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Causes of unsatisfactory performance in proficiency testing.

R W Jenny¹, K Y Jackson-Tarentino

¹Laboratory for Molecular Diagnostics, Division of Molecular Medicine, Wadsworth Center, New York State Department of Health, Albany, NY 12201-0509, USA. jenny@wadsworth.org

Clinical Chemistry

|January 6, 2000

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Laboratory quality control errors stem from procedural lapses and instrument issues, with common analytic errors occurring at a 0.7% rate. Improving laboratory testing requires aligning quality control error allowances with manufacturer specifications.

Area of Science:

Clinical Chemistry
Laboratory Quality Assurance
Toxicology Testing

Background:

Proficiency testing (PT) is crucial for assessing laboratory quality assurance effectiveness.
Unsatisfactory performance (UNSAT) in PT evaluations highlights unexpected testing errors.
Identifying root causes of errors drives continuous improvement in laboratory services.

Purpose of the Study:

To characterize the quality of toxicology testing using PT data.
To identify the root causes of laboratory testing errors.

Main Methods:

Utilized participant data from the New York State Department of Health PT program.
Analyzed outcomes of laboratory investigations into UNSAT causes.
Collected data on quality control practices from all participants.

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Main Results:

Two error classes identified: spurious results (300/million assays) and common-cause analytic error (7000/million assays, 0.7% UNSAT rate).
Spurious error causes included dilution correction inaccuracies, code misinterpretations, and sampling errors.
Calibration drift was the most frequent common-cause error; many labs exceeded manufacturer error thresholds for quality control.

Conclusions:

Spurious results necessitate ongoing analyst competency testing and improved instrument design.
Intrinsic laboratory testing quality improvement depends on aligning quality control error allowances with manufacturer specifications for stable performance.