Home Medicine What is diagnostic safety? A review of safety science paradigms and rethinking paths to improving diagnosis
Article
Licensed
Unlicensed Requires Authentication

What is diagnostic safety? A review of safety science paradigms and rethinking paths to improving diagnosis

  • Justin J. Choi ORCID logo EMAIL logo
Published/Copyright: May 27, 2024
Diagnosis
From the journal Diagnosis Volume 11 Issue 4

Abstract

Diagnostic errors in health care are a global threat to patient safety. Researchers have traditionally focused diagnostic safety efforts on identifying errors and their causes with the goal of reducing diagnostic error rates. More recently, complementary approaches to diagnostic errors have focused on improving diagnostic performance drawn from the safety sciences. These approaches have been called Safety-II and Safety-III, which apply resilience engineering and system safety principles, respectively. This review explores the safety science paradigms and their implications for analyzing diagnostic errors, highlighting their distinct yet complementary perspectives. The integration of Safety-I, Safety-II, and Safety-III paradigms presents a promising pathway for improving diagnosis. Diagnostic researchers not yet familiar with the various approaches and potential paradigm shift in diagnostic safety research may use this review as a starting point for considering Safety-I, Safety-II, and Safety-III in their efforts to both reduce diagnostic errors and improve diagnostic performance.

Keywords: diagnostic errors; diagnostic safety; safety-I; safety-II; safety-III; resilience engineering
Corresponding author: Justin J. Choi, MD, MSc, Assistant Professor of Medicine, Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, 420 East 70th Street, LH-355, New York, NY, USA, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: Authors state no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: Not applicable.

References

1. Patient safety [Internet]. Available from: https://www.who.int/news-room/fact-sheets/detail/patient-safety [cited 7 Jan 2024].Search in Google Scholar

2. Singh, H, Schiff, GD, Graber, ML, Onakpoya, I, Thompson, MJ. The global burden of diagnostic errors in primary care. BMJ Qual Saf 2017;26:484–94. https://doi.org/10.1136/bmjqs-2016-005401.Search in Google Scholar PubMed PubMed Central

3. Gunderson, CG, Bilan, VP, Holleck, JL, Nickerson, P, Cherry, BM, Chui, P, et al.. Prevalence of harmful diagnostic errors in hospitalised adults: a systematic review and meta-analysis. BMJ Qual Saf 2020;29:1008–18. https://doi.org/10.1136/bmjqs-2019-010822.Search in Google Scholar PubMed

4. Cheraghi-Sohi, S, Holland, F, Singh, H, Danczak, A, Esmail, A, Morris, RL, et al.. Incidence, origins and avoidable harm of missed opportunities in diagnosis: longitudinal patient record review in 21 English general practices. BMJ Qual Saf 2021;30:977–85. https://doi.org/10.1136/bmjqs-2020-012594.Search in Google Scholar PubMed PubMed Central

5. Newman-Toker, DE, Wang, Z, Zhu, Y, Nassery, N, Saber Tehrani, AS, Schaffer, AC, et al.. Rate of diagnostic errors and serious misdiagnosis-related harms for major vascular events, infections, and cancers: toward a national incidence estimate using the “Big Three”. Diagnosis (Berl) 2021;8:67–84. https://doi.org/10.1515/dx-2019-0104.Search in Google Scholar PubMed

6. Auerbach, AD, Lee, TM, Hubbard, CC, Ranji, SR, Raffel, K, Valdes, G, et al.. Diagnostic errors in hospitalized adults who died or were transferred to intensive care. JAMA Intern Med 2024;184:164–73. https://doi.org/10.1001/jamainternmed.2023.7347.Search in Google Scholar PubMed PubMed Central

7. Committee on Diagnostic Error in Health Care, Board on Health Care Services, Institute of Medicine, The National Academies of Sciences, Engineering, and Medicine. In: Balogh, EP, Miller, BT, Ball, JR, editors. Improving diagnosis in health care. Washington, DC: National Academies Press (US); 2015.Search in Google Scholar

8. Zwaan, L, El-Kareh, R, Meyer, AND, Hooftman, J, Singh, H. Advancing diagnostic safety research: results of a systematic research priority setting exercise. J Gen Intern Med 2021;36:2943–51. https://doi.org/10.1007/s11606-020-06428-3.Search in Google Scholar PubMed PubMed Central

