J Clin Outcomes Manage
Determinants of quality control practices in physician office laboratories
Avery GH, Lee J, Falk S
Abstract Objective: To examine organizational and institutional correlates of quality control performance in physicians’ office laboratories in order to identify determinants of poor quality practices. Design: Data on laboratory structure, culture, regulatory strategies, and quality control practices for 10 CLIA “waived” tests were used to identify significant relationships between quality performance and predicting factors. Two-stage regression models were used to control for endogeneity in the selection of regulatory strategy for CLIA compliance. Setting: 188 physician office laboratories. Measurements: Standardized measures of quality control performed are used as dependent variables. Independent variables include the CLIA strategy, practice type, number of physicians and supervisors, annual test volume, and measures of organizational culture adapted from a standard instrument. Results: Regulation by public agencies is ineffective in producing quality control, although private accreditation bodies are effective. Group practice, testing volume, commitment to quality, profit orientation, and resource issues are important predictors of quality control performance. Conclusions: The level of quality control is the result of a production function determined by the trade-off between the cost of quality and the value of quality. Regulatory strategies that minimize compliance costs are likely to be more effective than others in securing quality, and pay-for-quality mechanisms also may be useful in modifying the quality practices in physician office laboratories
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