Semin Thromb Hemost 2012; 38(06): 565-575
DOI: 10.1055/s-0032-1315961
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Quality Standards for Sample Collection in Coagulation Testing

Giuseppe Lippi
1   Department of Pathology and Laboratory Medicine, Laboratory of Clinical Chemistry and Hematology, Academic Hospital of Parma, Parma, Italy
,
Gian Luca Salvagno
2   Department of Life and Reproductive Sciences, Section of Clinical Biochemistry, University of Verona, Verona, Italy
,
Martina Montagnana
2   Department of Life and Reproductive Sciences, Section of Clinical Biochemistry, University of Verona, Verona, Italy
,
Gabriel Lima-Oliveira
2   Department of Life and Reproductive Sciences, Section of Clinical Biochemistry, University of Verona, Verona, Italy
,
Gian Cesare Guidi
2   Department of Life and Reproductive Sciences, Section of Clinical Biochemistry, University of Verona, Verona, Italy
,
Emmanuel J. Favaloro
3   Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, New South Wales, Australia
› Author Affiliations
Further Information

Publication History

Publication Date:
05 June 2012 (online)

Abstract

Preanalytical activities, especially those directly connected with blood sample collection and handling, are the most vulnerable steps throughout the testing process. The receipt of unsuitable samples is commonplace in laboratory practice and represents a serious problem, given the reliability of test results can be adversely compromised following analysis of these specimens. The basic criteria for an appropriate and safe venipuncture are nearly identical to those used for collecting blood for clinical chemistry and immunochemistry testing, and entail proper patient identification, use of the correct technique, as well as appropriate devices and needles. There are, however, some peculiar aspects, which are deemed to be particularly critical when collecting quality specimens for clot-based tests, and these require clearer recognition. These include prevention of prolonged venous stasis, collection of nonhemolyzed specimens, order of draw, and appropriate filling and mixing of the primary collection tubes. All of these important preanalytical issues are discussed in this article, and evidence-based suggestions as well as recommendations on how to obtain a high-quality sample for coagulation testing are also illustrated. We have also performed an investigation aimed to identify variation of test results due to underfilling of primary blood tubes, and have identified a clinically significant bias in test results when tubes are drawn at less than 89% of total fill for activated partial thromboplastin time, less than 78% for fibrinogen, and less than 67% for coagulation factor VIII, whereas prothrombin time and activated protein C resistance remain relatively reliable even in tubes drawn at 67% of the nominal volume.

