Disclosure requires some hard choices

Disclosing unanticipated outcomes can be a dicey operation, much more difficult than you might at first imagine; and in some cases, failure to disclose can lead to charges of fraudulent concealment.

That’s the cautionary advice from speakers at the recent VHA Clinical Advantage seminar on patient safety in Atlanta, sponsored by the Berwyn, PA-based VHA East. Health care providers should have a formal policy on the release of information about "unanticipated outcomes" — which includes medical errors, but also a range of other occurrences, both good and bad — but writing that policy can be a challenge, says Grena Porto, RN, ARM, DFASHRM, senior director of clinical operations at VHA Inc. in Berwyn, PA, and past president of the American Society for Healthcare Risk Management (ASHRM).

"What at first doesn’t seem so complicated changes when you try to put it on paper," she says. "You suddenly realize you have a lot of questions."

The key to devising a policy on unanticipated outcomes is to focus on the patient’s perspective, Porto says. It won’t do to focus more on your needs as a health care provider than on the patient’s need for information.

"Patients have really been following this patient safety debate and they’re more aware than ever before that they might encounter problems with their care and that they should know about it," she says. "Unfortunately, they can have a negative impression because all they know is what’s in the paper, and because we have not done a good job informing them. Remember that patients say their No. 1 problem with health care is that they can’t get their providers to talk to them."

Unanticipated outcomes

New patient safety standards that went into effect on July 1 require hospitals to initiate specific efforts to prevent medical errors and to tell patients when they have been harmed during their treatment. The new standards are based both on the Joint Commission on Accreditation of Healthcare Organizations’ own six-year experience in overseeing the management of sentinel events in accredited organizations, and on the opinions of a special panel that included patient safety experts as well as leaders from government, hospitals, insurance companies, universities, and consumer advocacy groups.

A new document from ASHRM can help risk managers developing a policy on unanticipated outcomes. "Perspective on Disclosure of Unanticipated Outcome Information" examines the ethical and legal context for withholding information from a patient, liability issues, and some practical concerns about how to disclose information. (The full document is available for free to ASHRM members on the group’s web site at www.ashrm.org.)

The ASHRM paper does not spell out exactly how providers should address unanticipated outcomes, but it explores some of the issues and provides a framework that risk managers can use to write their own policy. Each health care organization will have to write its own policy, but Porto cautions against letting it become a bureaucratic boondoggle.

"Avoid the pitfall of trying to define all the terms. Just don’t!" she says. "I once saw a disclosure policy that was pages long because they define unanticipated,’ outcome,’ sentinel event,’ disclose’ — everything. They spent a lot of time and ended up with a policy I could not understand. I told them that if I can’t understand it, there’s no hope for that tired nurse reading it at 3 a.m."

Porto encourages risk managers to focus on how patients would most like to receive information about unanticipated outcomes. The health care community is still figuring out what that means, but Porto says one thing is clear: Patients don’t think of the issue in the same way as health care professionals.

"This is not about just writing a policy. It’s a long journey, and I think that five years from now, we will have much more literature about what patients want and how to give it to them," she says. "Far fewer physicians than patients think that they should disclose adverse events and possible complications. You’re going to encounter that resistance from providers, and you should be prepared to overcome it."

One problem with devising a policy is deciding what should be disclosed. If the attendees at the VHA seminar are any indication, everyone has an opinion and no two are alike. Only the extreme ends of the spectrum led to consensus. Nearly everyone agreed that a serious medical error causing serious harm to the patient should be disclosed, especially since the patient or family is likely to find out, anyway. And a great many agreed that disclosure was not unnecessary when these conditions were met:

  1. The error itself was so small as to be inconsequential.
  2. There was no immediate harm to the patient and no possibility of future complications.
  3. The patient or family doesn’t know and isn’t likely to find out.

Lots of gray areas to debate

Nearly everything in between those ends of the spectrum was worthy of heated debate. What if the patient or family doesn’t know and isn’t likely to find out? What if there was no immediate injury but complications could occur later? What if a doctor finds evidence that the referring physician committed an error but the patient doesn’t seem to know?

