Comments

American Society of Nephrology | 09/19/2023

Dear Dr. Rudow and Dr. Stewart Lewis:

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who comprise the American Society of Nephrology (ASN), thank you for the opportunity to respond to provide comment regarding the Organ Procurement and Transplantation Network (OPTN) proposal “Require Reporting of Patient Safety Events.”

ASN supports the proposal to require transplant hospitals and organ procurement organizations to report certain serious patient safety events, detailed in the proposal, so that the OPTN and the Health Resources and Services Administration (HRSA) are aware of all instances of these events. Current OPTN policy does not require OPTN members to report all these types of events, and ambiguity exists regarding the definitions of some of these events. By requiring reporting and establishing standard definitions, the OPTN Medical Professional Standards Committee (MPSC) and HRSA can be aware of these patient safety situations. Since at least 2011, reporting of these events to HRSA has been an outstanding concern expressed by the HRSA Administrator, and ASN appreciates MPSC and OPTN’s attention to them at this time. ASN is particularly supportive of the proposal’s observation that, “the MPSC will also be able to use available data from these reports to assess the prevalence of these concerning patient safety events and, provide guidance regarding effective practices to.”

In any instance where additional reporting is considered, ASN considers the balance of the burden of the reporting with the value the additional information may yield. The patient safety events considered in this proposal are all potentially serious in nature and, as MPSC details, relatively rare: from August 2022 through May 2023, OPTN received just 17 reports that would meet the proposed criteria. While that number is anticipated to increase somewhat if this proposal is finalized, ASN concurs that these events are serious enough in nature that reporting and documenting their occurrence outweighs the nominal additional reporting burden. The proposal does not detail whether or how these aggregate data may be shared outside of the MPSC, OPTN, or HRSA. While the society recognizes the imperative of protecting patient privacy, ASN recommends that this information be shared for research purposes with the research community and encourages the committee to consider whether or not suitable mechanisms may exist to share the information in an appropriately contextualized manner more broadly.

ASN’s comments on the specific elements of the OPTN proposal are below.

Near-miss event definition: ASN commends the MPSC’s efforts to develop a consistent definition to the “HRSA criteria,” which had previously been described as “a near-miss transplant of the wrong organ into an organ recipient” or “a near-miss transplant into the wrong organ recipient” or “an event should be considered a ‘near-miss’ if the error is not caught before the recipient is brought to the surgery holding area.” Having consistent, universally-agreed upon definitions is essential to ensure the MPSC, OPTN, and HRSA receive uniform information that will allow them to understand and, if needed, improve upon patient safety practices nationwide.

Living donors added to the waiting list within two years of donation: As the proposal outlines, the addition of a living donor to the waiting list within two years of donation could indicate that something was missed in their evaluation. As part of ASN’s commitment to better support living donors over the long-term, the society supports the collection of this information. ASN encourages OPTN (particularly the MPSC and the Living Donor Committee) to articulate how the collection of this information by the MPSC may align with the proposed data collection considered in the Living Donor Committee’s concept paper “Concepts for a Collaborative Approach to Living Donor Data Collection.” ASN appreciates that MPSC has documented that this proposal would incur minimum additional reporting burden, but wishes to ensure that multiple proposals moving forward at the same time do not inadvertently establish duplicative means of reporting the same information.

Transportation events: ASN appreciates MPSC’s inclusion of transportation-related events in this proposal, particularly given the ongoing focus on these types of events in the community in recent years, and that these concerns were highlighted by the HRSA Administrator as early as 2011. ASN supports the proposal requiring hospitals to report the following events so that OPTN (MPSC) and HRSA are aware of their occurrence:

• An organ was delivered to the incorrect transplant hospital and resulted in non-use of the organ.

• The incorrect organ was delivered to the transplant hospital and resulted in non-use of the organ.

• An organ did not arrive when expected and resulted in the intended candidate not receiving a transplant from the intended donor because of the transportation issue.

ASN notes and agrees with the observation in the proposal that “in most instances, the transplant hospital that will be required to report these transportation-related events will not bear any responsibility for the event; however, these events are concerning enough that the MPSC would like to know when they happen so the event can be investigated.”

ABO typing error or discrepancy: MPSC notes in the proposal that past reviews of ABO typing errors or discrepancies have raised serious patient safety concerns and, as a result, recommends that transplant hospitals and OPOs be required to report them. ASN concurs with this recommendation and again, supports the MPSC’s proposal of a consistent definition that all stakeholders can share.

24-hour reporting timeframe: The proposal recommends a 24-hour reporting timeframe, noting that the report is one of the first steps in the process of responding to a potential safety event, not the last. An investigation would still occur to gather more information regarding the event and to determine if there were any violations of OPTN obligations by the member. Recognizing that the OPTN contract requires reporting to HRSA in either 24 hours (or one business day), and 24 hours would be universally defined the same everywhere with no confusion, ASN has no objections to this proposed timeframe.

Exclusions: The proposal recommends two specific potential patient safety events that OPTN members should not be required to report to OPTN: events that constitute CMS “never events,” and events that involve the use of a device that is contraindicated by the use of the U.S. Food and Drug Administration. First, ASN concurs that OPTN members should not have to report CMS “never events” to OPTN, because they are already mandated to report those events to CMS. Duplicative reporting to MPSC increase the administrative burden on, and potentially result in confusion for, members. Second, ASN has no objections to the rationale laid out for not requiring OPTN members to report the use of a device that is contraindicated by the use of the U.S. Food and Drug Administration. The information the MPSC provides, such as that the use of such devices is common in some types of transplant surgery like lung transplant appears outside the realm of kidney transplantation. However, agrees with the MPSC that OPTN members are expected to report events that include the use of a device that is contraindicated by the FDA and also pose a threat to patient health and public safety.

Update to improving patient safety portal instructions: ASN supports the proposal to list the events members will be required to report in the OPTN Improving Patient Safety Portal Safety Situation and Living Donor Event form instructions, providing an immediate reference for members. Anything else that can be done to further streamline the reporting process for these patient safety events should be strongly considered to help minimize the administrative burden.