 
  • References

  • 1 Seigworth GR. Bloodletting over the centuries. N Y State J Med 1980; 80 (13) 2022-2028
  • 2 Occupational Safety and Health Administration. Disposal of Contaminated Needles and Blood Tube Holders Used for Phlebotomy. Available at: http://www.osha.gov/dts/shib/shib101503.html . Accessed on: May 30, 2012
  • 3 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 (4) 358-365
  • 4 Lippi G, Simundic AM. Total quality in laboratory diagnostics. It's time to think outside the box. Biochem Med 2010; 20: 5-8
  • 5 Lippi G, Chance JJ, Church S , et al. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med 2011; 49 (7) 1113-1126
  • 6 Favaloro EJ, Lippi G, Adcock DM. Preanalytical and postanalytical variables: the leading causes of diagnostic error in hemostasis?. Semin Thromb Hemost 2008; 34 (7) 612-634
  • 7 Preston FE, Lippi G, Favaloro EJ, Jayandharan GR, Edison ES, Srivastava A. Quality issues in laboratory haemostasis. Haemophilia 2010; 16 (5) 93-99
  • 8 Bonar R, Favaloro EJ, Adcock DM. Quality in coagulation and haemostasis testing. Biochem Med 2010; 20 (2) 184-199
  • 9 Lippi G, Salvagno GL, Montagnana M, Franchini M, Guidi GC. Phlebotomy issues and quality improvement in results of laboratory testing. Clin Lab 2006; 52 (5-6) 217-230
  • 10 Adcock-Funk DM, Lippi G, Favaloro EJ. Quality standards for sample processing, transportation and storage in hemostasis testing. Semin Thromb Hemost 2012; 38 (6) 576-585
  • 11 Clinical and Laboratory Standard Institute. Procedures for the Handling and Processing of Blood Specimens; Approved Guideline. 4th ed. CLSI document H18–A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2010
  • 12 Narayanan S. The preanalytic phase. An important component of laboratory medicine. Am J Clin Pathol 2000; 113 (3) 429-452
  • 13 Banfi G, Salvagno GL, Lippi G. The role of ethylenediamine tetraacetic acid (EDTA) as in vitro anticoagulant for diagnostic purposes. Clin Chem Lab Med 2007; 45 (5) 565-576
  • 14 Favaloro EJ, Lippi G, Franchini M. Contemporary platelet function testing. Clin Chem Lab Med 2010; 48 (5) 579-598
  • 15 Favaloro EJ. More on preanalytical variables affecting platelet function testing using light transmittance aggregometry. Clin Chem Lab Med 2011; 49 (4) 737-739
  • 16 Favaloro EJ, Wong RC. Laboratory testing for the antiphospholipid syndrome: making sense of antiphospholipid antibody assays. Clin Chem Lab Med 2011; 49 (3) 447-461
  • 17 Lippi G, Lima-Oliveira G, Salvagno GL , et al. Influence of a light meal on routine haematological tests. Blood Transfus 2010; 8 (2) 94-99
  • 18 Walenga JM, Jackson CM, Kessler CM. Low molecular weight heparins differ substantially: impact on developing biosimilar drugs. Semin Thromb Hemost 2011; 37 (3) 322-327
  • 19 Tufano A, Coppola A, Cerbone AM, Ruosi C, Franchini M. Preventing postsurgical venous thromboembolism: pharmacological approaches. Semin Thromb Hemost 2011; 37 (3) 252-266
  • 20 Favaloro EJ, Lippi G, Koutts J. Laboratory testing of anticoagulants: the present and the future. Pathology 2011; 43 (7) 682-692
  • 21 Favaloro EJ, Lippi G. Laboratory testing and/or monitoring of the new oral anticoagulants/antithrombotics: for and against?. Clin Chem Lab Med 2011; 49 (5) 755-757
  • 22 Lippi G, Favaloro EJ, Salvagno GL, Franchini M. Laboratory assessment and perioperative management of patients on antiplatelet therapy: from the bench to the bedside. Clin Chim Acta 2009; 405 (1-2) 8-16
  • 23 Favaloro EJ, Lippi G. Laboratory reporting of hemostasis assays: the final post-analytical opportunity to reduce errors of clinical diagnosis in hemostasis?. Clin Chem Lab Med 2010; 48 (3) 309-321
  • 24 Favaloro EJ, McDonald D, Lippi G. Laboratory investigation of thrombophilia: the good, the bad, and the ugly. Semin Thromb Hemost 2009; 35 (7) 695-710
  • 25 Heleen van Ommen C, Middeldorp S. Thrombophilia in childhood: to test or not to test. Semin Thromb Hemost 2011; 37 (7) 794-801
  • 26 Lippi G, Maffulli N. Biological influence of physical exercise on hemostasis. Semin Thromb Hemost 2009; 35 (3) 269-276
  • 27 Banfi G, Del Fabbro M. Biological variation in tests of hemostasis. Semin Thromb Hemost 2009; 35 (1) 119-126
  • 28 Montagnana M, Salvagno GL, Lippi G. Circadian variation within hemostasis: an underrecognized link between biology and disease?. Semin Thromb Hemost 2009; 35 (1) 23-33
  • 29 Pamukcu B, Oflaz H, Onur I, Cimen A, Nisanci Y. Effect of cigarette smoking on platelet aggregation. Clin Appl Thromb Hemost 2011; 17 (6) E175-E180
  • 30 Clinical Laboratory Standards Institute (CLSI). Platelet Function Testing by Aggregometry; Approved Guideline. CLSI document H58-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2008
