General Hospital
Effective: ___/___/20__
Review: ___/___/20__
Approved By: _________
1.0 PURPOSE
1.1 Purpose Statement
- 1.1.1 To establish a single, comprehensive Operating Theatre infection prevention and environmental control system that reduces microbial contamination, prevents surgical site infections (SSI), and ensures a controlled, auditable environment across patient pathways, staff behaviors, room discipline, and cleaning/disinfection practices. (iris.who.int)
- 1.1.2 To standardize OT zones, attire, traffic discipline, hand hygiene/surgical scrub, aseptic technique (gowning/gloving/draping), sterile field maintenance, isolation workflows, cleaning/turnover processes, spill management, equipment decontamination, sterile supplies handling, CSSD interfaces, and linen management under one policy.
- 1.1.3 To ensure compliance with evidence-based international guidance for SSI prevention and infection prevention best practices (WHO/CDC) and engineering/environmental control principles relevant to operating rooms (ASHRAE/ASHE Standard 170 concepts such as pressure relationships and environmental control). (iris.who.int)
2.0 SCOPE
2.1 Included
- 2.1.1 All OT areas including unrestricted, semi-restricted, restricted zones, operating rooms, sterile core interfaces, scrub areas, storage areas, and OT corridors.
- 2.1.2 All surgical cases (elective/urgent/emergency), including isolation cases and high-risk procedures.
- 2.1.3 Environmental controls (traffic, doors, pressure relationships, temperature/humidity monitoring and logging where applicable), cleaning/disinfection, and workflow discipline.
- 2.1.4 CSSD interface requirements from point-of-use pre-cleaning through transport and loaner tray governance.
2.2 Excluded (Managed by Separate Policies)
- 2.2.1 Detailed antimicrobial stewardship and antibiotic prescribing protocols (covered in Pharmacy/AMS policy); OT verifies compliance with required documentation only.
- 2.2.2 Detailed engineering commissioning standards and mechanical system design calculations (covered in FMS/Engineering policy); OT defines operational expectations and monitoring interfaces.
3.0 DEFINITIONS
- 3.1 Unrestricted Zone: Area where street clothes may be permitted (e.g., public corridors outside OT suite, designated administrative zones).
- 3.2 Semi-Restricted Zone: Area where surgical attire is required; traffic controlled (e.g., clean corridors, sterile core access corridors).
- 3.3 Restricted Zone: Operating rooms and sterile field–critical areas; highest discipline; masks and head coverings required as per policy.
- 3.4 SSI (Surgical Site Infection): Infection related to an operative procedure occurring at/near the surgical incision within defined surveillance periods; preventable proportion is significant with evidence-based strategies. (CDC Stacks)
- 3.5 Aseptic Technique: Practices that prevent contamination of the sterile field and operative site.
- 3.6 Event-Related Sterility: Sterility of packaged items maintained until an event compromises package integrity rather than a fixed time alone (facility policy defines shelf life approach).
- 3.7 Contact Time: Minimum wet time required for a disinfectant to be effective; must follow product label requirements.
4.0 POLICY STATEMENT
- 4.1 The OT shall maintain a clean, dust-controlled environment with minimal storage and controlled activity, including monitored ventilation/pressure relationships as applicable to facility design and policy. (ASHRAE)
- 4.2 The OT shall implement a controlled zoning system and enforce attire, traffic, and door discipline to reduce microbial burden and airborne contamination risk. (Aorn.org)
- 4.3 The OT shall implement evidence-based SSI prevention practices across the intraoperative phase including hand hygiene, surgical scrub, skin antisepsis with alcohol-based agents where appropriate, sterile gowning/gloving, draping, and sterile field maintenance. (iris.who.int)
- 4.4 Cleaning and disinfection shall be performed between cases and at end-of-day/terminal intervals using approved agents, verified contact times, and documented sign-off, consistent with CDC environmental cleaning and disinfection guidance.
- 4.5 OT shall apply standard precautions for all patients and implement enhanced workflows for isolation cases, including PPE, route control, and environmental cleaning sign-off.
- 4.6 Sterile supplies, instruments, and linen shall be handled and transported using clean-to-dirty separation and controlled workflows, aligned with recognized sterile processing guidance and infection control principles. (The ANSI Blog)
- 4.7 Noncompliance is a patient safety risk. The OT shall monitor compliance through audits and corrective actions.
