Prostate biopsy mix-up shows need to meet liability problems head-on

Hospital admits false-negative reports, faces bad publicity

Administrators at a hospital in the Boston area recently faced a devastating discovery: Several years ago, 19 men had been told their prostate biopsies were negative when they had cancer. The hospital and the individual pathologists faced massive liability, and the hospital risked losing its good reputation in the community.

The hospital took an active approach in its response, providing the community with information soon after the false test results became public knowledge. That is the perfect response to such a tragic mistake, says Michael Zuckerman, JD, assistant professor of risk insurance and health care management at Temple University’s Fox School of Business and Management in Philadelphia. "The public can be very forgiving, " he says. "If the hospital knows what happened, it has an obligation to tell the public and explain what you’re doing to mitigate the situation. Then your customer base is going to say, Fine, they had a problem and they corrected it.’"

While a hospital can’t release information freely when there may be a lawsuit, Zuckerman says there’s nothing wrong with telling the truth. If you know mistakes were made at your facility and you will not argue that in a malpractice suit, he advises giving the information to the public.

"I compare it to the situation that the manufacturer faced when there was tampering with Tylenol," he says. "They moved quickly to pull the product from shelves and calm the public. They showed that they were willing to lose money initially to protect the public, and it paid off for them handsomely in retaining their critical customer base."

Admit errors, assure public of improvements

That was the hope of administrators at Sturdy Memorial Hospital in Attleboro, MA. Adminis trators immediately decided to be forthright with the media, says Sharon Simoneau, ASHRM, CHRM, director of risk management, quality assessment, and medical staff services at the 138-bed hospital. After contacting the patients who were involved, hospital officials decided to be as honest as possible in response to media inquiries, and that meant admitting the hospital’s pathologists had made errors.

"Early and honest reporting was definitely the best thing we could have done," Simoneau says. "We also made sure the patients had been contacted before the media reported anything, so that we could say, If you haven’t received a phone call, your biopsy was not involved in this.’ That was very reassuring for our patients to know that."

She says the hospital leadership wanted to release as much information as possible without breaching confidentiality of patients. The hospital involved legal counsel right away, partly to make sure the information being provided to the many regulatory agencies was not privileged.

President and CEO Linda Shyavitz announced soon after the discovery that the 19 prostate biopsies were indeed misread between 1995 and 1997. She said the hospital had reviewed 279 tests, finding that two pathologists had misread 20 biopsies on 19 patients. The hospital is continuing to review 15,000 additional biopsies, she said in a statement released to the media.

Hospital officials were alerted to the misread biopsies recently when a patient tested positive for prostate cancer, and the doctor checked the earlier test result to see why the cancer had not been caught sooner. Early detection of prostate cancer greatly improves the survival rate. Two of the 19 patients since have died of unrelated causes.

"We want all patients to understand we don’t hide our errors," Shyavitz says. "Our concern is the patients we take care of."

In speaking with the media, Simoneau says hospital officials were careful not to say anything that sounded like an excuse. Although prostate biopsies are known to be difficult to read, hospital officials did not say that because it might have sounded defensive. But Simoneau says they were pleased to hear objective pathology experts point out that fact in national news stories.

The Massachusetts State Board of Registration announced that the two pathologists accused of making the errors recently volunteered to give up their medical licenses while the charges are under investigation. They agreed not to practice medicine for 60 days and resigned their positions at the hospital. Shyavitz says no disciplinary action was taken against them.

Simoneau says there has been no indication so far that any patients intend to sue the hospital, but Zuckerman says failure-to-diagnose malpractice lawsuits are inevitable in this situation. He notes that the hospital would not have been any better off if the pathologists were not employed by the hospital. The courts have made it clear that you’re responsible for anything that happens within the walls of your hospital, he says.

"Whether that’s justified or not is hard to say until we see all the facts about the hospital’s involvement, but I don’t see how they’re going to get out of it," he says. "I would urge them to settle the cases as quickly and as early as possible. If they stonewall, they’re just looking at very large damage assessments down the road."

A risk manager on the insurance side agrees that lawsuits are inevitable. R. Stephen Trosty, JD, MHA, director of risk management at Mutual Insurance Corporation of America in East Lansing, MI, says the plaintiffs are likely to argue that they missed the opportunity to take advantage of therapies proven useful in treating prostate cancer when caught early. If they can prove the prostate cancer has spread significantly since the time of the biopsy, they will have a good case for a large damage award, he says.

"One thing that may be to the hospital’s advantage is that prostate cancer is one of the slowest spreading forms of cancer," Trosty says. "But there really is not any hope of evading the damages here. The question is not are they going to pay, but how much."

(See box at right for advice on notifying your insurance carrier. See p. 80 for more on how the mix-up occurred and what the hospital has done to prevent recurrences.)

JCAHO not yet involved in investigation

Trosty notes that the hospital may have mitigated some of the damage by notifying patients promptly when the errors were discovered and going beyond any requirements to look for more misread biopsies. Those steps may explain why the hospital has not been served papers from any of the patients, but he says the good will probably won’t last. Lawyers very likely are working with the patients already, and he says it is just a matter of time before the hospital is involved in a number of devastating lawsuits.

Early prostate cancer treatment can preserve sexual function, unlike some treatments used later in the course of the disease, Trosty notes. That raises the possibility of patients suing for loss of consortium, he says.

The Joint Commission on the Accreditation of Health Care Organizations (JCAHO) in Oak -brook Terrace, IL, has not yet approached Sturdy Memorial Hospital about treating the biopsy mix-up as a sentinel event, and Simoneau says she is not considering self-reporting. The incident has received widespread media attention, so it is likely JCAHO knows about it already, and Simoneau says she is content for now to wait and see if the incident must be treated as a sentinel event. She is busy responding to a host of state and local regulatory agencies, and she says the hospital already is gathering the information that would be necessary for the root-cause analysis required after a sentinel event.

Simoneau says handling the crisis is "probably the most stressful thing I’ve ever done. I don’t think we’ve seen the worst of it. We don’t know exactly what the repercussions will be."

One of the primary goals when responding to a crisis should be maintaining your reputation in the community, Zuckerman says. You will find your organization’s public relations department to be a major ally in that effort, he says. To make the most use of their skills, you should include them in the crisis planning. "I’m amazed at how many organizations still do not involve public relations in the crisis planning efforts," he says. "Don’t just throw it in their laps when a crisis happens. Get them in on the planning so that they know their roles when something happens, just like everyone else knows how to respond without asking. They will have a major impact on how your institution weathers the storm."

Many risk managers have authority over the organization’s public relations department, especially in a crisis, and will determine what sort of information is released. Be careful not to take too much responsibility in that role, he cautions. For instance, he says it is not a good idea for the risk manager to act as spokesperson for the hospital.

"You shouldn’t be the one in front of the cameras. You’re too close to the fire," he says. "In a crisis, there will be adrenaline flowing through [you] and [you’re] going to be excited. It’s like a weatherman during a big storm. You could say the wrong thing, maybe get defensive. If you’re under fire from the media and you let it slip out that you don’t think this case is worth much of a payout, you’re in big trouble."

Zuckerman also suggests that the risk manager should not take complete responsibility for deciding what information is released to the media. You may be heading the crisis management effort, but he suggests that a group of senior executives should decide what information is released.

"Cool heads prevail when several people get together on important decisions," he says.