Trends in quality assurance of metal determination in clinical chemistry†

Abstract

A summary is given of the main strategies that can be used to obtain high quality results in the determination of metals in clinical chemistry. The trends in quality assurance of metal analyses are discussed.

References

1. International Standards Organisation, Accuracy (Trueness and Precision) of Measurement Methods and Results. Part 1: General Principles and Definitions, ISO Standard 5725-1, ISO, Geneva, 1994.
2. B. E. Broderick, W. P. Cofino, R. Cornelis, K. Heydorn, W. Horwitz, D. T. E. Hunt, R. C. Hutton, H. M. Kongston, H. Muntau, R. Baudo, D. Rossi, J. G. vaan Raaphorst, T. T. Lub, P. Schramel, F. T. Smyth, D. E. Wells and A. G. Kelly, Mikrochim. Acta, 1991, II, 523.
3. G. T. Wernimont, Use of Statistics to Develop and Evaluate Analytical Methods, ed. Spindley, W., Association of Official Analytical Chemists, Arlington, VA, 1985.
4. J. M. Christensen, O. M. Poulsen and T. Anglov, in Handbook on Metals in Clinical and Analytical Chemistry, ed. Seiler, H. G., Sigel, A., and Sigel, H., Marcel Dekker, New York, 1994, pp. 45–46.
5. J. M. Christensen, Mikrochim. Acta, 1996, 123, 231.
6. International Standards Organisation, Control Charts - General Guide and Introduction, ISO 7870, ISO, Geneva, 1993.
7. International Standards Organisation, Control Charts for Arithmetic Means and Warning Limits, ISO 7873, ISO, Geneva, 1993.
8. International Standards Organisation, Acceptance Control Charts, ISO 7966, ISO, Geneva, 1993.
9. International Standards Organisation, Shewhart Control Charts, ISO 8258, Geneva, 1991.
10. M. Thompson and R. Wood, Pure Appl. Chem., 1995, 67, 649.
11. International Standards Organisation, Uses of Certified Reference Materials, ISO Guide 33, ISO, Geneva, 1989.
12. R. Cornelis, Mikrochim. Acta, 1991, III, 37.
13. General criteria for the operation of testing laboratories, Committé Européen de Normalisation/Committé Européen de Normalisation Electrotechnique, Brussels, EN 45001, 1989.
14. J. M. Christensen and E. Olsen, Ann. Ist. Super. Sanità, 1996, 32, 285.
15. European Commission, Guidelines for the Production and Certification of BCR Reference Materials, Doc. BCR/48/93, Commission of the European Community, Brussels, 1994.
16. B. N. Taylor and C. E. Kuyatt, Guidelines for evaluating and expressing the uncertainty of NIST measurement results. NIST Technical Note 1297, 1994 edn., United States Department of Commerce, National Institute of Standards and Metrology, Gaithersburg, MD.
17. A. Lamberty, L. Van Nevel, J. R. Moody and P. De Bievre, Accred. Qual. Assur., 1996, 1, 71.
18. Bureau International des Poids et Mesures, International Electrochemical Commision, International Federation of Clinical Chemistry, International Organization for Standardization, International Organization for Pure and Applied Chemistry, International Organization for Pure and Applied Physics and International Organization of Legal Metrology, International Vocabulary of Basic and General Terms in Metrology, ISO, Geneva, 1993.
19. J. M. Christensen, J. Kristiansen, K. Heydorn, E. Damsgaard and R. Cornelis, IAEA meeting report, in the press.
20. H. Klich, in Quality Assurance and TQM for Analytical Laboratories, ed. Parkany, M., The Royal Society of Chemistry, Cambridge, 1995, pp. 80–85.
21. S. Rasberry, ISO/REMCO, ISO, Geneva, 1995.
22. International Standards Organisation, Contents of Certificates of Reference Materials, ISO Guide 31, ISO, Geneva, 1981.
23. International Standards Organisation, International Organization for Standardization, ISO Guide 34, ISO, Geneva, 1996.
24. International Standards Organisation, Certification of Reference Materials—General and Statistical Principles, ISO Guide 35, ISO, Geneva, 1989.
25. J. K. Taylor, Handbook for SRM Users, ed. Trahey, N. M, United States Department of Commerce, National Institute of Standards and Metrology, Gaithersburg, MD, 1993.
26. J. Kristiansen, J. M. Christensen, L. Lillemark, S. A. Linde, J. Merry, B. Nyeland and O. Petersen, Fresenius' J. Anal. Chem., 1995, 352, 157.
27. Bureau International des Poids et Mesures, International Electrochemical Commission, International Federation of Clinical Chemistry, International Organization of Standardization, International Union of Pure and Applied Chemistry, International Union of Pure and Applied Physics and International Organization of Legal Metrology, Guide to the Expression of Uncertainty in Measurement, ISO, Geneva, 1993.
28. J. Kristiansen, J. M. Christensen and J. L. Nielsen, Mikrochim. Acta, 1996, 123, 241.
29. J. Kristiansen and J. M. Christensen, Ann. Clin. Biochem., in the press.
30. European cooperation for Accreditation of Laboratories, European Confederation of Laboratory Medicine, Publication EAL-G25, Accreditation for Medical Laboratories, EAL/ECLM, 1997.
31. International Standards Organisastion, General Requirements for the Competence of Testing and Calibration laboratories, ISO/IEC Guide 25, ISO, Geneva, 1990.
32. Proficiency Testing by Interlaboratory Intercomparisons—Part 1: Development and Operation of Proficiency Testing Schemes—Part 2: Selection and Use of Proficiency Testing Schemes by Laboratory Accreditation Bodies, ISO, Geneva, 1996.
33. M. Thompson and R. Wood, Pure Appl. Chem., 1993, 65, 2123.
34. A. Uldall, EQAnews, 1996, 8, 3.
35. R. Cornelis, B. Heinzow, R. F. M. Herber, J. Molin Christensen, O. M. Poulsen, E. Sabbioni, D. M. Templeton, Y. Thomassen, M. Vahter and O. Vesterberg, Pure Appl. Chem., 1995, 67, 1575.
36. P. J. H. A. M. van de Leemput, Accred. Qual. Assur., 1997, 2, 263.
37. Good Automated Laboratory Practices, U.S. Environmental Protection Agency, North Carolina, 1995.
38. International Standards Organisation, Quality Systems—Model for Quality Assurance in Design, Development, Production, Installation and Servicing, ISO 9001, ISO, Geneva, 1994.
39. International Standards Organisation, Quality Systems—Model for Quality Assurance in Production, Installation and Servicing, ISO 9002, ISO, Geneva, 1994.
40. A. Taylor, Mikrochim. Acta, 1996, 123, 251.
41. A. Taylor, M. Patriarca, A. Menditto and G. Morisi, Ann. Ist. Super Sanità, 1996, 32, 295.