General Hospital
Effective: ___/___/20__
Review: ___/___/20__
Approved By: (Medical Director)
1.0 PURPOSE
1.1 Purpose Statement
1.1.1 This policy establishes the Operating Theatre (OT) system that ensures the correct patient, the correct procedure, and the correct site/side are verified reliably before surgery or any invasive procedure begins, and that the process remains reliable through critical transitions (arrival, room entry, incision, and exit).
1.1.2 This policy standardizes:
- a) patient identification using two approved identifiers and prohibits unsafe identifiers (e.g., room/bed number).
- b) verification of informed consent documentation (surgery and additional consents when required, e.g., blood transfusion, implants/prostheses) as a verification step supporting patient rights and safe surgery governance.
- c) verification of site marking and management of approved exceptions using internationally recognized correct-site surgery processes.
- d) governance and reliable use of the WHO Surgical Safety Checklist (Sign-In / Time-Out / Sign-Out) as the OT’s standard safe surgery process.
- e) discrepancy handling and Stop-the-Line escalation for any mismatch or uncertainty.
- f) structured communication of critical information (allergies, isolation status, implants, key risks) and use of interpreter/communication support when needed to protect patient understanding and safety.
2.0 SCOPE
2.1 In Scope
- 2.1.1 This policy applies to all surgical and invasive procedures conducted in the Operating Theatre Department and any procedure room under OT governance.
- 2.1.2 This policy applies across the OT pathway, including:
- a) pre-OT arrival verification at OT reception/holding (OT side)
- b) entry into the operating room
- c) pre-induction/pre-procedure phase (Sign-In)
- d) immediately before incision/start (Time-Out)
- e) before the patient leaves the operating room (Sign-Out)
- 2.1.3 This policy applies to all patients: adult, pediatric, obstetric, elective, urgent, and emergency cases.
2.2 Out of Scope (Managed Elsewhere)
- 2.2.1 Clinical anesthesia management (sedation governance, anesthesia monitoring protocols, anesthesia machine checks) is managed under the Anesthesia Department manual.
- 2.2.2 Medical decision-making regarding whether surgery is clinically appropriate remains the responsibility of the treating physicians. OT responsibilities under this policy are verification, documentation readiness checks, communication, and escalation.
3.0 DEFINITIONS
3.1 Two Approved Patient Identifiers
3.1.1 Two approved identifiers are used to verify a patient’s identity. Examples include:
- a) Full name + medical record number (MRN)/unique patient ID
- b) Full name + date of birth
- c) MRN/unique patient ID + date of birth (where appropriate)
3.1.2 Prohibited identifiers include: room number, bed number, physical location, or any non-unique descriptor.
3.2 Verification
3.2.1 Verification is a structured process that confirms, using reliable sources of truth, the correct patient/procedure/site and required prerequisites before proceeding.
3.3 Site Marking
3.3.1 Site marking is an unambiguous visible mark placed on the intended operative site/side for procedures where wrong-site risk exists, with defined exceptions and alternative controls.
3.4 Informed Consent
3.4.1 Informed consent is a documented process and authorization based on the patient’s (or legal representative’s) understanding and agreement, consistent with Saudi MOH guidance.
3.5 WHO Surgical Safety Checklist
3.5.1 The WHO checklist is a three-phase tool:
- a) Sign-In (before induction/before start)
- b) Time-Out (before incision/before start)
- c) Sign-Out (before leaving OR)
3.6 Stop-the-Line
3.6.1 Stop-the-Line is an immediate pause of workflow triggered by uncertainty, mismatch, missing required documentation, or safety concern, continuing until resolved or escalated to appropriate authority.
4.0 POLICY STATEMENT
- 4.1 The OT shall identify each patient using two approved identifiers at defined critical points of care and shall not use room/bed number as an identifier.
- 4.2 The OT shall verify that required consent documentation is present, valid, complete, and consistent with the planned procedure/site/side before proceeding to incision, except under approved emergency exceptions consistent with Saudi MOH informed consent guidance and hospital emergency policy.
- 4.3 The OT shall verify site marking (including approved exceptions) for cases requiring marking and shall not proceed to incision when marking requirements are not met or when uncertainty remains.
