambulance service shall be aware of its role as defined by local, county, and state emergency operations plans and shall be able to access the emergency operations plan as needed. 33-11-01.2-21. Denials, suspension, or revocation of licensure.
Failure to meet standards outlined in article 33-11 may result in sanctions based on the severity of the noncompliance. Based on each individual case, the department may impose the following sanctions on licensed ambulance services:
1.Require the ambulance service to submit a detailed plan of correction that acknowledges the deficiencies as designated by the department and outlines the steps needed to become fully compliant with standards.
2.Require the ambulance service to follow sanction requirements as outlined in department policy.
3.Revocation or suspension of ambulance service licensure. 33-11-01.2-22. Industrial site ambulance services.
An operator of a ground ambulance service intended for industrial site use may be issued a special license by the department.
1.The ambulance service may not advertise or offer service to the general public.
2.The ambulance service may provide advanced life support interventions on an as-needed
basis if all requirements of chapter 33-11-03 are satisfied. 33-11-01.2-23. Government agency ambulance services.
An operator of a ground ambulance service intended for federal or state government emergency operations may be issued a special license by the department.
1.The ambulance service may offer service to the general public and special populations during emergency operations.
2.The ambulance service may provide basic and advanced life support interventions as needed provided the service has met all minimum staffing and equipment requirements of chapters 33-11-02 and 33-11-03, respectively. 33-11-01.2-24. General operating standards.
1.Documentation requirements for licensure. An applicant for an emergency medical service agency license shall have the following documents available, paper or online, for inspection by the department:
a.A roster of active personnel, including the emergency medical service agency medical director, with licensure numbers and dates of licensure expiration for each emergency medical service provider.
b.A record of the age of each emergency medical service provider and emergency medical service vehicle operator and a copy of the driver's license for each emergency medical service vehicle operator.
c.Documentation, if applicable, of the initial and most recent review of each emergency medical service provider's competence by the emergency medical service agency medical director and the emergency medical service provider licensure level at which each emergency medical service provider is permitted to practice.
d.The process for scheduling staff to ensure that the minimum staffing requirements as required by this chapter are met.
e.Identification of individuals who are responsible for making operating and policy decisions for the emergency medical service agency, such as officers, directors, and other emergency medical service agency officials.
f.Criminal, disciplinary, and exclusion information for all individuals who staff the emergency medical service agency as required under subsection 5.
g.Copies of the ambulance service's emergency medical services protocols.
h.Copies of the written policies required under this section.
i.Emergency medical service patient care records.
j.Call volume records from the previous year's operations. These records must include a record of each call received requesting the emergency medical service agency to respond to an emergency, as well as a notation of whether it responded to the call and the reason if it did not respond.
k.A record of the time periods for which the emergency medical service agency notified the public safety answering point, under subdivision a of subsection 6, that it would not be available to respond to a call.
2.Emergency medical service vehicles, equipment and supplies. The department shall publish in administrative rules the vehicle construction and equipment and supply requirements for emergency medical service agencies based upon the types of services they provide and the emergency medical service vehicles they operate. Required equipment and supplies must be carried and readily available in working order.
3.Use of individuals under eighteen years of age. The emergency medical service agency shall comply with chapter 34-07 of the North Dakota Century Code, relating to child labor; chapter 46-02-07; the Fair Labor Standards Act of 1938 [Pub. L. 75-718; 52 Stat. 1060; 29 U.S.S. 201 et seq.], and rules or regulations adopted pursuant to chapter 34-07 of the North Dakota Century Code or Fair Labor Standards Act of 1938 [Pub. L. 75-718; 52 Stat. 1060; 29 U.S.S. 201 et seq.] when it is using individuals under eighteen years of age to staff its operations.
The emergency medical service agency shall also ensure that an emergency medical service provider under eighteen years of age, when providing emergency medical services on behalf of the emergency medical service agency, is directly supervised by an emergency medical service provider who is at least eighteen years of age who has the same or higher-level of emergency medical service provider licensure and at least one year of active practice as an emergency medical service provider.
4.Emergency medical service agency medical director. An emergency medical service agency shall have an emergency medical service agency medical director.
5.Responsible staff. An emergency medical service agency shall ensure that individuals who staff the emergency medical service agency, including its officers, directors and other members of its management team, emergency medical service providers, and emergency medical service vehicle operators, are responsible individuals. In making that determination, an emergency medical service agency shall require each individual who staffs the emergency medical service agency to provide it with the information and documentation related to criminal convictions, disciplinary sanctions, and exclusions and require each emergency medical service vehicle operator to provide it with the information and documentation related to his or her driving record and to update that information if and when additional convictions, disciplinary sanctions, and exclusions occur. The emergency medical service agency shall consider this information in determining whether the individual is a responsible individual. An emergency medical service agency shall also provide the department with notice of any change in its management personnel to include as a new member of its management team an individual who has reported to it information required under this subsection.
6.Communicating with public safety answering points.
a.Responsibility to communicate unavailability. An emergency medical service agency shall apprise the public safety answering point in its area, in advance, as to when it will not be in operation due to inadequate staffing or for another reason and when its resources are committed in a manner that it will not be able to respond with an emergency medical service vehicle, if applicable, and required staff, to a request to provide emergency medical services.
b.Responsibility to communicate delayed response. An emergency medical service agency shall apprise the public safety answering point as soon as practical after receiving a dispatch call from the public safety answering point, if it is not able to have an appropriate emergency medical service vehicle, if applicable, or otherwise provide the requested level of service, including having the required staff en route to an emergency within the time as may be prescribed by a public safety answering point for that type of dispatch.
c.Responsibility to communicate with public safety answering point generally. An emergency medical service agency shall provide a public safety answering point with information, and otherwise communicate with a public safety answering point, as the public safety answering point requests to enhance the ability of the public safety answering point to make dispatch decisions.
d.Response to dispatch by public safety answering point. An emergency medical service agency shall respond to a call for emergency assistance as communicated by the public safety answering point, provided it is able to respond as requested. An emergency medical service agency is able to respond as requested if it has the staff and an operational emergency medical service vehicle, if needed, capable of responding to the dispatch. An emergency medical service agency may not refuse to respond to a dispatch based upon a desire to keep staff or an emergency medical service vehicle in reserve to respond to other calls to which it has not already committed.
7.Patient management. All aspects of patient management are to be handled by an emergency medical service provider with the level of licensure necessary to care for the patient based upon the condition of the patient.
8.Use of lights and other warning devices. An emergency medical services operation utilizing a class A authorized emergency vehicle must submit a warning lights and sirens use policy to the department.
9.Explosives. Explosives may not be carried aboard an emergency medical service vehicle. This subsection does not apply to law enforcement officers who are serving in an authorized law enforcement capacity.
10.Accident, injury, and fatality reporting. An emergency medical service agency shall report to the department, in a form or electronically, as prescribed by the department, an emergency medical service vehicle accident that is reportable under chapter 39-08 of the North Dakota Century Code and an accident or injury to an individual that occurs in the line of duty of the emergency medical service agency that results in a fatality or medical treatment by a licensed health care practitioner. The report shall be made within twenty-four hours after the accident or injury. The report of a fatality shall be made within eight hours after the fatality.
11.Safety and quality improvement. An emergency medical service agency shall have a mechanism to address safety issues and quality improvement. This may be in the form of a committee or committees or other format that meets the need of the emergency medical service agency.
12.Emergency medical service provider credentialing. The emergency medical service agency shall maintain a record of the emergency medical service agency medical director's assessments and recommendations for emergency medical service provider credentialing. An emergency medical service agency may not permit an emergency medical service provider at or above the emergency medical technician level to provide emergency medical services at the emergency medical service provider's licensure level if the emergency medical service agency medical director determines that the emergency medical service provider has not demonstrated the knowledge and skills to competently perform the skills within the scope of practice at that level or the commitment to adequately perform other functions relevant to an emergency medical service provider providing emergency medical services at that level.
Under these circumstances, an emergency medical service agency may continue to permit the emergency medical service provider to provide emergency medical services for the emergency medical service agency only in accordance with the restrictions as the emergency medical service agency medical director may prescribe. The emergency medical service agency shall notify the department within ten days after it makes a decision to allow an emergency medical service provider to practice at a lower level based upon the assessment of the emergency medical service provider's skills and other qualifications by the emergency medical service agency medical director, or a decision to terminate the emergency medical service agency's use of the emergency medical service provider based upon its consideration of the emergency medical service agency medical director's assessment.
13.Display of license and registration certificates. The emergency medical service agency shall display its license certificate in a public and conspicuous place in the emergency medical service agency's primary operational headquarters.
14.Monitoring compliance. An emergency medical service agency shall monitor compliance with the requirements that the emergency medical services statutes and rules impose upon the emergency medical service agency and its staff. An emergency medical service agency shall file a written report with the department if it determines that an emergency medical service provider or emergency medical service vehicle operator who is on the staff of the emergency medical service agency, or who has recently left the emergency medical service agency, has engaged in conduct not previously reported to the department, for which the department may impose disciplinary action. The duty to report pertains to conduct that occurs during a period of time in which the emergency medical service provider or emergency medical service vehicle operator is functioning for the emergency medical service agency.
15.Policies and procedures. An emergency medical service agency shall maintain policies and procedures ensuring that each of the requirements imposed under this section, as well as any requirements imposed by statute, rules, or internal policy are satisfied by the emergency medical service agency and its staff. 33-11-01.2-25. General standards for providing emergency medical services.
Regardless of the type of service through which an emergency medical service agency is providing emergency medical services, the following standards apply to the emergency medical service agency and its emergency medical service providers when functioning as an emergency medical service provider on behalf of an emergency medical service agency, except as otherwise provided in this
section:
1.An emergency medical service provider who encounters a patient before the arrival of other emergency medical service providers shall attend to the patient and begin providing emergency medical services to the patient at that emergency medical service provider's skill level.
2.An emergency medical responder may not be the emergency medical service provider who primarily attends to a patient unless another higher-level emergency medical service provider is not present or all other emergency medical service providers who are present are attending to other patients. An emergency medical responder may not attend to a patient during transport unless another higher-level emergency medical service provider is present.
3.Except as set forth in subsection 2, or unless there are multiple patients and the emergency medical services needs of other patients require otherwise, among emergency medical service providers who are present, an emergency medical service provider who is certified at or above the emergency medical services skill level required by the patient shall be the emergency medical service provider who primarily attends to the patient.
4.If a patient requires emergency medical services at a higher skill level than the skill level of the emergency medical service providers who are present, unless there are multiple patients and the emergency medical services needs of other patients require otherwise, an emergency medical service provider who is licensed at the highest emergency medical services skill level among the emergency medical service providers who are present shall be the emergency medical service provider who primarily attends to the patient.
5.A member of the emergency medical service vehicle crew with the highest level of emergency medical service provider licensure shall be responsible for the overall management of the emergency medical services provided to the patient or patients by the members of that emergency medical service vehicle crew. If more than one member of the emergency medical service vehicle crew is an emergency medical service provider above the advanced emergency medical technician level, any of those emergency medical service providers may assume responsibility for the overall management of the emergency medical services provided to the patient or patients by the members of that emergency medical service vehicle crew.
6.If an emergency medical service vehicle crew needs additional assistance in attending to the needs of a patient or patients, it shall contact a public safety answering point or its emergency medical service agency dispatch center to request that assistance.
7.Except as otherwise provided in rule, a ground ambulance service shall operate twenty-four hours per day seven days per week, each type of service it is licensed to provide at each location it is licensed to operate that service.
8.A member of an emergency medical service vehicle crew who responds to a call in a personal vehicle may not transport in that vehicle medications, equipment, or supplies that an emergency medical technician is not authorized to use.
Chapter 33-11-02 Basic Life Support Ground Ambulance License
N.D. Admin. Code 33-11-02-01 Standards for emergency medical service vehicle operator
The emergency medical service vehicle operator shall have a current driver's license, cardiopulmonary resuscitation certification, and emergency vehicle operators training.
April 1, 2024.
History
- History: Effective March 1, 1985; amended effective January 1, 1986; August 1, 2003; July 1, 2010;
N.D. Admin. Code 33-11-02-02 Staffing
The primary care provider must have current emergency medical technician license or its equivalent and must have current cardiopulmonary resuscitation certification.
1.The minimum staffing for a basic life support ambulance crew when responding to a call to provide emergency medical services and transporting a patient is:
a.An emergency medical service provider at or above the emergency medical technician level; and
b.An emergency medical service vehicle operator.
2.For the purposes of this section, an emergency medical service provider at or above the emergency medical technician level includes an emergency medical technician, advanced emergency medical technician, or paramedic or a physician assistant, nurse practitioner, or registered nurse that has been authorized by the emergency medical service agency medical director to function as an emergency medical service provider.
3.Responding ambulance crew members may arrive at the scene separately, but the ambulance shall be fully staffed at or above the required minimum staffing level before transporting a patient.
4.Providing emergency medical service when dispatched with a higher-level emergency medical service vehicle crew. If a basic life support ambulance and a higher-level emergency medical service vehicle crew are dispatched to provide emergency medical services for a patient, the following shall apply:
a.Basic life support ambulance crew members shall begin providing emergency medical services to the patient at their skill levels, including transportation of the patient to a receiving facility if the ambulance crew determines transport is needed, until a higher level of emergency medical services is afforded by the arrival of a higher-level emergency medical service provider.
b.Upon the arrival of a higher-level emergency medical service vehicle crew, the basic life support ambulance shall continue transporting the patient or release the patient to be transported by the higher-level emergency medical service vehicle crew, consistent with local emergency medical service protocols, as directed by the emergency medical service provider exercising primary responsibility for the patient.
c.The basic life support ambulance crew shall reassume primary responsibility for the patient if that responsibility is relinquished back to that ambulance crew by the emergency medical service provider of the higher-level emergency medical service vehicle crew who had assumed primary responsibility for the patient.
d.A basic life support ambulance and its ambulance crew may transport from a receiving facility a patient who requires emergency medical services above the skill level at which the ambulance is operating, if the sending or a receiving facility provides a registered nurse, nurse practitioner, physician assistant, or physician to supplement the ambulance crew, that individual brings on board the ambulance equipment and supplies to provide the patient with emergency medical services above the emergency medical service level at which the basic life support ambulance is operating to attend to the emergency medical services needs of the patient during the transport, and that individual attends to the patient during the patient transport.
5.Application. For purposes of this section, the term "higher-level of emergency medical service" means the emergency medical service vehicle crew of a basic life support ambulance performing advanced life support interventions as defined in section 33-11-02-06, an advanced life support ambulance, or air ambulance.
January 1, 2006; April 1, 2024.
History
- History: Effective March 1, 1985; amended effective January 1, 1986; August 1, 1994; August 1, 2003;
N.D. Admin. Code 33-11-02-03 Minimum equipment requirements
In addition to a vehicle as described in section 33-11-01-15, the ambulance shall have the following, unless otherwise approved by the department:
1.Patient transport:
a.Mounted ambulance cot with retaining straps.
b.Stretchers with retaining straps. Vehicle design dictates quantity.
2.Spinal stabilization:
a.One adult long backboard, with retaining straps.
b.One seated spinal immobilization device, with retaining straps.
c.One pediatric-safe transport device.
d.One adult cervical collar.
e.One pediatric cervical collar.
3.Oxygen delivery:
a.Piped oxygen system - with appropriate regulator and flow meter, or two "E" size bottles for minimum oxygen supply with regulator and flowmeter.
b.Portable oxygen unit with carrying device, including one "D" size bottle with another "D" bottle in reserve.
c.Three adult cannulas.
d.Three pediatric nasal cannulas.
e.Three adult nonrebreather oxygen masks.
f.Three pediatric nonrebreather oxygen masks.
g.Three sets of oxygen supply tubing.
h.Noninvasive positive pressure ventilation device.
i.Nebulizer with tubing.
4.Suction:
a.Wall-mounted suction capable of achieving a minimum of four hundred millimeters of mercury vacuum within four seconds or less after clamping the suction tube.
b.Portable suction capable of achieving a minimum of four hundred millimeters of mercury vacuum within four seconds or less after clamping the suction tube.
c.One rigid tonsil tip suction catheter.
d.One flexible suction catheter between size six and ten french.
e.One flexible suction catheter between twelve and sixteen french.
5.Airway adjuncts:
a.One set of adult sizes nasopharyngeal airways.
b.One set of pediatric sizes nasopharyngeal airways.
c.One set of adult sizes oropharyngeal airways.
d.One set of child sizes oropharyngeal airways.
e.One set of infant sizes oropharyngeal airways.
f.Alternative airway devices such as a supraglottic airway as approved by local medical direction.
6.Bag valve masks:
a.One adult bag valve mask resuscitation unit with face mask.
b.One child bag valve mask resuscitation unit with face mask.
c.One infant bag valve mask resuscitation unit with face mask.
7.Splinting:
a.Adult commercial fracture splints usable for open and closed fractures, or padded boards.
b.Pediatric commercial fracture splints usable for open and closed fractures, or padded boards.
c.Adult lower extremity traction splint.
d.Pediatric lower extremity traction splint.
8.Environmental:
a.Four cold packs.
b.Four hot packs.
9.Bandaging and bleeding control:
a.Two sterile burn sheets or equivalent.
b.Three triangular bandages or commercial slings.
c.Two trauma dressings - approximately ten inches [25.4 centimeters] by thirty-six inches [91.44 centimeters].
d.Twenty-five sterile gauze pads - approximately four inches [10.16 centimeters] by four inches [10.16 centimeters].
e.Twelve soft roller self-adhering type bandages - approximately five yards [4.57 meters] long.
f.Two sterile occlusive dressings approximately three inches [76.2 millimeters] by nine inches [228.6 millimeters].
g.Two commercial "tactical" tourniquets.
10.Diagnostic:
a.Adult blood pressure cuff.
b.Large adult blood pressure cuff.
c.Child blood pressure cuff.
d.Stethoscope.
e.Pulse oximeter.
f.Glucose measuring device.
g.Penlight.
h.Thermometer.
11.Medications:
a.Three oral doses of glutose or glucose.
b.One small bottle, chewable aspirin.
c.Epinephrine, auto-injector for adult and pediatric doses or intramuscular, including syringes and needles for intramuscular delivery, if approved by medical director.
d.Naloxone, auto-injector (0.8 mg) or intranasal (4 mg - nasal spray, or syringe and atomizer).
12.Personal protective equipment:
a.One size small box of nitrile gloves.
b.One size medium box of nitrile gloves.
c.One size large box of nitrile gloves.
d.Box of surgical masks.
e.N95 masks, in small, medium, and large sizes and at least one per crew member.
f.Four nonabsorbent gowns.
g.Four pairs of protective eyeware.
13.Cleaning and biological:
a.Three red biohazard bags.
b.Biological fluid cleanup kit.
c.One sharps container, that is less than half full.
d.Medical grade disinfectant.
e.One gallon [3.79 liters] of distilled water or saline solution.
f.One bedpan.
g.One emesis basin.
h.One urinal.
i.One container of nonwater hand disinfectant.
14.Safety:
a.Two reflective vests.
b.A minimum set of three reflectorized flares.
c.Two flashlights.
d.A minimum of two dry chemical, mounted, five-pound [2.27-kilogram] fire extinguishers located in patient compartment and in either cab or exterior compartment.
e.Helmet, protective safety glasses or goggles eyewear, and leather or extrication gloves per crew member.
f.Two window and glass punches located in patient compartment and in cab.
15.Communications:
a.Radio, compatible with local communications system.
b.Portable, hand-held radio, rechargeable, battery-operated, compatible with local communications system.
16.Other:
a.Automated external defibrillator.
b.Twenty-five triage tags.
c.Pediatric reference material for equipment sizing and medication dosing.
d.Four assorted sizes rolls of tape.
e.Two blunt shears.
f.Cot-mounted or ceiling hooks intravenous fluid holder.
g.Two blankets.
h.Four sheets.
i.Four towels.
j.Disposable or sterilizable that includes an infant bulb suction and receiving blanket with head cover obstetrical kit.
k.One current edition of the Emergency Response Guidebook.
l.Alcohol or iodine swabs.
m.Water-soluble lubricant.
n.Razor.
August 1, 1994; August 1, 2003; January 1, 2006; July 1, 2010; April 1, 2024.
History
- History: 33-11-01-11; redesignated effective March 1, 1985; amended effective February 1, 1989;
N.D. Admin. Code 33-11-02-04 Medical direction
1.Each ground ambulance service shall have a signed agreement on file with the department with a North Dakota licensed physician who shall serve as official medical director and whose duties include establishing written medical protocols, recommending optional equipment, oversight of a quality assurance program, and maintaining current training requirements for personnel.
2.Each ambulance service must have written treatment protocols for adult and pediatric medical conditions approved by the medical director and available for reference when providing patient care.
3.Ambulance services must have a written process for accessing adult and pediatric online medical control that includes contacting a medical practitioner at a hospital that has continual in-house emergency room coverage or having the ability to directly contact the on-call emergency room medical practitioner while the practitioner is not at the hospital.
History
- History: Effective August 1, 2003; amended effective January 1, 2006; January 1, 2008; July 1, 2010.
N.D. Admin. Code 33-11-02-05 Basic life support ambulance performing advanced life support interventions
Basic life support ambulance services may provide advanced life support interventions on an as-needed basis if the following requirements are met:
1.The primary care provider is licensed to provide the level of care required.
2.The service complies with the equipment list as set forth by its medical director.
3.A North Dakota licensed physician has authorized advanced life support interventions by verbal or written order.
History
- History: Effective January 1, 2006.
Chapter 33-11-03 Advanced Life Support Ground Ambulance License
N.D. Admin. Code 33-11-03-01 Staffing
1.The minimum staffing requirement for an advanced life support licensed ground ambulance must consist of a paramedic or equivalent and an emergency medical technician or equivalent. If the crew consists of three or more personnel, the paramedic and emergency medical technician crew may have an emergency medical service vehicle operator as defined in section 33-11-01.2-01 as a third crew member.
2.The primary care provider, whose duties include an assessment of each patient, must hold current cardiopulmonary resuscitation certification and be a licensed paramedic or its equivalent with the following exceptions:
a.If, based on the paramedic's, or its equivalent's, assessment findings, a patient's condition requires only basic life support, an emergency medical technician or its equivalent may assume primary care of the patient.
b.For scheduled basic life support transfers with a crew of two personnel, the driver and the primary care provider must be at least licensed emergency medical technicians or its equivalent.
3.Responding ambulance crew members may arrive at the scene separately, but the ambulance shall be fully staffed at or above the minimum staffing level before transporting a patient.
4.Providing emergency medical services when dispatched with a lower-level emergency medical service vehicle crew. If an advanced life support ambulance and a lower-level emergency medical service vehicle crew are dispatched to provide emergency medical services for a patient, the following shall apply:
a.Upon arrival of an emergency medical service provider from the advanced life support ambulance crew who is a higher-level emergency medical service provider than the highest-level emergency medical service provider of the lower-level emergency medical service vehicle crew who is present, that emergency medical service provider shall assume primary responsibility for the patient.
b.If the patient is assessed by the advanced life support ambulance crew to require emergency medical services above the skill level at which the lower-level emergency medical service vehicle crew is operating, and requires transport to a receiving facility, the emergency medical service provider who is responsible for the overall management of the emergency medical services provided to the patient shall decide, consistent with local emergency medical service protocols, who will transport the patient. An appropriately licensed member of the advanced life support ambulance crew shall attend to the patient during the transport. If the lower-level emergency medical service vehicle is used to transport the patient, that emergency medical service provider shall use the equipment and supplies on the lower-level emergency medical service vehicle, supplemented with the additional equipment and supplies, including medications, from the advanced life support ambulance.
c.If at the scene or during patient transport by the lower-level emergency medical service vehicle crew, the emergency medical service provider of the advanced life support ambulance crew who has assumed primary responsibility for the patient determines that the lower-level emergency medical service vehicle crew is operating at the skill level needed to attend to the patient's emergency medical services needs, consistent with local emergency medical service protocols, that emergency medical service provider may relinquish responsibility for the patient to the lower-level emergency medical service vehicle crew.
January 1, 2006; January 1, 2008; July 1, 2010; April 1, 2024.
History
- History: Effective March 1, 1985; amended effective January 1, 1986; August 1, 1994; August 1, 2003;
N.D. Admin. Code 33-11-03-02 Minimum equipment standards
The ambulance must contain all the equipment requirements as found in section 33-11-02-03, except for having an automated external defibrillator, unless the required manual cardiac monitor is not able to function as an automated external defibrillator, plus the following, unless otherwise approved by the department:
1.Oxygen delivery. End-tidal carbon dioxide detectors with pediatric and adult capability.
2.Suction. One meconium aspirator adaptor.
3.Airway adjuncts:
a.Adult endotracheal airway equipment.
b.Pediatric endotracheal airway equipment.
c.One size zero straight laryngoscope blade.
d.One size one straight laryngoscope blade.
e.One size two straight laryngoscope blade.
f.One size three or four straight laryngoscope blade.
g.One size two curved laryngoscope blade.
h.One size three or four curved laryngoscope blade.
i.One adult stylette.
j.One pediatric stylette.
k.One pair of adult Magill forceps.
l.One pair of pediatric Magill forceps.
m.One adult laryngoscope handle with extra batteries.
n.One pediatric laryngoscope handle with extra batteries.
4.Diagnostic:
a.Manual cardiac monitor defibrillator with transcutaneous pacing, waveform capnography and pediatric capabilities.
b.Monitor electrocardiogram paper rolls.
c.Monitor electrodes.
d.Adult defibrillator pads.
e.Pediatric defibrillator pads.
5.Medication delivery:
a.Intravenous therapy equipment, including venous restriction device, micro and macro drip administration sets, catheters from sixteen gauge to twenty-four gauge, intraosseous needles, tubing, solutions, and intravenous arm boards for both pediatric and adult patients, as approved by local medical direction.
b.Syringes and needles.
July 1, 2010; April 1, 2024.
History
- History: Effective March 1, 1985; amended effective August 1, 1994; August 1, 2003; January 1, 2008;
N.D. Admin. Code 33-11-03-03 Minimum medication requirements
The ambulance must carry the following functional classification of medications in pediatric and adult dosages:
1.Alkalinizer agent.
2.Bronchodilator - adrenergic intravenous or subcutaneous.
3.Bronchodilator for nebulized delivery.
4.Antidysrhythmic or antiarrhythmic.
5.Anticholinergen parasympatholitic.
6.Opioid antagonist.
7.Coronary vasodilator, antianginal.
8.Anxiolytic.
9.Dextrose containing solution.
10.Anticonvulsant.
11.Analgesic.
12.Antiemetic.
History
- History: Effective March 1, 1985; amended effective August 1, 1994; August 1, 2003; April 1, 2024.
N.D. Admin. Code 33-11-03-04 Medical direction
1.Each ground ambulance service shall have a signed agreement on file with the department with a North Dakota licensed physician who shall serve as official medical director and whose duties include establishing written medical protocols, recommending optional equipment, oversight of a quality assurance program, and maintaining current training requirements for personnel.
2.Each ambulance service must have written treatment protocols for adult and pediatric medical conditions approved by the medical director and available for reference when providing patient care.
3.Ambulance services must have a written process for accessing adult and pediatric online medical control that includes contacting a medical practitioner at a hospital that has continual in-house emergency room coverage or having the ability to directly contact the on-call emergency room medical practitioner while the practitioner is not at the hospital.
History
- History: Effective March 1, 1985; amended effective August 1, 2003; January 1, 2006; January 1, 2008; July 1, 2010.
N.D. Admin. Code 33-11-03-05 Number of ambulances staffed
One advanced life support ambulance must be staffed. Additional ambulances may be required to meet community needs, demand, or the response time standards as defined in section 33-11-01.2-17 and may be staffed and equipped at the basic life support level.
January 1, 2006; January 1, 2008; July 1, 2010; April 1, 2024.
History
- History: Effective March 1, 1985; amended effective January 1, 1986; August 1, 1994; August 1, 2003;
N.D. Admin. Code 33-11-03-06 Advertising restrictions
No ambulance service may advertise itself as an advanced life support ambulance service unless it is so licensed.
History
- History: Effective March 1, 1985.
Chapter 33-11-04 North Dakota Air Ambulance Services
N.D. Admin. Code 33-11-04-01 Definitions
1."Air ambulance run" means the response of an aircraft and personnel to an emergency or nonemergency for the purpose of rendering medical care or transportation, or both, to someone who is sick or injured. Includes canceled calls, no transports, and standby events where medical care may be rendered.
2."Aircraft" means either an airplane also known as a fixed-wing, or a helicopter also known as a rotor-wing.
3."Commission on accreditation of medical transport systems" means a nationally recognized body for accreditation of air medical transportation systems.
4."Department" means the department of health and human services.
5."Equivalent" means qualifications reasonably comparable to those specifically listed as required for training, certification, licensure, credentialing, or recognition.
6."Personnel" means an individual maintained on an air ambulance roster.
History
- History: Effective August 1, 2003; amended effective January 1, 2006; January 1, 2008; April 1, 2024.
N.D. Admin. Code 33-11-04-02 License required - Fees
1.No air ambulance service as defined in North Dakota Century Code chapter 23-27 shall be advertised or offered to the public or any person unless the operator of such air ambulance service is licensed by the department.
2.The license shall expire midnight on October thirty-first of the even year following issuance.
The department shall relicense for a two-year period, expiring on October thirty-first, an air ambulance service successfully meeting the requirements of the North Dakota air ambulance licensure program.
3.A license is valid only for the service for which it is issued. A license may not be sold, assigned, or transferred.
4.The license shall be displayed in a conspicuous place inside the patient compartment of the aircraft. An operator operating more than one aircraft out of a town, city, or municipality will be issued duplicate licenses for each aircraft at no additional charge.
5.The biennial license fee shall be fifty dollars for each air ambulance service operated.
History
- History: Effective August 1, 2003; amended effective January 1, 2008; April 1, 2024.
N.D. Admin. Code 33-11-04-03 Application for license
An application for an air ambulance service license shall be submitted on a form or through an electronic process, as prescribed by the department. The application must contain the following information as well as additional information and documents that may be solicited by the application form:
1.Contact information:
a.The name, mailing address, and electronic mail address of the applicant.
b.A primary contact person, including telephone number, to be reached twenty-four hours per day seven days per week.
2.The name under which the applicant will be holding itself out to the public in conducting its emergency medical service operations and the address of its primary location in this state out of which it will be conducting its emergency medical service operations.
a.If the applicant seeks to conduct emergency medical service agency operations out of more than one location, the address of its primary operational headquarters and each other location out of which it intends to operate must also be provided.
b.If the applicant will be holding itself out to the public under different fictitious names for the emergency medical service operations it will conduct at different locations, the fictitious name under which it intends to operate at each location.
3.The manner in which the applicant is organized.
4.The tax status of the applicant.
5.An up-to-date roster of active personnel.
6.The number and types of aircraft to be operated by the applicant and identifying information for each aircraft.
7.The communication access and capabilities of the applicant.
8.A full description of the emergency medical service agency services that it intends to provide out of each location and how it intends to respond to flight transport requests.
9.The names, titles, and summary of responsibilities of individuals who will be staffing the emergency medical service operation as officers, directors, or other emergency medical service agency officials.
10.A statement attesting to the veracity of the application, which must be signed by the principal official of the applicant.
History
- History: Effective August 1, 2003; amended effective January 1, 2006; April 1, 2024.
N.D. Admin. Code 33-11-04-04 Issuance and renewal of licenses
1.The department or its authorized agent may inspect the air ambulance service. If minimum standards are met, the department shall issue a license.
2.A service may request that the department consider it in compliance with this chapter if it is fully accredited by the commission on accreditation of medical transport systems or its equivalent.
3.Services requesting their compliance with this chapter be verified through an accrediting agency shall submit to the department a copy of the entire accrediting agency survey report.
Subsequent accreditation or revisit documentation must be submitted prior to license renewal.
History
- History: Effective August 1, 2003; amended effective January 1, 2006; April 1, 2024.
N.D. Admin. Code 33-11-04-05 Availability of air ambulance services
Critical care air ambulance services shall be available twenty-four hours per day and seven days per week, except as limited by weather or aircraft maintenance or by unscheduled pilot duty limitations in accordance with federal aviation administration regulations.
History
- History: Effective August 1, 2003; amended effective March 24, 2004; January 1, 2006; April 1, 2024.
N.D. Admin. Code 33-11-04-06 Number of personnel required
For a licensed critical care air ambulance service, the minimum number of personnel required is two providers as defined in chapter 33-11-07 and one pilot.
History
- History: Effective August 1, 2003; amended effective March 24, 2004; January 1, 2006; April 1, 2024.
N.D. Admin. Code 33-11-04-07 Out-of-state operators
1.Operators licensed in another state may pick up patients within North Dakota for transportation to locations within this state under the following circumstances:
a.When there is a disaster or incident which may require elevated response to transport the injured.
b.When an out-of-state air ambulance is traveling through the state for whatever purpose comes upon an accident or medical emergency where immediate emergency air ambulance services are necessary.
2.Out-of-state air ambulance services that expect to pick up patients from within this state and transport to locations within this state shall meet the North Dakota standards and become licensed under North Dakota Century Code chapter 23-27 and this chapter.
N.D. Admin. Code 33-11-04-08 Required certificate of airworthiness
An air ambulance service must have a certificate of airworthiness from the federal aviation administration for each aircraft it uses as an air ambulance, which is maintained current by compliance with all required federal aviation administration inspections as defined by federal aviation administration
regulation 14 CFR 135.
N.D. Admin. Code 33-11-04-09 Securing of equipment
All equipment and materials used in an air ambulance must be secured in accordance with title 14, Code of Federal Regulations, part 135.
N.D. Admin. Code 33-11-04-10 Aircraft doors
Aircraft doors must accommodate passage of a patient lying on a stretcher with no more than thirty degrees rotation or forty-five degrees pitch.
N.D. Admin. Code 33-11-04-11 Required lighting
Lighting of at least forty foot-candles of illumination must be available in the patient care area to afford observation by medical personnel. Lighting must be shielded from the pilot of the aircraft so as not to interfere with operation of the aircraft.
N.D. Admin. Code 33-11-04-12 Required power source
The aircraft will be equipped with a federal aviation administration approved electrical power source that will accommodate commonly carried medical equipment, both AC and DC powered, and that is not dependent upon a portable battery.
N.D. Admin. Code 33-11-04-13 Required radio communication
The aircraft must have a radio communication system that will allow the communications between the aircraft and medical facilities, between the medical crew and the pilot, and between the medical crew on board the aircraft.
N.D. Admin. Code 33-11-04-14 Medical direction
1.Each air ambulance service shall have a signed agreement on file with the department with a North Dakota licensed physician who shall serve as official medical director and whose duties include establishing written medical protocols, recommending optional equipment, oversight of a quality assurance program, and maintaining current training requirements for personnel.
2.Each air ambulance service must have written treatment protocols for adult and pediatric medical conditions approved by the medical director and available for reference when providing patient care.
3.Air ambulance services must have a written process for accessing adult and pediatric online medical control that includes contacting a medical practitioner at a hospital that has continual in-house emergency room coverage or having the ability to directly contact the on-call emergency room medical practitioner while the practitioner is not at the hospital.
April 1, 2024.
History
- History: Effective August 1, 2003; amended effective January 1, 2006; January 1, 2008; July 1, 2010;
N.D. Admin. Code 33-11-04-15 Other requirements
1.The aircraft must have sufficient space to accommodate at least one pilot, one patient on a stretcher, two medical personnel, and the medical equipment required.
2.The aircraft must be configured to allow medical personnel to have a good patient view and access to equipment and supplies in order to initiate both basic and advanced life support.
3.All licensed air ambulance services shall keep the aircraft and other equipment clean and in proper working order.
4.All linens, and all equipment and supplies coming in direct contact with the patient, must be either a single-use disposable type or cleaned, laundered, or disinfected after each use.
5.When an aircraft has been utilized to transport a patient known to have a communicable disease, the aircraft and all exposed equipment shall be disinfected before the transport of another patient.
6.Each air ambulance run must be reported to the department electronically via an electronic patient care record that is compatible with the North Dakota emergency medical service data repository within seventy-two hours.
Chapter 33-11-05 Basic Life Support Air Ambulance License [Repealed]
N.D. Admin. Code 33-11-05 Basic Life Support Air Ambulance License [Repealed]
CHAPTER 33-11-05
BASIC LIFE SUPPORT AIR AMBULANCE LICENSE [Repealed effective April 1, 2024]
Chapter 33-11-06 Advanced Life Support Air Ambulance License [Repealed]
N.D. Admin. Code 33-11-06 Advanced Life Support Air Ambulance License [Repealed]
CHAPTER 33-11-06
ADVANCED LIFE SUPPORT AIR AMBULANCE LICENSE [Repealed effective April 1, 2024]
Chapter 33-11-07 Critical Care Air Ambulance License
N.D. Admin. Code 33-11-07-01 Training standards for care providers
Both care providers shall be critical care providers as listed in subsection 3 of section 33-11-01.2-12.
History
- History: Effective January 1, 2006; amended effective April 1, 2009; July 1, 2010; April 1, 2024.
N.D. Admin. Code 33-11-07-02 Minimum equipment requirements
In addition to an aircraft as described in subsection 3 of section 33-11-04-01, the air ambulance shall have the following, unless otherwise approved by the department:
1.Patient litter or stretcher for patient transport.
2.Spinal immobilization:
a.One pediatric-safe transport device.
b.One adult cervical collar.
c.One pediatric cervical collar.
3.Oxygen delivery:
a.An onboard oxygen system, with the following:
(1)Cylinders with a capacity of one thousand two hundred liters.
(2)The cylinders must have at least one thousand six hundred fifty pounds per square inch [11376.35 kilopascals] at the time of inspection.
(3)A flow meter with a range of zero to twenty-five liters per minute delivery.
b.Two D size oxygen cylinders or one D size oxygen cylinder and an onboard system capable of providing, at a minimum, an additional four hundred fifteen liters of oxygen.
c.Nonsparking wrench or tank opening device.
d.Gauge or flow meter not gravity dependent and can deliver between zero and twenty-five liters per minute.
e.Three adult nasal cannulas.
f.Three pediatric nasal cannulas.
g.Three adult nonrebreather oxygen masks.
h.Three pediatric nonrebreather oxygen masks.
i.Three sets of oxygen supply tubing.
j.Noninvasive positive pressure ventilation device.
k.Nebulizer with tubing.
l.End-tidal carbon dioxide detectors with pediatric and adult capability.
m.Multifunction mechanical ventilator.
4.Suction:
a.Portable suction unit with wide-bore tubing that is capable of achieving a minimum of three hundred millimeters of mercury vacuum within four seconds or less after clamping the suction tube or an aircraft suction system meeting the same or similar performance standards and a portable manual suction device.
b.One rigid tonsil tip suction catheter.
c.One flexible suction catheter between size six and ten french.
d.One flexible suction catheter between twelve and sixteen french.
5.Airway adjuncts:
a.One set of adult sizes nasopharyngeal airways.
b.One set of pediatric sizes nasopharyngeal airways.
c.One set of adult sizes oropharyngeal airways.
d.One set of child sizes oropharyngeal airways.
e.One set of infant sizes oropharyngeal airways.
f.Alternative airway devices such as a supraglottic airway as approved by local medical direction.
g.Adult endotracheal airway equipment.
h.Pediatric endotracheal airway equipment.
i.One size zero straight laryngoscope blade.
j.One size one straight laryngoscope blade.
k.One size two straight laryngoscope blade.
l.One size three or four straight laryngoscope blade.
m.One size two curved laryngoscope blade.
n.One size three or four curved laryngoscope blade.
o.One adult stylette.
p.One pediatric stylette.
q.One pair of adult Magill forceps.
r.One pair of pediatric Magill forceps.
s.One adult laryngoscope handle with extra batteries.
t.One pediatric laryngoscope handle with extra batteries.
6.Bag valve masks:
a.One adult bag valve mask resuscitation unit with face mask.
b.One child bag valve mask resuscitation unit with face mask.
c.One infant bag valve mask resuscitation unit with face mask.
7.One pelvic stabilization device for splinting.
8.Environmental:
a.Four cold packs.
b.Four hot packs.
9.Bandaging and bleeding control:
a.Two sterile burn sheets or equivalent.
b.Three triangular bandages or commercial slings.
c.Two trauma dressings approximately ten by thirty-six inches [25.4 by 91.44 centimeters].
d.Twenty-five sterile gauze pads approximately four by four inches [10.16 by 10.16 centimeters].
e.Twelve soft roller self-adhering type bandages approximately five yards [4.57 meters] long.
f.Two sterile occlusive dressings approximately three by nine inches [76.2 by 228.6 millimeters].
g.Two commercial tactical tourniquets.
10.Diagnostic:
a.Manual cardiac monitor defibrillator with transcutaneous pacing, waveform capnography, and pediatric capabilities.
b.Monitor electrocardiogram paper rolls.
c.Monitor electrodes.
d.Adult defibrillator pads.
e.Pediatric defibrillator pads.
f.Adult blood pressure cuff.
g.Large adult blood pressure cuff.
h.Child blood pressure cuff.
i.Stethoscope.
j.Pulse oximeter.
k.Glucose measuring device.
l.Penlight.
m.Thermometer.
11.Medication delivery:
a.Four of each size and individually wrapped and sterile hypodermic needles size sixteen to eighteen gauge, twenty to twenty-two gauge, twenty-three to twenty-five gauge, and two hypodermic needles of assorted sizes, including at least one with a one milliliter volume.
b.Intravenous therapy equipment, including venous restriction device, micro and macro drip administration sets, catheters size sixteen gauge to twenty-four gauge, intraosseous needles, tubing, solutions, and intravenous arm boards for both pediatric and adult patients, as approved by local medical direction.
c.Two three and one-quarter inch [8.26 centimeters] over the needle catheter in ten, twelve, or fourteen gauge.
d.Three intravenous infusion pumps or one multichannel unit capable of managing three simultaneous infusions.
e.Two intravenous bag holders with straps.
12.Medications:
a.Alkanilizing agent.
b.Anxiolytic.
c.Anticholinergen parasympatholytic.
d.Anticonvulsants.
e.Antidysrhythmic/antiarrhythmic.
f.Antiemetic.
g.Antihistamine.
h.One small bottle of chewable aspirin.
i.Adrenergic intravenous or subcutaneous bronchodilator or sympathomimetic.
j.Adult and pediatric doses of epinephrine administered through an autoinjector or intramuscular, if approved by medical director. If epinephrine is administered intramuscular the air ambulance shall have syringes and needles for intramuscular delivery.
k.Bronchodilator for nebulized delivery.
l.Dextrose containing solution.
m.Coronary vasodilator, antianginal.
n.Corticosteroid or glucocorticoid.
o.Opioid antagonist.
p.Analgesic.
q.Other medications may be carried as approved by the medical director.
13.Personal protective equipment:
a.Personal infection control kit, which includes the following:
(1)Eye protection, clear, and disposable for each crew member.
(2)Gown or coat for each crew member.
(3)Disposable surgical cap and foot coverings, for each crew member.
(4)Exam gloves for each crew member.
(5)Sharps containers and red bags per infectious control plan.
(6)N95 respirator for each crew member.
(7)Hand disinfectant for each crew member.
(8)Ten alcohol sponges.
14.Two liters of sterile water or normal saline.
15.Safety:
a.For rotor-wing aircraft, flight helmet with built-in communication for each crew member.
b.One survival bag.
c.One fully charged fire extinguisher rated at least 5 B:C securely mounted where it can be reached by the pilot or crew members. The fire extinguisher must be intact with safety seal, have been inspected within the previous twelve calendar months, and have the appropriate inspection tag attached.
16.Communications:
a.Two-way radio communications for the pilot to be able to communicate with hospitals, public safety answering points, and ground ambulances in areas to which the air ambulance routinely provides service.
b.For fixed-wing aircraft, at least one headset per crew member with built-in communication among the crew when the aircraft is operating and noise levels prevent normal conversation.
17.Other:
a.Four assorted rolls of adhesive tape, with at least one hypoallergenic roll.
b.One bandage shears.
c.Pediatric length-based drug dosing and equipment sizing tape, most current version available.
d.One sterile obstetrical kit.
e.One separate sterile bulb syringe.
f.One silver swaddler sterile thermal blanket or one roll of sterile aluminum foil for use on infants and newborns.
g.Appropriate patient coverings capable of maintaining body temperature based on anticipated weather conditions.
h.Two sterile water-soluble lubrication, two cubic centimeter or larger tubes.
i.Copy of most current version of agency protocols, as approved by medical director.
History
- History: Effective January 1, 2006; amended effective April 1, 2024.
N.D. Admin. Code 33-11-07-03 Advertising restrictions
No air ambulance service may advertise itself as a critical care air ambulance service unless it has been issued a critical care air ambulance license by the department.
History
- History: Effective January 1, 2006.
Chapter 33-11-08 Emergency Medical Services Grants
N.D. Admin. Code 33-11-08-01 Eligibility for emergency medical services grants
Certain ambulance services may be eligible for grants on an annual basis dependent upon legislative appropriation. In addition to compliance with chapter 23-46 of the North Dakota Century Code the following conditions must be met to be eligible for an emergency medical services grant.
1.Application for the grant shall be made in the manner and time frame prescribed by the department.
2.The ambulance service must be based in North Dakota.
3.The ambulance service must be licensed as a basic life support ground ambulance as described in chapter 33-11-02 or licensed as an advanced life support ground ambulance as described in chapter 33-11-03 for at least twelve months prior to the filing of the application.
4.The ambulance service must bill for services at a level at least equivalent to the Medicare billing level.
5.Criteria for grant approval shall be established by the state health council and shall at a minimum include consideration of:
a.The transportation distance to hospitals.
b.The size of the ambulance service area.
c.Contributing factors that may affect the number of patient care providers on the ambulance service.
d.The volume of ambulance runs.
History
- History: Effective January 1, 2008.
- General Authority: NDCC 23-46
- Law Implemented: NDCC 23-46
N.D. Admin. Code 33-11-08-02 Use of funds
The state health officer or designee shall determine the scope of the project, eligibility of emergency medical services operations, and distribution amounts on an annual basis. Considerations shall include:
1.How the emergency medical services operation fits into the overall structure of provision of emergency medical services in the state;
2.The needs of the emergency medical services operation and neighboring operations;
3.Compliance with the requirements set forth in chapter 23-46 of the North Dakota Century Code; and
4.Existence of local matching funds.
History
- History: Effective January 1, 2008.
- General Authority: NDCC 23-46
- Law Implemented: NDCC 23-46
Article 33-12 Care of Tubercular Persons
Chapter 33-12-01 Tuberculosis
N.D. Admin. Code 33-12-01-01 Purpose
It is the purpose of this article to provide inpatient and outpatient care to persons afflicted or suspected of being afflicted with tuberculosis in order to protect the public health, safety, and welfare of the people of the state of North Dakota. It is also the intent of this article to promote and apply procedures necessary to prevent the spread of tuberculosis in the state. This article shall be applied in conjunction with North Dakota Century Code chapters 23-01 and 23-07.1.
The North Dakota state department of health has been authorized to promulgate and administer this article under North Dakota Century Code chapters 23-01 and 23-07.1. 33-12-01-01.2. Definitions.
As used in this article, the following words shall have the meanings given to them in this section, unless otherwise made inappropriate by use and context.
1."Afflicted" means having documented active tuberculous disease.
2."Communicable" means capable of being transmitted from one person to another.
3."Contagious" means bearing contagion and communicable by contact.
4."Contract" means an agreement (monetarily) between the state health department and any hospital for the care of a tuberculosis patient.
5."Designee" means a state health department employee designated to administer the tuberculosis control program.
6."Epidemiology" means the process of controlling a disease in a population.
7."Evaluation" means medical and medication status, determined by physician, nurse practitioner, or nurse.
8."Inpatient" means hospitalized for treatment of tuberculous disease.
9."Isolation" means separation, for the period of communicability, of infected persons from others, to prevent conveyance of infectious agent to susceptible persons.
10."License hospital" means any hospital which is licensed by the hospital facilities division of the state department of health.
11."Outpatient" means being followed for treatment, diagnostic, and epidemiologic purposes.
12."Practicing physician" means any licensed medical doctor practicing medicine.
13."Quarantine" means limitation of freedom of movement of a diseased person until the person is no longer a public health hazard.
14."Recalcitrant" means a person with active, contagious tuberculosis not responsive to handling or treatment.
15."State health council" means the policymaking body of the state health department.
16."Suspect" means a person whose medical history and symptoms suggests that the person may be developing some communicable disease.
17."Temporary order" means process by which an individual in question is commanded to appear and answer cause.
History
- Law Implemented: NDCC 23-07.1-01 33-12-01-01.1. Authority.
N.D. Admin. Code 33-12-01-02 Contract fee for general hospitals
1.The department should establish a contract with the general hospitals in the larger cities for the care of tuberculosis patients, who do not have a third-party payment source.
2.The department will pay the standard fee for hospitalization.
3.The department will only pay for services relevant to the treatment of tuberculosis. Payment for services above the normal treatment requirement for tuberculosis will be the responsibility of the patient and/or provider.
N.D. Admin. Code 33-12-01-03 Hospitalization
The state department of health will authorize therapeutic admissions and the patients being treated for established tuberculosis are eligible for continued hospitalization as long as medically indicated; however, the state department of health will not pay for any patient care, treatment, maintenance, or transportation if assistance is available through other sources or that third-party payers are required to provide.
N.D. Admin. Code 33-12-01-04 Outpatient services
1.Tuberculosis diagnostic services are available at state supported outpatient clinics. Payment for diagnostic services performed at a facility other than the state supported outpatient clinics will be the responsibility of the patient.
2.Upon discharge from a contract hospital for treatment of active tuberculosis, each patient may receive some or all of the patient's medical supervision at an existing state supported outpatient clinic.
N.D. Admin. Code 33-12-01-05 Drugs and medication
1.All antituberculosis drugs and medication approved by the state department of health for treatment of tuberculosis patients shall be provided by the state department of health.
2.All approved tuberculosis drugs and medications utilized for preventive treatment (chemoprophylaxis) shall be provided by the state department of health. If they are provided by an unauthorized facility they must be at the expense of the patient or other applicable third parties.
N.D. Admin. Code 33-12-01-06 Bacteriology
Any specimens taken from a patient in an attempt to isolate microbacterium tuberculosis shall be processed at the Bismarck public health laboratory. Specimens not run at the public health laboratory will not be authorized by the state department of health and if they are performed at an unauthorized facility they must be at the expense of the patient or other applicable third parties.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
N.D. Admin. Code 33-12-01-07 Severability
If any provision of this article or the application thereof to any person or circumstances is held to be invalid, such invalidity shall not affect other provisions or application of any other part of this article which can be given effect without the invalid provision or application and to this end the provisions of this article and the various applications thereof are declared to be severable.
History
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
Article 33-13 Mental Health and Retardation Service Units
Chapter 33-13-01 Licensure of Community Mental Health and Retardation Centers (Service Units)
N.D. Admin. Code 33-13-01-01 Management/support services
1.Management.
a.Governing authority.
(1)A community mental health and retardation center shall be established in accordance with the provisions of North Dakota Century Code chapter 25-12.
(a)If the governing authority is a public organization, it shall describe the administrative framework within which it operates.
(b)If the governing authority is a private, nonprofit corporation, it shall provide written documentation of its source of authority through charter, constitution and bylaws, and if required, its state license.
(2)A community mental health and retardation center, whether established by a political subdivision or a body corporate, shall be governed by and under the general supervision of a board of directors appointed in the manner described in North Dakota Century Code chapter 25-12-03.
(3)The center's governing board shall adopt bylaws which shall state the purposes of the board and shall at least:
(a)Define the powers and duties of the board, its officers, and committees.
(b)Describe the authority and responsibility delegated to the executive director of the center, and retain the right to rescind such delegation.
(c)Provide for selection of its officers, and for appointment of standing and special committees necessary to effect the discharge of its responsibilities.
(d)Provide for the adoption of a schedule of meetings and attendance requirements.
(e)Require that minutes be kept of the board deliberations and decisions. [1]The center shall provide a copy of the bylaws and any ensuing revisions to the division of mental health and retardation. [2]There shall be documentation verifying that the bylaws of the governing
authority are reviewed and updated at least annually. [3]There shall be documentation verifying that the governing board shall be an active agent in the direction and supervision of center operations.
(4)The governing board shall appoint an executive director to discharge its responsibilities.
(a)The executive director shall have overall authority and responsibility for the operation of the center.
(b)The executive director shall be a qualified mental health professional with clinical, administrative, and community organization training or experience appropriate to a community mental health center setting.
(c)Prior to the appointment of the executive director, the governing board shall consult with the division of mental health and retardation, state department of health, regarding the qualifications of the applicant for that position.
(d)The executive director shall be a full-time employee of the center, and shall not be permitted to engage in private practice.
(e)To ensure effective communication between the governing board and the center staff, the executive director shall attend all its meetings. The board shall also use any other appropriate means to assure adequate communication with the staff of the center.
(5)The governing board shall appoint a medical director, who may also be the executive director, who shall assume the medical responsibility for each patient served by the center.
(a)The governing board shall describe in writing the role and responsibilities of the medical director and the medical director's relationship to the executive director, if that position is occupied by another mental health professional.
(b)The medical director shall be a board eligible or board certified psychiatrist licensed to practice medicine in North Dakota.
(6)The governing board shall prepare an annual report which shall include full disclosure of center ownership and control, fiscal information including receipts and disbursements, a table of organization depicting center programs and staff functions and responsibilities, and a summary of center activities reflecting services provided during the year.
(a)Such a report shall be filed with the division of mental health and retardation, state department of health, funding sources, and others upon request.
(7)The governing board shall take an active role in informing the community about the center and its programs, and shall actively solicit the involvement of the community in the affairs of the center.
(a)The governing board shall exert every effort to secure needed financial support for the ongoing operation of the center.
(8)The governing board of the center shall assure that there is continuing review of the quality of care provided by the center.
b.Fiscal management.
(1)The center's executive director shall designate an administrator or business manager who shall be responsible for the efficient management of the center and the maintenance of buildings and equipment.
(a)This individual shall be a full-time professional who shall supervise and coordinate such functions as general maintenance, purchasing and supply, accounting records, transportation, payroll, employee records, inventory control, and patient billings.
(2)An accounting system shall be maintained which provides information that reflects the fiscal experience and current financial position of the center.
(a)Such system shall accurately account for all revenues by source, federal, state, local, third party payments, and others.
(b)Such system shall have the capacity to determine the direct and indirect cost of each type of service provided by the center.
(c)Such system shall accurately indicate the center's operational costs.
(d)Such system shall be responsive to reporting requirements set by the division of mental health and retardation, state department of health.
(3)The center's executive director shall submit an annual budget to the governing body of the center for the purpose of discussion, modification and approval.
(a)The budget shall be developed with the participation of appropriate treatment and administrative staff.
(b)The budget shall categorize revenues for the center by source.
(c)The budget shall categorize expenses by the types of services or program components provided.
(d)Revisions of the budget during the fiscal year of operations shall be reviewed and approved by the center's governing body.
(e)After review and approval by the governing body, a copy of the budget, and any revisions thereafter, shall be filed with the division of mental health and retardation, state department of health.
(4)The fiscal management system shall include a fee schedule.
(a)The center shall maintain a current written schedule of rate and charge policies that has been approved by the center's governing body and the division of mental health and retardation, state department of health. [1]The fee schedule shall be accessible to all center staff and individuals served by the center. [2]The fee schedule shall be based on the patient's ability to pay taking into consideration income and family size.
(b)The center shall provide needed services for persons regardless of ability to pay. All persons shall be able to seek and receive services in the center, and shall not be denied services solely on the basis of inability or ability to pay.
(5)The fiscal management system shall have an audit of the financial operations of the center performed by an independent certified public accountant at least annually, in conformance with guidelines issued by the North Dakota state auditor. A copy of this audit shall be filed with the center's governing body, the state auditor's office, the fiscal officer, state department of health and the division of mental health and retardation, state department of health.
(6)The fiscal management system shall have appropriate insurance coverage for the protection of its staff, governing body, patients, the general public and the physical facilities. This insurance coverage shall include fire and extended coverage for buildings, contents and vehicles; public liability insurance; workmen's compensation for employees; and professional liability insurance.
(7)The fiscal management system shall provide that the center makes use of space owned by an organization other than the center, an agreement covering the terms of such usage shall be consummated.
c.Personnel.
(1)The center shall have written personnel policies and practices covering all employees of the center or its affiliates, or both.
(a)There shall be documentation verifying that the center's governing body has approved all written personnel policies and practices.
(b)There shall be documentation verifying that these personnel policies and practices are reviewed and updated at least annually.
(2)The center shall have written job descriptions for all staff positions.
(a)Each job description shall set forth the qualifications, reporting supervisor, positions supervised, and duties.
(b)There shall be documentation verifying that each job description is reviewed and updated at least annually for continuing appropriateness.
(c)Full-time professionals of the center shall not be permitted to engage in private practice.
(3)The written personnel policies and practices shall require that all personnel meet any local, state, or federal legal requirements for licensing, registration, or certification.
(4)The written personnel policies and practices shall stipulate that qualifications for all positions be nondiscriminatory.
(5)The written personnel policies and practices shall describe methods and procedures for the supervision of all personnel, including volunteers.
(6)The written personnel policies and practices shall include fringe benefits, recruitment, termination, promotions, and employee grievances.
(7)The written personnel policies and practices shall include a mechanism for evaluation of personnel performance on at least an annual basis.
(a)The evaluation shall be in writing.
(b)The evaluation shall be reviewed with the employee.
(8)The center shall maintain individual employee records, including the employee's application and statement of qualifications, transcripts, employment conditions and salary, accumulation and use of sick leave, vacation and administrative leave, and annual evaluations of the employee's performance.
(9)The written personnel policies and practices shall include a mechanism for suspension or dismissal of an employee for cause.
(10)All personnel policies and practices shall be given to each employee and be available to others upon request.
(11)The center shall have a written statement of its policies and practices for handling cases of neglect and abuse of its patients. Alleged violations and the results of any investigation shall be documented.
(12)The center shall have a written plan for the professional growth and development of all personnel. This plan shall include but not be limited to orientation procedures, inservice training programs, outside continuing education opportunities, and availability of professional reference material.
(13)The center shall document the involvement of its staff and governing body in the development and implementation of all of these policies, practices, statements, and plans.
(14)The center shall file with the division of mental health and retardation a copy of its personnel policies and practices at least on an annual basis. The same procedure applies to any changes, modifications or additions which may occur during the year.
d.Planning.
(1)The center shall carry out or have available to it a needs assessment or market study for the population it serves. The center shall document the methods and procedures for completing the needs assessment, as well as an analysis of the results.
(2)The center shall compile an inventory of existing resources for the population it serves, including a listing of all financial, staff, and service resources available.
(3)The center shall involve community participation in the planning process.
(4)The planning process shall be continuous.
(5)There shall be documentation verifying that the center's present services as well as new services are based upon the planning process and approved by the governing board.
(6)The center shall take into consideration and conform with all existing local, regional and state comprehensive planning for human services.
e.Evaluation.
(1)The center shall periodically evaluate its performance against its stated goals and objectives.
(a)The evaluation shall include mechanisms for assessing the attainment of the center's goals and objectives.
(b)The evaluation shall include mechanisms for assessing the effective utilization of staff and program resources toward the attainment of the center's goals and objectives.
(2)The center shall measure the effectiveness of its programs and services in terms of the progress of its patients toward the objectives specified in their individual treatment plans.
(3)The center's evaluation process shall include mechanisms for the consequent review and modification of its objectives, policies, and practices.
