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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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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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Acknowledgements

Contributions of the WI PT program were supported by grant H46MC00123 from the Bureau of Maternal and Child Health, Health Resources and Services Administration, US Dept. of Health and Human Services. The authors also wish to acknowledge Dr. Eric Zink and Robb Morse of ESA for their efforts during the investigation, and for their helpful review of this manuscript.

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Authors and Affiliations

  1. Toxicology Section, Wisconsin State Laboratory of Hygiene, PO Box 7996, Madison, WI, 53707-7996, USA

    Noel V. Stanton & Tracy Fritsch

  2. New York State Department of Health, Trace Elements Laboratory, Wadsworth Center, PO Box 509, Albany, NY, 12201-0509, USA

    Ciaran Geraghty, Mary Frances Verostek & Patrick J. Parsons

  3. ESA Inc., 22 Alpha Drive, Chelmsford, MA, 01824, USA

    Bruce Weiner

  4. Department of Environmental Health Sciences, School of Public Health, University at Albany, PO Box 509, Albany, NY, 12201-0509, USA

    Patrick J. Parsons

Authors
  1. Noel V. Stanton
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  2. Tracy Fritsch
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  3. Ciaran Geraghty
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  4. Mary Frances Verostek
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  5. Bruce Weiner
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  6. Patrick J. Parsons
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Correspondence to Noel V. Stanton.

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Stanton, N.V., Fritsch, T., Geraghty, C. et al. The role of proficiency testing in the detection and resolution of calibration bias in the LeadCare® blood lead analyzer; limitations of peer-group assessment. Accred Qual Assur 11, 590–592 (2006). https://doi.org/10.1007/s00769-006-0189-6

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  • DOI: https://doi.org/10.1007/s00769-006-0189-6

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