- 4.4 The OT shall implement, govern, document, and audit the WHO Surgical Safety Checklist (Sign-In/Time-Out/Sign-Out) as the standard OT safe surgery process, with meaningful team participation and required verbal confirmations.
- 4.5 Any discrepancy or uncertainty related to identity, procedure, site/side, consent, or critical information shall trigger Stop-the-Line escalation and shall be documented and reported according to OT quality and patient safety processes.
- 4.6 The OT shall ensure critical information (allergies, isolation status, implants, key risks) is reliably communicated and visible at the time of Sign-In and Time-Out, and shall ensure interpreter/communication support is used when language barriers could affect safe identification or consent validity.
5.0 PRINCIPLES AND SAFETY RULES
- 5.1 Two-Source Truth: OT shall treat the wristband plus the authoritative record (EHR/paper chart) as the primary identity sources; verbal confirmation is an additional check when the patient is able to participate.
- 5.2 No “Assumption Culture”: “We know the patient” is not an acceptable justification to skip identification steps.
- 5.3 Standard Words: Procedure name and site/side shall be stated using standard terminology (no nicknames or abbreviations that could create confusion).
- 5.4 Active Participation: Checklist steps are not “tick-box”; they require verbal confirmation and team attention.
- 5.5 Stop-the-Line: Any team member has the authority and obligation to request a pause if they identify a mismatch or cannot confirm the required elements.
- 5.6 Equivalence for Exceptions: When a standard safety step is not possible (e.g., marking exception), an alternative control must be used that provides an equivalent safety function and must be documented.
6.0 ROLES AND RESPONSIBILITIES
6.1 OT Director/Chair
- 6.1.1 Ensures implementation, resource support, and governance for this policy.
- 6.1.2 Ensures persistent issues (noncompliance, repeated discrepancies, poor checklist engagement) are escalated to OTMC/hospital QPS as required.
6.2 OT Nurse Manager
- 6.2.1 Ensures training, competency validation, audit program execution, and corrective actions.
- 6.2.2 Ensures availability of tools: wristbands, printers/labels, approved marking pens, checklists, interpreter access processes.
6.3 OT Charge Nurse
- 6.3.1 Ensures daily operational compliance and supports Stop-the-Line escalation.
- 6.3.2 Coordinates rapid resolution of documentation and readiness issues and escalates unresolved conflicts.
6.4 Circulating Nurse
- 6.4.1 Leads verification within the OR and leads checklist execution and documentation.
- 6.4.2 Confirms critical information is communicated and visible (allergy alerts, isolation precautions, implant readiness).
6.5 Scrub Nurse/Technologist
- 6.5.1 Participates in Time-Out and Sign-Out confirmations (procedure name, count completion status, specimen labeling read-back).
6.6 Surgeon/Proceduralist
- 6.6.1 Ensures correct procedure and site/side are confirmed during Time-Out and that site marking is completed according to policy.
- 6.6.2 Ensures the planned procedure matches consent and documentation.
6.7 Sending Team (Ward/Clinic/ED)
- 6.7.1 Ensures wristband is applied and legible, and documentation accompanies the patient or is accessible.
- 6.7.2 Provides accurate handover, including allergies and isolation status.
6.8 Interpreter/Communication Support Services
- 6.8.1 Provides qualified interpretation support when needed for safe identification confirmation and consent validity, per organizational process. (jointcommission.org)
7.0 PROCEDURES (SEC 6.1 – 6.7)
7.1 PATIENT IDENTIFICATION (TWO IDENTIFIERS)
7.1.1 Approved Identifiers and Prohibited Practices
7.1.1.1 The OT shall use at least two approved identifiers and shall not use room/bed number as an identifier.
7.1.1.2 Staff shall not “pre-identify” a patient based on appearance, location, staff familiarity, or scheduled list position.
7.1.1.3 When the patient is conscious and able to participate, staff should ask the patient to state (not confirm by “yes/no” only):
- a) full name
- b) date of birth (or MRN, as appropriate)
This reduces confirmation bias and improves accuracy.
7.1.2 Mandatory Identification Points (Process Map)
7.1.2.1 Point 1 — OT Reception/Holding Acceptance
- a) OT receiving nurse verifies two identifiers on wristband against the authoritative record and OT list.
- b) Any wristband illegibility or mismatch triggers hold and escalation.