(4)The center shall provide its funding sources with qualitative evidence of accomplishments and shortcomings in relation to its stated goals and objectives.
(5)The center shall utilize the results of the evaluation process in its continuous planning efforts.
f.Data collection.
(1)Statistical data concerning caseload, flow of clients into and out of the center, and services rendered by the staff shall be maintained in accordance with guidelines and forms promulgated by the division of mental health and retardation.
(a)The data collected, its analysis, and results shall be made available to the center's governing body, funding sources, and others upon request.
(b)The data collected shall be utilized in the planning process, evaluation of the services provided by the center, and research activities.
g.Patients' rights.
(1)The center's policies and procedures shall be designed to enhance the dignity of all patients and to protect their rights as human beings.
(a)The patient shall have the right to treatment solely on the basis of need.
(b)The patient shall have the right to be received and treated with dignity and concern in accordance with accepted standards of care.
(c)The patient shall have the right to communicate with the patient's family, attorney, physician, clergyman, and any others.
(d)The patient shall have the right to be protected against unwarranted invasion of the patient's privacy.
(2)The center shall review and respond to patient's opinions, recommendations, and grievances in ways that will enhance the center's relationship with patients.
h.Environment.
(1)The center facility shall be structurally sound and shall meet the requirements of applicable federal, state, and local laws and regulations pertaining to physical safety, sanitation, adequacy of entry and exit capability, fire protection, and all other aspects of physical safety and serviceability.
(2)The center facility shall contribute to the patient's comfort and therapy and enhance the positive image of the center.
(3)A disaster plan shall be maintained and rehearsed by the center at least twice a year.
2.Support services.
a.Patients' records.
(1)The center shall develop and maintain a record of clinical information for each patient.
(a)The patient record shall include identifying data, evaluation, history, treatment plan, treatment course, and termination and disposition information. The patient record shall include a treatment plan outlining the goals and objectives for the individual during treatment.
(b)The patient record shall provide for a continued assessment of the progress of the individual towards the goals and objectives outlined in the treatment plan.
(c)The patient record shall not be a public record and shall not be released outside the center without the written authorization of the patient. [1]Documents or reports released outside the center shall contain no references to an identified patient, and shall contain no pictures or other identifying material unless written authorization of the patient is obtained. [2]Administrative and governing boards, funding agencies, or other interested persons or parties shall not have access to clinical information concerning center patients, except that those agencies responsible for assessing, surveying, and determining compliance with these standards shall have access to any and all information available to the center.
Information provided to the governing boards, funding agencies, and other interested groups shall be limited to such financial, statistical, and summary data as may be necessary for them to discharge their responsibility.
(d)When the patient's treatment is terminated, the center shall enter into the patient's record a discharge summary delineating the progress of the patient toward the goals and objectives set forth in the initial treatment plan.
b.Medication. The center shall have written policies and procedures designed to ensure that all medications are dispensed and administered safely and properly.
(1)Medication orders shall be written only by physicians who are in direct care and treatment of patients.
(2)A training program shall be provided for clinical staff members authorized to administer medications in accordance with state laws.
(3)There shall be a specific routine of drug administration.
(4)There shall be methods of checking to detect unhealthy side effects or toxic reactions.
(5)Drug storage areas shall be well lighted, safely secured, and maintained in accordance with the security requirements of federal, state, and local laws.
c.Referrals. The center shall have written referral policies and procedures that facilitate patient referral between the various components of the center or other community service providers, or both.
(1)The written referral policies and procedures shall include a description of the mechanisms designed to assure continuity of care for the patient.
(a)All services of the center shall be readily accessible on the basis of the patient's needs. This includes the movement of a patient from one direct care component to another as the patient's need dictates and with as few obstacles and as little interruption in the patient's therapeutic treatment as possible.
(b)Pertinent portions of records and other relevant information shall be readily transferable between all service components.
(c)Arrangements shall be made for the same staff member or members to assume primary responsibility for a patient throughout the patient's course of treatment whenever possible.
(2)The center shall indicate the means by which it assists in the referral of those patients who seek services the center does not provide.
(3)The center shall provide an adequate referral system, including followup, between its various components and private practitioners and other agencies and organizations.
(4)The center shall keep a current, confidential record of all referrals that it initiates and receives.
d.Research. The center may conduct basic and applied research to provide information regarding community needs resources, the impact of service delivery, and the extent to which the center is meeting its objectives and goals.
(1)The center shall have written policies and procedures encompassing the purpose and conduct of all research.
(2)When research involves staff, patients or the general public, care shall be taken to assure the anonymity of individual persons and the protection of human rights.
N.D. Admin. Code 33-13-01-02 Direct services
1.Inpatient care.
a.Principle. The inpatient care component shall provide twenty-four hour supervised therapeutic care under the direction of a physician in a hospital. This service should be utilized only when, and for so long as, other services of the center are not appropriate.
The goal of the inpatient care component is to provide appropriate and effective treatment to facilitate the patient's earliest return to the community.
(1)The inpatient care component shall have a written statement describing its philosophy and objectives in the provision of care to patients with emotional problems.
(a)This written statement shall include a statement of the primary diagnostic and treatment modalities utilized.
(b)This written statement shall delineate the interrelationship of the inpatient care component and its personnel with other components.
(2)The inpatient care component shall provide an intensive treatment program in a therapeutic environment. There shall be documentation that an evaluation of the needs of the patient has been conducted within twenty-four hours of the patient's entry into the inpatient care component.
(a)This evaluation shall be carried out by or under the supervision of a qualified physician.
(b)The process and results of this evaluation shall be documented in the patient's inpatient record.
(3)There shall be a written, individualized treatment plan based on the diagnostic assessment of the patient's needs.
(a)Any mental health professional may be involved in the patient's treatment under the supervision of a physician.
(b)The treatment plan shall be aimed at moving the patient from the inpatient care component into another care component of the center, or into the community as soon as the patient is sufficiently improved.
(4)The inpatient care component shall be reasonably accessible and immediately available.
(a)Patients who need inpatient care shall be hospitalized without delay.
(b)In the event that all inpatient care beds are filled, the center has the responsibility for arranging a suitable place for the patient's care.
(5)Whenever possible, a person shall be admitted voluntarily to the inpatient care component. However, the center shall be prepared to receive clients who are committed to the inpatient care component through legal action.
(6)The inpatient care component shall be structurally suitable to assure the patient of privacy when the patient desires it, and to encourage therapeutic interaction between patients and staff members.
(7)Hospital inpatient care facilities, staffing, records, procedures, and programs shall meet the requirements for licensure by the state of North Dakota and, if appropriate, meet the requirements for accreditation by the joint commission on accreditation of hospitals.
2.Partial care.
a.Principle. The partial care component shall be designed to provide a therapeutic program for those persons who require less than twenty-four hour a day care, but more than outpatient care. Partial care is an effective alternative to inpatient care. Partial care can serve as an effective transition between full-time care and return to the community. When so utilized, partial care can appreciably shorten the duration of a person's inpatient stay.
(1)The partial care component shall have a written plan describing its treatment (a)The written plan shall define the roles and responsibilities of the partial care personnel and the lines of authority.
(b)The written plan shall delineate the interrelationship of the partial care component and its personnel with other center care components.
(2)The partial care component shall have at least a day and night care program.
(3)There shall be trained staff and supporting personnel to perform the services of the partial care component.
(a)Performance of the services of the partial care component shall be verified by documentation of the implementation of individualized treatment plans and attainment of treatment objectives.
(b)There shall be a written plan for the training of all partial care personnel.
(4)The physical facility shall be appropriate for the partial care component.
(a)The day care program may take place at the center in a designated area or in the community utilizing available resources, or both.
(b)The night care program usually takes place in a hospital setting where appropriate bed space shall be provided.
(c)The center shall employ facilities for the partial care component which contribute to the ease and effectiveness of the program, such as encouraging communication with staff and patients.
(5)The partial care component shall be accessible to the community and be conveniently available by way of public or center-arranged transportation.
3.Outpatient care.
a.Principle. The outpatient care component shall be designed to provide the necessary treatment modalities for patients who need to spend relatively little time at the center on both a scheduled basis and a nonscheduled basis.
(1)The outpatient care component shall have a written plan describing its treatment (a)The treatment philosophy shall include a justification of the primary diagnostic and treatment modalities utilized.
(b)The plan shall include a description of the objectives of the outpatient care component. The description of the objectives shall demonstrate the indicators used to measure progress toward attainment of the objectives.
(c)The written plan shall define the roles and responsibilities of the outpatient care personnel and the lines of authority.
(d)The written plan shall delineate the interrelationship of the outpatient care component and its personnel with other center care components.
(e)The written plan shall include a mechanism and assurances for the care of patients who may require treatment services unavailable in the outpatient care component.
(2)The outpatient care component, including intake and treatment, shall be promptly available during normal center working hours.
(a)A patient has a right to seek and receive timely help at the center without being placed on a "waiting list".
(b)The center shall find ways and means of handling new intakes swiftly and effectively, and to get the patient started in a suitable treatment program without delay.
(3)There shall be a written, individualized treatment plan that is based upon the psychiatric/psychological/social evaluation.
(a)The treatment plan shall specify those services planned for meeting the patient's needs.
(b)The treatment plan shall include referrals for services not provided by the outpatient care component.
(c)There shall be documentation verifying that the treatment plan is reviewed and updated at least monthly.
(4)There shall be trained staff and supporting personnel to perform the services of the outpatient care component.
(a)Performance of the services of the outpatient care component shall be verified by documentation of the implementation of individualized treatment plans and the attainment of treatment objectives.
(b)There shall be a written plan for the training of all outpatient care personnel.
4.Emergency care.
a.Principle. The emergency care component shall provide immediate mental health care for persons in a crisis on a twenty-four hour a day, seven-day a week basis. The emergency care component shall include adequate provision for effective handling of special situations, including violent, criminal and suicidal clients and persons brought to the service through legal or police action.
(1)The emergency care component shall have a written plan describing its treatment (a)The written plan shall include the emergency component's philosophy toward emergency services and their delivery.
(b)The written plan shall define the roles and responsibilities of the emergency care personnel and the lines of authority.
(c)The written plan shall delineate the interrelationship of the component and its personnel with other center care components.
(d)The written plan shall delineate the methods by which the emergency care component, upon contact with an emergency, determines the level of the emergency and the appropriate services to be performed.
(2)The emergency care component shall maintain a twenty-four hour telephone service. The telephone emergency service shall be publicized adequately by such means as brochures, newsletters, or the mass media.
(3)The emergency care component available on a twenty-four hour basis shall include but not be limited to (a) the determination by trained staff of whether each person should receive a medical, psychological or social evaluation; (b) treatment of acute and potentially life threatening disorders and (c) supervision of medically ill persons by trained medical staff.
(a)Medical services shall be available to the emergency care component at all times.
(b)The emergency care component shall have the capability of providing evaluation and treatment services outside the center facility as necessary such as in homes, jails, schools, general hospitals and any other location where emergencies are likely to happen.
(4)The emergency care component shall be available to assist other center staff in handling emergencies, crises or unusual situations as requested.
(5)The emergency care component shall keep a record for each emergency telephone call involving suicidal threats and other serious problems or situations, including records of referrals made and the response of agencies or persons to whom a patient has been referred.
(a)These records shall be available to all staff members carrying out emergency duties and to the other center clinical staff as needed.
(b)There shall be assurance that patients receiving emergency care can be readily transferred to other services of the center, as their need dictates.
(6)There shall be a written plan for the training of all emergency care personnel. This training plan shall be updated at least annually for adjustment to changing needs.
N.D. Admin. Code 33-13-01-03 Indirect services
1.Consultation.
a.Principle. The consultation component involves the provision of mental health assistance to a wide variety of community agents and caregivers, including but not limited to schools, courts, police, clergy, and health care personnel such as physicians and public health nurses.
(1)The consultation component shall have a written plan describing the procedures by which the consultation needs of community groups or agencies are assessed and the goals and objectives derived from the assessed needs.
(2)The center shall periodically evaluate the effectiveness of its consultation component in attaining its goals and objectives.
(3)The consultation component shall be coordinated with all other center services.
(4)The center should enter into agreements with community groups or agencies delineating the scope and extent of the consultation service.
(5)The center shall provide for the training of its staff in consultation activities.
2.Education.
a.Principle. The education component shall be designed to increase the visibility, identifiability and accessibility of the center for all persons who require the center's services. A center cannot serve as an effective community resource if the community is unaware of its purposes, functions, location or its relevance to community needs. The education component shall be designed to also promote mental health and to prevent emotional disturbance through the dissemination of relevant mental health knowledge.
(1)The education component shall have a written plan describing the philosophy and goal of its program and services.
(2)The education component shall utilize but not be limited to brochures or fact sheets on services currently provided, newsletters, audiovisual materials, a speaker's bureau, program presentations, meetings and seminars, school and college class presentations, and the mass media.
(3)The center shall periodically evaluate the effectiveness of its education component in attaining its goals and objectives.
(4)The education component shall be coordinated with all other center services.
(5)The education component shall conduct activities that express and recognize citizen support of program needs.
(6)The center shall provide for the training of its staff in education activities.
N.D. Admin. Code 33-13-01-04 Services to special groups
1.Mental retardation services.
a.The various services provided by the center shall be available to the mentally retarded and other developmentally disabled persons.
b.These services shall be designed to meet the developmental needs of the patient throughout the patient's life span, maximize the patient's human qualities, adapt the patient's behavior, and enhance the patient's ability to cope with the patient's environment.
c.These services shall be developed with the principle of normalization and shall be so defined as to meet the patient's culturally, normative environment.
2.Alcoholism and drug abuse services. The alcoholism and drug abuse services provided by the center shall meet the policies and standards set forth in article 33-08.
N.D. Admin. Code 33-13-01-05 Glossary
1."Affiliate" means an agency which provides services included in the organization and operation of a community mental health and retardation center and which is related to that center by formal agreement or contract.
2."Aftercare" means the process of providing continued contact with a patient after the patient's treatment at the center.
3."Alcoholism program" means a program designed to identify, evaluate, and treat persons who experience problems related to alcohol use.
4."Audit (financial)" means an independent opinion by a certified public accountant verifying the center's financial condition as to its soundness and validity.
5."Clinical staff" means that group of personnel which is directly involved in patient care and treatment.
6."Consultation" means the act of providing information or technical assistance, or both, to a particular group or individual seeking to resolve an existing or potential problem.
7."Contract" means a formal legal document adopted by the center's governing body and any other organization, agency, or individual that specifies services, personnel, and space to be provided to the program as well as the moneys to be expended in exchange.
8."Cost accounting" means the accounting procedure concerned with the determination of costs of services provided by the center, as well as the provision of data for control of operations.
9."Diagnostic service" means an assessment or evaluation of a patient including recommendations for appropriate care carried out by center staff.
10."Documentation" means provision of evidence to substantiate compliance with standards such as minutes of meetings, memoranda, schedules, notices, and announcements.
11."Education" means the dissemination of relevant information to professionals and laymen about any aspect of mental health.
12."Emergency care" means the provision of immediate mental health care and evaluation for persons in crisis on a twenty-four hour a day basis.
13."Executive director" means the mental health professional appointed by the governing
authority to act in its behalf in the overall management of the center.
14."Fiscal management system" means procedures that provide management control of the financial aspects of program operations such as budgeting, materials purchasing, and patient billing.
15."Full-time employee" means a person employed by the center to work the regular forty-hour week.
16."Inpatient care" means the treatment of patients who require twenty-four hour supervision in a hospital setting as a result of mental disorder.
17."Medical care" means those diagnostic and treatment services that are provided by or under the supervision of a licensed physician.
18."Medical director" means a licensed physician (psychiatrist) who has responsibility for the medical care of center patients.
19."Medication" means the use of drugs in the treatment of patients.
20."Mental health professional" means an individual who has completed successfully an organized program of education and training devoted to principles of mental health and the care and treatment of those with mental disorders, or a person who has completed successfully a basic education in another discipline who, by virtue of additional training or experience, becomes qualified to carry out the person's professional activities in a mental health setting.
21."Outpatient care" means the process of providing mental health services to patients on a regularly scheduled basis with arrangements made for nonscheduled visits during times of increased stress or crisis.
22."Partial care" means those treatment services which are usually available and utilized by patients who require less than twenty-four hour a day care, but more than outpatient care.
23."Patient (client)" means an individual who has contacted the center seeking service and for whom treatment responsibility is accepted by the center.
24."Patient record" means a compilation of those events and processes that describe and document the evaluation and treatment of the patient.
25."Physician" means a doctor of medicine, licensed to practice medicine in North Dakota.
26."Precare and aftercare service" means the screening of patients prior to hospital admissions, home-visiting before and after hospitalization, and maintaining contact with the patient after discharge from the center's treatment program.
27."Psychiatric nurse" means a professional who is licensed to practice in North Dakota and holds a master's degree in the clinical speciality of psychiatry.
28."Psychiatrist" means a physician with three years of approved residency training in psychiatry who is licensed to practice medicine in North Dakota.
29."Psychologist" means a person who holds a doctor's degree in psychology who is licensed by the state of North Dakota.
30."Rehabilitative service" means social and vocational activities related to increasing the social and vocational skills of patients.
31."Social worker" means a person who holds a master's degree from an accredited school of social work and, if required, is licensed by the state of North Dakota.
History
- Law Implemented: NDCC 25-12-02(5), 25-12-04(5)
Article 33-14 Purchase of Residential Care for the Mentally Retarded
Chapter 33-14-01 Policy and Definitions
N.D. Admin. Code 33-14-01-01 Policy
It is the policy of the state department of health to require the highest standards of services for the mentally retarded in facilities licensed by the department which can reasonably be expected. This
article reflects the desire of the division of mental health and retardation of the state department of health to work with those who are developing services and facilities so that modern concepts of care and treatment of the retarded will be incorporated.
N.D. Admin. Code 33-14-01-02 Civil rights
The treatment and care center providing programs and services licensed under this article shall provide for protection of the civil rights of the residents as provided for in the Constitution of the United States, the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, Title III of the Older Americans Amendments of 1975, the Constitution of North Dakota, and all other relevant provisions of federal and state laws.
N.D. Admin. Code 33-14-01-03 Treatment or care center defined
As defined by North Dakota Century Code section 25-16-01, the treatment or care center means "any hospital, home, or other premises, owned or operated by a charitable nonprofit corporation or association, especially to provide relief, care, custody, treatment, training or education of the mentally retarded". It is interpreted that this law applies to those centers providing services on a twenty-four-hour
basis which are hereafter referred to as residential care.
N.D. Admin. Code 33-14-01-04 Types of residential care defined
Because the mentally retarded are a group of persons with different types and varying degrees of handicaps, it is essential that there be different types of facilities available to them. The following definitions of residential facilities represents groupings which take into consideration the needs of different age groups as well as variation in degree and type of handicap.
1."Halfway house, hostel, group home" is a facility which offers to mentally retarded persons training and experience in skills needed for independent placement in the community. These include personal and social skills for the retardate who attends school, is employed or potentially employable, and will profit from short-term training in independent living not to exceed nine residents.
2."Nursing care center, skilled or intermediate care facility" is a facility for mentally retarded persons who receive nursing care in addition to other needed care and treatment as defined under Article 33-07.
3."Residential center" is a facility for the twenty-four-hour residential care of mentally retarded persons who require care or supervision. It provides an organized program of services needed by those admitted to the facility exceeding ten or more residents.
4."Short-term care center", also known as respite, is a facility which provides intermittent care for mentally retarded for short periods of time. It is designed to provide a temporary separation from family or caretaker for mentally retarded persons during crisis periods such as illness or death of family members or caretakers, or to provide temporary relief for parents or caretakers from the care of a mentally retarded person when this is needed. It may also provide short-term care when necessary for diagnosis, observation or treatment of the mentally retarded person.
This type of care may also be provided in any one of the residential care centers defined in this article.
N.D. Admin. Code 33-14-01-05 Definitions
1."Dentist" means a person licensed to practice dentistry in North Dakota.
2."Dietitian" means a professional dietitian who has the basic degree in the dietitian's field and has completed an internship in an approved institution.
3."Physician" means a person licensed to practice medicine in North Dakota.
4."Psychologist" means a person licensed to practice psychology in North Dakota.
5."Registered nurse" means a professionally qualified person who is licensed as a registered nurse in North Dakota.
6."Screening team" consists of at least three persons (the director of the center, a social worker, and one person appointed by the governing body). Each residential center shall have a screening team and the purpose of the team shall be to establish admission policies for the facility consistent with the program offered.
7."Social worker" means a professionally qualified person who has completed a two-year graduate curriculum in an accredited school of social work and received a master's degree in social work. In addition, certification by the national association of social workers is required.
8."Teacher" means a professionally qualified person who possesses a valid North Dakota teaching certificate and a North Dakota special education credential.
Chapter 33-14-02 Licensure
N.D. Admin. Code 33-14-02-01 License required
Any charitable, nonprofit corporation or association operating a treatment or care center for mentally retarded persons shall obtain a license annually from the division of mental health and retardation of the state department of health.
History
- Law Implemented: NDCC 25-16-02
N.D. Admin. Code 33-14-02-02 Separate licenses for buildings on separate premises
In the case of a center where two or more buildings are used in the housing of residents, the license shall list separately each building if the buildings are on separate premises. Separate listing is not required for separate buildings on the same grounds. No fee shall be charged for such license.
N.D. Admin. Code 33-14-02-03 Renewal of license
A licensed treatment or care center planning to remain in operation for the following calendar year shall apply to the division of mental health and retardation for a renewal of its license.
N.D. Admin. Code 33-14-02-04 New centers and initial licensing
A center applying for its initial licensure shall submit information with its application to show that:
1.The premises to be used are in safe condition and properly equipped to provide good care and treatment.
2.The persons in active charge of the center and their assistants are qualified by training and experience to carry on efficiently the duties required of them.
3.The health, morality, safety, and well-being of the residents cared for and treated therein will be properly safeguarded.
4.There is sufficient entertainment, treatment, educational, and physical facilities and services available to the residents therein.
5.Medical and psychological examinations are made available to each resident at least once every six months.
6.Adequate staff is to be provided to perform necessary treatment and care.
N.D. Admin. Code 33-14-02-05 Content of licensure
North Dakota Century Code section 25-16-05 states:
The license to operate a treatment or care center for mentally retarded issued under the provisions of this chapter shall set forth:
1.The name of the licensee.
2.The premises to which the license is applicable.
3.The number of residents who may be received in such premises at any one time.
4.The date of expiration of the license.
History
- Law Implemented: NDCC 25-16-05
N.D. Admin. Code 33-14-02-06 Revocation of license
North Dakota Century Code section 25-16-08 states:
The division may revoke a license of a treatment or care center for mentally retarded upon a proper showing that:
1.Any of the conditions set forth in section 25-16-03 as requirements for the issuance of the license no longer exists;
2.The license was issued upon fraudulent or untrue representations;
3.The owner or operator has violated any of the rules and regulations of the division; or
4.The owner or operator of the center has been guilty of an offense determined by the division to have a direct bearing upon a person's ability to serve the public as an owner or operator, or the division determines, following conviction of an offense, that the person is not sufficiently rehabilitated under section 12.1-33-02.1.
History
- Law Implemented: NDCC 25-16-08
N.D. Admin. Code 33-14-02-07 Hearing on denial or revocation of license
North Dakota Century Code section 25-16-09 states:
Before any application for a license to conduct a treatment or care center for mentally retarded shall be denied or before the revocation of such license by the division, written charges as to the reasons therefor shall be served upon the applicant or licensee, who shall have the right to a hearing before the division, if such hearing is requested within ten days after service of written charges.
History
- Law Implemented: NDCC 25-16-09
N.D. Admin. Code 33-14-02-08 Inspection
1.The division of mental health and retardation shall inspect the facilities and premises of the applicant as often as necessary to determine the adequacy of program and services.
2.The division of mental health and retardation shall arrange for periodic inspection of the facilities and premises of the applicant to determine the adequacy of sanitary conditions and physical facilities.
3.The division of mental health and retardation shall call upon the state fire marshal, or the state fire marshal's designee, annually to inspect each treatment and care center for safety from fire hazards and will consider the state fire marshal's requirements and compliance therewith before issuing or renewing a license.
Chapter 33-14-03 Nursing Care Centers, Skilled or Intermediate
N.D. Admin. Code 33-14-03-01 Standards
Program and construction standards for nursing care centers shall be in accordance with the most current regulations for skilled and intermediate care facilities, article 33-07.
History
- General Authority: NDCC 28-32-02
- Law Implemented: NDCC 28-32-02
Chapter 33-14-04 Residential Centers
N.D. Admin. Code 33-14-04-01 Standards for administration
1.Administrator. In order to develop an adequate program of treatment and care it is essential that there be an administrator of maturity and experience to equip the administrator for the task. It is highly recommended that the administrator shall have had at least two years of previous professional work with the mentally retarded or administrative experience of similar duration with adequate programs of residential care. Professional preparation and experience in medicine, social work, or psychology are especially desirable.
2.Finances. A sound financial plan must be demonstrated. Adequate records must be kept of all income received and expended. An audit shall be performed annually and a copy of the audit report shall be submitted to the division of mental health and retardation of the state department of health. Financial records may be inspected by the division at any time.
Financial records must be kept for a period of fifteen years.
3.Insurance. Adequate insurance, including liability insurance, must be maintained.
4.Health clearance. The residential care center shall secure a written report from a licensed physician or health department that all personnel at the time of employment and annually thereafter are free of communicable and infectious diseases, including tuberculosis. Persons with infectious and communicable diseases shall not be on duty in any center.
5.Reports. Licensees shall furnish to the division of mental health and retardation such reports as may be required.
a.Injury and incident reports. A written report shall be submitted to the division within three days concerning any serious injury or unusual incident involving a resident including name, age, sex, date of admission, diagnosis, date of incident or death, nature of incident, medical findings and treatment, name of attending physician, and final disposition.
b.Death reports. Reports of all deaths from unnatural causes, including those reported to the coroner, shall be submitted to the division either as a special report or by copy of the death certificate within thirty days of occurrence.
c.Special reports. Any occurrences such as epidemic outbreaks, poisonings, reportable diseases, or other unusual occurrences which threaten the welfare, safety, or health of any resident admitted to any institution shall be immediately reported by telephone or telegram to the local health officer. The residential care center shall furnish such other pertinent information as the local or state department of health may require. The residential care center shall immediately submit an identical report to the division.
6.Fire safety. All residential care centers shall conform to the requirements established by the state fire marshal. An annual inspection shall be made by the state fire marshal, or the fire marshal's designee. A copy of the latest fire inspection clearance shall be on the premises.
7.Disaster program. All residential care centers shall adopt and maintain a written disaster program which shall provide plans for disasters occurring within and on the grounds of the center.
a.The written disaster program shall include:
(1)Administrative procedures.
(2)Plans for evacuation and continued care of residents.
b.The current plan shall be available on the premises and personnel shall be instructed in its implementation.
8.Telephones. All residential care centers shall have telephone service, including a telephone accessible to visitors. Each building housing residents shall have telephones or intercommunicating equipment.
9.Waiting and visiting space and public toilets. All residential care centers shall have ample waiting and visiting room space. Toilet facilities for the public shall include separate facilities for males and females.
10.Admission policies. All residential care centers shall have admission policies which are in writing and available to the public. No individual whose needs cannot be met by the facility shall be admitted to it. All admissions shall be in accordance with the facility's screening team's written policies.
11.Personnel policies and practices. All residential care centers shall have written policies and maintain accurate employee records.
12.Records. Records shall be kept on all residents admitted and shall be maintained after discharge or after a minor has reached eighteen years of age until such time as the statute of limitations no longer applies.
a.Maintenance of resident's records. The residential center shall maintain a separate clinical record for each resident admitted with all entries kept current, dated and signed.
The record shall include:
(1)Identification and summary sheets including resident's name, social security number, marital status, age, sex, home address and religion; names, addresses and telephone numbers of referral agency, personal physician, dentist and next of kin or other responsible person; admitting diagnosis, final diagnosis, conditions on discharge, and disposition.
(2)Initial medical evaluation including medical history, physical examination, diagnosis.
(3)The physician will make progress notes at each visit and the professional staff at the center shall write progress notes describing significant changes in the resident's behavior or at least monthly.
(4)Physician's orders, including all medication, treatment, diet, restorative, and special medical procedures required for the safety and well-being of the resident.
(5)Medication and treatment record including all medications, treatments, and special procedures performed for the safety and well-being of the resident.
(6)Laboratory and X-ray reports.
(7)Consultation reports.
(8)Dental reports.
(9)Social service notes.
(10)Resident care referral reports.
b.Confidentiality of records. All information contained in the clinical records shall be treated as confidential and may be disclosed only to authorized persons.
c.Staff responsibility for records. The center shall assign one staff member to be responsible for assuring that records are maintained, completed, and preserved.
13.Restraints.
a.Restraints or seclusion should be used only when all reasonable methods have failed and then should be used only for as brief a period as reasonably possible.
b.Restraints may be applied only by written order of the attending physician. In case of an emergency a verbal order may be accepted, but must be placed in writing on the resident's record within twelve hours.
c.When restraints or seclusion is used, a record shall be kept which will show:
(1)Name, age, and sex of resident.
(2)Type of procedure and device.
(3)Justification.
(4)Name of authorizing doctor.
(5)Date and hour placed in restraint or seclusion.
(6)Date and hour removed from restraint or seclusion.
N.D. Admin. Code 33-14-04-02 Staff
At least one staff member shall be in any building in which residents are present at all times.
Sufficient nursing and attendant staff are to be available for adequate care of residents at all times.
1.Arrangements must be demonstrated for the provision of adequate physician's services, including psychiatric and pediatric. If the director is not a physician, there must be services provided by a physician who will give regular health supervision and participate in the training of the staff. North Dakota Century Code section 25-16-03 requires medical examination of residents at least every six months.
2.Psychological services shall be provided and are to be under the direction of a psychologist licensed to practice psychology in North Dakota in conformity with the North Dakota licensure laws for psychologists. North Dakota Century Code section 25-16-03 requires psychological examination of residents at least every six months.
3.Social services are to be provided and shall be under the direction of a social worker.
4.Nursing services from registered nurses shall be provided as required by the program. This is especially important when the severely handicapped or those with serious medical problems are admitted to the center. When a professional nurse is included as a part of the staff, the nurse shall provide nursing services and participate in orientation and training of staff.
5.Qualified occupational, recreational, and speech therapists as well as qualified teachers shall be utilized as required.
6.A dietitian must be utilized in the food service. In the event that the center's program is not large enough to justify including a dietitian as a part of the staff, part-time services of a dietitian or dietetic consultation from the state department of health may be utilized.
7.Provisions shall be made for dental examinations and dental treatment by a dentist. A dentist shall assist the residential care center in developing an adequate program of oral hygiene.
8.Professional staff is to be utilized in the orientation and training of personnel.
9.Staff shall possess sufficient maturity and educational achievement to utilize the orientation and training program and to participate in a meaningful treatment and care program for the residents.
N.D. Admin. Code 33-14-04-03 Recreational activities
1.Every residential care center shall provide and conduct programs of purposeful activities in accord and with the interests, abilities, and needs of the residents.
2.Designated indoor and outdoor areas shall be provided to adequately meet the recreational needs of residents.
3.Facilities for children shall provide playgrounds and playrooms, adequately equipped with apparatus, games, etc.
4.Facilities for children of school age shall provide programs of education and training acceptable to the department of public instruction. If school facilities are utilized which are not on the premises, transportation which is in accordance with the needs of the resident shall be provided.
N.D. Admin. Code 33-14-04-04 Maintenance
1.Paramedical and adjunct services.
a.Mentally retarded persons who wear glasses, braces, or other appliances shall wear them as directed by the person who prescribed them and the center shall record these instructions in the resident's record and see that they are carried out.
b.Adequate facilities shall be made available to provide treatment (such as orthopedic and physiotherapy) by qualified personnel for residents who are physically handicapped in addition to being mentally retarded.
c.The center shall have an independent training program which makes every effort to help each resident achieve the resident's fullest potential for independence whether this be independence in self-care or for more complex activities leading to the goal of independent living.
d.Pharmacy. Where a pharmacy is operated, a registered pharmacist shall be in charge.
2.Medications.
a.All medicines, poisons, and other drugs shall be plainly labeled. They shall be stored in a specifically designated and well-illuminated area and made accessible only to responsible persons.
b.Medications requiring refrigeration shall be stored in a separate refrigerator or a separate
section of a refrigerator.
c.The specific name of the drug shall be plainly indicated on the container.
d.All medication ordered for residents shall be administered and recorded in accordance with the written order of the attending physician.
e.Custody of all medications, drugs, and poisons shall be the responsibility of registered nurses or supervisory personnel.
f.Responsibility for administration of one's own medications by any resident can only be given as part of an approved treatment plan and recorded as such in the resident's record.
g.There shall be compliance with state and federal regulations and laws governing use of drugs and narcotics.
3.Food service.
a.Diet plans shall be developed by a qualified dietitian who shall be responsible for development of special diets when ordered by the resident's physician. At least three meals shall be served daily to all residents either in the residential facility or made available at school or employment.
b.Menus shall be planned, written, and posted in the kitchen at least one week in advance.
Copies of menus, as served, shall be kept on file for at least four weeks.
c.Ambulatory residents shall be provided dining room service. Nonambulatory residents shall be served in such a way as to maximize independence and skills and still maintain an adequate state of nutrition.
4.Sanitation for preparing and serving food.
a.The storage, preparation, and serving of food and the cleaning and sanitizing of utensils shall be in accordance with the Ordinance and Code regulating eating and drinking establishments as recommended by the Public Health Service Food Service Sanitation Ordinance and Code (Part V), Food Service Sanitation Manual. Copies of this manual may be obtained from the state department of health.
b.The kitchen area shall provide adequate space for food preparation, dishwashing, refrigeration, and storage of bulk foods.
c.A janitor's closet and garbage can washing facility shall be provided.
5.Milk supply. The milk supply shall be from an approved source complying with the requirements of the Public Health Service Standard Milk Ordinance.
6.Water supply.
a.The water supply shall be from an approved source and must meet recognized standards of quality and quantity.
b.Sufficient facilities for producing a ready quantity of hot water for domestic needs shall be provided.
7.Waste disposal. Disposal of sewage and garbage shall be in an approved manner and must meet recognized standards.
8.Laundry.
a.Adequate arrangements for laundry service shall be made.
b.If the laundry is done within the facility, there shall be proper provision of spacing, sizing, and placing of equipment to assure satisfactory service to meet the demands of the residents.
N.D. Admin. Code 33-14-04-05 Resident rooms
1.Grade level. No resident shall be housed in a room unless a portion of it is at or above grade level and no resident room floor shall be more than thirty inches [76.2 centimeters] below the adjacent grade.
2.Floor area.
a.In single resident rooms the least dimension free of fixed obstructions shall not be less than eighty square feet [7.43 square meters].
b.Multibed rooms shall have as a minimum floor space, seventy-five square feet [6.97 square meters] of space free of fixed obstructions per bed. There shall be no more than four beds per room.
c.At least one water closet, lavatory, and tub or shower shall be provided for each five residents.
d.Window sills shall not be higher than three feet [91.44 centimeters] above the floor and shall be above grade. Each resident's room shall be an outside room with a satisfactory amount of natural light. The area of the glazing material in the windows shall not be less than one-tenth of the floor area of the room served by them.
e.If both males and females are housed in the same facility, separate water closets, lavatories, and tubs or showers will be required for both sexes.
N.D. Admin. Code 33-14-04-06 Services area
1.Clean linen storage. Enclosed storage space.
2.Nourishment station. Storage, refrigerator, hot plate, self-dispensing icemaker, and sink.
(Desirable but not mandatory.)
3.Equipment storage room. For storage of bulky equipment.
4.Janitor's closet. Large enough for storage of housekeeping supplies and equipment. Floor receptor.
5.Toilet room door. Doors to toilet rooms shall have a minimum width of two feet ten inches [86.36 centimeters] to admit a wheelchair.
6.Conference room. For consultation, examination, and treatment and therapeutic and nursing procedures to be used by physician or other facility staff.
7.Storage. Ample storage space for resident's personal belongings.
N.D. Admin. Code 33-14-04-07 Resident dining and recreation areas
The dining area and recreational activities area shall not be the same space.
1.Resident dining area. The total area set aside for this purpose shall not be less than fifteen square feet [1.39 square meters] per bed. Additional space shall be provided for outpatients if they participate in a day care program.
2.Resident recreation area.
a.The total area set aside for recreation shall be four hundred square feet [37.16 square meters] of clear space for the first ten beds. This shall be the minimum size. Additional space of ten square feet [.93 square meters] per bed shall be added for each additional bed over ten.
b.A source of water shall be provided for crafts.
c.Storage shall be provided for recreational equipment and supplies.
N.D. Admin. Code 33-14-04-08 Food services
Type, size, and layout of equipment shall provide optimal work flow and adequate food preparation to meet the needs of the residents.
1.Food preparation center. Provide handwashing lavatory but do not provide mirror.
2.Toilet room. Conveniently accessible for dietary staff.
N.D. Admin. Code 33-14-04-09 Administration area
1.Lobby and information center.
2.Administrator's office.
3.Public and staff toilet room.
4.Adequate office space for all faculty staff including consultation staff.
N.D. Admin. Code 33-14-04-10 Engineering service and equipment areas
1.Boiler room.
2.Mechanical, electrical equipment, and maintenance room or rooms.
3.Storage room for building maintenance supplies. May be part of maintenance shop.
4.Storage room for housekeeping equipment. Need not be provided if space is available in janitor's closet elsewhere.
5.Refuse space.
6.Yard equipment storage space. For yard maintenance equipment and supplies.
N.D. Admin. Code 33-14-04-11 Construction detail and finishing
A high degree of safety for the occupants in minimizing the incidence of accidents shall be provided. Hazards such as sharp corners shall be avoided. All details and finishes shall meet the following requirements:
1.All doors opening into corridors shall be swing-type except elevator doors. Alcoves and similar spaces which generally do not require doors are excluded from this requirement.
2.No doors shall swing into the corridor except closet doors.
3.Thresholds and expansion joint covers, if used, shall be flush with the floor.
4.Lavatories intended for use by residents shall be installed to permit wheelchairs to slide under.
5.Mirrors shall be arranged for convenient use by residents in wheelchairs as well as by patients in a standing position.
6.Paper towel dispensers shall be provided at all lavatories and sinks used by personnel for handwashing.
7.Ceiling heights.
a.Corridors, storage rooms, resident toilet room and other minor rooms shall not be less than seven feet six inches [2.29 meters].
b.All other rooms shall not be less than eight feet [2.44 meters].
8.Food preparation centers and laundries shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of eighty-five degrees Fahrenheit [29.44 degrees Celsius].
9.Finishes.
a.Floors shall be easily cleanable and shall have the wear resistance appropriate for the location involved. Floors in kitchens and related spaces shall be waterproof and greaseproof. In all areas where floors are subject to wetting, they shall have a nonslip finish.
b.Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
c.Walls shall be washable and in the immediate area of plumbing fixtures, the finish shall be moistureproof. Wall bases in dietary areas shall be free of spaces that can harbor insects.
d.Ceilings shall be acoustically treated in corridors in resident areas, nourishment stations and dining and recreation areas.
N.D. Admin. Code 33-14-04-12 Fire safety, zoning and building clearance
All construction for residential care centers shall conform to state building regulations related to fire safety as well as conform to local fire safety, zoning, and building ordinances. Evidence of conforming to zoning ordinances shall be presented in writing to the division of mental health and retardation. Fire codes and building codes used in the design of the building shall be recorded with plans submitted.
N.D. Admin. Code 33-14-04-13 Mechanical requirements
New construction or major remodeling shall conform to national accepted practices such as ASTRAE.
1.Heating and ventilation systems (this will apply to existing licensed facilities).
a.Temperatures. A minimum temperature of sixty-eight degrees to seventy-two degrees Fahrenheit [20 degrees to 22.22 degrees Celsius] shall be provided for all occupied areas at winter design conditions.
b.Ventilation systems. An adequate ventilation system shall be maintained.
2.Plumbing and other piping systems. All plumbing and piping systems shall conform to state and local plumbing codes.
N.D. Admin. Code 33-14-04-14 Electrical requirements
All spaces occupied by people, machinery, and equipment within buildings and the approaches thereto and parking lots shall have electrical lighting. All electrical requirements shall conform to state or local codes.
N.D. Admin. Code 33-14-04-15 Submission of building construction plans
Before construction is begun, plans and specifications covering the construction of new buildings, additions to an existing building, or a substantial alteration to an existing building shall be submitted to the division of mental health and retardation and approval shall be obtained from the division with respect to compliance with the minimum standards which have been established.
Note: In order to avoid unnecessary expense in changing final plans, it is suggested that as an initial step, proposed plans in sketch form be reviewed with the division.
Chapter 33-14-05 Halfway Houses, Hostels, Group Homes
N.D. Admin. Code 33-14-05-01 Standards for administration
1.Administrator. In order to develop an adequate program of treatment and care, it is essential that there be an administrator of maturity and experience to equip the administrator for the task. It is highly recommended that the administrator shall have had at least two years of previous professional work with the mentally retarded or administrative experience of similar duration in an adequate program. Professional preparation and experience in medicine, social work, or psychology are especially desirable. Either an administrator or supervisor of the staff (houseparent) may be in charge of the facility.
2.Finances. A sound financial plan must be demonstrated. Adequate records must be kept of all income received and expended. An audit shall be performed annually and a copy of the audit report shall be submitted to the division of mental health and retardation of the state department of health. Financial records may be inspected by the division at any time.
Financial records must be kept for a period of fifteen years.
3.Insurance. Adequate insurance, including liability insurance, must be maintained.
4.Health clearance. The halfway house, hostel, or group home shall secure a written report from a licensed physician or health department that all personnel at the time of employment and annually thereafter are free of communicable and infectious diseases, including tuberculosis. Persons with infectious and communicable disease shall not be on duty in any facility.
5.Reports. Licensees shall furnish to the division of mental health and retardation such reports as may be required.
a.Injury and Incident Reports. A written report shall be submitted to the division within three days concerning any serious injury or unusual incident involving a resident including name, age, sex, date of admission, diagnosis, date of incident of death, nature of incident, medical findings and treatment, name of attending physician, and final disposition.
b.Death reports. Reports of all deaths from unnatural causes including those reports to the coroner, shall be submitted to the division either as a special report or by copy of the death certificate within thirty days of occurrence.
c.Special reports. Any occurrences such as epidemic outbreaks, poisonings, reportable diseases, or other unusual occurrences which threaten the welfare, safety, or health of any resident admitted to any institution shall be immediately reported by telephone or telegram to the local health officer. The halfway house, hostel, or group home shall furnish such other pertinent information as the local or state department of health may require. The facility shall also immediately submit an identical report to the division.
6.Fire safety. All halfway houses, hostels and group homes shall conform to the requirements established by the state fire marshal. An annual inspection shall be made by the state fire marshal, or the fire marshal's designee. A copy of the current fire inspection clearance shall be on the premises.
7.Disaster program. All halfway houses, hostels, and group homes shall adopt and maintain a written disaster program which shall provide plans for disasters occurring within and on the grounds of the facility.
a.The written disaster program shall include:
(1)Administrative procedures.
(2)Plans for evacuation and continued care of residents.
b.The current plan shall be available on the premises and personnel shall be instructed in its implementation.
8.Telephones. All halfway houses, hostels, and group homes shall have telephone service, including a telephone accessible to visitors. Each building housing residents shall have telephone or intercommunicating equipment.
9.Admission policies. All halfway houses, hostels, and group homes shall have admission policies which are in writing and available to the public. No individual whose needs cannot be met by the facility shall be admitted to it. All admissions shall be in accordance with the facility's screening team's written policies.
10.Personnel policies and practices. All halfway houses, hostels, and group homes shall have written policies and maintain accurate employee records.
11.Records. Records shall be kept on all residents admitted and shall be maintained after discharge or after a minor has reached eighteen years of age until such time as the statute of limitations no longer applies.
a.Maintenance of resident's records. The halfway house, hostel, or group home shall maintain a separate clinical record for each resident admitted with all entries kept current, dated, and signed. The record shall include:
(1)Identification and summary sheets including resident's name, social security number, marital status, age, sex, home address, and religion; name, address and telephone number of referral agency, personal physician, dentist, and next of kin or other responsible person; admitting diagnosis, final diagnosis, conditions on discharge, and disposition.
(2)Initial medical evaluation including medical history, physical examination, diagnosis.
(3)The physician will make progress notes at each visit and the professional staff at the facility shall write progress notes describing significant changes in the resident's behavior or at least monthly.
(4)Physician's orders, including all medication, treatment, diet, restorative, and special medical procedures required for the safety and well-being of the residents.
(5)Medication and treatment record including all medications, treatments, and special procedures performed for the safety and well-being of the residents.
(6)Laboratory and X-ray reports.
(7)Consultation reports.
(8)Dental reports.
(9)Social service notes.
(10)Resident care referral reports.
b.Confidentiality of records. All information contained in the clinical records shall be treated as confidential and may be disclosed only to authorized persons.
c.Staff responsibility for records. The facility shall assign one staff member to be responsible for assuring that records are maintained, completed, and preserved.
12.Restraints.
a.Restraints or seclusion should be used only when all reasonable methods have failed and then should be used only for as brief a period as reasonably possible.
b.Restraints may be applied only by written order of the attending physician. In case of an emergency a verbal order may be accepted, but must be placed in writing on the resident's record within twelve hours.
c.When restraint or seclusion is used, a record shall be kept which will show:
(1)Name, age, and sex of resident.
(2)Type or procedure and device.
(3)Justification.
(4)Name of authorizing doctor.
(5)Date and hour placed in restraint or seclusion.
(6)Date and hour removed from restraint or seclusion.
N.D. Admin. Code 33-14-05-02 Staff
At least one staff member shall be in any building in which residents are present at all times.
Sufficient personnel staff are to be available for adequate care of residents at all times.
1.Arrangements must be demonstrated for the provision of adequate physician's services, including psychiatric and pediatric. If the director is not a physician, there must be services provided by a physician who will give regular health supervision and participate in the training of the staff. Medical services shall be made available as indicated at least every six months and an annual evaluation shall be completed on each resident.
2.Psychological services shall be provided and are to be under the direction of a psychologist licensed to practice psychology in North Dakota in conformity with the North Dakota licensure laws for psychologists. Psychological services shall be made available as indicated at least every six months and an annual evaluation shall be completed on each resident.
3.Social services are to be provided and shall be under the direction of a social worker.
4.Nursing services from registered nurses shall be provided as required by the program. This is especially important when severely handicapped or those with serious medical problems are admitted to the facility. When a professional nurse is included as a part of the staff, the nurse shall provide nursing services and participate in orientation and training of staff.
5.Qualified occupational, recreation, and speech therapists as well as qualified teachers shall be utilized as required.
6.A dietitian must be utilized in the food service. In the event that the facility's program is not large enough to justify including a dietitian as a part of the staff, part-time services of a dietitian or dietetic consultation from the state department of health may be utilized.
7.Provisions shall be made for dental examinations and treatment by a dentist. A dentist shall assist the facility in developing an adequate program of oral hygiene.
8.Professional staff is to be utilized in the orientation and training of personnel.
9.Staff shall possess sufficient maturity and educational achievement to utilize the orientation and training program and to participate in a meaningful treatment and care program for the residents.
N.D. Admin. Code 33-14-05-03 Recreational activities
1.Every halfway house, hostel, and group home shall provide and conduct programs of purposeful activities in accord and with the interests, abilities, and needs of the residents.
2.Designated indoor and outdoor areas shall be provided to adequately meet the recreational needs of residents.
3.Facilities for children shall provide playgrounds and playrooms, adequately equipped with apparatus, games, etc.
4.Facilities for children of school age shall provide programs of education and training acceptable to the department of public instruction. If school facilities are utilized which are not on the premises, transportation which is in accordance with the needs of the resident shall be provided.
N.D. Admin. Code 33-14-05-04 Maintenance
1.Paramedical and adjunct services.
a.Mentally retarded persons who wear glasses, braces, or other appliances shall wear them as directed by the person who prescribed them and the facility shall record these instructions in the resident's record and see that they are carried out.
b.Adequate facilities shall be made available to provide treatment (such as orthopedic and physiotherapy) by qualified personnel for residents who are physically handicapped in addition to being mentally retarded.
c.The facility shall have an independent training program which makes every effort to help each resident achieve the resident's fullest potential for independence whether this be independence in self-care or for more complex activities leading to the goal of independent living.
d.Pharmacy. Where a pharmacy is operated, a registered pharmacist shall be in charge.
2.Medications.
a.All medications, poisons and other drugs shall be plainly labeled. They shall be stored in a specifically designated and well-illuminated area and made accessible only to responsible persons.
b.Medications requiring refrigeration shall be stored in a separate refrigerator or a separate
section of a refrigerator.
c.The specific name of the drug shall be plainly indicated on the container.
d.All medication ordered for residents shall be administered and recorded in accordance with the written order of the attending physician.
e.Custody of all medications, drugs, and poisons shall be the responsibility of registered nurses or supervisory personnel.
f.Responsibility for administration of one's own medications by any resident can only be given as part of an approved treatment plan and recorded as such in the resident's record.
g.There shall be compliance with state and federal regulations and laws governing use of drugs and narcotics.
3.Food service.
a.Diet plans shall be developed in accordance with good diet practices. They shall be responsive to the special needs of the residents.
At least three meals shall be served daily to all residents either in the facility or made available at school or employment.
b.Menus shall be planned, written and posted in the kitchen. Copies of menus, as served, shall be kept on file for at least four weeks.
c.Ambulatory residents shall be provided dining room service. Nonambulatory residents shall be served in such a way as to maximize independence and skills and still maintain an adequate state of nutrition.
4.Sanitation for preparing and serving food.
a.The storage, preparation, and serving of food and the cleaning and sanitizing of utensils shall be in accordance with the Ordinance and Code regulating eating and drinking establishments as recommended by the Public Health Service Food Service Sanitation Ordinance and Code (Part V), Food Service Sanitation Manual. Copies of this manual may be obtained from the state department of health. In lieu thereof, accepted sanitation principles will be followed.
b.The kitchen area shall provide adequate space for food preparation, dishwashing, refrigeration, and storage of bulk foods.
5.Milk supply. The milk supply shall be from an approved source complying with the requirements of the Public Health Service Standard Milk Ordinance.
6.Water supply.
a.The water supply shall be from an approved source and must meet recognized standards of quality and quantity.
b.Sufficient facilities for producing a ready quantity of hot water for domestic needs shall be provided.
7.Waste disposal. Disposal of sewage and garbage shall be in an approved manner and must meet recognized standards.
8.Laundry.
a.Adequate arrangements for laundry service shall be made.
b.If the laundry is done within the facility, there shall be proper provision of spacing, sizing, and placing of equipment to assure satisfactory service to meet the demands of the residents.
N.D. Admin. Code 33-14-05-05 Resident rooms
1.In single resident rooms the least dimension free of fixed obstructions shall not be less than eighty square feet [7.43 square meters].
2.Multibed rooms shall have as a minimum sixty square feet [5.57 square meters] of floor space free of fixed obstructions per bed. There shall be no more than four beds per room. A double bunk bed is considered two beds.
3.At least one room with one water closet, lavatory, and tub or shower shall be provided for each five residents.
4.Each resident's room shall be an outside room with a satisfactory amount of natural light.
5.If males and females are housed in the same building, separate water closets, lavatories, and tubs or showers will be required for each.
N.D. Admin. Code 33-14-05-06 Services area
1.Clean linen storage. Enclosed storage space.
2.Equipment storage room. For storage of bulky equipment.
3.Storage. Ample storage space for resident's personal belongings.
N.D. Admin. Code 33-14-05-07 Resident dining and recreation areas
The dining area and recreational activities area shall not be the same space.
1.Resident dining area. The total area set aside for this purpose shall not be less than fifteen square feet [1.39 square meters] per bed. Additional space shall be provided for outpatients if they participate in a day care program.
2.Resident recreation area. Ample recreational areas will be provided to meet the program's needs. Twenty square feet [1.86 square meters] per bed is required.
N.D. Admin. Code 33-14-05-08 Food services
Type, size, and layout of equipment shall provide optimal work flow and adequate food preparation to meet the needs of the residents.
1.Food preparation center. Provide soap and paper towels for handwashing beside kitchen sink.
2.Toilet room. Conveniently accessible for dietary staff.
N.D. Admin. Code 33-14-05-09 Fire safety, zoning, and building clearance
All construction for halfway houses, hostels, and group homes shall conform to state building regulations related to fire safety as well as conform to local fire safety, zoning, and building ordinances.
Evidence of conforming to zoning ordinances shall be presented in writing to the division of mental health and retardation. Fire codes and building codes used in the design of the building shall be recorded with plans submitted.
N.D. Admin. Code 33-14-05-10 Mechanical requirements
1.Heating and ventilation systems.
a.Temperatures. A minimum temperature of sixty-eight degrees to seventy-two degrees Fahrenheit [20 degrees to 22.22 degrees Celsius] shall be provided for all occupied areas at winter design conditions.
b.Ventilation. A range hood and mechanical exhausts will be provided in the kitchen area.
2.Plumbing and other piping systems. All plumbing and piping systems shall conform to state and local plumbing codes.
N.D. Admin. Code 33-14-05-11 Electrical requirements
All electrical equipment will conform to state or local codes.
N.D. Admin. Code 33-14-05-12 Submission of building construction plans
Before construction is begun, plans and specifications covering the construction of new buildings, additions to an existing building or a substantial alteration to an existing building shall be submitted to the division of mental health and retardation and approval shall be obtained from the division with respect to compliance with the minimum standards which have been established.
Note: In order to avoid unnecessary expense in changing final plans, it is suggested that as an initial step, proposed plans in sketch form be reviewed with the division.
Chapter 33-14-06 Short-Term Care Center (Respite Care)
N.D. Admin. Code 33-14-06-01 Standards for administration
All rules and regulations shall be the same as for residential centers or halfway houses, hostels, or group homes depending on the number of residents in the facility. If the number exceeds ten, then the rules and regulations for residential centers will apply. If the number is less than eleven, the rules and regulations for halfway houses, hostels, or group homes will apply.
History
- General Authority: NDCC 28-32-02
- Law Implemented: NDCC 25-12-02(5), 25-12-04(5)
Article 33-23 Consolidated Laboratories
Chapter 33-23-01 Fees for Consolidated Laboratories Analyses
N.D. Admin. Code 33-23-01-01 Scope and purpose
This chapter is applicable to all consolidated laboratories analyses, and shall be applied in conjunction with subsection 6 of North Dakota Century Code section 23-01-09 to promote the public health, safety, and welfare and to enhance the environment for the people of the state.
History
- History: Effective March 1, 1979; amended effective May 1, 1989.
- General Authority: NDCC 23-01-03.3, 28-32-02
- Law Implemented: NDCC 23-01-09(6)
N.D. Admin. Code 33-23-01-02 Fees charged for laboratory analyses
Charges are based on reagent cost, testing time, personnel salaries, and overhead costs.
History
- History: Effective March 1, 1979; amended effective July 1, 1981; February 1, 1984; May 1, 1989.
- General Authority: NDCC 23-01-03, 28-32-02
- Law Implemented: NDCC 23-01-09(6)
N.D. Admin. Code 33-23-01-03 Fees charged for laboratory mineral analyses
Repealed effective May 1, 1989.
Article 33-28 North Dakota Adult Abuse Programs
Chapter 33-28-01 Spouse Abuse Programs
N.D. Admin. Code 33-28-01-01 Governing authority
Adult abuse programs receiving domestic violence prevention fund moneys shall operate in accordance with North Dakota Century Code chapter 14-07.1.
N.D. Admin. Code 33-28-01-02 Effect of rules
All rules adopted by the health council under the powers granted by any provisions of the North Dakota Century Code shall be binding upon all adult abuse programs receiving grants from the North Dakota domestic violence prevention fund, and shall have the force and effect of law.
N.D. Admin. Code 33-28-01-03 Definitions
1."Emergency safe housing" means any form of short-term housing other than a safe home or shelter provided to a victim of adult abuse.
2."Safe home" means a private volunteer home which has agreed to provide shelter to an abused adult and the adult's children for one to three days. The police may make regular patrols of the homes at the discretion of the individual programs.
3."Shelter" means a permanent shelter facility run by the program, making housing and food available to the abused adult and the adult's children twenty-four hours a day, seven days a week. Generally the length of stay in a shelter is longer than in a safe home; staying approximately five to ten days.
N.D. Admin. Code 33-28-01-04 Shelter facility management
In order to receive moneys from the domestic violence prevention fund, a spouse abuse program maintaining a shelter must meet these requirements:
1.The shelter shall provide twenty-four-hour supervision when clients are residing in the shelter.
2.The shelter shall develop and implement evacuation plans for fire and tornado disasters.
3.The shelter shall maintain an effective security system.
4.The shelter shall maintain fire safety standards of the state.
N.D. Admin. Code 33-28-01-05 Safe home system
In order to receive moneys from the domestic violence prevention fund, a spouse abuse program maintaining a safe home system must meet these requirements:
1.The program shall develop and implement a safe home recruitment procedure which involves a screening process and home interview.
2.The program shall provide a formal or informal support system for safe home providers, e.g., volunteer liaison, periodic meetings, etc.
3.The program shall provide at least three hours of orientation before beginning service as a safe home.
N.D. Admin. Code 33-28-01-06 Emergency safe housing
In order to receive moneys from the domestic violence prevention fund, a spouse abuse program maintaining emergency safe housing must meet these requirements:
1.The program must notify the management of an emergency safe housing system prior to utilization of that system as a housing for any abused adult.
2.The program must ensure that immediate access to program staff is available from the emergency safe housing facility.
N.D. Admin. Code 33-28-01-07 Twenty-four-hour service
All programs must have access to twenty-four-hour crisis lines by which project personnel may be reached.
N.D. Admin. Code 33-28-01-08 Training of volunteer staff advocates
Programs must provide a minimum of twelve hours of preservice training to volunteer staff advocates. Training must include:
1.Initial orientation.
2.On-the-job training and supervision.
3.An evaluation process.
N.D. Admin. Code 33-28-01-09 Staff evaluation
Programs must utilize a staff performance evaluation for both paid and volunteer staff.
N.D. Admin. Code 33-28-01-10 Nondiscrimination
Shelter facilities and all other shelter programs must implement a policy of racial nondiscrimination.
N.D. Admin. Code 33-28-01-11 Advocacy, information, or referral
Programs must provide advocacy with, information about, or referral to the following:
1.Court system.
2.Legal counsel.
3.Medical community.
4.Social service financial assistance programs.
5.Social service support services.
6.Community self-help groups.
7.Mental health professionals.
8.Law enforcement agencies.
N.D. Admin. Code 33-28-01-12 Data collection
Programs shall comply with the requirements of the division of maternal and child health, state department of health, in providing statistical data.
N.D. Admin. Code 33-28-01-13 Records and reporting
Programs shall agree to keep records relating to the disbursement of domestic violence prevention funds in a manner acceptable to the state department of health, and submit periodic fiscal and program reports, as required by the department.
N.D. Admin. Code 33-28-01-14 Local support
Programs must be able to demonstrate significant, active community support of and involvement in the program by providing a twenty-five percent match for grants (in cash or in kind) from local sources.
Article 33-29 Pool Facilities
Chapter 33-29-01 Pool Facilities in North Dakota
N.D. Admin. Code 33-29-01-01 Definitions
The following definitions apply as used in this chapter:
1."Appurtenances" means all filtration systems, chlorination systems, pumps, valves, meters, bathhouses or other devices, walkways, or buildings utilized for the proper supervision, operation, and maintenance of a pool facility.
