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Recommendation to treat continuous variable errors like attribute errors

  • Jan S. Krouwer
Published/Copyright: September 21, 2011

Abstract

Clinical laboratory errors can be considered as either belonging to attribute or continuous variables. Attribute errors are usually considered to be pre- or post-analytical errors, whereas continuous variable errors are analytical. Goals for each error type are different. Error goals for continuous variables are often specified as limits that contain 95% of the results, whereas attribute error goals are specified as allowed error rates for serious events. This leads to a discrepancy, because for a million results, there can be up to 50,000 medically unacceptable analytical errors, but allowable pre- and post-analytical error rates are much lower than 5%. Steps to remedy this are to classify analytical error rates into severity categories, exemplified by existing glucose error grids. The results in each error grid zone are then counted, as has been recommended by the Food and Drug Administration (FDA). This in effect transforms the continuous variable errors into attribute errors. This is an improvement over current practices for analytical errors, whereby the use of uncertainty intervals is recommended that include only 95% of the results (i.e., leaves out the worst 5%), and it is precisely this 5% of results that are likely to be in the most severe zones of an error grid.

Clin Chem Lab Med 2006;44:797–8.


Corresponding author: Jan S. Krouwer, 26 Parks Drive, Sherborn, MA 01770, USA Fax: +1-508-6479380

References

1. Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.Search in Google Scholar

2. The Lewin Group. The value of diagnostics: innovation, adoption and diffusion into health care. http://www.advamed.org/publicdocs/thevalueofdiagnostics.pdf, www.fda.gov/cdrh/postmarket/mdpi-report.pdf (accessed March 2, 2006).Search in Google Scholar

3. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997;1348–51.10.1093/clinchem/43.8.1348Search in Google Scholar

4. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002; 48:691–8.10.1093/clinchem/48.5.691Search in Google Scholar

5. Howanitz PJ. Errors in laboratory medicine: practical lessons to improve patient safety. Arch Pathol Lab Med 2005; 129:1252–61.10.5858/2005-129-1252-EILMPLSearch in Google Scholar PubMed

6. ISO 15197. In vitro diagnostic test systems – requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. http://www.ISO.org.Search in Google Scholar

7. Healthcare failure mode and effect analysis (HFMEA). VA National Center for Patient Safety. http://www.va.gov/ncps/SafetyTopics/HFMEA/HFMEAmaterials.pdf (accessed March 3, 2006).Search in Google Scholar

8. Dimech W, Francis B, Kox J, Roberts G. Calculating uncertainty of measurement for serology assays by use of precision and bias. Clin Chem 2006; 52:526–9.10.1373/clinchem.2005.056689Search in Google Scholar PubMed

9. Eurachem/CITAC. Quantifying uncertainty in analytical measurement. http://www.measurementuncertainty.org/mu/QUAM2000-1.pdf (accessed March 1, 2006).Search in Google Scholar

10. Cole LA, Rinne KM, Shahabi S, Omrani A. False positive hCG assay results leading to unnecessary surgery and chemotherapy and needless occurrences of diabetes and coma. Clin Chem 1999; 45:313–4.10.1093/clinchem/45.2.313Search in Google Scholar

11. Public Health Dispatch. Adverse events and deaths associated with laboratory errors at a hospital – Pennsylvania, 2001. MMWR Morb Mortal Wkly Rep 2001;50(33):10–1, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5033a4.htm (accessed March 2, 2006).Search in Google Scholar

12. Krouwer JS. A critique of the GUM method of estimating and reporting uncertainty in diagnostic assays. Clin Chem 2003; 49:1818–21.10.1373/clinchem.2003.019505Search in Google Scholar PubMed

13. Krouwer JS. An improved FMEA (failure mode effects analysis) for hospitals. Arch Pathol Lab Med 2004; 128:663–7.10.5858/2004-128-663-AIFMEASearch in Google Scholar PubMed

14. Clark WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 1987; 10:622–8.10.2337/diacare.10.5.622Search in Google Scholar PubMed

15. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000; 23:1143–8.10.2337/diacare.23.8.1143Search in Google Scholar PubMed

16. Draft guidance for industry and FDA staff. Recommendations for clinical laboratory improvement, amendments of 1988 (CLIA) waiver applications. http://www.fda.gov/cdrh/oivd/guidance/1171.pdf (accessed March 2, 2006).Search in Google Scholar

17. Kratz A, Januzzi JL, Lewandrowski K, Lee-Lewandrowski E. Positive predictive value of a point-of-care testing strategy on first-draw specimens for the emergency department-based detection of acute coronary syndromes. Arch Pathol Lab Med 2002; 126:1487–93.10.5858/2002-126-1487-PPVOAPSearch in Google Scholar PubMed

Received: 2006-3-3
Accepted: 2006-3-30
Published Online: 2011-9-21
Published in Print: 2006-7-1

©2006 by Walter de Gruyter Berlin New York

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