Definitions

• Medical error: an act or omission that leads to an unanticipated, undesirable outcome.
• Adverse event: an undesirable clinical outcome related to diagnosis or therapy while in the hospital, which may or may not result from a medical error.
• Near miss: an event that could have had an adverse patient consequence and was indistinguishable from an adverse event except for outcome.
• Negligence: failure to perform at the level of competence consistent with professional norms, practices and/or operations.

Context

Creating a culture of safety to reduce errors includes embracing the following ideas:

• Moving from the paradigm of errors as individual failures to system failures.
• Moving from a punitive environment to a just culture.
• Trading secrecy for transparency.
• Moving care from being provider-centered to patient-centered.
• Moving from models reliant on individual performance to collaborative teamwork.
• Embracing the idea that accountability is universal and reciprocal.

Application

• Reporting of medical errors: many hospitals use online Incident Reporting to alert the appropriate people of systems failures and to promote change without individual blame.
  • Reporting medical errors is essential to optimal patient care and promoting positive change.
  • If you believe a medical error occurred, check online for your institution’s Incident Reporting mechanism. If you are unclear about what needs to be reported or how to report an incident, consider involving your attending or risk management.
  • Even a “close call,” i.e. when no adverse event resulted from the error, should be reported.
  • Write down and report errors ASAP as often errors or their details are forgotten.
• Disclosure of medical errors: there is generally a large discrepancy in the percentage of patients desiring error disclosure and the percentage of physicians actually disclosing error. Disclosure of a medical error is an ethical obligation to the patient. Most states have mandated disclosure of serious unanticipated outcomes to patients.
  • Involve your attending physician and consider involving risk management prior to discussion with the patient.
  • Keys to disclosure of medical error include:
    • Disclosure:
      • Choose an appropriate setting that is private and uninterrupted, and give the patient the option to have support present.
      • Use layman’s terms, allowing time for silence and questions.
      • Provide facts about the event or systems errors if known.
      • Express regret for the unanticipated outcome.
      • Give a formal apology and discuss what will be done to prevent future errors (systems changes, root cause analysis, etc.).
    • Institutional requirements:
      • Integrate disclosure, patient-safety, and risk management activities.
      • Establish disclosure support system including disclosure education, emotional support for health care workers, administration, and patients and families.
      • Use performance-improvement tools to track and enhance disclosures.
    • Reducing medical errors: the reduction of medical errors involves defining and implementing “Patient Safety Practices,” processes meant to reduce the probability of adverse events resulting from exposure to the health care system. Below is a list of the most common medical errors and associated patient safety practices.

Berlinger N, Wu AW. Subtracting insult from injury: addressing cultural expectations in the disclosure of medical error. J Med Ethics 2005;32: 106-108.

Chang A, Schyve PM, Croteau RJ, O’Leary DS, Loeb JM. The JACHO patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events. International Journal for Quality in Health Care 2005:17 (2): 95-105.

Cullen DJ, Bates DW, Small SD, et al. The incident reporting system does not detect adverse drug event: a problem for quality improvement. Comm J Qual Improv 1995;21:541 –548.

Gallagher TM, Studdert D, Levinson W. Disclosing harmful medical errors to patients. N Engl J Med 2007l356:2713-9.

Grober ED, Bohnen JMA. Defining medical error. Canadian Journal of Surgery. 2005;48(1):39-44.

Kohn LT, Corrigan JM, Donaldson MS. To Err is Human: Building a Safer Health System. Washington, DC: National Academic Press. 2000.

Leap LL, Berwick DM. Five years after to err Is human: what have we learned? JAMA.2005;293:2384-2390.

Longtin Y, Sax H, Leape LL, Sheridan SE, Donaldson L, Pittet D. Patient participation: current knowledge and applicability to patient safety 2010. Mayo Clin Proc; 85:53-62.

Rosner F, Berger JT, Kark P, Potash K, Bennett AJ. Disclosure and prevention of medical errors. Committee on Bioethical Issues of the Medical Society of the State of New York. Arch Intern Med 2000; 160: 2089-2092.

Shojania KG, Duncan BW, McDonald KM, et al, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. evidence Report/Technology Assessment No. 43, AHRQ Publication No. 01-e058; July 2001. Available online at http://www.ahrq.gov/clinic/ptsafety/