2."Bather" means any person using the pool and adjoining deck areas for the purpose of water sports or related activities.
3."Maximum contaminant level" means the maximum permissible number of organisms as indicated on the standard plate count, membrane filter, or in the fermentation tube test.
4."Pool facility" means a public, semipublic, special use pool, or spa.
5."Premises" means the area enclosed by a barrier and any adjacent support facilities such as bathhouses, clubhouses, shower rooms, equipment rooms, etc., including the office of operational and maintenance personnel.
6."Private" means a pool or spa which is located on private property under the control of the homeowner, the use of which is limited to swimming or bathing by members of the owner's family or their invited guests.
7."Public" means a pool or spa intended to be used collectively by the general public for swimming or bathing, regardless of whether a fee is charged for such use.
8."Semipublic" means a pool or spa on the premises of, or part of, a motel, mobile home park, apartment, condominium, subdivision, club, camp, institution, school, or similar establishments where the primary business of the establishment is not the operation of a pool or spa and where admission to the use of the pool or spa is included in the fee, or consideration paid or given for the primary use of the premises to such groups and their invited guests.
9."Spa" means a pool used exclusively in conjunction with high velocity air or high velocity water recirculation systems utilizing hot, cold, or ambient temperature water including all appurtenances used in connection with the spa.
10."Special use" means a pool or spa used exclusively for a particular purpose, including but not limited to treatment pools, therapeutic pools, and special pools for water therapy.
11."Swimming pool" means any indoor or outdoor structure, basin, chamber, or tank containing an artificial body of water for swimming, diving, wading, or recreative bathing including all appurtenances used in connection with the swimming pool.
N.D. Admin. Code 33-29-01-02 Designated responsible individuals
N.D. Admin. Code 33-29-01-03 Certified laboratories and analytical procedures
N.D. Admin. Code 33-29-01-04 Maximum contaminant level
The maximum contaminant level for pool facility water may not exceed two hundred bacteria colonies per one milliliter of sample on a standard plate count or show the presence of organisms of the coliform group in a fermentation tube test or membrane filter test.
History
- History: Effective January 1, 1985.
N.D. Admin. Code 33-29-01-05 Microbiological contaminant sampling frequency and analysis
N.D. Admin. Code 33-29-01-06 Turbidity/clarity requirements
Swimming pool water must have sufficient clarity at all times such that the main drain or drains located at the deep end of the pool are clearly visible from the pool decking or a black and white disk, six inches [15.24 centimeters] in diameter, is clearly visible from the pool decking when placed at the deep end of the pool.
History
- History: Effective January 1, 1985.
N.D. Admin. Code 33-29-01-07 Disinfectant residual
All pool facilities shall disinfect the pool water by continuous chlorination or other means or methods of equal bactericidal efficiency. A minimum free chlorine residual of one milligram per liter (mg/1) or a halogen, or compounds of them, imparting an equivalent disinfecting residual must be maintained in the pool facility water at all times. All disinfectants utilized in a pool facility may not be detrimental to the health or safety of the general public.
N.D. Admin. Code 33-29-01-08 Record maintenance
The owner or operator of a pool facility shall retain on the premises or at a convenient location near the premises, the following records:
1.Microbiological analyses. Records of microbiological analyses must be kept for not less than three years.
2.Operation and maintenance records. All pool facilities shall maintain records of operation and maintenance to be kept for not less than three years. Daily records shall be kept of pH, disinfectant residual and temperature, together with other pertinent operational and maintenance data.
N.D. Admin. Code 33-29-01-09 Reporting requirements
N.D. Admin. Code 33-29-01-10 Right of onsite inspection
Repealed effective April 1, 1993
N.D. Admin. Code 33-29-01-11 Right of closure
N.D. Admin. Code 33-29-01-12 Observance of local rules
In the event of any conflict between the provisions of these rules and the provisions of any other ordinance, the provision imposing the higher standard or more stringent requirement is controlling.
N.D. Admin. Code 33-29-01-13 Administrative procedure and judicial review
N.D. Admin. Code 33-29-01-14 Injunction proceedings
N.D. Admin. Code 33-29-01-15 Enforcement
Article 33-30 Environmental Health Practitioner Licensure
Chapter 33-30-01 Board of Environmental Health Practitioner Licensure and General Provisions
N.D. Admin. Code 33-30-01-01 Organization of the board of environmental health practitioner licensure
1.History and function. The 1985 legislative assembly passed legislation to license environmental health practitioners, codified as North Dakota Century Code chapter 43-43.
This chapter authorized the secretary of state to carry out all functions necessary to licensure and to utilize the services of an advisory board as needed. The 1987 legislative assembly transferred this licensing function from the office of the secretary of state to the state health officer. The 2003 legislative assembly provided the authority to create specialty licenses within the practice of environmental health. The board's responsibility is advisory only. All statutory power is vested with the state health officer.
2.Board membership. The board consists of five members - the state health officer or an appointed agent; the commissioner of the North Dakota department of agriculture or an appointed agent; the president of the North Dakota environmental health association or an appointed agent; one member from a district or a local health unit who is a licensed environmental health practitioner; and one consumer. The environmental health practitioner and consumer must be appointed by the state health officer.
3.Officers. The state health officer shall serve as chairperson. The state health officer may appoint an executive secretary as necessary.
4.Inquiries. Inquiries may be addressed to:
State Health Officer State Department of Health 600 East Boulevard Avenue Bismarck, North Dakota 58505-0200
History
- History: Effective February 1, 1988; amended effective May 1, 1994; May 1, 2004.
N.D. Admin. Code 33-30-01-02 Scope of practice
This article applies to persons whose duties in environmental health and food safety require the application of scientific knowledge to recognize, evaluate, and control food and environmental hazards to preserve and improve environmental factors for the achievement of the health, safety, comfort, and well-being of the consuming public. It is the intent of the advisory board that these rules apply to all persons engaged in the practice of environmental health and the supervisors of those persons. Exempt are those supervisors employed on May 1, 2004.
History
- History: Effective May 1, 2004.
N.D. Admin. Code 33-30-01-03 Definitions
1."Board eligible" means having completed an application for licensure, paid the required fee, and met the necessary education requirements.
2."Certified professional - food safety" means a person who, by education and experience in food safety, is qualified, licensed, and limited to inspecting retail food, food service, food production or food manufacturing facilities, or conducting plan reviews for such establishments. For inspectors in the State Department of Agriculture's meat and poultry inspection program, certification through passage of the USDA-FSIS Food Safety Regulatory Essentials course, or its' state equivalent, shall be commensurate with the certified professional-food safety credential.
3."Continuing education unit" means ten contact hours earned in continuing education courses, seminars, workshops, and college courses. Ten hours of contact equals one continuing education unit.
4."Environmental health practitioner" means a person who, by environmental health science education and experience, is qualified and licensed to practice environmental health.
History
- History: Effective May 1, 2004; amended effective April 1, 2012.
Chapter 33-30-02 Initial Licensure and Renewals
N.D. Admin. Code 33-30-02-01 Licensure application
An application for a license to practice environmental health must be made to the department on forms provided by the department upon request. The application must contain reasonably required information.
1.Each application for a license must be accompanied by:
a.A prescribed fee.
b.A transcript verifying completion of college degree.
2.All applications must be signed by the applicant.
3.The department may request additional information or clarification of information provided in the application the department deems reasonably necessary.
4.If the department so directs, an applicant shall personally appear before the department concerning the application.
N.D. Admin. Code 33-30-02-02 Licensure renewal
A license is renewable biennially on January first of each biennium. A license must be renewed on forms provided by the department. The renewal forms must be accompanied by the renewal fee and proof of meeting the continuing education requirements. A license not renewed within two years of its expiration may not be renewed, and it may not be restored, reissued, or reinstated. An individual whose license has expired may reapply for a new license if the individual meets the requirements of North Dakota Century Code chapter 43-43 and this article.
N.D. Admin. Code 33-30-02-03 Fees
1.An applicant shall pay the following fees in connection with environmental health practitioner and certified professional - food safety applications, renewals, and penalties:
a.Application fee for an environmental health practitioner and certified professional - food safety license - $50.00.
b.Renewal fee for an environmental health practitioner and certified professional - food safety license - $15.00.
c.Late renewal penalty fee per month - $2.00.
d.Duplicate or changed license fee - $10.00.
2.The department shall assess licensure and renewal fees for a partial licensure period on a prorated basis.
January 1, 2026.
History
- History: Effective February 1, 1988; amended effective January 1, 1993; May 1, 2004; April 1, 2012;
N.D. Admin. Code 33-30-02-04 Qualifications and requirements for licensure as an environmental health practitioner
1.An applicant shall complete an application for licensure and pay the required application fee.
2.An applicant shall have received a baccalaureate degree that includes at least thirty semester or forty-five quarter credits in a physical, chemical, or biological science, or a degree beyond baccalaureate in environmental health or in a physical, chemical, or biological science.
3.The applicant shall pass the national registered environmental health specialist/registered sanitarian (REHS/RS) examination administered by the national environmental health association or equivalent. An applicant meeting the licensure requirements in subsections 1 and 2 who has not yet passed the environmental health REHS/RS examination is considered board eligible. An individual who is board eligible may work in the field of environmental health but such work must be under the direction and supervision of a licensed environmental health practitioner. An individual who is board eligible may work under a licensed environmental health practitioner for no more than a total of five years after which the individual may work in the field of environmental health only after passing the national REHS/RS examination. An environmental health practitioner licensed prior to January 1, 1993, is exempt from the examination requirement.
1.The applicant shall complete an application for licensure and pay the required application fee.
2.The applicant shall meet at least one of the following criteria in the "degree" or "experience" track:
a.Degree track:
(1)A baccalaureate degree in an accredited environmental health or food science curriculum or a baccalaureate in physical, chemical, or biological sciences, including at least thirty semester hours or forty-five quarter credits in a physical, chemical, or biological science, or a degree beyond baccalaureate in environmental health or in a physical, chemical, or biological science;
(2)A bachelor's degree with at least two years' experience in food protection; or (3)A bachelor's degree and possession of the NEHA REHS/RS credential.
b.Experience track:
(1)An associate's degree; and (2)Four years of progressive experience in food safety work and successful passage of the certified professional food manager (CPFM) or food safety managers certification examination (FSMCE), supersafe mark examination, or servsafe examination; or (3)A high school diploma or general educational development and five years of progressive experience in food-related work, and successful passage of the certified professional food manager (CPFM), food safety managers certification examination (FSMCE), supersafe mark examination, or servsafe examination.
3.The applicant shall pass the national certified professional - food safety (CP-FS) examination administered by the national environmental health association or equivalent. An applicant meeting the requirements in subsections 1 and 2 who have not yet passed the CP-FS examination is considered board eligible. An individual who is board eligible may work in the field of food safety but such work must be under the direction and supervision of a licensed certified professional-food safety, doctor of veterinary medicine, medical doctor, doctor of osteopathy, dentist, registered sanitarian, or registered environmental health specialist. An individual who is board eligible may work under the supervision of those previously listed for no more than a total of five years after which the individual may work in the field of food safety only after passing the CP-FS examination.
History
- History: Effective February 1, 1988; amended effective January 1, 1993; May 1, 2004; January 1, 2026. 33-30-02-04.1. Qualifications and requirements for licensure as a certified professional - Food safety.
- History: Effective May 1, 2004; amended effective April 1, 2012; January 1, 2026.
N.D. Admin. Code 33-30-02-05 Reciprocity
An individual may be licensed to practice environmental health in North Dakota if the individual presents an application, application fee, and proof of licensure in another state or county whose requirements for licensure equal those of North Dakota.
N.D. Admin. Code 33-30-02-06 Requirement for licensure
An individual engaged in the practice of environmental health in the state is required to be licensed.
Chapter 33-30-03 Continuing Education
N.D. Admin. Code 33-30-03-01 Continuing education
1.To renew a license a person must present proof of having attained at least 1.5 continuing education units of continuing education in the field of environmental health. Continuing education for licensure renewal must be completed in the biennium preceding the biennium for which licensure is sought. Under extraordinary circumstances the state health officer may consider a request for continuing education units obtained in the current biennium.
2.A curriculum review committee, composed of the advisory board members or their agent, shall meet at timely intervals to review applications for curriculum accreditation. Continuing education units must be assigned as one continuing education unit per ten hours of instruction. Curricula must have public health or environmental health orientation. Programs which already carry accreditation by a recognized educational agency or professional organization may be accepted by the committee. The committee, upon advice from the licensure board, may alter or reject accreditation assigned by another agency or organization if such action is necessitated by facts pointing to an erroneous accreditation having been assigned.
History
- History: Effective February 1, 1988.
- General Authority: NDCC 43-43-04
- Law Implemented: NDCC 43-43-04
Chapter 33-30-04 Code of Ethics
N.D. Admin. Code 33-30-04-01 Code of ethics
Licensees in the state of North Dakota shall subscribe to the national environmental health association's code of ethics in effect as of July 1, 1985. This code is incorporated in the rules by reference.
History
- History: Effective February 1, 1988.
- General Authority: NDCC 43-43-04
- Law Implemented: NDCC 43-43-04
Chapter 33-30-05 Grievances and Disciplinary Proceedings
N.D. Admin. Code 33-30-05-01 Grievance procedure
Grievances must be processed in accordance with North Dakota Century Code chapter 28-32.
History
- History: Effective February 1, 1988.
- Law Implemented: NDCC 43-43-04
N.D. Admin. Code 33-30-05-02 Grounds for disciplinary proceedings
The state health officer may refuse to issue or renew, suspend, revoke, or place on probationary status any license issued under this chapter or issue a written warning to a licensee upon proof at a hearing that the applicant or licensed person has engaged in unprofessional conduct. A person has engaged in unprofessional conduct if a person:
1.Obtained a license by means of fraud, misrepresentation, or concealment of material facts.
2.Violated the code of ethics referred to in section 33-30-04-01.
3.Has been convicted of a criminal offense, and the state health officer in accordance with North Dakota Century Code section 12.1-33-02.1, has determined that the person has not been sufficiently rehabilitated or that the offense has a direct bearing on the person's ability to serve the public in the capacity of a licensed environmental health practitioner.
4.Violated any order or rule adopted by the state health officer pertaining to the practice of environmental health.
5.Violated any provision of North Dakota Century Code chapter 43-43.
6.Is grossly negligent in the practice of environmental health.
7.Is addicted to the use of alcoholic beverages, drugs, narcotics, or stimulants to such an extent as to be incapacitated from the practice of environmental health.
History
- History: Effective January 1, 1993.
- Law Implemented: NDCC 43-43-07
N.D. Admin. Code 33-30-05-03 Hearings and disciplinary proceedings - Appeals
1.Upon receipt of a written and signed complaint that alleges that a licensee practicing in this state has engaged in unprofessional conduct as defined under section 33-30-05-02 and which sets forth information about which a reasonable person might believe that further inquiries should be made, the state health officer shall investigate the matter.
2.If the investigation reveals grounds to support the complaint, the advisory board shall initiate a disciplinary action by serving upon the licensee by certified mail a complaint setting forth the allegations upon which the action is based specifying the issues to be determined.
3.If a written response contesting the allegations is not received by the board within twenty days of service of the complaint, the allegations are deemed admitted and appropriate disciplinary sanctions are to be imposed.
4.If a disciplinary action has been initiated as provided in subsection 2, the state health officer may offer to meet with the licensee informally for the purpose of determining whether the disciplinary action, including imposition of appropriate sanctions, can be resolved by mutual agreement.
5.If an informal agreement cannot be reached, or the state health officer elects not to offer the licensee an opportunity for informal resolution of the matter, the licensee is entitled to a hearing under North Dakota Century Code chapter 28-32. Appeal from the board's final decision may be taken in accordance with North Dakota Century Code section 28-32-42.
6.Employers of persons licensed under this article will be notified of any action taken with respect to said license.
History
- History: Effective January 1, 1993; amended effective May 1, 2004; April 1, 2012.
- Law Implemented: NDCC 43-43-07
Chapter 33-30-06 Information Changes
N.D. Admin. Code 33-30-06-01 Address and home changes
Any licensee must report a change of address, home, or educational degree to the board. Proof of any educational degree change must also be submitted.
History
- History: Effective February 1, 1988.
- General Authority: NDCC 43-43-04
- Law Implemented: NDCC 43-43-04
Article 33-31 Foods, Drugs, and Cosmetics
Chapter 33-31-01 Rules Pertaining to Foods, Drugs, Cosmetics [Repealed]
N.D. Admin. Code 33-31-01 Rules Pertaining to Foods, Drugs, Cosmetics [Repealed]
ARTICLE 33-31
FOODS, DRUGS, AND COSMETICS
Chapter 33-31-01Rules Pertaining to Foods, Drugs, Cosmetics [Repealed] 33-31-02Definitions and Standards for Food Products [Repealed] 33-31-03Salvaged Food
CHAPTER 33-31-01
RULES PERTAINING TO FOODS, DRUGS, COSMETICS [Repealed effective August 1, 1999]
Chapter 33-31-02 Definitions and Standards for Food Products [Repealed]
N.D. Admin. Code 33-31-02 Definitions and Standards for Food Products [Repealed]
CHAPTER 33-31-02
DEFINITIONS AND STANDARDS FOR FOOD PRODUCTS [Repealed effective August 1, 1999]
Chapter 33-31-03 Salvaged Food
N.D. Admin. Code 33-31-03-01 Definitions
In this chapter, unless the context or subject matter otherwise requires:
1."Distressed food" means any food, the label of which has been lost, defaced, or obliterated; food that has been subjected to possible damage due to accident, fire, flood, adverse weather, or to any other similar cause; or food that is suspected of having been rendered unsafe or unsuitable for food use.
2."Labeling" means any legal or descriptive matter or design appearing upon an article of food or its container, and includes circulars, pamphlets, and the like, which are packed and go with the article to the purchaser, and placards that may be allowed to be used to describe the food.
3."Reconditioned or salvaged food" is reconditionable or salvageable food that has been reconditioned or salvaged under supervision of the department.
4."Reconditioning" or "salvaging" is the act of cleaning, culling, sorting, labeling, relabeling, or in any other way treating distressed food so that it may be deemed to be reconditioned or salvaged food and therefore is acceptable for sale or use as human food, animal feed, or seed as provided by the department.
5."Salvage food distributor" means a person who engages in the business of selling, distributing, or otherwise trafficking at wholesale in any distressed or salvaged food.
6."Salvaged processing facility" means an establishment engaged in the business of reconditioning or by any other means salvaging distressed food for human consumption or use.
N.D. Admin. Code 33-31-03-02 Protection of salvageable and salvaged merchandise
All salvageable and salvaged merchandise, while being stored or reconditioned at a salvage processing facility or during transportation, must be protected from contamination. All salvageable merchandise must be properly sorted and segregated from nonsalvageable food to prevent further contamination of the food to be reconditioned for sale or distribution.
N.D. Admin. Code 33-31-03-03 Reconditioning
1.All metal cans of food offered for sale or distribution must be essentially free from rust or pitting and dents, especially at rim, end double seams, or side seams. Leakers, springers, flippers, and swells must be deemed unfit for sale or distribution. Containers, including metal and glass containers with press caps, screw caps, pull rings, or other types of openings which have been in contact with water, liquid foam, or other deleterious substances, as a result of firefighting efforts, flood, sewer backups, or similar mishaps, must be deemed unfit for sale or distribution.
2.All metal containers of food, other than those mentioned in subsection 1, whose integrity has not been compromised and whose integrity would not be compromised by the reconditioning, and which have been in contact with water, liquid foam, or other deleterious substance as a result of flood, sewer backup, or other reasons, after thorough cleaning, must be subjected to sanitizing rinse of a concentration of one hundred ppm available chlorine for a minimum period of one minute, or must be sanitized by another method approved by the department.
They must subsequently be treated to inhibit rust formation.
N.D. Admin. Code 33-31-03-04 Labeling requirements
1.A container of food with the label of mandatory information missing which cannot be identified and relabeled correctly may not be sold. If original labels are missing or illegible, relabeling or overlabeling is required.
2.All salvaged food, except as described in subsection 5, must be identified to indicate the food has been salvaged by clearly marking the term "salvaged food" on all invoices, bills of lading, shipping invoices, receipts, and inventory records.
3.A person selling salvaged food at retail, except as described in subsection 5, shall notify the consumer the food is salvaged by labeling each retail package or container "salvaged" or "reconditioned" or posting a conspicuous placard at the retail display location stating "salvaged food" or "reconditioned food". Placards must be readable, using letters of not less than one and one-half-inch [3.81-centimeter] type. Placards must also state, "This item has been reconditioned and has been determined wholesome for human consumption under applicable state requirements by (name of food seller)".
4.All salvaged food in containers must be provided with labels that comply with the requirements contained in North Dakota Century Code chapter 19-02.1. If original labels are removed from containers that are to be resold or redistributed, the replacement labels must show as the distributor the name and address of the salvage food processor and the date of reconditioning for sale or distribution.
5.Subsections 2 and 3 do not apply to food products damaged in normal course of handling and transportation, if food is intact in its original container and has not been subject to fire, chemical spills, temperature abuse in perishable food products, in contact with water, or other similar risk of contamination.
History
- History: Effective March 1, 1996; amended effective January 1, 2026.
N.D. Admin. Code 33-31-03-05 Recordkeeping requirements
A written record or receipt of distressed, salvageable, and salvaged food must be kept by the salvage food processor and distributor for inspection by the department during business hours. The records must include the name of the product, the source of the distressed food, the date received, the type of damage, the salvage process conducted, and the purchaser of the salvaged food. These records must be kept on the premises of the salvage food processor and distributor for a period of one year following the completion of transactions involving the food.
N.D. Admin. Code 33-31-03-06 Salvage processing facilities and distributors outside the jurisdiction of the department
Salvaged merchandise from salvage processing facilities and distributors outside the jurisdiction of the department may be sold or distributed with the state if such facilities and distributors conform to the provisions of this code or substantially equivalent provisions. To determine the extent of compliance with such provisions, the department may accept reports from responsible authorities in other jurisdictions where such facilities and distributors operations are located.
N.D. Admin. Code 33-31-03-07 Salvaged food operator license fee
Before a salvaged food operator engages in the distribution or selling of distressed or salvaged food, the operator must be licensed by the department. Licenses expire on December thirty-first following the date of issuance. The annual license fee for a salvaged food distributor is one hundred twenty dollars. The plan review application fee for a salvaged food distributor is fifty percent of the annual license fee if a plan review application is required. For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars are required in addition to fifty percent of the annual license fee if a plan review application is required.
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
Article 33-32 Rules Initiated by the Registration Division
Chapter 33-32-01 Fertilizer
N.D. Admin. Code 33-32-01-01 Guarantees for micronutrients
Additional plant nutrients, besides nitrogen, phosphorus, and potassium, when mentioned or claimed on the label or container shall be registered and shall be guaranteed. Guarantees shall be made on the elemental basis. Sources of the elements guaranteed shall be shown on the application for registration. When claims for such nutrients are made on the label, container, or application for registration, the minimum percentages which will be accepted for registration are as follows:
Element Percent Calcium (Ca) 1.00 Magnesium (Mg) 0.50 Sulfur (S) 1.00 Boron (B) 0.02 Chlorine (Cl) 0.10 Cobalt (Co) 0.0005 Copper (Cu) 0.05 Iron (Fe) 0.10 Manganese (Mn) 0.05 Molybdenum (Mo) 0.0005 Sodium (Na) 0.10 Zinc (Zn) 0.05 Guarantees or claims for the above-mentioned additional plant nutrients are the only ones which will be accepted. Proposed labels and directions for use of the fertilizer shall be furnished with the application for registration upon request. Warning or caution statements are required on the label for any product which contains three-hundredths percent or more of boron in a water-soluble form or one-thousandth percent or more of molybdenum. Any of the above-listed elements which are guaranteed shall appear in the order listed, immediately following guarantees for the primary nutrients, nitrogen, phosphorus, and potassium.
History
- History: Effective August 1, 1988.
- General Authority: NDCC 19-20.1-12, 23-01-03(3)
- Law Implemented: NDCC 19-20.1-12
Chapter 33-32-02 Commercial Feed
N.D. Admin. Code 33-32-02-01 Definition and terms
1.The names and definitions for commercial feeds shall be the official definition of feed ingredients adopted by the association of American feed control officials, except as the department designates otherwise in specific cases.
2.The terms used in reference to commercial feeds shall be the official feed terms adopted by the association of American feed control officials, except as the department designates otherwise in specific cases.
3.The following commodities are hereby declared exempt from the definition of commercial feed, under the provisions of subsection 2 of North Dakota Century Code section 19-13.1-02: raw meat, hay, straw, stover, silages, cobs, husks, and hulls when unground and when not mixed or intermixed with other materials; provided that these commodities are not adulterated within the meaning of North Dakota Century Code section 19-13.1-07.
4.Individual chemical compounds and substances are hereby declared exempt from the definition of commercial feed under the provisions of subsection 2 of North Dakota Century Code section 19-13.1-02. It has been determined that these products meet the following criteria:
a.There is an adopted association of American feed control officials' definition for the product.
b.The product is either generally recognized as safe or is not covered by a specific food and drug administration regulation.
c.The product is either a natural occurring product of relatively uniform chemical composition or is manufactured to meet the association of American feed control officials' definition of the product.
d.The use of the product in the feed industry constitutes a minor portion of its total industrial use.
e.Small quantities of additives, which are intended to impart special desirable characteristics shall be permitted.
f.There is no need or problem of control of this product.
LIST OF EXEMPTED SUBSTANCES
Loose Salt
History
- Law Implemented: NDCC 19-13.1-02
N.D. Admin. Code 33-32-02-02 Label format
1.Commercial feed, other than customer-formula feed, shall be labeled with the information prescribed in this regulation on the principal display panel of the product and in the following general format:
a.Net weight may be stated in metric units in addition to the required avoirdupois units.
b.Product name and brand name if any.
c.If a drug is used:
(1)The word "medicated" shall appear directly following and below the product name in type size, no smaller than one-half the type size of the product name.
(2)The purpose of medication (claim statement).
(3)An active drug ingredient statement listing the active drug ingredients by their established name and the amounts in accordance with subsection 4 of section (4)The required directions for use and precautionary statements or reference to their location if the detailed feeding directions and precautionary statements required by sections 33-32-02-06 and 33-32-02-07 appear elsewhere on the label.
d.The guaranteed analysis of the feed as required under the provisions of subsection 3 of North Dakota Century Code section 19-13.1-04 include the following items, unless exempted in paragraph 9, and in the order listed:
(1)Minimum percentage of crude protein.
(2)Maximum or minimum percentage of equivalent protein from nonprotein nitrogen as required in subsection 5 of section 33-32-02-04.
(3)Minimum percentage of crude fat.
(4)Maximum percentage of crude fiber.
(5)Minerals, to include, in the following order: (a) minimum and maximum percentages of calcium (Ca), (b) minimum percentages of phosphorus (P), (c) minimum and maximum percentages of salt (NaCl), and (d) other minerals.
(6)Vitamins in such terms as specified in subsection 3 of section 33-32-02-04.
(7)Total sugars as invert on dried molasses products or products being sold primarily for their sugar content.
(8)Viable lactic acid producing microorganisms for use in silages in terms specified in subsection 7 of section 33-32-02-04.
(9)Exemptions.
(a)Guarantees for minerals are not required when there are no specific label claims and when the commercial feed contains less than six and one-half percent of calcium, phosphorus, sodium, and chloride.
(b)Guarantees for vitamins are not required when the commercial feed is neither formulated for nor represented in any manner as a vitamin supplement.
(c)Guarantees for crude protein, crude fat, and crude fiber are not required when the commercial feed is intended for purposes other than to furnish these substances or they are of minor significance relating to the primary purpose of the product, such as drug premixes, mineral or vitamin supplements, and molasses.
(d)Guarantees for micro-organisms are not required when the commercial feed is intended for a purpose other than to furnish these substances or they are of minor significance resisting to the primary purpose of the product, and no specific label claims are made.
e.Feed ingredients, collective terms for the grouping of feed ingredients, or appropriate statements as provided under the provisions of subsection 4 of North Dakota Century Code section 19-13.1-04.
(1)The name of each ingredient as defined in the official publication of the association of American feed control officials, common or usual name, or one approved by the department.
(2)Collective terms for the grouping of feed ingredients as defined in the official definitions of feed ingredients published in the official publication of the association of American feed control officials in lieu of the individual ingredients; provided that:
(a)When a collective term for a group of ingredients is used on the label, individual ingredients within that group may not be listed on the label.
(b)The manufacturer shall provide the feed control official, upon request, with a list of individual ingredients, within a defined group, that are or have been used at manufacturing facilities distributing in or into the state.
(3)The registrant may affix the statement, "Ingredients as registered with the State" in lieu of the ingredient list on the label. The list of ingredients must be on file with the department. This list must be made available to the feed purchaser upon request.
f.Name and principal mailing address of the manufacturer or person responsible for distributing the feed. The principal mailing address must include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in the current city directory or telephone directory.
g.The information required in subsections 1 through 5 of North Dakota Century Code
section 19-13.1-04 must appear in its entirety on one side of the label or on one side of the container.
2.Customer-formula feed must be accompanied with the information prescribed in this section using labels, invoice, delivery ticket, or other shipping document bearing the following information:
a.The name and address of the manufacturer.
b.The name and address of the purchaser.
c.The date of sale or delivery.
d.The customer-formula feed name and brand name if any.
e.The product name and net weight (may be stated in metric units in addition to the required avoirdupois) of each registered commercial feed and each other ingredient used in the mixture.
f.The direction for use and precautionary statements as required by sections 33-32-02-06 and 33-32-02-07.
g.If a drug-containing product is used:
(1)The purpose of the medication (claim statement).
(2)The established name of each active drug ingredient and the level of each drug used in the final mixture expressed in accordance with subsection 4 of section
N.D. Admin. Code 33-32-02-03 Brand and product names
1.The brand or product name must be appropriate for the intended use of the feed and must not be misleading. If the name indicates the feed is made for a specific use, the character of the feed must conform therewith. A mixture labeled "Dairy Feed", for example, must be suitable for that purpose.
2.Commercial, registered brand or trade names are not permitted in guarantees or ingredient listings and only in the product name of feeds produced by or for the firm holding the rights to such a name.
3.The name of a commercial feed may not be derived from one or more ingredients of a mixture to the exclusion of other ingredients and may not be one representing any components of a mixture unless all components are included in the name; provided, that if any ingredient or combination of ingredients is intended to impart a distinctive characteristic to the product which is of significance to the purchaser, the name of that ingredient or combination of ingredients may be used as a part of the brand name or product name if the ingredients or combination of ingredients is quantitatively guaranteed in the guaranteed analysis, and the brand or product name is not otherwise false or misleading.
4.The word "protein" is not permitted in the product name of a feed that contains added nonprotein nitrogen.
5.When the name carries a percentage value, it shall be understood to signify protein or equivalent protein, or both, content only, even though it may not explicitly modify the percentage with the word "protein"; provided, that other percentage values may be permitted if they are followed by the proper description and conform to good labeling practice. Digital numbers may not be used in such a manner as to be misleading or confusing to the customer.
6.Single ingredient feeds must have a product name in accordance with the designated definition of feed ingredients as recognized by the association of American feed control officials unless the department designates otherwise.
7.The word "vitamin", or a contraction thereof, or any word suggesting vitamin can be used only in the name of a feed which is represented to be a vitamin supplement, and which is labeled with the minimum content of each vitamin declared, as specified in subsection 3 of section
8.The term "mineralized" may not be used in the name of a feed except for "TRACE MINERALIZED SALT". When so used, the product must contain significant amounts of trace minerals which are recognized as essential for animal nutrition.
9.The term "meat" and "meat byproducts" shall be qualified to designate the animal from which the meat and meat byproducts is derived unless the meat and meat byproducts are made from cattle, swine, sheep, and goats.
History
- Law Implemented: NDCC 19-13.1-08
N.D. Admin. Code 33-32-02-04 Expression of guarantees
1.The guarantees for crude protein, equivalent protein from nonprotein nitrogen, crude fat, crude fiber, and mineral guarantees (when required) will be in terms of percentage.
2.Commercial feeds containing six and one-half percent or more calcium, phosphorus, sodium, and chloride shall include in the guaranteed analysis the minimum and maximum percentages of calcium (Ca), the minimum percentage of phosphorus (P), and if salt is added, the minimum and maximum percentage of salt (NaCl). Minerals, except salt (NaCl), shall be guaranteed in terms of percentage of the element. When calcium or salt, or both, guarantees are given in the guaranteed analysis such must be stated and conform to the following:
a.When the minimum is five percent or less, the maximum may not exceed the minimum by more than one percentage point.
b.When the minimum is above five percent, the maximum shall not exceed the minimum by more than twenty percent and in no case may the maximum exceed the minimum by more than five percentage points.
3.Guarantees for minimum vitamin content of commercial feeds must be listed in the order specified and are stated in milligrams per pound unless otherwise specified:
a.Vitamin A, other than precursors of vitamin A, in international units per pound.
b.Vitamin D-3 in products offered for poultry feeding, in international chick units per pound.
c.Vitamin D for other uses, international units per pound.
d.Vitamin E, in international units per pound.
e.Concentrated oils and feed additive premixes containing vitamins A, D, or E, or a combination thereof, may, at the option of the distributor be stated in units per gram instead of units per pound.
f.Vitamin B-12, in milligrams or micrograms per pound.
g.All other vitamin guarantees shall express the vitamin activity in milligrams per pound in terms of the following: menadione; riboflavine; d-pantothenic acid; thiamine; niacine; vitamin B-6; folic acid, chloline, biotin, inositol; p-amino benzoic acid; ascorbic acid; and carotene.
4.Guarantees for drugs must be stated in terms of percent by weight, except:
a.Antibiotics, present at less than two thousand grams per ton (total) of commercial feed must be stated in grams per ton of commercial feed.
b.Antibiotics present at two thousand or more grams per ton (total) of commercial feed, must be stated in grams per pound of commercial feed.
c.Labels for commercial feeds containing growth promotion or feed efficiency, or both, levels of antibiotics, which are to be fed continuously as the sole ration, are not required to make quantitative guarantees except as specifically noted in the federal food additive regulations for certain antibiotics, wherein, quantitative guarantees are required regardless of the level or purpose of the antibiotic.
d.The term "milligrams per pound" may be used for drugs or antibiotics in those cases where a dosage is given in "milligrams" in the feeding directions.
5.Commercial feeds containing any added nonprotein nitrogen must be labeled as follows:
a.For ruminants:
(1)Complete feeds, supplements, and concentrates containing added nonprotein nitrogen and containing more than five percent protein from natural sources shall be guaranteed as follows:
Crude Protein, minimum, -----% (This includes not more than -----% equivalent protein from nonprotein nitrogen).
(2)Mixed feed concentrates and supplements containing less than five percent protein from natural sources may be guaranteed as follows:
Equivalent Crude Protein from Nonprotein Nitrogen, minimum, -----% (3)Ingredient sources of nonprotein nitrogen such as urea, di-ammonium phosphate, ammonium polyphosphate solution, ammoniated rice hulls, or other basic nonprotein nitrogen ingredients defined by the association of American feed control officials shall be guaranteed as follows:
Nitrogen, minimum, -----% Equivalent Crude Protein from Nonprotein Nitrogen, minimum, -----%
b.For nonruminants:
(1)Complete feeds, supplements, and concentrates containing crude protein from all forms of nonprotein nitrogen, added as such, must be labeled as follows:
Crude protein, minimum, -----% (This includes not more than -----% equivalent crude protein which is not nutritionally available to (species of animal for which feed is intended).
(2)Premixes, concentrates, or supplements intended for nonruminants containing more than one and one-quarter percent equivalent crude protein from all forms of nonprotein nitrogen, added as such, must contain adequate directions for use and prominently state: WARNING: This feed must be used only in accordance with directions furnished on the label.
6.Mineral phosphatic materials for feeding purposes must be labeled with the guarantee for minimum and maximum percentage of calcium (when present), the minimum percentage of phosphorus, and the maximum percentage of fluorine.
7.Guarantees for micro-organisms must be stated in colony forming units per gram (CFU/g), when directions are for using the product in grams, or in colony forming units per pound (CFU/lb) when directions are for using the product in pounds. A parenthetical statement following the guarantee must list each species in order of predominance.
N.D. Admin. Code 33-32-02-05 Ingredients
1.The name of each ingredient or collective term for the grouping of ingredients, when required to be listed, shall be the name as defined in the official definitions of feed ingredients as published in the official publication of American feed control officials, the common or usual name, or one approved by the department.
2.The name of each ingredient must be shown in letters or type of the same size.
3.No reference to quality or grade of an ingredient may appear in the ingredient statement of a feed.
4.The term "dehydrated" may precede the name of any product that has been artificially dried.
5.A single ingredient product defined by the association of American feed control officials is not required to have an ingredient statement.
6.Tentative definitions or ingredients may not be used until adopted as official, unless no official definition exists or the ingredient has a common accepted name that requires no definition, (i.e., sugar).
7.When the word "iodized" is used in connection with a feed ingredient, the feed ingredient may contain not less than seven-thousandths percent iodine, uniformly distributed.
History
- Law Implemented: NDCC 19-13.1-03, 19-13.1-08
N.D. Admin. Code 33-32-02-06 Directions for use and precautionary statements
1.Directions of use and precautionary statements on the labeling of all commercial feeds and customer-formula feeds containing additives (including drugs, special purpose additives, or nonnutritive additives) must:
a.Be adequate to enable safe and effective use for the intended purposes by users with no special knowledge of the purpose and use of such articles; and
b.Include, but not be limited to, all information described by all applicable regulations under the Federal Food, Drug, and Cosmetic Act.
2.Adequate directions for use and precautionary statements are required for feeds containing nonprotein nitrogen as specified in section 33-32-02-07.
3.Adequate directions for use and precautionary statements necessary for safe and effective use are required on commercial feeds distributed to supply particular dietary needs or for supplementing or fortifying the usual diet or ration with any vitamin, mineral, or other dietary nutrient or compound.
N.D. Admin. Code 33-32-02-07 Nonprotein nitrogen
1.Urea and other nonprotein products defined in the official publication of the association of American feed control officials are acceptable ingredients only in commercial feeds for ruminant animals as a source of equivalent crude protein. If the commercial feed contains more than eight and seventy-five-hundredths percent of equivalent crude protein from all forms of nonprotein nitrogen, added as such, or the equivalent crude protein from all forms of nonprotein nitrogen, added as such, exceeds one-third of the total crude protein, the label must bear adequate directions for the safe use of feeds and a precautionary statement:
"CAUTION: USE AS DIRECTED". The directions for use and the caution statement must be in type of such size so placed on the label that they will be read and understood by ordinary persons under customary conditions of purchase and use.
2.Nonprotein nitrogen defined in the official publication of the association of American feed control officials, when so indicated, are acceptable ingredients in commercial feeds distributed to nonruminant animals as a source of nutrients other than equivalent crude protein. The maximum equivalent crude protein from nonprotein sources when used in nonruminant rations may not exceed one and twenty-five-hundredths percent of the total daily ration.
3.On labels such as those for medicated feeds which bear adequate feeding directions or warning statements, or both, the presence of added nonprotein nitrogen shall not require a duplication of the feeding direction or the precautionary statements as long as those statements include sufficient information to ensure the safe and effective use of this product due to the presence of nonprotein nitrogen.
N.D. Admin. Code 33-32-02-08 Drug and feed additives
1.Prior to approval of a registration application or approval of a label, or both, for commercial feed which contain additives (including drugs, other special purpose additives, or nonnutritive additives) the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.
2.Satisfactory evidence of safety and efficacy of a commercial feed may be:
a.When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in title 21 of the Code of Federal Regulations or which are "prior sanctioned" or "informal review sanctioned" or "generally recognized as safe" for such use;
b.When the commercial feed is itself a drug and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the food and drug administration under 21 U.S.C. 360(b); or
c.When one of the purposes for feeding a commercial feed is to impart immunity (that is to act through some immunological process) the constituents imparting immunity have been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913, administered by the animal and plant health inspection service, United States department of agriculture. The reason for the amendment is because of a problem encountered by feed control officials in developing the basis for evaluation of such products that have a primary purpose to impart immunity. States, in many cases, are unable to make correct judgments on the effectiveness on such products. The committee feels that this will definitely have more uniformity and effectiveness in handling product registrations.
N.D. Admin. Code 33-32-02-09 Adulterants
For the purpose of subsection 1 of North Dakota Century Code section 19-13.1-07, the terms "poisonous or deleterious substances" include, but are not limited to, the following:
1.Fluorine and any mineral or mineral mixture which is to be used directly for the feeding of domestic animals and in which the fluorine exceeds twenty-hundredths percent for breeding and dairy cattle; thirty-hundredths percent for slaughter cattle; thirty-hundredths percent for sheep; thirty-five-hundredths percent for lambs; forty-five-hundredths percent for swine; and sixty-hundredths percent for poultry.
2.Fluorine-bearing ingredients when used in such amounts that they raise the fluorine content of the total ration (exclusive of roughage) above the following amounts: four-thousandths percent for breeding and dairy cattle; nine-thousandths percent for slaughter cattle; six-thousandths percent for sheep; one-hundredths percent for lambs; fifteen-thousandths percent for swine; and three-hundredths percent for poultry.
3.Fluorine-bearing ingredients incorporated in any feed that is fed directly to cattle, sheep, or goats consuming roughage (with or without) limited amounts of grain, that results in a daily fluorine intake in excess of fifty milligrams of fluorine per one hundred pounds [45.36 kilograms] of body weight.
4.Soybean meal, flakes or pellets or other vegetable meals, flakes or pellets which have been extracted with trichloroethylene or other chlorinated solvents.
5.Sulfur dioxide, sulfurous acid, and salts of sulfurous acid when used in or on feeds or feed ingredients which are considered or reported to be a significant source of vitamin B-1 (thiamine).
History
- Law Implemented: NDCC 19-13.1-07
N.D. Admin. Code 33-32-02-10 Good manufacturing practices
The department adopts the following as current good manufacturing practices:
1.The regulations prescribing good manufacturing practices for type B and type C medicated feeds as published in title 21, Code of Federal Regulations, part 225, sections 225.1-225.115.
2.The regulations prescribing good manufacturing practices for type A medicated articles as published in title 21, Code of Federal Regulations, part 226, sections 226.1-226.115.
History
- Law Implemented: NDCC 19-13.1-09
N.D. Admin. Code 33-32-02-11 Permitted analytical variations
For the purpose of enforcing North Dakota Century Code section 19-13.1-07, a feed must be considered adulterated if analysis indicates the feed does not meet the tolerances shown in the table attached to this chapter as an appendix.
History
- Law Implemented: NDCC 19-13.1-07
Article 33-33 Rules Initiated by the Inspection Division
Chapter 33-33-01 Mobile Home Park Rules
N.D. Admin. Code 33-33-01-01 Definitions
As used in this chapter:
1."Accessory building or structure" means a building or structure that is an addition to a mobile home or that supplements the facilities provided in a mobile home. It is not a self-contained, separate, habitable building or structure.
2."Department" means the department of health and human services.
3."Service building" means a structure housing shower, bath, toilet, lavatory, and such other facilities as may be required by the North Dakota state plumbing code.
History
- History: Effective August 1, 1988; amended effective October 1, 1990; July 1, 2004; January 1, 2026.
- Law Implemented: NDCC 23-10-02
N.D. Admin. Code 33-33-01-02 Application for license
A complete scaled plan and list of specifications for new construction or for altering or enlarging of an existing mobile home park must be submitted to the department for approval. Mobile home parks which are enlarged shall meet all rules and regulations in effect at the time of enlarging for the portion of the park which is enlarged. The plans or specifications must contain the following:
1.A legal description of the property and a description of the site location with regard to highways, streets, and landmarks.
2.Name and address of developer.
3.Name and address of architect, engineer, or designer.
4.The area and dimensions of the site.
5.The number, location, and dimensions of all mobile home lots and detail of each typical lot for each mobile home.
6.The location and width of roadways, automobile parking facilities, and walkways, including whether they are paved, blacktopped, graveled, etc.
7.The location and details of any service buildings or other proposed structures.
8.The location and details of lighting and electrical systems.
9.The location and specifications of the water supply, sewer, and refuse disposal facilities, including approved soil testing results and details of wells, pumping stations, and service riser pipes.
History
- History: Effective August 1, 1988; amended effective October 1, 1990.
- Law Implemented: NDCC 23-10-02, 23-10-03
N.D. Admin. Code 33-33-01-03 Fire and life safety requirements
1.No portion of a mobile home, excluding the tongue, shall be located closer than ten feet [3 meters] side to side, eight feet [2.4 meters] end to side, or six feet [1.8 meters] end to end horizontally from any other mobile home, accessory building, or structure unless the exposed composite walls and roof of either structure are without openings and constructed of materials that will provide a one-hour fire-resistant rating or the structures are separated by a one-hour fire-rated barrier.
2.Accessory buildings or structures shall be permitted to be located immediately adjacent to a lot line when constructed of materials that do not support combustion and provided that such buildings or structures are not less than three feet [.9 meter] from an accessory building or structure on an adjacent lot. An accessory building or structure constructed of combustible materials shall be located no closer than five feet [1.53 meters] from the bordering lot line.
3.No mobile home, attachment, accessory building, or structure may be located so as to create hazard to the mobile home or park occupants or restrict emergency vehicles and personnel from performing necessary services.
4.Streets must be of adequate widths to accommodate the contemplated parking and traffic load in accordance with the type of street. In all cases, streets must meet the following minimum requirements:
a.Two-way streets with parking on both sides34 feet[10.36 meters]
b.Two-way streets with parking on one side only27 feet[8.23 meters]
c.Two-way streets without parking24 feet[7.32 meters]
d.One-way streets with parking on both sides27 feet[8.23 meters]
e.One-way streets with parking on one side only18 feet[5.49 meters]
f.One-way streets without parking14 feet[4.27 meters]
5.The street system must give an unobstructed access to the public street, highway, or access road.
History
- History: Effective August 1, 1988; amended effective October 1, 1990; June 1, 1991; July 1, 2004.
N.D. Admin. Code 33-33-01-04 Facilities provided
1.Conversion of a mobile home park, recreational vehicle park, or campground from one type to another must be approved by the department.
2.Streets and walkways must be lighted to provide a minimum average maintained illumination of four-tenths foot-candles [4.31 lux], with a uniformity ratio of no greater than six to one.
3.Each lot in a mobile home park must be provided with an approved electrical service outlet.
4.Each lot in a mobile home park must be provided with an approved plumbing system.
5.A certification from the electrical and plumbing installer, stating all installations were made in accordance with state codes, is required before issuance of the mobile home license.
6.An accessory building or structure may not obstruct the exit ways of the mobile home.
History
- History: Effective August 1, 1988; amended effective October 1, 1990; July 1, 2004; January 1, 2026.
- General Authority: NDCC 23-01-03(2), 23-10-02
N.D. Admin. Code 33-33-01-05 Noxious plant and animal control
1.The grounds, buildings, and structures of a mobile home park must be maintained free of harborage for insects, rodents, and other vermin. Extermination methods and other measures to control insects and rodents must conform with the requirements of the department.
2.All areas must be maintained free of accumulations of debris. The growth of brush, weeds, and grass must be controlled to prevent harborage or breeding places for noxious insects and vermin. Mobile home parks must be so maintained as to prevent the growth of noxious weeds considered detrimental to health.
3.Storage areas must be maintained so as to prevent rodent harborage. Lumber, firewood, pipe, and other building materials must be stored neatly at least one foot [.3 meter] above the ground.
4.Any skirting of mobile homes must be of a type and construction which will not provide harborage. Where mobile homes are skirted, an access opening must be provided near service connections.
History
- History: Effective August 1, 1988; amended effective October 1, 1990.
N.D. Admin. Code 33-33-01-06 Maintenance of service buildings
Service buildings, sinks, toilets, and other equipment must be kept in a clean and sanitary condition and in good repair at all times.
History
- History: Effective August 1, 1988.
N.D. Admin. Code 33-33-01-07 License fees
The department shall charge the following annual, administrative, and plan review fees for licenses to operate mobile home parks in this state:
1.For a mobile home park containing at least three but not more than ten lots,one hundred ten dollars.
2.For a mobile home park containing at least eleven but not more than twenty-five lots, one hundred sixty dollars.
3.For a mobile home park containing at least twenty-six but not more than fifty lots, two hundred ten dollars.
4.For a mobile home park containing at least fifty-one but not more than one hundred lots, two hundred sixty-five dollars.
5.For a mobile home park containing at least one hundred one but not more than one hundred fifty lots, three hundred twenty-five dollars.
6.For a mobile home park containing at least one hundred fifty-one but not more than two hundred lots, three hundred eighty-five dollars.
7.For a mobile home park containing at least two hundred one but not more than two hundred fifty lots, four hundred forty-five dollars.
8.For a mobile home park containing more than two hundred fifty lots, five hundred five dollars.
9.For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee if a plan review application is required.
10.For a mobile home park plan review, an application fee of fifty percent of the annual license fee if a plan review application is required.
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-10-02, 23-10-03, 23-10-07
N.D. Admin. Code 33-33-01-08 Reinspection fees
The department shall charge a reinspection fee of one hundred dollars for each reinspection required due to failure to correct repeat violations and any subsequent reinspection due to a notice of violation.
History
- History: Effective January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-10-02, 23-10-03, 23-10-07
Chapter 33-33-02 Recreational Vehicle Park and Campground Rules
N.D. Admin. Code 33-33-02-01 Definitions
As used in this chapter:
1."Recreational vehicle" means a travel trailer.
2."Service building" means a structure housing shower, bath, toilet, lavatory, and such other facilities as may be required by the North Dakota state plumbing code.
3."Tent" means a collapsible shelter of canvas or other fabric stretched and sustained by poles and used for camping outdoors.
History
- History: Effective August 1, 1988.
- Law Implemented: NDCC 23-10-01
N.D. Admin. Code 33-33-02-02 Application for license
A complete scaled plan and list of specifications for new construction or for altering or enlarging of an existing recreational vehicle park or campground must be submitted to the department for approval.
The application must contain the following:
1.A legal description of property and a description of the site location with regard to highways, streets, and landmarks.
2.Name and address of developer.
3.Name and address of architect, engineer, or designer.
4.The area and dimensions of the site.
5.The number, location, and dimensions of all recreational vehicle or campground lots and detail of each typical lot for each recreational vehicle or tent.
6.The location and width of roadways, automobile parking facilities, and walkways, including whether they are paved, blacktopped, graveled, etc.
7.The location and details of service buildings and any other proposed structures.
8.The location and details of lighting and electrical systems.
9.The location and specifications of the water supply, sewer, and refuse disposal facilities; including approved soil testing results and details of wells, pumping stations, and service riser pipes.
History
- Law Implemented: NDCC 23-10-03
N.D. Admin. Code 33-33-02-03 Spacing requirements
1.A tent, recreational vehicle, or other attachment may not be located within ten feet [3.05 meters] of any other tent, recreational vehicle, or part thereof. A recreational vehicle or tent in a recreational vehicle park or campground may not be located as to create a hazard to the recreational vehicle or tent or restrict emergency vehicles and personnel from performing necessary services.
2.Streets must be of adequate widths to accommodate the contemplated parking and traffic load in accordance with the type of street. In all cases, streets must meet the following minimum requirements:
a.Two-way streets with parking on both sides34 feet[10.36 meters]
b.Two-way streets with parking on one side only27 feet[8.23 meters]
c.Two-way streets without parking24 feet[7.32 meters]
d.One-way streets with parking on both sides27 feet[8.23 meters]
e.One-way streets with parking on one side only18 feet[5.49 meters]
f.One-way streets without parking14 feet[4.27 meters]
3.The street system must give an unobstructed access to the public street, highway, or access road.
4.Tenting areas must be designated for tents only.
History
- History: Effective August 1, 1988; amended effective July 1, 2004; January 1, 2026.
- General Authority: NDCC 23-10-02, 23-01-03(3)
N.D. Admin. Code 33-33-02-04 Facilities provided
1.Conversion of a mobile home park, recreational vehicle park, or campground from one type to another must be approved by the department.
2.Streets must be lighted to provide a minimum of one-tenth foot-candle [1.09 lux] throughout the street system. Potentially hazardous locations, such as major street intersections and steps or stepped ramps, must be individually illuminated with a minimum of three-tenths foot-candles [3.23 lux].
3.Where provided, electrical service outlets must be adequate and approved.
4.Where provided, individual sewer connections must be adequate and approved. Recreational vehicle waste disposal stations, watering stations, and service building facilities must be provided and constructed in accordance with the North Dakota state plumbing code.
5.A certification from the electrical and plumbing installer, stating all installations were made in accordance with state codes, is required before issuance of the recreational vehicle park or campground license.
N.D. Admin. Code 33-33-02-05 Noxious plant and animal control
1.The grounds, buildings, and structures of a recreational vehicle park or campground must be maintained free of harborage for insects, rodents, and other vermin. Extermination methods and other measures to control insects and rodents must conform with the requirements of the department.
2.All areas must be maintained free of accumulations of debris; the growth of brush, weeds, and grass must be controlled to prevent harborage or breeding places for noxious insects and vermin. Recreational vehicle parks and campgrounds must be so maintained as to prevent the growth of noxious weeds considered detrimental to health.
3.Storage areas must be maintained so as to prevent rodent harborage; lumber, firewood, pipe, and other building materials must be stored neatly at least one foot [.3 meter] above the ground.
N.D. Admin. Code 33-33-02-06 Maintenance of service buildings
1.Service buildings, sinks, toilets, and other equipment must be kept in a clean and sanitary condition and in good repair at all times.
2.Toilet tissue must be provided and conveniently located in each toilet room.
History
- History: Effective August 1, 1988.
N.D. Admin. Code 33-33-02-07 License fees
The department shall charge the following annual, administration, and plan review fees for licenses to operate recreational vehicle parks or campgrounds in this state:
1.For a recreational vehicle park or campground containing at least three but not more than ten lots, one hundred ten dollars.
2.For a recreational vehicle park or campground containing at least eleven but not more than twenty-five lots, one hundred sixty dollars.
3.For a recreational vehicle park or campground containing at least twenty-six but not more than fifty lots, two hundred ten dollars.
4.For a recreational vehicle park or campground containing at least fifty-one but not more than one hundred lots, two hundred sixty-five dollars.
5.For a recreational vehicle park or campground containing at least one hundred one but not more than one hundred fifty lots, three hundred twenty-five dollars.
6.For a recreational vehicle park or campground containing at least one hundred fifty-one but not more than two hundred lots, three hundred eighty-five dollars.
7.For a recreational vehicle park or campground containing at least two hundred one but not more than two hundred fifty lots, four hundred forty-five dollars.
8.For a recreational vehicle park or campground containing more than two hundred fifty lots, five hundred five dollars.
9.For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee if a plan review application is required.
10.For a recreational vehicle park or campground plan review, a plan review application fee of fifty percent of the annual license fee if a plan review application is required.
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-10-02, 23-10-03, 23-10-07
N.D. Admin. Code 33-33-02-08 Reinspection fees
The department shall charge a reinspection fee of one hundred dollars for each reinspection required due to failure to correct repeat violations and any subsequent reinspection due to a notice of violation.
History
- History: Effective January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-10-02, 23-10-03, 23-10-07
Chapter 33-33-03 Food Vending Rules
N.D. Admin. Code 33-33-03-01 Definitions
The following definitions apply in the interpretation and the enforcement of this chapter.
1."Adulterated" means the condition of a food (a) if it bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health; (b) if it bears or contains any added poisonous or deleterious substance for which no safe tolerance has been established by rule, or in excess of such tolerance if one has been established; (c) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for human consumption; (d) if it has been processed, prepared, packed, or held under unsanitary conditions, whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (e) if its container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health.
2."Approved" means acceptable to the department based on a determination as to conformance with appropriate standards and good public health practice.
3."Closed" means fitted together snugly leaving no openings large enough to permit the entrance of vermin.
4."Commissary" means catering establishment, restaurant, or any other place in which food, containers, or supplies are kept, handled, prepared, packaged, or stored, and directly from which vending machines are serviced.
5."Corrosion-resistant material" means a material which maintains its original surface characteristics under prolonged influence of the food, cleaning compounds, and sanitizing solutions which may contact it.
6."Department" means the department of health and human services.
7."Easily cleanable" means readily accessible and of such material and finish, and so fabricated that residue may be completely removed by normal cleaning methods.
8."Employee" means any operator or any person employed by the operator who handles any food to be dispensed through vending machines, or who comes into contact with food-contact surfaces of containers, equipment, utensils, or packaging materials, used in connection with vending machine operations, or who otherwise services or maintains one or more such machines.
9."Food" means any raw, cooked, processed edible substance, or combination of substances, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption.
10."Food-contact surfaces" means surfaces of equipment and utensils with which food normally comes in direct contact, and surfaces with which food may come in contact and drain back onto surfaces normally in contact with food.
11."Machine location" means the room, enclosure, space, or area where one or more vending machines are installed and operated.
12."Misbranded" means the presence of any written, printed, or graphic matter, upon or accompanying food or containers of food, including signs or placards displayed in relation to such products, which is false or misleading, or which violates any applicable state or local labeling requirements.
13."Operator" means any person who by contract, agreement, or ownership takes responsibility for furnishing, installing, servicing, operating, or maintaining one or more vending machines, or provides space for vending machines.
14."Perishable food" means any food of such type or in such condition as may spoil.
15."Person" means an individual, or a firm, partnership, company, corporation, trustee, association, or any public or private entity. 16.."Safe temperature" as applied to time and temperature control for safety food, means temperatures of forty-one degrees Fahrenheit [5.0 degrees Celsius] or below, or one hundred thirty-five degrees Fahrenheit [57.22 degrees Celsius] or above.
17."Sanitize" means effective bactericidal treatment of clean surfaces of equipment and utensils by a process which has been approved by the department as being effective in destroying micro-organisms, including pathogens.
18."Single-service articles" means cups, containers, lids or closures, plates, knives, forks, spoons, stirrers, paddles; straws, place mats, napkins, doilies, wrapping materials; and all similar articles which are constructed wholly or in part from paper, paperboard, molded pulp, foil, wood, plastic synthetic, or readily destructible materials, and which are intended for one usage only, then to be discarded.
19."Time and temperature control for safety food" means a food that requires time and temperature control for safety to limit pathogenic microorganisms growth or toxin formation.
20."Vending machine" means any self-service device which upon insertion of a coin, coins, bills, tokens, or an electronic payment method, dispenses food without the necessity of replenishing the device between each vending operation. The term also includes all freezers, refrigerators, and ovens used to store or prepare prepackaged, preserved foods regardless of the manner in which the food is taken from the freezer, refrigerator, or oven. Excluded from the definition of food vending machines are bottled or canned non-time and temperature control for safety food soft drink dispensers; prepackaged ice dispensers and freezers; prepackaged candy, cookie, cracker, or similar non-time and temperature control for safety food dispensers; and gumball, nut, and panned candy dispensers.
History
- History: Effective August 1, 1988; amended effective January 1, 2026.
N.D. Admin. Code 33-33-03-02 License issuance, suspension, revocation, and reinstatement
1.It is unlawful for any person to engage in the operation of one or more vending machines in North Dakota if that person does not possess a currently valid vending license from the department. Only persons who comply with the provisions of this chapter are entitled to receive such a license. The annual license fee for operating a vending machine is forty dollars.
The plan review application fee for an operator is fifty percent of the annual license fee if a plan review application is required. For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee if a plan review application is required.
