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) 1289: Run an ongoing, documented analytic systems quality assessment covering the procedure manual, test systems, performance specifications, maintenance, calibration, controls, specialty requirements, comparisons, corrective actions and test records, with effectiveness review, procedure revision and staff discussion

What does 1289 require?

The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the analytic systems requirements of sections 493.1251 to 493.1283. The assessment must include review of the effectiveness of corrective actions, revision of policies and procedures to prevent recurrence, and discussion of the analytic systems reviews with appropriate staff, and all activities must be documented.

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.