7.1.2.2 Point 2 — Before Entry to the Operating Room
- a) Circulating nurse verifies two identifiers and confirms procedure/site/side match the record.
- b) The patient shall not enter the OR until identity verification is completed (except true emergencies under emergency ID process).
7.1.2.3 Point 3 — WHO Sign-In
- a) Identity is verbally confirmed and documented before induction/procedure start.
7.1.2.4 Point 4 — WHO Time-Out
- a) Identity is reconfirmed with full team presence immediately before incision/start.
7.1.2.5 Point 5 — Specimen/Implant Documentation
- a) Patient identifiers are verified on specimen labels and implant traceability records; no unlabeled specimen containers are permitted.
7.1.2.6 Point 6 — OR Exit / Transfer Handover
- a) Patient identification is confirmed during transfer handover (OT to recovery/ward) to prevent downstream identity errors.
7.1.3 Special Situations and Controls
7.1.3.1 Unknown/Unidentified Emergency Patient
- a) Apply the hospital emergency identification process (temporary unique ID) immediately.
- b) Use two identifiers from the temporary system (e.g., temporary ID + DOB estimate or barcode + temporary name) as defined locally.
- c) Reconcile temporary to permanent identifiers as soon as identity is confirmed.
7.1.3.2 Pediatrics/Neonates
- a) Verify identifiers with guardian and wristband.
- b) Where mother-baby band systems exist, verify both according to hospital policy.
7.1.3.3 Same Name / Similar Name Risks
- a) Apply “Same Name Alert” flags (chart alert, wristband marker, OT list warning) and require heightened vigilance.
- b) Require the team to verbalize both identifiers during Sign-In and Time-Out.
7.1.3.4 Communication Barrier
- a) Use interpreter/communication support when language barriers may compromise identity confirmation (see 7.7).
7.1.4 Identification Failure Handling
7.1.4.1 If any staff member cannot confirm identity with two identifiers:
- a) Stop immediately (no OR entry, no induction, no incision).
- b) Inform charge nurse.
- c) Verify using authoritative record and wristband; replace wristband if illegible.
- d) Document the discrepancy and resolution; report as near-miss/hazard as applicable.
7.2 INFORMED CONSENT VERIFICATION (SURGERY, BLOOD, IMPLANTS — VERIFICATION STEP)
7.2.1 General Consent Verification Standard
7.2.1.1 OT verification confirms: presence, completeness, validity, and match (patient/procedure/site/side) of consent documentation.
7.2.1.2 OT verification does not replace the clinician’s responsibility to obtain informed consent, but OT shall not allow surgery to proceed when required consent documentation is missing, incomplete, or inconsistent (except approved emergency exception).
7.2.2 Consent Types Included in OT Verification
7.2.2.1 Surgical/Procedure Consent
- a) Confirm the procedure name is written clearly and matches the scheduled procedure.
- b) Confirm site/side/laterality is specified when applicable.
- c) Confirm patient identifiers match wristband and record.
- d) Confirm signatures and dates meet hospital requirements.
7.2.2.2 Blood Transfusion Consent (When Required by Hospital Policy)
- a) Confirm presence if blood transfusion is planned/anticipated and consent is required.
- b) Confirm identifiers match.
- c) Confirm that blood product requests in the record align with the planned procedure (OT coordination interface; not clinical prescribing).
7.2.2.3 Implants/Prostheses Consent (When Required)
- a) Confirm consent includes implant/prosthesis authorization when required by local policy.
- b) Confirm implant intent matches the surgical plan.
7.2.3 Consent Verification Checkpoints
7.2.3.1 Checkpoint A — Pre-List/Day-Before Verification (Elective)
- a) OT coordinator/charge nurse checks consent completeness during list readiness review.
- b) Any missing consent is escalated to the surgical service before day of surgery.
7.2.3.2 Checkpoint B — Arrival to OT Holding
- a) Circulating nurse confirms consent presence and match.
- b) If patient questions or refuses, stop and contact responsible clinician for discussion; document outcome.
7.2.3.3 Checkpoint C — Sign-In
- a) Consent presence and match are verbally confirmed and documented.
