Korean J Blood Transfus.
2011 Dec;22(3):198-203.
Experience of a Performing Alternative Assessment Procedure for Tests without External Proficiency Test Program
- Affiliations
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- 1Department of Laboratory Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 2Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. yonggoo@catholic.ac.kr
- 3Department of Laboratory Medicine, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 4Department of Laboratory Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 5Department of Laboratory Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 6Department of Laboratory Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 7Department of Laboratory Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
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.
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