Federal register
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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 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.