7.2.4 Consent Quality Checks (Common Failure Modes)
7.2.4.1 OT staff shall actively screen for common consent vulnerabilities:
- a) Wrong patient identifiers on consent
- b) Procedure written as a vague term (“operation,” “surgery”) without specifics
- c) Laterality missing for a laterality-sensitive procedure
- d) Consent signed but not dated/time-stamped (if required)
- e) Consent present but does not match updated surgical plan
7.2.4.2 Any such vulnerability triggers Stop-the-Line until corrected (see 7.5).
7.2.5 Emergency Consent Exceptions
7.2.5.1 In true life-saving emergencies where consent cannot be obtained in time, the team follows hospital emergency consent policy consistent with Saudi MOH principles and documents:
- a) reason consent could not be obtained
- b) decision authority
- c) steps taken to contact family/guardian when possible
- d) post-event documentation completion requirements
7.2.6 Consent and Interpreter Use
7.2.6.1 When language barriers exist, interpreter support must be used to support consent validity and patient understanding per organizational process.
7.2.6.2 Interpreter involvement must be documented (see 7.7).
7.3 SITE MARKING VERIFICATION (INCLUDING EXCEPTIONS)
7.3.1 Cases Requiring Site Marking
7.3.1.1 Site marking is required when wrong-site risk exists, including laterality, multiple sites, multiple levels, or multiple lesions.
7.3.2 Authorized Marking and Accountability
7.3.2.1 The surgeon/proceduralist is accountable for correct site marking completion according to hospital rules.
7.3.2.2 If delegation is permitted, delegation must follow hospital authorization rules and be documented; accountability remains with surgeon.
7.3.3 Marking Standard (Visibility and Clarity)
7.3.3.1 The mark must be:
- a) unambiguous (defined symbol/initials per hospital rule)
- b) indelible
- c) placed as near as possible to the incision site
- d) visible after skin preparation and draping, or verified and re-verified immediately before draping when visibility after prep is not feasible
7.3.3.2 The mark must not be placed on removable items (dressings) or locations likely to be covered without verification plan.
7.3.4 Verification Timing
7.3.4.1 Site mark is verified:
- a) before OR entry (OT receiving/circulating nurse)
- b) during Time-Out with the full team
7.3.5 Exceptions and Equivalent Alternative Controls
7.3.5.1 Any exception must be predefined in hospital policy and must include an alternative control that achieves the same safety function, consistent with correct-site surgery guidance.
7.3.5.2 Common exception categories (must be locally approved):
- a) midline single-site procedures without laterality relevance
- b) internal organ procedures where external marking is not meaningful
- c) neonates/premature skin fragility (use alternative verification)
- d) cases where the surgical site remains continuously visible and can be confirmed through imaging/documented verification steps
7.3.5.3 For each exception:
- a) document the reason and alternative method
- b) require enhanced Time-Out confirmation focusing on anatomy and planned approach
- c) include imaging confirmation when relevant
7.3.6 Site Marking Discrepancy Handling
7.3.6.1 Missing/unclear mark when required is a Stop-the-Line condition (see 7.5).
7.4 SAFE SURGERY PROCESS: SIGN-IN / TIME-OUT / SIGN-OUT (WHO CHECKLIST GOVERNANCE)
7.4.1 Checklist Governance Structure
7.4.1.1 The WHO Surgical Safety Checklist is adopted as the OT’s standard safe surgery checklist and may be adapted locally while retaining safety intent, consistent with WHO guidance that adaptations are encouraged to fit local practice.
7.4.1.2 Governance responsibilities include:
- a) maintaining an approved checklist version under document control
- b) defining who leads each phase
- c) defining mandatory verbal read-back items
- d) training and competency validation for checklist leadership
- e) auditing compliance and meaningful participation
- f) corrective action for noncompliance (process fixes and escalation) (ncbi.nlm.nih.gov)
7.4.2 Checklist Leadership and Participation Rules
7.4.2.1 The circulating nurse is the default checklist coordinator unless the hospital designates another role.
7.4.2.2 Participation is mandatory for: surgeon/proceduralist, anesthesia provider (if present), circulating nurse, scrub nurse/technologist.
7.4.2.3 During Time-Out:
- a) all noncritical activity pauses
- b) team faces the checklist leader where feasible
- c) distractions (phone calls, equipment setup) are paused unless life-critical
7.4.3 SIGN-IN (Before Induction / Before Procedure Start)
7.4.3.1 Objective: confirm patient identity, procedure/site, consent, marking, and readiness before induction/procedure start.
