Towards a new paradigm in laboratory medicine: The five rights

Clinical Chemistry and Laboratory Medicine

Volumn 54, Issue 12, 2016, Pages 1881-1891

  Plebani, Mario ^a  

^a UNIVERSITY HOSPITAL OF PADOVA   (Italy)

Author keywords

analytical quality; diagnostic errors; laboratory medicine; patient safety; pre analytical phase; total testing process

Indexed keywords

CLINICAL LABORATORY; CLINICAL OUTCOME; DIAGNOSTIC ERROR; HUMAN; LABORATORY PERSONNEL; LABORATORY TEST; MEDICINE; PATIENT HARM; PATIENT SAFETY; PRIORITY JOURNAL; REFERENCE VALUE; REVIEW; TURNAROUND TIME; LABORATORY; STANDARDS;

CLINICAL LABORATORY TECHNIQUES; DIAGNOSTIC ERRORS; HUMANS; LABORATORIES;

EID: 84994504335     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2016-0848     Document Type: Review

References (79)

1. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691-8.
2. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101-10
3. 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.
4. Institute of Medicine. Improving diagnosis in health care. Washington, DC: National Academies of Sciences, Engineering, and Medicine, 2015. Available at: http://iom. nationalacademies. org/Reports/2015/Improving-Diagnosis-in-Healthcare. Aspx.
5. Vogeser M, Seger C. Quality management in clinical application of mass spectrometry measurement systems. Clin Biochem 2016;49:947-54.
6. Sturgeon CM, Viljoen A. Analytical error and interference in immunoassay: minimizing risk. Ann Clin Biochem 2011;48:418-32.
7. Lippi G, Plebani M, Favaloro EJ. Interference in coagulation testing: focus on spurious hemolysis, icterus, and lipemia. Semin Thromb Hemost 2013;39:258-66.
8. Westgard JO, Westgard SA. Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys. Clin Chem Lab Med 2015;53:1531-5.
9. Lundberg GD. Adding outcome as the 10th step in the brain-tobrain laboratory test loop. Am J Clin Pathol 2014;141:767-9.
10. Van Houcke SK, Thienpont LM. "Good samples make good assays" - The problem of sourcing clinical samples for a standardization project. Clin Chem Lab Med 2013;51:967-72.
11. Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/ external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670-80.
12. Clerico A, Ripoli A, Masotti S, Prontera C, Storti S, Fortunato A, et al. Pilot study on harmonization of cardiac troponin I immunoassays using patients and quality control plasma samples. On behalf of the Italian Section of the European Ligand Assay Society (ELAS) and of the Study Group on Cardiovascular Biomarkers of the Società Italiana di Biochimica Clinica (SIBioC). Clin Chim Acta 2016 1;456:42-8.
13. Clerico A, Ripoli A, Zucchelli GC, Plebani M. Harmonization protocols for thyroid stimulating hormone (TSH) immunoassays: different approaches based on the consensus mean value. Clin Chem Lab Med 2015;53:377-82.
14. Ellervik C, Vaught J. Preanalytical variables affecting the integrity of human biospecimens in biobanking. Clin Chem 2015;61:914-34.
15. Holman JW, Mifflin TE, Felder RA, Demers LM. Evaluation of an automated preanalytical robotic workstation at two academic health centers. Clin Chem 2002;48:540-8.
16. Da Rin G. Pre-analytical workstations: A tool for reducing laboratory errors. Clin Chim Acta 2009;404:68-74.
17. Campbell K, Muniak A, Rothwell S, Dempster L, Per J, Barr K. Improving Quality and Safety through Positive Patient Identification. Healthc Q 2015;18:56-60.
18. College of American Pathologists, Valenstein PN, Raab SS, Walsh MK. Identification errors involving clinical laboratories: A College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions. Arch Pathol Lab Med 2006;130:1106-13.
19. Van Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, et al. Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Patient identification and tube labelling - A call for harmonisation. Clin Chem Lab Med 2016;54:1141-5.
20. Bolton-Maggs PH, Wood EM, Wiersum-Osselton JC. Wrong blood in tube-potential for serious outcomes: can it be prevented Br J Haematol 2015;168:3-13.
21. Lang T. The Association for Clinical Biochemistry & Laboratory Medicine. National minimum re-testing interval project. Prepared for the Clinical Practice Group of the ACB and supported by the Royal College of Pathologists; 2013:1-36.
22. Pelloso M, Basso D, Padoan A, Fogar P, Plebani M. Computerbased-limited and personalised education management maximise appropriateness of vitamin D, vitamin B12 and folate retesting. Clin Pathol 2016;69:777-83.
23. Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta 2009;404:16-23.
24. Zhi M, Ding EL, Theisen-Toupal J, Whelan J, Arnaout R. The landscape of inappropriate laboratory testing: A 15-year metaanalysis. PLoS One 2013;8:e78962.
