Download PDF
Semin Thromb Hemost 2012; 38(06): 553-558
DOI: 10.1055/s-0032-1315960
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Patient Safety and Quality in Laboratory and Hemostasis Testing: A Renewed Loop?

Mario Plebani
1   Dipartimento Medicina di Laboratorio, Azienda Ospedaliera-Università di Padova, Padova, Italy
,
Emmanuel J. Favaloro
2   Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, Westmead, Australia
,
Giuseppe Lippi
3   U.O. Diagnostica Ematochimica, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
02 June 2012 (online)

    Permissions and Reprints

Abstract

More than three decades ago, George Lundberg first introduced the concept of the brain-to-brain loop for laboratory diagnostics. According to this pioneering model, the first step in the loop involves the selection of laboratory tests in the brain of the physician caring for the patient, and the final step is the transmission of test results back to the ordering physician. There are several intermediary steps, some of which are preanalytical (e.g., identification of patient and blood samples, the process of blood collection, and specimen handling); some are analytical and relate to the actual performance of the test(s); whereas others are postanalytical and involve release of test results into the medical record and further steps such as the physician's reaction to laboratory information, their interpretation of these results, and subsequent appropriate clinical action. Hemostasis testing should also be viewed within such a paradigm, so that quality throughout the total testing process can be assured. For hemostasis testing, particular attention is required to ensure provision of appropriate test samples in the preanalytical phase. Nevertheless, the timeliness of testing and an appropriate interpretation of test results are also paramount. This article overviews the concept of quality testing within hemostasis as critical to ensuring patient safety and optimal clinical and therapeutic management.

