Experience of a Performing Alternative Assessment Procedure for Tests without External Proficiency Test Program / 대한수혈학회지

ABSTRACT

BACKGROUND: Proficiency testing is part of a total quality management program that provides objective evidence of clinical laboratory testing competence for customers, accrediting bodies, and regulatory agencies. Performing alternative assessment procedures for clinical tests, without proficiency testing, is recommended by Clinical and Laboratory Standards Institute (CLSI) guideline. In our study, an alternative assessment procedure was performed for blood bank tests that do not have an external proficiency program. METHODS: The laboratory for development and an evaluation center, supervised the program. Proficiency testing by seven institutions was performed 3 times at 6 month intervals by evaluating isoagglutinin and anti-D titers, and Weak D, Rh C and E typing, using ID-Internal Quality Control (Bio-Rad Laboratories) kits. RESULTS: Isoagglutinin and anti-D titer results were within one fold dilution range for all seven participating institutions, and Weak D, Rh C and E typing results all demonstrated identical antigenic reference patterns. CONCLUSION: An alternative assessment procedure was successfully performed without a proficiency testing program. Commercially manufactured reference materials could be an alternative method to support commutable, external, proficiency testing program.