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Steady state errors and risk of a QC strategy
Mark A Mackay1, Tony C Badrick1
1RCPA Quality Assurance Programs, St Leonards, Sydney, NSW, Australia 2065.
Clinical Biochemistry
|December 16, 2018
Summary
Laboratories can minimize patient harm by implementing robust quality control (QC) strategies. This study introduces a functional QC run length calculation to assess assay performance risks, aiding in QC optimization.
Area of Science:
- Clinical laboratory science
- Analytical chemistry
- Quality management systems
Background:
- Laboratories must establish quality control (QC) strategies to minimize patient harm from assay results.
- Monitoring assay performance against analytical and clinical risk is essential for patient safety.
Purpose of the Study:
- To develop a method for calculating functional QC run length based on steady-state errors.
- To evaluate the suitability of this technique using real laboratory data and performance specifications.
- To provide laboratories with a tool for assessing QC strategy effectiveness.
Main Methods:
- Calculated steady-state errors normalized for Assay Capability (imprecision) and Assay Stability (drift).
- Determined QC run length and functional run length considering error detection.
- Examined technique suitability using external quality assurance (EQA) imprecision and drift data.
Main Results:
- Steady-state errors, error detection, and functional QC run length are significantly influenced by imprecision, drift, and performance specifications.
- Laboratory steady-state errors varied widely, with Assay Capability and Assay Stability contributions differing between laboratories.
- The proposed method demonstrated the impact of various factors on QC effectiveness.
Conclusions:
- Steady-state errors are inherent in all assays and accumulate over time.
- The functional QC run length offers a risk-based approach, incorporating key elements for assessing QC strategies.
- Laboratories can use this method to evaluate combinations of QC parameters (run length, algorithm, workload, timing) and the impact of common performance specifications.
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