Korean J Blood Transfus.  2011 Dec;22(3):198-203.

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

• Jekarl DW
• Lee GW
• Kim Y
• Song YS
• Jang HS
• Park GH
• Youn SO
• Jo SJ
• Park GH
• Lim S
• Lee MS

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.

Keyword

Proficiency testing; External quality assessment test; Blood bank

MeSH Terms

Blood Banks
Isoantibodies
Mental Competency
Quality Control
Total Quality Management
Isoantibodies