Wrong-Site Surgeries Continue Despite Universal Protocol

March 14th, 2012


By , BSN, RN

This week we are talking about mistakes, or more importantly, trying to prevent them. Medical mistakes take roughly 100,000 lives each year and injure many, many more. Among those injuries are a certain number of wrong-site surgeries.

According to The Joint Commission (JCAHO), officials estimate wrong-site surgeries occur about 40 times a week in United States hospitals and clinics. JCAHO is the organization that accredits more than 19,000 healthcare organizations in the United States. Their declared mission is ”to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.” Part of that improvement plan is to find ways to cut down on medical mistakes, including wrong-site surgeries.

Finding a Solution

Wrong site, wrong procedure, and wrong person surgeries are considered sentinel events (an unexpected occurrence involving death or serious physical or psychological injury) that are tracked through The Joint Commission sentinel event database. In 2003, JCAHO hosted a Wrong Site Surgery Summit, with the goal of obtaining consensus on the adoption of a “universal protocol” for preventing wrong-site surgeries. Organizations that participated included: The American Medical Association, American Hospital Association, American College of Physicians, American College of Surgeons, American Dental Association, and American Academy of Orthopaedic Surgeons and leaders from 30 other groups.

Summit participants agreed that a universal protocol could help prevent the occurrence of wrong-site surgeries. The protocol needed to be very specific, so as to eliminate confusion about site marking and facilitate communication among surgical team members; and it should provide the flexibility needed for unique surgical situations.

During the public comment period more that 3,000 responses poured in from surgeons, nurses, and other health care professionals, overwhelmingly in support of the Universal Protocol. Their comments also provided the basis for a number of refinements to the protocol.

The Universal Protocol was largely unchanged until 2010 when based on feedback from the field and other stakeholders certain revisions were made. The intent of the revisions was to address patient safety issues while allowing organizations flexibility in applying the requirements within existing work processes, given the diversity of organizations that need to use it.


The Association of peri-Operative Registered Nurses (AORN) is one of the largest participant groups in the use of the Universal Protocol. Parts of the protocol are predominantly the territory of operating room circulating nurses and it is their responsibility to make sure the protocol items are recognized and acted upon. There are four major sections to the Universal Protocol and within each section there is a list of requirements that must be met.

The World Health Organization (WHO) has adopted the Universal Protocol and added areas of their own they feel need to addressed by the surgical team. The Joint Commission does not stipulate which team member initiates any section of the checklist (except for site marking) but over time different activities have fallen into hands of specific members of the surgical team. Below are the recognized requirements of the Universal Protocol. I have combined both the requirements of JCAHO, WHO and the joint agreed upon items of their checklists.

  1. Pre-Procedure check-In – In the pre-operative holding area the patient or their representative confirm with the OR nurse the patient’s identity, the procedure site, that the site is marked and who will be performing the procedure. The RN also confirms the presence of: the History and Physical (H&P), the pre-anesthesia assessment, the diagnostic and radiologic test results, the need for any blood products, and any other special equipment.
  2. Sign-In – Before the induction of anesthesia the circulating nurse and the anesthesia care provider again confirm the patient’s identity, procedure, site, and marking. They also confirm if the patient has any allergies, has a difficult airway or is at risk for aspiration, the potential risk for blood loss and that the anesthesia safety check is complete.
  3. Time-Out – Before skin incision the Time-Out is initiated by a member of the surgical team. While the Time-Out is being completed all other activities in the operating room should be suspended unless there is a life-threatening emergency. The team members introduce themselves and confirm the identity of the patient, the procedure, the site and that it is marked and that all relevant images are properly labeled and displayed. Any equipment concerns are discussed.

    Under the WHO guidelines, the surgeon should then state the anticipated case duration, anticipated blood loss, and any critical or non-routine steps. The anesthesia provider will confirm the initiation of antibiotic prophylaxis and any additional concerns and the scrub and circulating nurse will confirm that all the instrumentation has been confirmed as sterile.

  4. Sign-Out – At the end of the procedure and before the patient leaves the room the circulating nurse confirms the operative procedure, that the sponge, sharps and instrument counts are complete and correct, that all specimens have been identified and labeled, and any equipment problems are being addressed.

It has been eight years now that the Universal Protocol has been being used. While it is a great tool, it seems that some researchers and safety experts say the problems of wrong-site surgery have not improved. In fact, the problem may be getting worse according to an article published last year in the Washington Post. According to the author, in 2010, there were 93 wrong-site, wrong procedure or wrong patient surgeries reported to JCAHO. That was actually almost double the 49 cases reported in 2004.

Part of the problem is that reporting is voluntary and confidential in order to encourage doctors and hospitals to come forward. About half the states don’t require any kind of reporting and “in two states that track and intensively study these errors, 48 cases were reported in Minnesota last year, up from 44 in 2009; Pennsylvania has averaged about 64 cases for the past few years,” the article says.

Hopefully, we will see more reports of the problem, and fewer problems, in the next few years as Medicare and Medicaid now require reporting and do not pay for wrong-site surgeries. Many private insurers have followed suit.

But, again, like with medication errors, despite all the standards and protocols put into place, we are still making too many medical mistakes. It falls upon all of us in healthcare to be vigilant. I certainly don’t have the answers, but I am always thinking about what could be done to make it better—safer.

I would love to hear your ideas.

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