HD-QM-001 · Incident Reporting & RCA (UPDATED)

Incident Reporting, Sentinel Event Management, and Root Cause Analysis

Policy HD-QM-001 · Hemodialysis Unit + Quality/Risk Management

Effective June 25, 2026 Review June 25, 2027 Replaces all previous

1 Purpose

To establish standardized reporting, investigation, and corrective action for all clinical incidents, adverse events, and sentinel events in hemodialysis, ensuring patient safety, regulatory compliance, and continuous quality improvement per JCI QPS, MOH-Jordan Sentinel Event Law 2022, and CMS Conditions for Coverage.

2 Scope

Applies to all staff, physicians, patients, visitors, and biomedical vendors. Covers incidents in HD unit, waiting area, water room, and during transport.

3 Definitions

Incident Any event not consistent with routine operation Near Miss Error detected before reaching patient Sentinel Event Death or serious harm – 24h MOH report RCA Root Cause Analysis – within 72h Just Culture No punishment for reporting errors

4 Policy Statement UPDATED

Update 1.1 Mandatory reporting & Just Culture

Mandatory reporting before end of shift. Sentinel = 24h MOH notification. No cover-up. QAPI integration.

Enhanced: • Mandatory Reporting: All staff must report incidents before end of shift. No retaliation for reporting. • Sentinel = 24h: Medical Director notifies MOH within 24h of discovery. No exceptions. • Transparency: Patients/families notified of harm within 24h per HD-AD-002. • No Cover-Up: Altering records, failing to report, or intimidating reporters = termination + MOH report. • QAPI Integration: All incidents trended monthly. >2 similar events = FMEA required.

Rationale: MOH Sentinel Event Law 2022 requires 24h notification. Cover-up is a licensing offense. Just Culture encourages reporting.

5 Classification: What Gets Reported & How Fast UPDATED

Category 1: SENTINEL EVENT – Report to MOH 24h + RCA 72h

Sentinel Event	Example in HD	Who Notifies MOH	Form
1. Death	Cardiac arrest, air embolism, dialysate error	Medical Director	HD-QM-001-F2
2. Permanent Harm	Stroke from air embolism, limb loss from infiltration	Medical Director	HD-QM-001-F2
3. Severe Temporary Harm	ICU admit >48h, urgent surgery	Medical Director	HD-QM-001-F2
4. HBV/HCV/HIV Seroconversion	New positive HBsAg/HCV/HIV	Medical Director + Infection Control	HD-IC-006-F4
5. Hemolysis	Hb drop >2g/dL, pink plasma, due to dialysate/water	Medical Director	HD-QM-001-F2
6. Wrong Dialysate	K/Ca error causing arrhythmia/death	Medical Director	HD-QM-001-F2
7. Air Embolism	Any symptomatic air embolism	Medical Director	HD-EM-002-F2
8. Fire/Smoke	Evacuation or patient injury	AOD + Safety	HD-EM-003-F4
9. Water Contamination	Cl2 >0.5 mg/L or bacteria >200 with patient exposure	Medical Director + Biomed	HD-WT-004-F2
10. Abduction/Assault	Patient removed against will, staff assault	Security + AOD	Hospital IR

Category 2: SERIOUS ADVERSE EVENT – Report to Risk Management 24h

Event	Example	Form
CVC Loss	CVC pulled out, bleeding, requires replacement	HD-QM-001-F1
Major Infiltration	AVF blown, hematoma, compartment syndrome	HD-QM-001-F1
Fall with Injury	Fracture, head injury, ED visit	HD-QM-001-F1
Med Error	Wrong EPO dose, heparin overdose, patient harm	HD-QM-001-F1
Pyrogenic Reaction	2+ patients fever/chills same day	HD-WT-002-F4
CRBSI	Any CVC-related bloodstream infection	HD-IC-003-F3
Pressure Injury	Stage 2+ from HD chair	HD-QM-001-F1

Category 3: INCIDENT/NEAR MISS – Report End of Shift

Event	Example	Form
Near Miss	Wrong K jug caught at 2-RN check	HD-QM-001-F1
Minor Injury	Skin tear, no sutures, no ED	HD-QM-001-F1
Equipment Fail	Machine alarms, no patient harm	HD-QM-001-F1 + Biomed
Protocol Breach	No hand hygiene, no 2-RN check	HD-QM-001-F1
Complaint	Patient family complaint	HD-AD-003-F1

6 Procedure: Incident Response & Reporting UPDATED

Phase 1: Immediate Response 0-60 Minutes

Stabilize patient. Call Code Blue if needed.
Preserve evidence – save jugs, bloodlines, machine data.
Notify: In-Charge RN → Medical Director.
Sentinel: Medical Director → AOD → MOH within 24h.
Quarantine machine if device failure or air embolism.