5.0 RESPONSIBILITIES
5.1 OT Director/Chair
- 5.1.1 Ensures enforcement of OT IPC standards and escalation of systemic failures (HVAC issues, repeated door discipline failure, cleaning noncompliance, sterile supply defects).
- 5.1.2 Chairs or delegates OT IPC review within OTMC/QPS.
5.2 OT Nurse Manager
- 5.2.1 Ensures training, competency validation, and daily supervision of IPC practices.
- 5.2.2 Ensures availability of supplies: PPE, hand hygiene products, scrub supplies, sterile drapes, spill kits, disinfectants, label/contact time guides.
5.3 IPC Lead / Infection Control Practitioner
- 5.3.1 Provides oversight, audits, outbreak advice, and liaison with OT leadership.
- 5.3.2 Supports SSI surveillance metrics and improvement projects (bundles).
5.4 OT Charge Nurse (Per Shift)
- 5.4.1 Enforces zoning, attire, traffic, and door discipline.
- 5.4.2 Ensures cleaning/turnover is completed and documented before next patient.
- 5.4.3 Ensures isolation workflows and PPE readiness.
5.5 Circulating Nurse
- 5.5.1 Ensures sterile field protection and contamination response.
- 5.5.2 Verifies skin prep completion and draping discipline.
- 5.5.3 Coordinates equipment cleaning between patients as per policy.
5.6 Scrub Nurse/Technologist
- 5.6.1 Maintains aseptic technique within the sterile field and participates in contamination response actions.
5.7 Housekeeping/Environmental Services (EVS)
- 5.7.1 Performs between-case cleaning and terminal cleaning using approved products and documented contact times.
5.8 CSSD
- 5.8.1 Ensures reprocessing meets standards, supports transport/loaner tray governance, and communicates defects/nonconformities. (The ANSI Blog)
5.9 Engineering/FMS
- 5.9.1 Maintains ventilation, pressure relationships, temperature/humidity performance, preventive maintenance logs, and responds to OT environmental alarms/events. (ASHRAE)
6.0 GENERAL ENVIRONMENTAL CONTROL REQUIREMENTS
6.1 Cleanliness and Storage Discipline
- 6.1.1 OT areas shall be kept clean, dust-controlled, and free of unnecessary storage.
- 6.1.2 Only essential items shall be kept in restricted areas; excess storage increases dust load and cleaning complexity.
6.2 Ventilation, Pressure, Temperature, and Humidity (Operational Expectations)
- 6.2.1 Operating rooms shall maintain appropriate pressure relationships (typically positive to adjacent spaces where required) per facility design standards and commissioning documentation; pressure relationships and tolerances should be defined and monitored by engineering/FMS. (ASHRAE)
- 6.2.2 Temperature and relative humidity shall be maintained within facility-approved ranges; the OT shall coordinate with engineering/FMS to log and respond to out-of-range events. (ASHRAE)
- 6.2.3 OT shall implement operational controls that protect airflow performance: minimize door opening, limit traffic, and avoid unnecessary movement during critical phases. (aornjournal.onlinelibrary.wiley.com)
6.3 Eating/Drinking/Personal Items Control
- 6.3.1 Eating, drinking, and smoking are prohibited in clinical OT zones except in designated areas; personal items are controlled to reduce contamination risk.
7.0 PROCEDURES — PART III / SEC 9
(Sections 9.1–9.17 are mandatory components of this single policy.)
9.1 OT ZONING (UNRESTRICTED / SEMI-RESTRICTED / RESTRICTED)
9.1.1 Objectives
- 9.1.1.1 To create a controlled gradient of microbial reduction from outer areas to sterile-critical zones.
- 9.1.1.2 To reduce airborne and contact contamination of sterile supplies and operative fields.
9.1.2 Zone Definitions and Access Rules
9.1.2.1 Unrestricted Zone
- a) Examples: outer corridors, reception outside OT suite, administrative areas.
- b) Attire: street clothes may be permitted; OT attire not required unless entering semi-restricted/restricted zones.
- c) Access: public and staff access controlled according to facility security policy.
9.1.2.2 Semi-Restricted Zone
- a) Examples: clean corridors within OT suite, sterile core access corridors, clean supply areas.