7.4.3.2 Mandatory Sign-In Verification Items (Minimum):
- a) confirm two identifiers
- b) confirm procedure name and site/side
- c) verify consent present and matches
- d) verify site mark present when required (or exception documented)
- e) confirm allergies and critical alerts
- f) confirm isolation status and precautions if applicable
- g) confirm essential imaging available if required
- h) confirm implants/special equipment availability for relevant cases
7.4.3.3 Sign-In Documentation Standard:
- a) time performed
- b) name/role of checklist leader
- c) “pass/hold” result
- d) issues identified and resolution steps
7.4.3.4 Sign-In Failure Rules:
- a) any mismatch triggers Stop-the-Line
- b) unresolved issues must not be deferred (“we will fix later”)
7.4.4 TIME-OUT (Before Skin Incision / Before Procedure Start)
7.4.4.1 Objective: final team confirmation of correct patient/procedure/site and shared understanding of critical risks immediately before incision/start.
7.4.4.2 Timing: immediately before incision or procedural start, with full team presence and attention.
7.4.4.3 Minimum Time-Out Script Elements (Verbal Confirmation):
- a) “This is [Patient Name] / [MRN or DOB]” (two identifiers)
- b) “Procedure planned: [standard procedure name]”
- c) “Site/side: [left/right/level] — site mark visible / exception documented”
- d) “Allergies: [state allergy or ‘none known’ as documented]”
- e) “Isolation status: [none / contact / droplet / airborne]”
- f) “Implant required: [yes/no; correct implant and size available]” (when applicable)
- g) “Essential imaging displayed: [yes/no/NA]”
- h) “Any team concerns?” (mandatory invitation for speaking up)
7.4.4.4 Time-Out Read-Back Discipline:
- a) scrub and circulating confirm agreement
- b) surgeon confirms site/side and procedure clearly
- c) any disagreement triggers immediate pause and resolution
7.4.4.5 Time-Out Failure Rules:
- a) if the team cannot state the same procedure/site/side, the case must not proceed
- b) if mark is absent when required, the case must not proceed
- c) if consent mismatch exists, the case must not proceed
7.4.5 SIGN-OUT (Before Patient Leaves Operating Room)
7.4.5.1 Objective: ensure counts, specimen labeling, documentation, and key recovery issues are reliably addressed before transfer out of the OR.
7.4.5.2 Mandatory Sign-Out Items (Minimum):
- a) confirm procedure performed (as recorded)
- b) confirm instrument/sponge/needle counts complete
- c) specimen labeling read-back: labels read aloud including patient name/identifiers
- d) implant documentation completed when applicable (stickers/serial/lot)
- e) any equipment problems to be addressed (report/biomed ticket)
- f) key concerns for recovery/ongoing care (as communicated by surgeon/anesthesia/nurse)
7.4.5.3 Sign-Out Failure Rules:
- a) unresolved count discrepancy = Stop-the-Line (patient remains in OR until resolved according to counts policy)
- b) specimen labeling uncertainty = Stop-the-Line (no specimen leaves OR until resolved)
7.4.6 Local Checklist Adaptation Control
7.4.6.1 Any local additions must be approved by OT leadership/QPS, version controlled, and trained. (ncbi.nlm.nih.gov)
7.4.6.2 Adaptations must not remove core safety items without equivalent alternative controls.
7.5 DISCREPANCY HANDLING & STOP-THE-LINE ESCALATION
7.5.1 Discrepancy Categories
- 7.5.1.1 Identity discrepancy (wristband vs record vs list mismatch)
- 7.5.1.2 Procedure discrepancy (procedure differs among documents or team understanding)
- 7.5.1.3 Site/side discrepancy (laterality conflict, missing mark, mark not visible or unclear)
- 7.5.1.4 Consent discrepancy (missing/invalid/inconsistent consent)
- 7.5.1.5 Critical information discrepancy (allergy conflicts, unknown isolation status, implant not available as planned)
7.5.2 Stop-the-Line Triggers (Non-Negotiable)
7.5.2.1 Stop-the-Line is mandatory when:
- a) identity cannot be confirmed using two identifiers
- b) site/side cannot be confirmed with mark or documented exception
- c) required consent is missing or inconsistent
- d) the team cannot agree on the procedure/site during Time-Out
- e) specimen labeling cannot be confirmed
7.5.3 Stop-the-Line Response Steps
- 7.5.3.1 Step 1: Pause the workflow at the current stage (do not move forward).
