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)

Clinical Chemistry and Laboratory Medicine

Volumn 53, Issue 3, 2015, Pages 357-370

  Lippi, Giuseppe ^a   Banfi, Giuseppe ^b   Church, Stephen ^c   Cornes, Michael ^d   De Carli, Gabriella ^e   Grankvist, Kjell ^f   Kristensen, Gunn B ^g   Ibarz, Mercedes ^h   Panteghini, Mauro ⁱ   Plebani, Mario ^j   Nybo, Mads ^k   Smellie, Stuart ^l   Zaninotto, Martina ^j   Simundic, Ana Maria ^m  

^a ACADEMIC HOSPITAL OF PARMA   (Italy)

^b UNIVERSITY OF MILAN   (Italy)

^c Becton Dickinson UK Ltd   (United Kingdom)

^d NEW CROSS HOSPITAL   (United Kingdom)

^e NATIONAL INSTITUTE FOR INFECTIOUS DISEASES L SPALLANZANI   (Italy)

^f UMEÅ UNIVERSITY   (Sweden)

^g Norwegian Clinical Chemistry EQA Program   (Norway)

^h HOSPITAL ARNAU DE VILANOVA   (Spain)

ⁱ UNIVERSITY OF MILAN   (Italy)

^j UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^k ODENSE UNIVERSITY HOSPITAL   (Denmark)

^l Bunny Hill Primary Care Centre   (United Kingdom)

^m SESTRE MILOSRDNICE UNIVERSITY HOSPITAL   (Croatia)

more..

Author keywords

harmonization; laboratory errors; preanalytical variability; standardization

Indexed keywords

CONTRAST MEDIUM;

BLOOD SAMPLING; CENTRIFUGATION; CLINICAL CHEMISTRY; DIET RESTRICTION; EUROPEAN UNION; EVIDENCE BASED PRACTICE; HEALTH CARE COST; HEALTH CARE MANAGEMENT; HUMAN; LABORATORY TEST; MEDICAL SOCIETY; NEEDLESTICK INJURY; PATIENT MONITORING; PHYSICAL ACTIVITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SYSTEMATIC REVIEW (TOPIC); TEMPERATURE; TOTAL QUALITY MANAGEMENT; DIAGNOSTIC ERROR; DIAGNOSTIC PROCEDURE; LABORATORY DIAGNOSIS; STANDARDS;

BLOOD SPECIMEN COLLECTION; CHEMISTRY, CLINICAL; CLINICAL LABORATORY TECHNIQUES; DIAGNOSTIC ERRORS; EUROPEAN UNION; HUMANS; QUALITY IMPROVEMENT; SPECIMEN HANDLING;

EID: 84923088348     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2014-1051     Document Type: Review

References (92)