  • 31 Bazzano LA, He J, Muntner P, Vupputuri S, Whelton PK. Relationship between cigarette smoking and novel risk factors for cardiovascular disease in the United States. Ann Intern Med 2003; 138 (11) 891-897
  • 32 Ozdemir O, Karaaslan Y, Ozcebe O, Dündar S, Kirazli S. The acute effect of smoking on platelet and endothelial release reaction is suppressed in chronic smokers. Thromb Res 1992; 65 (2) 263-274
  • 33 Lippi G, Favaloro EJ, Franchini M, Guidi GC. Air pollution and coagulation testing: a new source of biological variability?. Thromb Res 2008; 123 (1) 50-54
  • 34 Lippi G, Plebani M. Identification errors in the blood transfusion laboratory: a still relevant issue for patient safety. Transfus Apheresis Sci 2011; 44 (2) 231-233
  • 35 Lippi G, Blanckaert N, Bonini P , et al. Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med 2009; 47 (2) 143-153
  • 36 Joint Commission. Laboratory: 2012 National Patient Safety Goals. Available at: http://www.jointcommission.org/lab_2012_npsgs/ . Accessed on: May 30, 2012
  • 37 Lippi G, Sonntag O, Plebani M. Appropriate labelling of blood collection tubes: a step ahead towards patient's safety. Clin Chem Lab Med 2011; 49: 1921-1923
  • 38 Lippi G, Mattiuzzi C, Guidi GC. Laboratory quality improvement by implementation of phlebotomy guidelines. MLO Med Lab Obs 2006; 38 (1) 6-7 , author reply 7
  • 39 Lippi G, Caputo M, Banfi G , et al. for the Gruppo di Studio Intersocietario SIBioC-SIMeL-CISMEL sulla variabilità extra-analitica del dato di laboratorio. Raccomandazioni per il prelievo di sangue venoso. Biochim Clin 2008; 32: 569-577
  • 40 Kiechle FL, Adcock DM, Calam RR, Davis C, Schwartz JG. So You're Going to Collect a Blood Specimen. An Introduction to Phlebotomy. 12th ed. Northfield, IL: College of American Pathologists; 2007
  • 41 Lippi G, Salvagno GL, Montagnana M, Guidi GC. Short-term venous stasis influences routine coagulation testing. Blood Coagul Fibrinolysis 2005; 16 (6) 453-458
  • 42 Lima-Oliveira G, Salvagno GL, Lippi G , et al. Elimination of the venous stasis error for routine coagulation testing by transillumination. Clin Chim Acta 2011; 412 (15-16) 1482-1484
  • 43 Lippi G, Salvagno GL, Montagnana M, Brocco G, Cesare Guidi G. Influence of the needle bore size used for collecting venous blood samples on routine clinical chemistry testing. Clin Chem Lab Med 2006; 44 (8) 1009-1014
  • 44 Lippi G, Salvagno GL, Montagnana M, Poli G, Guidi GC. Influence of the needle bore size on platelet count and routine coagulation testing. Blood Coagul Fibrinolysis 2006; 17 (7) 557-561
  • 45 Lippi G, Salvagno GL, Guidi GC. No influence of a butterfly device on routine coagulation assays and D-dimer measurement. J Thromb Haemost 2005; 3 (2) 389-391
  • 46 Favaloro EJ, Lippi G, Raijmakers MT, Vader HL, van der Graaf F. Discard tubes are sometimes necessary when drawing samples for hemostasis. Am J Clin Pathol 2010; 134 (5) 851
  • 47 Clinical and Laboratory Standard Institute. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline. 5th ed. CLSI document H21–A5. Wayne, PA: Clinical and Laboratory Standards Institute; 2008
  • 48 Gosselin RC, Janatpour K, Larkin EC, Lee YP, Owings JT. Comparison of samples obtained from 3.2% sodium citrate glass and two 3.2% sodium citrate plastic blood collection tubes used in coagulation testing. Am J Clin Pathol 2004; 122 (6) 843-848
  • 49 Fiebig EW, Etzell JE, Ng VL. Clinically relevant differences in prothrombin time and INR values related to blood sample collection in plastic vs glass tubes. Am J Clin Pathol 2005; 124 (6) 902-909
  • 50 Kratz A, Stanganelli N, Van Cott EM. A comparison of glass and plastic blood collection tubes for routine and specialized coagulation assays: a comprehensive study. Arch Pathol Lab Med 2006; 130 (1) 39-44
  • 51 Toulon P, Ajzenberg N, Smahi M, Guillin MC. A new plastic collection tube made of polyethylene terephtalate is suitable for monitoring traditional anticoagulant therapy (oral anticoagulant, unfractionated heparin, and low molecular weight heparin). Thromb Res 2007; 119 (2) 135-143
  • 52 D'Angelo G, Villa C. Comparison between siliconized evacuated glass and plastic blood collection tubes for prothrombin time and activated partial thromboplastin time assay in normal patients, patients on oral anticoagulant therapy and patients with unfractioned heparin therapy. Int J Lab Hematol 2011; 33 (2) 219-225
  • 53 Lippi G, Lima-Oliveira G, Nazer SC , et al. Suitability of a transport box for blood sample shipment over a long period. Clin Biochem 2011; 44 (12) 1028-1029
  • 54 Plebani M, Lippi G. Is laboratory medicine a dying profession? Blessed are those who have not seen and yet have believed. Clin Biochem 2010; 43 (12) 939-941