- b) Attire: scrub attire required; head covering as per facility policy; footwear policy enforced. (Aorn.org)
- c) Traffic: controlled; only authorized personnel.
9.1.2.3 Restricted Zone
- a) Examples: operating rooms, scrub areas adjacent to OR, sterile field–critical areas.
- b) Attire: scrub attire + head covering; mask required when open sterile supplies are present or per facility rule for restricted zones. (Aorn.org)
- c) Behavior: strict door discipline; minimal personnel; controlled conversation and movement.
9.1.3 Physical Controls and Signage
- 9.1.3.1 Zones shall be clearly marked with signage and floor plans.
- 9.1.3.2 Entry/exit routes shall be defined to support clean-to-dirty flow and prevent cross-contamination.
9.1.4 Monitoring
- 9.1.4.1 Charge nurse conducts daily zone compliance checks.
- 9.1.4.2 Monthly audits include traffic, attire compliance, and door discipline.
9.2 OT ATTIRE & DRESS CODE
9.2.1 Objectives
- 9.2.1.1 To reduce shedding of microorganisms and particles into the OT environment and sterile field.
- 9.2.1.2 To enforce consistent attire practices aligned with semi-restricted and restricted zone requirements. (Aorn.org)
9.2.2 Scrub Attire Standards
- 9.2.2.1 Scrub attire shall be worn in semi-restricted and restricted areas only; street clothes are not permitted beyond defined unrestricted zones.
- 9.2.2.2 Scrub attire shall be clean, facility-laundered where policy requires, and changed when visibly soiled or after contamination events.
- 9.2.2.3 Changing areas and routes shall be controlled so staff do not enter restricted zones without proper attire.
9.2.3 Head and Hair Covering
- 9.2.3.1 Hair/scalp shall be covered upon entry to semi-restricted and restricted areas; facial hair coverage rules follow facility policy. (Aorn.org)
- 9.2.3.2 If reusable head coverings are permitted, laundering frequency and method must be defined by the facility. (Aorn.org)
9.2.4 Masks and Eye Protection
- 9.2.4.1 Surgical masks shall be worn in restricted areas according to facility policy, especially when sterile supplies are open and during sterile procedures.
- 9.2.4.2 Eye/face protection shall be used when splash/spray risk exists (blood/body fluids).
9.2.5 Footwear
9.2.5.1 Footwear shall be dedicated or protected per policy; shoe covers used when required by facility rule and removed upon leaving restricted zones if policy mandates.
9.2.6 Personal Items
- 9.2.6.1 Jewelry, watches, and nonessential items are restricted in sterile-critical zones.
- 9.2.6.2 Mobile phone use is restricted; if permitted in specific areas, hand hygiene must be performed before and after handling devices.
9.2.7 Attire Noncompliance
9.2.7.1 Immediate correction required; repeated noncompliance escalated to OT manager and addressed through competency and HR processes.
9.3 TRAFFIC CONTROL / DOOR OPENING DISCIPLINE
(Expanded scientific explanatory text required.)
9.3.1 Objectives
- 9.3.1.1 To reduce airborne microbial contamination by controlling the primary drivers of particle disruption: movement, door opening, and personnel density.
- 9.3.1.2 To maintain positive pressure and designed airflow patterns that protect the sterile field, recognizing that frequent door openings disrupt pressure gradients and airflow stability. (ASHRAE)
9.3.2 Scientific Rationale
- 9.3.2.1 The operating room environment is designed to limit microbial load through controlled ventilation and airflow distribution. When doors open, pressure relationships may be disrupted, allowing movement of airborne particles and potentially microorganisms from adjacent zones into the OR. (ASHRAE)
- 9.3.2.2 Studies and perioperative literature describe frequent door openings as common and associated with increased contamination risk; therefore, traffic reduction is a recognized quality and safety target. (aornjournal.onlinelibrary.wiley.com)
9.3.3 Core Traffic Rules (Mandatory)
9.3.3.1 Keep OR Doors Closed
- a) OR doors shall remain closed except for necessary entry/exit and essential supply transfer.
- b) Doors must not be propped open.
- c) Door opening is minimized especially during: skin incision, implant insertion, wound closure, and sterile field setup.
9.3.3.2 Only Necessary Personnel
- a) Only essential staff are permitted in the OR.