2.Any person desiring to operate one or more vending machines in North Dakota shall make an application in writing for each vending machine to the department on forms provided by the department. The applicant shall provide the following information:
a.The applicant's full name, residence, and post-office address.
b.The name and location of the commissary or commissaries where the vending machines are to be located and the name and location of the company or companies servicing the vending machines.
c.The identity of the products to be dispensed through vending machines.
d.The signature of the applicant or applicants.
3.Upon receipt of the application, the department shall issue a license to the applicant. The license is not transferable. The operator's license must be displayed and be readily visible in the immediate area of the vending machines. In order to retain an operator's license, the operator shall comply with the requirements of these regulations.
4.After an opportunity for a hearing, and following the procedures provided in section 33-33-03-04, an operator's license may be suspended temporarily by the department upon violation by the licenseholder of any of the provisions of this chapter or may be revoked upon serious or repeated violation of such section, or for interference with the department's performance of its duties.
5.Notwithstanding any other provisions of this chapter, whenever the department finds unsanitary or other conditions involving the operation of any vending machine or commissary which, in the judgment of the department, constitutes a substantial hazard to the public health, it may, without notice or hearing, issue a written order to the operator citing the existence of such condition and specifying corrective action to be taken and, if deemed necessary, requiring immediate discontinuance of operation. The order is effective immediately and applies only to the vending machine, commissary, or product involved. Any operator to whom such order is issued shall comply therewith, but upon petition to the department, must be afforded a hearing as soon as possible. If necessary corrective action has been taken and upon receipt of a written request from the operator, the department shall make a reinspection to determine whether operations may be resumed.
6.After any hearing held under the provisions of this chapter, the department shall sustain, modify, or rescind any notice or order considered in the hearing.
7.Any operator whose license has been suspended may at any time make application for the reinstatement of the license. Within ten days after the receipt of a written application, accompanied by, or including, a statement signed by the operator to the effect that in the operator's opinion the violated term or terms of this chapter have been complied with, the department shall make a reinspection. If the applicant is again complying with the terms of this
chapter, the license must be reinstated.
January 1, 2026.
History
- History: Effective August 1, 1988; amended effective January 1, 2006; April 1, 2008; January 1, 2014;
N.D. Admin. Code 33-33-03-03 Sale, examination, condemnation of adulterated or misbranded food
It shall be unlawful for any person within North Dakota to sell, offer, or expose for sale, through vending machines, or to have in possession with intent to sell therefrom any food which is adulterated or misbranded. Samples of food may be taken and examined by the department as often as may be necessary to determine freedom from adulteration or misbranding. The department may, on written notice to the operator, impound and forbid the sale of any food which is adulterated or misbranded, or which the department has probable cause to believe to be adulterated or misbranded. After the operator has been given an opportunity for a hearing, the department may cause to be removed or destroyed any food which is adulterated or misbranded; provided, that in the case of misbranding which can be corrected by proper labeling, such food may be released to the operator for correct labeling under the supervision of the department.
N.D. Admin. Code 33-33-03-04 Inspection of machines and commissaries
1.The department may inspect the servicing, maintenance, and operation of vending machines and commissaries as often as needed to determine compliance with this chapter. The department, after proper identification, shall be permitted to enter at any reasonable time upon any private or public property within North Dakota where vending machines or commissaries are operated, or from which such machines are otherwise serviced, for the purpose of determining compliance with the provisions of these regulations. The operator shall make provision for the department to have access, either in company with an employee or otherwise, to the interior of all vending machines operated by the operator.
2.Whenever the department discovers a violation of any provision of this chapter, it shall notify the operator concerned either by the inspection report form or by other written notice. Such form or notice shall (1) describe the condition found and state which section of this chapter is violated by such condition; (2) provide a specific and reasonable period of time for the correction of the condition; and (3) state that an opportunity for a hearing on inspection findings will be provided, if a written request for such hearing is filed with the department within ten days of receipt of the notice. The department may also advise the operator in writing that unless the violations are corrected within the specified period of time, any license issued under the provisions of this chapter may be suspended or revoked, in accordance with provisions of section 33-33-03-02, or court action may be initiated.
N.D. Admin. Code 33-33-03-05 Sanitation requirements
1.Food, consumer containers, equipment maintenance, and operations.
a.Food intended for sale through vending machines and condiments available at vending machine locations shall be obtained from sources complying with the regulations of North Dakota. Such food shall be wholesome, free from spoilage, and shall be processed, prepared, handled, and stored in such a manner as to be protected against contamination and adulteration. All food-contact surfaces of containers and equipment shall be protected from contamination. If condiments are provided for service in conjunction with food dispensed by a vending machine, they shall be packaged in individual portions in single-service containers or shall be dispensed from approved sanitary dispensers which are washed, sanitized, and filled at the commissary. Relish bowls and similar non-self-closing condiment containers shall not be used. Potentially hazardous food shall be held at safe temperatures except during necessary periods of preparation.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)All food offered for sale through vending machines shall be manufactured, processed, and prepared in commissaries or establishments which comply with all applicable state laws and regulations.
(2)All food offered for sale through vending machines shall be wholesome.
(3)All food shall be stored or packaged in clean protective containers, and shall be handled, transported, and vended in a sanitary manner. Condiments provided for service in conjunction with food dispensed by a vending machine shall be packaged in individual portions in single-service containers or shall be dispensed from approved sanitary dispensers which are washed, sanitized, and filled at the commissary. Fresh fruits which may be eaten raw without peeling may be dispensed unpackaged but must be thoroughly washed in potable water before being placed in the vending machine. Storage of cartoned, bottled, canned, or packaged food by placing or submerging it in liquid is prohibited. Submerging such containers of food in ice is prohibited.
(4)Potentially hazardous food offered for sale through vending machines shall be handed or dispensed to the consumer in the individual original container or wrapper into which it was placed at the commissary or at the manufacturer's or processor's plant, or such products shall be dispensed into single-service containers from containers which were filled at the commissary or at the manufacturer's or processor's plant.
(5)In those vending machines which dispense potentially hazardous food from bulk, the bulk supplies of such food shall be transferred only to bulk vending machine containers and appurtenances which have been cleaned and sanitized.
(6)Potentially hazardous food within the vending machine shall be maintained at a temperature of forty-five degrees Fahrenheit [7.22 degrees Celsius] or below, or one hundred forty degrees Fahrenheit [60 degrees Celsius] or above, whichever is applicable; provided, that exceptions may be made for (a) the actual time required to load or otherwise service the machine and for a maximum recovery period of thirty minutes, following completion of loading or servicing operation; and (b) in the case of hot food vending machines, a maximum of one hundred twenty minutes to heat food through the forty-five degrees Fahrenheit [7.22 degrees Celsius] to one hundred forty degrees Fahrenheit [60 degrees Celsius] temperature zone. In hot food vending machines which are not equipped with refrigerated storage, there shall be no time delay to preclude heat from being applied to potentially hazardous food immediately after it is loaded or placed in the machine. Potentially hazardous food once heated to, or held at, a temperature of one hundred forty degrees Fahrenheit [60 degrees Celsius] or above, shall be maintained at such temperature until served or discarded.
Vending machines dispensing potentially hazardous food shall be provided with adequate refrigerating or heating units, or both, and thermostatic controls which ensure the maintenance of applicable temperatures at all times. Such vending machines shall also have controls which prevent the machine from vending potentially hazardous food until serviced by the operator, in the event of power failure or other condition which results in noncompliance with temperature requirements in the food storage compartment.
Hot food vending machines designed to heat food through the forty-five degrees Fahrenheit [7.22 degrees Celsius] to one hundred forty degrees Fahrenheit [60 degrees Celsius] temperature range, shall also be equipped with automatic controls which render the machine incapable of vending potentially hazardous food until serviced by the operator in the event that heating through this temperature range is not accomplished in one hundred twenty minutes or less.
Potentially hazardous food which has failed to conform to the time-temperature requirements of this paragraph shall be removed from the vending machine, and be denatured or otherwise rendered unusable for human consumption.
Vending machines dispensing potentially hazardous food shall be provided with one or more thermometers which, to an accuracy of minus two degrees Fahrenheit [minus 18.89 degrees Celsius], indicates the air temperature of the warmest part of the refrigerated food storage compartment, or the coldest part of the heated food storage compartment, whichever is applicable.
(7)Milk and fluid milk products offered for sale through vending machines shall be pasteurized and shall be dispensed only in individual, original containers or from bulk containers into which such product was placed at the milk plant; provided, that such products may be reconstituted automatically within the vending machine when (a) the powder or concentrate is made from a pasteurized milk or milk product and is from an approved source; (b) the mixing chambers or bowls and any food-contact surface downstream from such mixing units are maintained at safe temperatures; and (c) the product is reconstituted for immediate dispensing in individual unit servings.
(8)Milk and fluid milk products used as an ingredient in hot liquid beverages dispensed from vending machines may be transferred to a multiuse machine canister at the machine location; provided, that (a) the location offers adequate protection against dust, insects, and other contamination; (b) the milk or fluid milk product is transferred from a dairy-filled container of not to exceed one-half gallon [1.89 liter] capacity; (c) the entire contents of such dairy-filled container are used in the transfer; (d) unused portions removed from the machine are discarded to waste; and (e) the milk or fluid milk product is poured only into an empty canister which has been effectively cleaned and sanitized at the commissary; provided further, that milk or fluid milk products shall not be used as an ingredient under the terms of this paragraph unless the temperature of the hot beverage at the point of mixing with the milk product is one hundred sixty degrees Fahrenheit [71.11 degrees Celsius] or higher.
Vending machine canisters and appurtenances used for the transfer of such milk products shall be effectively cleaned and sanitized at approved, fixed facilities at the commissary by methods approved by the department. After sanitization, the canister and appurtenances shall be fully wrapped in a single-service bag or cover which shall not be opened until the canister unit is installed in the refrigerated compartment of the vending machine. Canisters and appurtenances shall be so designed and constructed that the handling of contact surfaces at the machine location is unnecessary; and, such surfaces shall not be handled during canister installation, tube insertion, or product transfer.
(9)All parts of any bulk milk vending machine which come into direct contact with the milk or milk product shall be effectively cleaned and sanitized at the milk plant; provided, that single-service dispensing tubes which receive sanitizing treatment at the fabricating plant and which are individually packaged in such manner as to preclude contamination, may be exempted from this provision. The can or other bulk milk container shall be filled only at the milk plant and shall be sealed in such manner as to make it impractical to withdraw any part of its contents or to introduce any substance without breaking the seal or seals. The delivery tube and any milk-contact parts of the dispensing device shall be attached at the milk plant, and shall be protected by a moistureproof covering, or housed in a compartment with a moisture-tight closure which shall not be removed until after the container is placed in the refrigerated compartment of the vending machine.
(10)With the exception of food-contact surfaces of bulk milk vending machines for which separate provisions for cleaning and sanitizing are specified in paragraph 9, all multiuse containers or parts of vending machines which come into direct contact with potentially hazardous food shall be removed from the machine daily and shall be thoroughly cleaned and effectively sanitized at the commissary or other approved facility; provided, that the requirement for daily cleaning and sanitizing may be waived for those food-contact surfaces which are maintained at all times at a temperature of forty-five degrees Fahrenheit [7.22 degrees Celsius] or below, or one hundred forty degrees Fahrenheit [60 degrees Celsius] or above, whichever is applicable, and an approved cleaning frequency is followed. Such parts shall, after sanitizing, be protected from contamination.
(11)All parts of vending machines which come into direct contact with other than potentially hazardous food shall be thoroughly cleaned by approved methods. The frequency of such cleaning shall be established by the department based upon the type of product being dispensed. A record of such cleaning operations shall be maintained by the operator in each machine or shall be made available at the time of inspection and shall be current for at least the past thirty days.
(12)All single-service articles shall be purchased in sanitary cartons or packages which protect the articles from contamination, shall be stored in a clean, dry place until used, and shall be handled in a sanitary manner. Such articles shall be stored in the original carton or package in which they were placed at the point of manufacture until introduced into the magazine or dispenser of the vending machine.
Single-service articles stored within the vending machine shall be protected from manual contact, dust, insects, rodents, and other contamination.
2.Machine location.
a.The machine location shall be such as to minimize the potential for contamination of the food, shall be well-lighted, easily cleanable, and shall be kept clean. Conveniently located handwashing facilities shall be available for use by employees servicing or loading bulk food machines.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)Each vending machine shall be located in a room, area, or space which can be maintained in a clean condition and which is protected from overhead leakage or condensation from water, waste, or sewer piping. The immediate area in which the machine is located shall be well-lighted. Each vending machine shall be so located that the space around and under the machine can be easily cleaned and maintained, and so that insect and rodent harborage is not created.
(2)The floor area where vending machines are located shall be reasonably smooth, of cleanable construction, and be capable of withstanding repeated washing and scrubbing. This space and the immediate surroundings of each vending machine shall be maintained in a clean condition.
(3)Adequate handwashing facilities, including hot and cold or tempered running water, soap, and individual towels, shall be convenient to the machine location and shall be available for use by employees servicing or loading bulk food machines.
3.Exterior construction and maintenance.
a.The exterior construction of the vending machine shall be such as to facilitate cleaning and to minimize the entrance of insects and rodents, and the exterior of the machine shall be kept clean. Service connections to machines vending potentially hazardous food or food in bulk shall be such as to protect against unintentional or accidental interruption of service to the machine.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)The vending machine shall be of sturdy construction and the exterior shall be so designed, fabricated, finished, and maintained so as to facilitate its being kept clean, and to minimize the entrance of insects and rodents. The exterior of the machine shall be kept clean.
(2)Door and panel access openings to the food and container storage spaces of the machine shall be tight-fitting, and if necessary, gasketed, so as to prevent the entrance of dust, moisture, insects, and rodents.
(3)All ventilation louvers or openings into vending machines shall be effectively screened. Screening material for openings into food and container storage spaces of the machine shall be not less than sixteen mesh to the inch [2.54 centimeters] or equivalent. Screening material for openings into condenser units which are separated from food and container storage spaces shall be not less than eight mesh to the inch [2.54 centimeters] or equivalent.
(4)In all vending machines in which the condenser unit is an integral part of the machine, such unit when located below the food and container storage space shall be separated from such space by a dustproof barrier, and when located above, shall be sealed from such space.
(5)Unless the vending machine is sealed to the floor or counter so as to prevent seepage underneath, or can be manually moved with ease, one or more of the following provisions shall be utilized to facilitate cleaning operations: (a) The machine shall be mounted on legs six inches [l5.24 centimeters] or more in height; provided, that countertype machines may use four-inch [10.16-centimeter] legs; or (b) the machine shall be mounted on casters or rollers; or (c) the machine shall be mounted on gliders which permit it to be easily moved.
(6)All service connections through an exterior wall of the machine, including water, gas, electrical, and refrigeration connections, shall be grommeted or closed to prevent the entrance of insects and rodents. All service connections to machines vending potentially hazardous food or food in bulk shall be such as to discourage their unauthorized or unintentional disconnection.
4.Interior construction and maintenance.
a.All interior surfaces and component parts of the vending machine shall be so designed and constructed as to permit easy cleaning, and shall be kept clean. All food-contact surfaces of the machine shall be of smooth, nontoxic, corrosion-resistant, and relatively nonabsorbent material, and shall be capable of withstanding repeated cleaning and sanitizing by normal procedures. Such surfaces shall be protected against contamination.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)The non-food-contact surfaces of the interior of vending machines shall be so designed and constructed as to permit easy cleaning, and to facilitate maintenance operations. Inaccessible surfaces or areas shall be minimized.
(2)All food-contact surfaces of vending machines shall be smooth, in good repair, and free of breaks, corrosion, open seams, cracks, and chipped places. The design of such surfaces shall be such as to preclude routine contact between food and V-type threaded surfaces. All joints and welds in food-contact surfaces shall be smooth; and all internal angles and corners of such surfaces shall be rounded to facilitate cleaning.
(3)All food-contact surfaces of vending machines, including containers, pipes, valves, and fittings, shall be constructed of nontoxic, corrosion-resistant, and relatively nonabsorbent materials, and shall be kept clean. In all vending machines in which carbon dioxide is used to propel water, food, or other ingredients, all food-contact surfaces in the system shall be of such material as to preclude the production of toxic substances which might result from interaction between the carbon dioxide and food-contact surfaces. All food-contact surfaces, unless designed for inplace cleaning, shall be accessible for manual cleaning and inspection: (a) without being disassembled; (b) by disassembly without the use of tools; or (c) by easy disassembly with the use of only simple tools such as a screwdriver or an open-end wrench. In machines of such design that food-contact surfaces are not readily removable, inplace cleaning of such surfaces may be permitted; provided, that (a) they are so arranged that cleaning and sanitizing solutions can be circulated throughout the fixed system; (b) such solutions will contact all food-contact surfaces;
(c) the system is self-draining or otherwise completely evacuated; and (d) the procedures utilized result in thorough cleaning of the equipment.
(4)The openings into all nonpressurized containers used for the storage of vendable food, including water, shall be provided with covers which prevent contamination from reaching the interior of the containers. Such covers shall be designed to provide a flange which overlaps the opening, and shall be sloped to provide drainage from the cover wherever the collection of condensation, moisture, or splash is possible. Concave covers or cover areas are prohibited. Any port opening through the cover shall be flanged upward at least three-sixteenths inch [4.76 millimeters], and shall be provided with an overlapping cover flanged downward. Condensation, drip, or dust deflecting aprons shall be provided on all piping, thermometers, equipment, rotary shafts, and other functional parts extending into the food container, unless a watertight joint is provided. Such aprons shall be considered as satisfactory covers for those openings which are in continuous use.
Gaskets, if used, shall be of a material which is nontoxic, relatively stable, and relatively nonabsorbent, and shall have a smooth surface. All gasket retaining grooves shall be easily cleanable.
(5)The delivery tube or chute and orifice of all bulk food and bulk beverage vending machines shall be protected from normal manual contact, dust, insects, rodents, and other contamination. The design shall be such as to divert condensation or other moisture from the normal filling position of the container receiving the food or beverage. The vending stage of such machines shall be provided with a tight-fitting, self-closing door or cover which is kept shut, except when food is being removed.
(6)The food storage compartment within vending machines dispensing packaged liquid food shall be so constructed as to be self-draining, or shall be provided with a drain outlet which permits complete draining of the compartment. All such drains shall be easily cleanable.
(7)Opening devices which come into contact with the food or the food-contact surface of the containers shall be constructed of smooth, nontoxic, corrosion-resistant, and relatively nonabsorbent materials. Unless the opening device is of a single-service type, it shall be readily removable for cleaning, and shall be kept clean. Parts of multiuse opening devices which come into contact with the food or food-contact surface of containers shall be reasonably protected from manual contact, dust, insects, rodents, and other contamination; and such parts shall be readily removable for cleaning.
5.Water supply.
a.Water used in vending machines shall be from an approved source, and shall be of a safe and sanitary quality. Vending machines shall be so installed and operated as to prevent the production of toxic substances in the water.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)All water used in vending machines shall be of a safe and sanitary quality and from an approved source. Water used as a food ingredient shall be piped to the vending machine under pressure or brought to the vending machine in portable containers or urns which have been filled in a sanitary manner directly from an approved water supply outlet at the commissary or other approved location. Ingredient water shall not be transferred from one container to another at the machine location. Containers for the storage of ingredient water or ice, which are not a part of this closed water system, shall be designed and maintained as food-contact surfaces. Water containers or urns shall be cleaned and sanitized at the commissary or other approved facility after each use. Such portable containers shall be continuously protected against contamination from the time of sanitizing until placed in the vending machine. Protection shall be effected which will prevent unauthorized persons from tampering with or refilling the water container. All plumbing connections and fittings shall be installed in accordance with state and local plumbing regulations.
(2)If used, water filters or other water-conditioning devices shall be of a type which may be disassembled for periodic cleaning or replacement of the active element.
Replacement elements shall be handled in a sanitary manner.
(3)All vending machines which dispense carbonated beverages, and which are connected to a water supply system, shall be equipped with two (or a double) check valves; or an airgap; or a device to vent carbon dioxide to the atmosphere; or other approved device, which will provide positive protection against the entrance of carbon dioxide or carbonated water into the water supply system.
(4)Where check valves are used for the protection of the water supply system, a screen of not less than one hundred mesh to the inch [2.54 centimeters] shall be installed in the waterline immediately upstream from the check valves.
(5)In all vending machines which dispense carbonated beverages and which are connected to a water supply system, the ingredient water-contact surfaces from the check valves or other protective device downstream, including the device itself, shall be of such material as to preclude the production of toxic substances which might result from interaction with carbon dioxide or carbonated water.
6.Waste disposal.
a.All wastes shall be properly disposed of, and pending disposition, shall be kept in suitable containers so as to prevent creating a nuisance.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)All trash and other waste material shall be removed from the machine location as frequently as may be necessary to prevent nuisance and unsightliness, and shall be disposed of in an approved manner.
(2)Self-closing, leakproof, easily cleanable, plainly labeled and designated waste container or containers shall be provided in the vicinity of each machine or machines to receive used cups, cartons, wrappers, straws, closures, and other single-service items. After being emptied, each waste container shall be thoroughly cleaned. Such waste containers shall not be located within the vending machine; provided, that an exception may be made for those machines dispensing only packaged food with crown closures. In case of an exception, the closure receptacle may be located within the machine. Suitable racks or cases shall be provided for multiuse containers or bottles.
(3)Containers shall be provided within all machines dispensing liquid food in bulk for the collection of drip, spillage, overflow, or other internal wastes. An automatic shutoff device shall be provided which will place the vending machine out of operation before such container overflows. Containers or surfaces on which such wastes may accumulate shall be readily removable for cleaning, shall be easily cleanable, and shall be corrosion-resistant. If liquid wastes from drip, spillage, or overflow, which originate within the machine are discharged into a sewerage system, the connection to the sewer shall be through an airgap.
7.Delivery of food, equipment, and supplies to machine location.
a.Food, food-contact surfaces of containers, equipment, and supplies shall be protected from contamination while in transit to machine location. Potentially hazardous food, while in transit and in storage on location, shall be maintained at safe temperatures.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the (1)Food, while in transit to vending machine locations, shall be protected from the elements, dirt, dust, insects, rodents, and other contamination. Similar protection shall be provided for single-service containers, and for the food-contact surfaces of equipment, containers, and devices in transit to machine locations.
(2)Potentially hazardous food, prior to being loaded in the delivery vehicle, shall be maintained at a temperature of forty-five degrees Fahrenheit [7.22 degrees Celsius] or below, or one hundred forty degrees Fahrenheit [60 degrees Celsius] or above, whichever is applicable. Such food shall also comply with the applicable temperature requirements while in transit to machine locations.
(3)If potentially hazardous food is stored at machine locations, the applicable safe temperature shall be maintained during storage.
8.Cleanliness of personnel.
a.Employees shall maintain a high degree of personal cleanliness and shall conform to hygienic practices while engaged in handling foods, or food-contact surfaces of utensils or equipments.
b.Satisfactory compliance. Subdivision a shall be deemed to have been satisfied when the requirements of this subdivision are met. Employees shall wash their hands immediately prior to engaging in any vending machine servicing operation which may bring them into contact with food, or with food-contact surfaces of utensils, containers, or equipment.
While engaged in such servicing operations, employees shall wear clean outer garments, shall conform to hygienic practices, and shall not use tobacco in any form.
N.D. Admin. Code 33-33-03-06 Disease control
No person, while affected with any disease in a communicable form, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or an acute respiratory infection, shall work in any area of a commissary or vending operation in any capacity in which there is a likelihood of such person contaminating food or food-contact surfaces with pathogenic organisms, or transmitting disease to other individuals. No person known or suspected of being affected with any such disease or condition shall be employed in such an area or capacity. If the manager or person in charge of the establishment has reason to suspect that any employee has contracted any disease in a communicable form or has become a carrier of such disease, the manager or person in charge shall notify the department immediately.
N.D. Admin. Code 33-33-03-07 Procedure when infection is suspected
When the department has reasonable cause to suspect the possibility of disease transmission from any employee, the department shall secure a morbidity history of the suspected employee or make such other investigation as may be indicated, and take appropriate action. The department may require any or all of the following:
1.The immediate exclusion of the employee from all commissaries and vending machine operations.
2.The immediate closure of the commissaries and operations concerned until, in the opinion of the department, no further danger of disease outbreak exists.
3.Restriction of the employee's services to some area of work where there would be no danger of transmitting disease.
4.Adequate medical examination of the employee and of the employee's associates, with such laboratory examinations as may be indicated.
N.D. Admin. Code 33-33-03-08 Commissaries outside North Dakota
Food from commissaries outside of North Dakota may be sold within the state if such commissaries conform to the provisions of the food-service establishment sanitation regulations of North Dakota, or to substantially equivalent provisions. To determine the extent of compliance with such provisions, the department may accept reports from the responsible authorities in the jurisdictions where the commissary or commissaries are located.
Chapter 33-33-04 Food Code [Repealed]
N.D. Admin. Code 33-33-04 Food Code [Repealed]
CHAPTER 33-33-04
FOOD CODE [Repealed effective January 1, 2018]
Chapter 33-33-04.1 Food Code
N.D. Admin. Code 33-33-04.1 Food Code
CHAPTER 33-33-04.1
FOOD CODE
Section 33-33-04.1-01Adoption of the United States Food and Drug Administration 2017 Model Food Code by Reference 33-33-04.1-01. Adoption of the United States food and drug administration 2017 Model Food Code by reference.
The provisions of the United States food and drug administration 2017 Model Food Code and its supplement are adopted by reference into this chapter, with the following modifications:
1.Paragraph 1-201.10 Statement of Application for Listing of Terms. For purposes of this
chapter, subparagraph (3)(f) of the food establishment definition is revised as follows:
(f)A kitchen in a private home, such as a self-declared child care provider or an early childhood program licensed for thirty or fewer children pursuant to North Dakota Century Code chapter 50-11.1; or a bed-and-breakfast operation that prepares and offers food to guests if the home is owner occupied, the number of available guests bedrooms does not exceed six, breakfast is the only meal offered, the number of guests served does not exceed eighteen, and the consumer is informed by statements contained in published advertisements, mailed brochures, and placards posted at the registration area that the food is prepared in a kitchen that is not regulated and inspected by the regulatory
authority; or
2.Paragraph 2-102.12 Certified Food Protection Manager. For the purposes of this chapter, is excluded.
3.Paragraph 2-102.20 (B) Food Protection Manager Certification. For the purposes of this
chapter, is excluded.
4.Paragraph 8-401.10 Establishing Inspection Interval. For the purposes of this chapter, is revised as follows:
a.Except as specified in subdivisions b and c of this subsection, the regulatory authority, at any time during operation, may inspect a food establishment. The department shall determine the frequency of inspection based on the level of risk categorization, complaints, and previous compliance history.
b.The regulatory authority may increase the interval between inspections if:
(1)The food establishment is fully operating under an approved and validated hazard analysis critical control point plan as specified under section 8-201.14 and paragraphs 8-103.12 (A) and (B);
(2)The food establishment is assigned a less frequent inspection frequency based on a written risk-based inspection schedule that is being uniformly applied throughout the jurisdiction. The food establishment may be contacted by telephone or other means by the regulatory authority to ensure the establishment manager and the nature of food operation are not changed; or (3)The establishment's operation involves only coffee service and other unpackaged or prepackaged food that is not time/temperature control for safety food, such as carbonated beverages and snack food, such as chips, nuts, popcorn, and pretzels.
c.The regulatory authority periodically shall inspect throughout its permit period a temporary food establishment that prepares, sells, or serves unpackaged time/temperature control for safety food and that:
(1)Has improvised rather than permanent facilities or equipment for accomplishing functions, such as handwashing, food preparation and protection, food temperature control, warewashing, providing drinking water, waste retention and disposal, and insect and rodent control; or (2)Has inexperienced food employees.
5.Paragraph 8-405.11 Timely Correction. For the purpose of this chapter, is revised as follows:
a.Except as specified in subdivision b of this subsection, a permitholder at the time of inspection shall correct a violation of a priority item or priority foundation item of this code and implement corrective actions for a hazard analysis critical control point plan provision that is not in compliance with its critical limit.
Pf
b.Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the regulatory authority may agree to or specify a longer time frame and approve a compliance schedule.
6.Paragraph 8-406.11 Time Frame for Correction. For the purpose of this chapter, is revised as follows:
a.Except as specified in subdivision b of this subsection, the permitholder shall correct core items by a date and time agreed to or specified by the regulatory authority.
b.The regulatory authority may approve a compliance schedule that extends beyond the time limits specified under subdivision a of this subsection if a written schedule of compliance is submitted by the permitholder and no health hazard exists or will result from allowing an extended schedule for compliance.
History: Effective January 1, 2018; amended effective January 1, 2024.
General Authority: NDCC 23-09
Law Implemented: NDCC 23-09
Chapter 33-33-05 Smoke Detector Rules
N.D. Admin. Code 33-33-05-01 Smoke detectors required
Every sleeping room in a lodging establishment or assisted living facility shall be equipped with a smoke detection device which has been inspected and listed by underwriters laboratories, factory mutual engineering division or equivalent. Smoke detectors shall be installed in accordance with the manufacturer's installation instructions.
N.D. Admin. Code 33-33-05-02 Passageway devices - General alarm
Lodging establishments or assisted living facilities without direct access from sleeping rooms to the outside shall have hallways or exit corridors equipped with listed smoke detection devices. Hallway or exit corridor smoke detection devices shall be wired into an approved fire alarm system so as to sound an alarm when any of the smoke detection devices are activated. Audible signaling appliances shall be located so as to be clearly heard throughout the facility regardless of the maximum noise level under normal conditions of occupancy. In all cases one appliance must be installed at manufacturer's recommendations or for each thirty feet [9.15 meters] of hallway or exit corridor or fraction thereof.
N.D. Admin. Code 33-33-05-03 Devices for the hard of hearing
At least one sleeping room in every lodging establishment or assisted living facility shall be equipped with a listed smoke detection device capable of producing at least eighty-five decibels of sound at ten feet [3.05 meters] and capable of flashing a two hundred fifty watt bulb for a period of five minutes.
N.D. Admin. Code 33-33-05-04 Initial testing and certification
After a smoke detection system has been initially installed, the lodging establishment or assisted living facility owner or manager shall certify in writing to the state department of health that the system has been tested and that each smoke detection device is working properly. Copies of written installer certifications will be accepted as owner or manager certifications.
N.D. Admin. Code 33-33-05-05 System inspection - Testing - Maintenance
1.No smoke detection device shall be approved unless the device installer:
a.Instructs the owner or manager in the operation of the system.
b.Provides the owner or manager with a set of written instructions for the proper maintenance and testing of the system.
2.The owner or manager or designee of the owner or manager of a lodging establishment or assisted living facility shall test at least ten percent of the battery-operated smoke detectors weekly and at least ten percent of the hard-wired detectors monthly on a systematic basis.
The owner or manager or designee of the owner or manager shall maintain written records for two years which:
a.Detail the date of the test, the units tested, the name of the person conducting the test, and the results of the test.
b.Indicate the date, results, and name of the person conducting a complete system maintenance inspection and test. Complete tests shall be conducted once each year or more often as necessary to assure proper operational condition.
3.The owner or manager of a lodging establishment or assisted living facility is responsible for, and shall cause, the necessary maintenance service or repairs to be made to ensure proper operational conditions of the smoke detection system at all times.
Chapter 33-33-06 Bed and Breakfast Facilities
N.D. Admin. Code 33-33-06-01 Definitions
1."Approved" means acceptable to the department based on a determination as to conformance with appropriate standards and good public health practice.
2."Corrosion-resistant material" means a material which maintains its original surface characteristics under prolonged influence of the food, cleaning compounds, and sanitizing solutions which may contact it.
3."Department" means the department of health and human services.
4."Easily cleanable" means that surfaces are readily accessible and made of such materials and finish and so fabricated that residue may be effectively removed by normal cleaning methods.
5."Employee" means the permitholder, individuals having supervisory or management duties, and any other individual working in a bed and breakfast facility.
6."Equipment" means stoves, ovens, ranges, hoods, slicers, mixers, meatblocks, tables, counters, refrigerators, sinks, dishwashing machines, steamtables, and similar items other than utensils, used in the operation of a bed and breakfast facility.
7."Food" means any raw, cooked, processed edible substance, or combination of substances, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption.
8."Food-contact surfaces" means those surfaces of equipment and utensils with which food normally comes in direct contact, and those surfaces with which food may come in contact and drain back onto surfaces normally in contact with food.
9."Kitchenware" means all multiuse utensils other than tableware.
10."Perishable food" means any food of such type or in such condition as may spoil.
11."Private home" means a place of residence of an individual or family.
12."Proprietor" means the person in charge of the bed and breakfast facility whether as owner, lessee, manager, or agent.
13."Sanitize" means effective bactericidal treatment of clean surfaces of equipment and utensils by a process which has been approved by the department as being effective in destroying micro-organisms, including pathogens.
14."Single-service articles" means cups, containers, lids or closures, plates, knives, forks, spoons, stirrers, paddles, straws, place mats, napkins, doilies, wrapping materials, and all similar articles which are constructed wholly or in part from paper, paperboard, molded pulp, foil, wood, plastic synthetic, or readily destructible materials, and which are intended for one usage only, then to be discarded.
15."Sleeping unit" means a room used for sleeping purposes by guests.
16."Tableware" means multiuse eating and drinking utensils.
17."Time and temperature control for safety food" means a food that requires time and temperature control for safety to limit pathogenic microorganism growth or toxin formation.
18."Utensil" means any implement used in the storage, preparation, transportation, or service of food.
History
- History: Effective August 1, 1988; amended effective January 1, 1990; December 1, 1991; April 1, 2012; January 1, 2026.
N.D. Admin. Code 33-33-06-02 Water supply
The water supply must be adequate, of a safe sanitary quality and from a source approved by the department. The water supply may not contain bacteriological, chemical, or physical impurities which affect, or tend to affect public health, must meet the bacteriological standards of the United States public health service for waters used upon public or interstate common carriers, and is subject to examination by the department. If it is unfit for drinking under these requirements, it either shall be improved to fulfill the standards or the use thereof shall be discontinued.
1.Each private water source shall be sampled and tested for bacteria initially and every twelve-month period thereafter. Seasonal operations shall be sampled during the peak operating season.
2.Each private water source shall be sampled initially for nitrate analysis. Seasonal operations shall be sampled during the peak operating season.
3.Additional bacteriological or chemical tests may be required by the department.
4.Initially each private source shall be inspected for location, source protection, and design standards.
5.No cross connections with unapproved water supplies may exist.
6.Adequate hot water heating facilities shall be provided. Hot and cold running water under pressure shall be provided to food preparation areas, and any other areas in which water is required for cleaning.
N.D. Admin. Code 33-33-06-03 Sewage
All sewage shall be disposed of in a public sewerage system or in a sewage disposal system approved by the department.
1.An initial inspection shall be made of all existing onsite sewage disposal systems by the department. This inspection shall evaluate system adequacy and if no expansion of existing dwelling facilities is occurring, no expansion of the system may be required as long as the system is not failing or otherwise contaminating surface or ground water.
2.If an expansion of the dwelling facilities occurs, then evaluation of the onsite sewage disposal system shall be completed by the department. If the system is adequate, then no expansion of the system will be required. If the system is not adequate in size, then system expansion shall be required as per local regulations or, the requirements in ND Publication WP-74-1R (Septic Tank and Absorption Field Disposal Systems for the Home). Plans for expansion shall be submitted to the local jurisdiction or, the department, water supply and pollution control division, for review and approval prior to construction.
3.The department may require that the septic tank be opened to check its construction. If the department determines that pumping of the tank is necessary, the department may require this to occur.
4.If the department determines that the onsite system needs repair or a new system is required, then the system shall be repaired or replaced in accordance with local regulations, or ND Publication WP-74-1R (Septic Tank and Absorption Field Disposal Systems for the Home).
History
- History: Effective August 1, 1988; amended effective January 1, 1990; April 1, 2012.
N.D. Admin. Code 33-33-06-04 Food supplies
Food must be in sound condition, free from spoilage, filth, or other contamination and must be safe for human consumption. Food shall be obtained from or be equal to food from sources that comply with all laws relating to food and food labeling. Before serving any food to the public, the bed and breakfast facility shall comply with all applicable inspections of food required by law. Fluid milk and fluid milk products used or served shall be pasteurized and shall meet the grade A quality standards established by law.
History
- History: Effective August 1, 1988; amended effective May 1, 1989.
N.D. Admin. Code 33-33-06-05 General food protection
1.At all times, including while being stored, prepared, displayed, served, or transported, food shall be protected from potential contamination, including dust, insects, rodents, unclean equipment and utensils, unnecessary handling, coughs and sneezes, flooding, drainage, overhead leakage or overhead drippage from condensation and chemicals. The temperature of potentially hazardous food must be forty-one degrees Fahrenheit [5 degrees Celsius] or below or one hundred thirty-five degrees Fahrenheit [57.2 degrees Celsius] or above at all times, except during necessary periods of preparation and serving. Frozen food shall be kept at such temperatures as to remain frozen, except when being thawed for preparation or use.
Potentially hazardous frozen food shall be thawed at refrigerator temperatures of forty-one degrees Fahrenheit [5 degrees Celsius] or below; or quick-thawed as part of the cooking process. An indicating thermometer shall be located in each refrigerator. Raw fruits and vegetables shall be washed thoroughly before use. Stuffings, poultry, stuffed meats and poultry, and pork and pork products shall be thoroughly cooked before being served. Salads made of meat, poultry, potatoes, fish, shellfish, or eggs, and other potentially hazardous prepared food, shall be prepared, preferably from chilled products, with a minimum of manual contact. Portions of food once served to an individual may not be served again.
2.Refrigeration facilities, hot food storage facilities, and effective insulated facilities shall be provided as needed to assure the maintenance of all food at required temperatures during storage, preparation, and serving.
3.Live pets are not allowed in any room or area in which food is being prepared for guests.
History
- History: Effective August 1, 1988; amended effective April 1, 2012.
N.D. Admin. Code 33-33-06-06 Food service equipment and utensils materials
Multiuse equipment and utensils shall be constructed and repaired with safe materials, including finishing materials, shall be corrosion-resistant and nonabsorbent; and shall be smooth, easily cleanable, and durable under conditions of normal use. Single-service articles shall be made from clean, sanitary, safe materials. Equipment, utensils, and single-service articles may not impart odors, color, or taste, nor contribute to the contamination of food.
Multiuse eating and drinking utensils, kitchenware, and tableware used in the facility shall be sanitized after each use or, single-service items may be used.
Acceptable means of dishwashing/sanitization shall be:
1.Manual cleaning and sanitizing utilizing a sink with two or three compartments with approved chemical sanitizer. Utensils shall be air-dried.
2.Mechanical home style dishwasher with a one hundred sixty degrees Fahrenheit [71.1 degrees Celsius] water supply provided by a booster heater or sanitizing cycle.
N.D. Admin. Code 33-33-06-07 General employee health
1.No employee, while infected with a disease in a communicable form that can be transmitted by foods or who is a carrier of organisms that can cause such a disease or while afflicted with a boil, an infected wound, or an acute respiratory infection, may work in a bed and breakfast facility in any capacity in which there is a likelihood of such employee contaminating food or food-contact surfaces with pathogenic organisms or transmitting disease to other persons.
2.Bed and breakfast employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practices. Employees shall thoroughly wash their hands with soap and warm water before preparing or serving food.
N.D. Admin. Code 33-33-06-08 Lighting and ventilation
Rooms and areas used in conjunction with bed and breakfast facilities shall be lighted and ventilated as needed and shall be effective under actual use conditions. Lighting fixtures and ventilating equipment shall be kept clean and in good repair.
N.D. Admin. Code 33-33-06-09 Toilet, handwashing, laundry, and bathing facilities
1.Bed and breakfast facilities shall be provided with approved sanitary toilet, handwashing, and bathing facilities. These facilities, and laundry facilities used in conjunction with bed and breakfast facilities, shall be kept clean and in good repair.
2.All lavatories and baths shall be supplied with hot and cold running water. Each person who is provided accommodations shall be provided individual soap and clean individual bath cloths and towels.
3.The temperature of hot water furnished to handwashing sinks (lavatories), showers, and bathtubs may not exceed one hundred twenty degrees Fahrenheit [48.9 degrees Celsius].
4.Clean towels and bath cloths shall be stored and handled in a sanitary manner.
N.D. Admin. Code 33-33-06-10 Beds, linens, and furniture
1.Furniture, mattresses, curtains, and draperies, etc., shall be kept clean and in good repair.
2.Clean bed linen in good repair shall be provided for each guest who is provided accommodations and shall be changed between guests and as often as necessary.
3.Clean linen shall be stored and handled in a sanitary manner and separate from soiled linen.
N.D. Admin. Code 33-33-06-11 Insect and rodent control
Effective measures intended to minimize the presence of rodents, flies, and other insects on the premises shall be utilized. The premises shall be kept in such condition as to prevent the harborage or feeding of insects or rodents. Openings to the outside shall be protected effectively against the entrance of rodents and insects by tight-fitting, self-closing doors, closed windows, screening, or other means.
N.D. Admin. Code 33-33-06-12 General requirements
1.Pesticides, herbicides, and other substances which may be hazardous if ingested, inhaled, or handled shall be stored in a closet, cabinet, or box not accessible to young children.
2.Household cleaning agents such as bleaches, detergents, and polishes shall be stored out of the reach of young children.
3.Medications shall be stored in a separate cabinet, closet, or box not accessible to young children.
4.Bed and breakfast facilities shall be kept in a clean and sanitary condition.
N.D. Admin. Code 33-33-06-13 Swimming pools and spas
When swimming pools and spas are provided for use by bed and breakfast facility guests, they must be designed, constructed, and maintained to protect the health and safety of its guests. A colorimetric test kit is required for the monitoring and adjusting of disinfectant levels and pH in swimming pools, spas, or other water recreational facilities. A weekly log of disinfection levels and pH must be maintained by the owner of the facility.
History
- History: Effective August 1, 1988; amended effective April 1, 2012.
N.D. Admin. Code 33-33-06-14 Fire safety
Bed and breakfast facilities shall be in compliance with the requirements of the Uniform Building Code and Uniform Fire Code as adopted and enforced by the state fire marshal. The department shall report to the state fire marshal violations of any provision of the code which might constitute a fire hazard in the premises so inspected.
The requirements for fire/life/safety shall include, but not be limited to, the following:
1.Smoke detectors.
a.A smoke detection device in good operating condition shall be mounted on the ceiling or wall at a point centrally located in the corridor or area giving access to rooms used for sleeping purposes. All smoke detectors shall be inspected and listed by underwriters' laboratories or an equivalent. Smoke detectors shall be installed in accordance with the manufacturer's installation instructions.
b.A smoke detector shall be installed in the basement of dwelling units having a stairway which opens from the basement into the dwelling. Such detector shall be connected to a sounding device or other detector to provide an alarm which will be audible in the sleeping area.
c.The owner of the facility shall test the battery-operated smoke detectors at least weekly and hard-wired detectors at least monthly and shall maintain written records which detail the date and results of the test.
2.Every sleeping unit shall provide a minimum of fifty square feet [4.65 square meters] of floor area per guest.
3.Every sleeping unit shall have at least one operable window or exterior door approved for emergency escape or rescue. The units shall be operable from the inside to provide a full clear opening without the use of separate tools. All escapes or rescue windows from sleeping rooms must have a minimum net clear opening of 5.7 square feet [.52 square meters]. The minimum net clear opening height dimension must be twenty-four inches [60.96 centimeters].
The minimum net clear opening width dimensions must be twenty inches [50.8 centimeters].
Where windows are provided as a means of escape or rescue, they must have a finished sill height not more than forty-four inches [111.76 centimeters] above the floor. No sleeping unit in bed and breakfast facilities may be in attic lofts or in basement rooms with a single major means of escape.
4.A fire extinguisher rated 2A and having a BC rating must be conveniently located and accessible in the bed and breakfast facility. The maximum travel distance to the extinguisher must be no more than seventy-five feet [22.86 meters].
5.Emergency numbers shall be posted on the telephones in the bed and breakfast facility.
History
- History: Effective August 1, 1988; amended effective January 1, 1990; April 1, 2012.
N.D. Admin. Code 33-33-06-15 Inspection - Records kept
Repealed effective January 1, 1990.
N.D. Admin. Code 33-33-06-16 License - Application
Repealed effective January 1, 1990.
N.D. Admin. Code 33-33-06-17 Failure to comply with provisions of chapter
Any proprietor of any bed and breakfast facility who fails to comply with any of the requirements of this chapter, or chapter 23-09.1 of the North Dakota Century Code, shall be given notice of the violation and of a reasonable time within which to comply with the requirements. The notice shall be in writing and shall be delivered personally by the department or shall be sent to the proprietor by any form of mail requiring a signed receipt and resulting in delivery to the proprietor. If the proprietor of the bed and breakfast facility fails to remedy the violations within the time stated within the notice, the department may refuse to grant a new license, or suspend or revoke the license through an administrative hearing held pursuant to chapter 28-32 of the North Dakota Century Code.
N.D. Admin. Code 33-33-06-18 License fees
The annual license fee paid to the department by proprietors of bed and breakfast facilities is sixty dollars. The plan review application fee for a bed and breakfast facility is fifty percent of the annual license fee if a plan review application is required. For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee if a plan review application is required. An additional amount of fifty percent of the license fee must be imposed upon renewal if the license was not renewed on or before February first following the expiration date.
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
- General Authority: NDCC 23-01-03
Chapter 33-33-07 Beverage License Fees
N.D. Admin. Code 33-33-07-01 Beverage license fees
Before any beverage bottler, manufacturer, processor, importer, jobber, or other retailer sells or distributes any nonalcoholic beverage in North Dakota, that beverage must be licensed by the department. The license fees for beverages are as follows:
1.Soda water, ginger ale, root beer, and pop, each brand or class, one hundred dollars.
2.Concentrated extracts, fountain syrups, and beverage bases, each brand, one hundred dollars.
3.True fruit juices and imitation or compound fruit beverages, each brand, one hundred dollars.
Mineral and spring water, and potable water sold by a private individual, firm, corporation, or limited liability company for household or culinary purposes, each brand, one hundred dollars.
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
Chapter 33-33-08 Food Establishment License Fees
N.D. Admin. Code 33-33-08-01 Food establishment license fees
1.The proprietors of food establishments, assisted living facilities, schools, or child care food service establishments shall pay the following annual, administration, and plan review license fees:
a.For a restaurant or catering kitchen used for general food service, one hundred thirty dollars plus fifty cents per seat, with a maximum license fee of three hundred ten dollars.
b.For a limited restaurant, one hundred thirty dollars.
c.For a retail food store, retail meat market, or bakery with not more than two thousand five hundred square feet [232.26 square meters], one hundred thirty dollars.
d.For a retail food store, retail meat market, or bakery with two thousand five hundred to five thousand square feet [232.26 to 464.52 square meters], one hundred forty-five dollars.
e.For a retail food store, retail meat market, or bakery with more than five thousand square feet [464.52 square meters], one hundred seventy dollars.
f.For a bar or tavern dispensing beer, liquor, or other alcoholic beverages, one hundred dollars.
g.For a mobile food unit, one hundred thirty dollars.
h.For a temporary food service establishment, pushcart, or food stand, fifty dollars at each event that operates at a fixed location for not more than fourteen consecutive days, with a maximum annual fee of two hundred fifty dollars.
i.For a food processing facility, one hundred thirty dollars.
j.For an assisted living facility, one hundred seventy dollars.
k.For a school, one hundred seventy dollars.
l.For a child care facility, sixty dollars.
m.For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee if a plan review application is required. The license application administration fee does not apply to temporary food service establishments.
n.For a proprietor, a plan review application fee of fifty percent of the annual license fee if a plan review application is required.
2.If a business operates more than one type of food establishment on the same premises and under the same management, the department shall issue a single license stating the types of establishments the business is licensed for and the maximum annual license fee charged may not exceed one hundred eighty dollars for those establishments with not more than two thousand five hundred square feet [232. square meters], two hundred fifty-five dollars for those establishments with two thousand five hundred square feet [232.26 square meters] to not more than five thousand square feet [464.52 square meters], and three hundred fifty dollars for those establishments over five thousand square feet [464.52 square meters].
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-01-03
Chapter 33-33-09 Assisted Living Facilities
N.D. Admin. Code 33-33-09-01 Emergency lighting
Emergency lighting for means of egress shall be provided in all assisted living facilities. Emergency illumination shall be provided for not less than one and one-half hours in the event of failure of normal lighting. Emergency lighting facilities shall be arranged to provide initial illumination that is not less than an average of one footcandle [10 lux]. Where each living unit has a direct exit to the outside of the building at ground level, no emergency lighting shall be required.
N.D. Admin. Code 33-33-09-02 Emergency plans
All assisted living facilities must have a current, written emergency disaster plan. That plan must contain a plan for evacuation, addresses elements of sheltering in place, identifies temporary relocation sites, and details staff assignments in the event of a disaster or an emergency. The emergency disaster plan must be readily available for review by any tenant, family member, or emergency responders. An emergency evacuation route should be posted prominently in the facility.
N.D. Admin. Code 33-33-09-03 Sprinkler systems
If sprinkled, systems should be inspected and maintained according to National Fire Protection Association 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems. Smoke detection systems shall be installed and maintained as specified in chapter 33-33-05.
Chapter 33-33-10 Preparation of Cottage Food Products for Sale
N.D. Admin. Code 33-33-10-01 Definitions
N.D. Admin. Code 33-33-10-02 Cottage food products
N.D. Admin. Code 33-33-10-03 Safe handling instructions and product disclosure statement
N.D. Admin. Code 33-33-10-04 Illness or environment health complaint investigation
1.Authorized representatives of the department or local regulating authority may access a cottage food production area of a cottage food operator's private home, point of sale, or venue where transactions of cottage foods take place to conduct an investigation upon complaint of an illness or environmental health. The cottage food operator may request to see the representatives' credentials.
2.If the department or local regulatory authority determines, as part of an investigation conducted in accordance with subsection 9 of North Dakota Century Code section 23-09.5-02 the source of an environmental health hazard or an illness complaint is associated with preparation, processing, packaging, or point of sale of a cottage food product, or otherwise associated with the cottage food operation, and poses a threat to public health or safety, where all reasonable measures have not been taken to ensure a cottage food product is not adulterated, contaminated by undesirable micro-organisms, or that cottage food product is misbranded or misrepresented to the informed end consumer, the cottage food operator will be notified and the department will act in accordance with North Dakota Century Code chapter 19-02.1.
3.The cottage food operator shall prepare and submit to the department a plan of correction in accordance with the minimum standards of these rules and North Dakota Century Code
chapter 23-09.5. The plan shall contain adequate information to enable the department to determine whether the proposed corrective action measures will abate or prevent ongoing threat to public health.
History
- History: Effective January 1, 2020.
- General Authority: NDCC 23-01-03(3)
- Law Implemented: NDCC 19-02.1, 23-09.5-02(9)
N.D. Admin. Code 33-33-10-05 Infectious disease
A cottage food operator or member of the cottage food operator's private home afflicted with symptoms consistent with a contagious or infectious disease may not knowingly:
1.Handle or prepare cottage food products; or
2.Work in a cottage food production area.
History
- History: Effective January 1, 2020.
- General Authority: NDCC 23-01-03(3)
- Law Implemented: NDCC 23-01-03(3), 23-09.5
Article 33-36 Emergency Medical Services Personnel
Chapter 33-36-01 Emergency Medical Services Personnel Training, Testing, Certification, and Licensure
N.D. Admin. Code 33-36-01-01 Definitions
Words defined in North Dakota Century Code chapter 23-27 have the same meaning in this
chapter.
1."Advanced emergency medical technician" means an individual certified by the national registry as an advanced emergency medical technician. An advanced emergency medical technician is eligible for licensure as an advanced emergency medical technician upon completion of a license application and approval by the department.
2."Cardiopulmonary resuscitation", initial and refresher, means the American heart association health care provider standards or its equivalent which includes the following skills: adult one-person and two-person cardiopulmonary resuscitation, adult obstructed airway, child one-person and two-person cardiopulmonary resuscitation, child obstructed airway, infant one-person and two-person cardiopulmonary resuscitation, infant obstructed airway, and automated external defibrillator.
3."Clinical and field internship preceptor" means a qualified individual designated by an emergency medical services instructor or emergency medical services training institute to supervise a student during clinical or field internship training.
4."Department" means the department of health and human services.
5."Emergency medical services instructor" means an individual who is licensed to conduct emergency medical services courses, including continuing education courses.
6."Emergency medical technician" means an individual certified by the national registry as an emergency medical technician. An emergency medical technician is eligible for licensure as an emergency medical technician upon completion of a license application and approval by the
7."Equivalent" means training of equal or greater value which accomplishes the same results.
8."National registry" means the national registry of emergency medical technicians located in Columbus, Ohio.
9."On call" means that an individual is expected to be available for emergency response when alerted by a method determined by the public safety answering point or dispatch center and report after notification.
July 1, 2010; April 1, 2024.
History
- History: Effective April 1, 1992; amended effective August 1, 2003; January 1, 2006; January 1, 2008;
N.D. Admin. Code 33-36-01-02 Emergency medical services training courses
The department acknowledges the following emergency medical services courses and personnel:
1.Courses leading to national registry certification:
a.Emergency medical responder;
b.Emergency medical technician;
c.Advanced emergency medical technician; and
d.Paramedic.
2.Courses requiring current department licensure that provide supplementary qualifications by the department:
a.Emergency medical services instructor;
b.Community emergency medical technician;
c.Community advanced emergency medical technician; and
d.Community paramedic.
August 1, 2004; January 1, 2006; January 1, 2008; July 1, 2010; April 1, 2024.
History
- History: Effective April 1, 1992; amended effective October 1, 1992; August 1, 1994; August 1, 2003;
N.D. Admin. Code 33-36-01-03 Training, testing, certification, and licensure standards for emergency medical services personnel
The department shall authorize all courses leading to approval, certification, or licensure by the department prior to the course being conducted in North Dakota contingent upon the course being offered by a licensed emergency medical services training institute and on the following requirements:
1.Emergency medical responder:
a.Course. A course conducted in North Dakota must adhere to the national emergency medical services education standards for emergency medical responders as published by the United States department of transportation, national highway traffic safety administration. Prior to student eligibility for certification by the national registry, competency in the required knowledge and skills must be verified by a North Dakota emergency medical services instructor or North Dakota licensed emergency medical services training institute.
b.Course instructors. Course instructors must be approved by the licensed emergency medical services training institute and be knowledgeable in course content, effective in teaching their assigned subjects, and capable through academic preparation, training, and experience to teach courses or topics to which they are assigned.
c.An emergency medical responder student may practice all the skills defined in the scope of practice for emergency medical responder while in the classroom and during a clinical or field internship while under direct supervision of an instructor or clinical and field internship preceptor and if registered with the department as an emergency medical responder student.
d.Initial certification. Individuals sixteen years of age and older who are certified as an emergency medical responder by the national registry are eligible for certification by the department. Upon completion and department approval of an application, eligible applicants may be certified by the department for a two-year period until June thirtieth of the second year.
e.Recertification. An individual that maintains certification from the national registry is eligible for recertification. Upon completion and approval of an application, eligible applicants may be recertified by the department for a two-year period until June thirtieth of the second year.
f.Individuals certified as emergency medical responders as of January 1, 2024, and those attending emergency medical responder courses approved before January 1, 2024, and certified by June 30, 2024, will not be required to obtain national registry certification.
(1)Prior to student eligibility for initial certification by the department under the conditions identified in this subdivision, competency in the required knowledge and skills must be verified by a North Dakota emergency medical services instructor or North Dakota licensed emergency medical services training institute.
(2)Prior to eligibility for recertification by the department under the conditions identified in this subdivision, individuals must complete recertification requirements equivalent to those required by the national registry.
2.Emergency medical technician:
a.Course. A course conducted in North Dakota must adhere to the national emergency medical services education standards for emergency medical technicians as published by the United States department of transportation, national highway traffic safety administration. Prior to student eligibility for certification by the national registry, competency in the required knowledge and skills must be verified by a North Dakota emergency medical services instructor or North Dakota licensed emergency medical services training institute.
b.Course instructors. Course instructors must be approved by the licensed emergency medical services training institute and be knowledgeable in course content, effective in teaching their assigned subjects, and capable through academic preparation, training, and experience to teach courses or topics to which they are assigned.
c.An emergency medical technician student may practice all the skills defined in the scope of practice for emergency medical technician while in the classroom and during a clinical or field internship while under direct supervision of an instructor or the clinical and field internship preceptor and if registered with the department as an emergency medical technician student.
d.Emergency medical technician initial licensure. Individuals sixteen years of age and older who are certified as emergency medical technicians by the national registry are eligible for licensure. Upon completion and department approval of a license application, eligible applicants may be licensed by the department. The applicant must be affiliated with a North Dakota licensed emergency medical services operation or obtain medical direction from a North Dakota licensed physician. Licensure will expire ninety days after the national registry emergency medical technician expiration date.
e.Relicensure of emergency medical technicians. An individual that maintains certification from the national registry as an emergency medical technician is eligible for relicensure.
Upon completion and approval of a license application, eligible applicants may be relicensed by the department. The applicant must be affiliated with a North Dakota licensed emergency medical services operation or obtain medical direction from a North Dakota licensed physician. Licensure will expire ninety days after the national registry expiration date.
3.Advanced emergency medical technician:
a.Student prerequisite. Students must be certified as an emergency medical technician by the national registry or licensed as an emergency medical technician or its equivalent.
b.Course. The course must adhere to the national emergency medical services education standards for advanced emergency medical technicians as published by the United States department of transportation, national highway traffic safety administration. Prior to student eligibility for certification by the national registry, competency in the required knowledge and skills must be verified by a North Dakota emergency medical services instructor or North Dakota licensed emergency medical services training institute.
c.An advanced emergency medical technician student may practice all the skills defined in the scope of practice for advanced emergency medical technician while in the classroom and during a clinical or field internship while under direct supervision of an instructor or clinical and field internship preceptor and if registered with the department as an advanced emergency medical technician student.
d.Advanced emergency medical technician initial licensure. An individual eighteen years of age or older who is certified as an advanced emergency medical technician by the national registry is eligible for licensure. Upon completion and department approval of a license application, eligible applicants may be licensed by the department. The applicant must be affiliated with a North Dakota licensed emergency medical services operation or obtain medical direction from a North Dakota licensed physician. Licensure will expire ninety days after the national registry advanced emergency medical technician expiration date.
e.Relicensure of advanced emergency medical technician. An individual that maintains certification from the national registry as an advanced emergency medical technician is eligible for relicensure. Upon completion and approval of a license application, eligible applicants may be relicensed by the department. The applicant must be affiliated with a North Dakota licensed emergency medical services operation or obtain medical direction from a North Dakota licensed physician. Licensure will expire ninety days after the national registry advanced emergency medical technician expiration date.
4.Paramedic:
a.Student prerequisite. Students must be certified at minimum as an emergency medical technician or licensed at minimum as an emergency medical technician or its equivalent.
b.Course. The course must adhere to the national emergency medical services education standards for paramedics as published by the United States department of transportation, national highway traffic safety administration and be conducted by a commission on accreditation of allied education programs accredited paramedic education program.
c.A paramedic student may practice all the skills defined in the scope of practice for paramedic while in the classroom and during a clinical or field internship while under direct supervision of an instructor or clinical and field internship preceptor and if registered with the department as a paramedic student.
d.Paramedic initial licensure. An individual eighteen years of age or older who is certified as a paramedic by the national registry is eligible for licensure. Upon completion and department approval of a licensed application, eligible applicants may be licensed by the department. The applicant must be affiliated with a North Dakota licensed emergency medical services operation or obtain medical direction from a North Dakota licensed physician. Licensure will expire ninety days after the national registry paramedic expiration date.
e.Relicensure of paramedic. An individual that maintains certification from the national registry as a paramedic is eligible for relicensure. Upon completion and approval of a license application, eligible applicants may be relicensed by the department. The applicant must be affiliated with a North Dakota licensed emergency medical services operation or obtain medical direction from a North Dakota licensed physician. Licensure will expire ninety days after the national registry paramedic expiration date.
