The Universal Protocol for Surgery is a mandatory patient safety initiative designed to prevent preventable errors, known as “Never Events,” in medicine. These errors include performing the wrong procedure, operating on the wrong body part, or operating on the wrong person entirely. The protocol establishes a standardized, multi-step process that healthcare teams must follow before any invasive procedure begins. Its goal is to ensure the correct patient receives the correct procedure at the correct site every single time.
Why the Universal Protocol Was Created
The need for a standardized protocol arose from the persistent occurrence of serious, preventable surgical errors. The Joint Commission classifies these as Sentinel Events, meaning they result in death, permanent harm, or severe temporary harm. Historically, wrong-site surgery occurred frequently, highlighting a systemic failure in earlier, less formal safety checks.
To address this concern, The Joint Commission, a national accrediting body, developed and mandated the Universal Protocol in July 2004. This mandate established a national standard for patient safety, requiring implementation across all accredited hospitals, ambulatory care centers, and office-based surgery facilities. The protocol applies to any invasive procedure where a mistake could negatively affect patient safety. By 2009, the Centers for Medicare and Medicaid Services stopped reimbursing hospitals for the costs associated with these specific surgical errors.
The Three Essential Steps
The Universal Protocol is built upon three distinct components that must be completed before the first incision is made. These steps are designed to create redundancy in the safety system, ensuring multiple checks and confirmations of the planned procedure. This process aims to catch any discrepancies before the patient is under anesthesia and the procedure is underway.
Pre-procedure Verification Process
The pre-procedure verification process involves a comprehensive check of all relevant documentation and equipment. This must be completed before the patient enters the procedure room or before they are sedated. The team confirms the correct patient identity, the specific procedure planned, and the exact site of the operation.
Verification involves reviewing the patient’s medical records, signed consent form, imaging studies, and any necessary blood products or specialized implants. If any information is missing or a discrepancy is identified, the procedure cannot move forward until the issue is fully resolved. Ideally, the patient is awake and involved in this verification, confirming their identity and procedure details.
Marking the Operative Site
This step requires clearly marking the intended incision or insertion site on the patient’s body. Marking is mandatory when there is more than one possible location for the procedure, such as operations involving laterality (left versus right) or multiple levels (like vertebrae). The mark must be made by the licensed practitioner who will perform the procedure and be present during it.
The marking is done with a permanent surgical marker and must remain visible after the patient is prepped and draped for surgery. Whenever possible, the patient should be involved in the site-marking process to confirm the location. For spinal procedures, the skin is marked preoperatively, and special imaging techniques are used later to confirm the exact vertebral level.
The Time-out
The final step is the “Time-out,” a mandatory, team-wide pause that takes place immediately before the procedure begins. During this standardized pause, all members of the immediate procedure team, including the surgeon, anesthesia provider, and circulating nurse, must actively stop all other activity. The designated team leader verbally confirms the patient’s identity, the correct procedure, and the correct surgical site with everyone present.
The Time-out serves as the final, collective check, ensuring every person in the room agrees on the plan. It is a vocal, active process where the team also confirms the availability of any specialized equipment or implants. If any team member raises a question or concern during this final confirmation, the procedure cannot start until the issue is addressed and resolved.
Accountability in the Operating Room
The successful implementation of the Universal Protocol relies heavily on establishing a culture of safety that extends beyond a simple checklist. While the surgeon is ultimately responsible for leading the procedure, the protocol emphasizes that patient safety is a shared responsibility among the entire surgical team. This includes nurses, anesthesiologists, technicians, and anyone actively involved in the patient’s care.
This shared accountability means that any team member, regardless of their position or seniority, is empowered and expected to speak up if they observe a discrepancy or have a safety concern. The ability for any individual to call a halt to the procedure is a fundamental safeguard of the protocol. Organizations must foster a non-punitive environment where staff feel comfortable questioning potential errors without fear of repercussion, recognizing that human factors are a major contributor to adverse events.