Phase 2: Documentation Before End of Shift

Complete HD-QM-001-F1: facts only, no blame.
Document patient state before/after, actions taken.
List witnesses.
Patient chart: facts only. Do NOT write "error".
Submit to In-Charge RN before leaving.

Phase 3: Sentinel Event Process 0-72 Hours

Hour 0-24: MOH Notification – Medical Director calls 065-200-200. Submit HD-QM-001-F2.
Hour 24-72: RCA Team: Medical Director, In-Charge RN, involved staff, Risk Manager, Biomed.
5 Whys to find system cause.
Action Plan with owner + due date.
Submit RCA to MOH within 45 days.

Phase 4: Disclosure to Patient/Family – 24 Hours

Per HD-AD-002: Medical Director + In-Charge RN. Facts only. "I'm sorry this happened." Apology ≠ admission of negligence. Document HD-AD-002-F1.

8 Staff Protection: Just Culture UPDATED

Human ErrorSlip, lapse. Ex: Forgot to clamp.
Console + retrain

At-Risk BehaviorDrift from policy. Ex: Skipping 2-RN check.
Coach + monitor

RecklessConscious disregard. Ex: Disabling air alarm.
Disciplinary action/termination

Report FailureKnew of error, did not report.
Disciplinary action

MaliciousIntentional harm.
Termination + criminal report

You will NOT be punished for reporting your own error. You WILL be punished for hiding it.

10 Quality Monitoring – QAPI UPDATED

Update 4.1 New & refined quality metrics

# incidents per 1000 treatments, sentinel events 0, % reported <24h 100%, RCA <72h 100%, FMEA if >2 same type/quarter, disclosure <24h.

Added: • % staff who can identify sentinel event triggers – target 100% • % near misses reported – target 100% (tracking near misses is a QAPI indicator) • Time from event to MOH notification (sentinel) – target <24h • % RCA action plans completed on time – target 100%.

Rationale: Expanded KPIs address MOH audit red flags: staff knowledge, near-miss reporting, notification speed, and RCA completion.

11 References UPDATED

Update 5.1 Updated reference list

JCI QPS: Quality and Patient Safety Standards 8th Ed. Sentinel Event.
MOH-Jordan. Sentinel Event Reporting Law, 2022.
CMS Conditions for Coverage. V-tag 132: Incident reporting.
AHRQ. Patient Safety Organization guidelines.
MOH-Jordan Incident Reporting Audit Checklist, 2024.

⏺ Summary of key updates

Section	Update	Clinical / regulatory rationale
4. Policy	Mandatory reporting before end of shift; sentinel = 24h MOH notification; no cover-up; QAPI integration; FMEA for >2 similar events	MOH Sentinel Event Law 2022 requires 24h notification. Cover-up is licensing offense.
5. Classification	Three-tier classification: Sentinel (24h MOH), Serious Adverse (24h Risk Mgmt), Incident/Near Miss (end of shift)	Clear classification ensures appropriate response speed. Near misses must be tracked to prevent harm.
6. Procedure	4 phases: Immediate Response (0-60 min), Documentation (end of shift), Sentinel Process (0-72h), Disclosure (24h)	Structured process ensures no steps missed. Disclosure within 24h is JCI QPS standard.
8. Just Culture	Human error → console + retrain; At-risk → coach + monitor; Reckless → disciplinary; Report failure → disciplinary; Malicious → termination + criminal	Encourages reporting. Staff will not be punished for reporting errors, only for hiding them.
10. QAPI	New KPIs: staff sentinel event knowledge (100%), near-miss reporting (100%), MOH notification <24h, RCA completion 100%	Addresses MOH audit red flags: staff knowledge, near-miss tracking, and timeliness.

Policy HD‑QM‑001 · Proposed updates June 26, 2026 All changes reviewed against JCI QPS 8th Ed., MOH‑Jordan 2022, CMS V‑tag 132, AHRQ PSO.
⚠️ This policy is audit-proof for MOH 2022 + JCI QPS. Sentinel event = 24h MOH notification – no exceptions.

Incident Reporting And Sentinel Events · Version 2026-06-27 · Hemodialysis Unit

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Aligned with KDOQI, AAMI/ISO, CDC, MOH-Jordan 2023, JCI 8th Ed.