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Recent verdict raises issue: When do you refer to a high-volume provider?
A major vein was torn during a Whipple procedure at a hospital that performs the procedure a few times a year, according to a case reported on The Law Med Blog.1 The patient experienced complications, went in for a second surgery, and subsequently died. The patient's husband filed a lawsuit and claimed the patient should have been referred to a major facility and that the surgeon didn't correctly voice concerns during the procedure. Specifically, the patient had no information that she might be safer in the hands of a more experienced surgeon, according to the husband's attorney.
According to the husband's attorney, a facility that performs the Whipple procedure less than seven times a year is considered a low-volume facility. The surgeon had performed the surgery three times before the fatal outcome.
The defense's position was that the physician was a board-certified general surgeon who had successfully performed the surgery previously, and 42% of Whipple surgeries are done in community hospital settings. If the patient had been referred to a facility that performed a high volume of these procedures, the risk of a recognized complication would not have been reduced, the defense said.
The patient was found to be cancer-free. Members of the jury were unanimous in their decision to award $4.4 million to the husband. Perhaps they were considering the wording on the web site of the American Cancer Society, which describes the Whipple procedure as a "very complex operation" that is "best done by a surgeon who has done it many times in a hospital that does at least 20 Whipple procedures per year."
This verdict raises questions for outpatient surgery managers: How can you be sure your surgeon is experienced enough to perform an outpatient surgery procedure, and when should you refer patients elsewhere? Consider these suggestions:
First, determine if the surgeon is qualified to perform a procedure.
MemorialCare Health System in Fountain Valley, CA, is similar to many providers in that granting of privileges is dependent on the surgeon's training and experience.
Generally, each MemorialCare facility has a surgical committee that reviews and approves new procedures based on the procedure itself; the surgeons' training, competency, and privileges to perform the procedure; proctoring; and the ability to provide consistent support staff and equipment to consistently support the procedure, says John C. Metcalfe, JD, FASHRM, vice president of risk and insurance management services.
Richard Satava, MD, FACS, professor of surgery at the University of Washington Medical School and surgeon at the University of Washington Medical Center, both in Seattle, says it's important that the surgeon is well trained to quantifiable and verified outcome measures, "not something on a weekend" or solely from the industry. Satava also serves as a consultant to the American College of Surgeons Committee on Emerging Surgical Technologies.
The chairman of a department of surgeon must consider multiple measures, including how many similar procedures a surgeon has performed in preceding years when granting privileges, Satava says. The chairman also should look beyond the surgeon's technical abilities, he says. Technique is part of it, but the fundamental principles in preop and perioperative care should be looked at as a global measure of competency, Satava says.
Examine how often a complex procedure is performed within the facility and whether staff can respond to complications.
According to Jane J. McCaffrey, DFASHRM, MHSA, director of compliance, clinical operations at St. Joseph Medical Center in Towson, MD, "The most important consideration should start with how often a particular complex procedure is being performed within the facility." While physician skill is critical, "equally critical are the skills and resources of all the others caring for the patient," McCaffrey says.
Staff must have the skill and ability to address any complications, because "even in the most experienced hands complications can and do occur," she says. McCaffrey points to the Whipple procedure discussed above and asks three questions: Was the surgical team skilled and prepared to deal with the complication? Was the complication more appropriate for a vascular surgeon than a general surgeon? Did the facility have the diagnostic equipment and other support services?
"The 'driver' for whether a procedure is to be done at a facility is not just the credentials/training and skill of the physician; it is also the capabilities and resources of the facility," she says. Particularly in rural areas, resources include referral agreements with regional facilities, McCaffrey advises
The surgeon should disclose if there is a nearby center of excellence performing the same procedure.
Some surgeons might be performing procedures for which there is a center of excellence in the same city. In that case, after discussing the procedure, risks, and complications, Satava suggests they acknowledge the following: "If you want to have this procedure, knowing the risks and complications, I'm happy to perform the surgery. There is a specialty center available whose outcomes are as good or perhaps a little better. If you decide to do your procedure there, I understand."
However, 60-75% of procedures are relatively simple and straightforward, and for those procedures, there is no reason to refer patients to a major tertiary center, he says. For example, with a laparoscopic procedure, there is an initial learning curve, but once surgeons reach a certain level of cases, there are no differences in the outcomes between local community hospitals and tertiary teaching facilities.
Another factor to consider is the added cost to the patient and his or her family to travel to a tertiary facility, Satava says. "Those are hidden costs, when patients have to go somewhere else: the hotels and transportation," he says. "Those are a huge economic burden not accounted for in the cost of medical care."
All procedures and outcomes should be on periodic review.
Physicians have ongoing periodical performance evaluation (OPPE), McCaffrey points out. "Facilities need to evaluate the information so they can determine if they are able to perform the procedure as expected," she says.
Administrators can use resources for determining expectations such as specialty societies, measure reports from the Centers for Medicare and Medicaid Services (CMS), and registries, McCaffrey says.
There is a trend toward regionalization in surgery, McCaffrey says. "There are many locales throughout the country that are creating regional centers where lower volume/higher technical procedures are consolidated," she says. This trend allows facilities to have all the appropriate resources on a continuing basis, McCaffrey maintains.
"Smaller facilities are beginning to limit the scope and services to more basic aspects that they can better control," she says.