- b) Nonessential observers are limited, approved, and supervised (see SEC 4 ethics/observers rules).
9.3.3.3 Define Entry/Exit Routes
- a) Staff shall use designated routes and entrances.
- b) Clean items enter via clean routes; soiled items exit via defined routes to prevent cross-traffic.
9.3.3.4 Supply Planning to Reduce Door Openings
- a) Case carts and supply staging shall be prepared before patient entry.
- b) Preference cards and procedure-specific packs should be used to minimize ad-hoc retrieval.
- c) “Runner” role (outside OR) should retrieve additional items when needed to reduce door opening frequency and crowding inside OR.
9.3.4 Door Opening Discipline (Operational Controls)
9.3.4.1 Door opening events shall be treated as controllable process steps, not casual behaviors.
9.3.4.2 Charge nurse establishes expected behaviors:
- a) knock before entry
- b) enter/exit quickly, close door fully
- c) avoid conversation at doorway
- d) avoid holding door open while waiting
9.3.5 High-Risk Period Controls (Enhanced)
9.3.5.1 During implant cases, orthopedic arthroplasty, and other high-risk SSI procedures, enhanced door discipline applies:
- a) restrict entry after Time-Out unless urgent
- b) designate runner outside OR
- c) pre-position all anticipated implant trays and sizes.
9.3.6 Communication and Culture
- 9.3.6.1 Door/traffic discipline is a team responsibility; leadership must support respectful reminders.
- 9.3.6.2 A simple script is approved: “Door closed for sterile safety.”
9.3.7 Monitoring and Auditing
- 9.3.7.1 OT shall conduct at least monthly audits of door openings/traffic.
- 9.3.7.2 Thresholds may be defined locally (e.g., door openings per hour); audit results must drive corrective actions and workflow redesign.
9.3.8 Corrective Actions
9.3.8.1 Recurrent door opening causes (missing supplies, unclear preference cards, equipment storage location) must be corrected by system redesign rather than repeated reminders alone.
9.4 HAND HYGIENE + SURGICAL HAND SCRUB
9.4.1 Objectives
- 9.4.1.1 To reduce transient flora and minimize transmission risk to patients and sterile supplies.
- 9.4.1.2 To standardize surgical hand antisepsis before donning sterile attire, aligned with WHO hand hygiene guidance. (www3.paho.org)
9.4.2 Hand Hygiene Indications in OT
9.4.2.1 Perform hand hygiene:
- a) on entering and leaving the OR
- b) before and after patient contact
- c) after contact with contaminated surfaces
- d) after glove removal
- e) before handling sterile supplies (if not scrubbed)
- f) after touching personal devices.
9.4.3 Alcohol-Based Hand Rub vs Soap and Water
- 9.4.3.1 Use alcohol-based hand rub (ABHR) for routine hand hygiene when hands are not visibly soiled. (www3.paho.org)
- 9.4.3.2 Use soap and water when hands are visibly soiled or after contact with spore-forming organisms as per IPC policy.
9.4.4 Surgical Hand Antisepsis (Scrub) — Standard
9.4.4.1 Scrub sinks must be maintained in good working order with adequate supplies.
9.4.4.2 Surgical scrub may be performed by:
- a) antimicrobial soap scrub (timed method) OR
- b) alcohol-based surgical hand rub with persistent activity, following manufacturer IFU and facility policy. (www3.paho.org)
9.4.5 Scrub Technique (Minimum Requirements)
- 9.4.5.1 Remove jewelry; nails short; no artificial nails.
- 9.4.5.2 Use approved nail cleaning method at first scrub of the day if facility policy requires.
- 9.4.5.3 Follow defined scrub duration/steps per product and policy; keep hands above elbows; avoid splashing.
- 9.4.5.4 Dry hands with sterile towel before gowning and gloving (for traditional scrub method).
9.4.6 Compliance Monitoring
9.4.6.1 Direct observation audits, with feedback and corrective actions.
9.5 STERILE GOWNING
9.5.1 Objectives
9.5.1.1 To create a sterile barrier between sterile field and the wearer’s clothing/skin.
9.5.2 Timing and Preconditions
- 9.5.2.1 Gowning occurs after surgical hand antisepsis and before gloving.
- 9.5.2.2 Sterile gown package integrity must be checked before opening.
