Patient Safety, Risk Management, and Legal Issues
Domain 7 - Patient Safety, Risk Management, and Legal Issues. This domain tests how organizations prevent harm, respond when harm occurs, and meet legal duties. Questions often blend safety science with liability concepts.
Safety science
- Errors are slips/lapses (execution), mistakes (planning), and violations. The Swiss cheese model shows defenses failing in alignment.
- High-reliability practices: preoccupation with failure, reluctance to simplify, sensitivity to operations, deference to expertise, resilience.
- Just culture distinguishes human error, at-risk behavior, and reckless behavior. Sentinel events trigger root cause analysis; FMEA is prospective.
- Joint Commission National Patient Safety Goals include patient identification, handoff communication, medication safety, and infection prevention.
Legal duties
- Negligence requires duty, breach, causation, and damages; malpractice is professional negligence. Respondeat superior holds employers liable for employees acting in scope.
- Informed consent requires capacity, disclosure of risks, benefits, and alternatives, and voluntariness; emergencies create exceptions.
- EMTALA mandates screening and stabilization. HIPAA permits disclosure for treatment, payment, and operations, and in defined public-health and legal situations. Stark and the Anti-Kickback Statute restrict physician arrangements.
Worked example
A wrong-site surgery occurs. Reasoning: care for the patient and disclose the event honestly; preserve records; report as required; conduct RCA to find system failures (timeout, marking, scheduling); redesign the process; and use FMEA on related procedures. An apology is part of transparency and is not, by itself, an admission of liability.
Traps
- Blaming an individual when the system permitted the error.
- Equating a bad outcome with negligence.
- Disclosing PHI outside permitted exceptions.
- Assuming apology language creates liability.