CC BY-NC-ND 4.0 · Semin Thromb Hemost 2020; 46(04): 398-409
DOI: 10.1055/s-0039-1697677
Review Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

International Council for Standardization in Haematology Recommendations for Hemostasis Critical Values, Tests, and Reporting

Robert C. Gosselin
1   Thrombosis and Hemostasis Center, University of California, Davis Health System, Sacramento, California
,
Dorothy Adcock
2   Laboratory Corporation of America, Burlington, North Carolina
,
Akbar Dorgalaleh
3   Department of Hematology and Blood Transfusion, School of Allied Medicine, Iran University of Medical Sciences, Tehran, Iran
,
Emmanuel J. Favaloro
4   Department of Haematology, Sydney Centres for Thrombosis and Haemostasis, Institute of Clinical Pathology and Medical Research (ICPMR), NSW Health Pathology, Westmead Hospital, Westmead, New South Wales, Australia
,
Giuseppe Lippi
5   Dipartimento di Scienze Neurologiche e del Movimento, Sezione di Biochimica Clinica, Universita degli Studi di Verona, Verona, Italy
,
João M. Pego
6   Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
,
Irene Regan
7   Coagulation Department, Our Lady's Children's Hospital, Crumlin, Dublin, Ireland
,
Virginie Siguret
8   Service d'hématologie Biologique, Hôpital Lariboisière, Université Paris Descartes, Paris, France
› Author Affiliations
Further Information

Publication History

Publication Date:
22 October 2019 (online)

Abstract

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH), the aim of which is to provide hemostasis-related guidance documents for clinical laboratories. The current ICSH document was developed by an ad hoc committee, comprising an international collection of both clinical and laboratory experts. The purpose of this ICSH document is to provide laboratory guidance for (1) identifying hemostasis (coagulation) tests that have potential patient risk based on analysis, test result, and patient presentations, (2) critical result thresholds, (3) acceptable reporting and documenting mechanisms, and (4) developing laboratory policies. The basis for these recommendations was derived from published data, expert opinion, and good laboratory practice. The committee realizes that regional and local regulations, institutional stakeholders (e.g., physicians, laboratory personnel, hospital managers), and patient types (e.g., adults, pediatric, surgical) will be additional confounders for a given laboratory in generating a critical test list, critical value thresholds, and policy. Nevertheless, we expect this guidance document will be helpful as a framework for local practice.

