Health Care Financing Administration/Clinical Laboratory Improvement Amendments of 1988

The Health Care Financing Administration has introduced new concepts for the Clinical Laboratory Improvement Amendments of 1988 survey program. Surveyors now look at the laboratory as a whole as opposed to each regulatory requirement independently. This quality assurance approach allows the surveyor to assess the laboratory's ability to provide quality test results as well as identify and correct its own problems. Significant problems in laboratories are more easily identified using this method. Another new concept allows good performing laboratories to go longer between on-site surveys by completing a self-assessment questionnaire on alternate cycles. The Health Care Financing Administration is asking both surveyors and laboratories to evaluate these new approaches. The Health Care Financing Administration continues to work with the Food and Drug Administration through our Memorandum of Understanding to assess Food and Drug Administration requirements in hospitals and laboratories that provide transfusion services. Transfusion-related fatalities must be reported to the Food and Drug Administration and may be investigated by either the Health Care Financing Administration or the Food and Drug Administration. For fatalities needing investigation by both agencies, every effort will be made to conduct these jointly.