Comments

Region 5 | 09/25/2024

Sentiment: 1 strongly support, 21 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 supported this project. An attendee suggested the committee collaborate with the MPSC to verify they support the proposed personnel changes.

UC San Diego Health Center for Transplantation | 09/24/2024

The UC San Diego Health Center for Transplantation appreciates the time and effort put forth by the OPTN Histocompatibility Committee in their mindful attention to the Histocompatibility Bylaws to ensure they align with the Clinical Laboratory Improvements Act (CLIA) regulations. CLIA represents well-established standards for laboratory operations and aligning stands to simplify the regulatory landscape, reducing the burden on laboratories that currently must navigate multiple sets of rules. It strikes us as most appropriate for the OPTN delegate and defer the responsibilities of ensuring regulatory compliance and quality laboratory practices to the accrediting organizations who hold CMS deemed status for the histocompatibility specialty.

Lenore Hicks | 09/24/2024

I agree with the update from CLIA. The training for laboratory directors should be more stringent than that of CLIA. Since you are proposing, that laboratories may have two directors. ASHI has a requirement that directors have two years of training and also 50 cases. Need more clarification on subcontractors and their reasonability for having a system to report critical HLA discrepancies. As a matter of safety, all subcontractor's work should be reviewed to ensure that it aligns with the patient. I believe that new personnel should have the knowledge that is required for the responsibilities they will assume. This could be met by certification or length and responsibilities in the laboratory. Having a data entry person as the (POC) for the OPTN should be a person who knows what is immunologically significant since they will be the one reporting to the OPTN with critical HLA discrepancies. The laboratory where the error is found should be the lab to initiate the reporting to the OPTN. Labs are under pressure to perform and do it in the least amount of time. Safety must always be first.

Gift of Life Michigan | 09/24/2024

We appreciate the Committee’s work and recommendations and support them fully. We believe the proposed bylaws changes would bring the bylaws to a more current position, and that they reflect careful consideration of interface with other requirements from a regulatory and experiential perspective.

We defer to the Committee’s technical expertise to define critical discrepancies, but strongly believe they should be reported within 24 hours. We recognize that validation and investigation will take longer; however, the possible benefit to patient safety outweighs the administrative technicality of who reports it when and the length of time to resolve the issue.

OPTN Kidney Transplantation Committee | 09/24/2024

The Kidney Committee thanks the OPTN Histocompatibility Committee for their work on this proposal, and expressed support for this proposal. The Kidney Committee had no additional comments. 

Region 3 | 09/24/2024

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

American Nephrology Nurses Association | 09/24/2024

ANNA agrees. Changes to the OPTN bylaws should align with the Clinical Laboratory Improvement Amendments (CLIA) update.

Region 11 | 09/23/2024

Sentiment: 3 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Lenore Hicks | 09/23/2024

I agree with the training requirements for Lab Directors. I am not clear about the roles and responsibilities of the two directors. Will one be responsible for the day-to-day function while the other handles regulatory issues? Will each one serve six months at that laboratory and then the other director serves six months? Will one change the way the laboratory functions? I think there should be some notification about TAT. The delay might increase the cold ischemic time. attachment

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/20/2024

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on each of the proposed changes included in this proposal.

ASHI supports the proposal to allow multiple OPTN-approved laboratory directors within a histocompatibility lab. This would align with current practice and at time of HLA Director departure, facilitate more seamless transitions without interruption to patient care.

OPTN approval of new HLA Laboratory Directors to assure proper accreditation and clinical practice experience is essential for patient safety, given CMS’s definition of Histocompatibility testing as High Complexity and High Risk. It is noteworthy to add that CMS approved accreditation programs such as ASHI have a well-established structure and process with stringent requirements for training and certifying new histocompatibility laboratory directors, which already includes a submission of 50 clinical cases per category, detailed case write-ups, and an oral interview. Moreover, this accreditation process is overseen by the American College of Histocompatibility and Immunogenetics (ACHI) Board and is audited by CMS.

ASHI strongly recommends that OPTN retain the requirement for new HLA Laboratory Directors to undergo a portfolio review, but recommends collaborating and deferring the portfolio approval process to the accreditation organizations. This will ensure the validity, transparency, and oversight of the process and minimize delays in HLA Laboratory Director transitions to a new laboratory and potential interruption of patient care.