 
  • References

  • 1 Lundberg GD. When to panic over abnormal values. Med Lab Observer 1972; 4: 47-54
  • 2 Lundberg GD. Critical (panic) value notification: an established laboratory practice policy (parameter). JAMA 1990; 263 (05) 709
  • 3 Kost GJ. Critical limits for urgent clinician notification at US medical centers. JAMA 1990; 263 (05) 704-707
  • 4 Pai M, Moffat KA, Plumhoff E, Hayward CP. Critical values in the coagulation laboratory: results of a survey of the North American Specialized Coagulation Laboratory Association. Am J Clin Pathol 2011; 136 (06) 836-841
  • 5 Wagar EA, Friedberg RC, Souers R, Stankovic AK. Critical values comparison: a College of American Pathologists Q-Probes survey of 163 clinical laboratories. Arch Pathol Lab Med 2007; 131 (12) 1769-1775
  • 6 Lippi G, Adcock D, Simundic AM, Tripodi A, Favaloro EJ. Critical laboratory values in hemostasis: toward consensus. Ann Med 2017; 49 (06) 455-461
  • 7 Thomas L. Critical limits of laboratory results for urgent clinician notification, eJIFCC vol 14 no 1. Available at: http://www.ifcc.org/media/477036/ejifcc2003vol14no1pp011-018.pdf . Accessed July 31, 2019
  • 8 Hashim IA, Cuthbert JA. Establishing, harmonizing and analyzing critical values in a large academic health center. Clin Chem Lab Med 2014; 52 (08) 1129-1135
  • 9 Kopcinovic LM, Trifunović J, Pavosevic T, Nikolac N. Croatian survey on critical results reporting. Biochem Med (Zagreb) 2015; 25 (02) 193-202
  • 10 Keng TB, De La Salle B, Bourner G. , et al; International Council for Standardization in Haematology (ICSH). Standardization of haematology critical results management in adults: an International Council for Standardization in Haematology, ICSH, survey and recommendations. Int J Lab Hematol 2016; 38 (05) 457-471
  • 11 Associated Regional and University Pathologists (ARUP). Critical value test list. Available at: https://www.aruplab.com/Testing-Information/resources/PDF_Brochures/ARUP_Critical_Values.pdf . Accessed July 31, 2019
  • 12 Mayo Clinical Laboratories. Critical value list. Available at: https://www.mayocliniclabs.com/it-mmfiles/DLMP_Critical_Values_-_Critical_Results_List.pdf . Accessed July 31, 2019
  • 13 Quest Diagnostics. Laboratory priority value table. Available at: https://www.questdiagnostics.com/dms/Documents/test-center/Quest_Diagnostics_Priority_Value_Tables.pdf . Accessed July 31, 2019
  • 14 Stanford University Health Care. Critical/panic value list. Available at: https://stanfordhealthcare.org/health-care-professionals/laboratory-critical-value-list.html . Accessed July 31, 2019
  • 15 University of Iowa. Critical laboratory tests and values. Available at: https://www.healthcare.uiowa.edu/path_handbook/Appendix/Common/UN_CRIT_LAB_VAL.html . Accessed July 31, 2019
  • 16 Zhu W, He W, Guo L, Wang X, Hong K. The HAS-BLED score for predicting major bleeding risk in anticoagulated patients with atrial fibrillation: a systematic review and meta-analysis. Clin Cardiol 2015; 38 (09) 555-561
  • 17 Parks AL, Fang MC. Scoring systems for estimating the risk of anticoagulant-associated bleeding. Semin Thromb Hemost 2017; 43 (05) 514-524
  • 18 Brigden ML, Kay C, Le A, Graydon C, McLeod B. Audit of the frequency and clinical response to excessive oral anticoagulation in an out-patient population. Am J Hematol 1998; 59 (01) 22-27
  • 19 Price EA, Jin J, Nguyen HM, Krishnan G, Bowen R, Zehnder JL. Discordant aPTT and anti-Xa values and outcomes in hospitalized patients treated with intravenous unfractionated heparin. Ann Pharmacother 2013; 47 (02) 151-158
  • 20 Smythe MA, Priziola J, Dobesh PP, Wirth D, Cuker A, Wittkowsky AK. Guidance for the practical management of the heparin anticoagulants in the treatment of venous thromboembolism. J Thromb Thrombolysis 2016; 41 (01) 165-186
  • 21 Doering TA, Plapp F, Crawford JM. Establishing an evidence base for critical laboratory value thresholds. Am J Clin Pathol 2014; 142 (05) 617-628
  • 22 Spahn DR, Spahn GH, Stein P. Indications and risks of fibrinogen in surgery and trauma. Semin Thromb Hemost 2016; 42 (02) 147-154
  • 23 Rodeghiero F, Tosetto A, Castaman G. How to estimate bleeding risk in mild bleeding disorders. J Thromb Haemost 2007; 5 (Suppl. 01) 157-166
