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Related Experiment Videos

Evaluating laboratory performance. Historical and governmental perspectives.

D J Boone1

  • 1Division of Assessment and Management Consultation, Centers for Disease Control, Atlanta, GA 30333.

Archives of Pathology & Laboratory Medicine
|April 1, 1988
PubMed
Summary
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Defining laboratory performance quality for medical decisions remains challenging. Establishing medically relevant analytic performance goals is crucial for improving laboratory methods and avoiding unnecessary regulations.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Medical Diagnostics

Background:

  • Historically, laboratory performance quality has been defined by analytical variance, total variance (analytical and biological), and medical-usefulness criteria.
  • These definitions have influenced instrument manufacturers, professional societies, and regulatory agencies.
  • A scientific and medical consensus on laboratory performance requirements has not yet been reached.

Purpose of the Study:

  • To review historical approaches to defining laboratory performance quality.
  • To highlight the need for medically relevant analytic performance goals.
  • To emphasize the benefits of consensus-based performance standards.

Main Methods:

  • Review of historical definitions and their impact on laboratory practice and regulation.

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  • Analysis of the limitations of current approaches to quality goals.
  • Discussion of the potential benefits of medically relevant performance criteria.
  • Main Results:

    • Past efforts to define laboratory quality have resulted in varied approaches but no universal consensus.
    • Existing quality goals have influenced industry and practice but lack a unified scientific and medical basis.
    • The lack of consensus hinders consistent improvement in laboratory instrumentation and methods.

    Conclusions:

    • Establishing medically relevant goals for analytic performance is essential for laboratory quality.
    • Such goals can prevent costly and unnecessary regulatory burdens.
    • Consensus on performance requirements will drive innovation in laboratory instrumentation and methods.