- 7.5.3.2 Step 2: Inform charge nurse immediately.
- 7.5.3.3 Step 3: Identify the authoritative source of truth (EHR/paper chart + wristband).
- 7.5.3.4 Step 4: Resolve through approved documentation correction pathways (no informal edits).
- 7.5.3.5 Step 5: Re-perform the relevant verification step(s) after correction.
- 7.5.3.6 Step 6: Document discrepancy and resolution, and report as near-miss/hazard per OT QPS policy (SEC 3).
7.5.4 Escalation Levels
- 7.5.4.1 Level 1: Charge nurse + surgeon resolve at point of care.
- 7.5.4.2 Level 2: OT Nurse Manager/OT Director engaged for unresolved or high-risk discrepancy.
- 7.5.4.3 Level 3: Medical Director/Administrator on call for persistent conflict, systemic failure, or operational impact requiring leadership decision.
7.5.5 Discrepancy Documentation Requirements
7.5.5.1 Document:
- a) category of discrepancy
- b) stage detected (arrival/Sign-In/Time-Out/Sign-Out)
- c) actions taken
- d) authority involved
- e) outcome (delay/proceed/cancel)
- f) incident report reference number where applicable
7.6 CRITICAL INFORMATION COMMUNICATION (ALLERGY ALERTS, ISOLATION STATUS, IMPLANTS)
7.6.1 Minimum Critical Information Set (OT Standard)
- 7.6.1.1 Allergy status and reaction type (where documented)
- 7.6.1.2 Isolation status and precautions required
- 7.6.1.3 Implant requirement and availability (when applicable)
- 7.6.1.4 Specimen plan (when applicable)
- 7.6.1.5 Special equipment requirements and readiness (when applicable)
7.6.2 Where Critical Information Must Be Visible
- 7.6.2.1 In the authoritative patient record (EHR/paper).
- 7.6.2.2 On approved alert mechanisms (bands/flags) per hospital policy.
- 7.6.2.3 In verbal confirmation during Sign-In and Time-Out.
7.6.3 Allergy Communication Standard
7.6.3.1 Allergy verification occurs at:
- a) OT reception/holding
- b) Sign-In
- c) Time-Out
7.6.3.2 Any conflict or “unknown” allergy status must be escalated and clarified before incision.
7.6.4 Isolation Status Communication Standard
7.6.4.1 Isolation status must be communicated before staff PPE decisions and before OR entry.
7.6.4.2 Unclear status triggers escalation to IPC/sending unit; apply precautionary approach per IPC policy until clarified.
7.6.5 Implant Communication Standard
7.6.5.1 For implant cases, before incision:
- a) verify correct implant system and size availability
- b) verify loaner trays are released by CSSD where applicable
- c) prepare traceability documentation for completion at Sign-Out
- d) include implant confirmation in Time-Out when locally approved
7.7 INTERPRETER / COMMUNICATION SUPPORT (WORKFLOW)
7.7.1 Identification of Need
7.7.1.1 Interpreter need is identified in clinic/ward and reconfirmed in OT holding as needed.
7.7.1.2 Triggers include: patient/guardian does not understand the language used for consent and critical confirmation, or staff doubts understanding.
7.7.2 Interpreter Use Requirements
7.7.2.1 Interpreter support shall be used for consent discussions and critical confirmations when language barriers exist, consistent with organizational standards and patient safety goals emphasizing effective communication. (jointcommission.org)
7.7.2.2 Interpreter method options: in-person, phone, or video, according to hospital resources.
7.7.3 Workflow Steps
- 7.7.3.1 Request interpreter via approved channel.
- 7.7.3.2 Document interpreter identity/service reference and language.
- 7.7.3.3 Use interpreter support for:
- a) confirmation of identity details when patient participation is needed
- b) addressing patient questions/concerns regarding consent
- c) confirming restrictions related to teaching/photography when applicable
- 7.7.3.4 Document interpreter use in medical record/OT checklist fields.
