Harmonization in laboratory medicine: The complete picture

Clinical Chemistry and Laboratory Medicine

Volumn 51, Issue 4, 2013, Pages 741-751

  Plebani, Mario ^a  

^a UNIVERSITY HOSPITAL OF PADOVA   (Italy)

Author keywords

Harmonization; Laboratory medicine; Patient safety; Quality; Standardization; Total testing process

Indexed keywords

ALBUMIN; ANTIVITAMIN K; CHOLESTEROL; CREATININE; ELECTROLYTE; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; GROWTH HORMONE; HORMONE; INSULIN; PARATHYROID HORMONE; PLASMA PROTEIN; POTASSIUM; PROSTATE SPECIFIC ANTIGEN; PROTEIN; REAGENT;

ACCREDITATION; ACCURACY; ANALYTICAL ERROR; CALIBRATOR; CERTIFICATION; CLINICAL CHEMISTRY; CLINICAL LABORATORY; CONSENSUS; ELECTRONIC MEDICAL RECORD; GLOMERULUS FILTRATION RATE; HEALTH CARE QUALITY; HEMOGLOBIN DETERMINATION; HUMAN; IMMUNOASSAY; INFORMATION TECHNOLOGY; INTERNATIONAL NORMALIZED RATIO; INTERPERSONAL COMMUNICATION; LABORATORY PERSONNEL; LABORATORY TEST; MEASUREMENT; MEDICAL SOCIETY; MEDICINE; PATIENT CARE; PATIENT SAFETY; POINT OF CARE TESTING; POLICY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONALISM; QUALITY CONTROL; REFERENCE VALUE; REVIEW; STANDARD; STANDARDIZATION; THYROID FUNCTION TEST; TURNAROUND TIME; UNCERTAINTY;

ACCREDITATION; HUMANS; LABORATORIES; QUALITY CONTROL; QUALITY INDICATORS, HEALTH CARE; REFERENCE VALUES; SPECIMEN HANDLING; UNCERTAINTY;

EID: 84882259359     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2013-0075     Document Type: Review

References (75)

