OAR Chapter 325 — Oregon Patient Safety Commission

Division 1 PROCEDURAL RULES

Or. Admin. R. 325-001-0001 Notice To Interested Persons

Before adopting, amending, or repealing any permanent rule, the Patient Safety Commission will give notice of its intended action:

(1) In the Secretary of State’s Bulletin referred to in ORS 183.360 at least 21 days before the effective date of the rule;

(2) By providing a copy of the notice to persons on the Patient Safety Commission’s distribution list established pursuant to ORS 183.335(8) at least 28 days before the effective date of the rule;

(3) By providing a copy of the notice to legislators specified in ORS 183.335(15) at least 49 days before the effective date of the rule; and

(4) By providing a copy of the notice to:

(a) The Hospital Association of Oregon;

(b) The Oregon Health Care Association;

(c) Oregon State Pharmacy Association;

(d) Oregon Medical Association;

(e) The Oregon Board of Pharmacy;

(f) Oregon Nurses Association;

(g) The Oregon Ambulatory Surgery Center Association;

(h) Affected health care facilities and pharmacies; and

(5) By putting a copy of proposed rules on the Commission website.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 183.341(4)
• PSC 1-2024, amend filed 02/07/2024, effective 02/07/2024
• PSC 2-2015, f. & cert. ef. 7-10-15
• PSC 1-2008, f. & cert. ef. 4-14-08
• Reverted to PSC 3-2005, f. & cert. ef. 9-26-05
• PSC 5-2007(Temp), f. & cert. ef. 10-19-07 thru 4-11-08
• PSC 3-2005, f. & cert. ef. 9-26-05

Or. Admin. R. 325-001-0005 Model Rules of Procedure

The Patient Safety Commission adopts, in their entirety, the current Attorney General's Uniform and Model Rules of Procedure under the Administrative Procedures Act.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 183.341
• PSC 2-2015, f. & cert. ef. 7-10-15
• PSC 1-2005, f. & cert. ef. 6-8-05

Division 5 COMMISSION ADMINISTRATION

Or. Admin. R. 325-005-0015 Biennial Budget

The Oregon Patient Safety Commission (OPSC) hereby establishes the OPSC 2025-2027 biennial budget of $4,347,510 covering the period July 1, 2025, through June 30, 2027. The OPSC Executive Director will amend budgeted accounts as necessary within the approved budget of $4,347,510 for the effective operation of the agency. OPSC will not exceed the approved 2025-2027 biennium budget without amending this rule, notifying interested parties, and holding a public hearing as required by ORS 182.462. Copies of the budget are available by email at info@oregonpatientsafety.org and are posted on the OPSC website.

History

• Statutory/Other Authority: ORS 442.820-442.851
• Statutes/Other Implemented: ORS 182.462
• PSC 1-2025, amend filed 05/16/2025, effective 05/16/2025
• PSC 1-2023, amend filed 05/17/2023, effective 07/01/2023
• PSC 1-2022, amend filed 12/16/2022, effective 12/19/2022
• PSC 1-2021, amend filed 06/03/2021, effective 07/01/2021
• PSC 1-2019, amend filed 05/21/2019, effective 06/30/2019
• PSC 3-2017, f. & cert. ef. 8-1-17
• PSC 2-2017, f. 5-19-17, cert. ef. 6-30-17
• PSC 1-2017, f. 2-28-17, cert. ef. 3-1-17
• PSC 1-2016, f. & cert. ef. 1-29-16
• PSC 2-2015, f. & cert. ef. 7-10-15
• PSC 1-2015, f. & cert. ef. 3-17-15
• PSC 1-2014, f. 3-18-14, cert. ef. 3-21-14
• PSC 2-2013, f. & cert. ef. 7-3-13
• PSC 1-2013, f. & cert. ef. 4-25-13
• PSC 1-2012, f. 3-27-12, cert. ef. 4-1-12
• PSC 1-2011, f. & cert. ef. 7-1-11
• PSC 1-2009, f. & cert. ef. 6-26-09
• PSC 4-2007, f. & cert. ef. 7-2-07
• PSC 1-2006, f. & cert. ef. 2-6-06

Division 11 OREGON PATIENT SAFETY REPORTING PROGRAM

Or. Admin. R. 325-011-0001 Definitions

As used in OAR 325-011-0001 to 325-011-0055:

(1) “Adverse event” means an objective and definable negative consequence of patient care, or the risk of an objective and definable negative consequence of patient care, that:

(a) Is unanticipated and usually preventable; and

(b) Results in or presents a risk of resulting in physical injury to the patient.