9.5.3 Technique (Standard)
- 9.5.3.1 Open gown using aseptic method; avoid touching outside surfaces with nonsterile hands.
- 9.5.3.2 Don gown without contaminating outer surface; circulating nurse assists with back closure using nonsterile technique.
- 9.5.3.3 If contamination is suspected at any point: stop, remove, and re-gown.
9.5.4 Gown Removal
9.5.4.1 Remove gowns appropriately and dispose/contain before leaving restricted area when contaminated or at case end.
9.6 STERILE GLOVING
9.6.1 Objectives
9.6.1.1 To maintain sterile barrier for hands and prevent contamination of sterile field.
9.6.2 Technique (Standard)
- 9.6.2.1 Closed-glove technique is preferred after gowning.
- 9.6.2.2 Double gloving is recommended for high-risk procedures per local risk assessment; change outer gloves when contaminated or punctured.
9.6.3 Glove Integrity and Change
9.6.3.1 Change gloves:
- a) when puncture suspected
- b) after contact with nonsterile surfaces
- c) after handling contaminated items
- d) when moving from dirty to clean tasks within sterile field.
9.6.4 Glove Removal
9.6.4.1 Remove gloves before leaving restricted zones when contaminated and perform hand hygiene after glove removal.
9.7 SURGICAL SKIN ANTISEPSIS
9.7.1 Objectives
9.7.1.1 To reduce skin microbial load at operative site immediately before incision to reduce SSI risk.
9.7.2 Evidence-Based Expectations
9.7.2.1 CDC SSI guideline supports intraoperative skin preparation with an antiseptic containing alcohol unless contraindicated. (CDC Stacks)
9.7.3 Pre-Skin Prep Verification
- 9.7.3.1 Confirm correct site/side and marking verification per OT-IPSG policy.
- 9.7.3.2 Check for contraindications (allergy, mucous membrane exposure risk, ignition risk management with alcohol solutions).
9.7.4 Standard Skin Prep Procedure
- 9.7.4.1 Use approved antiseptic product per facility formulary and manufacturer IFU.
- 9.7.4.2 Apply from incision site outward using sterile technique; avoid retracing from dirty to clean.
- 9.7.4.3 Respect required contact time and allow complete drying before draping and before use of electrosurgical devices when alcohol-based prep used (fire risk control).
9.7.5 Special Situations
- 9.7.5.1 Pediatric/neonate skin sensitivity: use appropriate agent and technique per policy.
- 9.7.5.2 Hair removal: only when necessary; use clippers, not razors (if included in facility SSI bundle approach). (iris.who.int)
9.7.6 Documentation
9.7.6.1 Record agent, site, time applied, and confirmation of drying (as required).
9.8 DRAPING
9.8.1 Objectives
9.8.1.1 To isolate operative site from surrounding nonsterile areas and provide a sterile working field.
9.8.2 Principles
- 9.8.2.1 Drapes are handled only by scrubbed personnel.
- 9.8.2.2 Draping proceeds from incision site outward; avoid reaching over nonsterile areas.
- 9.8.2.3 Maintain drape integrity; secure to prevent slippage.
9.8.3 Specialty Draping Requirements
9.8.3.1 Implant cases may require specialized drapes; ensure correct packs are available before case start.
9.8.4 Drape Failure
9.8.4.1 If drape is contaminated or falls below sterile field: replace if possible; document and report per contamination response.
9.9 MAINTAINING STERILE FIELD & CONTAMINATION RESPONSE
9.9.1 Objectives
9.9.1.1 To maintain a sterile field throughout the procedure and respond decisively to contamination to protect the patient.
9.9.2 Core Sterile Field Rules
9.9.2.1 Sterile items remain sterile only when:
- a) within the sterile field boundaries
- b) continuously observed
- c) protected from moisture compromise
- d) not touched by nonsterile surfaces/personnel.
9.9.2.2 Movement discipline:
- a) sterile personnel remain within sterile zone; nonsterile personnel maintain distance from sterile field
- b) passing: sterile-to-sterile and nonsterile-to-nonsterile only.
9.9.3 Contamination Definitions (Operational)
- 9.9.3.1 Major contamination: sterile instrument dropped, nonsterile contact with wound/sterile instruments, wet pack/compromised packaging, unknown sterility.
- 9.9.3.2 Minor contamination: contamination limited to noncritical area with immediate correction possible (as defined by risk assessment).
