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Development of criteria for the evaluation of reference method values
1INSTAND e.V., Düsseldorf, Germany.
Summary
A new concept standardizes reference methods (RMs) for German external quality assessment (EQA) target-setting. It mandates that the total allowable error (TAE) for RMs be 0.2 times EQA acceptance limits, defining bias and imprecision criteria.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Quality Assurance
Background:
- External Quality Assessment (EQA) schemes are crucial for monitoring laboratory performance.
- Target-setting in EQA relies on the quality of Reference Methods (RMs).
- A standardized approach for RM requirements in EQA is currently lacking.
Purpose of the Study:
- To establish a uniform concept for the requirements of Reference Methods (RMs).
- To define criteria for target-setting within the German External Quality Assessment (EQA) scheme.
- To ensure the reliability and comparability of EQA results.
Main Methods:
- Proposing a specific ratio for Total Allowable Error (TAE) of RMs relative to EQA acceptance limits.
- Deriving maximum permissible bias for RMs based on the TAE.
- Deriving maximum permissible imprecision for RMs based on the TAE.
- Establishing criteria for the number of measurements required for RM validation.
Main Results:
- A uniform concept for RM requirements in the German EQA scheme is presented.
- The proposed TAE for RMs is 0.2 times the EQA scheme's acceptance limits.
- Derived limits provide clear specifications for maximum RM bias, RM imprecision, and the number of measurements.
Conclusions:
- The proposed concept offers a standardized framework for RM requirements in EQA.
- Implementation of these requirements will enhance the robustness of target-setting in EQA.
- This approach contributes to improved laboratory performance and patient safety through reliable EQA.