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The Oregon Administrative Rules contain OARs filed through November 15, 2014
 
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OREGON PATIENT SAFETY COMMISSION

 

DIVISION 30

OREGON PATIENT SAFETY REPORTING PROGRAM
FOR OUTPATIENT RENAL DIALYSIS FACILITIES

325-030-0001

Definitions

As used in OAR 325-030-0001 to 325-030-0060:

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

(2) “Event Report” means the form designated by the Commission to be used by Renal Dialysis Participants for the reporting of Reportable Renal Dialysis Adverse Events.

(3) “Renal Dialysis Participant” means an outpatient renal dialysis facility as defined in ORS 442.015, that has volunteered to participate in the Oregon Patient Safety Reporting Program.

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

(5) “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.

(6) “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 established in ORS 442.820;

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

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

(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 the Oregon Patient Safety Reporting Program.

(7) “Patient Safety Data” means oral communication or written reports, data, records, memoranda, analyses, deliberative work, statements, root cause 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 the Oregon 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 Oregon Patient Safety Reporting Program; or

(b) Are created by or at the direction of the Patient Safety Reporting Program, including communication, reports, notes, or records created in the course of an investigation undertaken at the direction of the Oregon Patient Safety Commission.

(8) “Reportable Adverse Event” for the purposes of OAR 325-030-0001 to 325-030-0060 means any unanticipated, usually preventable consequences of patient care that result in patient death or serious physical injury. This includes events that:

(a) Are not related to the natural course of the patient’s illness or underlying condition; and

(b) Resulted in temporary and/or permanent physical harm.

NOTE: In addition, Reportable Adverse Events include those described in Appendix A. Appendix A is incorporated by reference.

[ED. NOTE: Appendices referenced are not included in rule text. Click here for PDF copy of appendicies.]

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0005

Enrollment in the Oregon Patient Safety Reporting Program

(1) Participation in the Oregon Patient Safety Reporting Program is voluntary. Renal Dialysis Participants are entitled to the benefits and subject to the obligations set forth in these administrative rules.

(2) Interested Renal Dialysis Facilities may apply for participation in the Oregon Patient Safety Reporting Program by completing the Commission’s registration form. The registration form must include the name of a designated contact person. Changes to any information on the registration form must be reported to the Commission with 30 days of the effective change.

(3) In agreeing to participate, a Renal Dialysis Facility must affirm that it is willing to share fully all requested Patient Safety Data with the Commission. This statement must be signed by the Renal Dialysis Facility’s regional chief executive and Quality Director, or their equivalents.

(4) Upon enrolling in the Oregon Patient Safety Reporting Program, a Renal Dialysis Participant must have adopted policies and procedures describing patient safety activities, including how it triages adverse events; how it investigates adverse events, and how it provides notice of serious adverse events to a patient and/or family member. The Renal Dialysis Participant must provide copies to the Commission upon request.

(5) Within 30 calendar days of receipt and acceptance of the registration form the Commission will issue a certificate establishing a Renal Dialysis Participant’s enrollment in the Oregon Patient Safety Reporting Program. The Renal Dialysis Participant should conspicuously post the certificate in public view.

(6) The Commission will issue a press release on a regular basis, which will provide a list of Renal Dialysis Participants to the public.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0010

Annual Renal Dialysis Fee

(1) All renal dialysis facilities, as defined in ORS 442.015, must pay an annual fee of $750. Per ORS 442.850 these fees will be assessed independent of participation status in the Oregon Patient Safety Reporting Program.

(2) Annual Renal Dialysis fees will be due by December 1 for the next year’s enrollment. A delinquent renewal fee of up to 25% of the renewal fee may be assessed against a Renal Dialysis Facility submitting fees postmarked after December 31st.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0015

Termination of Participation

(1) The Commission’s reporting program relies on voluntary reporting. However, the Commission is responsible for ensuring that those who choose to participate also comply with the standards established by the Commission.

(2) Participation requirements include the reporting of all Reportable Adverse Events; fully completing Event Reports; creating and implementing acceptable action plans; and providing written disclosure to patients or families following a Reportable Adverse Event.

(3) If the Commission believes a Renal Dialysis Participant is not meeting its participation requirements, the Commission must provide the Renal Dialysis Participant with a written notice explaining why. The Renal Dialysis Participant will have 30 calendar days to respond and come into compliance.

(4) The Commission may deny, suspend, or revoke a Renal Dialysis Participant’s status when the Commission finds that there has been a substantial failure to comply with the provisions of participation. Upon written notification by the Commission of revocation, suspension, or denial of a Renal Dialysis Participant enrollment in the Oregon Patient Safety Reporting Program, a Renal Dialysis Participant may request a hearing. Hearings will be held in accordance with ORS 183.310 to 183.470.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0020

Re-Issue of Suspended or Revoked Participation Certificate

The Commission may re-issue a participation certificate that has been suspended or revoked if the Commission determines that the Renal Dialysis applying for re-enrollment meets the provisions of participation.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0025

Reporting Adverse Events

(1) The Commission will provide an Event Report form to be used by Renal Dialysis Participants for reporting Reportable Adverse Events. The Event Report will include a summary description of the event; a description of the Renal Dialysis Participant’s complete, thorough, and credible analysis for that event; information about plans to implement improvements to reduce risk. The meaning of terms “complete,” “thorough,” and “credible” are explained in OAR 325-030-0035.