9.9.4 Contamination Response Algorithm (Mandatory)
- 9.9.4.1 Stop the action immediately.
- 9.9.4.2 Announce contamination clearly.
- 9.9.4.3 Remove contaminated item from sterile field.
- 9.9.4.4 Replace with sterile item (new instrument, new drape, re-glove, re-gown as needed).
- 9.9.4.5 Assess whether wound contamination occurred; surgeon/IPC notified as appropriate.
- 9.9.4.6 Document event and report if significant or repeated.
9.9.5 Wet Packs / Compromised Packaging
9.9.5.1 Considered nonsterile; do not use; segregate and return to CSSD with documentation; investigate per CSSD policy.
9.9.6 Sterile Field Monitoring
9.9.6.1 Circulating nurse monitors traffic, door discipline, and behaviors threatening sterile field.
9.10 ISOLATION CASE WORKFLOW (PPE, ROUTES, CLEANING SIGN-OFF)
9.10.1 Objectives
9.10.1.1 To prevent transmission of pathogens during operative care and protect patients and staff using standard and transmission-based precautions.
9.10.2 Pre-Case Planning
- 9.10.2.1 Identify isolation type (contact/droplet/airborne) before patient transfer.
- 9.10.2.2 Assign designated OR if facility policy requires; minimize equipment brought into room.
- 9.10.2.3 Prepare PPE station and waste disposal plan.
9.10.3 Patient Routing
- 9.10.3.1 Use predetermined route to minimize exposure to other patients/areas.
- 9.10.3.2 Limit corridor time; keep doors closed.
9.10.4 PPE Rules
9.10.4.1 PPE per IPC policy and risk assessment; don/doff in correct sequence; hand hygiene performed at each step.
9.10.5 Equipment Controls
- 9.10.5.1 Use disposable items where appropriate.
- 9.10.5.2 Reusable equipment must be cleaned/disinfected according to IFU and policy before leaving room.
9.10.6 Post-Case Environmental Cleaning and Sign-Off
- 9.10.6.1 Perform enhanced cleaning/terminal cleaning as required by pathogen and policy.
- 9.10.6.2 Cleaning sign-off required before next case.
9.10.7 Documentation
9.10.7.1 Isolation checklist completed and retained as record.
9.11 BETWEEN-CASE CLEANING & TURNOVER (ROLES, AGENTS, CONTACT TIME)
9.11.1 Objectives
- 9.11.1.1 To remove bioburden and reduce cross-contamination between patients.
- 9.11.1.2 To standardize EVS/OT responsibilities and ensure disinfectant contact time compliance.
9.11.2 Role Allocation
- 9.11.2.1 EVS: floors, environmental surfaces, high-touch areas, waste removal, terminal routines per checklist.
- 9.11.2.2 OT staff: immediate removal of sharps, containment of instruments for CSSD, wiping of anesthesia/OT equipment per assigned responsibilities (as defined by local split).
9.11.3 Between-Case Cleaning Steps (Minimum)
- 9.11.3.1 Remove waste and soiled linen in closed bags.
- 9.11.3.2 Clean and disinfect high-touch surfaces: OR table surfaces, light handles (if touched), door handles, touch screens, carts, stools, cords where appropriate.
- 9.11.3.3 Use approved disinfectant and ensure required wet contact time per label.
- 9.11.3.4 Spot-clean visible soil before disinfection.
9.11.4 Turnover Sequencing
9.11.4.1 Clean from cleaner areas to dirtier areas; high-touch surfaces prioritized.
9.11.5 Documentation
9.11.5.1 Between-case cleaning checklist signed by EVS and verified by charge nurse/circulating nurse.
9.12 END-OF-DAY / TERMINAL CLEANING
9.12.1 Objectives
9.12.1.1 To reduce environmental reservoir contamination after daily activities, addressing surfaces not fully cleaned during turnover.
9.12.2 Terminal Cleaning Standards
9.12.2.1 Follow CDC environmental cleaning procedures and local terminal cleaning protocol; ensure thorough cleaning of:
- a) OR table base and wheels
- b) anesthesia work areas (as assigned)
- c) monitors/cables (per IFU)
- d) lights, booms, walls where indicated
- e) floors (wet clean) and corners.
