July 1, 2004 -- "Timeouts" may be helpful in keeping kindergarten classrooms orderly. But now they're being translated to the operating room.
The aim? To avoid mix-ups at U.S. hospitals that can result in lost limbs or even death. Beginning today, accredited hospitals must ensure that each surgery begins with a "timeout" to verify the patient's identity, the procedure to be performed, and the site of the procedure.
The new "timeout" requirement is part of a three-pronged pre-operative process meant to ensure that each of the 70 million surgeries is being performed on the right body part of the right person.
As many as 98,000 Americans die each year as a result of medical errors, the eighth leading cause of death for Americans, exceeding AIDS, breast cancer and motor vehicle accidents, according to a 1999 Institute of Medicine report. And that's a "conservative estimate," says Dr. Robert Wise, vice president at the Joint Commission on Accreditation of Healthcare Organizations, or JCAHO, which has developed the new protocol.
While similar policies have been implemented at individual hospitals, the new protocol is the first instance of such an initiative being standardized on a national scale. Hospitals must follow it to receive Medicare reimbursements.
Wrong Site Surgery
A common and significant medical error occurs when surgeons operate on the wrong part of the body. Instead of amputating the left leg, for instance, the surgeon removes the right.
According to Wise, there are no hard-and-fast data on the incidence of wrong site surgeries specifically, and the overwhelming majority go unreported. But a voluntary medical error database maintained by the organization has shown an alarming number of wrong site errors each year, and the numbers only seem to be increasing, with 75 reported cases in 2003.
While this trend may also reflect doctors' increasing willingness to disclose errors, the statistics were striking enough to prompt JCAHO to convene a summit last year for the purpose of developing this protocol.
"We should not have been receiving any reports," insists JCAHO spokesman Mark Forstneger. "Wrong site surgery is intolerable, it's preventable."
According to Forstneger, the incidence reports showed that "one of the main problems was communication issues, in particular with continuum of care." The multiple hand-offs as a patient goes through admissions, gets lab work done, and is prepped for surgery provide ample opportunity for "communication errors to crop up if redundancies [are] not put into place," says Forstneger.
Another major issue addressed by the new protocol is lack of consistency with pre-operative procedures across hospitals. Says Wise, "There was disagreement [between hospitals] if the right leg was marked because that was the one you should operate on, or the left leg because that was the one you should not operate on." Doctors working at multiple hospitals had trouble, he says.
Communication Is Key
Although the protocol is already implemented to varying degrees in most major hospitals, JCAHO-accredited institutions were given one year to formally comply with the regulations. Most say they find it a manageable and worthwhile process.
Dr. Gabriel Aldea, a cardiothoracic surgeon at the University of Washington, says that at first, there was concern among surgeons, since the new procedure seemed like "a waste of time" for surgeons who "know what we're doing."
But Aldea believes that ultimately the pre-operative meeting stipulated in the protocol makes things more efficient. "People around you know what you're thinking," says Aldea, and "that communication alone gives [O.R. personnel] the opportunity to participate and focus. It formalizes communication so that the possibility for error is reduced."
Pat Thornton, the perioperative clinical educator for the O.R. at Children's Healthcare of Atlanta and president of the Atlanta Chapter of Perioperative Nurses, says that, " 'Timeout' is helping the surgeons, technicians, RNs, anesthesiologist and all personnel in the O.R. to communicate and be on the same page."
And according to Kate Betancourt, the director of performance improvement at New Britain General Hospital in Connecticut, "The benefit of a universal protocol is that since all facilities have the same ultimate goal, this creates uniform expectations for facilities and for patients. It is the result of consensus among a variety of stakeholders, and is based on evidence of what works best in preventing errors."
A key component of the plan is patient participation. According to Dr. Thoralf Sundt, a heart surgeon at the Mayo Clinic, surgeons there "mark the site with the patient awake to reconfirm with the patient what is going to happen."
Linda Kenney, founder and president of Medically Induced Trauma Support Services Inc. in Mansfield, Mass., and a medical error trauma survivor herself, agrees that patients "have a responsibility, but it's really limited."
JCAHO does recommend that patients bring a friend or family member to help look out for their interests.
"You should have someone with you who's going to advocate," agrees Kenney. "Once you become the patient you're much more vulnerable, even the most educated consumers."
Fittingly, Kenney notes she benefited personally from the improving procedures. "I just had surgery in November," she says. "It was on my right ankle, and every single person I came in contact with verified that it was the right one."
Just One Step
Wrong site-wrong patient-wrong procedure surgeries are relatively rare occurrences, but because these errors are "the most spectacular, the most dramatic" ones, says Aldea, they are "not an unreasonable place to start."
Harmful drug interactions account for the majority of medical error deaths, according to a number of health-care professionals. Medical errors in the administration of drugs, including inappropriate doses and overlooked drug allergies or interactions land thousands of people in the hospital each year.
Many hospitals are taking steps to reduce these drug errors. At University of Washington Medical Center, Aldea reports, "A Ph.D. pharmacist sees all patients with us. When medications are ordered, they are checked against patients known allergies, drug interactions, and dosing."
But with something as complex as medical care, it is difficult to anticipate everything that might go wrong.
"People expect it to be perfect but it never will be," Dr. Craig Smith, chief of cardiothoracic surgery at the Columbia University Medical Center, says of surgery. "It's layers upon layers and it will never be perfect."
Any policy that reduces the chance of error, he adds, can only be beneficial.