9. Aven, T. What is safety science? Saf Sci 2014;67:15–20. https://doi.org/10.1016/j.ssci.2013.07.026.Search in Google Scholar

10. Safety-I and safety-II: the past and future of safety management - 1st [Internet]. Available from: https://www.routledge.com/Safety-I-and-Safety-II-The-Past-and-Future-of-Safety-Management/Hollnagel/p/book/9781472423085 [cited 7 Jan 2024].Search in Google Scholar

11. Hollnagel, E, Wears, RL, Braithwaite, J.: Resilient Health Care Net; 2015. http://resilienthealthcare.net/onewebmedia/WhitePaperFinal.pdf [Accessed 20 Mar 2024].Search in Google Scholar

12. RFA-HS-22-008: diagnostic centers of excellence: partnerships to improve diagnostic safety and quality (R18) [Internet]. Available from: https://grants.nih.gov/grants/guide/rfa-files/RFA-HS-22-008.html [cited 7 Jan 2024].Search in Google Scholar

13. Graber, ML, Franklin, N, Gordon, R. Diagnostic error in internal medicine. Arch Intern Med 2005;165:1493–9. https://doi.org/10.1001/archinte.165.13.1493.Search in Google Scholar PubMed

14. Schnipper, JL, Raffel, KE, Keniston, A, Burden, M, Glasheen, J, Ranji, S, et al.. Achieving diagnostic excellence through prevention and teamwork (ADEPT) study protocol: a multicenter, prospective quality and safety program to improve diagnostic processes in medical inpatients. J Hosp Med 2023;18:1072–81. https://doi.org/10.1002/jhm.13230.Search in Google Scholar PubMed PubMed Central

15. Hollnagel, E. Is safety a subject for science? Saf Sci 2014;67:21–4. https://doi.org/10.1016/j.ssci.2013.07.025.Search in Google Scholar

16. Kuhn, GJ. Diagnostic errors. Acad Emerg Med 2002;9:740–50. https://doi.org/10.1111/j.1553-2712.2002.tb02155.x.Search in Google Scholar PubMed

17. Graber, M. Diagnostic errors in medicine: a case of neglect. Joint Comm J Qual Patient Saf 2005;31:106–13. https://doi.org/10.1016/s1553-7250(05)31015-4.Search in Google Scholar PubMed

18. Schiff, GD, Hasan, O, Kim, S, Abrams, R, Cosby, K, Lambert, BL, et al.. Diagnostic error in medicine: analysis of 583 physician-reported errors. Arch Intern Med 2009;169:1881–7. https://doi.org/10.1001/archinternmed.2009.333.Search in Google Scholar PubMed

19. Graber, M, Gordon, R, Franklin, N. Reducing diagnostic errors in medicine: what’s the goal? Acad Med 2002;77:981–92. https://doi.org/10.1097/00001888-200210000-00009.Search in Google Scholar PubMed

20. Giardina, TD, King, BJ, Ignaczak, AP, Paull, DE, Hoeksema, L, Mills, PD, et al.. Root cause analysis reports help identify common factors in delayed diagnosis and treatment of outpatients. Health Aff 2013;32:1368–75. https://doi.org/10.1377/hlthaff.2013.0130.Search in Google Scholar PubMed PubMed Central

21. Rogith, D, Iyengar, MS, Singh, H. Using fault trees to advance understanding of diagnostic errors. Joint Comm J Qual Patient Saf 2017;43:598–605. https://doi.org/10.1016/j.jcjq.2017.06.007.Search in Google Scholar PubMed

22. Peerally, MF, Carr, S, Waring, J, Dixon-Woods, M. The problem with root cause analysis. BMJ Qual Saf 2017;26:417–22. https://doi.org/10.1136/bmjqs-2016-005511.Search in Google Scholar PubMed PubMed Central

23. Vincent, C, Taylor-Adams, S, Stanhope, N. Framework for analysing risk and safety in clinical medicine. BMJ 1998;316:1154–7. https://doi.org/10.1136/bmj.316.7138.1154.Search in Google Scholar PubMed PubMed Central