1. Lundberg GD. Managing the patient-focused laboratory. Oradell, NJ: Medical Economics CO, 1975:9-42.
2. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101-10.
3. Rodin N. What is a standard? Clin Chem 1967;13:55-76.
4. Bossuyt X, Louche C, Wiik A. Standardization in clinical laboratory medicine: an ethical reflection. Ann Rheum Dis 2008;67:1061-3.
5. Ungerer JP, Marquart L, O ' Rourke PK, Wilgen U, Pretorious CJ. Concordance, variance, and outliers in 4 contemporary cardiac troponin assays: implications for harmonization. Clin Chem 2012;58:274-83.
6. De la Salle B. Pathology harmony moves on: progress on implementation in haematology. Br J Haematol 2012;158:804-5.
7. Barry MJ, Edgman-Levitan S. Shared decision making-the pinnacle of patient-centered care. N Engl J Med 2012;366:780-1.
8. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011;136:829-33.
9. International Organization for Standardization. ISO 15189:2007: Medical laboratories: particular requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2007.
10. Henricks WH. " Meaningful use " of electronic health records and its relevance to laboratories and pathologists. J Pathol Inform 2011;2:7-20.
11. International Organization for Standardization ISO 17511:2003. In vitro diagnostic medical devices-measurement of quantities in biological samples-metrological traceability of values assigned to calibrators and control materials. Geneva, Switzerland: International Organization for Standardization, 2003.
12. White GH. Metrological traceability in clinical biochemistry. Ann Clin Biochem 2011;48:393-409.
13. Ambruster D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote standardisation of clinical laboratory test results. Clin Biochem Rev 2007;28:105-13.
14. Siekmann L. Metrologial traceability-a concept for standardization in laboratory medicine. Clin Chem Lab Med 2012. doi: 10.1515/cclm-2012-0710. Epub ahead of print: Nov 12, 2012.
15. Miller WG, Myers GL, Rej R. Why commutability matters. Clin Chem 2006;52:553-4.
16. Franzini C, Ceriotti F. Impact of reference materials on accuracy in clinical chemistry. Clin Biochem 1998;31:449-57.
17. Vesper HW, Thienpont LM. Traceability in laboratory medicine. Clin Chem 2009;55:1067-75.
18. Greg Miller W, Myers GL, Lou Gantzer M, Kahn SE, Sch ö nbrunner ER, Thienpont LM, et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem 2011;57: 1108-17.
19. Panteghini M. Implementation of standardization in clinical practice: not always an easy task. Clin Chem Lab Med 2012;50:1237-41.
20. Stockl D, Sluss PM, Thienpont LM. Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin Chim Acta 2009;408:8-13.
21. Infusino I, Braga F, Mozzi F, Valente C, Panteghini M. Is the accuracy of serum albumin measurements suitable for clinical application of the test? Clin Chim Acta 2011;412:791-2.
22. Panteghini M, John WG; IFCC Scientific Division. Implementation of haemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med 2007;45:942-4.
23. Stephan C, Kahrs AM, Klotzek S, Reiche J, M ü ller C, Lein M, et al. Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards. Clin Chem Lab Med 2008;46:623-9.
24. 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.
25. Plebani M, Lippi G. Reference values and the Journal: why the past is now the present. Clin Chem Lab Med 2012;50:761-3.
26. Panteghini M, Ceriotti F. Obtaining reference intervals traceable to reference measurement systems: it is possible, who is responsible, what strategy? Clin Chem Lab Med 2012;50:813-7.
27. Morris HA. Traceability and standardization of immunoassays: a major challenge. Clin Biochem 2009;42:241-5.
28. Lustig V, Papanastasiou-Diamandis A, Goldberg DM. Evaluation of commercially formulated aspartate aminotransferase and alanine aminotransferase activity determinations by the Scandinavian Committee on Enzymes and IFCC methods as modified for use with automated enzyme analysers. Clin Biochem 1988;21:283-90.
29. Johnson AM, Whicher JT. Effect of certified reference material 470 (CRM 470) on national quality assurance programs for serum proteins in Europe. Clin Chem Lab Med 2001;39:1123-8.
30. Zegers I, Keller T, Schreiber W, Sheldon J, Albertini R, Blirup-Jensen S, et al. Characterization of the new serum protein reference material ERM-DA470k/IFCC: value assignment by immunoassay. Clin Chem 2010;56:1880-8.
31. Thienpont LM, Van Uytfanghe K, Van Houcke S; IFCC Working Group for Standardization of Thyroid Function Tests (WG-STFT). Standardization activities in the field of thyroid function tests: a status report. Clin Chem Lab Med 2010;48:1577-83.
32. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 1: thyroid-stimulating hormone. Clin Chem 2010;56:902-11.
33. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 2: free thyroxine and free triiodothyronine. Clin Chem 2010;56:912-20.
34. Miller WG, Thienpont LM, Van Uytfanghe K, Clark PM, Lindstedt P, Nilsson G, et al. Toward standardization of insulin immunoassays. Clin Chem 2009;55:1011-8.
35. Souberbielle JC, Roth H, Fouque DP. Parathyroid hormone measurement in CKD. Kidney Int 2010;77:93-100.
36. Davidson J. Harmonisation of growth hormone assays in Australasia. Clin Biochem Rev 2012;33:101-2.
37. Favaloro EJ, Adcock DM. Standardization of the INR: how good is your laboratory ' s INR and can it be improved? Semin Thromb Hemost 2008;34:593-603.
38. Meijer P, Haverkate F, Kluft C, de Moerloose P, Verbruggen B, Spannagl M. A model for the harmonisation of test results of different quantitative D-dimer methods. Thromb Haemost 2006;95:567-72.
39. Zwart A, van Assendelft OW, Bull BS, England JM, Lewis SM, Zijlstra WG. Recommendations for reference method for haemoglobinometry in human blood (ICSH standard 1995) and specifications for international haemiglobinocyanide standard (4th edition). Clin Pathol 1996;49:271-4.
