Comments

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.