Evaluation of Blood Lead Proficiency Testing: Comparison of Open and Blind Paradigms

Most proficiency testing (PT) programs operate with an open design in which clearly identified performance samples are distributed directly to participating laboratories on a shipping schedule announced in advance. In this study, we examine the effectiveness of assessing clinical laboratory performa...

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Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 2001-02, Vol.47 (2), p.322-330
Main Authors: Parsons, Patrick J, Reilly, Andrew A, Esernio-Jenssen, Debra, Werk, Lloyd N, Mofenson, Howard C, Stanton, Noel V, Matte, Thomas D
Format: Article
Language:English
Subjects:
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Chemical and industrial products toxicology. Toxic occupational diseases
Clinical Laboratory Techniques - standards
Data Interpretation, Statistical
Double-Blind Method
Fundamental and applied biological sciences. Psychology
Humans
Inorganic compounds
Lead - blood
Medical sciences
Metals and various inorganic compounds
Other biological molecules
Quality Control
Reference Values
Toxicology
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Summary:Most proficiency testing (PT) programs operate with an open design in which clearly identified performance samples are distributed directly to participating laboratories on a shipping schedule announced in advance. In this study, we examine the effectiveness of assessing clinical laboratory performance for blood lead with an open PT by comparing its results with a double-blinded testing protocol. Aliquots from up to 72 blood lead performance pools from the New York State Department of Health and the Wisconsin State Laboratory of Hygiene were disguised as routine patient specimens and submitted in two phases to up to 42 certified clinical laboratories for blood lead analysis. These 42 laboratories also received aliquots of the same performance samples for blood lead analysis directly from the "open" PT program provider. Data reported under blind and open strategies were scored against acceptable target ranges using the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) criteria established for blood lead, i.e., +/- 0.19 micromol/L (+/- 4 microg/dL) or +/- 10%, whichever is greater. Performance differences between the strategies were also assessed. We found that 17.7% of all blind PT results were classified as unacceptable compared with only 4.5% of open PT results (P
ISSN:0009-9147
1530-8561
DOI:10.1093/clinchem/47.2.322