Update Histocompatibility Bylaws

At a glance

Current policy

In December 2024, updates to the Clinical Laboratory Improvements Act (CLIA) will be implemented. The OPTN Histocompatibility Committee is proposing changes to the OPTN bylaws to align with the CLIA updates.

Supporting media

Presentation

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Proposed changes

Allow multiple OPTN-approved laboratory directors at a histocompatibility lab, with one primary laboratory director responsible for OPTN operations
Update laboratory director education and training requirements to align with CLIA
Clarify and expand requirements for laboratory agreements with transplant hospitals and organ procurement organizations (OPOs)
Modify required personnel and add a primary data coordinator to act as the point of contact for the OPTN
Update laboratory subcontracting requirements and remove requirement for the laboratory director to review and approve all subcontracting results before release
Expand inactivation and withdrawal notification requirements
Remove requirements that are redundant to other existing regulatory requirements for labs and clarify language

Anticipated impact

What it's expected to do
- Allow multiple laboratory directors for each histocompatibility laboratory to be OPTN-approved
- Align laboratory director education and training with CLIA requirements
- Provide clarity in laboratory agreements with transplant hospitals and OPOs

What it won't do
- This proposal will not eliminate training or education requirements for laboratory directors

Terms to know

Antibody: A protein molecule produced by the immune system in response to a foreign body, such as virus or a transplanted organ. Since antibodies fight the transplanted organ and try to reject it, recipients are required to take anti-rejection (immunosuppressive) drugs.
Antigen: An antigen is any substance that causes your immune system to produce antibodies against it. An antigen may be a foreign substance from the environment such as chemicals, bacteria, viruses, pollen, or foreign tissues. An antigen may also be formed within the body, as with bacterial toxins.
Crossmatch: A blood test to determine compatibility between donor and recipient. A positive crossmatch indicates incompatibility. If the crossmatch is "negative," then the transplant may proceed. Crossmatching is performed for many organ transplants.
Human Leukocyte Antigen (HLA): Molecules found on cells in the body that are inherited genetically. In donor-recipient matching, HLAs help to determine compatibility between a donor and recipients.