ABSTRACT
BACKGROUND: Viral screening assays performed for blood donors are required to have high sensitivity because false negative results can lead to transfusion-transmitted infections. To minimize the number of false negative cases, a systematic quality assurance program is required to verify donor screening tests. METHODS: The current status of quality assurance (QA) for blood donor screening tests in Korea and other countries was reviewed. A quality assurance program using the national standards of the Korea Food and Drug Administration (KFDA) was done as a pilot study to evaluate both the need for such a program and the feasibility of such a program. RESULTS: Singapore had a national quality assurance programs for the anti-HIVdonor screening tests. In the United Kingdom, all laboratories use the NIBSC working standards as QA materials for the donors screening. Ninety-five % (84/80) of blood centers replied that they would participate in a national quality assessment program and 92% (84/77) of the blood centers also felt that an independent organization should be designated to operate the program. Quality control materials with a weak reactivity should be included in a quality assessment program for donor screening. CONCLUSION: We propose 2 models for a National Quality Assurance Program (NQAP). In the first model, an independent national reference laboratory (NRL) needs to be established that operates the national quality assurance program. The second model involves the integration of the national quality assurance program for donor screening into the External Quality Assurance Survey run by the Korean Association of Clinical Assurance for Clinical Laboratory (KAQACL) using the national standards.