25. Fryer AA, Smellie WS. Managing demand for laboratory tests: A laboratory toolkit. J Clin Pathol 2013;66:62-72.
26. Plebani M, Panteghini M. Promoting clinical and laboratory interaction by harmonization. Clin Chim Acta 2014;432:15-21.
27. Morden NE, Schwartz LM, Fisher ES, Woloshin S. Accountable prescribing. N Engl J Med 2013;369:299-302.
28. Cornes MP, Atherton J, Pourmahram G, Borthwick H, Kyle B, West J, et al. Monitoring and reporting of preanalytical errors in laboratory medicine: The UK situation. Ann Clin Biochem 2016;53:279-84.
29. Karcher DS, Lehman CM. Clinical consequences of specimen rejection: A College of American Pathologists Q-Probes analysis of 78 clinical laboratories. Arch Pathol Lab Med 2014;138:1003-8.
30. Dikmen ZG, Pinar A, Akbiyik F. Specimen rejection in laboratory medicine: necessary for patient safety Biochem Med (Zagreb) 2015;25:377-85.
31. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Haemolysis: An overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008;46:764-72.
32. Cao L, Chen M, Phipps RA, Del Guidice RE, Handy BC, Wagar EA, et al. Causes and impact of specimen rejection in a clinical chemistry laboratory. Clin Chim Acta 2016;458:154-8.
33. Stark A, Jones BA, Chapman D, Well K, Krajenta R, Meier FA, et al. Clinical laboratory specimen rejection-association with the site of patient care and patients' characteristics: findings from a single health care organization. Arch Pathol Lab Med 2007;131:588-92.
34. Howanitz PJ, Lehman CM, Jones BA, Meier FA, Horowitz GL. Practices for identifying and rejecting hemolyzed specimens are highly variable in clinical laboratories. Arch Pathol Lab Med 2015;139:1014-9.
35. Becker N, Lockwood CM. Pre-analytical variables in miRNA analysis. Clin Biochem 2013;46:861-8.
36. Lippi G, Simundic AM. Laboratory networking and sample quality: A still relevant issue for patient safety. Clin Chem Lab Med 2012;50:1703-5.
37. Zaninotto M, Tasinato A, Padoan A, Vecchiato G, PinatoA, Sciacovelli L, et al. An integrated system for monitoring the quality of sample transportation. Clin Biochem 2012;45:688-90.
38. Lippi G, Banfi G, Church S, Cornes M, De Carli G, Grankvist K, et al. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). Clin Chem Lab Med 2015;53:357-70.
39. ISO 15189:2012. Medical laboratories-requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2012.
40. Vasikaran S, Sikaris K, Kilpatrick E, French J, Badrick T, Osypiw J, et al; on behalf of the IFCC WG Harmonization of Quality Assessment of Interpretative Comments. Assuring the quality of interpretative comments in clinical chemistry. Clin Chem Lab Med 2016;54:1901-11.
41. Howanitz JH, Howanitz PJ. Laboratory results. Timeliness as a quality attribute and strategy. Am J Clin Pathol 2001;116:311-5.
42. Steindel SJ, Howanitz PJ. Physician satisfaction and emergency department laboratory test turnaround time. Arch Pathol Lab Med 2001;125:863-71.
43. Novis DA, Walsh MK, Dale JC, Howanitz PJ; College of American Pathologists Q-Tracks. Continuous monitoring of stat and routine outlier turnaround times: Two College of American Pathologists Q-Tracks monitors in 291 hospitals. Arch Pathol Lab Med 2004;128:621-6.
44. Plebani M, Lippi G. Improving the post-analytical phase. Clin Chem Lab Med 2010;48:435-6.
45. Lippi G, Plebani M. Toxic alcohol calculations and misinterpretation of laboratory results. JAMA Intern Med 2016;176:1228-9.
46. Oosterhuis WP, Ulenkate HJ, Goldschmidt HM. Evaluation of LabRespond, a new automated validation system for clinical laboratory test results. Clin Chem 2000;46:1811-7.
47. Guidi GC, Poli G, Bassi A, Giobelli L, Benetollo PP, Lippi G. Development and implementation of an automatic system for verification, validation and delivery of laboratory test results. Clin Chem Lab Med 2009;47:1355-60.
48. Demirci F, Akan P, Kume T, Sisman AR, Erbayraktar Z, Sevinc S. Artificial neural network approach in laboratory test reporting: learning algorithms. Am J Clin Pathol 2016;146:227-37.
49. Plebani M. Harmonization in laboratory medicine: requests, samples, measurements and reports. Crit Rev Clin Lab Sci 2016;53:184-96.
50. Plebani M. Harmonization in laboratory medicine: The complete picture. Clin Chem Lab Med 2013;51:741-51.
51. Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Pathol Lab Med 2004;128:1424-7.
52. Vasikaran SD, Lai LC, Sethi S, Lopez JB, Sikaris KA. Quality of interpretative commenting on common clinical chemistry results in the Asia-Pacific region and Africa. Clin Chem Lab Med 2009;47:963-70.