(2) “Eligible entity” means an entity eligible to participate in the Patient Safety Reporting Program pursuant to OAR 325-011-0002.

(3) “Health care facility” as defined in ORS 442.015 means a hospital, a long term care facility, an ambulatory surgical center, a freestanding birthing center, an outpatient renal dialysis facility, or an extended stay center.

(4) “Oregon Patient Safety Reporting Program” means the Patient Safety Reporting Program, as defined in ORS 442.837, and operated by OPSC.

(5) “Oregon Patient Safety Reporting Portal” means the portal maintained by the Oregon Patient Safety Commission for the purpose of the submission of adverse event reports to the Oregon Patient Safety Reporting Program. This Portal is a component of the Oregon Patient Safety Reporting Program.

(6) “Participant” means an entity that reports Patient Safety Data to the Oregon Patient Safety Reporting Program, and any agent, employee, consultant, representative, volunteer or medical staff member of the entity.

(7) “Patient Safety Activities” include but are not limited to:

(a) The collection and analysis of Patient Safety Data by a Participant;

(b) The collection and analysis of Patient Safety Data by the Oregon Patient Safety Commission (OPSC) established in ORS 442.820;

(c) The utilization of Patient Safety Data by Participants;

(d) The utilization of Patient Safety Data by OPSC to improve the quality of care with respect to patient safety and to provide assistance to health care providers to minimize patient risk;

(e) Oral and written communication regarding Patient Safety Data among two or more Participants with the intent of making a disclosure to or preparing a report to be submitted to a Patient Safety Reporting Program; and

(f) Collaboration between OPSC and participants on patient safety initiatives.

(8) “Patient Safety Data” means oral communication or written reports, data, records, memoranda, analyses, deliberative work, statements, event investigations and analyses or action plans that are collected or developed to improve patient safety or health care quality that:

(a) Are prepared by a Participant for the purpose of reporting Patient Safety Data voluntarily to or otherwise working with the Patient Safety Reporting Program, or that are communicated among two or more Participants with the intent of making a disclosure to or preparing a report to be submitted to the Patient Safety Reporting Program;

(b) Are collected or prepared by a patient safety organization certified by the United States Department of Health and Human Services under 42 U.S.C. 299b-24; or

(c) Are created by or at the direction of the Patient Safety Reporting Program, including communication, reports, notes or records created in the course of a patient safety initiative undertaken at the direction of or in collaboration with OPSC.

(9) “Patient Safety Report” means a form designated by the Oregon Patient Safety Commission (OPSC) to be used for the reporting of Patient Safety Data.

(10) “Serious adverse event” for the purposes of OAR 325-011-0001 to 325-011-0060 means an objective and definable negative consequence of patient care, or the risk of an objective and definable negative consequence of patient care, that:

(a) Is unanticipated and usually preventable; and

(b) Results in, or presents a significant risk of, the patient’s death or serious physical injury.

(11) “These rules” means OAR 325-011-0001 to 325-011-0060.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 2-2025, amend filed 05/16/2025, effective 05/16/2025
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0002 Participation in the Oregon Patient Safety Reporting Program

(1) Participation in the Oregon Patient Safety Reporting Program is voluntary.

(2) The following entities are eligible to participate:

(a) Hospitals as defined in ORS 442.015;

(b) Long term care facilities as defined in ORS 442.015;

(c) Pharmacies licensed under ORS chapter 689;

(d) Ambulatory surgical centers as defined in ORS 442.015;

(e) Outpatient renal dialysis facilities as defined in ORS 442.015;

(f) Freestanding birthing centers as defined in ORS 442.015;

(g) Independent professional health care societies or associations; and

(h) Extended stay centers licensed under ORS 441.026.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0005 Reporting Patient Safety Data

(1) The Oregon Patient Safety Commission (OPSC) will provide Participants with the means to submit Patient Safety Reports.

(2) Participants must use the format specified by OPSC when reporting Patient Safety Data.

(3) If a Participant submits Patient Safety Data that does not meet established reporting requirements, OPSC may request additional information or choose not to accept submission.

