When performing a verification or validation study, the basic documentation that is necessary includes the verification/validation plan and the verification/validation summary. The minimum period that verification and validation documents and records must be retained is two years. If use of the test system is permanently suspended within two years of introduction into the laboratory, verification and validation documents and records must still be kept for a minimum of two years. A legacy assay is any assay that was introduced to the clinical laboratory for testing prior to April 24, 2003. This date is the Clinical Laboratory Improvement Amendments (CLIA) cutoff for identifying which nonwaived test systems require verification or validation. Accredited laboratories and laboratories in exempt states should reach out to their appropriate agency to confirm any additional agency requirements for legacy assays.