Quality specifications: Self pleasure for clinical laboratories or added value for patient management?

Clinical Chemistry and Laboratory Medicine

Volumn 45, Issue 4, 2007, Pages 462-466

  Plebani, Mario ^a  

^a UNIVERSITY HOSPITAL OF PADOVA   (Italy)

Author keywords

Analytical quality specifications; Clinical outcomes of evidence based laboratory medicine; Communication to clinicians; Pre analytical variation

Indexed keywords

ARTICLE; CLINICAL DECISION MAKING; CLINICAL LABORATORY; CONSENSUS; HEALTH CARE QUALITY; PATIENT CARE; PRIORITY JOURNAL; QUALITY CONTROL; TOTAL QUALITY MANAGEMENT;

EVIDENCE-BASED MEDICINE; LABORATORIES; PATIENT CARE MANAGEMENT;

EID: 34247355558     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2007.094     Document Type: Article

References (36)

1. Davis D, Evans M, Jadad A, Perrier L, Rath D, Ryan D, et al. The case for knowledge translation: shortening the journey from evidence to effect. Br Med J 2003;327:33-5.
2. Kilpatrick ES, Holding S. Use of computer terminals on wards to access emergency test results: a retrospective study. Br Med J 2001;322:1101-3.
3. Plebani M. Charting the course of medical laboratories in a changing environment. Clin Chim Acta 2002;319:87-100.
4. Tonks D. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963;9:217-33.
5. Barnett RN. Medical significance of laboratory results. Am J Clin Pathol 1968;50:671-6.
6. Cotlove E, Harris E, Williams G. Biological and analytical components of variation in long-term studies of serum constituents in normal subjects: III. Physiological and medical implications. Clin Chem 1970;16:1028-32.
7. Westgard JO. Six sigma quality design and control. Madison, WI: Westgard QC, Inc. 2001.
8. Fraser CG. Biological variation: from principles to practice. Washington DC: AACC Press, 2001.
9. Klee GG. Tolerance limits for short-term analytical bias and analytical imprecision derived from clinical assay specificity. Clin Chem 1993;39:1514-8.
10. Fraser CG, Hyltoft Petersen P, Ricos C, Haeckel R. Proposed quality specifications for the imprecision and inaccuracy of analytical systems in clinical chemistry. Eur J Clin Chem Clin Biochem 1992;30:311-7.
11. Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999. Scand J Clin Lab Invest 1999;59:475-6.
12. Kaplan LA. Determination and application of desirable analytical performance goals: the ISO/TC 212 approach. Scand J Clin Lab Invest 1999;59:479-82.
13. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691-8.
14. Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44:750-59.
15. Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side of the moon in laboratory testing. Clin Chem Lab Med 2006;44:358-65.
16. Kalra J. Medical errors: impact on clinical laboratories and other critical areas. Clin Biochem 2004;37:1052-62.
17. Plebani M. What information on quality specifications should be communicated to clinicians, and how? Clin Chim Acta 2004;346:25-36.
18. Rej R. Proficiency testing and external quality assurance: crossing borders and disciplines. Accred Qual Assur 2002;7:335-40.
19. The Joint European Society of Cardiology/American College of Cardiology Committee. Myocardial infarction redefined - a consensus document of the European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol 2000;36:959-69.
20. Howanitz PJ. Errors in laboratory medicine. Practical lessons to improve patient safety. Arch Pathol Lab Med 2005;129:1252-61.
21. Lichtenberg FR. Better information, better health: the value of clinical laboratory innovations. In: 2005 IQLM Conference: recognizing excellence in practice, Apr 28-30, 2005. Atlanta, GA.
22. Aronsson T, de Verdier C-H, Groth T. Factors influencing the quality of analytical methods: a system analysis with use of computer simulation. Clin Chem 1974;23:1857-67.
23. Siest G, Henny J. Commission on "Reference values". Production of reference values in healthy subjects. Ann Biol Clin 1981;39:235-44.
24. PetitClerc C, Wilding P. International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section. The theory of reference values. Part 2. Selection of individuals for the production of reference values. J Clin Chem Clin Biochem 1984;22:203-8.
25. Plebani M. The future of clinical laboratories: more testing or knowledge services? Clin Chem Lab Med 2005;43:893-6.
26. Lundberg GD. The need for an outcome research agenda for clinical laboratory testing. J Am Med Assoc 1998;280:565-6.
27. ISO 15189: 2003. Medical laboratories - particular requirements for quality and competence.
28. Bianchi MT, Alexander BM. Evidence based diagnosis: does the language reflect the theory? Br Med J 2006;333:442-5.
29. Jaffe AS, Babuin L, Apple FS. Biomarkers in acute cardiac disease. The present and future. J Am Coll Cardiol 2006;48:1-11.
30. Rifai N, Warnick GR. Quality specifications and the assessment of biochemical risk of atherosclerosis. Clin Chim Acta 2004;346:55-64.
31. Heim SW, Schectman JM, Siadaty MS, Philbrick JT. D-Dimer testing for deep venous thrombosis: a meta-analysis. Clin Chem 2004;50:1136-47.
32. Basso D, Guariso G, Plebani M. Serological testing for celiac disease. Clin Chem 2002;48:2082-3.
33. Van Meensel B, Hiele M, Hoffman I, Vermeire S, Rutqueerts P, Geboes K, et al. Diagnostic accuracy of ten second-generation (human) tissue transglutaminase antibody assays in celiac disease. Clin Chem 2004;50:2125-35.
34. Bassuk SS, Rifai N, Ridker P. High sensitivity C-reactive protein: clinical importance. Curr Probl Cardiol 2004;29:439-93.
35. Jones GR. Effect of the reporting-interval size on critical difference estimation: beyond "2.77". Clin Chem 2006;52:880-5.
36. Krouwer JS. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem 2002;48:919-27.