(4) If a Participant believes OPSC should immediately issue an alert based on a specific Adverse Event, the Participant should provide an initial report to the Commission. The Participant and Commission will work together to identify information to include in the alert.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0010 Reporting of Less Serious Adverse Events or Close Calls

In addition to Serious Adverse Events, Participants are also encouraged to report less serious adverse events and close calls. Participants should do so when they believe other organizations will benefit from the information or when they believe such events present the potential for significant harm.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0015 Auditing and oversight of the Oregon Patient Safety Reporting Program

The Oregon Patient Safety Commission (OPSC) Board of Directors will establish auditing and oversight procedures for the Oregon Patient Safety Reporting Program, including a process to:

(1) Evaluate the effectiveness of the Oregon Patient Safety Reporting Program in advancing the mission of OPSC described in ORS 442.820 (2), including:

(a) Operating the Oregon Patient Safety Reporting Program;

(b) Sharing system-level improvement techniques to reduce systems’ errors; and

(c) Sharing evidence-based prevention practices to improve patient safety;

(2) Review the list of objective and definable adverse events and OPSC’s definition of active participation, including:

(a) Determining a regular cadence at which the OPSC Board of Directors will do this review; and

(b) Defining criteria to evaluate if changes are needed; and

(3) Obtain certification by the Public Health Officer that OPSC is administering the Oregon Patient Safety Reporting Program consistent with the mission described in ORS 442.820 (2) and the requirements of 442.831 (1).

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0020 Public Health Officer Certification

(1) At least annually, the Oregon Patient Safety Commission (OPSC) will request that the Public Health Officer certify that OPSC is administering the patient safety reporting program consistent with the mission described in ORS 442.820 (2) and the requirements of ORS 442.831 (1). OPSC will request that the Public Health Officer:

(a) Develop independent and objective standards for their evaluation; and

(b) Use those standards to certify the Oregon Patient Safety Reporting Program.

(2) OPSC will provide information to the Public Health Officer to assist the Public Health Officer in completing the certification processes listed in (1) of this rule, consistent with OAR 325-011-0035.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0025 Patient Notification of Serious Adverse Events

(1) After a Serious Adverse Event occurs, a Participant must notify each affected patient or the patient's personal representative. Notification must be timely and should be consistent with the Participant's internal communication and disclosure policies.

(2) The Oregon Patient Safety Commission (OPSC) encourages Participants to notify each affected patient or the patient's personal representative of less serious adverse events.

(3) As provided in ORS 442.837(4), notification provided under this subsection may not be construed as an admission of liability in a civil action.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0030 Waivers

The Oregon Patient Safety Commission (OPSC) may waive any provision of these rules if the waiver will not adversely affect OPSC’s mission described in ORS 442.820.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 2-2025, amend filed 05/16/2025, effective 05/16/2025
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0035 Protection of Patient Safety Data

(1) The Oregon Patient Safety Commission (OPSC) is subject to all the confidentiality provisions set forth in ORS 442.820, 442.831, 442.837, and 442.846.

(2) OPSC will maintain the confidentiality of all Patient Safety Data that identifies or could be reasonably used to identify a Participant or an individual who is receiving or has received health care from the Participant.

(3) Before it takes receipt of any confidential Patient Safety Data, OPSC will have in place appropriate safeguards and security measures to ensure the technical integrity and physical safety of such data.

(4) Pursuant to ORS 442.820(4), meetings or portions of meetings where the Oregon Patient Safety Commission Board of Directors, or subcommittees or advisory committees consider information that identifies a Participant or patient are not subject to the Oregon Public Meetings Law, 192.610 to 192.690.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0040 Commission’s Use of Patient Safety Data

(1) The Oregon Patient Safety Commission (OPSC) may create ad hoc committees to advise OPSC on best practices in patient safety, including but not limited to learning from and sharing Patient Safety Data.

(2) At least quarterly, OPSC will provide Participants with patient safety information derived from Patient Safety Data.

(3) At least annually, OPSC will publish a report to the public summarizing Patient Safety Data for the preceding calendar year.

(4) OPSC will work with representatives of organizations participating in the Oregon Patient Safety Reporting Program and with other interested parties to develop recommendations for continued improvements in the collection and use of Patient Safety Data.

(5) OPSC, within its resource limitations, will provide technical assistance to Participants, including but not limited to recommendations or advice regarding patient safety systems and practices, and use of the Oregon Patient Safety Reporting Program.

