EFLM WG-Preanalytical phase opinion paper: Local validation of blood collection tubes in clinical laboratories

Clinical Chemistry and Laboratory Medicine

Volumn 54, Issue 5, 2016, Pages 755-760

  Lippi, Giuseppe ^a,b   Cornes, Michael P ^a,c   Grankvist, Kjell ^a,d   Nybo, Mads ^a,e   Simundic, Ana Maria ^a,f  

^a Working Group for Preanalytical Phase (WG PRE)   (United States)

^b UNIVERSITY OF VERONA   (Italy)

^c NEW CROSS HOSPITAL   (United Kingdom)

^d UMEÅ UNIVERSITY   (Sweden)

^e ODENSE UNIVERSITY HOSPITAL   (Denmark)

^f University Hospital Sveti Duh   (Croatia)

Author keywords

blood collection; blood tubes; errors; preanalytical variability; venipuncture

Indexed keywords

ARTICLE; BLOOD COLLECTION TUBE; BLOOD SAMPLING; CLINICAL LABORATORY; HUMAN; LABORATORY PERSONNEL; PRIORITY JOURNAL; RESPONSIBILITY; VALIDATION PROCESS; CLINICAL CHEMISTRY; CONSENSUS; LABORATORY TECHNIQUE; RESEARCH; STANDARDS; VALIDATION STUDY;

BLOOD SPECIMEN COLLECTION; CHEMISTRY, CLINICAL; CLINICAL LABORATORY TECHNIQUES; CONSENSUS; HUMANS; RESEARCH REPORT;

EID: 84966573898     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2015-1274     Document Type: Article

References (25)

1. 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.
2. Simundic AM, Lippi G. Preanalytical phase-a continuous challenge for laboratory professionals. Biochem Med (Zagreb) 2012;22:145-9.
3. 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 2015;53:371-6.
4. Stankovic AK, Silvestri J, Mails M, Najork C. Total quality in laboratory diagnostics: the role of commercial companies. Biochem Med 2010;20:207-14.
5. Clinical and Laboratory Standards Institute (CLSI). Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline. Wayne, PA: Clinical and Laboratory Standards Institute, 2010. CLSI document GP34-A.
6. International Organization for Standardization. Quality management systems-Fundamentals and vocabulary. ISO 9000:2005. ISO, Geneva, Switzerland, 2005.
7. 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.
8. Plebani M, Caputo M, Giavarina D, Lippi G. Methodological notes on acquisition and use of close evacuated systems for collection, handling and storage of venous blood samples for laboratory diagnostics. Biochim Clin 2013;37:244-52.
9. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Preanalytical management: serum vacuum tubes validation for routine clinical chemistry. Biochem Med (Zagreb) 2012;22:180-6.
10. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Sodium citrate vacuum tubes validation: preventing preanalytical variability in routine coagulation testing. Blood Coagul Fibrinolysis 2013;24:252-5.
11. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Poli G, Solero GP, et al. K(3)EDTA Vacuum Tubes Validation for Routine Hematological Testing. ISRN Hematol 2012;2012:875357.
12. Zungun C, Yilmaz FM, Boru EG, Topcuoglu C. Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators. Clin Chem Lab Med 2015;53:231-8.
13. Häntzsch M, Tolios A, Beutner F, Nagel D, Thiery J, Teupser D, et al. Comparison of whole blood RNA preservation tubes and novel generation RNA extraction kits for analysis of mRNA and MiRNA profiles. PLoS One 2014;9:e113298.
14. Zhang H, Korenková V, Sjöback R, Švec D, Björkman J, Kruhøffer M, et al. Biomarkers for monitoring pre-analytical quality variation of mRNA in blood samples. PLoS One 2014;9:e111644.
15. Clinical and Laboratory Standards Institute (CLSI). Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard-Sixth Edition; Approved Guideline. Wayne, PA: Clinical and Laboratory Standards Institute; 2010. CLSI document GP39-A6.
16. Plebani M, Lippi G. Closing the brain-to-brain loop in laboratory testing. Clin Chem Lab Med 2011;49:1131-3.
17. Jiang Y, Jiang H, Ding S, Liu Q. Application of failure mode and effects analysis in a clinical chemistry laboratory. Clin Chim Acta 2015 25;448:80-5.
18. Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition; Approved Guideline. Wayne, PA: Clinical and Laboratory Standards Institute; 2010. CLSI document CLSI EP28-A3.
19. 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.
20. Yao NA. Health Services & Policy Research in translational medicine. Ann Transl Med 2014;2:72.
21. Lippi G, Plebani M. Personalized medicine: moving from simple theory to daily practice. Clin Chem Lab Med 2015;53:959-60.
22. Tuck MK, Chan DW, Chia D, Godwin AK, Grizzle WE, Krueger KE et al. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res 2009;8:113-7.
23. El Messaoudi S, Rolet F, Mouliere F, Thierry AR. Circulating cell free DNA: Preanalytical considerations. Clin Chim Acta 2013;424:222-30.
24. Channavajjhala SK, Rossato M, Morandini F, Castagna A, Pizzolo F, Bazzoni F, et al. Optimizing the purification and analysis of miRNAs from urinary exosomes. Clin Chem Lab Med 2014;52:345-54.
25. Bowen RA, Remaley AT. Interferences from blood collection tube components on clinical chemistry assays. Biochem Med (Zagreb) 2014;24:31-44.