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Related Experiment Videos

Optimal analytical performance for point of care testing.

C G Fraser1

  • 1Biochemical Medicine, Tayside University Hospitals NHS Trust, Ninewells Hospital and Medical School, DD1 9SY, Scotland, Dundee, UK. callum.fraser@tuht.scot.nhs.uk

Clinica Chimica Acta; International Journal of Clinical Chemistry
|May 23, 2001
PubMed
Summary

Establishing robust analytical quality in laboratory testing requires setting reliable performance specifications. A hierarchical framework is now the expert-accepted global strategy for defining these quality specifications in laboratory medicine.

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Area of Science:

  • Laboratory Medicine
  • Analytical Chemistry
  • Quality Management

Background:

  • Reliable performance characteristics, including precision and bias, are essential for laboratory test quality.
  • Numerous strategies exist for establishing these critical quality specifications.
  • A consensus-driven hierarchical framework represents the current best practice.

Purpose of the Study:

  • To present the expert-accepted hierarchical framework for setting quality specifications in laboratory medicine.
  • To advocate for the universal adoption of this framework in quality planning.
  • To emphasize the importance of these specifications across all laboratory settings, including point-of-care testing.

Main Methods:

  • Review and synthesis of existing strategies for setting analytical quality specifications.

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  • Establishment of a hierarchical framework based on expert consensus.
  • Evaluation of the framework's applicability in diverse laboratory settings.

    • Main Results:

    • A hierarchical framework for quality specifications has been established and accepted by experts.
    • Higher-tier models within the hierarchy are preferred for optimal quality control.
    • Lower-tier approaches serve as a minimum acceptable standard when higher tiers are not feasible.

    Conclusions:

    • The hierarchical framework is the optimal global strategy for setting quality specifications in laboratory medicine.
    • Implementation of this framework is crucial for consistent and reliable laboratory testing, including point-of-care testing.
    • Even minimum standards derived from lower-tier approaches are vital for maintaining analytical quality.