40. Holden MJ, Madej RM, Minor P, Kalman LV. Molecular diagnostics: harmonization through reference materials, documentary standards and proficiency testing. Expert Rev Mol Diagn 2011;11:741-55.
41. van der Burg SH, Kalos M, Gouttefangeas C, Janetzki S, Ottensmeier C, Welters MJ, et al. Harmonization of immune biomarker assays for clinical studies. Sci Transl Med 2011;3:108-44.
42. Clinical and Laboratory Standards Institute (CLSI) Harmonized Terminology Database. Available from: http://www.clsi. org/source/custom/termsall.cfm? Section = Harmonized- Terminology-Database. Accessed 29 June 2012.
43. Tate JR, Johnson R, Legg M. Harmonisation of laboratory testing. Clin Biochem Rev 2012;33:81-4.
44. Smellie WS. Time to harmonise common laboratory test profiles. BMJ 2012;344:e1169.
45. Sturgeon CM, Duffy MJ, Hofmann BR, Lamerz R, Fritsche HA, Gaarenstroom K, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in liver, bladder, cervical, and gastric cancers. Clin Chem 2010;56:e1-48.
46. Aakre K, Langlois M, Watine J, Barth JH, Baum H, Collinson P, et al. Critical review of laboratory investigations in clinical practice guidelines; proposals for the description of investigation. Clin Chem Lab Med 2012. doi: 10.1515/cclm-2012-0574. Epub ahead of print: Oct 5, 2012.
47. Association for Clinical Biochemistry. National Minimum Re-testing Interval Project, 2012. In press.
48. Deetz CO, Nolan DK, Scott MG. An examination of the usefulness of repeat testing practices in a large hospital clinical chemistry laboratory. Am J Clin Pathol 2012;137:20-5.
49. 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.
50. Lippi G, Salvagno GL, Montagnana M, Lima-Oliveira G, Guidi GC, Favaloro EJ. Quality standards for sample collection in coagulation testing. Semin Thromb Hemost 2012;38:565-75.
51. Zaninotto M, Tasinato A, Padoan A Vecchiato G, Pinato A, Sciacovelli L, et al. An integrated system for monitoring the quality of sample transportation. Clin Biochem 2012;45: 688-90.
52. Zaninotto ML, Tasinato A, Padoan A, Vecchiato G, Pinato A, Sciacovelli L, et al. Effects of sample transportation on commonly requested laboratory tests. Clin Chem Lab Med 2012;50:1755-60.
53. Laboratory Medicine: A National Status Report. Available from: https://www.futurelabmedicine.org/pdfs/2007%20 status%20report%20laboratory- medicine-a-national- status-report-from-the-lewin-group.pdf. Accessed January 11, 2013.
54. Jones RG. And we call ourselves scientists..Bull Roy Coll Pathol 2012;157:45-6.
55. Legg M, Swanepoel C. The Australian Pathology Units and Terminology standardization project-an overview. Clin Biochem Rev 2012;33:103-8.
56. The International System of Units (SI), 8th ed. S è vres, France: Bureau International des Poids et Mesures, 2006. Available from: http://www.bipm.org. Accessed April 10 2011.
57. Ceriotti F, Hinzmann R, Panteghini M. Reference intervals: the way forward. Ann Clin Biochem 2009;46:8-17.
58. 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 2011;50:813-7.
59. Barth JH. Reference ranges still need further clarity. Ann Clin Biochem 2009;46:1-2.
60. Berg J, Lane V. Pathology harmony; a pragmatic and scientific approach to unfounded variation in the clinical laboratory. Ann Clin Biochem 2011;48:195-7.
61. Al-Ansary L, Farmer A, Hirst J, Roberts N, Glasziou P, Perera R, et al. Point-of-care testing for HbA1c in the management of diabetes: a systematic review and metaanalysis. Clin Chem 2011;57:568-76.
62. The Joint Commission: 2012 National Patient Safety Goals, Laboratory Accreditation Program. Available from: www. jointcommission.org/assets/1/6/NPSG- Chapter-Jan2012-LAB. pdf Accessed 17 August 2012.
63. Valenstein PN, Wagar EA, Stankovic AK, Walsh MK, Schneider F. Notification of critical results: a College of American Pathologists Q-Probes study of 121 institutions. Arch Pathol Lab Med 2008;132:1862-7.
64. Lippi G, Giavarina D, Montagnana M, Salvagno GL, Cappelletti P, Plebani M, et al. National survey on critical values reporting in a cohort of Italian laboratories. Clin Chem Lab Med 2007;45:1411-3.
65. Piva E, Sciacovelli L, Laposata M, Plebani M. Assessment of critical values policies in Italian institutions: comparison with the US situation. Clin Chem Lab Med 2010;48:461-8.
66. Plebani M, Sciacovelli L, Lippi G. Quality indicators for laboratory diagnostics: consensus is needed. Ann Clin Biochem 2011;48:479.
67. Plebani M, Chiozza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med 2012;28:1-9.
68. Sciacovelli L, O ' Kane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, et al. Quality indicators in laboratory medicine: from theory to practice. Preliminary data from the IFCC Working Group Project " Laboratory Errors and Patient Safety " . Clin Chem Lab Med 2011;49:835-44.
69. Rifai N, Watson ID, Miller WG. Commercial immunoassays in biomarkers studies: researchers beware! Clin Chem 2012;58:1387-8.
70. Price CP, Christenson RH. Evaluating new diagnostic technologies: perspectives in the UK and US. Clin Chem 2008;54:1421-3.
71. Favaloro EJ, Plebani M, Lippi G. Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing? Clin Chem Lab Med 2011;49:1965-73.
72. Ioannidis JP. Biomarker failures. Clin Chem 2013;59:202-4.
73. Van Houcke SK, Thienpont LM. "Good samples make good assays"-the problem of sourcing clinical samples for a standardization project. Clin Chem Lab Med 2012. doi: 10.1515/cclm-2012-0617. Epub ahead of print: Oct 6, 2012.
74. Bauer D, Krege J, Lane N, National bone health alliance bone turnover marker project: current practices and the need for US harmonization, standardization, and common reference ranges. Osteoporos Int 2012;23:2425-33.
75. Vasikaran S, Cooper C, Eastell R, Griesmacher A, Morris HA, Trenti T, et al. International osteoporosis foundation and International federation of clinical chemistry and laboratory medicine position on bone marker standards in osteoporosis. Clin Chem Lab Med 2011;49:1271-4