(6) OPSC may initiate other projects using patient safety data when consistent with its mission and in accordance with existing confidentiality protections.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0045 Commitment to Adverse Event Reporting

(1) Eligible entities reporting adverse events in the Oregon Patient Safety Reporting Portal pursuant to a completed commitment agreement as described in this section are entitled to the benefits set forth in these rules and ORS 442.844 and 442.846.

(2) Eligible entities may request access to the Oregon Patient Safety Reporting Program Portal by completing Oregon Patient Safety Commission (OPSC)’s commitment agreement. The commitment agreement must include the:

(a) Name of a designated contact person; and

(b) Signature of either:

(A) a facility representative in a quality oversight role who is authorized to commit the eligible entity to comply with the terms of the commitment agreement; or

(B) an executive or designee who is authorized to sign on behalf of the facility.

(3) In committing to report adverse events in the Oregon Patient Safety Reporting Portal, an eligible entity shall affirm its commitment to sharing Patient Safety Data with OPSC and at least once per quarter submitting patient safety data related to an adverse event or close call.

(4) Eligible entities with access to the Oregon Patient Safety Reporting Portal are responsible for informing OPSC of any changes to the entity’s designated contact person.

(5) OPSC will make a determination regarding access to the Oregon Patient Safety Reporting Portal and notify the eligible entity of that decision within 30 calendar days of receipt of the commitment agreement.

(6) Term of Commitment Agreement:

(a) Commitment agreements shall expire on a term as established by the OPSC Board of Directors. If the eligible entity does not sign a new commitment agreement by the expiration date, OPSC shall process the existing commitment agreement as withdrawn pursuant to OAR 325-011-0050(2).

(b) Eligible entities with an active Oregon Patient Safety Commission Participation Agreement as of May 16, 2025, shall complete a commitment agreement as described in this rule by a date established by the OPSC Board of Directors.

(c) The commitment agreement described in this rule shall remain in effect until the eligible entity withdraws from the commitment agreement as described in OAR 325-011-0050, or until the commitment agreement expires as described in subsection (a) of this section.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 2-2025, amend filed 05/16/2025, effective 05/16/2025
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0046 Patient Safety Activity Agreements

(1) Prior to engaging in a patient safety activity convened or facilitated by the Oregon Patient Safety Commission (OPSC), all individuals shall complete and submit a signed patient safety activity agreement.

(2) Participants who have completed and signed a patient safety activity agreement are, for the patient safety activity and patient safety data to which the agreement pertains, entitled to the benefits set forth in these rules and ORS 442.844 and 442.846.

(3) Patient safety activity agreements shall include but not be limited to:

(a) Acknowledgement of confidentiality provisions applicable to any patient safety data being shared with OPSC or among other Patient Safety Reporting Program participants, pursuant to ORS 442.844 and 442.846; and

(b) Confirmation that the individual is participating as:

(A) A representative of an eligible entity;

(B) A facilitator or presenter who has created patient safety data in furtherance of a patient safety initiative, at the direction of or in collaboration with OPSC; or

(C) An invited representative of an organization or a provider across the continuum of health care.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 2-2025, adopt filed 05/16/2025, effective 05/16/2025

Or. Admin. R. 325-011-0050 Withdrawal from Commitment Agreement

(1) If an eligible entity chooses to withdraw from the commitment agreement to report adverse events as described in OAR 325-011-0045, it must submit its withdrawal request in writing to the Oregon Patient Safety Commission (OPSC). The request must include its reason for withdrawing from the commitment agreement.

(2) OPSC will process withdrawals of commitment agreements and remove each of the facility’s user accounts from the Oregon Patient Safety Reporting Portal within 30 days.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 2-2025, amend filed 05/16/2025, effective 05/16/2025
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0055 Annual Participant Fee

(1) All hospitals, ambulatory surgery centers, and renal dialysis facilities licensed under ORS 441.015, all community retail pharmacies licensed under ORS 689, and all long term care facilities licensed under OAR 411, division 085 must pay an annual fee. Per ORS 442.850 these fees will be assessed independent of participation status in the Oregon Patient Safety Reporting Program. Health care facilities must pay according to the following table for the 2024 calendar year: [See attached table.]

(2) Initial fees will be due by December 31 of the year a health care facility becomes licensed by the state of Oregon. Annual fees for a calendar year will be due by December 31 of the prior calendar year. Any uncollected fees are turned over to the Department of Revenue for collection on or after April 1 following the date of invoice.

(3) Participation fees will not be refunded due to participant withdrawal from the Oregon Patient Safety Reporting Program.