ASHI agrees with the need to update and align HLA Laboratory Director education requirements with CLIA regulations; however, ASHI strongly recommends retaining the minimum 2-year training requirement within a Histocompatibility Laboratory. CLIA does not mandate Histocompatibility training for some HLA Director qualification tracks. Given CMS’s definition of Histocompatibility testing as High Complexity and High Risk it is imperative that all OPTN approved HLA Directors have sufficient training in assay interpretation, assay limitations, and the quality assessments required within a clinical HLA laboratory.

ASHI agrees with a proposal to reorganize and update the required elements in the written agreements between the laboratories and the transplant programs and OPOs they served. ASHI supports the proposed removal of the much out-of-date requirement for the extended HLA typing process. These modifications will provide additional clarity and will facilitate testing support from the histocompatibility laboratories. while maintaining compliance with CLIA regulations

ASHI requests further clarification on whether a formal service agreement is required for histocompatibility laboratories that are OPO-based (operated and/or owned and within the same entity). To minimize unnecessary administrative burdens for these entities, ASHI would NOT recommend such formal written agreements, provided that the required elements are addressed in the laboratories’ existing policies, testing protocols and standard operating procedures, and are made available upon request during laboratory inspection.

ASHI generally agrees with the proposal to add a requirement for a primary data coordinator role to serve as the point of contact with OPTN. Nevertheless, the primary duties and responsibilities as well as the qualification requirements for this role are unclear and must be better defined and delineated. As it stands, “…as the point of contact for questions and communications from the OPTN on data submission…” is vague as laboratories need to estimate the effort and time commitment required for this role. It is also unclear whether the name and contact information of the primary data coordinator will be listed in a public domain and who will have access to the contact information.

ASHI generally agrees with the proposal for the expansion of inactivation and withdrawal notification requirements. However, in alignment with other requirements outlined by the OPTN, ASHI membership proposes voluntary inactivation if/when laboratories are unable to provide testing for 30 days or more. While there currently are no notification requirements to the OPTN or its’ members upon inactivation or withdrawal, the inability to provide testing for 15 days may be too short of a timeframe for many laboratories.

Overall, ASHI strongly recommends and encourages the OPTN to enhance collaboration with, as well as to delegate and defer the responsibilities of ensuring regulatory compliance and quality laboratory practices to the accrediting organizations who hold CMS deemed status for the histocompatibility specialty. This recommendation also includes the evaluation and approval of personnel qualifications.

Region 10 | 09/20/2024

Sentiment: 4 strongly support, 14 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Association of Organ Procurement Organizations | 09/20/2024

Multiple OPTN-Approved Laboratory Directors

AOPO supports the OPTN Histocompatibility Committee’s (“Committee’s”) proposal to update and align the histocompatibility bylaws with the most recent version of the Clinical Laboratory Improvements Act (CLIA). Importantly, the Committee has identified the need to permit multiple OPTN-approved laboratory directors at a single histocompatibility lab, with one primary laboratory director responsible for OPTN operations.

This important change eliminates duplicative administrative work by permitting any individual who fulfills the requirements of a laboratory director to submit an extensive and specific portfolio to the OPTN one time to become approved as an OPTN laboratory director, regardless of whether another individual is already serving as a primary director at the same laboratory. If this approved director then transitions to another laboratory, they will not need to spend countless hours assembling another portfolio for OPTN review; only a key personnel application will be required.

Additionally, this change will allow members of the OPTN Membership and Professional Standards Committee (MPSC) to focus time and resources on more pressing issues than reviewing documentation submitted by professionals who have already been reviewed and accredited by subject matter experts in their fields hailing from accrediting and regulatory bodies such as the American Society for Histocompatibility and Immunogenetics and the College of American Pathologists.

Delays in Turn Around Time

AOPO notes the Committee’s proposal to clarify and expand requirements for laboratory agreements with transplant hospitals and organ procurement organizations (OPOs) to include “the expected turnaround time from receipt of sample to reporting results to the transplant program and process of notification if turnaround time is going to be exceeded.” AOPO supports the requirement of an OPO to include a notification process if turnaround time is going to be exceeded; however, the Committee’s proposal lacks specificity related to the timing and form of such notification. For example, does the Committee expect laboratories to engage in real-time or proactive notification to transplant hospitals of delays? Has the Committee considered that real-time and proactive notifications will increase administrative work and may further delay testing?