(2) Renal Dialysis Participants must use the Event Report form when reporting Adverse Events to the Commission.

(3) Renal Dialysis Participants must submit a completed Event Report to the Commission within 45 calendar days of discovery of a Reportable Adverse Event.

(4) If a Renal Dialysis Participant believes the Commission should immediately issue an alert to all Oregon Renal Dialysis Facilities based on a specific Reportable Adverse Event, the Renal Dialysis Participant should provide an initial report to the Commission within 3 business days of discovery of the event, or sooner. The Renal Dialysis Participant and Commission will work together to identify information to include in the alert.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0030

Renal Dialysis Reporting of Close Calls and Less Serious Events

(1) In addition to Reportable Adverse Events, Participating Renal Dialysis Facilities are also encouraged to report less serious events and close calls/near misses. Participating Renal Dialysis Facilities should do so when they believe such events present the potential for significant harm.

(2) To report such events, Renal Dialysis Participants should use the appropriate sections of the Event Report form. Renal Dialysis Participants will not be required to complete detailed root cause analysis for these close calls or less serious events.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0035

Commission Review of Reports

(1) When the Commission receives an Event Report from a Renal Dialysis Participant, the Commission will determine whether that Event Report is complete, thorough, credible, and acceptable. As used by the Commission:

(a) A report is complete if it contains all the information requested in the Event Report, or explains, to the Commission’s satisfaction, why that information is not available or not necessary to provide;

(b) A report is thorough if the investigation (root cause analysis) of the event includes an analysis of all relevant systems issues and shows evidence of an inquiry into all appropriate areas;

(c) A report is credible if it shows evidence that the investigation of the Reportable Renal Dialysis Adverse Event included participation by leadership within the organization and was logically consistent; and

(d) A report is acceptable if all the above standards are met and the action plans clearly describe meaningful system-level improvement strategies designed to minimize risk, or indicate why only individual improvement strategies are appropriate for the reported event.

(2) If the Commission believes that an Event Report received from a Renal Dialysis Participant is incomplete or unacceptable in some manner, it will inform the Renal Dialysis Participant’s contact person within 10 business days of receipt of the Event Report.

(3) On an annual basis, the Commission will query Renal Dialysis Participants regarding the status of action plans identified in their Event Reports.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0040

Public Health Officer Certification

(1) At least annually, the Commission will request that the Public Health Officer certify the completeness, credibility, and thoroughness of each Renal Dialysis Participant’s reporting during the applicable period.

(2) The Commission will request that the Public Health Officer develop independent and objective standards to evaluate the overall integrity of the Patient Safety Reporting Program. On an annual basis, the Commission will request that the Public Health Officer use those standards to certify the Oregon Patient Safety Reporting Program.

(3) The Commission will provide information to the Public Health Officer to assist the Public Health Officer in completing the certification processes listed in (1) and (2) of this rule, consistent with OAR 325-030-0055.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0045

Patient Notification

(1) After a Reportable Adverse Event that results in death or serious physical injury, a Renal Dialysis Participant must provide written notification to each affected patient, or, if necessary, to the patient’s personal representative. Notification must be timely and should be consistent with the Renal Dialysis Participant’s internal communication and disclosure policies.

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

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0050

Extensions and Waivers

(1) The Commission may grant an extension of any time requirement stipulated in these rules if the Renal Dialysis Participant provides justification that the delay is due to factors beyond its control or that the delay will not adversely affect the purposes of the Commission. A Renal Dialysis Participant requesting a waiver must submit a written request to the Commission prior to the deadline for the required action. Facsimile requests are acceptable.

(2) The Commission may grant a waiver of any other provision of these rules if the Renal Dialysis Participant provides justification that granting the waiver will not adversely affect the purposes of the Commission.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0055

Protection of Patient Safety Data

(1) The Commission is subject to all the confidentiality provisions set forth in ORS 442.819 to 442.846.

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

(3) Before it takes receipt of any confidential Patient Safety Data, the Commission 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, ORS 192.610 to 192.690.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

325-030-0060

Commission’s Use of Patient Safety Data

(1) The Commission will create a standing committee on best practices in patient safety. This committee will advise the Commission on effective methods for making use of and sharing information gathered from the Commission’s review of Event Reports.

(2) At least quarterly, the Commission will provide Renal Dialysis Participants with patient safety quality improvement information derived from Patient Safety Data.

(3) During the second quarter of each year, the Commission will publish a report to the public summarizing Patient Safety Data for the preceding calendar year. This report will use aggregate, de-identified data from the program and will describe statewide adverse event patterns and best practices to avoid the occurrence or minimize the effects of adverse events.

(4) The Commission will maintain an easily accessible and well-publicized website to share patient safety information directly with consumers.

(5) The Commission, within its resource limitations, will provide technical assistance to Renal Dialysis Participants, including but not limited to recommendations and advice regarding methodology, communication, dissemination of information, data collection, security and confidentiality.

(6) The Commission 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 utilization of Patient Safety Data.

Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819 - 442.851 & 442.837(2)(e)
Hist.: PSC 1-2010, f. & cert. ef. 4-26-10

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