About Test Method Verification and Validation 

Clinical laboratory testing should be accurate and reliable to ensure correct diagnosis and treatment. Laboratories that perform testing on human specimens for the purpose of diagnosis, treatment or mitigation of a disease or disease state must demonstrate that new instruments and tests have acceptable performance prior to implementation. Studies that demonstrate the performance characteristics of the instrument or assay must be documented and accessible for external inspections and assessments. This process is known as verification or validation. 

About the Verification and Validation Toolkit

The Verification and Validation Toolkit can assist laboratories determining the difference between a validation and a verification, when each should be performed and how to perform them. 

This toolkit will help laboratories plan, implement and analyze data associated with new testing methods (FDA-approved tests and FDA-modified or laboratory developed tests) and technology implementation. In addition, the toolkit serves as a guide to help determine if the quality requirements for establishment of a new test system have been met. These recommendations should be followed to ensure a new or modified method, analyte or instrumentation (the "test method") has acceptable performance. 

This toolkit is the result of collective knowledge of subject matter experts and contains guidance for performing verifications and validations that will be compliant with requirements defined by the Clinical Laboratory Improvement Amendments (CLIA). Many of the described processes may be useful for other regulatory requirements. 

The examples in the toolkit are primarily focused on microbiology; the toolkit will be expanded to other testing areas in the future.

The APHL Verification and Validation Toolkit

The toolkit is broken down into eight main sections, plus additional reference documents. Download a complete version of the toolkit or download individual sections from within the dropdowns below.

Download the complete Verification and Validation Toolkit