J Clin Pathol Qual Control.  1997 Dec;19(2):303-322.

Influence of Control Material Source of Laboratory Tests on the Evaluation of External Quality Assurance Program

Affiliations
  • 1Department of Clinical Pathology, Korea University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND: The Variance Index Score (VIS) system has been used in the external quality control program of the Korean Association of Quality Assurance (KAQA) for clinical chemistry since 1980. As average VIS of all participants showed severe fluctuations in some analytes, it was questioned whether the VIS actually had reflected the performance of each participants. The purpose of this study was to explore the effects of the control material sources on the efficiency of the external quality control system.
METHODS
The author analysed VISs calculated from reported results of 391 participants for 19 analytes (sodium, potassium, chloride, blood urea nitrogen, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, protein, albumin, cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase) in 30 trials from 1994 to 1996. The VISs were analysed among the manufacturing sources, within the manufacturing sources, and with in lots from the same manufacturer. The differences among manufacturers were also evaluated with main analytical method and with reference laboratories.
RESULTS
Fourteen of nineteen analytes showed differences among manufacturing sources, and six to twelve analytes showed differences within manufacturing sources, but most of them did not show any differences within the lots. There were significant differences among analytical methods in 16 analytes, among instruments in all 19 analytes and among reagents in 14 analytes. With the most frequently used analytical methods and reference laboratories, significant differences existed in 12 and 18 analytes, respectively.
CONCLUSIONS
As there were significant differences among manufacturing sources of control materials and lots, it is very important to establish the protocol for control material production. The control materials showing relatively constant VIS must be produced or selected to improve the Korean external quality control program and to enhance accuracy of the national test.


MeSH Terms

Alanine Transaminase
Alkaline Phosphatase
Aspartate Aminotransferases
Bilirubin
Blood Urea Nitrogen
Calcium
Chemistry, Clinical
Cholesterol
Creatinine
Glucose
Indicators and Reagents
L-Lactate Dehydrogenase
Phosphorus
Potassium
Quality Control
Triglycerides
Uric Acid
Alanine Transaminase
Alkaline Phosphatase
Aspartate Aminotransferases
Bilirubin
Calcium
Cholesterol
Creatinine
Glucose
Indicators and Reagents
L-Lactate Dehydrogenase
Phosphorus
Potassium
Triglycerides
Uric Acid
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