5.Emergency medical services instructor:
a.Student prerequisite. A candidate for certification as an emergency medical services instructor must be at least eighteen years of age and licensed for at least two years as an emergency medical technician, advanced emergency medical technician, or paramedic.
b.Course. The course must be approved by the department.
c.Initial certification. The department shall issue initial certification to individuals who have successfully completed an approved course and meet the prerequisites. Individuals possessing a bachelor's degree in education, a teacher's certification in education, a master's degree or doctorate and meeting the student prerequisites are eligible for initial certification upon application to the department. Emergency medical services instructor certification is concurrent with emergency medical services licensure.
d.Recertification. The department may recertify as emergency medical services instructors those individuals who maintain emergency medical services licensure and:
(1)Are employed or affiliated with a licensed emergency medical services training institution and submit documentation of eight hours of adult instructional education approved by the licensed emergency medical services training institute; and (2)Instruct or coordinate a minimum of one authorized emergency medical responder, emergency medical technician, advanced emergency medical technician, or paramedic education program every two years.
6.Community emergency medical technician:
a.The department shall certify as a community emergency medical technician an individual who meets the following qualifications:
(1)Has a current license as an emergency medical technician issued by the (2)Has two years of service as an emergency medical technician.
(3)Has successfully completed a community emergency medical technician education program from a college or university that has been approved by the department or accredited by a department approved accreditation organization. The education program must include clinical experience that is provided under the supervision of a physician, advanced practice registered nurse, physician assistant, or public health nurse operating under the direct authority of a local unit of government.
b.A community emergency medical technician shall practice in accordance with protocols and standards established by a medical director and provide services as directed by a patient care plan developed by a patient's primary or specialty care physician, advanced practice registered nurse, or physician assistant. In the absence of a primary or specialty care provider, the patient care plan may be directed by the medical director.
c.A community emergency medical technician must be employed by a licensed ground ambulance or licensed hospital.
d.In addition to the relicensure requirements in subdivision e of subsection 2, a community emergency medical technician shall complete an additional twelve hours of continuing education in clinical topics approved by the medical director.
e.No individual shall hold themself out as a community emergency medical technician or provide the services of a community emergency medical technician unless such individual is certified by the department.
7.Community advanced emergency medical technician:
a.The department shall certify as a community advanced emergency medical technician an individual who meets the following qualifications:
(1)Has a current license as an advanced emergency medical technician issued by the (2)Has two years of service as an advanced emergency medical technician.
(3)Has successfully completed a community advanced emergency medical technician education program from a college or university that has been approved by the department or accredited by a department approved accreditation organization. The education program must include clinical experience that is provided under the supervision of a physician, advanced practice registered nurse, physician assistant, or public health nurse operating under the direct authority of a local unit of government.
b.A community advanced emergency medical technician shall practice in accordance with protocols and standards established by a medical director and provide services as directed by a patient care plan developed by a patient's primary or specialty care physician, advanced practice registered nurse, or physician assistant. In the absence of a primary or specialty care provider, the patient care plan may be directed by the medical director.
c.A community advanced emergency medical technician must be employed by a licensed ground ambulance or licensed hospital.
d.In addition to the relicensure requirements in subdivision e of subsection 3, a community advanced emergency medical technician shall complete an additional twelve hours of continuing education in clinical topics approved by the medical director.
e.No individual shall hold themself out as an community advanced emergency medical technician or provide the services of an community advanced emergency medical technician unless such individual is certified by the department.
8.Community paramedic:
a.The department shall certify as a community paramedic an individual who meets the following qualifications:
(1)Has a current license as a paramedic issued by the department.
(2)Has two years of service as a paramedic.
(3)Has successfully completed a community paramedic education program from a college or university that has been approved by the department or accredited by a department approved accreditation organization. The education program must include clinical experience that is provided under the supervision of a physician, advanced practice registered nurse, physician assistant, or public health nurse operating under the direct authority of a local unit of government.
b.A community paramedic shall practice in accordance with protocols and standards established by a medical director and provide services as directed by a patient care plan developed by a patient's primary or specialty care physician, advanced practice registered nurse, or physician assistant. In the absence of a primary or specialty care provider, the patient care plan may be directed by the medical director.
c.A community paramedic must be employed by a licensed ground ambulance or licensed hospital.
d.In addition to the relicensure requirements in subdivision e of subsection 4, a community paramedic shall complete an additional eighteen hours of continuing education in clinical topics approved by the medical director.
e.No individual shall hold themself out as a community paramedic or provide the services of a community paramedic unless such individual is certified by the department.
9.Emergency medical dispatch. An individual authorized to provide prearrival emergency medical instructions for a public safety answering point shall satisfactorily complete an emergency medical dispatch course of instruction approved by the department. A certificate indicating satisfactory completion of the emergency medical dispatch course of instruction must be submitted to the department by the public safety answering point prior to the individual providing prearrival emergency medical instructions for a public safety answering point.
January 1, 2008; July 1, 2010; April 1, 2024. 33-36-01-03.1. Limited temporary certification or licensure of emergency medical services training course graduates. 33-36-01-03.2. Continuing education.
An entity or individual that offers continuing education shall follow the continuing education policy as published in the department's emergency medical services instructor handbook.
History
- History: Effective April 1, 1992; amended effective August 1, 1994; August 1, 2003; January 1, 2006;
- History: Effective July 1, 2010; amended effective April 1, 2024.
N.D. Admin. Code 33-36-01-04 Training, testing, and certification standards for certification scope enhancement courses. 33-36-01-04.1. Training, testing, and certification standards for certification refresher courses
N.D. Admin. Code 33-36-01-05 Denial, suspension, or revocation of certification or licensure
The department may deny, suspend, or revoke the certification or licensure of an individual who:
1.Has misrepresented to others that the individual is a physician, nurse, or health care provider other than the highest level for which they are certified or licensed.
2.Is incapable of properly performing the skills for which the individual has been certified or licensed.
3.Performs a skill which exceeds those allowed by the individual's level of certification or licensure.
4.Is under indictment for or has been convicted of a misdemeanor or felony which has a direct bearing upon the individual's ability to serve the public in a capacity certified or licensed by this chapter, or has been convicted of a crime that requires the individual to register as a sex offender in any state. Individuals certified or licensed who are under indictment for or have been convicted of a misdemeanor or felony or required to register as a sex offender in any state must report the information to the department within two business days.
5.Has been found by a court of law to be mentally incompetent.
6.Failure to follow examination policies as a student, instructor, or course coordinator.
7.Diversion of drugs for personal or unauthorized use.
8.Performance of care in a manner inconsistent with acceptable standards or protocols.
9.Has attempted to obtain by fraud or deceit a certification or license or has submitted to the department any information that is fraudulent, deceitful, or false.
10.Has had the individual's national registry or other health care certification or license encumbered for any reason. Individuals certified or licensed as described in this chapter must report any encumbrance of their national registry or other health care certification or licensure to the department within two business days.
11.Has misrepresented to others that the individual is an employee, volunteer, or agent of an ambulance service, quick response unit, or rescue squad to offer emergency medical services.
12.Unprofessional conduct, which may give a negative impression of the emergency medical services system to the public.
13.As an instructor has failed to have emergency medical services training authorized as required or has not met required education standards.
14.Providing emergency medical or community emergency medical technician, community advanced emergency medical technician, or community paramedic services without authorization from a physician.
15.Has been found to be under the influence of alcohol or mind-altering drugs while on call, on duty, or during an emergency medical or community emergency medical technician, community advanced emergency medical technician, or community paramedic response or interfacility transfer.
16.Failing to respond to an emergency while on call or on duty. The failure to respond must be caused by the individual's willful disregard and not caused by a good-faith error or circumstances beyond the individual's control as determined by the department.
July 1, 2010; April 1, 2024. 33-36-01-05.1. Criminal history background checks.
The department may perform criminal history background checks on any applicant requesting a certification or license or an individual requesting to be listed on an ambulance service or quick response unit's roster as a driver. A driver may be denied participation in any emergency medical services operation based on the driver's criminal background history or any occurrence listed in section 33-36-01-05.
History
- History: Effective April 1, 1992; amended effective August 1, 2003; January 1, 2006; January 1, 2008;
- History: Effective January 1, 2008; amended effective April 1, 2024.
- General Authority: NDCC 12-60-24, 23-27-04.3
- Law Implemented: NDCC 12-60-24, 23-27-04.3
N.D. Admin. Code 33-36-01-06 Revocation process
The department may revoke an individual's certification or license after making a diligent effort to:
1.Inform the individual by the department of the allegations.
2.Inform the individual of the department's investigation results.
3.Inform the individual of the department's intent to revoke and provide a notice of right to request hearing.
4.Provide the individual opportunity to request a hearing and rebut the allegations.
History
- History: Effective April 1, 1992; amended effective August 1, 2003; January 1, 2006.
N.D. Admin. Code 33-36-01-07 Hearing
A request for hearing must be received by the department no later than twenty days following the individual's receipt of the allegations against the individual. If a hearing is requested, the department will apply to the office of administrative hearings for appointment of a hearing officer. The department will notify any complainants and the accused of the date set for the hearing. The hearing officer will conduct the hearing and prepare recommended findings of fact and conclusions of law as well as a recommended order for the department. The department shall notify the individual of its findings in writing after receiving the attorney general's finding of fact, conclusion of law, and recommended order.
History
- History: Effective April 1, 1992.
N.D. Admin. Code 33-36-01-08 Waivers
Based on each individual case, the department may waive any provisions of this chapter that may result in unreasonable hardship upon the individual or the individual's emergency medical service operation, provided such a waiver does not adversely affect the health and safety of patients. The department may consider waivers for the following situations and conditions:
1.An individual had completed all the requirements for recertification or relicensure and a good-faith effort was made by that individual to recertify with the national registry and by no fault of the individual recertification was not granted.
2.An individual who was current in the individual's certification or license was called to active duty in the United States armed forces and deployed to an area without the resources to maintain the individual's certification or license resulting in a lapse of the individual's certification or license.
3.Other reason as determined by the department.
4.A waiver may be granted for a specific period of time not to exceed one year and shall expire on June thirtieth of each year.
History
- History: Effective January 1, 2006; amended effective July 1, 2010; April 1, 2024.
Chapter 33-36-02 Licensing of Emergency Medical Services Training Institutions
N.D. Admin. Code 33-36-02-01 Definitions
Words defined in North Dakota Century Code chapter 23-27 have the same meaning in this
chapter.
1."Acceptable criminal background requirements" means that a student's criminal background is acceptable by the department and the national registry for entry into the profession.
2."Accrediting agency" means the commission on accreditation on allied health education programs or its equivalent.
3."Candidate" means a person that has completed a primary training course and is in the testing process.
4."Certifying examination" means a national registry test.
5."Department" means the North Dakota state department of health.
6."Emergency medical services equipment" means automated external defibrillator, long back board, Kendrick extrication device, oxygen delivery equipment, rigid splints, traction splint, suction equipment, bandages, and other equipment needed to accomplish training.
7."National registry" means the national registry of emergency medical technicians located in Columbus, Ohio.
8."Physician" means a person licensed by the North Dakota board of medical examiners to practice medicine.
9."Primary education course" means the initial or refresher training course for emergency medical responder, emergency medical technician, emergency medical technician-intermediate, and paramedic.
10."Student" means a person that is actively in a primary training course and has not yet completed the course.
N.D. Admin. Code 33-36-02-02 License required - Fees
1.No North Dakota emergency medical services training institution, as defined in North Dakota Century Code chapter 23-27, shall be advertised or offered to the public or any person as a licensed training institution unless the operator of such service is licensed by the department.
2.The license shall expire midnight on October thirty-first of the third year following issuance.
License renewal shall be on a three-year basis.
3.A license is valid only for the training institution for which it is issued. A license may not be sold, assigned, or transferred.
4.The license shall be displayed in a conspicuous place.
5.The three-year license fee shall be seventy-five dollars which is nonrefundable.
N.D. Admin. Code 33-36-02-03 Application for license
An application for licensure as an emergency medical services training institution may be submitted on a form provided by the department or an alternate format which includes the following information:
1.Applicant information:
a.Name of the training institution;
b.Mailing address;
c.Telephone number;
d.Name of program coordinator;
e.Name of training institution medical director; and
f.E-mail address of contact person;
2.A copy of the written agreement with the physician medical director;
3.A copy of the written agreement with the hospitals, clinics, ambulance services, and physicians' offices that will provide field internship training;
4.A listing of the names of the persons or organizations that have financial interest in the institution;
5.A copy of the student handbook for the institution; and
6.A signed statement attesting to the accuracy of the application and all of its attachments.
N.D. Admin. Code 33-36-02-04 Issuance and renewal of licenses
1.The department or its authorized agent shall inspect the training institution. If minimum standards are met, the department shall issue a license.
2.A training institution may request that the department consider it in compliance with this
chapter if it is fully accredited by the commission on accreditation of allied health education programs or its equivalent. The training institution must provide any additional information to the department that is required of licensed emergency medical services training institutions but not evaluated in the accreditation process.
3.Training institutions requesting their compliance with this chapter to be verified through an accrediting agency shall submit to the department appropriate documentation to include the site visit survey report and official letter from the accrediting agency citing any deficiencies.
Subsequent accreditation or revisit documentation must be submitted prior to license renewal.
4.Training institutions that offer paramedic training shall have the paramedic course accredited by an accrediting agency by January 1, 2010.
History
- History: Effective January 1, 2006; amended effective January 1, 2008.
N.D. Admin. Code 33-36-02-05 Training institution director requirements
Each licensed training institution must have a director who serves as the administrator of the training institution and who is responsible for:
1.Planning, conducting, and evaluating the program;
2.Selecting students and instructors;
3.Documenting and maintaining records;
4.Developing a curriculum; and
5.Acting as or appointing the test site coordinator for practical examinations if applicable.
N.D. Admin. Code 33-36-02-06 Training institution medical director requirements
Each licensed training institution shall have an agreement on file at the department with a physician whose responsibilities include:
1.Ensuring an accurate and thorough presentation of the medical content of each training program;
2.Certifying that each candidate has successfully completed the training course;
3.In conjunction with the training program director, planning the clinical training;
4.Being available for practical test site consultations; and
5.Acting as a liaison between the training institution and the medical community.
N.D. Admin. Code 33-36-02-07 Course instructors
Primary course instructors must be licensed as an instructor coordinator as defined in section 33-36-01-04 and hold a certificate or license in or above the discipline that they are teaching.
History
- History: Effective January 1, 2006; amended effective January 1, 2008; July 1, 2010.
N.D. Admin. Code 33-36-02-08 Training institution policies, records, and quality assurance
North Dakota licensed emergency medical services training institutions must:
1.Publish a student handbook which includes at least the following information:
a.The full name and address of the school;
b.Names of owners and officers, including governing boards;
c.A description of each educational service offered, including tuition, fees, and length of courses;
d.Enrollment procedures and entrance requirements, including late enrollment if permitted;
e.A description of the institution's tuition assistance. If no assistance is offered, the institution must state this fact;
f.Attendance policy, including minimum attendance requirements;
g.A policy explaining satisfactory student progress which includes:
(1)How progress is measured and evaluated, including an explanation of any system of grading used;
(2)The conditions under which the student may be readmitted if terminated for unsatisfactory progress; and (3)Explanation of any probation policy;
h.A description of the system used to make progress reports to students; and
i.An explanation of the refund policy which also includes the training agency's method of determining the official date of termination.
2.Maintain as a minimum, the following records for emergency medical services courses taught:
a.Student records must be maintained for five years and include:
(1)Name and address for each student enrolled in an emergency medical services course;
(2)Grades for each written examination;
(3)Copies of each student's documentation of entrance requirements to each course, including a copy of the individual's cardiopulmonary resuscitation certification and criminal history statement; and (4)Field internship student evaluation forms from each field or clinical internship session. The form must include the evaluator's printed name, contact information, and signature.
b.Instructor and course records that include:
(1)Names and qualifications of the primary instructors;
(2)Names and qualification of guest instructors;
(3)Instructor evaluation records completed by students and training institution personnel; and (4)Names of the practical examination evaluators.
3.Have at least seventy percent of the candidates who successfully complete a primary training course certified or licensed by the department or certified by the national registry within two years of course completion.
4.Develop and implement a quality assurance program for instruction. The quality assurance program must:
a.Establish and implement policies and procedures for periodic evaluation of all instructors, field internship sites, equipment, and other training resources;
b.Establish and implement a mentoring program for each new instructor. Each new instructor will be assigned a mentor who has a background in the course being taught or in teaching. The assigned mentor will complete an evaluation of the assignee at least once;
c.Establish and have completed student evaluations during and after each course taught; and
d.Establish and implement a remediation plan for all noted instructor deficiencies.
Documentation of remediation shall be maintained for five years.
N.D. Admin. Code 33-36-02-09 Other training institution requirements
North Dakota licensed emergency medical services training institutions must:
1.Have adequate classroom and laboratory space to conduct emergency medical services training.
2.Have appropriate dedicated emergency medical services equipment for training.
3.Determine the eligibility of prospective students in regard to age, minimum prior training requirements, and acceptable criminal background requirements.
4.Maintain a written agreement with a licensed medical facility and licensed ambulance service designating a field internship site.
5.After each primary training class is complete, notify the department of the starting date and number of students initially enrolled and the number of students fully completing the course.
6.Provide proof of liability insurance that covers the training institution and primary instructors.
7.Notify the department prior to conducting primary education courses in a format determined by the department.
N.D. Admin. Code 33-36-02-10 Practical examination administration
A licensed training institution may conduct practical examinations under the following conditions:
1.The institution must be designated by the department to conduct practical examinations.
2.The facility must have adequate room to accommodate a test. Each test station must be well away from others so that the privacy of the candidate and the security of the test are maintained. There must be a separate monitored room for candidates to wait. The designated department representative may shut down or cancel a test because of inadequate facilities.
3.Test site dates must be approved by the department. For an advanced life support test site, the test site coordinator must notify the department eight weeks prior to the test date and submit a roster of probable candidates for the practical test. For a basic life support test site, the test site coordinator must notify the department two weeks prior to the test date and submit a roster of probable candidates for the practical test. The test site coordinator may accept candidates from other licensed training institutions or department-authorized courses or qualified candidates from other states if the test site coordinator has verified the eligibility of the candidate.
4.The test site coordinator is responsible for all logistics of the test site. The test site coordinator must remain at the test site for the duration of the test.
5.A national registry representative approved by the department or a designated department representative must oversee the test site. The national registry or department representative's only duties are to ensure the integrity of the test site and submit results to the national registry or the department. The designated department representative may not have an affiliation with the training institution.
6.The training institution must provide an adequate number of qualified evaluators for the number of students to be tested. For every eight candidates there must be at least one evaluator. The evaluators may not evaluate a candidate in a practical station for which the evaluator had been a guest lecturer, or had been the training institution coordinator or the primary instructors of the candidates. Evaluators must use and adhere to the department's testing evaluation forms.
7.An emergency medical technician candidate must pass all stations of a practical test site within two years of course completion. The required practical stations are:
a.Patient assessment management - trauma;
b.Patient assessment management - medical;
c.Cardiac arrest management/automated external defibrillator;
d.Spinal immobilization, seated or supine;
e.Bag valve mask, apneic patient with a pulse; and
f.One of the following random skills chosen by the department:
(1)Long bone immobilization;
(2)Joint dislocation immobilization;
(3)Traction splinting;
(4)Bleeding control and shock management;
(5)Upper airway adjuncts and suction; or (6)Supplemental oxygen administration.
8.A candidate may fail no more than three stations at any one test site. The candidate may retest those failed stations one time on the same day at the discretion of the test site coordinator. If a candidate fails four or more stations, the candidate must retest all stations at a later date.
9.All emergency medical technician practical test results must be reported to the department within one week of the practical test by the department representative. The department will determine the eligibility of the candidates to retest according to department policy.
10.Retesting candidates that have failed all or part of the emergency medical technician practical test will be done in accordance with department policy. The number of times a candidate may retest all or part of the emergency medical technician practical test is determined by department policy.
11.An advanced level practical test site must be approved by the department and comply with national registry rules and policies.
History
- History: Effective January 1, 2006; amended effective January 1, 2008; July 1, 2010.
N.D. Admin. Code 33-36-02-11 Continuing education
Repealed effective July 1, 2010.
N.D. Admin. Code 33-36-02-12 Denial, suspension, or revocation of licensure
The department may deny, suspend, or revoke the license of a training institution or license of an individual to instruct or practice under the following circumstances:
1.Negligence in performing or instructing emergency medical care.
2.Fraud, forgery, or misrepresentation of facts in procuring or attempting to procure licensure as an emergency medical service training institution.
3.Violation of this chapter promulgated to regulate emergency medical services training institutions.
4.Falsely passing candidates or discrimination of candidates at a practical test site.
5.Grossly immoral or dishonorable conduct.
6.Diversion of drugs for personal or unauthorized use.
7.The licensed training institution receives adverse accreditation action from a national accrediting agency.
8.Failing to submit required course documentation to the department either prior to the conduct of the course, for those courses that require prior authorization, or within a reasonable amount of time after the course is complete, for those courses that require course completion documentation submission.
History
- History: Effective January 1, 2006; amended effective January 1, 2008; July 1, 2010.
N.D. Admin. Code 33-36-02-13 Suspension or revocation process
The department may suspend or revoke a training institution's or individual's license after making a diligent effort to:
1.Inform the training institution or individual of the allegations.
2.Inform the training institution or individual of the department's investigation results.
3.Inform the training institution or individual of the department's intent to suspend or revoke and provide a notice of right to request hearing.
4.Provide the training institution or individual opportunity to request a hearing and rebut the allegations.
N.D. Admin. Code 33-36-02-14 Hearing
A request for hearing must be received by the department no later than twenty days following the training institution's or individual's receipt of the allegations. If a hearing is requested, the department will apply to the office of administrative hearings for appointment of a hearing officer. The department will notify any complainants and the accused of the date set for the hearing. The hearing officer will conduct the hearing and prepare recommended findings of fact and conclusions of law as well as a recommended order for the department. The department shall notify the training institution or individual of its findings in writing after receiving the hearing officer's finding of fact, conclusion of law, and recommended order.
N.D. Admin. Code 33-36-02-15 Waivers
Based on each individual case, the department may waive any provisions of this chapter.
Chapter 33-36-03 Scope of Practice for Unlicensed Emergency Medical Services Personnel
N.D. Admin. Code 33-36-03-01 Definitions
Words defined in chapter 23-27 of the North Dakota Century Code have the same meaning in this
chapter. For purposes of this chapter:
1."Advanced first-aid ambulance attendant" means a person that has fulfilled the training, testing, and certification process for advanced first-aid ambulance attendant as required in
chapter 33-36-01.
2."Airway adjuncts" means oxygen and oxygen delivery equipment, oropharyngeal airways, nasopharyngeal airways, bag-valve-mask ventilator, or any other mechanical ventilator or respiratory care equipment.
3."Cardiopulmonary resuscitation" means the American heart association health care provider standards or its equivalent which includes the skills adult one-person and two-person cardiopulmonary resuscitation, adult obstructed airway, child one-person and two-person cardiopulmonary resuscitation, child obstructed airway, infant cardiopulmonary resuscitation, infant obstructed airway, and automated external defibrillator.
4."Driver" means a person that is registered with the department as an uncertified crew member of a basic life support ambulance.
5."Emergency medical responder" means a person that has fulfilled the training, testing, and certification process for emergency medical responder as required in chapter 33-36-01.
6."Primary care provider" means a qualified individual responsible for the care of the patient and supervision of all ambulance personnel while on the ambulance run.
History
- History: Effective January 1, 2008; amended effective July 1, 2010.
- General Authority: NDCC 23-27-04.3
- Law Implemented: NDCC 23-27-04.3
N.D. Admin. Code 33-36-03-02 Scopes of practice
Each level of emergency medical services provider has a scope of practice that includes the scopes of practice of all subordinate emergency medical services providers. The hierarchy of emergency medical services providers is listed sequentially in this section.
1.Driver.
a.Scope. The driver's minimum scope of practice primarily focuses on driving the basic life support ambulance and assisting the other emergency medical services personnel on the ambulance crew with nonpatient care issues. The driver's maximum scope of practice is limited to providing cardiopulmonary resuscitation without mechanical resuscitation equipment or airway adjuncts but including the use of an automated external defibrillator if the driver is certified in cardiopulmonary resuscitation. A major difference between the layperson and the driver is the "duty to act" as part of an organized emergency medical services response.
b.Curriculum. The driver must hold a valid operator's license under chapter 39-06 of the North Dakota Century Code.
c.Occupational setting. Drivers may only participate in the emergency medical services system as part of a crew of a basic life support ambulance service or quick response unit. At no time may a driver respond without other higher level emergency medical services personnel.
d.Medical oversight. Because transport is an important part of the patient care continuum, a driver functions with physician oversight through protocol.
e.Supervision. A driver is supervised by the primary care provider.
2.Emergency medical responder.
a.Scope. The emergency medical responder core scope of practice includes simple, noninvasive skills focused on lifesaving interventions for critical patients based on assessment findings. The emergency medical responder renders onscene emergency care while awaiting additional emergency medical services response and may serve as
part of the transporting crew, but not as the primary care provider. An emergency medical responder is not prepared to make decisions independently regarding the appropriate disposition of patients. An emergency medical responder must function with an emergency medical technician or higher level personnel during the transportation of patients. The emergency medical responder's scope includes all of the skills included in the driver's scope. A major difference between a driver and an emergency medical responder is the training and skills to provide immediate lifesaving interventions.
b.Curriculum. The educational requirements include successful completion of a state-authorized emergency medical responder training program and continued educational requirements as defined in chapter 33-36-01.
c.Scope enhancements. Emergency medical responders may provide enhanced treatments beyond the core scope if they have successfully completed training as defined in section 33-36-01-04 and have authorization to perform those skills from their medical director.
d.Skills. Specific skills for the emergency medical responder are defined by the department. Local medical directors may limit the specific skills that an emergency medical responder may provide and they may not exceed those specific skills defined by the department.
e.Occupational setting. Emergency medical responders may participate in the emergency medical services system as a sole responder in a quick response unit or as part of the crew of a basic life support ambulance service but not as the primary care provider.
Emergency medical responders may also provide services to a private company or organization as part of a response team that is not offered to the public.
f.Medical oversight. An emergency medical responder provides medical care with physician oversight. A physician credentials the emergency medical responder and establishes patient care standards through protocol.
g.Supervision. An emergency medical responder may be the highest trained person on a quick response unit and may supervise other emergency medical responders or drivers.
As part of a basic life support ambulance crew, an emergency medical responder is supervised by the primary care provider.
3.Advanced first-aid ambulance attendant.
a.Scope. The advanced first-aid ambulance attendant's scope of practice is equal to the emergency medical technician's as defined in section 33-36-04-02.1. The advanced first-aid ambulance attendant's scope includes the skills in the first responder's scope and the driver's scope. The major difference between an advanced first-aid ambulance attendant and first responder is the knowledge and skills necessary to provide medical transportation of emergency patients.
b.Curriculum. The curriculum for advanced first-aid ambulance attendant is no longer supported. Therefore, no new advanced first-aid ambulance attendants can be trained.
Continued educational requirements are defined in chapter 33-36-01.
c.Scope enhancements. Advanced first-aid ambulance attendants may provide enhanced treatments beyond the core scope if they have completed training as defined in section 33-36-01-04 and have the authorization to perform those skills from their medical director.
d.Skills. Specific skills for the advanced first-aid ambulance attendant are defined by the department. Local medical directors may limit the specific skills that an advanced first-aid ambulance attendant may provide and they may not exceed those specific skills defined by the department.
e.Occupational setting. Advanced first-aid ambulance attendants may participate in the emergency medical services system as a sole responder in a quick response unit or as a primary care provider on a basic life support ambulance service. Advanced first-aid ambulance attendants may also provide services to a private company or organization as
part of a response team that is not offered to the public.
f.Medical oversight. An advanced first-aid ambulance attendant provides medical care with physician oversight. A physician credentials the advanced first-aid ambulance attendant and establishes patient care standards through protocol.
g.Supervision. An advanced first-aid ambulance attendant may be the primary care provider on a quick response unit or basic life support ambulance and may supervise other advanced first-aid ambulance attendants, first responders, or drivers.
History
- History: Effective January 1, 2008; amended effective July 1, 2010.
- General Authority: NDCC 23-27-04.3
- Law Implemented: NDCC 23-27-04.3
Chapter 33-36-04 Scope of Practice for Emergency Medical Services Professionals
N.D. Admin. Code 33-36-04-01 Definitions
Words defined in chapter 23-27 of the North Dakota Century Code have the same meaning in this
chapter. For purposes of this chapter:
1."Advanced emergency medical technician" means a person that has fulfilled the training, testing, certification, and licensure process for advanced emergency medical technician as required in chapter 33-36-01.
2."Emergency medical technician" means a person that has fulfilled the training, testing, certification, and licensure process for emergency medical technician as required in chapter 33-36-01.
3."Emergency medical technician-intermediate/85" means a person that has fulfilled the training, testing, certification, and licensure process for emergency medical technician-intermediate/85 as required in chapter 33-36-01.
4."Emergency medical technician-intermediate/99" means a person that has fulfilled the training, testing, certification, and licensure process for emergency medical technician-intermediate/99 as required in chapter 33-36-01.
5."Paramedic" means a person that has fulfilled the training, testing, certification, and licensure process for paramedic as required in chapter 33-36-01.
6."Primary care provider" means a qualified individual responsible for the care of the patient and supervision of all ambulance personnel while on the ambulance run.
History
- History: Effective January 1, 2008; amended effective July 1, 2010.
- General Authority: NDCC 23-27-04.3
- Law Implemented: NDCC 23-27-04.3
N.D. Admin. Code 33-36-04-02 Scopes of practice
Each level of emergency medical services professional has a scope of practice that includes the scopes of practice of all subordinate emergency medical services professionals and the scopes of all emergency medical services providers listed in chapter 33-36-03. The hierarchy of emergency medical services professionals is listed sequentially in this section.
1.Emergency medical technician.
a.Scope. The emergency medical technician's core scope of practice includes basic, noninvasive interventions to reduce the morbidity and mortality associated with acute out-of-hospital medical and traumatic emergencies. Emergency care is based on assessment findings. An emergency medical technician is not prepared to make decisions independently regarding the appropriate disposition of patients. The emergency medical technician may make destination decisions in collaboration with medical oversight. The principal disposition of the patient encounter will result in the direct delivery of the patient to an acute care facility. The primary differences between an advanced first-aid ambulance attendant and emergency medical technician are the educational and testing requirements required for licensure as an emergency medical technician.
b.Curriculum. The educational requirements include successful completion of a state-authorized emergency medical technician training program and continued educational requirements as defined in chapter 33-36-01.
c.Scope enhancements. Emergency medical technicians may provide enhanced treatments beyond the core scope if they have completed training as defined in section 33-36-01-04 and have authorization to perform those skills from their medical director.
d.Skills. Specific skills for the emergency medical technician are defined by the department. Local medical directors may limit the specific skills that an emergency medical technician may provide and they may not exceed those specific skills defined by the department.
e.Occupational setting. Emergency medical technicians may participate in the emergency medical services system as a sole responder in a quick response unit, as the primary care provider of a basic life support air or ground ambulance service, or as part of the crew of an advanced life support air or ground ambulance service. Emergency medical technicians may also provide services to a private company or organization as part of a response team that is not offered to the general public.
f.Medical oversight. An emergency medical technician provides medical care with physician oversight. A physician credentials the emergency medical technician and establishes patient care standards through protocol.
g.Supervision. An emergency medical technician may be the highest trained person on a quick response unit and as the primary care provider may supervise other emergency medical technicians, emergency medical responders, or drivers. As part of a basic life support ambulance crew, an emergency medical technician may supervise subordinate emergency medical services personnel. As part of an advanced life support ambulance service, an emergency medical technician is supervised by a paramedic.
2.Emergency medical technician-intermediate/85.
a.Scope. The scope of practice of an emergency medical technician-intermediate/85 includes basic, limited advanced interventions to reduce the morbidity and mortality associated with acute out-of-hospital medical and traumatic emergencies. Emergency care is based on assessment findings. An emergency medical technician-intermediate/85 is not prepared to make decisions independently regarding the appropriate disposition of patients. The emergency medical technician-intermediate/85 may make destination decisions in collaboration with medical oversight. The principal disposition of the patient encounter will result in the direct delivery of the patient to an acute care facility. The primary differences between an emergency medical technician and emergency medical technician-intermediate/85 are the basic, limited advanced interventions that an emergency medical technician-intermediate/85 may provide.
b.Curriculum. The core educational requirements include successful completion of a state-authorized emergency medical technician-intermediate/85 training program and
c.Scope enhancements. Emergency medical technicians-intermediate/85 may provide enhanced treatments beyond the core scope if they have completed training as defined in section 33-36-01-04 and have the authorization to perform those skills from their medical director.
d.Skills. Specific skills for the emergency medical technician-intermediate/85 are defined by department policy. Local medical directors, or hospitals if working in the hospital setting may limit the specific skills that an emergency medical technician-intermediate/85 may provide. They may not exceed those specific skills defined by department policy.
e.Occupational setting. Emergency medical technicians-intermediate/85 may participate in the emergency medical services system as a sole responder in a quick response unit, as the primary care provider of a basic life support air or ground ambulance service, or as
part of the crew of an advanced life support air or ground ambulance service. Emergency medical technicians-intermediate/85 may work for a hospital in a nonemergency setting or provide services to a private company or organization as part of a response team that is not offered to the general public.
f.Medical oversight. An emergency medical technician-intermediate/85 working in a prehospital setting provides medical care with physician oversight. In this circumstance a physician credentials the emergency medical technician-intermediate/85 and establishes patient care standards through protocol. An emergency medical technician-intermediate/85 working in a hospital setting is credentialed by the hospital.
g.Supervision. An emergency medical technician-intermediate/85 may be the highest trained person on a quick response unit and as the primary care provider may supervise other emergency medical technicians-intermediate/85, emergency medical technicians, first responders, or drivers. As part of a basic life support ambulance crew, an emergency medical technician-intermediate/85 may supervise subordinate emergency medical services personnel. As part of an advanced life support ambulance service an emergency medical technician-intermediate/85 is supervised by a paramedic.
Emergency medical technicians-intermediate/85 working in a hospital setting are supervised by nursing staff.
3.Advanced emergency medical technician.
a.Scope. The advanced emergency medical technician's scope of practice includes basic, limited advanced interventions to reduce the morbidity and mortality associated with acute out-of-hospital medical and traumatic emergencies. Emergency care is based on assessment findings. An advanced emergency medical technician is not prepared to make decisions independently regarding the appropriate disposition of patients. The advanced emergency medical technician may make destination decisions in collaboration with medical oversight. The principal disposition of the patient encounter will result in the direct delivery of the patient to an acute care facility. The primary differences between an emergency medical technician and advanced emergency medical technician are the basic, limited advanced interventions that an advanced emergency medical technician may provide.
b.Curriculum. The core educational requirements include successful completion of a state-authorized advanced emergency medical technician training program and
c.Skills. Specific skills for the advanced emergency medical technician are defined by department policy. Local medical directors, or hospitals if working in the hospital setting, may limit the specific skills that an advanced emergency medical technician may provide.
They may not exceed those specific skills defined by department policy.
d.Occupational setting. Advanced emergency medical technicians may participate in the emergency medical services system as a sole responder in a quick response unit, as the primary care provider of a basic life support air or ground ambulance service, or as part of the crew of an advanced life support air or ground ambulance service. Advanced emergency medical technicians may work for a hospital in a nonemergency setting or provide services to a private company or organization as part of a response team that is not offered to the general public.
e.Medical oversight. An advanced emergency medical technician working in a prehospital setting provides medical care with physician oversight. In this circumstance, a physician credentials the advanced emergency medical technician and establishes patient care standards through protocol. An advanced emergency medical technician working in a hospital setting is credentialed by the hospital.
f.Supervision. An advanced emergency medical technician may be the highest trained person on a quick response unit and as the primary care provider may supervise other advanced emergency medical technicians, emergency medical technicians, first responders, or drivers. As part of a basic life support ambulance crew, an advanced emergency medical technician may supervise subordinate emergency medical services personnel. As part of an advanced life support ambulance service an advanced emergency medical technician is supervised by a paramedic. Emergency medical technicians working in a hospital setting are supervised by nursing staff.
4.Emergency medical technician-intermediate/99.
a.Scope. The scope of practice of an emergency medical technician-intermediate/99 includes basic, limited advanced and pharmacological interventions to reduce the morbidity and mortality associated with acute out-of-hospital medical and traumatic emergencies. Emergency care is based on assessment findings. An emergency medical technician-intermediate/99 is not prepared to make decisions independently regarding the appropriate disposition of patients. The emergency medical technician-intermediate/99 may make destination decisions in collaboration with medical oversight. The principal disposition of the patient encounter will result in the direct delivery of the patient to an acute care facility. The primary differences between an emergency medical technician-intermediate/85 and emergency medical technician-intermediate/99 are the limited pharmacological interventions that an emergency medical technician-intermediate/99 may provide.
b.Curriculum. The core educational requirements include successful completion of a state-authorized emergency medical technician-intermediate/99 training program and
c.Scope enhancements. Emergency medical technicians-intermediate/99 may provide enhanced treatments beyond the core scope if they have completed training as defined in section 33-36-01-04 and have the authorization to perform those skills from their medical director.
d.Skills. Specific skills for the emergency medical technician-intermediate/99 are defined by department policy. Local medical directors, or hospitals if working in the hospital setting, may limit the specific skills that an emergency medical technician-intermediate/99 may provide. They may not exceed those specific skills defined by department policy.
e.Occupational setting. Emergency medical technicians-intermediate/99 may participate in the emergency medical services system as a sole responder in a quick response unit, as the primary care provider of a basic life support air or ground ambulance service, or as
part of the crew of an advanced life support air or ground ambulance service. Emergency medical technicians-intermediate/99 may work for a hospital in a nonemergency setting or provide services to a private company or organization as part of a response team that is not offered to the general public.
f.Medical oversight. An emergency medical technician-intermediate/99 working in a prehospital setting provides medical care with physician oversight. In this circumstance a physician credentials the emergency medical technician-intermediate/99 and establishes patient care standards through protocol. An emergency medical technician-intermediate/99 working in a hospital setting is credentialed by the hospital.
g.Supervision. An emergency medical technician-intermediate '99 may be the highest trained person on a quick response unit and as the primary care provider may supervise other emergency medical technicians-intermediate/99, emergency medical technicians-intermediate/85, emergency medical technicians, emergency medical responders, or drivers. As part of a basic life support ambulance crew, an emergency medical technician-intermediate/99 may supervise subordinate emergency medical services personnel. As part of an advanced life support ambulance service an emergency medical technician-intermediate/99 is supervised by a paramedic.
Emergency medical technicians-intermediate/99 working in a hospital setting are supervised by nursing staff.
5.Paramedic.
a.Scope. The paramedic's scope of practice includes invasive and pharmacological interventions to reduce the morbidity and mortality associated with acute out-of-hospital medical and traumatic emergencies. Emergency care is based on an advanced assessment and the formulation of a field impression. The paramedic may make destination decisions in collaboration with medical oversight. The principal disposition of the patient encounter will result in the direct delivery of the patient to an acute care facility. The major difference between the paramedic and the emergency medical technician-intermediate/99 is the ability to perform a broader range of advanced skills.
These skills carry a greater risk for the patient if improperly or inappropriately performed, are more difficult to attain and maintain competency in, and require significant background knowledge in basic and applied sciences.
b.Curriculum. The core educational requirements include successful completion of a state-authorized paramedic training program and continued educational requirements as defined in chapter 33-36-01.
c.Skills. Specific skills for the paramedic are defined by department policy. Local medical directors, or hospitals if working in the hospital setting, may limit the specific skills that a paramedic may provide and they may not exceed those specific skills defined by department policy.
d.Occupational setting. Paramedics may participate in the emergency medical services system as a sole responder in a quick response unit, as the primary care provider of a basic life support air or ground ambulance service, as the primary care provider of an advanced life support air or ground ambulance service, or as the primary care provider of a critical care air ambulance service. Paramedics may work for a hospital in an emergency or nonemergency setting or provide services to a private company or organization as part of a response team that is not offered to the general public.
e.Medical oversight. A paramedic working in a prehospital setting provides medical care with physician oversight. In this circumstance a physician credentials the paramedic and establishes patient care standards through protocol. A paramedic employed by and working in a hospital setting is credentialed by the hospital.
f.Supervision. A paramedic may supervise all subordinate levels of emergency medical services personnel. Paramedics working in a hospital setting are supervised by the hospital's nurse executive.
History
- History: Effective January 1, 2008; amended effective July 1, 2010.
- General Authority: NDCC 23-27-04.3
- Law Implemented: NDCC 23-27-04.3
Article 33-37 Epinephrine Administration
Chapter 33-37-01 Epinephrine Administration
N.D. Admin. Code 33-37-01-01 Persons eligible to administer epinephrine
A person whose employment creates a reasonable expectation to care for the health and safety of others may administer epinephrine to persons suffering from an anaphylactic reaction. A person who is deemed to have a reasonable expectation to care for the health and safety of others includes a teacher, camp counselor, day care operator, and security person. Prehospital emergency medical services personnel must meet the requirements specified in chapter 33-36-01.
N.D. Admin. Code 33-37-01-02 Training requirements
A person authorized to administer epinephrine under this chapter shall complete training by a physician licensed by the North Dakota state board of medical examiners or the physician's designee.
The physician shall determine the training content, criteria for satisfactory completion, and frequency.
The physician shall maintain a record of the training which identifies the individuals trained, the training content, and the date of the training. The physician shall make training records available to the state department of health upon request.
N.D. Admin. Code 33-37-01-03 Administration devices
A person authorized to administer epinephrine shall utilize a single use disposable device that automatically injects a premeasured dose. The device may be obtained by a trained person from a pharmacy upon the request of a licensed physician. The device must be stored and maintained where trained staff are present.
Article 33-38 State Trauma System
Chapter 33-38-01 Trauma System Regulation
N.D. Admin. Code 33-38-01-01 Definitions
Words defined in North Dakota Century Code chapter 23-01.2 have the same meaning in this
chapter. As used in this chapter:
1."Advanced trauma life support" means the most current edition of the course as developed by the American college of surgeons - committee on trauma, or its equivalent, as determined by the department.
2."Department" means the state department of health.
3."Emergency medical services" means the system of personnel who provide medical care from the time of injury to hospital admission.
4."Local emergency medical services transport plans" means plans developed by emergency medical services, medical directors, and hospital officials which establish the most efficient method to transport trauma patients.
5."Major trauma patient" means any patient that meets the criteria in step one or two of the field triage decision scheme provided by the American college of surgeons, committee on trauma, as published by the most current edition of the Resources for Optimal Care of the Injured Patient.
6."Online medical control" consists of directions given over the telephone or by radio directly from the medical director or designated physician.
7."Provisional designation" means a state process of designating a facility as a trauma center based on American college of surgeons or department standards for a period determined by the department and the state trauma committee or until an American college of surgeons verification visit or state designation visit is completed.
8."Trauma" means tissue damage caused by the transfer of thermal, mechanical, electrical, or chemical energy, or by the absence of heat or oxygen.
9."Trauma center" means a facility that has made a commitment to serve the trauma patient, has met the standards of the trauma system, and has obtained designation as a trauma center.
10."Trauma code" includes the activation and assembly of the trauma team to provide care to the major trauma patient.
11."Trauma quality improvement program" means a system of evaluating the prehospital, trauma center, and rehabilitative care of trauma patients.
12."Trauma registry" includes the collection and analysis of trauma data from the trauma system.
13."Trauma team" includes a group of health care professionals organized to provide care to the trauma patient.
N.D. Admin. Code 33-38-01-02 Trauma system
A statewide trauma system shall be adopted by the state health council. The trauma system shall consist of the following:
1.Standardized definition of major trauma patient.
2.Trauma code activation protocols.
3.Local emergency medical services transport plans.
4.Trauma center designation process.
5.Revocation of trauma center designation process.
6.Statewide trauma registry.
7.Quality improvement process.
8.State trauma committee.
9.Four regional trauma committees.
10.Injury prevention.
N.D. Admin. Code 33-38-01-03 Activation of trauma codes for trauma patients
Emergency medical services and trauma centers shall assess patients and activate a trauma code.
1.Emergency medical services must activate a trauma code if the trauma patient meets one or more of the criteria in step one, two, or three of the field triage decision scheme, provided by the current edition of the American college of surgeons Resources for Optimal Care of the Injured Patient. Step four of the field triage scheme may be used as discretionary criteria for activating trauma code. The field triage scheme is used as a minimal standard and additional activation criteria may be added.
2.A level I, level II, or level III trauma center must follow the minimum criteria for highest level of activation set by the American college of surgeons committee on trauma.
3.A level IV and level V trauma center must activate a trauma code if the trauma patient meets one or more of the criteria in step one, two, or three of the field triage decision scheme, provided by the current edition of the American college of surgeons Resources for Optimal Care of the Injured Patient. Step four of the field triage scheme may be used as discretionary criteria for activating trauma code. The field triage scheme is used as a minimal standard and additional activation criteria may be added.
N.D. Admin. Code 33-38-01-04 Emergency medical services
All emergency medical services licensed or certified by the department shall establish each of the following:
1.Trauma code activation protocols.
2.Trauma patient care protocols that have been reviewed and approved by a medical director.
3.Local emergency medical services transport plans.
History
- History: Effective July 1, 1997.
N.D. Admin. Code 33-38-01-05 Local emergency medical services transport plans
Emergency medical services shall develop local emergency medical services transport plans for the transport of trauma patients meeting the criteria in step one, two, three, or four of the field triage decision scheme, provided by the current edition of the American college of surgeons Resources for Optimal Care of the Injured Patient by appropriate means to the nearest designated trauma center.
1.Emergency medical services may bypass the nearest designated trauma center for a higher level trauma center provided that it does not result in an additional thirty minutes or more of transport time. If the additional transport time would be greater than thirty minutes, the transporting emergency medical services personnel must contact online medical direction for permission to bypass or as defined in the transport protocol.
2.If there are multiple trauma centers in the community, the major trauma patient meeting one or more of the criteria in step one or two of the field triage decision scheme provided by the current edition of the American college of surgeons Resources for Optimal Care of the Injured Patient should be taken to a trauma center per local emergency medical trauma transport plans approved by the department and state trauma committee.
N.D. Admin. Code 33-38-01-06 Trauma center designation
1.Five levels of hospital designation must be established.
2.Hospitals applying for level I, level II, or level III designation shall present evidence of having current trauma center verification from the American college of surgeons. The department shall issue designation with an expiration date consistent with the American college of surgeons verification expiration date.
3.Hospitals applying for level IV and level V trauma center designation must submit an application to the department. Once the application is approved by the department, an onsite verification visit shall be conducted by the department or its designee. The verification team shall compile a report. The application and report will be reviewed by the state trauma committee. If approved, the department shall issue the designation for up to three years to the facility.
4.Hospitals without trauma center designation or currently designated as a level IV or level V trauma center planning to apply for a level I, level II, or level III trauma center designation may apply for a provisional designation by submitting an application to the department. Once the application is approved by the department, an onsite visit shall be conducted by a team designated by the state trauma committee. The team shall compile a report. The application and report will be reviewed by the state trauma committee. If approved, the department shall issue a provisional designation for a maximum of twenty-four months. During these twenty-four months, the facility must complete an American college of surgeons verification visit.
5.Provisional trauma center designations for level I, level II, or level III trauma centers may be issued by the department to hospitals with deficiencies identified by the American college of surgeons and that are partially compliant with the trauma center standards. Hospitals must submit a plan of correction within one month after notification for deficiencies that are identified by the verification team. The plan of correction will be reviewed by the state trauma committee. If approved, the department may issue a provisional designation to the hospital for up to eighteen months or until another American college of surgeons verification visit is completed.
6.Provisional trauma center designations for level IV and level V trauma centers may be issued by the department to hospitals with deficiencies identified by the site survey team and reviewed by the state trauma committee and are partially compliant with the trauma center standards. Hospitals must submit a plan of correction within one month after notification for deficiencies that are identified by the site survey team. The plan of correction will be reviewed by the state trauma committee. If approved, the department may issue a provisional designation for up to twelve months to the hospital or until another state designation visit is completed.
7.The health council, in establishing a comprehensive trauma system, may designate an out-of-state hospital as a trauma center within fifty miles of any border of North Dakota.
N.D. Admin. Code 33-38-01-07 Trauma center revocation of designation
The department may revoke designation of a trauma center if evidence exists that the facility does not meet the required trauma center standards. The department or its designee may inspect any trauma center or applicant for trauma center designation at any time for compliance with the standards.
Designation must be revoked if a facility denies or refuses inspection.
Failure to follow an approved plan of correction or maintain trauma center designation standards will result in:
1.Revocation of the trauma center's designation.
2.Notification to the division of health facilities regarding the failure to comply with state law.
3.Placement of a public notice in the newspapers in the area which the hospital is located to notify the public of the enforcement action to be imposed and the effective dates. The department shall notify the hospital in writing of the impending notice fifteen days prior to the publication of the notice.
N.D. Admin. Code 33-38-01-08 State trauma registry
The department shall establish a trauma registry including the minimum data elements. All hospitals must report the minimum data elements to the department.
Reporting shall occur by a method approved by the department. Information may not be released from the state trauma registry except as permitted by North Dakota Century Code sections 23-01-15 and 23-01-02.1.
N.D. Admin. Code 33-38-01-09 Quality improvement process
A quality improvement process shall be established by the state trauma committee. The process must include evaluation criteria that will provide guidelines for acceptable standards of care, address system issues, and monitor patient outcomes.
The regional committees shall evaluate the trauma system within their regions based upon the evaluation criteria. The regional trauma committee shall make recommendations to emergency medical services and trauma centers in the development of plans to improve the system.
N.D. Admin. Code 33-38-01-10 State trauma committee membership
The state trauma committee membership must include the following:
1.One member from the North Dakota committee on trauma - American college of surgeons, appointed by the committee.
2.One member from the American college of emergency physicians - North Dakota chapter, appointed by the chapter.
3.One member from the North Dakota health care association, appointed by the association.
4.One member from the North Dakota medical association, appointed by the association.
5.One member from the North Dakota EMS association - basic life support, appointed by the association.
6.One member from the North Dakota EMS association - advanced life support, appointed by the association.
7.One member from the North Dakota nurses association, appointed by the association.
8.One member on the faculty of the university of North Dakota school of medicine and health sciences, appointed by the dean of the medical school.
9.One member from the North Dakota emergency nurses association, appointed by the association.
10.One member from Indian health service, appointed by the Aberdeen area director of the service.
11.One member from accredited trauma rehabilitation facilities, appointed by the state health council.
12.One member who is a hospital trauma coordinator, appointed by the trauma coordinators committee.
13.The medical director of the division of emergency medical services and trauma of the department.
14.The regional trauma committee chair from each region, if not representing an association.
15.One member representing injury prevention, appointed by the health council.
16.One member representing the public appointed by the health council.
17.One member representing the legislative assembly selected by the health council.
18.One member representing emergency preparedness and response appointed by the department.
19.One member representing pediatric physicians appointed by the North Dakota American academy of pediatrics.
20.Four additional ad hoc members, appointed by the health council.
N.D. Admin. Code 33-38-01-11 Trauma regions - Regional trauma committee
The state trauma committee shall establish four trauma regions. The regions must be designated northwest, northeast, southeast, and southwest. An emergency medical service or trauma center that is located within fifteen miles [24.14 kilometers] of a regional boundary may request to function within another region. This request shall be reviewed and is subject to approval by the state trauma committee.
The state trauma committee shall appoint a regional trauma committee to serve each trauma region. The regional committees may consist of members representing the following:
1.North Dakota committee on trauma - American college of surgeons.
2.North Dakota chapter of American college of emergency physicians.
3.Physician of a level IV and level V trauma center.
4.Level IV or level V hospital representative.
5.All hospital trauma coordinators within the region.
6.Accredited rehabilitation facility representative.
7.Indian health service or tribal government representative.
8.North Dakota EMS association.
9.Other members, chosen by the state trauma committee.
N.D. Admin. Code 33-38-01-12 Trauma center name restriction
No health care facility in North Dakota may use the title "trauma center" or otherwise hold itself out as a trauma center unless the facility is designated by the department as a trauma center.
History
- History: Effective July 1, 1997.
N.D. Admin. Code 33-38-01-13 Level IV trauma center designation standards
The following standards must be met to achieve level IV designation:
1.Trauma team activation plan.
2.Trauma team leader must be a physician currently certified in advanced trauma life support who is on call and available within twenty minutes. If the trauma team leader is not current in advanced trauma life support, the facility must provide a backup physician that is current in advanced trauma life support to assess and evaluate the trauma patients meeting step one, two, or three of the field triage decision scheme, provided by the current edition of the American college of surgeons Resources for Optimal Care of the Injured Patient when the noncertified physician is on call. If backup cannot be provided, the facility must go on diversion and notify the surrounding emergency medical services and the department.
3.The facility must have transfer agreements with facilities capable of caring for major trauma patients, burn care, pediatric trauma management, acute spinal cord and traumatic brain injury management, and rehabilitation services for long-term care.
4.Equipment for resuscitation and life support as determined by the department and state trauma committee.
5.Quality improvement programs, to include:
a.Focused audit of selected criteria.
b.Trauma registry in accordance with section 33-38-01-08.
c.Focused audit for all trauma deaths.
d.Morbidity and mortality review.
e.Medical nursing audit, utilization review, and issue review.
6.Trauma transfer protocol to identify trauma patients whose condition may require care which exceeds current resources available.
History
- History: Effective June 1, 2001; amended effective July 1, 2010.
N.D. Admin. Code 33-38-01-14 Level V trauma designation standards
The following standards must be met to achieve level V designation:
1.Trauma team activation plan.
2.Trauma team leader must be on call and available within twenty minutes. The trauma team leader must be one of the following:
a.A physician who is current in advanced trauma life support.
b.A physician assistant, whose supervising physician has delegated to the physician assistant the authority to provide care to trauma patients and is current in advanced trauma life support.
c.A nurse practitioner whose scope of practice entails the care of trauma patients, is current in advanced trauma life support, and whose scope of practice is approved by the state board of nursing.
d.If the trauma team leader is not current in advanced trauma life support, the facility must provide a backup team leader that is current in advanced trauma life support to assess and evaluate the trauma patients meeting step one, two, or three of the field triage decision scheme, provided by the current edition of the American college of surgeons Resources for Optimal Care of the Injured Patient when the noncertified provider is on call. If backup cannot be provided, the facility must go on diversion and notify the surrounding emergency medical services and the department.
3.The facility must have transfer agreements with facilities capable of caring for major trauma patients, burn care, pediatric trauma management, acute spinal cord and traumatic brain injury management, and rehabilitation services for long-term care.
4.Equipment for resuscitation and life support as determined by the department.
5.Quality improvement programs to include:
a.Focused audit of selected criteria.
b.Trauma registry in accordance with section 33-38-01-08.
c.Focused audit for all trauma deaths.
d.Morbidity and mortality review.
e.Medical nursing audit, utilization review, and issue review.
f.Current advanced trauma life support certified physician review of all trauma codes managed by a physician assistant or nurse practitioner within seventy-two hours. This may be either the consulting or transfer receiving physician.
6.Trauma transfer protocols to identify trauma patients whose condition may require care which exceeds current resources available.
History
- History: Effective June 1, 2001; amended effective July 1, 2010.
Article 33-39 Lodging Establishments
Chapter 33-39-01 Lodging Establishment Sanitation Standards
N.D. Admin. Code 33-39-01-01 Definitions
For purposes of this chapter:
1."Approved" means acceptable to the department based on compliance with applicable standards and public health practices.
2."Clean" means free of visible stains, foreign material, organic material, soil, dirt, dust, sludge, grease, rubbish, garbage, slime, algae, fungi, mold, rust, mineral deposits, food debris, and other offensive, unsightly, or extraneous matter.
3."Cleaning" means the removal of visible stains, foreign material, organic material, soil, dirt, dust, sludge, grease, rubbish, garbage, slime, algae, fungi, mold, rust, mineral deposits, food debris, and other offensive, unsightly, or extraneous matter from objects and is normally accomplished using water with detergents or enzymatic products and is required before sanitization or disinfection.
4."Department" means the department of health and human services.
5."Equipment" means an article that is used in the operation of a food establishment such as a freezer, microwave, hood, ice maker, mixer, oven, reach-in refrigerator, sink, slicer, stove, table, temperature measuring device for ambient air, coffee machine, or warewashing machine.
6."Extensively remodeled" means significant physical changes to all or part of an establishment, including upgrades or replacement of major systems, such as the electrical, plumbing, heating, or ventilation systems, demolition of interior or exterior areas, or installation or removal of walls. Extensively remodeled does not include routine replacements of equipment, furnishings, or fixtures that do not require new plumbing or electrical work.
7."Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.
8."Furnishings" means all articles or objects used in the establishment such as draperies, beds, mattresses, appliances, furniture, lamps, floor coverings, and decorative items.
9."Good repair" means free of corrosion, breaks, leaks, cracks, chips, pitting, excessive wear and tear, obstructions, and similar defects to constitute a good and sound condition which is fully operational for the purpose intended.
10."Guest" means a transient guest occupant of a guest room in a lodging establishment.
11."Guest room" means any room used or intended to be used by a transient guest for sleeping accommodations.
12."Imminent health hazard" means a fire, significant flooding, sewage backup, infestation, misuse of poisonous or toxic materials, evidence of water systems or recreational water facilities contaminated with legionella bacteria, gross unsanitary occurrence or condition, or any other condition that could endanger the health and safety of guests, employees, or the general public.
13."Infestation" means the presence of pests, including bed bugs, cockroaches, or rodents, which is indicated by observation of living or dead pests or pest carapace, eggs or egg casings, or the typical brownish or blood-colored spotting on linens, mattresses, or furniture, or the presence of pest droppings.
14."Linen" means a cloth item used in the lodging establishment, such as a sheet, bedspread, blanket, quilt, pillowcase, mattress pad, towel, and washcloth.
15."Lodging establishment" means any hotel, motel, resort, building, or structure that is kept, used, maintained, or held out to the public as a place where sleeping accommodations are furnished to transient guests for charge. The term does not include:
a.Single structures with five or fewer guest rooms and ten or fewer total occupants;
b.A series or group of buildings or structures containing five or fewer guest rooms and ten or fewer total occupants operated as one entity under a single ownership on the same property or physical location;
c.A facility providing personal care services directly through contract services as defined in North Dakota Century Code section 23-09.3-01 or 50-32-01; or
d.Primitive lodging cabins, lodges, or ranches.
16."Pest" means any unwanted animal, including a rodent and insect, which is a potential vector for human disease or presents a risk to public health.
17."Plumbing fixture" means a receptacle, device, or appliance such as a toilet, sink, shower, and faucet, which is supplied with water or receives liquid or liquid-borne wastes and discharges such wastes into the drainage system to which it may be directly or indirectly connected.
18."Primitive lodging cabins, lodges, or ranches" means a cabin, lodge, or ranch that does not have indoor plumbing and may consist of a permanent structure such as a hut or cabin with walls and a floor or a moveable structure with fabric coverings such as a dome or a yurt.
