Written and maintained by CASRAI Editorial Board
Last updated
The Universal Protocol is The Joint Commission’s accreditation requirement for preventing wrong-site, wrong-procedure, and wrong-person surgery. It has three components — pre-procedure verification, site marking, and a time-out immediately before starting — and it is closely related to, but not identical with, the WHO Surgical Safety Checklist, a separate three-phase (Sign In / Time Out / Sign Out) tool that many hospitals adopt or adapt to satisfy the Universal Protocol’s requirements in practice. Because the operational question a clinical or perioperative team actually has is “what does the time-out need to cover, and does our checklist satisfy it,” this page treats the Universal Protocol’s requirements and the WHO checklist’s structure as one topic.
Page checked in August 2026. jointcommission.org blocks automated retrieval and no archived snapshot was available, so the Universal Protocol’s three-component structure and its core content below is described at the level of well-established, widely-published perioperative and patient-safety literature rather than sourced from a fresh, direct fetch of the current accreditation manual text — confirm exact current wording and any program-specific variation against your own Joint Commission accreditation manual. The WHO Surgical Safety Checklist framing is based on its widely-published three-phase structure (Sign In, Time Out, Sign Out) from WHO’s Safe Surgery Saves Lives initiative.
Why This Exists: Wrong-Site Surgery Is a Preventable Sentinel Event
Wrong-site, wrong-procedure, and wrong-person surgery are the category of error the Universal Protocol targets directly. These events are rare but almost always preventable, and a confirmed occurrence is the kind of adverse event that meets most hospitals’ criteria for a sentinel event review, given that it results from a breakdown in a defined verification process rather than an unavoidable clinical complication.
Component 1: Pre-Procedure Verification
Before the patient enters the procedure room, the team verifies — using multiple sources of information, not a single form — that the correct patient, correct procedure, correct site, and correct implants or equipment are all confirmed and consistent across the consent, the scheduling information, the history and physical, imaging, and the patient’s own confirmation where possible. The verification is meant to happen at more than one point (for example, at scheduling, at admission or entry, and again before entering the procedure room), so that a discrepancy introduced at any single point has a chance to be caught before the patient reaches the table.
Component 2: Site Marking
The intended surgical site is marked, for procedures involving laterality (left/right), multiple structures (e.g., fingers, toes, lesions), or multiple levels (e.g., spinal surgery). The mark should be made by the person performing the procedure (or, in some accepted variations, another licensed practitioner who will be present), made with the patient involved and awake where possible, and made in a way that remains visible after the patient is prepped and draped. Marking is generally required for any site with laterality or multiple possible sites, and the mark itself is checked again during the time-out below — it is not a substitute for the verbal verification, but a physical confirmation that has to agree with it.
Component 3: The Time-Out
The time-out is a final, active verification step performed immediately before starting the procedure — with the entire relevant team present and actively participating, not passively listening. It typically confirms, out loud, before the first incision or start of the procedure:
- Correct patient identity;
- Correct procedure to be performed;
- Correct site (and side, where applicable), matched against the visible site mark;
- Correct patient position;
- Availability of correct implants or special equipment, where relevant; and
- Any other team-specific confirmations relevant to the procedure (e.g., relevant imaging displayed, antibiotic prophylaxis timing, anticipated critical steps).
The defining feature of a properly performed time-out is active engagement from the full team — surgeon, anesthesia provider, and nursing/scrub staff each confirming aloud, with the procedure not starting until any team member’s concern is resolved — rather than a single person reading a checklist while others proceed with setup.
How the WHO Surgical Safety Checklist Maps to This
The WHO Surgical Safety Checklist, developed under WHO’s Safe Surgery Saves Lives initiative, is a widely adopted operational tool that many hospitals use to structure and document Universal Protocol compliance, organized around three checkpoints in the surgical timeline rather than the Universal Protocol’s three components directly:
- Sign In — before induction of anesthesia: confirms patient identity, procedure, and consent; site marking; anesthesia safety check; pulse oximeter functioning; and known allergy and airway/aspiration risk.
- Time Out — before skin incision: the full team introduces themselves by name and role, confirms patient/procedure/site aloud (mapping directly to the Universal Protocol time-out above), reviews anticipated critical events, confirms antibiotic prophylaxis timing, and confirms essential imaging is displayed.
- Sign Out — before the patient leaves the operating room: confirms the procedure performed, completion of instrument/sponge/needle counts, specimen labeling, and any equipment problems to address, plus key concerns for recovery and post-operative management.
The WHO checklist’s “Time Out” phase is the direct operational equivalent of the Universal Protocol’s time-out component, but the checklist’s Sign In and Sign Out phases add structured safety checks — anesthesia safety, counts, specimen handling — that sit outside the Universal Protocol’s three named components but address adjacent, well-documented sources of surgical harm (retained foreign objects, specimen mislabeling, anesthesia-related events).
Where Teams Get This Wrong in Practice
The recurring, well-documented failure mode across perioperative safety literature is not the absence of a checklist — it is a checklist performed as a formality rather than an active verification: one person reading items aloud while the rest of the team continues unrelated tasks, a time-out proceeding despite genuine team uncertainty being raised and then dismissed, or verification relying on a single source of truth (for example, only the consent form) rather than cross-checking multiple independent sources. A time-out or checklist step that does not actually pause the workflow, and does not genuinely empower any team member to stop the procedure over an unresolved discrepancy, does not deliver the safety benefit the process is designed to provide — even if it is documented as completed.
Related CASRAI Guides
A wrong-site or wrong-procedure event is a strong candidate for sentinel event classification and comprehensive systematic analysis, and the case is often also discussed in a hospital’s M&M conference to identify the systems failure behind the breakdown, separate from any disciplinary review of the individuals involved.
Frequently Asked Questions
Is the Universal Protocol the same as the WHO Surgical Safety Checklist?
No, though they are closely related and often conflated. The Universal Protocol is The Joint Commission’s accreditation requirement, defined by three components (pre-procedure verification, site marking, time-out). The WHO Surgical Safety Checklist is a separate, widely adopted operational tool organized around three different checkpoints (Sign In, Time Out, Sign Out) that many hospitals use as their method of satisfying — and going somewhat beyond — the Universal Protocol’s requirements.
Who is required to participate in the time-out?
The entire relevant procedural team present for the case — typically the surgeon or proceduralist, anesthesia provider, and nursing or scrub staff — with each expected to actively confirm the verified information aloud, not simply be present while one person reads from a form.
Does every procedure require site marking?
Site marking is required for procedures involving laterality (left or right), multiple possible structures (such as fingers, toes, or lesions), or multiple levels (such as spinal surgery) — not universally for every procedure performed. Check your facility’s specific policy for the exact scope, since implementation can vary by procedure type and setting.
What happens if a team member raises a concern during the time-out?
The procedure should not proceed until the concern is resolved. A functioning time-out process gives every team member — regardless of role or seniority — standing to pause the case over an unresolved discrepancy, and a time-out that does not actually stop the workflow when a genuine concern is raised is not delivering its intended safety function even if documented as completed.