9.12.3 Contact Time Compliance
9.12.3.1 Must follow disinfectant label instructions; document product used and completion time.
9.12.4 Terminal Cleaning Sign-Off
9.12.4.1 Required sign-off by EVS and verification by OT supervisor.
9.13 BLOOD/BODY FLUID SPILL MANAGEMENT
9.13.1 Objectives
9.13.1.1 To prevent exposure and environmental contamination from blood/body fluids and ensure safe decontamination.
9.13.2 Spill Kit Availability
9.13.2.1 Spill kits must be available in OT areas and checked daily.
9.13.3 Immediate Actions
- 9.13.3.1 Restrict access to spill area.
- 9.13.3.2 Don appropriate PPE.
- 9.13.3.3 Absorb and remove visible material first, then disinfect using approved product per contact time.
9.13.4 Sharps Safety
9.13.4.1 Do not pick up sharps with hands; use tools; dispose in sharps container.
9.13.5 Documentation
9.13.5.1 Significant spills and exposures reported via incident system; repeated spills trigger process review.
9.14 EQUIPMENT CLEANING BETWEEN PATIENTS
9.14.1 Objectives
9.14.1.1 To prevent transmission via shared devices (monitors, cables, pumps, tourniquet systems, positioning aids).
9.14.2 Classification and IFU
9.14.2.1 Follow device IFU and disinfection/sterilization guidance for noncritical surfaces; CDC provides recommendations for disinfection of noncritical surfaces and equipment.
9.14.3 Minimum Standards
9.14.3.1 Clean and disinfect:
- a) monitor controls and touch screens
- b) cables and probes (per IFU)
- c) infusion pumps surfaces
- d) suction handles and canisters (as applicable)
- e) positioning devices and straps.
9.14.4 Accountability
9.14.4.1 Each OR shall have an equipment cleaning responsibility matrix signed by OT and EVS leadership.
9.14.5 Documentation
9.14.5.1 Equipment cleaning checklist completed between cases for defined items.
9.15 STERILE SUPPLIES HANDLING, STORAGE, EVENT-RELATED STERILITY
9.15.1 Objectives
9.15.1.1 To ensure sterile supplies remain sterile until point of use and are protected from events that compromise packaging.
9.15.2 Receiving and Storage
9.15.2.1 Store sterile supplies in clean, dry, temperature-controlled areas; protect from dust, moisture, crushing, and overhandling.
9.15.3 Handling Rules
9.15.3.1 Inspect packaging integrity before bringing into OR:
- a) no tears/punctures
- b) seals intact
- c) no moisture/wet packs
- d) indicators appropriate.
9.15.3.2 Do not use compromised packages; return to CSSD with documentation.
9.15.4 Event-Related Sterility Approach
9.15.4.1 Sterility is considered maintained unless an event compromises packaging or storage integrity; facility policy defines shelf life and audit method; sterile processing standards discuss sterility assurance and handling controls.
9.15.5 Expiry Management
- 9.15.5.1 Check expiration dates and rotate stock (FIFO/FEFO).
- 9.15.5.2 Expired items removed immediately and documented.
9.16 CSSD INTERFACE: POINT-OF-USE PRE-CLEANING, TRANSPORT, LOANER TRAYS GOVERNANCE
9.16.1 Objectives
9.16.1.1 To ensure instruments are protected from drying bioburden, transported safely, and reprocessed reliably with traceable documentation.
9.16.2 Point-of-Use Pre-Cleaning (Immediate Post-Use)
- 9.16.2.1 Remove gross soil promptly; keep instruments moist per policy (e.g., damp towel or approved enzymatic spray if permitted by IFU).
- 9.16.2.2 Segregate delicate instruments and sharps; protect tips.
- 9.16.2.3 Do not soak powered instruments unless IFU permits.
9.16.3 Safe Transport
- 9.16.3.1 Use closed, leak-proof, labeled transport containers/carts.
- 9.16.3.2 Maintain clean-to-dirty separation routes.
- 9.16.3.3 Transport promptly to CSSD decontamination area; do not store soiled instruments in clean corridors.
9.16.4 Loaner Trays / Vendor Sets Governance
- 9.16.4.1 Loaner sets must arrive within defined time window before surgery to allow complete reprocessing and inspection.
- 9.16.4.2 Documentation must include: tray list, delivery time, CSSD receipt time, release time, and missing/damaged item log.
