Evaluation of the Impact of Mandatory Regulations on Clinical Laboratory Performance

摘要

This study was intended to assist the Department of Health and Human Services to determine: (a) Whether a relationship exists between the promulgation and application of clinical laboratory regulations and the quality of laboratory performance over time; and (b) Which specific regulatory interventions appear to be most effective in improving clinical laboratory performance. The study provides a description of the universe of clinical laboratories. This descriptive assessment reviewed the types of laboratories subject to regulations and describes how the regulatory mechanisms operate. The various licensing, certification and accreditation programs were examined, focusing on their membership, inspection process and proficiency testing programs. The study initially intended to collect data on both hospital-based laboratories and independent laboratories. It was discovered, however, that detailed inspection data were not available on hospital-based laboratories prior to 1978. Thus, hospital laboratories which comprise about 60% of all laboratories were excluded from the study and, therefore, this study was able to address itself only to independent laboratories. Inspection data were collected on 284 active and 257 terminated laboratories. Of these 541 laboratories, 277 were Medicare-certified facilities, 160 were CLIA licensed, and 104 were joint CLIA/Medicare laboratories.