Fed Regist. 1994 Dec 6;59(233):62606-9.
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.
本最终规则延长了1992年2月28日发布的法规中临床实验室要求的某些生效日期，该法规实施了1988年《临床实验室改进修正案》（CLIA）的条款，并宣布我们批准了一个为合格细胞技术人员提供认证的组织。本规则延长了个人必须参加医疗保险和医疗补助服务中心（HCFA）批准的细胞学能力验证测试（PT）计划的日期，以及拥有博士学位的个人必须获得委员会认证才能有资格担任进行高复杂性检测的实验室主任的日期。此外，我们正在延长适用于未经修改、中等复杂性且已获美国食品药品监督管理局（FDA）批准用于商业销售的检测的质量控制要求的逐步实施期。我们正在延长使用商业性、未修改检测的实验室满足适用的CLIA质量控制（QC）要求的日期。这些生效日期的延长并不会降低当前对质量检测性能的要求。由于目前运行的细胞学PT计划数量有限且范围较窄、资源限制导致无法开始大量质量控制审查，以及许多实验室主任无法在最初规定的时间段内完成认证要求，所以有必要延长日期。