Keywords

patient safety - quality - hemostasis - testing - laboratory errors
 

  • References

  • 1 Lundberg GD. Acting on significant laboratory results. JAMA 1981; 245 (17) 1762-1763
    CrossrefPubMedGoogle Scholar
  • 2 Plebani M, Lippi G. Closing the brain-to-brain loop in laboratory testing. Clin Chem Lab Med 2011; 49 (7) 1131-1133
    CrossrefPubMedGoogle Scholar
  • 3 Lundberg GD. The need for an outcomes research agenda for clinical laboratory testing. JAMA 1998; 280 (6) 565-566
    CrossrefPubMedGoogle Scholar
  • 4 Vincent C. Patient Safety. Edinburgh: Elsevier Churchill Livingstone; 2006
    Google Scholar
  • 5 Bruns DE. Laboratory-related outcomes in healthcare. Clin Chem 2001; 47 (8) 1547-1552
    PubMedGoogle Scholar
  • 6 Porter ME. What is value in health care?. N Engl J Med 2010; 363 (26) 2477-2481
    CrossrefPubMedGoogle Scholar
  • 7 Zaninotto M, Plebani M. The “hospital central laboratory”: automation, integration and clinical usefulness. Clin Chem Lab Med 2010; 48 (7) 911-917
    CrossrefPubMedGoogle Scholar
  • 8 Lippi G, Plebani M, Simundic AM. Quality in laboratory diagnostics: from theory to practice. Biochem Med 2010; 20 (2) 126-130
    PubMedGoogle Scholar
  • 9 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
    CrossrefPubMedGoogle Scholar
  • 10 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
    CrossrefPubMedGoogle Scholar
  • 11 Preston FE, Lippi G, Favaloro EJ, Jayandharan GR, Edison ES, Srivastava A. Quality issues in laboratory haemostasis. Haemophilia 2010; 16 (Suppl. 05) 93-99
    CrossrefPubMedGoogle Scholar
  • 12 Lippi G, Favaloro EJ. Laboratory diagnostics and appropriate care of people with haemophilia. Haemophilia 2011; 17 (5) 824-825
    PubMedGoogle Scholar
  • 13 Bonar R, Favaloro EJ, Adcock DM. Quality in coagulation and haemostasis testing. Biochem Med 2010; 20 (2) 184-199
    PubMedGoogle Scholar
  • 14 Lippi G, Plebani M, Favaloro EJ, Trenti T. Laboratory testing in pharmacies. Clin Chem Lab Med 2010; 48 (7) 943-953
    CrossrefPubMedGoogle Scholar
  • 15 Lippi G, Favaloro EJ, Plebani M. Direct-to-consumer testing: more risks than opportunities. Int J Clin Pract 2011; 65 (12) 1221-1229
    CrossrefPubMedGoogle Scholar
  • 16 Guidi GC, Lippi G. Laboratory medicine in the 2000s: programmed death or rebirth?. Clin Chem Lab Med 2006; 44 (8) 913-917
    CrossrefPubMedGoogle Scholar
  • 17 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 (6) 829-833
    CrossrefPubMedGoogle Scholar
  • 18 Otto CN. Patient safety and the medical laboratory using the IOM aims. Clin Lab Sci 2011; 24 (2) 108-113
    PubMedGoogle Scholar
  • 19 Valenstein PN, Walsh MK, Meier F ; College of American Pathologists. Heparin monitoring and patient safety: a College of American Pathologists Q-Probes study of 3431 patients at 140 institutions. Arch Pathol Lab Med 2004; 128 (4) 397-402
    PubMedGoogle Scholar
  • 20 Drewes HW, Lambooij MS, Baan CA, Meijboom BR, Graafmans WC, Westert GP. Needs and barriers to improve the collaboration in oral anticoagulant therapy: a qualitative study. BMC Cardiovasc Disord 2011; 11 (1) 76
    CrossrefPubMedGoogle Scholar
  • 21 Berrettini M, Agnelli G. Management of oral anticoagulant therapy in Italy. Semin Thromb Hemost 1999; 25 (1) 27-31
    Article in Thieme ConnectPubMedGoogle Scholar
  • 22 ISO 1589:2007. Medical laboratories—particular requirements for quality and competence
    PubMedGoogle Scholar
  • 23 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
    CrossrefPubMedGoogle Scholar
  • 24 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
    CrossrefPubMedGoogle Scholar
  • 25 Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010; 47 (Pt 2) 101-110
    CrossrefPubMedGoogle Scholar
  • 26 Tufano A, Guida A, Di Minno MN, Prisco D, Cerbone AM, Di Minno G. Prevention of venous thromboembolism in medical patients with thrombocytopenia or with platelet dysfunction: a review of the literature. Semin Thromb Hemost 2011; 37 (3) 267-274
    Article in Thieme ConnectPubMedGoogle Scholar
  • 27 Heleen van Ommen C, Middeldorp S. Thrombophilia in childhood: to test or not to test. Semin Thromb Hemost 2011; 37 (7) 794-801
    Article in Thieme ConnectPubMedGoogle Scholar
  • 28 Lippi G, Favaloro EJ, Cervellin G. Prevention of venous thromboembolism: focus on mechanical prophylaxis. Semin Thromb Hemost 2011; 37 (3) 237-251