19."Sanitizing solution" means a pesticide used to kill bacteria and other microorganisms that may be present on surfaces used to prepare, serve, transport, and store food.
20."Single-service articles" means tableware, carry-out utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one-time, one-individual use after which they are intended for disposal.
21."Single-use articles" means utensils and bulk food containers designed and constructed to be used once and discarded, such as wax paper, butcher paper, plastic wrap, aluminum containers, jars, plastic tubs, ketchup bottles, and number ten cans, which do not meet the standards under chapter 33-33-04.1.
22."Time and temperature control for safety food" means a food that requires time and temperature control for safety to limit pathogenic microorganism growth or toxin formation.
23."Utensil" means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware, tableware, and ice buckets, which are multiuse, single-service, or single-use; gloves used in contact with food; and temperature-sensing probes of food temperature measuring devices.
24."Warewashing" means the cleaning and sanitizing of utensils and food-contact surfaces of equipment.
A lodging establishment shall:
1.Post the current license in a location of the lodging establishment which is conspicuous to the public.
2.Ensure no room or any portion of the lodging establishment is used unless the room or portion of the lodging establishment is safe and sanitary.
3.Ensure the safe operation and maintenance of the lodging establishment including:
a.All floors, walls, and ceilings of the general premises must be maintained clean and in good repair;
b.Repairs, construction, renovations, and maintenance must be conducted in a manner that provides safeguards as required by applicable state and local building and fire codes for guests and the public;
c.Handrails and guardrails must be firmly fastened and maintained clean and in good repair inside and outside the establishment;
d.All guest rooms and other areas used by guests or the public in which lighting, either natural or artificial, is essential to efficient business operations, must be well lit; and
e.Carpeting in toilet rooms, bathing facilities, and kitchens is prohibited.
4.Except as otherwise provided in this chapter, ensure the water supply system:
a.Is constructed, maintained, and operated in accordance with applicable law;
b.Provides only potable water obtained from an approved source; and
c.Provides sufficient potable water under pressure to meet the needs of the entire lodging establishment.
5.Except as otherwise provided in this chapter, ensure the plumbing system:
a.Is installed and maintained in accordance with all applicable state and local plumbing codes, and in the absence of local plumbing codes, all plumbing must be installed and maintained by a licensed plumber;
b.Provides potable water under pressure at all times at each plumbing fixture designed to provide water; and
c.Provides hot water capacity sufficient to meet the demands of the entire lodging establishment at each plumbing fixture designed to use hot water.
6.Except as otherwise provided in this chapter, ensure the sewage system disposes of all wastewater through an approved method, including one of the following:
a.A city or public sewage system; or
b.A private sewage disposal system that is constructed, maintained, and operated in accordance with the applicable state and local codes and regulatory requirements.
7.Ensure the electrical system is:
a.Installed and maintained in accordance with all applicable state and local electrical codes and in the absence of local electrical codes, the electrical wiring must be installed and maintained by a licensed electrician;
b.Adequate to maintain all premises lighting; and
c.Monitored to prohibit the use of light bulbs that exceed the wattage rating of the corresponding light fixture and empty light sockets.
8.Ensure adequate heating and ventilation is installed and maintained in accordance with all applicable state and local requirements and according to the manufacturer's specifications, including:
a.Bathrooms, toilet rooms, and laundry rooms must be provided with either natural ventilation or mechanical ventilation connected directly to the outside;
b.All gas water heaters, gas furnaces, and other gas heating appliances must be provided with ventilation to the outside;
c.Each furnace room or room containing a gas water heater or any other fuel-fired appliance must be provided with adequate air for circulation; and
d.Mechanical clothes dryers must be vented to the outside air. If vented to the outside air, the discharge may not create a health hazard.
History
- Law Implemented: NDCC 23-09-02 33-39-01-01.1. General requirements for lodging establishments.
- Law Implemented: NDCC 23-09-09, 23-09-10, 23-09-16
N.D. Admin. Code 33-39-01-02 Personnel - Employee health, cleanliness, and clothing
1.An individual while infected with any communicable disease or a carrier of such a disease, or while having symptoms of boils, infected wounds, or sores must be excluded by the lodging establishment from any area of a lodging establishment in any capacity in which there is a likelihood of transmission of disease to other employees or guests in the normal course of employment.
2.Employees shall wear clean outer clothing and maintain personal cleanliness while on duty.
3.Employees shall wash hands thoroughly before starting work and as often as necessary to remove soil and contamination after using the toilet room or any other activity that contaminates the hands. Employees shall use sinks designated for handwashing and are prohibited from using mop sinks and ware washing sinks for handwashing.
N.D. Admin. Code 33-39-01-03 Ice and ice dispensing
A lodging establishment shall meet the following requirements:
1.Ice must be manufactured, stored, transported, and handled in a manner approved by the department.
2.Ice, if provided in a public area to guests or the general public, must be provided through an automatic self-service dispensing machine only. The automatic self-service dispensing machine must be constructed to prevent direct access to bulk ice storage compartments by guests or the general public.
3.Ice machines other than the type specified in subsection 2 which allow direct access to the bulk ice storage compartments must only be accessible to employees, and:
a.Employees shall wash their hands prior to dispensing in accordance with chapter 33-33-04.1;
b.Employees shall dispense ice with scoops, tongs, or other ice-dispensing utensils;
c.Ice-dispensing utensils must be stored on a clean surface or in the ice with the dispensing handle extending out of the ice; and
d.Scooping of ice with a cup, glass, or similar container is prohibited.
4.Processes and controls must be designed and monitored to ensure all ice and ice-dispensing equipment is clean to sight and touch and maintained in accordance with the manufacturer's specifications such that neither the product nor the product area is subject to contamination.
5.Ice-dispensing utensils must be cleaned and sanitized in accordance with section 33-39-01-05 and a minimum of once every twenty-four hours or any time contamination may have occurred.
6.Ice machines used on the premises must be cleaned and sanitized in accordance with the manufacturer's specifications at the frequency recommended by the manufacturer.
N.D. Admin. Code 33-39-01-04 Guest rooms
1.A lodging establishment shall provide toilet, sink, bathing or shower facilities, and plumbing fixtures in accordance with all state and local building and plumbing codes, including:
a.All plumbing fixtures must be provided with hot and cold running water under pressure at a maximum temperature of one hundred twenty degrees Fahrenheit [48.9 degrees Celsius] at the tap.
b.Bathing or shower facilities must have a nonslip floor surface: and
c.Toilets, sinks, bathing and shower facilities, and plumbing fixtures must be kept clean, sanitary, and in good repair when the guest room is in use and between each guest.
2.A lodging establishment's guest room must have walls, floors, ceilings, doors, windows, and all furnishings constructed of materials intended for its utilized purpose, maintained in good repair, and cleaned, painted, or replaced as necessary with regard to the health and safety of each guest.
3.The use of portable electrical or open-flame cooking devices in guest rooms is prohibited.
4.A lodging establishment's guest room must be equipped with bolts or locks in accordance with North Dakota Century Code chapter 23-09-08:
a.At least one secondary lock, such as a deadbolt lock, thumb bolt, chain lock, or similar device, must be provided in addition to the primary lock, and must be installed in accordance with the manufacturer's specifications;
b.Each key, entry code, or key card furnished to each guest may not unlock the door to any other guest room;
c.Connecting guest rooms must have two doors in the connecting doorway. Each door must be equipped with a deadbolt lock on only the guest's side of the door; and
d.All locks must be in good repair and operational.
5.A guest room that has any visible mold-like substance may not be used until the source is remediated and cleanup is completed.
6.A lodging establishment that allows pets into any guest room conspicuously shall provide notice to guests that the establishment is "pet friendly".
History
- Law Implemented: NDCC 23-09-08, 23-09-09
N.D. Admin. Code 33-39-01-05 Utensil and equipment warewashing
1.A lodging establishment shall meet the following requirements:
a.All utensil and equipment warewashing must be in compliance with chapter 33-33-04.1, except as provided under subsection 2;
b.Sanitizing solutions must comply with chapter 33-33-04.1;
c.After warewashing, all utensils and equipment must be permitted to drain and air dry and must be handled in a manner that prevents contamination;
d.After drying and until use, all contact surfaces of equipment and utensils must be wrapped, sealed, or stored in a manner that protects them from contamination; and
e.All utensils and equipment intended for repeat use must be made of safe, durable, and nonabsorbent material and must be kept in good repair, and no cracked or chipped utensils or equipment may not be provided for use by guests or employees.
2.A lodging establishment may provide utensils and equipment in a guest room if the following notice conspicuously is posted within the guest room:
"Notice to Guests: Utensils and equipment have been provided in this room for guest convenience. These items have been cleaned within this room using ordinary household dishwashing facilities and agents. They have not been sanitized according to federal and state standards for public food service establishments."
N.D. Admin. Code 33-39-01-06 Single-service and single-use articles
1.Lodging establishments which do not have facilities for warewashing utensils and equipment that meet the requirements in chapter 33-33-04.1 may only use single-service or single-use articles and shall meet the following requirements:
a.All single-service and single-use articles must be constructed of safe, durable, and nonabsorbent materials; and
b.All single-service or single-use articles must be stored, handled, and dispensed in a sanitary manner and may be used only once.
2.The use of common drinking containers in public places is prohibited.
N.D. Admin. Code 33-39-01-07 Beds and linen
1.Lodging establishments shall provide linens for each guest and the linens must be sufficient in quantity and appropriately sized for the bed, bunk, or cot to be occupied by the guest, or each guest must be informed prior to their stay that linens are not provided.
2.Lodging establishments shall ensure:
a.All linens used by one guest are washed and mechanically dried before being furnished to another guest;
b.All linens and furnishings are kept clean, in good repair, stored in a sanitary manner, and repaired or replaced as necessary;
c.Soiled linens and furnishings are kept separate from clean linens to prevent cross-contamination;and
d.All clean linens are stored on smooth, nonabsorbent, cleanable surfaces located a minimum of six inches [152.4 millimeters] above the floor.
N.D. Admin. Code 33-39-01-08 Housekeeping and laundry facilities
1.All parts of the lodging establishment and its premises must be kept neat, clean, and free from litter and rubbish.
2.Cleaning operations must be conducted by the lodging establishment in a manner that minimizes contamination of facilities.
3.A lodging establishment shall ensure guest rooms are cleaned between each guest.
4.Guests may request no housekeeping activities be completed during their stay.
5.All toilet paper and, if provided, prepackaged toiletry items, must be replenished as necessary.
6.All toilets, sinks, bathtubs, and shower facilities must be adequately cleaned and sanitized between each guest.
7.A lodging establishment shall ensure housekeeping and laundry facilities and equipment are clean and maintained in good repair.
8.Each housekeeping cart must be designed, maintained, and operated to protect clean glasses, utensils, dishware, single-service articles, food, coffee, and condiments from dirty linens and other sources of contamination, including dirty glasses and dishware, cleaning and sanitizing agents, and poisonous or toxic materials.
9.The laundry facilities and equipment must be kept clean and free from accumulated lint and dust.
10.All laundry equipment must be functional and in good repair.
11.Clean linens may not be contaminated by dirty linens or other contaminants.
N.D. Admin. Code 33-39-01-09 Water recreation facilities
All water recreation facilities, including swimming pools, spas, and water slides operated by a lodging establishment and used by guests or the general public must be:
1.Designed, constructed, and maintained to protect the health and safety of its guests; and
2.Licensed and inspected by the applicable regulatory authority and in compliance with all state and local requirements. All records of licensure and inspection must be maintained onsite for at least one year and must be made available upon request.
N.D. Admin. Code 33-39-01-10 Submission of plans
1.Whenever a lodging establishment is constructed or extensively remodeled, properly prepared plans and specifications for such construction or remodeling must be submitted to the department for review and approval before construction or remodeling is begun. The plans and specifications must:
a.Indicate the proposed layout, arrangement, and construction materials, paying particular attention to all fire or life safety provisions required by law; and
b.Include additional documentation as required by the department, which may include:
(1)Documentation of wastewater system, water system, and local planning and zoning approval from the applicable regulatory authority; and (2)Certifications stating all work was completed in accordance with applicable plumbing, electrical, building, and fire codes.
2.The department shall approve the plans and specifications if they meet the requirements of this chapter and North Dakota Century Code chapter 23-09.
History
- Law Implemented: NDCC 23-09-03, 23-09-06, 23-09-07, 23-09-09, 23-09-11
N.D. Admin. Code 33-39-01-11 Fire safety
A lodging establishment shall ensure the requirements of all applicable state and local fire codes are met. Fire and life safety requirements of lodging establishments must include the following:
1.Fire protection systems must be provided, maintained, and inspected as required by applicable state and local building and fire codes and chapter 33-33-05. Written records of maintenance and inspection must be provided to the department as requested;
2.Operable smoke detection and alarm systems must be installed, maintained, and inspected as required by applicable state and local building and fire codes and in accordance with chapter 33-33-05;
3.Fire extinguishers must be provided on each level of the building and within seventy-five feet [22.86 meters] of any point in the building and maintained annually; and
4.Emergency exits must be kept unlocked, unobstructed, and be indicated by operable exit lighting and signs.
History
- Law Implemented: NDCC 23-09-02.1, 23-09-03, 23-09-06, 23-09-07, 23-09-09
N.D. Admin. Code 33-39-01-12 Food establishment license requirements at lodging establishments
1.A lodging establishment that prepares, packages, serves, or otherwise provides food to guests or the general public shall obtain an appropriate food service license in accordance with
chapter 33-33-04.1 and North Dakota Century Code section 23-09-16 and shall operate in accordance with all applicable laws and rules.
2.Lodging establishments that provide only non-time and temperature control for safety food that is commercially prepared, individually portioned, prepackaged, or whole uncut fresh produce are not required to apply for a food service license.
History
- Law Implemented: NDCC 23-09-01, 23-09-16
N.D. Admin. Code 33-39-01-13 Employee and public toilets and toilet rooms
Employee and public toilet rooms in lodging establishments must be:
1.In the number and capacity required by all state and local building and plumbing codes;
2.Equipped with adequate toilets and sinks in accordance with all state and local building and plumbing codes;
3.Equipped with self-closing doors;
4.Maintained clean and in good repair; and
5.If used by employees, accessible at all times and equipped with handwashing signs conspicuously posted in each toilet room notifying employees to wash their hands before returning to work.
N.D. Admin. Code 33-39-01-14 Poisonous or toxic materials
1.A lodging establishment shall allow on the premises poisonous or toxic materials if they are used in the operation and maintenance of the lodging establishment, including:
a.Detergents, sanitizers, cleaning or drying agents, caustics, acids, polishes, and similar chemicals;
b.Insecticides and rodenticides;
c.Building maintenance materials, including paint, varnish, stain, glue, and caulking; and
d.Landscaping materials, including herbicides, lubricants, and fuel for equipment.
2.A lodging establishment shall meet the following requirements for the storage of poisonous or toxic materials:
a.Poisonous or toxic materials must be stored on separate shelves or in separate cabinets inaccessible to guests except for provided detergents and sanitizers for guest use, and these shelves and cabinets may be used for no other purpose; and
b.Poisonous or toxic materials may not be stored above food, ice or ice-making equipment, linens, towels, utensils, single-service articles, furnishings, or guest toiletry items.
3.A lodging establishment shall ensure the use of poisonous or toxic materials meets the following requirements:
a.Each bulk or original container of a poisonous or toxic material must bear a legible manufacturer's label and must be readily available for reference or inspection;
b.All poisonous or toxic materials taken from a bulk or original container and put into another container must be clearly identified with the common name of the material and the original manufacturer's label must be maintained onsite until that product has been discarded or completely used; and
c.Each poisonous or toxic material must be used according to the manufacturer's directions and additional safety requirements regarding the safe use of poisonous or toxic materials may be established by the applicable regulatory authority upon later discovery of the unsafe use of these materials.
N.D. Admin. Code 33-39-01-15 Pests
1.Every area of the lodging establishment premises must be free of any harborage conditions that may lead to or encourage infestations of rodents, insects, or any other pests.
2.If rodents, insects, any other pests, or evidence of pests are present, the lodging establishment shall use approved pest control measures, including cleaning and maintenance or replacement of seals for outer openings, tight fitting screens, or other means necessary for their elimination.
3.A lodging establishment shall consult a professional pest control management provider or certified commercial pesticide applicator to exterminate rodents, insects, or any other pests if determined necessary by the department.
4.The use of any pesticide classified by the environmental protection agency as restricted-use must be applied by a certified commercial pesticide applicator or an individual under the direct supervision of a certified commercial pesticide applicator and in accordance with all applicable statutes and regulations.
N.D. Admin. Code 33-39-01-16 Exterior premises and grounds maintenance
1.A lodging establishment shall ensure the exterior areas and surfaces, including alleys, driveways, walkways, guardrails, handrails, balconies, landings, porches, decks, stairways, ramps, and parking areas are:
a.Maintained clean, well-drained, free of debris, and in good repair;
b.Adequately illuminated for guest safety; and
c.Free from safety hazards such as slippery surfaces or inappropriate storage of items in stairways, walkways, landings, and ramps.
2.A lodging establishment shall ensure garbage and refuse are:
a.Kept in leakproof, nonabsorbent receptacles that are:
(1)Kept covered with tight-fitting lids if filled, stored, or not in continuous use to minimize accessibility by rodents, insects, and other pests;
(2)Of sufficient number and capacity to prevent overflow accumulation; and (3)Kept clean, in good repair, and replaced as necessary;
b.Removed from the premises at a frequency that minimizes the development of objectionable odors and other conditions that attract or harbor rodents, insects, and other pests; and
c.Disposed of in a sanitary manner in compliance with state and local requirements.
N.D. Admin. Code 33-39-01-17 Imminent health hazard
A lodging establishment shall discontinue operations of the affected portions of the lodging establishment immediately upon discovery that an imminent health hazard exists. A proprietor shall notify the department by phone or email within twenty-four hours of identifying an imminent health hazard.
Chapter 33-39-02 License Fees
N.D. Admin. Code 33-39-02-01 License fees
The proprietors of lodging establishments shall pay the following annual, administration, and plan review license fees:
1.For a lodging establishment containing not more than three sleeping rooms, sixty dollars.
2.For a lodging establishment containing at least four sleeping rooms but not more than ten sleeping rooms, eighty-five dollars.
3.For a lodging establishment containing more than ten sleeping rooms and not more than twenty sleeping rooms, one hundred twenty dollars.
4.For a lodging establishment containing more than twenty sleeping rooms and not more than fifty sleeping rooms, one hundred forty-five dollars.
5.For a lodging establishment containing more than fifty sleeping rooms and not more than one hundred sleeping rooms, one hundred eighty dollars.
6.For a lodging establishment containing more than one hundred sleeping rooms and not more than two hundred fifty sleeping rooms, two hundred seventy dollars.
7.For a lodging establishment containing more than two hundred fifty sleeping rooms and not more than five hundred sleeping rooms, three hundred ninety dollars.
8.For a lodging establishment containing more than five hundred sleeping rooms and not more than one thousand sleeping rooms, five hundred forty dollars.
9.For a lodging establishment containing more than one thousand sleeping rooms, seven hundred twenty dollars.
10.For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee when a plan review application is required.
11.For a proprietor, a plan review application fee of fifty percent of the annual license fee when a plan review application is required.
History
- History: Effective January 1, 2006; amended effective April 1, 2008; January 1, 2014; January 1, 2026.
- General Authority: NDCC 23-01-03
- Law Implemented: NDCC 23-09-02
Article 33-41 Tattoo and Body Art
Chapter 33-41-01 Tattoo and Body Art
N.D. Admin. Code 33-41-01-01 Definitions
The terms used throughout this article have the same meaning as in North Dakota Century Code
Chapter 12.1-31, except:
1."Aftercare" means written instructions given to the client, specific to the body art procedures rendered, about caring for the body art and surrounding area. These instructions must include information about when to seek medical treatment, if necessary.
2."Antiseptic" means an agent that destroys disease-causing microorganisms on human skin or mucosa.
3."Body art" means the practice of physical body adornment by permitted or licensed establishments and operators using techniques including body piercing, tattooing, cosmetic tattooing, branding, scarification, and subdermal implanting. This definition does not include, for the purpose of this article, piercing of the outer perimeter or lobe of the ear with presterilized single-use stud-and-clasp ear-piercing systems.
4."Body art establishment" means any place or premise, whether public or private, temporary or permanent, in nature of location, where the practices of body art, whether or not for profit, are performed.
5."Body piercing" means puncturing or penetration of the skin of a person with presterilized single-use needles and the insertion of presterilized jewelry or other adornment thereto in the opening, except that puncturing the outer perimeter or lobe of the ear with a presterilized single-use stud-and-clasp ear-piercing system shall not be included in this definition.
6."Branding" means inducing a pattern of scar tissue by use of a heated material (usually metal) to the skin, making a serious burn, which eventually becomes a scar.
7."Contaminated waste" means any liquid or semiliquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semiliquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; sharps and any wastes containing blood and other potentially infectious materials, as defined in 29 Code of Federal Regulations part 1910.1030, known as "occupational exposure to bloodborne pathogens".
8."Cosmetic tattooing" is included in the definition of tattooing.
9."Department" means the state department of health.
10."Disinfection" means the destruction of disease-causing microorganisms on inanimate objects or surfaces, thereby rendering these objects safe for use or handling.
11."Ear piercing" means the puncturing of the noncartilaginous perimeter or lobe of the ear with a presterilized single-use stud-and-clasp ear-piercing system following manufacturer's instructions. Under no circumstances shall ear-piercing studs and clasps be used anywhere on the body other than the outer perimeter and lobe of the ear.
12."Equipment" means all machinery, including fixtures, containers, vessels, tools, devices, implements, furniture, display and storage areas, sinks, and all other apparatus and appurtenances used in connection with the operation of a body art establishment.
13."Handsink" means a lavatory equipped with hot and cold running water under pressure, used solely for washing hands, arms, or other portions of the body.
14."Hot water" means water that attains and maintains a temperature of at least one hundred degrees Fahrenheit.
15."Instruments used for body art" means hand pieces, needles, needle bars, and other instruments that may come in contact with a client's body or may be exposed to bodily fluids during body art procedures.
16."Invasive" means entry into the body either by incision or insertion of an instrument into or through the skin of mucosa, or by any other means intended to puncture, break, or compromise the skin or mucosa.
17."Jewelry" means any personal adornment inserted into a newly pierced area, which may be made of surgical implant-grade stainless steel; solid fourteen karat or eighteen karat white or yellow gold, niobium, titanium, or platinum; or a dense, low-porosity plastic, which is free of nicks, scratches, or irregular surfaces and which has been properly sterilized prior to use.
18."Liquid chemical germicide" means a disinfectant or sanitizer registered with the United States environmental protection agency or an approximately one-to-one hundred dilution of household chlorine bleach made fresh daily and dispensed from a spray bottle (five hundred parts per million, one-fourth cup per gallon, or two tablespoons per quart of tap water).
19."Mobile body art establishment or unit" means a mobile establishment or unit which is self-propelled or otherwise movable from place to place and is self-sufficient for utilities such as gas, water, electricity, and liquid waste disposal which operates at a fixed location where a permitted or licensed operator performs body art procedures.
20."Operator" means any person who controls, operates, manages, conducts, or practices body art activities at a body art establishment and who is responsible for compliance with these rules, whether actually performing body art activities or not. The term includes an assistant technician who works under the operator and performs body art activities.
21."Person" means an individual, any form of business or social organization or any other nongovernmental legal entity, including corporations, partnerships, limited liability companies, associations, trusts, or unincorporated organizations.
22."Physician" means a person currently licensed by the state of North Dakota to practice medicine pursuant to the provisions of chapter 43-17 of the North Dakota Century Code.
23."Procedure surface" means any surface of an inanimate object that contacts the client's unclothed body during a body art procedure, skin preparation of the area adjacent to and including the body art procedure, or any associated work area which may require sanitizing.
24."Sanitization procedure" means a process of reducing the numbers of microorganisms on cleaned surfaces and equipment to a safe level as judged by public health standards and which has been approved by the department.
25."Sharps" means any objects (sterile or contaminated) that may purposefully or accidentally cut or penetrate the skin or mucosa, including presterilized, single-use needles; scalpel blades; and razor blades.
26."Sharps container" means a puncture-resistant, leak-proof container that can be closed for handling, storage, transportation, and disposal and that is labeled with the international biohazard symbol.
27."Single-use" means products or items that are intended for one-time, one-person use and are disposed of after use on each client, including cotton swabs or balls, tissues or paper products, paper or plastic cups, gauze and sanitary coverings, razors, piercing needles, scalpel blades, stencils, ink cups, and protective gloves.
28."Sterilization" means a process resulting in the destruction of all forms of microbial life, including highly resistant bacterial spores.
29."Tattooing" means any method of placing ink or other pigment into or under the skin or mucosa by the aid of needles or any other instrument used to puncture the skin, resulting in permanent coloration of the skin or mucosa. This term includes all forms of cosmetic tattooing.
30."Temporary body art establishment" means any place or premise operating at a fixed location where an operator performs body art procedures for no more than fourteen days consecutively in conjunction with a single event or celebration.
31."Ultrasonic unit" means a unit approved by the department, physically large enough to fully submerge instruments in liquid, which removes all foreign matter from the instruments by means of high-frequency oscillations transmitted through the contained liquid.
32."Universal precautions" means a set of guidelines and controls, published by the centers for disease control and prevention (CDC) as "Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health Care and Public Safety Workers" in Morbidity and Mortality Weekly Report (MMWR), June 23, 1989, vol. 38, no. S-6, and as "Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures", in (MMWR), July 12, 1991, vol. 40, no. RR-8. This method of infection control requires the employer and the employee to assume that all human blood and specified human body fluids are infectious for HIV, HBV, and other blood pathogens. Precautions include handwashing; gloving; personal protective equipment; injury prevention; and proper handling and disposal of needles, other sharp instruments, and blood-contaminated and body fluid-contaminated products.
N.D. Admin. Code 33-41-01-02 Requirements for premises
Following are the minimum requirements for construction, materials, and general condition of a body art establishment:
1.The operator of a new or extensively remodeled body art establishment shall submit a scale drawing and floor plan of the proposed establishment for a plan review by the department, as
part of the license application process.
2.All walls, floors, ceilings, and procedure surfaces of a body art establishment shall be smooth, free of open holes or cracks, light-colored, washable, and in good repair. Walls, floors, and ceilings shall be maintained in a clean condition. All procedure surfaces, including client chairs and benches, shall be of such construction as to be easily cleaned and sanitized after each client. All body art establishments shall be completely separated by solid partitions or by walls extending from floor to ceiling, from any room used for human habitation, any food establishment or room where food is prepared, any hair salon, any retail sales, or any other such activity that may cause potential contamination of work surfaces, exposed equipment, or client procedure sites.
3.Effective measures shall be taken by the body art operator to protect against entrance into the establishment and against the breeding or presence on the premises of insects, vermin, and rodents. Insects, vermin, and rodents shall not be present in any part of the establishment, its appurtenances, or appertaining premises.
4.There shall be adequate floor space for the operator in each procedure room. Each establishment shall have procedure rooms that may be closed or screened, or both, from public view for clients requesting privacy.
5.The establishment shall be well-ventilated and provided with an artificial light source equivalent to at least twenty foot candles measured three feet off the floor, except that at least one hundred foot candles shall be provided at the level where the body art procedure is being performed, and where instruments and sharps are assembled.
6.No animals of any kind shall be allowed in a body art establishment except service animals used by persons with disabilities (e.g., seeing eye dogs). Fish aquariums shall be allowed in waiting rooms and nonprocedural areas.
7.A separate, readily accessible handsink with hot and cold running water, under pressure, preferably equipped with wrist-operated or foot-operated controls and supplied with liquid soap and disposable paper towels shall be readily accessible within the body art establishment.
One handsink shall serve no more than three operators. In addition, there shall be a minimum of one lavatory, excluding service sinks, and one toilet in a body art establishment.
8.At least one covered waste receptacle shall be provided in each operator area and each toilet room. Receptacles in the operator area shall be emptied daily, and solid waste shall be removed from the premises at least weekly. All refuse containers shall be lidded, cleanable, and kept clean.
9.All instruments and supplies shall be stored in clean, dry, and covered containers.
10.Reusable cloth items shall be mechanically washed with detergent and chlorine bleach and dried after each use. The cloth items shall be stored in a dry, clean environment until used.
History
- History: Effective January 1, 2008
N.D. Admin. Code 33-41-01-03 Body art operator requirements
1.The following information shall be kept on file on the premises of a body art establishment and available for inspection by the department:
a.Employee information:
(1)Full names and exact duties;
(2)Date of birth;
(3)Gender;
(4)Home address;
(5)Home and work telephone numbers; and (6)Identification photos of all body art operator/technicians.
b.Establishment information:
(1)Establishment name;
(2)Hours of operation; and (3)Owner's name and address.
c.A complete description of all body art procedures performed.
d.An inventory of all instruments and body jewelry, all sharps, and all inks used for any and all body art procedures, including names of manufacturers and serial or lot numbers, if applicable. Invoices or orders shall satisfy this requirement.
e.A copy of these regulations.
2.The body art operator must be a minimum of eighteen years of age.
3.Smoking, eating, or drinking is prohibited in the area where body art is performed.
4.Operators shall refuse service to any person who, in the opinion of the operator, is under the influence of alcohol or drugs.
5.The operator shall maintain a high degree of personal cleanliness, conform to hygienic practices, and wear clean clothes when performing body art procedures. Before performing body art procedures, operators must thoroughly wash their hands in hot running water with liquid soap, then rinse hands and dry with disposable paper towels. This shall be done as often as necessary to remove contaminants.
6.In performing body art procedures, the operator shall wear disposable medical gloves. Gloves must be changed if they become contaminated by contact with any nonclean surfaces or objects or by contact with a third person. The gloves shall be discarded, at a minimum, after the completion of each procedure on an individual client, and hands shall be washed before the next set of gloves is donned. Under no circumstances shall a single pair or gloves be used on more than one person. The use of disposable medical gloves does not preclude or substitute for handwashing procedures as part of a good personnel hygiene program.
7.If, while performing a body art procedure, the operator's glove is pierced or torn, or otherwise contaminated, the procedure delineated in subsection 6 shall be repeated immediately. The contaminated gloves shall be immediately discarded, and the hands washed thoroughly as described in subsection 6 before a fresh pair of gloves is applied. Any item or instrument used for body art that is contaminated during the procedure shall be discarded, and replaced immediately with a new disposable item or a new sterilized instrument or item before the procedure resumes.
8.Contaminated waste that may release liquid blood or body fluids when compressed or may release dried blood or body fluids when handled must be placed in an approved red bag marked with the international biohazard symbol. It must then be disposed of by a waste hauler approved by the department or, at a minimum, in compliance with 29 CFR part 1910.1030, "occupational exposure to bloodborne pathogens". Sharps ready for disposal shall be disposed of in approved sharps containers. Contaminated waste that does not release liquid blood or body fluids when compressed or does not release dried blood or body fluids when handled may be placed in a covered receptacle and disposed of through normal, approved disposal methods. Storage of contaminated waste onsite shall not exceed the period specified by the department or more than a maximum of thirty days, as specified in 29 CFR part 1910.1030, whichever is less.
9.No person shall perform any body art procedure upon a person under the age of eighteen years without the presence, written consent, and proper identification of a parent, legal custodial parent, or legal guardian. Nothing in this section is intended to require an operator to perform any body art procedure on a person under eighteen years of age with parental or guardian consent.
10.Any skin or mucosa surface to receive a body art procedure shall be free of rash or any visible infection.
11.The skin of the operator shall be free of rash or infection. No person or operator affected with boils, infected wounds, open sores, abrasions, keloids, weeping dermatological lesions, or acute respiratory infection shall work in any area of a body art establishment in any capacity in which there is a likelihood that the person could contaminate body art equipment, supplies, or working surfaces with body substances or pathogenic organisms.
12.The operator shall be vacinnated against the hepatitis B virus. The operator is responsible for ensuring that all individuals working at the operator's establishment initiate the hepatitis B vaccination series within thirty days of starting work unless the individuals have previously received the complete hepatitis B vaccination series and can provide documentation to the department, antibody testing has revealed that the individual is immune, or the vaccine is contraindicated for medical reasons.
13.The operator shall be certified in cardiopulmonary resuscitation.
N.D. Admin. Code 33-41-01-04 Public notification requirements
1.Verbal and written public educational information, approved by the department, shall be required to be given to all clients wanting to receive body art procedures. Verbal and written instructions, approved by the department, for the aftercare of the body art procedure site shall be provided to each client by the operator upon completion of the procedure. The written instructions shall advise the client to consult a physician at the first sign of infection and shall contain the name, address, and telephone number of the establishment. These documents shall be signed and dated by both parties, with a copy given to the client and the operator retaining the original with all other required records. In addition, all establishments shall prominently display a disclosure statement, provided by the department, which advises the public of the risks and possible consequences of body art services. The facility licenseholder shall also post in public view the name, address, and telephone number of the local or state department that has jurisdiction over this program and the procedure for filing a complaint.
The disclosure statement and the notice for filing a complaint shall be included in the establishment license application packet.
2.All infections, complications, or diseases resulting from any body art procedure that become known to the operator shall be reported to the department by the operator within twenty-four hours.
N.D. Admin. Code 33-41-01-05 Client records
1.So that the operator can obtain knowledge about the client's health status for receiving a body art procedure, the operator or technician shall ask for the information as follows:
So your body art procedure heals properly, we ask that you disclose if you have or have had any of the following conditions:
a.Diabetes;
b.History of hemophilia (bleeding);
c.History of skin diseases, skin lesions, or skin sensitivities to soaps, disinfectants, etc.;
d.History of allergies or adverse reactions to pigments, dyes, or other skin sensitivities;
e.History of epilepsy, seizures, fainting, or narcolepsy;
f.Use of medications such as anticoagulants, which thin the blood or interfere with blood clotting;
g.Use of medications other than routine antibiotics, allergy medication, or birth control pills;
h.Hepatitis;
i.HIV positive;
j.High blood pressure or heart disease;
k.Pregnancy;
l.Contagious diseases;
m.Immune system disorder; or
n.Serious physical or mental health problems.
2.The operator shall ask the client to sign a release form confirming that the information described in subsection 1 was obtained or that the operator attempted to obtain the information. The client shall be asked to disclose any other information that would aid the operator in evaluating the client's body art healing process.
3.Each operator shall keep records of all body art procedures administered, including client name and signature, date of birth, date, time, identification and location of the body art procedure performed, and the operator's name. If the client is a minor, proof of parental or guardian presence and consent must be obtained and signed and the record retained. All client records shall be confidential and be retained for a minimum of three years and made available to the department upon notification.
4.Nothing in this section shall be construed to require the operator to perform a body art procedure upon a client.
N.D. Admin. Code 33-41-01-06 Records retention
The body art establishment shall keep a record of all persons who have had body art procedures performed. The record shall include the name, date of birth, and address of the client; the date and time of the procedure; the name of the operator who performed the procedures; type and location of procedure performed; and the signature of the client; and, if the client is a minor, proof of parental or guardian presence and consent, i.e., signature. Such records shall be retained for a minimum of three years and shall be available to the department upon request. The department and the body art establishment shall keep such records confidential.
N.D. Admin. Code 33-41-01-07 Preparation and care of the body art area
1.Before a body art procedure is performed, the immediate skin area and the areas of skin surrounding where the body art procedure is to be placed shall be washed with soap and water or an approved surgical skin preparation, depending on the type of body art to be performed. If shaving is necessary, single-use disposable razors or safety razors with single-service blades shall be used. Blades shall be discarded after each use, and reusable holders shall be autoclaved after use. Following shaving, the skin and surrounding area shall be washed with soap and water. The washing pad shall be discarded after a single use.
2.In the event of blood flow, all products used to check the flow of blood or to absorb blood shall be single-use and disposed of immediately after use in appropriate covered containers, unless the disposal products meet the definition of biomedical waste. The use of styptic pencils or alum solids shall not be used to check the flow of blood.
N.D. Admin. Code 33-41-01-08 Sanitation and sterilization procedures
1.All nonsingle-use, nondisposable instruments used for body art shall be cleaned thoroughly after each use by scrubbing with an appropriate soap or disinfectant solution and hot water or by following the manufacturer's instructions, to remove blood and tissue residue, and shall be placed in an ultrasonic unit also operated in accordance with the manufacturer's instructions.
2.After being cleaned, all nondisposable instruments used for body art shall be packed individually in peel-packs and subsequently sterilized as specified in subsection 3. All peel-packs shall contain either a sterilizer indicator or internal temperature indicator.
Peel-packs must be dated with an expiration date not to exceed six months.
3.All cleaned, nondisposable instruments used for body art shall be sterilized in a steam autoclave or dry-heat sterilizer (if approved by the department). The sterilizer shall be used, cleaned, and maintained according to manufacturer's instruction. A copy of the manufacturer's recommended procedures for the operation of the sterilization unit must be available for inspection by the department. Sterile equipment may not be used if the package has been breached or after the expiration date without first repackaging and resterilizing. Sterilizers shall be located away from workstations or areas frequented by the public. If the body art establishment uses only single-use, disposable instruments and products, and uses sterile supplies, an autoclave shall not be required.
4.Each holder of a license to operate a body art establishment shall demonstrate that the sterilizer used is capable of attaining sterilization by monthly spore destruction tests. These tests shall be verified through an independent laboratory. The license shall not be issued or renewed until documentation of the sterilizer's ability to destroy spores is received by the department. These test records shall be retained by the operator for a period of three years and made available to the department upon request.
5.Tattoo needles and piercing needles are not reusable under any circumstances. After use, all needles, razors, and other sharps shall be immediately disposed of in red sharps containers, appropriately labeled with the international biohazard symbol. After sterilization, all reusable instruments used for tattooing or body piercing shall be stored in a dry, clean cabinet or other tightly covered container reserved for the storage of such instruments.
6.All instruments used for tattooing or body piercing shall remain stored in sterile packages until just prior to the performance of a body art procedure. When assembling instruments used for body art procedures, the operator shall wear disposable medical gloves and use medically recognized techniques to ensure that the instruments and gloves are not contaminated.
7.All inks, dyes, pigments, needles, and equipment shall be specifically manufactured for performing body art procedures and shall be used according to manufacturer's instructions.
The mixing of approved inks, dyes, or pigments or their dilution with potable water is acceptable. Immediately before a tattoo is applied, the quantity of the dye to be used shall be transferred from the dye bottle and placed into single-use paper cups or plastic cups. Upon completion of the tattoo, these single cups or cups and their contents shall be discarded.
N.D. Admin. Code 33-41-01-09 Requirements for single-use items
1.Single-use items shall not be used on more than one client for any reason. After use, all single-use needles, razors, and other sharps shall be immediately disposed of in approved sharps containers.
2.All products applied to the skin, including body art stencils, shall be single-use and disposable.
If the department approves, acetate stencils shall be allowed for reuse if sanitization procedures as specified in subsection 24 of section 33-41-01-01 are performed between uses.
Petroleum jellies, soaps, and other products used in the application of stencils shall be dispensed and applied on the area to be tattooed with sterile gauze or in a manner to prevent contamination of the original container and its contents. The gauze shall be used only once and then discarded.
N.D. Admin. Code 33-41-01-10 License requirements
1.No person, firm, partnership, joint venture, association, business trust, corporation, or organized group of persons may operate a body art establishment except with a body art establishment license from the department.
2.It is prohibited to obtain or attempt to obtain any body art establishment or operator permit by means of fraud, misrepresentation, or concealment.
3.A license for a body art establishment shall not be transferable from one place or person to another.
4.The current body art establishment license shall be posted in a prominent and conspicuous area where it may be readily observed by clients.
5.The annual license fee for all types of body art establishments is one hundred thirty-five dollars.
History
- History: Effective January 1, 2008; amended effective January 1, 2014.
N.D. Admin. Code 33-41-01-11 Temporary establishment license
Temporary establishment licenses, when required, may be issued for body art services provided outside of the physical site of a certified facility for the purposes of product demonstration, industry trade shows, or education. Temporary establishment licenses will not be issued unless:
1.The applicant furnishes proof of compliance with section 33-41-01-10 relating to license requirements;
2.The applicant is currently affiliated with a fixed location or permanent facility which, where applicable, is licensed by the appropriate state or local jurisdiction; and
3.The temporary site complies with section 33-41-01-12 temporary demonstration license requirements.
N.D. Admin. Code 33-41-01-12 Temporary demonstration permit requirements
1.A person who wishes to obtain a temporary demonstration license must submit the request in writing for review by the department at least thirty days prior to the event. The request must specify:
a.The purpose for which the license is requested.
b.The period of time during which the license is needed, not to exceed fourteen calendar days per event, without reapplication.
c.The location where the temporary demonstration license will be used.
2.The applicant's demonstration project must be contained in a completely enclosed, nonmobile facility (e.g., inside a permanent building).
3.Compliance with all of the requirements of this code includes the following:
a.Conveniently located handwashing facilities with liquid soap, paper towels, and hot and cold water under adequate pressure shall be provided. Drainage in accordance with local plumbing codes is to be provided. Tuberculocidal single-use hand wipes, approved by the department, to augment the handwashing requirements of this section must be available in each booth or cubicle.
b.There shall be at least one hundred foot candles of light at the level where the body art procedure is being performed.
c.Facilities to properly sterilize instruments and evidence of a spore test performed on sterilization equipment thirty days or less prior to the date of the event must be provided, or only single-use, prepackaged, sterilized equipment obtained from reputable suppliers or manufacturers will be allowed.
d.Ability to properly clean and sanitize the area used for body art procedures is required.
4.The facility where the temporary demonstration license needed must be inspected by the department and the license issued prior to the performance of any body art procedure.
5.Temporary demonstration licenses issued under the provisions of this code may be suspended by the department for failure of the holder to comply with the requirements of this code.
6.All establishment licenses and the disclosure notice must be readily seen by clients.
N.D. Admin. Code 33-41-01-13 Mobile body art establishments
In addition to complying with all of the requirements of this code, mobile body art vehicles working from a mobile body art establishment shall also comply with all of the following requirements:
1.Mobile body art establishments are licensed annually, and no body art procedures are to be performed before a license is issued. Licenseholders are responsible for ensuring that all other local agency regulations are complied with, including zoning and business license requirements.
2.Body art performed pursuant to this section shall be done only from an enclosed vehicle such as a trailer or mobile home. No body art procedures shall be performed outside of the enclosed vehicle.
3.The mobile body art establishment shall be maintained in a clean and sanitary condition at all times. Doors shall be self-closing and tight-fitting. Openable windows shall have tight-fitting screens.
4.Mobile body art establishments must have approved sterilization equipment available, in accordance with all requirements of section 33-41-01-08.
5.The mobile body art establishment shall be used only for the purpose of performing body art procedures. No habitation or food preparation is permitted inside the vehicle unless the body art workstation is separated by walls, floor to ceiling, from culinary or domicile areas.
6.The mobile body art establishment shall be equipped with an equipment washing sink and a separate handsink for the exclusive use of the operator for handwashing and preparing the client for the body art procedure. The handsink shall be supplied with hot and cold running water under pressure to a mixing type faucet and liquid soap and paper towels in dispensers.
An adequate supply of potable water shall be maintained for the mobile body art establishment at all times during operation. The source of the water and storage, in gallons, of the tanks shall also be identified. Tuberculocidal single-use hand wipes, approved by the department, to augment the handwashing requirements of this section, must be available.
7.All liquid wastes shall be stored in an adequate storage tank with a capacity at least fifty percent greater than the capacity of the onboard potable water supply. Liquid wastes shall be disposed of at a site approved by the department.
8.Restroom facilities must be available within the mobile body art establishment. A handsink must be available inside the restroom cubicle. The handsink shall be supplied with hot and cold running water under pressure to a mixing type faucet, as well as liquid soap and paper towels in dispensers. Restroom doors must be self-closing and adequate ventilation must be available.
9.No animals, except service animals of clients, shall be allowed in the mobile body art establishment at any time.
10.Mobile body art establishments must receive a preoperational inspection to ensure compliance with structural requirements.
11.All mobile body art establishment licenses, as well as the disclosure notice, must be readily seen by clients.
N.D. Admin. Code 33-41-01-14 Enforcement
1.It is a class B misdemeanor for establishments that continue to operate without proper permits from the department or operate in violation of these regulations.
2.A representative of the department shall provide proper identification as such before entering a body art establishment to make an inspection. Such an inspection must be conducted as often as necessary throughout the year to ensure compliance with this code.
3.It is unlawful for any person to interfere with the department in the performance of its duties.
4.A copy of the inspection report must be furnished to the licenseholder or operator of the body art establishment, with the department retaining possession of the original.
5.If, after investigation, the department should find that a licensee is in violation of this code, the department may advise the licensee, in writing, of its findings and instruct the licensee to take specific steps to correct such violations within a reasonable period of time.
6.If the department has reasonable cause to suspect that a communicable disease is or may be transmitted by an operator, by use of unapproved or malfunctioning equipment, or by unsanitary or unsafe conditions that may adversely affect the health of the public, upon written notice to the owner or operator, the department may do any or all of the following:
a.Issue an order excluding any or all operators from the licensed body art establishment who are responsible, or reasonably appear responsible, for the transmission of a communicable disease until the department determines there is no further risk to public health.
b.Issue an order to immediately suspend the license of the establishment until the department determines there is no further risk to the public health. Such an order shall state the cause for the action.
7.Licenses issued under the provisions of the code may be suspended temporarily by the department for failure of the holder to comply with the requirements of this code.
8.Whenever a licenseholder or operator has failed to comply with any notice issued under the provisions of this code, the operator must be notified in writing that the license is, upon service of this notice, immediately suspended. The notice must also contain a statement informing the licenseholder or operator that an opportunity for a hearing will be provided if a written request for a hearing is filed with the department.
9.Any person whose license has been suspended may, at any time, make application for reinstatement of the license. Within ten days of receipt of a written request, including a statement signed by the applicant, that in the applicant's opinion the conditions causing the suspension have been corrected, the department shall reinspect the body art establishment or evaluate documentation provided by an operator. If the applicant is in compliance with the provisions of this code, the license will be reinstated.
10.For repeated or serious (any code infraction that threatens the health of the client or operator) violations of any of the requirements of this code or for interference with department personnel in the performance of their duties, a license may be permanently revoked after a hearing.
Before taking such action, the department shall notify the licenseholder or operator in writing, stating reasons for which the license is subject to revocation and advising the licenseholder or operator of the requirements for filing a request for a hearing. A license may be suspended for cause, pending its revocation or hearing relative thereto.
11.The department may permanently revoke a permit after five days following service of the notice unless a request for hearing is filed within the five-day period with the department by the licenseholder.
12.The hearings provided for in this section must be conducted by the department at a time and place designated by the hearing officer. On the basis of the record of the hearing, the department shall make a finding and may sustain, modify, or rescind any official notice or order considered in the hearing. A written report of the hearing decision must be furnished to the licenseholder or operator by the department.
Article 33-42 Tanning Facilities
Chapter 33-42-01 Tanning Facilities
N.D. Admin. Code 33-42-01-01 Applicability
This chapter applies to all persons who possess or operate tanning devices available to the public for the purpose of artificial light skin tanning, including those offered for use as part of a membership or premium offer in a health club, condominium, apartment complex activity center, or hotel or motel rental.
N.D. Admin. Code 33-42-01-02 Definitions
The terms used throughout this article have the same meaning as in North Dakota Century Code
chapter 23-39 except:
1."Applicant" means any person who applies to the department for a license to operate a tanning facility.
2."Customer" 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 benefit of membership in or access to a health club, condominium ownership, apartment complex activity center, hotel or motel room rental, or other offer.
3."Department" means the department of health and human services.
4."Operator" means an individual designated by the licenseholder to manage the tanning facility and to assist and instruct the public in the correct operation of the tanning devices.
5."Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group or agency, or a representative or agent of any of these.
6."Protective eyewear" means any apparatus designed to be worn over the eyes by a user of tanning devices which absorbs all UV-A, UV-B, and visible light up to five hundred nanometers but permits sufficient light to pass through to allow a user to safely negotiate obstacles, and that complies with the standards set forth in 21 CFR 1040.20.
7."Radiation" means ultraviolet radiation.
8."Ultraviolet radiation" means electromagnetic radiation with a wavelength in air of two hundred to four hundred nanometers.
9."UV-A" means ultraviolet radiation having a wavelength in air of three hundred twenty to four hundred nanometers.
10."UV-B" means ultraviolet radiation having a wavelength in air of two hundred ninety to three hundred twenty nanometers.
History
- History: Effective January 1, 2008; amended effective January 1, 2026.
N.D. Admin. Code 33-42-01-03 Advertising
1.No tanning facility may state in any advertising, written or verbal, that tanning is free of hazards from ultraviolet radiation or has any health benefits other than those recognized by a credible scientific or medical source.
2.No person may state or imply that any activity under a license has been approved by the department.
N.D. Admin. Code 33-42-01-04 Warning sign
1.Location and content. Tanning facilities shall prominently display a warning sign in each area where a tanning device is used. A sign shall be located within one meter of each device. The sign shall be readily legible, clearly visible, and not obstructed by any barrier, equipment, or other item present so that the customer can easily view the warning sign before turning on the tanning device.
2.Lettering. The lettering on each warning sign shall be at least five millimeters high for the word "WARNING", All capital letters shall be at least five millimeters high and all lowercase letters shall be at least three millimeters high. The warning sign must contain the following warnings:
WARNING
DANGER - ULTRAVIOLET RADIATION
Follow Instructions.
Avoid too frequent or too lengthy exposure. Like exposure to the sun, use of a tanning device can cause eye and skin injury and allergic reactions. Repeated exposure can cause chronic sun damage, which is characterized by wrinkling, dryness, fragility and bruising of the skin, and skin cancer.
WEAR FOOD AND DRUG ADMINISTRATION-APPROVED PROTECTIVE EYEWEAR.
FAILURE TO WEAR PROTECTIVE EYEWEAR MAY RESULT IN SEVERE BURNS OR
LONG-TERM INJURY TO THE EYES.
Ultraviolet radiation from tanning devices will aggravate the effects of the sun, so do not sunbathe during the twenty-four hours immediately preceding or immediately following the use of a tanning device.
Medications and cosmetics may increase your sensitivity to ultraviolet radiation. Consult a physician before using a tanning device if you are using medications, have a history of skin problems, or believe that you are especially sensitive to sunlight. Women who are pregnant or using birth control pills and who use a tanning device may develop discolored skin.
If your skin does not tan when exposed to sun, it is unlikely that your skin will tan when exposed to this tanning device.
N.D. Admin. Code 33-42-01-05 Lamp replacement
1.The tanning facility shall maintain a record of the dates on which the tubes, bulbs, or lamps were replaced.
2.The tubes, bulbs, or lamps shall be replaced at the frequency recommended by the manufacturer or when the tubes, bulbs, or lamps become damaged or defective. A replacement lamp for a tanning unit shall be compatible with the original lamp as specified by the manufacturer of the unit or shall be substantially equivalent to the manufacturer's original lamp type. In this subsection, "substantially equivalent" means within ten percent of the UV-B emission of the original lamp and meeting the performance requirements of the United States food and drug administration in 21 CFR 1040.20(c)(1).
3.The facility shall maintain the device manufacturer's literature indicating the rating, output, or intensity of the tube, lamp, or bulb required for replacement.
4.No tube, bulb, or lamp designated for medical use only may be used.
N.D. Admin. Code 33-42-01-06 Duties of the operator
1.Use only tanning equipment manufactured and certified to comply with 21 CFR part 1040,
section 1040.20, "sunlamp products and ultraviolet lamps intended for use in sunlamp products", in tanning facilities. Compliance shall be based on the standard in effect at the time of manufacture as shown on the device identification label required by 21 CFR part 1010
section 1010.3.
2.Use only tanning equipment that has a timer which complies with the requirements of 21 CFR
part 1040, section 1040.20(c)(2). The timer shall be incorporated in the tanning device. The maximum timer interval shall not exceed the manufacturer's maximum recommended exposure time.
3.Ensure that protective acrylic sheets are in place when a tanning device is in use, except that the protect acrylic may be sleeves over the lamps in the upper portion of a device or over lamps in booth devices.
N.D. Admin. Code 33-42-01-07 Cleanliness and sanitation
1.Walls, floors, and fixtures shall be kept clean at all times in the entire facility.
2.No article or equipment shall be used or offered for use by a patron unless that article has first been cleaned with an environmental protection agency-approved sanitizer. A test kit or other device that accurately measures the concentration of the sanitizing solution in parts per million shall be used to measure the strength of the sanitizing solution when the concentrate and water dilution is initially prepared and at least daily thereafter to ensure sufficient strength of the sanitizing solution.
3.Paper towels or a clean cloth towel shall be provided. If reusable cloth towels are provided, they shall be mechanically washed with detergent and mechanically dried after each use. The cloth towels must be stored in a dry, clean environment until used.
N.D. Admin. Code 33-42-01-08 Reports of injury
If a customer of a tanning facility reports a sunburn injury to that facility resulting from the use of its tanning device, the owner shall provide the customer with written information on how to report the alleged injury to the department on a form prescribed by the department. The report shall be sent to the department as soon as possible and shall include:
1.The name of the affected individual and date of the actual or alleged injury.
2.The name and location of the tanning facility.
3.The nature of the alleged injury and duration of the tanning exposure.
4.Information on the device involved, such as manufacturer and model number and any other information considered relevant to the situation.
5.The name and address of the health care provider and treatment, if any.
N.D. Admin. Code 33-42-01-09 Recordkeeping
1.The operator of a tanning facility shall maintain the following records:
a.Each customer's total number of tanning visits and dates and duration of tanning exposure.
b.Each customer's signature and acknowledgment that the customer has read and understands the written notice as required in subsection 2 of section 23-39-03 of the North Dakota Century Code and the warning sign as prescribed in section 33-42-01-04 of this chapter.
c.Each parental or legal guardian's written consent for customers under eighteen years of age as required in subdivision a of subsection 1 of section 23-39-05 of the North Dakota Century Code.
All customer records shall be maintained for three years after the last tanning visit.
2.The operator shall maintain the following information for each tanning device:
a.Manufacturer's equipment or operator's manual and any service-related material.
b.Inspections, maintenance, and notifications performed on the tanning device, including the date of service and dates of bulb replacement. Device records shall be maintained for three years.
N.D. Admin. Code 33-42-01-10 Permits - Licenses
A person may not operate a tanning facility without a license issued by the department. The department shall conduct a preoperational inspection prior to initial licensure or changes in ownership to insure operator compliance and understanding of all laws and regulations. License renewals must be submitted to the department during December every year. A tanning facility license expires on December thirty-first of each year. If the license renewal application and renewal fee are not received by December thirty-first, the license expires and the licensee may not operate. Within sixty days after December thirty-first, an expired license may be renewed by submitting the renewal application, renewal fee, and a late fee in the amount of fifty percent of the license fee. Licenses are not transferable. The annual license fee for a tanning facility containing one to five tanning beds is ninety dollars plus ten dollars per bed and one hundred eighty dollars for facilities with more than five beds. A plan review application fee for a licensee is fifty percent of the annual license fee if a plan review application is required. For a person's initial license application, an annual license fee and a license application administration fee of one hundred dollars is required in addition to fifty percent of the annual license fee if a plan review application is required.
History
- History: Effective January 1, 2008; amended effective January 1, 2014; January 1, 2026.
N.D. Admin. Code 33-42-01-11 Denial, suspension, or revocation of license
1.The department may deny issuance of a license or suspend or revoke a license issued under this chapter if the applicant or licenseholder does not comply with or violates chapter 23-39 of the North Dakota Century Code or any provision of this chapter or if the applicant or licenseholder does any of the following:
a.Submits false or misleading information in the application or in reports.
b.Fails to construct, operate, or maintain the tanning facility in accordance with the application.
c.Operates the tanning facility in a way that causes or creates a nuisance or hazard to the public health or safety.
d.Violates any condition upon which the license was issued.
e.Fails to allow the department or a duly authorized agent to inspect the facility at a reasonable hour and in a reasonable manner for the purpose of determining compliance with this chapter.
f.Fails to pay the license fee.
2.Whenever the proprietor of any tanning facility fails to comply with this chapter, the operator must be given notice of the time within which the proprietor must meet the requirements. The notice must be in writing and delivered personally by an inspector of the department or sent by registered mail.
Article 33-43 Nurse Aide Training, Competency Evaluation, and Registry
Chapter 33-43-01 Nurse Aide Training, Competency Evaluation, and Registry
N.D. Admin. Code 33-43-01-01 Definitions
1."Abuse" includes mental, physical, sexual, and verbal abuse. "Mental abuse" includes humiliation, harassment, threats of punishment, or deprivation. "Physical abuse" includes hitting, slapping, pinching, kicking, and controlling behavior through corporal punishment.
"Sexual abuse" includes sexual harassment, sexual coercion, sexual contact, or sexual assault. "Verbal abuse" includes any use of oral, written, or gestured language that includes disparaging and derogatory terms to residents or their families, or within their hearing distance, to describe residents, regardless of their age, ability to comprehend, or disability.
2."Agency" means home health agency.
3."Certified nurse aide" means an individual who has successfully completed the requirements for the department-approved certified nurse aide training and competency evaluation program, or department-approved certified nurse aide competency evaluation program to provide nursing or nursing-related services to residents and is entered on the department's nurse aide registry as a certified nurse aide.
4."Competence" means the application and integration of knowledge, skills, ability, and judgment necessary to meet standards.
5."Delegation" means the authorization for performance of selected nursing interventions from a licensed nurse to a certified nurse aide, home health aide, nurse aide, or medication assistant I or II.
6."Deny" means the department's refusal to issue or renew a current registration on the nurse aide registry.
7."Department" means the state department of health.
8."Encumber" means to place on probation.
9."Health care facility" means any health care facility licensed by the department which provides nursing-related services to consumers of nursing care other than nursing facilities.
10."Home health aide" means an individual who renders personal related service under the supervision of a registered nurse and is registered on the department's nurse aide registry as a home health aide.
11."Letter of concern" means a statement of the department's concerns regarding the conduct of a registrant.
12."Medication administration" means the delivery of medication, by an individual delegated to and supervised by a licensed nurse, to a client whose use of that medication must be monitored and evaluated applying specialized knowledge, skills, and abilities possessed by a licensed nurse.
13."Medication assistant" means an individual who is registered on the nurse aide registry as a certified nurse aide or nurse aide who has successfully completed the requirements of a department-approved medication assistant program for a specific employment setting. Upon successful completion of a medication assistant program, the certified nurse aide or nurse aide is eligible to be registered on the department's nurse aide registry as a medication assistant I or a medication assistant II.
a.Medication assistant I is a certified nurse aide or nurse aide who has completed all the requirements for a department-approved medication assistant I program. A medication assistant I is limited to employment in a setting in which a licensed nurse is not regularly scheduled.
b.Medication assistant II is a certified nurse aide who has completed all the requirements for a department-approved medication assistant II program. A medication assistant II may be employed both in a setting in which a licensed nurse is regularly scheduled and a setting in which a licensed nurse is not regularly scheduled.
14."Medication assistant training program" means a program of study and clinical practice in the administration of routine, regularly scheduled medications which meets the department's
15."Misappropriation of a resident property" means the deliberate misplacement, exploitation, or wrongful, temporary or permanent, taking or use of a resident's belongings or money, or both, without the resident's consent.
16."Neglect" includes failure to carry out resident services as directed or ordered by the physician or other authorized personnel, failure to give proper attention to residents, or failure to carry out resident services through careless oversight.
