Master Ethics & Patient Safety
for SMLE

What the SMLE Tests in Ethics & Patient Safety

This exam tests application of the GMC's 'Good Medical Practice' framework to clinical scenarios. Candidates must demonstrate knowledge of informed consent (capacity assessment using the Mental Capacity Act 2005 criteria), confidentiality breaches (e.g., disclosing HIV status to a partner without consent, or reporting a notifiable disease under the Public Health (Control of Disease) Act 1984), and end-of-life decisions (e.g., DNACPR orders, the Mental Capacity Act's best interests checklist). Patient safety questions focus on root cause analysis of adverse events (e.g., wrong-site surgery, medication errors with warfarin or insulin), the WHO Surgical Safety Checklist, and the 'Swiss cheese model' of error causation. Specific knowledge of the 'never events' list (e.g., retained swab, wrong-route administration of chemotherapy) and the duty of candour (being open with patients after harm) is essential. Questions often present a junior doctor facing a dilemma—e.g., a confused patient refusing antibiotics for pneumonia, or a colleague with impaired fitness to practise due to alcohol misuse.

High-Yield Concepts

• Mental Capacity Act 2005: Capacity Assessment: A two-stage test: (1) Does the patient have an impairment of mind or brain? (2) If so, can they (a) understand, (b) retain, (c) weigh/use, and (d) communicate the decision? All four must be present for capacity. A temporary cause (e.g., delirium, hypoglycaemia) must be treated before concluding incapacity. The best interests checklist includes past wishes, beliefs, and consulting relevant others.
• Informed Consent: Montgomery Criteria: Consent is valid if the patient is informed of material risks—those a reasonable person in the patient's position would attach significance to (e.g., 1% risk of stroke with carotid endarterectomy, or 0.5% risk of permanent nerve damage from a lumbar puncture). The doctor must disclose alternatives (e.g., conservative management for appendicitis). Failure to do so is battery or negligence.
• Confidentiality: Exceptions to Duty: Disclosure without consent is permitted for: (a) public interest (e.g., preventing serious harm to others, such as a patient with untreated HIV who refuses to inform partner), (b) court order, (c) statutory duty (e.g., notifiable diseases: meningitis, measles, TB under the Health Protection Regulations), (d) serious crime (e.g., terrorism, child abuse). Always document the rationale.
• DNACPR and Advance Decisions: A DNACPR form is a medical order, not a patient decision, and must be reviewed after every significant change (e.g., new stroke, sepsis). An advance decision to refuse life-sustaining treatment must be in writing, signed, witnessed, and state the specific treatment refused (e.g., 'I refuse cardiopulmonary resuscitation'). It is legally binding if valid and applicable.
• Never Events: 2024 List: Key never events include: wrong-site surgery (e.g., left vs right knee arthroscopy), retained foreign object post-procedure (e.g., swab, instrument), wrong-route administration of chemotherapy (e.g., intrathecal instead of intravenous), and mis-selected strong opioid (e.g., giving morphine 30 mg instead of 3 mg). Root cause analysis (RCA) is mandatory within 72 hours.
• Duty of Candour: Being Open: Under the Health and Social Care Act 2008, if a patient suffers moderate or severe harm (e.g., permanent injury, prolonged hospital stay due to a medication error), the clinician must inform the patient in person, apologise, provide a written account, and offer support. Failure is a fitness-to-practise issue.
• Fitness to Practise: Impaired Colleague: If a colleague is impaired by alcohol, drugs, or mental illness (e.g., a surgeon with untreated depression making errors), you must report to the GMC or your Responsible Officer immediately if there is a risk to patients. The 'GMC's Good Medical Practice' states patient safety is paramount, overriding loyalty to colleagues.
• WHO Surgical Safety Checklist: Three Phases: Sign In (before anaesthesia): confirm patient identity, site, and known allergies (e.g., latex, penicillin). Time Out (before skin incision): team introduces themselves, surgeon confirms planned procedure, anaesthetist confirms airway/aspiration risk (e.g., difficult intubation, obesity). Sign Out (before leaving theatre): count of swabs/needles, specimen labelled, and any equipment issues (e.g., broken diathermy).

Common Traps in Ethics & Patient Safety Questions

• Trap: Assuming a patient who refuses treatment automatically lacks capacity—refusal is not evidence of incapacity; capacity is decision-specific and time-specific.
• Trap: Confusing confidentiality with absolute secrecy—disclosure is permitted for public interest (e.g., a patient with active TB who refuses isolation).
• Trap: Thinking a DNACPR order means 'do not treat'—it only applies to cardiopulmonary arrest; all other treatments (e.g., antibiotics, fluids) must still be considered.
• Trap: Believing a patient's advance decision can be overridden by family—it is legally binding if valid and applicable; only a court can overturn it.
• Trap: Assuming a medication error that causes no harm does not require disclosure—the duty of candour applies even for near misses if the patient expects an explanation.
• Trap: Forgetting that the 'never events' list includes wrong-route administration of chemotherapy (e.g., vincristine given intrathecally) and mis-selected potassium chloride concentrate.

How to Revise Ethics & Patient Safety for the SMLE

Prioritise the GMC's 'Good Medical Practice' domains: consent, confidentiality, and end-of-life decisions. Questions are typically scenario-based, asking 'What is the most appropriate next step?'—focus on process (e.g., assess capacity first, then best interests) rather than outcome. Practise applying the Mental Capacity Act's two-stage test to common scenarios (e.g., dementia with pneumonia, schizophrenia refusing amputation). For patient safety, memorise the top five never events and the WHO checklist phases. Review root cause analysis templates (fishbone diagram, 5 whys) for medication errors (e.g., insulin, heparin). Spend 20% of revision time on ethical frameworks (four principles: autonomy, beneficence, non-maleficence, justice) but know that SMLE favours legal/regulatory specifics over philosophy. Use past papers to identify recurring themes: duty of candour, fitness to practise, and consent in emergencies.

Practise it: MedLumen has 50 Ethics & Patient Safety questions for the SMLE, each with a full explanation and references.