Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter September 21, 2011

Preanalytical variability: the dark side of the moon in laboratory testing

  • Giuseppe Lippi , Gian Cesare Guidi , Camilla Mattiuzzi and Mario Plebani

Abstract

Remarkable advances in instrument technology, automation and computer science have greatly simplified many aspects of previously tedious tasks in laboratory diagnostics, creating a greater volume of routine work, and significantly improving the quality of results of laboratory testing. Following the development and successful implementation of high-quality analytical standards, analytical errors are no longer the main factor influencing the reliability and clinical utilization of laboratory diagnostics. Therefore, additional sources of variation in the entire laboratory testing process should become the focus for further and necessary quality improvements. Errors occurring within the extra-analytical phases are still the prevailing source of concern. Accordingly, lack of standardized procedures for sample collection, including patient preparation, specimen acquisition, handling and storage, account for up to 93% of the errors currently encountered within the entire diagnostic process. The profound awareness that complete elimination of laboratory testing errors is unrealistic, especially those relating to extra-analytical phases that are harder to control, highlights the importance of good laboratory practice and compliance with the new accreditation standards, which encompass the adoption of suitable strategies for error prevention, tracking and reduction, including process redesign, the use of extra-analytical specifications and improved communication among caregivers.


Corresponding author: Prof. Giuseppe Lippi, MD, Istituto di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Ospedale Policlinico G.B. Rossi, Piazzale Scuro, 10, 37134 Verona, Italy Phone: +39-045-8074516, Fax: +39-045-8201889,

References

1. Sharpe VA, Faden AI. Medical harm: historical, conceptual, and ethical dimensions of iatrogenic illness. New York, NY: Cambridge University Press, 1998.Search in Google Scholar

2. Wachter RM. The end of the beginning: patient safety five years after ‘to err is human’. Health Aff (Millwood) 2004;Suppl Web Exclusives:W4-534-45.10.1377/hlthaff.W4.534Search in Google Scholar

3. AHRQ. Medical errors: the scope of the problem. Publication No. AHRQ 00-P037. Rockville, MD: Agency for Healthcare Research and Quality (http://www.ahrq.gov/qual/errback.htm).Search in Google Scholar

4. Kohn L, Corrigan J, Donaldson M, editors. To err is human: building a safer health system. Washington, DC: National Academies Press, 2000.Search in Google Scholar

5. McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, et al. The quality of health care delivered to adults in the United States. N Engl J Med 2003; 348:2635–45.10.1056/NEJMsa022615Search in Google Scholar PubMed

6. Anderson G, Hussey PS. Comparing health system performance in OECD countries. Organization for Economic Cooperation and Development. Health Aff (Millwood) 2001; 20:219–32.10.1377/hlthaff.20.3.219Search in Google Scholar PubMed

7. Graber M, Gordon R, Franklin N. Reducing diagnostic errors in medicine: what's the goal? Acad Med 2002; 77:981–92.10.1097/00001888-200210000-00009Search in Google Scholar PubMed

8. Bonini PA, Plebani M, Ceriotti F, Francesca Rubboli F. Errors in laboratory medicine. Clin Chem 2002; 48:691–8.10.1093/clinchem/48.5.691Search in Google Scholar

9. ISO/WD TS 22367. Medical laboratories – reduction of error through risk management and continual improvement.Search in Google Scholar

10. Kalra J. Medical errors: impact on clinical laboratories and other critical areas. Clin Biochem 2004; 37:1052–62.10.1016/j.clinbiochem.2004.08.009Search in Google Scholar PubMed

11. Lapworth R, Teal TK. Laboratory blunders revisited. Ann Clin Biochem 1994; 31:78–84.10.1177/000456329403100113Search in Google Scholar PubMed

12. McSwiney RR, Woodrow DA. Types of error within a clinical laboratory. J Med Lab Technol 1969; 26:340–6.Search in Google Scholar

13. Chambers AM, Elder J, O'Reilly DS. The blunder-rate in a clinical biochemistry service. Ann Clin Biochem 1986; 23:470–3.10.1177/000456328602300415Search in Google Scholar PubMed

14. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997; 43:1348–51.10.1093/clinchem/43.8.1348Search in Google Scholar

15. Stahl M, Lund ED, Brandslund I. Reasons for a laboratory's inability to report results for requested analytical tests. Clin Chem 1998; 44:2195–7.10.1093/clinchem/44.10.2195Search in Google Scholar

16. Hofgartner WT, Tait JF. Frequency of problems during clinical molecular-genetic testing. Am J Clin Pathol 1999; 112:14–21.10.1093/ajcp/112.1.14Search in Google Scholar

