Infection Control Sops

Standard Operating Procedure: Institutional Infection Control Protocols

1. Document Control Block

• Document ID: SOP-TR-IC-402
• Effective Date: October 24, 2023
• Version: 3.2
• Review Cadence: Semi-Annual
• Target Audience: Clinical Operations Staff, Facilities Management, Infection Prevention & Control (IPC) Officers, Environmental Services (EVS) Teams

2. Executive Summary & Scope

This Standard Operating Procedure (SOP) defines the mandatory biological safety protocols, containment measures, and sterilization standards across all Template Registry operational facilities. Adherence to this protocol is legally binding and designed to mitigate biohazard transmission risks, ensure regulatory compliance with OSHA (29 CFR 1910.1030), CDC guidelines, and ISO 14644 cleanroom standards, and safeguard patient and personnel health. The scope encompasses all operational environments, including clinical touchpoints, diagnostic laboratories, handling areas for potentially infectious materials, and waste management sectors.

3. Prerequisites & Tool Requirements

• Personal Protective Equipment (PPE):
  • NIOSH-certified N95 or PAPR respirators (fit-tested within the last 12 months).
  • Fluid-resistant disposable isolation gowns (AAMI Level 3 or 4).
  • Nitrile examination gloves (double-gloving required for high-risk containment zones).
  • Face shields or ANSI-approved protective eye goggles.
• Decontamination Agents & Equipment:
  • EPA-registered hospital-grade disinfectants with verified efficacy against emerging viral pathogens and bacterial spores (List K / List N).
  • Ultraviolet-C (UVC) mobile sterilization units.
  • Autoclave validation strips and biological indicators (Geobacillus stearothermophilus).
• Software & Access Systems:
  • Enterprise Bio-Asset Tracking System (EBATS) for material logging.
  • Facility Environmental Monitoring Dashboard (v4.1+).
• Certifications:
  • OSHA Bloodborne Pathogen Standard Certification.
  • Annual Aseptic Technique and Bio-Waste Handling Competency.

4. Roles & Responsibilities (RACI Matrix Table)

Note: R = Responsible (does the work), A = Accountable (owns the final output), C = Consulted (provides input), I = Informed (kept updated).

5. Step-by-Step Operational Procedure

Phase 1: Pre-Operational Assessment & Gowning

• Verify facility differential pressure gauges indicate negative pressure relative to corridors in designated isolation zones.
• Inspect all PPE inventories to ensure integrity, correct sizing, and non-expired manufacturing lots.
• Perform mandatory hand hygiene using an alcohol-based hand rub (60–95% ethanol or isopropanol) for a minimum of 20 seconds.
• Don PPE in the prescribed sequence: (1) Isolation Gown, (2) N95/PAPR Respirator with seal check, (3) Eye Protection/Face Shield, (4) Examination Gloves (pulled over gown cuffs).

Phase 2: Active Containment & Environmental Disinfection

• Restrict zone access using physical barriers and biohazard warning signage immediately upon breach notification or routine cycle initiation.
• Apply EPA-registered disinfectant to high-touch environmental surfaces using a two-step clean-and-disinfect methodology.
• Maintain mandatory wet-contact dwell times as specified by the disinfectant manufacturer (typically 4 to 10 minutes depending on pathogen target).
• Execute continuous HEPA-filtration air exchange cycles (minimum 12 air changes per hour in critical zones).
• Log all chemical applications, surface wipings, and air-scrubbing metrics into the EBATS database.

Phase 3: Post-Operational Waste Management & Decontamination

• Segregate generated waste strictly into biomedical waste containers (red bags/sharps containers) at the point of origin.
• Seal biohazard bags using the goose-neck tie method when two-thirds full; verify exterior bag integrity and weight compliance.
• Transport sealed containers via dedicated, leak-proof utility carts to the on-site autoclave or incineration staging area.
• Doff PPE in the designated clean zone in the reverse sequence to avoid self-contamination: (1) Gloves, (2) Face Shield/Goggles, (3) Gown, (4) Respirator. Perform hand hygiene between intermediate steps.

6. Quality Assurance & Verification Criteria

• Audit Checklist:
  • Daily spot-checks of differential pressure logs.
  • Weekly ATP (Adenosine Triphosphate) bioluminescence surface swabbing (passing threshold: < 50 Relative Light Units per 10 cm²).
  • Monthly spore-test validation of all steam sterilization autoclaves.
• Tolerance Thresholds: Zero tolerance for breach of containment barriers in negative-pressure zones; 100% compliance on PPE donning sequencing during unannounced audits.
• Acceptance Benchmarks: Successful biological indicator destruction (zero colony growth of Geobacillus stearothermophilus post-cycle) and complete electronic chain-of-custody logging for 100% of generated bio-waste.

7. Practical Troubleshooting Scenarios

Scenario A: Negative Pressure Failure in Isolation Zone

• Trigger: Facility Environmental Monitoring Dashboard alerts that an isolation room/zone has shifted to neutral or positive pressure.
• Immediate Corrective Action Protocol:
  1. Cease all active sample transfers and high-risk aerosol-generating procedures immediately.
  2. Evacuate non-essential personnel from the compromised zone and secure perimeter doors.
  3. Contact Facilities Management instantly to isolate the HVAC VAV (Variable Air Volume) box and override to 100% exhaust mode.
  4. Deploy portable HEPA air-scrubbing units directly into the zone to establish immediate negative pressure mitigation.
  5. File an urgent incident report via the EBATS safety module within 1 hour of stabilization.

Scenario B: Disinfectant Dwell Time Non-Compliance / Surface Contamination Breach

• Trigger: Environmental audit reveals staff are wiping surfaces prior to meeting the manufacturer's mandatory 10-minute wet-contact time for spore eradication.
• Immediate Corrective Action Protocol:
  1. Halt ongoing cleaning activities in the affected sector.
  2. Re-apply the approved EPA-registered disinfectant to all prematurely dried surfaces to ensure a fresh, uninterrupted wet dwell time.
  3. Issue a mandatory on-the-spot corrective briefing to the EVS team regarding chemical contact physics and regulatory expectations.
  4. Perform secondary ATP testing on the re-treated surfaces after dwell time completion to verify biological cleanliness before re-clearing the zone for operational use.