US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1251: Maintain a written procedure manual for every test, assay and examination, followed by staff, containing the fourteen required elements where applicable, approved, signed and dated by the current director before use and on every change, with retired procedures kept with their dates of use

What does 1251 require?

A written procedure manual for all tests, assays and examinations must be available to and followed by laboratory personnel; textbooks may supplement but not replace it. Where applicable each procedure must cover patient preparation, specimen collection, labelling, storage, preservation, transport, processing, referral and acceptability criteria; microscopic examination including detection of inadequately prepared slides; step-by-step performance with calculations and interpretation; preparation of slides, solutions, calibrators, controls, reagents, stains and other materials; calibration and calibration verification; the reportable range; control procedures; corrective action when calibration or control results fail; methodology limitations including interfering substances; reference intervals; imminently life-threatening, panic or alert values; pertinent literature; the system for entering results and reporting, including the protocol for life-threatening results; and the course of action if the test system becomes inoperable. Manufacturer instructions or operator manuals may supply the first twelve elements where applicable, with the laboratory supplying anything missing. Procedures and changes must be approved, signed and dated by the current director before use, and a copy of each procedure kept with its dates of initial use and discontinuance as section 493.1105 requires.

Maintained by Gerard Blokdyk

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  • 7.3.6 7.3.6 Documentation of examination procedures

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.