The role of external quality assessment schemes in monitoring and improving the standardization process

Clinica Chimica Acta

Volumn 432, Issue , 2014, Pages 77-81

  Ceriotti, Ferruccio ^a  

^a SAN RAFFAELE HOSPITAL   (Italy)

Author keywords

Accuracy; External quality assessment; Traceability

Indexed keywords

ARTICLE; CLINICAL LABORATORY; COMMUTABILITY; EXTERNAL QUALITY ASSESSMENT; FIELD METHOD; HARMONIZATION; HISTORY; HUMAN; LABORATORY TEST; MEDICAL SPECIALIST; MONITORING; PRIORITY JOURNAL; QUALITY CONTROL; QUALITY CONTROL PROCEDURES; REFERENCE VALUE; STANDARD; STANDARDIZATION; TRACEABILITY; UNCERTAINTY; VALIDATION PROCESS; DIAGNOSTIC PROCEDURE; HEALTH CARE QUALITY; PROCEDURES; STANDARDS;

CLINICAL LABORATORY TECHNIQUES; HUMANS; QUALITY ASSURANCE, HEALTH CARE; REFERENCE STANDARDS;

EID: 84901624869     PISSN: 00098981     EISSN: 18733492     Source Type: Journal    
DOI: 10.1016/j.cca.2013.12.032     Document Type: Article

References (54)

