Comments

UC San Diego Health Center for Transplantation | 03/20/2024

SUPPORT WITH AMENDMENTS. UCSD Center for Transplantation (CASD) appreciates the effort the DTAC put forth in drafting the proposal to Standardize the Patient Safety Contact and Reduce Duplicate Reporting. While we generally support this proposal there are several operational components that we do not believe will result in improvement.

•We agree that each member should have a minimum of two current patient safety contacts listed, however, each member has very different roles, job descriptions and methods to manage such processes. For example, some may have an individual contact whereas others may utilize a notification group. Further, given the ongoing staffing crisis in healthcare which is directly resulting in an increased utilization of contact labor, it is important to allow for flexibility.

•Rather than sending a notice to the primary contact and then a subsequent notice to the secondary contact if the primary does not acknowledge it, we would recommend that both contacts be notified simultaneously. This would help to avoid notification delays that may otherwise be posed due to a person dependent process for those members that do list an individual as opposed to a group(s).

•While we recognize the importance of keeping these contacts up to date, we do not support requiring members to complete an audit and attestation every 6 months. Rather we would recommend that this be incorporated into the annual UNOS RFI to reduce unnecessary administrative burden on members. With the requirement that there be at least two patient safety contacts, the likelihood that both would become null in the same time period is highly unlikely.

• We support removing the duplicate reporting requirements and designating the transplant centers as the responsible party for reporting recipient illness to the OPTN.

• We absolutely support more policy guidance and standardization with responses and acknowledgement of results. We would also request that the UNOS Quality and Patient Safety teams revisit some of their template communications to improve clarity and consistency.

Infinite Legacy | 03/19/2024

Infinite Legacy supports the notification of the patient safety contact (PSC) for streamlined communication. A test notification of the PSC should be included to confirm the system works as expected. Because third parties may or may not be a member of the OPTN, the transplant center should identify a PSC. OPOs struggle with PSC notification, as the lists are not kept up to date including secondary backup notifications. OPOs often struggle to talk with someone to ensure communication has been acknowledged and received. Patient safety is an important topic, and both transplant centers and OPOs should be held to a high standard that includes monitored escalation plans and monitoring/testing of the plans to ensure no gaps exist.

LifeLink Foundation (FLWC, GALL, PRLL) | 03/19/2024

The OPOs of the LifeLink Foundation (LifeLink of Florida, Georgia, and Puerto Rico) support the efforts of DTAC to improve efficiencies in communication post-transplant between the OPOs and transplant programs.

We support both the effort to ensure there is a designated Patient Safety Contact (PSC) and the use of the OPTN computer system as a vehicle to communicate post cross-clamp information. These steps are necessary as we continue to increase the number of transplanted organs, which currently creates an undue burden when reporting due to our existing processes. Use of technology will continue to enhance and facilitate efficiency in the system while ensuring the safety of the transplant recipients.

Colleen O'Donnell Flores | 03/19/2024

We support standardizing the Patient Safety Contact and encourage improving communication however, we are aligned with the feedback from the ASTS regarding the mechanism for the management of the on-call function. The transplant programs work in teams and we should be allowed to assign groups (i.e. post-transplant coordinators, the quality team, etc.) ideally to one of the two Patient Safety Contacts. This is necessary to provide comprehensive and standardized coverage.

We would also like to suggest a few enhancements: 1) a standardized format for all positive donor cultures, to include the Donor ID & Match ID to enable efficient recipient care; 2) 72-hour feedback response time in UNet; 3) recommend the audit correspond with the existing UNet User Audits and security group monitoring; 4) recommend the ability to review a log of the alerts and the response from the TH to ensure we are compliant with response times 5) recommend separate or enhanced pathway be considered for serious disease-transmission events.

Thank you for your consideration.

International Society for Heart and Lung Transplantation | 03/19/2024

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Mid-America Transplant | 03/19/2024

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to the OPTN regarding the Patient Safety Model. As a high-performing organ procurement organization (OPO), MT is committed to its mission of saving lives through excellence in organ and tissue donation, and we are grateful for OPTN’s efforts to improve safety and efficiency in the organ transplant system.

MT strongly supports the additional patient safety requirements, especially those around automated system enhancements. To appropriately assign accountability, MT believes that transplant centers should bear the responsibility of reporting recipient illness, as the OPO does not have this information, and conversely, the OPO should bear the responsibility of reporting any new donor information.

