Master Ethics & Patient Safety
for SMLE

Core Concepts

• **Four Pillars of Medical Ethics:**
  • **Autonomy:** Patient's right to make informed decisions about their care, free from coercion. Requires capacity.
  • **Beneficence:** Act in the best interest of the patient; providing care that benefits them.
  • **Non-maleficence:** Do no harm; avoid causing injury or suffering. "Primum non nocere."
  • **Justice:** Fair distribution of healthcare resources; equitable treatment of patients.
• **Key Ethical Principles:**
  • **Veracity:** Truthfulness and honesty with patients.
  • **Confidentiality:** Protecting patient information; disclosure only with consent or legal/ethical justification (e.g., public safety, court order).
  • **Fidelity:** Loyalty and commitment to patients; upholding professional duties.
• **Informed Consent:** A process, not just a signature. Requires:
  • **Capacity:** Patient's ability to understand information and make a reasoned decision. (Competence is a legal determination by a court).
  • **Voluntariness:** Decision free from coercion or undue influence.
  • **Information:** Adequate disclosure of diagnosis, prognosis, treatment options (including risks, benefits, alternatives, and no treatment), and opportunity to ask questions.
• **Patient Rights (SMLE Context):**
  • Right to receive medical information in an understandable manner.
  • Right to refuse treatment (if capacitous).
  • Right to privacy and confidentiality.
  • Right to a second opinion.
  • Right to complain.
• **Patient Safety:**
  • **Definition:** Prevention of harm to patients, learning from errors, and building a culture of safety.
  • **Medical Error:** An unintended act of omission or commission in the planning or execution of care that contributes or could contribute to an adverse outcome.
  • **Adverse Event:** An injury resulting from medical management rather than from the underlying disease.
  • **Near Miss:** An error that had the potential to cause harm but did not. Opportunity for learning without patient injury.
  • **System-Based Approach:** Focus on improving processes and systems to prevent errors, rather than solely blaming individuals.
  • **Culture of Safety:** Environment where staff feel safe to report errors without fear of punishment, fostering open communication and learning.

Clinical Presentation

• **Ethical Dilemmas:**
  • Conflict between patient's autonomy and clinician's beneficence (e.g., refusal of life-saving treatment).
  • Requests for futile treatment.
  • Resource allocation disputes (e.g., ICU beds, organ transplantation).
  • Balancing confidentiality with public safety (e.g., infectious disease, impaired driver).
  • Truth-telling to patients with poor prognoses.
• **Informed Consent Issues:**
  • Performing procedures without adequate discussion or patient understanding.
  • Patient appearing coerced or pressured into a decision.
  • Lack of documentation of the consent process.
• **Patient Safety Incidents:**
  • **Medication errors:** Wrong drug, dose, route, time, patient.
  • **Procedure-related errors:** Wrong-site surgery, retained surgical items.
  • **Hospital-acquired infections:** Catheter-associated UTIs, central line-associated bloodstream infections.
  • **Falls:** Patients falling during hospital stay.
  • **Communication failures:** Handoff errors, miscommunication during referrals.
  • **Delayed or missed diagnoses.**

Diagnosis (Gold Standard)

• **Ethical Dilemma Resolution:**
  • **Structured Framework:** Apply ethical principles (Autonomy, Beneficence, Non-maleficence, Justice) to analyze the situation systematically.
  • **Ethics Committee Consultation:** For complex cases, seeking expert guidance and consensus from a multidisciplinary committee.
  • **Legal Counsel:** For legal clarity, especially regarding capacity, advanced directives, or mandatory reporting.
• **Patient Safety Incident Analysis:**
  • **Incident Reporting System:** Prompt, accurate reporting of all errors, near misses, and adverse events.
  • **Root Cause Analysis (RCA):** A structured process for identifying underlying causal factors of an adverse event, focusing on system failures rather than individual blame.
  • **Mortality and Morbidity (M&M) Conferences:** Regular review of patient deaths and complications to identify learning opportunities.

Management (First Line)

• **Ethical Dilemma Management:**
  • **Open Communication:** Facilitate discussions with patient, family, and healthcare team to understand perspectives and seek common ground.
  • **Respect Autonomy:** Prioritize and respect the capacitous patient's informed decisions, even if clinicians disagree.
  • **Documentation:** Meticulously document discussions, decisions, and rationale for actions taken.
  • **Ethics Consultation:** Utilize the institutional ethics committee when consensus cannot be reached or for complex cases.
  • **Adherence to Law:** Ensure compliance with local laws, especially concerning consent, confidentiality, and mandatory reporting.
• **Patient Safety Incident Management:**
  • **Immediate Patient Care:** Prioritize patient safety and mitigate harm immediately following an incident.
  • **Disclosure:** Timely, honest, and empathetic disclosure of the error and its consequences to the patient and/or family.
  • **Incident Reporting:** Promptly report through established hospital channels.
  • **Systemic Response:** Conduct RCA (if appropriate) to identify and address system deficiencies, implement corrective actions (e.g., new protocols, training, technology).
  • **Support for "Second Victims":** Provide emotional and professional support to healthcare workers involved in adverse events.

Exam Red Flags