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[Problems in practical implementation of the external quality control program in clinical laboratory investigations]
Klinicheskaia Laboratornaia Diagnostika
|July 1, 1995
Summary
Russia established a national quality assessment program for laboratory medicine in 1992. The program found that laboratory errors were mainly due to methodology variability, which was minimal.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Quality Assessment
Background:
- The Center for External Quality Assessment in Laboratory Medicine was established in Russia.
- A National External Quality Assessment Scheme (NEQAS) was implemented in 1992 for 16 common clinical chemistry analyses.
Purpose of the Study:
- To assess the accuracy and precision of laboratory analyses within the Russian NEQAS program.
- To identify sources of error in laboratory testing.
Main Methods:
- 636 laboratories analyzed 4 control serum pools (2 normal, 2 elevated concentrations).
- Each pool was analyzed twice to estimate accuracy and precision separately.
- Accuracy was determined by bias from method-dependent means and reference values.
- Reference methods were used for sodium, potassium, total protein, cholesterol, and triglycerides.
Main Results:
- Analysis of variance indicated that laboratory errors primarily stemmed from methodology variations.
- The variability between different laboratory methodologies was found to be negligible.
- Data from 636 participating laboratories were analyzed.
Conclusions:
- The Russian NEQAS program effectively monitors laboratory performance.
- Methodology variability is not a significant contributor to errors in clinical chemistry analyses within this scheme.
- Further investigation into other potential sources of error may be warranted.