Risk Management in Clinical Laboratory Based on ISO 15189:2022 for Plasma-based Testing of Prothrombin Time and Activated Partial Thromboplastin Time

Published date: Dec 31 2025

Journal Title: Dubai Medical Journal

Issue title: Dubai Medical Journal (DMJ): Volume 8, Issue 4

Pages: 597-611

DOI: 10.18502/dmj.v8i4.20496

Antony Thomasdrantony@primehealth.aeDepartment of Pathology, Prime Healthcare Group, Dubai

Parampreet KaurDepartment of Pathology, Prime Healthcare Group, Dubai

Kavita KrishnanDepartment of Pathology, Prime Healthcare Group, Dubai

Introduction: In the new ISO 15189:2022 standard, risk management in the clinical laboratory has been hugely emphasized. The purpose of detailed risk analysis and management is to eliminate the known risk factors as much as possible and to minimize the residual risk to an acceptable level. We chose to give precedence to plasma-based tests for Prothrombin time (PT) and activated partial thromboplastin time (aPTT) to conduct a more thorough risk analysis. These tests involve multiple sensitive steps and are overly critical for patient care as test results are self-sufficient to start the treatment.

Methods: We applied risk control measures using FMEA (failure mode and effects analysis) based risk analysis process in every step including all phases of the testing process.

Results: Many risk factors were identified; control measures and continuous surveillance processes were put in place to avoid recurrence of high-risk events that could affect the test results.

Conclusion: It was concluded that with stringent risk management processes in place, risk could be reduced significantly thus minimizing the impact on patient results.

Keywords: coagulation tests, hematology, ISO15189:2022, laboratory, prothrombin time, risk management

[1] Communications team. A new international standard: The introduction of ISO 15189:2022. The Royal College of Pathologists; 2022 December 6 [cited 2024 April 25]. Available from: https://www.rcpath.org/discover-pathology/news/a-new-international-standard-the-introductionof- iso-15189-2022.html

[2] Schirn A. Changes in the new ISO 15189:2022. ANSI National Accreditation Board; 2022 December 16 [cited 2024 Apr 25]. Available from: https://blog.ansi.org/anab/changes-in-the-new-iso-15189- 2022/#gref

[3] Committee ISO/TC 212. ISO 22367:2020(en) Medical laboratories — Application of risk management to medical laboratories [Internet]. 1st ed. International Organization for Standardization; 2020 [cited 2024 Apr 25]. Available from: https://www.iso.org/obp/ui/#iso:std:iso:22367:ed-1:v1:en

[4] World Health Organization. Laboratory biosafety manual [Internet]. 4th ed. 2020 [cited 2024 Apr 25]. Available from: https://www.who.int/publications/i/item/9789240011311

[5] 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.

[6] Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48(5):691–698.

[7] 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.

[8] Clinical Laboratory Standards Institute. Procedures for the collection of diagnostic blood specimens by venipuncture; Approved standard. CLSI document H3-A6. 2007;27(26).

[9] Kitchen S, Adcock DM, Dauer R, Kristoffersen AH, Lippi G, Mackie I, et al. International Council for Standardisation in Haematology (ICSH) recommendations for collection of blood samples for coagulation testing. Int J Lab Hematol. 2021;43(4):571–580.

[10] Arora S, Kolte S, Dhupia J. Hemolyzed samples should be processed for coagulation studies: The study of hemolysis effects on coagulation parameters. Ann Med Health Sci Res. 2014;4(2):233–237.

[11] Sung YH, Hwang MS, Lee JH, Park HD, Ryu KH, Cho MS, et al. [A comparison of the rates of hemolysis and repeated blood sampling using syringe needles versus vacuum tube needles in the emergency department]. J Korean Acad Nurs. 2012;42(3):443–451.

[12] Lippi G, Salvagno GL, Montagnana M, Lima-Oliveira G, Guidi GC, Favaloro EJ. Quality standards for sample collection in coagulation testing. Semin Thromb Hemost. 2012;38(6):565–575.

[13] Green SF. The cost of poor blood specimen quality and errors in preanalytical processes. Clin Biochem. 2013;46(13-14):1175–1179.

[14] Newman RS, Fagin AR. Heparin contamination in coagulation testing and a protocol to avoid it and the risk of inappropriate FFP transfusion. Am J Clin Pathol. 1995;104(4):447–449.

[15] Lyman GH, Carrier M, Ay C, Di Nisio M, Hicks LK, Khorana AA, et al. American Society of Hematology 2021 guidelines for management of venous thromboembolism: Prevention and treatment in patients with cancer. Blood Adv. 2021;5(4):927–974.

[16] Kitchen S, Gray E, Mackie I, Baglin T, Makris M; BCSH committee. Measurement of non-coumarin anticoagulants and their effects on tests of Haemostasis: Guidance from the British Committee for Standards in Haematology. Br J Haematol. 2014;166(6):830–841.

[17] Marlar RA, Potts RM, Marlar AA. Effect on routine and special coagulation testing values of citrate anticoagulant adjustment in patients with high hematocrit values. Am J Clin Pathol. 2006;126(3):400– 405.

[18] Lippi G, von Meyer A, Cadamuro J, Simundic AM. Blood sample quality. Diagnosis (Berl). 2019;6(1):25– 31.

[19] CLSI guideline H21. Collection, transport, and processing of blood specimens for testing plasma-based coagulation assays. 6th ed. Clinical and Laboratory Standards Institute; 2024.

[20] Key NS, Khorana AA, Kuderer NM, Bohlke K, Lee AY, Arcelus JI, et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO guideline update. J Clin Oncol. 2023;41(16):3063– 3071.

[21] Kitchen S, Adcock DM, Dauer R, Kristoffersen AH, Lippi G, Mackie I, et al. International Council for Standardization in Haematology (ICSH) recommendations for processing of blood samples for coagulation testing. Int J Lab Hematol. 2021;43(6):1272–1283.