US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart M: personnel for nonwaived testing, qualifications and responsibilities (sections 493.1351 to 493.1495) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1413-1451: The technical consultant (moderate complexity) or technical supervisor (high complexity, by specialty) provides accessible technical and scientific oversight: method selection, verification of procedures and performance characteristics, PT enrolment and participation, the quality control program and performance parameters, resolution of technical problems and remedial action, no reporting until corrected, training needs and in-service education, competency evaluation using the six required methods, and documented performance evaluation semiannually in the first year then annually or on method change; in cytology the technical supervisor also sets and reassesses workload limits, performs the section 493.1274 reviews, ensures individual PT participation and records their own screening volumes

What does 1413-1451 require?

The technical consultant for moderate complexity testing and the technical supervisor for high complexity testing are responsible for the technical and scientific oversight of the laboratory; neither need be onsite whenever testing is performed, but each must be accessible to provide onsite, telephone or electronic consultation as needed. Each is responsible for selecting test methodology appropriate to the clinical use of the results; verifying the test procedures and establishing the laboratory's performance characteristics including precision and accuracy; enrolment and participation in an approved PT program commensurate with the services; establishing a quality control program and the parameters for acceptable analytic performance and ensuring they are maintained from specimen receipt through reporting; resolving technical problems and ensuring remedial action when systems deviate from specifications; ensuring patient results are not reported until all corrective actions are taken and the system functions properly; identifying training needs and ensuring regular in-service training and education appropriate to the testing; evaluating and maintaining the competency of all testing personnel through at least direct observation of routine test performance including patient preparation, specimen handling, processing and testing, monitoring of result recording and reporting, review of intermediate results or worksheets, quality control, PT and preventive maintenance records, direct observation of maintenance and function checks, assessment through previously analysed, blind or PT samples, and assessment of problem solving skills; and evaluating and documenting each individual's performance at least semiannually during the first year of patient testing and at least annually thereafter, with re-evaluation before reporting results after a change of methodology or instrumentation. In cytology the technical supervisor (or the individual qualified under section 493.1449(e)(2)) may perform the cytology general supervisor and cytotechnologist duties, must set and at least every six months reassess each slide examiner's workload limit, perform the section 493.1274(d) and (e) functions, ensure every individual examining gynecologic preparations participates in and passes the approved cytology PT program, and if screening slides must document their own slide numbers and hours per 24-hour period.

Maintained by Gerard Blokdyk

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Other controls in Subpart M: personnel for nonwaived testing, qualifications and responsibilities (sections 493.1351 to 493.1495) – 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.