Medicare, Medicaid and CLIA programs; extension of certain effective dates for clinical laboratory requirements and personnel requirements for cytologists--HCFA. Final rule with comment period.
This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, which implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and announces our approval of a certifying organization for qualifying cytotechnologists. This rule extends the date by which an individual must enroll in an HCFA-approved cytology proficiency testing (PT) program and the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. In addition, we are extending the phase-in of the quality control requirements applicable to unmodified, moderate complexity tests cleared for commercial distribution by the Food and Drug Administration (FDA). We are extending the date to meet applicable CLIA QC requirements for laboratories using commercial, nonmodified tests to fulfill certain quality control (QC) requirements. These effective date extensions do not reduce the current requirements for quality test performance. The date extensions are necessary due to the limited number and scope of currently operating cytology PT programs, resource constraints that have prevented commencement of the substantial number of quality control reviews, and inability of many laboratory directors to complete certification requirements within the time period originally specified.
D014487:Centers for Medicare and Medicaid Services, U.S.; D002983:Clinical Competence; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards; D008484:Medicaid; D017056:Medical Laboratory Personnel / Q000331:legislation & jurisprudence* / Q000592:standards; D006278:Medicare; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D014481:United States