Developed by: Committee on Patient Safety and Education
Original Approval: October 18, 2023
Patient safety is a top priority for ASA, and therefore ASA strongly opposes the criminalization of medical errors that are not due to reckless action. Despite remarkable advances in patient safety, errors occur in the practice of medicine, contributing to over 250,000 deaths per year in the United States before the COVID-19 pandemic.1 A robust safety culture is characterized by the intentional commitment to organizational learning from these events, emphasizing psychological safety and the value of event reporting.2 A Just Culture emphasizes that individuals should not be blamed for medical errors or adverse events that result from systematic design flaws, but also that individuals who are reckless must be held accountable. Any response to medical errors must employ the values of a healthy safety culture and reinforce a Just Culture. The criminalization of medical errors endangers these ideals and poses a major threat to patient safety.
According to the National Academy of Medicine, a medical error is defined as the “failure of a planned action to be completed as intended (i.e. error of execution), or the use of a wrong plan to achieve an aim (i.e., error of planning).”3 The Institute for Healthcare Improvement (IHI) defines medical error as “failures in processes of care,” whether or not they result in patient harm.4 In contrast to medical errors such as slips or lapses, violations are deliberate deviations from standard of care. While medical errors may not lead to adverse events, they must still be carefully analyzed to prevent future possible adverse events.
The response to a medical error can include peer review, root-cause analysis and other forms of organizational learning, the tort system, complaints to the state licensing board, and the criminal justice system. In adverse event analysis, clinicians investigate the event through a protected process with a systematic lens and identify areas for improvement, either through education or addressing system flaws. Affected patients can seek redress for deficiencies in care through the tort system, or complaints can be made to the state licensing board. Rarely, recklessness may be of such sufficient degree as to warrant scrutiny from the criminal justice system.
A very small percentage of medical errors may be due to reckless behavior. The distinction between a blameless error and a reckless violation can be determined by the use of algorithms such as James Reason’s decision tree for determining culpability for unsafe acts,5 the United Kingdom National Patient Safety Agency Incident Decision Tree,6 or the Leonard and Frankel Model of Accountability.7 In each of these algorithms, a reckless action is defined as the intentional and knowing violation of a best practice or standard of care. According to Just Culture, these individuals should be held accountable for their actions. However, the vast majority of errors are not committed by clinicians being reckless.
The criminalization of medical errors has the potential to hinder patient safety, negatively impact safety culture, and impair clinician well-being. The criminalization of medical errors also negatively impacts error reporting, which is a crucial driver of systems improvement and patient safety. Hesitancy or failure to report adverse events for fear of criminal prosecution will perpetuate systemic deficiencies in care and the likelihood of ongoing patient harm. In a systematic review, the most frequent barrier to reporting medical errors was the fear of the consequences (63%), followed by work climate and culture (27%).8 The threat of malpractice litigation also represents a barrier to error reporting; however, physicians are more willing to report errors when the disclosure is not met with a punitive response and when they are confident that it will result in systems improvement.9, 10 Voluntary reporting is still the most common way for organizations to discover medical errors.11, 12 Without the psychological safety to discuss errors in an open and transparent fashion, clinicians are at increased risk for burnout and development of the second victim effect. Lack of support at work is the highest risk factor for burnout in anesthesiologists.13 Thus, the criminalization of medical errors has the potential to be a major contributor to burnout, which can also diminish patient safety.14-20
While reckless individuals must be held accountable for their actions, the criminal justice system should not punish healthcare professionals for medical errors. A healthy culture of safety and improved patient safety can only occur in organizations that celebrate psychological safety. Clinicians must be able to report adverse events in an open and blame-free manner for threats to patient safety to be addressed. Disclosure of medical errors by individual clinicians and organizations is key to protecting both patients and clinicians. The criminalization of medical error can lead to a dysfunctional safety culture, impaired psychological safety, increased clinician burnout, and consequently, diminished patient safety. The criminalization of medical errors may cause irreparable harm to institutional patient safety and reporting culture. For these reasons, ASA strongly opposes the criminalization of medical errors that are not due to reckless action.
