National Inventory of Clinical Laboratory Testing Services (NICLTS) - Development and test distribution for 1996

Context.-A statistically valid inventory of the distribution, both geograph ic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laborator y Improvements Amendments of 1988 and to provide information for other heal th care and public health policy decisions. Objective.-To present initial US laboratory testing volume data compiled by the National inventory of Clinical laboratory Testing Services. Design.-Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by metho d and analyte. Data were collected by field tabulators (moderate- or high-c omplexity laboratories) or through a mail/telephone survey (waived or provi der-performed microscopy laboratories) for each site. Participants.-Laboratories that were enrolled in the 1996 Online Certificat ion Survey and Reporting System, maintained by the US Health Care Finance A dministration, and that performed laboratory testing during 1996. Main Outc ome Measure.-Laboratory testing distribution for 1996 in the United States by analysis, method and specimen type. Results,An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microsc opy laboratories. The estimated total US testing volume for 1996 was 7.25 /- 1.09 billion tests, Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limi ts, 43% to 100%) of the testing volume. Glucose analysis was the most frequ ently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.-A statistically valid, consistent survey of the distribution o f US laboratory testing was obtained. Simple analysis of these data by labo ratory type and geographic region can provide insights into where laborator y testing is performed. The study design allows extensions that will facili tate collection of additional data of importance to public health and medic al care delivery.