1. Lippi G, Simundic AM, Mattiuzzi C. Overview on patient safety in healthcare and laboratory diagnostics. Biochem Med (Zagreb) 2010;20:131-43.
2. Plebani M, Lippi G. Closing the brain-to-brain loop in laboratory testing. Clin Chem Lab Med 2011;49:1131-3.
3. Simundic AM, Lippi G. Preanalytical phase-a continuous challenge for laboratory professionals. Biochem Med (Zagreb) 2012;22:145-9.
4. Sonntag O. Quality in the analytical phase. Biochem Med (Zagreb) 2010;20:147-53.
5. Plebani M, Lippi G. Improving the post-analytical phase. Clin Chem Lab Med 2010;48:435-6.
6. Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med 2007;45:720-7.
7. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med 2011;49:1113-26.
8. Lippi G, Becan-McBride K, Behúlová D, Bowen RA, Church S, Delanghe J, et al. Preanalytical quality improvement: in quality we trust. Clin Chem Lab Med 2013;51:229-41.
9. Miller WG, Tate JR, Barth JH, Jones GR. Harmonization: the sample, the measurement, and the report. Ann Lab Med 2014;34:187-97.
10. Simundic AM, Cornes MP, Grankvist K, Lippi G, Nybo M, Ceriotti F, et al. Colour coding for blood collection tube closures-a call for harmonisation. Clin Chem Lab Med [Epub ahead of print 2014 Oct 14]. doi: 10.1515/cclm-2014-0927.
11. Tate JR, Johnson R, Barth JH, Panteghini M. Harmonization of laboratory testing-current achievements and future strategies. Clin Chim Acta 2014;432:4-7.
12. van Walraven C, Naylor CD. Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. J Am Med Assoc 1998;280:550-8.
13. Lippi G, Favaloro EJ, Franchini M. Dangers in the practice of defensive medicine in hemostasis testing for investigation of bleeding or thrombosis: part I-routine coagulation testing. Semin Thromb Hemost 2014;40:812-24.
14. Smellie WS, Galloway MJ, Chinn D. Is clinical practice variability the major reason for differences in pathology requesting patterns in general practice? J Clin Pathol 2002;55:312-4.
15. Smellie WS. Appropriateness in pathology. A new era or reinventing the wheel? Ann Clin Biochem 2003;40:585-92.
16. Young DS, Sachais BS, Jefferies LC. Laboratory costs in the context of disease. Clin Chem 2000;46:967-75.
17. Plebani M, Zaninotto M, Faggian D. Utilization management: a European perspective. Clin Chim Acta 2014;427:137-41.
18. Lippi G, Mattiuzzi C. Testing volume is not synonymous of cost, value and efficacy in laboratory diagnostics. Clin Chem Lab Med 2013;51:243-5.
19. Fryer AA, Hanna FW. Managing demand for pathology tests: financial imperative or duty of care? Ann Clin Biochem 2009;46(Pt 6):435-7.
20. Fryer AA, Smellie WS. Managing demand for laboratory tests: a laboratory toolkit. J Clin Pathol 2013;66:62-72.
21. De Carli G, Abiteboul D, Puro V. The importance of implementing safe sharps practices in the laboratory setting in Europe. Biochem Med (Zagreb) 2014;24:45-56.
22. Joint EPSU-HOSPEEM Project 'Promotion and support of the implementation of Directive 2010/32/EU on the prevention of sharps injuries in the hospital and health care sector'. Final Project Report, 15 November 2013. Available from: http://hospeem. org/wordpress/wp-content/uploads/2013/10/Final-Report-ICF-GHK-15.11.13-EN+TW.pdf. Accessed 10 October, 2014.
23. Written questions by Members of the European Parliament and their answers given by a European Union institution. E-014392/13 by Marian Harkin to the Commission. Answer given by Mr Andor on behalf of the Commission (18 February 2014). Official Journal of the European Union C 275/1, 21.08.2014. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?qid?=?1412176568 796&uri?=?OJ:JOC-2014-275-R-0001. Accessed 10 October, 2014.
24. Gomez S, De Raeve P. EFN Report on the Implementation of Directive 2010/32/EU on the prevention of sharps injuries in the healthcare sector. Descriptive and Explorative Cluster Analysis of Directive 2010/32/EU Implementation into Clinical Practice Data. Presented at 4th European Biosafety Summit, Warsaw, Poland, 2/12/2013. Available from: http://www.efnweb.be/wp-content/uploads/EFN-Report-on-Sharps-Injuries-DIR32-Implementation-forwebsite1.pdf. Accessed 10 October, 2014.
25. Nybo M, Grinsted P, Jørgensen PE. Blood sampling: is fasting properly defined? Clin Chem 2005;51:1563-4.
26. Lippi G, Lima-Oliveira G, Salvagno GL, Montagnana M, Gelati M, Picheth G, et al. Influence of a light meal on routine haemato-logical tests. Blood Transfus 2010;8:94-9.
27. Lima-Oliveira G, Salvagno GL, Lippi G, Danese E, Gelati M, Montagnana M, et al. Could light meal jeopardize laboratory coagulation tests? Biochem Med (Zagreb) 2014;24:343-9.
28. Lima-Oliveira G, Salvagno GL, Lippi G, Gelati M, Montagnana M, Danese E, et al. Influence of a regular, standardized meal on clinical chemistry analytes. Ann Lab Med 2012;32:250-6.
29. Kackov S, Simundic AM, Gatti-Drnic A. Are patients well informed about the fasting requirements for laboratory blood testing? Biochem Med (Zagreb) 2013;23:326-31.
30. Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M. Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Clin Chim Acta 2014;432:33-7.
31. Lippi G, Banfi G, Botrè F, de la Torre X, De Vita F, Gomez-Cabrera MC, et al. Laboratory medicine and sports: between Scylla and Charybdis. Clin Chem Lab Med 2012;50:1309-16.
32. Sanchis-Gomar F, Lippi G. Physical activity-an important preanalytical variable. Biochem Med (Zagreb) 2014;24:68-79.
33. Banfi G, Dolci A. Preanalytical phase of sport biochemistry and haematology. J Sports Med Phys Fitness 2003;43:223-30.
34. Lippi G, Mattiuzzi C, Banfi G. Controlling sources of preanalyti-cal variability in doping samples: challenges and solutions. Bioanalysis 2013;5:1571-82.
35. Lombardi G, Lanteri P, Colombini A, Lippi G, Banfi G. Stability of haematological parameters and its relevance on the athlete's biological passport model. Sports Med 2011;41:1033-42.
36. Lippi G, Plebani M, Sanchis-Gomar F, Banfi G. Current limitations and future perspectives of the Athlete Blood Passport. Eur J Appl Physiol 2012;112:3693-4.
37. Bickham P, Golembiewski J. Contrast media use in the operating room. J Perianesth Nurs 2010;25:94-103.
38. Lippi G, Daves M, Mattiuzzi C. Interference of medical contrast media on laboratory testing. Biochem Med (Zagreb) 2014;24:80-8.
39. Daves M, Lippi G, Cosio G, Raffagnini A, Peer E, Dangella A, et al. An unusual case of a primary blood collection tube with floating separator gel. J Clin Lab Anal 2012;26:246-7.
40. Clinical Laboratory Standards Institute. Procedures for collection of diagnostic blood specimens by venipuncture; approved guideline-6th ed. CLSI document H3-A6. CLSI: Wayne, PA, 2007.
41. World Health Organization. WHO guidelines on drawing blood: best practices in phlebotomy. WHO Press: Geneva, 2010.
42. Sun N, Knauf R. Cross contamination solved by technique. ASCP Summary Report. 1977;14:3.
43. Calam RR, Cooper MH. Recommended 'order of Draw' for collecting blood specimens into additive-containing tubes. Clin Chem 1982;28:1399.
44. Sulaiman RA, Cornes MP, Whitehead S, Othonos N, Ford C, Gama R. Effect of order of draw of blood samples during phlebotomy on routine biochemistry results. J Clin Pathol 2011;64:1019-20.
45. Salvagno G, Lima-Oliveira G, Brocco G, Danese E, Guidi GC, Lippi G. The order of draw: myth or science? Clin Chem Lab Med 2013;51:2281-5.
46. Lima-Oliveira G, Salvagno GL, Danese E, Favaloro EJ, Guidi GC, Lippi G. Sodium citrate blood contamination by K2-ethylene-diaminetetraacetic acid (EDTA): impact on routine coagulation testing. Int J Lab Hematol [Epub ahead of print 2014 Oct 13]. doi: 10.1111/ijlh.12301.
47. Lima-Oliveira G, Salvagno GL, Danese E, Brocco G, Guidi GC, Lippi G. Contamination of lithium heparin blood by K2-ethylen-ediaminetetraacetic acid (EDTA): an experimental evaluation. Biochem Med (Zagreb) 2014;24:359-67.
48. Berg JE, Ahee P, Berg JD. Variation in phlebotomy techniques in emergency medicine and the incidence of haemolysed samples. Ann Clin Biochem 2011;48:562-5.
49. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Incorrect order of draw could be mitigate the patient safety: a phlebotomy management case report. Biochem Med (Zagreb) 2013;23:218-23.
50. Cornes MP, Ford C, Gama R. Spurious hyperkalaemia due to EDTA contamination: common and not always easy to identify. Ann Clin Biochem 2008;45:601-3.
51. Sharratt CL, Gilbert CJ, Cornes MP, Ford C, Gama R. EDTA sample contamination is common and often undetected, putting patients at unnecessary risk of harm. Int J Clin Prac 2009;63:1259-62.
52. Lippi G, Simundic AM. Laboratory networking and sample quality: a still relevant issue for patient safety. Clin Chem Lab Med 2012;50:1703-5.
53. Lippi G, Lima-Oliveira G, Nazer SC, Moreira ML, Souza RF, Salvagno GL. Suitability of a transport box for blood sample shipment over a long period. Clin Biochem 2011;44:1028-9.
54. Clinical and Laboratory Standards Institute. Procedures for handling and processing of blood specimens for common laboratory tests. H18-A4; approved guideline-4th ed. CLSI: Wayne, PA, 2010.
55. 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.
56. Zaninotto M, Tasinato A, Padoan A, Vecchiato G, Pinato A, Sci-acovelli L, et al. Effects of sample transportation on commonly requested laboratory tests. Clin Chem Lab Med 2012;10: 1755-60.
57. Lippi G, Salvagno GL, Montagnana M, Guidi GC. Preparation of a quality sample: effect of centrifugation time on stat clinical chemistry testing. Lab Med 2007;38:172-6.
58. Clinical and Laboratory Standards Institute. Collection, transport, and processing of blood specimens for coagulation testing and general performance of coagulation assays. Approved guideline H21-A5-5th ed. CLSI: Wayne, PA, 2008.
59. Lippi G, Salvagno GL, Danese E, Lima-Oliveira G, Brocco G, Guidi GC. Inversion of lithium heparin gel tubes after centrifuga-tion is a significant source of bias in clinical chemistry testing. Clin Chim Acta 2014;436:183-7.