(4) Fees shall be annually adjusted by the Oregon Patient Safety Commission (OPSC) Board of Directors, at a rate equal to the annual average Consumer Price Index for All Urban Consumers, West Region (All Items), as published by the United States Department of Labor, Bureau of Labor Statistics for every fiscal year.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.850-442.851
• PSC 3-2025, amend filed 07/29/2025, effective 07/29/2025
• PSC 2-2024, amend filed 08/30/2024, effective 08/30/2024
• PSC 1-2024, adopt filed 02/07/2024, effective 02/07/2024

Or. Admin. R. 325-011-0060 List of Participants

The Oregon Patient Safety Commission (OPSC) shall maintain a list on its website of eligible entities that, in the 12-month period preceding the creation of the list, have:

(1) Submitted one or more patient safety data reports related to an adverse event or close call to the Oregon Patient Safety Reporting Portal; or

(2) Reported patient safety data as part of one or more patient safety activities convened or facilitated by OPSC.

History

• Statutory/Other Authority: ORS 442.820 & 442.831
• Statutes/Other Implemented: ORS 442.819-442.851
• PSC 2-2025, adopt filed 05/16/2025, effective 05/16/2025

Division 35 EARLY DISCUSSION AND RESOLUTION

Or. Admin. R. 325-035-0001 Definitions

As used in OAR 325-035-0001 to 325-035-0050:

(1) “Adverse health care incident” means an objective, definable and unanticipated consequence of patient care that is usually preventable and results in the death of or serious physical injury to the patient.

(2) “Business day” means any day other than a federal or State of Oregon legal holiday or a day other than a day on which offices of the State of Oregon are otherwise authorized by law to remain closed.

(3) “Commission” means the Oregon Patient Safety Commission.

(4) “Discussion” means:

(a) All communications, written and oral, that are made in the course of a discussion under Oregon Laws 2013, Chapter 5, Section 3; and

(b) All memoranda, work products, documents and other materials that are prepared for or submitted in the course of or in connection with a discussion under Oregon Laws 2013, Chapter 5, Section 3.

(5) “Early Discussion and Resolution” means the confidential process established in Oregon Laws 2013, Chapter 5 that includes, but is not limited to: the filing a notice of adverse health care incident with the Commission by a patient, health care provider or health care facility, discussions with all parties to seek resolution about the incident, and mediation if necessary to attempt to resolve the matter.

(6) “Health care facility” as defined in ORS 442.015 means a hospital, a long term care facility, an ambulatory surgical center, a freestanding birthing center, or an outpatient renal dialysis center.

(7) “Health care provider” means a person practicing within the scope of the person’s license, registration or certification to practice as:

(a) A psychologist under ORS 675.030 to 675.070, 675.085 and 675.090;

(b) An occupational therapist under ORS 675.230 to 675.300;

(c) A physician under ORS 677.100 to 677.228;

(d) An emergency medical services provider under ORS chapter 682;

(e) A podiatric physician and surgeon under ORS 677.820 to 677.840;

(f) A registered nurse under ORS 678.010 to 678.410, including nurse practitioner;

(g) A dentist under ORS 679.060 to 679.180;

(h) A dental hygienist under ORS 680.040 to 680.100;

(i) A denturist under ORS 680.515 to 680.535;

(j) An audiologist or speech-language pathologist under ORS 681.250 to 681.350;

(k) An optometrist under ORS 683.040 to 683.155 and 683.170 to 683.220;

(l) A chiropractor under ORS 684.040 to 684.105;

(m) A naturopath under ORS 685.060 to 685.110, 685.125 and 685.135;

(n) A massage therapist under ORS 687.011 to 687.250;

(o) A direct entry midwife under ORS 687.405 to 687.495;

(p) A physical therapist under ORS 688.040 to 688.145;

(q) A medical imaging licensee under ORS 688.445 to 688.525;

(r) A pharmacist under ORS 689.151 and 689.225 to 689.285;

(s) A physician assistant under ORS 677.505 to 677.525; or

(t) A professional counselor or marriage and family therapist under ORS 675.715 to 675.835.

(8) “Location operated by a health care facility” means a satellite as defined by OAR 333-500-0010.

(9) “Mediation” as defined in ORS 36.110(5) means a process in which a mediator assists and facilitates two or more parties to a controversy in reaching a mutually acceptable resolution of the controversy and includes all contacts between a mediator and any party or agent of a party, until such time as a resolution is agreed to by the parties or the mediation process is terminated.

