Errors in phlebotomy: a systematic analysis of causes, risks, and mitigation strategies

Cover Page

Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Introduction. Phlebotomy, being one of the most common invasive procedures, is a critical component of the pre-analytical phase, which accounts for up to 60–70% of all errors in laboratory diagnostics.

Aim. The aim of this theoretical review is to conduct a systematic analysis of the causes, types, and consequences of errors occurring during phlebotomy, as well as to assess the potential of the regulatory framework for their minimization.

Materials and methods. An analytical review of current national (GOST R 59778-2021, GOST R ISO 20658-2025) and international (ISO 20658:2023) standards, scientific literature, and guidelines dedicated to the problems of the pre-analytical stage was conducted.

Results. It was established that errors are systemic in nature, with root causes being a lack of specialized staff training, non-compliance with regulations, and organizational stress. Technical factors directly affecting specimen quality were detailed: choice of needle and collection system, tourniquet application time, skin preparation technique. It is shown that the consequences of errors form a cascade from direct harm to the patient (complications) through the risk of diagnostic errors to significant economic losses for the healthcare system.

Conclusions. Despite the development of a detailed regulatory framework, the key challenge remains its implementation in practice. To minimize risks, coordinated actions are required: integration of standard requirements into the quality management system of healthcare organizations, implementation of mandatory specialized training modules for nurses within the framework of continuing medical education, and creation of conditions for safe work and regular auditing of the procedure quality.

About the authors

Irina V. Ostrovskaya

S.M. Kirov Military Medical Academy, Ministry of Defense of the Russian Federation (Branch)

Author for correspondence.
Email: irina.ostrov@gmail.com
ORCID iD: 0000-0001-7932-4216
SPIN-code: 2400-9600

Candidate of Psychological Sciences, MBA, Associate Professor of the Department of Nursing Management

Russian Federation, Moscow

Ekaterina M. Kolesnikova

Autonomous Healthcare Institution of the Voronezh Region "Voronezh Regional Clinical Consultative and Diagnostic Center"