OPTN Transplant Administrators Committee | 03/19/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Disease Transmission Advisory Committee’s policy proposal on ¬Standardize Patient Safety Contact and Reduce Duplicate Reporting. The Committee offers the following feedback for consideration:

•It is suggested that adding a required review of Patient Safety Contacts (PSCs) every 6 months might create an additional burden on staff. The Committee advises that the annual survey process might be a more appropriate vehicle for reviewing PSCs unless there are extenuating circumstances.

•“Require that PSCs work at the OPO or transplant program for which they are listed” The Committee recommends this language be more clearly defined as organizational and corporate structures vary and could be interpreted as restrictive of contracted work. It was suggested to rewrite or specifically spell out what constitutes 3rd party work versus contracted work.

Overall, the Committee supports the proposal and requests that the above comments be taken into consideration.

Region 10 | 03/19/2024

12 strongly support, 9 support, 0 neutral/abstain, 2 oppose, 0 strongly oppose

Member of the region were supportive of the proposal. One attendee noted that the requirement to verify the listed Patient Safety Contact every six months may be too infrequent. A few attendees expressed concerns with the requirement that Patient Safety Contacts must be employed by the institution and can no longer be third party contractors. One attendee added that it is critical to acknowledge that many transplant programs have established contracted relationships with third party contractors and these contractual relationships are tried-and-tested with seamless communication. Another attendee added that it is up to the centers to work with their third-party contractors to ensure they have access to the appropriate transplant center staff to pass along the information. If this is a problem with some safety notifications, those transplant centers should be held accountable. Do not penalize all centers using contracted services for the poor planning on the part of some centers. Lastly, an attendee noted that this will help the reporting process/timeline/data tracking tremendously from the OPO perspective. Trying to track down Patient Safety Contacts that don't answer, don't know what to do with the information, or directing that information to someone else increases unnecessary workload for the OPO and potentially puts the transplant patient at risk for delayed response/treatment due to this run around. Having it built directly into the system would prevent the burden OPOs currently experience by having to make multiple attempts to find the correct person to receive it and confirm the information that has been received. Instead, the OPO should be able to input the information into the OPTN computer system and the system should send automatic notifications to those programs that accepted the donor organs and require acknowledgement of that notification. The OPOs have performed the tests, received the results, and are ready to report them but are being held responsible when the transplant center is not prepared, which is not fair.

American Nephrology Nurses Association | 03/19/2024

ANNA strongly supports all three of the proposed changes to standardize the patient safety contact and reduce duplicate reporting.

Region 9 | 03/19/2024

2 strongly support, 8 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, the region supports this proposal. Several members commented that they would like to see better technology to support communication between centers. One attendee suggested a mobile option, another requested a portal for reporting instead of relying on an email response. A member stated how they would like to see the patient safety contact work like how contact management works, where you can set a preference on being contacted via phone or email. The member suggested adding an auditing or tracking mechanism, so centers can see what was reported and when. They also preferred a 72 hour response requirement rather than 24 hours so prioritize patient care and not disturb people over the weekends over an administrative issue. Another attendee commented that patients would find information about disease transmissions very valuable when evaluating transplant centers. 

OPTN Membership & Professional Standards Committee | 03/19/2024

The Membership and Professional Standards Committee (MPSC) appreciates the work done by the Ad Hoc Disease Transmission Advisory Committee to develop this proposal and the opportunity to provide feedback. A member advocated for mobile functionality of the system enhancement to support compliance with the 24-hour acknowledgment requirement. Another member voiced support for the requirement for the patient safety contact (PSC) to be employed by the member organization, emphasizing that the OPTN does not have oversight of contracted non-member organizations. A member voiced support for the proposal to improve the disease reporting and communication process. Another member noted that OPOs maintain extensive documentation and reporting for disease communication and felt this proposal would maintain the OPTN standards for patient safety.

OPTN Transplant Coordinators Committee | 03/19/2024

The OPTN Transplant Coordinators Committee appreciates the opportunity to comment on the Standardize Patient Safety Contact and Reduce Duplicate Reporting policy proposal. The Committee offers the following as feedback for consideration.

The Committee supports the additional requirements proposed to enhance the notification process and reduce duplication. Multiple members endorse implementing an annual email reminder to transplant centers to verify that their listed contacts remain current. Members also largely align with the proposal to send notices to primary and secondary contacts simultaneously, as this approach would increase visibility and ensure timely communication.

The Committee recommends annual cycle verification schedule would be more appropriate rather than the proposed 6-month schedule, barring extenuating circumstances. The Committee advises that an annual verification process may align better with typical operational cycles and reduce administrative burden.

Additionally, the Committee suggests removing the inclusion of 3rd party contacts as some felt it added complexity without providing significant value.

OPTN Living Donor Committee | 03/19/2024

The OPTN Living Donor Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their efforts on the Standardize the Patient Safety Contact and Reduce Duplicate Reporting proposal.