    Article in Thieme ConnectPubMedGoogle Scholar
  • 29 Bikdeli B, Sharif-Kashani B. Prophylaxis for venous thromboembolism: a great global divide between expert guidelines and clinical practice?. Semin Thromb Hemost 2012; 38 (2) 144-155
    Article in Thieme ConnectPubMedGoogle Scholar
  • 30 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 (12) 1424-1427
    PubMedGoogle Scholar
  • 31 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
    CrossrefPubMedGoogle Scholar
  • 32 Favaloro EJ, Lippi G, Koutts J. Laboratory testing of anticoagulants: the present and the future. Pathology 2011; 43 (7) 682-692
    CrossrefPubMedGoogle Scholar
  • 33 Barth JH. Clinical quality indicators in laboratory medicine: a survey of current practice in the UK. Ann Clin Biochem 2011; 48 (Pt 3) 238-240
    CrossrefPubMedGoogle Scholar
  • 34 Dighe AS, Soderberg BL, Laposata M. Narrative interpretations for clinical laboratory evaluations: an overview. Am J Clin Pathol 2001; 116 (Suppl) S123-S128
    PubMedGoogle Scholar
  • 35 Laposata M, Dighe A. “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory. Clin Chem Lab Med 2007; 45 (6) 712-719
    CrossrefPubMedGoogle Scholar
  • 36 Lippi G, Favaloro EJ, Franchini M, Guidi GC. Milestones and perspectives in coagulation and hemostasis. Semin Thromb Hemost 2009; 35 (1) 9-22
    Article in Thieme ConnectPubMedGoogle Scholar
  • 37 Lippi G, Franchini M. Pathogenesis of venous thromboembolism: when the cup runneth over. Semin Thromb Hemost 2008; 34 (8) 747-761
    Article in Thieme ConnectPubMedGoogle Scholar
  • 38 Lippi G, Franchini M, Targher G. Arterial thrombus formation in cardiovascular disease. Nat Rev Cardiol 2011; 8 (9) 502-512
    CrossrefPubMedGoogle Scholar
  • 39 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 40 Favaloro EJ, Reben R, Mohammed S, Koutts J. Clinical audit of antiphospholipid antibody testing in tertiary practice: towards improved relevance in thrombophilia investigations. Intern Med J 2012; 42 (4) 427-434
    CrossrefPubMedGoogle Scholar
  • 41 Favaloro EJ, Mohammed S, Pati N, Ho MY, McDonald D. A clinical audit of congenital thrombophilia investigation in tertiary practice. Pathology 2011; 43 (3) 266-272
    CrossrefPubMedGoogle Scholar
  • 42 Favaloro EJ. Assessment for antithrombin deficiency in the real world. Int J Lab Hematol 2011; 33 (6) 656-658 , author reply 659–660
    CrossrefPubMedGoogle Scholar
  • 43 Montagnana M, Favaloro EJ, Franchini M, Guidi GC, Lippi G. The role of ethnicity, age and gender in venous thromboembolism. J Thromb Thrombolysis 2010; 29 (4) 489-496
    CrossrefPubMedGoogle Scholar
  • 44 Lippi G, Franchini M, Montagnana M, Salvagno GL, Poli G, Guidi GC. Quality and reliability of routine coagulation testing: can we trust that sample?. Blood Coagul Fibrinolysis 2006; 17 (7) 513-519
    CrossrefPubMedGoogle Scholar
  • 45 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
    Google Scholar
  • 46 Lippi G, Salvagno GL, Montagnana M, Guidi GC. Short-term venous stasis influences routine coagulation testing. Blood Coagul Fibrinolysis 2005; 16 (6) 453-458
    CrossrefPubMedGoogle Scholar
  • 47 Adcock DM, Hoefner DM, Kottke-Marchant K, Marlar RA, Szamosi DI, Warunek DJ. 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 Laboratory Standards Institute; 2008
    Google Scholar
  • 48 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 49 Favaloro EJ, Adcock D, Lippi G. Preanalytical variables in coagulation testing associated to diagnostic errors in hemostasis. Lab Med 2012; 43 (2) 1-10
    CrossrefPubMedGoogle Scholar
  • 50 Zürcher M, Sulzer I, Barizzi G, Lämmle B, Alberio L. Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature. Thromb Haemost 2008; 99 (2) 416-426
    PubMedGoogle Scholar
  • 51 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
    PubMedGoogle Scholar
  • 52 Favaloro EJ. More on preanalytical variables affecting platelet function testing using light transmittance aggregometry. Clin Chem Lab Med 2011; 49 (4) 737-739
    CrossrefPubMedGoogle Scholar
  • 53 Lippi G, Salvagno GL, Montagnana M, Lima-Oliveira G, Guidi GC, Favaloro EJ. Quality standards for sample collection in coagulation testing. Sem Thromb Hemost 2012; 38 (6) 565-575
    Article in Thieme ConnectPubMedGoogle Scholar
  • 54 Adcock-Funk D, Lippi G, Favaloro EJ. Quality standards for sample processing, transportation and storage processing. Sem Thromb Hemost 2012; 38 (6)