24. Konopasky, A, Artino, AR, Battista, A, Ohmer, M, Hemmer, PA, Torre, D, et al.. Understanding context specificity: the effect of contextual factors on clinical reasoning. Diagnosis (Berl) 2020;7:257–64. https://doi.org/10.1515/dx-2020-0016.Search in Google Scholar PubMed

25. Graber, ML. Progress understanding diagnosis and diagnostic errors: thoughts at year 10. Diagnosis (Berl) 2020;7:151–9. https://doi.org/10.1515/dx-2020-0055.Search in Google Scholar PubMed

26. Ranasinghe, U, Jefferies, M, Davis, P, Pillay, M. Resilience engineering indicators and safety management: a systematic review. Saf Health Work 2020;11:127–35. https://doi.org/10.1016/j.shaw.2020.03.009.Search in Google Scholar PubMed PubMed Central

27. Hollnagel, E, Woods, DD, Leveson, N. Resilience engineering: concepts and precepts. Ashgate Publishing, Ltd; 2006.Search in Google Scholar

28. Hollnagel, E, Sujan, M, Braithwaite, J. Resilient health care – making steady progress. Saf Sci 2019;120:781–2. https://doi.org/10.1016/j.ssci.2019.07.029.Search in Google Scholar

29. Hollnagel, PE, editor. Resilience engineering in practice: a guidebook. Revised. Farnham, England: Ashgate Publishing; 2011.Search in Google Scholar

30. Wiig, S, Aase, K, Billett, S, Canfield, C, Røise, O, Njå, O, et al.. Defining the boundaries and operational concepts of resilience in the resilience in healthcare research program. BMC Health Serv Res 2020;20:330. https://doi.org/10.1186/s12913-020-05224-3.Search in Google Scholar PubMed PubMed Central

31. Yang, D, Fineberg, HV, Cosby, K. Diagnostic excellence. JAMA 2021;326:1905–6. https://doi.org/10.1001/jama.2021.19493.Search in Google Scholar PubMed

32. Mannion, R, Braithwaite, J. False dawns and new horizons in patient safety research and practice. Int J Health Policy Manag 2017;6:685–9. https://doi.org/10.15171/ijhpm.2017.115.Search in Google Scholar PubMed PubMed Central

33. Thomas, EJ. The harms of promoting “Zero Harm”. BMJ Qual Saf 2020;29:4–6. https://doi.org/10.1136/bmjqs-2019-009703.Search in Google Scholar PubMed

34. Erik, H. FRAM: the functional resonance analysis method: modelling complex socio-technical systems. Boca Raton, FL: CRC Press; 2017.10.1201/9781315255071Search in Google Scholar

35. van Dijk, LM, Meulman, MD, van Eikenhorst, L, Merten, H, Schutijser, BCFM, Wagner, C. Can using the functional resonance analysis method, as an intervention, improve patient safety in hospitals? A stepped wedge design protocol. BMC Health Serv Res 2021;21:1228. https://doi.org/10.1186/s12913-021-07244-z.Search in Google Scholar PubMed PubMed Central

36. Damen, NL, de Vos, MS, Moesker, MJ, Braithwaite, J, de Lind van Wijngaarden, RAF, Kaplan, J, et al.. Preoperative anticoagulation management in everyday clinical practice: an international comparative analysis of work-as-done using the functional resonance analysis method. J Patient Saf 2021;17:157–65. https://doi.org/10.1097/pts.0000000000000515.Search in Google Scholar

37. Verhagen, MJ, de Vos, MS, Sujan, M, Hamming, JF. The problem with making Safety-II work in healthcare. BMJ Qual Saf 2022;31:402–8. https://doi.org/10.1136/bmjqs-2021-014396.Search in Google Scholar PubMed

38. Yousef, EA, Sutcliffe, KM, McDonald, KM, Newman-Toker, DE. Crossing academic boundaries for diagnostic safety: 10 complex challenges and potential solutions from clinical perspectives and high-reliability organizing principles. Hum Factors 2022;64:6–20. https://doi.org/10.1177/0018720821996187.Search in Google Scholar PubMed

39. Leveson, N. Safety III: a systems approach to safety and resilience. Boston, MA: MIT Engineering Systems Lab; 2020.Search in Google Scholar

40. Cooper, MD. The emperor has no clothes: a critique of safety-II. Saf Sci 2022;152:105047. https://doi.org/10.1016/j.ssci.2020.105047.Search in Google Scholar

