Experience of a Performing Alternative Assessment Procedure for Tests without External Proficiency Test Program.
- Author:
Dong Wook JEKARL
1
;
Gyoo Whung LEE
;
Yonggoo KIM
;
Young Sun SONG
;
Hyun Sik JANG
;
Gyu Ho PARK
;
Soun Ok YOUN
;
Seung Jin JO
;
Gun Hee PARK
;
Song LIM
;
Myoung Shin LEE
Author Information
1. Department of Laboratory Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- Publication Type:Original Article
- Keywords:
Proficiency testing;
External quality assessment test;
Blood bank
- MeSH:
Blood Banks;
Isoantibodies;
Mental Competency;
Quality Control;
Total Quality Management
- From:Korean Journal of Blood Transfusion
2011;22(3):198-203
- CountryRepublic of Korea
- Language:Korean
-
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.
