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) 1281: Twice a year evaluate and define the relationship between results for the same test performed by different methods, instruments or sites, and maintain a system that flags patient results inconsistent with age, sex, diagnosis, result distribution or related parameters, documenting all comparison activity

What does 1281 require?

If the laboratory performs the same test using different methodologies or instruments, or at multiple testing sites, it must have a system that twice a year evaluates and defines the relationship between the results obtained by each. It must also have a system to identify and assess patient test results that appear inconsistent with relevant criteria where available: patient age, sex, diagnosis or pertinent clinical data, the distribution of patient results, and the relationship with other test parameters. All test result comparison 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.

  • 7.3.7.4 7.3.7.4 Comparability of examination results

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.