Fed Regist. 1997 May 12;62(91):25855-8.
This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends 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. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.
本最终规则延长了1992年2月28日发布、随后于1994年12月6日修订的法规中临床实验室要求的某些生效日期，这些法规实施了1988年《临床实验室改进修正案》（CLIA）的条款。本规则延长了适用于中等和高复杂性检测的质量控制要求的逐步实施日期，并延长了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。延长这些生效日期是为了让该部门有更多时间发布修订后的质量控制要求，并确保实验室主任能够完成认证要求。这些生效日期的延长不会降低当前对质量检测性能的要求。
