Histocompatibility laboratories (“laboratories”) are a vital component to proper organ allocation, acceptance, transplantation, and post-transplant care. Laboratories perform high complexity testing that assists transplant programs and OPOs in the allocation process and carries important implications for patient safety, post-transplant care, and survival. Accordingly, the OPTN has an interest in ensuring that laboratories have adequate facilities, equipment, and resources to perform high quality histocompatibility testing.

Many of the OPTN Bylaws governing laboratories are ambiguous, fail to reflect advances in technology and current clinical practice, or are more appropriately monitored by the histocompatibility accrediting agencies (ASHI and CAP). As a result, the OPTN/UNOS Histocompatibility Committee conducted a comprehensive review of the OPTN Bylaws governing histocompatibility laboratories. The Committee determined that rewriting the Bylaws was a large project and decided to split the rewrite into two phases. In November 2013, the Committee completed and the Board of Directors approved the first phase of changes in the Bylaws. This phase included changes that required all laboratories to comply with the requirements in the documents issued by ASHI and CAP (as of a date certain), expanded the definition of changes in key personnel, and required laboratories to submit a coverage plan to the OPTN. Those changes became effective February 1, 2014. The Committee is now proposing the following additional changes:

• Adding the general supervisor to the list of laboratory key personnel.
• Creating two pathways for approval of OPTN histocompatibility laboratory directors-- M.D./D.O. or earned doctoral degree. Each pathway specifies particular education, experience, and certification requirements. The Committee also proposes the addition of a foreign equivalent qualifier for both pathways (current Bylaws are silent on foreign equivalent education and experience for laboratory directors).
• Simplifying requirements for the technical supervisor, general supervisor, and clinical consultant by only requiring that these individuals meet the requirements in the federal Clinical Laboratory Improvement Amendments (CLIA).
• Eliminating references to the histocompatibility technologist, since no requirements for this position are stated in the Bylaws.Adding criteria for performance review of a histocompatibility laboratory, including HLA typing errors that result in an incompatible transplant or the reallocation of an organ.
• Removing sections that are out of date or more appropriately monitored by the histocompatibility accrediting agencies.

Read the full proposal