Policies and procedures for waived tests are established, current, approved, and readily avai...

(1)

The person from the hospital whose name appears on the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) certificate, or a qualified designee, establishes written policies and procedures for waived testing that address the following: - Clinical usage and limitations of the test methodology - Need for confirmatory testing (for example, recommendations made by the manufacturer for rapid tests) and result follow-up recommendations (for example, a recommendation to repeat the test when results are higher or lower than the reportable range of the test) - Specimen type, collection, and identification and required labeling - Specimen preservation, if applicable - Instrument maintenance and function checks, such as calibration - Storage conditions for test components - Reagent use, including not using a reagent after its expiration date - Quality control (including frequency and type) and corrective action when quality control is unacceptable - Test performance - Result reporting, including not reporting individual patient results unless quality control is acceptable - Equipment performance evaluation Note 1: Policies and procedures for waived testing are made available to testing personnel. Note 2: The designee should be knowledgeable by virtue of training, experience, and competence about the waived testing performed.

(2)

Policies or procedures for each waived test are consistent with manufacturers’ instructions for use and include specific operational policies (that is, detailed quality control protocols and any other institution-specific procedures regarding the test or instrument).