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Phys Topicsgeneral-medicine

Phys · general-medicine

Medical Errors and Open Disclosure

Also known as medical error · adverse event · patient safety incident · near miss · never event · sentinel event · open disclosure · duty of candour · root cause analysis · RCA · Swiss cheese model · human factors · just culture · second victim · mandatory notification · notifiable conduct · coronial referral · incident report

Consultant-physician guide to medical errors and open disclosure: the four definitions that anchor the field (medical error, adverse event, near miss, never event), the Swiss cheese model of Reason (active failures and latent conditions, slips lapses and mistakes, errors of execution versus planning), the types of error by stage of care (diagnostic, treatment, preventive, other), the high-alert medicines that concentrate risk (insulin, anticoagulants, opioids), the Australian Open Disclosure Framework (the staged process and the four elements — apology, factual explanation, acknowledgement, prevention), the duty of candour, root cause analysis and the London Protocol, the just culture algorithm, and the reporting and medico-legal pathways (incident report, AHPRA mandatory notification, coronial referral, medical defence organisation).

high6 referencesUpdated 26 July 202610 min readVerification in progress

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Red flags

  • An unexpected death or serious deterioration after an intervention or medication is an adverse event until proven otherwise — ask 'could this have been caused by the treatment rather than the disease', stabilise the patient, preserve the evidence, and notify the senior clinician before anything else.
  • An apology (an expression of regret) is NOT an admission of legal liability under Australian civil liability legislation and under the Australian Open Disclosure Framework — withholding an apology for fear of litigation breaches the ethical and (in many jurisdictions) legal duty of candour and paradoxically increases the risk and value of a claim.
  • A death attributable to an adverse event or medical procedure is reportable to the coroner — do NOT complete the ordinary death certificate or release the body for cremation; the duty is to report, to preserve the record and any equipment, and to let the coronial process run.
  • Wrong-site surgery, wrong-patient surgery, wrong-procedure surgery, retained foreign object, and incompatible blood transfusion are never events — they trigger a mandatory sentinel event review, an external report to the ACSQHC, and a full root cause analysis regardless of the clinical outcome.
  • Practising while intoxicated, sexual misconduct in connection with practice, impairment placing the public at risk, and a significant departure from accepted professional standards are AHPRA notifiable conduct — a treating practitioner who forms a reasonable belief must notify AHPRA; the threshold is public protection, not peer disapproval, and mandatory notification is distinct from the internal incident report.
  • Insulin written with a U for units (4U read as 44), a trailing zero (5.0 versus 5), or a missing leading zero (.5 versus 0.5) are documented causes of tenfold and greater insulin overdose — write units in full, never use a trailing zero, and always use a leading zero; these are non-negotiable prescribing standards.
  • The second victim — the clinician involved in the adverse event — commonly suffers acute distress, loss of confidence, intrusive thoughts, and, in severe cases, suicidal ideation; failing to support the second victim drives concealment, burnout, and attrition, and is itself a patient-safety risk.
  • A punitive blame culture causes clinicians to conceal errors, prevents the latent conditions from being surfaced and fixed, and guarantees that the same error recurs in a different clinician — the durable fix is a just culture that distinguishes human error (console), at-risk behaviour (coach), and reckless behaviour (punish).
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FRACP DWEFRACP DCEMRCP Part 1MRCP Part 2MRCP PACESABIM Internal Medicine

Red flags

  • An unexpected death or serious deterioration after an intervention or medication is an adverse event until proven otherwise — ask 'could this have been caused by the treatment rather than the disease', stabilise the patient, preserve the evidence, and notify the senior clinician before anything else.
  • An apology (an expression of regret) is NOT an admission of legal liability under Australian civil liability legislation and under the Australian Open Disclosure Framework — withholding an apology for fear of litigation breaches the ethical and (in many jurisdictions) legal duty of candour and paradoxically increases the risk and value of a claim.
  • A death attributable to an adverse event or medical procedure is reportable to the coroner — do NOT complete the ordinary death certificate or release the body for cremation; the duty is to report, to preserve the record and any equipment, and to let the coronial process run.
  • Wrong-site surgery, wrong-patient surgery, wrong-procedure surgery, retained foreign object, and incompatible blood transfusion are never events — they trigger a mandatory sentinel event review, an external report to the ACSQHC, and a full root cause analysis regardless of the clinical outcome.
  • Practising while intoxicated, sexual misconduct in connection with practice, impairment placing the public at risk, and a significant departure from accepted professional standards are AHPRA notifiable conduct — a treating practitioner who forms a reasonable belief must notify AHPRA; the threshold is public protection, not peer disapproval, and mandatory notification is distinct from the internal incident report.
  • Insulin written with a U for units (4U read as 44), a trailing zero (5.0 versus 5), or a missing leading zero (.5 versus 0.5) are documented causes of tenfold and greater insulin overdose — write units in full, never use a trailing zero, and always use a leading zero; these are non-negotiable prescribing standards.
  • The second victim — the clinician involved in the adverse event — commonly suffers acute distress, loss of confidence, intrusive thoughts, and, in severe cases, suicidal ideation; failing to support the second victim drives concealment, burnout, and attrition, and is itself a patient-safety risk.
  • A punitive blame culture causes clinicians to conceal errors, prevents the latent conditions from being surfaced and fixed, and guarantees that the same error recurs in a different clinician — the durable fix is a just culture that distinguishes human error (console), at-risk behaviour (coach), and reckless behaviour (punish).

Medical Errors and Open Disclosure

The one-line answer

Medical errors are common, and the way a physician responds when one occurs is a defining act of professional practice. Act in a fixed sequence — stabilise the patient, recognise the event, disclose it openly, report it, investigate the system, and support the clinician. Two examiner errors lose the marks every time: treating the disclosure as an admission of liability (it is not), and blaming the individual at the sharp end while the latent system defect stays in place. The fix is James Reason's Swiss cheese model and an apology that the law protects.[1]

Meet the patient

A nurse calls you to the ward at 2am. Your patient is clammy, confused, and the bedside glucose is 1.2 mmol per litre. You discover the insulin chart reads "4U" and was given as 44 units. The two questions that decide the next hour are the two that decide every adverse event: is the patient safe, and what happens next — and "next" means disclosure, reporting, and a system fix, not a hunt for someone to blame.[1]

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References6ShowHide
  1. [1]Reason J Human error: models and management BMJ, 2000.PMID 10720363
  2. [2]Makary MA, Daniel M Medical error-the third leading cause of death in the US BMJ, 2016.PMID 27143499
  3. [3]Studdert DM, Mello MM, Gawande AA, Brennan TA, Wang YC Disclosure of medical injury to patients: an improbable risk management strategy Health Aff (Millwood), 2007.PMID 17211031
  4. [4]Studdert DM, Mello MM, Gawande AA, Gandhi TK, Kachalia A, Yoon C, Puopolo AL, Brennan TA Claims, errors, and compensation payments in medical malpractice litigation N Engl J Med, 2006.PMID 16687715
  5. [5]Gallagher TH, Studdert D, Levinson W Disclosing harmful medical errors to patients N Engl J Med, 2007.PMID 17596606
  6. [6]Rathnayake D, Sasame A, Radomska A, et al. What can we learn from patient and family experiences of open disclosure and how they have been evaluated? A systematic review BMC Health Serv Res, 2025.PMID 39939873

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