Cover Story: Patient Safety and the Surgery Checklist
by Don Sadler
“Nobody’s perfect.” We’ve all heard this before, and most of us have used it at one time or another as an excuse for a mistake. But mistakes in the OR can be especially devastating — not only for patients, but also for the hospital and OR staff.
And there are few OR mistakes as potentially devastating as wrong site surgeries. “For patients and their loved ones, a wrong site or wrong side surgery or a wrong surgical procedure is life-changing,” says Linda Groah, MSN RN CNOR NEA-BC FAAN, the executive director and CEO of the Association of periOperative Registered Nurses (AORN).
“And for surgical teams and healthcare administrators, a sentinel event of any kind is profoundly demoralizing to the spirit, as well as damaging to their reputation,” Groah adds.
Rare But Preventable
Although wrong site surgery is a rare event, it remains a serious and preventable threat to patients in the OR that should never happen. The Joint Commission Center for Transforming Healthcare reports that “wrong patient, wrong site and wrong procedures” is the second most frequently reported sentinel event, with 109 such procedures reported in 2012.
However, many experts believe the actual numbers are much higher than this, since reporting is not mandatory in most states. Even more disturbing is the fact that these 109 reported cases are more than double the 49 cases that were reported in 2004, according to Groah. This is the year when the Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery was first implemented.
The Universal Protocol is a standardized approach to eliminating wrong patient, wrong site and wrong procedures that includes pre-procedure verification, site marking and a surgery “time out” to confirm the surgical site, patient and procedure. At this time, the entire surgical team pauses to confirm and agree that the appropriate surgery is about to be performed.
According to Groah, the surgery time out is conducted immediately before starting the invasive procedure or making the incision. It involves the immediate members of the procedure team, which typically includes the individual performing the procedure, anesthesia providers, circulating nurse, operating room technician, and other active participants who will be participating in the procedure from the beginning.
“When the designated team member — usually the circulating nurse or surgeon — calls for time out, the surgical team members must cease all their activities and give their full attention to the review of the surgery checklist,” says Groah. “This process not only covers the items on the checklist, but also includes all members of the team introducing themselves and the surgeon giving a brief description of the procedure. The surgeon should also address any questions or concerns members of the team may have at this time.”
The surgery time out is similar to the prescribed checklist that pilots and co-pilots are required to complete without interruption before a commercial airliner can take off. But unlike in the aviation industry, surgeons and OR staff are not legally required to perform the surgery time out.
More OR Safety Checklists
In addition to the Joint Commission’s Universal Protocol, the World Health Organization (WHO) has created a 19-point Surgical Safety Checklist that also includes a surgery time out. And AORN has created a Comprehensive Surgical Checklist that includes the safety checks outlined in the WHO Surgical Safety Checklist, while also meeting the safety checks within The Joint Commission’s Universal Protocol in order to meet accreditation requirements.
The AORN Comprehensive Surgical Checklist uses color codes to signify WHO and Joint Commission guidelines as well as areas where the two overlap.
“It offers guidance for pre-procedure check-in, sign-in, time out and sign out,” says Groah. “Open-ended questions are also included under the time out portion to encourage active participation from all members of the surgery team.”
The AORN checklist is useful in all types of facilities, including hospital ORs, ambulatory surgery centers and physicians’ offices. You can download it for free as a Word document or PDF at www.aorn.org/Clinical_Practice/ToolKits/Correct_Site_Surgery_Tool_Kit/Comprehensive_checklist.aspx.
A well-publicized study that was conducted in 2009 determined that the WHO’s Surgical Safety Checklist cut mortality rates by up to 50 percent in eight hospitals located in eight different cities. More recently, two German studies conducted in 2012 reported decreases in perioperative mortality rates of 47 percent and 62 percent. In addition, one of the German studies determined that using the WHO checklist could have prevented more than 85 percent of wrong side surgical errors.
And in a study conducted last year to determine the value of checklists during a surgical crisis like a cardiac arrest or unstable pulse or blood pressure, researchers in Boston found that surgical teams that used a checklist were 74 percent less likely to skip a potentially life-saving step during the intraoperative crisis. The study simulated more than 100 OR emergencies using a robotic patient.
Surgical teams in the study that used checklists missed six percent of life-saving processes, while teams without checklists missed 23 percent of life-saving processes. Upon completion of the simulation, almost all of the participants (97 percent) said they would prefer to have a checklist in the event of an OR crisis.
“The standard practice across the country has just been, you work from memory and reason your way through a crisis,” says Atul Gawande, one of the authors of the 2009 WHO study who spearheaded the recent Boston study. “But when things hit the fan, it’s total chaos.”
It’s worth noting that a more recent study conducted in Canada questions whether or not surgical checklists and the surgery time out are as effective in reducing surgery mortality and complication rates as the 2009 WHO study seems to indicate. In this study, the reductions achieved in surgery mortality and complication rates were statistically insignificant.
However, even the authors of this study acknowledge the value of checklists. According to the lead author, David Urbach, the study was not conducted to advocate the elimination of surgery checklists and the surgery time out, but rather to provide a realistic picture of how difficult it is to improve patient safety.
“There is probably a lot of value in checklists, even if it can’t be measured in terms of reducing the risk of bad outcomes,” Urbach says.
Structured Training Required
Gawande stresses that surgery checklists must be supplemented with specialized training that can take months to complete. And the researchers who conducted the German studies noted that implementing the WHO checklist was most effective when it included exemplary implementation by team leaders and structured training.
“Typical errors in implementation are lack of completeness and processing in the absence of team members,” stated the authors of one of the German studies. “It is also wrong for a single person to go through all of the items on the list without communicating his or her content to others or providing any opportunity for an exchange of information.”
Groah notes that June 11 will mark the 10th anniversary of National Time Out Day, an awareness campaign that AORN initiated in collaboration with The Joint Commission, WHO and the Council on Surgical and Perioperative Safety (CSPS).
“The surgery checklist serves as a reminder of all the processes that are important for every patient, during every procedure, every time,” Groah says. “In particular, the time out procedure is a critically important communication interaction for the preservation of patient safety in the surgical setting.”