Mandatory Audit Directive: This inspection form must be completed monthly for all inpatient wards, outpatient clinics, surgical suites, and support services. Any "FAIL" on critical infection control or life safety parameters requires immediate escalation within 2 hours.
1. FACILITY & AUDIT METADATA Mandatory Tracking
Facility / Hospital Name
Unit / Department / Floor
Audit Date & Time
Lead Auditor Name & Credentials
Unit Manager / Escort
Audit Type
2. INFECTION PREVENTION & CONTROL STANDARDS OSHA & CDC Guidelines
Item # | Audit Parameter & Compliance Criterion | Data / Readings | Pass | Fail | N/A | Ref ID | |
|---|---|---|---|---|---|---|---|
2.1 | Hand Hygiene Stations: Wall dispensers full, active, and accessible within 10ft of every patient care station. | ||||||
2.2 | Isolation Room Pressure: Airborne Infection Isolation Rooms (AIIR) maintaining negative pressure (≥ 2.5 Pa). | ||||||
2.3 | Personal Protective Equipment (PPE): Stock of gowns, N95/surgical masks, and face shields verified in ante-room. | ||||||
2.4 | High-Touch Surface Disinfection: Bed rails, IV poles, and monitors sanitized with EPA-registered disinfectant. | ||||||
2.5 | Soiled Utility Room: Proper segregation of contaminated linen and waste, negative airflow verified. |
3. ENVIRONMENTAL & CLIMATE CONTROL ASHRAE 170 Standards
Item # | Audit Parameter & Compliance Criterion | Measured Values | Pass | Fail | N/A | Ref ID | |
|---|---|---|---|---|---|---|---|
3.1 | Operating Theatre / ICU Humidity: Relative humidity maintained strictly between 30% and 60%. | ||||||
3.2 | Air Exchange Rates: Clean utilities and patient areas meeting required air changes per hour (ACH ≥ 6). | ||||||
3.3 | Environmental Cleanliness: Floor surfaces, acoustic ceiling tiles, and vents free of dust, leaks, or mold. |
4. MEDICATION STORAGE & PHARMACEUTICAL SAFETY USP & Safe Harbor Rules
Item # | Audit Parameter & Compliance Criterion | Recorded Data | Pass | Fail | N/A | Ref ID | |
|---|---|---|---|---|---|---|---|
4.1 | Refrigerated Med Temp: Vaccine and drug refrigerators maintained at 2.0°C to 8.0°C with continuous logging. | ||||||
4.2 | Controlled Substance Vault: Double-locked storage, dual-sign dispenser log, and physical count reconciliation. | ||||||
4.3 | Expired Drug Verification: Zero expired medications, multi-dose vials dated upon opening (30-day discard). | ||||||
4.4 | Emergency Crash Cart: Tamper seal intact, daily checklist completed, defibrillator battery tested. |
5. HAZARDOUS WASTE & BIO-SAFETY MANAGEMENT EPA & OSHA Bloodborne Pathogens
Item # | Audit Parameter & Compliance Criterion | Observation / Capacity | Pass | Fail | N/A | Ref ID | |
|---|---|---|---|---|---|---|---|
5.1 | Sharps Container Safety: Wall-mounted, puncture-resistant, locked, and under 3/4 capacity fill line. | ||||||
5.2 | Bio-Hazard Bag Segregation: Red biohazard bags used exclusively for regulated infectious waste; lids closed. | ||||||
5.3 | Safety Data Sheets (SDS): Digital and hardcopy SDS accessible to staff for all departmental chemicals. |
6. BIO-MEDICAL EQUIPMENT & MAINTENANCE FDA & ECRI Standards
Item # | Audit Parameter & Compliance Criterion | Calibration Due Date | Pass | Fail | N/A | Ref ID | |
|---|---|---|---|---|---|---|---|
6.1 | PM Inspection Stickers: All active ventilators, monitors, and infusion pumps display current PM tags. | ||||||
6.2 | Electrical Safety Grounding: Line leakage and ground integrity tested on critical life-support systems. | ||||||
6.3 | Suction & Oxygen Outlets: Wall medical gas outlets functional, flowmeters tested, no audible leaks. |
7. LIFE SAFETY & FIRE COMPLIANCE NFPA 101 Life Safety Code
Item # | Audit Parameter & Compliance Criterion | Verification | Pass | Fail | N/A | Ref ID | |
|---|---|---|---|---|---|---|---|
7.1 | Egress Corridors: Corridors clear of equipment, crash carts, or boxes (minimum 8-ft clear width). | ||||||
7.2 | Fire Exit Doors & Shutters: Self-closing mechanisms active, exit signs illuminated, magnetic holds working. |
8. DEFICIENCY LOG & CORRECTIVE ACTION PLAN Mandatory Remediation
Ref ID | Deficiency / Non-Compliance Finding | Required Corrective Action | Assignee | Target Date | ||
|---|---|---|---|---|---|---|
1 | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
5 |
9. COMPLIANCE SCORING & GOVERNANCE SUMMARY Quantitative Assessment
Quantitative Audit Breakdown
Total Applicable Checkpoints evaluated
Compliant Checkpoints (Pass)
Non-Compliant Checkpoints (Fail)
Calculated Compliance Percentage
Final Rating
Infection Control Lead / Auditor
I attest that this inspection was conducted in strict compliance with facility protocols and national clinical standards.
Signature
Quality Assurance Officer / Department Head
I acknowledge the audit findings and confirm that all required corrective actions have been assigned with enforced completion windows.
Signature
Application Form Insights
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Here is a detailed breakdown explaining why every category and question in this template is vital for maintaining patient care standards, protecting staff, and ensuring regulatory readiness.
Mandatory Questions Recommendation
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Below is a breakdown of the mandatory questions on the inspection form, along with the operational and clinical rationales for why each must be strictly required.