Gentler lab regulations

Article Abstract:

The Health Care Financing Administration (HCFA) has agreed to amend new regulations governing inspections of clinical laboratories as mandated by the Clinical Laboratory Improvement Act of 1988 (CLIA). The HCFA will extend the time that physicians have to register labs until Dec 1. Private insurers will continue to pay claims for tests performed by such labs until that date. Unannounced inspections, the biggest source of complaints, have been dropped. Physicians must comply with all other provisions of CLIA.

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Money at the root of latest CLIA relaxation proposal

Article Abstract:

The federal government may loosen restrictions on the operation of clinical laboratories. The new plan, developed by the Department of Health and Human Services, would allow low-volume and low-risk labs to perform self-assessments instead of the on-site visits that are part of the Clinical Laboratory Improvement Amendments of 1988. In addition, laboratories that pass an inspection would be exempted from the next one. The measure is expected to encounter opposition in Congress.

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Medical Laboratories, Medical and Diagnostic Laboratories, Medical Facilities Regulation, Physicians, Medical professions, Health facilities, Medical law

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New category for microscopy tests a win for medicine

Article Abstract:

Regulations for microscopy procedures performed by physicians have been changed under the Clinical Laboratory Improvement Amendment of 1988. Doctors of medicine, podiatry and osteopathy may now perform KOH preparations, vaginal wet mounts, fern tests, urine sediment exams, pinworm preparations and postcoital exams in their own medical laboratories. The new regulations reduce the amount of federal oversight necessary to conduct these and other microscopy procedures.

Microscopy, Medical, Medical microscopy

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