title: A regulatory model for clinical laboratories: an empirical evaluation.
abstract: Clinical laboratories in the United States are subject to various regulatory and accreditation programs, which mandate a broad range of requirements regarding personnel, quality-control systems, and analytical proficiency standards. Reported here, for a cross-section of U.S. laboratories, is the degree of compliance with these regulatory requirements, some other laboratory characteristics, and their relation to analytical proficiency. The results suggest that those laboratory characteristics that predict highest proficiency-test performance differ for each laboratory specialty. Regression models are presented that explain from 12% to 35% of the variation in analytical performance and suggest that factors outside of those specified in the regulatory model and other characteristics measured in this research are important. Indeed, the current regulatory approach may not ensure highest performance. Also discussed are the current status, limitations, and prospects for change of the clinical laboratory regulatory system.
authors.affiliation: Graduate School of Public Health, College of Health and Human Services, San Diego State University, CA 92182-0405.
authors.forename: K M
authors.initials: KM
authors.lastname: Peddecord
mesh_terms: D000068:Accreditation; D001432:Bacteriology; D002624:Chemistry, Clinical; D006405:Hematology; D007753:Laboratories / Q000592:standards*; D008004:Licensure; D010274:Parasitology; D011786:Quality Control; D012044:Regression Analysis; D013223:Statistics as Topic; D014481:United States