US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1355-1365: For provider-performed microscopy procedures, have a qualified director (physician, independently practising midlevel practitioner or dentist, State-licensed where required) who directs no more than five laboratories, ensures each PPM procedure is personally performed by a qualified practitioner during the patient visit using a brightfield or phase contrast microscope and in line with Subparts H, J and K, and evaluates and documents testing personnel competency semiannually in the first year and annually thereafter

What does 1355-1365 require?

A laboratory performing PPM procedures must have a director qualified under section 493.1357 (a physician, a midlevel practitioner authorised by the State to practise independently, or a dentist, holding any State laboratory director licence required) who provides overall management and direction. The director may direct no more than five laboratories, must ensure every PPM procedure listed under section 493.19(c) is personally performed by an individual qualified under section 493.1363 and performed in accordance with Subpart M and the applicable requirements of Subparts H, J and K, must evaluate the competency of all testing personnel using at least direct observation of routine testing, monitoring of result recording and reporting, review of results or worksheets, assessment through internal blind or external PT samples and assessment of problem solving skills, and must evaluate and document each individual's performance at least semiannually during the first year and annually thereafter. PPM procedures must be personally performed by a physician, a supervised or State-authorised midlevel practitioner or a dentist during the patient's visit on a specimen from their own patient or a patient of their group practice, using a microscope limited to brightfield or phase contrast.