US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1463-1471: For high complexity testing the general supervisor is accessible to testing personnel whenever testing is performed, provides day-to-day supervision, is onsite to directly supervise individuals qualified under the high school route, monitors analyses and examinations for acceptable analytic performance and may carry delegated remedial action, result release, orientation and competency duties; the cytology general supervisor is accessible for technical problems and documents slide interpretations, slide counts across all employers and hours per 24-hour period

What does 1463-1471 require?

The general supervisor is responsible for day-to-day supervision or oversight of laboratory operation and of the personnel performing testing and reporting results. The general supervisor must be accessible to testing personnel at all times testing is performed to give onsite, telephone or electronic consultation to resolve technical problems under the policies the director or technical supervisor set; provides day-to-day supervision of high complexity testing by qualified testing personnel; must be onsite to provide direct supervision whenever high complexity testing is performed by individuals qualified under section 493.1489(b)(5), except for individuals in that category who were testing on or before January 19, 1993 and whose unsupervised testing is reviewed within 24 hours by a qualified general supervisor; and monitors test analyses and specimen examinations to ensure acceptable analytic performance is maintained. The director or technical supervisor may delegate to the general supervisor responsibility for ensuring remedial action on deviation from performance specifications, for ensuring results are not reported until corrective action is complete and the system functions, for orienting all testing personnel, and for evaluating and documenting competency. In cytology the technical supervisor may perform or delegate the cytology general supervisor duties to an individual qualified under section 493.1469, who is responsible for day-to-day supervision, must be accessible to resolve technical problems, document the slide interpretation results of each gynecologic and nongynecologic case examined or reviewed, document for each 24-hour period the total slides examined or reviewed in the laboratory and for any other laboratory or employer, and document the hours spent examining slides in each 24-hour period.