In sum, ASN appreciates OPTN’s and the committee’s dedication to protecting patient safety and encourages OPTN to finalize this proposal. Please contact ASN Strategic Policy Advisor Rachel Meyer at rmeyer@asn-online.org with any questions or to discuss this letter in more detail.

Sincerely,

Michelle A. Josephson, MD, FASN

President

View attachment from American Society of Nephrology

OPTN Patient Affairs Committee | 09/19/2023

The Patient Affairs Committee would like to thank the MPSC for their work on this proposal. As a committee comprised entirely of patients, living donors, patient caregivers, and donor families, we wholeheartedly support this proposal. The Committee is supportive of the efforts to better track patient safety events, especially those which are not currently tracked but present serious patient safety concerns, such as near misses. Collecting this data through the reporting requirements may shed light on why near misses happen and opportunities to develop best practices to help standardize operations for transplant centers and OPOs. The Patient Affairs Committee recommends making the data collected as a part of this proposal as public-facing as possible, and asks that the patient voice be included throughout the development of this project. The current proposal would require reporting a living donor who is added to the waiting list within two years of their donation; the PAC suggested perhaps that timeframe should be increased (5 or 10 years post-donation). 

View attachment from OPTN Patient Affairs Committee

Colleen O'Donnell Flores | 09/19/2023

I agree with the clarity on event reporting as proposed. I respectfully request a 36-48 hour time frame so that programs, mainly during off-hours, may concentrate on patient care first and allow for time for communication and reporting.

Also, as the Committee addresses the patient safety reporting, I hope the they will consider an important enhancement to the reporting system.

Right now, I am limited in my access to a letter of closure to any event other than an event I report. I believe we should be able to monitor all events for my center, closures and/or any ongoing monitoring of such events based on our user rights. I'm happy to provide further information on this request.

Thank you

Kasper Statz | 09/19/2023

As an OPO quality improvement professional, I strongly support this proposal. Promoting a culture of transparency will enable the whole system to improve and can help rebuild the trust of policy makers and the public that we serve.

Hospital of the University of Pennsylvania | 09/19/2023

Recommend an addition to this proposal to mandate reporting of errors by OPOs.

New England Donor Services | 09/19/2023

NEDS supports increased collection of patient safety data. The OPTN should align standards across the OPTN, MPSC and HRSA to ensure consistency of data collection and reporting; ultimately improving the quality of performance of its members. However, at this time the OPTN should limit the expansion of reporting requirements to align with the reporting requirements for HRSA (which do not include transportation-related events). NEDS supports the concept of reporting events that result in organ non-use to the OPTN but notes that there are events other than transportation-related events that contribute more significantly to organ non-use. The OPTN should undertake a comprehensive review of the donation and transplant system focusing on each step of the process to identify areas where errors have the most significant impact on utilization and then identify the types of events that contribute most substantially to organ non-use. In NEDS’ experience this may include for example, late declines by transplant programs of previously accepted organs or surgical errors made during organ recovery. If in the future the OPTN is going to collect data on transportation-related events, the OPTN should categorize transportation events into those that are within the OPO’s or program’s control and those outside their control. It is important that any data captured for delays in organ transport are based on agreed upon deviation from established transportation arrangements rather than based on dissatisfaction with the available options.

ABO Verification

Reliable testing to determine ABO, in all populations served by the OPTN, deceased donors, living donors, transplant candidates, is necessary to the safety of recipients. ABO typing, like all other tests, are not 100% accurate and can lead to discrepant results. NEDS recommends collecting ABO verification errors and near misses for all populations served by the OPTN to understand the common causes of these discrepancies before implementing the reporting requirement outlined in the proposal.

24 Hour Reporting Timeframe

Investigation and determination of whether an event is reportable can take more than 24 hours after the point of recognition of an event. OPOs should be encouraged to accurately collect the necessary information within a reasonable timeframe. NEDS recommends 2 business days.

Lorrinda Gray-Davis | 09/19/2023

Strongly Support

Region 8 | 09/19/2023

Sentiment: 6 strongly support, 10 support, 1 neutral/abstain, 2 oppose, 0 strongly oppose

Several members appreciated the alignment of reporting requirements and said it will be helpful to have these reports communicated back to the community so they can learn from each other. Several members supported the proposal and suggested a 72-hour reporting time period as opposed to a 24-hour reporting time period. They explained that the 24-hour reporting time period is too short and would be difficult to do on a Friday and could cause unnecessary reporting errors.

·      While a member supported clarification of reporting requirements, including near misses, they said the benefit of any safety events, particularly near misses, depends on aggregating the data and reporting it back to the community.

·      An attendee encouraged the committee to be really specific about what should be reported and be cautious about peer review and related protections issues. The term "sanction" is broad at best and reflects the full spectrum of potential reportable events, including accusations against a physician that are inappropriate for this exercise. This must be addressed to ensure reputations are intact, only until proven otherwise. A member asked for additional clarity to limit "near-miss" events to those occurring by chance or at the final step (as opposed to those being caught by existing processes) to prioritize efforts for areas where change is needed. They asked the committee to more clearly define "sanction" and "other professional body".

·      Another member suggested that OPTN members reporting requirements should be in alignment with the contract reporting requirements. They strongly supported the requirement of reporting for living donors placed on the waiting list for any organ two years after donation. And explained that transportation events absolutely need to be tracked and all events that resulted in non-use of the organ should be reported. An attendee said that collection of near-miss data is vital to preventing a “miss” scenario.

·      A member recommended OPO requirements be updated as effective once allocation starts and there is potential recipient impact. OPOs have checks in place (i.e. waiting for reverse DNA for ABO in the presence of mass transfusion) and processes prior to allocation to ensure safety. They recommended changing language to reflect this. They agreed with making the system as safe as possible and learning from near miss.