53. Vasikaran SD. Anatomy and history of an external quality assessment program for interpretative comments in clinical biochemistry. Clin Biochem 2015;48:467-71.
54. Lundberg GD. When to panic over abnormal values. MLO Med Lab Obs 1972;4:47-54.
55. Piva E, Pelloso M, Penello L, Plebani M. Laboratory critical values: Automated notification supports effective clinical decision making. Clin Biochem 2014;47:1163-8.
56. Campbell CA, Horvath AR. Harmonization of critical result management in laboratory medicine. Clin Chim Acta 2014;432:135-47.
57. Kilpatrick ES, Holding S. Use of computer terminals on wards to access emergency test results: A retrospective audit. Br Med J 2001;322:1101-3.
58. Poon EG, Gandhi TK, Sequist TD, Murff HJ, Karson AS, Bates DW. "I wish I had seen this test result earlier!": dissatisfaction with test result management systems in primary care. Arch Intern Med 2004;164:2223-8.
59. Elder NC, McEwen TR, Flach JM, Gallimore JJ. Management of test results in family medicine offices. Ann Fam Med 2009;7:343-51.
60. Elder NC, McEwen TR, Flach J, Gallimore J, Pallerla H. The management of test results in primary care: does an electronic medical record make a difference Fam Med 2010;42:327-33.
61. Gandhi TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon C, Brennan TA, et al. Missed and delayed diagnoses in the ambulatory setting: A study of closed malpractice claims. Ann Intern Med 2006;145:488-96.
62. Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. rch Intern Med 2005;165:1493-9.
63. Kachalia A, Gandhi TK, Puopolo AL, Yoon C, Thomas EJ, Griffey R, et al. Missed and delayed diagnoses in the emergency department: A study of closed malpractice claims from 4 liability insurers. Ann Emerg Med 2007;49:196-205.
64. Chen ET, Eder M, Elder NC, Hickner J. Crossing the finish line: follow-up of abnormal test results in a multisite community health center. J Natl Med Assoc 2010;102:720-5.
65. Schiff GD, Hasan O, Kim S, Abrams R, Cosby K, Lambert BL, et al. Diagnostic error in medicine: Analysis of 583 physician-reported errors. Arch Intern Med 2009;169:1881-7.
66. Callen J, Georgiou A, Li J, Westbrook JI. The safety implications of missed test results for hospitalised patients: A systematic review. BMJ Qual Saf 2011;20:194-9.
67. Harris DM, Westfall JM, Fernald DH, Duclos CW, West DR, Niebauer L, et al. Mixed methods analysis of medical error event reports: A report from the ASIPS collaborative. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in patient safety: from research to implementation (volume 2: concepts and methodology). Rockville, MD: Agency for Healthcare Research and Quality (US), 2005.
68. Westgard JO, Westgard SA. The quality of laboratory testing today: An assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol 2006;125:343-54.
69. Weykamp C, Secchiero S, Plebani M, Thelen M, Cobbaert C, Thomas A, et al. Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain. Clin Chem Lab Med 2016 Jul 22 pii:/j/cclm. Ahead-of-print/cclm-2016-0220/cclm-2016-0220. xml. doi:10. 1515/cclm-2016-0220. [Epub ahead of print].
70. Kristensen GB, Rustad P, Berg JP, Aakre KM. Analytical bias exceeding desirable quality goal in 4 out of 5 common immunoassays: results of a native single serum sample external quality assessment program for cobalamin, folate, ferritin, thyroid-stimulating hormone, and free T4 analyses. Clin Chem 2016;62:1255-63.
71. Nakhleh RE, Nosé V, Colasacco C, Fatheree LA, Lillemoe TJ, McCrory DC, et al. Interpretive diagnostic error reduction in surgical pathology and cytology: guideline from the college of american pathologists pathology and laboratory quality center and the association of directors of anatomic and surgical pathology. Arch Pathol Lab Med 2016;140:29-40.
72. Fraser CG, Kallner A, Kenny D, Petersen PH. Introduction: strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999;59:477-8.
73. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: consensus statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833-5.
74. Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med 2014;52:951-8.
75. Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med 2015;53:943-8.
76. Sciacovelli L, Aita A, Padoan A, Pelloso M, Antonelli G, Piva E, et al. Performance criteria and quality indicators for the postanalytical phase. Clin Chem Lab Med 2016;54:1169-76.
77. Plebani M. The quality indicator paradox. Clin Chem Lab Med 2016;54:1119-22.
78. Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: A new outcomes-based approach for laboratory medicine. BMJ Qual Saf 2013;22(Suppl 2):ii6-10.
79. Porter ME, Larsson S, Lee TH. Standardizing patient outcomes measurement. N Engl J Med 2016;374:504-6.