Never Events: Prevention with Universal Protocol Review

This year marks 15 years since The Joint Commission established a “Universal Protocol,” mandatory safety standards to prevent wrong-site, wrong-procedure and wrong-patient surgery. Despite the many years Universal Protocol has been in effect, claims continue to be filed alleging these surgical “never events.” The Agency for Healthcare Research and Quality defines a never event as a “particularly shocking medical error—such as wrong-site surgery—that should never occur.”

In the most recent headline dated March 2019, a Tennessee patient filed a lawsuit alleging her surgeon placed a stent in the wrong kidney, resulting in damage leading to her need for long-term dialysis. These claims also occur closer to home, with wrong operative side (right v. left) being especially vulnerable. Often, the “perfect storm” of process failures must happen in order to reach the patient, but these events still unfortunately occur.

Looking back through the claims history of the Trust Funds, there are several cases of wrong-site surgery involving fingers, hands, knees, ovaries and even the brain. In one case, a 27-year-old female with constant stomach/pelvic pain was admitted for the removal of a dermoid cyst on her right ovary. The left ovary was removed instead. The hospital’s root cause analysis found multiple contributing factors. The procedural consent form stated only “removal of ovary” and did not specify left or right. Additionally, the surgical site was not marked and several position changes by surgeon, tech and relief staff may have caused confusion.

Universal Protocol consists of three parts:

• Conducting a pre-procedure verification process to address inconsistencies prior to the procedure
• Marking the procedure site
• Performing a time-out immediately prior to starting the procedure

According to the Joint Commission Center for Transforming Healthcare, process errors resulting in wrong-site surgeries can occur in multiple areas:

• Scheduling- miscommunication between the hospital and physician offices
• Pre-Op/Holding- incomplete or missing documents, lack of verification, last-minute changes to consent forms
• Operating Room- errors in site marking, staff inattention, rushing through the time out

Considering the above root causes, can you or your team identify weaknesses in your facility’s compliance with Universal Protocol? What action can your facility take to bring Universal Protocol back into focus and proactively reduce risk?

From the clinical perspective, conducting a thorough review of your facility’s Universal Protocol process can be the first step in identifying opportunities to decrease the risk of wrong-site, wrong-procedure or wrong-person surgery. A thorough review can be conducted through the FMEA, Six Sigma or Lean Six Sigma processes. Consider these guidelines when reviewing the Universal Protocol process:

Pre-Procedure Verification

• During the scheduling process, a standardized form or electronic program utilized to document patient information regarding the to-be-scheduled surgery/procedure is recommended. When the staff member takes the information from the physician’s office, a quiet environment with limited distractions is imperative. Once all of the information has been obtained, the staff member should repeat it back to the caller to verify. The double-check can catch potential discrepancies at the very beginning of the process. This technique should be standardized and performed each and every time a surgery or procedure is scheduled.
• Once the patient has arrived for the surgery/procedure, a pre-procedure verification process should be completed and involve the patient if possible. The staff in the pre-op area are vital to conducting this process. A standardized checklist and a procedural consent form should be utilized to verify the correct surgery/procedure for the correct patient and the correct site. The checklist should also include all relevant documentation that needs to be completed prior to the surgery/procedure:
  • Updated history and physical
  • Signed consent form
  • Anesthesia pre-op assessment
  • Signed anesthesia consent
  • Radiology reports and images
  • Diagnostic/lab results
  • Blood products
  • Equipment such as implants, devices or special items needed for the surgery/procedure
• A surgical fire risk assessment should be conducted during the pre-procedure verification process to ensure that all precautions are taken if there is a high risk.
• Document this process in the medical record.

Site Marking

• The site should be marked when there is the possibility of more than one location for the surgery/procedure.
• Mark the site early in the pre-procedure process.
• If possible, involve the patient when marking the site.
• The site should be marked by a licensed independent practitioner who is ultimately responsible for the surgery/procedure and will be present when the surgery/procedure is performed.
• The site marking needs to be:
  • Made at or near the actual site of the surgery/procedure.
  • Unambiguous.
  • With standardized marking utilized throughout the organization.
  • Suitably permanent enough to be visible after skin prep is applied and draping is done.
• Document this process in the medical record.

Time-Out Process

• A time-out needs to be conducted prior to every surgery/procedure and should be a standardized hardwired process.
• The time-out involves the immediate members of the procedure team:
  • The healthcare provider performing the surgery/procedure
  • Anesthesia provider
  • Circulating nurse
  • OR Tech
  • Scrub Tech
  • Any other active participants who will be participating in the procedure from the beginning
• During the time-out, all relevant members of the surgical/procedure team are required to stop, actively participate, communicate any concerns and agree on the surgery/procedure being conducted.
• Utilizing the consent form during the time-out is important and can address any discrepancies.
• The time-out should address and verify:
  • Correct patient identity.
  • Correct site.
  • Correct surgery/procedure being done.
  • Fire risk assessment score.
  • If there are two or more surgeries/procedures being done on the same patient, each surgery/procedure needs a separate time-out.
  • Document this process in the medical record.

Reviewing your facility’s current process is a proactive way to identify opportunities and improve the Universal Protocol process within your organization.