·      For the ABO reporting events, a member recommended to consider making this required only after a match run and allocation has started. Regarding ABO reporting, they explained they can put a donor into DonorNet and put their ABO in and not run match runs or start allocation for quite some time. A lot of the ABO typing errors are around subtyping. It would require the OPO to report this as an event if we put them in but haven’t done anything yet. A lot of OPOs have processes in place that review everything prior to starting allocation. 

Association of Organ Procurements Organizations | 09/19/2023

AOPO members are committed to donor and recipient safety and review of safety events as a tool for continuous performance improvement. AOPO supports the OPTN’s commitment to data collection related to patient safety events, review within the Medical Peer Review Process of safety events with the goal of improving patient safety and reporting requirements for events that have been demonstrated to compromise patient health and safety.

Medical Peer Review Process

The OPTN should clarify that all reports made pursuant to the applicable OPTN Policy, and all reports made to MPSC leadership will be subject to and protected by the Medical Peer Review provisions of Appendix L.3. of the Bylaws regardless of whether MPSC pursues an investigation or other action. The principles underlying peer review privilege – to promote candid and thorough evaluation of performance in healthcare - are well established in healthcare generally. Providers are incentivized to review and report patient safety events to prevent medical errors and improve patient safety. AOPO encourages the OPTN to precisely define events requiring reporting to ensure that self-reflection can occur within the donation and transplant system as it occurs in the context of other healthcare providers – physicians, hospitals. Balancing reporting requirements and the peer review privilege protection will promote transparency and improve patient safety. To the extent events are reported to MPSC leadership simultaneously with member reporting to the OPTN, and the events are not referred to the MPSC for investigation, OPTN policies and procedures should make clear such reports to leadership are maintained within the peer review process.

Alignment with Contractual Reporting Requirements

The stated purpose of the policy change is to align member reporting requirements with the OPTN’s contractual requirements for reporting patient safety events to HRSA. The specific events identified in the proposed policy change include both events that OPTN is required to report to HRSA (“HRSA

Criteria”) and events that are not identified by HRSA as requiring 24-hour reporting, e.g., transportation events. While AOPO supports data collection related to events leading to non-use of organs with a goal of increasing transplants, the OPTN’s focus on transportation excludes other events occurring across the donation and transplant system that more significantly contribute to organ non-use such as avoidable late organ declines and surgical errors. The OPTN cites “ongoing discussions in the transplant community about the impact of transportation-related events on the utilization of recovered organs” as a basis for including transportation events as reportable events, despite not being within “HRSA criteria.” If the OPTN’s goal is to reduce non-use of transplantable organs, AOPO recommends that the OPTN align its reporting requirements with the HRSA Criteria as an initial step and address data collection related to other patient safety events separately. AOPO encourages the OPTN to comprehensively review each step in the organ donation and transplant process and identify quality events within the entire system that have the greatest impact on non-use (e.g., late declines, surgical errors) rather than focusing on one discreet step in the process that accounts for only a small percentage of non-utilization and is in most cases outside the control of the party arranging transportation (e.g., weather related delays).

Transportation Events

While AOPO supports the collection of data related to transportation events with the goal of eliminating barriers to transplant and identifying opportunities for improvement, OPTN should distinguish between transportation events within the control of the party arranging transportation and transportation events that are not within an OPO’s control. For example, a cancelled commercial or charter flight due to weather making travel dangerous, should be distinguished from a transportation event where a courier delivers an organ to the incorrect hospital as a result of miscommunication from an upstream OPTN member.

The OPTN should require that prior to reporting an event involving the delivery of the wrong organ or delivery to the wrong transplant center, the transplant center confirm with the OPO that the organ was not ultimately transplanted as the reporting transplant center will not always know whether the organ was transplanted. For example, while a transplant center who received the incorrect organ might not accept the organ for its recipient with the additional ischemic time and assume it was not transplanted, the OPO may be successful in placing the organ for transplant with a more aggressive center. Transplant centers should confirm disposition with the OPO before reporting.

AOPO recommends that the requirement for reporting when an organ did not arrive within the timeframe that was scheduled and resulted in the intended candidate not receiving the transplant from the intended donor be modified to require reporting only when (i) there was a mutually agreeable transportation plan; and (ii) the transportation event was the sole and direct cause of the intended recipient not receiving the transplant. In addition, the requirement should be modified to require reporting when the organ did not arrive within a reasonable time of the scheduled arrival as communicated by the entity arranging transportation. The “expected arrival” is subjective and may not be consistent with the planned/scheduled arrival.

ABO Verification

AOPO understands that ABO typing errors are important safety events and, subject to the discussion above regarding separation of alignment of HRSA Criteria reporting and data collection, agrees that data should be collected on these events to identify opportunities for improvement. ABO typing errors and discrepancies can occur under circumstances where there is no deviation from policy, making data collection the more appropriate approach (vs. mandatory immediate reporting to HRSA and MPSC) with deviations from policy and true errors captured under other reporting requirements. For example, an ABO test performed by an outside lab subsequent to the verification process, and outside the OPO’s control, could produce a discrepant result requiring a change in subtype. This can occur based on imprecision of available testing platforms, and not as a result of any error by the OPO or testing lab. If the OPTN maintains its current position, the OPTN should precisely define the types of results the OPO is required to report and distinguish between discrepancies and discordant results which occur without any error or deviation from policy.

24 Hour Reporting Timeframe

A 24-hour time frame for reporting events may not be sufficient for a member to determine whether an event is reportable. Staff involved and other information may not be available in that time frame for review and interview. A 2-3 business daytime frame is a more appropriate time frame to allow the member to comply with the requirements.

Evidence of Attempt to Deceive

The proposed policy change requires reporting if “evidence is discovered of an attempt to deceive the OPTN or the Department of Health and Human Services (HHS).” This requirement is subjective, vague, and overly broad. The OPTN should provide guidance on the types of “evidence” and “attempts to deceive” to ensure members are able to comply with this requirement.