  • 55 Plebani M, Lippi G. WITHDRAWN: Focused factories and boutique laboratories. The truth might lie in between. Clin Biochem 2010; 43: 1484-1485
  • 56 Lippi G, Salvagno GL, Adcock DM, Gelati M, Guidi GC, Favaloro EJ. Right or wrong sample received for coagulation testing? Tentative algorithms for detection of an incorrect type of sample. Int J Lab Hematol 2010; 32 (1 Pt 2) 132-138
  • 57 Lippi G, Blanckaert N, Bonini P , et al. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008; 46 (6) 764-772
  • 58 Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci 2011; 48 (3) 143-153
  • 59 Salvagno GL, Lippi G, Bassi A, Poli G, Guidi GC. Prevalence and type of pre-analytical problems for inpatients samples in coagulation laboratory. J Eval Clin Pract 2008; 14 (2) 351-353
  • 60 Lippi G, Musa R, Avanzini P, Aloe R, Pipitone S, Sandei F. Influence of in vitro hemolysis on hematological testing on Advia 2120. Int J Lab Hematol 2012; 34 (2) 179-184
  • 61 Lippi G, Salvagno GL, Montagnana M, Poli G, Guidi GC. Influence of the needle bore size on platelet count and routine coagulation testing. Blood Coagul Fibrinolysis 2006; 17 (7) 557-561
  • 62 Laga AC, Cheves TA, Sweeney JD. The effect of specimen hemolysis on coagulation test results. Am J Clin Pathol 2006; 126 (5) 748-755
  • 63 Lippi G, Fontana R, Avanzini P , et al. Influence of mechanical trauma of blood and hemolysis on PFA-100 testing. Blood Coagul Fibrinolysis 2012; 23 (1) 82-86
  • 64 Plebani M, Lippi G. Hemolysis index: quality indicator or criterion for sample rejection?. Clin Chem Lab Med 2009; 47 (8) 899-902
  • 65 Adcock DM, Kressin DC, Marlar RA. Are discard tubes necessary in coagulation studies?. Lab Med 1997; 28: 530-533
  • 66 Gottfried EL, Adachi MM. Prothrombin time and activated partial thromboplastin time can be performed on the first tube. Am J Clin Pathol 1997; 107 (6) 681-683
  • 67 Bamberg R, Cottle JN, Williams JC. Effect of drawing a discard tube on PT and APTT results in healthy adults. Clin Lab Sci 2003; 16 (1) 16-19
  • 68 Raijmakers MT, Menting CH, Vader HL, van der Graaf F. Collection of blood specimens by venipuncture for plasma-based coagulation assays: necessity of a discard tube. Am J Clin Pathol 2010; 133 (2) 331-335
  • 69 Smock KJ, Crist RA, Hansen SJ, Rodgers GM, Lehman CM. Discard tubes are not necessary when drawing samples for specialized coagulation testing. Blood Coagul Fibrinolysis 2010; 21 (3) 279-282
  • 70 Kunicki TJ, Williams SA, Salomon DR , et al. Genetics of platelet reactivity in normal, healthy individuals. J Thromb Haemost 2009; 7 (12) 2116-2122
  • 71 Adcock DM, Kressin DC, Marlar RA. Effect of 3.2% vs 3.8% sodium citrate concentration on routine coagulation testing. Am J Clin Pathol 1997; 107 (1) 105-110
  • 72 Peterson P, Gottfried EL. The effects of inaccurate blood sample volume on prothrombin time (PT) and activated partial thromboplastin time (aPTT). Thromb Haemost 1982; 47 (2) 101-103
  • 73 Reneke J, Etzell J, Leslie S, Ng VL, Gottfried EL. Prolonged prothrombin time and activated partial thromboplastin time due to underfilled specimen tubes with 109 mmol/L (3.2%) citrate anticoagulant. Am J Clin Pathol 1998; 109 (6) 754-757
  • 74 Adcock DM, Kressin DC, Marlar RA. Minimum specimen volume requirements for routine coagulation testing: dependence on citrate concentration. Am J Clin Pathol 1998; 109 (5) 595-599
  • 75 Siegel JE, Swami VK, Glenn P, Peterson P. Effect (or lack of it) of severe anemia on PT and APTT results. Am J Clin Pathol 1998; 110 (1) 106-110
  • 76 Lippi G, Salvagno GL, Montagnana M, Guidi GC. Influence of primary sample mixing on routine coagulation testing. Blood Coagul Fibrinolysis 2007; 18 (7) 709-711
  • 77 Parenmark A, Landberg E. To mix or not to mix venous blood samples collected in vacuum tubes?. Clin Chem Lab Med 2011; 49: 2061-2063
  • 78 Iversen LH. Pre-analytical variation in the measurements of sensitive markers of coagulation and fibrinolysis: the influence of venipuncture and mixing of blood. Haemostasis 1997; 27 (3) 119-124
  • 79 Chuang J, Sadler MA, Witt DM. Impact of evacuated collection tube fill volume and mixing on routine coagulation testing using 2.5-ml (pediatric) tubes. Chest 2004; 126 (4) 1262-1266
  • 80 Burns ER, Yoshikawa N. Hemolysis in serum samples drawn by emergency department personnel versus laboratory phlebotomists. Lab Med 2002; 33: 378-380
  • 81 Grant MS. The effect of blood drawing techniques and equipment on the hemolysis of ED laboratory blood samples. J Emerg Nurs 2003; 29 (2) 116-121
  • 82 Lippi G, Plebani M. Primary blood tubes mixing: time for updated recommendations. Clin Chem Lab Med 2012; 50 (4) 599-600