  • 24 Adelmann D, Klaus DA, Illievich UM. , et al. Fibrinogen but not factor XIII deficiency is associated with bleeding after craniotomy. Br J Anaesth 2014; 113 (04) 628-633
  • 25 Casini A, de Moerloose P, Neerman-Arbez M. Clinical features and management of congenital fibrinogen deficiencies. Semin Thromb Hemost 2016; 42 (04) 366-374
  • 26 Casini A, de Moerloose P. ; Congenital Fibrinogen Disorders Group. Management of congenital quantitative fibrinogen disorders: a Delphi consensus. Haemophilia 2016; 22 (06) 898-905
  • 27 Dorgalaleh A, Cassini A, Rahmani P. Congenital fibrinogen disorders. In: Dorgalaleh A. ., ed. Congenital Bleeding Disorders – Diagnosis and Management. Cham: Springer Press; 2018: 27-53
  • 28 Tabibian S, Motlagh H, Naderi M, Dorgalaleh A. Intracranial hemorrhage in congenital bleeding disorders. Blood Coagul Fibrinolysis 2018; 29 (01) 1-11
  • 29 Valentino LA, Pipe SW, Collins PW. , et al. Association of peak factor VIII levels and area under the curve with bleeding in patients with haemophilia A on every third day pharmacokinetic-guided prophylaxis. Haemophilia 2016; 22 (04) 514-520
  • 30 Konkle BA, Huston H, Nakaya Fletcher S. Hemophilia B. 2000 Oct 2 [updated 2017 Jun 15]. In: Adam MP, Ardinger HH, Pagon RA, Wallace SE, Bean LJH, Stephens K, Amemiya A. , eds. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993–2019. Available at: http://www.ncbi.nlm.nih.gov/books/NBK1495/ . Accessed July 31, 2019
  • 31 Girolami A, Ferrari S, Cosi E, Girolami B, Lombardi AM. Congenital prothrombin defects: they are not only associated with bleeding but also with thrombosis: a new classification is needed. Hematology 2018; 23 (02) 105-110
  • 32 Peyvandi F, Palla R, Menegatti M. , et al; European Network of Rare Bleeding Disorders Group. Coagulation factor activity and clinical bleeding severity in rare bleeding disorders: results from the European Network of Rare Bleeding Disorders. J Thromb Haemost 2012; 10 (04) 615-621
  • 33 Napolitano M, Siragusa S, Mariani G. Factor VII deficiency: clinical phenotype, genotype and therapy. J Clin Med 2017; 6 (04) E38
  • 34 Di Minno MN, Dolce A, Mariani G. ; STER Study Group. Bleeding symptoms at disease presentation and prediction of ensuing bleeding in inherited FVII deficiency. Thromb Haemost 2013; 109 (06) 1051-1059
  • 35 Di Minno MND, Napolitano M, Dolce A, Mariani G. ; STER Study Group. Role of clinical and laboratory parameters for treatment choice in patients with inherited FVII deficiency undergoing surgical procedures: evidence from the STER registry. Br J Haematol 2018; 180 (04) 563-570
  • 36 Bannow BS, Konkle BA. Inherited bleeding disorders in the obstetric patient. Transfus Med Rev 2018; 32 (04) 237-243
  • 37 Huq FY, Kadir RA. Management of pregnancy, labour and delivery in women with inherited bleeding disorders. Haemophilia 2011; 17 (Suppl. 01) 20-30
  • 38 Dorgalaleh A, Rashidpanah J. Blood coagulation factor XIII and factor XIII deficiency. Blood Rev 2016; 30 (06) 461-475
  • 39 Zucker M, Seligsohn U, Salomon O, Wolberg AS. Abnormal plasma clot structure and stability distinguish bleeding risk in patients with severe factor XI deficiency. J Thromb Haemost 2014; 12 (07) 1121-1130
  • 40 Warkentin TE. Heparin-induced thrombocytopenia. Curr Opin Crit Care 2015; 21 (06) 576-585
  • 41 Cuker A, Arepally GM, Chong BH. , et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: heparin-induced thrombocytopenia. Blood Adv 2018; 2 (22) 3360-3392
  • 42 Favaloro EJ, McCaughan G, Pasalic L. Clinical and laboratory diagnosis of heparin induced thrombocytopenia: an update. Pathology 2017; 49 (04) 346-355
  • 43 Joseph J, Rabbolini D, Enjeti AK. , et al. Diagnosis and management of heparin-induced thrombocytopenia: a consensus statement from the Thrombosis and Haemostasis Society of Australia and New Zealand HIT Writing Group. Med J Aust 2019; 210 (11) 509-516
  • 44 Metjian AD, Wang C, Sood SL. , et al; HTCN Study Investigators. Bleeding symptoms and laboratory correlation in patients with severe von Willebrand disease. Haemophilia 2009; 15 (04) 918-925
  • 45 Sadler JE. Low von Willebrand factor: sometimes a risk factor and sometimes a disease. Hematology Am Soc Hematol Educ Program 2009; 106-112
