Context.-Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to promote uniform quality and standards among all testing sites in the United States. The performance indicators specified in the legislation are proficiency testing (PT) performance and periodic inspections. Objective.-To evaluate variation in PT performance by type of testing facility during the first year of compulsory participation under CLIA. Design.-All 1994 PT score data electronically reported to the Health Care Financing Administration as a component of compliance with the CLIA regulations were obtained. Over 1.2 million PT event scores from 17 058 unique testing sites were sorted into 2 groups based on the type of testing facility: hospitals and independent laboratories (HI) and all other testing sites (AOT). Main Outcome Measures.-Satisfactory and unsatisfactory performance rates for HI and AOT for each analyte and/or test, according to the criteria specified by the CLIA regulations. Results.-The aggregate rates of satisfactory event performance for all regulated analytes, tests, and specialties were 97% and 91% for the HI and AOT groups, respectively. The aggregate odds ratio for unsatisfactory PT event performance for the AOT group compared with the HI group was 2.89, with a range of 2.19 to 7.51 for the individual analytes. Conclusion.-There was a consistent difference in PT performance during the first full year of compulsory PT under the CLIA regulations based on the type of testing facility performing the analysis. Traditional testing sites achieved higher rates of satisfactory performance than newly regulated, alternative testing sites.
A b s t r a c tWe rescreened Papanicolaou smear slidesfrom 40,245 women, which In 1987, articles in the Wall Street Journal questioned the compétence of laboratories that read Papanicolaou (Pap) smears and attributed misdiagnosed cases of cancer to "excessive workloads of cytotechnologists, lack of quality control procédures, and poorly educated personnel." 1 2 Congressional hearings on the matter followed, and in 1988, the Clinical Laboratory Improvement Amendments (CLIA) were enacted to require ail people screening or interpreting Pap smears to take a periodic proficiency test, with such testing to take place under normal working conditions. The régulations to implement CLIA specified that a glass-slide test should be used for this proficiency test. 3 It has not been possible to implement such a program nationwide because of the resources needed to assemble and maintain the necessary number of high-quality glass slides in the required diagnostic caté-gories for the test. [4][5][6] This has renewed a longstanding discussion about the validity of glass-slide proficiency testing in Pap smear quality assurance and stimulated a search for alternative testing stratégies. 7 -8 State operated and approved proficiency testing programs hâve been available in the United States for more than 20 years, and thèse hâve been studied in détail, 5 -9-19 but the validity of the glass-slide proficiency test for measuring screening skills has not been established firmly.
20The goals of the présent study were to détermine whether the performance of screeners who screen Pap smears (determined by rescreening their previous work) correlates with screeners' performance on a glass-slide proficiency test, as required by the CLIA régulations, and to evaluate a computer-based proficiency test recently developed at the
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