17."Nurse aide" means any individual who is registered on the nurse aide registry and who has successfully completed the competency requirements identified by the department to provide nursing or nursing-related services to an individual in a health care facility or other setting and is registered on the department's registry as a nurse aide.
18."Nurse aide competency evaluation" means a testing mechanism consisting of both a written or oral and a manual skills component, testing the necessary knowledge needed by a certified nurse aide, home health aide, or nurse aide to provide safe care in a nursing facility, other health care facility, or other setting.
19."Nurse aide registry" means a listing of individuals who the department has determined to have successfully completed the requirements established by the department to be designated as a certified nurse aide, home health aide, or nurse aide or medication assistant I or II.
20."Nurse aide training program" means a program to train nurse aides offered by a public or private organization that has been approved by the department.
21."Nursing facility" means a nursing facility licensed by the department, and does not include any institution that is for the care and treatment of persons with intellectual disabilities or persons with related conditions.
22."Other misconduct" means a conviction of a crime or proof of behavior which has a direct bearing on the individual's ability to care for others or is a threat to the health and safety of patients or clients.
23."Other setting" includes settings such as a clinic, outpatient service provider, or individual home where the individual on the department's nurse aide registry is employed to provide nursing-related services.
24."Qualified instructor for a certified nurse aide training program" means a registered nurse with a minimum of two years of nursing experience, at least one year of which must be in the provision of long-term care facility services. Instructors must have completed a course in teaching adults or have experience in teaching adults or supervising nurse aides. In a nursing facility-based program, the director of nursing is prohibited from performing the actual training.
However, a director of nursing who meets the qualified instructor requirements may provide the general supervision for the program. Other health-related professionals who have a minimum of one-year experience in their field may supplement the instructor.
25."Qualified instructor for a home health aide training program" is a registered nurse who possesses a minimum of two years of nursing experience, at least one year of which must be in the provision of home health care services. Other professionals may be used to provide instruction under the supervision or the qualified instructor.
26."Qualified instructor for a nurse aide training program" is a registered nurse.
27."Regularly scheduled presence of a licensed nurse" means that a licensed nurse is present a minimum of eight hours in a twenty-four-hour period of time in a setting where nursing care is continuously delivered.
28."Revoke" means the withdrawal by the department of the registration of an individual to be employed as a certified nurse aide, home health aide, nurse aide, or medication assistant I or II for a specified period of time of no less than one year. If no specified period of time is identified by the department, revocation is permanent. For a certified nurse aide, a finding of abuse or neglect will result in permanent revocation, although the finding of neglect may be requested to be removed after one year under section 33-43-01-24.
29."Routine, regularly scheduled medication" means the components of an identified medication regimen for an individuals or groups of individuals with stable conditions which are administered on a routine basis and do not require determination of need, drug calculation, or dosage conversion.
30."Significant requirements" means federal certification or state licensure requirements that have a serious or measurable impact on the health and safety of the resident in the facility.
This includes a nursing waiver. Significant requirements shall be determined to be out of compliance based on the considerations of severity of the noncompliance issue, frequency of the noncompliance issue, and history of prior noncompliance issues.
31."Stable" means a situation in which the patient's or client's clinical and behavioral status and nursing care needs are determined by the registered nurse or licensed practitioner to be predictable, nonfluctuating, and consistent or in which the fluctuations are expected and the interventions are planned.
32."Supervised practical skills training" means manual skills training in a laboratory or other setting in which the nurse aide demonstrates knowledge while performing tasks on an individual while under the direct supervision of a licensed nurse under the general supervision of a qualified instructor.
33."Supervision" means maintaining accountability to determine whether or not nursing care is adequate and delivered appropriately. Supervision includes the assessment and evaluation of the patient or client's condition and responses to the nursing plan of care and evaluation of the competence of the person providing the nursing or nursing-related care.
a."Direct supervision" means that the responsible licensed nurse or licensed practitioner is physically present in the patient or client area and is available to assess, evaluate, and respond immediately.
b."Indirect supervision" means that the responsible licensed nurse or licensed practitioner is available through periodic inspection and evaluation or by telecommunication, or both, for direction, consultation, and collaboration.
34."Suspend" means the withholding or withdrawing by the department of the registration of an individual on the department's nurse aide registry for a specified or indefinite period of time not to exceed one year.
History
- General Authority: NDCC 23-44-01, 23-44-02
- Law Implemented: NDCC 23-44-01, 23-44-02
N.D. Admin. Code 33-43-01-02 Conflict with federal requirements
If any part of this chapter is found to conflict with federal requirements, the more stringent shall apply. Such as finding or determination shall be made by the department and shall not affect the remainder of this chapter.
History
- General Authority: NDCC 23-01-03, 23-01-11, 23-44-02
- Law Implemented: NDCC 23-01-11, 23-44-02
N.D. Admin. Code 33-43-01-03 Responsibilities of training programs for screening of potential students
1.Certified nurse aide, home health aide, nurse aide, and medication assistant training programs must screen potential students or individuals seeking entry into a training program.
This screening should be completed prior to beginning the training program and should occur in sufficient advance of the training to minimize delays and allow for changes in career choices in a timely manner.
2.Those applicants with a history including conviction of a crime substantially related to the qualification, functions, or duties of a certified nurse aide, home health aide, nurse aide, or medication assistant or a finding on a state nurse aide registry or federal registry should be informed they might not be allowed to begin the training program or take the test without providing specific information relating to their background, criminal history, or impairment.
3.The training program is responsible to provide sufficient screening to identify those individuals that would be a risk to the vulnerable populations served by the certified nurse aide, home health aide, nurse aide, or medication assistant and to submit that information to the department for review prior to entering the individual into a program.
N.D. Admin. Code 33-43-01-04 Nurse aide training program requirements
1.Any individual employed by a nursing facility to provide nursing or nursing-related services who is not a licensed nurse or volunteer or pursuing nurse aide certification and entry on the nurse aide registry must successfully complete a department-approved certified nurse aide training program consisting of a minimum of seventy-five hours and a department-approved competency evaluation or a department-approved competency evaluation.
a.The certified nursing aide training program must be under the general supervision of a qualified instructor.
(1)A qualified instructor for certified nurse aide training is a registered nurse with a minimum of two years of nursing experience, at least one year of which must be in the provision of long-term care facility services.
(2)Instructors must have completed a course in teaching adults or have experience in teaching adults or supervising nurse aides.
(3)In a nursing facility-based program, the director of nursing is prohibited from performing the actual training. However, a director of nursing who meets the qualified instructor requirements may provide the general supervision for the program.
(4)Other health-related professionals who have a minimum of one-year experience in their field may supplement the instructor.
b.Individuals employed by nursing facilities pursuing registration as a certified nurse aide must complete a minimum of sixteen hours of classroom training in the following areas from a department-approved nurse aide training program prior to any hands-on contact with residents or patients. The areas are:
(1)Communication and interpersonal skills;
(2)Infection control;
(3)Safety and emergency procedures, including the Heimlich maneuver;
(4)Promoting residents' independence; and (5)Respecting residents' rights.
c.The remainder of the seventy-five-hour-approved training and competency evaluation program must be completed within four months of the date of first employment in the facility as a nurse aide and must include at least sixteen hours of supervised practical training.
d.Other areas that are required to be addressed in the certified nurse aide training program include:
(1)Basic nursing skills;
(2)Personal care skills;
(3)Mental health and social service needs;
(4)Care of residents or clients with cognitive impairments;
(5)Basic restorative services; and (6)Resident or patient rights.
e.Individuals may not perform tasks for which competence has not been determined unless under the direct supervision of a licensed nurse.
f.Individuals trained and determined proficient by the instructor to provide specific services to residents who have not completed the competency evaluation program shall provide these services under the general provision of a licenced nurse.
g.The certified nurse aide training program must ensure that individuals in the training program who are employed by or have an offer of employment from a nursing facility to work as a certified nurse aide are not charged for any portion of the nurse aide training program, including fees for textbooks or other required course materials.
2.Any individual employed by a home health agency to provide home health aide services directly or by contract must successfully completed a home health aide training and competency evaluation program or competency evaluation program.
a.The training program must total at least seventy-five clock hours, with at least sixteen of the seventy-five hours being devoted to classroom training prior to initiating the supervised practical training. At least sixteen hours of the total program hours must be devoted to supervised practical training.
b.The training, including supervised practical training, of the home health aides must be performed under the general supervision of a qualified instructor.
(1)A qualified instructor for a home health training program is a registered nurse who possesses a minimum of two years of nursing experience, at least one year of which must be in the in the provision of home health care services.
(2)Other professionals may be used to provide instruction under the supervision of the qualified instructor.
c.The training must, at a minimum, include the following topics:
(1)Communication skills;
(2)Observation, reporting, and documentation of patient status and care or services furnished;
(3)Reading and recording of temperature, pulse, and respirations;
(4)Basic infection control procedures;
(5)Basic elements of body functioning and changes in body functioning that must be reported to an aide's supervisor;
(6)Maintenance of a clean, safe, and healthy environment;
(7)Recognizing emergencies and knowledge of emergency procedures;
(8)The physical, emotional, and developmental needs of and ways to work with the patients served;
(9)Patient rights;
(10)Appropriate and safe techniques in personal hygiene and grooming which include:
(a)Bed bath;
(b)Sponge, tub, or shower bath;
(c)Sink, tub, or bed shampoo;
(d)Oral hygiene; and (e)Nail or skin care.
(11)Safe transfer techniques and ambulation;
(12)Normal range of motion and positioning;
(13)Adequate nutrition and fluid intake; and (14)Any other tasks the agency may choose to have the home health aide perform.
d.The agency must maintain sufficient documentation to demonstrate that the requirements for the training of home health aides of this section are met.
3.Any individual who is not a licensed nurse who is employed directly or by contract to provide nursing or nursing-related services by a health care facility or other setting that is not a nursing facility or a home health agency must successfully complete a nurse aide training program under the direction of a qualified instructor and competency evaluation or competency evaluation.
a.A qualified instructor for a nurse aide training program is a licensed nurse.
b.The training program must, at a minimum, include the following areas:
(1)Infection control;
(2)Safety and emergency procedures;
(3)Collection and documentation of basic subjective and objective client data, including vital signs;
(4)Activities of daily living (bathing, dressing, personal hygiene, oral hygiene, transfer, ambulation, toileting, and eating) applicable to setting.
(5)Decisionmaking skills;
(6)Client rights, including freedom from abuse, neglect, misappropriation of client property, respect, privacy, dignity, and confidentiality;
(7)Communication and interpersonal skills; and (8)Care of the client with cognitive impairments.
c.The nurse aide may not need to be retrained for each client cared for by the nurse aide, provided the nurse aide's knowledge and skills are maintained.
d.Additional training must be provided to nurse aides by a qualified instructor for clients whose needs or conditions would require variation from the typical manner the nursing-related task would be performed.
e.The nurse aide shall perform the delegated nursing-related task only on the client for whom the delegation is specified, exactly as taught, and in accordance with employers' policies or directives.
N.D. Admin. Code 33-43-01-05 Nurse aide competency evaluation
1.Any individual employed by a nursing facility to provide nursing or nursing-related services, who is not a licensed nurse or volunteer, must successfully complete a department-approved certified nurse aide competency evaluation program to be eligible to apply to be placed on the department's nurse aide registry.
a.The department-approved certified nurse aide competency evaluation program must allow a nurse aide the option of establishing competency through written or oral and manual skills examination.
b.The written or oral examination must address all areas required in the department-approved training program.
c.The written or oral examination must be developed from a pool of test questions, only a portion of which may be utilized in any one examination.
d.The competency evaluation program must include a demonstration of the randomly selected tasks the individual will be expected to perform as part of the individual's function as a nurse aide.
e.The competency evaluation program must provide for a system that prevents disclosure of both pool questions and the individual competency evaluations.
f.The competency evaluation program must ensure that nurse aides employed by or having an offer of employment from a facility are not charged for any portion of the competency evaluation program.
2.Any individual employed by a home health agency to provide home health aide services must complete a home health competency evaluation program to be eligible to apply to be placed on the department's nurse aide registry. The competency evaluation program consists of the
a.The competency evaluation must be conducted by a registered nurse who possesses a minimum of two years of nursing experience, at least one year must be in the provision of home health care.
b.The competency evaluation must address each of the items listed in subdivision c of subsection 2 of section 33-43-01-04.
(1)The items listed in paragraphs 3, 10, 11, and 12 of subdivision c of subsection 2 of
section 33-43-01-04 must be completed by observation of the aide's performance of the tasks with a patient or other live individual.
(2)All other items listed in subdivision c of subsection 2 of section 33-43-01-04 can be evaluated through written or oral examination or observation of the aide with a patient.
c.A home health aide is not considered to have successfully passed a competency evaluation program if the aide has an unsatisfactory rating in more than one of the required areas.
(1)A home health aide cannot perform any task for which the aide is evaluated to perform unsatisfactorily unless under the direct supervision of a licensed nurse.
(2)The home health aide must receive training in the areas determined unsatisfactory and pass a subsequent evaluation satisfactorily prior to performing a task without supervision.
d.The agency must maintain documentation that the competency evaluation requirements of this subsection have been met be each home health aide.
3.Any individual who is employed directly or by contract by a health care facility or other setting that is not a nursing facility or a home health agency must successfully complete a nurse aide competency evaluation program to be eligible to apply to be placed on the department's nurse aide registry.
a.The competency evaluation program must be completed by a licensed nurse or employer.
b.The competency evaluation must, at a minimum, address the areas listed in subdivision a of subsection 3 of section 33-43-01-04.
c.A nurse aide is not considered to have successfully passed a competency evaluation program if the individual has an unsatisfactory rating in a required area identified in subdivision a of subsection 3 of section 33-43-01-04.
d.A nurse aide may perform tasks for which the aide has been competency evaluated to perform, and may not perform tasks for which the competency evaluation was unsatisfactory unless under the direct supervision of a licensed nurse.
N.D. Admin. Code 33-43-01-06 Administration of nurse aide competency evaluation programs
1.A certified nurse aide competency evaluation must be administered and evaluated by the department or a department-approved entity that is not a nursing facility licensed by the department.
a.The entity that administers the competency evaluation must advise the individual in advance that a record of the successful or unsuccessful completion of the evaluation will be included on the department's nurse aide registry.
b.The skills demonstration portion of the test must be administered in the facility or laboratory setting comparable to the setting in which the individual will function.
c.The skills demonstration portion of the test must be administered and evaluated by a registered nurse with at least one year of experience in providing care for the elderly or chronically ill of any age.
d.The department may permit the written or oral examination to be proctored by facility personnel if the department determines that the procedure adopted assures the competency evaluation is:
(1)Secure from tampering.
(2)Standardized and scored by a testing, educational, or other organization approved by the department.
(3)Exempt from any scoring by facility personnel.
e.The department shall retract the right to proctor nurse aide competency evaluations from facilities in which the department finds any evidence of impropriety, including tampering by facility personnel.
2.A home health aide competency evaluation program must be administered consistent with the requirements in subsection 2 of section 33-43-01-05 and may be evaluated for compliance periodically by the department. However, the department may permit the use of a home health aide competency evaluation program that is standardized and scored by a testing, educational, or other organization approved by the department.
3.A nurse aide competency evaluation program must be administered consistent with the requirements in subsection 3 of section 33-43-01-05 and may be evaluated as determined necessary by the department.
N.D. Admin. Code 33-43-01-07 Withdrawal and approval of nurse aide training program status
1.Certified nurse aide training program status withdrawal and approval of status is as follows:
a.The department shall withdraw approval of a nursing facility-based certified nurse aide training program when a determination has been made that the facility has been found to be out of compliance with significant federal certification or state licensure requirements.
The facility may apply for reinstatement after providing evidence of remaining in compliance with significant requirements for a period of twenty-four consecutive months.
b.The department shall withdraw approval of a certified nurse aide training and competency evaluation program if the entity providing the program refuses to permit announced or unannounced visits by the department to ascertain compliance with program requirements.
c.Approval of a nurse aide training and competency evaluation program shall be granted by the department for a period not to exceed two years.
d.The department may approve only those certified nurse aide training programs that meet the requirements in subsection 1 of section 33-43-01-04.
2.Home health aide training program status withdrawal and approval of training program status is as follows:
a.A home health aide training program must meet the requirements of subsection 2 of
section 33-43-01-04 to be considered approved by the department.
b.Home health agencies that have had state or federal enforcement action, other than the citation of deficiencies, filed against them in the past two years are not eligible to operate a home health aide training program.
3.Nurse aide training withdrawal and approval of training status is as follows:
a.Nurse aide training must meet the requirements of subsection 3 of section 33-43-01-04 to be considered approved by the department.
b.Failure to meet the requirements of subsection 3 of section 33-43-01-04 may result in a determination by the department that the entity can no longer provide nurse aide training until the requirements are met.
N.D. Admin. Code 33-43-01-08 Completion of the nurse aide competency evaluation program
1.To complete the competency evaluation successfully the individual shall, at a minimum, successfully complete the competencies in subsection 1, 2, or 3 of section 33-43-01-05.
2.A record of successful completion of the competency evaluation for individuals seeking registration as a certified nurse aide, home health aide, or nurse aide must be included in the nurse aide registry within fourteen days of the date the individual was found to be competent.
3.If the individual fails to complete the evaluation satisfactorily, the competency evaluation program must advise the individual of the areas of which the individual was adequate or inadequate, and that the individual has not more than three opportunities to take the competency evaluation.
4.If the individual seeking registration fails the competency evaluation on the third attempt, the individual must enroll in and complete a department-approved certified nurse aide training program, home health aide training program, or nurse aide training program prior to taking the competency evaluation again.
N.D. Admin. Code 33-43-01-09 Registry information
1.The department is responsible for the entering of individual names on the nurse aide registry upon receipt of information verifying completion of a department-approved certified nurse aide training and competency evaluation program or a department-approved certified nurse aide competency evaluation program, a home health aide training and competency evaluation program or a home health aide competency evaluation program, or a nurse aide competency evaluation program.
2.Upon the completion of a department-approved medication assistant I competency evaluation program by a certified nurse aide or nurse aide, or department-approved medication assistant II competency evaluation program by a certified nurse aide and application to the department, the department will add information to the certified nurse aide or nurse aide's registry listing verifying the completion of the medication assistant I or II program.
3.Information included on the registry must include name, address, social security number, birth date, registry categories, the date the nurse aide became eligible for entry on the registry, and the place of employment. The social security number will not be included in registry information released to the public.
4.The department shall include documentation of validated findings of abuse, neglect, misappropriation of resident property, or other misconduct by the certified nurse aide, home health aide, or nurse aide or medication assistant I or II on the registry when validated by the department.
5.Certified nurse aide applicants for the nurse aide registry who submit proof of meeting the requirements of another jurisdiction will be granted reciprocity and entered on the nurse aide registry and may use the title "certified nurse aide". The individual must meet North Dakota requirements for active registry status.
6.Nurse aides meeting the waiver provisions of twenty-four months of continuous employment as a nurse aide prior to December 19, 1989, granted by the department will be listed on the registry with a special designation. This designation will signify the nurse aide has been waived from training and testing requirements but is not certified.
History
- Law Implemented: NDCC 23-01-11, 23-17.3-08, 23-44-02
N.D. Admin. Code 33-43-01-10 Disclosure of information
1.Information contained in the registry will be disclosable to any Medicare or Medicaid participating facility, nursing facility, home health agency, hospital, basic care facility, assisted living facility, ombudsman, other representative of an official agency, or other individuals requesting information, upon request.
2.Upon request, the department shall provide the requester with the following information regarding individuals on the registry:
a.The date the individual's name was eligible for entry on the registry.
b.Any documented validated findings of abuse, neglect, misappropriation, or other misconduct, including the nature of the allegation and summary of the evidence supporting the validated finding, the date and outcome of hearing if one occurred, and any statement by the individual disputing the allegation that led to the validated finding.
c.Any additional information that the department deems necessary.
3.All information contained on the registry regarding a certified nurse aide, home health aide, nurse aide, or medication assistant I or II will be provided to that individual upon written request to the department.
N.D. Admin. Code 33-43-01-11 Initial certified nurse aide, home health aide, and nurse aide registration and renewal
Individuals may not be employed to provide nursing or nursing-related services as a certified nurse aide, home health aide, or nurse aide, or hold themselves out to be a certified nurse aide, home health aide, or nurse aide unless the individual is registered on the department's nurse aide registry according to this chapter.
1.An individual who applies for initial registry status as a certified nurse aide shall submit a completed certified nurse aide application and verification of successful completion of a department-approved certified nurse aide training and competency evaluation program or competency evaluation program. Upon receipt and review for approval of the required information, the individual will be placed on the department's registry with a designation of certified nurse aide.
a.An individual who is enrolled in a department-approved certified nurse aide training and competency evaluation program may be employed to perform nursing or nursing-related services under the supervision of a licensed nurse for no more than four months without obtaining registry status.
b.An individual who is not a licensed nurse who is not enrolled in a department-approved certified nurse aide training program may not be employed in a nursing facility to provide nursing or nursing-related services until the individual obtains registry status as a certified nurse aide.
c.Individuals who have met the requirements for registry listing as a certified nurse aide in other states, have a current registry status, and no validated finding may be endorsed onto the department's registry as a certified nurse aide.
d.Registry status is limited to twenty-four months. Upon receipt of a completed certified nurse aide renewal application, and verification of employment within the immediate past twenty-four months, the certified nurse aide registry status will be updated to indicate current status.
e.A certified nurse aide who has not performed at least eight hours of nursing or nursing-related services for pay within a continuous twenty-four-month period shall complete a department-approved training and competency evaluation program or a department-approved competency evaluation to renew current registry status.
f.An individual seeking initial certified nurse aide registry status or registry renewal as a certified nurse aide on the department's nurse aide registry may not be charged a fee.
2.An individual who applies for initial registry status as a home health aide shall submit a completed home health aide application, a nonrefundable fee of twenty-five dollars, and an attestation from a qualified instructor that the individual has successfully completed a home health aide training and competency program or home health aide competency program.
Upon receipt and review for approval of the required information, the individual will be placed on the department's registry with a designation of home health aide.
a.An individual who is in a home health aide training and competency program may be employed to perform nursing or nursing-related services under the supervision of a licensed nurse for no more than four months without obtaining registry status.
b.An individual who is not in a home health aide training program may not be employed by the home health agency to provide home health aide services until the individual obtains registry status as a home health nurse aide.
c.Initial registry listing will be subject to renewal on or before September thirtieth of the second year and every two years thereafter.
d.Upon receipt of a completed home health aide renewal application and a nonrefundable fee of twenty-five dollars, the home health aide registry status will be updated to indicate current status. The home health aide's registry status will be considered temporary until such time the payment is confirmed and may be rescinded if payment is not received.
3.An individual who applies for initial registry status as a nurse aide shall submit a completed nurse aide application, including documentation of verification of competency and a nonrefundable fee of twenty-five dollars. Upon receipt and review for approval of the required information, the individual will be placed on the department's registry with a designation of nurse aide.
a.An individual who is in a nurse aide training and competency evaluation program may be employed to perform nursing or nursing-related services under the supervision of a licensed nurse for no more than four months without obtaining registry status.
b.An individual who is not in a nurse aide training program may not be employed as a nurse aide until the individual obtains registry status as a nurse aide.
c.Initial registry listing will be subject to renewal on or before September thirtieth of the second year and every two years thereafter.
d.Upon receipt of a completed nurse aide renewal application, including verification of competence within the past twelve months and a nonrefundable fee of twenty-five dollars, the nurse aide registry will be updated to indicate current status. The nurse aide's registry status will be considered temporary until such time the payment is confirmed and may be rescinded if payment is not received.
N.D. Admin. Code 33-43-01-12 Supervision and delegation of nursing interventions
An individual on the department's nurse aide registry may perform nursing interventions which have been delegated by a licensed nurse. An individual on the department's nurse aide registry as delegated and supervised by a licensed nurse:
1.Contributes to the assessment of the health status of clients, including interactions of clients with family members or group members by:
a.Collecting basic subjective and objective data from observations and interviews, including taking vital signs; and
b.Reporting and recording the collected data.
2.Identifies basic signs and symptoms of deviations from normal health status and provides basic information which licensed nurses' use in identification of problems and needs.
3.Contributes to the development of the plan of care for individuals by reporting basic data.
4.Participates in the giving of direct care by:
a.Assisting with activities of daily living and encouraging self-care;
b.Providing comfort measures and emotional support to the client whose condition is stable and predictable;
c.Assisting with basic maintenance and restorative nursing;
d.Supporting a safe and healthy environment;
e.Documenting and communicating completion of delegated nursing interventions and client responses; and
f.Seeking guidance and direction when appropriate.
5.Contributes to the evaluation by:
a.Documenting and communicating client responses; and
b.Assisting with collection of data.
History
- General Authority: NDCC 23-44-02, 43-12.1-16.1
- Law Implemented: NDCC 23-44-02, 43-12.1-16.1
N.D. Admin. Code 33-43-01-13 Medication assistant requirements for supervision
An individual on the department's nurse aide registry may perform medication administration that has been delegated by a licensed nurse.
1.In a nursing facility, the medication assistant may perform medication assistance only when a licensed nurse is on the unit and available for immediate direction.
2.In a health care facility where the licensed nurse delegates the intervention of giving medications to another individual, the individual on the department's nurse aide's registry may perform the delegated medication assistance only when a licensed nurse is available for direction.
3.In any other setting where the licensed nurse delegates the intervention of medication administration to another individual, the individual on the department's nurse aide registry may perform the delegated medication administration only if the licensed nurse has established in writing the process for providing the supervision in order to provide safeguards for the individual receiving the medication.
4.Individuals on the department's nurse aide registry may not be delegated to or perform medication administration in acute care settings or for individuals with unstable or changing nursing care needs.
5.The medication assistant requirements in this chapter do not apply to an individual who provides medication administration that is not registered under this chapter and is:
a.Within a correctional facility, in compliance with North Dakota Century Code section 12-44.1-29;
b.Within a psychiatric residential treatment facility for children licensed under North Dakota Century Code chapter 25-03.2 and North Dakota Administrative Code chapter 75-03-17;
c.Within a treatment or care center for intellectual or developmentally disabled persons licensed under North Dakota Century Code chapter 25-16;
d.Within a group home, a residential child care facility, or an adult foster care facility licensed under North Dakota Century Code section 50-11-01 or North Dakota Administrative Code chapter 75-03-16;
e.Within the development center at Westwood Park, Grafton, to the extent the individual who provides medications is a direct training technician or a vocational training technician as approved by the department of human services; or
f.Within a human service center licensed under North Dakota Century Code chapter 50-06.
N.D. Admin. Code 33-43-01-14 Medication assistant I training and competency evaluation program The medication assistant I program requirements are applicable to settings in which a licensed nurse is not regularly scheduled and provides direct or indirect supervision. The medication assistant I program consists of the theoretical concepts of medication administration and supervised clinical administration of medication. The curriculum must meet the requirements established by the department and include at a minimum:
1.Instructor. A registered nurse is responsible for the development of the theory, the laboratory or clinical component, and supervision of the medication assistant training program.
2.Course objectives. Described in terms of student outcome competencies, including the
a.Utilize the principles of safety in the administration of medication;
b.Define terms related to the administration of medications;
c.Correctly interpret abbreviations commonly used in administration of medication;
d.Know and apply laws related to medication administration;
e.Keep accurate records; and
f.Identify legal parameters of the medication assistant role.
3.Curriculum. The medication assistant program I curriculum for delegated medication administration must include:
a.Medication concepts:
(1)Terminology and standardization abbreviations;
(2)Classification of medication;
(3)Generic and trade names;
(4)Dosage, range, and action;
(5)Side effects;
(6)Medication routes; and (7)References and sources of information.
b.Roles, responsibilities, legal aspects, and limitations of medication assistant I and licensed nurse:
(1)Scope of duties for medication assistant I;
(2)Licensed nurse responsibilities in relationship to a medication assistant I;
(3)Client rights, including the right to refuse medication; and (4)Knowledge of organization policy related to medication administration.
c.Methods for medication packaging.
d.Storage and disposal of medication.
e.Administering and charting medication:
(1)Preparation and administration of medication;
(2)Safety and six rights of medication administration;
(3)Use of medication administration record to:
(a)Administer medications; and (b)Document medication administration;
(4)Prevention of medication errors; and (5)Causes and reporting of medication errors.
f.Standard precautions for infection control.
g.An overview of the major classes of medications related to body systems.
h.Additional instruction must include those categories of medications relevant to the health care setting where the medication assistant will be employed.
i.Clinical instruction for the purpose of demonstration of medication administration and evaluation of individual competence.
4.Medication assistant I program students must complete the clinical portion of the medication assistant program within six months of completion of the theory portion. Failure to do so will render the individual ineligible to administer medications.
5.A passing score of eighty-five percent is required on the theory test with an opportunity to retake the test one time. If a student fails on a retake, additional instruction is required before further testing is allowed.
6.Medication assistant I program students shall demonstrate satisfactory performance of medication administration as evidenced by satisfactory completion of the clinical skills checklist.
7.During the clinical learning experience, the licensed nurse shall:
a.Provide direct over-the-shoulder supervision with initial medication pass;
b.Observe and evaluate the student's performance until a ninety percent performance standard on the clinical skills checklist is obtained; and
c.Decreased the amount of supervision only when the student demonstrates the ninety percent performance standard.
8.The medication assistant I program coordinator is required to submit to the department, which two weeks of completion of the course, a list of students successfully completing the medication assistant I program. The information submitted to the department for initial medication assistant I registration for each student must include:
a.Name and location of the institution and course title;
b.Date of completion;
c.Full name, address, and social security number of the student;
d.The name and qualifications of the instructors;
e.The clinical facility or employer and address;
f.The facility clinical coordinator of each student who successfully completes the course;
g.Copies of the completed theoretical curriculum and clinical performance testing results for the student;
h.A copy of a certificate of successful completion, if awarded by the teaching institution;
i.A completed medication assistant I application; and
j.A nonrefundable fee of twenty-five dollars.
9.Medication assistant I programs shall maintain records that are available for a period of seven years. Those records must include:
a.Program records, including curriculum and evaluation tools for student performance, both theory and clinical.
b.Students records, including course start and completion date, clinical skills checklist, examination scores, and a copy of the certificate of successful completion.
10.The medication assistant I program will submit a renewal application for review by the department for a determination on continued approval at least every four years.
N.D. Admin. Code 33-43-01-15 Medication assistant II training and competency evaluation program The medication assistant II program requirements are applicable to settings in which a licensed nurse may or may not be regularly scheduled. The medication assistant II program consists of a minimal time frame, including forty hours of theory, eight hours of laboratory, and thirty-two hours of clinical learning experience. The curriculum must meet the requirements in this section, and include at a minimum:
1.Instructor. A registered nurse is responsible for the development of the theory, laboratory component, and supervision of the medication assistant II program. All medication administration as a part of the clinical learning experience must be supervised by a licensed nurse.
2.Course objectives. Described in terms of student outcome competencies, including the
a.Utilize the principles of safety in the administration of medications;
b.Define terms related to the administration of medications;
c.Correctly interpret abbreviations commonly used in administration of medications;
d.Know and apply laws related to medication administration;
e.Keep accurate records; and
f.Identify legal parameters of the medication assistant role.
3.Curriculum. The medication assistant program II curriculum for delegated medication administration must include:
a.Medication concepts:
(1)Terminology and standardized abbreviation;
(2)Classification of medication;
(3)Generic and trade names;
(4)Dosage, range, and action;
(5)Side effects;
(6)Medication routes; and (7)References and sources of information.
b.Roles, responsibilities, legal aspects, and limitations of medication assistant II and licensed nurse:
(1)Scope of duties for a medication assistant II;
(2)Licensed nurse responsibilities in relationship to a medication assistant II;
(3)Client rights, including the right to refuse medication;
(4)Laws related to medication administration; and (5)Knowledge of organization policy related to medication administration.
c.Methods for medication packaging.
d.Storage and disposal of medication.
e.Administering and charting medications:
(1)Preparation and administration of medications;
(2)Safety and six rights of medication administration;
(3)Use of medication administration record to:
(a)Administer medications; and (b)Document medication administration;
(4)Prevention of medication errors; and (5)Causes and reporting of medication errors.
f.Standard precautions for infection control.
g.Major classes of medications related to body systems, including:
(1)Cardiovascular;
(2)Endocrine;
(3)Gastrointestinal;
(4)Integumentary;
(5)Musculoskeletal;
(6)Nervous;
(7)Reproductive;
(8)Respiratory;
(9)Sensory; and (10)Urinary.
h.Additional instruction must include those categories of medications relevant to the heath care setting where the medication assistant will be employed.
i.Laboratory and clinical instruction for the purpose of demonstration of medication administered and evaluation of individual competence.
4.Medication assistant program II students who complete the classroom portion of the medication assistant program have six months from the completion of classroom instruction to successfully complete the clinical portion of the program. Failure to do so will render the individual ineligible to complete the clinical portion of the program.
5.Tests are developed for each unit in the curriculum, including a final test. A passing score of eighty-five percent is required on each unit test with an opportunity to retake each test one time. If a student fails on retake, additional instruction is required before further testing is allowed. The theory portion of the course must be successfully completed before beginning the clinical portion.
6.Medication assistant students shall demonstrate satisfactory performance of medication administration as evidenced by satisfactory completion of the laboratory skills and clinical skills checklist.
7.During the clinical learning experience, the licensed nurse shall:
a.Provide direct over-the-shoulder supervision with initial medication pass;
b.Observe and evaluate the student's performance until a ninety percent performance standard on the clinical checklist is obtained; and
c.Decrease the amount of supervision only when the student demonstrates the ninety percent performance standard.
8.The medication assistant II program coordinator is required to submit to the department, within two weeks of completion of the course, a list of students successfully completing the medication assistant II program. The information submitted to the department for initial medication assistant II registration for each student must include:
a.Name and location of the institution and course title;
b.Date of completion;
c.Full name, address, and social security number of the student;
d.The name and qualifications of the instructors;
e.The clinical facility or employer and address;
f.The facility clinical coordinator of each student who successfully completes the course;
g.Copies of the completed theoretical curriculum and clinical performance testing results for the student;
h.A copy of a certificate of successful completion;
i.A completed medication assistant II application; and
j.A nonrefundable fee of twenty-five dollars.
9.Medication assistant II programs shall maintain records that are available for a period of seven years. Those records must include:
a.Program records, including curriculum and evaluation tools for student performance, both theory and clinical; and
b.Student records, including course start and completion date, laboratory and clinical skills checklist, examination scores, and a copy of the certificate of successful completion.
10.The medication assistant II program will submit a renewal application for review by the department for a determination on continued approval at least every four years.
N.D. Admin. Code 33-43-01-16 Specific delegation of medication administration
An individual on the department's nurse aide registry may accept the delegation of the delivery of specific medication for a specific client by a licensed nurse if the following steps are followed:
1.The individual on the department's nurse aide registry must receive the organization procedural guidelines for the certified nurse aide, home health aide, nurse aide, or medication assistant I or II to follow in the administration of medication by specific delegation.
2.The individual on the department's nurse aide is taught by a licensed nurse for each specific client's medication administration which includes verbal and written instruction for the specific client's individual medications, including:
a.The medication trade name and generic name;
b.The purpose of the medication;
c.Signs and symptoms of common side effects, warnings, and precautions;
d.Route and frequency of administration; and
e.Instructions under which circumstances to contact the licensed nurse or licensed health care practitioner.
3.The individual on the department's nurse aide registry is observed by a licensed nurse administering the medication to the specific client until competency is demonstrated.
4.The individual on the department's nurse aide registry has been verified as competent by a licensed nurse through a variety of methods, including oral quizzes, written tests, and observation. The individual on the department's nurse aide registry must be verified as competent in the following areas:
a.Knows the six rights for each medication for the specific client, which include right client, right medication, right dosage, right route, right time, and right documentation;
b.Knows the name of the medication and common dosage;
c.Knows the signs and symptoms of side effects for each medication;
d.Knows when to contact the licensed nurse;
e.Can administer the medication properly to the client; and
f.Documents medication administration according to organization policy.
5.Documentation that the individual on the department's nurse aide registry has received the training related to the receipt of specific delegation of medication administration for each client must be maintained and updated when further instruction is received as necessary to implement a change.
N.D. Admin. Code 33-43-01-17 Routes or types of medication administration
1.Administration of the initial dose of a medication that has not been previously administered to the client must be administered according to the organization policy.
2.Medication assistant students and medication assistants may administer medications by the following routes to individuals or groups of individuals with stable, predictable conditions according to the organization policy:
a.Oral, sublingual, and buccal medications;
b.Eye medications;
c.Ear medications;
d.Nasal medications;
e.Rectal medications and enemas;
f.Vaginal medications;
g.Skins ointments, topical medications, including patches and transdermal medications;
h.Metered hand-held inhalants; and
i.Unit dose nebulizers.
3.Medication assistants I and II may administer medications by the following routes only when specifically delegated by a licensed nurse for a specific client:
a.Gastrostomy;
b.Jejunostomy;
c.Subcutaneous; and
d.Premeasured injectable medication for allergic reactions.
4.Medication assistant students and medication assistants I and II may not administer medications by the following routes:
a.Central lines;
b.Colostomy;
c.Intramuscular injection;
d.Intravenous;
e.Intravenous lock;
f.Intrathecal;
g.Nasogastric tube;
h.Nonmetered inhaler;
i.Intradermal;
j.Nonunit dose aerosol or nebulizer; or
k.Urethral catheter.
5.Medication assistant students and medication assistants I and II may not administer the following kinds of medications:
a.Barium and other diagnostic contrast media;
b.Chemotherapeutic agents except oral maintenance chemotherapy; or
c.Through any medication pumps, or assume responsibility for medication pumps, including client-controlled analgesia.
N.D. Admin. Code 33-43-01-18 Pro re nata medications
1.The decision to administer pro re nata medications cannot be delegated in situations where an onsite assessment of the client is required prior to administration.
2.Some situations allow the administering of pro re nata medications without directly involving the licensed nurse prior to each administration.
a.The decision regarding whether an onsite assessment is required is at the discretion of the licensed nurse.
b.Written parameters specific to an individual client's care must be written by the licensed nurse for use by the medication assistant when an onsite assessment is not required prior to administration of a medication. The written parameters:
(1)Supplement the physician's pro re nata order; and (2)Provide the medication assistant with guidelines that are specific regarding the pro re nata medication.
N.D. Admin. Code 33-43-01-19 Medication interventions that may not be delegated
The medication assistant I or medication assistant II, or other individual listed on the department's nurse aide registry, may not perform the following acts even if delegated by a licensed nurse:
1.Conversion or calculation to medication dosage;
2.Assessment of client need for or response to medications; and
3.Nursing judgement regarding the administration of pro re nata medications.
N.D. Admin. Code 33-43-01-20 Medication assistant I and II initial registration and renewal
Individuals may not be employed as a medication assistant I or medication assistant II or hold themselves out to be a medication assistant I or medication assistant II unless the individual holds a registration as a medication assistant I or medication assistant II on the department's nurse aide registry. Individuals with delegated responsibility for administration of medication to a client as a medication assistant I must hold a current status on the department's registry as a certified nurse aide or nurse aide. Individuals with delegated responsibility for administration of medication to a client as a medication assistant II must hold a current status on the department's registry as a certified nurse aide.
1.An application for registration as a medication assistant I or II and a nonrefundable twenty-five dollar fee must be submitted to the department. Upon receipt of the required information, the department shall issue a medication assistant I or II registration consistent with the type of training and competency program completed.
a.A medication assistant I may work in settings where the licensed nurse is not regularly scheduled, however, may not work in a nursing facility or acute care setting, including clinics.
b.A medication assistant II may work in the same settings as the medication assistant I and nursing facilities, however, may not work in acute care settings, including clinics.
2.Individuals may obtain initial medication assistant I registration by successfully completing a department-approved medication assistant I program.
3.Individuals may obtain initial medication assistant II registration by successfully completing a department-approved medication assistant II program.
4.A certified nurse aide's initial and renewal medication assistant I or II registry listing will be subject to renewal on the same date as the individual's certified nurse aide registration, not to exceed two years. A nurse aide's initial or renewal medication assistant I registry listing will be subject to renewal on the same date as the individual's nurse aide registration status, on or before September thirtieth of the second year and every two years thereafter.
a.The individual must submit a nonrefundable twenty-five dollar renewal fee along with a completed medication assistant renewal application form, including verification of continued competency by a licensed nurse. The medication assistant's registry status will be considered temporary until such time the payment is confirmed, and may be rescinded if payment is not received.
b.Upon receipt and approval of the required information, the department will update the nurse aide registry to reflect current registration status.
N.D. Admin. Code 33-43-01-21 Complaint investigations
1.The department will investigate a complaint reported involving individuals registered on the department's nurse aide registry.
2.The complaint investigation will be conducted according to the department's established complaint investigation policies and procedures.
N.D. Admin. Code 33-43-01-22 Disciplinary actions
1.The department may deny, suspend, revoke, or encumber the registration status of, or issue a letter of concern against, an individual listed on the department's nurse aide registry who:
a.Has obtained or attempted to obtain registration as a nurse aide by fraud, deceit, or intentional misrepresentation;
b.Has been convicted of a crime substantially related to the qualifications, functions, or duties of a nurse aide;
c.Has impersonated a licensed nurse or other licensed health care provider;
d.Has intentionally or negligently engaged in conduct that has resulted in a significant risk to the health or safety of a client or in injury to a client;
e.Is incapable of working with reasonable skill, competence, and safety for the public; or
f.Has misappropriated the property of, abused, or neglected a client.
2.An individual denied registration or an individual on the department's registry will be notified of the individual's right to request a hearing regarding the department's decision to deny registration, revoke, suspend, or encumber the individual's registry status within thirty days of the notification.
3.If the employer continues to use the individual during the investigation process, the employer must take reasonable steps to prevent further harm to residents or clients.
4.If an individual listed on the department's nurse aide registry is determined to have practiced with an expired registration, the following actions will be taken:
a.If an individual on the department's nurse aide registry is identified as performing nursing-related services for pay with an expired registration status of thirty days or less, the department will notify the individual and the individual's employer, if known, that the individual must immediately cease to work until the renewal application process is completed and the individual's registry status becomes current.
b.If an individual on the department's nurse aide registry is identified as performing nursing-related services for pay with an expired registration of more than thirty days to six months, the department will notify the state survey agency, the employer, and the individual that the individual must immediately cease to work until the renewal application process is completed and the individual's registry status become current.
c.If an individual on the department's nurse aide registry is identified as performing nursing-related services for pay with an expired registration of more than six months, the department will notify the state survey agency, the employer, and the individual that the individual must immediately cease to work. The individual's registry status will no longer be recognized by the department. To obtain current registry status again, the individual must follow the process for initial application for registry status.
N.D. Admin. Code 33-43-01-23 Hearing process for individuals on the nurse aide registry
1.Individuals who have been denied registry status will be informed of the reasons why and provided an opportunity for a hearing consistent with this section.
2.Individuals registered on the department's registry against whom allegations of abuse, neglect, misappropriation of resident property, or other misconduct are made will be:
a.Informed by the department of the allegations;
b.Informed of the investigation results; and
c.If the allegations are found valid, notified of their right to request a hearing regarding the department's decision to revoke, suspend, or encumber the individual's registry status within thirty days of the notification.
3.If a hearing is not timely requested, the department's finding will be final and the department will submit information specific to validated allegations to the registry.
4.If a hearing is timely requested, the department will apply to the office of administrative hearings for appointment of an administrative law judge. The office of administrative hearings will notify the accused of the date set for the hearing.
5.The administrative law judge will conduct the hearing and prepare recommended findings of fact and conclusions of law, as well as a recommended order. If through the department's investigation process, there is evidence that abuse, neglect, misappropriation of resident property, or other misconduct has occurred, the department will notify law enforcement officials and other officials as determined appropriate.
6.Allegations of abuse, neglect, misappropriation of resident property, or other misconduct by an individual on the department's nurse aide registry, validated by the department or through the hearing process, shall:
a.Be identified in the nurse aide registry within ten days of the validation; and
b.Remain on the registry permanently, unless the validation was made in error, the individual was found not guilty in a court of a law, or the department is notified of the nurse aide's death. After a period of one year, an individual with a finding of neglect placed on the individual's registry listing may petition the state to have the finding removed from the individual's registry listing consistent with the process identified in
section 33-43-01-24, if determined eligible by the department.
7.Within thirty days following the addition of information regarding a validation to the registry, the department will provide the individual on the department's nurse aide registry with a copy of all information which will be maintained in the registry.
8.Within thirty days of mailing the notification of a finding adverse to an individual on the department's nurse aide registry, the individual may contact the department and correct any misstatements or inaccuracies in the information regarding the individual maintained by the registry.
9.Any Medicare or Medicaid participating nursing facility, home health agency, hospital, basic care facility, assisted living facility, ombudsman, other representative of an official agency, or other individual with a need to know may receive information contained in the registry by making a written request.
History
- General Authority: NDCC 23-44-02, 28-32-02(1)
N.D. Admin. Code 33-43-01-24 Review process for findings of neglect placed on an individual nurse aide's registry listing
1.An individual on the department's nurse aide registry with a finding of neglect placed on the individual's nurse aide registry listing may petition the department in writing to have the finding removed from the individual's registry listing. The individual must provide the department with authorization for any releases of information the department deems appropriate in conducting the investigation. The department will consider whether to remove the finding from the registry when:
a.The employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect. For the purposes of this section, a pattern is defined as two or more occurrences of abusive or neglectful behavior toward another individual which resulted in the potential for a negative outcome or an actual negative outcome to the other individual;
b.The neglect involved in the original finding was a singular occurrence that resulted in a potential or actual negative resident outcome; and
c.A background check, including a criminal history investigation or report, reveals no
history of mistreatment findings, including instances of domestic abuse, the granting of a restraining order which has not been overturned, an adverse finding entered on any child abuse information index, or any conviction of any crime involving violence or the threat of violence.
2.Once a determination has been made by the department that the individual has met the criteria identified in subsection 1 and is eligible for review, the following steps will be taken:
a.The individual requesting the review must submit a written statement to the department, in a format prescribed by the department, which includes:
(1)An explanation of the incident;
(2)Why the individual believes the individual would not repeat the incident;
(3)Why the individual believes the individual is not competent; and (4)Why the department should remove the finding from the individual's nurse aide registry listing, including any education or rehabilitation efforts that the individual has completed since the finding of neglect was placed on the individual's registry listing.
b.The original incident, the written information submitted to the department under subdivision a, and any other information collected by the department shall be reviewed by a committee consisting of a staff member of the state department of health, a provider representative, and the state ombudsman.
(1)The committee may consult with the department's attorney as deemed necessary.
(2)Information obtained by the department from sources other than the petitioning individual and the department's file regarding the original incident will be provided to the individual, who will have thirty days after mailing to respond to the committee in writing.
c.The petition, all information contained in the department's file regarding the original incident, and information received by the department will be reviewed by the committee with consideration given to the following factors:
(1)The degree of negligence;
(2)The severity of the potential negative resident outcome;
(3)The severity of the actual negative resident outcome;
(4)The forthrightness and cooperation of the individual;
(5)The opinion of the individual's employer at the time of the incident regarding removing the finding from the individual's registry listing, including the employer's willingness to rehire the individual;
(6)The resident's opinion as to willingness to be cared for by this individual again, if available;
(7)Any rehabilitation or education completed by the individual since the incident; and (8)Any other factors or considerations the committee determines to be pertinent to its decision. The committee may request additional information from the individual if more information is required to make a determination or if the committee deems a matter not addressed by the individual to be relevant.
d.Based on the review by the committee, with consideration given to the factors identified in subdivision c, the committee may:
(1)Remove the finding from the individual's registry listing;
(2)Require the individual demonstrates successful completion of a state-approved training and competency evaluation program prior to the finding being removed from the registry;
(3)Require the individual to complete a rehabilitation or education program as identified by the committee prior to the finding being removed from the registry;
(4)Require the individual to provide the committee with documentation that a nursing facility or health care facility has offered to employ the individual once the finding is removed from the individual's registry listing and that the nursing facility or health care facility is willing to monitor the resident care services provided by the individual;
(5)Identify any additional time frame the finding will remain on the registry. The additional time frame identified by the committee may range anywhere from one month to permanent placement on the registry;
(6)Take other action as identified appropriate by the committee; or (7)Implement any combination of the above actions.
3.The department must provide the individual and the registry with written results of the review within one hundred twenty days from the time the department has determined the individual is eligible for review and has received the written information submitted by the individual consistent with subdivisions a and b of subsection 1 and any additional information collected by the department.
4.The individual has only one opportunity to request the department to review the permanent placement of the neglect finding on the registry and to request the department remove the finding.
5.The review must be conducted based on written documentation submitted to the department.
A face-to-face meeting with the individual may be requested by the committee as determined necessary.
6.The committee shall issue a written statement of fact, conclusions of law, and its order based on upon findings and conclusions. This statement must be mailed to the individual requesting the review. An appeal for reconsideration of the order must be filed with the department within thirty days from the date the order is mailed. The department may allow a petition for reconsideration of the order if the petition is received within fifteen days after the statement is mailed. If the department is petitioned for reconsideration, the department will review and reconsider the determination. Upon completion of the review, the determination will become the final order for purposes of appeal.
7.If a new finding of neglect is placed on the individual's registry listing after the previous finding of neglect has been removed, the new finding will remain on the registry permanently with no opportunity for review.
History
- General Authority: NDCC 23-44-02, 28-32-02(1)
- Law Implemented: NDCC 23-01-03, 23-44-02, 28-32-05.2
N.D. Admin. Code 33-43-01-25 Grandfather provisions
The department will grandfather the approval and current registry status of the nurse aides, home health aides, and medication assistants I and II and related training programs transferred from the state board of nursing to the state department of health July 1, 2011, until the next renewal date consistent with this chapter.
N.D. Admin. Code 33-43-01-26 Waiver provision
Any provisions of this chapter may be waived by the department for a specified period in specific instances, provided such a waiver does not adversely affect the health and safety of the clients and would result in unreasonable hardship upon the entity requesting the waiver. A waiver may be granted for a specific period of time not to exceed one year and shall expire on December thirty-first of the year issued.
History
- General Authority: NDCC 23-01-03, 23-44-02, 28-32-02
- Law Implemented: NDCC 23-16-01, 23-44-02, 28-32-02
Article 33-44 Medical Marijuana
Chapter 33-44-01 Medical Marijuana
N.D. Admin. Code 33-44-01-01 Definitions
In this chapter, unless the context otherwise requires:
1."Activation time" means the amount of time it is likely to take for an individual to begin to feel the effects of ingesting or inhaling usable marijuana.
2."Adverse reaction" means an unwanted, unexpected, or dangerous effect caused by the administration of usable marijuana dispensed pursuant to North Dakota Century Code chapter 19-24.1.
3."Analyte" means a component, substance, or chemical or microbiological constituent that is of interest in an analytical procedure or test.
4."Batch" means a quantity of dried leaves and flowers from a harvest lot, a quantity of cannabinoid concentrate, or medical cannabinoid product from a process lot.
5."Compliance test" means a test required by these rules to be performed by a laboratory selected by the department in order to allow the transfer or sale of usable marijuana.
6."Container" means a sealed, hard- or soft-bodied receptacle in which usable marijuana is placed.
7."Container identification number" means the identification number that was generated by the manufacturing facility at the time the usable marijuana was packaged and labeled for sale to the dispensary.
8."Cotyledons" means an embryonic leaf of a plant, one or more of which are the first leaves to appear.
9."Date of harvest" means the date the mature marijuana plants in a harvest lot were removed from the soil or other growing media. If the harvest occurred on more than one day, the "date of harvest" is the day the last mature marijuana plant in the harvest lot was removed from the soil or other growing media.
10."Degradation compound" or "Pesticide degradate" means a resultant product from the transformation of a parent compound to a product with different physical and chemical properties, the fate and significance of which, is altered due to the structural changes.
11."Harvest lot" means a specifically identified quantity of the same strain of marijuana that is cultivated utilizing the same growing practices, harvested within a seventy-two-hour period at the same location, and cured under uniform conditions.
12."Hazardous waste" means the same as defined in North Dakota Century Code chapter 23-20.3.
13."Laboratory" means a laboratory selected by the department in accordance with section 33-44-01-36 to sample and conduct tests in accordance with these rules.
14."Medical marijuana waste" means the same as defined in North Dakota Century Code chapter 19-24.1.
15."Net weight" means the gross weight minus the tare weight of the packaging.
16."Parent compound" means the original molecular structure from which other compounds can be derived through a chemical reaction or natural breakdown process.
17."Pediatric symbol" means the image, established by the department and made available to manufacturing facilities, indicating the product complies with the pediatric medical marijuana maximum concentration limit as defined in North Dakota Century Code chapter 19-24.1.
18."Plant" means a marijuana plant that has produced cotyledons or a cutting of a marijuana plant that has produced cotyledons.
19."Process lot" means any amount of:
a.Cannabinoid concentrate of the same type and processed within a forty-eight-hour period, unless prior written authorization is received from the department, using the same extraction methods, standard operating procedures, and batches, not to exceed three, of the same strain from the same or a different harvest lot; or
b.Medical cannabinoid product of the same type and processed within a forty-eight-hour period, unless prior written authorization is received from the department, using the same ingredients, standard operating procedures, and a process lot or process lots, not to exceed three, of cannabinoid concentrate as defined in subsection a.
20."Product identity" means a common name of the product that is contained in the package.
21."Remediation" means a process used by a manufacturing facility to remedy a lot or batch that has failed testing.
22."Sterilization" means the removal of all micro-organisms and other pathogens from usable marijuana by treating it with approved chemicals or subjecting it to high heat.
23."Tentatively identified compounds" means compounds detected in a sample using gas chromatography mass spectrometry or liquid chromatography mass spectrometry that are not among the target analytes for the residual solvent analysis and pesticide and mycotoxin analysis.
24."Test sample" means anything collected by a laboratory from a compassion center for testing.
25."Unit of sale" means an amount of usable marijuana commonly packaged in a container for transfer to a registered qualifying patient or registered designated caregiver, or capable of being packaged in a container for transfer to a registered qualifying patient or registered designated caregiver.
26."Universal symbol" means the image, established by the department and made available to manufacturing facilities, indicating the product contains marijuana.
27."Water activity" means a measure of the free moisture in usable marijuana and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature, and is indicated by the symbol a w .
28."Written notice" means a notice provided to the department via letter, electronic mail, or other electronic form or medium made available on the department's website.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022.
- General authority: NDCC 19-24.1-01
- Law Implemented: NDCC 19-24.1-01
N.D. Admin. Code 33-44-01-02 Cardholder notification of change
A registered qualifying patient or registered designated caregiver who is required to provide notification in accordance with subsection 1 of North Dakota Century Code section 19-24.1-10 shall provide the department written notice.
N.D. Admin. Code 33-44-01-03 Fees for failure to provide notice
A compassion center that fails to provide notice as required by North Dakota Century Code chapter 19-24.1 and these rules, is subject to a fee in the amount of one hundred fifty dollars.
The department may process a qualifying patient application for a registry identification card without the signature of the minor's parent or legal guardian if the applicant is eighteen years of age and the department determines the minor has no parent or legal guardian with responsibility for health care decisions of the minor.
The department shall collect nonrefundable original application fees and nonrefundable renewal application fees for registry identification cards as follows:
1.For resident qualifying patient applications, forty dollars.
2.For nonresident qualifying patient applications, forty dollars.
3.For compassion center agent application fees, two hundred dollars.
For a cardholder's first time losing a qualifying patient registry identification card or compassion center agent registry identification card, the department shall collect no fees for issuing a new registry identification card. For a cardholder's second and subsequent times losing a qualifying patient registry identification card or compassion center registry identification card, the department shall collect a twenty-five-dollar fee for issuing a new registry identification card.
History
- General Authority: NDCC 19-24.1-20
- Law Implemented: NDCC 19-24.1-20 33-44-01-03.1. Minor application.
- History: Effective July 1, 2022.
- General Authority: NDCC 19-24.1-03
- Law Implemented: NDCC 19-24.1-03 33-44-01-03.2. Application fees for registry identification cards.
- History: Effective October 1, 2022; amended effective October 1, 2025.
- General Authority: NDCC 19-24.1-03, 19-24.1-18
- Law Implemented: NDCC 19-24.1-03, 19-24.1-03.3, 19-24.1-18 33-44-01-03.3. Replacement fees for registry identification cards.
- History: Effective October 1, 2022; amended effective October 1, 2025.
- General Authority: NDCC 19-24.1-10, 19-24.1-18
- Law Implemented: NDCC 19-24.1-10, 19-24.1-18
N.D. Admin. Code 33-44-01-04 Cardholder disposal of usable marijuana
1.An individual who is no longer registered with the department or a cardholder who is no longer eligible shall dispose of any usable marijuana in their possession by:
a.Returning it to a dispensary; or
b.Rendering it unusable in accordance with subsection 4 of section 33-44-01-15.
2.Except as provided in this section, an individual who is no longer registered with the department or a cardholder who is no longer eligible may not transfer, share, give, sell, or deliver any usable marijuana in their possession to anyone, regardless of whether the individual possesses a valid registry identification card.
3.An individual who is no longer registered with the department or a cardholder who is no longer eligible may not dispose of usable marijuana in any manner other than as permitted by these rules.
4.After the death of a registered qualifying patient, any usable marijuana that was in the cardholder's possession or in the possession of the registered qualifying patient's registered designated caregiver must be disposed of within fifteen days. The registered qualifying patient's registered designated caregiver or next of kin shall dispose of any usable marijuana by rendering it unusable in accordance with subsection 4 of section 33-44-01-15.
5.After the death of a registered designated caregiver, any usable marijuana that was in the cardholder's possession must be disposed of within fifteen days. The registered designated caregiver's next of kin shall dispose of any usable marijuana by:
a.Allowing the registered qualifying patient for whom it was dispensed to take possession of the usable marijuana; or
b.Rendering it unusable in accordance with subsection 4 of section 33-44-01-15.
N.D. Admin. Code 33-44-01-05 Expiration of registry identification cards
An initial registry identification card expires one year after the date of issuance, unless the health care provider's written certification identifies the benefit from the medical use of marijuana is less than a year. To prevent interruption of possession of a valid registry identification card, a renewal of a registry identification card may have an expiration date from date of issuance in excess of one year.
History
- General Authority: NDCC 19-24.1-11
- Law Implemented: NDCC 19-24.1-11
N.D. Admin. Code 33-44-01-06 Compassion center application process
1.The department shall announce the open application period for the submission of compassion center applications. The announcement may be made using the department's website, electronic mail, press release, or any other means determined by the department. The announcement must include:
a.Instructions;
b.Forms;
c.Deadline for submission;
d.Criteria and score sheet to be used to review applications;
e.Number, and category, of compassion centers eligible for registration; and
f.Department contact information.
2.The department shall announce a change to the application requirements in the same manner used to announce the open application period.
3.The department may use a separate open application period for each category of compassion center.
4.Each proposed compassion center must be a separate legal entity and must submit a complete application.
5.The department shall establish a panel to evaluate all complete compassion center applications received before the deadline. The panel must be comprised of at least three, but no more than five, members. Panel members shall execute a conflict of interest form developed by the department. An individual with a conflict of interest, as determined by the department, may not participate as a panel member.
6.The panel shall evaluate all complete compassion center applications using an impartial and numerical scoring system. The panel must include the criteria in subsection 2 of North Dakota Century Code section 19-24.1-14 when reviewing compassion center applications. The department may include additional criteria in the review as long as the criteria is included in the open application period announcement.
7.Each panel member shall review and score every complete application.
8.The cumulative total of all the scores assigned to an application by each panel member is the final score. The final score will determine which applicants are eligible for registration.
