Guideline References

Verification of Comparability of Patient Results within One Health Care System

The primary standard for demonstrating that multiple instruments within a single health care system produce comparable patient results. EP31 provides study design guidance, acceptance criteria based on TEa, and documentation requirements for inter-instrument comparability studies.

Measurement Procedure Comparison and Bias Estimation Using Patient Samples

Governs the broader framework of method comparison using paired patient samples. The statistical principles in EP09C — including bias estimation and the use of TEa as an acceptance criterion — underpin the Error Index approach used in the MIMC module.

Accreditation and Regulatory Requirements

CAP requires laboratories to perform and document instrument comparisons when the same test is performed on multiple analyzers. CLIA requires split-sample comparisons at defined intervals to ensure inter-instrument agreement.