(10) “Minor” means anyone under the age of 18 but does not mean a minor who has been emancipated in accordance with ORS 419B.550 to 419B.558.

(11) “Notice” means a written or oral report, submitted by a patient, health care provider or health care facility to the Commission in the form and manner specified in OAR 325-035-0010, that indicates the filer’s desire to engage in Early Discussion and Resolution.

(12) “Party or Parties” means any health care facility, health care provider, employer of a health care provider, and patient involved in the adverse health care incident.

(13) “Patient” means:

(a) The patient; or

(b) If the patient is a minor, is deceased or has been medically confirmed by the patient’s treating physician to be incapable of making decisions for purposes of Oregon Laws 2013, Chapter 5, Sections 1 to 10, the patient’s representative as provided in Oregon Laws 2013, Chapter 5, Section 8.

(14) “Serious physical injury” means an injury that:

(a) Is life threatening; or

(b) Results in significant impairment of a body function or significant damage to a body structure; or

(c) Necessitates medical or surgical intervention to prevent, mitigate or correct significant impairment of a body function or significant damage to a body structure.

History

• Statutory/Other Authority: Oregon Law 2013 & Ch. 5
• Statutes/Other Implemented: Oregon Law 2013 & Ch. 5
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0005 Filing a Notice of Adverse Health Care Incident

When an adverse health care incident occurs in a health care facility, a location operated by a health care facility, or outside a health care facility and the incident involves a health care provider, the health care facility, health care provider or employer of the health care provider, or a patient, may file a notice with the Commission in accordance with this rule. The filing of a notice enables the parties to engage in Early Discussion and Resolution.

(1) A notice may be filed with the Commission electronically, by telephone, or by submitting a written form prescribed by the Commission that contains the information described in sections (3) or (5) of this rule.

(2) A notice should not be filed with the Commission if:

(a) The incident does not meet the definition of an adverse health care incident;

(b) The adverse health care incident occurred before July 1, 2014;

(c) The adverse health care incident occurred outside of Oregon;

(d) The adverse health care incident did not involve at least one health care facility, location operated by a health care facility, or health care provider; or

(e) The filer is an inmate as defined in ORS 30.642.

(3) A notice filed by a health care facility, a health care provider, or an employer of a health care provider must include, but is not limited to:

(a) Incident date (this may be an approximation);

(b) Incident location; and

(c) Incident description.

(4) A notice filed by a health care facility or an employer of a health care provider shall not include the name of a health care provider.

(5) A notice filed by a patient must include, but is not limited to:

(a) Patient name;

(b) Patient date of birth;

(c) Incident date (this may be an approximation);

(d) Incident description;

(e) Incident location; and

(f) Adequate contact information for any health care facility or health care provider involved in the incident so the Commission may notify the facility or provider that a notice has been filed.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5, Secs. 2 & 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 2 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0010 Notifying a Health Care Facility, Health Care Provider, or Patient of a Notice of Adverse Health Care Incident

(1) When the Commission receives a notice from a patient, the Commission must notify all health care facilities and health care providers named in the notice, using email, telephone, or the US mail as appropriate. The Commission will attempt to contact all health care facilities and health care providers within seven business days of receiving the notice. If a patient is unable to provide accurate contact information for a health care facility or a health care provider, the Commission must attempt to notify the health care facility or health care provider and provide the required notice.

(a) If the Commission is not able to identify and contact a health care facility or a health care provider, the Commission must notify the patient in writing that unless accurate contact information for the health care facility or health care provider is received by the Commission within 30 days, the Commission will consider the matter closed.

(b) If the Commission does not receive accurate contact information for the health care facility or health care provider within 30 days, the Commission must inform the patient in writing that the Commission has closed the matter.

(2) A health care facility, health care provider, or employer of a health care provider who files a notice must:

(a) Provide a copy of the notice to the patient; and

(b) Notify any health care provider involved in the adverse health care incident of the notice.

(3) The Commission must notify a health care provider or health care facility of any notice that is filed by a patient, regardless of whether it appears that incident falls within the definition of an adverse health care incident. A health care provider or health care facility must make its own determination, after being notified by the Commission that a notice has been filed, as to whether the incident is an adverse health care incident such that the parties may engage in discussions.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5 & Sec. 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 2 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0015 Procedures for Conducting Discussions

(1) A health care facility, health care provider, or employer of a health care provider who files or is named in a notice of adverse health care incident and the patient who is the subject of the adverse health care incident may engage in Early Discussion and Resolution in an attempt to resolve the incident.

