Which document is listed as a key CAP Accreditation document related to verifying test methods?

• A. Quality Management Plan
• B. Document Control Process
• C. Test Method Validation Documentation
• D. Laboratory Information System (LIS)

Answer: (C)

This item tests the requirement to have formal documentation that a test method has been validated for its intended use. CAP accreditation expects clear, organized evidence that a method performs as required before results are reported. Test Method Validation Documentation gathers the validation plan, acceptance criteria, and actual results demonstrating key performance characteristics such as accuracy, precision, linearity, reportable range, limits of detection/quantitation, robustness, interference, carryover, and stability. It may also include method comparison or reference-method data and any deviations with conclusions about whether the method is acceptable for routine use. This focused documentation provides inspectors with a single, verifiable record that the method has been properly evaluated and approved for patient testing. Other documents, while important to the quality system, do not specifically capture the validation evidence needed to verify test methods.