Medical Board and other Sanctions

AOPO recommends that the OPTN clarify that members are required to report sanctions taken by a

state medical board or other professional body against a transplant professional working for an OPTN member when the OPTN member is notified by the transplant professional or the medical board or other professional body imposing the sanction, or the sanction is publicly available and discovered in the usual course of the member’s review of credentials in accordance with its standard policies and procedures.

OPTN Transplant Administrators Committee | 09/19/2023

The OPTN Transplant Administrators Committee thanks the OPTN Membership and Professional Standards Committee for their dedication and work on this project. The Committee agrees that there is important data to be collected here and recommends broadening the definition of “near miss” as that would capture events which occur during the verification process. Another recommendation is to expand the reporting deadline to 72 hours instead of 24 hours for near-miss events. Additionally, the Committee advises that there be more clarification provided on what constitutes a professional body and what is meant by “sanctions” as that definition can vary state to state. The Committee recommends that providing more clarity in word choice and explanation could strengthen the proposal greatly.

Region 9 | 09/19/2023

Sentiment: 2 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

An attendee suggested having the system automatically flag when a prior living donor is listed for another organ. Many attendees were concerned with how “professional body” and “sanction” would be defined. One attendee suggested refining the definition to be more specific, like revocation of a medical license by the state medical board or termination from a position based on clinical grounds. A member agreed with requiring reporting of living donors that are added to the wait list for any organ within 2 years of donation. One attendee commented that they were pleased to see this direction overall and hoped that the goal of this is to prioritize patient safety and improve care, rather than just penalize programs. Another attendee agreed, stating that programs may hesitate to report events if the focus is on penalties. For the timeframe for reporting, there was mixed feedback. A member stated support for the 24 hour reporting timeframe, while others felt that 48 hours or the next business day would be appropriate. A member expressed support for including the transportation events outlined in the proposal, with one attendee adding that travel and shipping errors should be included, even when the organ is used as they add cold time and could disadvantage the recipient. Another member suggested collaborating with NQF, AHQR, JCAHO & others in the patient safety community on this, rather than reinventing the wheel. 

National Kidney Foundation | 09/19/2023

Attachment

View attachment from National Kidney Foundation

Region 3 | 09/19/2023

Sentiment: 2 strongly support, 13 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose

One attendee recommended expanding the list of reportable events to include ABO typing, potential candidate issues, etc. Other attendees commented about transportation events and noted that the proposal only requires the transplant center to report a transportation event and not OPOs. They added that when transportation events happen it is important for transplant centers and OPOs to communicate about the event with each other in addition to the OPTN. They added that there should also be a requirement for member organizations to share information with each other. There was also discussion about third parties who arrange transportation and that the onus for reporting is with the member organization.  

OPTN Living Donor Committee | 09/19/2023

The OPTN Living Donor Committee thanks the OPTN Membership & Professional Standards Committee for their efforts in developing this public comment proposal, Require Reporting of Patient Safety Events. Specific to the proposal updates related to Living Donors, the Committee supports required reporting for whether any prior living donor was placed on the wait list regardless of the previous organ donation. While the Committee acknowledges that requiring reporting on whether a prior living donor subsequently received dialysis is out of scope, they suggest considering this in the future if feasible. The Committee also supports the inclusion of requiring reporting of transportation events. The Committee suggests that if living donor follow-up is extended, as we currently propose with a concept paper, then the timeframe for required reporting of living donation related safety events should also be extended.

OPTN Histocompatibility Committee | 09/19/2023

The OPTN Histocompatibility Committee strongly supports the proposal to require reporting of patient safety events and asks that the MPSC consider critical HLA typing discrepancies as critically as it considers ABO typing errors, as both have serious patient safety implications. In addition, the Committee asks for more clarity on what professional sanctions would need to be reported to the MPSC, to ensure that the MPSC is only receiving reports of sanctions that would be critical for patient safety.

NATCO | 09/19/2023

Although NATCO overall supports this endeavor, we do have a few concerns. The terms “sanction” and “other professional bodies” requires further definition, as both phrases can have broad interpretations as well as differ among states. The reporting of transportation issues is supported by NATCO in the hopes that any issues identified may be shared with the transplant community to allow for process improvements across the nation. Near-miss reporting is strongly supported. Reporting of living donor listings should be able to be automated, sometimes centers do lose track of donors and people move to other states, thereby a center may not know a living donor’s circumstances. In addition, NATCO’s membership understands that reporting events in a timely fashion is vital, however, it is felt that a window of 24 hours may be too narrow given numerous circumstances that could occur, i.e. overnight, weekend, holiday events, unexpected personal time away, etc…and suggest a longer window to report.

Region 10 | 09/19/2023

Sentiment: 3 strongly support, 9 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose

Members of the region support the proposal. The general consensus was in favor of timely reporting of patient safety events, but there was a shared sentiment that the committee should re-evaluate the urgency requirement for reporting instances that may not immediately jeopardize patient safety. Furthermore, consideration should be given to potential data duplication if similar information is already being reported through other channels. One attendee emphasized the critical nature of near misses in HLA typing errors, suggesting that the committee should consider a requirement in the TIEDI system for the completion of the Donor Histocompatibility Form (DHF) within two months after an event. Others recommended minimizing the workload on programs for reporting while maintaining clear and strict definitions. There was a call for more detailed clarification on the term "sanction taken by a state medical board or other professional body" to ensure that instances involving professionals losing medical licenses or clinical privileges are reported. The suggestion to create a specific list of acceptable reasons for submitting a Patient Safety Report was put forth to enhance the efficiency of the reporting process and time management. While supporting the reporting of patient safety events, an attendee expressed uncertainty about the necessity of reporting all events within a 24-hour window, extending this period to 48 hours seems reasonable. Lastly, a point of contention was raised regarding the addition of living donors to the transplant waitlist within two years of donation as a patient safety event. The attendee did not see this as aligned with the concept of patient safety events.

