Medical Errors and Open Disclosure — Viva

Long Case Viva Defence

Candidate's opening statement (model answer)

"Mr Robert Hayes is a 72-year-old man with type 2 diabetes, ischaemic heart disease, and stage 3 chronic kidney disease, admitted with community-acquired pneumonia, who on day two sustained a tenfold insulin overdose (40 units instead of 4, from a prescription written as 4U) causing profound neuroglycopenic hypoglycaemia requiring 50 per cent intravenous dextrose and ICU transfer. He has made a full recovery. Concurrently his metformin was not ceased despite a rising creatinine from 140 to 230 micromoles per litre, exposing him to lactic acidosis that did not eventuate. [1]

His problem list is: (1) a preventable adverse event — a tenfold insulin overdose — that has caused harm and requires immediate stabilisation, evidence preservation, and structured open disclosure; (2) a concurrent medication-monitoring error — the failure to cease metformin in acute kidney injury — that did not cause harm but is part of the same system failure; (3) the underlying community-acquired pneumonia with evolving acute kidney injury that requires ongoing treatment; (4) the medico-legal and reporting obligations — incident report, medical defence organisation notification, and an assessment of whether AHPRA mandatory notification or coronial referral is triggered; (5) the root cause analysis and the system changes to prevent recurrence; and (6) the second victim — the prescribing registrar and the overnight nurse — who require support within a just culture. [1]

My immediate priorities are, in order: stabilise the patient (done — he is in ICU and recovering), preserve the evidence (the medication chart, the insulin pen, the prescription), and notify the consultant and the medical defence organisation. I will then conduct the staged open disclosure under the Australian Open Disclosure Framework, file the incident report, and convene a root cause analysis using the London Protocol contributory factors." [1]

Examiner probing questions and model answers

"Classify this event in the patient-safety taxonomy." [1]

"This is a preventable adverse event — an injury caused by medical management rather than by the underlying pneumonia, resulting in ICU transfer. It is not a near miss, because the error reached the patient and caused harm. It is not a never event, because insulin abbreviation error is not on the never-event list (wrong-site surgery, retained foreign object, incompatible transfusion, and the like). In Reason's taxonomy it is an error of execution — the plan to give 4 units was correct, but the execution failed through the ambiguous prescription 4U read as 40 — and specifically a rule-based mistake (a non-compliant local habit of abbreviating units) compounded by a lapse at the administration step (no independent check). The metformin error is a monitoring error — a failure to act on the rising creatinine — which is a separate active failure" [1].

"Walk me through the Swiss cheese analysis." [1]

"The Swiss cheese model holds that an adverse event occurs only when the holes in every layer of defence momentarily align. Here the layers were: the organisation's policy (which prohibits the U abbreviation but did not enforce it — a latent condition); the prescribing step (the registrar wrote 4U — an active failure); the pharmacy review (the order may not have been reviewed by a pharmacist overnight — a latent condition in after-hours prescribing); the administration step (the nurse read 4U as 40 and gave it, with no independent double-check — an active failure and a latent condition in the absence of a mandatory check for high-alert medicines); and the monitoring step (the hypoglycaemia was recognised and treated — this defence held). The durable fixes are at the latent-condition level: a hospital-wide ban on the U abbreviation with audit, mandatory independent double-checks for insulin, and computerised physician order entry with a hard dose-range alert for insulin in renal impairment. The active failures are proximate, but the latent conditions are the root causes." [1]

"How would you conduct the open disclosure?" [1]

"Under the Australian Open Disclosure Framework, staged. First, the initial disclosure, as soon as practicable and within 24 hours, once the patient is stable. In a private setting with the consultant and an open disclosure facilitator, I would open with an apology — an expression of regret that is explicitly NOT an admission of legal liability under Australian civil liability legislation. I would give a factual, plain-language account: that an insulin dose ten times the intended amount was given overnight due to a prescribing abbreviation, and that the metformin was not stopped when the kidneys failed. I would acknowledge the impact — the hypoglycaemia, the ICU stay, the fear. I would state what is being done — a formal root cause analysis — and offer support: a second opinion, counselling, advocacy. I would not speculate about the cause or blame the nurse or the registrar. Second, ongoing communication as the investigation proceeds. Third, the formal open disclosure meeting once the RCA is complete. Fourth, follow-up with the written outcome and the actions taken" [3].

"Is the apology an admission of liability?" [1]

"No. An apology is an expression of regret for what happened and for the impact on the patient. The civil liability legislation of the Australian states expressly provides that an apology is not an admission of liability and is not admissible as evidence of liability. The Australian Open Disclosure Framework restates this. The ethical duty of candour requires the apology, the law protects it, and the evidence shows that open disclosure with a genuine apology reduces the number and value of civil claims. The largest single driver of complaints and litigation is not the harm itself but the perception of a cover-up — the patient who was not told. Open disclosure addresses that driver directly" [2].

