US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1405-1489: Employ only personnel who meet the Subpart M qualification standards for their role and the complexity of testing: laboratory director, technical consultant, clinical consultant and testing personnel for moderate complexity, and laboratory director, technical supervisor (by specialty), clinical consultant, general supervisor, cytology general supervisor, cytotechnologist and testing personnel for high complexity, each with the State licence where required and the education, board certification, training and experience the sections specify, and keep the qualification evidence on file

What does 1405-1489 require?

Each personnel position in a nonwaived laboratory carries a qualification standard. For moderate complexity testing the director (section 493.1405) must be a licensed pathologist, or a physician with at least a year directing or supervising nonwaived testing and 20 continuing education credit hours in laboratory practice covering the director responsibilities, or a doctoral scientist with the specified coursework or thesis and board certification, or qualify under the earlier routes the section preserves, and must be eligible to operate a laboratory under Subpart R; the technical consultant (section 493.1411) and clinical consultant (section 493.1417) and testing personnel (section 493.1423, at minimum a high school diploma with documented training, with the degree, military and prior-experience routes the section allows) have their own standards. For high complexity testing the director (section 493.1443) must be a licensed pathologist, a physician with two years directing or supervising high complexity testing plus 20 continuing education credit hours, or a board-certified doctoral scientist; the technical supervisor (section 493.1449) must be qualified by education and training or experience for each specialty and subspecialty, with specialty-specific routes for microbiology, chemistry, hematology, cytology, histopathology, oral pathology, radiobioassay, immunohematology, clinical cytogenetics and histocompatibility; the clinical consultant (section 493.1455), general supervisor (section 493.1461), cytology general supervisor (section 493.1469), cytotechnologist (section 493.1483) and testing personnel (section 493.1489, generally an associate degree in laboratory science or equivalent 60 semester hours with the specified coursework and training, or the grandfathered high school route under paragraph (b)(5) with onsite general supervision) each have defined standards. Any State licence required for the role must be current. The laboratory must be able to show, for every individual, the documents that establish the qualification relied on.