  • 46 Hawke L, Grabell J, Sim W. , et al. Obstetric bleeding among women with inherited bleeding disorders: a retrospective study. Haemophilia 2016; 22 (06) 906-911
  • 47 Favaloro EJ, Pasalic L, Curnow J. Laboratory tests used to help diagnose von Willebrand disease: an update. Pathology 2016; 48 (04) 303-318
  • 48 Mancuso ME, Cannavo A. Immune tolerance induction in hemophilia. Clin Investig (Lond) 2015; 5 (03) 321-335 . Availabel at: https://www.openaccessjournals.com/articles/immune-tolerance-induction-in-hemophilia.pdf . Accessed August 23, 2019
  • 49 Kruse-Jarres R, Kempton CL, Baudo F. , et al. Acquired hemophilia A: updated review of evidence and treatment guidance. Am J Hematol 2017; 92 (07) 695-705
  • 50 Zeitler H, Ulrich-Merzenich G, Goldmann G, Vidovic N, Brackmann HH, Oldenburg J. The relevance of the bleeding severity in the treatment of acquired haemophilia - an update of a single-centre experience with 67 patients. Haemophilia 2010; 16 (102) 95-101
  • 51 Baluwala I, Favaloro EJ, Pasalic L. Therapeutic monitoring of unfractionated heparin - trials and tribulations. Expert Rev Hematol 2017; 10 (07) 595-605
  • 52 Nieuwenhuis HK, Albada J, Banga JD, Sixma JJ. Identification of risk factors for bleeding during treatment of acute venous thromboembolism with heparin or low molecular weight heparin. Blood 1991; 78 (09) 2337-2343
  • 53 Schechter T, Finkelstein Y, Ali M. , et al. Unfractionated heparin dosing in young infants: clinical outcomes in a cohort monitored with anti-factor Xa levels. J Thromb Haemost 2012; 10 (03) 368-374
  • 54 Douxfils J, Gosselin RC. Laboratory assessment of direct oral anticoagulants. Semin Thromb Hemost 2017; 43 (03) 277-290
  • 55 Gosselin RC, Adcock DM, Bates SM. , et al. International Council for Standardization in Haematology (ICSH) recommendations for laboratory measurement of direct oral anticoagulants. Thromb Haemost 2018; 118 (03) 437-450
  • 56 Spyropoulos AC, Al-Badri A, Sherwood MW, Douketis JD. To measure or not to measure direct oral anticoagulants before surgery or invasive procedures: comment. J Thromb Haemost 2016; 14 (12) 2556-2559
  • 57 Tripodi A, Marongiu F, Moia M. , et al. The vexed question of whether or not to measure levels of direct oral anticoagulants before surgery or invasive procedures. Intern Emerg Med 2018; 13 (07) 1029-1036
  • 58 Tripodi A. To measure or not to measure direct oral anticoagulants before surgery or invasive procedures. J Thromb Haemost 2016; 14 (07) 1325-1327
  • 59 Douketis JD, Spyropoulos AC, Anderson JM. , et al. The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study for patients on a direct oral anticoagulant who need an elective surgery or procedure: design and rationale. Thromb Haemost 2017; 117 (12) 2415-2424
  • 60 Touzé E, Gruel Y, Gouin-Thibault I. , et al. Intravenous thrombolysis for acute ischaemic stroke in patients on direct oral anticoagulants. Eur J Neurol 2018; 25 (05) 747-e52
  • 61 Zheng XL. ADAMTS13 and von Willebrand factor in thrombotic thrombocytopenic purpura. Annu Rev Med 2015; 66: 211-225
  • 62 Lippi G, Mattiuzzi C. Critical laboratory values communication: summary recommendations from available guidelines. Ann Transl Med 2016; 4 (20) 400
  • 63 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 (04) 461-468
  • 64 The Joint Commission. National Patient Safety Goals effective January 2019. Available at: https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2019.pdf . Accessed March 12, 2019
  • 65 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
  • 66 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 (03) 432-441
  • 67 Lippi G, Plebani M. Informatics aids to reduce failure rates in notification of abnormal outpatient test results. Arch Intern Med 2009; 169 (19) 1815-1817 , author reply 1816–1817
  • 68 Singh H, Thomas EJ, Sittig DF. , et al. Notification of abnormal lab test results in an electronic medical record: do any safety concerns remain?. Am J Med 2010; 123 (03) 238-244
  • 69 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
  • 70 Plebani M, Sciacovelli L, Aita A. Quality indicators for the total testing process. Clin Lab Med 2017; 37 (01) 187-205