9.The department shall notify, in writing, the highest scoring applicants for each category of compassion center of their eligibility for registration. Upon approval of the criteria in subsection 1 of North Dakota Century Code section 19-24.1-15 the department shall issue a compassion center registration certificate to the eligible compassion centers in each category.
A separate legal entity may possess only one compassion center registration certificate. The department shall notify, in writing, compassion center applicants who are not selected for registration.
10.The department shall determine the amount and acceptable evidence of the financial assurance or security bond required in subsection 1 of North Dakota Century Code section 19-24.1-15. The amount may not exceed one hundred thousand dollars for a dispensary and may not exceed one million dollars for a manufacturing facility.
11.If a compassion center applicant eligible for registration does not meet the criteria in subsection 1 of North Dakota Century Code section 19-24.1-15, the department may select the next highest scoring compassion center applicant in the category for registration, or establish a new open application period.
History
- History: Effective April 1, 2018; amended effective October 1, 2022.
- General Authority: NDCC 19-24.1-12
- Law Implemented: NDCC 19-24.1-12
N.D. Admin. Code 33-44-01-07 Establishing additional compassion centers
If the department determines additional compassion centers are necessary to increase access to usable marijuana by registered qualifying patients and registered designated caregivers, the department may register additional compassion centers as follows:
1.The application and selection process for establishing additional compassion centers must be in accordance with section 33-44-01-06.
2.In addition to the criteria in subsection 2 of North Dakota Century Code section 19-24.1-14, the department also shall consider the location of the proposed compassion center, including its proximity to previously approved compassion centers of the same category and whether the population of registered qualifying patients supports the need for an additional facility in the area.
The department may use the compassion center application and selection process in accordance with North Dakota Century Code chapter 19-24.1 and section 33-44-01-06 to register a manufacturing facility as a specific category of a medical marijuana establishment. A manufacturing facility selected and registered as a specific category of medical marijuana establishment shall comply with applicable compassion center requirements of North Dakota Century Code chapter 19-24.1 and these rules. The category of medical marijuana establishments are as follows:
1.A production only authorized manufacturing facility is a specific category of manufacturing facility. The activities of a production only authorized manufacturing facility are limited to producing and to related activities, including acquiring, possessing, storing, transferring, and transporting marijuana and the dried leaves or flowers of the plant of the genus cannabis in a combustible delivery form for the sole purpose of selling dried leaves or flowers of the plant of the genus cannabis in a combustible delivery form to a dispensary.
2.A medical marijuana product processor only authorized manufacturing facility is a specific category of manufacturing facility. The activities of a medical marijuana product processor only authorized manufacturing facility are limited to producing and processing and to related activities, including acquiring, possessing, storing, transferring, and transporting marijuana and medical marijuana products for the sole purpose of selling medical marijuana products to a dispensary.
The department shall collect nonrefundable application fees for compassion centers as follows:
1.For a manufacturing facility, three thousand dollars.
2.For a dispensary, two thousand dollars.
The department shall collect certification fees for compassion center registrations as follows:
1.For a manufacturing facility, seventy-five thousand dollars.
2.For a dispensary, sixty thousand dollars.
3.For a production only authorized manufacturing facility, forty thousand dollars.
4.For a medical marijuana product processor only authorized manufacturing facility, twenty thousand dollars.
The department shall collect an additional certification fee of five thousand dollars for every five hundred plants in excess of one thousand plants a manufacturing facility possesses.
History
- General Authority: NDCC 19-24.1-12
- Law Implemented: NDCC 19-24.1-12 33-44-01-07.1. Additional categories of registered medical marijuana establishments.
- History: Effective October 1, 2022. 33-44-01-07.2. Compassion center application fees.
- History: Effective October 1, 2022; amended effective October 1, 2023.
- General Authority: NDCC 19-24.1-14
- Law Implemented: NDCC 19-24.1-14 33-44-01-07.3. Compassion center certification fees.
- History: Effective October 1, 2022; amended effective October 1, 2023.
- General Authority: NDCC 19-24.1-15
- Law Implemented: NDCC 19-24.1-15 33-44-01-07.4. Compassion center additional certification fees.
- History: Effective October 1, 2023.
- General Authority: NDCC 19-24.1-15
- Law Implemented: NDCC 19-24.1-15
N.D. Admin. Code 33-44-01-08 Compassion center inventory limits
1.A manufacturing facility shall grow an amount of marijuana sufficient to meet the qualifying patient population demands. A manufacturing facility may possess up to fifty plants for the
purpose of department-authorized research and development related to production and processing. Plants for research and development shall:
a.Be included in inventory;
b.Be located in a restricted area separate from the restricted area containing plants used for producing and processing of usable marijuana; and
c.Not be used in the production and processing of usable marijuana that is sold to a dispensary for patient consumption unless authorized by the department in writing.
2.A manufacturing facility with a registration certificate may use additional structures located within five hundred feet [152.40 meters] of the location described in the original application.
Prior to using additional structures, the manufacturing facility shall submit a written request to the department. The written request must include the reason the structures are necessary, verification the additional structures do not jeopardize public health or safety, and evidence from the appropriate local government official that the additional structures are at least one thousand feet [304.80 meters] from a property line of a pre-existing public or private school.
The department shall approve or deny a request within thirty calendar days. The department shall deny a request if the department makes an affirmative finding the use of additional structures would jeopardize public health or safety or the additional structures are within one thousand feet [304.80 meters] of a property line of a pre-existing public or private school.
3.A dispensary may not possess more than three thousand five hundred ounces [99.22 kilograms] of usable marijuana at any time, regardless of formulation.
History
- General Authority: NDCC 19-24.1-17, 19-24.1-24
- Law Implemented: NDCC 19-24.1-17, 19-24.1-24
N.D. Admin. Code 33-44-01-09 Use of pesticides prohibited
Except for minimum-risk pesticides identified in North Dakota Century Code section 4.1-34-10, the use of pesticides, as defined in North Dakota Century Code section 4.1-34-01, in the production, processing, or storage of marijuana is prohibited. Prior to using any minimum-risk pesticide a compassion center must receive written approval from the department.
N.D. Admin. Code 33-44-01-10 Pesticide presence
All marijuana or usable marijuana inventory affected or contaminated, as defined by these rules, by pesticides must be disposed of in accordance with these rules, or as required by the department of agriculture.
History
- General Authority: NDCC 19-24.1-23
- Law Implemented: NDCC 19-24.1-23
N.D. Admin. Code 33-44-01-11 Operations manual
1.A compassion center operations manual must include:
a.Procedures for the oversight of the compassion center, including documentation of the reporting and management structure of the compassion center. The procedures must include a business continuity plan.
b.Procedures to ensure accurate recordkeeping.
c.Employee security policies, including information related to the unauthorized entrance into restricted access areas.
d.Personal safety and crime prevention techniques.
e.Safety and security procedures, including a disaster plan with procedures to be followed in case of fire, security breach, or other emergency. Security breach procedures must include an event occurring during the transportation of marijuana, usable marijuana, and marijuana waste.
f.An overview of the inventory control provisions consistent with North Dakota Century Code section 19-24.1-26 and these rules.
g.A job description or employment contract developed for all employees and volunteers which includes duties, responsibilities, authority, qualification, and supervision.
h.An alcohol-free and drug-free workplace policy.
i.A description of the usable marijuana containers the compassion center utilizes in accordance with North Dakota Century Code section 19-24.1-21 and these rules.
j.A description of the documentation required to accompany a registered compassion center agent while transporting marijuana, usable marijuana, and medical marijuana waste on behalf of the compassion center. Documentation must be in accordance with these rules.
k.Procedures for the mandatory, or voluntary, recall of usable marijuana in accordance with these rules.
l.Any other information requested by the department.
2.A manufacturing facility's operations manual must also include:
a.Detailed procedures regarding the producing, processing, and testing of marijuana and usable marijuana. The procedures must include a description of how marijuana will be sampled and tested in accordance with these rules.
b.Procedures for ensuring compliance with quality control and quality assurance requirements in accordance with these rules.
c.Procedures for ensuring manufacturing areas are maintained in a clean and orderly condition.
d.Procedures for addressing infestation by insects, rodents, birds, or vermin of any kind.
e.A description of the types of usable marijuana produced and processed by the manufacturing facility.
3.A dispensary's operations manual also must include:
a.Procedures for safely dispensing usable marijuana to registered qualifying patients and registered designated caregivers.
b.A distribution plan to provide registered qualifying patients and registered designated caregivers access to usable marijuana.
c.A description of the dispensary's outreach activities for registered qualifying patients and registered designated caregivers which must include:
(1)Offering each new registered qualifying patient who visits the dispensary with a department-issued document that explains the state and federal law limitations of usable marijuana;
(2)Offering information regarding the forms of usable marijuana available at the dispensary;
(3)Offering information regarding potential side effects of marijuana use; and (4)A plan regarding the implementation of outreach activities.
4.A compassion center shall maintain and follow its operations manual at all times. A compassion center shall provide the department with written notice of any updates or revisions to the operations manual within thirty days of the changes.
History
- General Authority: NDCC 19-24.1-27
- Law Implemented: NDCC 19-24.1-27
N.D. Admin. Code 33-44-01-12 Restricted access areas
1.Except as provided in section 33-44-01-13, compassion center restricted access areas include:
a.All areas containing marijuana, usable marijuana, and medical marijuana waste.
b.All areas used for production and processing.
2.A compassion center shall use an electronic controlled access system to limit entrance to all restricted access areas of its facility.
a.An electronic controlled access system must:
(1)Limit access to authorized individuals.
(2)Track specific personnel entry and exit times.
(3)Lock down the facility in the event of a security threat.
(4)Store data for retrieval.
(5)Remain operable in the event of power failure.
(6)Enable remote administration.
b.A compassion center immediately shall submit stored controlled-access-system data to the department upon request.
c.Restricted access areas must be identified with a sign that states: "Do Not Enter - Restricted Access Area - Access Limited to Authorized Personnel Only."
3.Individuals authorized to enter restricted access areas include:
a.Compassion center agents;
b.Laboratory agents;
c.Authorized department personnel;
d.Individuals accompanied by a compassion center agent when the compassion center agent has received written authorization from authorized department personnel; and
e.Individuals accompanied by authorized department personnel.
4.A compassion center shall maintain documentation of access to restricted areas for individuals included in paragraphs b, c, d, and e of subsection 3. The documentation must include date of entry, time of entry, time of exit, name of individual, reason for access, and any other information required by the department. The documentation must be retained for at least three years.
5.Law enforcement, fire personnel, or emergency medical service professionals may enter restricted access areas in the event of an emergency requiring immediate action.
N.D. Admin. Code 33-44-01-13 Dispensary display areas
1.A dispensary may have a display area where usable marijuana is displayed in enclosed locked cases accessible only by compassion center agents. The purpose of the display area is to provide registered qualifying patients and registered designated caregivers the opportunity to view usable marijuana and receive education regarding its use. Usable marijuana may not be visible from the street or other public areas.
2.Individuals authorized to enter dispensary display areas include:
a.Registered qualifying patients;
b.Registered designated caregivers;
c.Compassion center agents;
d.Authorized department personnel;
e.Individuals accompanied by a compassion center agent when the compassion center agent has received written authorization from authorized department personnel; and
f.Individuals accompanied by authorized department personnel.
3.Before allowing an individual to enter a dispensary display area, the dispensary shall verify the validity of a cardholder's registry identification card.
4.A dispensary shall post department-provided signs or materials regarding warnings, recalls, and education materials in a display area or lobby.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022.
N.D. Admin. Code 33-44-01-14 Usable marijuana take back
1.A dispensary may accept at no charge unused, excess, or contaminated usable marijuana for disposal. A dispensary shall maintain a written record of returned usable marijuana that includes:
a.The name of the registered qualifying patient;
b.The registered qualifying patient's registry identification number;
c.The date the usable marijuana was returned;
d.The quantity of usable marijuana returned; and
e.The type of usable marijuana returned.
2.A dispensary shall dispose of the returned usable marijuana as follows:
a.In accordance with these rules; or
b.By transferring it to a manufacturing facility for disposal in accordance with these rules. A dispensary shall maintain a written record that includes the amount of returned usable marijuana transferred to a manufacturing facility for disposal and the date.
3.A manufacturing facility may accept returned usable marijuana from a dispensary. Any returned usable marijuana accepted from a dispensary must be disposed of in accordance with these rules. A manufacturing facility shall maintain a written record that includes the amount of returned usable marijuana and the date accepted by a manufacturing facility for disposal.
N.D. Admin. Code 33-44-01-15 Medical marijuana waste disposal
1.All medical marijuana waste generated during production, processing, and testing, must be stored, managed, and disposed of in accordance with these rules.
2.All medical marijuana waste generated during production, processing, and testing must be evaluated against the state's hazardous waste regulations to determine if the medical marijuana waste is designated as hazardous waste. It is the responsibility of each medical marijuana waste generator to properly evaluate their medical marijuana waste to determine if it is designated as hazardous waste. If a generator's medical marijuana waste is designated as hazardous waste, the medical marijuana waste is subject to the hazardous waste management standards in North Dakota Century Code chapter 23-20.3.
3.Medical marijuana waste not designated as hazardous waste must be rendered unusable in accordance with subsection 4 prior to disposal. Medical marijuana waste rendered unusable must be disposed of in accordance with subsection 5.
4.The required method for rendering medical marijuana waste unusable is by grinding the medical marijuana waste and incorporating it with other ground materials so the volume of the resulting mixture is less than fifty percent medical marijuana waste. All other methods for rendering medical marijuana waste unusable must be approved by the department before implementation. Medical marijuana waste to be disposed in a landfill may be mixed with soil or other material as approved by the department.
5.Medical marijuana waste rendered unusable in accordance with subsection 4 can be disposed.
a.Disposal of the medical marijuana waste rendered unusable may be delivered to a permitted and state-approved solid waste facility for final disposition.
b.A compassion center or laboratory shall maintain a record of the final destination of medical marijuana waste rendered unusable. The record shall be maintained for a period of seven years.
History
- General Authority: NDCC 19-24.1-16, 19-24.1-23
- Law Implemented: NDCC 19-24.1-16, 19-24.1-23
N.D. Admin. Code 33-44-01-16 Recall procedures
Each compassion center shall establish a procedure for issuing voluntary and mandatory recalls for usable marijuana.
1.Factors that require a recall include:
a.Defective or potentially defective usable marijuana.
b.Usable marijuana that has failed laboratory testing in accordance with these rules.
c.Reasonable probability that use of the usable marijuana or exposure to the usable marijuana will cause serious adverse health consequences.
d.Any other instances as determined by the department that would warrant a recall.
2.The procedure must include:
a.The compassion center agents who are responsible for overseeing the recall.
b.The procedures for notifying everyone affected by a recall, including registered qualifying patients, registered designated caregivers, and other compassion centers.
c.Instructions for registered qualifying patients, registered designated caregivers, and other compassion centers, regarding proper product handling of any recalled usable marijuana.
3.A dispensary shall maintain a list of registered qualifying patients and registered designated caregivers and current contact information to provide notice in the event of a recall.
N.D. Admin. Code 33-44-01-17 Surveillance requirements
1.To prevent unauthorized access to marijuana and usable marijuana, the compassion center shall have video surveillance equipment to deter the unauthorized entrance into restricted access areas.
a.The compassion center shall operate, monitor, and maintain in good working order a closed-circuit television surveillance system on all of its premises, which must operate at all times and visually record:
(1)All phases of production and processing.
(2)All compassion center points of entry and exit, sales and display areas, and garages.
(3)The entrance to the video surveillance room.
(4)Any parking lot, which must have appropriate lighting for the normal conditions of the area under surveillance.
b.Video surveillance systems must:
(1)Capture clear and certain identification of any person entering or exiting a compassion center.
(2)Have the ability to produce a clear, color, still photo either live or from a recording.
(3)Have an embedded date-and-time stamp on all recordings which must be synchronized and not obscure the picture.
(4)Continue to operate during a power outage.
c.Video recording specifications include:
(1)A video recording must export still images in an industry standard image format, including .jpg, .bmp, and .gif.
(2)Exported video must be archived in a proprietary format that ensures authentication and guarantees the recorded image has not been altered.
(3)Exported video must be saved in an industry standard file format that can be played on a standard computer operating system.
(4)Upon completion of the required retention period, all recordings must be erased or destroyed before disposal.
2.The compassion center shall maintain all security system equipment and recordings in a secure location to prevent theft, loss, destruction, corruption, and alterations.
3.The compassion center shall ensure that twenty-four hour recordings from all video cameras are:
a.Available for viewing by the department through a secure internet connection.
b.Retained for a period of at least ninety calendar days during the first year of operation, and upon department approval, for at least sixty calendar days thereafter.
c.Maintained free of alteration or corruption.
d.Retained longer if the compassion center is given notice of a pending criminal, civil, or administrative investigation, or other legal proceeding for which the recording may contain relevant information.
N.D. Admin. Code 33-44-01-18 Alarm system requirements
1.A compassion center shall install and maintain a professionally monitored security alarm system that provides intrusion and fire detection of all:
a.Facility entrances and exits.
b.Rooms with exterior windows.
c.Rooms with exterior walls.
d.Roof hatches.
e.Skylights.
2.A security alarm system means a device or series of devices that summons law enforcement personnel during, or as a result of, an alarm condition. Devices may include:
a.Hardwired systems and systems interconnected with a radio frequency method, such as cellular or private radio signals that emit or transmit a remote or local audio, visual, or electronic signal.
b.Motion detectors.
c.Pressure switches.
d.A duress alarm.
e.A panic alarm.
f.A holdup alarm.
g.An automatic voice dialer.
h.A failure notification system that provides an audio, text, or visual notification of any failure in the surveillance system.
3.A compassion center's security alarm system and all devices must continue to operate during a power outage.
4.The compassion center shall test the security alarm system and all devices on a monthly basis and maintain a record of all tests.
5.The compassion center's security alarm system must be inspected and all devices tested annually by a qualified alarm vendor.
N.D. Admin. Code 33-44-01-19 Inventory control measures
1.The department shall maintain a computer information system for inventory control and registry identification card verification.
2.A compassion center inventory control system shall interface with the computer information system maintained by the department. All costs associated with interfacing are the responsibility of the compassion center. If the compassion center's inventory control system does not adequately, as determined by the department, interface with the computer information system maintained by the department, the department may require the compassion center to use the system maintained by the department.
History
- General Authority: NDCC 19-24.1-26
- Law Implemented: NDCC 19-24.1-26
N.D. Admin. Code 33-44-01-20 Conducting inventory
1.Each compassion center, prior to commencing business, shall:
a.Conduct an initial inventory of all marijuana and usable marijuana at the compassion center. If a compassion center commences business with no marijuana or usable marijuana, the compassion center shall record the initial inventory as zero.
b.After the initial inventory, conduct an inventory of marijuana and usable marijuana once a week for a period of at least six months, and upon department approval, at least monthly thereafter.
c.Conduct each inventory in a manner that includes two individuals. One of the two individuals must be a supervisor or manager.
2.Inventory documentation must include:
a.The date of the inventory;
b.Detailed inventory results; and
c.The name, signature, and title of the individuals who conducted the inventory and an attestation by both individuals as to the accuracy of the inventory.
History
- History: Effective April 1, 2018; amended effective October 1, 2025.
- General Authority: NDCC 19-24.1-26
- Law Implemented: NDCC 19-24.1-26
N.D. Admin. Code 33-44-01-21 Personnel record retention
1.Personnel records maintained by the compassion center must include:
a.Recruiting and screening documents, such as:
(1)Application.
(2)Resume.
b.Job descriptions.
c.Records relating to job offers, promotion, demotion, transfer, layoff, and education and training.
d.Records related to other employment practices, such as policy acknowledgments and agreements.
e.Letters of recognition.
f.Warnings, counseling, and disciplinary notices.
g.Performance evaluation and goal setting records.
h.Termination records.
i.References and background checks.
2.Records must be retained longer than as required by North Dakota Century Code section 19-24.1-30, if the compassion center is given notice of a pending criminal, civil, or administrative investigation, or other legal proceeding for which the record may contain relevant information.
History
- General Authority: NDCC 19-24.1-30
- Law Implemented: NDCC 19-24.1-30
N.D. Admin. Code 33-44-01-22 Compassion center and laboratory incidents
1.Compassion centers and the laboratory shall contact 911 in the event of an emergency and contact law enforcement or 911 to report criminal activities.
2.Compassion centers and the laboratory shall provide the department with written notice, within twenty-four hours, of any of the following:
a.A breach of security;
b.Failures of, or tampering with, security and surveillance equipment, cameras, or recordings;
c.Power failures lasting longer than two hours;
d.Embezzlement or fraud;
e.Contacting 911 or contact with law enforcement;
f.Incidents that occur while transporting marijuana, usable marijuana, and medical marijuana waste;
g.Attempts to obtain marijuana or usable marijuana in a manner not prescribed by North Dakota Century Code chapter 19-24.1 and these rules; and
h.Violations of North Dakota Century Code chapter 19-24.1 and these rules.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022.
N.D. Admin. Code 33-44-01-23 Advertising and marketing
1.A dispensary may:
a.Display its business name and logo on labels, signs, websites, and informational material provided to registered qualifying patients and registered designated caregivers. The name or logo may not include:
(1)Images of marijuana or marijuana paraphernalia.
(2)Colloquial references to marijuana.
(3)Names of marijuana plant strains.
(4)Medical symbols that bear a reasonable resemblance to established medical associations, including the American medical association or American academy of pediatrics.
b.Maintain a website that may contain:
(1)The facility name.
(2)Contact information.
(3)Hours of operation.
(4)The usable marijuana offered.
(5)Product pricing.
(6)Other information as approved by the department.
2.A manufacturing facility may:
a.Display its business name and logo on labels, websites, and informational material. The name or logo may not include:
(1)Images of marijuana or marijuana paraphernalia.
(2)Colloquial references to marijuana.
(3)Names of marijuana plant strains.
(4)Medical symbols that bear a reasonable resemblance to established medical associations, including the American medical association or American academy of pediatrics.
b.Maintain a website that may contain:
(1)The facility name.
(2)Phone number.
(3)Other information as approved by the department.
3.A dispensary only may dispense usable marijuana if it has been purchased by a registered qualifying patient or registered designated caregiver. A dispensary may not provide free usable marijuana to a registered qualifying patient or registered designated caregiver.
4.Marketing or advertising activities of a compassion center may not be marketed to a minor.
5.Marketing or advertising activities, not covered under subsections 1 and 2, are subject to department approval. The compassion center shall request approval from the department, and the department shall approve or deny the request within thirty calendar days.
History
- History: Effective April 1, 2018; amended effective October 1, 2025.
N.D. Admin. Code 33-44-01-24 Strain or brand names
A manufacturing facility may not use strain or brand names containing any words that refer to products commonly associated with minors, marketed to minors, or any names that are false or misleading. 33-44-01-24.1. Medical cannabinoid product formulation.
A manufacturing facility must have a certificate of authenticity or similar documentation approved by the department for all ingredients used in formulating a medical cannabinoid product. A certificate of authenticity or similar documentation approved by the department must include the date of expiration.
Nonmarijuana ingredients for a medical cannabinoid product intended for ingestion must be of foodgrade quality.
1.A cannabinoid edible product must be marked, stamped, or otherwise imprinted with the letters "THC" or other marking approved by the department.
2.A cannabinoid edible product may not be covered or coated with sugar, candy, or a flavor enhancing ingredient. With written department approval, a cannabinoid edible product may be covered or coated in a nonflavored enhancing wax or oil to enhance shelf stability or usage of the product.
3.Depictions of the product, cartoons, or images other than the universal symbol, pediatric symbol, or manufacturing facility logo may not be included on the cannabinoid edible product packaging.
History
- History: Effective July 1, 2022; amended effective October 1, 2025. 33-44-01-24.2. Cannabinoid edible product.
- History: Effective October 1, 2025.
N.D. Admin. Code 33-44-01-25 Usable marijuana packaging
Usable marijuana packaging used by a manufacturing facility must be approved by the department.
A manufacturing facility shall package all usable marijuana intended for distribution according to the following standards:
1.Usable marijuana containers must be:
a.Plain and opaque.
b.Tamper-evident.
c.Child-resistant.
2.Usable marijuana must be packaged to minimize its appeal to minors.
3.Usable marijuana packaging may not be similar to or bear a reasonable resemblance to any commercially available product.
4.Usable marijuana packaging must be resealable if intended for more than a single use.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; October 1, 2025.
N.D. Admin. Code 33-44-01-26 Manufacturing facility labeling
1.A manufacturing facility shall label all usable marijuana in accordance with the following before their sale or transfer to a dispensary:
a.A container holding dried leaves and flowers must include the following information:
(1)Manufacturers' business or trade name and registry certification number;
(3)Batch number;
(4)Date of harvest;
(5)Name of strain;
(6)Net weight in United States customary or metric units;
(7)Concentration of total tetrahydrocannabinol and total cannabidiol as identified by the laboratory selected by the department in accordance with section 33-44-01-36;
(8)Activation time expressed in words or through a pictogram;
(9)Expiration date;
(10)Universal symbol; and (11)Consumer warnings that state:
(d)"It is illegal to drive or to be in actual physical control of a motor vehicle while
b.A container holding a cannabinoid concentrate must include the following information:
(1)Manufacturing facility's business or trade name and registry certification number;
(3)Process lot number;
(4)Product identity;
(5)Date the concentrate was made;
(6)Net weight or volume in United States customary or metric units;
(7)If applicable, serving size and number of servings per container or amount suggested for use by the consumer or patient at any one time;
(8)Concentration or amount of total tetrahydrocannabinol, and the concentration or amount of total cannabidiol, by weight or volume in the container as identified by the laboratory selected by the department in accordance with section 33-44-01-36;
(9)Activation time, expressed in words or through a pictogram;
(10)Expiration date;
(11)A disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process;
(12)Universal symbol;
(13)Pediatric symbol, if applicable; and (14)Consumer warnings that state:
(d)"It is illegal to drive or to be in actual physical control of a motor vehicle while
c.A container holding a medical cannabinoid product must include the following information:
(1)Manufacturers' business or trade name and registry certification number;
(3)Process lot number;
(4)Product identity;
(5)Date the product was made;
(6)Net weight or volume in United States customary or metric units;
(7)If applicable, serving size and number of servings per container;
(8)Concentration or amount of total tetrahydrocannabinol, and the concentration or amount of total cannabidiol, by weight or volume in each serving and in each container as identified by the laboratory selected by the department in accordance with section 33-44-01-36;
(9)List of ingredients in descending order or predominance by weight or volume used to process the medical cannabinoid product;
(10)Activation time, expressed in words or through a pictogram;
(11)Expiration date;
(12)A disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process;
(13)Universal symbol;
(14)Pediatric symbol, if applicable; and (15)Consumer warnings that state:
(d)"It is illegal to drive or to be in actual physical control of a motor vehicle while
2.Usable marijuana labels required in accordance with this section must be no smaller than eight point, arial or calibri, font. If, due to the size of the container, sufficient space does not exist for a label containing all of the required information, the manufacturing facility may:
a.Use a peel-back or accordion label if, the peel-back or accordion label is easily identified as containing the required information; or
b.Reduce the size of the required information to six point font.
3.Usable marijuana labels may not contain the word "organic".
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022.
N.D. Admin. Code 33-44-01-27 Dispensary labeling
1.All usable marijuana delivered to a dispensary from a manufacturing facility must meet the labeling requirements in section 33-44-01-26.
2.A dispensary shall affix a label to all usable marijuana distributed to registered qualifying patients and registered designated caregivers that includes:
a.The registered qualifying patient's name and department-issued registry identification card number.
b.The name of the dispensary.
c.Date dispensed.
3.Usable marijuana labels required in accordance with this section must be no smaller than eight point, arial or calibri, font. If, due to the size of the container, sufficient space does not exist for a label containing all of the required information, the dispensary may:
a.Use a peel-back or accordion label if, the peel-back or accordion label is easily identified as containing the required information; or
b.Reduce the size of the required information to six point font.
N.D. Admin. Code 33-44-01-28 Removal of product labels
All usable marijuana labels affixed by a compassion center must remain on the packaging. The department may revoke or suspend a cardholder's registry identification if the cardholder alters, obliterates, or destroys any label affixed to a usable marijuana package or container.
N.D. Admin. Code 33-44-01-29 Transportation authorization
1.Transportation of marijuana, usable marijuana, and medical marijuana waste by a manufacturing facility is authorized as follows:
a.A manufacturing facility may transport usable marijuana:
(1)From its manufacturing facility to a dispensary;
(2)From its manufacturing facility to its quality control and quality assurance testing location; and (3)From a dispensary to its manufacturing facility.
b.A manufacturing facility may transport marijuana or medical marijuana waste:
(1)From its manufacturing facility to its quality control and quality assurance testing location;
(2)From its manufacturing facility or a dispensary to a waste disposal site; and (3)From a dispensary to its manufacturing facility.
2.Transportation of usable marijuana and medical marijuana waste by a dispensary is authorized as follows:
a.A dispensary may transport usable marijuana:
(1)From a manufacturing facility to its dispensary;
(2)From its dispensary to a manufacturing facility; and (3)From its dispensary to a registered qualifying patient or registered designated caregiver.
b.A dispensary may transport medical marijuana waste:
(1)From its dispensary to a manufacturing facility; and (2)From its dispensary to a waste disposal site.
3.A laboratory may transport marijuana, usable marijuana, or medical marijuana waste:
a.From a manufacturing facility or a dispensary to its laboratory;
b.From its laboratory to a manufacturing facility; and
c.From its laboratory to a waste disposal site.
N.D. Admin. Code 33-44-01-30 Transportation requirements
1.Any compassion center or laboratory transporting marijuana, usable marijuana, or medical marijuana waste shall use a manifest system, approved by the department, to track transportation. The manifest must be in a vehicle transporting marijuana, usable marijuana, or medical marijuana waste. The manifest must be provided to law enforcement upon request.
a.The manifest system must include a chain of custody that records:
(1)The name and address of the destination.
(2)The description of each individual container that is part of the shipment and the total number of individual containers.
(3)The date and time the shipment is placed into the transport vehicle.
(4)The date and time the shipment is accepted at the delivery destination.
(5)The person's identity, and the circumstances, duration, and disposition of any other person who had custody or control of the shipment.
(6)Any handling or storage instructions.
b.Before transporting marijuana, usable marijuana, or medical marijuana waste, a compassion center or laboratory shall:
(1)Complete a manifest on a form approved by the department.
(2)Transmit a copy of the manifest to the receiving entity or individual.
c.The manifest must be signed by:
(1)A compassion center agent or laboratory agent upon departure.
(2)A compassion center agent, laboratory agent, an employee of a waste facility, registered qualifying patient, or registered designated caregiver upon its receipt.
d.A compassion center agent or laboratory agent receiving marijuana or usable marijuana shall:
(1)Verify and document the type and quantity of the transported marijuana, usable marijuana, or medical marijuana waste, against the manifest.
(2)Return a copy of the signed manifest to the originating entity upon completion.
e.A compassion center also shall record the marijuana or usable marijuana that is received as inventory in accordance with section 33-44-01-20.
f.A compassion center or laboratory shall maintain all manifests for at least seven years and make them available upon request by the department.
2.A compassion center or laboratory shall ensure that marijuana, usable marijuana, or medical marijuana waste, except for medical marijuana waste that has been rendered unusable in accordance with section 33-44-01-15, is transported as follows:
a.Packaged in tamper-evident containers.
b.Transported so it is not visible or recognizable from outside the vehicle.
c.Transported in a vehicle that does not bear any markings to indicate the vehicle contains marijuana, usable marijuana, or medical marijuana waste, or bear the name or logo of the compassion center or laboratory.
d.Transported in an enclosed, locked storage compartment that is secured, or affixed, to the vehicle.
3.Compassion center agents or laboratory agents who are transporting marijuana, usable marijuana, or medical marijuana waste shall:
a.Travel directly to the designation specified on the manifest.
b.Document on the manifest refueling and all other stops during transit, including:
(1)The reason for the stop;
(2)The duration of the stop;
(3)The location of the stop; and (4)All activities of compassion center agents or laboratory agents exiting the vehicle.
c.If an emergency requires stopping the vehicle, the compassion center agent or laboratory agent shall contact 911.
d.Under no circumstances may any person other than the designated compassion center agent or laboratory agent have physical control of the motor vehicle that is transporting the marijuana, usable marijuana, or medical marijuana waste.
e.A compassion center shall staff all motor vehicles with a minimum of two compassion center agents when transporting usable marijuana between compassion centers. At least one agent shall remain with the motor vehicle at all times when the motor vehicle contains usable marijuana.
f.A single compassion center agent may transport medical marijuana waste between compassion centers or to a waste facility. A single dispensary agent may transport usable marijuana to a registered qualifying patient or registered designated caregiver. A single laboratory agent may transport marijuana, usable marijuana, or medical marijuana waste to its laboratory, to a manufacturing facility, or to a waste facility.
g.Each compassion center agent or laboratory agent in a transport motor vehicle must have communication access with the compassion center or laboratory and have the ability to contact law enforcement through the 911 emergency system.
h.A compassion center agent or laboratory agent shall carry their registry identification card at all times when transporting marijuana, usable marijuana, or medical marijuana waste.
i.A compassion center agent or laboratory agent may not leave a vehicle that is transporting marijuana, usable marijuana, or medical marijuana waste unattended overnight.
N.D. Admin. Code 33-44-01-31 Compassion center inspections and compliance
The department, or a department designee, shall conduct inspections of compassion centers to ensure compliance with North Dakota Century Code chapter 19-24.1 and these rules. Compassion centers shall receive the results of an inspection in writing. Issues of noncompliance and concerns about the continued operation of the compassion center may result in a plan of correction, suspension, or revocation of a registry identification card or registration certificate.
N.D. Admin. Code 33-44-01-32 Plan of correction
1.Upon request, a compassion center shall submit to the department a plan of correction addressing issues of noncompliance and concerns identified during an inspection.
2.A plan of correction must include:
a.How the corrective action will be accomplished;
b.What changes will be made to ensure the issues of noncompliance and concerns identified during an inspection do not recur; and
c.How the compassion center will monitor the corrective actions to ensure the issues of noncompliance and concerns identified during an inspection are corrected and do not recur.
3.A compassion center shall provide the department with a plan of correction within ten business days of receipt of the department request.
4.A plan of correction is subject to acceptance, acceptance with revisions, or rejection by the department.
5.A compassion center shall complete all corrections within thirty calendar days of acceptance of the correction plan by the department, unless an alternative schedule of correction has been specified by the department.
N.D. Admin. Code 33-44-01-33 Data reporting
Data related to usable marijuana dispensed for a registered qualifying patient use must be submitted to the North Dakota prescription drug monitoring program. The department shall submit the data to the prescription drug monitoring program.
History
- General Authority: NDCC 19-24.1-37
- Law Implemented: NDCC 19-24.1-37
N.D. Admin. Code 33-44-01-34 Law enforcement reportable incidents
1.Law enforcement shall notify the department within five business days, using a form developed by the department, if an individual who is not a registered cardholder is found in possession of usable marijuana dispensed pursuant to North Dakota Century Code chapter 19-24.1 or if a registered qualifying patient or a registered designated caregiver is found in possession of an amount greater than the allowable amount of usable marijuana in accordance with state law. Unlawful possession of usable marijuana includes:
a.Possession of usable marijuana by anyone other than a registered cardholder.
b.Possession of usable marijuana by a registered qualifying patient or registered designated caregiver not in possession of a valid registration card.
c.Possession of usable marijuana by a registered cardholder if the registration card is no longer valid due to suspension, revocation, or expiration.
2.Law enforcement shall secure all confiscated usable marijuana in accordance with adopted evidence policies and procedures.
N.D. Admin. Code 33-44-01-35 Reporting adverse reactions
1.Incidents involving overdose or adverse reaction related to the use of usable marijuana must be reported to the department. The department shall provide an electronic form for reporting incidents involving overdose or adverse reactions to the department.
2.Individuals required to report incidents involving overdose or adverse reactions to the department include:
a.Registered qualifying patients.
b.A registered qualifying patient's registered designated caregiver.
c.Compassion center agents.
d.Law enforcement.
e.Health care professionals.
f.Emergency medical services professionals.
g.Emergency department personnel at any health care facility in which a patient presents for treatment of an incident involving overdose or adverse reaction related to the use of usable marijuana.
N.D. Admin. Code 33-44-01-36 Laboratory procurement process
The department may contract with a laboratory or laboratories to conduct random quality sampling testing of a compassion center's marijuana and usable marijuana. The department shall procure the laboratory testing services in accordance with North Dakota Century Code chapter 54-44.4. An awarded laboratory must be properly accredited as determined by the department.
N.D. Admin. Code 33-44-01-37 Laboratory authority
The activities of a department-awarded laboratory include providing laboratory services and related activities, including acquiring, possessing, storing, transferring, and transporting marijuana, usable marijuana, and medical marijuana waste in accordance with North Dakota Century Code chapter 19-24.1 and these rules.
N.D. Admin. Code 33-44-01-38 Laboratory agent registry identification cards
1.Each laboratory agent who performs activities in accordance with North Dakota Century Code
chapter 19-24.1 and these rules shall obtain a registry identification card.
2.Upon initial award of a contract, the department shall provide the laboratory a registration form to complete for each laboratory agent. Except for the fee, the form must require the laboratory to provide the same information for laboratory agents as required for compassion centers agents in subsection 2 of North Dakota Century Code section 19-24.1-18. The laboratory shall submit to the department:
a.A complete agent registration form for each laboratory agent;
b.All documents required for conducting a criminal history record check under North Dakota Century Code section 12-60-24 for each laboratory agent; and
c.Payment of all applicable fees associated with the criminal history record check.
3.The laboratory shall complete additional laboratory agent registration forms as required by this
section.
4.Upon approval of a laboratory agent registration form and verification of compliance with the requirements in subdivision c of subsection 3 of North Dakota Century Code section 19-24.1-18, the department shall issue, within thirty calendar days and at no cost, a laboratory agent registry identification card. The expiration date of the laboratory agent registry identification card must coincide with the contract expiration date. Only registered agents of an awarded laboratory have the authority to provide services authorized in section 33-44-01-37.
5.Each laboratory agent registry identification card must include the following information:
a.The name of the cardholder;
b.A designation the cardholder is a laboratory agent;
c.The date of issuance and expiration date;
d.A random ten-digit alphanumeric identification number containing at least four numbers and at least four letters which is unique to the cardholder;
e.A photograph of the cardholder; and
f.The phone number or website address at which the card can be verified.
6.The laboratory is responsible for distributing and collecting laboratory agent registry identification cards that are no longer valid or belong to employees who no longer have responsibilities requiring a valid registry identification card. The laboratory shall shred collected laboratory agent registry identification cards. The laboratory shall notify the department in writing within two calendar days of the date a laboratory agent registry identification card is destroyed.
N.D. Admin. Code 33-44-01-39 Laboratory inspection
An awarded laboratory is subject to random inspection by the department, or a department designee, to ensure compliance with North Dakota Century Code chapter 19-24.1 and these rules.
N.D. Admin. Code 33-44-01-40 Usable marijuana testing
1.A manufacturing facility shall have all usable marijuana tested in accordance with sections 33-44-01-42, 33-44-01-43, and 33-44-01-44 by a laboratory selected by the department as described in section 33-44-01-36. The manufacturing facility shall pay all costs of testing usable marijuana in accordance with these rules.
2.A manufacturing facility may not transfer usable marijuana to a dispensary until it is tested and passes compliance testing in accordance with these rules.
3.A dispensary may not accept usable marijuana from a manufacturing facility unless it is tested and passes compliance testing in accordance with these rules.
N.D. Admin. Code 33-44-01-41 Ordering tests
1.A manufacturing facility shall provide a laboratory with the following information, at a minimum, prior to the laboratory taking samples:
a.The name, address, and contact information of the manufacturing facility;
b.Type of usable marijuana;
c.Batch numbers to be tested;
d.Harvest lot number or numbers associated with the batch numbers;
e.Process lot number associated with the batch numbers, if applicable;
f.Total mass or volume of each batch to be tested;
g.For medical cannabinoid products, the unit of sale;
h.Concentration information, if known; and
i.Identification of the test or tests the manufacturing facility is requesting the laboratory to conduct.
2.The manufacturing facility shall order the tests necessary to comply with North Dakota Century Code chapter 19-24.1 and these rules.
N.D. Admin. Code 33-44-01-42 Compliance testing requirements for dried leaves and flowers
A manufacturing facility shall have every batch from a harvest lot of dried leaves and flowers, to be
1.Pesticides and degradation compounds in accordance with section 33-44-01-47.
2.Microbiological contaminants and mycotoxins in accordance with section 33-44-01-48.
3.Heavy metals in accordance with section 33-44-01-48.1.
4.Water activity and moisture content in accordance with section 33-44-01-50.
5.Concentration in accordance with section 33-44-01-51.
N.D. Admin. Code 33-44-01-43 Compliance testing requirements for cannabinoid concentrates
1.A manufacturing facility shall have every process lot of cannabinoid concentrate, to be
a.Pesticides and degradation compounds in accordance with section 33-44-01-47.
b.Microbiological contaminants and mycotoxins in accordance with section 33-44-01-48.
c.Heavy metals in accordance with section 33-44-01-48.1.
d.Solvents in accordance with section 33-44-01-49.
e.Concentration in accordance with section 33-44-01-51.
2.A manufacturing facility is exempt from testing for solvents under this section if the manufacturing facility did not use any solvent or the department provides the manufacturing facility with a written exemption if the manufacturing facility uses a closed loop carbon dioxide extraction method.
N.D. Admin. Code 33-44-01-44 Compliance testing requirements for medical cannabinoid products
A manufacturing facility shall have every process lot of a medical cannabinoid product, to be
1.Pesticides and degradation compounds in accordance with section 33-44-01-47.
2.Microbiological contaminants and mycotoxins in accordance with section 33-44-01-48.
3.Heavy metals in accordance with section 33-44-01-48.1.
4.Solvents in accordance with section 33-44-01-49.
5.Concentration in accordance with section 33-44-01-51. 33-44-01-44.1. Terpene analysis.
Upon a manufacturing facility's request, a terpene analysis may be performed by a laboratory selected by the department as described in section 33-44-01-36. The manufacturing facility shall pay all costs associated with a terpene analysis. A manufacturing facility may include terpenoid profile information on the label of a container holding dried leaves and flowers, a cannabinoid concentrate, or medical cannabinoid product only when a terpene analysis is performed under this section.
History
- History: Effective October 1, 2019.
N.D. Admin. Code 33-44-01-45 Batch requirements for compliance testing
1.For compliance testing of dried leaves and flowers, a manufacturing facility shall separate each harvest lot into no larger than ten-pound batches.
2.For compliance testing of cannabinoid concentrates, a process lot is considered a batch.
3.For compliance testing of medical cannabinoid products, a manufacturing facility shall separate process lots into not larger than five thousand unit of sale batches.
4.A manufacturing facility shall assign each batch a unique batch number and that unique batch number must be:
a.Documented and maintained in the manufacturing facilities records, including the compassion center's inventory control system;
b.Provided to the laboratory agent responsible for taking samples; and
c.Included on the batch label as required in section 33-44-01-46.
5.A manufacturing facility may not reuse a unique batch number.
N.D. Admin. Code 33-44-01-46 Manufacturing facility requirements for labeling, storing, and securing usable marijuana batches
When samples are taken from a harvest or process lot batch, a manufacturing facility shall:
1.Store and secure the batch in a manner that prevents the product from being tampered with or transferred prior to required tests being completed.
2.Be able to easily locate a batch stored and secured under subsection 2 and provide that location to the department or a laboratory upon request.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022.
N.D. Admin. Code 33-44-01-47 Standards for pesticides and degradation compounds compliance testing
1.A batch fails pesticide and degradation compound testing if a sample does not satisfy the most stringent acceptable standard for a pesticide chemical residue in any food item as set forth in subpart C of the United States environmental protection agency's regulations for Tolerances and Exemptions for Pesticide Chemical Residues in Food, 40 CFR 180, in effect as of January 1, 2018. A batch of dried leaves and flowers failing pesticide and degradation compound testing is considered affected or contaminated.
2.A degradation compound identified in testing must be reported to and reviewed by the department. The department, in consultation with the laboratory, shall determine whether the batch is considered to be affected or contaminated and fails pesticide and degradation testing.
3.If the samples do not pass testing standards for pesticides and degradation compounds, the manufacturing facility shall comply with section 33-44-01-52.
N.D. Admin. Code 33-44-01-48 Standards for microbiological contaminants and mycotoxin compliance testing
1.Usable marijuana required to be tested for microbiological contaminants under sections 33-44-01-42, 33-44-01-43, and 33-44-01-44 must be sampled using appropriate aseptic techniques.
2.For purposes of the microbiological test, a usable marijuana sample is deemed to have passed if it meets the following standards for microbial and fungal limits in colony forming units per gram (CFU/g):
Concentrates Dried Leaves or Flowers and Medical Cannabinoid Products Total viable aerobic bacteria10 Total yeast and mold10 Total coliforms10 Bile-tolerant gram-negative bacteria10 Escherichia coli (pathogenic strains) and salmonella species Not detected in one gramNot detected in one gram
3.For purposes of the mycotoxin test, a usable marijuana sample is deemed to have passed if it meets the following standards:
a.The total of aflatoxin B1, B2, G1, and G2 is less than 20 μg/kg of substance; and
b.Ochratoxin A is less than 20 μg/kg of substance.
4.If the samples do not pass testing standards for microbiological contaminants or mycotoxins, the manufacturing facility shall comply with section 33-44-01-52. 33-44-01-48.1. Standards for heavy metals compliance testing.
A batch fails heavy metals testing if the presence of one of the following metals, at a minimum, is above the following listed limit:
Parts per Million (ppm)
Inorganic arsenic0.4 Cadmium0.3 Lead1.0 Mercury0.2
History
- History: Effective October 1, 2019.
N.D. Admin. Code 33-44-01-49 Standards for solvents compliance testing
1.A batch fails solvent testing if the presence of one of the following solvents, at a minimum, is above the action level listed in the published International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidance for industry Impurities:
Residual Solvents Q3C(R6) in effect as of January 1, 2018: a.1,4-Dioxane. b.2-Butanol. c.2-Ethoxyethanol. d.2-Propanol (IPA).
e.Acetone.
f.Acetonitrile.
g.Benzene.
h.Cumene.
i.Cyclohexane.
j.Dichloromethane.
k.Ethyl acetate.
l.Ethyl ether.
m.Ethylene glycol.
n.Heptane.
o.Hexanes.
p.Isopropyl acetate.
q.Methanol.
r.Pentanes.
s.Tetrahydrofuran.
t.Toluene.
u.Xylenes.
2.In addition to subsection 1, a batch fails solvent testing if the presence of one of the following solvents exceeds the limits in the following table:
Parts Per Million (ppm)
Butanes5,000 Ethylene oxide50 Propane5,000
3.A manufacturing facility must receive written approval from the department prior to using any solvent not listed in subsection 1 and subsection 2. The department shall include in the written approval an action level, not to be exceeded, that is to be used as the standard for solvent testing.
4.A manufacturing facility only may use a solvent that is at least ninety-nine percent purity or is food-grade.
5.If the samples do not pass testing standards for solvents, the manufacturing facility shall comply with section 33-44-01-52.
N.D. Admin. Code 33-44-01-50 Standards for water activity and moisture content compliance testing
1.Dried leaves and flowers to be packaged in a container for transfer to a dispensary, must be tested for:
a.Water activity; and
b.Moisture content.
2.If a sample has a water activity rate of more than 0.65 a w the sample fails.
3.If a sample has a moisture content of more than fifteen percent the sample fails.
4.If the samples do not pass testing standards for water activity and moisture content, the manufacturing facility shall comply with section 33-44-01-52.
N.D. Admin. Code 33-44-01-51 Standards for concentration compliance testing
1.Usable marijuana concentration testing must include:
a.Tetrahydrocannabinol (THC).
b.Tetrahydrocannabinolic acid (THCA).
c.Cannabidiol (CBD).
d.Cannabidiolic acid (CBDA).
2.The total tetrahydrocannabinol and total cannabidiol must be calculated as follows:
a.Total tetrahydrocannabinol, where M is the mass or mass fraction of tetrahydrocannabinol or tetrahydrocannabinolic acid:
M total THC = THC + (0.877 x M THCA)
b.Total cannabidiol, where M is the mass or mass fraction of cannabidiol and cannabidiolic acid:
M total CBD = M CBD + (0.877 x M CBDA)
3.Test results must report tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabidiol, and cannabidiolic acid content by dry weight calculated as follows:
a.P THC(dry) = P THC(wet) / [1-(P moisture/100)].
b.P THCA(dry) = P THCA(wet) / [1-(P moisture/100)].
c.P CBD(dry) = P CBD(wet) / [1-(P moisture/100)].
d.P CBDA(dry) = P CBDA(wet) / [1-(P moisture/100)].
4.The concentration test fails if the total amount of tetrahydrocannabinol and tetrahydrocannabinolic acid, as calculated pursuant to this section, exceeds the maximum concentration or amounts permitted in North Dakota Century Code chapter 19-24.1.
5.The concentration test fails if the tetrahydrocannabinol or cannabidiol content of a medical cannabinoid product is determined through testing not to be homogenous. A medical cannabinoid product is considered not to be homogenous if test results identify a total tetrahydrocannabinol or cannabidiol variation of plus or minus fifteen percent. A medical cannabinoid product intended for ingestion must include concentration homogeneity testing.
6.If the samples do not pass testing standards for concentration, the manufacturing facility must comply with section 33-44-01-52.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022; October 1, 2025.
N.D. Admin. Code 33-44-01-52 Failed test samples
1.If a sample fails any test, the manufacturing facility may submit a written request to the department for a reanalysis. The request must be received by the department within seven calendar days from the date the laboratory sent notice of the failed test to the manufacturing facility. The department, in consultation with the laboratory, shall determine whether a reanalysis will be performed on the samples held by the laboratory or a new sample will be selected from the batch. The reanalysis must be completed by the laboratory within thirty days from the date the reanalysis request was received.
2.If a sample fails a test or a reanalysis under subsection 1:
a.The batch may be remediated or sterilized in accordance with this section; or
b.If the batch is not or cannot be remediated or sterilized under this section, the batch must be disposed of in accordance with section 33-44-01-15.
3.If a sample from a batch of dried leaves and flowers, cannabinoid concentrate, or cannabinoid product fails pesticide or degradation compound testing, the batch may not be remediated and must be disposed of as ordered by the department or the department of agriculture. An affected or contaminated batch may not be destroyed without obtaining written permission from the department or the department of agriculture.
4.A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for microbiological contaminant or mycotoxin testing:
a.If a sample from a batch of dried leaves and flowers fails microbiological contaminant or mycotoxin testing, the batch may be used to make a cannabinoid concentrate if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a carbon dioxide closed loop system, or the processing method selectively removes the mycotoxins from the batch.
b.If a sample from a batch of a cannabinoid concentrate fails microbiological contaminant or mycotoxin testing, the batch may be further processed if:
(1)The processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a carbon dioxide closed loop system; or (2)The processing method selectively removes the mycotoxins from the batch.
c.If a sample from a batch of a medical cannabinoid product fails microbiological contaminant or mycotoxin testing, the batch may be remediated if written approval from the department is obtained prior to remediation.
d.A batch that is remediated in accordance with subdivision a, b, or c of subsection 4 must be sampled and tested in accordance with these rules.
e.A batch that fails microbiological contaminant or mycotoxin testing after undergoing remediation in accordance with subdivision a, b, or c of subsection 4 must be disposed of in accordance with section 33-44-01-15.
5.If a sample from a batch of dried leaves and flowers, cannabinoid concentrate, or cannabinoid product fails heavy metals testing, the batch may be remediated if written approval from the department is obtained prior to remediation. A batch that is remediated must be sampled and tested in accordance with these rules. A batch that fails heavy metals testing after undergoing remediation must be disposed of in accordance with section 33-44-01-15.
6.A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for solvent testing:
a.If a sample from a batch fails solvent testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level established in these rules.
b.A batch that is remediated in accordance with subdivision a of subsection 6 must be sampled and tested in accordance with these rules.
c.A batch that fails solvent testing after undergoing remediation in accordance with subdivision a must be disposed of in accordance with section 33-44-01-15.
7.A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for water activity and moisture testing:
a.If a sample from a batch of dried leaves and flowers fails for water activity or moisture testing, the batch from which the sample was taken may:
(1)Be used to make a cannabinoid concentrate or a medical cannabinoid product and must comply with testing requirements established in these rules; or (2)Continue to dry or cure.
b.A batch that undergoes additional drying or curing as described in paragraph 2 of subdivision a must be sampled and tested in accordance with these rules.
8.A manufacturing facility shall comply with the following requirements when a sample fails to meet the standards for concentration testing:
a.A batch that has a sample failing concentration testing under subsection 4 of section 33-44-01-51 may be remediated to meet the concentration limits permitted in North Dakota Century Code chapter 19-24.1.
b.If a sample from a batch of pediatric medical marijuana fails concentration testing, the manufacturing facility may use the batch for nonpediatric usable marijuana rather than remediating the pediatric medical marijuana in accordance with subdivision a. No additional testing is required if the manufacturing facility does not label the usable marijuana for pediatric use and does no further processing with a batch of pediatric medical marijuana failing concentration testing. Any usable marijuana processed with a batch from a failed pediatric medical marijuana concentration test must be sampled and tested in accordance with these rules.
c.A batch that has a sample failing concentration testing under subsection 5 of section 33-44-01-51 may be remediated or the manufacturing facility may use the concentration test results of the laboratory for labeling purposes.
d.A batch that has a sample failing concentration testing under subsection 6 of section 33-44-01-51 may be remediated.
e.A batch that is remediated in accordance with subdivision a, c, or d must be sampled and tested in accordance with these rules.
9.A manufacturing facility shall, as applicable:
a.Have detailed written procedures for remediation processes to be used pursuant to this
section.
b.Document all remediation processes used pursuant to this section.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; July 1, 2022.
N.D. Admin. Code 33-44-01-53 Tentative identification of compounds
1.A laboratory shall report tentatively identified compounds to the manufacturing facility and the department.
2.Following the receipt of a tentatively identified compounds report, the department may initiate an investigation. The investigation may include requiring a sample be selected of marijuana or usable marijuana of a manufacturing facility. Testing of samples may include testing for analytes that are not required by these rules. Costs of tests performed under this section must be paid by the manufacturing facility.
N.D. Admin. Code 33-44-01-54 Random testing
The department may require, at any time, a manufacturing facility to permit sampling of marijuana, usable marijuana, or medical marijuana waste to determine whether a manufacturing facility is in compliance with North Dakota Century Code chapter 19-24.1 and these rules. Costs of tests performed under this section must be paid by the manufacturing facility.
N.D. Admin. Code 33-44-01-55 Manufacturing facility quality control and quality assurance program
1.A manufacturing facility shall develop and follow a written quality control and quality assurance program. The program must be established to protect qualifying patient health and implemented in a manner to assist in complying with testing required in sections 33-44-01-42, 33-44-01-43, and 33-44-01-44. A manufacturing facility is not prohibited by these rules to test marijuana and usable marijuana as part of a quality control and quality assurance program.
2.A quality control and quality assurance program must include an assessment of the profile of the active ingredients, including expiration date, and the presence of inactive ingredients and contaminants. Testing results must be used to determine appropriate conditions and expiration dates.
3.A manufacturing facility shall develop and follow written procedures for sampling marijuana and usable marijuana. Procedures must be developed related to sampling methods, sample collection, and documentation of sampling. Test results from random samples must be retained for at least three years.
4.The manufacturing facility shall develop and follow written procedures for performing stability testing of usable marijuana to determine product expiration date. Once an expiration date has been determined through testing described in subsection 5, a manufacturing facility must perform periodic stability testing to verify expiration dates.
5.If stability testing has not been completed within one year of production, a manufacturing facility may assign a tentative expiration date based on available stability information. Stability testing is to include, at a minimum, an assessment of microbiological contaminants and mycotoxins, heavy metals, and concentration. If applicable, the stability testing must include water activity and moisture content or solvents. If an expiration date is one year or less, at a minimum, a stability test must be performed once before fifty percent of the period has expired and at the end of the expiration date. If an expiration date is more than one year, at a minimum, a stability test must be performed at no less than six-month intervals and at the end of the expiration date. After the manufacturing facility verifies the tentative expiration date, or determines the appropriate expiration date, the manufacturing facility shall include the expiration date on each batch of marijuana or usable marijuana.
6.A manufacturing facility shall retain a uniquely labeled reserve sample representing each harvest lot, process lot of cannabinoid concentrate to be packaged in a container for transfer to a dispensary, and process lot of medical cannabinoid product for at least six months following the expiration date. The reserve sample must be stored in the same immediate container-closure system the usable marijuana is packaged in for dispensaries, or in one that has similar characteristics. The reserve sample must consist of the quantity necessary to perform all required tests.
History
- History: Effective April 1, 2018; amended effective October 1, 2019; October 1, 2025.
Chapter 33-02
N.D. Admin. Code 33-02
ARTICLE 33-02
MARRIAGE CONTRACT [Repealed effective August 1, 1999]
Chapter 33-08
N.D. Admin. Code 33-08
ARTICLE 33-08
ADDICTION HOSPITALS AND RELATED FACILITIES [Superseded by Article 75-09]
Chapter 33-10
N.D. Admin. Code 33-10
ARTICLE 33-10
RADIOLOGICAL HEALTH RULES [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-15
N.D. Admin. Code 33-15
ARTICLE 33-15
AIR POLLUTION CONTROL [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-16
N.D. Admin. Code 33-16
ARTICLE 33-16
CONTROL, PREVENTION, AND ABATEMENT OF POLLUTION OF SURFACE WATER [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-17
N.D. Admin. Code 33-17
ARTICLE 33-17
PUBLIC WATER SUPPLY SYSTEMS [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-18
N.D. Admin. Code 33-18
ARTICLE 33-18
WATER WELL CONTRACTORS [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-19
N.D. Admin. Code 33-19
ARTICLE 33-19
CERTIFICATION OF WATER AND WASTEWATER SYSTEMS OPERATORS [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-20
N.D. Admin. Code 33-20
ARTICLE 33-20
SOLID WASTE MANAGEMENT AND LAND PROTECTION [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-21
N.D. Admin. Code 33-21
ARTICLE 33-21
CESSPOOLS, SEPTIC TANKS, PRIVIES [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-22
N.D. Admin. Code 33-22
ARTICLE 33-22
PRACTICE AND PROCEDURE [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-24
N.D. Admin. Code 33-24
ARTICLE 33-24
HAZARDOUS WASTE MANAGEMENT [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-25
N.D. Admin. Code 33-25
ARTICLE 33-25
UNDERGROUND INJECTION CONTROL [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-26
N.D. Admin. Code 33-26
ARTICLE 33-26 [Reserved]
Chapter 33-27
N.D. Admin. Code 33-27
ARTICLE 33-27
LAKE RESTORATION PROGRAM [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-34
N.D. Admin. Code 33-34
ARTICLE 33-34
PETROLEUM AND FUEL PRODUCTS [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-35
N.D. Admin. Code 33-35
ARTICLE 33-35
REVOLVING LOAN FUND [Repealed effective January 1, 2020, and transferred to Title 33.1 under Chapter 199 of the 2017 Session Laws]
Chapter 33-40
N.D. Admin. Code 33-40
ARTICLE 33-40
DNA ANALYSIS [Repealed effective May 1, 2004, and transferred to Article 10-17 under Chapter 469 of the 2003 Session Laws]
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