Additionally, if the Committee expects real-time notifications, what duration of delay prompts this required notification? Fifteen minutes? Two hours? If changed, notification expectations must be clearly defined. Further, the Committee should consider the distractions and inefficiencies that will occur if laboratory staff are required to stop testing to make real-time notifications to transplant physicians, which may have the impact of waking a sleeping surgeon to inform them of a delay that may not impact the timing of transplantation. Alternatively, the Committee might consider requiring laboratories to record testing delays in a report to be sent to transplant hospitals at regularly defined intervals in order to minimize additional testing delays and unnecessary administrative work. Ideally, the Committee should leave the specificity of testing delays and related notifications to the laboratory and the transplant center to negotiate what works best for them as the parties to the commercial contract.

Verification of Results and Changes

The Committee also proposes a required process for “reporting of HLA results to the OPTN and verification of results, including verification if changes occur,” however, the proposal is silent regarding the process laboratories should use to report physical and virtual crossmatch results. Additionally, the Committee fails to explain how laboratories should document or “prove” results have been verified, and further, the proposal lacks any guidance explaining how laboratories can document that results have been verified when there is no change following verification. AOPO cannot support this proposal as written because it is unclear and lacks a framework for compliance.

Notification of Lab Inactivation or Withdrawal

Another proposal by the Committee would require laboratories to notify the OPTN and OPTN members if laboratories become voluntarily or involuntarily inactive or withdraw from OPTN membership. There is currently no notification requirement to the OPTN or OPTN members that a laboratory serves upon inactivation or withdrawal. AOPO has no objection to the inclusion of this new notice requirement and its related deadlines, as these will assist transplant hospitals and OPOs with future planning and contracting and reduce the likelihood of testing interruptions thereby stabilizing the donation and transplantation system as a whole.

Histocompatibility Bylaws Should Align with CLIA Standards

Finally, the Committee seeks comment regarding whether it should change requirements related to the training, education, and qualifications of lab directors as well as the minimum number of cases they must review each year. AOPO strongly supports and stands behind CLIA and the subject matter experts who promulgate these regulations. Therefore, AOPO supports complete alignment of the histocompatibility bylaws with CLIA standards pertaining to the training, education, qualifications, and reviewing required by laboratory directors and general supervisors. AOPO discourages the Committee from enacting more stringent standards than set forth by the federally designated accrediting organization that regularly ensures the competency of lab directors and encourages the Committee to focus its resources on aspects of the system that remain unregulated.

Region 7 | 09/17/2024

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

Overall, the region is supportive of this proposal. One attendee commented that the OPTN having a separate approval process for HLA lab directors is redundant, and recommended collaboration with accreditation organizations for this process.

Membership and Professional Standards Committee | 09/16/2024

The Membership and Professional Standards Committee (MPSC) appreciates the work of the Histocompatibility Committee in developing this proposal and presenting it to the Committee. A member sought clarification on the certification requirements for technical supervisors, which are now only housed in the CLIA regulations. A member noted the value of allowing multiple laboratory directors to be OPTN-approved to meet bylaw requirements for currency without having to compile a portfolio potentially decades later. The MPSC is supportive of the Histocompatibility Committee’s proposal and believes this work would be strengthened by the continued review of membership requirements in the OPTN Bylaws.

American Society of Transplantation | 09/12/2024

The American Society of Transplantation (AST) generally supports the proposal, “Update Histocompatibility Bylaws.” Aligning OPTN Bylaws with Clinical Laboratory Improvements Act (CLIA) regulations – a well-established framework that sets high standards for laboratory operations – stands to simplify the regulatory landscape, reducing the burden on laboratories that must navigate multiple sets of rules.

Proposing a minimum number of cases a laboratory director must review per year and, separately, expanding the required General Supervisor qualifications could be a valuable addition. The AST recommends that the OPTN only pursue this if there are data that support the need for these additional qualifications and the specific proposed requirements, factoring the administrative burden that these additional requirements will create.

Finally, regarding the proposed removal of the requirement that written agreements between histocompatibility laboratories and transplant programs must include the duration for which specimens need to be stored for repeat or future testing. Has the Committee considered whether a requirement to store candidate or recipient specimens would be useful for root cause analysis of crossmatching events? For example, the wrong patient specimen was used, a physical crossmatch was negative, and the recipient experienced hyperacute rejection.

