All laboratory testing performed must have approved policies and procedures available for use by testing personnel. Policies and procedure must meet the complexity level requirements of CLIA, the state regulations, and the appropriate accreditation agency, if appropriate. All complexity levels must follow all manufacturer's recommendations for each test method. Policies and procedure must be updated with any change or modification in methods or test kits.
The policies and procedures must be approved and signed by the laboratory director at the time they are put into use. The procedures must also be periodically reviewed by the laboratory director or designee. This is done on an annual or every two-year (biennially) basis, depending on regulatory and accrediting requirements. The review is to be documented and includes the appropriate signatures and the date the review is performed.
Revisions (all major) must be approved and signed by the laboratory director at the time of inception. Retired policies and procedures must be maintained for the period specified by applicable state, federal, and regulatory guidelines, which is commonly at least two years from the date of retirement.
Package inserts may be used as a procedure but must be signed and dated by the laboratory director. The inserts must be updated with each revision, then signed and dated.