- Makary MA, Daniel M. Medical error-the third leading cause of death in the US. Bmj. May 3 2016;353:i2139. doi:10.1136/bmj.i2139
- American Society of Anesthesiologists. Statement on Safety Culture. Updated October 26, 2022. Accessed April 11, 2023, 2023. https://www.asahq.org/standards-and-guidelines/statement-on-safety-culture
- Institute of Medicine Committee on Quality of Health Care in A. In: Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. National Academies Press (US) Copyright 2000 by the National Academy of Sciences. All rights reserved.; 2000.
- Griffin FA RR. IHI Global Trigger Tool for Measuring Adverse Events. Second ed. IHI Innovation Series white paper. Institute for Healthcare Improvement; 2009.
- Frankel A. Decision Tree for Unsafe Acts Culpability. Accessed April 11, 2023, 2023. https://www.ihi.org/resources/Pages/Tools/DecisionTreeforUnsafeActsCulpability.aspx
- Meadows S BK, Butler J. The Incident Decision Tree: Guidelines for Action Following Patient Safety Incidents. In: Henriksen K BJ, Marks ES et al, ed. Advances in Patient Safety: From Research to Implementation (Volume 4: Programs, Tools, and Products). Agency for Healthcare Research and Quality; 2005.
- Leonard MW, Frankel A. The path to safe and reliable healthcare. Patient Educ Couns. Sep 2010;80(3):288-92. doi:10.1016/j.pec.2010.07.001
- Aljabari S, Kadhim Z. Common Barriers to Reporting Medical Errors. ScientificWorldJournal. 2021;2021:6494889. doi:10.1155/2021/6494889
- Garbutt J, Waterman AD, Kapp JM, et al. Lost opportunities: how physicians communicate about medical errors. Health Aff (Millwood). Jan-Feb 2008;27(1):246-55. doi:10.1377/hlthaff.27.1.246
- Heard GC, Sanderson PM, Thomas RD. Barriers to adverse event and error reporting in anesthesia. Anesth Analg. Mar 2012;114(3):604-14. doi:10.1213/ANE.0b013e31822649e8
- Bates DW, Levine DM, Salmasian H, et al. The Safety of Inpatient Health Care. N Engl J Med. Jan 12 2023;388(2):142-153. doi:10.1056/NEJMsa2206117
- Panagioti M, Khan K, Keers RN, et al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. Bmj. Jul 17 2019;366:l4185. doi:10.1136/bmj.l4185
- Afonso AM, Cadwell JB, Staffa SJ, Zurakowski D, Vinson AE. Burnout Rate and Risk Factors among Anesthesiologists in the United States. Anesthesiology. May 1 2021;134(5):683-696. doi:10.1097/aln.0000000000003722
- Dewa CS, Loong D, Bonato S, Trojanowski L. The relationship between physician burnout and quality of healthcare in terms of safety and acceptability: a systematic review. BMJ Open. Jun 21 2017;7(6):e015141. doi:10.1136/bmjopen-2016-015141
- Williams ES, Manwell LB, Konrad TR, Linzer M. The relationship of organizational culture, stress, satisfaction, and burnout with physician-reported error and suboptimal patient care: results from the MEMO study. Health Care Manage Rev. Jul-Sep 2007;32(3):203-12. doi:10.1097/01.Hmr.0000281626.28363.59
- Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review. PLoS One. 2016;11(7):e0159015. doi:10.1371/journal.pone.0159015
- Rathert C, Williams ES, Linhart H. Evidence for the Quadruple Aim: A Systematic Review of the Literature on Physician Burnout and Patient Outcomes. Med Care. Dec 2018;56(12):976-984. doi:10.1097/mlr.0000000000000999
- Salyers MP, Bonfils KA, Luther L, et al. The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis. J Gen Intern Med. Apr 2017;32(4):475-482. doi:10.1007/s11606-016-3886-9
- Tawfik DS, Profit J, Morgenthaler TI, et al. Physician Burnout, Well-being, and Work Unit Safety Grades in Relationship to Reported Medical Errors. Mayo Clin Proc. Nov 2018;93(11):1571-1580. doi:10.1016/j.mayocp.2018.05.014
- Tawfik DS, Scheid A, Profit J, et al. Evidence Relating Health Care Provider Burnout and Quality of Care: A Systematic Review and Meta-analysis. Ann Intern Med. Oct 15 2019;171(8):555-567. doi:10.7326/m19-1152