Abstract
An overview of the principles and practices of Quality Control (QC) in laboratory medicine, encompassing the origins of bias and variability in laboratory measurement, the regulation of same through internal (within-lab) and external (between-lab) QC programs, and concluding with an account of the strategies proposed for defining meaningful analytical goals in respect of the “quality” component of QC.
References
- 1 J. H. Boutwell ed. (1978). A National Understanding for the Development of Reference Materials and Methods for Clinical Chemistry—Proceedings of a Conference. AACC Press, Washington.
- 2 Bull, B. S. & Elashoff, R. M. (1974). The use of patient derived haematology data in quality control, Proceedings of the San Diego Biomedical Symposium 13, 515–519.
- 3 Bull, B. S., Elashoff, R. M., Heilbron, D. C. & Couperus, J. (1974). A study of various estimators for the derivation of quality control procedures from patient erythrocyte indices, American Journal of Clinical Pathology 61, 473–481.
- 4 Buttner, J., Borth, R., Boutwell, J. H. & Broughton, P. M. G. (1983). Federation of clinical chemistry: approved recommendation (1983) on quality control in clinical chemistry: IV. Internal quality control, European Journal of Clinical Chemistry and Clinical Biochemistry 21, 877–884.
- 5 Buttner, J., Borth, R., Boutwell, J. H., Broughton, P. M. G. & Bowyer, R. C. (1983). International federation of clinical chemistry: approved recommendation (1983) on quality control in clinical chemistry: V. External quality control, European Journal of Clinical Chemistry and Clinical Biochemistry 21, 885–892.
- 6 Cembrowski, G. S., Westgard, J. O., Eggert, A. A. & Toren, E. C. Jr. (1975). Trend detection in control data: optimization and interpretation of Trigg's technique for trend analysis, Clinical Chemistry, 21, 1396–1405.
- 7 Cotlove, E., Harris, E. K. & Williams, G. Z. (1970). Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medical implications, Clinical Chemistry 16, 1028–1032.
- 8 Ehrmeyer, S. S., Laessig, R. H., Leinweber, J. E. & Oryall, J. J. (1990). Medicare/CLIA final rules for proficiency testing: minimum intralaboratory performance characteristics (CV and bias) needed to pass, Clinical Chemistry 36, 1736–1740.
- 9 Ekins, R. (1991). Immunoassay standardization, Scandinavian Journal of Clinical Laboratory Investigation Supplement 205, 33–46.
- 10 F. R. Elevitch ed. (1977). Proceedings of the 1976 Aspen Conference on Analytical Goals in Clinical Chemistry, College of American Pathologists, Skokie.
- 11 Linnet, K. (2002). EZ rules: automatic selection of statistical control rules for laboratory tests: software review, Clinical Chemistry 48, 594–595.
- 12 Fraser, C. G. (2001). Biological Variation: from Principles to Practice. AACC Press, Washington.
- 13 Fraser, C. G. & Harris, E. K. (1989). Generation and application of data on biological variation in clinical chemistry, Critical Reviews in Clinical Laboratory Sciences 27, 409–437.
- 14 Fraser, C. G. & Hyltoft Peterson, P. (1999). Analytical performance characteristics should be judged against objective quality specifications, Clinical Chemistry 45, 321–323.
- 15 Fraser, C. G., Hyltoft Petersen, P., Ricos, C. & Haeckel, R. (1992). Proposed quality specifications for the imprecision and inaccuracy of analytical systems in clinical chemistry, European Journal of Clinical Chemistry and Clinical Biochemistry 30, 311–317.
- 16 Hahn, G. J., Hill, W. J., Hoerl, R. W. & Zinkgraft, S. A. (1999). The impact of six sigma improvement—a glimpse into the future of statistics, The American Statistician 532, 208–215.
- 17 Henry, R. J. & Segalove, M. (1952). The running of standards in clinical chemistry and the use of the control chart, Journal of Clinical Pathology 5, 305–311.
- 18 Hirst, A. D. (1998). External quality assurance, Annals of Clinical Biochemistry 35, 12–18.
- 19 Jay Smith, S. & Myers, G. L. (1991). Analyzing quality-control trends with moving slope charts, Clinical Chemistry 37, 341–346.
