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OREGON PATIENT SAFETY COMMISSION

 

DIVISION 25


OREGON PATIENT SAFETY
REPORTING PROGRAM FOR AMBULATORY SURGERY CENTERS

325-025-0001
Definitions
As used in OAR 325-025-0001 to 325-025-0060:
(1) "Commission" means the
Oregon Patient Safety Commission.
(2) "Event Report" means
the form designated by the Commission to be used by Ambulatory Surgery Center Participants
for the reporting of Reportable Ambulatory Surgery Center Adverse Events.
(3) "Ambulatory Surgery Center
Participant" means an ambulatory surgery center 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 a 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 a 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 a 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 a
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) "Serious Adverse Event"
for the purposes of OAR 325-025-0001 to 325-025-0060 means any unanticipated, usually
preventable consequence of patient care that results in patient death or serious
physical injury, either temporary or permanent.
(9) "Reportable Adverse Event"
for the purposes of OAR 325-025-0001 to 325-025-0060 means any unanticipated, usually
preventable consequence of patient care that results in patient harm, including
the events described in Appendix A and any Serious Adverse Events. Appendix
A is incorporated by reference.
[ED. NOTE: Appendices referenced are
available from the agency.]
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0005
Enrollment in the Oregon Patient
Safety Reporting Program
(1) Participation in the Oregon Patient
Safety Reporting Program is voluntary. Ambulatory Surgery Center Participants are
entitled to the benefits and subject to the obligations set forth in these administrative
rules.
(2) Interested ambulatory
surgery centers may apply for participation in the Oregon Patient Safety Reporting
Program by completing the Commission's participation agreement. The participation
agreement must include the name of a designated contact person.
(3) In agreeing to participate
an ambulatory surgery center must affirm that it is willing to fully share requested
Patient Safety Data with the Commission. This statement must be co-signed by the
ambulatory surgery center's Chief Executive Officer, Chairperson of the Governing
Body, and the Director of Quality Management, or their equivalents.
(4) Upon enrolling in the
Oregon Patient Safety Reporting Program, an Ambulatory Surgery Center 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 adverse events to a patient and/or patient's personal
representative. The Ambulatory Surgery Center Participant must provide copies to
the Commission upon request.
(5) Within 30 calendar days
of receipt and acceptance of the participation agreement the Commission will issue
a certificate establishing an Ambulatory surgery center Participant's enrollment
in the Oregon Patient Safety Reporting Program. The Ambulatory surgery center Participant
should conspicuously post the certificate in an area where patients are admitted.
(6) The Commission will maintain
and update a website that lists all Ambulatory Surgery Center Participants.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0010
Annual Ambulatory surgery center
Participant Fee
(1) All ambulatory surgery centers licensed
under ORS 441.015 must pay an annual fee of $975 for each facility. Per ORS 442.850
these fees will be assessed independent of participation status in the Oregon Patient
Safety Reporting Program.
(2) Initial fees will be
due by December 31 of the year an ambulatory surgery center becomes licensed by
the state of Oregon. Annual fees will be due by December 31 each 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) No participation fees
will be refunded due to withdrawal or termination from the Oregon Patient Safety
Reporting Program.
(4) Fees shall be annually
adjusted by the Commission Board, at a rate equal to the annual average Consumer
Price Index for All Urban Consumers of the Portland, Oregon, Metropolitan Statistical
Area, as compiled by the United States Department of Labor, Bureau of Labor Statistics,
for every fiscal year beginning on or after July 1, 2008.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0015
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 their personal representatives following a Serious Adverse Event.
(3) If the Commission believes
an Ambulatory Surgery Center Participant is not meeting its participation requirements,
the Commission must provide the Ambulatory Surgery Center Participant with a written
notice explaining why. The Ambulatory Surgery Center Participant will have 30 calendar
days to respond and come into compliance.
(4) The Commission may deny,
suspend or revoke an Ambulatory Surgery Center 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 an Ambulatory Surgery Center Participant enrollment in the Oregon Patient
Safety Reporting Program, an Ambulatory Surgery Center 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
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0020
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 ambulatory surgery center applying for re-enrollment meets the provisions of
participation.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0025
Reporting Adverse Events
(1) The Commission will provide an Event
Report form to be used by Ambulatory Surgery Center Participants for reporting Reportable
Adverse Events. The Event Report will include: a summary description of the event;
