The impact of laboratory improvement programs on laboratory performance: the CLIA 67 experience.

The experience acquired by the Center for Diseases Control during the past 7 years in the administration of the Clinical Laboratories Improvement Act of 1967 suggests that the key indicators of reliability have been identified and that sensitive measurement of those indicators is now possible and practical. The costs of assuring high quality are inconsequential compared to the costs to the patient and taxpaying public of inaccurate test results. This objective system for evaluating clinical laboratories has been applied to licensed interstate laboratories and has been shown to be effective. This proven system has been offered to the Bureau of Health Insurance of the Social Security Administration for application to Medicare laboratories.