Salesman in OR leads to state fine, lawsuits after patient death

Investigators claim salesman actually performed part of procedure

A New York hospital is facing major malpractice lawsuits, a state-imposed fine, and a public relations disaster after an incident in which a woman died during what should have been a routine procedure. Investigators claim the woman died because two surgeons made gross medical errors. They also claim that an equipment salesman actually performed part of the procedure.

The incident should be a warning about the risks of allowing salespeople in the operating room without adequate constraints, some observers say. Even though the salesman’s alleged participation in the procedure apparently was not the cause of the woman’s death, it greatly complicates the defense of the malpractice cases and creates extremely bad publicity for the facility, Beth Israel Medical Center in New York City.

The immediate fallout from the incident was a $30,000 fine imposed on Beth Israel by New York state health officials. The officials concluded that a salesman of hysteroscopy equipment participated in the procedure, actually manipulating the new electrosurgery system because the doctors and nurses did not know how to operate it.

But that is only the beginning of the hospital’s troubles. The woman’s husband has filed suit against the hospital, both surgeons, the anesthesiologist, and Ethicon, the company whose salesman allegedly participated in the procedure. Ethicon is a division of Johnson & Johnson.

Observers also expect the incident will be considered a sentinel event by the Joint Commission on Accreditation of Healthcare Organizations, obligating the hospital to conduct a thorough analysis of how it happened and how it can be prevented in the future. Sentinel event status is likely because the incident was widely reported in the general media, one of the Joint Commission’s main sources for identifying sentinel events, and because it so obviously signals a major problem at the hospital.

The extreme nature of the problem is mind-boggling, says Sam Bishop, ARM, vice president of compliance and insurance services for Wellstar Health System in Marietta, GA. Though it is not the first time he has heard of such an incident, Bishop says hands-on participation by salespeople is obviously wrong.

"This is just a nightmare, a failure of the system that is supposed to protect the patient," he says. "There’s no way to make an excuse for this, to make this sound like anything better than what it is. You’d think these things just couldn’t happen, but then they seem to pop up every once in a while."

The incident shows that staff may need to be educated and reminded about issues that seem obvious to risk managers and other managers, Bishop says. It may be time to remind surgical staff about proper conduct of visitors in the operating room. (See p. 5 for more on how such incidents can be avoided.)

Procedure should have been routine

The incident began in October 1997, according to a report from the New York state health department. Ethicon salesman David Myers reportedly met with Allan Jacobs, MD, chairman of the hospital’s OB-GYN department, to introduce an Ethicon product used for hysteroscopies, a minimally invasive procedure. The product, the Versapoint Bipolar Hysteroscopy Electrosurgery System, allows the surgeon to cut and ablate with electrosurgery probes.

Jacobs made no commitment to purchase the product but did not dissuade Myers from seeking the support of surgeons and other administrators, according to the report. Myers arranged to have the product used in surgery about a month later with OB-GYN partners Marc Sklar, MD, and Robert Klinger, MD. The patient, Lisa Smart, 30, was a healthy accountant and financial analyst undergoing hysteroscopy for the removal of a benign fibroid tumor — a routine procedure with relatively little risk.

State health investigators say the OR nurses told the surgeons they were not familiar with the new electrosurgery system, but that the surgeons dismissed the nurses’ concerns and said Myers would operate it. The salesman was scrubbed and did operate the electrosurgery system during the procedure, according to the health department report.

However, the report does not claim the salesman’s actions led to the woman’s death. As a normal part of the procedure, the patient’s uterus was filled with saline, and nurses monitored the fluid output closely to make sure the patient was not overloaded with fluids. The salesman reportedly was operating the electrosurgery equipment and had no involvement in the fluid administration. The state report says that a nurse told the doctors several times during the surgery that the fluid output was too low, but her concerns were dismissed.

But immediately after the surgery, the patient appeared bloated from excess fluid. According to the state report, one of the OR nurses claims Klinger admitted to shutting off the fluid outflow so he could get a better view of the uterus, an action that could lead to fluid overload if not corrected quickly. Klinger denied shutting off the flow or making the statement afterward, according to the report.

As a result of the fluid overload, the woman went into cardiac arrest soon after surgery and died in the emergency department. The autopsy determined she had died of "excessive infusion and absorption of normal saline."

Healthcare Risk Management contacted Sklar’s and Klinger’s offices to request comments, as well as the attorneys representing both doctors, but the calls were not returned. Beth Israel released a statement saying, "those who acted inappropriately violated Medical Center rules and procedures and have been severely disciplined."

Salespeople in the OR are nothing new, and risk managers have expressed concern about them in the past. (For details, see HRM, "Who is that performing surgery in the OR? A doctor or a sales rep?" February 1997, pp. 13-15.) The Beth Israel incident raises troubling questions nonetheless. If the state health report is accurate, the nurses knew before the procedure was under way that the salesman would be operating the electrosurgery system, which means there was, presumably, time to try to stop the procedure. The implications of that scenario would differ significantly from those resulting from an infraction occurring after a procedure begins; in that case, the damage may be done before the staff can protest.

A failure to refuse improper orders?

If the incident happened as state health officials say, the nurses should have reported the surgeons’ intent to their supervisors and not proceeded with the surgery, says Margaret Douglass, MPH, RN, director of risk management at FPIC, a physicians’ insurance company based in Jacksonville, FL. Such an incident would serve as a clear example of a situation in which nurses must refuse improper orders and report the problem through the chain of command, she says.

"Absolutely, the nurses should know just from being a nurse that it’s not right for a salesperson to perform patient care," she says. "They should have questioned the doctor’s orders on the spot and then should have run right out and grabbed their OR supervisor. This certainly was out of the ordinary, and they should have acted to protect the patient."

If the nurses did not refuse unusual instructions, it would raise questions about their nursing education and Beth Israel’s risk management program, according to both Douglass and Bishop. If they were risk managers at a hospital where such an incident happened, both say they would question their risk management efforts and wonder how nurses and physicians could feel comfortable with allowing it to happen.

"It would signal some major problems within the facility that I, as a risk manager, would feel somewhat responsible for," Douglass says. "I would want to see the policies in place at the time, the chain of command policies, and shoot the charts through peer review to see if any education is needed for the physicians involved. In addition to the chain of command questions, I’d want to know whether there had been any education on fluid overload."

Bishop and Douglass question why the nurses might not have followed the chain of command, both surmising that nurses must realize a salesperson’s participation in a procedure is wrong. That question remains unanswered, but Bishop and Douglass speculate that young nurses might be intimidated, or, conversely, more experienced nurses might be so comfortable with the doctors that they trust them even after such unusual instructions.

Who was protecting the patient?

Bishop acknowledges it might be very stressful for a nurse to challenge a surgeon’s instructions, and if the surgeon persisted with the plan, to invoke the chain of command. Nevertheless, he says this action must be expected of nurses and any other staff who have knowledge of improper care. He suggests the circulating nurse may have to take the initiative if the surgery is under way.

"The circulating nurse should have slipped out of that room and invoked the chain of command," he says. "Nobody wants to encourage staff to ignore physicians’ orders when they’re legitimate, but the nurse has to do what is necessary to protect the patient."

Bishop tells HRM it is rare for nurses to have to go that far to protect the patient, but he has seen it happen. He once had a nurse invoke the chain of command during a surgical procedure because she felt the doctor was exhibiting psychotic behavior and was not capable of operating.

"She called it to his attention, but he continued with the procedure," he says. "She was very concerned, so she slipped out and called the chief of service, who removed the doctor during the procedure. That’s the way it’s supposed to work."