OPTN policy 2.2.4 requires that OPOs perform laboratory screening tests on all donors. This policy states:
“All donor laboratory testing must be performed in an appropriately accredited laboratory utilizing FDA licensed, approved, or cleared serological screening tests…
…Diagnostic testing is NOT acceptable for Anti-HIV.”
This policy has been in effect since January 10, 2011. It requires OPOs to use serological anti-HIV screening tests, NOT diagnostic tests, for evaluation of all deceased donors.
OPOs should review their current practice for policy 2.2.4 compliance. During on-site reviews, UNOS site surveyors are actively checking that OPOs perform serological HIV tests to evaluate donors and are in compliance with this policy.
If an OPO has been performing diagnostic testing for anti-HIV testing after January 10, 2011, the OPO is in violation of policy 2.2.4 and must:
Self report the violation to UNOS.
Notify all transplant centers receiving donor organs since January 10, 2011 that the OPO performed diagnostic HIV testing instead of serological screening in violation of OPTN policy 2.2.4.
Take corrective action to come into immediate compliance with OPTN policy 2.2.4.
Corrective action may include:
• Using a local properly accredited laboratory to perform anti-HIV screening tests for the OPO.
• Contacting nearby OPOs for help with anti-HIV testing until a permanent solution is found.
• Shipping samples to other laboratories that perform U.S. Food and Drug Administration (FDA)-approved licensed Anti-HIV I and II serological screening tests.
Note that OPOs should complete all donor evaluations using screening serological testing, when available.
Click here for a complete list of current (FDA)-approved licensed Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays.
