Clinical Laboratory Improvement Amendments

Federal legislation, and the personnel and procedures established by it under the aegis of the Health Care Financing Administration (HCFA), for the surveillance and regulation of all clinical laboratory procedures in the U.S.The C. of 1988 (CLIA '88) were passed by Congress in response to public concerns about the quality of laboratory testing, particularly in physician office laboratories and in Pap smear interpretation. This legislation brought all 150,000 U.S. clinical laboratories, including physician office laboratories, under uniform regulations. A clinical laboratory is defined as any facility where materials derived from the human body are examined for the purpose of providing information for the diagnosis, prevention, or treatment of disease or the assessment of health. Standards applied to laboratory personnel and procedures are based on test complexity and potential harm to the patient. The regulations establish application procedures and fees for CLIA registration, enforcement and surveillance methods, and sanctions applicable when laboratories fail to meet standards. CLIA regulations define three categories of testing complexity : waived, moderate, and high. A subcategory for physician-performed microscopy exists at the moderate complexity level. For tests of moderate or high complexity, the laboratory must participate in a continuing program of proficiency testing whereby an independent laboratory periodically submits specimens of known composition for testing. The imposition and enforcement of CLIA regulations have elicited opposition, particularly from private physicians performing office testing. Opponents of the legislation claim that, while there is little, if any, demonstrable evidence that the CLIA rules have resulted in an improvement in patient care, regulation of office laboratories impedes the ability of physicians to serve their patients' needs. Patients and third-party payers have had to absorb increases in the cost of laboratory testing due to compliance with CLIA regulations. In addition, about one-third of physicians have discontinued some or all office testing as a result of CLIA. This has led to added inconvenience and expense for both patients and physicians. Particularly for children, the poor, and the elderly, the difficulty of arranging repeated visits and of complying with monitoring schedules decreases the quality of overall patient care. Delayed receipt by physicians of laboratory test results diminishes patient compliance, leads to delays or errors in diagnosis, and requires the use of anticipatory treatment, which leads to unnecessary expense and in some cases avoidable hospitalization.