Infinite Legacy | 09/19/2023

Infinite Legacy supports automatic reporting of events by transplant centers that result in the non-transplant of an organ into an intended recipient due to transportation to align with OPTN contractor reporting requirements. The OPO maximizes utilization of organs that encounter uncontrolled transportation events by strong back up and aggressive placement strategies; the OPO could report rare events that result in non-utilization of an organ to improve system measures that maximize utilization when transportation events occur. We also support the reporting of events with specificity to ensure that appropriate and comprehensive review and reflection can occur within the donation and transplant system, as it similarly occurs in the context of other healthcare provider systems. To that end, and to ensure the continued encouragement of transparent, comprehensive and accurate reporting, we would emphasize the importance of maintaining the confidentiality of the peer review process for all OPTN members in the name of prioritizing patient safety.

UC San Diego Health | 09/19/2023

SUPPORT WITH AMENDMENTS - The UCSD Health Center for Transplantation greatly appreciates the OPTN Membership and Professional Standards Committee’s work to align member patient safety event reporting requirements with the obligations set forth in the OPTN contract. While it’s anticipated that events meeting these criteria will be infrequent, we agree that available data from these reports will allow the MPSC to better assess the prevalence and provide clear guidance regarding effective practices to the transplant community to limit risk to transplant candidate, recipient, and living donors.

We do however, have some concerns regarding the ambiguity of the proposed requirement that members report “Any sanction taken by a state medical board or other professional body against a transplant professional working for an OPTN member” absent clear definitions of “sanction” and “other professional body.” A sanction could be broadly interpreted to mean any action including but not limited to investigation, hearings, suspension, probation, dismissal (or denial of reappointment), public reprimand, fines, remediation and revocation of licensure. Likewise, a professional body could be assumed to include even an institutions internal medical staffing and performance committees.

Section D.10 of the OPTN Bylaws, Investigation of Transplant Personnel, states, “The hospital’s investigation must use the hospital’s standard medical peer review process for conducting inquiries of potential professional misconduct and conclude with appropriate action consistent with this process.” While we recognize the importance of transparency and the need to ameliorate threats to patient safety and so forth within the transplant community, but we are concerned that if the MPSC’s intention is to incorporate the broader definitions that this may deny providers a fair internal peer review process and unnecessarily put the program and or institution at risk for claims of defamation, particularly if any ongoing investigation ultimately finds the provider acted reasonably and within the standard of care or restitution has been made and sanctions lifted or overturned. On the contrary, if the MPSC’s intent is to limit the definitions and scope to include for example, revocation of license, we have concerns regarding the timing of reporting such events as medical boards often have prolonged deliberations and may not move forward such a recommendation for a more than a year following the event prompting review. In scenarios involving these delayed recommendations, it is entirely plausible that the provider in question departs the institution or even state at which the initial event occurred. What then is the institution’s obligation to monitor the outcome of such investigations and subsequently report any sanctions handed down?

Additionally, we believe the Community would benefit from additional information regarding both the investigation process and the OPTN reporting process to HRSA when such events occur and what the potential implications of such reporting may be. Given HRSA’s direct linkage to CMS, it would be reasonable to assume that such a report from the OPTN to HRSA has the potential to impact a provider’s Medicare billing privileges and any corresponding provider or supplier agreement. Transparency is critical to community trust in the system.

Again, we appreciate and fully support the intent but urge the MPSC to further refine this particular proposed requirement before moving for Board approval.

HonorBridge | 09/18/2023

HonorBridge appreciates the work of the Committee and the opportunity to comment on this policy proposal. While we largely support the policy, it is HonorBridge’s opinion that reporting of discordant ABO sub typing results does not meet the HRSA requirement and should not be required to be reported under this policy. OPTN policy 2.6.C. already protects recipients by requiring using the parent type for discordant results. Thus, the system already protects patients from discordant ABO subtype results so requiring reporting of such does not add value and may dilute the impact of real patient safety reporting while also adding unnecessary administrative burden to the OPTN, OPTN membership, HRSA and MPSC.

Region 7 | 09/18/2023

Sentiment: 6 strongly support, 7 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose

Overall, there was strong support for reporting specific safety events, with recommendations for streamlining the reporting process and providing guidance documents to assist in reporting. Attendees suggested modernizing the reporting system to streamline the process and reduce redundancy, making it easier for centers and organizations to report safety events. An attendee recommended treating wrong HLA typing similarly to ABO errors, as incorrect HLA typing could lead to the transplantation of the wrong organ, particularly in highly immunized candidates. Another attendee noted the importance of technological solutions for situations like when living donors are later placed on a waiting list. There was an interest in enhancing the computer system, especially regarding Social Security Number registration. Attendees agreed on the definition of a near miss and discussed the information that should be gathered when a near miss is reported to prevent future incidents from recurring. Questions about missing information were mentioned, suggesting that the reporting system should prompt for necessary details. Attendees discussed ways to encourage reporting and stressed the importance of sharing information and lessons learned from near misses with the transplant community to benefit everyone. Some participants emphasized the importance of reporting any time a living donor is placed on the waitlist, not just within the first two years. This data is seen as crucial for long-term living donor outcomes. There were differing opinions on the timeline for reporting patient safety events with some participants suggested extending the required time frame from 24 hours to 72 hours or eliminating it altogether to avoid punitive measures. Additionally, the tracking of transportation events, particularly involving third-party vendors responsible for organ transportation, was considered important. Concerns were raised about whether punitive measures would be applied to member institutions when errors occurred due to third party vendors. Lastly, maintaining public confidence through enhanced transparency regarding safety events was seen as critical.

American Society of Transplant Surgeons | 09/18/2023

See attachment.

View attachment from American Society of Transplant Surgeons

Region 1 | 09/15/2023

Sentiment: 1 strongly support, 4 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

The region supported this proposal. One attendee suggested including HLA discrepancies in the proposal, as they can be very serious for highly sensitized patients. Another attendee commented that the living donor recovery hospital may not know if a living donor has been listed for any organ transplant and suggested that perhaps the system should link prior living donor status with the patient’s social security number, so in the event a prior living donor is listed, there would be an automatic notification. A member stated that the committee needs to define ABO discrepancy very specifically because issues with ABO typing happen fairly often. An attendee suggested that reporting living donors listed for another organ within five years makes sense. A couple members recommended considering other errors or events that result in non-use like late turndowns. Another member said that there should be a way to capture events outside of policy in a way that they could be reviewed by the MPSC.