The Committee supports this proposal and notes that the proposed solutions are reasonable for timely communication on important issues.

The Committee suggests that there should be an ability to enter more than two patient safety contacts as it may be beneficial for larger transplant programs. The Committee encourages easy modification of patient safety contacts to support updated and accurate information.

The Committee suggests that the OPTN Ad Hoc Disease Transmission Advisory Committee may consider revisiting required serology testing as a future project given endemic shifts and increase in paired donation.

Region 6 | 03/19/2024

3 strongly support, 10 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 6 supported this proposal. One attendee commented that they support any process that streamlines communication if guidelines and expectations are clear. Another attendee commented that this would lead to improved safety for patients and standardize center requirements. One attendee commented that many programs are using 3rd party vendors and requiring the contact to be at the transplant program may cause burden on the programs. They added that eliminating OPO duplicate reporting is a good idea.

Anonymous | 03/18/2024

This writer supports any efforts to improve PSC reporting, however the policy improvements to not address our issues. Our OPO's biggest problem is transplant centers reaching out to us when we are not the correct PSC. UNOS's system does not separate OPOs and transplant centers and we frequently receive incorrect notifications that are actually meant for the transplant center. This occurs a few times a month for our organization. We have to tell the OPO that we are also an OPO and they need to reach out to the transplant center in the PSC to report to team taking care of the recipient. We highly recommend improving the system so that OPOs and Transplant Centers can be identified easier, as this is causing significant delays in appropriate reporting and is a problem with the UNOS system.

The only concern I have is with entering an additional person in the UNOS system. We currently developed a process so that our operator will call us with any PSC related issues and we have an e-mail address that mass e-mails for this purpose. Managing another call schedule in UNOS will add additional unnecessary administrative burden for our team when this process is working for us (except for the reasons listed above).

NATCO | 03/18/2024

NATCO supports the standardization of the Patient Safety Contact (PSC) in UNet and believes that the communication of positive cultures/updated tests coming through the UNet system will greatly improve delivery and acknowledgement of these important notifications. However, with many transplant centers now using outside call teams for their after-hours calls, we do not believe restricting this position to a direct employee of the transplant center is wise. Instead, recommendations regarding the monitored email and direct telephone number of the primary PSC should suffice.

Furthermore, we recommend that consideration is given to the addition of a field for a PSC for serious Potential Disease Transmission Events. Often the day to day handling of positive donor cultures is very different than a notification on a disease-transmission.
Although patient safety is of utmost importance, it is extremely burdensome to have someone from the transplant center to be available 24/7 for the amount of positive donor cultures and updated post-clamp lab results that are reported at any time of day or night.

Region 7 | 03/18/2024

8 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Members of the region are supportive of the proposal. One attendee noted strong support of standardizing the patient safety contact as it will improve communication on potential disease transmissions.

Region 1 | 03/18/2024

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

A member expressed support for the ability to have a group email serve as the secondary contact, as their center uses a group email for these types of incidents. An attendee expressed some concern with the requirement to confirm receipt in 24 hours, as 80% or more of these reports do not result in any change in clinical practice. They suggested a 72 hour requirement instead. A member stated that centers should be able to change the primary and secondary contact for this the same way it is done for primary and secondary contact for organ offers. Two attendees suggested there must be a more streamlined way to approach this workflow than what the committee is proposing. A member asked for more consideration of the reporting of donor cultures, as there are multiple notifications for the same donor with preliminary results and final culture reports.

Region 5 | 03/15/2024

13 strongly support, 18 support, 1 neutral/abstain, 2 oppose, 0 strongly oppose 

Region 5 supports this proposal. Specifically, an attendee supported the requirement for designating a specific transplant professional at a center, as the point person. And suggested that it could be optional for transplant programs to complete electronic recording of cultures and associated work. A member suggested that communication could be via computer systems, using the enhancement to communicate any potential donor derived transmission. Another pointed out that centers may not have the capacity nor resources to hire or assign additional staff to support, and the committee needs to mindful to not require additional onerous regulatory rules. There was support for the implementation to be as simple as possible. A member commented that this initiative will go a long way to potentially increase the efficiency in information transfer. A member institution agreed with reducing duplicate work but disagreed on having only one listed patient safety contact. They explained that this responsibility is typically given to a staff member who works Monday through Friday, and most of the critical information regarding a donor result is sent to the person on-call. They believe that a full-time patient safety contact will be a staff burden for the transplant program. 

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) strongly supports the proposal, “Standardize the Patient Safety Contact and Reduce Duplicate Reporting.”