an overview of the Ambulatory Surgery Center Participant's complete, thorough and
credible investigation for that event; information about plans to implement improvements
to reduce risk. The meaning of terms "complete," "thorough," and "credible" are
explained in OAR 325-025-0035.
(2) Ambulatory Surgery Center
Participants must use the Event Report form when reporting Reportable Adverse Events
to the Commission.
(3) Ambulatory Surgery Center
Participants must submit a completed Event Report to the Commission within 45 calendar
days of discovery of a Reportable Adverse Event.
(4) Ambulatory Surgery Center
Participants must make a good faith effort to report events that occur or are discovered
following discharge from the ambulatory surgery center.
(5) If an Ambulatory Surgery
Center Participant believes the Commission should immediately issue an alert to
all Oregon ambulatory surgery centers based on a specific Reportable Adverse Event,
the Ambulatory Surgery Center Participant should provide an initial report to the
Commission within three business days of discovery of the event, or sooner. The
Ambulatory Surgery Center 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
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0030
Ambulatory Surgery Center Reporting
of Less Serious Adverse Events and Close Calls
(1) In addition to the list of Reportable
Adverse Events, Participating Ambulatory Surgery Centers are also encouraged to
report less serious adverse events and close calls. Participating Ambulatory Surgery
Centers should do so when they believe other organizations will benefit from the
information.
(2) To report such events,
Ambulatory Surgery Center Participants should use the appropriate sections of the
Event Report form.
(3) Ambulatory Surgery Center
Participants are not required by the Commission to provide written disclosure of
less serious adverse events or close calls to patients or their personal representatives.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0035
Commission Review of Reports
(1) When the Commission receives an
Event Report from an Ambulatory Surgery Center Participant, the Commission will
determine whether that Event Report is complete, thorough, credible and acceptable.
The definitions for the terms complete, thorough, credible and acceptable are:
(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 root cause analysis 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 Ambulatory Surgery
Center Adverse Event included participation by leadership within the organization
and was internally consistent; and
(d) A report is acceptable
if all the above standards are met and the action plans clearly describe meaningful
improvement strategies designed to minimize risk.
(2) If the Commission believes
that an Event Report received from an Ambulatory Surgery Center Participant is incomplete
or unacceptable in some manner, it will inform the Ambulatory Surgery Center Participant's
contact person within 10 business days of receipt of the Event Report.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0040
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 Ambulatory Surgery Center 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 325-025-0055.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0045
Patient Notification Of Serious
Adverse Events
(1) After a Serious Adverse Event occurs,
an Ambulatory Surgery Center 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 Ambulatory Surgery Center 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
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0050
Extensions And Waivers
(1) The Commission may grant an extension
of any time requirement stipulated in these rules if the Ambulatory Surgery Center
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. An Ambulatory
Surgery Center Participant requesting a waiver must submit a written request to
the Commission prior to the deadline for the required action.
(2) The Commission may grant
a waiver of any other provision of these rules if the Ambulatory Surgery Center
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
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0055
Protection Of Patient Safety Data
(1) The Commission is subject to all the
confidentiality provisions set forth in ORS 442.820, 442.831, 442.837, and 442.846.
(2) The Commission will maintain
the confidentiality of all Patient Safety Data that identifies or could be reasonably
used to identify an Ambulatory Surgery Center Participant or an individual who is
receiving or has received health care from the Ambulatory Surgery Center 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, 192.610 to 192.690.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15
325-025-0060
Commission’s Use Of Patient
Safety Data
(1) The Commission will create an ad
hoc advisory group 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 Ambulatory Surgery Center 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 Ambulatory Surgery
Center 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.
The Commission will revise its reporting form as necessary based on feedback from
Participants.
(7) The Commission may initiate
other projects using patient safety data when consistent with its mission and in
accordance with existing confidentiality protections.
Stat. Auth.: ORS 442.820
Stats. Implemented: ORS 442.819-442.851
Hist.: PSC 3-2007, f. &
cert. ef. 5-4-07; PSC 2-2015, f. & cert. ef. 7-10-15

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