Gift of Life Michigan | 09/15/2023

We appreciate the Membership and Professional Standards Committee’s (MPSC) action to ensure the safety of patients and the integrity of the transplantation system in the United States of America.

We broadly support the Committee’s proposal, except for the proposed requirements about reporting a living donor being listed for an organ transplant with two years of their donation. Our hesitation with this element is that it seems outside the definition of a patient safety event as described in the proposal. We understand and support that if a living donor should fall victim to end-stage organ failure that they should be recognized in the waitlist process; however, we do not see it as a safety event. For example, a living kidney donor could potentially develop end-stage liver disease and require a transplant, but it seems that would be addressed in the process of listing the patient, not in the Patient Safety Portal. The other events described in this proposal rise to the level of urgent, whereas reporting a living donor’s health condition at some point after their donation seems to belong in an entirely different category.

Region 6 | 09/15/2023

Sentiment: 1 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose 

Several attendees commented that there needs to be more clarification around different types of transportation issues and whether they resulted in non-utilization of organs. One concern raised was that transportation issues, despite their impact, are often beyond the control of OPOs and transplant centers. One attendee suggested involving industry partners when reporting on transportation events. One attendee recommended removing the requirement of reporting when a transportation issue results in the organ not being transplanted into the intended recipient.  Another attendee commented that the 24-hour time limit may not be long enough to evaluate an event and determine if it is reportable. One attendee commented that the reporting system needs to be more user-friendly to allow OPOs and transplant hospitals to easily communicate. One attendee recommended extending the ABO typing error to any blood typing done during potential registration/evaluation because those values can be sued during verification. Several attendees were supportive of reporting these events and collecting data to increase patient safety.

OPTN Data Advisory Committee | 09/15/2023

The OPTN Data Advisory Committee (DAC) thanks the OPTN Membership and Professional Standards Committee for their work on the proposal, and for the opportunity to comment on the proposal.

DAC members reviewed the proposal on their own and offered the following comments. A member indicated no concerns with the proposed definition of a near-miss event. The member also agreed with the proposed requirement to report when a living donor is waitlisted within 2 years of donation, regardless of the organ for which they are listed. The member agreed with the proposed analysis of transportation events that may contribute to non-utilization in order to identify process improvements. The member also indicated that aligning OPTN members’ patient safety reporting requirements with those of HRSA is a step in the right direction, and will not increase the administrative burden on OPTN member organizations. 

Another Committee member requested clarification of specifically who is required to report an incident within the 24-hour window described in the proposal. The member indicated a preference that the proposed policy be specific to a transplant program provider/employee, and not be defined broadly to include any employee of the transplant hospital. The member also pointed out that given the confidentiality requirements surrounding employee records established by many organizations, transplant program employees may not be aware of sanctions taken against fellow program employees, unless an employee is specifically prohibited from employment. The member questioned whether it is practical or appropriate to require transplant program’s to report such information within 24-hours?

OPTN Organ Procurement Organization Committee | 09/15/2023

The OPTN Organ Procurement Organization Committee thanks the OPTN Member Professional Standards Committee (MPSC) for their work and for the opportunity to comment on this proposal.

A member recommended that any transportation event resulting in the re-allocation of an organ be included in the definition. 

A member recommended that there is clarification around what type of transportation is included in the policy. A member agreed that clarifying language would be beneficial. 

A member asked if the intent of tracking transportation issues for quality improvement of if there would be punitive actions associated with it. The MPSC representative said this was from a data gathering perspective, not to take any punitive actions. The member said understanding how this happens is very important, as well as finding a solution.  

The member added that it seems unnecessary to report the incorrect subtyping of blood type if OPOs have not executed a match run or started allocation and have addressed the issue prior to doing so.

A member asked if the MPSC considered input from histocompatibility labs, as they also run crossmatches for blood. They believe the language in the proposal is sufficient but stated that histocompatibility labs may not be as familiar with OPO requirements, and some labs may consider this more of an OPO policy, thus they may not pay close attention to this policy.

A member recommended that the policy require OPTN members to report ABO discrepancies, so that it is not just limited to OPOs. This would include histocompatibility labs as well as transplant centers. 

A member agreed that any living donor who ends up requiring an organ later should be reviewed and feels that two years is a short time.

A member asked if the policy included reporting when they have the correct patient, but a left kidney is sent when a right kidney is expected, or a similar event. The proposed policy does include “incorrect organ” language and there was a recommendation to include laterality so that the language is more easily understood.

American Society of Transplantation | 09/15/2023

The American Society of Transplantation (AST) generally supports the proposal, “Require Reporting of Patient Safety Events,” and provides the following comments for consideration:

•The AST agrees with the proposed expanded patient safety event reporting requirements. Having a broader safety event reporting structure will help guide policy making in the future and improve patient outcomes.

•The AST requests that the OPTN address the ambiguity of the proposed requirement that members report “Any sanction is taken by a state medical board or other professional body against a transplant professional working for an OPTN member” absent clear definitions of “sanction” and “other professional body.” A sanction could be broadly interpreted to mean any action- investigation, hearings, suspension, probation, dismissal (or denial of reappointment), public reprimand, fines, remediation, revocation of licensure, etc. Likewise, a professional body could be assumed to include even an institution’s internal medical staffing and performance committees.