Association of Organ Procurement Organizations | 03/14/2024

AOPO agrees with the goal of this proposed policy change to improve effective and efficient communication between transplant programs and OPOs. The proposed modifications by the Ad Hoc Disease Transmission Advisory Committee will achieve this goal by providing a more consistent and improved level of information shared when there is a potential patient safety event.

In addition, AOPO supports eliminating the potential for OPOs to report transplant recipient illness to the OPTN Patient Safety Reporting Portal. This change will reduce and eliminate duplicate reporting of potential donor-derived transmission events.

In closing, AOPO strongly supports any policy change that improves communication between OPOs and transplant programs. We do not find the proposed changes for any entities involved in this proposed change to be overly burdensome to implement and should achieve the goal of this proposed policy change. 

Anonymous | 03/14/2024

Strongly Support

American Society of Transplant Surgeons | 03/12/2024

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Region 3 | 03/11/2024

8 strongly support, 8 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 supported the proposal. During the discussion, one attendee voiced support from the OPO perspective and commented that the proposal addresses a current challenge. Another attendee supported allowing group emails so that multiple staff can be aware of any reporting requirements.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/09/2024

This proposal is not pertinent to ASHI or its members.

OPTN Vascularized Composite Allograft Transplantation Committee | 03/08/2024

The OPTN Vascularized Composite Allograft Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for the opportunity to provide feedback on this proposal. The Committee supports this proposal, specifically the additional requirements for the patient safety contact. The Committee appreciates the amount of time that will be saved with this standardization, as a member noted that their organ procurement organization (OPO) spends a lot of time with post-procurement reporting of cultures and the patient safety contact often says they do not deal with this. The Committee is extremely supportive of this proposal. 

Region 8 | 03/05/2024

3 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 8 supported this proposal and offered suggestions. A member asked for clarity for what electronic notification means and did not support requiring UNET sign in (since reports may occur during non-business hours). An institution supported the proposal and requested the policy to clarify that only one of the PSC needs to be an employee of the transplant hospital/OPO, not that both need to be an employee. Several attendees support the requirement to list a secondary PSC and to review every 6 months for accuracy. Another attendee suggested an annual review. An attendee commented that OPOs should not be accountable when a transplant center does not acknowledge receipt within 24 hours. Another explained that attempting to verify safety contact information without requiring an immediate action or response is an unacceptable policy. The attendee suggested a more appropriate approach might be to employ a mass email/notification and add a requirement that all emergency contacts respond to the notification.  

UC Davis Transplant Center | 03/05/2024

We support standardizing the Patient Safety Contact but strongly oppose mandating that the individual(s) need to be a direct employee of the transplant center. We are one of many centers that have had to employ an on-call team from the sheer volume of offers and after-hour calls (such as critical labs, patients, and positive donor cultures). We do not understand why OPTN would mandate this, rather than just improving the notification system itself, which is also being done with the electronic notifications. Our call team is a dedicated team of RNs who have UC Davis email addresses and are trained to take and further notify our team of these calls.

In addition we would like to suggest that there is a mechanism for the reporting of positive donor cultures and post-donation lab updates that is separated from serious disease-transmission events. While we feel that our on-call staff do a great job with positive donor cultures and result updates, we do have a dedicated Patient Safety Contact at the transplant center that is responsible for disease transmission events (both incoming and outgoing). Currently, there is no mechanism to indicate this in the PSC fields.

Region 2 | 02/29/2024

10 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Members of the region were supportive of the proposal, with several OPO attendees noting their strong support as the current patient safety contact process can be time consuming and inefficient. One attendee stated that this is a needed update as there are significant deficits in the current reporting system. It was also noted that by improving the reporting efficiency it may lead to decreased costs. Another attendee added that while this will streamline communications, with any new system there needs to be a review of the process to make sure it is meeting the project’s goals. They would encourage the OPTN to continue to monitor this process in order to improve efficiency. Another attendee added that there is a need for an assessment of the communication portal to ensure that all is streamlined and efficient. It was also noted that there needs to be more information about the notification process, the timing to acknowledge a patient safety event, and the escalation process if a notification is not acknowledged. Another attendee suggested that technology programming should allow for alternate coverage to account for staffing changes or when a patient safety contact is out on leave. In addition to the yearly attestation from patient safety contacts, there should be quarterly notifications to the patient safety contacts to ensure accurate and timely reporting. In regard to using third parties as patient safety contacts, there was mixed feedback from the region. One attendee noted support for using third party contractors, while another attendee stated that patient safety contacts should be employed at the institution and not a third-party vendor. There was also a suggestion to allow for the OPTN to be simultaneously notified when OPOs reach out to transplant programs.

