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Related Experiment Videos

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
PubMed
Summary
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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.