CLIA Compliance Record
Compliance record for the US federal regime that attaches to the testing site rather than the organisation, so every location performing testing needs its own certificate. Determines test complexity, from which everything else follows; matches personnel criteria to that level as criteria rather than titles; enrols in proficiency testing per regulated specialty; and states the proficiency-sample prohibitions whose sanctions do not distinguish motive. Maps to 42 CFR Part 493.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
The US clinical laboratory regime is federal law, applies to any site testing human specimens for health assessment or the diagnosis, prevention or treatment of disease, and attaches to the site rather than the organisation. A physician office running a single test is within it. The determination that governs everything else is test complexity, and it is made per test, by the site, before the first result leaves the building.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
42 CFR Part 493 implements the Clinical Laboratory Improvement Amendments — certificate types by test complexity, personnel qualification requirements at each level, proficiency testing enrolment and the handling prohibitions, and the performance specifications a laboratory establishes before reporting patient results. It does not classify your particular test menu or decide which of your locations is a testing site; those determinations belong to the organisation operating them. The record structure here is SPEQ practitioner synthesis, and SPEQ neither certifies nor accredits any laboratory.