17. Howanitz PJ. Errors in laboratory medicine: practical lessons to improve patient safety. Arch Pathol Lab Med 2005; 129:1252–61.10.5858/2005-129-1252-EILMPLSearch in Google Scholar

18. Stroobants AK, Goldschmidt HM, Plebani M. Error budget calculations in laboratory medicine: linking the concepts of biological variation and allowable medical errors. Clin Chim Acta 2003; 333:169–76.10.1016/S0009-8981(03)00181-5Search in Google Scholar

19. Stankovic AK. The laboratory is a key partner in assuring patient safety. Clin Lab Med 2004; 24:1023–35.10.1016/j.cll.2004.05.017Search in Google Scholar PubMed

20. Wiwanitkit V. Types and frequency of pre-analytical mistakes in the first Thai ISO 9002:1994 certified clinical laboratory, a 6-month monitoring. BMC Clin Pathol 2001;1:5.10.1186/1472-6890-1-5Search in Google Scholar PubMed PubMed Central

21. Hollensead SC, Lockwood WB, Elin RJ. Errors in pathology and laboratory medicine: consequences and prevention. J Surg Oncol 2004; 88:161–81.10.1002/jso.20125Search in Google Scholar PubMed

22. Jones BA, Calam RR, Howanitz PJ. Chemistry specimen acceptability: a College of American Pathologists Q-Probe study of 453 labs. Arch Pathol Lab Med 1997; 121:19–26.Search in Google Scholar

23. Lippi G, Brocco G, Franchini M, Schena F, Guidi G. Comparison of serum creatinine, uric acid, albumin and glucose in male professional endurance athletes compared with healthy controls. Clin Chem Lab Med 2004; 42:644–7.10.1515/CCLM.2004.110Search in Google Scholar PubMed

24. Lippi G, Franchini M, Guidi G. Haematocrit measurement and antidoping policies. Clin Lab Haem 2002; 24:65–6.10.1046/j.1365-2257.2002.00425.xSearch in Google Scholar PubMed

25. Lippi G, Brocco G, Salvagno GL, Montagnana M, Dima F, Guidi GC. High-workload endurance training may increase the serum ischemia modified albumin concentrations. Clin Chem Lab Med 2005; 43:741–4.10.1515/CCLM.2005.126Search in Google Scholar PubMed

26. Lippi G, Salvagno GL, Montagana M, Guidi GC. Chronic influence of vigorous aerobic training on hemostasis. Blood Coagul Fibrinolysis 2005; 16:533–4.10.1097/01.mbc.0000183117.66605.a3Search in Google Scholar PubMed

27. Lippi G, Salvano GL, Montagnana M, Schena F, Balestrieri F, Guidi GC. Influence of physical exercise and relationship with biochemical variables of NT-pro-brain natriuretic peptide and ischemia modified albumin. Clin Chim Acta 2006. In press.10.1016/j.cca.2005.11.018Search in Google Scholar

28. Burns ER, Yoshikawa N. Hemolysis in serum samples drawn by emergency department personnel versus laboratory phlebotomists. Lab Med 2002; 33:378–80.10.1309/PGM4-4F8L-2P1M-LKPBSearch in Google Scholar

29. Carraro P, Servidio G, Plebani M. Hemolyzed specimens: a reason for rejection or a clinical challenge? Clin Chem 2000; 46:306–7.10.1093/clinchem/46.2.306Search in Google Scholar

30. Lippi G, Montagnana M, Salvagno GL, Guidi GC. Interference of blood cell lysis on routine coagulation testing. Arch Pathol Lab Med 2006. In press.10.5858/2006-130-181-IOBCLOSearch in Google Scholar

31. Lippi G, Salvagno GL, Montagnana M, Brocco G, Guidi GC. Influence of hemolysis on routine clinical chemistry testing. Clin Chem Lab Med 2006; 44:311–6.10.1515/CCLM.2006.054Search in Google Scholar

32. Lippi G, Salvagno GL, Montagnana M, Guidi GC. Influence of short-term venous stasis on clinical chemistry testing. Clin Chem Lab Med 2005; 43:869–75.10.1515/CCLM.2005.146Search in Google Scholar

33. Lippi G, Salvagno GL, Montagnana M, Guidi GC. Short term venous stasis influences routine coagulation testing. Blood Coagul Fibrinolysis 2005; 16:453–8.10.1097/01.mbc.0000178828.59866.03Search in Google Scholar

