Fed Regist. 1992 Feb 28;57(40):7002-186.
This final rule revises regulations applicable to laboratories and implements provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. The regulation applies to laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. They specify the performance requirements, based on 19 test complexity and risk factors related to erroneous test results, that apply to laboratories that are subject to CLIA. They also list requirements for laboratories performing certain limited testing to be eligible for a certificate of waiver. These laboratories will not be inspected routinely, nor will they be required to meet certain other CLIA requirements.
本最终规则修订了适用于实验室的法规，并实施了1988年《临床实验室改进修正案》（CLIA）（公法100 - 578）的相关规定。该法规适用于对人体标本进行检查以用于诊断、预防或治疗人类任何疾病或损伤，或评估人类健康状况的实验室。它们根据19种检测复杂性以及与错误检测结果相关的风险因素，规定了适用于受CLIA监管的实验室的性能要求。它们还列出了进行某些有限检测的实验室获得豁免证书所需满足的要求。这些实验室将不会接受常规检查，也无需满足某些其他CLIA要求。
