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1
Laboratory Control, Ltd., 1005 Pennsylvania Ave., Ottumwa, IA 52501.
2
Department of Pathology, University of Iowa, Iowa
City, IA 52242.
a Author for correspondence. Fax (515) 682-8976.
We have studied 219 353 individual clinical chemistry results obtained
in methods comparison studies. Each result was prospectively compared
with its replicate, comparative, or repeat value to identify
differences from expected values. Unacceptable results were defined as
differing from the expected values by 
7 SDs or CVs. We believe these
differences represent special-cause variation and should be expressed
as unacceptable rates per million results (ppm). We observed 447 ppm
unacceptables: 196 ppm in control samples and 251 ppm in patients'
samples. Results judged likely to alter patient care occurred at a rate
of 41 ppm. To better understand the magnitude of these rates, we
compared these results with reports of error rates in HIV testing and
the airline industry. The measurements reported were made for the
purpose of quality improvement, not judgment or discovery. The
significance of these findings for laboratorians, manufacturers, and
regulators is discussed.
Key Words: indexing terms: accuracy • bias • precision • quality assurance • quality control • statistics • special-cause variation • statistical process control
The following articles in journals at HighWire Press have cited this article:
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  M. J O'Kane, P L M. Lynch, and N. McGowan The development of a system for the reporting, classification and grading of quality failures in the clinical biochemistry laboratory Ann Clin Biochem, March 1, 2008; 45(2): 129 - 134. [Abstract] [Full Text] [PDF]
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 H. J. Vermeer, E. Thomassen, and N. de Jonge Automated Processing of Serum Indices Used for Interference Detection by the Laboratory Information System Clin. Chem., January 1, 2005; 51(1): 244 - 247. [Full Text] [PDF]
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S. C. Kazmierczak, V. Ostoich, K. Aron, A. Hickey, D. E. Kazmierczak, and D. M. Bleile Clinical Evaluation of an Algorithm for Short Sample Detection on a Multi-analyte Panel Using a Point-of-Care Analyzer Clin. Chem., October 1, 2004; 50(10): 1947 - 1949. [Full Text] [PDF]
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P. Bonini, M. Plebani, F. Ceriotti, and F. Rubboli Errors in Laboratory Medicine Clin. Chem., May 1, 2002; 48(5): 691 - 698. [Abstract] [Full Text] [PDF]
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 M.J. Murphy and J.R. Paterson Point-of-care testing: no pain, no gain QJM, November 1, 2001; 94(11): 571 - 573. [Full Text] [PDF]
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W. P. Oosterhuis, H. J.L.M. Ulenkate, and H. M.J. Goldschmidt Evaluation of LabRespond, a New Automated Validation System for Clinical Laboratory Test Results Clin. Chem., November 1, 2000; 46(11): 1811 - 1817. [Abstract] [Full Text] [PDF]
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R. W. Jenny and K. Y. Jackson-Tarentino Causes of Unsatisfactory Performance in Proficiency Testing Clin. Chem., January 1, 2000; 46(1): 89 - 99. [Abstract] [Full Text] [PDF]
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S. Shahangian, R. D. Cohn, E. E. Gaunt, and J. M. Krolak System to Monitor a Portion of the Total Testing Process in Medical Clinics and Laboratories: Evaluation of a Split-Specimen Design Clin. Chem., February 1, 1999; 45(2): 269 - 280. [Abstract] [Full Text] [PDF]
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M. Stahl, E. D. Lund, and I. Brandslund Reasons for a Laboratory's Inability to Report Results for Requested Analytical Tests Clin. Chem., October 1, 1998; 44(10): 2195 - 2197. [Full Text] [PDF]
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D. Stockl, M. Plebani, P. Carraro, W. Hoelzel, A. Finke, and K. Miedema Modern Quality Management Misunderstood? The authors of one of the articles referred to above reply: Clin. Chem., May 1, 1998; 44(5): 1066 - 1067. [Full Text] [PDF]
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