Email: irina.ostrov@gmail.com
ORCID iD: 0009-0008-7804-4798

Master of Management, Senior Nurse

Russian Federation, Voronezh

References

  1. ГОСТ Р 52623.4-2015. Технологии выполнения простых медицинских услуг инвазивных вмешательств. М.: Стандартинформ, 2015. 46 с. GOST R 52623.4-2015. [Technologies of simple medical services for invasive interventions. M.: Standartinform; 2015. 46 p. (In Russ.)]
  2. Lippi G., Cadamuro J., von Meyer A. et al. Practical recommendations for managing hemolyzed samples in clinical chemistry testing. Clin Chem Lab Med. 2018 Apr 25;56 (5):718-727. doi: 10.1515/cclm-2017-1104.
  3. Ковалевская С.Н., Гильманов А.Ж., Зыбина Н.Н. и др. Новое о флеботомии. Резюме на Практические рекомендации по взятию проб венозной крови для лабораторных исследований. Лабораторная служба. 2023. 12 (1): 33–39 [Kovalevskaya S.N., Gil’manov A.Zh., Zybina N.N. et al. New insights into phlebotomy. Summary of Practical recommendations for venous blood sampling for laboratory research. Laboratornaya sluzhba [Laboratory Service]. 2023; 12 (1): 33–39 (In Russ.)]. doi: 10.17116/labs20231201133.
  4. Соболев В.С. Экономические последствия медицинских ошибок в системе здравоохранения. Экономист лечебного учреждения. 2019; 8 [Sobolev V.S. Economic consequences of medical errors in the healthcare system. Ekonomist lechebnogo uchrezhdeniya [Economist of a healthcare institution]. 2019 (8) (In Russ.)]. URL: https://panor.ru/articles/ekonomicheskie-posledstviya-meditsinskikh-oshibok-v-sisteme-zdravookhraneniya/8698.html#
  5. ГОСТ Р 59778-2021. Процедуры взятия проб венозной и капиллярной крови для лабораторных исследований. М.: Российский институт стандартизации, 2021. 44 с. GOST R 59778-2021. [Procedures for taking venous and capillary blood samples for laboratory research. M.: Russian Institute of Standardization; 2021. 44 p. (In Russ.)].
  6. ГОСТ Р ИСО 15189-2024. Медицинские лаборатории. Требования к качеству и компетентности. М.: Российский институт стандартизации, 2024. 68 с. [GOST R ISO 15189-2024. Medical laboratories. Requirements for quality and competence. M.: Russian Institute of Standardization; 2024. 68 p. (In Russ.)].
  7. ГОСТ Р ИСО 20658-2025. Исследования медицинские лабораторные. Требования к взятию и транспортировке образцов. — М.: Российский институт стандартизации, 2025. 64 с. [GOST R ISO 20658-2025. Medical laboratory research. Requirements for collection and transport of specimens. M.: Russian Institute of Standardization; 2025. 64 p. (In Russ.)].
  8. ISO 20658:2023. Medical laboratories — Requirements for the collection and transport of specimens. URL: https://www.iso.org/standard/80035.html
  9. Пискунов Д.П., Данилова Л.А., Пушкин А.С. и др. Влияние экзогенных и эндогенных факторов на качество преаналитического этапа лабораторных исследований (обзор литературы). Клиническая лабораторная диагностика. 2020; 65 (12): 778–784 [Piskunov D.P., Danilova L.A., Pushkin A.S. et al. Influence of exogenous and endogenous factors on the quality of the preanalytical stage of laboratory research (literature review). Klinicheskaya laboratornaya diagnostika [Clinical Laboratory Diagnostics]. 2020; 65 (12): 778–784 (In Russ.)]. doi: 10.18821/0869-2084-2020-65-12-778-784.
  10. Практические рекомендации по взятию проб венозной крови для лабораторных исследований. М.: Комитет по преаналитике РФЛМ, 2021. 51 с. [Practical recommendations for taking venous blood samples for laboratory research. Moscow: Committee on Preanalytics of RFLM; 2021. 51 p. (In Russ.)].
  11. WHO guidelines on drawing blood: best practices in phlebotomy. Geneva: World Health Organization; 2010. 109 p. URL: https://www.who.int/publications/i/item/9789241599221
  12. Иванов А.Б., Петрова В.Г. Внедрение стандартов преаналитического этапа в практику сестринских процедурных кабинетов: барьеры и решения. Проблемы стандартизации в здравоохранении. 2024; (3): 45–52 [Ivanov A.B., Petrova V.G. Implementation of preanalytical stage standards in the practice of nursing treatment rooms: barriers and solutions. Problemy standartizatsii v zdravookhranenii [Health Care Standardization Problems]. 2024; (3): 45–52. (In Russ.)].
  13. Совместные EFLM–COLABIOCLI рекомендации по взятию проб венозной крови. Версия 1.1, 2018. / А.-М. Симундич [и др.] Федерация лабораторной медицины [Simundic A.-M. et al. Joint EFLM–COLABIOCLI recommendations for venous blood sampling. Version 1.1, 2018. Federation of Laboratory Medicine] URL: https://clck.ru/3Qwgkp
  14. ГОСТ Р ИСО 9001-2015. Системы менеджмента качества. Требования. М.: Стандартинформ, 2015. 32 с. GOST R ISO 9001-2015. Quality management systems. Requirements. M.: Standartinform; 2015. 32 p. (In Russ.).
  15. Nordin N., Ab Rahim S.N., Wan Omar W.F.A. et al. Preanalytical errors in clinical laboratory testing at a glance: source and control measures. Cureus. 2024; 16 (3): e57243. doi: 10.7759/cureus.57243.

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2026 Russkiy Vrach Publishing House