"What would the root cause analysis find?" [1]

"Using the London Protocol contributory-factor domains: patient factors — complex comorbidity (diabetes, ischaemic heart disease, CKD) making the dose critical and the margin narrow; task factors — the sliding-scale protocol and the dose-adjustment task in AKI lacked an embedded forcing function; individual factors — the registrar used a non-compliant abbreviation and the nurse read it without a check, both active failures but neither reckless; team factors — the handover at the evening shift change did not flag the rising creatinine or the need to review dosing; environment — the ward, the after-hours staffing; organisation — the latent conditions, the persistence of the U abbreviation in practice despite policy, the absence of an independent double-check for high-alert medicines, the absence of a hard alert in the prescribing system; institutional context — the accreditation of the insulin-prescribing process against the NSQHS Standards. The durable fixes are at the latent-condition level." [1]

"How do you apply the just culture algorithm here?" [1]

"The just culture algorithm distinguishes human error (console), at-risk behaviour (coach), and reckless behaviour (manage). Here the abbreviation was a human error — an inadvertent use of a non-compliant habit — and the missing check was a lapse, also human error. The response is to console the individuals and fix the system, not to discipline. Both the registrar and the nurse are second victims who will suffer acute distress, intrusive thoughts, loss of confidence, and, in severe cases, suicidal ideation. They require peer support, debriefing, access to the employee assistance programme and the medical defence organisation, and a structured re-entry to practice. Failing to support the second victim is itself a patient-safety risk because the distressed clinician is more error-prone." [1]

"What are the reporting and medico-legal obligations?" [1]

"The internal incident report is filed for every adverse event and triggers the severity assessment and the RCA. The medical defence organisation is notified of the serious adverse event and before any formal statement. AHPRA mandatory notification is NOT required here — the threshold is notifiable conduct (intoxication, sexual misconduct, impairment placing the public at risk, a significant departure from professional standards), and an unintentional abbreviation error by an otherwise competent clinician is an error, not notifiable conduct. Coronial referral is NOT required because the patient recovered — had he died from the hypoglycaemia, the death would have been reportable as an unexpected death resulting from a medical intervention, the ordinary death certificate would not have been issued, and the record would have been preserved. The complaint, the claim, and the mandatory notification are three distinct pathways that run in parallel." [1]

"How does this topic scale to the population burden?" [1]

"The IOM report To Err is Human (1999) estimated 44,000 to 98,000 US deaths annually from medical error. Makary and Daniel re-estimated the figure at more than 250,000 US deaths per year — if correct, medical error is the third leading cause of death in the United States, behind heart disease and cancer. The estimate is contested but the direction is clear: medical error is a leading cause of preventable death, and most of those deaths are preventable by system change, not by exhorting clinicians to be more careful. The Studdert analysis of US malpractice claims confirmed that claims and compensation are concentrated in high-severity injuries and that disclosure and early resolution reduce both." [1]

Short Case Discussion — Classification of error types

Examiner: "A pharmacist intercepts a prescription for DOBUTamine written at a dose appropriate for DOPamine before administration. The patient comes to no harm. Classify this and tell me its value." [1]

"This is a near miss — an incident that did not reach the patient because it was intercepted. The active failure is a prescribing error (the wrong drug chosen, likely a confusion of the two look-alike sound-alike inotropes), and the latent conditions are the look-alike packaging and labelling, the absence of tall-man lettering (DOPamine versus DOBUTamine), and the absence of a barcode administration check. Near misses are the richest source of latent-condition intelligence because the patient was not harmed and staff report them more freely, and a high near-miss reporting rate is a marker of a healthy safety culture, not a dangerous unit. Every near miss should be reported to the incident management system regardless of harm, because the aggregate of reports reveals patterns that single-event review cannot detect. The fix here is tall-man lettering in the formulary, a clinical decision support flag for the two drugs, and a barcode administration check." [1]

Examiner: "Define a never event and give two examples." [1]

"A never event — also termed a sentinel event — is a serious, largely preventable patient safety incident that should not occur if the available preventions are in place. Two examples are wrong-site surgery (operating on the wrong limb or the wrong side) and a retained foreign object (a swab or instrument left in a body cavity after closure). Other examples include wrong-patient surgery, wrong-procedure surgery, incompatible blood transfusion, and medication error leading to death or severe harm. Never events trigger a mandatory organisational response — a full root cause analysis and external reporting to the ACSQHC — regardless of the clinical outcome." [1]

Examiner: "Distinguish a slip from a lapse from a mistake." [1]

"A slip is an action-based failure — the plan was right but the execution failed, such as picking up the wrong syringe. A lapse is a memory-based failure, such as forgetting to check the allergy box or forgetting to give a dose. A mistake is a planning failure — the plan itself was wrong, such as misdiagnosing and treating for the wrong condition. Slips and lapses are skill-based errors; mistakes divide into rule-based (the wrong rule applied) and knowledge-based (incomplete knowledge). The taxonomy matters because the countermeasures differ: slips are reduced by forcing functions and standardisation, lapses by checklists and prompts, mistakes by decision support, cognitive aids, and education." [1]

Examiner: "What is the difference between an error and a violation?" [1]

"A violation is a deliberate — though usually well-intentioned — deviation from a rule or protocol, such as bypassing the two-patient-identifier check because you know the patient, or working beyond safe hours. An error is unintentional. Routine violations are a warning sign of a poorly designed system (a rule that cannot realistically be followed) and are themselves a latent condition for future error. Reckless violations are a conduct issue managed separately from the systems analysis. The just culture algorithm operationalises the distinction: human error is consoled, at-risk behaviour is coached, and reckless behaviour is managed." [1]

Examiner: "What are the four elements of disclosure?" [1]

"The four elements are constant across jurisdictions: an apology (an expression of regret, not an admission of liability); a factual explanation (a plain-language account of what is known and what is not); an acknowledgement (a recognition of the impact on the patient); and a plan to prevent recurrence (what is being done and what will be done differently). Whatever the framework — the Australian Open Disclosure Framework, the English statutory duty of candour, or the US CANDOR toolkit — these four elements are present." [1]