Other Components of a QA Programcontinued
ACTIVITY EXPLANATION
Personnel competency assessment
Proficiency testing (PT)
Standard operating procedure (SOP)
CLIA requires documentation of competency assessment on hire, at 6 months, & then annually.
Testing of unknowns submitted by outside agency, e.g., CAP. Unknowns must not receive pref-
erential treatment. Results reported to agency, which compares them to results from other
labs. CLIA requires all labs performing nonwaived tests (moderate or high complexity) to
participate in PT.
Set of instructions for methods used in the laboratory. Also known as procedure manual.
Laboratory Operations Review 60
