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Summary
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Setting quality specifications for laboratory tests is crucial for analytical quality control. A newly agreed hierarchical framework offers the best global strategy for establishing these specifications, applicable across all laboratory settings.

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Area of Science:

  • Laboratory Medicine
  • Analytical Chemistry
  • Quality Management

Background:

  • Establishing robust quality specifications for laboratory tests, focusing on precision and bias, is essential for reliable analytical quality.
  • Numerous strategies have been proposed for setting these critical performance characteristics.

Purpose of the Study:

  • To present a globally agreed-upon hierarchical framework for setting quality specifications in laboratory medicine.
  • To advocate for the universal adoption of this framework in quality planning.

Main Methods:

  • Expert consensus on a hierarchical framework for quality specification setting.
  • Review of existing strategies for laboratory test quality control.

Main Results:

  • A hierarchical framework is identified as the current best approach for global quality specification setting in laboratory medicine.
  • Higher-level models within the hierarchy are preferred, but lower-level approaches are valuable when higher ones are unavailable.

Conclusions:

  • The hierarchical framework should be implemented in all laboratory medicine settings, including Point-of-Care Testing (POCT).
  • This framework provides a standardized and optimal strategy for ensuring the reliability of laboratory test performance characteristics.