John Banja, PhD, director of the Center for Ethics in Public Policy and the Professions at Emory University in Atlanta, says there can be some circumstances in which you are not obligated to disclose an unanticipated outcome.

"If the patient is not physically harmed or psychologically harmed, and the patient has no idea something is not right, and the patient requires no further care in response, there is no ethical obligation to disclose," he says. "But that’s rare because you can’t be sure the patient doesn’t know and won’t find out later. Remember that the person encouraging the patient to sue is often just someone who saw the error in the patient’s chart later on, not an attorney."

Porto agrees that a totally inconsequential incident does not have to be disclosed, but she says those are quite rare. The slightest variation in those three factors for nondisclosure will tip the scales. She offers an example that occurred in her facility years ago. A patient was about to undergo surgery and already had been anesthetized when the OR table collapsed. Luckily, the patient was not injured in any way and was completely unaware. The surgery was rescheduled and performed later without incident.

"There was no injury, and we really thought the patient was not likely to find out," she says. "So did we disclose it? Yes we did, because it was a serious incident."

Think in terms of the patient’s best interest

Porto urged the attendees to think in terms of the patient’s best interest and not just instinctively seek to protect information that might harm the hospital or physician. That’s simply the moral, ethical thing to do, she says, but in most cases it also is the most pragmatic solution for the health care organization.

"Disclosure does not lead to increased claims. The fear of litigation after disclosure is greatly exaggerated," she says. "But it doesn’t prevent litigation, either. It’s a wash in that respect."

Porto says disclosure does drive down costs by dissipating anger and encouraging a faster resolution of the case. If the circumstances are such that you will eventually have to pay the claim no matter what, denial does nothing but drive up your costs, Porto says.

There also can be a legal duty to disclose, she says. Courts have ruled that the provider/patient relationship is a fiduciary one, and failure to disclose important information could lead to charges of fraud or fraudulent concealment. Porto says she once had a physician sued for malpractice and charged with concealment because he did not disclose a medical error to the patient’s family. The surgeon accidentally severed the man’s pulmonary artery during a procedure for tuberculosis and the man bled out. He told the family that the patient died from "complications during surgery" but never said he had injured the man.

Eventually, a nurse decided to notify the family and the medical examiner through anonymous letters. The physician settled out of pocket because his malpractice insurance did not cover fraudulent concealment. Porto says the case illustrates two important points: First, the patient or family will almost always find out, and more elapsed time will only make them angrier and more likely to sue. And second, fraudulent concealment will leave you standing alone at the settlement meeting. Your insurance will not cover it.

What is fraudulent concealment?

"Mere silence can be fraud. There is no need to actually speak a lie," she says. "Are you going to give them the whole truth or are you going to dance around the edges without getting your feet wet? If you ignore or deflect a patient’s questions regarding possible errors, that can be fraudulent concealment. Or if you say something true like, He died of complications in surgery,’ but don’t say you caused the complications — that can be fraud."

Porto says many insurers are supportive of disclosure. COPIC, Medical Defense Associates, MMI, and Norcal all support disclosure, she says.

"Carriers are really coming around on this," Porto says. "They’ll stand behind you if you do the right thing and do it the right way." (See article, at right, for tips on how to disclose.)

Don’t focus too much on being defensive

When making a disclosure, Banja says health care providers must be careful not to choose their words so carefully that they defeat the purpose of disclosure. When in doubt, ask yourself why the disclosure is stated the way it is.

"Ethics is, by its nature, other-oriented,’" he says. "The ethical action is the one that does not primarily seek to protect the intents of the actor. So if you have a statement whose real function is protecting you, that’s probably not the right one if you’re truly interested in disclosing to the patient."

Banja also notes that harm from negligence is not covered in the informed consent process, so you still have to disclose errors even if the consent process included a warning that there could be unanticipated developments or outcomes. And if more treatment is necessary to correct the damage done by the error, you probably will need a new informed consent form unless the situation is an emergency.

"That second informed consent can be difficult to obtain," he says. "If you tell them you need it because of an error, they might hesitate to give you permission again. And if you don’t disclose, it’s hard to get consent again without them asking why."