34. Lippi G, Salvagno GL, Solero GP, Guidi GC. The influence of the tourniquet time on hematological testing for antidoping purposes. Int J Sports Med 2006. In press (DOI: 10.1055/s-2005-865749).Search in Google Scholar

35. Young DS. Conveying the importance of the preanalytical phase. Clin Chem Lab Med 2003; 41:884–7.10.1515/CCLM.2003.133Search in Google Scholar

36. Morrissey MB, Wilson AJ. The potential costs of accounting for genotypic errors in molecular parentage analyses. Mol Ecol 2005; 14:4111–21.10.1111/j.1365-294X.2005.02708.xSearch in Google Scholar

37. Narayanan S. Considerations in the application of selected molecular biology techniques in the clinical laboratory: preanalytical and analytical issues. Rinsho Byori 1996; 103(Suppl):262–70.Search in Google Scholar

38. Plebani M. Appropriateness in programs for continuous quality improvement in clinical laboratories. Clin Chim Acta 2003; 333:131–9.10.1016/S0009-8981(03)00177-3Search in Google Scholar

39. Winkelman JW, Mennemeyer ST. Using patient outcomes to screen for clinical laboratory errors. Clin Lab Manage Rev 1996; 10:134–6.Search in Google Scholar

40. Fogt EJ. Continuous ex vivo and in vivo monitoring with chemical sensors. Clin Chem 1990; 36:1573–80.10.1093/clinchem/36.8.1573Search in Google Scholar

41. Ashley K. Developments in electrochemical sensors for occupational and environmental health applications. J Hazard Mater 2003; 102:1–12.10.1016/S0304-3894(03)00198-5Search in Google Scholar

42. Ulber R, Frerichs JG, Beutel S. Optical sensor systems for bioprocess monitoring. Anal Bioanal Chem 2003; 376:342–8.10.1007/s00216-003-1930-1Search in Google Scholar

43. Frost MC, Meyerhoff ME. Implantable chemical sensors for real-time clinical monitoring: progress and challenges. Curr Opin Chem Biol 2002; 6:633–41.10.1016/S1367-5931(02)00371-XSearch in Google Scholar

44. Sieg A, Guy RH, Delgado-Charro MB. Noninvasive and minimally invasive methods for transdermal glucose monitoring. Diabetes Technol Ther 2005; 7:174–97.10.1089/dia.2005.7.174Search in Google Scholar

45. Leboulanger B, Guy RH, Delgado-Charro MB. Reverse iontophoresis for non-invasive transdermal monitoring. Physiol Meas 2004; 25:R35–50.10.1088/0967-3334/25/3/R01Search in Google Scholar

46. Ricos C, Garcia-Victoria M, de la Fuente B. Quality indicators and specifications for the extra-analytical phases in clinical laboratory management. Clin Chem Lab Med 2004; 42:578–82.10.1515/CCLM.2004.100Search in Google Scholar

47. Jekelis AW. Increased instrument intelligence – can it reduce laboratory error? Biomed Instrum Technol 2005; 39:232–6.Search in Google Scholar

48. Blumenthal D. The errors of our ways. Clin Chem 1997; 43:1305.10.1093/clinchem/43.8.1305Search in Google Scholar

49. Kazmierczak SC. Laboratory quality control: using patient data to assess analytical performance. Clin Chem Lab Med 2003; 41:617–27.10.1515/CCLM.2003.093Search in Google Scholar

50. Plebani M. Charting the course of medical laboratories in a changing environment. Clin Chim Acta 2002; 319:87–100.10.1016/S0009-8981(02)00028-1Search in Google Scholar

51. Plebani M. Towards quality specifications in extra-analytical phases of laboratory activity. Clin Chem Lab Med 2004; 42:576–7.10.1515/CCLM.2004.099Search in Google Scholar PubMed

52. Weydert JA, Nobbs ND, Feld R, Kemp JD. A simple, focused, computerized query to detect overutilization of laboratory tests. Arch Pathol Lab Med 2005; 129:1141–3.10.5858/2005-129-1141-ASFCQTSearch in Google Scholar PubMed

53. Neilson EG, Johnson KB, Rosenbloom ST, Dupont WD, Talbert D, Giuse DA, et al. The impact of peer management on test-ordering behavior. Ann Intern Med 2004; 141:196–204.10.7326/0003-4819-141-3-200408030-00008Search in Google Scholar PubMed

Received: 2005-11-19
Accepted: 2006-1-3
Published Online: 2011-9-21
Published in Print: 2006-4-1

©2006 by Walter de Gruyter Berlin New York

Downloaded on 28.3.2024 from https://www.degruyter.com/document/doi/10.1515/CCLM.2006.073/html
Scroll to top button