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Related Experiment Videos

Governmental perspectives on evaluating laboratory performance

D J Boone1

  • 1US Department of Health and Human Services, Centers for Disease Control and Prevention. Atlanta, GA 30333.

Clinical Chemistry
|July 1, 1993
PubMed
Summary
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Defining laboratory test quality requires considering analytical variance, total variability, diagnostic efficiency, and medical usefulness. Medically relevant results necessitate a holistic approach, encompassing accuracy, accessibility, and minimizing pre- and post-analytical errors.

Area of Science:

  • Clinical Laboratory Science
  • Medical Diagnostics
  • Health Services Research

Background:

  • Laboratory test quality is crucial for medical decision-making.
  • Existing definitions of analytical performance quality vary.
  • These definitions include analytical variance, total variance, diagnostic efficiency loss, and medical usefulness.

Purpose of the Study:

  • To define the required quality of laboratory analytical performance for medical relevance.
  • To consider the federal government's perspective on laboratory test quality.
  • To establish medically relevant goals for laboratory testing.

Main Methods:

  • Review and synthesis of existing frameworks for defining laboratory test quality.
  • Analysis of factors influencing medical relevance, including clinical context, access, timeliness, and cost.

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  • Consideration of analytical precision, accuracy, and errors in pre- and post-analytical phases.
  • Main Results:

    • Medical relevance requires more than just analytical precision and accuracy.
    • It must also include accessibility of effective tests and reduction of errors throughout the total testing process.
    • Errors in pre- and post-analytical steps can lead to medically misleading information.

    Conclusions:

    • Medically relevant laboratory results depend on a comprehensive approach to quality.
    • Regulatory requirements, instrumentation, and methodology should focus on the entire testing process.
    • Effective management of the total testing process is essential for ensuring medically relevant results.