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Related Experiment Videos

Errors, mistakes, blunders, outliers, or unacceptable results: how many?

D L Witte1, S A VanNess, D S Angstadt

  • 1Laboratory Control, Ltd. Ottumwa, IA 52501, USA.

Clinical Chemistry
|August 1, 1997
PubMed
Summary

Clinical chemistry testing reveals unacceptable error rates, with 447 unacceptable results per million. A significant portion, 41 ppm, could impact patient care, highlighting the need for continuous quality improvement in laboratory diagnostics.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Quality Control

Background:

  • Methods comparison studies are crucial for evaluating laboratory test performance.
  • Assessing the frequency and impact of unacceptable results is vital for patient safety.
  • Understanding variation in clinical chemistry testing informs quality improvement initiatives.

Purpose of the Study:

  • To quantify the rate of unacceptable results in clinical chemistry testing.
  • To determine the frequency of results that could potentially alter patient care.
  • To provide context for laboratory error rates by comparing them to other industries.

Main Methods:

  • Analysis of 219,353 clinical chemistry results from methods comparison studies.
  • Prospective comparison of each result with its replicate, comparative, or repeat value.

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  • Definition of unacceptable results as deviations exceeding 7 standard deviations (SDs) or coefficients of variation (CVs).

    • Main Results:

    • An overall unacceptable rate of 447 parts per million (ppm) was observed.
    • Unacceptable rates were 196 ppm in control samples and 251 ppm in patient samples.
    • Results likely to alter patient care occurred at a rate of 41 ppm.

    Conclusions:

    • The study quantifies special-cause variation in clinical chemistry testing.
    • Observed error rates provide a benchmark for quality improvement efforts.
    • Findings have implications for laboratorians, manufacturers, and regulatory bodies in ensuring test accuracy and patient safety.