- 9.16.4.3 Any late delivery jeopardizing safe reprocessing triggers escalation and potential case delay/cancellation under OT flow policy.
9.16.5 Sterilization Failure and Nonconformities
9.16.5.1 If sterility indicators fail or wet packs occur, follow CSSD failure investigation process aligned with sterile processing guidance.
9.17 LINEN HANDLING & CLEAN/DIRTY SEPARATION
9.17.1 Objectives
9.17.1.1 To prevent spread of contamination via textiles and ensure safe handling and transport.
9.17.2 Handling Rules
- 9.17.2.1 Handle soiled linen as contaminated; avoid shaking.
- 9.17.2.2 Place into designated bags at point of use; close before transport.
- 9.17.2.3 Separate clean and soiled linen storage and routes; do not store in corridors or mixed areas.
- 9.17.2.4 Follow facility laundry process consistent with environmental infection control guidance.
9.17.3 Linen in Isolation Cases
9.17.3.1 Use appropriate bagging and labeling per IPC policy; transport using defined route.
8.0 TRAINING AND COMPETENCY
8.1 All OT staff must complete orientation and annual refreshers on:
- 8.1.1 zoning and attire requirements
- 8.1.2 traffic/door discipline and its impact on environment
- 8.1.3 WHO hand hygiene and surgical scrub technique
- 8.1.4 sterile gowning/gloving, draping, sterile field maintenance
- 8.1.5 isolation workflows and PPE practice
- 8.1.6 cleaning/turnover/terminal cleaning with correct contact time
- 8.1.7 CSSD interface and instrument transport safety
8.2 Competency validation includes direct observation checklists (Appendices).
9.0 MONITORING, AUDIT, AND KPI REQUIREMENTS
9.1 Audit Program (Minimum Monthly Audits)
- 9.1.1 Zone compliance and attire compliance.
- 9.1.2 Door opening and traffic discipline (count per hour, reasons).
- 9.1.3 Hand hygiene and scrub compliance (observation).
- 9.1.4 Skin antisepsis compliance (agent, drying time documentation) aligned with CDC/WHO guidance.
- 9.1.5 Cleaning/terminal cleaning completion and contact time compliance.
- 9.1.6 Sterile supplies integrity defects and wet pack rate.
- 9.1.7 CSSD interface: tray completeness defects, loaner tray timing compliance.
9.2 KPIs (Minimum Set)
- 9.2.1 SSI bundle compliance (selected measures as per hospital program).
- 9.2.2 Door openings per hour (trend, high-risk cases).
- 9.2.3 Hand hygiene compliance rate.
- 9.2.4 Between-case cleaning compliance and contact time compliance.
- 9.2.5 Wet pack/pack integrity failure rate and corrective actions.
10.0 NONCOMPLIANCE AND ESCALATION
10.1 Critical noncompliance includes:
- 10.1.1 entering restricted zones without required attire
- 10.1.2 propping OR doors open or repeated unnecessary door opening
- 10.1.3 failure to perform hand hygiene/surgical scrub per policy
- 10.1.4 proceeding with compromised sterile supplies (wet pack/torn wrapper)
- 10.1.5 initiating next case without documented between-case cleaning completion
10.2 Critical noncompliance triggers immediate correction, documentation, and escalation to OT manager and IPC.
11.0 REFERENCES (ENGLISH)
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11.1 WHO Global guidelines for the prevention of surgical site infection (2018 edition).
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11.2 CDC Guideline for the Prevention of Surgical Site Infection, 2017 (JAMA Surgery PDF / CDC stacks).
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11.3 WHO Guidelines on Hand Hygiene in Health Care (2009).
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11.4 ASHRAE/ASHE Standard 170 addenda (ventilation expectations and operational considerations).
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11.5 CDC Environmental Cleaning Procedures (terminal cleaning order and principles).
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11.6 CDC Summary recommendations for disinfection and sterilization (disinfectant label and contact time).
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11.7 CDC/HICPAC Guidelines for environmental infection control in healthcare facilities (laundry/textiles and environmental control).
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11.8 ANSI/AAMI ST79 Resources and summaries for steam sterilization and sterility assurance principles (sterile processing interface).
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11.9 AORN Surgical attire guidance (semi-restricted/restricted area practices).