    PubMedGoogle Scholar
  • 55 Goswami B, Tayal D, Chawla R, Mallika V. Pre-analytical factors that influence the interpretation of prothrombin time in the clinical laboratory: one year experience in a super speciality hospital in India. Clin Chim Acta 2009; 410 (1-2) 93-94
    CrossrefPubMedGoogle Scholar
  • 56 Salvagno GL, Lippi G, Montagnana M, Franchini M, Poli G, Guidi GC. Influence of temperature and time before centrifugation of specimens for routine coagulation testing. Int J Lab Hematol 2009; 31 (4) 462-467
    CrossrefPubMedGoogle Scholar
  • 57 Lippi G, Salvagno GL, Montagnana M, Manzato F, Guidi GC. Influence of the centrifuge time of primary plasma tubes on routine coagulation testing. Blood Coagul Fibrinolysis 2007; 18 (5) 525-528
    CrossrefPubMedGoogle Scholar
  • 58 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 (7) 477-478
    CrossrefPubMedGoogle Scholar
  • 59 Meijer P, Haverkate F, Kluft C. Performance goals for the laboratory testing of antithrombin, protein C and protein S. Thromb Haemost 2006; 96 (5) 584-589
    PubMedGoogle Scholar
  • 60 Plebani M, Sanzari MC, Zardo L. Quality control in coagulation testing. Semin Thromb Hemost 2008; 34 (7) 642-646
    Article in Thieme ConnectPubMedGoogle Scholar
  • 61 Favaloro EJ, Lippi G, Franchini M. Contemporary platelet function testing. Clin Chem Lab Med 2010; 48 (5) 579-598
    CrossrefPubMedGoogle Scholar
  • 62 Favaloro EJ. Internal quality control and external quality assurance of platelet function tests. Semin Thromb Hemost 2009; 35 (2) 139-149
    Article in Thieme ConnectPubMedGoogle Scholar
  • 63 Favaloro EJ, Bonar R. Proficiency testing/external quality control for the PFA-100. Clin Chem Lab Med 2012; 50: 1393-1401
    PubMedGoogle Scholar
  • 64 Perry DJ, Fitzmaurice DA, Kitchen S, Mackie IJ, Mallett S. Point-of-care testing in haemostasis. Br J Haematol 2010; 150 (5) 501-514
    CrossrefPubMedGoogle Scholar
  • 65 Favaloro EJ, Lippi G. Coagulation update: what's new in hemostasis testing?. Thromb Res 2011; 127 (Suppl) (2) S13-S16
    PubMedGoogle Scholar
  • 66 Wegner J, Popovsky MA. Clinical utility of thromboelastography: one size does not fit all. Semin Thromb Hemost 2010; 36 (7) 699-706
    Article in Thieme ConnectPubMedGoogle Scholar
  • 67 Clinical Laboratory Standards Institute (CLSI). Platelet Function Testing by Aggregometry; Approved Guideline. CLSI document H58-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2008
    Google Scholar
  • 68 Lippi G, Favaloro EJ. Unsuspected coagulopathy rarely prevents IV thrombolysis in acute ischemic stroke. Neurology 2010; 74 (18) 1477 , author reply 1477–1478
    CrossrefPubMedGoogle Scholar
  • 69 Stavelin A, Meijer P, Kitchen D, Sandberg S. External quality assessment of point-of-care International Normalized Ratio (INR) testing in Europe. Clin Chem Lab Med 2012; 50 (1) 81-88
    CrossrefPubMedGoogle Scholar
  • 70 Piva E, Lippi G, Plebani M. Notification of abnormal and critical values: the road ahead. Am J Med 2010; 123 (10) e19 , author reply e21
    CrossrefPubMedGoogle Scholar
  • 71 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 (11) 1355-1360
    CrossrefPubMedGoogle Scholar
  • 72 Piva E, Sciacovelli L, Laposata M, Plebani M. Assessment of critical values policies in Italian institutions: comparison with the US situation. Clin Chem Lab Med 2010; 48 (4) 461-468
    CrossrefPubMedGoogle Scholar
  • 73 Pai M, Moffat KA, Plumhoff E, Hayward CPM. Critical values in the coagulation laboratory: results of a survey of the North American Specialized Coagulation Laboratory Association. Am J Clin Pathol 2011; 136 (6) 836-841
    CrossrefPubMedGoogle Scholar
  • 74 Piva E, Sciacovelli L, Zaninotto M, Laposata M, Plebani M. Evaluation of effectiveness of a computerized notification system for reporting critical values. Am J Clin Pathol 2009; 131 (3) 432-441
    CrossrefPubMedGoogle Scholar
  • 75 Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta 2009; 404 (1) 16-23
    CrossrefPubMedGoogle Scholar
  • 76 Graber ML. The physician and the laboratory. Am J Clin Pathol 2005; 124 (Suppl) (1) S1-S4
    CrossrefPubMedGoogle Scholar
  • 77 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 (8) 720-725
    PubMedGoogle Scholar
  • 78 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 (12) 1965-1973
    CrossrefPubMedGoogle Scholar