Purpose - to examine the effects of the Clinical Laboratory Improvement Amendments of 1988 on clinical laboratories and to determine if there is a basis in patient outcomes for regulations governing personnel and equipment.
Design - Retrospective analysis of Medicare claims and death records for 1992-1993 in 6 states and laboratory registrations collected by HCFA following the initiation of federal licensure requirements under the CLIA ‘88.
Outcome Measures. - Occurrence of death, bleeding, stroke myocardial infarction or no adverse event within 6 days of an outpatient prothrombin time test.
Results. Pre-CLIA ‘88 findings that small volume physician office laboratories pose a greater risk to patients were not confirmed after implementation of the regulations. Occurrence of adverse events was sensitive to the duties and qualifications of personnel in POLs but not in commercials. For POLs, the relative risk of an adverse event was lowed when a technologist supervised the laboratory instead of a physician but it was raised when a physician performed testing instead of a technologist. The probability of an adverse outcome was affected in POLs by equipment configurations but in commercial laboratories few configurations mattered.
Conclusion. CLIA ‘88 required virtually all clinical laboratories to obtain licenses and demonstrate proficiency in performing certain types of "difficult" tests, including prothrombin time. Our findings are consistent with reports that some smaller POLs ceased operations or reduced their variety of tests in response to these requirements.
Learning Objectives: The purpose of the paper is to help laboratory policy makers identify the scientific basis and cost effectiveness of regulatory policy. This is NOT a paper for training laboratory managers on how to comply with the existing regulatory requirements
Keywords: , Regulations
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: HCFA, CDC regulations
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.