Region 9 | 09/10/2024

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

Overall, the region supports the proposal to allow labs to have more than one OPTN approved Lab Director.  This would allow for smoother transitions when there is a change in lab director and it would also allow easier transfer from one program to another or allow for coverage of multiple labs by a single director without duplicating certification paperwork and processes that have already been completed.  In addition, there are some time sensitive elements to the certification that we could avoid having issues with if we would “certify” someone at a point in time with all of the key information documented and approved by OPTN. An attendee commented that the OPTN should consider this idea in other areas, such as with primary physicians or surgeons, as it would make personnel changes much easier.

Region 6 | 09/03/2024

Sentiment: 3 strongly support, 8 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 1 | 08/29/2024

Sentiment: 2 strongly support, 5 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, the region supports the proposal. Two attendees commented that aligning requirements with CLIA makes sense. 

Region 8 | 08/27/2024

Sentiment: 5 strongly support, 13 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

The region supported this proposal and provided the following responses to community questions. They supported allowing multiple OPTN-approved laboratory directors at a histocompatibility lab, with one primary laboratory director responsible for OPTN operations. (But noted that the OPTN should save its volunteer resources for other key issues instead of reviewing laboratory director case portfolio submissions.) The OPTN has recognized laboratory accreditation organizations which are already used for laboratory site surveys/inspections and are key regulatory partners ensuring OPTN compliance for laboratories under their jurisdiction. These organizations have thorough processes for approving laboratory directors including a case portfolio review. The attendee commented that we should utilize these partners for director approval rather than duplication of the work for OPTN volunteers.

· For the question on whether OPTN laboratory director education and training requirements should be more stringent than CLIA, or align with CLIA regulations as proposed, an attendee said “no” and that all OPTN laboratory personnel requirements should align with CLIA regulations and not be more stringent.

· On whether the components required within the transplant program and OPO laboratory agreements sufficient and clear, an attendee explained: the process and timing for laboratory testing turn-around-time should be left to the parties involved. Currently, the proposal language implies that notification of extended testing time should occur prospectively on every test that goes over. Resources at the laboratory, transplant programs, and OPOs would better be utilized if the agreeing parties set the terms for communication of TAT (for example, a monthly or quarterly report of TAT).

· For the potential future proposal of General Supervisor qualifications, an attendee reiterated that the OPTN shouldn’t require anything more than CLIA requires.

· Regarding whether the Committee should consider proposing a minimum number of cases a laboratory director must review per year as a future proposal, an attendee commented that only if the MPSC has found repeated instances where lack of sufficient case experience has led to HLA laboratory performance issues. 

Region 4 | 08/19/2024

Sentiment: 2 strongly support, 6 support, 5 neutral/abstain, 4 oppose, 2 strongly oppose 

During the discussion, concerns were raised about the potential adoption of CLIA requirements by the OPTN. One attendee warned that this could lead to pathologists without experience or HLA training signing off on HLA reports, a situation currently prevented by OPTN policy, which they argued is vital for patient care. They also expressed concern about the possibility of allowing multiple lab directors and recommended that OPTN policy explicitly define the role of "Lab Director." Another attendee agreed, noting that the term "Histo Lab Director" is not consistently defined, as in some labs, this role overlaps with the CLIA lab director, while in others, it does not. They highlighted the challenges posed when the CLIA lab director specializes in another field, especially regarding clinical consultant roles. The attendee suggested that the requirements for lab directors should align more closely with technical supervisor standards and emphasized that the policy needs substantial revisions before it can be approved. One attendee opposed CLIA oversight as CLIA does not provide HLA training or expertise in the field of HLA.

Region 2 | 08/16/2024

Sentiment: 5 strongly support, 12 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose 

Overall, the region was supportive of the proposed changes to the Histocompatibility Bylaws.  One attendee noted that by correctly setting the bylaws will standardize the overall procurement and transplantation process.  Another attendee added that histocompatibility bylaws are difficult to understand for those outside of the histocompatibility field, despite how clear they bylaws are written.  Of the opposition noted, one attendee suggested that the American Society for Histocompatibility and Immunogenetics (ASHI) or the College of American Pathologists (CAP) should undertake these changes, not the OPTN.  

Anonymous | 08/14/2024

Neutral/Abstain