US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1235: Establish and follow written policies and procedures to assess the competency of employees and, where applicable, consultants, as the Subpart M personnel responsibilities require

What does 1235 require?

As specified in the Subpart M personnel requirements, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. The assessment procedures, carried out by the technical consultant, technical supervisor or general supervisor, cover the six elements set out in sections 493.1413 and 493.1451 and are performed semiannually in the first year an individual tests patient specimens and annually thereafter, with reassessment before results are reported after a change of method or instrument.