7.7.4 Emergency Exceptions
7.7.4.1 In immediate life-saving emergencies where interpreter support cannot be obtained in time, proceed under emergency rules and document the circumstances; provide interpreter support as soon as feasible afterward.
8.0 DOCUMENTATION AND CONTROLLED RECORDS
- 8.1 Completed WHO Surgical Safety Checklist (Sign-In/Time-Out/Sign-Out) is a controlled record and must be stored according to hospital MOI/document retention rules.
- 8.2 Patient identification verification fields in OT documentation (as applicable).
- 8.3 Consent verification documentation (presence/match/exception notes).
- 8.4 Site marking verification fields and exception documentation.
- 8.5 Discrepancy/Stop-the-Line record and incident reporting reference (as applicable).
- 8.6 Interpreter use documentation (language, interpreter ID/service reference, mode, time).
9.0 TRAINING AND COMPETENCY REQUIREMENTS
9.1 Initial orientation and annual refresher training must include:
- 9.1.1 two-identifier rules and prohibited identifiers
- 9.1.2 site marking verification and exception handling
- 9.1.3 WHO checklist leadership, participation expectations, and documentation quality
- 9.1.4 Stop-the-Line escalation process and documentation
- 9.1.5 consent verification principles aligned with Saudi MOH informed consent guidance
- 9.1.6 interpreter workflow and documentation requirements (jointcommission.org)
9.2 Competency validation methods may include direct observation audits, scenario drills, and documentation review.
10.0 MONITORING, AUDIT, AND KPI REQUIREMENTS
10.1 Minimum Audits
- 10.1.1 Two-identifier compliance audit (monthly observational sampling).
- 10.1.2 Checklist compliance audit (monthly): completeness + meaningful participation indicators.
- 10.1.3 Site marking verification audit (monthly/quarterly): marking or documented exception with alternative control.
- 10.1.4 Consent verification audit (monthly): presence/match/exception documentation.
- 10.1.5 Discrepancy reporting trend review (quarterly): number and type of Stop-the-Line events and corrective actions.
10.2 KPI Dashboard (Minimum)
- 10.2.1 % cases with two-identifier verification documented at required points.
- 10.2.2 % cases with complete Sign-In/Time-Out/Sign-Out documentation.
- 10.2.3 % applicable cases with compliant site marking/exception documentation.
- 10.2.4 Number of Stop-the-Line events per 1,000 cases (tracked with learning actions).
- 10.2.5 % cases with consent verification compliance; number of prevented “missing consent before incision” events.
- 10.2.6 % cases requiring interpreter support with interpreter documentation completed. (jointcommission.org)
10.3 Corrective Actions
10.3.1 Noncompliance triggers corrective action plans including targeted coaching, workflow redesign, increased observation, and OTMC review for persistent trends.
11.0 NONCOMPLIANCE MANAGEMENT
11.1 Critical noncompliance includes:
- a) incision/procedure start without completed Time-Out
- b) identification performed with only one identifier or using room/bed number
- c) proceeding with unresolved site/side uncertainty
- d) proceeding with missing required consent without approved emergency exception
11.2 Critical noncompliance requires immediate escalation to OT leadership and hospital QPS and may trigger formal investigation and disciplinary action per hospital policy.
12.0 REFERENCES (ENGLISH)
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12.1 WHO Surgical Safety Checklist (Sign-In/Time-Out/Sign-Out).
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12.2 WHO Guidelines for Safe Surgery 2009 Guidance on checklist use, adaptation, and measurement. (ncbi.nlm.nih.gov)
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12.3 WHO Patient Safety Solution: Patient Identification (two identifiers; do not use room number).
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12.4 Joint Commission FAQ (room number not an acceptable patient identifier). (jointcommission.org)
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12.5 Saudi Ministry of Health Saudi Guidelines for Informed Consent (PDF).
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12.6 WHO High 5s Correct Site Surgery (Implementation Guide and SOP).
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12.7 JCI International Patient Safety Goals overview (identify patients correctly; ensure safe surgery). (jointcommission.org)
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12.8 CBAHI/NCC Perioperative Safety risks (wrong site surgery, retained foreign body, mislabeled/lost specimens, equipment not available, miscommunication).