1. Panteghini M. Traceability as a unique tool to improve standardization in laboratory medicine. Clin Biochem 2009, 42:236-240.
2. Müller M.M. Implementation of reference systems in laboratory medicine. Clin Chem 2000, 47:1907-1909.
3. Cali J.P. An idea whose time has come. Clin Chem 1973, 19:291-293.
4. Tietz N.W. A model for a comprehensive measurement system in clinical chemistry. Clin Chem 1979, 25:833-839.
5. Belk W.P., Sunderman F.W. A survey of chemical analyses in clinical laboratories. Am J Clin Pathol 1947, 17:853-861.
6. Wootton I.D.P. International biochemical trial 1954. Clin Chem 1956, 2:296-301.
7. Tonks D.B. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963, 9:217-233.
8. Vanzetti G. A survey on a national scale in the field of clinical chemistry: results and prospects. Minerva Med 1967, 58:2724-2735.
9. Whitehead T.P., Browning D.M., Gregory A. A comparative survey of the results of analyses of blood serum in clinical chemistry laboratories in the United Kingdom. J Clin Pathol 1973, 26:435-445.
10. Howerton D., Krolak J.M., Manasterski A., Handsfield J.H. Proficiency testing performance in US laboratories: results reported to the Centers for Medicare & Medicaid Services, 1994 through 2006. Arch Pathol Lab Med 2010, 134:751-758.
11. Büttner J., Borth R., Boutwell J.H., Broughton P.M.G., Bowyer R.C. Provisional recommendation on quality control in clinical chemistry. Part 5. external quality control. Clin Clim Acta 1978, 83:189F-202F.
12. Pickup J.F., Jackson M.J., Price E.M., et al. Use of the reference method for determination of serum calcium in a quality-assurance survey. Clin Chem 1975, 21:1416-1421.
13. Stamm D. A new concept for quality control of clinical laboratory investigations in the light of clinical requirements and based on reference method values. J Clin Chem Clin Biochem 1982, 20:817-824.
14. Lasky F.D. Proficiency testing linked to the National Reference System for the clinical laboratory: a proposal for achieving accuracy. Clin Chem 1992, 38:1260-1267.
15. Franzini C. The reference method value. Ann Ist Super Sanita 1991, 27:359-363.
16. Libeer J.C., Baadenhuijsen H., Fraser C.G., et al. Characterization and classification of External Quality Assessment Schemes (EQA) according to objectives such as evaluation of method and participant bias and standard deviation. Eur J Clin Chem Clin Biochem 1996, 34:665-678.
17. Rej R., Jenny W., Bretaudiere J.P. Quality control in clinical chemistry: characterization of reference materials. Talanta 1984, 31:851-862.
18. Rej R. Accurate enzyme activity measurements: two decades of progress in the commutability of enzyme materials. Arch Pathol Lab Med 1993, 117:352-364.
19. Rej R. Proficiency testing, matrix effects, and method evaluation. Clin Chem 1994, 40:345-346.
20. Franzini C. Commutability of reference materials in clinical chemistry. J Int Fed Clin Chem 1993, 5:169-173.
21. Ross J.W., Myers G.L., Gilmore B.F., Cooper G.R., Naito H.R., Eckfeldt J. Matrix effects and the accuracy of cholesterol analysis. Arch Pathol Lab Med 1993, 117:393-400.
22. Carobene A., Ferrero C., Ceriotti F., et al. Creatinine measurement proficiency testing: assignment of matrix-adjusted ID GC-MS target values. Clin Chem 1997, 43:1342-1347.
23. Tietz N.W., Rodgerson D.O., Laessig R.H. Are clinical laboratory proficiency tests as good as they can be?. Clin Chem 1992, 38:473-475.
24. Tietz N.W. Accuracy in clinical chemistry - does anybody care?. Clin Chem 1994, 40:859-861.
25. Stockl D., Libeer J.C., Reinauer H., Thienpont L.M., De Leenheer A.P. Accuracy-based assessment of proficiency testing results with serum from single donations: possibilities and limitations. Clin Chem 1996, 42:469-470.
26. Armbruster D., Miller R.R. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardisation of clinical laboratory test results. Clin Biochem Rev 2007, 28:105-113.
27. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices 1998, 1-37. Official Journal of the European Communities L 331.
28. EN 14136 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures [accessed June 22nd 2013]. http://esearch.cen.eu/esearch/extendedsearch.aspx.
29. ISO 17043 Conformity assessment - general requirements for proficiency testing http://www.iso.org/iso/catalogue_detail.htm?csnumber=29366.
30. Miller W.G., Myers G.L., Ashwood E.R., et al. State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry. Arch Pathol Lab Med 2008, 132:838-846.
31. Cobbaert C., Weykamp C., Franck P., et al. Systematic monitoring of standardization and harmonization status with commutable EQA samples - five year experience from The Netherlands. Clin Chim Acta 2012, 414:234-240.
32. Miller W.G., Jones G.R.D., Horowitz G.L., Weykamp C. Proficiency Testing/External Quality Assessment: current challenges and future directions. Clin Chem 2011, 57:1670-1680.
33. ISO 17511 In vitro diagnostic medical devices - measurement of quantities in biological samples - metrological traceability of values assigned to calibrators and control materials 2003, ISO, Geneva, Switzerland, [2003].
34. Wood W.G. Has the introduction of the European Parliament Directive 98/79/EC from 1998-10-27 concerning in-vitro diagnostic devices (IVD-directive) influenced performance of hormone immunoassay kits in terms of precision and accuracy? Results from selected external quality assessment (EQA) schemes between 1993 and 2008. Clin Lab 2009, 55:86-105.
35. Zegers I., Beetham R., Keller T., et al. The importance of commutability of reference materials used as calibrators: the example of ceruloplasmin. Clin Chem 2013, 59:1322-1329.
36. Boulo S., Hanisch K., Bidlingmaier M., et al. Gaps in the traceability chain of human growth hormone measurements. Clin Chem 2013, 59:1074-1082.
37. [accessed June 24, 2013]. http://www.bipm.org/jctlm/.
38. Bais R., Armbruster D., Jansen R.T., et al. IFCC Working Group on Allowable Error for Traceable Results (WG-AETR). Defining acceptable limits for the metrological traceability of specific measurands. Clin Chem Lab Med 2013, 51:973-979.
39. Infusino I., Panteghini M. Serum albumin: accuracy and clinical use. Clin Chim Acta 2013, 419:15-18.
40. CLSI Characterization and qualification of commutable reference materials for laboratory medicine. Approved guideline. CLSI document C53-A 2010, Clinical and laboratory standards Institute, Wayne, PA.
41. CLSI Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline. CLSI document C37-A 1999, Clinical and laboratory standards Institute, Wayne, PA.
42. Miller W.G., Myers G.L. Commutability still matters. Clin Chem 2013, 59:1291-1293.
43. Kessler A., Siekmann L., Weykamp C., et al. on behalf of the IFCC Committee on Traceability in Laboratory Medicine (C-TLM). External Quality Assessment Scheme for reference laboratories - review of 8years' experience. Clin Chem Lab Med 2013, 51:997-1005.
44. Panteghini M., Ceriotti F. Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?. Clin Chem Lab Med 2012, 50:813-817.
45. Panteghini M. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement. Clin Chem Lab Med 2010, 48:7-10.
46. Fraser C.G., Petersen P.H. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999, 45:321-323.
47. Dybkær R., Jørgensen K. International Union of Pure and Applied Chemistry, and International Federation of Clinical Chemistry, Commission on Clinical Chemistry. Quantities and units in clinical chemistry including recommendation 1966 1967, Munksgaard, Copenhagen.
48. ISO 15189 2012 medical laboratories - requirements for quality and competence 2012, International Organisation for Standardisation, Geneva.
49. Jones G.R. Reporting units for therapeutic drug monitoring: a correctable source of potential clinical error. Med J Aust 2007, 186:420-421.
50. Férard G., Dybkaer R. on the behalf of the IFCC and IUPAC Joint Committee for Nomenclature, Properties and Unit (C-NPU). Recommendations for clinical laboratory science reports regarding properties, units, and symbols: the NPU format. Clin Chem Lab Med 2013, 51:959-966.
51. García-Santamarina S., Suarez-Vega I., Fuentes-Arderiu X. Significant decimals and rounding. Clin Chem Lab Med 2004, 42:1071-1072.
52. Hawkins R.C., Badrick T., Hickman P.E. Over-reporting significant figures - a significant problem?. Clin Chim Acta 2007, 375:158-161.
53. Jones GR. Survey assay and laboratory performance in the traceability era: closing the loop with analytical traceability by appropriate quality control. 7th CIRME International Scientific Meeting, Stresa 24-05-2013. available at (accessed June 26, 2013). http://users.unimi.it/barb/public/UploadAttach/meeting%20STRESA%202013/05-Stresa-EQA-2013-Jones(1).pdf.
54. Bossuyt X., Louche C., Wiik A. Standardisation in clinical laboratory medicine: an ethical reflection. Ann Rheum Dis 2008, 67:1061-1063.