Appendix D.10 of the OPTN Bylaws, Investigation of Transplant Personnel, states, “The hospital’s investigation must use the hospital’s standard medical peer review process for conducting inquiries of potential professional misconduct and conclude with appropriate action consistent with this process.” While we recognize the importance of transparency and the need to ameliorate threats to patient safety within the transplant community, we are concerned that if the MPSC’s intention is to incorporate the broader definitions, this may deny providers a fair internal peer review process and unnecessarily put the program and or institution at risk for claims of defamation, particularly if any ongoing investigation finds the provider acted reasonably and within the standard of care. On the contrary, if the MPSC’s intent is to limit the definitions and scope to include for example, revocation of license, we would have some concerns regarding the timing of such events as medical boards often deliberate for great lengths of time and may not move forward such a recommendation for a more than a year following the event prompting review. In scenarios involving these delayed recommendations, it is entirely plausible that the provider in question departs the institution at which the initial event occurred. What then is the institution’s obligation to monitor the outcome of such investigations and subsequently report any sanctions handed down?

• There are concerns with prescriptively defining “near miss” events as proposed. Heterogeneity in center practices may lead the same occurrence to be classified as a “near miss” at one center and not another (e.g., based on the center’s workflow of when recipients are brought to the OR holding area or the timing of verifications). The proposed definitions also prompt concerns that occurrences involving appropriate leveraging of safety processes will be inappropriately classified as a near miss. The AST suggests "near miss" events that rise to the level of alerting the OPTN/HRSA would be those in which an error was caught by chance after making it through all the check points and safety measures already in place (or perhaps caught at the last routine check point), suggesting that additional precautions may be needed to reliably prevent the error.

• Currently, the OPTN is not required to report transportation issues to HRSA. Therefore, the rationale for including these events with events the OPTN is required to report to HRSA is unclear. If collection of information focused on the non-use of organs as a safety event is an OPTN priority, AST suggests excluding transportation issues from this proposal and addressing transportation issues – including clearer definitions focused on member preventable causes – with a separate proposal. In that case, reporting requirements for non-use of organs intended for transplant should be broadened to include other, more common causes, for example- surgical recovery errors.

View attachment from American Society of Transplantation

American Society for Histocompatibility and Immunogenetics | 09/14/2023

The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback regarding a new policy that will require reporting of patient safety events. This policy will not cause additional burden as these events are already reported to HRSA. The timeframe required for reporting (24 hours) may not take into consideration repeat testing in the case of laboratory test results, ASHI would support a 24–36-hour window for reporting ABO discrepancy.

View attachment from American Society for Histocompatibility and Immunogenetics

George Surratt | 09/13/2023

It is vital that the system remains as robust as possible. The "feedback loop" on quality of care and outcomes, in this case, the reporting of safety events, is critical to the overall success of transplant processes, and the continuous improvements necessary to ensure an even more robust future. Full root cause analysis should be done in all such cases and meaningful corrective/preventive actions put in place, with control plans.

Region 5 | 09/13/2023

Sentiment: 6 strongly support, 16 support, 1 neutral/abstain, 1 oppose, 1 strongly oppose

An attendee commented they were pleased by recent efforts to share information about events in the hopes of preventing similar events elsewhere. An attendee asked for specifications, specifically for reporting requirements for sanctions taken by professional bodies. There is lack of definition as to what includes a “sanction” and what an “other professional body” may entail. This is very concerning, especially in California, as this can mean many things. The attendee explained that it is unclear at which points in the current proposal when centers must report this. Often there are multiple bodies investigating issues, including medical boards, public health departments, amongst others, which can take a very long time. MPSC may want to take a step back and address those issues and bring that part of the proposal back forward. The attendee thought it would be beneficial for the community to know and understand when a report is issued and when HRSA is notified and what potential actions HRSA may take, specifically with sanctions. An attendee pointed out that transportation is a large barrier at their center since it is in a largely rural setting, and some of these difficulties that clearly impact patient care should be reported to better understand the issue.

OPTN Pediatric Transplantation Committee Meeting | 09/13/2023

The OPTN Pediatric Transplantation Committee thanks the OPTN Membership and Professional Standards Committee for their work on this proposal and for the opportunity to give feedback. Overall, the Committee is supportive of this proposal to identify and track important patient safety events, and offers a few additional suggestions for inclusion in the proposal. 

First, the Committee suggests making it extremely clear that all entities (whether that be an individual, an OPO, or transplant hospital) are encouraged to report all potential patient safety events, even when not required by policy. Second, the Committee agrees with the proposed requirement to require reporting if a living donor of any organ is added to any organ waitlist, however, the Committee asks the MPSC to also consider adding a reporting requirement if a living donor of any organ begins dialysis within two years of the living donation. While it is especially important to know if a living kidney donor begins dialysis within two years, it would also be important to track if a living donor of any other organ begins dialysis within two years, both for consistency and for ensuring patient safety. 

Third, the Committee noted that the reporting requirements for a transportation event may be too limited. This is such a high area of concern and certain events, such as organ lost in baggage or organ delayed due to flight delay, may be missed through the proposed requirements. The Committee noted the difficulty in determining a threshold of time for reporting a delay, especially because delays impact each organ differently. However, because of the importance of organs arriving when expected and the catastrophic consequences for organs delayed through transportation events, the Committee urges the MPSC to consider adding future requirements for transportation events that led to delay or to impairment of graft function, though this may be hard to define. The Committee was supportive of the other components and proposed requirements in the proposal.

Anonymous | 09/12/2023

I would propose to include additional qualifying events from an organ not arriving as expected in addition to a candidate not receiving the transplant. Some would be for a primary non-function of the organ, extended OR time/ intra-op or post- transplant complications that are believed to be related to the transportation complications.

Region 11 | 09/12/2023

Sentiment: 8 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Multiple members agreed with requiring reporting for living donors placed on the wait list for any organ within two years after donation. Members also agreed that the transportation events included in this proposal as required reports are appropriate. There was significant discussion about delays and errors in transporting organs and many agreed that there is variability in the quality of courier services. Members recommended tracking delays and other quality issues with couriers. A member stressed the importance of coordination before the organ is sent to decrease errors and that when there is a delay with transportation, kidneys should be monitored for delayed graft function. A member commented that uniformity in reporting is welcome as long as it is not punitive and another member stated that there should be a single reporting mechanism for both OPTN and HRSA and if the information comes from sharing of reporting between centers and HRSA who then informs UNOS, that is acceptable and preferable to requiring duplicative reporting.

