A laboratory's technical supervisor/technical consultant or the laboratory director holds the responsibility for designing the verification or validation study in the clinical microbiology laboratory as well as the responsibility for performing appropriate result analysis following completion of the study. The laboratory director must also provide final approval of the protocol. Manufacturers of commercial test systems may NOT perform the verification study; laboratory personnel must perform the study. Manufacturers, however, may provide a recommended verification procedure. There is no defined length of paused testing time at which laboratory personnel should consider re-verification. The technical consultant/technical supervisor or the laboratory director is responsible for designing the verification or validation study as well as analysis of study results. Testing personnel who meet Clinical Laboratory Improvement Amendments (CLIA) requirements for performing nonwaived testing may be involved in performing the verification or validation study.