Surgery is an invasive procedure that carries weighty risks such as anesthesia reactions, infections, and wrong-site, or wrong procedure. Thankfully, today’s OR teams are more skilled than ever in proper techniques, protocol, and patient safety requirements. The OR team works in harmony with specific functions to safely complete the procedure, protect the patient, and deliver a positive surgical outcome. One of the basic protocols required by the Joint Commission is the Universal Protocol.

The Joint Commission estimates that each week in the U.S. there are 50 cases of wrong-site incidents. Of the many risks surgeons and nurses worry about in their day to day routines, wrong-site surgeries are among the scariest. Many checklists are put in place to ensure the OR team accounts for all resources needed for the day of surgery. One practice that helps reduce the stress of surgery is one that many may overlook. The Universal Protocol has been specifically created to assist surgeons and related staff to ensure all of these needs are met prior to the words, “scalpel, please”.  Taking a look back to this simple but necessary protocol can be the item that all surgeons will never forget to check off.

How Universal Protocol Was Established

The Universal Protocol (UP) was enacted by the Joint Commission in 2004 after an increase of wrong-site, wrong-procedure, and wrong-patient (WSPE) incidences were reported. It was developed through expert consensus on principles and guidelines to help prevent WSPE incidences. The protocol was applicable for all accredited hospitals, outpatient surgery centers, and office-based surgery centers.

WSPE incidences are undoubtedly among the most severe patient safety errors. The  Joint Commission classifies WSPE incidences as Sentinel Events and the National Quality Forum categorizes WSPEs as never events, as in they should never occur. Sentinel Events are defined as events that result in death, permanent harm, or severe temporary harm.³ The Centers for Medicare and Medicaid Services (CMS) announced in 2009 that hospitals will not be reimbursed for WSPEs. To help avoid preventable WSPEs, adhering to The Universal Protocol is critical.

Below are the 3 main steps of Universal Protocol.

  • Pre-Procedure Verification– This step is to ensure that all tools, equipment, documents are ready before the procedure begins. These assets would also need to be identified and labeled correctly with patient identifiers. All of these aspects must be reviewed by the team and match what is shared with the patient.
  • Site Marking– This step requires the individual with the most knowledge of the procedure (usually the surgeon) to mark the patient’s procedure site. Involving the patient in this process is recommended.
  • Time Out-A main point of the protocol is to conduct a “time-out” with the patient prior to surgery. At this point, all of the procedures aspects are discussed with the patient.  The patient can then raise any questions or concerns they may have.

One thing to consider when implementing this protocol is to validate that all facilities have a standardized process. This will avoid confusion between rotating staff.  Using active communication with staff will enable them to work more efficiently through the Universal Protocol. Not only will they be able to speak for themselves, but also for the patient’s wellbeing.

For more information about the Universal Protocol, visit

PDC offers Time Out labels, which are critical for patient safety and used as reminders for clinicians to follow The Joint Commission’s Universal Protocol. These labels are used to verify the correct patient, procedure, site, and implants before the start of a procedure. Affix this label to the patient record to document compliance with The Joint Commission’s Universal Protocol.

³Sentinel event policy and procedures. The Joint Commission. sentinel_event_policy_and_procedures/. Accessed September 13, 2017

Reducing Wrong-Site Operations: How Universal Protocol Was Established
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Reducing Wrong-Site Operations: How Universal Protocol Was Established
Many checklists are put in place ensure that everything is prepared and that all needs are met before an invasive procedure begins. These systems minimize stress and the risk of errors, some of which can be potentially devastating. One of the most severe errors that surgeons worry about are wrong-site operations, and they happen quite often. Which is why it’s important to implement Universal Protocol, the principles and guidelines created to help prevent these incidences.
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PDC Healthcare
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Jess Johnson is the Senior Brand Manager for Healthcare at PDC, helping to communicate to healthcare customers how PDC solutions can help them with workplace and patient safety. She joined PDC in 2019, with a background in B2B marketing communications and content creation. Jess has Marketing and Journalism degrees from Miami University in Oxford, OH. Originally from Northeast Ohio, Jess now lives in Santa Clarita, CA with her husband and pit-lab mix, Cashmere.


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