The role of proficiency testing in the detection and resolution of calibration bias in the LeadCare® blood lead analyzer; limitations of peer-group assessment |
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Authors: | Noel V. Stanton Tracy Fritsch Ciaran Geraghty Mary Frances Verostek Bruce Weiner Patrick J. Parsons |
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Affiliation: | (1) Toxicology Section, Wisconsin State Laboratory of Hygiene, PO Box 7996, Madison, WI 53707-7996, USA;(2) New York State Department of Health, Trace Elements Laboratory, Wadsworth Center, PO Box 509, Albany, NY 12201-0509, USA;(3) ESA Inc., 22 Alpha Drive, Chelmsford, MA 01824, USA;(4) Department of Environmental Health Sciences, School of Public Health, University at Albany, PO Box 509, Albany, NY 12201-0509, USA |
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Abstract: | Following implementation of the CLIA ‘88 laboratory regulations, the primary role of proficiency testing (external quality assessment, PT) in the U.S. has been widely viewed as one of assuring regulatory compliance. PT can also be an effective tool for detecting widespread analytical problems, subject to limitations based on the method of PT assigned value determination. A recent case study describes the role of two PT programs in detecting and resolving a calibration bias in the LeadCare blood lead analyzer, and illustrates the limitations of peer-group target determination in fulfilling that PT role. |
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Keywords: | Proficiency testing Blood lead Target determination |
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