- 20 Johnson, R. A. & Bagshaw, M. (1974). The effect of serial correlation on the performance of CUSUM tests, Technometrics 16, 103–112.
- 21 Kringle, R. O. & Bogovitch, M. (1999). Statistical procedures, in Tietz Textbook of Clinical Chemistry, 3rd Ed, C. A. Burtis & E. R. Ashwood, eds. W.B. Saunders Co, Philadelphia, 288–294.
- 22
Lunetsky, E. S. &
Cembrowski, G. S.
(1987).
Performance characteristics of Bull's multirule algorithm for the quality control of multichannel hematology analyzers,
American Journal of Clinical Pathology
33,
634–638.
10.1093/ajcp/88.5.634 Google Scholar
- 23 NCCLS Document C24-A2 (1999). Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guidelines, 2nd Ed. National Committee for Clinical Laboratory Standards, Wayne.
- 24 NCCLS Document EP5-A (1999). Evaluation of Precision Performance of Clinical Chemistry Devices: Tentative Guidelines, 2nd Ed. National Committee for Clinical Laboratory Standards, Wayne.
- 25 Neubauer, A. S. (1997). The EWMA control chart: properties and comparison with other quality-control procedures by computer simulation, Clinical Chemistry 43, 594–601.
- 26 Page, E. S. (1954). Continuous inspection schemes, Biometrika 14, 100–115.
- 27 Ricos, C., Alvarez, V., Cava, F., Garcia-Lario, J. V., Hernandez, A., Jimenez, C. V., Minchinela, J., Perich, C. & Simon, M. (1999). Current databases on biologic variation: pros, cons, and progress, Scandinavian Journal of Clinical Laboratory Investigation 59, 491–500.
- 28 Sheiner, L. B., Wheeler, L. A. & Moore, J. K. (1979). The performance of delta check methods, Clinical Chemistry 25, 2034–2037.
- 29 Shewhart, W. A. (1931). Economic Control of Quality of Manufactured Product. Van Nostrand, New York.
- 30 Strike, P. W. (1991). Statistical Methods in Laboratory Medicine. Butterworth-Heinemann Ltd, Oxford.
- 31 Strike, P. W. (1996). Measurement and Control in Laboratory Medicine: A Primer on Control and Interpretation. Butterworth-Heinemann Ltd, Oxford.
- 32 Tietz, N. W. (1979). A model for a comprehensive measurement system in clinical chemistry, Clinical Chemistry 25, 833–839.
- 33 Trigg, D. W. (1964). Monitoring a forecasting system, Operational Research Quarterly 15, 271–274.
- 34 Uriano, G. A. & Cali, J. P. (1977). Role of reference materials and reference methods in the measurement process, in Validation of the Measurement Process, J. R. Voe, ed. American Chemical Society, Symposium series, Washington, DC.
- 35 U.S. Department of Health and Human Services: Clinical Laboratory Improvements Amendments of 1988. Final Rule. Laboratory Requirements, February 28, (1992). Federal Register 57, 7002–7288.
- 36 Westgard, J. O. (1992). Charts of operational process specifications (“OP-Specs charts”) for assessing the precision, accuracy, and quality control needed to satisfy proficiency testing criteria, Clinical Chemistry 38, 1226–1233.
- 37 Westgard, J. O., Barry, P. L., Hunt, M. R. & Groth, T. (1981). A multi-rule Shewhart chart for quality control in clinical chemistry, Clinical Chemistry 27, 493–501.
- 38 Westgard, J. O. & Groth, T. (1979). Power functions for statistical control rules, Clinical Chemistry 25, 863–869.
- 39 Westgard, J. O., Groth, T., Aronsson, T. & de Verdier, C. (1977). Combined Shewhart-Cusum control chart for improved quality control in clinical chemistry, Clinical Chemistry 23, 1881–1887.
- 40 Westgard, J. O. & Klee, G. G. (1999). Quality management, in Tietz Textbook of Clinical Chemistry, 3rd Ed, C. A. Burtis & E. R. Ashwood, eds. W.B. Saunders Co, Philadelphia, 384–418.
- 41 Westgard, J. O., Seehafer, J. J. & Barry, P. L. (1994). European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria, Clinical Chemistry 40, 1228–1232.
