Patient Safety and Risk Management
Domain 8 covers patient safety and risk management: event reporting, root cause analysis, failure mode and effects analysis, disclosure, claims management, and high-risk clinical processes. Expect questions on sentinel events, near misses, just culture, and the difference between reactive and proactive analysis.
Core rules
- An adverse event causes harm; a near miss did not reach the patient; a sentinel event reaches the patient and results in death, permanent harm, or severe temporary harm, or is on the accreditor's defined list.
- Root cause analysis is reactive, triggered by a serious event. It examines systems, not individual blame, and produces corrective actions with owners and measures.
- Failure mode and effects analysis is proactive: identify a high-risk process, list failure modes, score severity, occurrence, and detection, and redesign before harm occurs.
- Disclosure includes an honest explanation, apology, and follow-up; coordinate with risk management and legal counsel but do not delay clinically necessary communication.
- Report and trend events; protect peer review and confidentiality as required by law.
Worked example
A wrong-site procedure occurs. The team immediately stops, cares for the patient, preserves equipment and records, notifies risk management and leadership, and discloses to the patient. A root cause analysis examines pre-op verification, marking, time-out, scheduling, and communication. Corrective actions may include a hard stop in the time-out and audit of compliance. The root cause analysis is not a disciplinary hearing.
Traps
Do not call every adverse event a sentinel event. Do not use failure mode and effects analysis after harm; that is root cause analysis. Do not let the analysis end with re-educate staff without system changes and measurement.