US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1425-1495: Testing personnel (and cytotechnologists) perform only the tests the director authorises and that match their skill; follow the laboratory's procedures for handling, testing, reporting and record keeping; keep records showing PT samples are tested like patient samples; adhere to quality control policies and document control, calibration and maintenance; follow corrective action procedures when systems are out of limits; identify and correct or escalate problems; document corrective actions; and, if qualified under the high school route, perform high complexity testing only under onsite direct general supervision; cytotechnologists document their interpretations, slide counts across employers and hours

What does 1425-1495 require?

Testing personnel are responsible for specimen processing, test performance and reporting results. Each individual performs only the moderate or high complexity tests the laboratory director authorises and that require a degree of skill commensurate with the individual's education, training or experience and technical abilities. Each must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient results; maintain records demonstrating that PT samples are tested in the same manner as patient samples; adhere to the quality control policies and document all quality control activities, instrument and procedural calibrations and maintenance performed; follow the established corrective action policies and procedures whenever test systems are not within acceptable performance levels; be capable of identifying problems that may adversely affect test performance or reporting and either correct them or immediately notify the general supervisor, technical consultant or supervisor, clinical consultant or director; and document all corrective actions taken when systems deviate from performance specifications. An individual qualified for high complexity testing under section 493.1489(b)(5) performs such testing only under the onsite direct supervision of a qualified general supervisor, save the pre-1993 exception with 24-hour review. The cytotechnologist must document the slide interpretation results of each gynecologic and nongynecologic case examined or reviewed, the total slides examined or reviewed in each 24-hour period in this and any other laboratory or for any other employer, and the hours spent examining slides in each 24-hour period.