Region 11 | 02/29/2024

10 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

The region supports this proposal. Two members expressed specific support for the proposal and that the patient safety contact should work for a third party vendor. One attendee suggested that if changes are made to patient safety contacts during the six months between audits, there should be a required timeframe for updating that information. One member stated opposition to the proposal because it is unclear whether the OPTN has the authority to determine how a transplant center staffs its operations.  

UAMS | 02/27/2024

Based on an evaluation of the proposal to Standardize the Patient Safety Contact and Reduce Duplicate Reporting, we are in support of a partial change. We believe the additional requirements for the Patient Safety Contact (requirement to work at institution listed and have a valid phone number and email address listed) are reasonable requirements. These additional requirements will ensure time sensitive information that can have a direct impact on patient outcomes is received and acknowledged by the correct contact and proper treatment can occur for the recipient. The problem highlighted with only one listed patient safety contact is this responsibility is typically given to a M-F employee and there are occasions where response is not obtained within 24 hours. With our current system, most of the critical information regarding a donor result is sent to the person on-call. By providing this information to the staff on call, the chain of communication is shortened, and treatment is likely to be initiated sooner than if it is communicated to someone who may not be able to respond immediately. If a second safety contact is designated, the only concern would be that this information might no longer be relayed to the on-call staff. We agree that a review every 6 months should be required to ensure the proper staff is listed and updated contact information is available to UNOS. If this information is being reported to OPTN multiple times with the current practices in place, we do agree that steps should be taken to eliminate this and possibly allow the saved time from duplicate reporting to be allocated to another care improvement effort.

Region 4 | 02/26/2024

1 strongly support, 9 support, 1 neutral/abstain, 2 oppose, 1 strongly oppose

During the discussion several attendees supported revising the language to recommend Patient Safety Contacts be employed by the transplant center but not make it a requirement. They added that having third party vendors as Patient Safety Contacts is essential to avoid overburdening individuals and programs. One attendee added that leaving the requirement in the policy is too prescriptive particularly since the transplant center is ultimately responsible for performance of vendors they hire to serve in this role. One attendee commented that if third party vendors are allowed to serve as Patient Safety Contacts, the OPTN should have standards for the vendors as well as a statement of responsibility. Several attendees supported the requirement that Patient Safety Contacts be employed by the centers, adding that it is crucial to avoid delays. They went on to comment that members need to be accountable for safety and communication. One attendee recommended including language requiring the use of the Patient Safety Contact information provided in UNet. They added that sometimes the transplant center or OPO use the institution’s main number which causes delays in reaching the appropriate Patient Safety Contact. One member recommended allowing a “generic” email or phone number that is monitored 24/7 by a qualified team to avoid gaps in the system updates between the member and the OPTN. Several members supported the proposal and are happy to see the removal of duplicate reporting. 

Anonymous | 02/21/2024

Strongly Support

OPTN Organ Procurement Organization Committee | 02/20/2024

The OPTN Organ Procurement Organization (OPO) Committee thanks the Ad Hoc Disease Transmission Advisory for their work on this proposal and the opportunity to provide feedback. The Committee was strongly supportive of this proposal, particularly the proposal to require that the listed Patient Safety Contact must work at the OPO or transplant program for which they are listed. The Committee noted that third-party patient safety contacts may not always know what to do with potential disease transmission information, and thus create additional inefficiency in ensuring patient safety. There was also support for eliminating the requirement for OPOs to report recipient illness to the OPTN, particularly as this is both duplicative in consideration of transplant program requirements, and as the OPO is not responsible for the recipient’s care and follow-up.

Anonymous | 02/08/2024

Strongly agree with the key points mentioned and proposed changes. The amount of time spent entering information that had previously been submitted and waiting for responses from other centers can span over into the following day. Definitely agree with needing valid phone numbers (not pagers) and email addresses that are regularly monitored by an individual who understands the purpose of Patient Safety Contact and reporting. "Be available 24 hours a day" more often is met with voice messages of M-F office hours and no weekends/out of office for extended time with no delegate.
Having a secondary contact listed should alleviate this search/waiting task; however, suggest including if neither contact can be reached within the 24hrs, than notification goes directly to OPTN. This would be a built-in audit for OPTN of which centers need to update information/process implementation.
Thank you to the Committee for taking the time to acknowledge and propose changes to address common concerns and inefficiency.

Déboralis Ramos | 01/31/2024

Strongly Support

Anonymous | 01/24/2024

The core patient's safety is the set priority in the medical industry. Without the measure of safety, the patients are exposed to infections, collateral contamination or death.