OPTN Vascularized Composite Allograft Transplantation Committee | 09/12/2023

The OPTN Vascularized Composite Allograft Transplantation Committee thanks the OPTN Membership and Professional Standards Committee for their time and dedication to this project. The VCA Committee supports this project and agrees with the standards of reporting that it will require. In addition to the recommendations made by the proposed policy change, the Committee suggests that for delivery of the wrong organ, perhaps organ procurement organizations (OPOs) might be better suited to report these events rather than the transplant hospitals, as OPOs would then be required to re-transport and/or reallocate the organ in some such instances. Furthermore, the Committee recommends providing clarity regarding the language that requires reporting on non-safety related state medical boards or national body sanctions.

OPTN Operations and Safety Committee | 09/11/2023

The OPTN Operations and Safety Committee thanks the OPTN Membership and Professional Standards Committee for their work and for the opportunity to comment on this proposal.

Committee members provided the following feedback:

•There was support for requiring reporting of certain events, as the Operations and Safety Committee reviews patient safety data every six months. However, most of that data is voluntary. 

•There was a comment about how transportation data might be challenging due to broader distribution because the number of transportation events has increased significantly.

•There was a question about the process for reporting ABO subtyping discrepancies after the ABO verification process. Several members expressed concern about the number of discrepant subtyping results due to the increased use of subtyping. Additionally, OPOs might receive different results than the transplant hospital. 

•There was support for capturing information about late declines, however it might be challenging because there is no current definition, and that definition might be different by organ type. There are also late declines due to a variety of reasons and additional discussion would be required to determine what exactly would need to be reported. There was a suggestion to limit late decline reporting based on information that was provided earlier in the allocation process. For example, if a transplant program declines an organ for hepatitis C or biopsy results that were provided earlier, and not declining for something like organ visualization in the operating room.

•There was a comment about how late declines are like transportation issues where it is beyond the control of the members, such as weather or other circumstances. There was support for collecting data to better understand why issues occur when they shouldn’t. 

•There was a recommendation to update the patient safety portal to allow for specific reasons, if known, for delay or non-arrival of an organ. That will allow for identification of key information to figure out the real issue instead of trying to identify every delay when there is a rationale reason for it. 

•There was a question about the proposed requirement for recovery hospitals to report a living donor if they get listed for a transplant within two years. If the organ is recovered at the donor hospital, then sent to another location, it might be difficult for the donor hospital to be aware of the listing. 

•There was a question about the requirements to report sanctions taken by a professional or state board against a medical professional. For example, if the OPO, transplant hospital, and lab all become aware of a sanction against a recovery surgeon, will all the organizations need to report the sanction. There was a recommendation to clarify the requirement so it is clear to members.  

American Nephrology Nurses Association (ANNA) | 09/11/2023

ANNA supports this proposal to promote safety and consistency with reporting events.

Region 2 | 09/05/2023

Sentiment: 7 strongly support, 11 support, 1 neutral/abstain, 2 oppose, 0 strongly oppose

Members of the region are supportive of the proposal. An attendee suggested automating the reporting of prior living donors who subsequently get listed for an organ transplant. This approach would alleviate the burden of reporting from the transplant programs, shifting the responsibility to an automated system. An attendee noted no concerns with the "near miss" definition in the proposal. Reporting transportation events are valuable in providing clarification regarding instances where an organ did not arrive on time. The attendee also agreed with reporting of ABO typing errors or discrepancies. Several other attendees also noted their support of reporting transportation events that lead to delays in transplantation or organ non-use.

Region 4 | 08/30/2023

Sentiment: 10 strongly support, 11 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Region 4 supported the proposal. While there was not a lot of discussion during the meeting, attendees were able to submit comments in writing. One attendee commented that data is essential for tracking and system improvement. They added that collecting the data should not result in any punitive action but rather should inform improvement actions by members. Two attendees commented that it is critical that the MPSC report what types of events are occurring so OPOs and transplant centers can work to prevent such events in their systems. One added that this information should be reported back to the community every 3-6 months. Another attendee went on to comment that continuing to "black box" blinded, aggregated patterns and trends of patient safety events is a huge disservice to the community and sharing this information will likely be a component of reducing risk of repeated events in other agencies/geographies. Another attendee supported giving members 72 hours to report rather than 24 hours. One attendee questioned how compliance would be monitored. Another attendee commented that there needs to be more clarity about what types of events are expected to be reported so that the cause of the event can be analyzed. Another attendee recommended that living donors being registered on the waiting list within 2 years of their donation should only be required reporting if it is related to the donation and not if it is an unrelated reason (i.e. car accident, gunshot wound, etc.).  One attendee commented that this will be an additional administrative burden.

OPTN Transplant Coordinators Committee | 08/28/2023

The OPTN Transplant Coordinators Committee thanks the OPTN Membership and Professional Standards Committee for their work and for the opportunity to comment on this proposal.

A member agreed that the near-miss definitions are appropriate and very important to gather information. They said that this proposal will help alleviate discomfort with reporting events that are not necessarily required.

A member said they support the requirement of reporting for living donors placed on the waiting list for any organ two years after donation, especially considering the concept paper that was issued this public comment cycle by the OPTN Living Donor committee.

A member commented that they believe transportation events included in this proposal should be tracked so that data can be collected about these events, specifically noting trends of non-use and to help prevent future similar events from occurring.

A member said they strongly supported the proposal, specifically the transparency it provides. The member had one concern about clearly defining what a “sanction” is and what “other professional bodies” means, as both phrases can have broad interpretations. A member added that if there is a broad definition, then operational guidance should be issued as well.

Rebecca Baranoff | 08/15/2023

It makes sense to align OPTN members’ patient safety reporting requirements with the OPTN Contractor’s requirements and it may make it easier and more accurate for OPTN to provide their reports. This also follows the direction of transparency.