(2) If the parties choose to participate in Early Discussion and Resolution, the initial discussion should take place as soon as possible and generally within 72 hours of a health care facility or health care provider filing a notice or being informed by the Commission that a notice was filed by a patient, and conclude within 180 days of the initial filing of the notice.

(3) The parties may agree to extend the 180 day time limit described in section (2) of this rule if they also agree to extend the statute of limitations applicable to a negligence claim.

(4) Each party involved in Early Discussion and Resolution may include other persons in the discussion, including a mediator as outlined in OAR 325-035-0035.

(5) The health care facility, health care provider, or employer of a health care provider who chooses to participate in Early Discussion and Resolution must notify the patient and all other parties involved in the adverse health care incident of the date, time, and location of the discussions and shall reasonably accommodate all persons who have been invited to participate by the parties and wish to attend.

(6) Discussions may include:

(a) An explanation of what occurred and the implications for the patient’s health and well-being;

(b) An explanation of the causes of the incident;

(c) An apology or expression of regret to the patient;

(d) The steps the health care facility or health care provider will take to prevent future occurrences of the adverse health care incident; and

(e) Compensation for the adverse health care incident.

(7) If the health care facility or health care provider is not going to make an offer of compensation, the health care facility or health care provider may communicate that to the patient orally or in writing.

(8) If compensation is offered, the offer must be in writing and the patient must be advised by the health care facility or health care provider of their right to seek legal advice before accepting the offer.

(9) Discussions and offers of compensation made in Early Discussion and Resolution:

(a) Do not constitute an admission of liability;

(b) Are confidential and may not be disclosed; and

(c) Except as provided in Oregon Laws 2013, Chapter 5, Section 3, are not admissible as evidence in any subsequent adjudicatory proceeding and may not be disclosed by the parties in any subsequent adjudicatory proceeding.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5, Sec. 3 & 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 3, 4 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0020 Filing Reports about Resolution

(1) The Commission must request a confidential report indicating the status of the matter from the person that filed the notice within 180 days after the notice was filed. If the matter is not resolved 180 days after the notice was filed, the Commission may request additional reports from the person that filed the notice as necessary.

(2) A report may include:

(a) Whether the matter has been resolved;

(b) Whether an apology was offered or there were expressions of regret;

(c) Whether the health care facility or health care provider agreed to take steps to prevent future occurrences of the adverse health care incident;

(d) How many oral communications, including face-to-face discussions, the parties have had;

(e) Who has participated in the oral communications, including face-to-face discussions;

(f) Whether the parties engaged in mediation; and

(g) Whether compensation was offered and accepted.

(3) If an offer of compensation is accepted by a patient at any point during discussions, the health care facility or provider must notify the Commission.

(4) If the parties to Early Discussion and Resolution resolve the matter, the person who filed the notice may submit a report about resolution as described in section (1) of this rule.

(5) If resolution is not achieved within 180 days, the Commission may request a report about resolution at a later date.

(6) The Commission may accept a report about resolution from an individual to whom the person who filed the notice has delegated authority to submit the report.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5 & Sec. 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 3 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0025 Mediation

(1) If a discussion as described in OAR 325-035-0015 does not result in the resolution of an adverse health care incident, the patient and the health care facility or health care provider who files or is named in a notice of adverse health care incident may enter into mediation.

(2) The parties who have agreed to participate in mediation shall bear the cost of mediation equally unless otherwise mutually agreed.

(3) Other persons that may participate in the mediation include, but are not limited to:

(a) Members of the patient’s family, at the discretion of the patient;

(b) Attorneys for the patient, the health care facility and the health care provider;

(c) Professional liability insurance carriers;

(d) Risk management personnel; and

(e) Any lien holder with an interest in the dispute.

(4) Mediation under this rule is subject to ORS 36.110 through 36.238.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5 & Sec. 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 5 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0030 Adding a Mediator to the Mediator Panel

(1) The Commission must develop and maintain a panel of mediators that meet the qualifications established in this rule.

