The Universal Protocol (UP) is a standardized set of procedures mandated by The Joint Commission (TJC) to significantly reduce surgical errors. It was developed to prevent three devastating errors: operating on the wrong patient, performing the wrong procedure, or operating on the wrong body part. The protocol establishes a clear, multi-step safety process that every accredited healthcare organization must follow.
Defining the Scope of Application
The Universal Protocol applies to all invasive procedures that carry a risk of harm to the patient, not just those performed in the traditional operating room. This includes procedures in areas such as interventional radiology, cardiac catheterization labs, endoscopy suites, and certain procedures conducted at the patient’s bedside.
An invasive procedure is defined as any process involving a skin incision, puncture, or the insertion of an instrument into the body (e.g., a biopsy or nerve block). Applicability is determined by the potential for patient risk, requiring facilities to identify all such procedures that fall under the UP mandate. Compliance is the responsibility of the entire procedural team, led by the licensed independent practitioner performing the procedure.
Pre-Procedure Verification Process
The first pillar of the Universal Protocol is the pre-procedure verification process, an ongoing review of documentation that begins when the procedure is scheduled. This initial check uses a standardized checklist to confirm the patient’s identity, the planned procedure, and the correct site. Verification must be repeated at multiple points, including upon the patient’s admission and before the patient leaves the pre-operative holding area.
The team must reconcile all relevant documents to ensure consistency with the planned procedure. This includes reviewing the patient’s history and physical (H&P) report, signed consent forms, and any diagnostic images. The process also confirms that all necessary specialized equipment, implants, or blood products are present and correctly matched to the patient. Patient involvement is mandatory; the patient must be asked to actively confirm their identity and the planned procedure site, whenever possible.
Marking the Surgical Site
The second core principle is physically marking the procedural site, confirming the intended location. The site must be marked for any procedure involving laterality, multiple structures (like fingers or toes), or multiple spinal levels. The licensed practitioner performing the procedure must make the mark, preferably while the patient is awake to participate in the confirmation.
The mark must be permanent, clear, and positioned to remain visible after the skin has been prepped and draped. Standardized markings often involve the proceduralist’s initials or a clear word like “YES” near the incision site. Exceptions exist for areas like teeth or premature infants where marking is impractical or unsafe, requiring the facility to use an alternative, approved process.
The Mandatory Time-Out
The final safety barrier is the mandatory time-out, a focused pause performed by the entire procedural team immediately before the start of the invasive procedure. All routine activities must cease during this pause to ensure the complete attention of every team member, including the surgeon, nurse, and anesthesia provider. The proceduralist typically leads this final verification, which is conducted using active, verbal communication.
During the time-out, the team confirms the patient’s identity using at least two identifiers, the exact procedure to be performed, and the correct site, referencing the visible site mark. They also confirm that all necessary equipment is available and address any concerns or questions raised by any member of the team. The procedure cannot begin until all questions are resolved, and the team achieves consensus that the plan is correct.