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) 1252: Select test systems and perform testing to the manufacturer's instructions within the laboratory's stated performance specifications; define, monitor and document the storage and operating conditions essential to reliable testing (water quality, temperature, humidity, power protection); label reagents and materials with identity, strength, storage, preparation and expiry; never use expired, deteriorated or substandard materials; and do not mix kit components across lots unless the manufacturer allows

What does 1252 require?

Test systems must be selected by the laboratory and testing performed following the manufacturer's instructions in a manner that gives results within the performance specifications the laboratory determined under section 493.1253. The laboratory must define criteria for the conditions essential to proper storage of reagents and specimens, accurate and reliable test system operation and result reporting, consistent with the manufacturer's instructions, and must monitor and document those conditions, which where applicable include water quality, temperature, humidity and protection of equipment from electrical fluctuations and interruptions that could affect results. Reagents, solutions, culture media, control and calibration materials and other supplies must be labelled with identity and, where significant, titer, strength or concentration, storage requirements, preparation and expiration dates and other information needed for proper use; must not be used past their expiration date or when deteriorated or of substandard quality; and components of reagent kits of different lot numbers must not be interchanged unless the manufacturer specifies otherwise.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

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)

Query this from an agent

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