(2) To be included in the Commission’s panel of mediators, an individual must meet the qualifications set forth is OAR 325-035-0035 and provide information to the Commission about themselves and their qualifications by completing and submitting the mediator panel application on the Commission’s website (http://oregonpatientsafety.org). Information provided must include but is not limited to:

(a) Contact information;

(b) Education level;

(c) Number of mediations conducted, approximate number of hours of mediation experience, and approximate number of hours dealing with cases or matters involving medical malpractice or personal injury;

(d) General mediator training;

(e) Specific subject training;

(f) Continuing education;

(g) Professional standards of mediation practice to which the mediator adheres;

(h) Counties of Oregon that they are willing to serve;

(i) Languages spoken;

(j) Website links, if applicable; and

(k) Fee information.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5, Secs. 5 & 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 5 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0035 Mediator Qualifications

(1) The Commission will consider a mediator to have met the required qualifications if the individual has:

(a) Formally mediated 50 cases or engaged in 500 hours of formal mediation;

(b) Completed 30 hours of education meeting the standards in Appendix A or equivalent training;

(c) Received an orientation to Early Discussion and Resolution, made available by the Commission;

(d) Completed at least 16 additional hours of professionally accredited subject-specific training (which may include, but is not limited to: training related to medicine, health care, medical or hospital culture, health care transformation, mental health, grief counseling, psychology, risk management, key substantive, procedural or evidentiary laws relating to personal injury or adverse health care incidents, and adverse incident mediation discussion or role-playing);

(e) Have at least 150 hours of experience dealing with cases or matters that involve medical malpractice or personal injury as a mediator, facilitator, doctor, nurse, social worker, judge, consultant, psychologist, or attorney; and

(f) Provided the ethics and standards of practice to which they adhere.

(2) A mediator may request a waiver from the Commission from any mediator qualification. Such a request must be in writing and must describe why the qualification cannot be met and the facts that otherwise make the mediator qualified to be listed on the panel. The Commission may, in its discretion, waive a requirement for mediator qualification if it appears that the mediator has qualifications or the experience necessary to appropriately mediate matters involving adverse health care incidents.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5, Secs. 5 & 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 5 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0040 Publication of Mediator Panel

(1) If a mediator has submitted information in accordance with OAR 325-035-0030 and attested that he or she meets the qualifications in OAR 325-035-0035, the Commission must publish the mediator’s name, contact information, and responses to questions asked on the mediator panel application on the Commission’s website.

(2) Annually, the Commission must contact all listed mediators requesting that they update or confirm their information and qualifications. Mediators who do not confirm their information or continuing qualifications within the timeframe established by the Commission must be removed from the list, but may reapply for inclusion. Mediators may update or confirm their information at any time.

(3) If at any time the Commission discovers that a mediator does not meet qualifications, they will be removed from the list.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5 & Sec. 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 5 & 9
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14

Or. Admin. R. 325-035-0045 The Role of the Administrative Entity

(1) The Commission shall use notices of adverse health care incidents to:

(a) Establish quality improvement techniques to reduce patient care errors that contribute to adverse health care incidents;

(b) Develop evidence-based prevention practices to improve patient outcomes and disseminate information about those practices; and

(c) Upon the request of a health care facility or health care provider, assist the facility or provider in reducing the frequency of a particular adverse health care incident, including, but not limited to, determining the underlying cause of the incident and providing advice regarding preventing reoccurrence of the incident.

(2) The Commission may disseminate information relating to a notice of adverse health care incident to the public and to health care providers and health care facilities not involved in the incident as necessary to meet the goals described in section 1 of this rule. Information disclosed must not identify a health care facility, health care provider or patient involved in the adverse health care incident.

(3) The Commission may not disclose any information provided pursuant to a discussion under Oregon Laws 2013, Chapter 5, Section 3 to a regulatory agency or licensing board.

(4) The Commission may use and disclose information provided pursuant to a discussion under Oregon Laws 2013, Chapter 5, Section 3 as necessary to assist a health care facility or health care provider involved in an adverse health care incident in determining the cause of and potential mitigation of the incident. If the Commission discloses information under this section to a person not involved in the incident, the information may not identify a health care facility, health care provider or patient involved in the incident.

(5) The Commission will periodically disseminate aggregate information about incidents reported in notices and what has been learned about successful resolution. Additional information may be disseminated depending on data available.

History

• Statutory/Other Authority: Oregon Law 2013, Ch. 5 & Sec. 9
• Statutes/Other Implemented: Oregon Law 2013, Ch. 5, Secs. 9 & 10
• PSC 2-2014, f. 6-12-14, cert. ef. 7-1-14