41. Choi, JJ, Osterberg, LG, Record, JD. Exploring ward team handoffs of overnight admissions: key lessons from field observations. J Gen Intern Med 2024;39:808–14. https://doi.org/10.1007/s11606-023-08549-x.Search in Google Scholar PubMed PubMed Central

42. Leveson, NG. Engineering a safer world: systems thinking applied to safety. Boston, MA: The MIT Press; 2012.10.7551/mitpress/8179.001.0001Search in Google Scholar
Received: 2024-01-09
Accepted: 2024-05-13
Published Online: 2024-05-27

© 2024 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Should APTT become part of thrombophilia screening?
  4. Review
  5. n-3 fatty acids and the risk of atrial fibrillation, review
  6. Guidelines and Recommendations
  7. Root cause analysis of cases involving diagnosis
  8. Opinion Papers
  9. What is diagnostic safety? A review of safety science paradigms and rethinking paths to improving diagnosis
  10. Interprofessional clinical reasoning education
  11. Original Articles
  12. Quality of heart failure registration in primary care: observations from 1 million electronic health records in the Amsterdam Metropolitan Area
  13. Typology of solutions addressing diagnostic disparities: gaps and opportunities
  14. Diagnostic errors and characteristics of patients seen at a general internal medicine outpatient clinic with a referral for diagnosis
  15. Cost-benefit considerations of the biased diagnostician
  16. Delayed diagnosis of new onset pediatric diabetes leading to diabetic ketoacidosis: a retrospective cohort study
  17. Monocyte distribution width (MDW) kinetic for monitoring sepsis in intensive care unit
  18. Are shortened aPTT values always to be attributed only to preanalytical problems?
  19. External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020–2022
  20. Recent mortality rates due to complications of medical and surgical care in the US
  21. Short Communication
  22. The potential, limitations, and future of diagnostics enhanced by generative artificial intelligence
  23. Case Report – Lessons in Clinical Reasoning
  24. Lessons in clinical reasoning – pitfalls, myths, and pearls: a case of persistent dysphagia and patient partnership
  25. Letters to the Editor
  26. The ‘curse of knowledge’: when medical expertise can sometimes be a liability
  27. A new approach for identifying innate immune defects
https://doi.org/10.1515/dx-2024-0008
Keywords for this article
diagnostic errors; diagnostic safety; safety-I; safety-II; safety-III; resilience engineering

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Should APTT become part of thrombophilia screening?
  4. Review
  5. n-3 fatty acids and the risk of atrial fibrillation, review
  6. Guidelines and Recommendations
  7. Root cause analysis of cases involving diagnosis
  8. Opinion Papers
  9. What is diagnostic safety? A review of safety science paradigms and rethinking paths to improving diagnosis
  10. Interprofessional clinical reasoning education
  11. Original Articles
  12. Quality of heart failure registration in primary care: observations from 1 million electronic health records in the Amsterdam Metropolitan Area
  13. Typology of solutions addressing diagnostic disparities: gaps and opportunities
  14. Diagnostic errors and characteristics of patients seen at a general internal medicine outpatient clinic with a referral for diagnosis
  15. Cost-benefit considerations of the biased diagnostician
  16. Delayed diagnosis of new onset pediatric diabetes leading to diabetic ketoacidosis: a retrospective cohort study
  17. Monocyte distribution width (MDW) kinetic for monitoring sepsis in intensive care unit
  18. Are shortened aPTT values always to be attributed only to preanalytical problems?
  19. External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020–2022
  20. Recent mortality rates due to complications of medical and surgical care in the US
  21. Short Communication
  22. The potential, limitations, and future of diagnostics enhanced by generative artificial intelligence
  23. Case Report – Lessons in Clinical Reasoning
  24. Lessons in clinical reasoning – pitfalls, myths, and pearls: a case of persistent dysphagia and patient partnership
  25. Letters to the Editor
  26. The ‘curse of knowledge’: when medical expertise can sometimes be a liability
  27. A new approach for identifying innate immune defects
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2026 De Gruyter Brill
Downloaded on 3.1.2026 from https://www.degruyterbrill.com/document/doi/10.1515/dx-2024-0008/html
Scroll to top button