US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1407-1445: The laboratory director takes responsibility for overall operation and administration and for compliance, is onsite at least twice a year at least four months apart with documented visits and remains accessible, directs no more than five laboratories, and ensures quality testing across all three phases, a safe physical plant, adequate methods and verification, PT enrolment with timely results and reviewed reports and corrective action plans, quality control and assessment programs, analytical performance levels, documented remedial action with results withheld until the system works, interpretable reports, client consultation, sufficient qualified staff, training and demonstrated competence before testing, competency monitoring policies, an approved procedure manual, and written duties for every consultant, supervisor and testing person

What does 1407-1445 require?

For both moderate and high complexity testing the laboratory director is responsible for the overall operation and administration of the laboratory, including employing competent personnel who perform tests and record and report results promptly, accurately and proficiently, and for assuring compliance with the regulations. The director may, if qualified, perform or delegate the technical, clinical, supervisory and testing roles but remains responsible for their proper performance; must be onsite at least once every six months with at least four months between the two minimum visits, stay accessible for telephone or electronic consultation, and document the visits and the director activities performed; and may direct no more than five laboratories. The director must ensure that the testing systems provide quality services across the preanalytic, analytic and postanalytic phases; that the physical plant and environment suit the testing and protect staff from physical, chemical and biological hazards; that methods selected can give the quality of results patient care requires, that verification procedures adequately determine accuracy, precision and other characteristics, and that staff perform the methods as required; that the laboratory is enrolled in an approved PT program, PT samples are tested as Subpart H requires, results are returned on time, all PT reports are reviewed by appropriate staff and an approved corrective action plan is followed for unacceptable results; that quality control and quality assessment programs are established and maintained to identify failures as they occur; that acceptable analytical performance levels are set and kept for each test system; that all necessary remedial actions are taken and documented on significant deviation from performance specifications and results are reported only when the system functions properly; that reports carry the information needed for interpretation; that consultation is available to clients on quality and interpretation; that for high complexity testing a general supervisor provides onsite supervision of testing personnel qualified under the high school route; that enough personnel with appropriate education and experience or training are employed; that before testing patient specimens all personnel have the appropriate education, experience and training and have demonstrated they can perform all testing operations reliably; that policies and procedures monitor the competency of everyone in each phase of testing and identify remedial training needs; that an approved procedure manual is available to all personnel; and that the responsibilities and duties of each consultant, supervisor and person engaged in testing are specified in writing, stating the examinations each may perform, whether supervision is required and whether consultant, supervisory or director review is required before results are reported.