60. Da Rin G, Lippi G. The quality of diagnostic testing may be impaired during shipment of lithium-heparin gel tubes. Clin Chem Lab Med 2014;52:1633-7.
61. Daves M, Giacomuzzi K, Tagnin E, Jani E, Adcock Funk DM, Favaloro EJ, et al. Influence of centrifuge brake on residual platelet count and routine coagulation tests in citrated plasma. Blood Coagul Fibrinolysis 2014;25:292-5.
62. Lippi G, Rossi R, Ippolito L, Zobbi V, Azzi D, Pipitone S, et al. Influence of residual platelet count on routine coagulation, factor VIII, and factor IX testing in postfreeze-thaw samples. Semin Thromb Hemost 2013;39:834-9.
63. Mensel B, Wenzel U, Roser M, Ludemann J, Nauck M. Considerably reduced centrifugation time without increased hemolysis: evaluation of the new BD Vacutainer SSTTMII Advance. Clin Chem 2007;53:794-5.
64. Suchsland J, Friedrich N, Grotevendt A, Kallner A, Lüdemann J, Nauck M, et al. Optimizing centrifugation of coagulation samples in laboratory automation. Clin Chem Lab Med 2014;52:1187-91.
65. Plebani M, Sciacovelli L, Lippi G. Quality indicators for laboratory diagnostics: consensus is needed. Ann Clin Biochem 2011;48:479.
66. Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem 2013;46:1170-4.
67. Plebani M, Sciacovelli L, Aita A, Padoan A, Chiozza ML. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Chim Acta 2014;432:44-8.
68. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79-85.
69. Sciacovelli L, O'Kane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, et al. IFCC WG-LEPS. 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.
70. 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.
71. Plebani M, Sciacovelli L, Aita A, Chiozza ML. Harmonization of pre-analytical quality indicators. Biochem Med (Zagreb) 2014;24:105-13.
72. International Organization for Standardization. ISO 15189: medical laboratories: particular requirements for quality and competence. IOS: Geneva, 2012.
73. Kristensen GB, Aakre KM, Kristoffersen AH, Sandberg S. How to conduct external quality assessment schemes for the pre-analytical phase? Biochem Med (Zagreb) 2014;24:114-22.
74. Lippi G, Luca Salvagno G, Blanckaert N, Giavarina D, Green S, Kitchen S, et al. Multicenter evaluation of the hemolysis index in automated clinical chemistry systems. Clin Chem Lab Med 2009;47:934-9.
75. Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44:750-9.
76. Lippi G, Salvagno GL, Montagnana M, Franchini M, Guidi GC. Phlebotomy issues and quality improvement in results of laboratory testing. Clin Lab 2006;52:217-30.
77. Amon E. Communication strategies for reducing hospital error and professional liability. Obstet Gynecol Surv 2002;57:713-4.
78. Francke AL, Smit MC, de Veer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decision Making 2008;8:38.
79. Bölenius K, Söderberg J, Hultdin J, Lindkvist M, Brulin C, Grankvist K. Minor improvement of venous blood specimen collection practices in primary health care after a large-scale educational intervention. Clin Chem Lab Med 2013;51:303-10.
80. Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M, Kovalevskaya S, et al. Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA). Clin Chem Lab Med 2013;51:1585-93.
81. Mittman BS, Tonesk X, Jacobson PD. Implementing clinical practice guidelines: social influence strategies and practitioner behavior change. Qual Rev Bull 1992;18:413.
82. Bölenius K, Brulin C, Grankvist K, Lindkvist M, Söderberg J. A content validated questionnaire for self-reported venous blood sampling practices. BMC Research Notes 2012;5:39.
83. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med 2009;47:143-53.
84. Giménez-Marín A, Rivas-Ruiz F, del Mar Pérez-Hidalgo M, Molina-Mendoza P. Pre-analytical errors management in the clinical laboratory: a five-year study. Biochem Med (Zagreb) 2014;24:248-57.
85. Baird G. The laboratory test utilization management toolbox. Biochem Med (Zagreb) 2014;24:223-34.
86. Janssens PM, Staring W, Winkelman K, Krist G. Active intervention in hospital test request panels pays. Clin Chem Lab Med [Epub ahead of print 2014 Oct 10]. doi: 10.1515/cclm-2014-0575.
87. Lippi G, Banfi G, Buttarello M, Ceriotti F, Daves M, Dolci A, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med 2007;45:728-36.
88. Nikolac N, Supak-Smolcic V, Simundic AM, Celap I; Croatian Society of Medical Biochemistry and Laboratory Medicine. Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling. Biochem Med (Zagreb) 2013;23:242-54.
89. Plebani M, Panteghini M. Promoting clinical and laboratory interaction by harmonization. Clin Chim Acta 2014;432:15-21.
90. Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta 2009;404:16-23.
91. Piva E, Pelloso M, Penello L, Plebani M. Laboratory critical values: automated notification supports effective clinical decision making. Clin Biochem 2014;47:1163-8.
92. Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741-51.