The Universal Protocol is a standardized set of practices developed to safeguard patients undergoing procedures in healthcare settings. It emerged from patient safety initiatives following a growing awareness of serious, preventable errors during medical interventions. This protocol provides a structured framework that healthcare teams use to confirm the details of a patient’s procedure before it begins.
Preventing Wrong Patient, Site, or Procedure Events
The primary goal of the Universal Protocol is the elimination of sentinel events known as Wrong Site, Wrong Procedure, and Wrong Person errors. These errors are considered “never events” because they are catastrophic and wholly preventable through systemic checks. The protocol ensures the medical team performs the correct operation on the correct individual at the correct anatomical location.
These mistakes often stem from communication failures or a breakdown in procedural oversight in settings where invasive procedures are performed. By mandating a robust, multi-step verification process, the protocol injects redundancy to catch errors before the procedure starts. This standardized approach empowers every team member to halt the procedure if a discrepancy is found.
The Three Mandatory Steps
The Universal Protocol is achieved through the consistent execution of three sequential, mandatory steps: the pre-procedure verification process, site marking, and the time-out. Each step serves as an independent check, building safety around the patient.
Pre-procedure Verification Process
The verification process is a systematic review completed before the patient enters the procedure room or receives deep sedation. This step ensures all relevant documents are present, reviewed, and consistent with the intended procedure. The team confirms the patient’s identity using at least two identifiers, such as name and date of birth, and checks that the consent form matches the scheduled procedure. Missing information, misplaced imaging studies, or any inconsistencies must be resolved before moving forward.
Site Marking
Site marking is required for procedures involving laterality, multiple structures, or multiple levels (e.g., left or right side of the body, a specific finger, or a spinal level). The site must be unambiguously marked with a permanent marker, typically by the licensed independent practitioner performing the procedure. The mark must remain visible after the patient has been prepped and draped, and the patient is involved in confirming the correct site whenever possible.
The Time-Out
The time-out is the final, mandatory pause performed immediately before the start of the invasive procedure. All members of the procedure team must actively participate in this verbal confirmation. During the time-out, the team agrees on the correct patient identity, the specific procedure, and the correct site. The procedure cannot begin until all questions or concerns raised by any team member are resolved, acting as a fail-safe mechanism.
Scope and Applicability
The Universal Protocol is a requirement for all accredited healthcare organizations, including hospitals, ambulatory surgery centers, and office-based surgical facilities. It is mandated by The Joint Commission, which accredits and certifies healthcare programs. The protocol applies to all settings where an invasive procedure is performed, not just traditional operating rooms.
This broad scope includes environments like interventional radiology suites, cardiac catheterization labs, endoscopy units, and bedside procedures involving puncture or incision. Compliance is mandatory for facilities to maintain their accreditation status. Procedures that are non-invasive or involve only minor surface procedures, such as venipuncture for blood draws, are excluded from the protocol.